Flaherty v. Mentor Worldwide Llc et al

MOTION for Partial Summary Judgment

M.D. Ga.October 24, 2016

IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:14-cv-00098 (Flaherty) DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR PARTIAL SUMMARY JUDGMENT AGAINST PLAINTIFF MARY FLAHERTY Pursuant to Rule 56 of the Federal Rules of Civil Procedure and Local Rule 56, Defendant Mentor Worldwide LLC (“Mentor”) respectfully moves the Court for summary judgment on Counts II–IX, XI, XIII–XV and XVII of Plaintiff’s Complaint. Specifically, these claims fail as a matter of law because:  The strict liability claims—design defect (Count II), manufacturing defect (Count III), failure to warn (Count IV), and defective product (Count V)— and breach of implied warranty claim (Count VII) fail because such claims are barred under Pennsylvania law.  The breach of express warranty claim (Count VI) is time-barred because Plaintiff filed suit more than four years after the claim accrued.  The fraud-based claims—fraudulent concealment (Count VIII), constructive fraud (Count IX), negligent misrepresentation (Count XI), and violation of consumer protection laws (Count XIII)—fail because Pennsylvania applies the learned intermediary doctrine to bar such claims under the facts of this case.  The unjust enrichment claim (Count XV) fails because Pennsylvania does not recognize such a claim under the facts of this case.  The gross negligence (Count XIV) and punitive damages claims (Count XVII) fail because Pennsylvania does not recognize either of these claims as independent causes of action. Case 4:14-cv-00098-CDL Document 36 Filed 10/24/16 Page 1 of 3 - 2 - The grounds for this Motion are set forth in more detail in the accompanying Memorandum in Support. Dated: October 24, 2016 Respectfully submitted, s/ John Q. Lewis John Q. Lewis TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, OH 44113-7213 Telephone: 216.592.5000 Facsimile: 216.592.5009 john.lewis@tuckerellis.com Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:14-cv-00098-CDL Document 36 Filed 10/24/16 Page 2 of 3 - 3 - 012813\002759\2882609.1 IN RE: MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL NO. 2004 CERTIFICATE OF SERVICE A copy of the foregoing was served via ECF on the following counsel this 24th day of October 2016: Ryan S. MacLeod rmacleod@arnolditkin.com Counsel for Plaintiff Mary Flaherty s/ John Q. Lewis John Q. Lewis Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:14-cv-00098-CDL Document 36 Filed 10/24/16 Page 3 of 3 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:14-cv-00098 (Flaherty) DEFENDANT MENTOR WORLDWIDE LLC’S MEMORANDUM IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT AGAINST PLAINTIFF MARY FLAHERTY Thirteen of Plaintiff’s claims fail for the following reasons:  The strict liability claims—design defect (Count II), manufacturing defect (Count III), failure to warn (Count IV), and defective product (Count V)— and breach of implied warranty claim (Count VII) fail because such claims are barred under Pennsylvania law.  The breach of express warranty claim (Count VI) is time-barred because Plaintiff filed suit more than four years after the claim accrued.  The fraud-based claims—fraudulent concealment (Count VIII), constructive fraud (Count IX), negligent misrepresentation (Count XI), and violation of consumer protection laws (Count XIII)—fail because Pennsylvania applies the learned intermediary doctrine to bar such claims under the facts of this case.  The unjust enrichment claim (Count XV) fails because Pennsylvania does not recognize such a claim under the facts of this case.  The gross negligence (Count XIV) and punitive damages claims (Count XVII) fail because Pennsylvania does not recognize either of these claims as independent causes of action. For these reasons, Mentor respectfully requests that this Court enter summary judgment in its favor on these claims. Case 4:14-cv-00098-CDL Document 36-1 Filed 10/24/16 Page 1 of 9 2 UNDISPUTED FACTS RELEVANT TO THIS MOTION This Court previously described general facts related to ObTape (e.g., Apr. 22, 2010 Order, Doc. 241 at 4-5); Mentor will not restate them here because this motion is premised on undisputed facts unique to Plaintiff Mary Flaherty. Plaintiff first developed symptoms of stress urinary incontinence (“SUI”) in 2000. (Separate Statement of Material Facts (“SSMF”) ¶ 1.) In 2004 Plaintiff saw her urologist, Dr. Frank Costa, for treatment of her SUI symptoms. (Id. ¶ 2.) On April 21, 2004, Dr. Costa implanted Plaintiff with an ObTape transobturator sling (“ObTape”) at UPMC St. Margaret’s Medical Center in Pittsburgh, Pennsylvania. (Id. ¶ 3.) Plaintiff testified that before her ObTape implant, she obtained a pamphlet created by Mentor regarding ObTape upon which she relied in making her decision to have her ObTape implanted. (Id. ¶ 4.) Plaintiff’s incontinence improved for five years following her ObTape implant, but in 2009 she presented to Dr. Costa with complaints of recurrence of her SUI symptoms. (Id. ¶ 5.) Dr. Costa ordered clinical testing to determine the nature of Plaintiff’s symptoms at that time and the test results were normal. (Id. ¶ 6.) Plaintiff continued to experience SUI symptoms and UTIs; in March 2010, Dr. Costa performed a cystoscopy, a bladder biopsy, and a holmium laser ablation of Plaintiff’s bladder. (Id. ¶ 7.) Dr. Costa determined that Plaintiff’s symptoms were unrelated to her ObTape and diagnosed her with inflammation of the bladder. (Id. ¶ 8.) Since the procedure performed by Dr. Costa in March 2010, Plaintiff has seen her primary care physician, a urogynecologist, and a gynecologist for recurrence of her SUI symptoms. (Id. ¶ 9.) None of Plaintiff’s healthcare providers have ever suggested that there was an issue with her ObTape. (Id. ¶ 10.) Plaintiff’s ObTape has never been Case 4:14-cv-00098-CDL Document 36-1 Filed 10/24/16 Page 2 of 9 3 removed and none of her healthcare providers have ever told her that any portion of her ObTape should be removed. (Id. ¶ 11.) Plaintiff is a Pennsylvania resident and all of her ObTape-related medical treatment occurred in Pennsylvania. (Id. ¶ 12.) She initially filed her Complaint in the United States District Court for the Southern District of West Virginia in In re: Coloplast Corp., Pelvic Support System Products Liability Litigation, MDL No. 2387, as Case No. 2:14-cv-13936, on April 3, 2014. (Id. ¶ 13.) On April 23, 2014, Plaintiff’s case was transferred from the Southern District of West Virginia to this Court. (Id. ¶ 14.) LAW AND ARGUMENT “The court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). Summary judgment is required “after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial.” Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). On a motion for summary judgment, “facts must be viewed in the light most favorable to the nonmoving party only if there is a ‘genuine’ dispute as to those facts.” Scott v. Harris, 550 U.S. 372, 380 (2007). A. Pennsylvania Law Applies To Plaintiff’s Claims. This case was originally filed in the United States District Court for the Southern District of West Virginia in the Coloplast MDL and subsequently transferred to this Court. (SSMF ¶¶ 13-14.) Plaintiff’s Short-Form Complaint listed 16 causes of action, including:  Negligence (Count I)  Strict Liability – Design Defect (Count II) Case 4:14-cv-00098-CDL Document 36-1 Filed 10/24/16 Page 3 of 9 4  Strict Liability – Manufacturing Defect (Count III)  Strict Liability – Failure to Warn (Count IV)  Strict Liability – Defective Product (Count V)  Breach of Express Warranty (Count VI)  Breach of Implied Warranty (Count VII)  Fraudulent Concealment (Count VIII)  Constructive Fraud (Count IX)  Discovery Rule – Tolling and Fraudulent Concealment (Count X)  Negligent Misrepresentation (Count XI)  Negligent Infliction of Emotional Distress (Count XII)  Violation of Consumer Protection Laws (Count XIII)  Gross Negligence (Count XIV)  Unjust Enrichment (Count XV)  Punitive Damages (Count XVII)1 (Compl. 4-5.) Because Plaintiff is a Pennsylvania resident and Pennsylvania is the proper venue for this action, Pennsylvania choice-of-law rules apply. (SSMF ¶ 13); see Wahl v. Gen. Elec. Co., 786 F.3d 491, 494-99 (6th Cir. 2015) (applying choice-of-law rules of state of proper venue, not where the matter had been direct-filed). There is, however, no choice-of-law issue in this case because Plaintiff lives in Pennsylvania and all of her ObTape-related medical care and claimed injuries occurred in Pennsylvania. (SSMF ¶ 12.) Pennsylvania substantive law therefore applies to her claims. B. Plaintiff’s Strict Liability-Based Claims (Counts II-V) And Breach Of Implied Warranty Claim (Count VII) Fail Because Such Claims Are Barred Under Pennsylvania Law. Counts II through V of Plaintiff’s Complaint sound in strict liability.2 Pennsylvania has adopted comment k of Section 402A of the Restatement (Second) of Torts, making manufacturers of prescription drugs “effectively immune from strict 1 Plaintiff did not allege a loss of consortium claim, which is identified as Count XVI in the Short-Form Complaint. 2 Plaintiff specifically asserts claims for strict liability design defect (Count II), strict liability manufacturing defect (Count III), strict liability failure to warn (Count IV), and strict liability defective product (Count V). Case 4:14-cv-00098-CDL Document 36-1 Filed 10/24/16 Page 4 of 9 5 liability suit in Pennsylvania.” Soufflas v. Zimmer, Inc., 474 F. Supp. 2d 737, 749 (E.D. Pa. 2007); see also Taylor v. Danek Medical, Inc., No. Civ.A. 95-7232, 1998 WL 962062, at *7 (E.D. Pa. Dec. 29, 1998) (attached as Ex. D to the Lewis Decl.); Hahn v. Richter, 673 A.2d 888, 889-91 (Pa. 1996). Although the Pennsylvania Supreme Court has not ruled on comment k’s application to prescription medical devices, the Pennsylvania Superior Court has held that there is “no reason why the same rational[e] applicable to prescription drugs may not be applied to medical devices.” Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006). And federal district courts in Pennsylvania routinely apply comment k to bar strict liability claims in medical device cases. See Runner v. C.R. Bard, 108 F. Supp. 3d 261, 265-66 (E.D. Pa. 2015) (dismissing strict liability design defect, manufacturing defect, and failure to warn claims); Krammes v. Zimmer, Inc., No. 3:11-CV-00916, 2015 WL 4509021, at *3-*5 (M.D. Pa. July 24, 2015) (attached as Ex. E to the Lewis Decl.); Soufflas, 474 F. Supp. 2d at 749-51 (citing cases).3 Accordingly, Counts II-V of Plaintiff’s Complaint should be dismissed. For the same reasons, Pennsylvania courts have also excluded claims for breach of implied warranty in cases involving prescription medical devices. See Taylor, 1998 WL 962062 at *13-*14 (granting summary judgment in favor of medical device manufacturer on breach of implied warranty claim based on comment k and Pennsylvania’s application of learned intermediary doctrine) (citing Hahn , 673 A.2d at 890). Count VII should thus also be dismissed. 3 Plaintiff’s strict liability claim for “defective product” (Count V) fails for the additional reason that such a claim is not recognized under Pennsylvania law. See Krammes, 2015 WL 4509021 at *3 (“Pennsylvania recognizes three types of defects that can give rise to a strict liability claim: design defect, manufacturing defect, and warning defect.”) (citations omitted). Case 4:14-cv-00098-CDL Document 36-1 Filed 10/24/16 Page 5 of 9 6 C. Plaintiff’s Breach of Express Warranty Claim (Count VI) Is Time-Barred. Under Pennsylvania law, the statute of limitations for breach of warranty claims is four years. 13 Pa. C.S.A. § 2725(a); 42 Pa. C.S.A. § 5525(2); see also Floyd v. Brown & Williamson Tobacco Corp., 159 F. Supp. 2d 823, 831 (E.D. Pa. 2001). Section 2725(b) provides: “A cause of action accrues when the breach occurs, regardless of the aggrieved party’s lack of knowledge of the breach.” Moreover, “[a] breach of warranty occurs when tender of delivery is made.”4 13 Pa. C.S.A. § 2725(b). That is, “the statute of limitations will begin to run on the date of sale of the product.” Floyd, 159 F. Supp. 2d at 831. Here, Plaintiff’s ObTape was “delivered,” and the express warranty claim accrued, no later than the date it was implanted—April 21, 2004. As such, any breach of express warranty claim had to be filed by April 21, 2008. Because it was not, Count VI is time-barred. D. Plaintiff’s Fraud-Based Claims (Counts VIII, IX, XI, and XIII) Fail Under Pennsylvania Law. Plaintiff asserts claims for fraudulent concealment (Count VIII), constructive fraud (Count IX), negligent misrepresentation (Count XI), and violation of consumer protection laws (Count XIII). Each of these fraud-based claims is based on an affirmative representation or omission directed at the claimant. See Kingston Coal Co. v. Felton Mining Co. Inc., 690 A.2d 284, 291 (Pa. Super. 1997) (fraudulent concealment); Acchione & Caruso, Inc., v. Commw. Dept. of Transp., 461 A.2d 765, 768 4 The only exception to the accrual-on-tender rule is where a warranty explicitly extends to future performance, in which case “the cause of action accrues when the breach is or should have been discovered.” But for the extension to apply, Pennsylvania courts are clear that the warranty must “explicitly extend[]” to a future performance because “[o]therwise, the aggrieved party’s knowledge or ability to know is irrelevant.” See, e.g., Cucchi v. Rollins Protective Servs. Co., 546 A.2d 1131, 1144-45 (Pa. Super. 1988) (citations omitted). Here, Plaintiff has never even alleged—much less presented evidence of—any specific reference to future performance. Case 4:14-cv-00098-CDL Document 36-1 Filed 10/24/16 Page 6 of 9 7 (Pa. 1983) (constructive fraud); Heritage Surveyors & Eng’r, Inc., v. Nat’l Penn Bank, 801 A.2d 1248, 1252 (Pa. Super. 2002) (negligent misrepresentation); Weinberg v. Sun Co., Inc., 777 A.2d 442, 444-45 (Pa. 2001) (consumer protection). Such claims are not permitted under Pennsylvania law. Pennsylvania applies the learned intermediary doctrine in cases involving prescription medical devices such that the manufacturer’s duty to provide information runs to the prescribing physician, not the patient. See Lawrence v. Synthes Inc., No. 94-07627, 2002 WL 32747667, at *25 (Pa. Ct. Com. Pl. July 25, 2002) (attached as Ex. F to the Lewis Decl.). Accordingly, Pennsylvania courts apply the learned intermediary doctrine to bar fraud-based claims in prescription medical device product liability cases. See id. (barring fraud and negligent misrepresentation claims against manufacturer of pedicle screw fixation device under learned intermediary doctrine); Kee v. Zimmer, Inc., 871 F. Supp. 2d 405, 411-12 (E.D. Pa. 2012) (applying Pennsylvania law) (same as to claims brought under Pennsylvania consumer protection statute). Based on the foregoing, Counts VIII, IX, XI, and XIII should be dismissed. E. Plaintiff’s Unjust Enrichment Claim (Count XV) Fails Because Pennsylvania Does Not Recognize Such A Claim In Cases Involving Prescription Medical Devices. To establish a claim for unjust enrichment under Pennsylvania law, “the plaintiff must demonstrate that he conferred a benefit on the defendant, that the defendant knew of the benefit and accepted or retained it, and that it would be inequitable to allow the defendant to keep the benefit without paying for it.” Zafarana v. Pfizer Inc., 724 F. Supp. 2d 545, 550 (E.D. Pa. 2010). Given these requirements, Pennsylvania courts have repeatedly held that such a claim cannot stand in the context of a case involving prescription medical products. See, e.g., Albertson v. Wyeth Inc., No. 2944 Aug. Term Case 4:14-cv-00098-CDL Document 36-1 Filed 10/24/16 Page 7 of 9 8 2002, 2003 WL 21544488, at *11-*12 (Pa. Ct. Com. Pl. July 8, 2003) (sustaining preliminary objections to unjust enrichment claim) (attached as Ex. G to the Lewis Decl.); Tatum v. Takeda Pharmaceutical North America, Inc., No. 12-1114, 2012 WL 5182895, at *4-*5 (E.D. Pa. Oct. 19, 2012) (finding no claim for unjust enrichment where there was no allegation that defendants “refused to provide a service or goods after Tatum provided defendants with a benefit”) (attached as Ex. H to the Lewis Decl.). Plaintiff’s claim thus fails. F. Plaintiff’s Gross Negligence Claim (Count XIV) And Punitive Damages Claim (Count XVII) Fail Under Pennsylvania Law. Under Pennsylvania law, gross negligence is not recognized as an independent cause of action. See, e.g., Kline v. Pfizer, Inc., No. 08-3238, 2008 WL 4787577, at *3 (E.D. Pa. Oct. 31, 2008) (dismissing gross negligence claim because “Pennsylvania courts do not recognize degrees of negligence” and “the term ‘gross negligence’ . . . refer[s] to a standard of care, rather than a separate, independent claim”) (attached as Ex. I to the Lewis Decl.). Count XIV fails on these grounds. Similarly, Plaintiff’s punitive damages claim (Count XVII) fails because it also is not recognized as an independent cause of action under Pennsylvania law. See Shorb v. State Farm Mutual Automobile Insurance Co., 2005 WL 1137881, at *5 (M.D. Pa. Apr. 25, 2005) (dismissing plaintiff’s punitive damages claim “‘since punitive damages is only an element of damages.’”) (attached as Ex. J to the Lewis Decl.) (quoting Kirkbride v. Lisbon Contractors, Inc., 555 A.2d 800, 802 (Pa. 1989)). CONCLUSION Plaintiff’s strict liability-based claims (Counts II-V) and breach of implied warranty claim (Count VII) fail because such claims are barred by comment k of Section 402A of the Restatement (Second) of Torts under Pennsylvania law. Plaintiff’s breach of Case 4:14-cv-00098-CDL Document 36-1 Filed 10/24/16 Page 8 of 9 9 express warranty claim (Count VI) fails because she failed to file it within four years of the date of accrual. The fraud-based claims (Counts VIII, IX, XI, and XIII) fail because such claims are barred by the learned intermediary doctrine. The unjust enrichment claim (Count XV) fails because Pennsylvania does not recognize such a claim in cases involving prescription medical products. And the gross negligence claim (Count XIV) and punitive damages claim (Count XVII) fail because they are not recognized as independent causes of action under Pennsylvania law. Summary judgment on these claims, therefore, is proper. Dated: October 24, 2016 Respectfully submitted, s/ John Q. Lewis John Q. Lewis TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, OH 44113-7213 Telephone: 216.592.5000 Facsimile: 216.592.5009 john.lewis@tuckerellis.com Designated Lead Counsel for Defendant Mentor Worldwide LLC 012813\002759\2881446 Case 4:14-cv-00098-CDL Document 36-1 Filed 10/24/16 Page 9 of 9 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:14-cv-00098 (Flaherty) DEFENDANT MENTOR WORLDWIDE LLC’S SEPARATE STATEMENT OF MATERIAL FACTS IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT AGAINST PLAINTIFF MARY FLAHERTY Pursuant to Rule 56 of the Federal Rules of Civil Procedure and Local Rule 56, Defendant Mentor Worldwide LLC (“Mentor”) submits this Separate Statement of Material Facts in support of its Motion for Partial Summary Judgment against Plaintiff Mary Flaherty. 1. Plaintiff first developed symptoms of stress urinary incontinence (“SUI”) in 2000. (Pl. Fact Sheet, § V(4)(b), attached as Ex. A to the Decl. of John Q. Lewis (“Lewis Decl.”).) 2. In 2004, Plaintiff saw her urologist, Dr. Frank Costa, for treatment of her SUI symptoms. (Pl. Fact Sheet, §§ II(2)-(3), VII(1).) 3. On April 21, 2004, Dr. Costa implanted Plaintiff with an ObTape transobturator sling (“ObTape”) at UPMC St. Margaret’s Medical Center in Pittsburgh, Pennsylvania. (Pl. Fact Sheet, § II(2)-(4).) 4. Plaintiff testified that before her ObTape implant, she obtained a pamphlet created by Mentor regarding ObTape upon which she relied in making her decision to have her ObTape implanted. (Dep. of Mary Flaherty (“Pl. Dep.”) 63:23-65:18, attached as Ex. B to the Lewis Decl.) Case 4:14-cv-00098-CDL Document 36-2 Filed 10/24/16 Page 1 of 3 2 5. Plaintiff’s incontinence improved for five years following her ObTape implant, but in 2009 she presented to Dr. Costa with complaints of recurrence of her SUI symptoms. (Pl. Dep. 110:14-111:10.) 6. Dr. Costa ordered clinical testing to determine the nature of Plaintiff’s symptoms at that time and the test results were normal. (Pl. Dep. 33:4-34:20.) 7. Plaintiff continued to experience SUI symptoms and UTIs and in March 2010, Dr. Costa performed a cystoscopy, a bladder biopsy, and a holmium laser ablation of Plaintiff’s bladder. (Pl. Dep. 34:21-37:10; Dep. of Frank Costa, M.D. (“Dr. Costa Dep.”) 97:19-98:17, attached as Ex. C to the Lewis Decl.) 8. Dr. Costa determined that Plaintiff’s symptoms were unrelated to her ObTape and diagnosed her with inflammation of the bladder. (Dr. Costa Dep. 99:8- 100:22.) 9. Since the procedure performed by Dr. Costa in March 2010, Plaintiff has seen her primary care physician, a urogynecologist, and a gynecologist for recurrence of her SUI symptoms. (Pl. Dep. 37:22-47:15.) 10. None of Plaintiff’s healthcare providers have ever suggested that there was an issue with her ObTape. (Id.) 11. Plaintiff’s ObTape has never been removed and none of her healthcare providers have ever told her that any portion of her ObTape should be removed. (Pl. Fact Sheet § II(5)-(11).) 12. Plaintiff is a Pennsylvania resident and all of her ObTape-related medical treatment occurred in Pennsylvania. (Pl. Fact Sheet §§ II-IV.) Case 4:14-cv-00098-CDL Document 36-2 Filed 10/24/16 Page 2 of 3 3 012813\002759\2882608.1 13. She initially filed her Complaint in the United States District Court for the Southern District of West Virginia in In re: Coloplast Corp., Pelvic Support System Products Liability Litigation, MDL No. 2387, as Case No. 2:14-cv-13936, on April 3, 2014. (Short Form Compl. Doc. 1.) 14. On April 23, 2014, Plaintiff’s case was transferred from the Southern District of West Virginia to this Court. (Doc. 5.) Dated: October 24, 2016 Respectfully submitted, s/ John Q. Lewis John Q. Lewis TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, OH 44113-7213 Telephone: 216.592.5000 Facsimile: 216.592.5009 john.lewis@tuckerellis.com Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:14-cv-00098-CDL Document 36-2 Filed 10/24/16 Page 3 of 3 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:14-cv-00098 (Flaherty) DECLARATION OF JOHN Q. LEWIS IN SUPPORT OF DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR PARTIAL SUMMARY JUDGMENT AGAINST PLAINTIFF MARY FLAHERTY I, JOHN Q. LEWIS, declare as follows: 1. I am an attorney admitted to practice law in the State of Ohio and admitted pro hac vice in this action. I am a partner at the law firm of Tucker Ellis LLP, and counsel of record for Defendant Mentor Worldwide LLC (“Mentor”) in this action. I have personal knowledge of the matters stated herein and, if called upon, I could and would competently testify to the matters contained in this Declaration. 2. Attached as Exhibit A is a true and correct copy of Plaintiff Mary Flaherty’s Plaintiff Fact Sheet, verified on May 12, 2016. 3. Attached as Exhibit B are true and correct copies of excerpts from the Deposition of Mary Flaherty, dated August 5, 2016. 4. Attached as Exhibit C are true and correct copies of excerpts from the Deposition of Frank Costa, M.D., dated August 15, 2016. 5. Attached as Exhibit D is a true and correct copy of an unreported case, Taylor v. Danek Medical, Inc., No. Civ.A. 95-7232, 1998 WL 962062 (E.D. Pa. Dec. 29, 1998). Case 4:14-cv-00098-CDL Document 36-3 Filed 10/24/16 Page 1 of 2 2 012813\002759\2882611.1 6. Attached as Exhibit E is a true and correct copy of an unreported case, Krammes v. Zimmer, Inc., No. 3:11-CV-00916, 2015 WL 4509021 (M.D. Pa. July 24, 2015). 7. Attached as Exhibit F is a true and correct copy of an unreported case, Lawrence v. Synthes Inc., No. 94-07627, 2002 WL 32747667 (Pa. Ct. Com. Pl. July 25, 2002). 8. Attached as Exhibit G is a true and correct copy of an unreported case, Albertson v. Wyeth Inc., No. 2944 Aug. Term 2002, 2003 WL 21544488 (Pa. Ct. Com. Pl. July 8, 2003). 9. Attached as Exhibit H is a true and correct copy of an unreported case, Tatum v. Takeda Pharmaceutical North America, Inc., No. 12-1114, 2012 WL 5182895 (E.D. Pa. Oct. 19, 2012). 10. Attached as Exhibit I is a true and correct copy of an unreported case, Kline v. Pfizer, Inc., No. 08-3238, 2008 WL 4787577 (E.D. Pa. Oct. 31, 2008). 11. Attached as Exhibit J is a true and correct copy of an unreported case, Shorb v. State Farm Mutual Automobile Insurance Co., 2005 WL 1137881 (M.D. Pa. Apr. 25, 2005). I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct. Executed this 24th day of October 2016, in Cleveland, Ohio. s/ John Q. Lewis John Q. Lewis Case 4:14-cv-00098-CDL Document 36-3 Filed 10/24/16 Page 2 of 2 EXHIBIT A Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 1 of 20 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE: MENTOR CORP. OBTAPE TRANSOBTURATION SLING PRODUCTS LIABILITY LITIGATION MDL NO. 2004 HON. CLAY D. LAND U.S. DISTRICT JUDGE THIS DOCUMENT RELATES TO: Mary Flaherty v. Mentor Worldwide, LLC Case No. 4:14-cv-00098-CDL PLAINTIFF’S FACT SHEET Please provide the following information for each individual on whose behalf a claim is being made. Whether you are completing this Plaintiff Fact Sheet for yourself or for someone else, please assume that “You” means the person who had the ObTape implanted. In filling out this form please use the following definition: “healthcare provider” means any hospital, clinic, center, physician’s office, infirmary, medical or diagnostic laboratory, or other facility that provides medical care or advice, and any pharmacy, x-ray department, radiology department, laboratory, physical therapist or physical therapy department, rehabilitation specialist, or other persons or entities involved in the diagnosis, care and/or treatment of you. In filling out any section or sub-section of this form, please submit additional sheets as necessary to provide complete information. In addition, if you learn that any of your responses are incomplete or incorrect at any time, please supplement your responses to provide that information as soon as you become aware of this information. In completing this Plaintiff Fact Sheet, you are under oath and must provide information that is true and correct to the best of your knowledge, information and belief. Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 2 of 20 2 I. CASE INFORMATION 1. Name of person completing this form: Mary Flaherty 2. Name of person on whose behalf a claim is being made: Mary Flaherty THE REST OF THIS PLAINTIFF FACT SHEET REQUESTS INFORMATION ABOUT THE PERSON WHO WAS IMPLANTED WITH THE OBTAPE II. CORE INFORMATION 1. Lot No. for the ObTape (please attach a copy of the stickers shown on the operative report): Mentor sling Ref# ad080069 Lot# 031017e 2. Date of Implantation: 4/21/2004 3. Name and Address of Implanting Surgeon(s): Dr. Frank Costa Urology Institute of Pittsburgh 4225 Northern Pike Monroeville, PA 15146 4. Name and Address of Hospital, Clinic, or Doctor’s Office where implantation surgery was performed: UPMC St. Margaret's Medical Center 815 Freeport Road Pittsburg, PA 15215 5. If the ObTape has been removed, provide the date on which it was removed: N/A 6. Name and Address of Surgeon(s) who removed the ObTape: N/A 7. Name and Address of Hospital, Clinic, or Doctor’s Office where surgery(ies) performed: N/A 8. Name of the Manufacturer and Type of the replacement sling, if any: N/A 9. Were any portions of the ObTape surgically removed? Yes  No  a) If yes, what is the present location of the removed portions of the ObTape? Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 3 of 20 3 10. Has any doctor ever told you that there are portions of the ObTape still in your body? Yes  No  Mesh is still in body because it has not been explanted If yes, please provide name and address of each such doctor: Dr. Frank Costa Urology Institute of Pittsburgh 4225 Northern Pike Monroeville, PA 15146 11. Has any doctor told you that those portions of the ObTape still in your body need to be removed? Yes  No  If yes, please provide name and address of each such doctor: III. PERSONAL INFORMATION 1. Name (first, middle name or initial, last): Mary Jeanne Flaherty 2. Maiden or other names used and dates you used those names: N/A 3. Current address and date when you began living at this address: 630 Snowball Road (1982 to Present) Monroeville, PA 15146 4. Identify each address at which you resided for the period from ten years before your ObTape surgery up to the present and the dates you resided at each one. N/A Address Dates of Residence 5. Social Security Number: 6. Date and place of birth: Braddock, PA 7. Current marital status: Single 8. If married, please provide the following information: N/A Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 4 of 20 4 9. Name(s) of former spouse(s), date(s) of marriage(s) and dates the marriage(s) were terminated, and the nature of the termination (i.e., death, divorce): N/A 10. If you have children, list each child’s name and date of birth and whether they were delivered vaginally or by Caesarian. N/A 11. Identify all schools you attended, starting with high school: Name of School Address Dates of Attendance Degree Awarded Major or Primary Field 12. Are you currently employed? Yes  No  If yes, please identify your current employer with name, address and telephone number and your position there: Retired If not, did you leave your last job for a medical reason? Yes  No  If yes, describe why you left: N/A 13. For the period of time from ten years before you had your ObTape surgery, until the present, please identify all of your employers, with name, address and telephone number, your employment dates, your position there, and your reason for leaving: Name of Employer Address and Telephone Number Dates of Employment and Wage/Salary Describe Your Position or Duties Reason for Leaving Pennsylvania Air National Guard 300 Tanker Road Corapolis, PA 15108 1983 thru 1997 Support Officer, Communications Manager, Chief of Supply, Total Quality Management Action Officer Retired 14. If you have Medicare, please state your HICN number: 15. For the period from ten years before your ObTape surgery to the present, have you been on or applied for workers’ compensation, social security, and/or state or federal disability benefits? Yes  No  If yes, then as to each application, separately state the following and attach any documents you have which relate to the application and/or award of benefits: Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 5 of 20 5 (a) Date (or year) of application: (b) Type of benefits: (c) Nature of claimed injury/disability: (d) Period of disability: (e) Amount awarded: (f) Basis of your claim: (g) Was claim denied? Yes  No  (h) To what agency or company did you submit your application: (i) Claim/docket number, if applicable: 16. Have you ever filed a lawsuit or made a claim (other than this suit)? Yes  No  If yes, please provide the following information and attach copies of all pleadings, releases or settlement agreements and deposition transcripts you have: Party You Sued/Made Claim Against Court in Which Suit Filed/Claim Made Case/Claim Number Attorney Who Represented You Nature of Claim and Injury Krystal Klexir Pool & Spa 5/2/2007; MDJ MJ 05207- cv-0000337 Pro Se Poor standard of work 17. Have you ever been convicted of, or pled guilty to, a felony or a crime of dishonesty within the past ten years? Yes  No  If yes, please state the charge to which you plead guilty or which you were convicted of, as well as the court where the action was pending and the date of such conviction or plea: 18. Have you or your spouse ever declared bankruptcy since the date of your initial ObTape surgery? Yes  No  If yes, please state when and in what court you filed your bankruptcy petition, including the docket number of the petition and the orders of discharge: 19. Have you or your spouse (if he/she is pursuing a loss of consortium claim) received any money from a third party in exchange for an assignment of any portion of your claim or recovery in this lawsuit, so that the payer or assignee has decision making authority over the terms of any settlement or other resolution of your claim or has lien rights (excluding liens by healthcare providers) against any funds generated by the resolution of your claim? Yes  No  If yes, please state the name and address of the third party with whom you have entered into such a contract. Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 6 of 20 6 IV. HEALTHCARE PROVIDERS 1. Identify each doctor, healthcare provider, hospital, clinic, surgery center, healthcare facility, physical therapy or rehabilitation centers (including but not limited to family/primary care physicians, surgeons, urologists, gynecologists, infectious disease specialists, physical therapists, practitioners of the healing arts) whom you have seen for medical care and treatment for the period ten years before your ObTape surgery to the present. To the best of Plaintiff’s memory and knowledge, Plaintiff states: Name (Specialty) Address and Telephone Number Approx Dates/Years of Visits Reason/Procedure Performed Dr. Frank Costa, Urology Institute of Pittsburgh 4225 Northern Pike Monroeville, PA 15146 412/373-2333 4/21/2004 Mentor ObTape mesh implant UPMC St. Margaret's Medical Center 815 Freeport Road Pittsburg, PA 15215 412/784-4000 4/21/2004 Mentor ObTape mesh implant Extended Family Care 10 Duff Road Pittsburgh, PA 15235 412/241-7292 4/22/2004 Post-op for mesh implant Dr. Halina Zyczynski, Magee-Womens Hospital of UPMC (Urologist) 300 Halket Street Pittsburgh, PA 15213 412/641-7850 Pelvic exams Dr. Lisa Ferrence, Partners in Health (General Practice) 838 Route 130 Level Green, PA 15085 412/856-7332 2004 thru 2014 Primary care Dr. Jennifer Rudin 2570 Haymaker Road Monroeville, PA 15146 412/856-0226 1/2010 and 2/2010 Urinary tract infections Forbes Lab, Forbes Hospital 2570 Hamaker Road Monroeville, PA 15146 412/858-2300 1/2010 and 2/2010 Urinary tract infections Dr. Mary Ellen Portman (retired) Stress urinary incontinence treatment UPMC Surgery Center 125 Daugherty Drive Monroeville, PA 15146 Dr. Susan Greenspan, Osteoporosis Prevention and Treatment Center 1110 Kaufmann Building Pittsburgh, PA 15213 412/692-2472 1999 thru 2012 Osteoporosis Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 7 of 20 7 Name (Specialty) Address and Telephone Number Approx Dates/Years of Visits Reason/Procedure Performed Dr. Tina Musahl, Digestive Health & Endoscopy (Gastroenterologist) 1000 Integrity Drive, Suite 110 Pittsburgh, PA 15235 412/342-0036 GERD Dr. Suresh Mulukutla (Cardiologist) 120 Lytton Avenue, Suite 100-B Pittsburgh, PA 15213 Cholesterol Dr. Thomas Sisk (Orthopedist) 3471 Fifth Avenue, Suite 1010 Pittsburgh, PA 15213 2015 thru Present Hip and knee Montifiore Imaging UPMC 3471 Fifth Avenue Pittsburgh, PA 15213 2016 Hip MRI Heather Kerle, PA-C 241 Freeport Road Pittsburgh, PA 15215 Dermatology East Suburban Physical Therapy 2644 Moside Boulevard Monroeville, PA 15146 2016 Hip and knee physical therapy Dr. Mark Schmidhoffer, UPMC Presbyterian (Cardiologist) 200 Lothrop Street Pittsburgh, PA 15213 2016 Cardiac follow-up Excela Health Route 30 2016 Mammogram Dr. David Kristo, Falk Clinic Lothrop Street Pittsburgh, PA 15213 2015 Pulmonary screening Dr. Alan Klein UPMC (Orthopedist) Northern Pike Monroeville, PA 15146 2015 thru Present Ankle and wrist Dr. Dean Soreantos, UPMC (Orthopedist) Northern Pike Monroeville, PA 15146 2016 Thumbs Dr. Albert Lin UPMC 3200 S. Water Street Pittsburgh, PA 15203 2013 Right shoulder UPMC East Mosside Boulevard Monroeville, PA 15146 2013 Shoulder surgery Dr. Thomas Lewelyn (Opthamologist) Pittsburgh, PA 2016 Opthamology UPMC Urgent Care William Penn Highway Monroeville, PA 2014 thru 2015 Tick removal, back injury Cara Troutman 3200 S. Water Street Pittsburgh, PA 15203 2015 Physical therapy for bursitis and hip Dr. Andrew Vayonis 2585 Freeport Road Pittsburgh, PA 15238 1999 thru 2012 Allergies Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 8 of 20 8 Name (Specialty) Address and Telephone Number Approx Dates/Years of Visits Reason/Procedure Performed Dr. Ooi Eugene (Opthamologist) Forbes Avenue Pittsburgh, PA 15213 2012 Opthamology Dr. Bon-Homme, UPMC Eye & Ear Hospital (Opthamologist) Lothrop Street Pittsburgh, PA 15213 2009 Opthamology Dr. Thomas Mertz, Allergy & Asthma Associates 2585 Freeport Road, Suite 210 412/828-3800 1999 thru 2013 Allergies Plaintiff reserves the right to supplement as she continues to be treated for injuries sustained as a result of the implant/explant of her mesh sling. 2. Identify each pharmacy, drugstore or any other facility or supplier (including but not limited to mail order pharmacies) where you ever received any prescription medication for the period ten years before your ObTape surgery to the present. To the best of Plaintiff’s memory and knowledge, Plaintiff states: Name of Pharmacy/Supplier Address and Telephone Number of Pharmacy/Supplier Approx. Dates/Years You Used Pharmacy/Supplier Express Scripts, Medco Health #59 7909 S. Hardy Drive Tempe, AZ 85284 877/363-1303 1997 thru 2014 Rite Aid William Penny Highway Monroeville, PA 15146 412/372-5288 2012 thru 2014 Giant Eagle Pharmacy 4010 Monroeville Boulevard Monroeville, PA 15146 412/372-1224 2006 thru 2012 V. MEDICAL BACKGROUND 1. Current Height: 5’7” 2. Please state your weight at the following times: (a) Current: 172 lbs. (b) Time of implant: 171 lbs. (c) Time of explant/excision surgery (if any): N/A Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 9 of 20 9 3. Smoking History (a) Have you ever smoked cigarettes? Yes  No  State amount smoked: packs per day for ______ years, during the years ____________ to _____________. 4. Other Conditions (a) To the best of your knowledge, have you ever experienced or been diagnosed with any of the following conditions from the time beginning ten years before your ObTape surgery to the present? Please select Yes or No for each condition. For each condition for which you answer Yes, please provide the additional information requested in the table following this chart: To the best of Plaintiff’s memory and knowledge, Plaintiff states: Condition Experienced or Diagnosed Yes No Don’t Know 1. Abnormal pap smear  2. Autoimmune disease  3. Bacterial vaginosis  4. Cervical cancer  5. Cystocele  6. Diabetes  7. Endometriosis  8. Gestational diabetes  9. Hormone deficiency  10. Hypertension/high blood pressure  11. Interstitial cystitis  12. Obesity  13. Ovarian cancer  14. Pelvic inflammatory disease  15. Polycystic ovary disease  16. Rectocele  17. Stress urinary incontinence  18. Thyroid disorder  19. Toxic shock syndrome  20. Urethral erosion  21. Urinary tract infection  22. Urge incontinence  23. Uterine cancer  24. Vaginal erosion  25. Vaginal infection  Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 10 of 20 10 Condition Experienced or Diagnosed Yes No Don’t Know 26. Venereal disease  27. Yeast infection  (b) For each condition for which you answered Yes in the previous chart, please provide the information requested below: Condition You Experienced Approximate Date of Onset Name, Address and Telephone Number of Treating Physician (if any) Treatment Received Stress urinary incontinence; Urge incontinence 2000 Dr. Mary Ellen Portman (retired) Kegel exercises Urinary tract infections 2010 Dr. Jennifer Rudin 2570 Haymaker Road Monroeville, PA 15146 412/856-0226 Antibiotics Yeast infections Dr. Mary Ellen Portman (retired) Antibiotics High blood pressure 2013 Dr. Lisa Ferrence Parners in Health 838 Route 130 Level Green, PA 15085 412/856-7332 Medication Thyroid disorder, Hashimoto’s Disease 1970 Total Thyroidectomy HRT related to Menopause 1987 Dr. Mary Ellen Portman (retired) Premarin, .3 mg Endometriosis Prior to 1980 Dr. Mary Ellen Portman (retired) Surgery VI. MEDICATIONS 1. List all of the medications (prescription and over the counter) you currently take. To the best of Plaintiff’s memory and knowledge, Plaintiff states: Medication Dose/Frequency/Dates of Use Physician Ordering Pharmacy Dispensing Purpose Bepotastine Besilate 1.5% drops as needed Eye irritation Biotin Oral 1000 mcg daily Vasotec 5 mg daily Synthroid 75 mcg daily Thyroid Patanol 1 drop, twice per day Dr. Thomas Mertz Eyes Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 11 of 20 11 Medication Dose/Frequency/Dates of Use Physician Ordering Pharmacy Dispensing Purpose Kenalog .1% topical cream, twice daily Vitamin D3 Daily Ibuprofen 200 mg as needed Pain Magnesium 30 mg, twice per day Aleve 220 mg daily as needed Breakthrough pain Metamucil 1 tablespoon daily Bowel regulation Aspercreme 10% topical cream as needed Pain Vitamin D 400 units daily Beprev As needed Dr. Vayonis Express Scripts Allergies – itching eyes Potassium Gluconate 99 mg daily Over the counter 2. To the best of your recollection, are there any prescription medications other than those identified that you have taken on a regular basis for any duration of more than two months for the period ten years before your ObTape surgery to the present? Yes  No  If yes, please identify the medication(s), the doctor(s) who prescribed it, the approximate dates/ years you have taken this medication, and why it was given to you: Medication Dose/ Frequency/Dates of Use Physician Ordering Pharmacy Dispensing Purpose Boniva IV, once every three months; 2008 thru 2010 Dr. Susan Greenspan Magee’s Women’s Health Help heal T-12 fracture Zetia Ended 2013 Dr. Suresh Mulukutla Express Scripts Cholesterol Fosomax 10 mg Dr. Mary Ann Portman Express Scripts Osteoporosis Premarin .3 mg Dr. Mary Ann Portman Express Scripts Post- Menopausal symptoms Nexium 20 mg daily, 2014 Dr. Tina Musahl Express Scripts GERD Crestor 10 mg daily, 2014 Dr. Suresh Mulukutla Express Scripts Cholesterol Levothyroxine .88 mcg daily, 2013 thru 2014 Dr. Lisa Ferrence Express Scripts Hypothyroidism Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 12 of 20 12 Medication Dose/ Frequency/Dates of Use Physician Ordering Pharmacy Dispensing Purpose Loratadine 10 mg daily, 2004 thru 2014 Dr. Andrew Vayonis Express Scripts Allergies Montelukast 10 mg daily, 2013 thru 2014 Dr. Thomas Mertz Express Scripts Decongestant Allergy shots Every three weeks, 1999 thru 2014 Dr. Thomas Mertz Allergies Carafate 10 l three times per day, 2014 Dr. Tina Musahl Express Scripts GERD VII. IMPLANT AND EXCISION/REMOVAL 1. Describe the condition for which the ObTape was implanted: Stress Urinary Incontinence (SUI) 2. Before the implantation of the ObTape, did you receive non-surgical treatment for your stress urinary incontinence? Yes  No  (a) State the period during which you received non-surgical treatment: 1/2010 thru 4/2010 (b) State the nature of the non-surgical treatment (e.g., physical therapy, medication, injections): Medication: Vesicare and Detrol (c) State the name and address of all doctors or health care providers involved in your non-surgical treatment: Dr. Frank Costa Urology Institute of Pittsburgh 4225 Northern Pike Monroeville, PA 15146 3. Did you see, read or rely upon any documents or other information from Mentor in making your decision to have the ObTape implanted? Yes  No  Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 13 of 20 13 (a) If yes, identify each document/source of information. (b) When did you read the document/receive the information? (c) How did you obtain the document or information? (d) Do you have the document or written information in your possession? If so, please produce a copy of it together with your answers to the Plaintiff Fact Sheet. Yes  No  Don’t Know  4. Have you had any communications with any present or former employee of Mentor or concerning ObTape or matters in any way related to this lawsuit? Yes  No  If yes, for each, please state: Date of Communication Name of Person with Whom You Communicated Mode of Communication (In Person, By Phone, By Email, By Mail) Do you have a writing or recording? (IF SO, PLEASE ATTACH) If the communication was by phone or in-person, please tell us what was said: VIII. INJURIES & DAMAGES 1. Are you claiming any physical injuries or illness as a result of the ObTape? Yes  No  If yes, please describe in detail the following: (a) The physical injuries or illness claimed and when the symptoms began: Following Plaintiff’s ObTape implant, she sustained injuries and has suffered from numerous complaints including, but not limited to, recurrent pain, infection, urinary problems, yeast infections and bleeding. In addition, these issues have caused mental anguish, pain and suffering. (b) Are those injuries or illnesses continuing? Yes  No  Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 14 of 20 14 (c) Provide the name and address of each health care provider that you have seen for these problems: Condition You Experienced Name, Address and Telephone Number of Health Care Provider (if any) Stress urinary incontinence, urge incontinence Dr. Frank Costa Urology Institute of Pittsburgh 4225 Northern Pike Monroeville, PA 15146 412/373-2333 Pelvic exams related to incontinence issues Dr. Halina Zyczynski Magee-Womens Hospital of UPMC 300 Halket Street Pittsburgh, PA 15213 412/641-7850 Stress urinary incontinence, urge incontinence Dr. Mary Ellen Portman (retired) 2. Have you ever been hospitalized as a result of any of these conditions? Yes  No  If yes, please provide the following information: (a) Approximate date(s) of hospital admission: (b) Approximate date(s) of discharge: (c) Hospital names(s) and address(es): 3. Do you claim any psychological or psychiatric injury (other than garden variety emotional distress) as a consequence of having the ObTape? Yes  No  If yes, please state the following as it pertains to your treatment for any psychiatric and/or psychological condition(s): Condition Name and Address of Mental Healthcare Provider (if any) Approx. Dates/Years of Treatment/Visits (if any) 4. Are you making a claim for lost wages or lost earning capacity? Yes  No  Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 15 of 20 15 1. If yes, describe your claim and attach your W-2 forms for the relevant years. Your description should include the total amount of time (and amount of income) which you have lost or will lose from work as a result of any condition which you claim or believe was caused by the ObTape, and an explanation of how those amounts were calculated: 2. If you claim a loss of earnings, state your earned income from work for the following years: YEAR INCOME 2012 $ 2011 $ 2010 $ 2009 $ 2008 $ 2007 $ 2006 $ 2005 $ 2004 $ 2003 $ 5. Is your spouse claiming loss of consortium? Yes  No  6. Is your spouse claiming physical injury from the ObTape? Yes  No  If yes, please describe in detail the following: (a) The physical injuries claimed and the approximate date of treatment for each injury, and identify the name and address of each health care provider that your spouse has seen for these problems: Condition Spouse Experienced Approximate Date of Treatment Name, Address and Telephone Number of Health Care Provider (if any) Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 16 of 20 16 IX. MEDICAL AND OUT-OF-POCKET EXPENSES 1. State the amount of medical expenses, by provider, which you have incurred, including amounts billed to insurers and other third party payors, which are related to any condition which you claim or believe was caused by the ObTape for which you seek recovery in this action: Plaintiff does not have exact calculation regarding economic damages or out of pocket expenses at this time and reserves the right to supplement concurrent with ongoing treatment. Name and Address of Provider Dates of Treatment Description of Treatment Amount of Medical Expenses $ $ For any expenses claimed above, have they been reimbursed by any third party? Yes  No  Don’t Know  If yes, identify which expenses, the amount reimbursed and the date reimbursed. X. FACT WITNESSES Please identify all persons whom you believe possess information concerning you injury(ies) and current medical conditions, other than your healthcare providers, and please state their name, address, and relationship to you: None XI. DOCUMENT DEMANDS These document requests are not intended to seek attorney client communications, or attorney work product materials. In addition, these requests do not encompass or seek information about expert witnesses or communications with and/or from experts or proposed trial exhibits or trial materials which may be subject to disclosure at a later date in accordance with subsequent Court Order or rule. Thus, if you have any of the following in your possession which is not protected as set forth above, please provide a copy of it with this Plaintiff Fact Sheet. Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 17 of 20 17 REQUEST NO. 1: All medical records (including, but no limited to, all charts, hospital records, consent forms, treating physician records, photographs, videotapes/DVDs, drawings, Xrays, ultrasounds, MRIs, CT scans, radiographs, angiograms, blood tests, laboratory reports, prescriptions, spirometry tests, electrocardiograms, urine tests, blood gases tests, psychometric tests, neuropsychological tests, stress tests, notes, telephone messages) from any physician, hospital, clinic, health care provider, pharmacy, psychiatrist, psychologist, counselor or therapist created since 1990 reflecting, referring or relating to Plaintiff. See medical and pharmacy records produced to date. Plaintiff reserves the right to supplement as she continues to be treated for injuries sustained as a result of the implant/explant of her mesh sling. REQUEST NO. 2: All medical bills for which plaintiff seeks recovery in this lawsuit, as well as all documents relating to third-party payments of medical bills. See billing records produced to date. Plaintiff reserves the right to supplement as she continues to be treated for injuries sustained as a result of the implant/explant of her mesh sling. REQUEST NO. 3: All records of any other expenses (including, but not limited to, nursing services, outpatient care, home health care, lost wages, etc.) allegedly incurred as a result of the injuries alleged in the complaint. See billing records produced to date. Plaintiff reserves the right to supplement as she continues to be treated for injuries sustained as a result of the implant/explant of her mesh sling. REQUEST NO. 4: All photographs and videos of plaintiff’s surgery and all photographs and videos of plaintiff which show plaintiff’s condition since the date of the original implantation. Plaintiff has no responsive documents currently in her possession. REQUEST NO. 5: Any documents including but not limited to literature, warnings or informed consent forms received by you from surgeons, physicians, or other health care professionals who have treated you for any condition related to ObTape. Plaintiff has no responsive documents currently in her possession. Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 18 of 20 18 XII. AUTHORIZATIONS Complete and sign the Authorization attached as Exhibit A. See attached medical authorization. Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 19 of 20 Case 4:14-cv-00098-CDL Document 36-4 Filed 10/24/16 Page 20 of 20 EXHIBIT B Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 1 of 29 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA 2 COLUMBUS DIVISION 3 - - - 4 IN RE MENTOR CORP. OBTAPE ) TRANSOBTURATOR SLING PRODUCTS ) 5 LIABILITY LITIGATION, )MDL Case No.: 2004 ) 6 )Indiv. Case No. )4:13-cv-00098 7 Defendant. )(Flaherty) 8 - - - 9 Videotape Deposition of MARY JEANNE FLAHERTY 10 Friday, August 5, 2016 11 - - - 12 The videotape deposition of MARY JEANNE FLAHERTY, one of the plaintiffs herein, called as 13 a witness by the defendant, pursuant to notice and the Federal Rules of Civil Procedure pertaining to 14 the taking of depositions, taken before me, the undersigned, Jessica L. Tapia, a Notary Public in 15 and for the Commonwealth of Pennsylvania, at the offices of Network Deposition Services, 707 Grant 16 Street, Suite 1101, Pittsburgh, Pennsylvania 15219, commencing at 12:59 o'clock p.m., the day 17 and date above set forth. 18 - - - 19 20 21 22 23 24 25 Job No. CS2354620 Page 1 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 2 of 29 1 APPEARANCES: 2 On behalf of the Plaintiff: 3 Arnold & Itkin, LLP: Ben Bireley, Esquire 4 6009 Memorial Drive Houston, Texas 77007 5 On behalf of the Defendant: 6 Tucker Ellis, LLP: 7 Madeline B. Dennis, Esquire 950 Main Avenue 8 Suite 1100 Cleveland, Ohio 44113-7213 9 - - - 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 2 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 3 of 29 1 didn't get there on time. 2 Q How often does that happen? 3 A In a time frame? 4 Q The past month or so. 5 A Probably three times. 6 Q Is that the extent of the symptoms 7 that you have with the incontinence today? 8 A Yes. 9 Q Are you wearing pads or anything like 10 that for protection? 11 A I am not today. 12 Q Do you have any other symptoms today 13 that you relate to your ObTape sling? 14 A No. 15 Q Now, I am going to ask you if there is 16 any injuries that you had in the past that you 17 relate to your ObTape sling that have since 18 resolved, if that makes sense. I asked you what 19 you're experiencing today, but I want to know 20 basically is there anything that has happened 21 before that you are not experiencing today that 22 you relate to your sling? 23 A Yes. 24 Q What symptoms have you had in the past 25 that you relate to your sling? Page 32 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 4 of 29 1 A Before I had the sling, I had the 2 feeling that my organs were not where they should 3 be, like they were moving downward. 4 Q What I mean is after your sling was 5 implanted until about a month ago, are there any 6 symptoms that you had that you relate to the sling 7 being the cause? Does that make sense? 8 A Yes. I had a recurrence of the 9 feeling about the pelvic organs. 10 Q So you have a feeling of your organs 11 were pushing down, is that what you said? 12 A Yes. 13 Q And you relate that to your ObTape 14 sling? 15 A Yes. 16 Q When did that occur? 17 A It started having issues again in 18 2009. 19 Q How often did it happen in 2009? 20 A A couple of times. 21 Q How long did it last when you had that 22 feeling that your organs were pushing down? 23 A It would -- if I moved into a 24 different position, I could have less of a pain. 25 Q So you adjusted the way you were Page 33 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 5 of 29 1 sitting or something like that? 2 A Yes. 3 Q And did you see a doctor about that 4 feeling of your organs pushing down? 5 A I did. 6 Q Who did you see? 7 A Dr. Costa. 8 Q What did he tell you about your 9 symptoms? 10 A He really didn't tell me about the 11 symptoms. He ordered some testing. 12 Q Did he tell you what the testing 13 results were? 14 A I think that he just remarked that 15 they were normal, that there wasn't -- 16 Q Was that in 2009? 17 A Yes, it was in 2009. 18 Q He told you that your test results 19 were normal. Did he tell you anything else? 20 A No, he didn't. 21 Q After you saw Dr. Costa, did you have 22 that feeling of your organs pushing down again 23 after that? 24 A Yes. 25 Q And did you go back to see him? Page 34 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 6 of 29 1 A I did go back to see him. 2 Q And did he give you any explanation 3 about symptoms? 4 A Not really. He suggested that I 5 should have -- I am trying to think of the name of 6 this. It's a procedure. 7 Q Did you look into doing that? 8 A I did. I did have that procedure. 9 Q You had the procedure? 10 A Yes. 11 Q When did you have the procedure? 12 A It was in March 2010. 13 Q Did the procedure help with your 14 symptoms that you were having? 15 A No. Dr. Costa really didn't tell me 16 that there were any problems, but he did recommend 17 that I have another procedure, which I declined to 18 do. 19 Q Why did you decline? 20 A The procedure was to inject collagen. 21 I didn't want to do that. I thought if I was 22 having an issue with the procedure that I had, I 23 didn't want to have another procedure. 24 Q Okay. Do you recall what procedure he 25 performed in 2010, what it was? Page 35 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 7 of 29 1 A I think it's a cystoplasty. 2 Q Cystoplasty? 3 A I have to verify that, but I -- 4 Q Were you under anesthesia? 5 A Yes. 6 Q Did you have any complications with 7 that surgery? 8 A I don't think so, but I wasn't exactly 9 aware of something that he did during that 10 procedure until I saw a record afterwards. 11 Q What was that? 12 A He checked the bladder and there was I 13 think it said there was a lesion in the bladder. 14 Q And they never told you that? 15 A No. 16 Q What did he tell you about that 17 procedure, do you recall? 18 A He really didn't give me any details 19 on that. 20 Q Did you ask him what he was doing with 21 the surgery? 22 A I don't think I asked him for any 23 details after -- he just said -- I am not sure of 24 the term -- cystoplasty. 25 Q Why didn't you ask him what he was Page 36 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 8 of 29 1 going to do? 2 A I think he told me what the procedure 3 was, but I don't think he told me about the 4 bladder. 5 Q Do you recall what the general 6 procedure was that he told you, what he was doing? 7 A Where they -- the procedure, they just 8 scan your pelvic area and -- 9 Q Do you know why he was doing that? 10 A Because I was having UTIs. 11 Q So this wasn't for the feeling that 12 your organs were pushing down? 13 A I think that was part of it. 14 Q Okay. So since that 2010 surgery, 15 have you felt like your organs -- I might have 16 asked you this already, but have you felt like the 17 symptoms of your organs pushing down since then? 18 A Yes. 19 Q And you said you experienced it a 20 couple of times. Is that accurate? 21 A Yes. 22 Q And have you seen any doctors besides 23 Dr. Costa about that symptom? 24 A I have seen my primary doctor. 25 Q And who is your primary doctor? Page 37 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 9 of 29 1 A Dr. Ferrence. 2 Q Is that a he or a she? 3 A Lisa. 4 Q What did she tell you about those 5 symptoms? 6 A That the recommendation was to do 7 Kegel's exercises. 8 Q Did you try that? 9 A Yes, I did. 10 Q Did it help? 11 A I am not sure if that helps or not. 12 It takes a lot of time. 13 Q When was the last time you had 14 symptoms of something pushing down on your organs? 15 A Probably last Thursday night. 16 Q Have you seen any doctors besides 17 Dr. Ferrence about it and Dr. Costa? 18 A I did see Dr. Zyczynski. 19 Q When did you see him or her? 20 A It's Helena. I saw her June 2013. 21 Q And what kind of doctor is she? 22 A She is a urogynecologist. 23 Q And did she have any treatment options 24 for your symptoms? 25 A She did, but she wasn't real specific Page 38 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 10 of 29 1 about what to do. 2 Q What do you recall about seeing her? 3 A I was first seen by a physician's 4 assistant. 5 Q This was in June of 2013? 6 A Yes. 7 Q And what did the physician's assistant 8 tell you? 9 A She really didn't tell me very much. 10 She did the exam, but she actually poked me 11 somehow that I had to say -- I guess I yelped. 12 Q And that was during the pelvic exam? 13 A Yes. 14 Q And she didn't tell you anything about 15 what she saw during the pelvic exam? 16 A She didn't. 17 Q Did Dr. Zyczynski talk with you? 18 A She did. She said that the implant 19 was still there. 20 Q Meaning your mesh sling? 21 A Yes. 22 Q What did she say about that? 23 A That was all she said, that that was 24 still there. 25 Q Did she indicate there was anything Page 39 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 11 of 29 1 wrong with the implant? 2 A She didn't say. 3 Q Did you ask her? 4 A I believe that was the reason I went 5 there, I wanted to know. And I told the intake 6 person I wanted to know about the condition of the 7 implant. 8 Q Okay. And when you asked, what did 9 she tell you? 10 A She just said it's there. That is all 11 she said. 12 Q And did you ask her if there was 13 anything wrong with it? 14 A No. 15 Q And she didn't indicate that there was 16 anything wrong with it? 17 A No, she just said it was there. 18 Q And what was her recommendation for 19 you at that time? 20 A I saw this in the after-visit summary 21 that the diagnosis was vaginal atrophy. 22 Q Do you understand what that means? 23 A I think so. A deterioration. 24 Q Okay. Did Dr. Zyczynski discuss the 25 atrophy with you at the visit? Page 40 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 12 of 29 1 A No. 2 Q Did she prescribe any treatment for 3 it? 4 A She prescribed Premarin cream. 5 Q And did you have any improvement with 6 any of the symptoms that you had after you -- did 7 you start taking the Premarin first? 8 A I did not. 9 Q Why not? 10 A I think I had had that prescribed at 11 some point. That didn't seem to do anything for 12 me. 13 Q Did you tell Dr. Zyczynski that? 14 A I didn't get a chance to really tell 15 her. 16 Q Did you know that she was prescribing 17 Premarin at the visit? 18 A No. The tech came in and said that 19 she was prescribing it. 20 Q And did you tell them that you had 21 tried that before? 22 A No, I did not. 23 Q Did you go back to her office after 24 that? 25 A No. Page 41 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 13 of 29 1 Q Did you go to anyone else's office 2 about the symptoms that you were having after that 3 point? 4 A I just seen my primary doctor. 5 Q Have you discussed the sling with your 6 primary care doctor? 7 A Not recently. 8 Q Have you ever talked about it with 9 her? 10 A Yes. 11 Q And when did you talk to her about 12 your sling? 13 A I don't recall exactly, but I see her 14 at least once a year. 15 Q And what would you have talked about 16 regarding your sling with Dr. Ferrence? 17 A Just telling her that I -- my 18 recurrence of my symptoms. 19 Q Okay. The recurrence of the 20 incontinence? 21 A Stress incontinence and urgency and 22 the feeling that the organs are falling. 23 Q And do you recall what she said when 24 you told her that? 25 A She recommended the Kegel's exercises. Page 42 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 14 of 29 1 Q Did she do a pelvic exam? 2 A She did. 3 Q Did she tell you anything looked 4 abnormal on her pelvic exam? 5 A Not that I recall. 6 Q Did she ever tell you that anything 7 was wrong with your sling? 8 A No. 9 Q Did she suggest that you should see a 10 urologist or gynecologist about it? 11 A No. 12 Q Do you recall the last time you spoke 13 with her about your sling? 14 A Not exactly, no. 15 Q Do you recall whether it was more than 16 once? 17 A That I talked to her? 18 Q About the sling. 19 A No, I don't recall. 20 Q When you saw Dr. Costa back in 2010, 21 did you ask him if there was anything wrong with 22 your sling? 23 A I don't think I asked him directly if 24 there was anything wrong with it. 25 Q Did he mention anything about your Page 43 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 15 of 29 1 sling when you saw him in 2010? 2 A I don't think he did. 3 Q So besides Dr. Ferrence and 4 Dr. Zyczynski, have you ever discussed your sling 5 with any doctor? 6 A I did with Dr. Rudin. 7 Q And what kind of doctor is Dr. Rudin? 8 A She is a gynecologist. 9 Q When did you see him about your sling? 10 MR. BIRELEY: Objection, assumes facts 11 not in evidence. 12 Q When did you discuss your sling with 13 him? 14 A I saw him in May 2016. 15 Q Why did you go see him? 16 A I needed to update my GYN status. 17 Q So a checkup? 18 A Yes, it was an annual exam is what 19 they call it. 20 Q And during that visit, you discussed 21 your sling with him? 22 A I asked him where it is. 23 Q And what did he say? 24 A That he could see it and -- 25 Q Did he perform a pelvic exam? Page 44 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 16 of 29 1 A He did. 2 Q And is that when he said he could see 3 the sling? 4 A I think he said he could feel it. 5 Q Okay. Did he perform any other kind 6 of exam besides the pelvic exam? 7 A He did a rectal exam. 8 Q Did he say he felt that anything was 9 wrong with the sling? 10 A No, he didn't. 11 Q Did you ask him if there was anything 12 wrong with it? 13 A Yes, I wanted to know if it was -- 14 where it was. 15 Q And you just wanted to know where it 16 was? 17 A The location, if it was in the same 18 place. 19 Q Why? 20 A Because I am feeling movement in the 21 pelvic area. 22 Q Did he have any explanation for that? 23 A He asked me if I knew I had rectocele, 24 and I said, no, I didn't. 25 Q Did he suggest any treatment for Page 45 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 17 of 29 1 rectocele? 2 A Kegel's exercises. 3 Q Kegel's exercises? 4 A Yeah. 5 Q Anything else? 6 A He asked me about a scar that I have. 7 Q What kind of scar? 8 A It's -- I don't know if it's abdominal 9 or pelvic, but I had surgery like in 1982. 10 Q What kind of surgery? 11 A I had endometriosis. 12 Q And you had a scar from a procedure 13 related to endometriosis? 14 A Yes. 15 Q And did he think there was anything 16 wrong with the scar? Do you recall -- did he 17 mention why he wanted to know about your scar? 18 A He asked me the question, and he said, 19 "Who did that to you". 20 Q Did Dr. Rudin say anything else during 21 that visit about the symptoms you were having? 22 A Not that I recall. 23 Q Okay. so other than Dr. Ferrence, 24 Dr. Zyczynski and Dr. Rudin, have you ever 25 discussed your sling with any other doctor or Page 46 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 18 of 29 1 health care provider? 2 A In the context if I went to a new 3 doctor and they were asking you about your 4 surgical procedures? 5 Q Like if you were just giving a medical 6 history? 7 A Right. 8 Q No. Have you ever talked to any 9 doctors about whether or not there might be 10 something wrong with the sling or your concerns 11 about the sling? 12 A No. 13 Q Has any doctor ever suggested that 14 there might be something wrong with the sling? 15 A Not that I recall. 16 Q Okay. And did you see Dr. Rudin more 17 than once? 18 A No. 19 Q So other than the recurrent 20 incontinence -- which you described as urgency and 21 frequency. Is that correct? 22 A Yes. 23 Q -- and the feeling of something 24 pushing down, are there any other symptoms or 25 injuries that you relate to your ObTape sling? Page 47 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 19 of 29 1 MR. BIRELEY: Do you mean today or -- 2 Q Ever. 3 A I have had a couple of discharges. 4 Q And what kind of discharge? 5 A Some type of vaginal discharge. 6 Q Can you describe the vaginal discharge 7 that you had. 8 A Semi-bloody. 9 Q And when did you have that? 10 A I think in March 2016. 11 Q That was the first time that you had 12 it? 13 A That was a recent time. 14 Q Have you ever had it before that? 15 A I have. 16 Q How many times? 17 A Once that I can recall. 18 Q And do you recall how long ago? 19 A No, I don't. 20 Q Did you tell any of your doctors about 21 the discharge? 22 A No, I didn't. 23 Q Any other symptoms or injuries that 24 you relate to your ObTape sling? 25 A I think I have limited stamina. Page 48 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 20 of 29 1 Q And do you recall providing the 2 information that is in this pamphlet? 3 A Yes. 4 Q If possible, I would like you to go 5 through and review this packet just to make sure 6 there is nothing that needs to be changed or 7 updated. Could you do that. 8 A Okay. 9 Q Just let me know if you come across 10 anything that you need to update or change as you 11 go. 12 A Okay. Item 10. 13 Q On which page. 14 A Page 3. 15 Q Okay. I see. So it should be no 16 instead of yes where it says "Has any doctor told 17 you that" -- wait. What is your -- 18 A Should be -- besides Dr. Costa, it 19 should be Dr. Zyczynski and Dr. Rudin. 20 Q Thank you. Got it. Dr. Zyczynski and 21 Dr. Rudin have also told you that the ObTape -- 22 that there is still portions of the ObTape in your 23 body? 24 A The tape is still there, yes. 25 Q Okay. Page 62 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 21 of 29 1 A On page 4, item 11. 2 Q Okay. 3 A I had submitted a separate sheet with 4 the names of the schools. 5 Q Perhaps your attorney can provide that 6 information for us. 7 A On page 8, item 2. My current weight 8 now is different than that. That is what I 9 weighed when I -- 10 Q What is your current? 11 A 160. 12 Q Thank you. 13 A You're welcome. On page 12, item 2 14 (a), I think this date is incorrect. 15 Q Yes. It looks like 2010. Do you know 16 what the correct date would be that you received 17 non-surgical treatment before your implant? 18 A I think that should be January of 2004 19 through -- well, it's not exactly through April 20 because I had the surgery in April of 2004. 21 Q Is (b) correct? 22 A Yes. 23 Q While we're on it, on page 12, No. 3 24 was left blank at the bottom there. And it asks, 25 "Did you see, read or rely upon any documents or Page 63 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 22 of 29 1 other information from Mentor in making your 2 decision to have the ObTape implanted". 3 What would your answer be, yes or no 4 for that? 5 A Yes. 6 Q What did you receive from Mentor? 7 A Dr. Costa had a seminar in January 8 2004 and he presented. There was a pamphlet from 9 Mentor. 10 Q You attended this seminar? 11 A I did. 12 Q Where was the seminar held? 13 A It was at Dr. Costa's office. 14 Q How did you find out about it? 15 A I saw an advertisement in the paper, 16 newspaper. 17 Q And you recall receiving a pamphlet, 18 is that what you said? 19 A There was a pamphlet at the 20 presentation. 21 Q Do you recall anything about the 22 pamphlet? 23 A It was about urinary incontinence. 24 Q Do you still have it? 25 A I had it at one time. I haven't been Page 64 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 23 of 29 1 able to locate it. 2 Q Have you looked for it though? 3 A I have looked for it, but I haven't 4 found it. 5 Q And you recall that it was about 6 urinary incontinence? 7 A And it talked about the OB -- they 8 called it an OB tape. 9 Q And you recall seeing OB tape on the 10 pamphlet? 11 A It was within the text of the 12 pamphlet. 13 Q Do you recall anything else about the 14 pamphlet? 15 A I don't, at the moment. 16 Q Did you read the pamphlet when you 17 received it? 18 A I did. 19 Q Did you have any questions about it? 20 A I would like to see one again. 21 Q Do you recall having any questions 22 about it back when you received it. 23 A Can I tell you about the presentation? 24 Q Sure. 25 A I think it may answer the question. Page 65 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 24 of 29 1 Q Yes. Tell me about the presentation. 2 A In the newspaper advertisement there 3 were words indicating that this was going to be a 4 permanent solution to this problem. 5 Q What newspaper advertisement? 6 A I think I submitted a copy somewhere 7 along the line. I am not sure if it was the 8 Pittsburgh Post-Gazette or the Pittsburgh Tribune 9 Review. 10 Q And you believe that you provided that 11 to your attorneys? 12 A I thought I did, but I have a copy of 13 it. 14 Q Can you provide that to your attorneys 15 if they don't have it? 16 A Yes. 17 Q And the newspaper advertisement, what 18 was it about? 19 A It listed the date and time of the 20 presentation and Dr. Costa. 21 Q Okay. That was about Dr. Costa? 22 A Dr. Costa. 23 Q Dr. Costa? 24 A Yes. It definitely had the words that 25 it was a permanent solution. Page 66 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 25 of 29 1 eating normally. 2 Q Did you have any limitations on your 3 activities? 4 A I did. I think there was a period of 5 time I couldn't drive. 6 Q And did you follow the instructions 7 that you were given? 8 A I did. 9 Q How long did your recovery period 10 after your implant surgery last? 11 A I think it was about a month. 12 Q Okay. Any problems or complications 13 during that time? 14 A No. 15 Q Did you have any follow-up visits with 16 Dr. Costa after your implant surgery? 17 A I did. 18 Q Do you recall when? 19 A I don't recall the date, but I know I 20 went back there and I had to do the cystogram. 21 Q Was this in 2004? 22 A Yes. 23 Q A couple of weeks later, a month later 24 would you say? 25 A I think it was within the month. Page 109 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 26 of 29 1 Q Okay. And you did some testing. Is 2 that what you said? 3 A Right. 4 Q Did you have any problems at that 5 visit? 6 A No, I didn't. 7 Q Did you have any other follow-up 8 visits with him in 2004? 9 A I think I did. I think there were a 10 couple of follows-ups to that. 11 Q Did you have any problems at either of 12 those visits? 13 A No. 14 Q And did your incontinence go away at 15 least for a period of time? 16 A It did. 17 Q And did that make things easier for 18 you in your life? 19 A Yes. 20 Q Did you -- were you able to do outdoor 21 housework and stuff like that -- 22 A Yes. 23 Q -- more easily? 24 A Yes. 25 Q Okay. So you weren't leaking at all Page 110 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 27 of 29 1 after the surgery? 2 A No. 3 Q Were you happy about that? 4 A Yes. 5 Q Your incontinence was resolved until 6 2009? 7 A Yes. 8 Q So you had around five years without 9 it -- 10 A Yes. 11 Q -- is that fair to say? Okay. When 12 your incontinence came back in 2009, were you 13 confused based on Dr. Costa's telling you that it 14 was supposed to be a permanent solution? 15 A I was concerned because I thought it 16 was going to be permanent. 17 Q Did you tell any doctors that you were 18 concerned about that in 2009? 19 A When I went back to see Dr. Costa. 20 Q And did he tell you -- what did he say 21 when you told him that? 22 A I don't think he made a comment about 23 it, just skipped on to something else. 24 Q But you asked him why your 25 incontinence was back? Page 111 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 28 of 29 1 A I think I told him I was having 2 problems again with the incontinence. 3 Q Did you tell him you were concerned 4 because you thought it was going to be permanent? 5 A I don't know if I used those exact 6 words, but I did think it was a permanent 7 solution. 8 Q He didn't respond to your concern? 9 A No. 10 Q Again, before your implant surgery, he 11 didn't guarantee that your incontinence would be 12 cured forever, did he? 13 A No, he didn't. 14 Q Did you understand that surgery 15 doesn't always work at the time? 16 A I understand there are always risks -- 17 Q Did you understand that -- 18 A -- of surgery. 19 Q Okay. And did you understand that one 20 of the risks is that the procedure might not do 21 what it's intended to do? 22 A I understand that now, but then, no, 23 because it was presented as a permanent solution, 24 so I didn't think that it wasn't going to work. 25 Q Okay. You didn't understand that for Page 112 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-5 Filed 10/24/16 Page 29 of 29 EXHIBIT C Case 4:14-cv-00098-CDL Document 36-6 Filed 10/24/16 Page 1 of 9 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA 2 COLUMBUS DIVISION 3 - - - - 4 RE: Mentor Corp. ) 5 OBTAPE TRANSOBTURATOR ) MDL NO. 2004 SLING PRODUCTS ) 6 LIABILITY LITIGATION ) ) 7 ********************* ) ******************** ) Civil Action No. 8 MARY FLAHERTY, ) 4:14-cv-00098-CDL ) 9 Plaintiff, ) ) 10 Vs. ) ) 11 MENTOR WORLDWIDE, ) LLC, ) 12 ) Defendant. ) 13 14 - - - - 15 VIDEOTAPED DEPOSITION OF: FRANK JOSEPH COSTA, M.D. 16 - - - - 17 DATE: Monday, August 15, 2016 18 19 LOCATION: Urology Institute of Pittsburgh 4225 Northern Pike 20 Monroeville, PA 15146 21 TAKEN BY: Defendant 22 23 REPORTED BY: Julie A. Gerano Notary Public 24 25 Job No. CS2354824 Page 1 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-6 Filed 10/24/16 Page 2 of 9 1 VIDEOTAPED DEPOSITION OF FRANK JOSEPH COSTA, M.D. a witness, called by the Defendant for examination, in 2 accordance with the Federal Rules of Civil Procedure, taken by and before Julie A. Gerano, a Court Reporter and 3 Notary Public in and for the Commonwealth of Pennsylvania, at the offices of Urology Institute of 4 Pittsburgh, 4225 Northern Pike, Monroeville, Pennsylvania, on Monday, August 15, 2016, commencing at 5 3:04 p.m. 6 - - - - 7 8 APPEARANCES: 9 FOR THE PLAINTIFF 10 Ryan S. MacLeod, Esq. ARNOLD & ITKIN, LLP 11 6009 Memorial Drive Houston, TX 77007 12 P 713-222-3800 Tpeebles@arnolditkin.com 13 14 FOR THE DEFENDANT 15 Madeline B. Dennis, Esq. TUCKER ELLIS, LLP 16 950 Main Avenue, Suite 1100 Cleveland, OH 44113 17 P 216-696-5801 Madeline.dennis@tuckerellis.com 18 19 20 21 22 23 24 25 Page 2 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-6 Filed 10/24/16 Page 3 of 9 1 women to get urinary tract infections. It is 2 something that happens with the relative 3 frequency? 4 Q. If a postmenopausal woman was not on any form 5 of hormone replacement therapy, would that 6 increase her risk of predisposition to UTI's? 7 A. I believe it would. 8 ATTORNEY MACLEOD: Objection, form. 9 Q. We talked about the mechanisms by which a 10 sling can cause UTI's, that being urethral 11 erosion, urinary retention and you mentioned 12 something about vaginal sutures from a 13 surgery? 14 A. I was just -- I mean, I have never -- I was 15 stating only in that that is something that is 16 also really considered a foreign body but 17 usually they dissolve and are not an issue. 18 Q. The sutures? 19 A. Right. 20 Q. Is there any other mechanism that you can 21 think of -- 22 A. Just what I just explained. 23 Q. -- by which the ObTape would cause the UTI? 24 A. Not that I can think of. 25 Q. You mentioned that she didn't have any signs Page 96 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-6 Filed 10/24/16 Page 4 of 9 1 of urinary retention, correct? In fact, she 2 was emptying quite well? 3 A. Um-hmm. 4 Q. Do you have any reason to suspect that the 5 ObTape sling was the cause of this UTI? 6 A. No. 7 ATTORNEY MACLEOD: Objection, form. 8 Q. The next page is from February 6, 2010 and it 9 looks like there was a procedure planned that 10 she couldn't have because he was on oral 11 Zyzox. Do you have any idea what procedure 12 might have been planned other than the 13 procedure on the next page that happened in 14 the end of March? 15 A. Well, I think that was probably the one that 16 she didn't have done on the 6th of January. 17 It was probably rescheduled and then she 18 didn't have that done. 19 Q. The surgery that you performed on March 26, 20 2010 included an cystoscopy, a bladder biopsy 21 and a holmium laser ablation of bladder 22 lesions. Do you recall -- can you tell by 23 looking at this why you might have performed 24 that procedure? 25 A. Well, because she claimed she had a recurrent Page 97 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-6 Filed 10/24/16 Page 5 of 9 1 infection and she had some leakage that 2 redeveloped. I thought that -- I actually -- 3 if you see where it says intrinsic sphincter 4 deficiency, I had suspected that maybe her 5 valve itself, the sphincter valve may not have 6 been totally working as it should and I wanted 7 to try to determine if there were any 8 intrinsic lesions in the bladder including 9 erosion of the sling, which I did not see at 10 that time. She had a little inflamed area in 11 the posterior wall of the bladder. 12 A biopsy came back negative. That 13 wouldn't be anything near the sling anyway, so 14 it wouldn't be involved with that. The sling 15 is in the urethra. This is in the posterior 16 wall of the bladder, so it is not anywhere 17 near there. 18 Q. Intrinsic sphincter deficiency, what causes 19 that? 20 A. I don't know that we know what causes that. 21 That is basically a weakness -- sometimes you 22 have a neurologic issue that can cause that. 23 That wouldn't be the case in her situation. 24 That would be when the valve itself has lost 25 its ability to contract and act like a valve Page 98 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-6 Filed 10/24/16 Page 6 of 9 1 and it just is lax. 2 Q. It is almost a weakness of that valve? 3 A. Correct. 4 Q. Is that caused by suburethral slings? 5 A. Is that what? 6 Q. Can that be caused by a suburethral sling? 7 A. No. 8 Q. The bladder lesions that you -- why did you 9 perform holmium laser ablation? 10 A. She had a little -- and that may have just 11 been from her infection. She had a little 12 inflammation. Sometimes it is like having a 13 little pustule and when you laser it, they 14 heal faster. 15 Q. You think that could have been related to her 16 urinary tract infection? 17 A. I am sure it was. 18 ATTORNEY MACLEOD: Objection, form. Go 19 ahead. 20 Q. The fact that it lists recurrent urinary tract 21 infections -- in the records we have one 22 urinary tract infection -- 23 A. Right. I was just going by her history. 24 Q. It would have been something that she 25 reported? Page 99 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-6 Filed 10/24/16 Page 7 of 9 1 A. Right. 2 ATTORNEY MACLEOD: Objection, leading. 3 Objection, counsel testifying. 4 Q. Looking at the pathology record is there 5 anything remarkable there? 6 A. No, it was normal. 7 Q. As you said, you didn't find any sling 8 erosion, correct? 9 A. No. 10 Q. Did you see anything else abnormal about the 11 sling? 12 A. No, not at all or I would have mentioned it. 13 Q. So this procedure that you were performing in 14 March of 2010 was not related to plaintiff's 15 ObTape sling, correct? 16 A. It wasn't related in terms of -- I did this to 17 see there was any cause for her infection, 18 which could have been related to that but I 19 didn't find any evidence of that. I would 20 have suspected that if the sling would have 21 eroded, it would have happened within five or 22 six years and there was no evidence of that. 23 ATTORNEY MACLEOD: Objection, 24 nonresponsive. 25 Q. This surgery was sort of an exploring -- you Page 100 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-6 Filed 10/24/16 Page 8 of 9 1 were exploring -- 2 A. It really wasn't a surgery. It was a 3 diagnostic test. 4 Q. You were trying to understand why she was 5 having -- 6 A. Yeah. You want to make sure there is not a 7 source -- you know, a foreign body or even -- 8 erosion. I saw no evidence of that. 9 Q. The next one is a record -- and I believe this 10 is the last date that we have records from. 11 It is August 20, 2010. Do you have that one 12 in front of you? 13 A. Yeah. Um-hmm. 14 Q. It looks like she came in and had -- it says, 15 "Uroflow/bladder scan performed, yes. Then 16 the cystometrogram is filled out, No. 1, 2, 17 and 3? 18 A. Um-hmm. 19 Q. What can you tell me about this page. 20 A. Well, to me it doesn't look like this makes a 21 lot of sense. It says her first desire to 22 void was 25 cc's and her capacity was 50 cc's, 23 which we know based on her uroflow that she 24 had done this was either -- sometimes a 25 patient can have a bladder spasm and you Page 101 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:14-cv-00098-CDL Document 36-6 Filed 10/24/16 Page 9 of 9 EXHIBIT D Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 1 of 13 Taylor v. Danek Medical, Inc., Not Reported in F.Supp.2d (1998) 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 KeyCite Yellow Flag - Negative Treatment Disagreement Recognized by Becker v. Danek Medical, Inc., M.D.Fla., April 6, 1999 1998 WL 962062 United States District Court, E.D. Pennsylvania. Sandra TAYLOR, et al. v. DANEK MEDICAL, INC., et al. No. Civ.A. 95–7232. | Dec. 29, 1998. Attorneys and Law Firms Mark W. Tanner, Joseph L. Messa, Jr., Ominsky, Messa and Tanner, P.C., Phila, PA, Andrew D. Swain, Ominsky, Welsh and Steinberg, P.C., Phila, PA, Tara B. Dickerman, Ominsky & Messa, PC, Phila, PA, for Sandra Taylor, Plaintiff. Mark W. Tanner, Joseph L. Messa, Jr., Andrew D. Swain, Tara B. Dickerman, (See above), for Raymond Taylor, H/ W, Plaintiff. Stephen S. Phillips, Philip H. Lebowitz, Richard L. Chamovitz, Pepper, Hamilton and Scheetz, Phila, PA, for Danek Medical, Inc., Defendant. Stephen S. Phillips, Philip H. Lebowitz, Richard L. Chamovitz, (See above), for Sofamor, Inc., Defendant. Stephen S. Phillips, Philip H. Lebowitz, Anthony C.H. Vale, Pepper, Hamilton & Scheetz, Phila, PA, Richard L. Chamovitz, (See above), for Sofamor/Danek Group, Inc, Defendant. Norman P. Jeddeloh, Burditt & Radzius, Chicago, IL, Lauren E. Remick, Burditt and Radzius, Phila, PA, Thomas Shahriari, Porter, Wright, Morris and Arthur, Washington, DC, for American Academy of Orthopaedic Surgeons, Defendant. June J. Essis, Fineman & Bach, P.C., Phila, PA, Shawn M. Collins, the Collins Law Firm, Naperville, IL, for North American Spine Society, Defendant. Janet L. Mac Donell, Deutsch, Kerrigan & Stiles, New Orleans, LA, Robert E. Nord, Julie A. Harms, Michael J. Leech, Thomas F. Ging, Hinshaw and Culbertson, Chicago, IL, for Scoliosis Research Society, Defendant. Brad Twedt, Caroline P. Golden, John N. Scholnick, Neal, Gerber and Eisenberg, Chicago, IL, for GICD– USA, Defendant. Louis A. Bove, Bodell, Bove, & Van Horn, Philadelphia, PA, for Acromed Corporation, Charter Number 614043, Defendant. Louis A. Bove, (See above), for Acromed Corporation, (Now Acromed Corporation, Charter Number 614043), Defendant. Louis A. Bove, (See above), for Acromed Corporation, Charter Number 816942, Defendant. Louis A. Bove, (See above), for Acromed, Inc., Charter Number 811415, Defendant. Louis A. Bove, (See above), for Acromed Incorporated, (Now Acromed Inc., Charter Number 811415), Defendant. Louis A. Bove, (See above), for Acromed Holding Corporation, Charter Number 811416, Defendant. Louis A. Bove, (See above), for Acromed Corporation, (Now Acromed Holding Corporation, Charter Number 811416), Defendant. James J. Donohue, White and Williams, Philadelphia, PA, Michael R. Fruehwald, Barnes & Thornburg, Indianapolis, IN, for ACE Medical Company, Defendant. George J. Murphy, Hecker, Brown, Sherry and Johnson, Phila, PA, for Advanced Spine Fixation Systems, Inc., Defendant. Stanton E. Shuler, Jr., Leake and Andersson, New Orleans, LA, for Cross Medical Products, Inc., Defendant. James J. Donohue, Michael R. Fruehwald, (See above), for Depuy–Motech, Inc., Defendant. J. Kurt Straub, Obermayer, Rebmann, Maxwell & Hippel, LLP, Philadelphia, PA, Jeffrey L. Steinbach, Baltimore, MD, for Scientific Spinal, Defendant. Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 2 of 13 Taylor v. Danek Medical, Inc., Not Reported in F.Supp.2d (1998) 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 Brian P. Quirk, Montgomery, Barnett, Brown, Read, Hammond & Mintz, New Orleans, LA, for Smith & Nephew Richards, Inc., Defendant. Robert R. Reeder, Cozen & O'Connor, Phila, PA, for Synthes (U.S.A .), Defendant. Robert R. Reeder, (See above), for Synthes, Inc., Defendant. Robert R. Reeder, (See above), for Synthes North America, Inc., Defendant. Francis P. Burns, III, Lavin, Coleman, O'Neill, Ricci, Finarelli & Gray, Phila, PA, Leslie S. Rogers, Baker & Daniels, Indianapolis, IN, for Zimmer, Inc., Defendant. Michelle Hart Yeary, Pepper Hamilton, LLP, Phila, PA, David Richman, Stephen S. Phillips, Pepper, Hamilton & Scheetz, Phila, PA, for Sofamor, S.N.C., fka Sofamor, S.A., Defendant. Carl A. Henlein, Brown, Todd and Heyburn, Louisville, KY, Arthur W. Hankin, Blank Rome Comisky & McCauley LLP, Philadelphia, PA, Charles M. Pritchett, Brown, Todd and Heyburn, Louisville, KY, Mary Ross Terry, Rebecca A. Dernberger, Douglas W. Langdon, Brown, Todd & Heyburn, PLLC, Louisville, KY, for Youngwood Medical Specialties, Inc. fka National Medical Specialty, Inc. fka Stuart Medical Specialty, Inc., Defendant. Robert R. Reeder, Cozen & O'Connor, Phila, PA, for Synthes, A.G., Chur, Defendant. MEMORANDUM BRODERICK, J. *1 This is a bone screw case. Plaintiff Sandra Taylor and her husband claim damages arising out of the implantation of the Cotrel–Dubousset (“CD”) system in Mrs. Taylor's spine during surgery on April 10, 1992. Defendants Danek Medical, Inc., Sofamor S .N.C., Sofamor–Danek and Sofamor Inc. (collectively “Sofamor”) are the manufacturers of the CD device. Defendant Youngwood Medical Specialties, Inc. f/ k/a National Medical Speciality, Inc., f/k/a Stuart Medical Speciality, Inc. (“Youngwood”) is the distributor. Presently before the court are Defendant Sofamor and Defendant Youngwood's motions for summary judgment. For the reasons which follow, the Court will grant in part and deny in part Defendants' motions for Summary Judgment. The material facts concerning which there are no genuine issues are summarized as follows: Mrs. Taylor, a nurse, injured her back while moving a patient in 1985 and injured it again while turning a patient in November 1991. An MRI performed by Dr. John Manning on January 25, 1992 revealed disk degeneration, bulging, and a small disk herniation, all at the L5–S1 level. Mrs. Taylor worked with Dr. Richard A. Balderston, M.D., an orthopedic surgeon, and on February 19, 1992, she came under his care. By March 3, 1992, her lower back pain, which radiated into her buttocks and posterior lateral thighs, had become so severe that she stopped working. Dr. Balderston diagnosed Plaintiff Taylor with instability at L5–S1 and she was scheduled for lumbar decompression and fusion surgery, with instrumentation. On April 10, 1992, Dr. Balderston performed surgery on Mrs. Taylor at Pennsylvania Hospital and implanted a Cotrel Dubosset (“CD”) device in Mrs. Taylor's spine. The device consists of screws, hooks, rods, transverse traction devices and connection components that allow surgeons to fashion a customized construct for each surgical case. The purpose of the construct is to align and immobilize the spine while the bone graft material grows together to form a solid, bony fusion. Dr. Balderston used a surgical technique, “pedicle fixation,” placing two screws in the sacrum and two screws in the pedicles of L5 to attach CD rods to Mrs. Taylor's spine. Following this procedure, Mrs. Taylor continued to suffer from a constant pain in her lower back without any relief. Mrs. Taylor also stated that after her surgery, her lower back pain was sharper and the pressure was higher. She further testified that the pain was worse than it was prior to surgery. For several years after her April 1992 surgery, Mrs. Taylor continued to experience pain. Dr. Edward J. Vresilovic removed the device from Mrs. Taylor's spine on March 13, 1997. While the fusion was explored and found to be solid bilaterally, Dr. Vresilovic implanted titanium cages and iliac crest bone graft at L5–S1. Mrs. Taylor continues to experience pain. Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 3 of 13 Taylor v. Danek Medical, Inc., Not Reported in F.Supp.2d (1998) 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 On October 2, 1996, Plaintiffs Sandra and Raymond Taylor filed an Amended Complaint alleging fraud on the FDA (Count I); civil conspiracy (Count II); concert of action (Count III); fraudulent marketing and promotion (Count IV); negligent misrepresentation (Count V); strict liability (Count VI); liability per se (Count VII); negligence (Count VIII); breach of implied warranty of merchantability (Count IX); and loss of consortium (Count X). Defendants Sofamor and Youngwood filed separate motions for summary judgment on Counts IV through X. Plaintiffs have opposed the motions. The CD Device *2 The CD device is a prescription medical device which is only available to the general public through a prescribing physician. The United States Food and Drug Administration (“FDA”), through the Food Drug and Cosmetic Act (“FDCA”) and Medical Device Amendments (“MDA”), regulates the marketing and labeling of medical devices, such as the CD device. See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (discussing history of the MDA). The MDA requires classification of medical devices into three categories based upon the risk that they pose to the public. Class I devices present no unreasonable risk of illness or injury and are subject only to general manufacturing controls. See 21 U.S.C. § 360c(a) (1)(A). Class II devices are potentially more harmful and are subject to federal performance regulations. Id § 360c(a)(1)(B). Class III devices present a potentially “unreasonable risk of illness or injury,” and are subject to the strictest regulation. Id. § 360c(a)(1)(C). Before a new Class III device may be introduced into the market, the manufacturer must provide the FDA with a “reasonable assurance” that the device is both safe and effective. Id. § 360e(d)(2). Securing this “premarket approval” is an arduous and time-consuming task, because each submission requires an average of 1,200 hours of FDA review. See Lohr, 518 U.S. at 477. The premarket approval process requires a manufacturer to submit, and the FDA to review: all available information concerning all investigations of the device's safety and effectiveness; detailed information regarding the device's design, components and principles of operation; a full description of manufacturing methods and controls; and a full statement of marketing plans. See 21 U.S.C. § 360e(c) (1). There are three important exceptions to the requirement that Class III medical devices receive premarket approval before being placed on the market. First, a manufacturer can obtain an Investigational Device Exemption (“IDE”), which allows limited use of an experimental medical device to gather the type of data necessary to support a premarket approval application. See 21 U.S.C. § 360j(g). Though an IDE allows use of a class III device in clinical trials, it does not permit introduction to the general public. Second, the MDA allows Class III devices that were in commerce prior to its enactment to remain on the market until the FDA initiates and completes a premarket approval analysis for those “predicate” devices. See id. § 360e(b)(1)(A). This “grandfathering” provision reflects Congress' recognition “that existing medical devices could not be withdrawn from the market while the FDA completed its PMA analysis for those devices.” Lohr, 518 U.S. at 477–78. Third, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices wait for FDA approval, and to ensure that improvements to existing devices are introduced quickly, the MDA allows devices that are “substantially equivalent” to an existing predicate device to avoid the premarket approval process. See Lohr, 518 U.S. at 478; 21 U.S.C. § 360e(b)(1)(B). The procedure a manufacturer follows to take advantage of this exception is known as the “ § 510(k) process” after the number of the relevant section in the original Act. Lohr, 518 U.S. at 478. A § 510(k) application must include information supporting the device's substantial equivalence to a predicate device and proposed labeling for the device. See 21 C.F.R. § 807.87. For a device to be approved under the § 510(k) process, the FDA must determine that the new device has the same intended use as the predicate device and that it possesses the same technological characteristics or is as safe and effective as the predicate device. See 21 U.S.C. § 360c(I)(1)(A). The advantage of the § 510(k) process is significant to manufacturers: review of a § 510(k) application by the FDA requires an average of only twenty hours of agency time, compared to the 1,200 hours required for full pre- market approval. See Lohr, 518 U.S. at 478–79. *3 In 1987, Sofamor, acting through Stuart Medical Specialty (now Youngwood), submitted a premarket notification to the FDA requesting § 510(k) clearance to market the CD device, which included a vertebral Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 4 of 13 Taylor v. Danek Medical, Inc., Not Reported in F.Supp.2d (1998) 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 screw component. On December 7, 1987, the FDA rejected the vertebral screw component of Sofamor's application, determining that the CD device's vertebral screws represent “new device designs and methods of posterior spinal fixation which raise new questions of safety and effectiveness.” FDA Letter attached as Defense Ex. D1. The FDA characterized the vertebral screws as Class III devices requiring premarket approvals before they could be marketed. Id. Several of the CD device components, however, including the CD rods and the sacral screws, were cleared for marketing by the FDA. Id. Standard for Summary Judgment The parties agree that the law of Pennsylvania is applicable to this diversity case. Pennsylvania is where Mrs. Taylor had her surgery, and where she currently lives and continues to experience back pain. Federal Rule 56 dictates that a court shall grant summary judgment “if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed.R.Civ.P. 56(c). A disputed factual matter is a genuine issue “if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A fact is material if it might affect the outcome of the lawsuit under the governing substantive law. Id. When ruling on a motion for summary judgment, the Court must view the evidence in the light most favorable to the non-movant. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). The Court must accept the non-movant's version of the facts as true, and resolve conflicts in the non-movant's favor. Big Apple BMW, Inc. v. BMW of North American, Inc., 974 F.2d 1358, 1363 (3d Cir.1992), cert. denied, 507 U.S. 912 (1993). In response to a motion for summary judgment, the non- moving party has the burden to “do more than simply show that there is some metaphysical doubt as to the material facts.” Matsushita, 475 U.S. at 586. The non- moving party may not rely on bare assertions, conclusory allegations or suspicions. Fireman's Ins. Co. of Newark v. DuFresne, 676 F.2d 965, 969 (3d Cir.1982). Rather, the non-movant must then “make a showing sufficient to establish the existence of every element essential to his case, based on the affidavits or by the depositions and admissions on file .” Harter v. GAF Corp., 967 F.2d 846, 852 (3d Cir.1992). In order to defeat a motion for summary judgment, the non-moving party must produce evidence which “set(s) forth specific facts showing that there is a genuine issue for trial.” Fed.R.Civ.P. 56(e). The “mere existence of a scintilla of evidence” to support the non-movant's position is not enough to defeat the summary judgment motion. Anderson, 477 U.S. at 252. Plaintiffs' Claims Count I *4 Count I, entitled “Fraud (on the FDA)” alleges a state fraud claim. Plaintiffs allege Defendants misrepresented to the FDA the intended use of the screws. Count I was dismissed by the transferee court on two grounds. In re: Orthopedic Bone Screw Prod. Liab. Litig., MDL 1014, 1997 WL 305257 (E.D.Pa. March 1997). First, the transferee court determined that allowing a fraud on the FDA claim would essentially create a private right of action for violation of the FDCA and that “any grant of an implied private right of action would be contrary to the letter and spirit of the statute.” Id. at * 2. Second, the transferee court determined that dismissal of plaintiffs' fraud on the FDA claims was warranted under Fed.R.Civ.P. 12(b)(6) because “the alleged fraud cannot be said to have been a proximate cause of plaintiffs' alleged injuries.” Id. at * 4. Plaintiffs appealed. On November 17, 1998, the Third Circuit reversed the transferee court. In re: Orthopedic Bone Screw Prod, Liab, Litig., 159 F.3d 817 (3d Cir.1998). The Third Circuit analyzed the transferee court's decision in light of the Supreme Court case Medtronic, Inc, v. Lohr, 518 U.S. 470 (1996). In reversing the transferee court's first ground, the Third Circuit held that “refusing to entertain ... fraudulent misrepresentation claims solely because the statutory scheme does not contain a private cause of action would be the equivalent of finding preemption of the state law claims contrary to the clear holding of Lohr.” Id. at 825. With respect to the transferee court's second ground, the Third Circuit concluded that the transferee court erred in determining that all of the MDL 1014 plaintiffs had failed to allege a legally sufficient causal nexus. The Third Circuit held that district courts must determine whether case specific plaintiffs have alleged Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 5 of 13 Taylor v. Danek Medical, Inc., Not Reported in F.Supp.2d (1998) 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 a causal nexus only after the controlling law has been identified in each case. Id. at 327. On December 1, 1998, Defendants filed a petition for rehearing en banc in the Third Circuit. Meanwhile, Plaintiffs Sandra and Raymond Taylor filed a motion in this Court to reinstate their fraud on the FDA claim. Defendants' motions for summary judgment do not address any claims in Count I. Count II Count II alleges two conspiracies by the defendants. See In Re: Orthopedic Bone Screw Prod. Liab. Litig. 1997 WL 186325 * 7 (E.D. Pa. April 1997). The first conspiracy alleges misrepresentations to the FDA in the documents submitted to obtain § 510(k) clearance for the medical device. Id. The second conspiracy alleges fraudulent and deceptive conduct which actively concealed material facts from surgeons who attended medical seminars. Id. On November 10, 1998, this Court severed and stayed the first conspiracy claim pending a decision by the Third Circuit on similar claims which had been appealed and by that same Order this Court dismissed the second conspiracy claim with the approval of the parties. *5 Defendants' motions for summary judgment do not address any claims in Count II. Count III Count III, which is labeled “Concert of Action” alleges fraudulent and deceptive conduct and is apparently based on the Restatement (Second) of Torts § 876. Insofar as the count alleges fraudulent and deceptive conduct which actively concealed material facts from surgeons who attended medical seminars, it was dismissed by this Court's Order of November 10, 1998, without any objection from the parties. Insofar as the count alleges misrepresentations to the FDA in the documents submitted to obtain § 510(k) clearance for the medical devices, it has been severed and stayed by this Court's Order of November 10, 1998, pending a decision by the Third Circuit on the viability of such claims. Defendants' motions for summary judgment do not address any claims in Count III. Count IV In Count IV, entitled “Fraudulent Marketing and Promotion,” Plaintiffs appear to allege a state fraud claim. Plaintiffs allege that Sofamor and Youngwood failed to disclose to surgeons that the FDA had not cleared the CD device for commercial distribution as a pedicle screw fixation device; that the Investigational Device Exemption clinical trials failed to produce reliable and scientific evidence that the CD device was safe and effective; and “that the incidence of painful and disabling complications known to be associated with the use of the CD device for pedicle screw fixation was not established by valid and reliable scientific evidence.” Amended Complaint ¶ 211. In sum, Plaintiffs allege the Defendants fraudulently failed to disclose the risks concerning the use of CD device for pedicle instrumentation. Defendants contend they are entitled to summary judgment because Plaintiffs have provided no evidence of causation or justifiable reliance on any alleged misrepresentation. Under Pennsylvania law, the elements of fraud are: (1) a representation; (2) which is material to the transaction at hand; (3) made falsely, with knowledge of its falsity; (4) with the intent of misleading another into relying on it; (5) justifiable reliance; and (6) resulting injury which was proximately caused by reliance. Gibbs v. Ernst, 647 A.2d 882, 889 (Pa.1994). Plaintiffs' theory is that, without Defendants' fraudulent representations to a surgeon, a surgeon would not have implanted the CD device in Plaintiff. The fact that the alleged misrepresentations were made to the surgeon and not directly to Mrs. Taylor is not a bar to her claim. Pennsylvania has adopted the Restatement (Second) of Torts. Section 310 of the Restatement (Second) makes it clear that “an actor who makes a misrepresentation is subject to liability to another for physical harm which results from an act done by ... a third person in reliance upon the truth of the representation....” As the Restatement (Second) indicates, however, Plaintiff must prove reliance on the Defendants' alleged misrepresentations. *6 The Third Circuit has provided guidance on what constitutes sufficient evidence of reliance. See Stanton by Brooks v. Astra Pharmaceutical Prod. Inc., 718 F.2d 553 (3d Cir., 1983) (Becker, J.). In Stanton, the Third Circuit discussed the evidence which formed a legally sufficient causal connection between a drug Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 6 of 13 Taylor v. Danek Medical, Inc., Not Reported in F.Supp.2d (1998) 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 manufacturing defendant's misleading conduct and the plaintiff's injury. While couched in terms of causation rather than reliance, the Stanton Court concluded that the testimony of four well qualified expert witnesses allowed the jury to infer that physicians receiving the correct information would have considered such information in deciding how and whether to use the drug on their patients. Id. at 569. Plaintiffs have not come forward with any evidence that surgeons receiving the correct information would have considered such information in deciding how and whether to use the device on their patients. While Plaintiffs have submitted several expert reports, these reports present no evidence of reliance. Therefore, this Court will grant summary judgment to the Defendants on Count IV on the ground that the non moving party (the Plaintiffs) may not rely on the allegations of the complaint, but must come forward with evidence which will establish the existence of every element essential to Plaintiffs' case. Plaintiffs have presented no evidence of “justifiable reliance” and have therefore failed to produce evidence of an essential element of their claim. Count V In Count V, entitled “Negligent Misrepresentation/402B of the Restatement of Torts (Second),” Plaintiffs allege that Defendants Sofamor and Youngwood failed to exercise reasonable care to assure that representations regarding the CD device were accurate, truthful, complete and not misleading. Section 402B of the Restatement (Second) of Torts provides: One engaged in the business of selling chattels who, by advertising, labels or otherwise, makes to the public a misrepresentation of a material fact concerning the character or quality of a chattel sold by him is subject to liability for physical harm to a consumer of the chattel caused by justifiable reliance upon the misrepresentation, even though: (a) it is not made fraudulently or negligently, and (b) the consumer has not bought the chattel from, or entered into any contractual relation with the seller. Pennsylvania adopted this provision of the Restatement in Klages v. General Ordnance Equip. Corp., 367 A.2d 304 (Pa.1977). An essential element of this claim is justifiable reliance. See Restatement (Second) of Torts § 402B. Comment j reads “The rule here stated applies only where there is justifiable reliance upon the misrepresentations of the seller, and physical harm results because of such reliance, and because of the fact which is misrepresented.” As this Court discussed with respect to Count IV, Plaintiffs have failed to come forward with any evidence of justifiable reliance on the alleged misrepresentations by the Defendants. As Plaintiffs have failed to produce evidence of an essential element of their claim, this Court will grant summary judgment for the Defendants on Count V, on the ground that the non-moving party may not rely on the allegations of the complaint, but must come forward with evidence which will establish the existence of every element essential to Plaintiffs' case. Plaintiffs have presented no evidence of “justifiable reliance” and have therefore failed to produce evidence of an essential element of their claim. Count VI *7 In Count VI of the Amended Complaint, entitled “Strict Liability in Tort,” Plaintiffs allege design defect (¶ 224), manufacturing defect (¶ 225), and failure to warn (¶¶ 226–230) claims. Pennsylvania has adopted Section 402A of the Restatement (Second) of Torts. Under Pennsylvania law, the elements of strict liability are: (1) the product was defective; (2) the defect was the proximate cause of plaintiff's injuries; and (3) the defect causing the injury existed at the time the product left the seller's hands. Pavlik v. Lane Limited/Tobacco Exporters International, 135 F.3d 876, 881 (3d Cir.1998). Design Defect Defendants contend they are entitled to summary judgment on the design defect claim because Plaintiffs have failed to produce evidence of a design defect and that the defect was the proximate cause of Mrs. Taylor's pain. As this Court noted above, two essential elements of any products liability claim are proof of an actual defect in Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 7 of 13 Taylor v. Danek Medical, Inc., Not Reported in F.Supp.2d (1998) 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 7 defendants' product and that the defect was the proximate cause of plaintiff's injuries. Davis v. Berwind Corp. 690 A.2d 186, 190 (Pa.1997). Under Pennsylvania law as it exists today, the Pennsylvania Supreme Court has interpreted the strict liability provisions of Section 402A of the Restatement (Second) of Torts as being inapplicable to prescription drugs. Hahn v. Richter, 673 A.2d 888, 891 (Pa.1996). It is clear that the Supreme Court of Pennsylvania has ruled that the negligence standard that was used in Hahn is applicable to prescription drugs. Id. The Supreme Court of Pennsylvania recognizes that prescription drugs present a unique set of risks and benefits in that what may be harmful to one patient may be beneficial to another. The Court stated in Hahn: “Comment k, titled ‘Unavoidably unsafe products,’ denies application of strict liability to products such as prescription drugs, which, although dangerous in that they are not without medical risks, are not deemed defective and unreasonably dangerous when marketed with proper warnings.” Id. Therefore, this Court predicts that the Pennsylvania Supreme Court will determine, pursuant to its reasoning in Hahn, that prescription medical devices are likewise not covered by Section 402A of the Restatement (Second) of Torts. Summary judgment will therefore be granted to Defendants on Plaintiffs' design defect claim under Section 402A of the Restatement (Second) of Torts. Furthermore, it is of interest to note that the Restatement (Third) of Torts: Products Liability states: A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients. Restatement (Third) of Torts: Products Liability § 6(c) (1998). This section incorporates the “learned intermediary rule” which has been recognized in Pennsylvania's negligence cases. See Incollingo v. Ewing, 282 A.2d 206 (Pa.1971). It is also this Court's prediction that the Supreme Court of Pennsylvania will eventually adopt Section 6(c) of the Restatement (Third) of Torts: Products Liability. Under the standard set forth in the Restatement (Third) of Torts, Products Liability, Defendants are likewise entitled to summary judgment in that Plaintiffs have not come forward with any evidence which would support a claim that “the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.” *8 For the above reasons, summary judgment will be granted to Defendants on Plaintiffs' strict liability design defect claim. Manufacturing Defect In their opposition to Defendants' summary judgment motions, Plaintiffs neither contend, nor provide any evidence, in support of their manufacturing defect claim. As heretofore discussed, to defeat a summary judgment motion, the non-moving party cannot rest on the allegations in the complaint, but must make a showing sufficient to establish the existence of every element essential to her case. Since Plaintiffs have failed to come forward with evidence of essential elements of their claim, this Court will grant summary judgment for Defendants on the manufacturing defect claim. Furthermore, as heretofore pointed out, this Court predicts that the Supreme Court of Pennsylvania will determine, pursuant to its reasoning in Hahn, that prescription medical devices are not covered by § 402A of the Restatement (Second) of Torts. Failure to Warn Plaintiffs' Amended Complaint alleges a failure to warn claim under strict liability. (¶¶ 226–230). As the Pennsylvania Supreme Court stated, in Hahn v. Richter, 673 A.2d 888, 890 (Pa.1996): In Incollingo v. Ewing, where the manufacturer of a prescription drug was alleged to have caused injury by providing inadequate warnings to physicians about dangers associated with use of the Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 8 of 13 Taylor v. Danek Medical, Inc., Not Reported in F.Supp.2d (1998) 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 8 drug, the manufacturer's duty to exercise reasonable care in providing adequate and proper warnings was recognized by this court. Negligence, not strict liability, was alleged as the basis for recovery. We noted that under comments j and k strict liability was not applicable to the case. We further stated: Since the strict liability rule of § 402A is not applicable, the standard of care required is that set forth in § 388 of the Restatement dealing with the lability of a supplier of chattel known to be dangerous for its intended use. Under this section, the supplier has a duty to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous. (internal citations omitted) (emphasis in original). It is clear, therefore, that where the adequacy of warnings associated with prescription drugs is at issue, negligence is the only recognized basis of recovery. Id. at 891. The Supreme Court of Pennsylvania recognizes that prescription drugs present a unique set of risks and benefits in that what may be harmful to one patient may be beneficial to another. Therefore, this Court predicts that the Pennsylvania Supreme Court will determine, pursuant to its reasoning in Hahn, that prescription medical devices are likewise not covered by Section 402A of the Restatement (Second) of Torts. Summary judgment will therefore be granted for Defendants on Plaintiffs' failure to warn claim under Section 402A of the Restatement (Second) of Torts. Again, it is of interest to note that the Restatement (Third) of Torts: Products Liability states: *9 A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to: (1) prescribing and other health- care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or (2) the patient when the manufacture knows or has reason to know that health-care provider will not be in a position to reduce the risks of harm in accordance with the instructions or warnings. Restatement (Third) of Torts: Products Liability, § 6(d)(1998). This section incorporates the “learned intermediary rule” which has been recognized in Pennsylvania's negligence cases. See Incollingo v. Ewing, 282 A.2d 206 (Pa.1971). It is also this Court's prediction that the Supreme Court of Pennsylvania will eventually adopt Section 6(d) of the Restatement (Third) of Torts: Products Liability. Under the standard set forth in the Restatement (Third) of Torts, Products Liability, Defendants are likewise entitled to summary judgment in that Plaintiffs have not come forward with any evidence which would support a claim under Section 6(d). For the above reasons, summary judgment will be granted to Defendants on Plaintiffs' strict liability failure to warn claim. Count VII In Count VII, titled “Liability Per Se,” Plaintiffs allege that Defendants violated provisions of the FDCA and MDA which caused harm to Plaintiff. Specifically, Plaintiffs allege Defendants violated 21 U.S.C. § 331 which reads: The following acts and the causing thereof are prohibited: (a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded. (b) The adulteration or misbranding or any food, drug, device or cosmetic in interstate commerce. (c) The receipt in interstate commerce of any food, drug, device or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise. Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 9 of 13 Taylor v. Danek Medical, Inc., Not Reported in F.Supp.2d (1998) 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 9 Under the FDCA, “a ... device shall be deemed to be adulterated” with respect to an intended use if it is a Class III device which has not received premarket approval or § 510(k) clearance with respect to that intended use. See 21 U.S.C. § 351(f). The FDCA provides that “a ... device shall be deemed to be misbranded” unless its labeling bears “adequate directions” for the intended use of the device including indications, effects, relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purposes for which it is intended. See 21 U.S.C. § 352(f); 21 C.F.R. §§ 801.4, 801.109. In sum, Plaintiffs allege Defendants marketed and sold the CD screws for pedicle fixation in the lumbar spine before the FDA cleared that intended use and in doing so violated the FDCA's provisions on adulteration and misbranding. *10 Negligence per se is a claim based on violation of a statute or regulation. See Cecile Indust. Inc., v. United States, 793 F .2d 97 (3d Cir.1986). When a statute or regulation provides that under certain circumstances particular acts shall or shall not be done, it may be interpreted as fixing a standard for all members of a community, from which it is negligence to deviate. Under Pennsylvania law, negligence per se consists of four elements: (1) the purpose of the statute must be, at least in part, to protect the interest of a group of individuals, as opposed to the public generally; (2) the statute or regulation must clearly apply to the conduct of the defendant; (3) the defendant must violate the statute or regulation; and (4) the violation of the statute or regulation must be the proximate cause of the plaintiff's injuries. Id. at 99–100. Regarding the first requirement, the Pennsylvania Supreme Court has stated that the purpose of the asserted statute or regulation must be: (a) to protect a class of persons which includes Plaintiff; (b) to protect the particular interest which is invaded; (c) to protect that interest against the kind of harm which has resulted and (d) to protect that interest against the particular hazard from which the harm results. Congini by Congini v. Portersville Valve Co., 470 A.2d 515, 517–18 (Pa.1983), quoting Restatement (Second) of Torts, § 286 (1965). In the instant case, the first two elements of negligence per se have been established. The FDCA and MDA were enacted “to provide for the safety and effectiveness of medical devices intended for human use.” Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). Plaintiff, as the ultimate user of a regulated medical device, is among the class of persons intended to be protected by the FDCA and MDA. In addition, the FDCA and MDA were enacted to protect Plaintiff from the particular hazard which resulted in Plaintiff's harm. As to the second element, the FDCA and MDA clearly apply to the alleged conduct of the Defendants. See, e.g., In Re: Orthopedic Bone Screw Prod. Liab. Litig., 159 F.3d 817 (3d Cir.1998). As the Third Circuit has recently pointed out, “a district court, having jurisdiction of the parties and the subject matter, cannot decline to enforce liability imposed by relevant state common law.” In Re: Orthopedic Bone Screw Prod. Liab. Litig., 159 F.3d 817, 824 (3d Cir.1998). The relevant state common law applicable to this count is negligence per se. With respect to the third element, the Plaintiffs have submitted evidence that, as of the date of Mrs. Taylor's surgery, Sofamor and Youngwood had not received FDA clearances to market screws for use in the pedicles of the lumbar spine. Plaintiffs have attached deposition testimony from surgeons showing that screws were delivered into interstate commerce for use in the pedicles of the lumbar spine. As to the fourth element, that the violation of the statute must be the proximate cause of Plaintiff's injury, Plaintiffs' expert Dr. Magdy Shady has concluded in his report that the screws used in the pedicles of the Mrs. Taylor's lumbar spine are the cause of her continued pain. *11 It appears, therefore, that Plaintiffs have come forward with evidence as to each element of a negligence per se claim under Pennsylvania law. Therefore, this Court will deny the defendants' motions for summary judgment in view of the fact that the Plaintiffs have raised genuine issues of material fact in connection with the negligence per se claim. Count VIII Count VIII of the Amended Complaint is entitled “Negligence.” Negligence is the doing of some act which a reasonably prudent person would not do, or the failure to do something which a reasonably prudent person would do. It is the failure to use the ordinary care a reasonably prudent person would use under the same or Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 10 of 13 Taylor v. Danek Medical, Inc., Not Reported in F.Supp.2d (1998) 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 10 similar circumstances. The plaintiff has the burden of proving not only that the defendant deviated from the standard of care, but that the defendant's negligence was the proximate cause of plaintiff's injuries. Plaintiffs have alleged negligence by Sofamor and Youngwood as follows: producing a device that was poorly designed (¶ ¶ 246–7); failing to conduct adequate tests and studies (¶ 248); failing to provide appropriate warnings (¶ 249); and failing to obtain proper regulatory clearances (¶ 251). The Court has determined that the first three allegations of negligence fall into two distinct categories and will discuss them under the headings “negligent design” and “negligent failure to warn.” With respect to the last allegation of negligence, failure to obtain proper regulatory clearances, this Court has already determined that failing to obtain proper regulatory clearances is the basis of Plaintiffs' negligence per se claim. Therefore, the discussion in Count VII is applicable to this allegation and the Court will not repeat the discussion here. The Defendants' motions of summary judgment will be denied on the ground that Plaintiffs have raised genuine issues of material fact in connection with Plaintiffs claim of failure to obtain proper regulatory clearances. Negligent Design As heretofore pointed out, in response to Defendants' motions for summary judgment, the Plaintiffs must come forward with evidence that the Defendants engaged in conduct that deviated from the general standard of care expected under the circumstances, and that this deviation proximately caused Plaintiffs actual harm. As evidence of negligence, Plaintiffs have produced the report of Dr. Harold Alexander. The transferee court has already ruled that Dr. Alexander is qualified to testify “on matters concerning orthopedic bioengineering and its related disciplines” including “biomechanics, biomaterial, biomedical engineering, and design and analysis of device research.” In Re Orthopedic Bone Screw Prod. Liab. Litig., 1997 WL 39583, * 3 (E.D.Pa. Jan. 23, 1997). In his report, Dr. Alexander states: Experts in the biomechanics of lumbar fusion, publishing in Spine in 1995 have ... proposed that the following specific actions should have been initiated: 1) Perform FEM studies of a complete fusion construct, including adjacent levels in different kinds of fusions with or without spinal instrumentation. 2) Perform diagnosis-specific clinical trials. These should be prospective an multicenter in nature. 3) Study the mechanical environment, particularly the strain magnitude and direction, to maximize fusion potential. 4) Resorbable devices should be studied because this alleviates potential long term problems associated with spinal implants. 5) The mechanical characteristics of different regions of the spine should be studied to assess differences in the potential for graft failure. 6) Because mechanical factors may affect bone induction, they should be studied in the presence of growth factors. *12 Plffs Ex 2 at 1–2. Dr. Alexander concludes: “These activities should have been initiated before the widespread use of these devices.” Id. Thus, Dr. Alexander states an opinion as an expert in orthopedic bioengineering that the CD device with pedicle screw fixation at the time of Plaintiff's surgery had been inadequately tested. In addition to providing evidence of negligence, Plaintiff must come forward with evidence that the manufacturer's negligence was the proximate cause of Plaintiff's injury. As the Court discussed earlier, the report of Dr. Shady concludes, in pertinent part, that “Ms. Taylor's increased pain was caused by the CD pedicle screw instrumentation.” Therefore, in response to Defendants' summary judgment motions, Plaintiffs have come forward with evidence of negligence and proximate cause, thereby raising a genuine issue of material fact as to whether Defendants' product was negligently designed and that this negligence caused Mrs. Taylor's injuries. Defendants' motions for summary judgment will be denied with respect to the negligent design claim on the ground that Plaintiffs have come forward with evidence which establishes the existence of each element of their claim. Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 11 of 13 Taylor v. Danek Medical, Inc., Not Reported in F.Supp.2d (1998) 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 11 Failure to Warn The learned intermediary rule was first applied by the Pennsylvania Supreme Court in Incollingo v. Ewing, 282 A.2d 206, 220 (1971). In describing the duty of manufacturers with respect to prescription drugs, the Court stated “[s]ince the drug was available only upon prescription of a duly licensed physician, the warning required is not to the general public or to the patient, but to the prescribing doctor.” Id. It is established under Pennsylvania law that a prescription drug manufacturer may meet its duty to warn by providing an adequate warning to a learned intermediary. Mazur v. Merck & Co. Inc. 964 F.2d 1348, 1355 (3d Cir.1992). Prescription drug manufacturers provide information about the risks of medicines “to the person who most needs and can best evaluate it—the physician.” Id. at 1357. As heretofore pointed out, this Court predicts the Supreme Court of Pennsylvania would apply the same learned intermediary doctrine to medical devices which can only be acquired by a physician's prescription. The Pennsylvania Supreme Court has formulated the prescription drug manufacturer's duty to warn under the Section 388 “reasonableness” standard of the Restatement (Second) of Torts. Mazur, 964 F.2d at 1354; see also Hahn v. Richter, 673 A .2d 888 (Pa.1996). Section 388 states: One who supplies directly or through a third person a chattel for another to use is subject to liability to those who the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied if the supplier ... fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous. *13 Restatement (Second) of Torts, § 388. The Plaintiffs must come forward with evidence that Defendants failed to exercise reasonable care in warning the learned intermediary, and that the failure to warn is the proximate cause of Mrs. Taylor's injury. Whether the warning was adequate depends on whether a learned intermediary, having considered the “the data supplied to him from the manufacturer, other medical literature, and any other sources available to him, and weighing that knowledge against the personal medical history of his patient,” would use his independent judgement to prescribe a medical device. Coyle v. Richardson–Merrell, Inc., 584 A.2d 1383 (Pa.1991). Generally, expert medical testimony is required to determine whether the drug manufacturer's warning to the medical community is adequate. See e.g., Demmler v. Smithkline Beecham Corp., 671 A.2d 1151, 1154 (Pa. Super 1996). Plaintiffs in this case have not called our attention to any expert who will testify that the package insert provided inadequate warning to a surgeon implanting a medical device. Plaintiffs have failed to come forward with any evidence that the Defendants' warning in this case was inadequate to discharge their duty to warn. The Defendants' motions for summary judgement in connection with negligent failure to warn will be granted on the ground that Plaintiffs have failed to come forward with evidence of an essential element of their claim. Count IX In Count IX of the Amended Complaint, entitled “Breach of Implied Warranty of Merchantability,” Plaintiffs allege that Defendants impliedly warranted to Plaintiff and Plaintiff's implanting surgeon that the CD device was merchantable. To establish liability for breach of an implied warranty of merchantability, the Plaintiff must prove Defendants' product failed to meet the definition of merchantable. Merchantable products must: “(1) pass without objection in the trade under the contract description; (2) in the case of fungible goods, [be] of fair average quality with the description; (3)[be] fit for the ordinary purposes for which such goods are used; (4) run, within the variations permitted by the agreement, of even kind, quality and quantity within each unit and among all units involved; (5)[be] adequately contained, packaged and labeled as the agreement may require; and (6) conform to the promises or affirmations of fact made on the container or label, if any.” 13 Pa. Stat. § 2314(b). This provision of the Code provides a remedy for the buyer of goods from a merchant. The implied warranty of Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 12 of 13 Taylor v. Danek Medical, Inc., Not Reported in F.Supp.2d (1998) 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 12 merchantability serves to protect buyers when the goods purchased are below commercial standards. As this Court noted earlier, the Pennsylvania Supreme Court has recently excluded prescription drugs from the applicability of Section 402A. Hahn v. Richter, 673 A.2d 888 (Pa.1996). The Hahn court specifically discusses comment k of the Restatement (Second) of Torts, entitled “unavoidably unsafe products,” and reasons that comment k denies application of strict liability to products such as prescription drugs, which have medical risks, but are not deemed defective and unreasonably dangerous when marketed with proper warnings. Id. at 890. The medical device at issue in this case is an “unavoidably unsafe product” within the meaning of comment k. *14 The very nature of prescription medical products which are considered “unavoidably unsafe products” precludes the imposition of a warranty of fitness for “ordinary purposes.” See e.g., Makripodis v. Merrell–Dow Pharm, Inc., 523 A.2d 374 (Pa.Super.1987). A patient's inability to assess and weigh the potential risks inherent in these products is precisely the reason that they are dispensed only by prescription, and that prescription medical product manufacturers have a duty to warn learned intermediaries, not the public or the patient. See Mazur v. Merck & Co., Inc., 964 F.2d 1348 (3d Cir.1992); Coyle v. Richardson–Merrell, Inc., 584 A.2d 1383 (Pa.1991). Because Pennsylvania does not recognize strict liability claims for prescription medical products and applies the learned intermediary doctrine, this Court predicts that the Pennsylvania Supreme Court would exclude a cause of action based on the implied warranty of merchantability for prescription medical devices. This Court will grant Defendants' motions for summary judgment on Count IX on the ground that Plaintiffs cannot recover under the implied warranty of merchantability for prescription medical devices under Pennsylvania law. An appropriate Order follows. ORDER AND NOW, this 29th day of December, Defendant Danek Medical, Sofamor S.N.C., Sofamor–Danek and Sofamor Inc. (collectively “Sofamor”) and Defendant Youngwood Medical Specialties, Inc. f/k/a National Medical Speciality, Inc., f/k/a Stuart Medical Speciality, Inc. (“Youngwood”) having each filed motions for summary judgment and the Plaintiff having opposed; for the reasons stated in this Court's Memorandum of December 29, 1998; IT IS ORDERED: Defendant Sofamor and Defendant Youngwood's Motions for Summary Judgment are GRANTED as to Plaintiffs' fraudulent marketing and promotion claim in count IV, negligent misrepresentation/ Section 402B of the Restatement (Second) of Torts claim in count V, design defect, manufacturing defect, and failure to warn claims pursuant to Section 402A of the Restatement (Second) of Torts in count VI, negligent failure to warn claim in count VIII, and breach of implied warranty of merchantability claim in count IX, and judgment shall be entered in favor of Defendant Sofamor and Defendant Youngwood and against Plaintiffs with respect to said claims; IT IS FURTHER ORDERED: Defendant Sofamor and Defendant Youngwood's motions for summary judgment are DENIED as to Plaintiffs' negligence per se claim in count VII and negligent failure to obtain proper regulatory clearances and negligent design claims in count VIII. All Citations Not Reported in F.Supp.2d, 1998 WL 962062, Prod.Liab.Rep. (CCH) P 15,442 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:14-cv-00098-CDL Document 36-7 Filed 10/24/16 Page 13 of 13 EXHIBIT E Case 4:14-cv-00098-CDL Document 36-8 Filed 10/24/16 Page 1 of 7 Kramme v. Zimmer, Inc., Not Reported in F.Supp.3d (2015) 2015 WL 4509021, Prod.Liab.Rep. (CCH) P 19,657 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 KeyCite Yellow Flag - Negative Treatment Declined to Follow by Bors v. Johnson & Johnson, E.D.Pa., September 20, 2016 2015 WL 4509021 United States District Court, M.D. Pennsylvania. James KRAMMES and Deborah, Krammes, h/w, Plaintiffs, v. ZIMMER, INC. & Zimmer Holdings, Inc., Defendants. Civil Action No. 3:11–CV–00916. | Signed July 24, 2015. Attorneys and Law Firms James R. Ronca, Anapol Schwartz, Harrisburg, PA, Melissa F. Hague, Thomas R. Anapol, Anapol, Schwartz, Weiss & Schwartz, Philadelphia, PA, for Plaintiffs. Andrea R. Pierson, Baker & Daniels LLP, Indianapolis, IN, Mark E. Gebauer, Ecker Seamans Cherin & Mellott, LLC, Harrisburg, PA, for Defendants. MEMORANDUM KOSIK, District Judge. *1 Before the Court are Defendants' Motion to Dismiss Plaintiffs' Second Amended Complaint (Doc. 26). For the reasons which follow, the Court will grant in part and deny in part Defendants' motion to dismiss. I. PROCEDURAL HISTORY On May 16, 2011, Plaintiffs filed a Complaint (Doc. 1). Defendants filed their first Motion to Dismiss (Doc. 5), on July 14, 2011. On August 16, 2011, by Order of the United States Judicial Panel on Multidistrict Ligitation, the case was transferred to the Northern District of Illinois (Doc. 13). The case was then transferred back to the Middle District of Pennsylvania on July 11, 2014 (Doc. 14). Plaintiffs filed the Amended Complaint (Doc. 23), on November 21, 2014. The Counts in the Amended Complaint include: Count I–Strict Liability (Design Defect); Count II–Strict Liability (Manufacturing Defect); Count III–Negligent Failure to Warn; Count IV–Negligent Design Defect; Count V–Negligence; Count VI–Negligent Misrepresentation; and Count VII–Loss of Consortium. Defendants filed the instant motion to dismiss (Doc. 26), on December 22, 2014. After extensions of time were granted, the motion was briefed by both parties. On March 17, 2015, the Court heard oral argument on the motion. The motion is ripe for disposition. II. FACTUAL BACKGROUND The following facts are taken from Plaintiffs' Amended Complaint and are accepted as true for purposes of the instant motion. Plaintiffs allege that Defendants developed, designed, tested, manufactured, distributed, marketed and sold the Zimmer NexGen Legacy Posterior Stabalized porous femoral component with a LPS Flex articular surface (“LPS High Flex”) and the NexGen Trabecular Metal MIS Stemmed Tibial component (“MIS Tibial”), of the Zimmer NexGen total knee replacement system. (Doc. 23, Second Am. Compl., at ¶ 1.) On August 1, 2008, Plaintiff James Krammes's physician, implanted a Zimmer NexGen Knee system, including a LPS High Flex, with a porous femoral component, and a MIS Tibial. (Id. at ¶ 54.) Following the knee replacement, Mr. Krammes experienced pain and returned to his physician several times. (Id. at ¶ 57.) On or about August 24, 2009, x-rays revealed prosthetic loosening for the first time. (Id. at ¶ 58.) Mr. Krammes had a second surgery on September 30, 2009, to revise/replace the MIS Tibial and LPS High Flex, due to loosening. (Id. at ¶ 59.) During surgery, “Plaintiff's doctor discovered a lack of boney ingrowth with the femoral component, delamination of the tibia component and loosening of the posterior page.” (Id.) The implant was then revised with the Zimmer NexGen Legacy Posterior Stabilized (“LPS”) femur, extra stemmed length tibial component, and a LCCK spacer. (Id.) On June 23, 2010, Mr. Krammes had a third surgery to revise/replace the implant due to a possible nickel allergy. (Id. at ¶ 60.) In December 2009, Zimmer recalled certain lots of the MIS Tibial implant because of a manufacturing defect. Case 4:14-cv-00098-CDL Document 36-8 Filed 10/24/16 Page 2 of 7 Kramme v. Zimmer, Inc., Not Reported in F.Supp.3d (2015) 2015 WL 4509021, Prod.Liab.Rep. (CCH) P 19,657 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 (Id. at ¶ 45.) It was determined that the titanium portion of the implant was separating from the trabecular metal material of the implant, which would cause the implant to delaminate and the implant become loose while in the patient. (Id.) 846 implants were affected by the recall. (Id.) On March 10, 2010, the Food and Drug Administration classified Defendants' efforts as a Class II Recall. (Id. at ¶ 47.) III. STANDARD OF REVIEW *2 A motion under Rule 12(b)(6) allows the defendant to raise the defense that the plaintiff fails to state a claim upon which relief can be granted. Fed.R.Civ.P. 12(b)(6). Rule 8 of the Federal Rules of Civil Procedure provides that a pleading must set forth a claim for relief which contains a short and plain statement of the claim showing that the pleader is entitled to relief; the complaint must provide the defendant with fair notice of the claim. See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). The issue in a motion to dismiss is whether the plaintiff should be entitled to offer evidence to support the claim, not whether the plaintiff will ultimately prevail. See Phillips v. Cnty. of Allegheny, 515 F.3d 224, 232 (3d Cir.2008) (the Rule 8 pleading standard “simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence of the necessary element.”); Nami v. Fauver, 82 F.3d 63, 65 (3d Cir.1996). The onus is on the plaintiff to provide a well-drafted complaint that alleges factual support for its claims. “While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the ‘grounds' of his ‘entitle[ment] to relief’ requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555 (alteration in original and internal citations omitted). The Court need not accept unsupported inferences, Cal. Pub. Employees Ret. Sys. v. The Chubb Corp., 394 F.3d 126, 143 (3d Cir.2004), nor legal conclusions cast as factual allegations, Twombly, 550 U.S. at 556. Legal conclusions without factual support are not entitled to the assumption of truth. See Ashcroft v. Iqbal, 556 U.S. 662, 677–679, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (“Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not” satisfy the requirements of Rule 8). Once the Court winnows conclusory allegations from those allegations supported by fact, which it accepts as true, the Court must engage in a common sense review of the claim to determine whether it is plausible. This is a context-specific task, for which the Court should be guided by its judicial experience. The Court must dismiss the complaint if it fails to allege enough facts “to state a claim to relief that is plausible on its face.” Iqbal, 556 U.S. at 677 (quoting Twombly, 550 U.S. at 570). A “claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 677. IV. DISCUSSION Defendants assert several reasons why Plaintiffs' Amended Complaint should be dismissed. First, Defendants assert that Plaintiffs' non-negligence claims of strict liability fail as a matter of law. Second, Defendants argue that Plaintiffs' claim for negligent misrepresentation fails because it is insufficiently pled. Third, Defendants argue that Plaintiffs' negligent failure to warn, negligence, and negligent misrepresentation claims are barred by the learned intermediary doctrine to the extent Plaintiffs allege that Defendants negligently misrepresented or failed to warn Plaintiffs themselves or the general public. Fourth, Defendants argue that Plaintiffs' claims for negligent failure to warn, negligent design defect, and negligence are duplicative and fail to state a claim of negligent design defect. Lastly, Defendants argue that Plaintiffs' claim for punitive damages fails because Plaintiffs have not alleged the requisite “outrageous conduct.” A. Non–Negligence Claims (Counts I & II) *3 Defendants argue that Plaintiffs' strict liability design defect and manufacturing defect claims fail as a matter of law because manufacturers of prescription medical devices are not subject to strict liability under Pennsylvania law. Plaintiffs respond by arguing that the Pennsylvania Supreme Court in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa.2014), established a new dual analysis applicable to strict liability claims against Case 4:14-cv-00098-CDL Document 36-8 Filed 10/24/16 Page 3 of 7 Kramme v. Zimmer, Inc., Not Reported in F.Supp.3d (2015) 2015 WL 4509021, Prod.Liab.Rep. (CCH) P 19,657 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 manufacturers of prescription devices. Plaintiffs also argue that prescription medical devices are more similar to a car than prescription drugs, which would at least allow a strict liability manufacturing defect claim. Pennsylvania law recognizes three types of defects that can give rise to a strict liability claim: design defect, manufacturing defect, and warning defect. Doughtery v. C.R. Bard, Civil Action No. 11–6048, 2012 WL 2940727, *2 (M.D.Pa. July 18, 2012) (citing Phillips v. A–Best Prods. Co., 542 Pa. 124, 665 A.2d 1167, 1170 (Pa.1995)). Section 402A of the Restatement (Second) of Torts “imposes strict liability for products sold ‘in a defective condition unreasonably dangerous to the user or consumer.’ “ Doughtery, 2012 WL 2940727 at *2 (internal quotations omitted). Pennsylvania has adopted and applied comment k of section 402A to prescription drugs. See Hahn v. Richter, 543 Pa. 558, 673 A.2d 888 (1996) (finding that the principles set forth in comment k, denying application of strict liability, applies in failure to warn cases involving prescription drugs). Comment k limits liability for “unavoidably unsafe products.” Specifically, comment k states: There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. *4 See Restatement (Second) of Torts § 402A cmt. k. Although the Pennsylvania Supreme Court has not spoken as to comment k's applicability to prescription medical devices, lower Pennsylvania courts and federal courts have applied comment k to prescription medical devices. See Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa.Super.2006) (finding that the appellants do not cite authority to restrict Hahn or comment k to prescription drugs, and that they do not provide significant analysis of the language they do seek to apply). Plaintiffs assert that Tincher's new dual analysis approach to strict liability claims is applicable here. Defendants respond by arguing that Tincher is inapplicable because it is not a prescription drug or device case, and does not change or overrule Lance v. Wyeth, 624 Pa. 231, 85 A.3d 434 (Pa.2014), and Hahn. In Tincher, homeowners brought an action against the manufacturer of stainless steel tubing. See Tincher, 104 A.3d at 335 –36. The Tincher court held that “in Pennsylvania, the cause of action in strict products liability requires proof, in the alternative, either of the ordinary consumer's expectations or of the risk-utility of a product.” Id. at 401. The Pennsylvania Supreme Court cautiously noted that “[b]right lines and broad rules always offer a superficially enticing option. However, we cannot elevate the lull of simplicity over Case 4:14-cv-00098-CDL Document 36-8 Filed 10/24/16 Page 4 of 7 Kramme v. Zimmer, Inc., Not Reported in F.Supp.3d (2015) 2015 WL 4509021, Prod.Liab.Rep. (CCH) P 19,657 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 the balancing of interests embodied by the principles underpinning [the jurisprudence of the relevant area of law].” Id. at 406 (quoting Scampone v. Highland Park Care Ctr., LLC, 618 Pa. 363, 57 A.3d 582, 598 (Pa.2012)). We agree with Defendants that Tincher did not change the existing jurisprudence concerning strict liability with respect to prescription drugs and medical devices. Plaintiffs' alternative argument is that comment k is inapplicable to the strict liability manufacturing defect claim, since it is no different than any other case alleging a manufacturing defect in the manufacturing process affecting a certain lot. Although there is a consensus among courts that comment k applies to prescription medical devices for failure to warn and design defect claims, federal courts are split as to whether comment k applies to a manufacturing defect claim involving a prescription medical device. Compare Terrell v. Davol, Inc., Civ. Action No. 13–5074, 2014 WL 3746532, *3– 5 (E.D.Pa. July 30, 2014) (predicting that after Lance, the Pennsylvania Supreme Court would apply comment k to a manufacturing defect claim of a medical device), and Soufflas v. Zimmer, Inc., 474 F.Supp.2d 737, 748–50 (E.D.Pa.2007) (finding that prescription medical devices are “unavoidably unsafe” for purposes of all strict liability claims), and Parkinson v. Guidant Corp., 315 F.Supp.2d 741, 747 (W.D.Pa.2004) (discussing Hahn and predicting that the Pennsylvania Supreme Court would equally apply comment k to prescription medical devices, as it does to prescription drugs), with Doughtery, 2012 WL 2940727, *4–6 (discussing the policy behind comment k and prescription drugs and finding that “similar concerns about strict liability do not apply in the context of manufacturing defect claims,” and finding that Pennsylvania law does not preclude a strict liability claim based on a manufacturing defect). *5 Defendants argue though, that recent authority suggests that there is no longer a split as to whether comment k applies to strict liability manufacturing claims involving a medical device. Defendants point out that in Terrell, the district court specifically notes the split among the district courts, and states that the decisions allowing strict liability claims when a manufacturing defect is alleged to proceed, all pre-date Lance. The Terrell court found that, since the Pennsylvania Supreme Court in Lance did not distinguish a manufacturing defect claim from its statement that they have declined to extend strict liability into the prescription drug arena, then the Pennsylvania Supreme Court would not treat a manufacturing defect claim concerning prescription medical devices, any differently. See Terrell, 2014 WL 3746532, at *5. In Lance, the plaintiff brought negligence claims against a drug manufacturer for putting “an untenably dangerous product” into the marketplace. Lance, 624 Pa. 231, 85 A.3d at 451. The Pennsylvania Supreme Court noted that although for policy reasons, it “declined to extend strict liability into the prescription drug arena,” it did not immunize drug companies from other applicable Pennsylvania tort law. Id at 453. Additionally, the Pennsylvania Superior Court in Creazzo, after discussing Hahn, found “no reason why the same rational[e] applicable to prescription drugs may not be applied to medical devices.” Creazzo, 903 A.2d at 31. For these reasons, we predict that the Pennsylvania Supreme Court would apply comment k to prescription medical devices, as it is applied to prescription drugs. Therefore, we will dismiss Plaintiffs' strict liability claims. B. Negligent Misrepresentation (Count VI) Defendants next argue that Plaintiffs' claim for negligent misrepresentation should be dismissed because comment k also bars claims sounding in fraud, and alternatively, because Plaintiffs failed to plead the claim with particularity, as required by Rule 9(b) of the Federal Rules of Civil Procedure. Defendants argue that Plaintiffs must plead facts sufficient to place Defendants on notice of the precise misconduct at issue. Plaintiffs respond by arguing that they have made their allegations of fraud with sufficient particularity, and that if any gap exists, it is because the information involved lies solely within Defendants' possession. Under Pennsylvania law, to prove negligent misrepresentation, a plaintiff must prove: “(1) a misrepresentation of a material fact; (2) made under circumstances in which the misrepresenter ought to have known of its falsity; (3) with an intent to induce another to act on it; and (4) which results in injury to a party acting in justifiable reliance on the misrepresentation.” Bortz v. Noon, 556 Pa. 489, 729 A.2d 555, 561 (Pa.1999) (citing Gibbs v. Ernst, 538 Pa. 193, 647 A.2d 882, 890 (Pa.1994)). Additionally, Rule 9(b) states, “In alleging fraud or mistake, a party must state with particularity the Case 4:14-cv-00098-CDL Document 36-8 Filed 10/24/16 Page 5 of 7 Kramme v. Zimmer, Inc., Not Reported in F.Supp.3d (2015) 2015 WL 4509021, Prod.Liab.Rep. (CCH) P 19,657 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 circumstances constituting fraud or mistake. Malice, intent, knowledge and other conditions of a person's mind may be alleged generally.” Fed.R.Civ.P. 9(b). The United States Court of Appeals for the Third Circuit has noted that Rule 9(b) “requires plaintiffs to plead with particularity the ‘circumstances' of the alleged fraud in order to place the defendants on notice of the precise misconduct with which they are charged, and to safeguard defendants against spurious charges.” Kester v. Zimmer Holdings, Inc., Civ. No. 2:10–CV–00523, 2010 WL 2696467, *12 (W.D.Pa. June 16, 2010) (quoting Seville Indus. Mach. Corp. v. Southmost Mach. Corp., 742 F.2d 786, 791 (3d Cir.1984)). Although allegations of time, date or place satisfy the particularity requirements, a plaintiff can also satisfy the pleading requirements by pleading with a “degree of precision or some measure of substantiation into the fraud allegation.” Id. (quoting Frederico v. Home Depot, 507 F.3d 188, 200 (3d Cir.2007)). *6 In this case, we find that Plaintiffs met the pleading requirements of Rule 9(b). Plaintiffs' claim of negligent misrepresentation satisfies the purpose behind Rule 9(b). The allegations contained in Count VI and the preceding paragraphs of the Amended Complaint incorporated by reference, place the Defendants on notice of the misconduct at issue. Therefore, we will not dismiss Count VI of Plaintiffs' Amended Complaint. C. Negligence Claims (Counts III, IV, V & VI) Defendants next argue that Plaintiffs' claims for negligent failure to warn (Count III), negligence (Count V), and negligent misrepresentation (Count VI), should be dismissed to the extent Plaintiffs allege that Defendants negligently misrepresented or failed to warn Plaintiffs themselves or the general public, due to the “learned intermediary doctrine.” We agree. It is well settled that under Pennsylvania law, the learned intermediary doctrine requires the duty to run from the manufacturer of a prescription drug to the physician, and not to the patient or general public. Kline v. Pfizer, Inc., Civ. Action No. 08–3238, 2008 WL 4787577, *3 (E.D.Pa.2008) (citing Baldino v. Castagna, 505 Pa. 239, 478 A.2d 807, 812 (Pa.1984)). “Where the manufacturer provides proper warning to a consumer's physician, it will have discharged its duty to the consumer.” Bergstresser v. Bristol–Myers Squibb Co., Civ. Action No. 3:12–1464, 2013 WL 1760525, *5 (M.D.Pa. April 24, 2013). Plaintiffs do not deny such a rule. Instead, Plaintiffs argue that they included, throughout the Amended Complaint, allegations that Mr. Krammes's physician and other physicians, did not receiving such warnings. Therefore, to the extent Plaintiffs' negligent failure to warn, negligent misrepresentation, and negligence claims rest on allegations that Defendants failed to adequately warn Plaintiffs and the general public, these claims will be denied. Defendants also argue that Plaintiffs' claims for negligent failure to warn, negligent design defect, and negligence, should be dismissed because they are duplicative and fail to state a claim of negligent design defect. Defendants argue that Lance v. Wyeth limits negligence claims against a pharmaceutical company, to allegations that the company breached its duty of care by entering a product into the marketplace that is “too harmful to be used by anyone.” Plaintiffs respond by arguing that Lance v. Wyeth recognized a continuum of requirements that manufacturers must adhere to when putting a product on the market. We agree with the Plaintiffs. In Lance, the Pennsylvania Supreme Court did note that, “A company which is responsible for tendering into the market a drug which it knows or should know is so dangerous that it should not be taken by anyone can be said to have violated its duty of care either in design or marketing.” Lance, 624 Pa. 231, 85 A.3d at 458 (citing Brief for Amici Am. & Pa. Ass'ns for Justice at 3 (“[A] manufacturer's negligent conduct can occur at any stage of the marketing process: in the initial design of the drug, in the failure to investigate information about the risks the drug poses, and in its decision to continue to sell the drug despite those unreasonable risks.”)). We do not believe that the Pennsylvania Supreme Court intended to limit negligence claims to only those products too dangerous to be taken by anyone. The Lance court stated, “We agree with Appellee that this entire continuum is within the scope of the general framework of the applicable duty of care, while highlighting our disapproval of Wyeth's petition for manufacturer immunity at the most severe end of the scale.” Id. at 460. Therefore, we will not dismiss Plaintiffs' claims for negligent failure to warn, negligent design defect, or negligence. D. Punitive Damages *7 Lastly, Defendants argue that Plaintiffs' request for punitive damages should be dismissed because Plaintiffs Case 4:14-cv-00098-CDL Document 36-8 Filed 10/24/16 Page 6 of 7 Kramme v. Zimmer, Inc., Not Reported in F.Supp.3d (2015) 2015 WL 4509021, Prod.Liab.Rep. (CCH) P 19,657 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 fail to allege facts, that if proven, would establish that Defendants' conduct was malicious, willful, oppressive, or exhibited reckless indifference of the rights of others. We reserve this issue to be decided at a later time in these proceedings. V. CONCLUSION For the reasons set forth above, the Court will grant in part and deny in part, Defendants' motion to dismiss. An appropriate order will follow. All Citations Not Reported in F.Supp.3d, 2015 WL 4509021, Prod.Liab.Rep. (CCH) P 19,657 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:14-cv-00098-CDL Document 36-8 Filed 10/24/16 Page 7 of 7 EXHIBIT F Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 1 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 2002 WL 32747667 Only the Westlaw citation is currently available. Court of Common Pleas of Pennsylvania, Chester County. Paul A. LAWRENCE and Linda Lawrence v. SYNTHES INC., et al. No. 94–07627. | July 25, 2002. Attorneys and Law Firms Scott D. Levensten, for Plaintiffs. Robert R. Reeder, John T. Salvucci, and Denise M. Bense, for Defendant Synthes, Inc. Mary Ellen Reilly, and Francis J. Greek, for Defendant F. Todd Wetzel. Opinion MAHON, J. *1 AND NOW, this 22 nd day of July, 2002, on consideration of the Motions of the parties described below; the documents including written argument, photocopies of reported and unreported judicial decisions primarily adjudications of various of the United States District Courts, deposition transcripts and excerpts thereof, medical records, answers to written interrogatories, expert witness reports, and affidavits filed in support thereof; the responses and documents including written argument, deposition transcripts and excerpts thereof, medical records, minutes of meetings of various medical professional societies concerned with treatment of conditions of the spine, abstracts of articles appearing in medical journals, expert reports, industry and trade materials having to do with Defendant Synthes, Inc. and its products of manufacture, answers to interrogatories, photocopies or reported and unreported judicial decisions, and affidavits filed in opposition thereto; and following more than four (4) hours of oral argument conducted on April 19, 2001, we enter the following: OPINION A precis of the factual context of this litigation may be found in the opinion filed in support of the February 29, 2000 order of the Pennsylvania Superior Court; reversing the January 20, 1999 order of this court dismissing the Plaintiffs' 1 cause as barred by the applicable statutory period of limitations; and remanding the record for further proceedings. Paul and Linda Lawrence bring this action for the recovery of damages against appellee Synthes, Inc., for the injuries caused by defective screw devices, against F. Todd Wetzel, M.D. and the Milton Hershey Medical Center for malpractice and the failure to secure an informed consent. The underlying factual history of this litigation commenced on November 16, 1988, when appellant Paul Lawrence sought treatment of back and leg pain and was examined by appellee F. Todd Wetzel, M.D. After a course of seven months of tests and examinations, Dr. Wetzel performed a fusion upon the spine of appellant using the pedicle screw fixation device of appellee Synthes, Inc., composed of four screws and two plates. Appellant continued in the care of Dr. Wetzel until, at least, December 4, 1992, when he was seen by Nancy A. Brown, M.D. and Bruce Nicholson, M.D., upon referral by Dr. Wetzel and then, subsequently came into the care of James Morrissey, M.D., who performed a further spinal fusion procedure and attempted to remove the screws but was only partially successful. Appellants commenced the instant action on September 23, 1994 by writ of summons. Slip Op. at 1–2. Now before the Court are a series of pre-trial motions interposed by various parties to this litigation. The motions now ripe for decision include: 1) The Plaintiffs' motion for change of venue filed on March 15, 2000; 2) The motion of Defendants the Milton S. Hershey Medical Center (“Hershey”) 2 and Dr. F. Todd Wetzel M.D. (“Wetzel”) filed on December 18, 2000 3 for bifurcation; Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 2 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 *2 3) A dispositive motion for summary judgment filed on December 15, 2000 on behalf of Defendant Synthes, Inc. (“Synthes”) with respect to all of the Plaintiffs' claims; 4) The Plaintiffs' motion for partial summary judgment filed on December 15, 2000 against Defendant Synthes on the issues of failure to warn, negligence, negligence per se, negligent misrepresentation, and to create and impose a presumption of causation; 5) The motion of Defendants Hershey and Wetzel filed on December 18, 2000 for partial summary judgment with respect to the Plaintiffs' conspiracy claim; 6) The Plaintiffs' motion in limine filed on December 5, 2000 seeking “to preclude any reference [to] or reliance on the final rule [of the United States Food and Drug Administration (“FDA”) promulgated at] 63 [F.R.] 40023 et seq. (July 27, 1998)”; 4 7) The motion in limine of Defendants Hershey and Wetzel filed on December 18, 2000 5 to preclude the introduction at trial of hearsay evidence in the form of “published articles, textbooks and medical studies”; 8) The motion in limine of Defendant Synthes filed on January 18, 2001 and seeking to preclude the use at trial of such terms as “experimental”, “unapproved”, “investigational” and the like in referring to the Synthes devices here implanted in Paul Lawrence or to pedicle screws generally; 9) The motions in limine of all Defendants seeking to preclude the introduction at trial of the testimonial and other evidence prepared or offered by the Plaintiffs' expert witness Dr. Carl Larson, Ph.D.; 6 10) The motions in limine of all Defendants seeking to preclude the introduction at trial of the testimonial and other evidence prepared or offered by the Plaintiffs' expert witness Lance Yarus, D.O.; 7 and 11) The motions in limine of all Defendants seeking to preclude the introduction at trial of the testimonial and other evidence prepared or offered by the Plaintiffs' expert witness Harold Alexander, Ph.D.; 8 The extensive pre-trial record; which includes thousands of pages of transcribed depositions and documentary evidence as well as thorough research and written argument 9 with respect to each of the issues presented, reveals the factual background in considerable detail. A brief summary will suffice for these introductory purposes. This is one of hundreds of individual cases that were initiated throughout the Commonwealth in which certain medical devices; referred to variously as “orthopedic bone screws” and as “pedicle screws” on account of the particular structure of the spine (bony protuberances on each side of each vertebrae) in which they are inserted to provide stability and immobilization during the period immediately following spinal fusion surgery, are alleged to have injured the patients in whom they were implanted. Defendant Synthes attributes the timing and volume of litigation to a report aired in December 1993 on the ABC News television program “20/20”. 10 Appended hereto as Appendix “A” are excerpts from the transcript of the said television program which concerned, specifically, a medical device denominated the “Steffe Plate 11 and Screws 12 in recognition of their inventor and the former chairman of AcroMed, Corporation; 13 Dr. Arthur Steffe. AcroMed's device made the subject of the “20/20” broadcast, like the Synthes device here at issue, includes a metal plate and threaded fasteners or screws by which the plate is attached to the pedicles on either side of the spine thereby immobilizing and stabilizing the vertebrae so that fusion can occur. *3 Spinal fusion is a surgical procedure indicated for the most severe and intractable back pain (as well as certain other conditions and deformities not here involved) where more conservative measures and modalities have failed. A one-level fusion links or fuses together two vertebral bones on either side of an offending disk. A two-level fusion links or fuses together three vertebral bones with two intervening disks. In order to accomplish the fusion, 14 the surgeon typically “harvests” bone chips from the patient's hip 15 as was done in this case 16 and inserts these chips in the space between the vertebrae to be immobilized. 17 Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 3 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 The inserted bone chips cause the formation of new bone thereby “cementing” the adjoining vertebrae one to the other and eliminating the movement which is believed to be the origin of the patient's pain. A solid bridge of bone eliminates motion that normally would take place at the disc space and in the joints of the spine. Where this process is successful, the new bone weld or bridge is termed a “fusion” or “arthrodesis”. Where the surgery is unsuccessful on account of the failure of new bone to form as intended, the soft and flexible tissue that forms between the vertebrae instead of the intended bone is termed a “pseduarthrosis” which is insufficiently rigid to provide stability, prevent movement or, therefore, to eliminate the patient's pain. The causes of such failure are incompletely understood. However, it is well-established that patients who smoke tobacco are less likely to be able to form the desired bony fusion and are more likely to suffer from a psedoarthrosis following spinal fusion surgery. At the time of his surgery in June, 1989, Paul Lawrence was then smoking and had smoked for many years one and one- half to two packs of cigarettes per day. 18 According to the American Academy of Orthopedic Surgeons about 258,000 spinal fusions were performed in 1999: about 119.000 procedures involving the upper (cervical) spine; and about 139,000 involving the lower (lumbar) spine. An “instrumented fusion” is one in which the surgeon employs a device or combination of devices like those manufactured by Synthes and AcroMed for the purpose of stabilizing and immobilizing the spine to facilitate fusion. Prior to the widespread acceptance of instrumented surgeries, spinal fusion typically involved multi-staged surgical procedures requiring hospitalization for one month or more; and total immobilization of the patient by means of a heavy plaster full-body cast for periods up to a year; the initial eight to ten months of which period were spent bedridden. Bracing therapies were also then in use in which patients were isolated and immobilized both before and after surgery by confinement in unwieldy metal and plaster apparatus to which they were firmly attached from the backs of their heads down to their hips. Some scoliosis patients now uniformly treated by means of instrumented surgeries were then subjected to so-called “halo-femoral traction”, in which screws placed in their skulls and knees were increasingly pulled apart during weeks of torture in rotating hospital beds in an attempt, often unsuccessful, to mechanically straighten the spine. *4 Fusion surgery can be employed with respect to any region of the spine. The five (5) vertebrae and six (6) disks located in the lower back and connecting the upper spine to the pelvis are known as the “lumbar” spine. A lumbar fusion like that here at issue, can be achieved in a variety of ways and through several different approaches to the spine involving an incision through the patient's abdominal wall, flank, back, or a combination of these approaches. 19 In this context, the term “anterior” means “from the front” and “posterior” means from the back. Another technique often used in lumbar fusions involves placing a bone “graft” along the sides of the spine (with or without plates and screws); termed a “posterolateral” fusion. The surgeon's description of the procedure performed on Paul Lawrence on June 22, 1989 at the Hershey Medical Center is “Posterolateral fusion L4–5 using iliac crest bone graft and AO 20 instrumentation” referring to the particular lumbar vertebrae sought to be immobilized. 21 This case, together with several hundred similar cases initiated in this and other of the Commonwealth's Courts of Common Pleas “concerning claims for injuries arising from bone screws implanted in the pedicle during back surgery” was, by order of the Honorable Sandra Moss dated September 6, 1994, consolidated before the Court of Common Pleas of Philadelphia County to Docket No. 9408–0002 captioned In Re: Orthopedic Bone Screw Litigation, for purposes of pleading and discovery. In addition, more than 2,000 civil actions in which the plaintiffs alleged that they were injured by the implantation of orthopedic bone screws in the pedicles of their spines, were filed on behalf of over 5,000 individuals in approximately sixty of the ninety-four federal judicial districts; were consolidated in August, 1994 and docketed to MDL No. 1014 by the Multidistrict Litigation Panel pursuant to 28 U.S.C. § 1407; and were transferred to the United States District Court for the Eastern District of Pennsylvania for pretrial management before the Honorable Louis Bechtle, Judge. All of these cases; both state and federal were, following the completion of discovery, remanded to the transferor courts for adjudication of dispositive and other case-specific motions and, ultimately if required, for trial on the merits. The instant action was commenced by writ of summons filed on September 23, 1994 followed by a form complaint filed on July 20, 1995 and was subject to the jurisdiction Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 4 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 of the Philadelphia Court of Common Pleas during the period from the filing on October 27, 1994 of a praecipe for coordination until return of the record to this Court on February 9, 1995. As we have noted, the Plaintiffs are Paul Lawrence and his wife Linda; residents of Douglassville, Berks County since 1966, where they raised two sons. (Lawrence Dep. at 13). Paul Lawrence was born June 11, 1938 (Id. at 8); graduated from Owen J. Roberts High School in 1957 (Id. at 22); began working for a local manufacturing enterprise Dana Corporation, 24 in 1965 or 1966 (Id. at 23–24); 25 and worked there steadily until severe back pain required him to take a medical leave in 1988 (Id. at 42). The particular incident to which the Plaintiff attributes his initial back injury took place at work in February, 1985 when he lifted a box weighing some one hundred pounds 26 from a pallet and heard something “snap”. (Id. at 39). *5 The Plaintiff was initially treated conservatively by a chiropractor until April, 1986 and, thereafter, by a non-defendant physician until June, 1988 27 at which time his employer required a second medical opinion the substance of which was that the Plaintiff required surgical intervention. 28 The Plaintiff was then referred to the Defendant Milton S. Hershey Medical Center where he was examined by Defendant Dr. F. Todd Wetzel, M.D. 29 The Plaintiff was at that time experiencing continuous, severe pain. 30 Wetzel ordered various tests but was initially unable to reach a diagnosis. 31 A discogram 32 was ordered which provided compelling evidence to Wetzel that the source of the Plaintiff's pain was the disk at L–4/ L–5 and that the immediately adjacent disks both above and below were not causing any of the discomfort. 33 As we have indicated, on June 22, 1989, 34 Wetzel performed on the Plaintiff an instrumented lumbar spinal fusion at L–4/ L–5 implanting the Synthes plate and screw devices. 35 Wetzel predicted that a full year following surgery would be required for complete recuperation. 36 X-ray studies performed during and immediately following surgery as well as in August and September 1989 disclosed no structural abnormalities and proper alignment of the Synthes instrumentation. 37 When examined at the beginning of January 1990, the Plaintiff's reported symptoms indicated improvement. The sensation in the Plaintiff's back previously reported as severe pain and burning was apparently now described by him as “pressure” limited in frequency and duration to the period of daily exercises (which the Plaintiff, nevertheless, was apparently able to perform) and while walking. Relief could be obtained by pressing the affected area. 38 X-ray studies performed on the same date indicated no change from prior findings in September 1989. 39 By letter dated March 8, 1990 Wetzel predicted the Plaintiff's return to work in some limited capacity as early as the following month. 40 In early April 1990; just over nine months following surgery, the Plaintiff's leg pain; which had been a major complaint at the time he initially consulted with Wetzel, was “gone”. 42 X-ray studies then performed by Wetzel indicated satisfactory maturity of the bone graft and proper positioning of the Synthes instrumentation. 43 However, the Plaintiff continued to complain of an area of burning sensation in the lower back and an occasional burning sensation on the left side. 44 One month later, Wetzel concluded: “[the Plaintiff] was seen April 11, [1990] at which time he noted continuing back pain despite an apparently maturing arthrodesis. My plan at this time, is to wait for one full year [from the June 1989 surgery] and if the patient is not symptomatically improved, repeat discography to determine whether or not there is a continuing source of chemical 45 irritation.” 46 During the summer months of calendar 1990, the Plaintiff continued to complain of back pain and was evaluated by a number of physicians. 47 In correspondence dated July 18, 1990, following an office consultation with the Plaintiff that date, Wetzel opined that only repeat lumbar discography would allow a determination of whether the Plaintiff continued to suffer discogenic 48 pain. Alternatively, Wetzel suggested: “[I]f discography is negative, then I would suggest he consider an inpatient rehabilitation program such as the one offered at York.” 49 Diagnostic radiology performed on July 18, 1990 revealed no abnormalities in the lumbar spine, “heterotopic bone formation at the L4–5 transverse processes” and “no change in bony alignment or appearance of the hardware since April 11, 1990.” 50 Repeat discography performed on August 15, 1990 by Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 5 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 John Mayer, M.D. failed to elicit a concordant pain response thereby ruling out pain of discogenic origin. 51 Following an examination of the plaintiff on August 21, 1990 and review of the repeat discography results, Wetzel opined that: *6 “[t]his study was negative, thus indicating the pain complex which motivated his initial surgery has disappeared. However, he continues to remain symptomatic from a plethora of low back complaints. At this point, I am unable to isolate any particular reversible lesion to account for them. Thus, it is my conclusion that he is probably suffering from a myofascial syndrome, as his fusion has healed uneventfully. Due to the prolonged nature of his disability. I think an inpatient program, such as that offered at the Rehab Hospital of York, represents his only chance to resume any sort of functional status. Accordingly, I will arrange a referral to Dr. Louis Poloni.” 52 The medical consensus appears to have been that the Plaintiff could derive the most benefit from a program of narcotic medication detoxification and pain management for myofascial pain syndrome 53 and he was admitted for these programs to the Rehabilitation Hospital of York on January 2, 1991 under the care of Dr. Poloni. The Plaintiff's discharge from this facility, twenty-eight days later, was accompanied by a determination that his myofascial pain syndrome and analgesic dependency had been “resolved”. Wetzel's evaluation of the Plaintiff on February 13, 1991 included the observation that he was “mentally improved following Dr. Poloni's program and states he is walking better” 54 although continuing to complain of moderate pain in the iliac spine region i.e. the lower back. 55 X-ray studies performed at this time showed no changes from those of July 18, 1990. 56 The next month, Wetzel again examined the Plaintiff, reviewed recent x-ray studies and an evaluation by another orthopedic surgeon performed on March 8, 1991 57 and concluded that the Plaintiff had achieved all that medical treatment could offer including a reduction of symptoms to those manageable without further intervention. 58 There the matter remained for more than one year until the Plaintiff returned to Wetzel in March, 1992 complaining of what he described as a “new symptom” involving pain in the right buttock and hip which he attributed to an incident while he was hunting at his deer camp. 59 X-ray studies depicted a broken screw in the instrumentation implanted in June, 1989 which Wetzel did not then believe was causing the Plaintiff's symptoms. 60 A series of epidural steroid injections were ordered by Wetzel the first of which gave several days of symptomatic relief while the second was less successful and the series was discontinued. 61 Wetzel then ordered a diagnostic trial in a back brace which did not provide relief and, on that basis, Wetzel concluded that the Plaintiff's current symptoms were not related to the extent of post-surgical fusion at L/4–5 or the lack of it and that the presumptive diagnosis was “epidural fibrosis with a myofascial component.” 62 The Plaintiff was then referred to Hershey's pain management program where he was examined and, as he describes the consultation, was told that Wetzel would be contacted in writing and directed to conduct a more thorough examination of the Plaintiff. 63 When the Plaintiff heard nothing further from Wetzel he consulted with a Dr. Morrissey in December, 1992 and x-ray studies were ordered which revealed that two of the four Synthes screws used in Wetzel's instrumented fusion surgery had broken. In March, 1993 the Plaintiff underwent surgery performed by Morrissey in which the two intact screws and the heads of the two broken screws were removed and a second fusion of L/4–5 was attempted; uninstrumented on this occasion, using both autologous bone from the patient's right iliac crest as well as cadaver bone as the graft. 64 *7 In a later surgery by Dr. David Bosacco at Hahnemann Hospital, the remaining screw fragments were removed. 65 While the combined effect of the surgeries performed by doctors Morrissey and Bosacco was to reduce the Plaintiff's back pain to some extent, complete relief 66 was not obtained and the Plaintiff sought a further consultation with Dr. Douglas S. Tase of Commonwealth Orthopaedic Associates at the end of June and again in mid-August, 1997. 67 Dr. Tase ordered MRI studies 68 and another course of “diagnostic lumbar diskometrics with provocative discography” 69 following which the discographer opined: “I completely agree with the assessment of Dr. Tase, who is suspicious of an ongoing diskopathic low back condition....[T]his may well relate to chronic internal disk disruption syndrome....” 70 Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 6 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 Thereafter, Dr. Tase performed a third spinal fusion, using an anterior approach on this occasion, and implating three BAK “cages” to facilitate the formation of an arthrodesis. 71 Following complete recovery from this most recent surgery, the Plaintiff's condition was, by his report made during the course of the deposition conducted on October 2, 1998, “a little better”. 72 The pending motions must be resolved in this factual context. In the discussion that follows, those motions will receive attention in order of logical priority. Viewed in that light, Plaintiff's motion for a change of venue demands first consideration. As we have indicated, the Plaintiff seeks to return the matter to the Court of Common Pleas of Philadelphia County where it was coordinated for purposes of pleading and discovery. Defendants vigorously oppose the motion and emphasize the following. The litigation was initiated by Plaintiffs' in this court in September 1994. The motion for change of venue was not filed until November 27, 2000; following the transfer of the record to the Court of Common Pleas of Philadelphia County on November 3, 1994 to Docket No. 9408–002 pursuant to the coordination order of that Court dated June 8, 1994 and as one of several hundred orthopedic bone screw cases administered by the mass tort program of the civil division of that Court; the disposition of all pre-trial matters raised in the coordinated cases; the return of the record to this Court on February 9, 1995 pursuant to an order of the Philadelphia County Court of Common Pleas dated January 24, 1995; assignment of the matter to Judge MacElrco of this Court on May 16, 1996; trial listings on April 20, 1998, June 15, 1998, July 6, 1998, August 17, 1998, September 28, 1998, and February 1, 1999; the denial of initial defense motions for summary judgment on September 3, 1998; the interposition of renewed motions for summary judgment by defendants on November 25, 1998 raising statute of limitations issues; the grant of summary judgment to all defendants by order dated January 20, 1999; the perfection by Plaintiffs of an appeal to the Pennsylvania Superior Court by notice filed February 18, 1999; the certification to the appellate court of this court's record in response to a writ therefor on March 31, 1999; and the reversal of this court's determination by order of the Superior Court dated February 29, 2000. 73 Following denial of allowance of appeal by the Supreme Court 74 and remand of the record to this court, the matter was assigned to this writer on November 29, 2000; 75 and the pre-trial motions described above were filed by the parties. *8 It is well-established that “questions of personal jurisdiction, venue, and notice ... must be raised at the first reasonable opportunity or they are waived.” Kubik v. Route 252, Inc., 762 A.2d 1119, 1123 (2000) citing Commonwealth ex rel. Schwarz v. Schwarz, 252 Pa. Superior Ct. 95, 380 A.2d 1299, 1301 (1977). This test is not met by the instant motion filed more than five (5) years after the Plaintiffs first invoked this Court's jurisdiction. In addition, as we have emphasized, the choice of forum most recently challenged by Plaintiffs was Plaintiffs' own. Case Management Order No. 12; entered by the Philadelphia Court of Common Pleas to govern all orthopedic bone screw cases originally filed in counties other than Philadelphia and transferred to Philadelphia pursuant to Case Management Order No. 1, provides, in ¶ 4: “As of the date of completion of discovery in each case, non-Philadelphia cases are no longer coordinated under the Court of Common Pleas of Philadelphia County. The court of the county of origin shall assume jurisdiction over each non-Philadelphia case.” It is the clear mandate of the court to which Plaintiffs here seek to transfer the matter that it remain instead in Chester Countythe forum initially chosen by Plaintiffs. Plaintiffs also assert that a change of venue is proper for the convenience of the parties pursuant to Pa.R.C.P. No. 1006(d)(1). None of the Defendants or their witnesses, however, are located in Philadelphia County. The corporate headquarters of Synthes, Inc. is in Paoli, Chester County with a manufacturing facility located in Exton, Chester County. Hershey and Wetzel were, at the time, located in Lancaster County; Wetzel has since relocated to Chicago, Illinois; and, as we have indicated, Plaintiffs have been domiciled for many years in Berks County. No good reasons appears why a change of venue at this late juncture would benefit any of the parties and, therefore, the motion is denied. We next consider the motions of all Defendants to preclude or exclude the testimonial and other evidence of the plaintiffs' expert witnesses Larson, Alexander, and Yaros. Carl A. Larson Ph.D. received a bachelors of science degree in physics from Drexel Institute of Technology Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 7 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 7 in 1960, a masters of science degree in engineering from the University of Alabama in 1966, a license as a professional engineer from the State of Alabama in 1966, and a doctorate in biomedical engineering from Drexel University in 1973. From October 1979 until January 1992, Dr. Larson served as Director of the FDA's Surgical and Rehabilitation Devices Division with responsibility for the management of the regulatory review process related to orthopedic devices including the spinal instrumentation and pedicle screws here at issue. In a report to Plaintiffs' counsel dated November 16, 1988, Dr. Larson described the FDA's regulatory review process under the MDAs; the primary exceptions to the requirement for premarket authorization for Class III devices including the so-called “ § 510(k) application” in which the manufacturer attempts to demonstrate that the device in question is “substantially equivalent” to an approved or “predicate” device; 76 the requirement in all other cases of the submission to the FDA of “extensive preclinical and clinical data and rigorous analysis of that data” 77 in order to establish the safety and efficacy of the device which data is obtained through the use of the Investigational Device Exemption. *9 Synthes and Wetzel both contend that Larson's report described above is inadmissible to support the Plaintiff's claims because the expert witness is now deceased and is not available for cross-examination. We are constrained to agree. In Pompa v. Hojancki, 445 Pa. 42, 281 A.2d 886 (1971), Pompa was injured by an exploding beer bottle and sued the brewer, manufacturer, distributor, and retail seller thereof. Initially, Pompa retained the shards of glass from the exploding bottle which were provided to the defendants' expert for examination and then, apparently, returned. The expert conducted an examination of the shards and prepared a report to be used at trial with respect to the cause of the accident. The expert witness died before trial and the defendants retained another expert and sought from Pompa the shards to be reexamined. Pompa failed to produce the fragments, asserting that he no longer had them. The trial court imposed a sanction on Pompa for failure to produce the shards that the factual description of the bottle fragments contained in the deceased expert's report could be admitted at trial as the basis for an opinion to be developed by the defendants' successor expert. Trial was conducted in this manner, a defense verdict was returned, and Pompa appealed contending that it was error for the trial court to impose the sanction described. The Court reversed, holding that no sanction was justified inasmuch as Pompa disregarded no order or directive of the trial court and simply failed to produce that which he no longer possessed; and that the admission of an expert report, even limited to the factual statements contained therein, prepared for trial by a witness no longer available for cross-examination, violated the opposing party's fundamental right of confrontation. As the Court wrote: This appeal raises the question of the admissibility of the ‘factual statements' contained in an expert's report prepared for purposes of litigation. We hold that the report was inadmissible hearsay, vacate the judgment and remand for a new trial. * * * * There remains only the question whether the report was otherwise admissible. There can be no doubt that the report, prepared by Ghering before trial, was hearsay. McCormick, Evidence s 225 at 460 (1954). Furthermore, in light of the missing glass fragments, the ‘factual statements' in this report were offered in lieu of the only direct evidence which could explain the shattering of the bottle. The other evidence consisted of appellant's testimony, hospital records, and medical testimony as to the extent of injury. Appellee practically concedes that the report is inadmissible hearsay. The report cannot qualify as an exception to the hearsay rule under the Business Records Act.... Appellee [the bottle manufacturer] contends that in the absence of the factual statements of the report, appellee's defenses were substantially undermined. Even assuming appellee's contention to be correct, it provides no legal basis for admitting the report, prepared solely for the purposes of litigation. No cross- examination of the author of the report was possible. Furthermore, cross-examination of the second expert who testified on the basis of the prior report is no substitute. The possible distortions and inaccuracies which may have occurred during Ghering's [the first expert; deceased at the time of trial] examination of the original glass fragments would not be disclosed. Nor can the report be admissible on the theory of the best evidence rule. The rule is not intended to justify admission of evidence otherwise inadmissible under Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 8 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 8 other rules of evidence. See McCormick, Evidence §§ 195–209 (1954). It follows that the testimony of appellee's expert at trial, based on the admission of Ghering's report, was error. We find it unnecessary to reach appellant's other allegations of error. *10 Id. at 43, 46–47, 281 A.2d at 886, 888–889. To the same effect, see Semieraro v. Commonwealth Utility Equipment Corp., 518 Pa. 454, 457, 544 A.2d 46 46 (1988) (“It is well established that a report prepared by an expert who is not called to testify as a witness is hearsay.”). The Plaintiffs here offer no basis on which the rule in Pompa and Semieraro could be disregarded. Nor do they advance any ground justifying an abrogation of the Defendants' right of confrontation. It is true that witness Larson was deposed in the MDL litigation but the report at issue was prepared subsequent to that deposition. Moreover, Hershey and Wetzel contend that they did not participate in Larson's deposition and Synthes asserts that Larson made no mention in his MDL deposition of the DCP and cancellous screws here at issue. Plaintiff does not controvert these factual assertions. The Larson expert report must be excluded; the Defendants' motion in limine with respect thereto will be granted. The primary issue with respect to the evidence of expert witness Dr. Harold Alexander, Ph.D. has been resolved by Plaintiffs' agreement (confirmed during the oral argument conducted with respect to these motions) that the scope of witness Alexander's evidence would be limited to the mechanical and biomechanical properties of pedicle screw devices including the Synthes product here implanted in the Plaintiff; and would not encompass other matters including, particularly, any opinion concerning the medical cause of the Plaintiff's symptoms or injuries. Dr. Alexander's educational background includes a bachelors of science degree in aeronautical engineering from the school of engineering and science of the New York University in 1962, and a masters of science degree and doctorate degree in applied mechanics from the same institution in 1963 and 1967, respectively. In the period from 1986 to 1996, Dr. Alexander was employed as the director of the department of bioengineering and as a professor of orthopaedic surgery at the New York University School of Medicine. By Pretrial Order No. 725 entered by Judge Bechtle for the United States District Court for the Eastern District of Pennsylvania to MDL 1014, granted in part the motion in limine of the manufacturer defendants with respect to Dr. Alexander's proffered opinions, as follows: 1. To the extent that Dr. Harold Alexander's proffered opinions are within the strict limits of the elements that comprise the field of orthopedic bioengineering (biomechanics, biomaterials, biomedical engineering, and design and analysis of device research) the defendant's motion is DENIED. 2. To the extent that Dr. Harold Alexander's opinions are governed or require expertise in any scientific field not included in paragraph 1, of this Order, the motion is GRANTED. We understand the Plaintiff's stipulation to be consistent with Pretrial Order 725. As the opinion filed by Judge Bechtle in support of the order makes clear, “Dr. Alexander's expertise in bioengineering does not necessarily make him particularly qualified to make ... statements in the additional disciplines of law, medicine, orthopedics, FDA regulatory practice, conflicts of interest, market surveys, and clinical studies.” 78 We understand the stipulation to preclude evidence by Dr. Alexander properly categorized in any of these “additional disciplines”. Most importantly for our present purposes, we understand the stipulation to preclude evidence by Dr. Alexander having to do with the medical cause of the Plaintiff's injury, symptoms, or damages. *11 In the absence of such a stipulation we would have been required to impose a materially identical restriction on Dr. Alexander's evidence in the exercise of our function as “gatekeeper” pursuant to Pa.R.C.P.No. 702; an obligation we had recent occasion to further describe in the opinion filed on June 22, 2001 in support of our order in Riccio and Ramos et al. v. S & T Contractors et al., 49 Ches. Co. Rep. 265 (2001) as follows: There can be no doubt that among the duties of this Court is the performance of its function as a “gatekeeper” whenever science enters the courtroom and, particularly, when expert testimony relying upon novel scientific evidence is offered. As the Pennsylvania Superior Court explained in Blum v. Merrell Dow, 705 A.2d 1314, 1322 (Pa.Super.1997) aff'd 564 Pa. 3, 764 A.2d 1 (2000): [I]n dealing with complex scientific theories, cross- examination is not the appropriate tool to test the Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 9 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 9 speciousness or accuracy of the expert's testimony where the evidence on which that testimony is based is not deemed reliable.... [T]he judge as gatekeeper decides whether the expert is offering sufficiently reliable, solid, trustworthy science. The question is: is the science good enough to serve as the basis for the jury's findings of fact, or is it dressed up to look good enough, but basically [is] so untrustworthy that no finding of fact can properly be based on it. If the latter is true, the integrity of the trial process would be tainted were the jury to consider it. The United States Supreme Court discussed the necessity of this judicial role in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 592, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) in the following terms: Unlike an ordinary witness ... an expert is permitted wide latitude to offer opinions, including those that are not based on firsthand knowledge or observation.... Presumably, this relaxation of the usual requirement of firsthand knowledge—a rule which represents “a ‘most pervasive manifestation’ of the common law insistence upon” the most reliable sources of information, ... is premised on an assumption that an expert's opinion will have a reliable basis in the knowledge and experience of his discipline.” Id. (Citations omitted). In this Commonwealth, a determination of the reliability and, therefore, admissibility of scientific evidence requires the proponent to establish that the evidence concerns a matter which “has achieved ‘general acceptance’ in the relevant scientific community.” Blum v. Merrell Dow Pharmaceuticals, Inc., 564 Pa. 3, 764 A.2d 1 at *3 (Decided December 22, 2000). 79 As the Court explained in Frye: The rule is that the opinions of experts or skilled witnesses are admissible in evidence in those cases in which the matter of inquiry is such that inexperienced persons are unlikely to prove capable of forming a correct judgment upon it, for the reason that the subject-matter so far partakes of a science, art, or trade as to require a previous habit of experience or study in it, in order to acquire a knowledge of it. When the question involved does not lie within the range of common experience or common knowledge, but requires special experience or special knowledge, then the opinions of witnesses skilled in that particular science, art, or trade to which the question relates are admissible in evidence. *12 Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized, and while courts will go a long way in admitting expert testimony deduced from a well- recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs. Id. 293 F. at 1014. There is some uncertainty as to whether it is the witness' conclusion or methodology or both which must have achieved general scientific acceptance as a precondition to evidentiary admissibility. See, for example, the dissenting Opinion of Mr. Justice Cappy in Blum which includes the following discussion: The Superior Court is correct that this court has long interpreted Frye as requiring that the methodology employed by the testifying scientist be generally accepted in the scientific community. See e.g. Commonwealth v. Blasioli, 552 Pa. 149, 713 A.2d 1117, 1119 (1998). Yet, we have not stated that the conclusion reached by the scientist regarding causation must also be generally accepted in the scientific community. As noted by the Superior Court, this additional step in the Frye test—requiring that the conclusion also be generally accepted by the scientific community—was added by the Commonwealth Court in McKenzie v. Westinghouse Electric Corp., 674 A.2d 1167 (Pa.Commw.Ct.1996). I cannot find that this court, however, has endorsed this interpretation of the Frye test. Id. (Emphasis in the original). But compare the decisions of the Pennsylvania Superior Court Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 10 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 10 reported as Thomas v. West Bend Co., Inc., 760 A.2d 1174, 1176 (Pa.Super.2000) (approving the trial court's conclusion with respect to the proffered expert witness that “[n]either his exemplary qualifications, nor his extensive experience, nor the soundness of his methodology is sufficient to overcome the novelty of his scientific advance.”); Wack v. Farmland Industries. Inc., 744 A.2d 265 (Pa.Super.1999) appeal denied 565 Pa. 649, 771 A.2d 1287, 2001 WL 355678 (Pa. April 10, 2001) (Blum “recognized admissibility requires both the causal relationship and the methodology to be generally accepted by the scientific community”); Checchio v. Frankford Hospital—Torresdale Division, 717 A.2d 1058, 1060 (Pa.Super.1998) (“This court, following Topa, ruled that the analysis to be applied in answering the question of whether the Frye/Topa admissibility criterion had been met was two pronged; acceptance in the scientific community of first the causal; and then the methodological relationship alleged”). Whatever its intellectual interest and present indeterminacy in the decisions of our Supreme Court, the distinction between conclusory and methodological acceptance is of no moment here because: (1) the parties have neither raised nor briefed the issue; (2) the Superior and Commonwealth Courts (decisions of which are here controlling) have each clearly stated that general scientific acceptance must be an attribute of both; and (3) for the reasons discussed at length below, neither the method nor the causal conclusion proffered by the Plaintiff have achieved the consensus requisite to testimonial admissibility. *13 We note in closing on this preliminary issue that in those cases, like that here presented, which turn on scientific causation, the authorities are clear and uniform that the causal conclusion itself must be accepted as a general matter in the relevant scientific community before expert testimony of the existence of causality in the particular case may be properly admitted. See, for example. Blum (causal relationship between ingestion by the mother of the prescription drug Bendectin and fetal abnormalities i.e. teratogenic property of Bendectin); Commonwealth v. Dunkle, 529 Pa. 168, 602 A.2d 830 (1992) (causal connection between sexual abuse and a syndrome of child behaviors); Thomas v. West Bend Co., (causal relationship between low voltage shock and cardiomyopathy); Wack v. Farmland Industries, Inc. (causal relationship between ingestion of benzene contaminated drinking water and rare salivary gland cancer); Checchio v. Frankford Hospital, (causal relationship between neonatal respiratory distress and autism); McKensie v. Westinghouse Electric Corp. (causal connection between mother's exposure to gasoline additive contaminated groundwater and neonatal cardiac abnormalities). Commonwealth v. Miller, 367 Pa. Superior Ct. 359, 532 A.2d 1186 (1987) (causal connection between alcohol consumption and horizontal gazo nystagmus). See also Wimberly v. Wyeth Laboratories, Inc., 48 Leh.L.J. 47 (1998) (causal connection between use of Norplant contraceptive and patient's stroke); Trach v. Thrift Drug, Inc., 46 D. & C. 4 th 231 (Lehigh County 2000) (causal relationship between ingestion of Doxepin, an antidepressant, and the patient's glaucoma and cognitive difficulties). As the Commonwealth Court explained in McKensie v. Westinghouse Electric Corp.: In order for scientific testimony indicating that an event causes a particular result to be admitted, there must be a showing not that the studies establishing the causal relationship follow generally accepted methodologies, but that the existence of the causal relationship is generally accepted by the relevant medical community. Id. 674 A.2d at 1172. Riccio Ramos, 49 Ches. Co. Rep. at 267–270. Courts which have considered the admissibility of Dr. Alexander's opinions on such matters outside the realm of bioengineering as medical causality in bone screw litigation have concluded that his evidence must be excluded. Dyer v. Danek Medical, Inc., 115 F.Supp.2d 732 (N.D.Tex.2000); King v. Danek Medical, Inc., 37 S.W.3d 429, 2000 WL 311143 (Tenn.Ct.App.2000) appeal denied November 6, 2000; Schmerling v. Danek Medical, Inc., 1999 WL 712591 (E.D.Pa.1999); Harris v. Danek Medical, Inc., 1999 WL 1117106 (M.D.La.1999); Talley v. Danek Medical, Inc., 7 F.Supp.2d 725, 731 n. 5 Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 11 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 11 (E.D.Va.1998) aff'd 179 F.3d 154 (4 th Cir.1999); Cosom v. Danek Medical; Philadelphia Common Pleas Order filed October 12, 1999. As the court wrote in Schmerling v. Danek: *14 In a footnote, plaintiffs seek to bolster their position by suggesting that causation may otherwise be established by the report of Dr. Harold Alexander, a Ph.D. in applied mechanics. Plaintiffs rely on Judge Bechtle's Pretrial Order 725 in In re Orthopedic Bone Screw Litig., No. MDL 1014, 1997 WL 39583 (E.D.Pa. Jan.23, 1997) for this proposition. Their reliance is misplaced. The report of Dr. Alexander on which plaintiffs rely is a generic critique of spine fixation devices which was submitted in virtually all of the bone screw cases. It does not mention any of the moving defendants in this case or any of their products and does not address plaintiff or how any C–D instrumentation, much less bone screws implanted in 1994, caused her symptoms. Judge Bechtle found that Dr. Alexander was qualified to offer expert testimony in the field of biomechanics or bioengineering, but was not qualified to give testimony requiring expertise in any other field including “clinical complications of pedicle fixation.” See 1997 WL 39583, *2. See also Baker, 35 F.Supp.2d at 881 (finding Dr. Alexander's report did not create a triable issue of fact); O'Brien, 1999 WL 239414, *2 n. 4 (“Dr. Alexander cannot testify that [the C– D system] caused [plaintiff's] medical condition to worsen”). Id. at *9. Similarly, the Superior Court wrote in Hall v. Balderston, 748 A.2d 1258 (1999) appeal denied 563 Pa. 663, 759 A.2d 387 (2000). Dr. Alexander is not a medical doctor. He admitted he does not have any formal medical training. Significantly, Dr. Alexander has no experience allowing him to testify to medical causation i.e., the cause of pain or clinical complications, etc. We are not aware of nor have appellants cited any cases which hold that a nonphysician can testify as to the cause of a medical condition. Thus, the trial court did not err by concluding that Dr. Alexander lacked the expertise to opine about the cause of any medical condition relevant to his case. The defense motions in limine with respect to the expert evidence of Dr. Harold Alexander will be granted in part and to the extent that the witness will be precluded from giving evidence on any subject other than bioengineering and, in particular, will be precluded from giving evidence on the matter of medical causation. We must now consider the motions in limine seeking to exclude the expert evidence of Dr. Lance O. Yarus, M.D. Dr. Yarus received his bachelors of science degree in psychology from Syracuse University in 1977 and began a masters of science program in biochemistry at Drexel University that year but discontinued those studies after one course on acceptance in June, 1978 as a student of the College of Osteopathic Medicine and Surgery in Des Moines, Iowa in which institution he was enrolled continuously until graduation therefrom in June, 1981. Thereafter, Dr. Yarus completed a one- year internship at Memorial Hospital, an osteopathic institution in Turnersville, N.J. 80 and a residency in the same institution which he completed in 1986. *15 Following his residency. Dr. Yarus immediately entered upon his private practice in the Lebanon– Lancaster area. The practice is described by him “as an overall general orthopedic practice [focusing] in mainly arthroscopic surgery and spine surgery.” 81 Arthroscopic surgery is predominantly directed to conditions of the knee and shoulder. 82 Dr. Yaros has not in recent years performed a lumbar fusion of any type. 83 Over the whole of his practice, Dr. Yarus described the number of spinal fusion surgeries of all types performed by him or under his direct surgical supervision as “a very minimal amount, if any.” 84 He has never performed an instrumented lumbar fusion, a lumbar fusion involving the removal or explanation of instrumentation, or a lumbar fusion utilizing an anterior surgical approach. 85 With the exception of observation during his residency of the use by another physician of another manufacturer's fixation device, he has had no training in the use of lumbar spine instrumentation. 86 Indeed, with this one exception Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 12 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 12 during residency, Dr. Yarus has had no experience with the use of implanted hardware in any part of the spine; 87 has never even directly observed an instrumented fusion procedure performed by another surgeon 88 and has never physically examined the Synthes device here at issue or any of the similar devices produced by any of the other manufactuers made defendants in MDL 1014. 89 He is not board certified in orthopedic surgery; 90 and has never taught, researched, or published in any area related to spine surgery. 91 When asked if he had ever “tried to quantify or assess in any way your experience” with lumbar fusion surgeries, Dr. Yarus responded in the negative and explained “[n]o, I would have never had enough in the series to even attempt that. I never attempted to publish.” 92 In this litigation, Dr. Yarus' efforts were limited to a review of certain documents provided by the Plaintiffs' counsel and a brief meeting with Mr. Lawrence. 93 No examination of the Plaintiff was performed by Dr. Yarus and no independent medical studies or tests were ordered or reviewed. Dr. Yarus' proffered opinion takes the form of two letters to the Plaintiffs' counsel dated June 30 and November 16, 1998, respectively. In the first of these, after cataloging the documents reviewed and restating the plaintiff's medical history, in a section of the correspondence styled “Case Review”, Dr. Yarus, without further discussion, reasoning, or citation to authorities, concludes: (1) “that there is a proximate cause and effect relationship between the implanted metallic devices and the symptoms that developed subsequent to the procedure including low back pain and radiating pain in the right lower extremity.” This conclusion is propounded by the witness without any recognition, analysis, or rebuttal of the established facts that: (a) the symptoms he describes as caused by the surgery both preceded Wetzel's surgical intervention (indeed, their relief was the purpose of the operation) and continued following explanation of the devices by Morrisey and Bosacco thereby leading the Plaintiff to seek a fourth lumbar procedure with Dr. Tase; (b) pain of the type described is a well known consequence of fusion failure whether the attempted fusion was instrumented or uninstrumented; (c) the post-surgery diagnostic procedures ordered by Wetzel including repeat myleograms, bracing trials, and epidural injections eliminated a causal connection between the persisting pain and processes at the L–4/5 disk; (d) none of the other physicians who examined the Plaintiff opined that his symptoms were a consequence of soft tissue damage caused by the implant; and *16 (2) “the metallic device and the surgery performed was (sic) not indicated for Mr. Lawrence.” The only support for this conclusion offered by Dr. Yarus is the opinion of Dr. Lignelli that conservative measures should be explored before surgical alternatives. This opinion, however, was given prior to the failure of those conservative measures and before Dr. Lignelli referred the Plaintiff to Wetzel for a surgical consultation. Dr. Yarus' implication to the contrary notwithstanding, there is no indication in the Plaintiffs' evidence that Dr. Lignelli disagreed with any of the actions taken by Wetzel or with their necessity; and (3) “Dr. Wetzel did not provide proper informed consent.” This conclusion is predicated on the failure of Wetzel to disclose to the Plaintiff the regulatory status of the Synthes instrumentality; that is, that it had been neither tested nor approved in June, 1989 by the FDA for use in the lumbar spine to facilitate fusion. Our Supreme Court, in Southard v. Temple University Hospital, 566 Pa. 335, 781 A.2d 101 (2001) directly rejected the legal position on which Dr. Yarus' opinion is founded; that is, the Court held that the doctrine of informed consent does not require a surgeon to disclose the regulatory status of spinal fusion instrumentation. Id. at 344–345, 781 A.2d at 107. Moreover, by proposed rule published on October 4, 1995 94 and by final rule effective on August 26, 1998 95 the FDA, on recommendation of its Orthopedic and Rehabilitation Devices Panel and the strength of a nationwide, retrospective Cohort study of 3,498 degenerative spondylolisthesis and spinal fracture patients treated with such devices by 314 orthopedic surgeons patients between January 1, 1990 and December 31, 1991, reclassified pedicle screw spinal fixation systems like that here at issue under the MDA's from Class III requiring premarket approval to Class II subject to less stringent controls. The factual findings on which the FDA predicated this reclassification including Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 13 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 13 the statistically significant higher rate of fusion in those patients in whom a pedicle screw device was implanted. The conclusions proffered by Dr. Yarus in his June 30 correspondence are, for the reasons discussed, inadequately supported. In the November 16, 1998 supplemental report, Dr. Yarus proffers a description of what is asserted to be the defective characteristics of the Synthes device design. Specifically, Dr. Yarus asserts, again without explanation, analysis, or citation to any authoritative source of similar or shared opinion, that the Synthes DCP was an “unconstrained” system and as such permitted movement of the attached vertebrae and, thereby, prevented fusion. As presented this is no more than an exercise in semantics. The Synthes device is defective because it permits movement and it permits movement because it is an unconstrained system. Nowhere does Dr. Yarus describe the particular design feature of the DCP which produces its unconstrained characteristic. Neither does Dr. Yarus describe the means by which the Synthes device could be made to constrain the vertebral movement or opine that such alternations in the design would be feasible. *17 Dr. Yarus further asserts that the wrong sized screws were used (6.5 mm instead of 4.0 mm) and then, somewhat inconsistently, contends that the larger screws were insufficiently strong to counter the loads placed on the device. The only support for the latter proposition offered by the witness is the fact that two of the screws fractured. However, Dr. Yarus does not analyze the intended purpose of the device or its intended lifespan of operation. Neither does the witness discuss the counter- view that such devices are intended only to support the spine and limit movement for the maximum period likely to be required for fusion to occur; that is, about one year. In Schindler v. Sofamor et al., 774 A.2d 765 (Pa.Super.2000) appeal denied 567 Pa. 727, 786 A.2d 989 (2001), the Superior Court affirmed the grant of a defense motion for judgment N.O.V. in a product liability case involving a failed fusion and a fractured spinal fixation device manufactured by Sofamor Danek Group, Inc. called a Cotrel–Dubosset (“CD”) device following a jury award to the plaintiff patient of more than $1.5 Million. The trial court's action was a consequence of its conclusion that the device at issue was not defective or unreasonably dangerous as a matter of law. The Plaintiff's biomechanical expert testified, and the jury apparently accepted, that the knurled or grooved surface placed on the rod components of the device during the manufacturing process in order to increase its holding power also reduced the mechanical strength of the component rendering it defective. The trial court rejected this conclusion and found that the rod was safe for its intended use in the following terms: The rod's surface was knurled, or grooved. The knurling provided improved holding power and was not decorative. Plaintiffs claimed that the knurled surface of the rod caused it to prematurely break. Plaintiff's expert opined that smooth metallic surfaces last longer than any metallic surfaces which have been altered. Thus, Plaintiffs claimed that the knurled surface was a design defect. An examination of the record clearly reveals that the CD Rod was not unreasonably dangerous for its intended use. The intended use of the rod was to stabilize the spine until fusion occurred. If fusion is to occur in an individual, it will occur within one year of surgery. The rod was never intended to last indefinitely in the absence of fusion. The testimony at trial established that all implants will eventually fracture in the event of non-fusion. Mrs. Schindler's surgery took place in January 1989 and fusion should have occurred by January 1990. Therefore, the CD Rod had served its intended purpose if it stabilized Mrs. Schindler's spine within the one year following her January 1989 surgery. Plaintiffs do not claim that the rod failed to align Mrs. Schindler's spine in the year following the surgery. The rod did not break until July 1993, four and a half years after the surgery and three and a half years after the point that fusion should have occurred. The CD Rod fulfilled its intended use in providing stabilization for an additional three and a half years past its intended use. *18 Id. at 769–770 excerpting the trial court opinion filed February 15, 2000. The Superior Court agreed with this analysis. Following an extended discussion of the judicial role in product liability cases and “the power [of trial courts] to reject design defect claims as a matter of law, even where Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 14 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 14 the plaintiff presents evidence tending to show that the product is defective” 96 after expressly recognizing “that the words, ‘unreasonably dangerous' have no independent significance and merely represent a label to be used where it is determined that the risk of loss should be placed upon the supplier ....”, 97 the appellate court reasoned as follows: In the instant case, the trial court was charged with deciding whether, “under the plaintiff's version of the facts, recovery would be justified.” Azzarello, 391 A.2d at 1026. As noted above, Appellants' version of the facts is that the CD Rod was designed to stay in place until fusion took place, and that the rod did not do so. Appellants conclude that their version of the facts compels a legal finding that the CD Rod was not fit for its intended purpose. For the following reasons, we disagree. This case hinges on the difference between averments of fact and conclusions of law. All parties agree that the CD Rod is designed to stabilize the spine “until” fusion takes place. It is also undisputed that the rods generally do stay in place forever if fusion takes place. Appellants would convert these statements of fact into a conclusion of law that the rod is defective if it breaks before fusion takes place. The unspoken assumption behind this statement is that fusion always takes place once a rod is inserted. Appellants would have the trial court accept this assumption as true, under the guise of construing all factual inferences in Appellant's favor. The trial court chose not to do so, and implicitly rejected this assumption as unreasonable. Instead, the trial court took the additional step of asking two questions: (1) whether fusion occasionally does not take place at all, and (2) whether the CD Rod was designed to stay in place indefinitely in such a situation. In doing so, the trial court took into account the fact that occasionally the spine does not fuse (a condition known as pseudoarthrosis), and that if the spine does fuse, it will generally do so within one year. The trial court concluded that “the rod was never intended to last indefinitely in the absence of fusion,” and that the rod served its purpose if it stabilized the spine for one year. Trial Court Opinion, 2/15/2000, at 5. We see no error of law in this statement of the CD Rod's intended purpose. Appellants presented no evidence that the CD Rod was intended to stabilize the spine indefinitely in the case of pseudoarthrosis. Rather, it would appear that if fusion does not take place within one year, physicians should take additional measures to encourage fusion, such as bone stimulation. In other words, the goal of the CD Rod is to facilitate bone fusion, not to substitute for fusion in the event of pseudoarthrosis. Moreover, the mere fact that stabilization rods generally last forever in the event of fusion does not necessarily imply that they last forever in the event of non-fusion. Thus, even if a smooth CD Rod would have lasted forever, this fact is irrelevant because the rod was not intended to last forever in the event of pseudoarthrosis. Based on the trial court's appropriatelylimited statement of the CD Rod's purpose, and the undisputed fact that the CD Rod did indeed stabilize the spine for well over one year. we see no error in the court's conclusion that the product was not unreasonably dangerous as a matter of law. JNOV was therefore appropriate. See, Davis, 690 A.2d at 190–191 *19 Schindler at 774–775 (footnotes omitted) (emphasis in the original) Identical considerations govern the assessment of Dr. Yarus defect claim. The syllogism that leads ineluctably from the fact of breakage to the conclusion of defect fails to account for the intended purpose of the device. The Synthes device, like the others of its type, was intended to restrict movement during the period required for a successful fusion; less than one year. The fusion surgery was performed on the Plaintiff by Wetzel in June, 1989. The first indication of screw breakage is found in Wetzel's March 11, 1992 office note. Indeed, x- ray studies performed as late as February, 1991; about twenty months after the surgery, disclosed no change in the instrumentation or its position. The Synthes device performed its intended function with a significant margin. Dr. Yarus conclusion that these facts require a finding of defect must be rejected. Other courts faced with the question of the admissibility Dr. Yarus' evidence in the context of bone screw litigation have concluded that the evidence must be excluded. The following critique is typical, appearing in the opinion reported as Moses v. Danek Corp., 1998 WL 1041279 (D.Nev.1998) filed in support of the grant Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 15 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 15 of a spinal fixation device manufacturer's motion for summary judgment and following a discussion of the court's gatekeeping role under Daubert v. Merrel Dow Pharmaceuticals, Inc., 509 U.S. 579, 590, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Dr. Yarus' letter, which opines a causal connection between implantation of the TSRH spinal fixation device and Plaintiff's injury, does not fair well under the scrutiny of these factors. First, there is no indication that Dr. Yarus' method, simple logic, as opposed to medical training, experience, and examination, has gained general acceptance in the relevant scientific community to diagnose the source of spinal pain. Plaintiff has suffered from several physical ailments, a number of which deal with her spine. To conclude that Plaintiff's pain is allegedly the result of a defective TSRH device, without examination of the device or Plaintiff's spine, and by only studying a portion of her medical history is rudimentary at best. A logical or spatial test is simply inadequate in light of the failure to exclude other potential causes. Second, there is no indication that Dr. Yarus' peers competently discover such causal relationships with the spine from a desk. Dr. Hammargren, a neurosurgeon with first hand experience with treatments involving spinal fixation devices, had an opportunity to examine Plaintiff with her symptoms in mind, not for a medical- legal purpose. Surprisingly, Dr. Hammargren did not know of a way to determine, in any given case, whether or not a spinal fixation device (hardware) could be pain producing.... A significant element of the Daubert inquiry is whether the expert has expressed an opinion in the normal practice of medicine, or for purposes of testifying at trial. *20 That the expert failed to subject his method to peer-review and to develop his opinion outside the litigation is not dispositive, but if these guarantees of reliability are not satisfied, the expert “must explain precisely how [he] went about reaching [his] conclusions and point to some objective source ... to show that [he has] followed the scientific method, as is practiced by (at least) a recognized minority of scientists in [his] field. Cabrera [v. Cordis Corp.], 134 F.3d [1418] at 1421 [9 th Cir.1998] (quoting Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1317 (9th Cir.1995) (Daubert II )). Dr. Yarus' letter was produced for the purpose of testifying at trial. The only contact Dr. Yarus has had with Plaintiff has been through her attorneys. Also, there is no indication that Dr. Yarus has attempted to treat Plaintiff's injuries or prescribe her any medication. Thus, for Dr. Yarus' opinion to be admissible, it must survive slightly greater scrutiny as directed by Daubert II. Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1317 (9th Cir.1995) (Daubert II ). Dr. Yarus' opinion merely cites a “cause and effect relationship” between Defendants' product and Plaintiff's alleged injury. Beyond this, the opinion cites conclusions only. Exhibits in Support volume 1(# 39), exhibit # 14. Dr. Yarus failed to “explain precisely how [he] went about reaching [his] conclusions and point to some objective source ... to show that [he has] followed the scientific method, as is practiced by (at least) a recognized minority of scientists in [his] field.” Cabrera v. Cordis Corp., 134 F.3d 1418, 1421 (9th Cir.1998)(quoting Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1317 (9th Cir.1995) (Daubert II )). Thus, Dr. Yarus' opinion, that the device was defective, should not be admissible in the case at bar. Id. at *7–8 (footnotes and record citations omitted). Dr. Yarus opinions in this case are subject to identical criticism. In Minisan v. Danek Medical, Inc., 79 F.Supp.2d 970 (N.D.Ind.1999) the court wrote the following concerning the admissibility of Dr. Yarus evidence applying the standards of admissibility under Daubert.: 98 In this case, Minisan offers the report of Dr. Lance Yarus as her only evidence. Dr. Yarus is an Osteopath (D.O.) with board certification in orthopedic surgery and pain management. His curriculum vita indicates at least some training in spine surgery as well as in general orthopedics. He has staff privileges at several hospitals and his teaching affiliations include orthopedic surgery. His credentials appear sufficient to survive the “qualification” hurdle in a Daubert analysis. See, McCollin, 50 F.Supp.2d 1119, 1125 Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 16 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 16 (finding Dr. Yarus marginally qualified). However, in addition to sufficient knowledge and training, an expert's testimony must be “reliable.” Daubert, 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469. District courts have routinely found causation lacking where experts offered only conclusory opinions, did not address whether other factors might have caused the plaintiff's injuries, and failed to state why or how he came to his conclusions. See generally, Valente v. Sofamor, S.N.C., 48 F.Supp.2d. 862 (E.D.Wis.1999) (no competent evidence of causation where plaintiff's expert gave conclusory opinions, failed to identify a defect in the design or manufacture of the device and failed to perform differential diagnosis); Cali v. Danek Medical, Inc., 24 F.Supp.2d 941 (W.D.Wis.1998) (no evidence of causation where experts' testimony was not scientifically reliable); Coleman v. Danek Medical, Inc., 43 F.Supp.2d 637, 650 (S.D.Miss.1999) (no causation where expert offered only conclusory assertions, failed to identify causal nexus between Danek's product and harm to plaintiff); Driggers v. Sofamor, S.N.C., 44 F.Supp.2d 760, 765 (M.D.N.C.1998) (no competent evidence of causation where expert failed to rule out other causes of plaintiff's pain). It is on this prong that Plaintiff's expert fails. Dr. Yarus states that he arrived at his conclusions based solely on an examination of Minisan's numerous medical records. He apparently never examined her, met with her or even spoke to her. Neither did he examine or test the TSRH device. Dr. Yarus concludes that “both surgical interventions were the proximate cause of the non-unions and subsequent development of pain.” He also concludes that Minisan's continued disability is directly related to the metallic devices. (Id.) Under Daubert, the expert “must explain precisely how [he] went about reaching [his] conclusions and point to some objective source ... to show that [he] has followed the scientific method ...” Daubert v. Merrell Dow Pharm., 43 F.3d 1311, 1317 (9th Cir.1995) (Daubert II ). Similar to his reports provided in other bone Screw cases, Dr. Yarus has failed to provide any explanation as to how he reached his conclusions. See McCollin, 50 F.Supp.2d 1119, 1126–27; Hartwell, 47 F.Supp.2d 703, 712–13; Pulice, 1999 WL 613370 at * 5– 9; Moses v. Danek Medical, Inc. No. CV 95–512, 1998 WL 1041279 at *7 (D.Nev. Dec.11, 1998). Dr. Yarus has not met the standard set forth in Daubert. The court therefore concludes that Dr. Yarus' opinion is simply insufficient to create a material fact issue for trial with respect to the issue of causation. Accordingly, Danek is entitled to summary judgment on both the strict liability and negligence claims because Minisan is unable to establish a causal nexus. *21 Minisan at 976–977 (record citations omitted) Finally, in Wooley v. Smith & Nephew Richards, Inc., 67 F.Supp.2d 703 (S.D.Tex.1999) the court collects those bone screw litigation decisions in which the evidence of Dr. Yarus was determined not to meet the standard of admissibility under Daubert. The court first reproduces an excerpt from Dr. Yarus opinion. The language excerpted is materially identical to that contained in the June 30, 1998 report submitted in this case. The court in Wooley then notes in the margin: FN1. The conclusion reached by Dr. Yarus in this case typifies this “expert's” apparent penchant for producing what some have called “cookie cutter” opinions for bone screw plaintiffs throughout the United States, because the language used here by Dr. Yarus closely mirrors that used in reports for plaintiffs in other bone screw litigation. See, e.g., McCollin v. Synthes, Inc., 50 F.Supp.2d 1119, 1126 (D.Utah 1999); McLellan v. Sofamor–Danek Group, Inc., No. 95–CV–0322E(H), 1999 WL 222591, at *3 (W.D.N.Y. April 12, 1999); Alexander v. Danek Med., Inc., 37 F.Supp.2d 1346 at 1349 (M.D.Fla.1999); Savage v. Danek Med., Inc., 31 F.Supp.2d 980, 983 (M.D.Fla.1999); West v. Danek Med., Inc., No. Civ–97–575–T, 1998 WL 1041327, at *2 (W.D.Okla.Dec.28, 1998). Id. at 707 n. 1. The court then writes: Because these two conclusory paragraphs represent the sum total of Dr. Yarus's analysis, the Court finds it reasonable to hold that Dr. Yarus's opinion lacks any scientific basis. This determination is justified for several reasons, each of which centers around the fact that Dr. Yarus has failed to offer a basis for his conclusions. First, Dr. Yarus has never personally examined the screw manufactured by Defendant, and Dr. Yarus's opinion does not identify any particular defect in Defendant's Simmons Plating System, nor does the report causally relate such alleged defect to Plaintiff Wooley's postoperative complaints. Second, the Court notes that Dr. Yarus has never personally examined Plaintiff Wooley, spoken with any of Plaintiff Wooley's treating physicians, or reviewed X-rays of Plaintiff Wooley's surgical site. Third, Dr. Yarus does not point out any symptoms occurring after the pedicle screw surgery that did not also exist before the surgery, Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 17 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 17 or any basis for concluding that the pedicle screw implant caused Plaintiff Wooley's pain when compared to other possible causes. Instead, Dr. Yarus appears to reach a generic conclusion by making a temporal connection between Plaintiff Wooley's alleged injuries and the surgical implants. See Pulice, 1999 WL 613370, at *5 (pointing out that because Dr. Yarus “has relied on nothing more than litigation reports and lawyer prepared summaries[,] it is reasonably clear that such materials ‘are not of a type reasonably relied upon by experts in a particular field” ’ (quoting United States v. Tran Trong Cuong, 18 F.3d 1132, 1143 (4th Cir.1994))). In the end, Plaintiffs have utterly failed to show that Dr. Yarus undertook a valid scientific methodology in reaching his conclusion that Defendant's Simmons Plating System caused Plaintiff Wooley's postoperative injuries. *22 Once again, the analysis in Wooley is equally pertinent to the expert's opinion in the case sub judice. The court ends the discussion with a catalog of consonant authorities. The Court is not alone in its rebuke of Dr. Yarus's opinion testimony. At least ten courts have already excluded Dr. Yarus's testimony in other bone screw products liability cases, calling his opinions methodologically unsound and therefore unreliable. See, e.g., Hartwell [v. Danek Medical, Inc.], 47 F.Supp.2d [703] at 712–13 (finding Yarus's opinion inadmissible under the standards of Daubert and Kumho [Tire co., Ltd. v. Carmichael, 526 U.S. 132 (1999) ] and stating that “Dr. Yarus' ... armchair-quarterback style evades meaningful testing, eludes peer review, and makes error rates incalculable.... Opinions based on his ill regard for the use of pedicle screw fixation are at best conclusory, and, at worst, just bad science and junk medicine”); Goodwin v. Danek Med., Inc., No. CV–S–95–433–HDM, slip op. at 6 (D.Nev. July 8, 1999) (“The Court concludes that an examination of the relevant nonexclusive factors [of Daubert ] establishes that Dr. Yarus' opinion has not been developed by the appropriate scientific method.”); Parks v. Danek Med., Inc., No. 2:95–CV–206, slip op. at 8 (N.D.Ind. June 17, 1999) (excluding Dr. Yarus's causation opinion because his report “merely concluded, without any showing, that the pedicle screws caused [the plaintiff's] alleged injuries”); McLellan, 1999 WL 222591, at *3 (striking Dr. Yarus's testimony as inadmissible under [Federal Rule of Civil Procedure No. 702); Edgar v. Danek Med., Inc., Prod.Liab.Rep. (CCH) p 15668 (M.D.Fla. Mar. 31, 1999) (noting Dr. Yarus's lack of reliability as an expert witness); West [v. Danek Medical, Inc.], 1998 WL 1041327 [W.D. Okl.1998] at *4 (finding Yarus's testimony insufficient to establish causation and granting summary judgment); Moses v. Danek Medical, Inc., CV–S–95–512–DWH, 1998 U.S. Dist. LEXIS 21110, at *17 (D.Nev. Nov. 18, 1998) (noting that Yarus's method of “simple logic as opposed to medical training, experience, and examination” has not gained acceptance in the relevant scientific community, that “there is no indication that Dr. Yarus' peers competently discover such causal relationships ... from a desk [as opposed to using patient examination],” and that Yarus's opinion “cites conclusions only ... Dr. Yarus's opinion ... should not be admissible in the case at bar”); Leigh v. Danek Medical, Inc., No. 4:95–CV797–A, 1998 WL 1041329 at *5 (N.D.Tex. Dec.14, 1998) (stating that “Yarus cannot point out any symptoms that plaintiff had after surgery that he did not have before surgery ... he simply opines that since the plaintiff had pain before surgery and that pain worsened after surgery, the worsened pain must be a result of the instrumentation. The only conclusion to be drawn in this case is that Yarus's testimony was influenced by a litigation-driven financial incentive”); Baker v. Danek Medical, 35 F.Supp.2d 875, 878–80 (N.D.Fla.1998) (holding that Yarus's testimony of a temporal connection between the implantation and plaintiffs symptoms was insufficient to show causation); see also Pulice [v. Smith and Nephew Richards, Inc.]. 1999 WL 613370, [N.D. Ark.1999] at *5 (finding no scientific basis to support Dr. Yarus's opinions because they appear “to be almost entirely unsubstantiated and little more than subjective belief and unsupported speculation”). *23 Many courts also have dismissed opinions such as Dr. Yarus's, which infer causation from the temporal relationship between pain and implantation surgery. See, e.g., Burton v. Danek Medical Inc., No. CIV.A.95– 5565, 1999 WL 118020 at *4–5 (E.D.Pa.Mar.1, 1999) (excluding a plaintiff's expert who failed to perform a differential diagnosis, stating that “there is no connection between [Plaintiff's] medical records and [the expert's] conclusion”); Hickman v. Sofamor–Danek Group, Inc., No. C–95–1095 CW, 1999 WL 606690, at *9 (N.D.Ca. Feb.17, 1999) (stating “[n]either [withess] ... supported his conclusions with peer- reviewed research, identified an objective source of Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 18 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 18 information on which his conclusions were based, or demonstrated that he followed a generally accepted or scientifically reliable diagnostic methodology used by other professionals ... neither doctor's testimony meets the standard for reliability established in Daubert”); Baker, 35 F.Supp.2d at 880 (characterizing Dr. Yarus's opinion that pedicle screw fixation devices are unreasonably dangerous as “hardly generally accepted in the scientific community” and granting summary judgment because “plaintiff has simply failed to provide any evidence, amounting to more than speculation, that demonstrates that the Danek device was defective, unreasonably dangerous or the cause of plaintiff's injuries”); Cali v. Danek Medical, Inc., 24 F.Supp.2d 941, 954 (W.D.Wis.1998) (holding that expert testimony was “unsupported speculation ... not entitled to the dignity of evidence,” and that “where symptoms may be the subject of a variety of causes it is insufficient for an expert to opine as to the cause of the symptom without some scientific basis other than his assertion of general experience”); West, 1998 WL 1041327, at *6 (W.D.Okla.Dec.28, 1998) (commenting that “the court does not understand how the surgery's asserted failure to alleviate the plaintiff's problems ... establishes the required connection between the fixation device and the plaintiff's present condition”); Huntman v. Danek Medical, Inc., No. 97–2155–IEG, slip op. at 7 (S.D.Cal. July 24, 1998) (stating that the fact plaintiff experienced pain after surgery is insufficient, by itself, to create an issue of fact regarding causation); Baker v. Smith & Nephew Richards, Inc., No. 95–58737, 1999 WL 811334, at *33 (152d Dist. Ct., Harris County, Tex. June 7, 1999) (excluding opinion testimony in a products liability case involving S & N's Rogozinski Spinal Rod System because “while [the expert] uses the proper ‘magic words' in his causation testimony, there is no reliable support for his conclusion in the sparse evidence offered by [Plaintiff].... [A]n expert's mere incantation of legally sufficient words or phrases does not make an expert's opinion admissible”). Given this evidence, the Court finds that Defendant has shown Dr. Yarus's opinion to be wholly lacking in reliability. Therefore Defendant's Motion to Exclude Dr. Yarus's Opinion Testimony is GRANTED. *24 Wooley at 708–711. The motions of defendants in limine and pursuant to Pa.R.C.P.No. 702 to exclude the evidence of Plaintiffs' expert witness Dr. Lance O. Yarus will be granted. We next turn to the defendant Synthes' dispositive motion for summary judgment. Our discussion to this point will facilitate the resolution of the remaining issues. In the absence of the evidence of expert witnesses Larson and Yarus and with witness Alexander constrained by agreement and this decision to matters of bioengineering, the Plaintiffs have failed to adduce substantial evidence of the medical cause of the injuries or conditions for which recovery is here sought. In the absence of evidence of causation, all of the Plaintiff's claims against the manufacturer defendant must fall. 99 In this regard there can be no doubt that the medical cause of a complex condition such as is here presented requires expert evidence. Hamil v. Bashline, 481 Pa. 256, 392 A.2d 1280 (1978). See also Jones v. Harrisburg Polyclinic Hospital, 496 Pa. 465, 437 A.2d 1134 (1980); Lamber v. Soltis, 442 Pa. 304, 221 A.2d 173, 175 (1966). The absence of such evidence in this case precludes any conclusion as to the cause of the Plaintiff's condition. In the absence of causation, Plaintiff's negligence, negligence per se, 100 strict product liability, 101 misrepresentation, fraud, consumer protection act, and conspiracy claims must all fall inasmuch as each theory of relief requires as a necessary element thereof establishment of a causal nexus between the defendant's conduct and the plaintiff's loss. A grant of summary judgment is proper [when] “the pleadings, depositions, answers to interrogatories, and admissions on file, together with affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Pa. R.C.P. No. 1035.2. The record is to be viewed in the light most favorable to the nonmoving party, and all doubts as to the presence of a genuine issue of material fact must be resolved against the moving party. Albright v. Abington Meml. Hosp., 548 Pa. 268, 280, 696 A.2d 1159, 1165 (1997) (citations omitted); see also Pa.R.C.P. 1035.1–1035.5. When sought by a party, like these defendants, not charged with the burden of proof, summary judgment may be granted only if at least one of two circumstances is present: (1) the moving party is entitled to judgment as a matter of law: or (2) the nonmoving party has failed to adduce any substantial evidence with respect to a necessary clement of the claim. Pa.R.C.P.No. 1035. Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 19 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 19 When a motion for summary judgment is made, the nonmoving party must set forth specific facts showing that there is a genuine issue for trial. Basile v. H. & R. Block, Inc., 777 A.2d 95, 100–101 (Pa.Super.2001). Under Pa.R.C.P.No. 1035.2(2), “if a defendant is the moving party, he may make the showing necessary to support the entrance of summary judgment by pointing to materials which indicate that the plaintiff is unable to satisfy an element of his cause of action.” Godlewski v. Pars Mfg. Co., 408 Pa.Super. 425, 597 A.2d 106, 109 (1991). Correspondingly, “[t]he non-moving party must adduce sufficient evidence on an issue essential to its case and on which it bears the burden of proof such that a jury could return a verdict favorable to the non-moving party.” McCarthy v. Dan Lepore & Sons Co., Inc., 724 A.2d 938, 940 (Pa.Super.1998). Where a plaintiff is the non-moving party, summary judgment is improper if the evidence, viewed favorably to the plaintiff, would justify recovery under the theory it has pled. See Kelly v. Ickes, 427 Pa.Super. 542, 629 A.2d 1002, 1005 (1993). In this case, even where the evidence is viewed most favorably to the position of the Plaintiffs, no evidence appears of a causal connection between the actions or inactions of the defendants and the injuries or conditions of Paul Lawrence. Therefore, no recovery could be justified on this record and summary judgment must be granted. *25 In addition, with reference to the informational causes of action such as the claims for fraud and negligent misrepresentation, express and implied warranty, and the like, the Plaintiff's claims are barred by the learned intermediary doctrine 102 and by the inability of the Plaintiff to adduce substantial evidence of the surgeon's reliance on any information provided by the manufacturer, Defendant Synthes. Here the surgeon defendant, Wetzel, denied being influenced in any way by communications of Synthes. 103 Plaintiff has adduced no contrary evidence. Neither has Plaintiff adduced an expert opinion that orthopedic surgeons specializing in instrumented spinal fusions would have been likely to alter their surgical approach if Synthes had provided them with accurate information concerning the matters here claimed to have been the subject of fraud; that is, the absence of testing of the DCP device in the spine and the refusal of the FDA to approve the device for that use. Compare Stanton by Brooks v. Astro Pharmaceutical Products, Inc., 718 F.2d 553 (3d Cir.1983) in which the court held that the opinion testimony of four qualified expert witnesses to the effect that a surgeon's conduct would likely be influenced by correction of the misleading information was sufficient to meet the plaintiff's production burden on causality and reliance. The instant pretrial record contains insufficient evidence to create a triable issue of reliance or causality thereby providing an additional compelling ground for dismissal of the counts sounding in fraud and misrepresentation. Taylor v. Danek Medical, Inc., 1998 WL 962062 (E.D.Pa.1998) at *6. We will grant the motion for summary judgment of Defendant Synthes. On these grounds we must also grant the motion of Wetzel for partial summary judgment with respect to the Plaintiffs' conspiracy claim. See Murray v. Synthes U.S.A., Inc., 1999 WL 672937 (E.D.Pa.1999) at *6. Having granted the Defendants' dispositive motions, the Defendants' motion for bifurcation and for partial summary judgment as well as the Plaintiffs' motions for partial summary judgment, are rendered moot. We will enter an appropriate order. AND NOW, this 22 nd day of July, 2002, for the reasons and on the basis of the authorities cited and discussed in the opinion filed simultaneously herewith, the Motion of Plaintiffs to change venue is hereby DENIED; the Motions in Limine of Defendants Synthes, Inc. and Dr. F. Todd Wetzel seeking to preclude the expert evidence of the Plaintiffs' expert witnesses Dr. Carl Larson and Dr. Lance Yarus and to restrict the scope of the evidence of Dr. Harold Alexander, are hereby GRANTED; the dispositive Motion of Defendant Synthes, Inc. for summary judgment with respect to all of the Plaintiffs' claims for failure to adduce substantial evidence creating a triable issue of causality, is hereby GRANTED. The motion of Defendant Dr. F. Todd Wetzel seeking partial summary judgment concerning the Plaintiffs' conspiracy claim is, on the same basis GRANTED. All other pending Motions are hereby DENIED AS MOOT. APPENDIX “A” *26 ABC NEWS 20/20 Transcript # 1353 December 17, 1993 HUGH DOWNS, ABC News: Good evening. I'm Hugh Downs. BARBARA WALTERS, ABC News: And I'm Barbara Walters and this is 20/20.... Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 20 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 20 TIUGH DOWNS: It's a fact that 80 percent of us will have back pain sometime during our lives. Now, for some of those with serious pain, there is a surgical treatment using back screws and every year tens of thousands of people have these screws surgically implanted into their spines. But a 20/20 investigation has uncovered some shocking facts about this technique that have never been reported before. BARBARA WALTERS: Well, first, the FDA says that these back screws are experimental, Patients don't know that and the results can be disastrous. And how can this happen when they are being used by doctors in hospitals across the country? And isn't the government supposed to protect us from this kind of risk? [voice-over] Tonight Dr. Timothy JOHNSON investigates these important questions ..... JOHNSON: [voice-over] Screws and plates are used in back surgery when there is a concern about the stability of the spine after surgery. In a typical operation, bone from the vertebra is removed. Then, to stabilize the spine, screws are inserted through plates into the part of the vertebra called the pedicle. The risks of the operation are frightening. The pedicle is right next to the spinal column and emerging spinal nerves. If the screws break or are inserted incorrectly, the results can be catastrophic, including permanent nerve damage. And the screws, as first developed in the early '80s, did often break, nearly one in three, according to one early study.... So how did spine plates and screws get unleashed on the public? Before a new device or an old device being proposed for a new use can be marketed, it must be approved by the Food and Drug Administration. Now, plates and screws like this have been approved for a long time for use in long bones—arms and legs—but back in the mid–1980's, Dr. Steffe and his new company, called AcroMed, went to the FDA and asked for the device to be approved for a new use, in the spine, Twice, they said no. They said, “That's a new, potentially dangerous use. It must be studied first for safety and effectiveness.” However, just a few months later, the FDA did approve the device after AcroMed simply changed the name from “spine plates and screws” to “bone plates and screws,” and Dr. Steffe now claims that meant he could use it in any bone, including the spine. [voice-over] But did the FDA ever give such approval? We showed current FDA commissioner, Dr. David Kessler, Dr. Steffe's video testimony when he was asked if the FDA said he could market his device for use in the spine. ATTORNEY: Did they say that, sir? DR. STEFFE: Yes, they did. Dr. KESSLER: That is an incorrect statement. JOHNSON: He said, “Yes, they did.” They never said that? Dr. KESSLER: FDA never said that. In fact, we repeatedly said they could not market the device for use in the spine. We had already told them twice. *27 JOHNSON: And they weren't changing their tune at this meeting. Dr. KESSLER: Absolutely not. JOHNSON: [voice-over/But for years. Dr. Steffe has stuck by his claim that the FDA did give him approval after he simply changed the name to bone screw. DR. STEFFE: But they said I could use it and could teach it and we could sell it as a bone plate and bone screw and it could be used by the physician at his discretion. JOHNSON: [voice-over] But now, for the first time, Dr. Kessler not only disputes Dr. Steffe's claim that he could use the device in the back, but Dr. Kessler makes a serious charge about what AcroMed did. Dr. KESSLER: It's fair to say that they circumvented the law. JOHNSON: You're being kindly and lawyerly and I know you're also a lawyer, but I mean they just literally— DR. KESSLER: Tim JOHNSON: It sounds to me like they lied, fiat and simple. They said they were going to use it in long bones for fractures. They didn't do it. Instead, they turn around and use it in the spine. Dr. KESSLER: Tim, it's an enormous concern to me what happened back in 1985, 1986. There is a fun-scale investigation underway. JOHNSON: 20/20 has learned that AcroMed is in fact the subject of a grand jury investigation for possible criminal violations, but the serious questions about AcroMed have remained a virtual secret until now, a secret that has allowed widespread abuse and the treatment of patients Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 21 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 21 with an experimental device without their knowledge. [voice-over] At St. Vincent's Hospital in Cleveland, Dr. Steffe taught the procedure to hundreds of surgeons. He not only trained the doctors in Lake Charles and Philadelphia, but they have testified Dr. Steffe told them the device was approved for use in the spine. In fact, 20/20 surveyed 18 of the most prestigious medical centers in, the United States who appeared on an AcroMed customer list. Thirteen of them either didn't know or refused to tell us whether they thought the devices were experimental. While the hospitals were under no legal obligation to know that, attorney Tschrin thinks they had a moral obligation. Mr. TSCHIRN: Oh, no question about it. The hospitals, I think, have a responsibility to ascertain that before a product comes into their hospital that it's been properly approved by the FDA for the intended usage for which that hospital is getting the product. JOHNSON: [voice-over] And so hospitals and doctors are still put-ting these devices in backs, often without telling their patients that they are experimental, Companies openly promote and sell these devices. An industry seemingly built around lies continues to flourish to the tune of over $150 million a year. And patients who were injured grow more and more angry over what they feel is at the hearth of what went wrong. CAROLYN DOUCETTE [described as a “Steffe Back Screw Victim”]: It all boils down to one thing—greed, money. They saw easy money and they took it. WALTERS: Well, Tim, then should these screws and plates never be used? *28 JOHNSON: No. In the right hands, the hands of a skilled surgeon who has experience in this kind of surgery, for the right reasons, such as certain surgery for tumors of the back of for certain kinds of frae-tures, those plates and screws can be very helpful. The problem is that when we're doing 50,000 to 70,000 s year, it's far too many. ORDER AND NOW, this 22 nd day of April, 2003, upon consideration of the Motion for Summary Judgment of Defendant Wetzel, it is hereby ORDERED that the Motion is GRANTED. Upon consideration of Plaintiff's Motion for Reconsideration of Summary Judgment and In Limine Rulings Based on Supplemental Authority, it is hereby ORDERED that the Motion is DENIED. All Citations Not Reported in A.2d, 2002 WL 32747667 Footnotes 1 As we will discuss, the plaintiffs at the initiation of this litigation were Paul and Linda Lawrence, husband and wife. Linda Lawrence's claims against all defendants were limited to loss of consortium; all other claims being those of Paul Lawrence who underwent the instrumented fusion surgery alleged to be the proximate cause of injury. By stipulation of all parties docketed on July 19, 2001, the loss of consortium claims of Linda Lawrence were voluntarily withdrawn. In the discussion that follows, references to “Plaintiffs” in the plural should be understood as Paul and Linda Lawrence as the parties plaintiff during all limes prior to July 19, 2001; and references to a singular “Plaintiff” without other qualification should be understood as Paul Lawrence as the remaining party plaintiff and as the principal plaintiff throughout. Where the context might lead to ambiguity, references to “Paul Lawrence” or “Lawrence” are adopted in the interest of clarity and without disrespect. 2 The following description of the Milton S. Hershey Medical Center, now associated with the Penn State University, appears at URL http://www.hmc.psu.edu/: “Founded in 1963 with a gift from The Milton S. Hershey Trust. Today, Penn State Hershey Medical Center is one of the leading teaching hospitals in the country. The 504–bed medical center annually admits nearly 20,800 patients, conducts more than 497,229 outpatient visits, conducts more than 25,600 emergency room visits and performs more than 15,455 surgical procedures” Hershey also presented a separate motion for summary judgment on January 15, 1999 in which it contended that Plaintiff had failed to adduce the necessary expert opinion evidence critical of the care provided by the facility. It is unnecessary that we resolve the issues raised by this motion, however, inasmuch as, by stipulation of all parties filed on April 23, 2001, Plaintiff's claims against Hershey wore voluntarily discontinued and the center was dismissed as a Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 22 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 22 party to these proceedings. We will continue to refer to Hershey in describing those procedural events which occurred during the period prior to its dismissal. 3 In which Defendant Synthes joined by motion filed on January 18, 2001. 4 By which pedicle screw devices like those here at issue and used in instrumented spinal fusion surgery were, for the purposes of the Medical Device Amendments of 1976 (“MDAs”) to the Food, Drug, and Cosmetic Act of 1938; 21 U.S.C. §§ 360c–360k, reclassified from Class III which, as devices implanted in the human body and posing a potentially unreasonable risk of injury (see 21 U.S.C. § 360c(a)(1)(C); 21 CFR § 360.3(c)(3)) subjected the devices to the most stringent of the FDA's regulatory oversight including the requirement of pre-market authorization (see 21 U.S.C. § 360e, 21 CFR § 814.1(c)); to Class II which includes no such requirement for prior approval but subjects the devices to certain performance standards, postmarket surveillance, and use guidelines. See 21 U.S.C. § 360c(a)(1)(B), 21 CFR § 860.3(c) (2). 5 In which Defendant Synthes joined by motion filed on January 18, 2001. A similar motion in limine was filed by Defendants Hershey and Wetzel on January 15, 1999 and remains outstanding. 6 Dr. Larson, now deceased, gave in 1995 and 1996 a deposition in the MDL 1014 litigation before the United States District Court for the Eastern District of Pennsylvania. A so-called “generic” deposition. Dr. Larson's discovery evidence was to be available generally to all of the cases consolidated by the federal court. The Plaintiff also seeks to make use at trial of an expert report apparently authored by Dr. Larson and dated November 18, 1998 in the matter of Plaintiffs' claims here at issue. Defendant Synthes first moved for preclusion of the Larson evidence on January 15, 1999. A similar motion was interposed by Defendants Hershey and Wetzel on December 18, 2000 in which Defendant Synthes joined; thereby renewing its motion, on January 18, 2001. 7 Filed by Defendant Synthes on December 15, 2000 and by Defendants Hershey and Wetzel on December 18, 2000. 8 Filed by Defendant Synthes on December 15, 2000 and by Defendants Hershey and Wetzel on December 18, 2000. 9 Including two bound volumes of unreported judicial opinions submitted by Defendant Synthes and two bound volumes of documentary exhibits presented by Plaintiffs in opposition to Defendant Synthes' motion for summary judgment. 10 See, for example, Defendant Synthes' Momorandum of Law in Support of its Motion for Summary Judgment filed December 15, 2000 at page 3. 11 U.S. Patent No. 4,696,290. 12 U.S. Patent No. 4,854,311. 13 On October 17, 1997, Judge Bechtle for the MDL court approved a $100 Million settlement of all “bone screw” claims against AcroMed. 14 Which can be understood as conceptually similar to a weld or bridge of solid bone. 15 Referred to as the iliac crest of the pelvis. 16 Alternatively, allegraft bone from a bone bank can be used for this purpose but is often less successful in accomplishing the desired fusion. 17 After “decompression” or surgical removal of the flexible structures located between healthy vertebrae known as the “disk”. 18 Lawrence Dep. at 2. 19 As Wetzel testified: The fusion could be done by any of a number of routes. It could be done from behind. It could be done from the front. Bone graft could be placed in the disc space, or bone graft could be placed posteriorly out to the sides. It could be done with Instrumentation or it could be done without Instrumentation.” Wetzel Dep. at 81. In the Spring of 1989, however, Wetzel did not perform anterior (that is, from the front) fusion surgeries for the Plaintiff's condition. Id. 20 The Acronym “AO” stands for the name of an organization which, in German, is known as Arbeitsgemeinschaft for Osteosynthesefragen which. In English, can be translated as Association for the Study of Internal Fixation and is often referred to by the acronym “ASIF” or “AO/ASIF”. AO International describes itself as: “A non profit organization dedicated to improving the care of patients with musculoskeletal injuries and their sequelac, through research, development, education and quality assurance in the principles, practice, and result of fracture treatment.” Similarly, the Mission Statement of the AO Foundation is “To improve the treatment of patients with trauma and disorders of the musculoskeletal system through Research, Development, Evaluation, Education and Quality Assurance”. In his document styled “Plaintiffs' Opposition To Defendant Synthes, Inc.'s Motion For Summary Judgment” at 2n.2 the Plaintiff asserts without record reference or other attribution: “Prior to plaintiff's surgery in 1989. Synthes, Inc. and ASIF Holding formed a partnership wherein Synthes, Inc. became 60% owner of Synthes, USA.” 21 Wetzel operative notes. See Wetzel Dep. at 100. See also, for example, P–26; August 20(sic), 1990 letter from Wetzel to Mark D. Myors, OTR/L at page 2. The procedure is further described with particular reference to the Synthes Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 23 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 23 devices employed, by Dr. William M. Iannacone, M.D., Ph.D., Chief, Division of Orthpaedic Surgery, Cooper Health System, University of Medicine & Dontistry of New Jersey, Robert Wood Johnson Medical School of Camden, in a letter to Defendant Synthes' counsel dated December 17, 1998, as follows: The procedure consisted of L–4/L–5 lumbar decompression with posterior lateral fusion of L–4/L–5 using two-two hole Dynamic Compression Plates and four 6.5 mm fully threaded cancellous bone screws, 45 mm in length.” The term “cancellous” refers to the type of bone represented by the spinal pedicles; that is, with a lattice-like internal structure. 24 Dana Corp, has manufacturing facilities in Pottstown and Reading with the former involved in the manufacture of motor vehicle drive shafts and the latter producing heavy-duty truck frames. Lawrence Dep. at 117–118. 25 Wetzel understood that Paul Lawrence was, at least during some of his time at Dane Corp., a forklift operator. Wetzel Dep. at 76. 26 The weight of the box is described in the pre-trial record variously as weighing between eighty and “more than one hundred” pounds. 27 The medical records of Dr. G.J. Lignolli, M.D. are identified as the Plaintiff's Exhibit No. 25 offered by Affidavit of Plaintiff's counsel in opposition to Synthes Motion for Summary Judgment. These exhibits are referred to hereinafter in the form: “P-[Exhibit # ]” or, in this instance, P–25. 28 See P–25; June 20, 1988 office note) 29 Sometimes referred to hereinafter without disrespect as “Wetzel”. 30 Lawrence Dep. at 45–48. 31 See P–26; Letter from Wetzel to Dana Corp. dated January 11, 1989. 32 A discogram is a medical diagnostic test to determine the anatomical source of law back pain in which the discographer inserts a needle in the patient's back into the center of the suspect disk; injects radiographic dye, and solicits the patient's description of the nature of the pain thereby produced. If the dye injection recreates the pain typically experienced by the patient (concordant pain), it is inferred that an abnormality of the specific disc injected is the source of pain. If the pain produced by the Injection is unlike the pain typically experienced (discordant pain) it is inferred that the dise injected with dye, whatever its appearance on x-ray or MRI study, is not the source of the patient's pain. The test itself is painful and the patient must be awake throughout the procedure in order to report to the discographer whether the pain generated by the injection is concordant or discordant. At this time Hershey was not equipped to perform discography and, therefore, the Plaintiff was referred in January, 1989 to a Dr. Charles April in New Orleans, Louisiana for performance of the test. See P–26; Dr. Gregory Lignolli, M.D. office note of January 11, 1989. See Wetzel Dep. at 74. 33 Wetzel Dep. at 78–79. See P–26; April 11, 1989 Wetzel outpatient visit note. 34 Surgery was originally scheduled for June 14, 1989 but a “scheduling mix-up” required it to be cancelled and the patient discharged. Wetzel Dep. at 98–99. See P–26 June 16, 1989 discharge summary dictated by Harlan Daubert, M.D. for Wetzel as attending physician. 35 P–23; Wetzel Dep. at 100–103. 36 See P–26; letter dated May 1, 1989 from Wetzel to Vicloria L. Ellis, R.N. Wetzel Dep. at 95. 37 See P–25; diagnostic radiology reports of Robert J. Sefczek, M.D. dated August 9, 1989 and Vladys low Gedroyc, M.D. dated September 20, 1989. 38 See P–26; Wetzel outpatient visit note dated January 3, 1990. 39 See P–26; diagnostic radiology report dated January 3, 1990 for Wetzel by Peter N. Waybill, M.D. 40 See P–26; March 8, 1990 letter of Wetzel to Sharon Doros, BSN, RN. 42 P–26; the April 11, 1990 office note. 43 See P–26; April 11, 1990 diagnostic radiology report for Wetzel by Hugh Logan, M.D. 44 Id. 45 This reference to the source of discogenic pain as “chemical” is unexplained on this record. 46 P–26; letter dated May 17, 1990 from Wetzel to Sharon Doros, BSN, RN. 47 Dr. DerKrikorian on May 3, 1990; Dr. Vernon Morris on June 20, 1990; Wetzel on July 18, 1990; Dr. John Mayor for repeat discography on August 15, 1990; and Dr. Roy G. Ysla on October 15, 1990. 48 That is, originaling in the spinal disk structure. 49 See P–26; July 18, 1990 letter from Wetzel to Mark D. Myers, OTR. 50 See P–26; July 18, 1990 report of Robert Wasserstrom, M.D. 51 See P–26; August 15, 1990 report of John Mayer, M.D. 52 See P–26; August 20(sic), 1990 letter of Wetzel to Marc D. Myers, OTR/L. Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 24 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 24 53 See also P–26; October 15, 1990 initial comprehensive evaluation performed by Dr. Roy Ysla, M.D. “Examination is consistent with myofascial pain syndrome.” Myofascial pain syndrome is a term often used by physicians to refer to pain syndromes otherwise unclassifiable. The Merck Manual of Diagnosis and Therapy, 17 Edition, 1999 gives a narrower referent; defining the term as an oral or dental disorder characterized by “spasm in the masticatory muscles (internal and external pterygoids, temporalis, and masseter) despite a normal TMJ [i.e. temporomandibular or law joint]”. It would appear that the physicians who here advanced this diagnosis had in mind the more general meaning of the term. In Wetzel's referral letter dated August 23, 1990 to Dr. Louis D. Poloni, Ph.D. of the Incentives Program, York Rehabilitation Hospital, the terms “significant secondary gain” and “possibility of somatic overlay” further indicate the physician's developing conclusion that medical and surgical modalities alone are unlikely to further reduce the Plaintiff's symptoms. 54 P–26; February 13, 1991 Wetzel office visit note. 55 Id. 56 P–26; diagnostic radiology report dated February 13, 1991 for Wetzel by Michael J. Manuell, M.D. 57 Dr. Noubar Didizian, M.D. of the Penn Diagnostic Center, Inc. 58 See March 27, 1991 office note. 59 P–26; March 11, 1992 Wetzel office visit note. 60 Lawrence Dep. at 198, 203. See P–35 61 Lawrence Dep. at 102. See P–26 Wetzel July 1, 1992 office visit note reporting that the second injection exacerbated the pain. 62 P–26; Wetzel October 14, 1992 office visit note. See also P–26; Wetzel's May 4, 1992 and July 1, 1992 office visit notes; Wetzel's undated request to Block Clinic for evaluation of Plaintiff for administration of opidural steroids; April 27, 1992 special consent form for epidural injections, consultation report, and progress notes. See P–26; May 28, 1992 Block Clinic consultation report to Wetzel including the following: “Pt [patient] reported complete relief of his chronic back pain and walked confidently after the injection.” 63 Lawrence Dep. at 107–108. 64 Lawrence Dep. at 110, 112, 117. See P–36: Morrissey March 9, 1993 history and physical including the following description of the surgical plan: “The patient is being admitted for removal of the plates and screws with the possibility of leaving the L5 screws in place and a fusion from the L4 to the sacrum. This will be done without Internal fixation.” 65 Lawrence Dep. at 133–135. 66 Lawrence Dep. at 166–167. 67 Lawrence Dep. at 137–138; P–37; Tase June 26, 1997 and August 14, 1997 progress notes. 68 See P–37; Report of Laurence Citro. M.D. dictated July 1, 1997. 69 That is, a diskogram as described above. See P–38; July 25, 1997 report of Kerry J. Thompson, M.D. 70 Id. 71 Lawrence Dep. at 160. The BAK devices are there described as made of titanium; hollow and threaded, to be packed with bone chips at the time of surgery and installed in the manner of a screw. 72 Lawrence Dep. at 165. 73 See Lawrence v. Synthes, Inc., 754 A.2d 28 (Pa.Super.2000) appeal denied. 568 Pa. 664, 795 A.2d 977 (Pa. August 28, 2000 Table, No. 221 and 223 M.D. Alloc, 2000) (a prior motion for venue change was filed by Plaintiffs on March 15, 2000 the disposition of which was initially precluded by the defense petition for allowance of appeal to the Supreme Court from the Superior Court order of February 29, 2000. Following the denial of the petition, Plaintiffs represented the instant motion. 74 By order entered August 28, 2000 to Nos. 221 and 223 MD Allocatur Docket 2000. 75 An interim assignment to Judge Cody of this court was effected by order of May 26, 2000. 76 These exceptions are the “grandfather” clause permitting without investigation all devices introduced in the market before May 28, 1976 (the effective date of the Act); see 21 U.S.C. § 360e(b)(1)(A); 21 CFR § 814.1(c)(1); as well as all devices later introduced which are “substantially equivalent” to such a predicate device. 21 U.S.C. § 360e(b)(1)(B); 21 C.F.R. § 807.87. As the United States Supreme Court has written with respect to these regulations: Not all, nor even most, Class III devices on the market today have received premarket (“PMA”) approval because of two Important exceptions to the PMA requirement. First, Congress realized that existing medical devices could not be withdrawn from the market while the FDA completed its PMA analysis for those devices. The statute therefore includes a “grandfathering” provision which allows pro–1976 devices to remain on the market without FDA approval until such Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 25 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 25 time as the FDA initiates and completes the requisite PMA. See 21 U.S.C. § 360e(b)(1)(A); 21 CFR § 814.1(c)(1) (1995). Second, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices clear the PMA hurdle, and to ensure that improvements to existing devices can be rapidly introduced into the market, the Act also permits devices that are “substantially equivalent” to pre-existing devices to avoid the PMA process. See 21 U.S.C. § 360e(b)(1)(B). Medtronic, Inc. v. Lohr, 518 U.S. 470, 477–478, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). See also Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 345, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) 77 Larson November 16, 1998 Report at 3. 78 See 1997 WL 39583 at *4. 79 Rejecting in Pennsylvania the less restrictive standard determined by the United States Supreme Court in Donbert to be mandated in federal jurisprudence by Fed. R. Civ. Pro. No. 702 and refusing to overturn the rule of Frye v. United States, 293 F. 1013 (D.C.Cir.1923) adopted as this Commonwealth's governing principle by Commonwealth v. Topa, 471 Pa. 223, 369 A.2d 1277 (1977). 80 Later purchased by the University of Medicine and Dentistry of New Jersey. 81 Deposition of Lanco O. Yarus taken January 30, 1998 in MDL 1014 for the case captioned Jason Leigh et al. v. Danek Medical, Inc. et al., CA No. 95–8021 appended as Exhibit “L.” to Synthes motion for summary judgment (hereinafter: “Yarus Dep.”) at 107. 82 Yarus Dep. at 107. 83 Yarus Dep. at 125 (last five to seven years). 84 Yarus Dep. at 124. 85 Yarus Dep. at 125. 86 Yarus Dep. at 125. 87 Yarus Dep. at 127. 88 Yarus Dep. at 58–59. 89 Yarus Dep. at 59–60. 90 Yarus Dep. at 65–66. 91 Yarus Dep. at 65. 92 Yarus Dep. at 129–130. 93 As Mr. Lawrence described the encounter: “I just went up and talked to him and showed him some x-rays and stuff and that was about it. Q: How long were you with him? A: Maybe 20 minutes. Q: Did he perform an examination during that 20 minutes or did you simply talk to him? A: Just talked to him at that time. Q: How many occasions have you gone to his office? A: Once.” Lawrence Dep. at 175. 94 See Volume 60, No. 192 of the Federal Register; 60 F.R. 51946 et seq. proposing amendments to 21 CFR Part 888 to FDA Docket No. 95N–0176. 95 See Volume 63, No. 143 of the Federal Register; 63 FR 40025 et seq. In In Re Orthopedic Bone Screw Litigation, 264 F.3d 344 (3d Cir.2001) the court affirmed Judge Bechtle's Order for the district court dismissing claims against the FDA brought pursuant to the Federal Tort Claims Act, 28 U.S.C. § 1346 et seq. and alleging improprieties in the approval of these devices. 96 Id. at 773 citing Jacobini v. V. & O. Press Co., 527 Pa. 32, 588 A.2d 476 (Pa.Super.1991); Riloy v. Warren Manufacturing Co., 455 Pa.Super. 384, 688 A.2d 221 (Pa.Super.1997); Fitzpatrick v. Madonna, 424 Pa. Superior Ct. 473, 623 A.2d 322 (1993); and Jordon v. K–Mart Corp., 417 Pa.Super. 186, 611 A.2d 1328, 1331 (1992) 97 Azzarello v. Black Bros. Co., Inc., 480 Pa. 547, 556, 391 A.2d 1020, 1024 (1978) 98 We noted in Riccio et al. that the standard of admissibility under Daubert utilized by the federal judiciary is less stringent than that mandated in this Commonwealth by our Supreme Court under Frye and Topa. Riccio. 49 Ches. Co. Rep. at 281. Therefore, we may conclude from the exclusion of Dr. Yarus evidence by the district courts cited, a fortiori, exclusion in this case is required. 99 In Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), the United States Supreme Court, reversing the decision of the United States Court of Appeals for the Third circuit thereby, in effect, reinstating the decision of Judge Bechtle for the United States District Court for the Eastern District of Pennsylvania in which the District Court dismissed the MDL 1014 plaintiffs' state fraud counts and, particularly, the counts denominated “fraud on the FDA” in which it was alleged that fraudulent misrepresentations by bone screw manufacturers had the effect of inducing regulatory approval of the devices here at issue. Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 26 of 27 Lawrence v. Synthes Inc., Not Reported in A.2d (2002) 2002 WL 32747667 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 26 The court held that the MDA “amply empowers the FDA to punish and deter fraud ...” as among the objectives the agency seeks to maintain in a “delicate balance” that could be “skewod” by permitting state law fraud claims. Id. at 348. Therefore, preemption was required. If it were necessary to do so, we would hold to be preempted the state common law fraud claims here presented. 100 See, for example, Glbbs v. Emst, 538 Pa. 193, 207–208, 647 A.2d 882, 889 (1994). Restatement (Second) of Torts § 525 (1977). 101 Moreover, In Hahn v. Richtor, 543 Pa. 558, 673 A.2d 888 (1996) the Supreme Court held that strict liability pursuant to § 402A of the Restatement (Second) of Torts was not available in a claim by an injured consumer against the manufacturer or seller of proscription drugs. Only common law negligence claims are viable in that context inasmuch as prescriptions drugs possess inherently dangerous propensities determined to be overborne by their ability to advance the public welfare and health. Prescription medical devices must be analyzed similarly, In Murrary v. Synthes U.S.A., Inc., 1999 WL 672937 (E.D.Pa.1999) the court held the rule of Hahn applicable to the medical devices here at issue and rejected on that basis a back surgery patient's strict liability claim. We would reach the same conclusion if Plaintiff's claims were not barred by the preemption under Buckman and by the failure to adduce substantial causal evidence. 102 In which a manufacturer is permitted to meet its informational duties by informing the physician of risks related to devices which can be obtained only through a physician's intervention. Incollingo v. Ewing. 444 Pa. 263, 288, 282 A.2d 200, 220 (1971); See Parks v. Simeone, et al., MDL 1014, Phila. Common Pleas No. 2492, June 12, 1998. In Murray v. Synthes U.S.A., Inc., 1999 WL 672937 (S.D.Pa.1999) the court rejected identical claims on this, and other equally compelling grounds, we adopt the reasoning of the court in Murray. 103 Affidavit of Wetzel taken November 18, 1998 (“Wetzel Affidavit”) at ¶¶ 18, 25–27. End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:14-cv-00098-CDL Document 36-9 Filed 10/24/16 Page 27 of 27 EXHIBIT G Case 4:14-cv-00098-CDL Document 36-10 Filed 10/24/16 Page 1 of 12 Albertson v. Wyeth Inc., Not Reported in A.2d (2003) 2003 WL 21544488, 63 Pa. D. & C.4th 514 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 KeyCite Yellow Flag - Negative Treatment Distinguished by Slemmer v. McGlaughlin Spray Foam Insulation, Inc., E.D.Pa., July 8, 2013 2003 WL 21544488 Pennsylvania Court of Common Pleas. ALBERTSON, et al. Plaintiffs v. WYETH INC. et al. Defendants FINNIGAN, et al. Plaintiffs, v. WYETH INC. et al. Defendants, EVERETTE, et al., Plaintiffs, v. WYETH INC., et al. Defendants. No. 2944 AUG.TERM 2002, 0007 AUG.TERM 2002, 0935 DEC.TERM 2002, CONTROL 020676. | July 8, 2003. Opinion SHEPPARD, J. *1 Presently before the court are the Preliminary Objections of Wyeth, Inc. and Wyeth Pharmaceuticals Inc. a/k/a Wyeth–Ayerst Pharmaceutical (“Wyeth”). These objections present a demurrer to plaintiffs' consolidated, Amended Complaint and a Motion to Strike plaintiffs' request for attorney fees. FACTUAL BACKGROUND The consolidated, Amended Complaint (“Complaint” or “Compl.”) sets forth the following factual allegations. 1 Wyeth manufactures, promotes and distributes three estrogens or hormone replacement drugs known as “Premarin,” “Prempro” and “Premphase.” Compl. ¶ 13. Premarin is a conjugated estrogen that was first manufactured and marketed by Wyeth in 1942. Compl. ¶ 15. It is prescribed for women suffering from severe menopausal symptoms. Compl. ¶ 15. When taken alone (or “unopposed”), conjugated estrogen increases the risk of uterine cancer in post-menopausal women with intact uteri. The use of estrogen alone is referred to as estrogen replacement therapy (“ERT”). Prempro consists of two types of hormones: conjugated equine estrogens and progestins. Compl. ¶ 15–16. Because it combines estrogen and progestin, Prempro is often abbreviated as “E & P.” The risk of uterine cancer is decreased when estrogen is combined with progestin. The use of estrogen and progestin in the treatment of menopausal symptoms is referred to as hormone replacement therapy (“HRT”). In December 1994, the United States Food and Drug Administration (FDA) granted Wyeth's petition for approval to market Prempro as separate tablets of Premarin (0.625 mg) and medroxyprogestrone acetate (MPA) called Cyrcrin (2.5 mg). Compl. ¶ 18. Prempro was to be prescribed for post-menopausal women with uteri for the treatment of moderate severe vasomotor symptoms associated with menopause, vulvar and vaginal atrophy and the prevention of osteoporosis. Compl. ¶ 18. According to plaintiffs, there are an estimated fifty million post-menopausal women in the United States. Compl. ¶ 20. In July 2002, approximately 38% of post-menopausal women in the United States used estrogen or HRT. Compl. ¶ 21. At that time, about six million American women were taking Prempro. Compl. ¶ 22. Prempro is the best-selling HRT or estrogen-progestin combination drug in the United States. Compl. ¶ 23. Wyeth has promoted Prempro and Premarin by marketing efforts directed to doctors and by direct-to- consumer efforts. According to plaintiffs, Wyeth utilized marketing techniques with the intention and effect of creating a lifelong demand for its estrogen replacement drugs on the part of post-menopausal women. Compl. ¶ 24. Wyeth's direct-to-consumer efforts have included print advertisements, videotapes, and brochures directed to consumers, as well as “product placement” efforts in which estrogen products are favorably positioned in entertainment vehicles or favorably described in the popular press by hired spokespersons. Compl. ¶ 25. *2 In 1999, Wyeth spent $34.7 million and in 2000, $37.9 million, on direct-to-consumer advertising for Prempro. Compl. ¶ 26. In 2001, Premarin became the first Wyeth brand to surpass $2 billion in annual sales. Compl. ¶ 27. According to plaintiffs, Wyeth's marketing of Prempro Case 4:14-cv-00098-CDL Document 36-10 Filed 10/24/16 Page 2 of 12 Albertson v. Wyeth Inc., Not Reported in A.2d (2003) 2003 WL 21544488, 63 Pa. D. & C.4th 514 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 and Premarin present menopause symptoms in dire and detailed fashion, describe purported benefits of ERT/ HRT that have never been proven and minimize and distort the risks associated with ERT/HRT. Compl. ¶ 30. Premarin and Prempro were designed and have been approved by the FDA to relieve only menopausal symptoms, such as hot flashes, vaginal atrophy and osteoporosis. Compl. ¶ 32. However, according to plaintiffs, Wyeth has long touted its estrogen products as having additional benefits. Compl. ¶ 32. Thus, in print advertisements, brochures, and magazine advertisements, Wyeth claimed that Premarin could be used to relieve various ills including tension, irritability, headaches, undue fatigue, depression and insomnia when caused by declining menopausal estrogen levels. Compl. ¶ 33. Additionally, Wyeth claimed that Alzheimer's disease, vision problems, tooth loss, heart disease and colon cancer could be treated with Premarin or Prempro. Compl. ¶ 35. Wyeth also suggested that its conjugated equine estrogen was appropriate for treating or preventing, among other things, memory loss, colon cancer and age-related vision loss. Compl. ¶ 36. In 1993, Wyeth distributed a videotape to consumers entitled “What every woman should know about estrogen.” The videotape claimed to be a seminar for women and depicted a female doctor advising women about menopause, conjugated equine estrogen (CEE) and progestin. Wyeth's video seminar warned of a wide variety of illnesses and ailments purportedly associated with menopause. Among other things, Wyeth represented that estrogen loss causes bone to become brittle, skin to become dryer and sexual intercourse to become “painful and irritating.” Plaintiffs allege that while the videotape was exhaustive in its warnings about menopause, it glossed over the dangers and risks associated with ERT. Compl. ¶ 43. Additionally, the video “seminar” recommended that estrogen should be combined with progestin when taken by women who have not had hysterectomies. Compl. ¶ 45. The video seminar also represented that estrogen provided “long term health protection” and should be continued indefinitely, even after short term menopausal symptoms, such as hot flashes, had subsided. When a purported consumer inquired how long Premarin should be taken, Wyeth's doctor spokesperson responded “anywhere from five to ten years in order to get protection from long term problems.” Compl. ¶ 46. With regard to breast cancer risks, Wyeth represented in its video seminar that the benefits of taking estrogen “far outweigh the risks for women unless they faced a particularly high risk of breast cancer.” Plaintiffs allege that the opposite is true: the risks of taking Prempro far outweigh the benefits. Compl. ¶ 47. Wyeth also allegedly misrepresented that most studies showed no increased risk of breast cancer associated with taking estrogen at usual doses, and that breast cancer risks were only elevated when estrogen was taken at higher doses “for more than ten years.” *3 At least until mid–2002, Wyeth distributed a Prempro promotional brochure targeted for women consumers that had the words “Starting your Hormone Replacement Therapy” at the top of the front cover. At the bottom of the cover of this brochure and at the bottom of nine of its seventeen pages of text, the following words appear: “Say yes to PREMPRO.” Compl. ¶ 49. Wyeth's “Say yes to PREMPRO” brochure contains testimonials from six women who claim to have used estrogen or Prempro for an average of 12.2 years. Each of these women is reported to have used Prempro and/or Wyeth's estrogen- only therapy, Premarin, for at least seven years. Compl. ¶ 50. Wyeth's annual report contains a similar testimonial from a woman. Compl. ¶ 52. According to plaintiffs, Wyeth's “Say yes to PREMPRO” brochure does not warn about, among other things, breast cancer even though its profiles all have used estrogen or Prempro for more than five years. Compl. ¶ 53. In the section of Wyeth's “Say yes to PREMPRO” brochure devoted to “side effects,” Wyeth warns about uterine cancer (associated with estrogen-only therapy), worsening diabetes, blood clots, nausea, abdominal pain, irregular bleeding, headache, hair loss, and breast tenderness, but does not warn about breast cancer. Compl. ¶ 54. Until mid–2002, Wyeth used a Prempro package insert, which states under the subheading “Cancer of the breast”: Most studies have not shown a higher risk of breast cancer in women who have ever used estrogen. However, some studies have reported that breast cancer developed more often (up to twice the usual rate) in women who used estrogen for long periods of time Case 4:14-cv-00098-CDL Document 36-10 Filed 10/24/16 Page 3 of 12 Albertson v. Wyeth Inc., Not Reported in A.2d (2003) 2003 WL 21544488, 63 Pa. D. & C.4th 514 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 (especially more than ten years), or who used high doses for shorter time periods. Compl. (¶ 55). Though worded slightly differently, this same statement appears in a November 2001 Wyeth leaflet that addresses estrogens generally. According to plaintiffs, the information provided by Wyeth to consumers from at least 1993 to mid–2002 consistently and uniformly misrepresented that its estrogen replacement products (with or without progestin) were to be used by consumers on a long term basis, even after menopausal symptoms had subsided, and did not present significant breast cancer risks unless consumed for ten years or more in unusually high doses. Wyeth also omitted from its 1993–2002 warnings and direct-to-consumer promotions any mention of the diminished effectiveness of standard mammography attributable to HRT. Compl. ¶ 61. In July 8, 2002, the National Heart, Lung, and Blood Institute (“NHLBI”) of the National Institutes of Health (“NIH”) announced that it had decided to terminate prematurely a portion of its Women's Heath Initiative (“WHI”) Study that was designed to examine the effect of estrogen plus progestin on the prevention of heart disease and hip fractures, and to identify any associated cancer risks (“WHI Study”). Compl. ¶ 64. The WHI Study was designed in light of earlier studies that had demonstrated that long term HRT or ERT increased breast cancer risks as well as the risks of blood clots in the legs and lungs. Compl. ¶ 75. The WHI Study was designed to continue for 8.5 years or until 2005. The NHLBI stopped the HRT portion of the study, however, after an average follow-up of only 5.2 years, primarily due to an unacceptable risk of invasive breast cancer associated with Prempro. Compl. ¶ 65. Prempro was the only HRT drug given to the women who participated in the WHI study. Compl. ¶ 66. *4 In the WHI study, the risk of invasive breast cancer increased by 26% after using Prempro for an average of 5.2 years. Compl. ¶ 67. The WHI study also demonstrated that, after five years of use, the overall risks of Prempro outweigh any benefits which it may produce. Compl. ¶ 68. In addition to the increased breast cancer risk associated with Prempro, the WHI Study showed the following increases among the women who participated in the Study: (1) a 41% increase in strokes, (2) a 29% increase in heart attacks, and (3) more than doubling in the rates of venous thromboembolism (blood clots). The benefits of Prempro revealed in the WHI Study appear to be fewer colorectal cancers and hip fractures. Compl. ¶ 69. When the WHI Data and Safety Monitoring Board decided to terminate the WHI Study prematurely, it sent a letter to each Study participant informing them that the Board had concluded that “it has become clear that the health risks of taking estrogen plus progestin now exceeds the benefits.” As a result, the WHI Study participants were instructed to “Stop taking your pills, maintain their clinic appointments and receive yearly mammograms.” Compl. ¶ 73. Although the WHI Study was the first large, randomized, and placebo-controlled trial to examine the risks and benefits for healthy women of taking estrogen and progestin over an extended period of time, a number of peer-review studies had previously shown higher breast cancer rates among women who were HRT users, especially those who were taking a formulation that, like Prempro, contained progestin and particularly when the drug was taken for five or more years. Com pl. ¶ 81–93. According to the plaintiffs, Wyeth knew or should have known that it was misleading to suggest to women that breast cancer only became pronounced after ten years or more of the estrogen use, particularly at unusually high doses. Compl. ¶ 94. By early 1997, the evidence of an association between HRT and breast cancer was strong enough to lead to the publication of a letter in the British Journal of Medicine entitled, “Women need to be warned about dangers of hormone replacement therapy.” Compl. ¶ 95. HRT significantly increases the risk of breast cancer to a far greater extent than does estrogen-only therapy. Compl. ¶ 97. A report published in Steroids 2000 Oct–Nov estimated that increased risk of breast cancer attributable to HRT use is some 212–fold greater than the effect of ERT. Compl. ¶ 97. Other studies have demonstrated that estrogen and progestin taken in combination increase breast tissue density to a greater extent than post- menopausal ERT alone and that HRT shows an increase in breast density on mammograms. Compl. ¶¶ 98–99. Increasing breast tissue density decreases the effectiveness of standard mammography. Compl. ¶ 100. Plaintiffs allege that the substantially increased risk of invasive breast cancer associated with long term use of estrogen and/or progestin had been clearly demonstrated well before the WHI Study. Wyeth failed to acknowledge Case 4:14-cv-00098-CDL Document 36-10 Filed 10/24/16 Page 4 of 12 Albertson v. Wyeth Inc., Not Reported in A.2d (2003) 2003 WL 21544488, 63 Pa. D. & C.4th 514 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 and provide this warning. Instead, Wyeth warned that the effect of adding progestins for the risk of breast cancer was unknown and suggested that ten years of exposure was the threshold for harm. Compl. ¶ 106. *5 In July 2002, as the result of the premature termination of the Prempro component of the WHI Study, Wyeth acknowledged the significant risks of breast cancer and cardiovascular disease presented by hormone therapy. In July 2002, Wyeth changed its warning labels and curtailed its direct to consumer marketing of Prempro. On September 4, 2002, Wyeth amended Prempro and Premarin package inserts in light of the WHI Study. Compl. ¶ 107. Wyeth forwarded letters to physicians informing them of the package insert update. Wyeth did not utilize a direct-to-consumer campaign to inform consumers of the package insert update. Compl. ¶ 108. The amended package insert acknowledges that “Prempro ... may increase your risk of getting breast cancer, blood clots, heart attacks and strokes.” Compl. ¶ 109. The new package insert does not refer to “a long term,” or give any indication that the risk refers to a time period other than the “ten years or more” period about which Wyeth warned previously. Compl. ¶ 109. The package insert also states, “Mammography should be scheduled depending on your risks' factors” and that in light of associated health risks Prempro should only be used “as long as needed for relief from menopausal symptoms.” Compl. ¶ 111. On August 21, 2002, plaintiffs Claudette Albertson and Thelma D. Reese, E.D. filed a complaint against Wyeth. On or about the same date, plaintiff Finnegan filed a similar complaint, followed by plaintiff Everette. On January 22, 2003, the matters were consolidated and a consolidated, Amended Complaint was filed. The Complaint asserts five counts against Wyeth: (a) negligence/medical monitoring (Count I), (b) unjust enrichment (Count II), (c) violation of the Pennsylvania Unfair Consumer Practice and Consumer Protection Law (Count III), (d) Breach of Fiduciary Duty (Count IV) and (e) Fraud (Count V). Wyeth has filed Preliminary Objections in the nature of a demurrer. Wyeth also contemporaneously filed a Motion to Strike plaintiffs' claim for attorney fees. DISCUSSION A preliminary objection in the nature of a demurrer tests the legal sufficiency of the complaint. Constantino v. University of Pittsburgh, 2001 Pa.Super. 4, 766 A.2d 1265, 1268 (2001). The question presented by a demurrer is whether, on the facts averred, the law says with certainty that no recovery is possible. Viglione v. Pennsylvania Dept. of Corrs., 781 A.2d 248, 250 n. 3 (Pa.Commw.2001). When considering preliminary objections, all material facts set forth in the complaint, as well as all inferences reasonably deducible therefrom are accepted as true, while conclusions of law, unwarranted inferences from facts, argumentative allegations or expressions of opinion need not be regarded as such. Wagner v. Waitlevertch, 2001 Pa.Super. 100, 774 A.2d 1247, 1250 (2001). Preliminary objections may only be granted in cases where it is clear and free from doubt that the facts alleged are legally insufficient to establish a right to relief. Stair v. Turtzo, Spry, Sbrocchi, Faul & LaBarre, 564 Pa. 305, 309, 768 A.2d 299, 301 (2001). For that reason, a demurrer should not be sustained simply because of the novelty of a claim. Denton v. Silver Stream Nursing and Rehabilitation Center, 739 A.2d 571, 575 (Pa.Super.1999). Furthermore, if there is any doubt as to whether a demurrer should be granted, it should be resolved in favor of overruling the preliminary objections. Lennon ex rel. v. Wyeth–Ayerst Laboratories Inc., 2001 WL 755944, *1 (Pa.Super. June 14, 2001). A. Demurrer to Count I (Negligence/Medical Monitoring) *6 Wyeth first asserts that Count I of plaintiffs' Complaint alleging a medical monitoring claim should be dismissed. This objection is overruled. In Simmons v. Pacor, Inc., 543 Pa. 664, 674 A.2d 232 (Pa.1996), our Supreme Court recognized medical monitoring as a viable cause of action under Pennsylvania law. In Simmons, the plaintiffs developed asymptomatic pleural thickening as a result of their occupational exposure to asbestos and sought damages for increased risk and fear of cancer. The Supreme Court held that damages for increased risk and fear of cancer were too speculative to be recoverable where cancer was not present. Because the plaintiffs in Simmons had not developed cancer, the court did not permit them to recover for their increase risk and fear of cancer. However, the Supreme Court did permit plaintiffs with asbestos-related asymptomatic pleural thickening to recover for medical Case 4:14-cv-00098-CDL Document 36-10 Filed 10/24/16 Page 5 of 12 Albertson v. Wyeth Inc., Not Reported in A.2d (2003) 2003 WL 21544488, 63 Pa. D. & C.4th 514 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 monitoring. Redland Soccer Club, Inc. v. Department of the Army and Dept. of Defense of the U.S., 548 Pa. 178, 696 A.2d 137, 145 (1997). In Redland Soccer Club Inc., supra., the Pennsylvania Supreme Court extended medical monitoring claims to non-asbestos-related injuries and articulated the necessary elements to state a claim for medical monitoring: 1) exposure greater than normal background levels; 2) to a proven hazardous substance; 3) caused by defendants' negligence; 4) as a proximate result of the exposure, plaintiffs have a significantly increased risk of contracting a serious latent disease; 5) a monitoring procedure exists that makes the early detection of the disease possible; 6) the prescribed monitoring regime is different from that normally recommended in the absence of exposure; and 7) the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles. Redland, 548 Pa. at 195–196, 696 A.2d at 145–146. The Supreme Court noted that expert testimony is required to prove each of these elements. Id. at 196, 696 A.2d at 146. The Redland court cited four important policy reasons for recognizing claims for medical monitoring. First, “medical monitoring promotes early diagnosis and treatment of disease resulting from exposure to toxic substances caused by a tortfeasor's negligence.” Second, “allowing recovery for such expenses avoids the potential for injustice of forcing an economically disadvantaged person to pay for expensive diagnostic examinations necessitated by another's negligence” and “affords toxic- tort victims, for whom other sorts of recovery may prove difficult, immediate compensation for medical monitoring needed as a result of exposure.” Third, medical monitoring “furthers the deterrent function of the tort system by compelling those who expose others to toxic substances to minimize risks and costs of exposure.” Finally, permitting the claim is “in harmony with the important public health interest in fostering access to medical monitoring testing for individuals whose exposure to toxic chemicals creates an enhanced risk of disease.” Redland at 194, 696 A.2d at 145 (quoting Hansen v. Mountain Fuel Supply Co., 858 P.2d 970, 976–977 (Utah 1993)). *7 Wyeth argues that plaintiffs have failed to meet the criteria enunciated in Redland, supra. to establish a claim for medical monitoring. Specifically, Wyeth contends that plaintiffs have failed to allege that they were exposed to a proven hazardous substance. Wyeth maintains that Prempro, a FDA approved drug, is not a hazardous substance since it is still on the market as a safe and effective treatment. Wyeth further maintains that it cannot be negligent for its pre-WHI Prempro warnings because the language it used was the precise warning language the FDA told Wyeth it should use. In other words, Wyeth claims that the pervasive scheme of federal regulation governing the production, labeling, and distribution of prescription drugs by the FDA implicitly preempts Pennsylvania's tort claims for prescription drug manufacturers' breach of duty to warn consumers. The concept of preemption has its roots in the supremacy clause of the U.S. Constitution, art. VI, cl. 2. Preemption may be express or implied. Hillsborough County, Fla. v. Automated Medical Laboratories, Inc., 471 U.S. 707, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985). Since Wyeth makes no claim that Congress expressly preempted state tort law, only the issue of implied preemption need be discussed. Implied preemption arises in two ways. First, Congress may indicate an intent to assign an entire field of regulation in a given area to the federal government. Fidelity Federal Sav. and Loan Ass'n. v. de la Cuesta, 458 U.S. 141, 102 S.Ct. 3014, 73 L.Ed.2d 664 (1982). Second, Congress may preempt state law to the extent that state law actually conflicts with federal law. Such a conflict arises when compliance with both federal and state law is impossible or when state law frustrates the purpose of federal law. Michigan Canners and Freezers Ass'n. v. Agricultural Marketing and Bargaining Bd., 467 U.S. 461, 104 S.Ct. 2518, 81 L.Ed.2d 399 (1984). There is no question that federal regulation of prescription drugs is comprehensive. Under the Food and Drug Administration (“FDA”) regulatory scheme, a manufacturer must obtain approval from the FDA to distribute its product. Sokoloski v. American Home Products, 2003 WL 1875113, *6 (Pa.Com.Pl.2003), citing Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et. seq. That approval is secured by formal application, which must include “full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use.” Sokoloski, quoting 21 U.S.C. § 355(b)(1)(A). Additionally, subsequent to FDA approval, a manufacturer is required to provide updated data or information to the FDA Case 4:14-cv-00098-CDL Document 36-10 Filed 10/24/16 Page 6 of 12 Albertson v. Wyeth Inc., Not Reported in A.2d (2003) 2003 WL 21544488, 63 Pa. D. & C.4th 514 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 Secretary, to enable the Secretary to determine whether grounds exist for revocation of approval for the drug. 21 U.S.C. § 355(k)(1). Moreover, the manufacturer, distributor or seller of the drug has the duty to label the prescription drug it has manufactured. Id., citing 21 U.S.C. § 352(b); 21 CFR § 201.100. *8 Preemption of state tort law, however, does not automatically follow extensive federal regulation. Mazur v. Merck & Co. Inc., 742 F.Supp. 239, 245 (E.D.Pa.1990) citing Hillsborough, 471 U .S. at 715, 105 S.Ct. at 2376. In the absence of express preemption, there is a strong presumption that Congress did not intend to displace state law. Id. at 256. The presumption against preemption is even stronger when federal regulation would work to preempt state tort remedies. Id., citing Silkwood v. Kerr– Mcgee Corp., 464 U.S. 238, 251, 104 S.Ct. 615, 623, 78 L.Ed.2d 443 (1984). In Silkwood v. Kerr–McGee Corp., supra., the Court found that the Atomic Energy Act and its enacting regulations did not preclude an award of punitive damages under state law. The Court recognized that states had been expressly prohibited from regulating the safety aspects of hazardous materials, but refused to extend that prohibition to state law remedies for persons injured from radiation exposure in nuclear plants. Id. at 250–51, 104 S.Ct. at 622–23. The Court rejected the contention that the award of damages would conflict with the federal remedial scheme, finding that “paying both federal fines and state-imposed punitive damages for the same incident would not appear to be physically impossible.” Id. at 257, 104 S.Ct. at 626. The Supreme Court has since unanimously confirmed that “ordinarily, state causes of action are not preempted solely because they impose liability over and above that authorized by federal law.” English v. General Elec. Co., 496 U.S. 72, 89, 110 S.Ct. 2270, 2280, 110 L.Ed.2d 65 (1990) (citation omitted). Here, if federal regulation of prescription drugs were deemed exclusive, Pennsylvania's ability to protect its citizens from the dangers of prescription drug use would be severely hampered. Further, it would leave Pennsylvania citizens harmed by prescription drugs without a state tort remedy. This court submits that Congress did not intend such a result. The tort law here is remedial and compensatory in nature, and does not conflict with any aspect of the FDA's regulatory scheme. Thus, preemption of the state remedial measures available to plaintiffs cannot be implied. Wyeth seeks to shield itself from liability, arguing that the language used for the warning label of Prempro was the precise language which the FDA approved. The same argument was raised and rejected in Mazur v. Merck & Co. Inc., 742 F.Supp. 239, 247 (E.D.Pa.1990). In Mazur, the defendant asserted that the pervasive scheme regulating all aspects of vaccines compelled a finding of implied preemption. The Court disagreed, stressing the strong presumption against preemption of state tort remedies in areas of health and safety, and noting that preemption would leave Pennsylvania citizens harmed by vaccines without a remedy. The Court in Mazur also rejected the defendant's narrower conflict preemption argument based on two observations appropriate to the circumstances here: *9 Mere compliance with a FDA suggestion, or for that matter, regulation or order, does not mean that state tort law becomes irrelevant. First, compliance with an FDA regulation may establish that the manufacturer met the appropriate minimum standards of due care, but compliance does not necessarily absolve the manufacturer of all liability. See, e.g., Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 658 (1 st Cir.1981). Manufacturers must meet state safety requirements, whether codified or embodied in the common law, in addition to satisfying the initial FDA requirements. Second, federal regulation serves a very different purpose than state tort law. Essentially, federal regulation serves a deterrent purpose by limiting the manufacturer of inherently dangerous products to those applicants who meet certain stringent safety standards, while state tort law serves the equally important purpose of compensating individuals injured by those very Case 4:14-cv-00098-CDL Document 36-10 Filed 10/24/16 Page 7 of 12 Albertson v. Wyeth Inc., Not Reported in A.2d (2003) 2003 WL 21544488, 63 Pa. D. & C.4th 514 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 7 same products. Because, compliance with FDA regulation will not ensure that a manufactured product will not cause injury, compliance will not necessarily exempt a manufacturer from liability. When those products do cause injuries, the state tort system provides a means of compensation. State tort law is intended to supplement federal regulation by providing a vehicle for compensation of vaccine related injuries. Id. at 247 (footnote omitted) (emphasis added). This analysis in Mazur supports this court's refusal to find in this case that plaintiffs' state tort claim is preempted, especially on preliminary objections. 2 Thus, Wyeth's preliminary objection on the ground that plaintiffs' claim is preempted by federal regulation is overruled. In addition, this court finds, that the Complaint makes sufficient allegations to establish a claim for medical monitoring. Plaintiffs allege that Prempro is a hazardous substance, and that Wyeth failed to use reasonable care in informing consumers of the risks of Prempro which they knew, or about which they reasonably should have known. Compl. ¶ 127. Plaintiffs further allege that Wyeth breached the duty owed to plaintiffs and that Wyeth's breach of the duty was the proximate cause of the injuries suffered. Compl. ¶ 130. According to plaintiffs, Wyeth's actions that give rise to liability include: (1) erroneously suggesting to doctors and patients that the risk of breast cancer associated with Prempro use did not become substantial until ten or more years of use, (2) failing to distinguish between the breast cancer risks posed by Prempro versus those posed by estrogen alone, (3) failing to inform doctors and patients that long-term use of HRT diminishes the effectiveness of standard mammography, (4) failing to inform doctors and patients that any bone density benefit that may be associated with Prempro was outweighed by increased risks of invasive breast cancer and cardiovascular disease, (5) failing to inform doctors and patients that, overtime, the overall risks of daily use of Prempro, including risks of heart attack, stroke and blood clot, outweigh any associated osteoporosis benefits, and (6) combining progestin and estrogen in a product to be taken orally on a long term basis, thereby substantially increasing plaintiffs' risks of suffering breast cancer, heart attacks, strokes and blood clots. Compl. ¶ 129 a-e. Plaintiffs have sufficiently alleged that they are at a significantly increased risk of harm for developing breast cancer and have also pleaded with sufficiency that the monitoring regime is different from that normally recommended. Compl. ¶¶ 94, 100, 105, 131–32 a-n. *10 At this juncture it is important to reiterate two points noted earlier. First, preliminary objections may be granted only where it is free from doubt that the alleged facts are insufficient and, if there is any doubt whether a demurrer should be granted, it must be resolved in favor of overruling the objections. 3 Second, in Redland, supra., our Supreme Court made clear that expert testimony is necessary to prove the elements requisite for a monitoring claim. 4 Recognizing that Redland provides that expert testimony is required and that plaintiffs receive all inferences reasonably flowing from the pleading, leads this court to overrule Wyeth's Preliminary Objection that plaintiffs failed to plead the elements of a negligence/medical monitoring claim. 5 B. Demurrer to Count II (Unjust Enrichment) Wyeth next contends that plaintiffs' claim for unjust enrichment is insupportable as a matter of law because plaintiffs had no dealings with Wyeth that would support a quasi-contractual or equitable claim for unjust enrichment and because plaintiffs cannot point to any unjust benefit Wyeth received as a result of plaintiffs' purchases of Prempro. Defendants' Memo, p. 13. “Unjust enrichment” is essentially an equitable doctrine. Mitchell v. Moore, 1999 Pa.Super. 77, 729 A.2d 1200, 1203 (1999). “Where unjust enrichment is found, the law implies a contract, which requires the defendant to pay the plaintiff the value of the benefit conferred.” Id., citing Schenck v. K.E. David, Ltd., 446 Pa.Super. 94, 666 A.2d 327 (1995). The elements necessary to prove unjust enrichment are: (1) benefits conferred on defendant by plaintiff; (2) appreciation of such benefits by defendant; and (3) acceptance and retention of such benefits under such circumstances that it would be inequitable for defendant to retain the benefit without payment of value. Id. at 1203, 666 A.2d 327. The application of Case 4:14-cv-00098-CDL Document 36-10 Filed 10/24/16 Page 8 of 12 Albertson v. Wyeth Inc., Not Reported in A.2d (2003) 2003 WL 21544488, 63 Pa. D. & C.4th 514 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 8 the doctrine depends on the particular circumstances presented. Further, “in determining if the doctrine applies, the focus is not on the intention of the parties, but rather on whether the defendant has been unjustly enriched.” Id. at 1203, 666 A.2d 327, quoting Schenck, A.2d 328. To support their claim of unjust enrichment, plaintiffs allege: (a) that they purchased Prempro to obtain safe and effective treatment for certain medical symptoms (Compl.¶ 135); (b) that defendants received payment from plaintiffs in exchange for Prempro under the guise that the drug was safe and effective (Compl.¶ 136); (c) that as the intended and expected result of defendant's non-disclosure and other wrongdoing, defendants have profited and benefitted from the purchase of Prempro (Compl.¶ 137); and (d) that defendants accepted and retained revenue and profits with full knowledge that plaintiff and the class were not receiving products of a quality, nature, fitness or value that they reasonably expected. (Compl.¶ 138.) The court finds plaintiffs' reliance upon Tesauro v. Quigley Corp., 2001 WL 1807782 (Pa.Com.Pl.2001) unpersuasive. In Tesauro, plaintiffs alleged that defendant Quigley, the manufacturer of Cold–Eeze zinc lozenges, touted its ability to prevent colds and pneumonia and to reduce the severity of colds and allergies. The advertisements described these health claims as clinically proven. As a result, in 1997 the sales of Cold–Eeze reached $10.2 million. Several years later, the Federal Trade Commission (“FTC”) filed a complaint against the defendant charging that the advertisements were false and misleading because defendant did not have a reasonable basis for claiming that Cold–Eeze had these beneficial health effects. The FTC and the defendant entered into a consent order that defendant would make no further health claims about Cold–Eeze until it had reasonable basis for making such a claim. Tesauro filed a complaint against Quigley, alleging unjust enrichment along with other claims to which the defendants filed preliminary objections. The court overruled the defendant's preliminary objections regarding plaintiffs' unjust enrichment claim because the complaint set forth a claim that plaintiffs did not receive a cold remedy when they bought Cold–Eeze, and it would be inequitable for the defendant to keep the money if the plaintiffs did not, in fact, receive a cold remedy. *11 Here, unlike Tesauro, plaintiffs did receive the product they sought, a hormone replacement thereapy. Plaintiffs merely allege that Prempro was not safe, and that Wyeth knew it was unsafe but promoted the drug anyway. These allegations are insufficient to state a claim for unjust enrichment. 6 The Preliminary Objection to Count II is sustained. C. Demurrer to Count III (Pennsylvania's Unfair Trade Practices and Consumer Protection Law) Wyeth preliminarily objects to Count III, alleging violations of the Pennsylvania Unfair Trade Practices and Consumer Protection Law (“UTPCPL”). Plaintiffs allege that Wyeth failed to provide plaintiffs with a full and accurate description of Prempro and knowingly and intentionally misrepresented, concealed or made false claims to plaintiffs regarding Prempro. Compl. ¶¶ 145–147. Plaintiffs urge that this conduct constitutes a violation of the UTPCPL. The UTPCPL makes unlawful unfair methods of competition and deceptive practices in the conduct of trade or commerce. Luke v. American Home Products Corp., 1998 WL 1781624 *8 (Pa.Com.Pl.1998), citing 73 P.S. §§ 201–3. The Act provides a means for redress for various misrepresentations and fraudulent conduct that create a likelihood of confusion or misunderstanding. Id., See 73 P.S. § 201–2(4). Wyeth maintains that plaintiffs cannot assert a UTPCPL claim since the Act does not apply to claims by prescription drug users against prescription drug manufacturers. To support this argument, Wyeth relies upon the learned intermediary doctrine which provides that a prescription drug manufacturer must provide its warnings about a drug to prescribing physicians, but need not provide the warnings to patients who use the drug. Further, Wyeth argues that plaintiffs fail to make a single well-founded allegation in support of their UTPCPL claim. Plaintiffs, on the other hand, argue that an unsettled question of law exists for this court to decide whether the UTPCPL applies to prescription drugs. Plaintiffs contend that the learned intermediary doctrine does not apply to the UTPCPL and that a drug manufacturer who engages in direct-to-consumer advertising has a duty not to withhold material information. Specifically, the plaintiffs urge that this court should create a limited exception to the learned intermediary doctrine where direct-to-consumer advertising is used. Case 4:14-cv-00098-CDL Document 36-10 Filed 10/24/16 Page 9 of 12 Albertson v. Wyeth Inc., Not Reported in A.2d (2003) 2003 WL 21544488, 63 Pa. D. & C.4th 514 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 9 In Luke v. American Home Products Corp., supra., the court addressed this same issue. In Luke, the plaintiff was prescribed dexfenfluramine hydrochloride (a/k/a/ Redux) as a weight loss treatment. After taking Redux for several months, the plaintiff began to experience difficulty breathing and was subsequently diagnosed with primary pulmonary hypertension and was placed on the list for a double transplant. Plaintiff filed a complaint against the manufacturer of Redux alleging, inter alia, a violation of the UTPCPL. The manufacturer filed preliminary objections. In sustaining the preliminary objections to plaintiffs' UTPCPL claim, the court reasoned that: *12 Under the “learned intermediary doctrine,” a manufacturer of prescription drugs must direct information and warnings to prescribing physicians, not the patient. See Taurino v. Ellen, 397 Pa.Super. 50, 579 A.2d 925 (Pa.Super.Ct.1990). There can be no cause of action based on Defendants' alleged omissions because defendants had no duty to disclose any information directly to plaintiff. Further, to permit a cause of action under the UTPCPL in this case would effectively make a drug manufacturer the absolute guarantor of the anticipated results and effects of a prescription drug. Pennsylvania law, however, recognizes that some prescription drugs by their very nature can never be made safe. See Makripodis by Makripodis v. Merrell–Dow Pharm., Inc., 361 Pa.Super. 589, 523 A.2d 374 (Pa.Super.Ct.1987). An inconsistency would result if we were to hold that drug manufacturers must guarantee that prescription drugs are completely safe. The premise behind the UTPCPL was not meant to engender such a result. Luke, at *8. This court finds the rationale in Luke persuasive, and believes it would be improvident to accede to plaintiffs' argument that a limited exception to the learned intermediary doctrine should be created based upon direct-to-consumer advertising. Media dissemination of information concerning the existence of these drugs does not enhance the public's ability to acquire them, as the skill and knowledge of the physician still must be brought to bear in a determination of whether the pharmaceutical is appropriate for the patient. Lennon ex rel. v. Wyeth–Ayerst Laboratories, Inc., 2001 WL 755944, *2 (Pa.Super.2001). Here, although Wyeth engaged in direct-to-consumer advertising, the consumer still required a prescription from a physician, a learned intermediary, to acquire Prempro. Wyeth's Preliminary Objections to Count III are sustained. 7 D. Demurrers to Count IV (Breach of Fiduciary Duty) and Count V (Fraud) Wyeth contends that plaintiffs' claims for breach of fiduciary duty and fraud are barred by the learned intermediary doctrine. The court agrees. The court finds that plaintiffs have no cause of action for breach of fiduciary duty and fraud in light of the learned intermediary doctrine. The Preliminary Objections with respect to plaintiffs' breach of fiduciary duty claim and fraud are sustained. E. Motion to Strike Plaintiffs' Claim for Attorney Fees In addition to the Preliminary Objections, Wyeth contemporaneously filed a Motion to Strike plaintiffs' request for attorney fees. Wyeth contends that plaintiffs' claim for attorney fees has no legal basis since there is no statutory or legal grounds that provides for such recovery. Wyeth further argues that medical monitoring does not give rise to counsel fees being paid out of a common fund. Under Pennsylvania law, ‘a litigant cannot recover counsel fees from an adverse party unless there is express statutory authorization, a clear agreement of the parties, or some other established exception.” Snyder v. Synder, 533 Pa. 203, 212, 620 A.2d 1133, 1138 (1993). This is commonly referred to as the “American” rule. Jones v. Muir, 511 Pa. 535, 541, 515 A.2d 855, 858 (1986). However, Pennsylvania has long recognized the common fund doctrine as an exception to the “American” rule. Id. In Jones, our Supreme Court held that the common fund doctrine is within the parameters of Section 2503(8) of the Judicial Code, 42 Pa.C.S. § 2503(8). Id. At 542, 515 A.2d at 858–59. Section 2503(8) of the Judicial Code authorizes the award of attorney fees to “[a]ny participant who is awarded counsel fees out of a fund within the jurisdiction of the court pursuant to any general rule relating to an award of counsel fees from a fund within the jurisdiction of the court.” 42 Pa.C.S. § 2503(8). *13 Our Supreme Court has repeatedly described the circumstances under which the “common fund” exception applies: Case 4:14-cv-00098-CDL Document 36-10 Filed 10/24/16 Page 10 of 12 Albertson v. Wyeth Inc., Not Reported in A.2d (2003) 2003 WL 21544488, 63 Pa. D. & C.4th 514 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 10 Where many persons have a common interest in a trust property or fund, and one of them, for the benefit of all, at his own cost and expense, brings suit for its preservation or administration, the court of equity in which suit is brought will order plaintiff to be reimbursed his costs and expenses, including counsel fees, from the property of the trust, or order those benefit to contribute proportionately toward that expense. International Organization Master, Mates and Pilots of America, Local No. 2 v. International Organization Master, Mates and Pilots of America, Inc. 497 Pa. 102, 439 A.2d 621, 627 (1981). Here, the plaintiffs filed a negligence/medical monitoring claim against Wyeth and request the creation of a fund from which a monitoring system could be established for the early detection of breast cancer. At this time, a fund does not exist and plaintiffs' claim for attorney fees is premature. Thus, for the present, this court grants Wyeth's Motion to Strike plaintiffs' claim for attorney fees and dismisses plaintiffs' claim for attorney fees without prejudice. CONCLUSION For the reasons discussed, this court finds that: (a) Wyeth's Preliminary Objections to plaintiffs' negligence/medical monitoring claim (Count I) is Overruled; (b) Wyeth's Preliminary Objection to plaintiffs' unjust enrichment claim (Count II) is Sustained; (c) Wyeth's Preliminary Objection to plaintiffs' claim under the UTPCPL (Count III) is Sustained; (d) Wyeth's Preliminary Objection to plaintiffs' breach of fiduciary duty claim (Count IV) is Sustained; (e) Wyeth's Preliminary Objection to plaintiffs' fraud claim (Count V) is Sustained; and (f) Wyeth's Motion to Strike plaintiffs' request for attorney fees is Granted. The court finds plaintiffs' claim for attorney fees is premature and is dismissed without prejudice. This court will issue a contemporaneous Order consistent with this Opinion. ORDER AND NOW, this 8th day of July 2003, upon consideration of Wyeth's Preliminary Objections to the consolidated, Amended Complaint and Wyeth's Motion to Strike plaintiffs' request for attorney fees, the responses in opposition, the respective memoranda, all matters of record, and after oral argument and in accord with the contemporaneous Opinion being filed of record, it is ORDERED that: (a) Wyeth's Preliminary Objection to plaintiffs' negligence/ medical monitoring claim (Count I) is Overruled; (b) Wyeth's Preliminary Objection to plaintiffs' unjust enrichment claim (Count II) is Sustained; (c) Wyeth's Preliminary Objection to plaintiffs' claim under the UTPCPL (Count III) is Sustained; (d) Wyeth's Preliminary Objection to plaintiffs' breach of fiduciary duty claim (Count IV) is Sustained; (e) Wyeth's Preliminary Objection to plaintiffs' fraud claim (Count V) is Sustained; and *14 (f) Wyeth's Motion to Strike plaintiffs' request for attorney fees is Granted. The court finds that plaintiffs' claim for attorney fees is premature and is at this juncture dismissed without prejudice. All Citations Not Reported in A.2d, 2003 WL 21544488, 63 Pa. D. & C.4th 514 Case 4:14-cv-00098-CDL Document 36-10 Filed 10/24/16 Page 11 of 12 Albertson v. Wyeth Inc., Not Reported in A.2d (2003) 2003 WL 21544488, 63 Pa. D. & C.4th 514 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 11 Footnotes 1 For purposes of these objections, the court will accept, as true, the facts set forth in the Complaint. 2 In addition, this court finds Wyeth's reliance upon White v. Weiner, 386 Pa.Super. 111, 119, 562 A.2d 378, 383 (1989), aff'd, 525 Pa. 572, 583 A.2d 789 (1991), misplaced. In White, our Superior Court addressed a matter that involved bulk sale of the drug protamine sulfate. The product was sold to Upjohn Pharmaceuticals Company for conversion into a final product which would then be distributed to medical care providers for prescription to the individual parties. In White, the Court declined to impose on a bulk supplier of pharmaceutical chemicals the same strict duty to warn required of the manufacturer of the marketed drug. 3 Discussion, supra., pp. 9–10. 4 Discussion, supra., p. 11. 5 The court acknowledges that it may be that the plaintiffs' expert reports will not be sufficient to meet the mandates of Redland. However, at this point in the proceedings it would be improvident to dismiss the claim. 6 Although Count II was designated a claim for unjust enrichment, the allegations suggest a claim for breach of an implied warranty of merchantability and fitness for a particular purpose. However, prescription drugs are not covered by a warranty of fitness for ordinary purpose. Luke v. American Home Products Corp., 1998 WL 1781624, *4–5 (Pa.Com.Pl.1998). 7 Because this court finds that plaintiffs have no cause of action under the UTPCPL based on the learned intermediary doctrine, it is not necessary to address Wyeth's further argument to the UTPCPL claim challenging the sufficiency of plaintiffs' pleading. End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:14-cv-00098-CDL Document 36-10 Filed 10/24/16 Page 12 of 12 EXHIBIT H Case 4:14-cv-00098-CDL Document 36-11 Filed 10/24/16 Page 1 of 6 Tatum v. Takeda Pharmaceuticals North America, Inc., Not Reported in F.Supp.2d (2012) 2012 WL 5182895 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 KeyCite Yellow Flag - Negative Treatment Declined to Follow by Terrell v. Davol, Inc., E.D.Pa., July 30, 2014 2012 WL 5182895 Only the Westlaw citation is currently available. United States District Court, E.D. Pennsylvania. David S. TATUM, Plaintiff, v. TAKEDA PHARMACEUTICALS NORTH AMERICA, INC., Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals International, Inc., Takeda Pharmaceuticals Company Limited, Takeda Pharmaceuticals, LLC, Takeda America Holdings, Inc., Takeda Global Research & Development Center, Inc., Takeda San Diego, Inc., Tap Pharmaceuticals Products, Inc., Abbott Laboratories, Inc., Does 1 through 100 Inclusive, Defendants. Civil Action No. 12–1114. | Oct. 19, 2012. Attorneys and Law Firms Claudine Q. Homolash, Sheller P.C., Philadelphia, PA, Kenneth G. Gilman, Gilman Law LLP, Bonita Springs, FL, for Plaintiff. Tiffany M. Alexander, Campbell Campbell Edwards & Conroy, Wayne, PA, for Defendants. MEMORANDUM DuBOIS, District Judge. I. INTRODUCTION *1 This is a product liability action in which plaintiff David S. Tatum alleges that the PREVACID designed, manufactured, and marketed by defendants weakened his bones, ultimately leading to hip fractures. The defendants filed a motion to dismiss many of the claims in Tatum's First Amended Complaint. For the reasons that follow, the Court grants in part and denies in part defendants' motion. II. BACKGROUND 1 Tatum was prescribed PREVACID, a pharmaceutical drug designed, manufactured, and marketed by defendants. (Am.Compl.3, 7.) After taking PREVACID, Tatum began feeling pain in his left hip, and he was later diagnosed with Stage III Avascular Necrosis. (Id. at 7.) Tatum's bones became weakened or brittle, causing multiple fractures. (Id. at 8.) As a result, he underwent total hip replacement surgery. (Id. at 7.) Tatum claims that defendants were aware of the risks of PREVACID, but chose not to disclose them. His First Amended Complaint contains fourteen counts: Count I—equitable tolling of applicable statute of limitations; Count II—negligence; Count III—negligent failure to adequately warn; Count IV—negligence per se; Count V—negligent misrepresentation; Count VI —breach of express warranty; Count VII—breach of implied warranty for a particular purpose; Count VIII —breach of implied warranty of merchantability; Count IX—strict product liability: defective design; Count X— strict product liability: manufacturing defect; Count XI —strict product liability: failure to warn; Count XII— fraudulent concealment; Count XIII—unjust enrichment; and Count XIV—violations of Pennsylvania Unfair Trade Practices and Consumer Protection Law. Tatum additionally alleges that he is entitled to punitive damages. Defendants have moved to dismiss Count I, Counts V to XIV, and the request for punitive damages. III. STANDARD OF REVIEW To survive a motion to dismiss under Rule 12(b)(6), a civil plaintiff must allege facts that “ ‘raise a right to relief above the speculative level.’ ” Victaulic Co. v. Tieman, 499 F.3d 227, 234 (3d Cir.2007) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). A complaint must contain “sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Twombly, 550 U.S. at 570). “[T]he tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Id. Case 4:14-cv-00098-CDL Document 36-11 Filed 10/24/16 Page 2 of 6 Tatum v. Takeda Pharmaceuticals North America, Inc., Not Reported in F.Supp.2d (2012) 2012 WL 5182895 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 IV. DISCUSSION Defendants have moved to dismiss eleven of the fourteen counts in the First Amended Complaint, in addition to Tatum's request for punitive damages. The Court will address each in turn. A. Count I: Equitable Tolling Defendants initially move to dismiss Tatum's claim for equitable tolling alleged in Count I. Tatum alleges that “[t]he running of any statute of limitations has been tolled by reason of Defendants' fraudulent concealment.” (Am.Compl.11.) Fraudulent concealment is a doctrine which “serves to toll the running of the statute of limitations.” Fine v. Checcio, 582 Pa. 253, 271, 870 A.2d 850 (2005). Unlike the tort of fraudulent concealment alleged in Count XII, this doctrine is not an independent cause of action. Thus, Count I is dismissed with prejudice. *2 It appears that by moving to dismiss Count I, defendants are also attempting to attack Tatum's tort claims, which are subject to a two-year statute of limitations. See 42 PA. CONS.STAT. ANN. § 5524; Mest v. Cabot Corp., 449 F.3d 502, 510 (2006). Generally, “a limitations defense must be raised in the answer, since Rule 12(b) does not permit it to be raised by motion.” Robinson v. Johnson, 313 F.3d 128, 134 (3d Cir.2002). However, the “Third Circuit Rule” allows defendants to raise a limitations defense in a Rule 12(b)(6) motion where the “time alleged in the statement of a claim shows that the cause of action has not been brought within the statute of limitations.” Id. at 135. Tatum filed his initial Complaint on March 1, 2012. (Compl.35.) In his First Amended Complaint, he states that “[a]t no point prior to March 2010 had Plaintiff experienced any type of abnormal hip pain ....” (Am.Compl.7.) As this allegation falls within the two-year period, the Court will not dismiss any claims on statute of limitations grounds on the present state of the record. B. Counts IX, X, and XI: Strict Liability Claims The Court next addresses Tatum's strict liability claims. Counts IX and XI which assert claims for strict liability based on design defect and strict liability based on failure to warn are not permitted under Pennsylvania law. Applying comment k to § 402A of the Restatement (Second) of Torts, the Pennsylvania Supreme Court ruled that “where the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer's negligence, is the only recognized basis of liability.” Hahn v. Richter, 543 Pa. 558, 563, 673 A.2d 888 (1996). As a result, Tatum cannot bring strict liability claims for design defect or failure to warn. Count X which alleges a claim of strict liability based on manufacturing defect, however, is permissible. Many courts have interpreted Hahn broadly to preclude all strict liability claims. See Doughtery v. C.R. Bard, Inc., No. 11– 6048, 2012 WL 2940727, at *4 (E.D.Pa. July 18, 2012) (collecting cases). However, this Court agrees with the decision in Doughtery, where the court concluded that strict liability claims for manufacturing defects are not prohibited. See id. at *4–6; Killen v. Stryker Spine, No. 11– 1508, 2012 WL 4498865, at *3–4 (W.D.Pa. Sept.28, 2012). Tatum's claims in Count IX for strict liability based on design defect and Count XI for strict liability based on failure to warn are dismissed with prejudice. The strict liability claim based on manufacturing defect asserted in Count X is permitted under Pennsylvania Law. Thus, the motion to dismiss with respect to the claim for strict liability based on manufacturing defect asserted in Count X is denied. C. Counts VI, VII, and VIII: Breach of Warranty Claims Defendants further move to dismiss Tatum's breach of warranty claims. In his First Amended Complaint, Tatum alleges breach of implied warranty of merchantability in Count VIII, breach of implied warranty for a particular purpose in Count VII, and breach of express warranty in Count VI. (a) Counts VII and VIII: Breach of Implied Warranty of Fitness for a Particular Purpose and Breach of Implied Warranty of Merchantability *3 “[T]he theories of strict liability and breach of the implied warranty of merchantability are parallel theories of recovery, one in contract and the other in tort.” Doughtery, 2012 WL 2940727 at *7 (internal quotations omitted). As discussed above, strict liability claims based on design defect or failure to warn are not permissible in Pennsylvania. “It would thus be inconsistent to exempt a manufacturer ... from strict liability under comment k Case 4:14-cv-00098-CDL Document 36-11 Filed 10/24/16 Page 3 of 6 Tatum v. Takeda Pharmaceuticals North America, Inc., Not Reported in F.Supp.2d (2012) 2012 WL 5182895 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 and apply a negligence standard to determine liability for a design defect or a failure to warn, but allow a plaintiff to recover for the same alleged defect under a theory of breach of the implied warranty of merchantability.” Id. The same analysis applies to the implied warranty of fitness for a particular purpose. Both claims are not cognizable under Pennsylvania law to the extent they are based on a design defect or failure to warn, but are permissible if based on manufacturing defect or any other theory. Thus, the motion to dismiss with respect to the claims, as limited by this Memorandum, for breach of the implied warranty fitness for a particular purpose asserted in Count VII and for breach of the implied warranty of merchantability asserted in Count VIII is denied. (b) Count VI: Breach of Express Warranty Tatum's remaining breach of warranty claim is for breach of express warranty. Federal courts are split concerning whether an express warranty claim against prescription drug manufacturers is permissible under Pennsylvania law. Id. (collecting cases). This Court concludes that such a claim is permitted. “While the reasoning of comment k may prevent certain warranties or promises from being implied by law,” that is not a “basis for declining to enforce a contractual promise expressly and voluntarily made by a manufacturer of prescription drugs or devices.” Id. Thus, the motion to dismiss with respect to the claim for breach of an express warranty asserted in Count VI is denied. D. Count V: Negligent Misrepresentation Defendants additionally move to dismiss Tatum's claim for negligent misrepresentation alleged in Count V because Tatum failed to allege his claim with the particularity required by Federal Rule of Civil Procedure 9(b). Although a plaintiff must plead negligent misrepresentation with a degree of specificity, Rule 9(b) does not govern negligent misrepresentation claims. Brandow Chrysler Jeep Co. v. DataScan Techs. 511 F.Supp.2d 529, 537 (E.D.Pa.2007); but see Scott v. Bimbo Bakeries, USA, Inc., 2012 WL 645905, at *5 (E.D.Pa. Feb.29, 2012) (noting “that there is disagreement among the district courts within the Third Circuit regarding the pleading standard that applies to claims of negligent misrepresentation.”). Tatum alleges that defendants falsely represented “that PREVACID was safe and fit for its intended purpose, was of merchantable quality, did not produce any dangerous side effects, and had been adequately tested.” (Am.Compl.18.) This is a sufficiently specific allegation. Thus, the motion to dismiss with respect to the claim for negligent misrepresentation asserted in Count V is denied. E. Counts XII and XIV: Fraudulent Concealment and Violations of Pennsylvania's Unfair Trade Practices and Consumer Protection Law *4 Defendants next move to dismiss Tatum's claims for fraudulent concealment alleged in Count XII and for violations of Pennsylvania's Unfair Trade Practices and Consumer Protection Law, 73 PA. CONS.STAT. ANN. §§ 201–1 et seq. (UTPCPL) alleged in Count XIV. Fraudulent concealment “has the same elements as intentional misrepresentation except in the case of intentional non-disclosure, the party intentionally conceals a material fact rather than making an affirmative misrepresentation.” Bortz v. Noon, 556 Pa. 489, 499, 729 A.2d 555 (1999) (internal quotations omitted). 2 Section 201–3 of the UTPCPL makes “[u]nfair methods of competition and unfair or deceptive acts or practices in the conduct of any trade or commerce ... unlawful.” Section 201–2(4)(xxi), the so-called “catch-all” definition, defines “[u]nfair methods of competition and unfair or deceptive acts or practices” as “[e]ngaging in any other fraudulent or deceptive conduct which creates a likelihood of confusion or of misunderstanding.” “A plaintiff may succeed under the catch-all provision by satisfying the elements of common-law fraud.” Vassalotti v. Wells Fargo Bank, N.A. 732 F.Supp.2d 503 (E.D.Pa.2010). The fraud can be based on the intentional concealment of information. Meeks– Owens v. Indymac Bank, F.S.B., 557 F.Supp.2d 566, 579 (M.D.Pa.2008). Thus, Tatum's claims for fraudulent concealment and for violations of the UTPCPL overlap. Defendants argue that both claims, which are based on intentional conduct, should be dismissed because they “do not rest on a theory of negligence.” (Def.Mot.12.) For this proposition, defendants cite the Pennsylvania Supreme Court's statement in Hahn that “where the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer's negligence, is the only recognized basis of liability.” 543 Pa. at 563, 673 A.2d 888. This Court disagrees. The court in Hahn stated that a seller of prescription drugs must not only warn of risks of which Case 4:14-cv-00098-CDL Document 36-11 Filed 10/24/16 Page 4 of 6 Tatum v. Takeda Pharmaceuticals North America, Inc., Not Reported in F.Supp.2d (2012) 2012 WL 5182895 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 he reasonably should have knowledge, but also warn of risks of which he did, in fact, have knowledge. Id. at 561, 673 A.2d 888. Accordingly, Hahn does not preclude claims where the plaintiff alleges that the seller had knowledge of the risks of prescription drugs and intentionally concealed them. For this reason, the motion to dismiss with respect to the claims for fraudulent concealment asserted in Count XII and for violations of Pennsylvania's Unfair Trade Practices and Consumer Protection Law asserted in Count XIV is denied. Since Tatum has stated a claim under the “fraud prong” of the catchall provision of the UTPCPL, the Court does not address the “deceptive conduct” prong of the catch-all provision or the other provisions of the UPTCPL referenced in the First Amended Complaint. F. Count XIII: Unjust Enrichment Defendants also move to dismiss Tatum's claim for unjust enrichment alleged in Count XIII. “Under Pennsylvania law, the plaintiff must demonstrate that he conferred a benefit on the defendant, that the defendant knew of the benefit and accepted or retained it, and that it would be inequitable to allow the defendant to keep the benefit without paying for it.” Zafarana v. Pfizer Inc., 724 F.Supp.2d 545, at 560 (E.D.Pa.2010). However, “[u]njust enrichment is not a substitute for failed tort claims in Pennsylvania ....” Id. (internal citations omitted). *5 This is not a case in which a claim for unjust enrichment is appropriate. Specifically, there is no allegation that defendants refused to provide a service or goods after Tatum provided defendants with a benefit. See id. at 561. Thus, Tatum's claim in Count XIII for unjust enrichment is dismissed with prejudice. G. Punitive Damages Finally, defendants move to dismiss Tatum's request for punitive damages. Defendants argue that under Pennsylvania law, punitive damages are not an independent cause of action. Kirkbride v. Lisbon Contractors, Inc., 521 Pa. 97, 101, 555 A.2d 800 (1989). That is correct. However, Tatum did not assert an independent claim for punitive damages in the First Amended Complaint. Rather, he requested punitive damages as a remedy. Punitive damages are properly alleged in the First Amended Complaint. V. CONCLUSION For the reasons set forth above, the Court grants in part and denies in part defendants' motion to dismiss. Count I—equitable tolling of applicable statute of limitations; Count IX—strict product liability: defective design; Count XI—strict product liability: failure to warn; and Count XIII—unjust enrichment; are dismissed with prejudice. The claims remaining for adjudication are: Count V —negligent misrepresentation; Count VI—breach of express warranty; Count VII—breach of implied warranty for a particular purpose; Count VIII—breach of implied warranty of merchantability; Count X—strict product liability: manufacturing defect; Count XII— fraudulent concealment; and Count XIV—violations of Pennsylvania Unfair Trade Practices and Consumer Protection Law. The Court concludes that many of Tatum's remaining claims are redundant or otherwise unnecessary, making this case unduly complicated. At the preliminary pretrial conference, the Court will address narrowing the scope of the issues presented. An appropriate order follows. All Citations Not Reported in F.Supp.2d, 2012 WL 5182895 Footnotes 1 As required on a motion to dismiss, the Court takes all plausible factual allegations contained in plaintiff's First Amended Complaint to be true. 2 The elements of intentional misrepresentation or fraud are: “(1) A representation; (2) which is material to the transaction at hand; (3) made falsely, with knowledge of its falsity or recklessness as to whether it is true or false; (4) with the intent of misleading another into relying on it; (5) justifiable reliance on the misrepresentation; and, (6) the resulting injury was proximately caused by the reliance.” Id. Case 4:14-cv-00098-CDL Document 36-11 Filed 10/24/16 Page 5 of 6 Tatum v. Takeda Pharmaceuticals North America, Inc., Not Reported in F.Supp.2d (2012) 2012 WL 5182895 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:14-cv-00098-CDL Document 36-11 Filed 10/24/16 Page 6 of 6 EXHIBIT I Case 4:14-cv-00098-CDL Document 36-12 Filed 10/24/16 Page 1 of 5 Kline v. Pfizer, Inc., Not Reported in F.Supp.2d (2008) 2008 WL 4787577 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 KeyCite Yellow Flag - Negative Treatment Declined to Follow by Doughtery v. C.R. Bard, Inc., E.D.Pa., July 18, 2012 2008 WL 4787577 Only the Westlaw citation is currently available. United States District Court, E.D. Pennsylvania. Brian KLINE, Plaintiff, v. PFIZER, INC., Defendant. Civil Action No. 08-3238. | Oct. 31, 2008. West KeySummary 1 Products Liability Warnings or Instructions Products Liability Drugs in General A prescription drug user's complaint alleging non-negligence claims against a prescription drug manufacturer were dismissed. The federal court, applying Pennsylvania law, held that negligence was the only theory upon which a prescription drug manufacturer could be held liable because adequacy of the warnings accompanying the prescription drugs used was at issue in the prescription drug user's complaint. Fed.Rules Civ.Proc.Rule 12(b)(6), 28 U.S.C.A. 17 Cases that cite this headnote Attorneys and Law Firms Scott D. Levensten, The Levensten Law Firm, Philadelphia, PA, for Plaintiff. Raymond M. Williams, DLA Piper Rudnick Gray Cary, Philadelphia, PA, for Defendant. MEMORANDUM ROBERT F. KELLY, Senior District Judge. *1 Presently before the Court is the Motion of Defendant Pfizer, Inc. (“Pfizer”) to dismiss Plaintiff Brian Kline's (“Kline”) Complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). For the reasons set forth below, Pfizer's Motion to Dismiss is granted with respect to Counts II, III, IV, V, VI, VIII and IX of the Plaintiff's Complaint. Counts I and VII survive the Motion to Dismiss. I. FACTS Defendant Pfizer is a prescription drug manufacturer responsible for the manufacture and distribution of the prescription smoking cessation drug, Chantix. Kline was prescribed and began using Chantix in July 2007. Shortly thereafter, Kline asserts that he began experiencing “manic behavior, aggressive and violent behavior and diagnosis of psychotic disorder for which [he] was hospitalized in August 2007.” (Compl.¶¶ 11, 19.) On July 10, 2008, Kline filed a Complaint against Pfizer in this Court, alleging that his symptoms were caused by his use of Chantix and that Pfizer had failed to adequately warn Kline, Kline's physician and the public of the dangers of ingesting the drug. The Complaint asserts a host of claims against Pfizer, including: negligence (Count I); strict liability (Count II); breach of express warranty (Count III); breach of implied warranty (Count IV); fraudulent misrepresentation (Count V); fraudulent concealment (Count VI); reckless and/or negligent misrepresentation & concealment (Count VII); gross negligence (Count VIII); and unjust enrichment (Count IX). Pfizer moved to dismiss the Complaint pursuant to Federal Rule of Civil Procedure 12(b)(6) on September 9, 2008. Kline filed his Response in Opposition on October 7, 2008. II. STANDARD OF REVIEW When deciding whether to grant a Rule 12(b)(6) Motion to Dismiss, this Court must accept as true all well-pleaded allegations in the Complaint, and view them in a light most favorable to the Plaintiff. Doe v. Delie, 257 F.3d 309, 313 (3d Cir.2001). Therefore, Defendant's Motion will be granted only if it is clear that no relief could be granted under any set of facts that could be proved consistent Case 4:14-cv-00098-CDL Document 36-12 Filed 10/24/16 Page 2 of 5 Kline v. Pfizer, Inc., Not Reported in F.Supp.2d (2008) 2008 WL 4787577 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 with the allegations. Id. Nonetheless, a plaintiff must plead specific factual allegations. Neither “bald assertions” nor “vague and conclusory allegations” must be accepted as true. See Morse v. Lower Merion Sch. Dist., 132 F.3d 902, 906 (3d Cir.1997); Sterling v. Southeastern Pa. Transp. Auth., 897 F.Supp. 893 (E.D.Pa.1995). III. DISCUSSION Pfizer moves to dismiss Kline's Complaint on several grounds. First, Pfizer argues that Kline's claim for strict liability (Count II), should be dismissed pursuant to the Pennsylvania Supreme Court's holding in Hahn v. Richter, which announced that prescription drugs are exempt from strict liability, and that failure to warn claims against drug manufacturers may be pursued under a negligence theory only. 543 Pa. 558, 673 A.2d 888, 891 (Pa.1996). With regard to Kline's claims for breach of implied warranty and gross negligence (Counts III and VIII), Pfizer argues that Pennsylvania law does not recognize such claims in the context of this case. Pfizer also asserts that Kline's fraud claims (Counts V and VI) fail under Rule 9(b) for failure to plead fraud with particularity, and that the facts alleged in the Complaint do not make out viable claims for breach of express warranty or unjust enrichment (Counts III and IX). Additionally, Pfizer asks this Court to dismiss the Complaint to the extent that it asserts liability against Pfizer for failure to warn Kline and/or the public. *2 In contrast, Kline argues that the allegations in the Complaint are sufficiently pled, and that he is entitled to relief on all counts. Specifically, he asserts that Pfizer attempts to dismiss his claims based on an overly- broad reading of Hahn and urges this Court to take a more narrow interpretation of the case. Additionally, Kline argues that each claim contains allegations specific enough to survive the Motion to Dismiss. A. Non-negligence claims and Hahn v. Richter Federal courts sitting in diversity must apply the substantive law of the forum state. Erie R.R. Co. v. Tompkins, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938). Here, neither party disputes that Pennsylvania law controls the allegations set forth in Kline's Complaint. Pennsylvania has adopted the Restatement (Second) of Torts § 402A(1), which imposes strict liability upon sellers of unreasonably dangerous products. Restatement (Second) of Torts § 402A(1) (1965) (“Restatement”). Nonetheless, comment k to § 402A provides an exception to the rule of strict liability for the makers of “unavoidably unsafe products.” Comment k reads: There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has Case 4:14-cv-00098-CDL Document 36-12 Filed 10/24/16 Page 3 of 5 Kline v. Pfizer, Inc., Not Reported in F.Supp.2d (2008) 2008 WL 4787577 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. Restatement § 402A(1) cmt. k. Pennsylvania courts have made clear that prescription drugs are “unavoidably unsafe products” within the meaning of comment k, and therefore, strict liability will not be imposed against manufacturers in suits for injuries relating to the use of prescription drugs. See Hahn, 672 A.2d at 889-90; Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206, 219-20 (Pa.1971). *3 In Hahn, a suit against a prescription drug manufacturer based on failure to warn, the Pennsylvania Supreme Court explicitly stated that “[s]ince the strict liability rule of § 402A is not applicable, the standard of care required is that set forth in § 388 of the Restatement .... Under this section, the supplier has a duty to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous.” 673 A.2d at 890. As such, the Hahn Court, relying on long line of Pennsylvania cases, held that where the adequacy of the warnings accompanying prescription drugs is at issue, negligence is the sole avenue of recovery. Id. (referencing Mazur v. Merck & Co., Inc., 964 F.2d 1348, 1353-55 (3d Cir.1992); Baldino v. Castagna, 505 Pa. 239, 478 A.2d 807 (Pa.1984); Incollingo, 282 A.2d at 220 n. 8). Since Hahn, Pennsylvania courts, as well as federal courts applying Pennsylvania law, have consistently held that negligence is the only theory upon which a prescription drug manufacturer can be held liable for failure to warn. See Colacicco v. Apotex, Inc., 432 F.Supp.2d 514 (E.D.Pa.2006); Lineberger v. Wyeth, 894 A.2d 141, 145 (Pa.Super.Ct.2006); Luke v. Am. Home Prod. Corp., No.1998-01977,1998 WL 1781624, at *7 (Pa.Commw.Ct. Nov. 18, 1998). In Colacicco, the Plaintiff brought suit against a prescription drug manufacturer for failure to warn, and asserted many of the same claims that Kline asserts in the present action. 1 432 F.Supp.2d at 518-20. There, the Court found that the Plaintiff's non-negligence claims must be dismissed under the rule of Hahn. Id. at 548. The Colacicco Court found that, after Hahn, it was clear that negligence was the sole cause of action that a Plaintiff may maintain against a prescription drug manufacturer for failure to warn under Pennsylvania law. Id. at 547-48. As such, Hahn requires that this Court dismiss those of Kline's claims that do not rest on a theory of negligence. B. Claims Sounding in Negligence With respect to Kline's negligence-based claims, the Complaint alleges three claims sounding in negligence: Count I asserts a claim for negligence; Count VII asserts a claim for reckless and/or negligent misrepresentation & concealment; and Count VIII asserts a claim for gross negligence. With respect to Kline's claim for gross negligence (Count VIII), we find that this claim must be dismissed. Pennsylvania courts do not recognize degrees of negligence. Floyd v. Brown & Williamson Tobacco Corp., 159 F.Supp.2d 823, 828 (E.D.Pa.2001) (applying Pennsylvania law). Rather, Pennsylvania courts regard the term “gross negligence” as referring to a standard of care, rather than a separate, independent claim. Id. Thus, the claim for gross negligence must be dismissed. To the extent that Kline's claims for negligence (Count I) and negligent misrepresentation & concealment (Count VII) rest on allegations that Pzifer failed to adequately warn Kline's physician concerning the dangers and possible side effects of using Chantix, these claims remain intact. It is well-settled that under Pennsylvania's “learned intermediary doctrine,” the duty of a drug manufacturer to warn of the possible dangers and side effects of prescription drugs runs to the physician, and not to the patient or to the general public. Baldino, 478 A.2d at 812 (citing Incollingo, 282 A.2d at 220); Lineberger, 894 A.2d at 149-50; Makripodis v. Merrell-Dow Pharm. Co., 361 Pa.Super. 589, 523 A.2d 374, 377-78 (Pa.Super.Ct.1987). A prescription drug manufacturer has “ ‘a duty to exercise reasonable care to inform those for whose use the article [was] supplied of the facts which make [the product] likely to be dangerous ....‘ However, the warnings which are required to be given by the manufacturer must be directed to the physician, not the patient-consumer.” Makripodis, 523 A.2d at 378 (quoting Incollingo, 282 A.2d at 220 n. 8). This is so because the physician acts as a “learned intermediary” between the manufacturer and consumer, and can use the information obtained from the manufacturer, as well as his independent medical knowledge and knowledge of the patient's medical history, in deciding whether or not to prescribe a certain Case 4:14-cv-00098-CDL Document 36-12 Filed 10/24/16 Page 4 of 5 Kline v. Pfizer, Inc., Not Reported in F.Supp.2d (2008) 2008 WL 4787577 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 prescription to a certain patient. Leibowitz v. Ortho Pharm. Corp., 224 Pa.Super. 418, 307 A.2d 449, 457 (Pa.Super.Ct.1973). Kline's Complaint alleges that Pfizer failed to adequately warn Kline himself, Kline's physician, and the public concerning the dangers of Chantix. As noted above, Pfizer had no duty under Pennsylvania law to warn Kline or the public of the dangers potentially caused by the use of Chantix. However, Pfizer could be held liable if it is later proven that it failed to adequately warn Kline's healthcare providers as to the dangers of the drug. As such, to the extent that Kline's claims for negligence and negligent misrepresentation & concealment rest upon allegations that Pfizer failed to adequately warn Kline's physician, these claims survive the Motion to Dismiss. *4 Because we find that Kline's non-negligence claims are barred by the Pennsylvania's Supreme Court's holding in Hahn, we need not go into detail concerning Pfizer's additional arguments for dismissal. We find that Kline's claims for strict liability (Count II); breach of express warranty (Count III); breach of implied warranty (Count IV); fraudulent misrepresentation (Count V); fraudulent concealment (Count VI); and unjust enrichment (Count IX) are barred by the holding of Hahn and must be dismissed. Similarly, the claim for gross negligence (Count VIII) must be dismissed, as Pennsylvania law does not recognize gross negligence as an individual claim. Kline's claims for negligence (Count I) and negligent misrepresentation & concealment (Count VII) survive to the extent that they assert liability for failure to adequately warn Kline's physician. An appropriate Order follows. ORDER AND NOW, this 31 st day of October, 2008, upon consideration the Defendant's Motion to Dismiss Plaintiff's Complaint pursuant to Rule 12(b)(6) (Doc. No. 6), and the response thereto, it is hereby ORDERED as follows: 1) The Motion to Dismiss is GRANTED with respect to Counts II, III, IV, V, VI, VIII and IX of Plaintiff's Complaint; 2) The Motion to Dismiss is DENIED with respect to Counts I and VII. All Citations Not Reported in F.Supp.2d, 2008 WL 4787577 Footnotes 1 The Complaint in Colacicco asserted the following claims: breach of express warranty (Count I); breach of implied warranty (Count II); fraud by intentional misrepresentation and violation of New York consumer protection law (Count III); negligent misrepresentation (Count IV); intentional infliction of emotional distress (Count V); negligent infliction of emotional distress (Count VI); negligence (Count VII); negligence per se (Count VIII); and strict products liability (Count IX). 432 F.Supp.2d at 518, 548. The Plaintiff later withdrew the claim for breach of express warranty. Id. at 518. End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:14-cv-00098-CDL Document 36-12 Filed 10/24/16 Page 5 of 5 EXHIBIT J Case 4:14-cv-00098-CDL Document 36-13 Filed 10/24/16 Page 1 of 6 Shorb v. State Farm Mut. Auto. Ins. Co., Not Reported in F.Supp.2d (2005) 2005 WL 1137881 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 2005 WL 1137881 Only the Westlaw citation is currently available. United States District Court, M.D. Pennsylvania. Fred L. SHORB and Linda J. Shorb, Plaintiffs v. STATE FARM MUTUAL AUTOMOBILE INSURANCE COMPANY, Defendant No. Civ.1CV-05-0296. | April 25, 2005. Attorneys and Law Firms John Richard Oare, Jr., York, PA, for Plaintiffs. Lee E. Ullman, Forry, Ullman, Ullman & Forry, P.C., Reading, PA, for Defendant. MEMORANDUM RAMBO, J. *1 Before the court is Defendant's partial motion to dismiss. The parties have briefed the issues, and the matter is ripe for disposition. For the reasons stated below, the court will grant Defendant's motion in part and deny it in part. I. Background A. Facts Plaintiff Fred Shorb purchased an automobile insurance policy from Defendant State Farm on or about August 27, 1975. (Compl. ¶ 4.) Plaintiff Fred Shorb's policy provided that he was entitled to “payment of any and all medical expenses, work loss, replacement services lost, or bodily injury due to an accident arising from the maintenance or use of a motor vehicle.” (Compl.¶ 4, Ex. 1.) On or about April 17, 1976, Plaintiff Fred Shorb was in an automobile accident resulting in “a cervical fracture that caused quadriplegia paralysis in the cervical area of his body.” (Id. ¶ 6.) Subsequent to his injury, Plaintiff Fred Shorb “underwent an extensive period of acute care hospitalization and rehabilitation ... beginning the period April 1976 and continuing to the present date.” (Id. ¶ 7.) Since 1976, Defendant has paid for the medical care and treatment needed by Plaintiff Fred Shorb. (Id. ¶¶ 8, 9.) Plaintiffs' complaint avers that Defendant authorized JWF Architects (“JWF”) to design the reconstruction or purchase of a home for Plaintiffs, so as to accommodate Plaintiff Fred Shorb's physical limitations and needs that were caused by his accident. (Id. ¶ 10.) JWF produced plans, including specifications and drawings that were proposed to meet Plaintiff Fred Shorb's specific physical limitations and needs. (Id. ¶ 11.) Defendant subsequently hired a second entity, GLP Construction Management, Inc. (“GLP”). (Id. ¶ 13.) GLP furnished a second proposal, containing a budgetary estimate and plans for construction of a home to meet the physical limitations and needs of Plaintiff Fred Shorb. (Id.) Plaintiffs' complaint asserts that GLP is not and was not qualified to design a dwelling for handicap means or to prepare a budgetary estimate to meet the physical limitations and needs of Plaintiff Fred Shorb. (Id. ¶ 15.) Defendant represented to Plaintiffs that GLP was an architectural firm. (Id. ¶ 23.) However, Plaintiffs aver that Defendant knew or should have known that GLP was not an architectural firm. (Id.) Defendant informed Plaintiffs that it was going to use GLP to review the reports and plans of JWF. (Id. ¶ 24.) A representative from GLP met with Plaintiffs and represented that he was there to review the JFW plans. (Id. ¶ 25.) However, Defendant, without the knowledge or consent of Plaintiff, authorized GLP to create its own house construction proposal. (Id. ¶ 26.) As of this date, Plaintiffs have not received the modifications to their residence. As a result of the lack of modifications to the current residence, Plaintiff Susan Shorb alleges that she has sustained bodily injuries in her efforts to accommodate the physical needs of her husband, Plaintiff Fred Shorb. (Id. ¶¶ 16, 17.) Additionally, Plaintiff Fred Shorb alleges that he has suffered physical pain and mental anguish as a result of the lack of the appropriate modifications to his residence. (Id. ¶¶ 18, 20.) B. Procedural History *2 A complaint in the instant matter was filed in the Court of Common Pleas of Adams County on December 7, 2004. The instant complaint was removed to federal district court on February 9, 2005. Plaintiffs' complaint alleges the following: 1) bad faith; 2) breach of contract; Case 4:14-cv-00098-CDL Document 36-13 Filed 10/24/16 Page 2 of 6 Shorb v. State Farm Mut. Auto. Ins. Co., Not Reported in F.Supp.2d (2005) 2005 WL 1137881 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 3) violations of the Unfair Insurance Claims Practices Act (“UIPA”), 40 Pa. Cons.Stat. Ann. § 1171.5(a); 4) violations of Pennsylvania's Unfair Trade Practices and Consumer Protection Law (“CPL”), 73 Pa. Cons.Stat. Ann. § 201; and 5) punitive damages. Defendant filed the instant partial motion to dismiss on February 15, 2005. II. Legal Standard: Motion to Dismiss In deciding a motion to dismiss pursuant to Federal Rule 12(b)(6), the court is required to accept as true all of the factual allegations in the complaint and all reasonable inferences that can be drawn from the face of the complaint. Worldcom, Inc. v. Graphnet, Inc., 343 F.3d 651, 653 (3d Cir.2003). “The complaint will be deemed to have alleged sufficient facts if it adequately put[s] the defendant[s] on notice of the essential elements of the plaintiff's cause of action.” Nami v. Fauver, 82 F.3d 63, 65 (3d Cir.1996). The court will not dismiss a complaint for failure to state a claim “unless it appears beyond a doubt that the plaintiff can prove no set of facts in support of his claim that would entitle him to relief.” Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957); Port Auth. of New York & New Jersey v. Arcadian Corp. ., 189 F.3d 305, 311 (3d Cir.1999). “To decide a motion to dismiss, courts generally consider only the allegations contained in the complaint, exhibits attached to the complaint and matters of public record.” Pension Benefit Guar. Corp. v. White Consol. Indus., 998 F.2d 1192, 1196 (3d Cir.1993) (citations omitted). Additionally, the court may consider “undisputedly authentic document[s] that a defendant attaches as an exhibit to a motion to dismiss if the plaintiff's claims are based on the [attached] document[s].” Id. In other words, “documents whose contents are alleged in the complaint and whose authenticity no party questions, but which are not physically attached to the pleading may be considered.” Pryor v. Nat'l Collegiate Athletic Ass'n, 288 F.3d 548, 560 (3d Cir.2002); see also U.S. Express Lines, Ltd. v. Higgins, 281 F.3d 383, 388 (3d Cir.2002) ( “Although a district court may not consider matters extraneous to the pleadings, a document integral to or explicitly relied upon in the complaint may be considered without converting the motion to dismiss into one for summary judgment.”) (internal quotation omitted). However, the court may not rely on other parts of the record in making its decision. Jordan v. Fox, Rothschild, O'Brien & Frankel, 20 F.3d 1250, 1261 (3d Cir.1994). Finally, in the Third Circuit, a court must grant leave to amend before dismissing a complaint that is merely deficient. See, e.g., Weston v. Pennsylvania, 251 F.3d 420, 428 (3d Cir.2001); Shane v. Fauver, 213 F.3d 113, 116-17 (3d Cir.2000). “Dismissal without leave to amend is justified only on the grounds of bad faith, undue delay, prejudice, or futility.” Alston v. Parker, 336 F.3d 229, 236 (3d Cir.2004). III. Discussion *3 Defendant contends that Plaintiffs' claims should be dismissed for the following reasons: 1) Plaintiffs fail to state a valid claim for bad faith under Pennsylvania law; 2) Plaintiffs fail to state a claim upon which relief can be granted with respect to the UIPA; 3) Plaintiffs fail to state a valid cause of action with respect to CPL; and 4) Plaintiffs fail to state a valid claim under Pennsylvania law with respect to their independent claim for punitive damages. For reasons stated below, the court will grant Defendant's motion in part and deny it in part. A. Bad Faith Plaintiffs assert that Defendant has acted in bad faith with respect to Plaintiff Fred Shorb's insurance claim. 1 The Third Circuit has provided that “[t]o make out a claim of bad faith, a plaintiff must show by clear and convincing evidence that the insurer (1) did not have a reasonable basis for denying benefits under the policy; and (2) knew or recklessly disregarded its lack of reasonable basis in denying the claim.” W.V. Realty, Inc. v. Northern Ins. Co., 334 F.3d 306, 312 (3d Cir.2003). While the term “bad faith” is not defined in the statute, Pennsylvania state courts and federal courts in Pennsylvania have relied upon Black's Law Dictionary, which states: “Bad faith” on [the] part of [the] insurer is any frivolous or unfounded refusal to pay proceeds of a policy; it is not necessary that such refusal be fraudulent. For purposes of an action against an insurer for failure to pay a claim, such conduct imports a dishonest purpose and means a breach of a known duty (i.e., good faith and fair dealing), through some motive of self-interest or ill will; mere negligence or bad judgment is not bad faith. Rottmund v. Continental Assur. Co., 813 F.Supp. 1104, 1108 (E.D.Pa.1992) (quoting Black's Law Dictionary (6 th ed.1990)); Terletsky v. Prudential Prop. & Cas. Ins. Co., Case 4:14-cv-00098-CDL Document 36-13 Filed 10/24/16 Page 3 of 6 Shorb v. State Farm Mut. Auto. Ins. Co., Not Reported in F.Supp.2d (2005) 2005 WL 1137881 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 437 Pa.Super. 108, 649 A.2d 680, 688 (Pa.Super.Ct.1994) (quoting Black's Law Dictionary (6 th ed.1990)); see also W.V. Realty, Inc., 334 F.3d at 311 (quoting Terletsky ). Defendant contends that Plaintiffs have failed to establish a claim for bad faith. Specifically, Defendant asserts that there are no facts in the complaint to suggest that Defendant acted without a reasonable basis or with the knowledge that it lacked a reasonable basis. The court is not convinced by Defendant's argument. Plaintiffs' complaint alleges that Defendant has refused to approve JWF's plans and instead shifted to plans prepared by GLP. Plaintiffs assert that GLP is not qualified to provide for the special needs of Plaintiff Fred Shorb. Moreover, Plaintiffs assert that Defendant was aware or should have been aware that GLP was not qualified. As stated, the court is required to accept as true all of the factual allegations in the complaint and all reasonable inferences that can be drawn from the face of the complaint. Worldcom, Inc., 343 F.3d at 653. Plaintiffs' response to Defendant's motion to dismiss is not the model of clarity. 2 However, the court finds that Plaintiffs' assertion, that Defendant refused to approve JWF's plans and shifted to plans by a knowingly unqualified builder, may be a denial of benefits without a reasonable basis. Accordingly, the court will deny Defendant's motion to dismiss Plaintiff's claim of bad faith. B. Unfair Insurance Claims Practices Act *4 Defendant asserts that Plaintiffs' UIPA claim should be dismissed for failure to state a cause of action upon which relief may be granted. Moreover, Plaintiffs do not come forward with an argument counter to Defendant's position. Briefly, “[i]t is well settled that private actions under the UIPA cannot be maintained.” Seidman v. Minn. Mut. Life Ins. Co., 40 F.Supp.2d 590 (E.D.Pa.1997) (citing Liberty Mut. Ins. Co. v. Paper Mfg. Co., 753 F.Supp. 156, 159 (E.D.Pa.1990); D'Ambrosio v. Pa. Nat'l Mut. Cas. Ins., 494 Pa. 501, 431 A.2d 966, 969-70 (Pa.1981); Romano v. Nationwide Mut. Fire, Ins. Co., 435 Pa.Super. 545, 646 A.2d 1228, 1232 (Pa.Super.Ct.1994)). Instead, the UIPA provides that “The Commissioner may examine and investigate the affairs of every person engaged in the business of insurance in this state in order to determine whether such person has been or is engaged in any unfair method of competition or in any unfair or deceptive act or practice prohibited by this act.” 40 Pa. Stat. Ann § 1171.7. Thus, Plaintiff cannot maintain an action under the UIPA. Accordingly, the court will grant Defendant's motion to dismiss Plaintiffs' UIPA claim. C. Unfair Trade Practices and Consumer Protection Law Unlike the UIPA, the CPL provides for individual causes of action. 3 In Pekular v. Eich, 355 Pa.Super. 276, 513 A.2d 427, 434 (Pa.Super.Ct.1986), the Pennsylvania Superior Court provided that a CPL cause of action may be maintained even if the alleged actions fall within the purview of the UIPA. See also Lombardo v. State Farm Mut. Auto. Ins. Co., 800 F.Supp. 208 (E.D.Pa.1992). Thus, Plaintiffs may be able to maintain a cause of action analogous to their claim under the UIPA through the CPL. Additionally, as provided in Pekular, “ ‘[a]s a statute for the prevention of fraud, [the CPL] must be liberally construed to effect the purpose.’ ” Pekular, 513 A.2d at 432 (quoting Verona v. Schenley Farms Co., 312 Pa. 57, 167 A. 317, 320 (Pa.1933)). In the instant case, Defendant asserts that Plaintiffs are only alleging nonfeasance. It is well established that the CPL applies only to misfeasance and not to nonfeasance. Gordon v. Pa. Blue Shield, 378 Pa.Super. 256, 548 A.2d 600, 604 (Pa.Super.Ct.1988); see also Klinger v. State Farm Mut. Auto. Ins. Co., 895 F.Supp. 709, 717 (M.D.Pa.1995) (finding that the refusal to pay benefits to which plaintiff was entitled constituted nonfeasance and was not actionable under the CPL). As the Superior Court of Pennsylvania has stated: “The test used to determine if there exists a cause of action in tort growing out of a breach of contract is whether there was an improper performance of a contracted obligation (misfeasance) rather than the mere failure to perform (nonfeasance).” Gordon, 548 A.2d at 604. In Gordon, the court stated that “[t]he only act alleged by appellant in this case was the refusal of appellee to pay benefits to which appellant felt entitled.” Id. As such, the Gordon court found that the appellant alleged nonfeasance. *5 Plaintiffs assert that Defendant engaged in unfair and deceptive practices with Plaintiffs. The court finds that Plaintiffs' allegations go beyond a mere failure to pay benefits. It is not disputed that Defendant had previously paid for medical treatment and equipment related to Plaintiff Fred Shorb's injuries. According to Plaintiffs, Defendant hired a qualified architect, JWF; however, Defendant subsequently hired a new architect, Case 4:14-cv-00098-CDL Document 36-13 Filed 10/24/16 Page 4 of 6 Shorb v. State Farm Mut. Auto. Ins. Co., Not Reported in F.Supp.2d (2005) 2005 WL 1137881 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 GLB, and misrepresented to Plaintiffs the qualifications of GLB. Thus, Plaintiffs' complaint does not assert that Defendant has failed to act, nonfeasance, but that Defendant has acted in an unfair and deceptive manner. The court finds that Plaintiffs' complaint avers incidents that may constitute the improper performance of a contractual obligation or misfeasance. Accordingly, the court will deny Defendant's motion to dismiss Plaintiff's claims under the Unfair Trade Practices and Consumer Protection Law. D. Punitive Damages Plaintiffs set forth punitive damages as an independent cause of action. Defendant counters that Plaintiffs cannot maintain an independent cause of action for punitive damages. As the Pennsylvania Supreme Court has stated, “[i]f no cause of action exists, then no independent action exists for a claim of punitive damage since punitive damages is only an element of damages.” Kirkbride v. Lisbon Contractors, Inc., 521 Pa. 97, 555 A.2d 800, 802 (Pa.1989). The court finds that Plaintiffs cannot maintain an independent cause of action for punitive damages. However, Plaintiffs may be able to maintain a claim of punitive damages contingent on another cause of action. Under Count I of Plaintiffs' complaint, bad faith, Plaintiffs request punitive damages. Pursuant to 42 Pa. Cons.Stat. § 8371 punitive damages are permitted for a bad faith claim. Count II of Plaintiffs' complaint is a breach of contract to which punitive damages are not available. Count III of Plaintiffs' complaint is Plaintiffs' claim under UIPA, which the court will dismiss. Count IV of Plaintiffs' complaint asserts a violation under the CPL. The CPL does not provide for punitive damages. See Samuel-Bassett v. KIA Motors America, Inc. 357 F.3d 392, 401 (3d Cir.2004) (“[U]nder the Consumer Protection Law no punitive damages other than the discretionary authority to treble is permitted.”). Accordingly, Plaintiffs' claim for punitive damages under their bad faith claim remains. However, there are no other claims asserted by Plaintiffs that provide for punitive damages. The court will grant Defendant's motion and dismiss Plaintiffs' independent claim for punitive damages. IV. Conclusion In accordance with the foregoing discussion, the court will grant Defendant's partial motion to dismiss with respect to Plaintiffs' claim under the UIPA and Plaintiffs' independent punitive damages claim. The court will deny Defendant's partial motion to dismiss with respect to Plaintiffs' bad faith and CPL claims. An appropriate order will issue. ORDER *6 In accordance with the accompanying memorandum of law, IT IS HEREBY ORDERED THAT Defendant's partial motion to dismiss Plaintiffs' complaint is GRANTED in part and DENIED in part as follows: 1) Defendant's motion to dismiss is GRANTED with respect to Plaintiffs' claim under the Unfair Insurance Claims Practices Act and Plaintiffs' independent cause of action for punitive damages. 2) Defendant's motion to dismiss is DENIED with respect to Plaintiffs' claims under Pennsylvania's Unfair Trade Practices and Consumer Protection Law and Plaintiff's claim of bad faith. 3) Plaintiffs' claim for punitive damages under their claim of bad faith remain. All Citations Not Reported in F.Supp.2d, 2005 WL 1137881 Footnotes 1 Pennsylvania's Bad Faith Insurance Statute, 42 Pa. Cons.Stat. § 8371, provides: In an action arising under an insurance policy, if the court finds that the insurer has acted in bad faith toward the insured, the court may take all of the following actions: (1) Award interest on the amount of the claim from the date the claim was made by the insured in an amount equal to the prime rate of interest plus 3%. (2) Award punitive damages against the insurer. (3) Assess court costs and attorney fees against the insurer. 2 For example, at page four of Plaintiffs' response, the final paragraph is seemingly cut off and not continued on page five. Thus, at least part of Plaintiffs' argument is incomprehensible. However, the court finds that Plaintiffs' complaint and Case 4:14-cv-00098-CDL Document 36-13 Filed 10/24/16 Page 5 of 6 Shorb v. State Farm Mut. Auto. Ins. Co., Not Reported in F.Supp.2d (2005) 2005 WL 1137881 © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 response to Defendant's motion to dismiss, combined with the applicable law is enough to survive Defendant's motion to dismiss. 3 Pennsylvania's Supreme Court articulated the purpose of the CPL in Commonwealth v. Monumental Properties, Inc., 459 Pa. 450, 329 A.2d 812, (Pa.1974). The Monumental Properties Court stated: The Legislature sought by the Consumer Protection Law to benefit the public at large by eradicating, among other things, “unfair or deceptive” business practices. Just as earlier legislation was designed to equalize the position of employer and employee and the position of insurer and insured, this Law attempts to place on more equal terms seller and consumer. These remedial statutes are all predicated on a legislative recognition of the unequal bargaining power of opposing forces in the marketplace. Id. at 815-16. End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:14-cv-00098-CDL Document 36-13 Filed 10/24/16 Page 6 of 6