Cole v. Mentor Corporation et alMOTION for Summary JudgmentM.D. Ga.August 29, 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. 4:13-cv-00321 (Cole) DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF LINDA FAYE COLE 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 all of Plaintiff Linda Faye Cole’s claims. Her negligence and strict liability claims fail because she cannot establish that a defect in her ObTape caused her claimed injuries. Ms. Cole’s failure to warn claims fail due to her inability to prove proximate causation as there is no evidence that a different warning regarding ObTape would have prevented her claimed injuries. Her breach of warranty claims fail because they are time-barred under Minnesota law. Last, Ms. Cole’s unjust enrichment claim fails because she has an adequate remedy at law and cannot establish that Mentor received an unjust benefit related to her ObTape implant. The grounds for this Motion are set forth in more detail in the accompanying Memorandum in Support. Dated: August 29, 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 4:13-cv-00321-CDL Document 40 Filed 08/29/16 Page 1 of 2 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 and email on the following counsel this 29th day of August, 2016: Frederick B. Darley, III beau.darley@beasleyallen.com Counsel for Plaintiff Linda Faye Cole s/ John Q. Lewis John Q. Lewis Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:13-cv-00321-CDL Document 40 Filed 08/29/16 Page 2 of 2 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. 4:13-cv-00321 (Cole) DEFENDANT MENTOR WORLDWIDE LLC’S MEMORANDUM IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF LINDA FAYE COLE Plaintiff Linda Faye Cole’s claims fail for the following reasons: The negligence (Count I) and strict liability-defective design (Count II) claims fail because Ms. Cole cannot establish the required element of causation as there is no evidence that an alleged defect in the ObTape caused any of her claimed injuries. The negligence (Count I), strict liability-failure to warn (Count III), common law fraud (Count VII), and negligent misrepresentation (Count VIII) claims, each of which is premised at least in part on a failure to warn, fail because Ms. Cole has no evidence that an inadequate warning caused her claimed injuries. The breach of warranty claims (Counts IV-V) are time-barred because Ms. Cole filed suit more than four years after the claims accrued. The unjust enrichment claim (Count VI) fails because Ms. Cole has pled alternative claims that would provide an adequate remedy at law and because she cannot establish the elements of an unjust enrichment claim under Minnesota law. For these reasons, Mentor respectfully requests that this Court enter summary judgment in its favor on these claims. 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 Linda Faye Cole. Case 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 1 of 13 2 Plaintiff Linda Faye Cole first developed stress urinary incontinence (SUI) in the late 1990s, which gradually worsened by the time she first saw Dr. John Peacock in 2004. (Separate Statement of Material Facts (“SSMF”) ¶ 1.) On July 30, 2004, Dr. Peacock surgically implanted an ObTape transobturator sling (“ObTape”) in Ms. Cole to treat her SUI. (Id. ¶ 2.) At the time of Ms. Cole’s implant surgery in July 2004, Dr. Peacock had “significant surgical experience” with ObTape “that had been overwhelmingly positive,” and he was satisfied with ObTape’s safety and performance. (Id. ¶ 3.) According to Dr. Peacock, he could not recall relying on any particular information from Mentor in deciding to use ObTape for Ms. Cole. (Id. ¶ 4.) Ms. Cole has never been diagnosed with any erosion or infection of her ObTape. (Id. ¶ 5.) Ms. Cole, who still has her entire ObTape implanted, claims that her ObTape caused recurrent incontinence, voiding problems (including urgency, retention, hematuria, and dysuria), urinary tract infections, dyspareunia, vaginal and pelvic pain, and thigh and back pain. (Id. ¶ 6.) But Ms. Cole experienced many of these symptoms before her ObTape implant, and no doctor with whom she has treated has ever told her that her symptoms might be related to or caused by her ObTape. (Id. ¶ 7.) Dr. Peacock testified that there is nothing in Ms. Cole’s medical record to indicate she has suffered any complications associated with her ObTape, nor is there any indication that she has had any issues with poor tissue ingrowth of her ObTape. (Id. ¶ 8.) Dr. Bryant Williams, III, an Alabama urologist who has treated Ms. Cole since December 2011, also testified that there is nothing in his medical records indicating that she has had any problems with her ObTape. (Id. ¶ 9.) Ms. Cole has resided in Alabama since at least 1983 and all of her ObTape-related medical care occurred in Alabama. (Id. ¶ 10.) Ms. Cole filed her lawsuit against Mentor Case 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 2 of 13 3 in the United States District Court for the District of Minnesota on July 9, 2013, and it was later transferred to this Court for coordinated proceedings. (Id. ¶ 11.) Ms. Cole asserts claims for negligence (Count I), strict liability-defective design defect (Count II), strict liability-failure to warn (Count III), breach of express and implied warranties (Counts IV-V), unjust enrichment (Count VI), common law fraud (Count VII), and negligent misrepresentation (Count VIII). (Id. ¶ 12.) Dr. Amanda White produced a Rule 26 case-specific expert report dated August 1, 2016 in this case. (Id. ¶ 13.) In her report, Dr. White opines that tissue ingrowth is prohibited by ObTape’s material properties (i.e., unwoven thermally bonded polypropylene microporous mesh) and that this results in an encapsulated graft with acute and chronic inflammation. (Id. ¶ 14.) But Dr. White does not explain how this alleged defect can cause Ms. Cole’s claimed injuries, nor does she point to any evidence in the record where Ms. Cole has been diagnosed with either inadequate tissue ingrowth or an encapsulated graft with acute and chronic inflammation that could have caused or contributed to these injuries. (Id. ¶ 15.) LAW AND ARGUMENT Summary judgment should be granted where “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). Indeed, Rule 56 “mandates the entry of summary judgment, 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). Facts are “material” only if they could affect the outcome of the suit under the governing substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. Case 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 3 of 13 4 242, 248 (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. Minnesota Law Applies to Ms. Cole’s Claims. Because this case was transferred to this Court from the District of Minnesota, this Court applies Minnesota’s choice-of-law rules to determine which state’s law controls. See In re Gen. Am. Life Ins. Co. Sales Practices Litig., 391 F.3d 907, 911 (8th Cir. 2004); accord Murphy v. Fed. Deposit Ins. Corp., 208 F.3d 959, 965 (11th Cir. 2000). The two possibilities are the law of Minnesota (where the suit was filed) and Alabama (where Ms. Cole lives and all ObTape-related medical care and treatment occurred). Under Minnesota law, this Court must first determine whether there is an actual conflict between Minnesota and Alabama law before proceeding to a choice-of-law analysis. Glover v. Merck & Co., Inc., 345 F. Supp. 2d 994, 997 (D. Minn. 2004) (citing Jepson v. Gen. Cas. Co. of Wisconsin, 513 N.W.2d 467, 469 (Minn. 1994)). A conflict exists if the rule of one state or the other is outcome-determinative. Id. If there is no actual conflict, or if the law at issue is procedural, then this Court should apply Minnesota law. See, e.g., Christian v. Birch, 763 N.W.2d 50, 58 (Minn. Ct. App. 2009). Here, there is no conflict with respect to the causation issues presented in this Motion. Both Minnesota and Alabama law require proof that a defect in a product caused the plaintiff’s injuries. Goree v. Winnebago Indus., Inc., 958 F. 2d 1537, 1541 (11th Cir. 1992) (citing Sears, Roebuck & Co. v. Haven Hills Farm, Inc., 395 So. 2d 991, 994 (Ala. 1981)); Bilotta v. Kelley Co., 346 N.W.2d 616, 623 n.3 (Minn. 1984). Likewise with respect to the failure to warn claims, both Minnesota and Alabama require that the Case 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 4 of 13 5 alleged failure to warn proximately caused those injuries. See Garrison v. Novartis Pharms. Corp., 30 F. Supp. 3d 1325, 1333 (M.D. Ala. Jul. 2, 2014) (“[T]he plaintiff must show not only that an inadequate warning was given, but also that an adequate warning would have prevented her injury.” (citing Deere & Co. v. Grose, 586 So. 2d 196, 198 (Ala. 1991))); Krein v. Raudabough, 406 N.W.2d 315, 320 (Minn. Ct. App. 1987) (concluding that to prevail on a failure to warn claim, “the manufacturer’s failure to warn must be the proximate cause of the plaintiff’s injury”). There is no conflict as to Ms. Cole’s unjust enrichment claim because both Minnesota and Alabama law require some showing of an unjust benefit received by the defendant, a standard that Ms. Cole cannot meet here. See infra at 12; In re Viagra Prods. Liab. Litig., 658 F. Supp. 2d 950, 968- 69 (D. Minn. 2009); S. v. Pfizer, Inc., 471 F. Supp. 2d 1207, 1219 (N.D. Ala. 2006) (citing Avis Rent A Car Systems, Inc. v. Heilman, 876 So. 2d 1111, 1123 (Ala. 2003) (stating that a plaintiff with an unjust enrichment claim must establish “either that the defendant holds money that, in equity and good conscience, belongs to the plaintiff, or that the defendant holds money that was improperly paid because of mistake or fraud”)). Last, there is no conflict with respect to the statute of limitations governing Ms. Cole’s breach of warranty claims as both Minnesota and Alabama apply a four-year limitations period for such claims. Minn Stat. § 336.2-725(1); Ala. Code § 7-2-725(1). Accordingly, the Minnesota statute of limitations and Minnesota substantive law govern the issues raised in Mentor’s Motion. B. Ms. Cole’s Negligence and Strict Liability-Defective Design Claims Fail for Lack of Any Evidence of General or Specific Causation. To establish a products liability claim under Minnesota law, “the plaintiff must demonstrate that a product was defective at the time it left the defendant's control and Case 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 5 of 13 6 that the defect caused injury to the plaintiff.” Duxbury v. Spex Feeds, Inc., 681 N.W.2d 380, 387 (Minn. Ct. App. 2004). With a product such as a medical device, the plaintiff is required to prove both general and specific medical causation of her injuries. See In re Viagra, 658 F. Supp. 2d at 968; Medalen v. Tiger Drylac U.S.A., Inc., 269 F. Supp. 2d 1118, 1126 (D. Minn. Mar. 21, 2003). General causation focuses on whether the claimed defect is capable of causing a particular injury, while specific causation focuses on whether the claimed defect actually caused plaintiff’s particular claimed injury. See Dittrich-Bigley v. Gen-Probe, Inc., Civil No. 11-1762 (MJD/FLN), 2013 WL 3974107, at *7 (D. Minn. Jul. 31, 2013) (attached as Ex. G to the Lewis Decl.); see also In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., 711 F. Supp. 2d 1348, 1365 (M.D. Ga. 2010) (“Plaintiffs must prove that [a defect in] ObTape can cause the type of injury suffered . . . (general causation) and that [a defect in] ObTape did in fact cause Plaintiff’s injuries (specific causation).” (citing Guinn v. AstraZeneca Pharms. LP, 602 F.3d 1245, 1249 n.1 (11th Cir. 2010))). Expert testimony is generally required to establish causation in cases involving medical devices because of the underlying “complex medical issues with which a jury is unlikely to have experience.” Rye v. Matrixx Initiatives, Inc., Civil No. 06-3288 (RHK/JSM), 2007 WL 2475960, at *4 (D. Minn. Aug. 24, 2007) (internal quotations and citations omitted) (attached as Ex. H to the Lewis Decl.). Where the plaintiff fails to establish that a defect was the cause of her claimed injuries, summary judgment is proper. See Nelson v. Navistar Int’l Corp., Civil No. 10-137 (JRT/SER), 2011 WL 5374438, at *3 (D. Minn. Nov. 7, 2011) (granting summary judgment to defendant because plaintiff had not established that the product was defective or was the cause of his injuries) (attached as Ex. I to the Lewis Decl.); In re Viagra, 658 F. Supp. 2d at 968. Case 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 6 of 13 7 Ms. Cole, who still has her entire ObTape implanted and has never experienced an erosion or an infection of her sling (SSMF ¶¶ 5-6), claims that her ObTape caused her to experience recurrent incontinence, voiding problems, urinary tract infections, dyspareunia, vaginal and pelvic pain, and thigh and back pain (id. ¶ 6). But Ms. Cole has not established that a defect in ObTape is capable of causing these injuries, let alone that such a defect in ObTape specifically caused these injuries in her. Indeed, many of the claimed injuries that she attributes to her ObTape predated her implant, and no doctor with whom she has treated has ever told her that her claimed injuries are related to or caused by her ObTape. (Id. ¶ 7.) Further, Dr. Peacock, Ms. Cole’s implanting surgeon, and Dr. Williams, her most recent treating urologist, testified that nothing in her medical records indicates she has had any complications caused by her ObTape, let alone by a defect in her ObTape. (SSMF ¶¶ 8-9.) Dr. Amanda White’s expert report in this case (see Amanda B. White, M.D.’s Rule 26 Expert Report (“White Report”), attached as Ex. F to the Lewis Decl.), does not create a genuine issue of material fact as to specific causation. First, while Dr. White points to an alleged defect in ObTape (i.e., unwoven thermally bonded polypropylene microporous mesh), and asserts that it causes inadequate tissue ingrowth and an encapsulated graft with acute and chronic inflammation, she does not explain how either inadequate tissue ingrowth or an encapsulated graft can cause the injuries that Ms. Cole claims. (SSMF ¶ 14.) But more importantly, there is no evidence that Ms. Cole has ever been diagnosed with either inadequate tissue ingrowth or an encapsulated graft with related inflammation. Indeed, Dr. Peacock’s testimony-that there is no indication that she has had any issues with poor tissue ingrowth of her ObTape-is the only record evidence on this issue. (SSMF ¶ 8.) Dr. White does not address this testimony, nor does Case 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 7 of 13 8 she identify any place in the record supporting her opinion that Ms. Cole herself experienced inadequate tissue ingrowth leading to an encapsulated graft and acute and chronic inflammation. (See White Report ¶ II(C)(4), at 7.)1 Dr. White cannot rely on inadequate tissue ingrowth as the cause of Ms. Cole’s claimed injuries without any evidence that inadequate tissue ingrowth, or an encapsulated graft with inflammation, actually occurred in this case. Because Ms. Cole has no specific causation testimony to support her claims that a defect in ObTape caused her injuries, her negligence and strict liability-defective design claims fail. C. Ms. Cole’s Failure-To-Warn-Based Claims Fail Because There Is No Evidence that a Failure to Warn Caused Her Claimed Injuries. As an initial matter, Ms. Cole’s fraud-based (Counts VII-VIII) and strict liability- failure to warn (Count III) claims and portions of her negligence claim (Count I) are each premised on an alleged failure to warn. See, e.g., Compl. ¶¶ 28-29, 55-62, 90-120; see also Bowman v. Wyeth, LLC, No. 10-1946 (JNE/SER), 2012 WL 684116, at *6 (D. Minn. Mar. 2, 2012) (concluding that plaintiff’s misrepresentation and fraud claims were all based on an alleged failure to warn even if “not specifically labeled” as such) (attached as Ex. K to the Lewis Decl.). Accordingly, to establish these claims, Ms. Cole must show that the alleged deficient warnings proximately caused her injuries. See Krein, 406 N.W.2d at 320. In Minnesota, a medical device manufacturer owes a duty to warn to the prescribing physician, not the patient. Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d 1 Her failure to do so distinguishes her report here from those produced in Burgess and Smart. See August 18, 2016 Order, In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., Case No. 4:13-cv-221 (Burgess), Case No. 4:13-cv-228 (Smart) (M.D. Ga. Aug. 18, 2016) (“Burgess and Smart Order”) (attached as Ex. J to the Lewis Decl.). Case 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 8 of 13 9 1128, 1152 (D. Minn. 2011) (concluding that “[u]nder the learned-intermediary doctrine, a maker of drugs or medical devices has a duty to warn only doctors . . . and not patients” about the risks of a medical device); Mozes v. Medtronic, Inc., 14 F. Supp. 2d 1124, 1130 (D. Minn. 1998). Thus, under Minnesota law, Mentor’s duty to warn ran only to Ms. Cole’s implanting surgeon, Dr. Peacock, not to Ms. Cole herself. The learned intermediary doctrine affects the means by which a plaintiff must establish proximate cause. Where the learned intermediary doctrine applies, the court must “conduct a careful examination of the prescribing physician’s experience, knowledge, and state of mind when making the decision to prescribe the particular drug at issue” to determine whether proximate cause exists. See In re Levaquin Prods. Liab. Litig., 726 F. Supp. 2d 1025, 1027 (D. Minn. 2010). On that score, “[t]he proper inquiry . . . is not only whether [the prescribing physician] would have prescribed [the drug at issue], but also whether he would have otherwise altered the course of treatment if he had received a more thorough warning.” Id. at 1036. Therefore, even if Ms. Cole could prove that Mentor’s warnings were inadequate, she also must establish that a different warning would have changed Dr. Peacock’s decision to select ObTape for her implant procedure. Id. Dr. Peacock’s testimony, however, demonstrates that any additional warning regarding ObTape would not have changed his prescribing decision with respect to Ms. Cole. At the time of Ms. Cole’s implant surgery in July 2004, Dr. Peacock had “significant surgical experience” with ObTape “that had been overwhelmingly positive,” and he was satisfied with the product’s safety and performance. (SSMF ¶ 3.) He did not recall relying on any particular information from Mentor in deciding to implant ObTape in Ms. Cole. (Id. ¶ 4.) Because he did not consider Mentor’s product information in Case 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 9 of 13 10 selecting ObTape for Ms. Cole, there is no evidence that any additional warning would have affected his implanting decision. Accordingly, proximate cause cannot be established and Ms. Cole’s failure-to-warn based claims fail. Greiner v. Sofamor, S.N.C., No. Civ. 4-95-645 RHK JMM, 1999 WL 716891, at *6-*7 (D. Minn. Mar. 8, 1999) (granting summary judgment to medical device manufacturer where there was no evidence that plaintiff’s physician would have altered his recommended course of treatment had he been given additional or different warnings) (attached as Ex. L to the Lewis Decl.); see Burgess and Smart Order, at 12-13 (granting summary judgment where plaintiff failed to point to any evidence to establish that the implanting surgeon would have changed his prescribing decision if Mentor had provided additional warnings). This is consistent with this Court’s order in Bromley, et al., in which the Court granted summary judgment on plaintiffs’ Minnesota law-based misrepresentation and common law fraud claims based on a lack of evidence that the implanting surgeon would have changed his or her ObTape prescribing decision had they been provided with additional risk information by Mentor. See In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., MDL Docket No. 2004, Nos. 4:13-cv-00017 (Bromley), 4:13-cv-00339 (Larranaga), 4:13-cv-00464 (Kaiser), 4:13-cv-00485 (Hill), 4:14-cv-00060 (Burt), 4:14-cv-0062 (Alexander), at 15 (M.D. Ga. Nov. 19, 2015) (attached as Ex. M to Lewis Decl.) To the extent Ms. Cole asserts that Mentor owed and breached a continuing, post-sale duty to warn (see Compl. ¶ 61), that claim also fails. As established above, Ms. Cole cannot demonstrate that any such failure-to-warn proximately caused her alleged injuries in the absence of any testimony from Dr. Peacock that he would have advised different follow-up treatment had he been subsequently warned about ObTape’s alleged Case 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 10 of 13 11 risks. See supra at 9-10; see also In re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig., Civil No. 06-25 (DWF/AJB), 2007 WL 2023569, at *3 (D. Minn. July 6, 2007) (applying California law and granting summary judgment for manufacturer on post-implant warning claim because plaintiff could not establish a causal link between the failure to give any post-implant warnings and the plaintiff’s injuries) (attached as Ex. N to the Lewis Decl.). For these reasons, the Court should dismiss Counts III and VII-VIII and the failure-to-warn portion of Count I of Ms. Cole’s Complaint. D. Ms. Cole’s Claims for Breach of Warranty Are Time- Barred. Minnesota imposes a four-year limitations period on claims arising under the Uniform Commercial Code, including claims for breach of warranty. Minn. Stat. 336.2- 725. Moreover, the statute is explicit as to when breach of warranty claims accrue: “[a] breach of warranty occurs when tender of delivery is made.”2 Here, Ms. Cole’s ObTape was “delivered,” and the warranty claims accrued, no later than the date it was implanted-July 30, 2004. As such, any breach of warranty claims had to be filed by July 30, 2008. Because they were not, they are time-barred. 2 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 “[m]ost courts have been very harsh in determining whether a warranty explicitly extends to future performance,” and to do so “there must be specific reference to a future time in the warranty.” Allstate Ins. Co. v. General Motors Corp., No. PD 04-12393, 2005 WL 264276, at *3-*4 (Minn. Dist. Ct. Jan. 24, 2005) (citing Standard Alliance Indus., Inc. v. Black Clawson, Co., 587 F.2d 813, 820 (6th Cir. 1978))) (attached as Ex. O to Lewis Decl.). Here, Ms. Cole has never even alleged-much less presented evidence of-any specific reference to future performance. Case 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 11 of 13 12 E. Ms. Cole’s Unjust Enrichment Claim Fails Because She Has an Adequate Remedy at Law and Mentor Has Not Received an Unjust Benefit Related to Her ObTape. “To establish an unjust enrichment claim it must be shown that a party has knowingly received something of value, not being entitled to the benefit, and under circumstances that would make it unjust to permit its retention.” In re Viagra, 658 F. Supp. 2d at 968-69 (quoting Southtown Plumbing, Inc. v. Har-Ned Lumber Co., 493 N.W.2d 137, 140 (Minn. Ct. App. 1992)). An unjust enrichment claim fails, however, if plaintiff has an adequate remedy at law - i.e., alternative claims that, if successfully proven, would provide adequate relief. Id. at 969 (granting summary judgment on plaintiffs’ unjust enrichment claim in part because they pled tort claims that, if proven, would have provided adequate relief). Here, because Ms. Cole asserted seven other causes of action that would provide adequate relief if she were able to prove them in this case, she is precluded from asserting an unjust enrichment claim. Further, because there is no record evidence that Ms. Cole experienced any complications as a result of her ObTape, as confirmed by Dr. Peacock and Dr. Williams, she cannot establish that Mentor received an unjust benefit from the sale of her ObTape. See id. (further granting summary judgment on the unjust enrichment claim on the grounds that plaintiffs failed to prove that the drug at issue caused their alleged injuries and thus there was no evidence that the manufacturer received a benefit “under circumstances that would make it unjust to permit its retention”). For these reasons, Ms. Cole’s unjust enrichment claim fails and should be dismissed. CONCLUSION Defendant Mentor Worldwide LLC is entitled to summary judgment on all of Plaintiff Linda Faye Cole’s claims. Summary judgment is warranted on the negligence Case 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 12 of 13 13 012813\001204\2810394 and strict liability-defective design claims because Ms. Cole cannot establish the causation element of her claims. Mentor is further entitled to summary judgment on Ms. Cole’s failure to warn claims because she cannot establish that a different warning would have changed her implanting surgeon’s treatment decisions had Mentor provided different or additional warnings. Ms. Cole’s breach of warranty claims should be dismissed as a matter of law because they are time-barred. And Ms. Cole’s unjust enrichment claim fails because she has alternative adequate remedies at law and because she has not established that Mentor received an unjust benefit related to her ObTape. Dated: August 29, 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 4:13-cv-00321-CDL Document 40-1 Filed 08/29/16 Page 13 of 13 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. 4:13-cv-00321 (Cole) DEFENDANT MENTOR WORLDWIDE LLC’S SEPARATE STATEMENT OF MATERIAL FACTS IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF LINDA FAYE COLE 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 Summary Judgment. 1. Plaintiff Linda Faye Cole first developed stress urinary incontinence (SUI) in the late 1990s (Dep. of Linda Faye Cole (“Cole Dep.”) 68:6-14, attached as Ex. A to the Decl. of John Q. Lewis (“Lewis Decl.”)), which gradually worsened by the time she first saw Dr. John Peacock in 2004 (Cole Dep. 75:3-77:6; Dep. of John Peacock, M.D. in Cole (“Peacock Cole Dep.”) 7:19-21, 8:19-9:5, attached as Ex. B to the Lewis Decl.). 2. On July 30, 2004, Dr. Peacock surgically implanted an ObTape transobturator sling (“ObTape”) in Ms. Cole to treat her SUI. (Pl. Fact Sheet §§ II(2)- (3), VII(1), at 2, 11, attached as Ex. C to the Lewis Decl.; Pl.’s Compl., Doc. No. 1, ¶¶ 20- 21.) 3. At the time of Ms. Cole’s implant surgery in July 2004, Dr. Peacock had “significant surgical experience” with ObTape “that had been overwhelmingly positive,” Case 4:13-cv-00321-CDL Document 40-2 Filed 08/29/16 Page 1 of 4 2 and he was satisfied with its safety and performance. (Dep. of John Peacock, M.D. in Burch (“Peacock Burch Dep.”) 50:15-17, 192:9-21, attached as Ex. D to the Lewis Decl.)1 4. According to Dr. Peacock, he could not recall relying on any particular information from Mentor in deciding to use ObTape for Ms. Cole. (Peacock Cole Dep. 11:14-17.) 5. Ms. Cole has never been diagnosed with any erosion or infection of her ObTape. (Pl. Fact Sheet, § V(4), at 9.) 6. Ms. Cole, who still has her entire ObTape implanted (id. § II(5), (9), at 2), claims that her ObTape caused recurrent incontinence, voiding problems (including urgency, retention, hematuria, and dysuria), urinary tract infections, dyspareunia, vaginal and pelvic pain, and thigh and back pain (Cole Dep. 16:12-18:18, 24:14-25:5, 107:17-108:14, 112:15-18, 118:17-120:23, 153:23-24; Pl. Fact Sheet, § VIII(1), at 14). 7. But Ms. Cole experienced many of these symptoms before her ObTape implant (Cole Dep. 62:6-10, 62:21-63:2, 75:3-18, 76:6-9, 77:10-79:2; Pl. Fact Sheet, § V(4), at 8-9), and no doctor with whom she has treated has ever told her that her symptoms might be related to or caused by her ObTape (Cole Dep. 124:1-4). 8. Dr. Peacock testified that there is nothing in Ms. Cole’s medical record to indicate she has suffered any complications associated with her ObTape, nor is there any indication that she has had any issues with poor tissue ingrowth of her ObTape. (Peacock Cole Dep. 18:17-21, 36:20-23.) 9. Dr. Bryant Williams, III, an Alabama urologist who has treated Ms. Cole since December 2011, also testified that there is nothing in his medical records 1 The parties in this case have agreed that Dr. Peacock’s general testimony in In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig. (Burch), Case No. 4:12- CV-00276, can be used in this case to avoid Dr. Peacock having to repetitively testify on the same subjects. (Peacock Cole Dep. 5:21-6:1.) Case 4:13-cv-00321-CDL Document 40-2 Filed 08/29/16 Page 2 of 4 3 indicating that she has had any problems with her ObTape. (Dep. of Bryant Williams, III, M.D. (“Williams Dep.”) 39:1-6, 42:6-10, 47:20-23, 54:8-13, 54:19-55:10, attached as Ex. E to the Lewis Decl.) 10. Ms. Cole has resided in Alabama since at least 1983 and all of her ObTape- related medical care occurred in Alabama. (Pl. Fact Sheet, §§ III(3)-(4), IV(1), VIII(1), at 3, 7, 14.) 11. Ms. Cole filed her lawsuit against Mentor in the United States District Court for the District of Minnesota on July 9, 2013 (Pl.’s Compl.), and it was later transferred to this Court for coordinated proceedings (Doc. 6). 12. Ms. Cole asserts claims for negligence (Count I), strict liability-defective design defect (Count II), strict liability-failure to warn (Count III), breach of express and implied warranties (Counts IV-V), unjust enrichment (Count VI), common law fraud (Count VII), and negligent misrepresentation (Count VIII). (Id.) 13. Dr. Amanda White produced a Rule 26 case-specific expert report dated August 1, 2016 in this case. (Amanda B. White, M.D. Rule 26 Expert Report, attached as Ex. F to the Lewis Decl.) 14. In her report, Dr. White opines that tissue ingrowth is prohibited by ObTape’s material properties (i.e. unwoven thermally bonded polypropylene microporous mesh) and that this results in an encapsulated graft with acute and chronic inflammation. (Id. § II(C)(4), at 7.) 15. But Dr. White does not explain how this alleged defect can cause Ms. Cole’s claimed injuries, nor does she point to any evidence in the record where Ms. Cole has been diagnosed with either inadequate tissue ingrowth or an encapsulated graft with Case 4:13-cv-00321-CDL Document 40-2 Filed 08/29/16 Page 3 of 4 4 012813\001204\2803933.1 acute and chronic inflammation that could have caused or contributed to these injuries. (See generally id.) Dated: August 29, 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 4:13-cv-00321-CDL Document 40-2 Filed 08/29/16 Page 4 of 4 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. 4:13-cv-00321 (Cole) DECLARATION OF JOHN Q. LEWIS IN SUPPORT OF DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR SUMMARY JUDGMENT AGAINST PLAINTIFF LINDA FAYE COLE 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 excerpts from the deposition of Linda Faye Cole, dated June 1, 2016. 3. Attached as Exhibit B is a true and correct copy of excerpts from the deposition of John Peacock, M.D., dated July 6, 2016. 4. Attached as Exhibit C is a true and correct copy of Plaintiff Linda Faye Cole’s Third Amended Plaintiff Fact Sheet, received unverified on May 31, 2016. Case 4:13-cv-00321-CDL Document 40-3 Filed 08/29/16 Page 1 of 3 2 5. Attached as Exhibit D is a true and correct copy of excerpts from the deposition of John Peacock, M.D. taken in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, Case No. 4:13-cv-00276 (Burch), dated April 20, 2015. 6. Attached as Exhibit E is a true and correct copy of excerpts from the Deposition of Bryant Williams, III, M.D., dated July 6, 2016. 7. Attached as Exhibit F is a true and correct copy of the Amanda B. White, M.D. Rule 26 Expert Report produced by Ms. Cole as part of her expert disclosures in this case. 8. Attached as Exhibit G is a true and correct copy of an unreported case, Dittrich-Bigley v. Gen-Probe, Inc., Civil No. 11-1762 (MJD/FLN), 2013 WL 3974107 (D. Minn. Jul. 31, 2013). 9. Attached as Exhibit H is a true and correct copy of an unreported case, Rye v. Matrixx Initiatives, Inc., Civil No. 06-3288 (RHK/JSM), 2007 WL 2475960 (D. Minn. Aug. 24, 2007). 10. Attached as Exhibit I is a true and correct copy of an unreported case, Nelson v. Navistar International Corp., Civil No. 10-137 (JRT/SER), 2011 WL 5374438 (D. Minn. Nov. 7, 2011). 11. Attached as Exhibit J is a true and correct copy of this Court’s Order in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, , MDL Docket No. 2004, Case No. 4:13-cv-221 (Burgess), Case No. 4:13-cv-228 (Smart) (M.D. Ga. Aug. 18, 2016). Case 4:13-cv-00321-CDL Document 40-3 Filed 08/29/16 Page 2 of 3 3 012813\001204\2808121.1 12. Attached as Exhibit K is a true and correct copy of an unreported case, Bowman v. Wyeth, LLC, No. 10-1946 (JNE/SER), 2012 WL 684116 (D. Minn. Mar. 2, 2012). 13. Attached as Exhibit L is a true and correct copy of an unreported case, Greiner v. Sofamor, S.N.C., No. Civ. 4-95-645 RHK JMM, 1999 WL 716891 (D. Minn. Mar. 8, 1999). 14. Attached as Exhibit M is a true and correct copy of this Court’s Order in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, Nos. 4:13-cv-00017 (Bromley), 4:13-cv-00339 (Larranaga), 4:13-cv- 00464 (Kaiser), 4:13-cv-00485 (Hill), 4:14-cv-00060 (Burt), 4:14-cv-0062 (Alexander) (M.D. Ga. Nov. 19, 2015). 15. Attached as Exhibit N is a true and correct copy of an unreported case, In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, Civil No. 06- 25 (DWF/AJB), 2007 WL 2023569 (D. Minn. July 6, 2007). 16. Attached as Exhibit O is a true and correct copy of an unreported case, Allstate Insurance Co. v. General Motors Corp., No. PD 04-12393, 2005 WL 264276 (Minn. Dist. Ct. Jan. 24, 2005). I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct. Executed this 29th day of August 2016, in Cleveland, Ohio. s/John Q. Lewis John Q. Lewis Case 4:13-cv-00321-CDL Document 40-3 Filed 08/29/16 Page 3 of 3 EXHIBIT A Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 1 of 24 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 1 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 Case No. 2004 Indiv. Case No. 4:13-cv-00321 * * * * * * * * * * * VIDEO DEPOSITION OF LINDA FAYE COLE, taken pursuant to stipulation and agreement before Lauryn Adams, Certified Court Reporter and Commissioner for the State of Alabama at Large, at Freedom Court Reporting, 206 North Lena Street, Dothan, Alabama, on Wednesday, June 1, 2016, commencing at approximately 9:05 a.m. * * * * * * * * * * Job No. CS2322697 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 2 of 24 2 3 4 5 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 16 questions about it, it will be fresh in your memory and, you know, we can go from there. Or, actually, you know what? Let's wait a little bit. Can we I changed my mind. Let's talk about your health today first. How is your health today? A.Well, I woke up sick this morning. Q.Sick with what? A.About 2 o'clock. Neck pain and abdominal pain. Q.Okay. And -- and what symptoms are you experiencing today that you attribute to ObTape? A.Well, my sex life is -- I just don't have one. Q.Okay. A.Haven't in years. Q.Any other symptoms you're experiencing today that you attribute to ObTape? A.None other than the -- the abdominal pain and -- Q.So aside from the or let's talk about the inability to have sex. Is it painful intercourse or is it -- 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 3 of 24 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 17 A.Yes. Q.It is? Okay. A.It is. Q.And do you experience this pain before sex, whenever you're attempting to have sex, or after sex? A.Both. I have sharp pains afterwards in the vaginal area. Q.And when was the last time you attempted to have sexual intercourse? A.I can't remember. It's been several years. Q.Years? Has it been since 2010? A.Yeah, it probably has. Q.Okay. So after 2010, you attempted to have sexual intercourse and were unable because of pain? A.Right. Q.And let's talk about your abdominal pain. Can you kind of describe what that pain feels like? A.Kind of like a cramp. You know, it -- it's just -- it will -- when I have one, it will make me double over sometimes. Q.And have you noticed anything that triggers the abdominal pain? Is there any kind of 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 4 of 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 activity or any kind of diet, something like that that -- A.N Q.-- brings it about? A.No. I've had them when I was sitting down. Page 18 Q.Okay. So aside from the pain associated with sex and the abdominal pain, are there any other symptoms you're experiencing today that you attribute to ObTape? A.Well, my thighs hurt, the inside of my thighs. Q.Can you describe that pain? A.Well, I woke up with it this morning, and it was, like, light pressure, you know, and I had a little nausea. Q.And when did this thigh pain begin? A.I'm guessing about a year after the surgery. Q.So 2005? A.Uh-huh. COURT REPORTER: Is that a "yes"? Is that a "yes"? THE WITNESS: Yes. MS. FULK: Answer verbally. THE WITNESS: Yes. 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 5 of 24 1 2 3 4 5 6 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 24 where they -- we made pillowcases. Q.Okay. A.Or that's what I did. I was -- made pillowcases. Q.And, so, about a year after the surgery when you began experiencing back pain, did you attribute that to the ObTape? MS. FULK: Object to form. A.No. I just -- Q.What did you think caused it? A.I just figured it was from standing up all day and, you know, being on a concrete floor. Q.And you said that you didn't see any doctors about that back pain, correct? A.No. Q.Okay. And is that still going on today? A.Yes. Q.Is the abdominal pain still going on today? A.Yes, it is. Q.Is the pain with sex still going on today? A.Yes, it is. Q.And is the thigh pain still going on today? A.Yes, it is. Q.So other than the pain with sex, the back 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 6 of 24 1 2 3 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 25 pain, the thigh pain, and the abdominal pain, are there any other symptoms that you attribute to ObTape today? MS. FULK: Object to form. A.No. Q.Now I'm going to take a break. And we can go off the record for you to review your Plaintiff Fact Sheet, and then we can come back on and verify that the information is correct, and I'll ask you a little bit about that. Is that okay? A.Okay. VIDEOGRAPHER: Going off the record at 9:26 a.m. (Brief recess) VIDEOGRAPHER: We're going back on the record at 10:10 a.m. Q.(Mr. Adams continuing:) Ms. Cole, I just want to go over a couple things we already discussed. Whenever you met with your first lawyer, how long was that meeting? A.With Chris, probably 30 minutes or 45. Q.Was anyone else present? A.No. Just me and him. Q.And you mentioned that you scratched down a 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 7 of 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 62 MS. FULK: Object to form. A.Yes. Q.And do you remember -- the record talks about a history of UTIs. I'll represent to you that UTIs is usually shorthand for urinary tract infections. Do you remember when those started? A.I think it was -- seems like I can remember starting to have those after my third child was born. Q.After your third child was born. Okay and were those consistent? Had those been consistent throughout your lifetime MS. FULK: Object -- Q.-- urinary tract infections? MS. FULK: Object to form. A.No. Q. I'm sorry? A.What was the question? I may have answered something I didn't know. Q.So the urinary tractions -- urinary tract infections that began after the birth of your third child, have those been consistent throughout the remainder of your lifetime? 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 8 of 24 1 2 3 4 5 6 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 63 MS. FULK: Object to form. A.Yes. Q.And how do you usually get those treated? A.I don't. I mean, like, -- like, here, I guess, you know, I don't remember what Dr. McLaughlin did for me when I had -- had this done. I don't remember. Q.Have you ever sought treatment for your urinary tract infections? A.Yeah. Q.And what type of treatment is usually prescribed? A.Medication was what they -- Q.Do you know the name of the medication by chance? A.Bactrim DS. Q.And do you remember whenever you first started taking Bactrim DS? A.No, I don't. Q.Was it before 2000? A.Yeah. Probably so. Q.Is it usually pretty effective at resolving the symptoms? A.Uh-huh. MS. FULK: Answer verbally. 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 9 of 24 1 2 3 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 68 Have you received any treatment for your hypertension? A.No. Q.No medications? A.No. Q.Okay. Then on to the next page, please. We've got "yes" stress urinary incontinence. And when did that start? A.Oh, right here? MS. FULK: Top of the page. Q.Top of the page, please. A. Oh. Q.Number 17. A.Stress urinary incontinence, that probably started -- well, I actually that started probably the late '90s. Q.And who diagnosed you? A.You know, I don't remember if Dr. B. did or -- Q.Doctor who? A.Bendinger. Q.And were you prescribed any treatments before the sling for your stress urinary incontinence? A.Uh-uh. 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 10 of 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 75 then we'll discuss it a little bit. Okay? A.(Nodding head). Q.So the very bottom, the last date, we've got 7/6/04, correct, on the left-hand side? A. 7/6/04. Yeah. Q.And then Patient, we've got Cole, Linda, correct? I'm reading. Sorry. Correct? A.Yeah. Q.Okay. And then kind of under the little chart here, we've got some text, and the second sentence reads, symptomatic again with recurrent infections, symptoms of incomplete voiding; and more problematic than anything is worsening incontinence. I think she is at the point now where she would like to consider options for surgery. Did I read that correctly? A.Yes. Q.And if you'll flip to the back with me, in that third sentence at the top, we will set her up an appointment to see Dr. Peacock in two to three weeks and let him talk with her and perhaps do a cysto, et cetera, with an eye toward bladder neck suspension surgery, if he deems that appropriate. Did 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 11 of 24 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 76 I read that correctly? A.Yes. Q.Okay. Is this record consistent with your recollection? A.Yeah. Q.Okay. So you remember having recurrent infections and symptoms of incontinence before you saw Dr. Peacock, correct? A.Yes. Q.Okay. And you were interested in the surgery at this point, correct? A.I was. Q.Okay. And you were interested because the incontinence was affecting your life in a negative way, correct? A.It was. Q.And you were wearing pads, correct? A. (Nodding head). Q.And was the incontinence -- A. Yes. Q.And was the incontinence preventing you from any of your daily activities? A.Yes. Q.Which ones? A.Well, shopping, you know, and just doing 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 12 of 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 77 things, you know, like working in my garden -- flower garden or flower beds and just having a social life. Q.So the incontinence was really impacting your social life, correct? A.Yes. Q.And that's why you were looking for the surgery, correct? A.Yeah. Q.And -- and it says here that, also -- let me find that -- that -- oh, I'm sorry. So this is the sentence that kind of flows over from 1 to 2. So it's going to say, I'm going to go ahead and restart the post- coital Macrodantin, as she has continued to have a lot of symptoms magnified after intercourse. And that's kind of consistent with what you were saying about having the pain and needing the cream, correct? MS. FULK: Object to form. A.Yes. Q.And by magnified after intercourse, does that mean the pain was present during intercourse or was only present afterwards? MS. FULK: Object to form. 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 13 of 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 78 A.It was both. Q.Okay. It was both? A.Yeah, it was both. Q.And what kind of pain was it? A.Afterwards, I -- it was, like, a sharp pain. And before, it was just, like, tender; you know, it was just tender. Q.So it was tender beforehand and, then it would turn into a sharp pain after intercourse? A.Afterwards. Q.And this was whenever you were on the cream, correct? MS. FULK: Object to form. Q.Sorry. Strike that. A.I don't remember. Q. This is -- MS. FULK: And I'm objecting because you're not specifying dates. MR. ADAMS: Right. Yeah. MS. FULK: So if you would just do that. MR. ADAMS: Sure. Q.And this is when you were on the Macrodantin cream in July of 2004 to treat 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 14 of 24 1 2 3 4 5 6 7 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 79 your pain after sex, correct? A.Yes. Q.You know what, Ms. Cole? I see that we need to change tapes. So why don't we take a quick break? A. Okay. VIDEOGRAPHER: Going off the record at 11:06 a.m. (Brief recess) VIDEOGRAPHER: This begins videotape number two. Going back on the record at 11:17 a.m. Q.(Mr. Adams continuing:) All right. Ms. Cole, we were talking about some of the symptoms you were experiencing before your ObTape surgery before we went on break. So I'm just going to kind of finish that line of questioning, and then we can transition. Had you ever experienced any vaginal bleeding before your ObTape surgery? A.No. Q.Have you ever -- had you ever experienced any vaginal odor before your ObTape surgery? A.Odor? 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 15 of 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 107 Q.Uh-huh. A.It was months later, I started back. Q.Okay. And, so, you knew the sling wasn't working? MS. FULK: Object to form. MR. ADAMS: Could you re-read the question? (Court reporter reads back from the record.) MS. FULK: Object to form. A.No. Q.No, you didn't know; or, no, you didn't believe the sling was working? MS. FULK: Object to form. Compound. A.I didn't know. Q.Okay. You knew the ObTape sling was going to be used to treat your incontinence, correct. MS. FULK: Object to form. A.Right. Q.Okay. And you were leaking months after the surgery, correct? A.Right I just figured it wasn't a success. Q.So you figured that your ObTape sling 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 16 of 24 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 108 procedure was not successful, correct? A.You're right. Q.And this is months after the surgery whenever you started leaking, correct? A.Yeah. Q.And by not successful, what do you mean? A.I didn't benefit from it. Q.You didn't benefit from it, correct? A.Right. Q.Okay. A.I still -- I was still leaking, you know. Q.So you weren't getting the intended benefit from the ObTape sling, correct? A.Correct. Q.Okay. A.I thought it -- you know, I wouldn't have that problem anymore. Q.And when you did have the problem, you didn't suspect anything was wrong with the ObTape sling? MS. FULK: Object to form. A.No. Q.What did you think was causing your leakage? A.Having sex. I mean, I leaked a lot when I 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 17 of 24 Page 112 Q.And then you're saying that a couple months after that, you discussed it with a doctor, correct? A.I don't know. No, I don't think so. Q.That's not what you just said? A.See, I'm not listening. MS. FULK: You need to listen. A.I'm not listening. MS. FULK: And you need to let him know if you're confused. You need to tell him. A.Well, I am. Q.Please do when you're confused. A.I am. Q.When did you start experiencing leaking after your ObTape surgery? A.It was probably four or five months after the surgery. Q.And when did you first tell a doctor that you were experiencing leaking after your ObTape surgery? A.It was probably several months after that. Q.So it was all within the first year after surgery? A.Yes. Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 18 of 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 118 A.No, I sure don't. Q.So if Dr. Smith testifies that you weren't taking your medication for a period of time, you can't contradict him, correct? MS. FULK: Object to form. A.No. Q.Okay. So we've talked before about some of the issues that you're still having that you attribute to ObTape, correct? A. (Nodding head). Q.Remember that at the beginning? I want to talk about kind of times where maybe you weren't experiencing those symptoms, from after your surgery until present day. Okay? A. (Nodding head). Q.So with your vaginal pain, was there any time after your surgery that you weren't experiencing vaginal pain? A.No, not after the surgery. Q.So it's been consistent since after surgery? A.Absolutely. Q.Okay. Was there any time that you weren't experiencing the thigh pain you referred 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 19 of 24 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 119 to? A.No. Q.So it's been consistent since surgery until present day? A.Well, it don't hurt every day, but it hurts a couple times a month, my legs will. Q.Okay. A.See, I woke up this morning with them hurting. Q.But that couple times a month, that is consistent from the surgery -- A.Oh, yeah. Q.-- until now? MS. FULK: Object to form. A.Yeah. Q.And the abdominal pain you're experiencing, has that been consistent since surgery? MS. FULK: Object to form. A.Yes. Well, I -- the abdominal pain, I refer to as my vaginal pain. Q.So you're not experiencing any abdominal pain? A.No abdominal pain. It's vaginal. Q.Okay. A.You know -- 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 20 of 24 1 2 3 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 120 MS. FULK: Do you want her to show you where the pain is located just so that we're clear for the record -- THE WITNESS: Yeah. MR. ADAMS: Sure. That would be great. MS. FULK: -- and for the jury? If you can stand up. A.It's down in here (indicating). Q.Okay. A.In my legs, in here (indicating). Q.So the thigh pain is also vaginal pain, or is it separate? MS. FULK: Object to form. A.It's separate. I mean, well, now, this morning, it was all together. Q.Okay. Okay. Just trying to understand where we're at. And the vaginal pain that you just described or showed, has that been consistent since the surgery? A.Yes. If I have sex, it does. And I've had it when I wasn't, those sharp pains. Q.Now, there are a couple of records in here that describe you telling various doctors 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 21 of 24 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 124 Q.Has any doctor ever told you that any of the complications you attribute to ObTape were actually caused by ObTape? A.No. Q.I'd like to talk about some of the other symptoms that you don't associate with ObTape. I'm starting with lupus. Can you describe the impact having lupus has on your life? A.Well, it affects my joints, and I just can't -- I -- I just can't do things I used to do. Q.What kinds of things can't you do that you used to do? A.Well, I can't clean house like I used to, and I can't go shopping. I can't -- I just can't do a lot of things, like -- Q.And are you seeking treatment for lupus? A.Yeah. Q.And with fibromyalgia, what kinds of things is that impacting -- or strike that. With fibromyalgia, what kind of daily activities is that affecting? MS. FULK: Object to form. A.Fibromyalgia is -- affects my nerves, and 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 22 of 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 153 A.Uh-uh. Q.Verbal answers. A.I was -- no. Q.And you did not is it correct that you did not have the sharp, shooting vaginal pain even without sexual activity before the mesh surgery? A.No. Q.That's not correct or it is correct? I'm sorry. I asked the question bad. MR. ADAMS: Object to asked and answered. A.Ask me again. MS. FULK: I just want to make sure we're clear for the record. A.Ask me again. Q.Did you have sharp, shooting vaginal pain without sexual activity before you had the mesh surgery? MR. ADAMS: Objection. Asked and answered. A.No. Q.Do you experience pelvic pain? A.I do. Q.All right. I would like you to stand up, 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 23 of 24 1 REPORTER'S CERTIFICATE 2 STATE OF ALABAMA 3 GENEVA COUNTY 4 I, Lauryn Adams, Certified Court Reporter 5 and commissioner for the State of Alabama at 6 Large, hereby certify that on June 1, 2016, 7 reported the video deposition of LINDA COLE, 8 and that pages 4 through 184 contain a true 9 and accurate transcription of the examination 10 of said witness by counsel for the parties set 11 out herein. 12 I further certify that I am neither kin 13 nor of counsel to any of the parties to said 14 cause, nor in any manner interested in the 15 results thereof. 16 17 RLAKJes 18 J 19 LAURYN ADAMS certified co Reporter 20 Commissioner or the state of Alabama at Large 21 License No. 623 22 23 24 25 MY COMMISSION EXPIRES: 5-9-20 Page 185 Case 4:13-cv-00321-CDL Document 40-4 Filed 08/29/16 Page 24 of 24 EXHIBIT B Case 4:13-cv-00321-CDL Document 40-5 Filed 08/29/16 Page 1 of 10 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION LINDA FAYE COLE, PLAINTIFF, VS. CASE NO. 4:13-CV-00321 IN RE MENTOR CORPORATION OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION, DEFENDANT. * * * * * * * * * * DEPOSITION OF JOHN C. PEACOCK, M.D., taken pursuant to stipulation and agreement before Heather Tatum, Court Reporter and Commissioner for the State of Alabama at Large, at the office of Urology Associates, 1118 Ross Clark Circle, Suite 500, on, Wednesday, July 6, 2016, commencing at approximately 1:38 p.m. Job No. CS2337204 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-5 Filed 08/29/16 Page 2 of 10 5 COURT REPORTER: Okay. Usual stipulations? MS. BUNCE: Yes. MR. NEWTON: We'd like to read and sign. DIRECT EXAMINATION BY MS. BUNCE: Q. Good after doc -- good afternoon, Dr. Peacock. A. Hello. Q. Can you please state your full name for the record? A. My full name is John C. Peacock, Jr., M.D. Q. We met off the record, but for the benefit of the record, my name is Sarah Bunce and I represent Defendant Mentor Worldwide, LLC, in a case that was brought by one of your patients, Linda Faye Cole, relating to her ObTape sling that was implanted in July 2004. Do you understand that you're here to give testimony in that case today? A. Yes, I do. Q. Now, before we get started, do you recall being previously deposed in the spring of last year in another ObTape matter? A. I do. Q. We wanted to let you know that the parties here today have agreed to use your general testimony from that deposition so we don't have to go over that information today. So this will be just case specific information related to Ms. Cole so hopefully we can get you on your way. Do you understand that? Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-5 Filed 08/29/16 Page 3 of 10 7 A. In 2006 -- excuse me. 2007. Q. And was he practicing up until the time he passed? A. He practiced up until about 12 to 18 months prior to his death. Q. So I'm going to hand you what I believe is the first record indicating your treatment of Ms. Cole, and I'm going to mark that Defense Exhibit Number 1. (Defendant's Exhibit No. 1 was marked for identification.) MS. BUNCE: Beau, for your benefit, this is Bates labeled Cole, comma, L000024. Q. I'll give you a chance to take a quick look at that record. MR. DARLEY: 244? MS. BUNCE: 24. 000024. MR. DARLEY: Do you have a copy of that? MS. BUNCE: I do. A. Yes. Q. Now, this record appears to be dated July 19th, 2004. Do you believe that this is your first visit with Ms. Cole? A. Yes. Q. Okay. Now, before we talk about your record specifically, I wanted to direct your attention to the continued note from July 6, 2004, that is right above your note. And again this appears to be a -- a note from Dr. Smyth Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-5 Filed 08/29/16 Page 4 of 10 8 that has the FWS -- A. That's correct. Q. -- initials there. The very last sentence of his note states, we will set her up an appointment to see Dr. Peacock in two to three weeks and let him talk with her and perhaps do cysto, et cetera, with an eye toward bladder neck suspension surgery, if he deems that appropriate. A. Right. Q. Now, why would Dr. Smyth have referred Ms. Cole to you for that conversation? A. Dr. Smyth would have referred her to me because he was my partner number one and then number two he was a nonoperative partner. Q. Got it. So he knew you to be a person that she could talk to if she did want to proceed with surgery? A. Yes. Q• So then taking a look at your note in July 19th, 2004, did you perform a cystic -- cystostic -- strike that. Looking at your note on July 19, 2004, did you perform a cystoscopy on on Ms. Cole? A. I did. Q. And what were the results? A. The findings were that she had a normal appearing bladder from a mucosa standpoint and she had urethral hypermobility and bladder neck descensus with Valsalva maneuver. Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-5 Filed 08/29/16 Page 5 of 10 9 Q. And what did that indicate to you? A. That indicates that she had stress urinary incontinence due to -- due to pelvic floor weakness or -- or as we determine it -- as we term it bladder neck descensus or urethral hypermobility. Q. And at this time, did you discuss with her the potential of proceeding with a surgical procedure to treat her stress urinary incontinence? A. Yes. Q. And during your previous deposition, you testified about the inherent risks of sling procedures -- A. Yes. Q. -- generally. And in your testimony, you testified that you understood that erosion, infection, pelvic pain, and dyspareunia are all inherent risks of implanting a suburethral sling. A. Yes. Q. Do you remember that testimony? A. I do. Q. Now, in July 2004 when you are discussing the ObTape implant procedure with Ms. Cole, did you understand those inherent risks we -- we just discussed -- A. Yeah. Q. -- to be inherent risks of the ObTape implant procedure? A. Yes. Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-5 Filed 08/29/16 Page 6 of 10 11 use ObTape -- A. Uh-huh. Q. -- in the sling procedure for Ms. Cole. A. Uh-huh. Q. What went into that decision-making process? A. My previous experience with sling surgery and this newer approach to placing a midurethral sling, being the transobturator approach which, from an anatomic standpoint, led to quicker recovery by the patients and, in in my opinion, a safer approach to this procedure. Q. And in July 2004 you had had a good experience with ObTape, correct? A. Yes. Q. And in July 2004 in making the decision to use ObTape with Ms. Cole, do you recall relying on any particular information from Mentor? A. At that particular -- no, I do not recall. Q. In July 2004 when you were making the decision to use ObTape with Ms. Cole, did you believe at that time that you had all the information that you needed necessary to make that decision? A. Yes. Q. And do you recall in July 2004, Mentor making any particular statements about the complication rates related to ObTape? Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-5 Filed 08/29/16 Page 7 of 10 18 A. Yes. Q. -- be able to review that -- A. Yes. Q. -- and know her what her history was -- A. All of my office records, yes. Q. Great. A. All of our documentation. Q. And so when you treated her in 2006, were you aware that she had had a history of experiencing cystitis after intercourse? A. Yes. Q. So this was not a new issue for her? A. No. Q. And those episodes of cystitis following intercourse was something that predated her ObTape implant procedure, correct? A. Yes. Q. So looking over these few records that we discussed today, is there anything here that you've seen that would indicate that Ms. Cole is having any issues related to her ObTape implant? A. No. MS. BUNCE: All right. Those are all the questions that I have. MR. DARLEY: Okay. What exhibit were we just on, Sarah? Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-5 Filed 08/29/16 Page 8 of 10 36 other versus continuously through. So, no, it doesn't surprise me. MR. DARLEY: Sarah, can we go off the record for a second? I just want to look through my notes -- MS. BUNCE: Sure. need. 2:24 p.m. 2:25 p.m. questions. MR. DARLEY: -- and make sure I got everything I THE VIDEOGRAPHER: We're going off the record at (Brief recess.) THE VIDEOGRAPHER: We're going back on the record at MR. DARLEY: Dr. Peacock, I've got no further THE WITNESS: Okay. MS. BUNCE: I just have one followup question from the line of questioning from opposing counsel. REDIRECT EXAMINATION BY MS. BUNCE: Q. Is there any indication from your records and your treatment of Ms. Cole that she had any issues with pore tissue ingrowth with her ObTape? A. No. MS. BUNCE: I have no further questions. Thank you for your time, Dr. Peacock. Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-5 Filed 08/29/16 Page 9 of 10 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 38 REPORTER'S CERTIFICATE STATE OF ALABAMA MONTGOMERY COUNTY I, Heather Tatum, Court Reporter, Commissioner for the State of Alabama at Large, hereby certify that on Wednesday, July 6, 2016, I reported the deposition of JOHN C. PEACOCK, M.D., who was first duly sworn or affirmed to speak the truth in the matter of the foregoing cause and that the pages herein contain a true and accurate transcription of the examination of said witness by counsel for the parties set out herein. I further certify that I am neither of kin nor of counsel to any of the parties to said cause, nor in any manner interested in the results thereof. /s/ Heather Tatum HEATHER TATUM, Court Reporter Commissioner for the State of Alabama at Large ACCR TL2046, Expires 05/30/2017 MY COMMISSION EXPIRES: 1/22/2020 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-5 Filed 08/29/16 Page 10 of 10 EXHIBIT C Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 1 of 22 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION LINDA FAYE COLE MDL CASE NO.: 4:08MD2004 DOCKET NO.: 4:13-CV-221-CDL Ind. Case No. 4:13-cv-321 THIRD AMENDED PLAINTIFF 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" mea.ns 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 pro-vide 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. 1 12813.000003\1345295.1 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 2 of 22 I. CASE INFORMATION Name of person completing this form: Linda Faye Cole 2. Name of person on whose behalf a claim is being made: Linda Faye Cole 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): 040430E 2. • Date of Implantation: July 30, 2004 3. Name and Address of Implanting Surgeon(s): John C. Peacock, MD Urology Associates 1118 Ross Clark Circle, Suite 500 Dothan, AL 36301 4. Name and Address of Hospital, Clinic, or Doctor's Office where implantation surgery was perfonned: Flowers Hospital 4370 West Main Street Dothan, AL 36305 5. If the ObTape has been removed, provide the date on which it was removed: NIA 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 potions of the ObTape surgically removed? Yes No X a. If Yes, what is the present location of the removed portions of the ObTape? 10, Has anv doctor ever told you that there are portions of the ObTape still in your body? Yes No X If Yes, please provide name and address of each such doctor: 2 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 3 of 22 11 Has any doctor told you that those portions of the ObTape still in your body need to be removed? Yes No X If Yes, please provide name and address of each such doctor: III. PERSONAL INFORMATION 1, Name (first, middle name or initial, last): Linda Faye Cole 2. Maiden or other names used and dates you used those names: Cole 3. Current address and, date when you began living at this address: Headland, AL 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. ...,,,, ch00 : at a 61 '., , _..; .. Abbeville A A-pprox. 1)b6-2009 beville, Approx. 2001-2006 -2001Abbeville Approx. 1983 to 5. Social Security Number: UM* 6. Date and place of birth: in Union Springs, AL 7. Current marital status: Divorced 8. • If married, please provide the following information: Date of marriage: N/A Name of spouse: N/A Date and place of birth of spouse: N/A 9. • Name(s) of former spouse(s), date(s) of marriage(s) Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 4 of 22 and dates the marriage(s) were terminated, and the nature of the termination (i.e., death, divorce): William Earl Barnette, married in 1978 and divorced in 1983 Darryl Norris, married in 1970 and divorced in 1974 10. If you have children, list each child's name and date of birth and whether they were delivered vaginally or by Caesarian. lh . 0 *Mg Jllxl Ilir h Viiginal or CstesAriau John Allen Cole Vaginal Wyman Earl Yates Vaginal Linda Michelle Norris MIR Vaginal 11. Identify all schools you attended, starting with high school: Nartie Ivlajor or Aimary Bullock County High School 108 Hardaway Ave. Union Springs, AL 36089 1963-1965 NIA N/A 12. Are you currently employed? No If yes, please identify your current employer with name, address and telephone number and your position there: If not, did you leake your last job for a medical reason? If Yes, describe why you left: No 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 ofEmployer • ,ii, Address & Telephone, , F ' Dates of .10iimen gage;/, ' ' •,„ , ' eseribe Your p 7 b': 4 ,.. IOW : Uason forR ' 1:600tra . Plant ClosedWestpoint Stevens P. O. Box 549 Abbeville, AL 36310 (334) 585-4229 511.75/hour Textra Operator 4 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 5 of 22 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 X 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: (a) Date (Or year) of application: January 4, 2012 (b) Type of benefits: Disability (c) Nature of claimed injury/disability: Lupus and Fibromyalgia (d) Period of disability: Began in February 2012 (e) Amount awarded: Approximately $1,328.00 per month (t) Basis of your claim: Lupus and Fibromyalgia (g) Was claim denied? Yes No X (h) To what agency or company did you submit your application Social Security Administration (i) Claim/docket number, if applicable: PRC 14571828 16. Have you ever filed a lawsuit or made a claim (other than this suit)? Yes No X Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 6 of 22 If Yes, please provide the following information and attach copies of all pleadings, releases or settlement agreements and deposition transcripts you have: Pa, Made oA -.: u • niin ainst ill e e 0 al I. , o . age t 6' tam blititY 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 X 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 X 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: 2008 or 2009 - Unknown 1 9. 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 N/A If Yes, please state: The name and address of the third party with whom you have entered into such a contract. Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 7 of 22 IV. TIEALTHCARE 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. Name (Specialty') Address andlideplione ' roximate,gaiesi , e Pr Ykits. , . ' Reason / rt19.0-re Perf014000 Rufus Smith, MD OB-GYN 4300 W. Main St. Ste. 31 Dothan, AL 36305 1993-2011 Annual Check-Ups Richard Bendinger, DO Family Practitioner 615 Ozark Rd. Abbeville, AL 36310 1983 to present Various Reasons Edmund G. Laeour, MD Rheumatology 1118 Ross Clark Circle Suite 100 Dothan, AL 36301 2011 to present Fibromyalgia and Lupus 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. e atti ' u 10 _ . , ' . , ,, - '' ' ' -!"- ' '' ". " , ,tottp: , . '' '' . ' ' 7 S '1 r • ,-, • -- NiDates . ears Si • ; ., s ;” ';• . Rite Aid 514 Kirkland St. Abbeville, AL 36310 Approx. 1994-2008 Jack's Drugs 1909 Honeysuckle Rd. Dothan, AL 36305 2008-2010 Jack's Drugs 15073 S U.S. Hwy 231 Midland City, AL 36350 2010-2014 Headland Pharmacy 202 Holman Dr. Headland, AL 36345 2013-2014 Walmart Pharmacy 14331 Co. Rd. 99 Headland, AL 36345 2014-present 7 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 8 of 22 V. MEDICAL BACKGROUND 1. Current Height: 5'2" 2. Please state your weight at the following times: (a) Current: 110 lbs. (b) Time of implant: 120 lbs. (c) Time of explant/excision surgery (if any): N/A 3. Smoking History (a) Have you ever smoked cigarettes? Yes X 1 State amount smoked: pack ;for yearK during the yea 1965. u 4. Other Conditions (a) To the best of your knowledge, have you ever experienced or been diagnosed with any of the following cc iditions 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: 1,Vf • n 914:. w 0 4 ..0 •. . .,, . s • . • ., n t..• • ._ , . Abnormal pap smear X 2. Autoimrnune disease X 3. Bacterial vaginosis 4. Cervical cancer X 5. Cystocele X 6. Diabetes X 7. Endometriosh. X •8. Gestational diabetes . 9. Hormone deficiency 10. Hypertension/high blood pres:iure 11. Interstitial cystitis X 12. Obesity X 13. Ovarian cancer X 14. Pelvic inflammatory disease X 15. Polycystic ovary disease • X 8 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 9 of 22 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 X 25. Vaginal infection X 26. Venereal disease 27. Yeast infection (b) For each condition for which you answered Yes in the previous chart, please provide the information requestrxi below: Condition You Experienced'D - *Xi ate ._, of Qnset • r' . . ame, A.ddre s'and . , , ' *phone tin, of 4. r r' ' ' ng Physrcio c( f'a 6' ' reatment • .Received,. Hormone Deficiency Rufus Smith, MD (334) 793-4697 Previously provided Hormone Replacement Therapy Hypertension/High Blood Pressure January 2013 Richard Bendinger, DO (334) 585-1171 Previously provided Medication Stress Urinary Incontinence 2003 John C. Peacock, MD (334) 794-4159 Previously provided Surgery Thyroid disorder Rufus Smith, MD Previously provided Medication Urinary tract infection 2002 Richard Bendinger, DO Previously provided Antibiotics Urge Incontinence 2003 John C. Peacock, MD Previously provided Surgery Yeast Infection 2007 Richard Bendinger, DO Previously provided Medication VI. MEDICATIONS 1. List all of the medications (prescription and over the counter) you currently take. • 9 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 10 of 22 0 'M.._ ' _,,... ..:1 Pensillg-. ,„., See attached list 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 X 10 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 11 of 22 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: cat° 3 0§0,/::.. ,D,a3tg„ 9' ' - ;'.6 .,, ... , _r ' .0bannooly ..0 PP1114„ is....g_ _.. 0 *se WA VII. IMPLANT AND EXCISION/REMOVAL 1. Describe the condition for which the ObTape was implanted: Stress Urinary Incontinence 2. Before the implantation of the ObTape, did you receive non-surgical treatment for your stress urinary incontinence? Yes X No (a) State the period during which you received non-surgical treatment: From September 2000 up until date of implant of ObTape. (b) State the nature of the rlon-surgical treatment (e.g., physical therapy, medication, injections): Medication (c) State the name and address of all doctors or health care providers involved in your non-surgical treatment 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 X 11 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 12 of 22 (a) If Yes, identify each docArment/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 I 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. X If Yes, for each, please state: 1)ate.,cif - .„. CornmuniCati4 , , . ..„ -. Ptanie of Person *Oh, idiom You.C6M6illii4ted . . „Emdie,.. ' idi of etiiiimpiicatitpn. ' • Person, 13,-*PliOn; By. ' - 1: -- , D...6 313U:have-a rriling or ,e recording,? . ' SO PLEASE „,' .' A ) .... If the communication was by phone or in-person, please tell us what was said: 12 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 13 of 22 VIII. INJURIES & DAMAGES 1. Are you claiming any physical injuries or illness as a result of the ObTape? Yes X No Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 14 of 22 If Yes, please describe in detail the following: (a) The physical injuries or illness claimed and when the symptoms began: Dyspareunia, pelvic pain, vaginal pain, leg pain, incontinence, hematuria, retention, urgency, frequency, dysmia and infections. Symptoms began around November 2004. (b) Are those injuries or illnesses continuing? Yes X No (c) Provide the name and ;address of each health care provider that you have seen for these problems: Condition Tou Experience • - . : , resiind 'klephone14 A -o r of -:,i`eealth Care. Provider (if 640All of the above Urological Associates, 118 Ross Clark Circle, Ste 500, Dothan AL 36301 UTIs Dr. Rufus Smith, 4300 W Main St., Ste. 31, Dothan, AL 36305 Pelvic Pain Dr. Ben Martin, 4300 W. Main St., Ste. 31, Dothan, AL 36305 2. Have you ever been hospitalized as a result of any of these conditions? Yes No X If Yes, please provide the following information: (i) Approximate date(s) of hospital admission: (ii) Approximate date(s) of dischaige: 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 X If Yes, please state the following as it pertains to your treatment for any psychiatric and/orpsychological condition(s): 14 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 15 of 22 t. .: IS ,,,Z......L4,41111rry. . . , .0 •. eS , .. 11 • , „: •••_.„„ ,:. ,:• . - 0 ....1:.,;0 .ates .. # • 2_ s! .. ..- . 4. Are you making a claim for lost wages or lost earning capacity? Yes No X (a) 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: 15 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 16 of 22 (b) If you claim a loss of earnings, state your earned income from work for the following years: 2012 • 2011 2010 2009 2008 2007 2006 2005 2004 2003 5. Is your spouse claiming loss of consortium? Yes No N/A 6. Is your spouse claiming physical injury from the ObTape? Yes No N/A 16 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 17 of 22 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: nd'itiiin 6 e :.. ,Experience .. 1.01410 ,, ' of 'Ikea en ' eldl*Ole'; , r O e4lith' are Provider IX. MEDICAL AND OUT 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: WILL SUPPLEMENT ame,ataAddliss of Provider .1:5 t -of - .. -aiieaatmes at i c .-ptio.4- or ' ' a "ent - 7-' ''' °u'ig t:nfsMesed- led •. ' ' $ For any expenses claimed above, have they been reimbursed by any third party? -Yes No X If Yes, identify which expenses, the amount reimbursed and the date reimbursed. 17 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 18 of 22 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: Name: Sharon Gray Address: Relationship to you: Sister Salem, AL 1111i Name: Wyman Earl Yates Address: Headland, ALM Relationship to you: Son XI. DOCUMENT DEMANDS These document requests are not intended to, seek attorney client communications, or attorney work product materials. In additicn, 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. REOUEST NO. 1. All medical records (including, but no limited to, all charts, hospital records, consent forms, treating physician records, photographs, videotapes/DVDs, drawings, X- rays, ultrasounds, MRIs, CT scans, radiographs, angiograms, blood tests, laboratory reports, prescriptions, spirometry tests, electrocardiograms, urine tests, blood gases tests, psychometric tests, neuropsychological tests, s ress tests, notes, telephone messages) from any physician, hospital, clinic, health care provider, pharmacy, psychiatrist, psychologist, counselor or therapist created since 1990 reflecting, refei-ring or relating to Plaintiff. RESPONSE: See attached. REOUEST 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. RESPONSE: Plaintiff is not possession of any medical bills. 18 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 19 of 22 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. RESPONSE: Plaintiff is not possession of any medical bills. 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. RESPONSE: None in Plaintiffs 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. RESPONSE: None in Plaintiff s possession. 19 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 20 of 22 XII. AUTHORTZATIONS Complete and sign the Authorization attached as Exhibit A. Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 21 of 22 XIII. VERIFICATION I declare under penalty of perjury that all of the information provided in this Plaintiff Fact Sheet is true and correct to the best of my knowledge upon information and belief, that I have supplied all the documents requested in part XI of this declaration, to the extent that such documents are in my possession, custody, or control, or in the possession, custody, or control of my lawyers, and that I have supplied the authorization attached to this declaration. Date: Signature 21 Case 4:13-cv-00321-CDL Document 40-6 Filed 08/29/16 Page 22 of 22 EXHIBIT D Case 4:13-cv-00321-CDL Document 40-7 Filed 08/29/16 Page 1 of 5 1 2 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION Barbara Burch, et al., Plaintiffs, vs. CASE NO. 4:12-CV-00276 MENTOR WORLDWIDE, LLC, Defendant. * * * * * * * * * VIDEOTAPED DEPOSITION OF JOHN C. PEACOCK, JR., MD, taken pursuant to stipulation and agreement before Sherry Mack, Certified Court Reporter and Commissioner for the State of Alabama at Large, in the Medical Offices of Urological Associates, 1118 Ross Clark Circle, Suite 500, Dothan, Alabama, on Monday, April 20, 2015, commencing at approximately 12:18 a.m. * * * * * * * * * * * Job No. CS2039572 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-7 Filed 08/29/16 Page 2 of 5 1 2 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 50 generation of materials made by the same company came out, I tried it; and I have had a similar experience with that. I've been -- had very good outcomes and have continued using that. Q.So you believe polypropylene slings are safe and effective treatment for stress urinary incontinence? A.Yes, I do. MR. WOELLNER: Object to the form. Q.And you mentioned this, but you're satisfied with the safety and performance of the slings you're using today? A.Yes. Q.And you were satisfied with the safety and the performance of the ObTape? A.Yes. Q.To your knowledge, is there now or has there ever been a suburethral sling that carries no risk -- A.No. Q.-- of complication? A.No, not to my knowledge. Q.And we talked about this earlier, but the risks could exist even if both the sling 800-567-8658 Veritext Legal Solutions 973-410-4040 Case 4:13-cv-00321-CDL Document 40-7 Filed 08/29/16 Page 3 of 5 Page 192 a sling, yes. Q.If that's the case, then in treating a complication that requires removal versus a different product treating the same complication can excise, is that a factor you would weigh in whether or not you're going to use the product? A.Potentially. Q.And then it could -- A.Again, I would say this. With direct relevance to your -- this situation, at the time that I think this information would have been available, I already had a significant surgical experience that had been overwhelmingly positive. And I never answered completely in the affirmative on any of those questions you asked me in that vein because I would consider them, certainly would consider them. But, again, I -- I did well and my patients overwhelming did very well. Q.Right. And when I asked you those questions, I asked them to you in whether or not you would evaluate those issues in deciding whether or not to use the Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-7 Filed 08/29/16 Page 4 of 5 1 Page 195 REPORTER'S CERTIFICATE 2 STATE OF ALABAMA 3 COLeta COUNTY 4 I, Sherry Mack, Certified Court Reporter 5 and Commissioner for the State of Alabama at 6 Large, hereby certify that the above and 7 foregoing deposition was taken down by me and 8 that foregoing pages contain a true and 9 accurate transcription of the examination of lo said witness by counsel for the parties set 11 out herein. 12 I further certify that I am neither of kin 13 nor of counsel to any of the parties to said 14 cause, nor in any manner interested in the 15 results thereof. 16 17 18 /s/Sherry Mack, CCR 19 SHERRY MACK, CCR Commissioner for the 20 State of Alabama at Large CCR 230, Expires 9/30/2015 21 MY CC4MISSION EXPIRES: 3/3/2019 22 23 Case 4:13-cv-00321-CDL Document 40-7 Filed 08/29/16 Page 5 of 5 EXHIBIT E Case 4:13-cv-00321-CDL Document 40-8 Filed 08/29/16 Page 1 of 8 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION LINDA FAYE COLE, PLAINTIFF, VS. CASE NO. 4:13-CV-00321 IN RE MENTOR CORPORATION OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION, DEFENDANT. * * * * * * * * * * DEPOSITION OF BRYANT WILLIAMS, III, M.D., taken pursuant to stipulation and agreement before Heather Tatum, Court Reporter and Commissioner for the State of Alabama at Large, at the office of Urology Associates, 1118 Ross Clark Circle, Suite 500, on, Wednesday, July 6, 2016, commencing at approximately 10:22 a.m. Job No. CS2337204 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-8 Filed 08/29/16 Page 2 of 8 39 Q. That's a -- that is a good question. Do you think that any of the issues that Ms. Cole is experiencing to this -- to this point are due to the design or composition of her ObTape implant sling? MR. DARLEY: Object to form, foundation. A. No. Q. Now, we have another record. I'm not going to put it in front of you. It was a followup visit after the Durasphere procedure in May of 2012 where you noted, she's doing well following the Durasphere injection. You also note that you recommended that she come back in four months' time. Is it typically your practice following a Durasphere injection to want to see the patient again a few months after the the injection to see how it's going? A. Yes. Q. And do you know whether or not Ms. Cole did return four months later in 2012? A. I'd have to review my record. Q. Take a look. A. If this record is complete, then she did not followup at that time. Q. And I ask that because the next record that we have for Ms. Cole is a January 5th, 2016, visit with you. Is that consistent with your record? A. Yes. Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-8 Filed 08/29/16 Page 3 of 8 42 mostly related to mesh that has been used -- I believe that should be in -- pelvic organ prolapse. Were you aware that there was also litigation involving suburethral slings for the treatment of stress urinary incontinence? A. Yes. Q. And on this date, based on your treatment of Ms. Cole, was there anything that you had seen in -- in her records that would indicate that she was having any problems related to her ObTape sling? A. No. (Defendant's Exhibit No. 8 was marked for identification.) Q. A11 right. You can set that record aside. I hand you the most recent record which is dated April 12th, 2016. This is Defense Exhibit 8. MS. BENCE: And, Beau, this is OBT Cole L 01334. Do you have a copy of that? MR. DARLEY: Yeah. Q. You noted earlier in your deposition that this is the most recent visit that you've had with Ms. Cole. Is that correct? A. Correct. Q. And in the HPI section of this report, you note that she reports that since her last visit in January she is having ongoing problems with recurrent infections. She states that Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-8 Filed 08/29/16 Page 4 of 8 injectable 47 urethral injectable agent, then it may result in urinary retention. When the bladder doesn't empty like it should, it -- it can become a source where bacteria are harbored within that residual urine and that can play into infections not going away. Q. So your comment here wasn't specific to the sling implant procedure that Ms. Faye -- excuse me -- Ms. Cole had had but also included the Durasphere procedure as well, correct? A. Any -- any form of -- of surgery for stress incontinence. Q. And again you said that is because those procedures involve a risk of urinary retention and that becomes a potential place where the bacteria can grow and proliferate, correct? A. Yes. Q. And in Ms. Cole's case, was there any indication that she was having issues with urinary retention? A. She -- nothing that she described. We didn't document any -- any form of post-void residual check or anything of that nature. Q. So as of April 12th, 2016, is there anything in your medical records to indicate to you that Ms. Cole was having any problems related to her ObTape sling? A. Not at that time. MS. BUNCE: I think at this point I am done with my questioning. Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-8 Filed 08/29/16 Page 5 of 8 54 A. Yes. Q. And where was that inflammation detected? A. Within the bladder. Q. Okay. That's all the questions I have, Dr. Williams. MS. BUNCE: I have just one followup question. REDIRECT EXAMINATION BY MS. BUNCE: Q. Looking at that Defense Exhibit Number 8 and the last line of questioning from opposing counsel, you indicated that the mild inflammation that you noted was inside the bladder. Do you have any reason to believe that the ObTape sling had any role in that mild inflammation inside her bladder? A. No. have. MS. BUNCE: Thank you. That's all the questions I MR. DARLEY: Just one followup question. RECROSS-EXAMINATION BY MR. DARLEY: Q. Dr. Williams, as far as your opinion that the ObTape is in no way related to the mild inflammation noted in the bladder, can you describe the -- the basis for -- for that opinion? A. Well, she -- she had been describing symptoms of infection and I presumed that she had been having infections, and I -- I didn't think it was related to her prior -- I Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-8 Filed 08/29/16 Page 6 of 8 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 55 didn't think the infection was related to her prior sling surgery. I thought they were sort of a run-of-the-mill cystitis that she had experienced in the past. Q. Okay. And do you believe the infections that she was having, is that the -- the cause of the inflammation that was noted on that cystourethroscopy? A. Yes. Q. And it's your opinion that that inflammation noted is in no way related to the Mentor ObTape? A. Yes. MR. DARLEY: Okay. That's all the questions I have. MR. NEWTON: Okay. MS. BUNCE: Thank you, Dr. Williams. THE VIDEOGRAPHER: This concludes the deposition. Going off the record at 11:58 a.m. Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-8 Filed 08/29/16 Page 7 of 8 REPORTER'S CERTIFICATE STATE OF ALABAMA MONTGOMERY COUNTY 56 I, Heather Tatum, Court Reporter, Commissioner for the State of Alabama at Large, hereby certify that on Wednesday, July 6, 2016, I reported the deposition of BRYANT WILLIAMS, III, M.D., who was first duly sworn or affirmed to speak the truth in the matter of the foregoing cause and that the pages herein contain a true and accurate transcription of the examination of said witness by counsel for the parties set out herein. I further certify that I am neither of kin nor of counsel to any of the parties to said cause, nor in any manner interested in the results thereof. /s/ Heather Tatum HEATHER TATUM, Court Reporter Commissioner for the State of Alabama at Large ACCR TL2046, Expires 05/30/2017 MY COMMISSION EXPIRES: 1/22/2020 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:13-cv-00321-CDL Document 40-8 Filed 08/29/16 Page 8 of 8 EXHIBIT F Case 4:13-cv-00321-CDL Document 40-9 Filed 08/29/16 Page 1 of 10 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 CASE NO. 2004 THIS DOCUMENT RELATES TO THE FOLLOWING CASE: LINDA COLE, Plaintiff, vs. Case No. 4:13-cv-135 MENTOR WORLDWIDE LLC, ETHICON, INC., ETHICON WOMEN'S HEALTH AND UROLOGY, a Division of Ethicon, Inc., GYNECARE, and JOHNSON & JOHNSON, Defendants. RULE 26 EXPERT REPORT OF AMANDA B. WHITE, M.D. The following report is provided pursuant to Rule 26 of the Federal Rules of Civil Procedure and includes my expert opinions regarding the claims of Plaintiff Linda Cole against Mentor Corporation, maker of the ObTape mid-urethral (transobturator) sling, and to provide an opinion on the nature and cause of her pelvic injuries. In addition to the medical review, I have also brought to bear my education, my experience as a practicing, board certified subspecialist and researcher in Female Pelvic Medicine and Reconstructive Surgery, and my knowledge of the scientific literature regarding pelvic floor dysfunction repair in reaching my conclusions. My medical opinions rendered in this report are all held to a reasonable degree of medical certainty, based on reasonable medical probability and scientifically reliable evidence. 1 Case 4:13-cv-00321-CDL Document 40-9 Filed 08/29/16 Page 2 of 10 I. BACKGROUND AND QUALIFICATIONS I am a full-time practicing urogynecologist. I completed medical school at the University of Texas Southwestern Medical at Dallas in 2003. Subsequently, I completed a four- year residency in obstetrics and gynecology at the University of Texas Southwestern Medical School at Dallas/ Parkland Memorial Hospital in 2007. I completed a three year subspecialty training program in Female Pelvic Medicine and Reconstructive Surgery at the University of Texas Southwestern Medical School at Dallas/ Parkland Memorial Hospital in 2010. I am board certified in obstetrics and gynecology and board certified in female pelvic medicine and reconstructive surgery. I am a member of the American College of Obstetrics and Gynecology, the American Urogynecologic Society, and the Systematic Review Group of the Society of Gynecologic Surgeons. Since 2010, I have been the Director of Female Pelvic Medicine and Reconstructive Surgery at the University of Texas Residency Programs at the Seton Healthcare Family in Austin, Texas. I am responsible for clinical care, resident education, and research. The scope of my practice is limited to female pelvic floor disorders, including both the nonsurgical and surgical management of urinary incontinence, pelvic organ prolapse, and fecal incontinence. I have implanted more than 800 mid-urethral slings in the last eight years. My practice is a referral practice in the region for patients with mesh-related complications. I am knowledgeable about the treatment of complications caused by the surgical management of these disorders, including those caused by genitourinary implants/devices. I have published numerous peer-reviewed articles including several anatomic studies and a large retrospective series on voiding dysfunction following placement of midurethral slings. 2 Case 4:13-cv-00321-CDL Document 40-9 Filed 08/29/16 Page 3 of 10 II. DISCUSSION OF OPINIONS A. ObTape Transobturator Sling Since the introduction of the tension free vaginal tape (TVT) by Ulmsten in 1996, the most common surgical treatment for symptomatic stress urinary incontinence has been the midurethral sling. While the originally described device involved passage of synthetic tape from a vaginal route through the retropubic space, subsequent modifications in technique introduced in 2001 have shown similar efficacy via a trans-obturator approach. Because of the concern for bladder perforation, trans-obturator slings remain a popular choice for the treatment of stress urinary incontinence. Relevant material properties of synthetic slings include pore size, weave, and elasticity. Integration of the device requires collagen in-growth and capillary permeability. The device must also allow permeability of both bacteria and host defense cells, including macrophages and lymphocytes, to prevent infection. The material properties of the device must discourage long-term complications and maintain efficacy. This requires a macroporous product. While initial devices were constructed of knitted, macroporous, polypropylene monofilament fibers, the ObTape device, introduced in September 2003 was constructed of nonwoven, non-knitted monofilament fibers which were heat bonded, resulting in significant decreases in pore size (Figure 1). 3 Case 4:13-cv-00321-CDL Document 40-9 Filed 08/29/16 Page 4 of 10 The introduction of the ObTape was not an introduction of a surgical technique, but rather a new material. While transobturator slings had been performed prior to the introduction of ObTape with similar efficacy and adverse event rates to the originally described tension free vaginal tape, the ObTape material was prone to infection and extrusion, as a result of its microporous properties. Importantly, there was no difference in peri-operative complications or patient demographics in patients undergoing ObTape, but rather an unacceptably high rate of delayed postoperative adverse events including infection and erosion. The clinical implications of this change in material properties are clearly documented in the medical literature. While transobturator midurethral slings made of Type I mesh have reported erosion rates ranging from 0.7 to 1.78%, with urethral erosions a rare occurrence, erosion rates of 5.4 to 20% have been documented in both case-series and comparative trials with ObTape. The ObTape has significantly higher rates of expected sling complications such as vaginal erosions as well. Importantly, however, previously unseen severe complications including delayed urethral erosions, ischiorectal abscesses, myositis, and necrotizing fasciitis requiring extensive debridement are also uniquely reported with this device. As early as 2005, surgeons reported an unacceptably high adverse event rate associated with the ObTape device. 4 Case 4:13-cv-00321-CDL Document 40-9 Filed 08/29/16 Page 5 of 10 B. Linda Cole - Clinical Summary Linda Cole is a 66 year-old multiparous female, gravida three para three, with a past medical history significant for lupus and fibromyalgia, as well arthritis who developed chronic bladder pain and infections after transobturator sling placement. Her past surgical history is significant for a hysterectomy performed in the 1974. The clinical course of Ms. Cole's treatment for bladder pain and infections will be reviewed below. Ms. Cole was referred to Urological Associates of Dothan in 2002 for evaluation of recurrent UTIs and stress urinary incontinence. At the time, she was bothered by incontinence, but she denied the need for protective garments. Subsequently, when evaluated at the same practice by Dr. Smyth in July of 2004, she was noted to have continued bother from stress urinary incontinence as well as urethral hypermobility. After reviewing options for management, she elected to undergo definitive surgical management with Dr. Peacock in the same practice. On July 30, 2004, Ms. Cole underwent placement of an ObTape transobturator sling. The procedure was completed without error. In fact, at follow-up on August 25, 2004, the patient reported that her stress urinary incontinence was cured. Over the course of the first eighteen months following ObTape placement, Ms. Cole was evaluated on six occasions. At each visit, aside from the initial post-operative visit, she complained of urinary frequency and pain with urination, as if she were infected. For instance, at the time of her follow-up in February of 2005, the patient reported that she "constantly feels a urinary tract infection" and "doesn't always feel as though she empties her bladder completely." In addition, she complained of dyspareunia and nocturia. Given her frequent infections, the patient underwent an office dilation procedure on August 23, 2007. The urethra was dilated to 26 french without difficulty. However, despite this 5 Case 4:13-cv-00321-CDL Document 40-9 Filed 08/29/16 Page 6 of 10 procedure, Ms. Cole continued to suffer from chronic dysuria and infections. She was placed on chronic antibiotic prophylaxis. The patient was not evaluated by urology again until December of 2011, at which time she was seen by Dr. Bryant Williams of Urological Associates of Dothan. At that time, Ms. Cole complained of recurrent urinary incontinence, worse than prior to sling placement. She noted the inability to sense the leakage. She was wearing 6-8 heavy pads per day for the leakage. She denied any recent infection. She underwent urodynamic testing on December 26, 2011. Her capacity was noted to be 170cc. She was noted to have leakage at 80cc with urgency. This was consistent with overactive bladder. She was started on anticholinergic bladder medication for the treatment of detrusor over-activity. Neither Vesicare nor Enablex were effective. Because of her recurrent symptoms, as well as her failure to improve with medication, Ms. Cole underwent injection of Durasphere for urethral bulking on May 14, 2012, by Dr. Williams At her two week follow-up appointment on May 31, 2012, the possibility of a repeat injection was discussed but thus far, she has not undergone a repeat injection. She presented to her gynecologist, Dr. Ben Martin, in February of 2013, complaining of pelvic pain. She was assessed by Mark Choquette, P.A. with suprapubic pain on May 31, 2013. She was evaluated again in January of 2016 for chronic right lower quadrant pain by Dr. Williams. Cystoscopy did not detect any bladder or urethral mesh erosion into the viscera. She did have significant trabeculations. She was instructed that her pain was unlikely related to the prior sling placement. She was started again on chronic antibiotics for frequent urinary tract infections/chronic dysuria. Considerable time and resources continue to be spent on ambulatory visits, antibiotics, and laboratory work-up for Ms. Cole's persistent symptoms. At the current time, Ms. Cole 6 Case 4:13-cv-00321-CDL Document 40-9 Filed 08/29/16 Page 7 of 10 continues to be bothered by significant pelvic pain, dyspareunia, nocturia, chronic urinary tract infections, irritative voiding symptoms, and refractory incontinence. She will require continued complex urologic care for the duration of her life. C. Medical Opinions Based on the above analysis, and my education, training, experience, knowledge, medical literature and review of the above-described documentation and medical records, it is my opinion to a reasonable degree of medical certainty that: 1. The Mentor ObTape is a substantial contributing cause of Ms. Cole's chronic bladder symptoms, including urgency and frequency, recurrent urinary tract infections, nocturia, pelvic pain, and dyspareunia, and need for subsequent procedures and treatments. The services rendered were medically necessary and reasonable for the ongoing refractory symptoms discussed above. 2. The initial operation performed in July 2004 by Dr. Peacock, namely the placement of the Mentor ObTape transobturator sling for symptomatic stress urinary incontinence, was completed without technical error. The operative procedure occurred without perioperative complication. She had no prior issue with poor healing and no evidence of urogenital atrophy on examination at the time of implantation. She was not a smoker. The patient experienced significant improvement in her stress urinary incontinence until the time of her chronic urinary tract infections which began approximately 3 'A months after surgery and have not subsided to date. 3. The patient's recurrent urinary tract infections were likely caused by the material properties of the ObTape device. In addition, the implantation of the ObTape device is the proximate cause for the subsequent procedures and treatments rendered to the patient. These services were medically necessary and reasonable for the ongoing refractory symptoms discussed above. 4. The material properties of the ObTape transobturator sling, namely unwoven, thermally bonded polypropylene microporous mesh are such that tissue in-growth with capillary penetration is prohibited. While bacteria are able to enter the graft, host defense mechanisms are unable to respond within the device secondary to the size of leukocytes and macrophages. The result is an encapsulated graft with acute and chronic inflammation. 5. Ms. Cole continues to be bothered by chronic irritative voiding symptoms, recurrent urinary tract infection which occurred as a result of ObTape implant. At a minimum, the patient will require ongoing visits with a specialist in the years to come. 7 Case 4:13-cv-00321-CDL Document 40-9 Filed 08/29/16 Page 8 of 10 6. The transobturator approach, such as that used with the Mentor ObTape, increases the risk of long-term, irreversible damage, including nerve injury, leg pain, muscle damage/spasms, chronic pain, chronic dyspareunia and sexual impairment, and vaginal scarring/banding. 7. Mentor did not warn physicians and patients about the possibility of serious and life- style altering complications including chronic inflammation; chronic pain; chronic dyspareunia and sexual dysfunction; groin and leg pain; vaginal scarring; recurrent urinary or bladder infections; the need for corrective surgery, sometimes multiple surgeries, that may or may not resolve the symptoms; the marked difficulty removing the mesh sling and that even worse complications may ensue from mesh removal, and the difficulties that occur in treating the worsening of SUI following sling removal, and others. 8. Mentor did not warn physicians about the possibility that complications, alluded to above, including erosion, could occur months or years after placement of a synthetic sling, such as the ObTape. 9. Removal of synthetic slings, like the ObTape, is technically difficult and requires considerable surgical expertise that many implanting surgeons do not possess. Further, there is a high likelihood of injuring adjacent structures and the corrective surgery often fails to alleviate symptoms. 10. Mentor did not warn doctors and patients about the difficulty removing its products, nor did it warn them about the suboptimal and unpredictable results when mesh excision or revision became necessary because of complications. III. Additional Disclosures I reserve the right to amend the medical opinions expressed in this report in the event that additional information is provided to me. Attached as Exhibit A is my current curriculum vitae. Exhibits which I plan to use as a summary of or in support of my opinions are as follows: 1. Materials listed in Exhibit B. Any additional materials to be used will be timely disclosed; 2. Any exhibit identified at any deposition taken in MDL 2004; and 3. All exhibits referenced in this report. The compensation per hour which I expect to be paid for my review, study and testimony is $500 per hour. 8 Case 4:13-cv-00321-CDL Document 40-9 Filed 08/29/16 Page 9 of 10 I previously testified or provided expert opinion in the following cases: Lambert, et al. v. C.R. Bard, Inc.: 2 : 14-cv-12092 Luttrell v. C.R. Bard, Inc. 2:13-cv-03151 Nevels, et al. v. C.R. Bard, Inc.: 2:13-cv-01024 Riley v. Mentor Worldwide, LLC: 4:11-cv-05066 Bergin v. Mentor Worldwide, LLC 4:13-cv-00135 Burgess, et al. v. Mentor Worldwide, LLC 4 :13-cv-00221 Smart v. Mentor Worldwide, LLC 4:13-cv-00228 Pierce v. Mentor Worldwide, LLC 4:13-cv-00239 Thompson v. Mentor Worldwide, LLC 4:13-cv-00473 Young v. Mentor Worldwide, LLC 4:13-cv-00476 This 1St day of August, 2016. 9 Case 4:13-cv-00321-CDL Document 40-9 Filed 08/29/16 Page 10 of 10 EXHIBIT G Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 1 of 13 Dittrich-Bigley v. Gen-Probe, Inc., Not Reported in F.Supp.2d (2013) 2013 WL 3974107 2013 WL 3974107 Only the Westlaw citation is currently available. United States District Court, D. Minnesota. Alicia DITTRICH-BIGLEY and Justin Dittrich-Bigley, Individually and as next Friends of CDB, a minor, Plaintiffs, v. GEN-PROBE, INC., Individually and d/b/ a Gen-Probe Sales & Service, Inc., Defendants. Civil No. 11-1762 (MJD/FLN). July 31, 2013. Attorneys and Law Firms Mark R. Mueller, Hunter Thomas Hillin and Breanne M. Vandermeer, Mueller Law Offices, for Plaintiffs. Michael D. Hutchens, Elizabeth Snyder Poeschl and Jon R. Russell, Meagher & Geer, P.L.L.P., for Defendants. MEMORANDUM OPINION AND ORDER MICHAEL J. DAVIS, Chief Judge. *1 Before the Court is Gen-Probe's motion to exclude the expert opinions of Dr. Robert Lerer, Dr. Mark Schleiss, Dr. Sonny Bal and Casey Dye. I. Background Plaintiffs Alicia Dittrich-Bigley and Justin Dittrich- Bigley, Individually and as Next Friends of CDB, a minor, brought this action against Defendants Gen-Probe, Inc. and d/b/a Gen-Probe Sales & Service, Inc. ("Gen-Probe") alleging a number of claims, including strict liability, negligence and gross negligence. Gen-Probe, a Delaware corporation, designed, manufactured and distributed the ACCUPROBE Group B Streptococcus Culture ID Test ("GBS Test"). (Second Amended Complaint ¶ 5.) Plaintiffs allege that Group B Streptococcus ("GBS") is a major infectious cause of illness and death in newborns in the United States and early-onset 1 GBS infections are caused by the transmission of GBS from the mother to the newborn either during delivery or in utero just prior to delivery. (Id.) 1 Early onset GBS infections are those that occur within the first week of life. In August 2002, the U.S. Centers for Disease Control and Prevention ("CDC") recommended that pregnant women should be screened for GBS at 35 to 37 weeks gestation. (Id. ¶ 6.) The GBS Test manufactured by Gen-Probe is a rapid DNA test that utilizes the techniques of nucleic acid hybridization for the identification of GBS from culture. (Id. ¶ 7.) The GBS Test contains a probe reagent to identify GBS in a patient specimen, and Gen-Probe uses a TECAN brand automatic pipetting machine to fill each GBS Test vial with 0.1 mL of probe reagent. (Id.) Following the production of each batch of GBS Tests, the tubing is filled with water. Prior to manufacturing each new batch of GBS Tests, the water in the tubing must be flushed out, or primed, to prevent the test vials from filling with water instead of the probe reagent or a combination of water and reagent. (Id) Plaintiffs allege that on or around September 2008, a servicing technician for Gen-Probe installed new tubing on the TECAN machine. The 81 mL volume tubing was replaced with 101 mL tubing. As a result, the newly installed tubing held an additional 20 mL of water than the previously installed tubing. (Id. ¶ 9.) The difference in tubing size was not taken into account, however, by the operators of the TECAN machine, and the priming program was not changed to reflect the difference. As a result, until the additional 20 mL was emptied from the tubing, a certain number of vials produced in each batch would be filled with water instead of the probe reagent. (M.1110.) On October 15, 2008, TECAN machine operators reported a problem to supervisors. In response, a molecular biologist at Gen-Probe, Michele Thomas, VO EST LAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 2 of 13 Dittrich-Bigley v. Gen-Probe, Inc., Not Reported in F.Supp.2d (2013) 2013 WL 3974107 changed the priming program to a troubleshooting program, but the troubleshooting program only emptied 0.8 mL of water from the tubing during priming. Thereafter, Thomas approved the machine for use. (Id. ¶ 11.) On October 16, 2008, the TECAN operators allegedly failed to follow standard operating procedure and skipped required steps in beginning production of the GBS Test using the TECAN machine. As a result, the TECAN machine continued to run the troubleshooting program instead of the correct program, which resulted in only 0.8 mL of water emptied instead of 81 mL. (Id. ¶ 12.) *2 Problems with the TECAN machine were reported in November 2008. A message was left with Thomas to troubleshoot the machine. (Id ¶ 14.) A few days later, Thomas investigated the reported problem and it was at this time that she realized the TECAN machine was running with the incorrect priming program and the correct program was restored. (Id II 15.) This issue was not investigated further. (Id. ¶ 17.) Plaintiffs allege that had it done so, Gen-Probe would have realized that the GBS Tests produced between October 15, 2008 and November 17, 2008, used an inappropriate program that emptied the incorrect amount of water during priming. Gen-Probe should have known that there was a number of kits that would not contain the improper amount of reagent, and that it was reasonably foreseeable that those users and consumers of such defective kits would receive a false negative result for GBS colonization and would not receive appropriate prophylaxsis. (Id) On December 3, 2008, Plaintiff Alicia Dittrich-Bigley was screened for GBS using a GBS Test manufactured after September 2008 as part of routine pre-natal care. (Id ¶ 18-19.) The test result was negative. (Id. ¶ 19.) On December 18, 2008, she gave birth to her son, CDB via vaginal delivery. (Id. ¶ 20.) Plaintiffs allege the history and physical notes from the hospital indicate that, according to prenatal labs, Alicia was GBS negative. (Id) On December 23, 2008, Gen-Probe was notified by one of its customers that probe reagent vials contained in GBS Test kits were empty and contained no reagent. (Id. ¶ 21.) Gen-Probe investigated this report and concluded that at least twelve batches had been affected and may contain the incorrect amount of probe reagent or no probe reagent. (Id 1122.) It was later determined that an additional 18- for a total of 30-batches of GBS Tests were affected by the inadequate priming of the TECAN machine. (Id.) On December 28, 2008, CDB was seen at the New River Medical Clinic with a low grade fever and decreased left arm movement. (Ex. B 2 .) Radiology was negative for any left arm injury, but he was diagnosed with Erb's Palsy of the left arm. (Id) The next day, CDB was seen at the Buffalo Clinic with the same symptoms. He was diagnosed with a left shoulder brachial plexus injury. (Ex. C.) 2 Unless otherwise noted, referenced exhibits are defense exhibits. On December 30, 2008, CDB was admitted to the hospital because of a persistent low-grade fever and decreased left arm movement. (Ex. D.) He underwent a septic work- up wherein blood and cerebrospinal fluid ("CSF") was drawn. (Ex. E.) CDB's test results showed elevated C- reactive protein and white blood cell count. (Id.) The blood and CSF cultures did not identify GBS, or any other infectious agent, so CDB was treated with antibiotic against a broad spectrum of potential pathogens. (Id) He was ultimately diagnosed with osteomyelitis, which is an acute bone infection that can be caused by GBS, Staphylococcus Aureus, Group A Streptococcus, Enteric Gram-Negative Bacilli or other organisms. (Ex. F; Ex. T (Expert Report of Dr. Don Goldmann); Ex. U (Goldmann Dep. at 23-25).) Plaintiffs allege that CDB continues to suffer from the effects of this infection. *3 Also on December 30, 2008, Gen-Probe issued a voluntary recall notice to its customers and distributors of the GBS Test after it was determined that certain assay tubes did not contain the probe reagent. (Am.Complf 23.) The recall notice provided that physicians should be notified of the possibility that the affected batches could result in a false negative. (Id.) Alicia's physician was notified that the GBS Test performed on Alicia was done with one of the affected batches subject to the recall. (Id.) CDB has been treating with Dr. Ann Van Heest, an orthopedic specialist, for his left arm issues. (Ex. H.) Dr. Van Heest's treatment has focused on nonsurgical CO 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 3 of 13 Dittrich-Bigley v. Gen-Probe, Inc., Not Reported in F.Supp.2d (2013) 2013 WL 3974107 therapies to improve range of motion, strength and active functional use. (Id.) Dr. Van Heest believes that at the present time, it is premature to fully delineate what long term problems CDB will have over the next 14 years. (Id.) She believes there is a less than 50% chance that CDB will require arm lengthening surgery. (Ex. I; Ex. J (Van Heest Dep. at 28-29, 34).) In the summer of 2010, CDB was seen by Dr. Matthew Griebie for suspected asthma. (Ex. L.) During a bronchoscopy, Dr. Griebie noted that CDB was unable to fully open his jaw. (Id) CDB was then seen by Dr. James Swift, an oral surgeon, for his jaw issues. (Ex. M.) Dr. Swift diagnosed CDB with temporomandibular joint ankylosis and abnormal bone formation. (Id) There are a number of causes of jaw ankylosis, including trauma, congenital anomalies, developmental growth changes, infections, systemic joint conditions and heterotopic bone formation with trauma being the most common cause. (Ex. O (Opinion Letter of Dr. James R. Fricton, DDS, MS).) Dr. Swift did not see any evidence of a bone infection when he examined CDB. (Ex. N (Swift Dep. at 14).) Dr. Swift does not have an opinion on what caused CDB's jaw ankylosis, but agreed that trauma is the most common cause. (Id. at 15-16.) CDB underwent a right TMJ arthoplasty with ankylosis release in April 2011. (Ex. R.) Dr. Swift stated that future surgical intervention for CDB is impossible to predict at this time. (Ex. N. (Swift Dep. at 29-31); Ex. S (Opinion Letter of Dr. James Swift).) II. Standard under Rule 702 Rule 702 of the Federal Rules of Evidence provides: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training or education, may testify thereto in the form of an opinion or otherwise if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case. The role of the trial court is to serve as "gatekeepers to `insure that the proffered expert testimony is both relevant and reliable.' " Wagner v. Hesston Corp., 450 F.3d 756, 758 (8th Cir.2006) (quoting Anderson v. Raymond Corp., 340 F.3d 520, 523 (8th Cir.2003)). In Daubert v. Merrell Dow Pharmaceuticals, Inc., the Supreme Court provided some general observations for the lower courts to consider in making determinations as to whether the scientific knowledge is relevant and reliable, such as whether it has been tested, subjected to peer review and publication, what is the known or potential rate of error, and whether it is generally accepted." 509 U.S. 579, 593-95 (1993). *4 In Kumho Tire Company, Ltd v. Carmichael, the Court extended the Daubert reasoning to non-scientist experts stating: We conclude that Daubert's general principles apply to the expert matters described in Rule 702. The Rule, in respect to all such matters, 'establishes a standard of evidentiary reliability.' It 'requires a valid ... connection to the pertinent inquiry as a precondition to admissibility.' And where such testimony's factual basis, data, principles, methods, or their application are called sufficiently into question, ... the trial judge must determine whether the testimony has 'a reliable basis in the knowledge and experience of the [the relevant] discipline.' 526 U.S. 137,149 (1999) (quoting Daubert, 509 U.S. at 590-92) (citation omitted). When addressing the reliability factor, the Court has held that "nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered." Gen. Elec. Co. v. Joiner, 522 U.S. 136,146 (1997). Moreover, [T]he factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for the opinion in cross-examination. Only if the expert's opinion is so fundamentally unsupported that it E © 2016 Thomson Reuters. No claim to original U,S. Government Works. 3 Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 4 of 13 Dittrich-Bigley v. Gen-Probe, Inc., Not Reported in F.Supp.2d (2013) 2013 WL 3974107 can offer no assistance to the jury must such testimony be excluded. Bonner• v. ISP Tech, Inc., 259 F.3d 924, 929-30 (8th Cir.2001) (citing Hose v. Chicago NW. Transp. Co., 70 F.3d 968, 974 (8th Cir.1996)). III. Gen-Probe's Motion to Exclude Expert Testimony A. Testimony as to Reliability of GBS Test Plaintiffs have designated a number of experts to provide expert medical opinions. Two of those experts, Dr. Robert Lerer and Dr. Mark Schleiss, have indicated on their expert disclosures that they would opine that had Ms. Dittrich-Bigley been tested with a reliable GBS Test, Ms. Dittrich-Bigley most likely would have tested positive for GBS. Gen-Probe argues that to the extent any of Plaintiffs' expert opinions are based on the assumption that Ms. Dittrich-Bigley received a defective GBS Test kit, such opinion must be excluded. Following its investigation of the allegedly defective GBS Tests, Gen-Probe determined only a small number of probe reagent tubes in the lots manufactured in the period September to October 2008 were likely affected. (Ex. DD (Final Investigation Report at GP001848).) To determine the number of GBS Tests affected, Gen-Probe ran a mock fill experiment under the same manufacturing conditions as the affected batches. (Ex. DD (Final Investigation Report at GP001853); Ex. EE (Rockwell Dep. at 33- 34).) The results of this experiment demonstrated that by vial 33 of each batch, 25% of the specified amount of probe reagent had been added to the vial. (Id.) Gen-Probe further notes that a probe reagent vial with only 25% of the specified amount of probe reagent is sufficient to detect GBS. (Ex. DD (Final Investigation Report at GP001856); Ex. EE (Rockwell Dep. at 34).) *5 The GBS Test kit administered to Ms. Dittrich-Bigley was within one of the affected batches-batch 553599. (Ex. DD (Final Investigation Report at GP001878.) Batch 553599 contained 18,615 probe reagent tubes. (Id.) Referring back to its experiment, if only 33 vials contained less than 25% reagent, GenProbe asserts there is only a .0018 probability that a tube being selected at random from batch 553599 contained less than 25% of the specified reagent. GenProbe further asserts that Dr. John Adams, who has a Ph .D. in statistics, analyzed the data and opined that only 16-25 of the tubes would have had less than 25% of the reagent, resulting in only a .086 to .134% chance of receiving the tube with less than 25% reagent. (Ex. FF (Report of John Adams); Ex. GG (Adams Dep. at 20-21).) Based on the above, Gen-Probe argues there is no evidentiary support for Drs. Lerer's and Schleiss's testimony that Ms. Dittrich-Bigley received a defective GBS Test kit, therefore they cannot reasonably conclude that it is more likely than not that Ms. Dittrich-Bigley received a defective kit. Plaintiffs respond that aside from the obvious bias in conducting an internal mock fill experiment that could not be reproduced, and that health care providers were told to discard the affected GBS Test kits which prevented a count of the actual number of defective kits, the predictability that a certain number of GBS Test kits were defective is not the relevant inquiry. Instead, the inquiry is whether a given GBS Test kit was defective, and the proof is in the circumstances. According to the CDC, the chances are very high-95 to 98%- that a nondefective kit will correctly determine the GBS status of the expectant mother. Plaintiffs thus argue it is reasonable to conclude that Ms. Dittrich-Bigley was GBS positive given the likelihood that CDB's osteomyelitis was acquired at birth due to an early onset GBS infection and the likelihood that GBS was the causative agent due to its prevalence and the manner in which the disease process revealed itself. To the extent that Plaintiffs' experts seek to provide an expert opinion that Ms. Dittrich-Bigley received a defective GBS Test kit, the Court agrees that such an opinion is not based on reliable evidence. While Plaintiffs challenge Gen-Probe's evidence that the probability that the subject GBS Test kit was defective is .086% to .18%, Plaintiffs concede that a nondefective GBS Test has a two to five percent chance of providing a false negative result. (Plaintiffs Mem. in Opp. at 15 (noting that the predictive value of a negative GBS test is 95-98 percent).) The record thus demonstrates that the probability of receiving a false negative result is slightly larger than the probability that Ms. Dittrich-Bigley received a defective GBS Test kit due to manufacturing errors. In addition, Dr. Lerer testified at his deposition that he did not intend to offer an opinion as to the adequacy of the GBS Test administered to Ms. Dittrich-Bigley. (Ex. JJ (Lerer Dep. at 25, 41).) Similarly, with regard to Dr. Adams' report, WESTLA (0 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 5 of 13 Dittrich-Bigley v. Gen-Probe, Inc., Not Reported in F.Supp.2d (2013) 2013 WL 3974107 Dr. Schleiss testified that he would have to defer to an expert on how to interpret that kind of information to determine the implications of the aberrant batch of GBS Test kits at issue in this case. (Ex. NN (Schleiss Dep. at 27- 28).) Accordingly, to the extent that Gen-Probe moves to exclude any expert testimony that it is more likely than not that Ms. Dittrich-Bigley received a defective GBS Test, the motion will be granted. *6 The Court further finds that Dr. Lerer is not qualified to render the opinion that if a reliable test had been performed, Ms. Dittrich-Bigley would have tested positive. He admitted at his deposition that he does not have any expertise as to the reliability of GBS testing, and that he would not be providing an opinion as to the product at issue because he is not an obstetrician and does not perform such testing. (Ex. JJ, Lerer Dep. at 25.) In fact, in response to the question of whether a proper test could result in a false negative, Dr. Lerer testified "I'm not an expert in obstetrics. I think it's a great question, but I'm not the person to answer it as an expert witness." (Id at 65.) He further admitted that he was unaware of the procedures required to obtain a reliable GBS test. (Id.) Dr. Lerer did clarify, however, that while he does not do the tests "if somebody asked me, Doctor, assume that there was something the matter with the test or the way the test was done, then could that result in a negative screen, then the answer is, of course, yes." (Id. at 63.) Based on Dr. Lerer's admissions during his deposition, the Court finds that Dr. Lerer's opinion that Ms. Dittrich- Bigley would have tested positive for GBS had a reliable test been used has no reliable foundation and should thus be excluded. However, the Court finds that Dr. Lerer's opinion that generally, an unreliable GBS test or a GBS test performed incorrectly, could result in a false negative is properly supported and is thus admissible. Similarly, Dr. Schleiss admitted that there are "a lot of issues with false negatives and false positives" with respect to GBS testing, but believed the tests had a "pretty high sensitivity and specificity." (Ex. NN (Schleiss Dep. at 32).) Dr. Schleiss was not able to address the probabilities the Ms. Dittrich-Bigley was given a reliable GBS test. (Id at 29.) Accordingly, to the extent that Dr. Schleiss opined that if a reliable test had been performed, Ms. Dittrich- Bigley would have tested positive, such opinion is not based on a reliable foundation. Dr. Schleiss may, however, testify as to his general knowledge as to the accuracy of GBS tests. B. Dr. Robert Lerer Dr. Lerer has been retained by Plaintiffs as a medical expert. Based on his experience, education and training, and his review of CDB's medical records, Dr. Lerer has provided the following opinions: 1) CDB's osteomyelitis was more likely than not caused by Type III serotype streptococcus; 2) Type III serotype strep is detectible by routine GBS screening; 3) CDB had GBS on or prior to one week of age, based on the symptoms, persistent fever, and the natural course of this particular strain of strep; 4) CDB most likely contracted strep during the labor and delivery process; 5) If a reliable test for GBS had been performed, Ms. Dittrich-Bigley would have most likely tested positive; 6) If a positive test result had been obtained, Ms. Dittrich-Bigley would have received prophylactic antibiotics during labor; and *7 7) If prophylactic antibiotics had been administered, it is more likely than not that CDB would not have contracted osteomyelitis. (Ex. II (Lerer Declaration at 2-3).) 1. Qualifications Dr. Lerer is a pediatrician licensed and practicing medicine in Ohio. He obtained his degree from Johns Hopkins Medical School and completed his residency at Yale University & Yale-New Haven Hospital. He is board certified in pediatrics and received a specialized fellowship in neonatology. (Id. (Lerer Curriculum Vitae).) Gen-Probe asserts that Dr. Lerer is not qualified to render the opinion that GBS caused CDB's osteomyelitis, as there is no evidence he possesses the specialized expertise in the etiology of osteomyelitis. Gen-Probe further argues that Dr. Lerer is not qualified to render an opinion about the efficacy of prophylactic antibiotics in preventing VsfESTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 6 of 13 Dittrich-Bigley v. Gen-Probe, Inc., Not Reported in F.Supp.2d (2013) 2013 WL 3974107 GBS infection in newborns or whether antibiotics were administered because he is not an obstetrician or an infectious disease expert. Gaps in an expert's qualifications generally go to the weight of the opinion, not to admissibility. See Robinson v. GEICO Gen. Ins. Co., 447 F.3d 1096, 1100 (8th Cir.2006) (finding that "[m]ost courts have held that a physician with general knowledge may testify regarding medical issues that a specialist might treat in a clinical setting.") The Court finds that Dr. Lerer is qualified to provide opinions as to causation and to the efficacy of prophylactic antibiotics. 2. Causation Generally, causation is divided into two components: general and specific. General causation is whether X can cause Y. Specific causation is whether X did cause Y. In a personal injury case, an opinion of specific causation may be made upon a differential diagnosis. In re Baycol Products Litig., No 02-1124, 2008 WL 8797733, at *7 (D.Minn. Aug. 25, 2008). While conducting a differential diagnosis is one way to satisfy the requirements of Rule 702 and Daubert, the admissibility of expert medical testimony nonetheless must be done on a case-by-case basis. Id. A differential diagnosis requires that all potential causes be considered, and then rule out the least plausible cause of injury until the most likely remains. Glastetter v. Novartis Pharm. Corp., 252 F.3d 986, 989-90 (8th Cir.2001). Dr. Lerer has offered opinions as to specific causation in this case: that CDB's osteomyelitis and jaw ankylosis were caused by an early-onset GBS infection, and that he most likely contracted the infection during labor and delivery. (Ex. II (Lerer Declaration).) Gen-Probe argues that these opinions are not based on a reliable foundation or derived from reliable methodology. Gen-Probe asserts that none of CDB's treating physicians made such a diagnosis, and CDB's symptoms were not those typical of a GBS infection. In fact, Dr. Lerer conceded that osteomyelitis from a GBS infection is very rare. (Ex. JJ (Lerer Dep. at 25-26).) Geh-Probe further asserts that Dr. Lerer did not perform a differential diagnosis to rule out other potential causes. In this case, Gen-Probe argues that a differential diagnosis is essential as there are a number of potential causes of osteomyelitis besides GBS, including: Staphylococcus Aureus, Group A Streptococcus, Enteric Gram-negative bacilli and a number of other organisms. (Ex. T (Expert Report Dr. Don Goldmann).) Gen-Probe asserts that Staphylococcus Aureus has been reported to be the most common cause of osteomyelitis in children. (Ex. X (Feign RD, et al., Textbook of Pediatric Infectious Diseases 713, 722 and Fig. 62-1 (5th Ed.2005).) *8 Gen-Probe also argues that to the extent that Dr. Lerer bases his opinions on statistics, he does not provide any references to the literature upon which he relies, and at his deposition, he admitted that he did not do any literature research in connection with his expert opinion. (Ex. JJ (Lerer Dep. at 26).) If Dr. Lerer is relying on statistics generated from epidemiological studies, such reliance is improper as such studies are exclusively concerned with general causation-not specific causation. (Ex. KK (Reference Manual on Scientific Evidence, 608, 609, FEDERAL JUDICIAL CENTER 2011 (3d ed.).) In addition, Dr. Lerer admitted during his deposition that use of statistical probabilities is unreliable and an invalid methodology in establishing specific causation. (Ex. JJ (Lerer Dep. at 73-74).) Dr. Lerer also identified CDB's jaw injury, which was not symptomatic for 1.5 years after delivery, as being linked to the early-onset GBS infection. Gen-Probe argues that there is no admissible medical evidence that the jaw ankylosis was caused by GBS or osteomyelitis. In addition, Dr. Lerer did not disclose this opinion in his expert report, therefore he should be precluded from offering such opinion pursuant to Rule 26(a)(2) and 37 of the Federal Rules of Civil Procedure. Nonetheless, Gen-Probe argues such opinion is inadmissible. Dr. Lerer testified that he believed his opinion was supported by medical literature, but did not reference such literature. He further stated that CDB's jaw ankylosis was caused by GBS, as a post infectious phenomenon, and that he was only repeating the opinions of CDB's treaters. (Ex. JJ (Lerer Dep. at 78).) Gen-Probe asserts that none of CDB's treaters holds such an opinion. Dr. Lerer further admitted that he had never treated a patient with jaw ankylosis caused by infection and he could not explain how CDB's jaw problem arose 1.5 years after birth, stating that you need to ask a dentist or orthopedist about that. (Id.) WESTLAVV © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 7 of 13 Dittrich-Bigley v. Gen-Probe, Inc., Not Reported in F.Supp.2d (2013) 2013 WL 3974107 Plaintiffs respond that Dr. Lerer intends to provide a general causation opinion based on medical literature and a specific causation opinion by reference to the literature in the context of the clinical facts of this case. Plaintiffs further assert that Dr. Lerer's opinions are well supported by medical literature. (Plaintiffs' Exs. W, U, Y, Z, AA, BB, CC, DD, EE, FF and GG.) Dr. Lerer also relies on statistics in providing a backdrop for his evaluation of this case, but he does not rely on statistics with regard to his opinion as to specific causation. Instead, he relies on the medical facts in this case in the context of what is known about the disease process. Plaintiffs further assert that Dr. Lerer's opinion that CDB suffered from early-onset GBS infection as the result of GBS transmission during delivery is not based solely on a hospital scan. Dr. Lerer also relies on the opinions of CDB's treating physicians that the abnormalities represented bone destruction due to GBS osteomyelitis. Just as Dr. Lerer did, the treating physicians were relying on the entire constellation of clinical facts rather than simply a bone scan. *9 Plaintiffs also argue that Dr. Lerer's opinion regarding the cause of the jaw ankylosis is sound and based on scientific principles and methodology. There is clear evidence of an osteomyelitis at birth that would be consistent with jaw ankylosis, and there is no evidence to support any of the other causes suggested by Gen-Probe. Other causes are effectively ruled out when there is no scientific basis to believe those medical facts exist. Based on the record before it, the Court finds that there is a reliable foundation for Dr. Lerer's general causation opinions to be presented to a jury. With respect to the specific causation opinion that CDB's osteomyelitis was caused by an early-onset GBS infection, and that he most likely contracted the infection during labor and delivery- the Court finds such expert testimony sufficiently reliable under Rule 702. Gen-Probe is free to challenge the factual basis of such opinion at trial. With respect to the specific causation opinion that CDB's jaw ankylosis was caused by an early-onset GBS infection, the Court finds that such opinion is not reliable. At his deposition, he testified that he was simply repeating the opinions of CDB's treating physicians that the jaw ankylosis was caused by an infection. (Ex. JJ (Lerer Dep. at 77).) However, there is no evidence in the record supporting this statement. In fact, Dr. Swift, CDB's treating oral surgeon, testified that he had no opinion as to what it was that caused CDB's ankylosis. (Ex. N (Swift Dep. at 15).) Accordingly, the Court will preclude Dr. Lerer from offering an opinion that the CDB's jaw ankylosis was caused by a GBS infection. 3. Antibiotic Dr. Lerer also opines that if Ms. Dittrich-Bigley would have tested positive for GBS, she would have been given antibiotics, and that an antibiotic would have prevented an infection. Gen-Probe moves to exclude these opinions as Dr. Lerer is not an obstetrician, and is not qualified to provide an opinion on the standards of care or the protocols used concerning the circumstances under which an obstetrician would administer antibiotics. In addition, he is not an infectious disease expert and does not provide any foundation or methodology for his opinion that antibiotics would have prevented an infection. Dr. Lerer admitted that he was not aware of the percentage of GBS-positive women who gave birth to a GBS-infected child after being given prophylactic antibiotics. (Ex. JJ (Lerer Dep. at 65).) Moreover, the CDC has reported that although intravenous administration of penicillin and ampicillin has been proven effective, alternative antibiotics and alternative administration have not. Dr. Lerer does not provide any opinion as to which antibiotic, or how, it would have been administered. Plaintiffs respond that the CDC has reported that with antibiotic prophylaxsis, the efficacy of preventing early- onset GBS infection in infants is as high as one hundred percent. (Plaintiffs' Ex. V (Morbidity and Mortality Weekly Report at 4).) There is thus support for Dr. Lerer's opinion that generally, antibiotic prophylaxsis is an effective means to prevent early-onset GBS infection in infants. *10 Based on the above, the Court finds Dr. Lerer's opinions as to the efficacy of antibiotic prophylaxsis in general are properly supported and are therefore reliable. Because it is Dr. Lerer's opinion that antibiotics are 100% effective in preventing early-onset GBS infections, it thus follows that Dr. Lerer's opinion that had Ms. Dittrich- Bigley been given antibiotics prior to CDB's birth, the antibiotics would have prevented infection in CDB is properly supported. Gen-Probe is free to challenge Dr. Lerer on cross-examination as to the factual bases for these opinions. ,A . 2016 Thomson Reuters. No claim to original U.S. Government Works. 7 Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 8 of 13 Dittrich-Bigley v. Gen-Probe, Inc., Not Reported in F.Supp.2d (2013) 2013 WL 3974107 C. Dr. Mark Schleiss Dr. Schleiss is a pediatric infectious disease specialist and has been retained by Plaintiffs as a medical expert. Based on his review of CDB's medical records, medical literature and based on his experience, education and training, Dr. Schleiss has provided the following opinions: 1) CDB's osteomyelitis was caused by GBS; 2) CDB's Erb's palsy presentation was secondary to osteomyelitis; 3) Type III strep is detectable through routine GBS screening; 4) Staph would be a plausible, but less likely, explanation; 5) CDB most likely contracted GBS during the labor and delivery process; 6) If a reliable screening test for GBS had been performed, Ms. Dittrich-Bigley would most likely have tested positive; 7) The negative predictive value of GBS cultures at less than or equal to 5 weeks before delivery is 95-98% and would have been higher for Ms. Dittrich-Bigley; 8) If a positive test result had been obtained, such result would have allowed for timely treatment which would have prevented infection in CDB; and 9) Had prophylactic antibiotics had been administered, CDB would have been spared from infection and all of the attendant sequelae. (Ex. MM (Schleiss Expert Disclosure).) 1. Causation Gen-Probe asserts that CDB's medical providers have never confirmed a GBS infection in CDB. Moreover, the CDC has concluded that GBS infection is characterized by sepsis, pneumonia or meningitis and infants with early- onset GBS infections generally present with respiratory distress, apnea or other signs of sepsis within 24-48 hours, and CDB did not experience any of these conditions. Yet, Dr. Schleiss opines that CDB was infected with GBS. He testified that it is a medical probabilities situation. (Ex. NN (Schleiss Dep at 23).) To support his conclusion, he relies on three case studies. Gen-Probe argues that these studies do not support his opinions. One article, An etiologic shift in infantile osteomyelitis, The emergence of the group B streptococcus, (hereinafter referred to as the "Edwards's Study") is a case series reporting on 21 infants who suffered from osteomyelitis between 1966-77. (Ex. 00.) The infectious agents were GBS (8), Staphylococcus aureus (6), gram-negative bacilli (4) and other agents accounted for the remainder. (Id at 579.) Gen-Probe asserts this article does not support Dr. Schleiss' opinion that GBS is the most likely cause of osteomyelitis, as the majority of the infections described in this article were caused by an agent other than GBS. The article also involved subjects that presented with single bone involvement where CDB presented with multiple bone involvement. (Id at 581 .) The authors also noted no functional deficits, whereas CDB is alleged to have suffered such deficits. (Id at 582.) *11 The next article, Skeletal infection by group B betahaemolytic streptococci in neonates, reports on one case of GBS osteomyelitis. (Ex. P P.) GBS was confirmed in that case-not in this case. Next, the report relates to late-onset GBS, here early onset is alleged. The report also involved single bone involvement, and the infant gained full use of the arm within five days. The authors noted that obstetric trauma appeared to predispose to infection. In this case, there is no evidence of obstetric trauma. The final article is Streptococcal Skeletal Infections, Observations in Four Infants. (Ex. QQ.) GBS was confirmed in all four cases. The authors also noted that "traditional diagnostic methods [ ] are necessary for a bacteriologic diagnosis and optimal therapy." (Id at 467.) The authors noted that GBS confirmation is necessary for a bacteriologic diagnosis because GBS osteomyelitis in the cases resemble that observed in other forms of osteomyelitis. (Id) Gen-Probe further notes that Dr. Schleiss did not perform a differential diagnosis to rule out other causes even though other causes were discussed in the literature upon which he relies. Dr. Schleiss agreed that it was possible that Ms. Dittrich-Bigley could have contracted GBS between the screening and delivery. (Ex. NN (Schleiss Dep. at 28- 29).) He believes that CDB was infected during labor and delivery because that is the statistically most plausible explanation. (Id at 28.) wesTLAw © 2016 Thomson Reuters. No claim to original U.S. Government Works. 8 Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 9 of 13 Dittrich-Bigley v. Gen-Probe, Inc., Not Reported in F.Supp.2d (2013) 2013 WL 3974107 Finally, Gen-Probe argues that Dr. Schleiss's causation opinions are based on speculation. At his deposition, he testified that the only unequivocal confirmation is to grow the organism by culture, and without that, it is just an educated guess. (Id at 31-32.) Although there are bases upon which to distinguish the above articles from the specific facts of this case, the Court nonetheless finds that the articles lend support for the general causation opinion that infant osteomyelitis may be caused by an early-onset GBS infection. Dr. Schleiss reviewed CDB's medical records and the relevant medical literature, and based on that review and his experience, he has rendered opinions as to the cause of CDB's injuries. Gen-Probe has not demonstrated that these opinions are so fundamentally unsupported so as not to offer any assistance to the trier of fact. Accordingly, Gen-Probes motion to exclude Dr. Schleiss's opinions as to causation of CDB's osteomyelitis will be denied. 2. Jaw Ankylosis Opinion Gen-Probe argues that at his deposition, Dr. Schleiss indicated that he would provide the opinion that CDB's jaw issues resulted from the previously diagnosed osteomyelitis. (Ex. NN (Schleiss Dep. at 35).) Specifically, he testified that CDB's jaw was seeded during his acute hematogenous osteomyelitis. (Id.) He further testified that this opinion was based, on a patient that he had treated years earlier, who had been diagnosed with osteomyelitis in the hip, and who later experienced complications in the jaw from the osteomyelitis. (Id) *12 Gen-Probe argues Dr. Schleiss' opinion that CDB's jaw ankylosis was caused by osteomyelitis lacks a reliable foundation and is derived from unreliable methodology. The opinion is not based on references to any literature or studies that support such opinion. Instead, it is based solely on the case history of a prior patient he treated in 2003. (Id at 35-36.) That case is distinguishable from this case, however, because the GBS infection was confirmed through cultures. (Id) In addition, without seeing the patient or reviewing medical records, Dr. Schleiss merely surmised that the jaw issues in that child were the result of GBS infection. Gen-Probe asserts that even if confirmed, it is merely one case report which is not a reliable basis for causation. Additionally, Gen-Probe argues that Dr. Schleiss's opinion as to causation of CDB's jaw ankylosis is not reliable because he did not conduct a differential diagnosis to rule in osteomyelitis and rule out other causes. The Court finds that Dr. Schleiss's experience as a pediatric infectious disease specialist, together with his experiences treating another patient with osteomyelitis and jaw ankylosis, the clinical facts of this case, and the absence of other factors that would point to another etiology, provides sufficiently reliable support for his conclusions as to the cause of CDB's jaw ankylosis. As with Dr. Lerer, Gen-Probe is free to challenge the factual basis of this opinion on cross-examination. 3. Antibiotic Dr. Schleiss also opines that if Ms. Dittrich-Bigley would have tested positive for GBS, she would have been given antibiotics. Gen-Probe argues that Dr. Schleiss is not qualified to render such an opinion, as he has no experience in the area of obstetrics. As such, he cannot provide such an opinion on the standards of care, or the protocols concerning the circumstances under which an obstetrician would administer antibiotics. Dr. Schleiss also does not provide any foundation or methodology for this opinion. The Court finds that there is sufficient support in the medical literature to support the opinion that generally, antibiotic prophylaxsis is an effective means to prevent early-onset GBS infection in infants. Accordingly, the Court finds Dr. Schleiss's opinions as to the efficacy of antibiotic prophylaxsis in general is properly supported and is therefore reliable. It thus follows that his opinion that had Ms. Dittrich-Bigley been given antibiotics prior to CDB's birth, the antibiotics would have prevented infection in CDB is properly supported. Gen-Probe is free to challenge Dr. Schleiss on cross-examination as to the factual bases for this opinion. D. Dr. Sonny Bal Dr. Bal is an Associate Professor in the Department of Orthopaedic Surgery at the University of Missouri Health Care in Columbia, Missouri. He attended Cornell University Medical College, the University of California Hospitals and Clinics in General Surgery and the University of Missouri School of Medicine in Kansas City in the Orthopaedic Surgery Department. Dr. Bal reviewed TIA CO 2016 Thomson Reuters. No claim to original U.S. Government Works. 9 Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 10 of 13 Dittrich-Bigley v. Gen-Probe, Inc., Not Reported in F.Supp.2d (2013) 2013 WL 3974107 CDB's medical records and has provided the opinion that to a reasonable degree of medical certainty, CDB will more likely than not require an arm lengthening procedure as he grows and that he will require replacement of his entire left shoulder joint. (Ex. RR.) 1. Qualifications *13 Gen-Probe argues that Dr. Bal does not have the specialized expertise to render the opinion as to CDB's future care, as he has never treated a child with GBS caused osteomyelitis. Further, he has never performed pediatric surgeries, and he has never performed an arm- lengthening surgery on a patient of any age. His speciality is hip and knee replacements. As noted previously, gaps in an expert's qualifications go to the weight of the opinion, not to admissibility. Dr. Bal is a board certified orthopedic surgeon, and as such, he is qualified to provide opinions as to orthopedic surgeries. 2. Reliability Gen-Probe further argues that Dr. Bal's opinions are not based on a reliable foundation or derived from a reliable methodology. With regard to the opinion that CDB will require an arm lengthening procedure, Dr. Bal admitted that such opinion was not based on any research, just on his experience and simple reason. (Ex. S S (Bal Dep. at 15-16).) Dr. Bal further admitted that he did not know whether CDB even had an arm length discrepancy, and admitted that some of his opinions may be speculative. (Id. at 20, 25, 26.) Gen-Probe further points out that Dr. Bal's opinion is contrary to the opinion of CDB's treating physician, Dr. Van Heest, that it is more likely than not that CDB will not need an arm lengthening procedure. (See Ex. I at 3.) With regard to the opinion that CDB will need shoulder surgery, Gen-Probe argues that Dr. Bal has also failed to sufficiently explain the foundation of this opinion, and the methodology used to reach such opinion, other than stating it is based on his review of the medical records and his experience. Under Daubert, Gen-Probe argues that expert witnesses must explain how that experience leads to the conclusion reached, why that experience is a sufficient basis for an opinion and how that experience is reliably applied. There is no dispute that CDB suffered from osteomyelitis, and that CDB has suffered a growth plate abnormality in his left shoulder. At his deposition, Dr. Bal sufficiently explained the basis for his opinion that CDB will require arm lengthening surgery in the future. He testified because of the growth plate injury "the arm or the humerus, that particular one, is not going to grow from that growth plate. The only place it can grow is the elbow." (Ex. S S (Bal Dep. at 15).) He further explained that where there is a growth plate injury from infection, there will be a limb length discrepancy. (Id) He also pointed out that CDB's treating physician has also indicated that the extent of the discrepancy is unknown, and will not be known until CDB stops growing. (Id at 24-25.) With regard to the opinion that CDB will require shoulder replacement surgery, Dr. Bal explained that such surgery will be required because CDB has already suffered damage to the ball and socket of his left shoulder. (Id. at 30.) In addition, CDB's treating orthopedic physician also believes CDB will require shoulder replacement surgery. (Id at 38.) *14 The Court finds that Dr. Bal's opinions that CDB may need limb lengthening surgery and shoulder replacement in the future are based on a reliable foundation and are derived from a reliable methodology. The motion to exclude Dr. Bal's opinions will be denied. E. Casey Dye Casey Dye was retained by Plaintiffs as an expert in the field of life care planning. Dye prepared a life care plan which sets forth CDB's anticipated future medical treatment and present day costs on August 1, 2012. (Ex. TT (Life Care Plan).) Dye was certified as a life care planner on August 3, 2012, after she prepared CDB's plan. CDB's life care plan is only the fourth or fifth plan she has completed. Under Minnesota law, a claim for damages for future medical expenses must be supported by evidence that "(1) demonstrate[s] that future medical treatments will be required and (2) establish[es] the amount of the damages." Lallas v. Paquette, No. A08-1364, 2009 WL 20115821 at *3 (Minn Ct App. Jul. 14, 2009) (citing Myers v. Hearth Techs., Inc., 621 N.W.2d 787, 793 (Minn. Ct App .2001), rev. denied, (Minn.2001)). "Both requirements must be substantiated through competent evidence, which ordinarily is established through expert WESTLA 2016 Thomson Reuters. No claim to original U.S. Government Works. 10 Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 11 of 13 Dittrich-Bigley v. Gen-Probe, Inc., Not Reported in F.Supp.2d (2013) 2013 WL 3974107 testimony." Id. Minnesota courts have, however, affirmed awards for future medical expenses in the absence of expert testimony. Shimek v. Weinig AG, No. 99-2015, 2002 WL 1839239, at *2-3 (D.Minn Aug. 9, 2002) (citing cases). In addition, a plaintiff need not establish future medical expense damages to an absolute certainty, only that the necessity of such expenses are more likely than not. Id. (citing Dornberg v. St. Paul City Ry., 253 Minn. 291, 295, 91 N.W.2d 178, 185 (1958)). Gen-Probe argues that unless treatment included in the life care plan is supported by a doctor's recommendation, it is not scientifically reliable. Here, Dye has relied on the opinions of Dr. Gary Yarkony for the inclusion of a speech language pathology evaluation, a nutritional evaluation, occupational therapy, individual psychological counseling, physical therapy, speech therapy, landscaping, handyman and home care in CDB's life care plan. (Ex. TT at 19, 25-26, 39.) Dr. Yarkony was originally identified as an expert by Plaintiffs, but he has since been de-designated. (Ex. WW.) Gen-Probe argues that as a result, Plaintiffs cannot demonstrate that Dyes inclusion of the above therapies are supported by admissible evidence, and must therefore be excluded. See Hale v. Gannon, Cause No. 1:11-cv-277, 2012 WL 3866864, at *5 (S.D.Ind. Sept. 5, 2012) (finding that "[i]f the underlying treatments are not proved by independent admissible evidence, then [the] projected cost of treatment is irrelevant.") Similarly, Dye has included future costs for jaw surgeries, orthodontic alignment prior to surgery, physical therapy evaluations after jaw surgeries and post-operative pain medications. (Ex. TT at 20, 22, 35.) These items rely on the opinions of CDB's treating oral surgeon. (Id.) Dr. Swift has opined, however, that surgical intervention is impossible to predict at the present time. (Ex. S.) Dye also relied on Dr Swift for inclusion of individual psychological counseling and evaluation, physical therapy sessions, dental cleaning, x-rays, CT scans, therabite devices and bite pads. (Ex. TT at 25-29.) Gen-Probe asserts there is no medical evidence to support dental cleaning, therabite devices and bite pads, therefore those items should be excluded. For the remaining items, Dye relies upon a questionnaire that she sent to Dr. Swift. However, Dr. Swift did not complete the questionnaire-it was completed by a surgical resident that has not been named as an expert in this case. (Ex. N (Swift Dep. at 28).) Even if Dr. Swift had completed the questionnaire, there is no opinion within the responses that CDB will need these items to a reasonable degree of medical certainty. (Ex. XX.) *15 Dye also included costs related to an arm lengthening procedure. Dye relies on Dr. Bal's opinion for inclusion of these items. As noted above, GenProbe moves to exclude this opinion of Dr. Bal. If the Court finds such opinion inadmissible, this aspect of Dyes life care plan must be excluded as well. Dye has also included the costs related to future shoulder surgeries. (Ex. TT at 22, 26.) Dye forecasts the first surgery will take place in 20-30 years, yet CDB's treating physician, Dr. Van Heest, did not provide a reasonable estimate as to when the first surgery would occur. (Ex. J.) Dr. Bal testified at his deposition that shoulder replacement surgery may be unnecessary as alternative treatments, such as stem cell and autologous cartilage treatments may be available. Therefore, inclusion of even one shoulder surgery is speculative. Plaintiffs assert that it is common practice and standard methodology for life care planners to rely on the opinions of medical experts in formulating a life care plan. (Ex. VV (Dye Affidavit); Ex. XX (Roger Weed and Debra E. Berens, Life Care Planning and Case Management Handbook, at 749, CRC Press (3d ed.).) Dyes opinions are based on her review of the medical records and they are supported by the opinions of experts and is based upon accepted principles of life care planning. The Court finds that Gen-Probes arguments go to the factual basis supporting Dye's opinions. Again, a challenge to the factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility. Bonner, 259 F.3d at 929-30. Gen-Probe has not demonstrated that Dyes opinions are so fundamentally unsupported to warrant their exclusion. Id IT IS HEREBY ORDERED that Gen-Probes Motion to Exclude Expert Testimony [Doc. No. 56] is GRANTED in part and DENIED in part as set forth in this Memorandum Opinion and Order. All Citations Not Reported in F.Supp.2d, 2013 WL 3974107 SIV EST LAW (6) 2016 Thomson Reuters. No claim to original U.S. Government Works. 11 Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 12 of 13 Dittrich-Bigley v. Gen-Probe, Inc., Not Reported in F.Supp.2d (2013) 2013 WL 3974107 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works, W TLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 12 Case 4:13-cv-00321-CDL Document 40-10 Filed 08/29/16 Page 13 of 13 EXHIBIT H Case 4:13-cv-00321-CDL Document 40-11 Filed 08/29/16 Page 1 of 7 Rye v. Matrixx Initiatives, Inc., Not Reported in F.Supp.2d (2007) 2007 WL 2475960 2007 WL 2475960 Only the Westlaw citation is currently available. United States District Court, D. Minnesota. Wendy RYE, Plaintiff, v. MATRIXX INITIATIVES, INC., et al., Defendants. Civil No. 06-3288 (RHK/JSM). Aug. 24, 2007. Attorneys and Law Firms Wendy Rye, Porter, MN, pro se. Amanda M. Cialkowski, Jan R. McLean Bernier, Scott A. Smith, Halleland Lewis Nilan & Johnson PA, Minneapolis, MN, for Defendants. ORDER RICHARD H. KYLE, United States District Judge. *1 The above-entitled matter comes before the Court upon the Report and Recommendation of United States Magistrate Judge Janie S. Mayeron dated July 30, 2007. No objections have been filed to that Report and Recommendation in the time period permitted. Based upon the Report and Recommendation of the Magistrate Judge, and all of the files, records and proceedings herein, IT IS ORDERED: 1. The Report and Recommendation (Doc. No. 68) is ADOPTED; 2. Defendants' Motion for Summary Judgment (Doc. No. 60) is GRANTED, and Plaintiffs Complaint is DISMISSED WITH PREJUDICE . LET JUDGMENT BE ENTERED ACCORDINGLY. REPORT AND RECOMMENDATION JANIE S. MAYERON, United States Magistrate Judge. The above matter came on before the undersigned upon defendants' motion for summary judgment [Docket No. 60]. Plaintiff did not file a response, and consequently, no hearing on the motion was held by the Court and defendants' motion is decided on the papers. This matter has been referred to the undersigned Magistrate Judge for a Report and Recommendation by the District Court pursuant to 28 U.S.C. § 636(b)(1)(B) and Local Rule 72.1(c). For the reasons discussed below, IT IS RECOMMENDED THAT: 1. Defendants' Motion for Summary Judgment [Docket No. 60] be GRANTED; and 2. Plaintiffs Complaint be DISMISSED WITH PREJUDICE. I. FACTUAL BACKGROUND This case arises out of plaintiff Wendy Rye's claim that she was injured by her use of Zicam Cold Remedy Nasal Gel ("Zicam"). Complaint, ¶ 10[Docket No. 46, Att. 2]. Plaintiff contends that Zicam was defective and unreasonably safe when being used in a foreseeable manner, and that defendants negligently designed, manufactured, sold and distributed the product. Complaint, ¶¶ 14, 17. Plaintiff also claims that defendants negligently failed to provide sufficient warning for use of Zicam, and that defendants are liable for her injuries based upon breach of warranty and breach of contract. Complaint, ¶¶ 20, 23. Plaintiffs suit originated in the U.S. District Court for the Northern District of Alabama on November 1, 2005. Counsel for plaintiff withdrew from the case on June 30, 2006. [Docket No. 46, Att. 50]. Counsel for plaintiff notified plaintiff, via certified mail, of the Court's Order permitting the withdrawal of counsel. [Docket No. 46, Att. 55]. On July 21, 2006, pursuant to defendants' motion to transfer venue, the case was transferred to this Court. [Docket No. 46, Att. 54]. On February 21, 2007, defendants filed the instant motion for summary judgment, and the Court set the hearing on the motion for April 12, 2007. On March 15, 2007, the Court entered an Order directing plaintiff to respond to defendants' motion on or before April 5, 2007, and informing plaintiff that the Court would consider granting WESTLAVY © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 Case 4:13-cv-00321-CDL Document 40-11 Filed 08/29/16 Page 2 of 7 Rye v. Matrixx Initiatives, Inc., Not Reported in F.Supp.2d (2007) 2007 WL 2475960 defendants' motion if plaintiff failed to adhere to the deadline. [Docket No. 67]. Plaintiff has never filed a response to defendants' motion, nor has she contacted the Court regarding the motion. *2 In her responses to defendants' first set of interrogatories, plaintiff stated that in May of 2003, she had a cold that was not getting better. Cialkowski Aff., Ex. B, p. 8 [Docket No. 63-3]. In June of 2003, plaintiff purchased Zicam Nasal Swabs, and used four to five swabs two to three times per day for about four days. Id It burned when she used it, and she had no smell or taste after using the product. Id. Zicam did not reduce the duration of her cold or severity of its symptoms. Id. With respect to defendants' Interrogatory No. 17 seeking to learn the opinions of any expert witnesses that plaintiff would offer, plaintiff provided the following response: Plaintiff objects to Interrogatory 17 because it seeks privileged information protected by the attorney work-product doctrine. The information sought constitutes the mental impressions, conclusions, legal theories, and/or opinions of plaintiffs counsel. The expert witnesses plaintiff intends to use in this case will be provided to the defendants in accordance with the Court's pre-trial and scheduling orders. Id. at p. 10. In response to Interrogatory Nos. 21 1 and 22 2 , where defendants sought to discover the factual basis for plaintiffs various claims, plaintiffs response to both interrogatories stated: 1 Interrogatory No. 21: "Set forth in full and complete detail each such defect which you contend existed in the Product, identify all other reasonable alternative designs that you contend existed and what you contend the warning on the Product should have stated, state precisely and with particularity all facts and information upon which you rely to support the contention, identify each person firm or corporation who has knowledge of such facts or information, and identify each VVESTLA: CO 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00321-CDL Document 40-11 Filed 08/29/16 Page 3 of 7 Rye v. Matrixx Initiatives, Inc., Not Reported in F.Supp.2d (2007) 2007 WL 2475960 document relating to or containing such facts or information." Cialkowski Aff., Ex. B, p. 11. Interrogatory No. 22: "With respect to your breach of warranty claims in Count Five of Plaintiffs Complaint, identify to whom, by whom and when the warranty was made, whether the warranty was oral or in writing, what it stated and state precisely and with particularity all facts or information upon which you rely to support the contention, identify each person, firm or corporation who has knowledge of such facts or information, and identify each document relating to or constituting the alleged warranty." Cialkowski Aff., Ex. B, p. 11. Plaintiff objects to [Interrogatories 21 and 22] because it seeks information protected by the attorney-client privilege and the attorney work-product privilege. Additionally, the information sought constitutes the mental impressions, conclusions, opinions, and/or legal theories of plaintiffs counsel. Please refer to the complaint. Id. Plaintiff did not supplement these responses. Similarly, defendants' first request for production of documents contained requests for documents bearing on plaintiffs expert witnesses' opinions and facts plaintiff was relying upon to support each of her claims. See Plaintiffs Responses to Defendants' First Requests for Production of Documents 1, 3, 4, 7, 19, 20, 21, 32, 33, 34, 35 and 37. Cialkowski Aff., Ex. D [Docket No. 63-4]. To each of defendants' requests, plaintiff responded with the following: WIESTLAV © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 Case 4:13-cv-00321-CDL Document 40-11 Filed 08/29/16 Page 4 of 7 Rye v. Matrixx Initiatives, Inc., Not Reported in F.Supp.2d (2007) 2007 WL 2475960 Plaintiff objects to this request on the basis that the information sought is privileged, confidential, prepared in anticipation of litigation and constitutes attorney work product. No decision has been made at this time as to whether any expert or experts will testify at the trial of this case. Plaintiff reserves the right to supplement this response pursuant to any Scheduling Orders from the Court that govern experts. Id. Plaintiff has not supplemented her responses to defendants' document requests. Plaintiff has also not provided any further information regarding expert testimony, or any further specificity regarding the nature of her claim. Defendants scheduled plaintiffs deposition for December 21, 2006, which was noticed by Certified Mail on December 13, 2006. See Cialkowski Aff., Ex. E. Plaintiff signed the Certified Mail receipt on December 15, 2006. Cialkowski Aff., Ex. F. Plaintiff did not appear for the deposition, nor did she contact counsel for defendants or the Court to request rescheduling. *3 In addition to plaintiffs refusal to respond to defendants' discovery or provide any expert opinion to support her claims that Zicam caused her injuries, defendants submitted the following evidence to the Court to support their defense that plaintiffs loss of taste and smell was due to causes other than Zicam. On May 8, 2003, plaintiff was seen at the Divine Providence Minneota Clinic for complaints of cough, sore throat and chest congestion. Cialkowski Aff., Ex. G. She was diagnosed with bronchitis and prescribed Z-Pack (Zithromax). Id On June 4, 2003, plaintiff returned to the clinic, complaining that she had not had any sense of taste or smell since the fourth day of taking the Z-Pack. The staff notes from the June 4, 2003 visit stated that the only new medication plaintiff was taking when she lost her sense of taste and smell was the Z-Pack. Id. On June 26, 2003, plaintiff went to the Ear, Nose & Throat Clinic in Sioux Falls, South Dakota complaining of loss of smell and taste. The recommendation of the treating physician stated that the most likely etiology of her condition was viral, and given her complete absence of taste and smell, the most likely cause was viral. Cialkowski Aff., Ex. D, p. 14. On July 22, 2003, plaintiff visited the Setliff Clinic in Sioux Falls, South Dakota, with the same complaints. Id at 13. The medical notes from that visit state that "the most likely explanation for her difficulty is a viral neuritis with secondary anosmia and loss of taste secondary to that." Id Dr. Setliff advised plaintiff that "most likely her difficulty is related to a viral etiology ..." II. STANDARD OF REVIEW Summary judgment is proper if, drawing all reasonable inferences favorable to the non-moving party, there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c); Celeotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-50 (1986); see also Unigroup, Inc. v. O'Rourke Storage & Transfer Co., 980 F.2d 1217, 1219 (8th Cir.1999). "[S]ummary judgment procedure is properly regarded not as a disfavored procedural shortcut, but rather as an integral part of the Federal Rules as a whole, which are designed to secure the just, speedy, and inexpensive determination of every action." Celotex, 477 U.S. at 327. " 'Only disputes over facts that might affect the outcome of the suit under the governing law will properly preclude the entry of summary judgment.' " DePugh v. Smith, 880 F.Supp. 651, 656 (N.D.Iowa 1995) (quoting Anderson, 477 U.S. at 248). The party moving for summary judgment bears the burden of showing that the material facts in the case are undisputed. Celotex Corp., 477 U.S. at 322-23; see also Mems v. City of St. Paul, Dept of Fire & Safety Servs., 224 F.3d 735, 738 (8th Cir.2000). If the moving party has carried its burden, the non-moving party must demonstrate the existence of specific facts in the record that create a genuine issue for trial. Anderson, 477 U.S. at 256; Krenik v. County of LeSueur, 47 F.3d 953, 957 (8th Cir.1995). "The nonmoving party may not rest on mere allegations or denials, but must show through the presentation of admissible evidence that specific facts exist creating a genuine issue for trial." Minnesota Laborers Health & Welfare Fund v. Swenke, 2003 U.S. Dist. LEXIS 11439, *4-5 (D.Minn.2003) (citations omitted). The non- moving party "must substantiate his allegations with sufficient probative evidence that would permit a finding ES 1LA 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 Case 4:13-cv-00321-CDL Document 40-11 Filed 08/29/16 Page 5 of 7 Rye v. Matrixx Initiatives, Inc., Not Reported in F.Supp.2d (2007) 2007 WL 2475960 in [their] favor based on more than mere speculation, conjecture, or fantasy." Wilson v. Intl Bus. Mach. Corp., 62 F.3d 237, 241 (8th Cir.1995). *4 Summary judgment is appropriate where the material facts are not in dispute, and the court need only apply the law to the facts in the record. See Eisenrich v. Minneapolis Retail Meat Cutters, 282 F.Supp. 1077, 1080-81 (D.Minn.2003) (citing Oldham v. West, 47 F.3d 985, 988 (8th Cir.1995)). III. DISCUSSION Plaintiffs claims are based on theories of product liability, i. e. defective design, manufacture, sale or distribution; failure to warn; and breach of warranty and contract. Defendants argue that plaintiff has failed to provide evidence of a defect in the Zicam product, or that the alleged defect cause her injuries. Further, defendants contend that because plaintiff has provided no expert testimony, she cannot prove that a product defect caused her injury and therefore defendants are entitled to summary judgment. In Minnesota, to establish a prima facie case of product liability, a plaintiff must demonstrate that (1) the product was in a defective condition unreasonably dangerous for its intended use, (2) the defect existed when the product left the manufacturer's control, and (3) the defect proximately caused the plaintiffs injuries. Patton v. Neivmar Corp., 538 N.W.2d 116, 119 (Minn.1995) (citing Bilotta v. Kelley Co., Inc, 346 N.W.2d 616, 623 n. 3 (Minn.1984) (citations omitted). "Claims of negligence and breach of warranty also include the causation element." Fireman's Fund Ins. Co. v. Canon U.S.A., Inc., 394 F.3d 1054, 1060 (8th Cir.2005) (citing Myers v. Hearth Techs., Inc., 621 N.W.2d 787, 792 (Minn.Ct.App.2001); Alley Constr. Co. v. State, 300 Minn. 346, 219 N.W.2d 922, 925 n. 1 (1974)). "Under Minnesota law, expert testimony is required to prove causation in cases involving complex medical issues with which a jury is unlikely to have experience." Johnson v. Zimmer, Inc., 2004 WL 742038 at *6 (D.Minn.) (citing Willert v. Ortho Pharmaceutical Corp., 995 F.Supp. 979, 983 (D.Minn.1998)). See also Mozes v. Medtronic, Inc., 14 F.Supp.2d 1124, 1128 (D.Minn.1998) (pacemaker products liability case involved issues of a complex nature and plaintiff was required to prove his defective product claims with expert testimony). Expert testimony is necessary in personal injury cases "involving pharmaceuticals, toxins or medical devices [because they involve] complex questions of medical causation beyond the understanding of a lay person." In re Baycol Products Litigation, 321 F.Supp.2d 1118, 1126 (D.Minn.2004) (citations omitted). Because a pharmaceutical is at issue in this case, plaintiff is required to present expert testimony to prove defect and causation. Plaintiff has not identified any experts or expert testimony that she will be relying upon in her case. Furthermore, the pretrial scheduling order governing this case required plaintiff to disclose her expert witnesses by January 10, 2007. Without expert testimony, plaintiff is unable to prove that the Zicam was defective, and that her usage of Zicam was the proximate cause of her loss of smell and taste. See Trost v. Trek Bicycle Corp., 162 F.3d 1004, 1009 (8th Cir.1998) (holding that where the only evidence plaintiff offered of product's defective condition under Minnesota law was expert testimony that the district court excluded, summary judgment was appropriate). *5 Furthermore, plaintiffs complaint and her answers to defendants' discovery contain no support for her allegation that the Zicam was defective, and lack any evidence that the allegedly defective Zicam caused her loss of smell and taste. In fact, plaintiffs medical records from two different clinics indicated that the cause of her loss of smell and taste was most likely viral. The medical records from the Divine Providence Minneota Clinic also indicated that the loss of smell and taste occurred four days after plaintiff began taking the Z-Pack, that the Z- Pack was the only new medication, and the records make no mention plaintiffs usage of the Zicam at all. Plaintiffs record from the Ear, Nose & Throat Clinic further stated that plaintiff "noted that she had bronchitis in the beginning of May and then shortly thereafter being on Zithromax, lost her sense of smell and taste completely." Cialkowski Aff., Ex. D, p. 14. According to plaintiff, she did not begin taking the Zicam until June of 2003. Cialkowski Aff., Ex. B., (Pl. Response to Interrogatory No. 12). While plaintiff stated that she had no smell or taste after using the Zicam, she did not state whether her senses of smell and taste were functional before she used the product. Id. However, none of plaintiffs medical records address plaintiffs usage of Zicam, or list it as a medicine used by plaintiff. Plaintiff has provided no support for her allegations that the allegedly defective Zicam was the cause of her loss of taste and smell. WEST MN © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 Case 4:13-cv-00321-CDL Document 40-11 Filed 08/29/16 Page 6 of 7 Rye v. Matrixx Initiatives, Inc., Not Reported in F.Supp.2d (2007) 2007 WL 2475960 In summary, the undisputed facts establish that plaintiff was diagnosed with bronchitis in May of 2003, and was prescribed the Z-Pack. Four days after using the Z- Pack, plaintiff lost her sense of smell and taste. Two different doctors attributed plaintiffs loss of sense and smell to a viral condition. Plaintiff has presented no expert testimony to support her claim that Zicam was the cause of her loss of sense of smell or taste. Under these facts, plaintiff has not shown that the Zicam was defective, or that it was the cause of her injuries. As such, plaintiffs claims fail as a matter of law, and summary judgment is proper in this case. See Fireman's Fund Ins. Co., 394 F.3d at 1061 (where plaintiff presented no evidence that product was defective and therefore could not prove that a defect in the product was the proximate cause of the injury, summary judgment for defendant was proper). The Court recommends that defendants' motion for summary judgment be granted. RECOMMENDATION For the reasons set forth above and based on all the files, records, and proceedings herein, IT IS RECOMMENDED that: 1. Defendants' Motion for Summary Judgment [Docket No. 60] be GRANTED; and 2. Plaintiffs Complaint be DISMISSED WITH PREJUDICE. A11 Citations Not Reported in F.Supp.2d, 2007 WL 2475960 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. MAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 Case 4:13-cv-00321-CDL Document 40-11 Filed 08/29/16 Page 7 of 7 EXHIBIT I Case 4:13-cv-00321-CDL Document 40-12 Filed 08/29/16 Page 1 of 7 Nelson v. Navistar Intern. Corp., Not Reported in F.Supp.2d (2011) 2011 WL 5374438 2011 WL 5374438 Only the Westlaw citation is currently available. United States District Court, D. Minnesota. Francis NELSON, Plaintiff, v. NAVISTAR INTERNATIONAL CORP., Defendant. Civil No. 10-137 (JRT/SER). Nov. 7, 2011. Attorneys and Law Firms Randall G. Knutson and Daniel J. Bellig, Farrish Johnson Law Office, Mankato, MN, for plaintiff. James H. Song and David N. Lutz, Bowman & Brooke LLP, Minneapolis, MN, for defendant. MEMORANDUM OPINION AND ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT JOHN R. TUNHEIM, District Judge. *1 Plaintiff Francis Nelson brought this action against Navistar International Corp. ("Navistar") 1 alleging negligent manufacture and installation of the driveshaft of a truck that Navistar manufactured. Nelson was operating a truck immediately behind the Navistar truck when the driveshaft and other debris fell out of the Navistar truck and into Nelson's lane of traffic. Nelson's truck ran over some of the debris, causing damage to the truck. While Nelson was inspecting the damage to his truck, a tire exploded, damaging Nelson's ear. Nelson is seeking damages for the injuries he suffered, including loss of hearing. Navistar has filed a motion for summary judgment. 1 The correct name of the defendant is Navistar, Inc., but it is incorrectly named as Navistar International Corporation in the Complaint. (Def.'s Mem Supp. Summ. J. at 1, Docket No. 42.) The Court will refer to the defendant as Navistar. The Court will grant summary judgment to Navistar because no reasonable fact finder could conclude it was more likely than not that a defective condition rendered the Navistar truck unreasonably dangerous or that a defect in the Navistar truck caused Nelson's injury. BACKGROUND Francis Nelson is a semi-truck driver who lives in Hector, Minnesota. (Compl., TT 1, 4, Docket No. 1.) He is fifty-six years old and has been an over-the-road truck driver for thirty-seven years. (Aff. of Daniel J. Bellig, May 20, 2011, Ex. D, Nelson Dep. at 45, 48, Docket No. 50.) On April 10, 2007, at approximately 12:15 p.m., Nelson was driving south in a Kenworth semi-truck on 1-95 (State Road 9) in Florida. Nelson was following a 2007 Navistar-built International 5600i 6x6 straight truck ("Navistar truck"). (Aff. of Roy S. Zeitlow, Apr. 28, 2011, ¶ 4, Docket No. 44; Bellig Aff., Ex. E, Arneson Dep. at 7, Docket No. 48.) The drive shaft and other debris fell from the Navistar truck and landed in Nelson's lane of traffic. (Nelson Dep. at 84.) Because of other traffic on the road, Nelson could not swerve and was forced to hit the metal debris. (Id at 84-85.) Nelson then pulled off the road and exited his truck. (Compl. ¶ 4; Nelson Dep. at 89.) He first spoke to WEST LAIN © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 Case 4:13-cv-00321-CDL Document 40-12 Filed 08/29/16 Page 2 of 7 Nelson v. Navistar Intern. Corp., Not Reported in F.Supp.2d (2011) 2011 WL 5374438 the driver of the car behind him, Sandra Taylor, whose car had also been hit by debris. (Nelson Dep. at 85-86.) After speaking to Taylor, Nelson inspected his vehicle for damage. (Id. at 88.) During the inspection, one of his truck's tires exploded, and as a result of the explosion, Nelson suffered hearing loss in his left ear. (Comp'. ¶ 4; Nelson Dep. at 7, 86, 88.) Nelson asserts, based on his observations of the incident and thirty-five years of experience being around trucking equipment, that the Navistar truck's transfer box exploded. (Nelson Dep. at 80-81.) Nelson testified, "I saw a great big puff of smoke and stuff fly off this truck, this International truck." (Id. at 79.) He also stated "I-what I think happened is the transfer box exploded." (Id. at 81.) Navistar asserts that Nelson is not qualified to offer this testimony because he is not an expert. In addition, Nelson had never before seen a transfer box explode, and did not know what would cause one to do so. (Id.) The explanation Nelson gave for his conclusion that the transfer box exploded was, "I really don't know how to explain it, but it's that that's what it seemed like to me because a truck of that type, they have them on there and it came from the general area where they are." (Id.) Navistar Truck *2 The Navistar truck had 8,159 miles on it at the time of the accident and had left Navistar's control five months prior to the accident. (Zeitlow Aff. 111 3-4.) Kobrin Builders Supply of Orlando, Florida owned the Navistar truck. (Pl.'s Mem. Opposing Def .'s Mot. to Change Venue, at 4, Docket No. 24.) Nothing in the record indicates that any modifications had been made to the truck by Kobrin Builders Supply. (See Pl.'s Mem. Opposing Summ. J. at 6, Docket No. 48.) Following the accident, the Navistar truck was towed to the Maudlin International dealership for assessment and repairs. (See Def.'s Reply Mem. Supp. Summ. J. at 14, Docket No. 51.) Someone at the dealership filled out a warranty claim form and submitted it to Navistar. (Arneson Dep. at 9.) The warranty claim form contains codes describing the basis for the claim. (Id. at 9-10, Ex. 4.) The codes indicted a "production part," the "real seal," was "inoperative." (Bellig Aff., Ex. A. at 3-4.) Ronald Arneson, a Customer Service Engineer for Navistar, performed a "failed parts inspection" of the Navistar truck for Navistar. (Arneson Dep. at 4, 11.) Following this inspection, Arneson directed Navistar to pay the warranty claim submitted by the dealership. (Id at 23.) Describing the process, Arneson stated, "I would have gone to the dealership, I would have viewed the available parts at that time and did not see a reason why we would deny the dealer's claim as a warranty repair." (Id. at 23.) Following an inspection, it is normal practice for the dealership to retain the failed parts for a limited amount of time. (Id at 38.) By the time he was deposed (in March 2011, nearly three years after the accident), Arneson believed the parts he inspected had already been disposed of. (Id. at 38.) Nelson's truck Nelson's Kenworth semi-truck also suffered extensive damage and was towed to a Kenworth dealership. (Nelson Dep. at 100 & Ex. 7.) Over $7,000 of repairs were performed on Nelson's truck by the dealership. (Id.) On August 24, 2007, FCCI Insurance Group, as "subrogee of Francis Nelson" in consideration of $3,916.98 "paid by and on behalf of International Truck and Engine Corporation" entered a Full and Final Settlement and General Release Agreement. (Aff. of James H. Song, Apr. 29, 2011, Ex. F. at 1, Docket No. 43.) The agreement states: [FCCI Insurance Group] intend to and hereby release and forever discharge International Truck and Engine Corporation ... from any and all property claims, causes of action and demands regarding property damage of every kind or nature, known or unknown, anticipated or unanticipated, suspected or unsuspected, including any claim for increased damaged for changed conditions and consequences flowing therefrom ... arising out of or in any way pertaining to any and all losses, costs, damages or expenses, whatsoever, resulting from or in any way growing out of the accident that occurred on April 10, 2007. . WESTL,AW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 Case 4:13-cv-00321-CDL Document 40-12 Filed 08/29/16 Page 3 of 7 Nelson v. Navistar Intern. Corp., Not Reported in F.Supp.2d (2011) 2011 WL 5374438 *3 (Id) International Truck and Engine Corporation sent two checks made payable to FCCI on August 24. (Arneson Dep., Ex. 6.) The letter accompanying the checks states that "$3,916.98 ... is for reimbursement of payments made by FCCI to Francis Nelson for property damage" and "$4,161.04 ... is for reimbursement of payments made to Sandra Taylor 2 for property damage." (Id) 2 Sandra Taylor was the driver of the car behind Nelson. (Nelson Dep. at 85-86.) On December 17, 2009, Nelson commenced this action against Navistar in Minnesota State Court seeking damages for losses associated with the injury to his ear. On January 15, 2010, Navistar removed this action to federal court. On August 4, 2010, this Court denied Navistar's motion to transfer venue to Florida. ANALYSIS I. STANDARD OF REVIEW Summary judgment is appropriate where there are no genuine issues of material fact and the moving party can demonstrate that it is entitled to judgment as a matter of law. Fed R. Civ. P. 56(a). A fact is material if it might affect the outcome of the suit, and a dispute is genuine if the evidence is such that it could lead a reasonable jury to return a verdict for either party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986). A court considering a motion for summary judgment must view the facts in the light most favorable to the non-moving party and give that party the benefit of all reasonable inferences that can be drawn from those facts. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). II. NAVISTAR'S SUMMARY JUDGMENT MOTION "Minnesota merges negligence and strict liability claims into a single products liability theory, which employs a reasonable-care balancing test to determine whether a product is defective." Thompson v. Hirano Tecseed Co., Ltd, 456 F.3d 805, 809 (8th Cir.2006). 3 To recover under a defect-design theory in Minnesota, an injured party must establish the following: 3 "Federal courts sitting in diversity apply the choice- of-law rules of the forum state." Cicle v. Chase Bank USA, 583 F.3d 549, 553 (8th Cir.2009). Applying Minnesota's choice- of-law rules, the first inquiry is "whether the choice of one states law over another's creates an actual conflict." Jepson v. Gen. Cas. Co. 3rJESTI,AW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 Case 4:13-cv-00321-CDL Document 40-12 Filed 08/29/16 Page 4 of 7 Nelson v. Navistar Intern. Corp., Not Reported in F.Supp.2d (2011) 2011 WL 5374438 of Wis., 513 N.W.2d 467, 469 (Minn.1994). The parties agree that there is no conflict of law between Minnesota and Florida product liability law and that Minnesota law applies. (1) that the product was in a defective condition unreasonably dangerous for its intended use; (2) that the defect existed when the product left the defendant's control; and (3) that the defect was the proximate cause of the injury sustained. Patton v. Newmar Corp., 538 N.W.2d 116, 119 (Minn.1995). The Court will grant Navistar's motion for summary judgment because Nelson has failed to provide enough evidence to demonstrate (1) that a defect rendered the product unreasonably dangerous for its intended use, (2) that the defect was the likely cause of the accident, or (3) that a defect was a proximate cause of the injury sustained. A. Evidence that a Defect Rendered the Product Dangerous for its Intended Use Nelson has not produced enough evidence to demonstrate that Navistar's product was defective, rendering it dangerous for its intended use. Nelson has the burden of introducing sufficient evidence that would permit a jury to find it more likely than not that the Navistar truck was defective. See Peterson v. Crown Zellerbach Corp., 209 N.W.2d 922, 923 (Minn.1973) (noting that the burden of proof is on the plaintiff). "It is never enough ... [to] suggest[ ] a possibility. The evidence in proof must justify sound and honest inferences." Id. at 923-24 (quoting LaFavor v. Ain. Nat'l Ins. Co., 155 N.W.2d 286, 291 (Minn.1967)). *4 Nelson need not necessarily rely on expert testimony to demonstrate that the product is defective. "Expert testimony is not necessary to establish a standard of care `where the acts or omissions complained of are within the general knowledge and experience of laypersons.' " Burris v. Versa Prods., Inc., 2009 WL 3164783, at *3 (D.Minn. Sept. 29, 2009) (quoting Mozes v. Medtronic, Inc., 14 F. Supp .2d 1124, 1128 (D. Minn .1998)); see also Peterson, 209 N.W.2d at 924 ("[T]here is no hard-and- fast rule requiring plaintiff to introduce expert testimony in product liability cases...."). "If, however, it would be speculative for the fact finder to decide the issue of negligence without having the benefit of expert testimony on the standard of care, the expert testimony is necessary." Mozes, 14 F.Supp.2d at 1129 (internal quotation marks and citation omitted). Nelson provides no expert testimony, but he asserts that Navistar's payment of the warranty claim evidences a product defect, establishing that "a failed rear seal" which is "a 'production part,' was inoperative and the cause of the parts failure." (Pl.'s Memo. Opposing Summ. J. at 9.) Navistar asserts that the warranty forms are inadmissible. Even assuming that the warranty repair forms are admissible, Nelson nevertheless fails to provide any evidence that the defect created a condition "unreasonably dangerous for its intended use." Patton, 538 N.W.2d at 119. Assuming that the evidence proves the ring seal was defective, there is no evidence that would allow a jury to determine that this defect created an unreasonably dangerous condition. No evidence connects the defective ring seal to the explosion observed by Nelson or to the disconnection of the drive shaft. Therefore, "it would be speculative for the fact finder to decide the issue of negligence" on the presented evidence. Mozes, 14 F.Supp.2d at 1128 (internal quotation marks and citation omitted). Any connection is just a "possibility"- insufficient to "justify sound and honest inferences." See Peterson, 209 N.W.2d at 923-24. Nelson also states that the lack of evidence demonstrating a defect could be overcome by an adverse inference instruction for spoliation of the Navistar parts. An adverse inference instruction is inappropriate here. Such in EST L. AIN © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 Case 4:13-cv-00321-CDL Document 40-12 Filed 08/29/16 Page 5 of 7 Nelson v. Navistar Intern. Corp., Not Reported in F.Supp.2d (2011) 2011 WL 5374438 an instruction for the pre-litigation destruction of evidence requires a showing of "intentional destruction indicating a desire to suppress the truth." Morris v.. Union Pac. R.R., 373 F.3d 896, 901 (8th Cir.2004) ((quotation marks and citation omitted). There is no evidence indicating that either Navistar or the dealership intentionally destroyed evidence to suppress the truth. Neither Navistar nor Arneson, its Customer Service Engineer, ever had custody of the parts. (Arneson Dep. at 39 .) Moreover, nothing in the record suggests that Navistar instructed the dealership to destroy the parts for any reason, much less in order to suppress evidence. Therefore, an adverse inference instruction would be inappropriate. *5 In conclusion, the Court finds Nelson has not produced expert testimony or any other evidence that would allow a reasonable fact finder to conclude that a defect existed, rendering the Navistar truck dangerous for its intended use. B. Evidence that a Defect Existed When the Truck left Navistar's Control Even if the Court had found a defect existed in the Navistar truck rendering it dangerous for its intended use, no record evidence suggests that the defect existed when the truck left Navistar's control. Nelson argues that payment of the warranty claim for the Navistar truck is an "admission of liability"-including the fact that the defect existed when it left Navistar's control. (Pl.'s Mem. Opposing Summ. J. at 14.) However, Nelson provided no evidence that the accident is necessarily attributable to a manufacturing defect and not "to one or more causes for which defendant is not responsible," such as debris on the road. Bossons v. Hertz Corp., 176 N.W.2d 882, 885 (Minn.1970). The Court concludes there is no evidence that would allow a reasonable fact finder to determine that a defect that caused the accident existed when the Navistar truck left Navistar's control. 1. The Doctrine of Res Ipsa Loquitur Does Not Rescue Nelson's Claim Nelson argues that sufficient circumstantial evidence exists to establish that the Navistar truck was defective and that the defect existed when the truck left Navistar's control. The doctrine of res ipsa loquitur "is merely another way of characterizing the minimal kind of circumstantial evidence which is legally sufficient to warrant an inference of negligence." Olson v. St. Joseph's Hosp., 281 N.W.2d 704, 708 (Minn.1979). To submit his claim to the jury on the theory of res ipsa loquitur, Nelson must establish sufficient evidence of three elements: (1) The event must be of a kind which ordinarily does not occur in the absence of someone's negligence; (2) it must be caused by an agency or instrumentality within the exclusive control of the defendant; and (3) it must not have been due to any voluntary action or contribution on the part of the plaintiff. Stelter v. Chiquita Processed Foods, LLC, 658 N.W.2d 242, 247 (Minn.Ct.App.2003) (quoting Warrick v. Giron, 290 N.W.2d 166, 169 (Minn.1980)). However, "the doctrine is inapplicable if the accident may reasonably be attributable to one or more causes for which defendant is not responsible." Bossons, 176 N.W.2d at 885. The Court finds the doctrine of res ipsa loquitur inapplicable because Nelson has failed to demonstrate (1) that the events would not normally occur in the absence of negligence or (2) that Navistar had exclusive control of the Navistar truck. 4 4 Neither party presented any evidence that Nelson contributed in any way to the accident. Nelson contends that his testimony, Arneson's testimony, and other record evidence of similar malfunctions demonstrate that the accident would not have occurred in the absence of negligence. However, neither Nelson nor Arneson provided testimony establishing that only negligence would cause parts to fall off the truck. Although Nelson asserts that other Navistar trucks in the same series have had chronic problems with drive shafts, he does not explain the relevance of or to lay foundation for these other instances, and the probative value of this evidence is unclear because of dissimilarities between this accident and the other instances. In sum, Nelson failed to W © 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 Case 4:13-cv-00321-CDL Document 40-12 Filed 08/29/16 Page 6 of 7 Nelson v. Navistar Intern. Corp., Not Reported in F.Supp.2d (2011) 2011 WL 5374438 present evidence that the only reason the drive shaft would have fallen out was someone's negligence. *6 At the time of the accident, Navistar no longer retained exclusive control over the Navistar truck. However, exclusivity for the purposes of res ipsa loquitor "is sufficiently shown if the defendant had control of the instrumentality at the time of the negligent act, even if control might have not been exclusive when the injury occurred." Stetter, 658 N.W.2d. at 248. Because Nelson has not identified the negligent act, the Court finds that Nelson has not presented sufficient evidence that Navistar had control of the truck at the time of the negligent act. The Court concludes Nelson has failed to demonstrate that the accident would not normally occur in the absence of negligence and that Navistar had exclusive control of the Navistar truck. Therefore, the doctrine of res ipsa loquitur does not rescue Nelson's claims that the Navistar truck was defective and that the defect existed when the truck left Navistar's control. C. Evidence that the Defect Was the Proximate Cause of Nelson's injuries Even if the Court found that the Navistar truck was defective and the defect existed at the time the truck left Navistar's control, there is insufficient evidence for a reasonable fact finder to determine that the defect was the cause of Nelson's injuries. A defect was the cause of Nelson's injuries only if the defect caused the drive shaft to fall from the Navistar truck, the drive shaft caused the damage to Nelson's truck, the damage to Nelson's truck caused his tire to explode-after some delay-and the explosion from his tire caused Nelson's hearing loss. There is no evidence for this causal connection other than the temporal proximity of the falling debris and Nelson's injury. The Court concludes that this connection is too attenuated to support a finding that the defect was the proximate cause of Nelson's injuries. The Court concludes that Nelson has not demonstrated sufficient evidence (1) that the Navistar truck was in a defective condition unreasonably dangerous for intended use, (2) that the defect existed when the truck left Navistar's control, or (3) that the defect was the proximate cause of Nelson's injuries. For these reasons, the Court grants Navistar's motion for summary judgment. ORDER Based on the foregoing, and all the files, records, and proceedings herein, IT IS HEREBY ORDERED that Navistar International Corporation's Motion for Summary Judgment [Docket No. 40] is GRANTED. LET JUDGEMENT BE ENTERED ACCORDINGLY. All Citations Not Reported in F.Supp.2d, 2011 WL 5374438 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. WESTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 Case 4:13-cv-00321-CDL Document 40-12 Filed 08/29/16 Page 7 of 7 EXHIBIT J Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 1 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 1 of 14 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE * MDL Docket No. 2004 4:08-MD-2004 (CDL) TRANSOBTURATOR SLING PRODUCTS Case Nos. LIABILITY LITIGATION * 4:13-cv-221 (Burgess) * 4:13-cv-228 (Smart) ORDER Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiffs Helen Burgess and Jeanie Smart were implanted with ObTape and assert that they suffered injuries caused by ObTape. Plaintiffs brought a product liability action against Mentor, contending that ObTape had design and/or manufacturing defects that proximately caused their injuries. Plaintiffs also assert that Mentor did not adequately warn their physicians about the risks associated with ObTape. Mrs. Burgess's husband Robert brought a loss of consortium claim. Mentor seeks summary judgment on Plaintiffs' claims, contending that they cannot establish causation. As discussed below, Mentor's summary judgment motion (ECF No. 39 in 4:13-cv-221) is granted as to Mrs. Burgess's failure to warn claim but denied as to the Burgesses' other claims. Mentor's summary judgment motion (ECF No. 39 in 4:13- Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 2 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 2 of 14 cv-228) is granted as to Smart's failure to warn and breach of warranty claims but denied as to Smart's other claims.' SUMMARY JUDGMENT STANDARD Summary judgment may be granted only "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). In determining whether a genuine dispute of material fact exists to defeat a motion for summary judgment, the evidence is viewed in the light most favorable to the party opposing summary judgment, drawing all justifiable inferences in the opposing party's favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). A fact is material if it is relevant or necessary to the outcome of the suit. Id. at 248. A factual dispute is genuine if the evidence would allow a reasonable jury to return a verdict for the nonmoving party. Id. FACTUAL BACKGROUND I. Helen Burgess On November 9, 2004, Dr. Luis Sanz implanted Mrs. Burgess with ObTape to treat her stress urinary incontinence. When he implanted Mrs. Burgess with ObTape, Dr. Sanz was aware that certain risks, including vaginal and urethral erosion, were generally associated with suburethral sling products. In his Smart and the Burgesses assert their claims separately in two independent civil actions. Because the resolution of the summary judgment motions in both actions involves similar issues related to causation, the Court decides both motions in this single order. 2 Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 3 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 3 of 14 deposition, Dr. Sanz testified that if Mentor had disclosed certain characteristics of ObTape or if Mentor had disclosed the true risks of ObTape before Mrs. Burgess's implant surgery, he "probably would have used an alternate product." Sanz Dep. 108:15-109:3, ECF No. 40-9 in 4:13-cv-221; accord id. at 112:13- 113:12.2 But Dr. Sanz also testified that he could not identify any statement or representation from Mentor that played any role in his decision to implant Mrs. Burgess with ObTape. Sanz Dep. 61:7-11, ECF No. 39-5 in 4:13-cv-221. At some point after the implant surgery, Mrs. Burgess began to experience pelvic pain and worsening urge incontinence. In 2011, Mrs. Burgess reported to her primary care physician that she was suffering progressively worsening recurrence of incontinence, and she sought treatment from several physicians for her symptoms. It is undisputed that Mrs. Burgess has never been diagnosed with an erosion or infection of her ObTape. 2 There is nothing in Mrs. Burgess's statement of material facts regarding this testimony, though the testimony is referenced in Mrs. Burgess's response brief. If counsel for Mrs. Burgess has other cases in this MDL, counsel is expected to follow the local rules when responding to summary judgment. Specifically, counsel is encouraged to review Local Rule 56, which requires that a summary judgment respondent "attach to the response a separate and concise statement of material facts, numbered separately, to which the respondent contends there exists a genuine dispute to be tried." M.D. Ga. L.R. 56. Such facts would, of course, include facts regarding causation, which Mrs. Burgess's counsel included in the brief but inexplicably did not include in the response to Mentor's statement of material facts. 3 Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 4 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 4 of 14 Dr. Amanda White reviewed Mrs. Burgess's medical records related to her ObTape treatment.3 Based on that review, Dr. White produced an expert report. Dr. White opines that the "material properties" of ObTape "are such that tissue in-growth with capillary penetration is prohibited." Pl.'s Resp. to Def.'s Mot. for Summ. J. Ex. 12, Rule 26 Expert Report of Amanda B. White, M.D. 8 ("Dr. White Report re Burgess"), ECF No. 40-14 in 4:13-cv-221. Because of those properties, "[w]hile bacteria are able to enter the graft, host defense mechanisms are unable to respond within the device secondary to the size of leukocytes and macrophages. The result is an encapsulated graft with acute and chronic inflammation that is likely to be extruded into the vagina or the urethra." Id. Dr. White noted that this result "can be seen in the case of induration and tenderness to palpation noted at the mid-urethra on examination of Helen Burgess." Id. Dr. White further opined, "Ms. Burgess continues to be bothered by severe urinary incontinence and groin pain, which occurred as a result of the chronic induration caused by the ObTape implant." Id. Mrs. Burgess brought claims for strict liability (design defect, manufacturing defect, failure to warn), negligence, and 3 There is nothing in Mrs. Burgess's statement of material facts regarding Dr. White's report, though the report is referenced in Mrs. Burgess's response brief. 4 Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 5 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 5 of 14 breach of express and implied warranties. Mr. Burgess brought a loss of consortium claim. II. Jeanie Smart On February 28, 2005, Dr. Lionel Meadows implanted Smart with ObTape to treat her stress urinary incontinence. Smart's ObTape has never been explanted, and she has never been diagnosed with an erosion of her ObTape. Smart contends that the ObTape has caused urinary tract infections, vaginal infections, soreness in her pelvic area, hematuria, dyspareunia, and urinary dysfunction. Between 2007 and 2015, Smart sought treatment for a variety of issues, including urinary tract infections, bacterial vaginitis, lower abdominal pain, dysuria, urinary urgency, and hematuria. In 2016, Smart was evaluated by Dr. Amanda White. Dr. White observed "significant induration and some granulation at the mid-urethra, and the area was extremely tender to palpation at the prior implant site." Pl.'s Resp. to Def.'s Mot. for Summ. J. Ex. G, Rule 26 Expert Report of Amanda B. White, M.D. 8 ("Dr. White Report re Smart"), ECF No. 40-9 in 4:13-cv-228. Dr. White also observed that "there was graft palpable, with only a thin layer of mucosa covering the graft at the mid-urethra." Id. Dr. White has recommended removal of Smart's ObTape. Id. 5 Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 6 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 6 of 14 Smart brought claims for strict liability, negligence, design defect, manufacturing defect, failure to warn, and breach of warranty. Smart concedes that Mentor is entitled to summary judgment on her failure to warn and breach of warranty claims. The Court therefore grants Mentor's summary judgment motion as to those claims. DISCUSSION The Burgesses filed their action in this Court on July 3, 2013 under the Court's direct filing order. Smart filed her action in this Court on July 8, 2013 under the Court's direct filing order. The parties agreed that for direct-filed cases, the "Court will apply the choice of law rules of the state where the plaintiff resides at the time of the filing of the complaint." Order Regarding Direct Filing § II(E), ECF No. 446 in 4:08-md-2004. The Burgesses live in West Virginia. It is not clear from the present record where Mrs. Burgess's ObTape- related treatment occurred, but the parties agree that her injuries occurred in West Virginia and that West Virginia law applies to the Burgesses' claims. When Smart filed her Complaint, she lived in Georgia. Smart's ObTape implant surgery took place in Georgia. The parties agree that Georgia law applies to Smart's claims. The main question presented by Mentor's summary judgment motions is whether Plaintiffs can establish that a defect in Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 7 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 7 of 14 ObTape caused their injuries. Plaintiffs do not dispute that they must establish both general causation and specific causation to prevail on their claims. General causation requires Plaintiffs to establish that a defect in ObTape has the potential to cause the type of injuries they suffered. Guinn v. AstraZeneca Pharm. LP, 602 F.3d 1245, 1249 n.1 (11th Cir. 2010) (per curiam) (applying Georgia law); accord Morningstar v. Black & Decker Mfg. Co., 253 S.E.2d 666, 682 (W. Va. 1979) (stating that in product liability cases, the inquiry "focuses on the nature of the defect and whether the defect was the proximate cause of plaintiff's injury); see also Meade v. Parsley, No. 2:09-CV-00388, 2010 WL 4909435, at *5 (S.D.W. Va. Nov. 24, 2010) (explaining general and specific causation). Specific causation requires Plaintiffs to show that a defect in ObTape actually caused their injuries. Guinn, 602 F.3d at 1249 n.l. To establish causation, Burgess points to the unsworn expert reports of Dr. Andrew Siegel and Dr. Amanda White, and Smart points to the unsworn expert reports of Dr. Donald Ostergard, Dr. Andrew Siegel, and Dr. Amanda White. Mentor argues that the Court may not consider these unsworn expert reports. As the Court recently explained, Mentor's argument is based on an Eleventh Circuit case evaluating a prior version of Federal Rule of Civil Procedure 56. In 2003, the Eleventh Circuit found that the district court did not err by declining 7 Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 8 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 8 of 14 to consider unsworn expert reports submitted in opposition to summary judgment. Carr v. Tatangelo, 338 F.3d 1259, 1273 n.26 (11th Cir. 2003), as amended (Sept. 29, 2003). The Eleventh Circuit emphasized that the version of Rule 56(c) in effect at the time stated that, at summary judgment, a district court could consider "[o]nly 'pleadings, depositions, answers to interrogatories, and admissions on file, together with affidavits." Id. (emphasis omitted) (quoting Fed. R. Civ. P. 56(c) (2003)). The present version of Rule 56(c)(1), which became effective December 1, 2010, states: A party asserting that a fact cannot be or is genuinely disputed must support the assertion by: (A) citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers,'or other materials; or (B) showing that the materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact. Rule 56. further provides: "A party may object. that the material cited to support or dispute a fact cannot be presented in a form that would be admissible in evidence." Fed. R. Civ. P. 56(c)(2). If a party objects that the material cited cannot be presented in an admissible form, then the proponent of the evidence must show "that the material is admissible as presented 8 Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 9 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 9 of 14 or . . . explain the admissible form that is anticipated." 2010 Advisory Comm. Note to Rule 56(c)(2). Based on the text of the current version of Rule 56, the Court finds that it may consider the unsworn expert reports over Mentor's objection as long as Plaintiffs explain how the opinions stated in the expert reports will be reduced to admissible form at trial. The Burgesses stated that they will present the testimony of Drs. Siegel and White at trial, and Smart stated that she will present the testimony of Drs. Ostergard, Siegel, and White at trial. The Court is thus satisfied that the expert reports will be reduced to admissible form at trial, and the Court will consider the expert reports. I. General Causation The first question is whether Dr. Siegel's report establishes that ObTape is capable of causing the types of injuries Plaintiffs suffered.4 Mentor asserts that Dr. Siegel has never opined that ObTape can cause the specific types of pelvic infections Plaintiffs suffered: groin pain for Mrs. Burgess and urinary tract infections, vaginitis, and pain for Smart. Dr. Siegel has opined that the physical properties of 4 Only Smart relies on Dr. Ostergard's expert report, which contains opinions similar to those in Dr. Siegel's report. See generally Pl.'s Resp. to Def.'s Mot. for Summ. J. Ex. E, Rule 26 Expert Report of Dr. Donald Ostergard 2-3, ECF No. 40-7 in 4:13-cv-228. Since Mrs. Burgess does not rely on Dr. Ostergard's report and since Dr. Siegel's report is sufficient to establish general causation, the Court does not discuss Dr. Ostergard's report here. 9 Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 10 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 10 of 14 ObTape can prevent normal tissue in-growth and can cause chronic inflammation. E.g., Pl.'s Resp. to Def.'s Mot. for Summ. J. Ex. F, Rule 26 Expert Report of Andrew L. Siegel, M.D. 3-4, ECF No. 40-8 in 4:13-cv-228. He also opined that these complications can lead to pain, infection, problems with pelvic muscle and nervous tissue, and other symptoms. Id. at 3-4. And he opined that due to ObTape's physical properties, ObTape complications occur more often and with greater severity than complications with other suburethral slings. Id. Though Smart did not point to a portion of either doctor's report specifically stating that ObTape could cause vaginitis or urinary tract infections, it is undisputed that both of these symptoms are pelvic infections, and Dr. Siegel opined that ObTape can cause pelvic infections. Likewise, Dr. Siegel opined that ObTape can cause groin pain. The Court is thus satisfied that Dr. Siegel's opinions are sufficient to establish that a defect in ObTape could cause Plaintiffs' injuries. II. Specific Causation A. The Burgesses' Claims Mentor does not appear to dispute that if Dr. White's expert report is considered in Mrs. Burgess's case, it is sufficient to create a genuine fact dispute on specific causation. See Dr. White Report re Burgess 8 (opining that "Ms. Burgess continues to be bothered by severe urinary incontinence 10 Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 11 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 11 of 14 and groin pain, which occurred as a result of the chronic induration caused by the ObTape implant"). Mentor is thus not entitled to summary judgment on Mrs. Burgess's design defect, manufacturing defect, and negligence claims. B. Smart's Claims Mentor does not appear to dispute that if Dr. White's expert report is considered in Smart's case, it is sufficient to create a genuine fact dispute on specific causation. See Dr. White Report re Smart 9 (opining, "to a reasonable degree of medical certainty that [t]he Mentor ObTape is a substantial contributing cause of Ms. Smart's recurrent urinary tract infections, recurrent vaginitis, persistent urinary incontinence, voiding obstruction, significant urgency and frequency, groin pain, dyspareunia, and need for subsequent surgeries and treatments"). Mentor is thus not entitled to summary judgment on Smart's product liability and negligence claims. III. Mrs. Burgess's Failure to Warn Claim Mentor argues that even if there is a genuine fact dispute on Mrs. Burgess's claims that a design defect or manufacturing defect in ObTape caused her injuries, her failure to warn claim still fails for lack of causation. Mrs. Burgess acknowledges that she must establish causation on her failure to warn claim- in other words, she must show that a different warning would 11 Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 12 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 12 of 14 have made a difference. Cf. Addair v. Island Creek Coal CO., No. 12-0708, 2013 WL 1687833, at *3 (W. Va. Apr. 17, 2013) (stating that a failure to warn must proximately cause the injury); Tracy v. Cottrell ex rel. Cottrell, 524 S.E.2d 879, 891 n.9 (W. Va. 1999) (finding no error in jury instruction stating that a manufacturer "may only be liable . for failure to warn where there is evidence that a warning would have made a difference"). Mrs. Burgess did not point to any evidence of what information she received from Mentor (via Dr. Sanz or otherwise), and she did not point to any evidence that if she had received different information from Mentor, her outcome would have changed. Mrs. Burgess does argue that different warnings to Dr. Sanz, her implanting physician, would have made a difference.5 But Dr. Sanz admitted that he could not identify any statement or representation from Mentor that played any role in his decision to implant Mrs. Burgess with ObTape. Although Dr. Sanz testified that he would not have implanted Mrs. Burgess with ObTape had Mentor disclosed additional facts about the product, Mrs. Burgess did not point to any evidence that Dr. 5 Although Mrs. Burgess contends that Mentor may not discharge its duty to warn her of the risks of ObTape by properly warning her prescribing physician of those risks, the only evidence Mrs. Burgess presented to establish causation on her failure to warn claim is Dr. Sanz's testimony that he would have used a different product if he had been made aware of problems with ObTape. The Court thus considers whether Dr. Sanz's testimony creates a fact dispute on causation. 12 Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 13 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 13 of 14 Sanz reviewed any materials from Mentor in selecting ObTape for Mrs. Burgess, so it is unclear how Dr. Sanz would have received additional facts about the product had Mentor disclosed them in its ObTape materials. In other words, given that Mrs. Burgess pointed to no evidence that Dr. Sanz read the warnings Mentor did provide, it is unclear how Dr. Sanz would have learned of additional warnings had Mentor provided them. See Meade, 2010 WL 4909435, at *10 (granting summary judgment based on failure to prove proximate causation where neither the doctor nor the patient read the existing warning "and therefore would not have seen a heightened warning even if it had been implemented"). For these reasons, Mentor is entitled to summary judgment on Mrs. Burgess's failure to warn claims. CONCLUSION For the reasons set forth above, Mentor's summary judgment motion (ECF No. 39 in 4:13-cv-221) is granted as to Mrs. Burgess's failure to warn claim but denied as to her other claims and as to Mr. Burgess's loss of consortium claim. This action is now ready for trial. Within seven days of the date of this Order, the Burgesses and Mentor shall notify the Court whether the parties agree to a Lexecon waiver. Mentor's summary judgment motion (ECF No. 39 in 4:13-cv- 228) is granted as to Smart's failure to warn and breach of warranty claims but denied as to her other claims. This action 13 Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 14 of 15 Case 4:13-cv-00221-CDL Document 45 Filed 08/18/16 Page 14 of 14 is now ready for trial. Within seven days of the date of this Order, Smart and Mentor shall file a joint report stating where in Georgia venue is proper. IT IS SO ORDERED, this 18th day of August, 2016. s/Clay D. Land CLAY D. LAND CHIEF U.S. DISTRICT COURT JUDGE MIDDLE DISTRICT OF GEORGIA 14 Case 4:13-cv-00321-CDL Document 40-13 Filed 08/29/16 Page 15 of 15 EXHIBIT K Case 4:13-cv-00321-CDL Document 40-14 Filed 08/29/16 Page 1 of 9 Bowman v. Wyeth, LLC, Not Reported in F.Supp.2d (2012) 2012 WL 684116 I KeyCite Yellow Flag - Negative Treatment Distinguished by Teva Pharmaceuticals USA, Inc. v. Superior Court, Cal.App. 4 Dist., June 13, 2013 2012 WL 684116 Only the Westlaw citation is currently available. United States District Court, D. Minnesota. Bobby Tate BOWMAN, Plaintiff, v. WYETH, LLC, f/k/a Wyeth, Inc., Wyeth Pharmaceuticals, Inc., and Teva Pharmaceuticals USA, Inc., Defendants. Civil No. 10-1946 (JNE/SER). March 2, 2012. Attorneys and Law Firms C. Andrew Childers, William A. Parker, Jr., Childers, Schlueter & Smith, LLC, Atlanta, GA, Lucia J.W. McLaren, Michael K. Johnson, Johnson Becker, PLLC, Mpls, MN, for Plaintiff. Erin M. Verneris, Bridget M. Ahmann, Faegre & Benson LLP, David L. Hashmall, Felhaber Larson Fenlon & Vogt, PA, Mpls, MN, David M. Melancon, Irwin Fritchie Urquhart & Moore LLC, New Orleans, LA, Richard A. Oetheimer, Goodwin Procter, LLP, Boston, MA, for Defendants. ORDER JOAN N. ERICKSEN, District Judge. *1 Plaintiff Bobby Tate Bowman ("Bowman") brought this action against Defendants Wyeth, LLC, Wyeth Pharmaceuticals, Inc., and Teva Pharmaceuticals USA, Inc. related to injuries he suffered from ingesting the prescription drug Reglan/metoclopramide. Now before the Court is Defendant Teva Pharmaceuticals USA, Inc.'s ("Teva") Motion for Judgment on the Pleadings. I. BACKGROUND Bowman filed this action on May 3, 2010, alleging claims of negligence and negligent misrepresentation and fraud. His claims are based on allegations that he was prescribed and ingested the prescription drug Reglan-and/or its generic equivalent, metoclopramide-and that his long- term use of the drug caused him to develop a condition known as Tardive Dyskinesia. 1 Teva manufactures and sells metoclopramide. Bowman alleges that Teva knew that the labeling for metoclopramide was inadequate and contained false and misleading information regarding metoclopramide's side effects. He further alleges that Teva encouraged long-term use of metoclopramide and concealed critical information indicating that long-term use of metoclopramide was unsafe. 1 Tardive Dyskinesia is a severe and often permanent disfiguring neurological movement disorder. On February 24, 2011, the Court stayed proceedings pending the United States Supreme Court's decision in the consolidated cases of Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir.2010) and Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir.2009). On June 23, 2011, the Supreme Court decided PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), holding that state-law tort claims based on an alleged failure to warn of the risks of generic medications are preempted by federal law because it is impossible to comply with both a state law duty to strengthen a generic drug warning and the federal mandate that a generic drug's labeling be the same as that of the brand-name drug. On August 23, 2011, the Court lifted the stay in this action. Teva has moved for Judgment on the Pleadings, arguing that all of Bowman's claims are preempted under PLIVA, Inc. v. Mensing. II. DISCUSSION A court should grant judgment on the pleadings only if the moving party clearly establishes that there are no material issues of fact and that it is entitled to judgment as a WESTLAW CO 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 Case 4:13-cv-00321-CDL Document 40-14 Filed 08/29/16 Page 2 of 9 Bowman v. Wyeth, LLC, Not Reported in F.Supp.2d (2012) 2012 WL 684116 matter of law. Porous Media Corp. v. Pall Corp., 186 F.3d 1077, 1079 (8th Cir.1999). A court evaluates a motion for judgment on the pleadings brought under Rule 12(c) of the Federal Rules of Civil Procedure under the same standard as a motion brought under Rule 12(b)(6). See Westcott v. City of Omaha, 901 F.2d 1486, 1488 (8th Cir.1990). In deciding a motion to dismiss for failure to state a claim pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure, a court must accept the facts alleged in the complaint as true and grant all reasonable inferences in favor of the plaintiff. Croolcs v. Lynch, 557 F.3d 846, 848 (8th Cir.2009). Although a complaint is not required to contain detailed factual allegations, "[a] pleading that offers 'labels and conclusions' or 'a formulaic recitation of the elements of a cause of action will not do.' " Ashcroft v. Iqbal, 556 U.S. 662 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). "To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.' " Id. (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." Id. A court may consider the complaint, matters of public record, orders, materials embraced by the complaint, and exhibits attached to the complaint in deciding a motion to dismiss under Rule 12(b)(6). Porous Media, 186 F.3d at 1079. A. The Mensing Decision *2 Mensing involved a plaintiff who ingested Reglan/metoclopramide and asserted a number of Minnesota tort-law claims against the brand-name and generic manufacturers of the drug. Her complaint asserted product liability claims of failure-to-warn, design defect, and manufacturing defect, as well as claims of negligence, negligent misrepresentation, misrepresentation by omission, constructive fraud, fraud by concealment, breach of express and implied warranties, and violations of several Minnesota consumer protection statutes. The generic manufacturer defendants moved to dismiss the complaint, asserting that the plaintiffs claims were essentially failure-to-warn claims and were preempted by the federal Food, Drug & Cosmetic Act. The plaintiff opposed the motion, and argued that even if her failure-to-warn claims were preempted, her other tort claims-such as design defect, negligent testing, and misrepresentation and fraud-would not be preempted. The district court granted the defendants' motion, noting that lallthough Plaintiff has asserted a variety of claims against Actavis and Pliva, at the core of all of Plaintiffs claims is the basic assertion that Actavis and Pliva failed to adequately warn about the association between long-term ingestion of [metoclopramide] and movement disorders." Mensing v. Wyeth, Inc., 562 F.Supp.2d 1056, 1058 (D.Minn.2008); see also id. at 1061 n. 6 (stating that "all of Plaintiffs claims are essentially 'failure to warn' claims and are encompassed by the Court's preemption analysis"). The court found that because, under federal law, a generic drug manufacturer cannot unilaterally strengthen or change a drug label, any state law imposing such a duty is preempted. Id. at 1064-65. The court rejected the plaintiffs argument that the generic manufacturers could have satisfied their duty by providing information to the Food and Drug Administration ("FDA") and having the FDA determine whether the labeling should be revised. "The outcome of any such request to make a revision is uncertain and would require speculation as to what the FDA might have done." Id. at 1065. Finally, the court rejected the plaintiffs argument that the defendants could have employed other means, such as submitting "Dear Doctor" letters, to warn health care professionals of the risks of metoclopramide, finding that such a duty would directly conflict with the statutory scheme of the Hatch-Waxman Act. Id On appeal, the Eighth Circuit reversed the district court's decision, finding that it would not be impossible for generic manufacturers to comply with both a heightened state law duty to warn and federal law. Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir.2009). The court stated that regardless of whether the generic manufacturers could unilaterally enhance a label warning, they "could have at least proposed a label change that the FDA could receive and impose uniformly on all metoclopramide manufacturers if approved." Id at 608. The generic manufacturers also "could have suggested that the FDA send out a warning letter to health care professionals." Id at 610. The court noted that there was no evidence suggesting that the FDA would have rejected such a label change proposal, and cited Wyeth v. Levine, 555 U.S. 555, 571 (2009), for the proposition that "absent clear evidence that the FDA would not have approved a change to [the drug]'s label, we will not conclude that it was impossible for [the manufacturer] to comply with both federal and state requirements." Mensing, 588 F.3d at 610. The court stated, WESTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 Case 4:13-cv-00321-CDL Document 40-14 Filed 08/29/16 Page 3 of 9 Bowman v. Wyeth, LLC, Not Reported in F.Supp.2d (2012) 2012 WL 684116 *3 [t]he generic defendants were not compelled to market metoclopramide. If they realized their label was insufficient but did not believe they could even propose a label change, they could have simply stopped selling the product. Instead, they are alleged to have placed a drug with inadequate labeling on the market and profited from its sales. If [plaintiff]'s injuries resulted from their failure to take steps to warn their customers sufficiently of the risks from taking their drugs, they may be held liable. Id at 611. The United States Supreme Court granted certiorari and on June 23, 2011, decided PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011). The Court reversed the Eighth Circuit's decision and found that it is impossible for a generic manufacturer to comply with both a heightened state law duty to warn and FDA regulations that require a generic manufacturer to have the same labels as the brand name drug. 2 Id at 2577-78. The Court first noted that if the manufacturer knew or should have known of a high risk of tardive dyskinesia related to the long-term use of the drug, and that its label did not adequately warn of that risk, "state law required the Manufacturers to use a different, safer label." Id at 2574. Federal law, however, requires that the warning label for a generic drug be the same as the label for the brand name drug. Id. (citing § 355(j)(2)(A)(v); § 355(j)(4)(G); 21 C.F.R. §§ 314.94(a)(8), 314.127(a)(7)). Thus, while brand-name manufacturers are responsible for the accuracy and adequacy of its label, "generic drug manufacturers have an ongoing federal duty of 'sameness.' " Id at 2574-75. 2 The Supreme Court in Mensing also reversed the Fifth Circuit's decision in Denwhy v. A ctavis, Inc., 593 F .3d 428 (5th Cir.2010). Deferring to the FDA's interpretation of its regulations, the Court rejected the plaintiff arguments that the FDA's "changes-being-effected" process allowed generic manufacturers to unilaterally change their labels or that generic manufacturers could provide additional warnings through "Dear Doctor" letters. Id at 2575- 76 ("A Dear Doctor letter that contained substantial new warning information would not be consistent with the drug's approved labeling. Moreover, if generic drug manufacturers, but not the brand-name manufacturer, sent such letters, that would inaccurately imply a therapeutic difference between the brand and generic drugs and thus could be impermissibly 'misleading.' "). Noting that under the Supremacy Clause, state law must give way to federal law where the laws directly conflict, the Court found that it was impossible for the generic drug manufacturers to comply with both state and federal law. Id at 2577. If the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law. Taking [plaintiffs] allegations as true, state law imposed on the Manufacturers a duty to attach a safer label to their generic metoclopramide. Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand- name drug labels. Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same. *4 Id at 2578. Even if there is a federal duty to ask the FDA for assistance in changing a drug label, the Court found that such a duty would not change the analysis. WEST1 CO 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 Case 4:13-cv-00321-CDL Document 40-14 Filed 08/29/16 Page 4 of 9 Bowman v. Wyeth, LLC, Not Reported in F.Supp.2d (2012) 2012 WL 684116 Id. ("Although requesting FDA assistance would have satisfied the Manufacturers' federal duty, it would not 3 have satisfied their state tort-law duty to provide adequate labeling. State law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label."). The Court also rejected the plaintiffs' argument that the manufacturers could have asked the FDA for assistance, which might have resulted in a labeling change for the drug. Id. The question for 'impossibility' is whether the private party could independently do under federal law what state law requires of it. Accepting [plaintiffs] argument would render conflict preemption largely meaningless because it would make most conflicts between state and federal law illusory. We can often imagine that a third party or the Federal Government might do something that makes it lawful for a private party to accomplish under federal law what state law requires of it.... If these conjectures suffice to prevent federal and state law from conflicting for Supremacy Clause purposes, it is unclear when, outside of express pre-emption, the Supremacy Clause would have any force. We do not read the Supremacy Clause to permit an approach to pre-emption that renders conflict pre-emption all but meaningless." Id. Id at 2579 (citation omitted). "[W]hen a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre- emption purposes." Id at 2581. "Here, state law imposed a duty on the Manufacturers to take a certain action, and federal law barred them from taking that action. The only action the Manufacturers could independently take -asking for the FDA's help-is not a matter of state-law concern. [Plaintiffs] tort claims are pre-empted." Id. Finally, noting the dissimilar statutory schemes for brand- name and generic drugs, the Court recognized that had the plaintiffs taken the brand-name drug, Reglan, rather than the generic drug, metoclopramide, "their lawsuits would not be preempted." Id. "We acknowledge the unfortunate hand that federal drug regulation has dealt [plaintiffs] and others similarly situated." Id 3 The Court reversed the judgments of the Fifth and Eighth Circuits and remanded the cases for further proceedings consistent with the opinion. The dissent also noted that a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand- name or generic drug ." M at 2583. The plaintiffs petitioned the Court for a rehearing, asserting that the Court "overlook[ed] the fact that the Petitioner generic drug companies could have `independently' complied with both state and federal law simply by suspending sales of generic metoclopramide with warnings that they knew or should have known were inadequate." Resp'ts' Pet. for Reh'g 1. The Supreme Court denied the petition. PLIVA, Inc. v. Mensing, 132 S.Ct. 55 (2011). *5 The plaintiff in Mensing then asked the Eighth Circuit to allow supplemental briefing regarding the implications of the Supreme Court's ruling. While acknowledging that WESTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 Case 4:13-cv-00321-CDL Document 40-14 Filed 08/29/16 Page 5 of 9 Bowman v. Wyeth, LLC, Not Reported in F.Supp.2d (2012) 2012 WL 684116 she could no longer pursue her failure-to-warn claims, she argued that claims based on other theories of liability survived the Court's decision. First, she contended that claims arising from the generic manufacturers' failure to communicate the FDA-approved changes to the Reglan label in July 2004 were not preempted. The generic manufacturers, she argued, could have implemented the labeling change "independently" once the Reglan labeling change was approved, and so claims based on this failure of the generic manufacturers were not preempted. Second, she asserted that the manufacturers should have suspended sales of the drug until an adequate label was approved by the FDA. "Nothing in federal law prohibited the Generic Drug Company Appellees from suspending sales of their drug, and action the companies could have taken entirely on their own initiative." Appellant's Mot. for Leave to File Supplemental Brief 4. Thus, she argued, claims based on failure to suspend sales were not preempted Finally, she argued that the Supreme Court only addressed federal preemption of failure-to-warn claims, and so non-failure-to-warn claims, such as her claims of negligence, breach of express warranty, fraud, misrepresentation, and violations of various Minnesota consumer protection statutes, would not be preempted. The Eighth Circuit rejected the plaintiffs arguments and denied her motion. The court vacated the portions of its prior opinion that found the failure-to-warn claims against the generic manufacturers were not preempted. It then ordered that the judgment of the district court be affirmed. Mensing v. Wyeth, Inc ., 658 F.3d 867 (8th Cir.2011). Similarly, in the Demahy case, the Fifth Circuit vacated the district court's order and remanded the case for entry of judgment in favor of the generic manufacturer. Demahy v. Actavis, Inc., 650 F.3d 1045 (5th Cir.2011). Pursuant to the Fifth Circuit's mandate, the district court entered judgment in favor of the defendants and dismissed the case with prejudice. Demahy v. Wyeth, Inc., Civil No. 08-3616, 2011 WL 5505399 (E.D.La. Aug. 30, 2011). The plaintiff in Demahy had also asserted claims of products liability, failure-to-warn, design defect, negligence, misrepresentation, and fraud. B. Application of Mensing to the Complaint Like the plaintiff in Mensing, Bowman urges the Court to adopt a very narrow reading of the Supreme Court's decision. He asserts that the only claims that are preempted are failure-to-warn claims relating to a generic manufacturer's failure to unilaterally change its labeling to differ from the approved labeling for the brand-name drug. He argues that Mensing did not consider whether a generic manufacturer could be "liable for selling an unreasonably dangerous product, for accompanying its product with false information about potential risks associated with metoclopramide, and for concealing important safety information from the FDA, consumers, and the medical community." Pl.'s Resp. Mem. 5 (emphasis in original). Thus, Bowman contends that he has asserted non-failure-to-warn claims that are not preempted. He also believes that claims based on Teva's alleged failure to include or communicate the 2004 labeling changes to the brand-name drug are not preempted. I. Bowman's "Other" Theories of Liability *6 Bowman contends that Mensing only pertained to failure-to-warn claims and does not affect claims based on other theories of liability. He states that in addition to providing inadequate warnings, Teva also "provided false information about the drug, concealed important safety information, and knowingly placed an unreasonably dangerous product into the stream of commerce...." Pl.'s Resp. Mem. 2. Although Bowman attempts to distinguish his various theories of liability, his claims are all based on Teva's alleged failure to provide adequate information or warnings, and thus are preempted under Mensing. In fact, his Complaint belies his own argument: "This case involves Pharmaceutical Defendants' failure to warn doctors and patients of information within their knowledge or possession which indicated that the subject Reglan/metoclopramide, when taken for long periods of time, caused serious, permanent, and debilitating side effects, including tardive dyskinesia." Complaint ¶ 27 (emphasis added). Like Mensing, "at the core of all of Plaintiffs claims is the basic assertion that [Teva] failed to adequately warn about the association between long-term ingestion of [metoclopramide] and movement disorders." Mensing v. Wyeth, Inc., 562 F.Supp.2d at 1058; see also Moretti v. Mut. Pharm. Co., Civil No. 10-896, 2012 WL 465867, at *4 (D.Minn Feb. 13, 2012) ("Despite the different 'labels' given these claims, the essence of these claims is that important safety information as to metoclopramide was not disseminated, or made clear, to the public or the medical community. In other words, Defendants failed to warn of material safety information concerning metoclopramide."). WESTLAW C:) 2016 Thomson Reuters. No claim to original U.S. Government Works. 5 Case 4:13-cv-00321-CDL Document 40-14 Filed 08/29/16 Page 6 of 9 Bowman v. Wyeth, LLC, Not Reported in F.Supp.2d (2012) 2012 WL 684116 Moreover, Bowman can point to no differences between his claims and those dismissed in Mensing. Even if the Supreme Court did not expressly hold that all state-law claims, even those not specifically labeled as "failure-to- warn" claims, are preempted, the Eighth Circuit appears to have adopted this position when it affirmed the district court's dismissal of all of Mensing's claims. Like Bowman, Mensing had also asserted claims of negligence, misrepresentation, and fraud. Mensing had also argued, to both the Supreme Court and the Eighth Circuit, that the generic drug manufacturers could have complied with state and federal law by suspending sales of the generic drug, or by withdrawing the drug from the market until the labeling could be made adequate. Both courts rejected this argument. There are no claims in Bowman's Complaint that were not also asserted in Mensing, and the Court cannot find any meaningful distinction between these two cases. 4 See Demahy v. Actavis, Inc., 650 F.3d 1045 (5h Cir.2011) (dismissing as preempted claims of failure-to-warn, design defect, negligence, misrepresentation, and fraud); Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir.2011) (finding claims of products liability, negligence, negligence per se, fraud, fraud by concealment, and breach of express and implied warranties preempted under Mensing ); Gaeta v. Perrigo Pharm. Co., No. 09-15001, 2012 WL 605678 (9th Cir. Feb. 27, 2012) (affirming the district court's dismissal of plaintiffs design defect, marketing defect, breach of express and implied warrant, negligence, and deceit by concealment claims, based on the Mensing decision). Thus, Bowman's negligence and negligent misrepresentation and fraud claims are preempted. Despite Bowman's arguments that claims of design defect and breach of express and implied warranties survive the Supreme Court's decision in Mensing, the Mensing complaint itself contained these types of claims and was nevertheless dismissed. Further, Bowman's Complaint does not expressly allege such claims, as conceded during oral argument, nor are there any factual allegations to support claims of that nature. 2. 2004 Labeling Change to Reglan *7 Bowman argued in his briefs that Teva could still be held liable, even after Mensing, for failing to update its labeling after the FDA approved a labeling change to the brand-name drug, Reglan, in July 2004.5 The Court need not address whether this type of claim is preempted under Mensing because Bowman does not assert this claim in his Complaint. His Complaint contains no specific allegation that he ingested metoclopramide after July 2004 (in fact, he does not even allege that he ingested metoclopramide for more than twelve weeks), nor does it contain any factual allegations relating to the 2004 labeling change WESTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 Case 4:13-cv-00321-CDL Document 40-14 Filed 08/29/16 Page 7 of 9 Bowman v. Wyeth, LLC, Not Reported in F.Supp.2d (2012) 2012 WL 684116 whatsoever. Bowman conceded at oral argument that he who asserts no arguments regarding the purported lag between ingested metoclopramide Reglan's approved labeling change in July 2004 and the through generic drug manufacturer's inclusion of that update in its 2005, own labeling. Further, Bowman continues to contend that brought even the post-July 2004 Reglan warnings were inadequate this -and there is no duty for a manufacturer to provide an issue to inadequate warning. Because Bowman makes no claim the regarding Teva's alleged failure to update its labeling after Eighth the 2004 labeling change for Reglan was approved, his Circuit's argument is without merit. 6 attention when 5 she In July requested 2004, permission the to file FDA supplemental approved briefing the -the addition court of denied "therapy that should request. not exceed 12 III. CONCLUSION weeks in duration" The Supreme Court in PLIVA, Inc. v. Mensing held to the that state-law tort claims based on a generic drug Reglan manufacturer's failure to warn are preempted by federal label. law. The sweeping language of the Supreme Court's 6 opinion, as well as the Eight Circuit's affirmation of theMoreover, it dismissal of all of Mensing's claims-even those claims appears not labeled as "failure-to-warn" claims-lead this Court as to find that all of Bowman's claims are preempted under though the theory of conflict preemption. This Court's conclusion the is in accordance with the tsunami of cases that have been Eighth decided since the Mensing decision. Based on the files, Circuit records, and proceedings herein, and for the reasons stated has above, IT IS ORDERED THAT: addressed this 1. Teva's Motion for Judgment on the Pleadings [Docket claim No. 43] is GRANTED. and found 2. Bowman's Complaint against Teva is DISMISSED it, too, to be WITH PREJUDICE. preempted under All Citations Mensing. Mensing, Not Reported in F.Supp.2d, 2012 WL 684116 WESTON © 2016 Thomson Reuters. No claim to original U.S. Government Works. 7 Case 4:13-cv-00321-CDL Document 40-14 Filed 08/29/16 Page 8 of 9 Bowman v. Wyeth, LLC, Not Reported in F.Supp.2d (2012) 2012 WL 684116 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1,4rESTLIMI CO 2016 Thomson Reuters. No claim to original U.S. Government Works. 8 Case 4:13-cv-00321-CDL Document 40-14 Filed 08/29/16 Page 9 of 9 EXHIBIT L Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 1 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 KeyCite Yellow Flag - Negative Treatment Distinguished by Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., D.Minn., August 26, 2011 1999 WL 716891 Only the Westlaw citation is currently available. United States District Court, D. Minnesota. Marilyn A. GREINER and Emil D. Greiner, Plaintiffs, v. SOFAMOR, S.N.C., et al., Defendants. No. Civ.4-95-645 RHK JMM. March 8, 1999. Attorneys and Law Firms Ronald Sidney Goldser, Keelyn M Friesen, Zimmerman Reed, Mpls, MN, Donna S Cummings, Frank C Dudenhefer, Jr, John J Cummings, III, Cummings, Cummings Dudenhefer & Martin, New Orleans, LA, for Marilyn A Greiner, plaintiff. Ronald Sidney Goldser, Keelyn M Friesen, Donna S Cummings, Frank C Dudenhefer, Jr., John J Cummings, III, for Emil D Greiner, plaintiff. Stuart T Williams, Bruce C Recher, William F Forsyth, David Bradley Olsen, Neil M Kliebenstein, Henson & Efron, Mpls, MN, Stephen S Phillips, Philip H Lebowitz, Noel Birle, David Richman, Gerald B Sullivan, Pepper Hamilton, Philadelphia, PA, for Sofamor, S .N.C. fka Sofamor, S.A., defendant. Stuart T Williams, Bruce C Recher, William F Forsyth, David Bradley Olsen, Neil M Kliebenstein, Stephen S Phillips, Philip H Lebowitz, Noel Birle, David Richman, Gerald B Sullivan, (See above), for Sofamor, Inc., defendant. Stuart T Williams, Bruce C Recher, William F Forsyth, David Bradley Olsen, Neil M Kliebenstein, Stephen S Phillips, Philip H Lebowitz, Noel Birle, David Richman, Gerald B Sullivan, (See above), for Sofamor-Danek Group, Inc., defendant. Linda Susan Svitak, Peter John Goss, Faegre & Benson, Mpls, MN, Carl A Henlein, Susan S Wettle, Steven M Crawford, Ann E Eberle, Brown Todd & Heyburn, Louisville, KY, for Youngwood Medical Specialties, Inc. fka Stuart Medical, Inc. fka National Medical Specialty, Inc. fka Stuart Medical Specialty, Inc. fka Stuart Drug and Surgical Supply, Inc., defendant. David Alan Allgeyer, Sally J Whiteside, Lindquist & Vennum, Mpls, MN, John N Scholnick, Bradley C Twedt, Caroline P Golden, Neal Gerber & Eisenberg, Chicago, IL, for Gicd-USA Institute, Inc. aka Gicd-USA, Inc., defendant. Stuart T Williams, Bruce C Recher, William F Forsyth, David Bradley Olsen, Neil M Kliebenstein, Stephen S Phillips, Philip H Lebowitz, Noel Birle, David Richman, Gerald B Sullivan, (See above), for Danek Medical, Inc., defendant. Wayne David Struble, Bowman & Brooke, Albert J Dahm, Baker & Daniels, fort Wayne, IN, Thomas G Stayton, Baker & Daniels, Indianapolis, IN, for Zimmer, Inc., defendant. Ronald S. Goldser, Keelyn M. Friesen, and Karen Cody Hopkins, Zimmerman & Reed, Minneapolis, Minnesota, Thomas J. Kliebert, Kliebert & Heitz, Gramercy, Louisiana, Frank C. Dudenhefer, Jr., Cummings, Cummings, & Dudenhefer, New Orleans, Louisiana, and Arnold Levin, Plaintiffs' Legal Committee, Philadelphia, Pennsylvania, for Plaintiffs. Stuart T. Williams, Bruce C. Recher, William F. Forsyth, David B. Olsen, and Neil M. Kliebenstein, Henson & Efron, Minneapolis, Minnesota, Stephen S. Phillips, Philip H. Lebowitz, David Richman, and Gerald B. Sullivan, Pepper Hamilton, Philadelphia, Pennsylvania, for Defendants Danek Medical, Inc., Sofamor, Inc., Sofamor, S.N.C., and Sofamor-Danek Group, Inc. Linda S. Svitak and Peter J. Goss, Faegre & Benson, Minneapolis, Minnesota, and Susan S. Wettle and Steven M. Crawford, Brown, Todd, & Heyburn, Louisville, Kentucky, for Defendant Youngwood Medical Specialties, Inc. MEMORANDUM OPINION AND ORDER KYLE, J. WESILPON © 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 2 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 Introduction 1 1 96- 1095/ RHK/ JMM, In 4-96- addition 1160/ to the RHK/ instant JMM, Memorandum 3-96- Opinion 1094/ and RHK/ Order, JMM, the 3-96- Court 1090/ today RHK/ has JMM, issued a 4-96- Memorandum 1157/ Opinion RHK/ and JMM, Order in 97- Bruzer, 1137/ et al. v. RHK/ Danek JMM, Medical, & 3-96- Inc., et 1098/ al., No. RHK/ 3-95- JMM. 971/ Because RHK/ the JMM general and a background consolidated of the Memorandum cases Opinion and the and legal Order principles entitled involved In re overlap, Orthopedic the Bone Court Screw has, Litigation, where dealing appropriate, with applied several the other same bone analysis screw in each cases in of the this three district. documents. See 3- Where W 571 AW ID 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 3 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 *1 the cases differ in any material aspect, however, the Court has separately examined the issues. The case currently before the Court is part of a broad multidistrict litigation involving the promotion, marketing, sale, and use of pedicle screw fixation devices ("bone screws") that were affixed to the spines of patients suffering certain types of lower back pain. The Plaintiffs initially asserted claims against not only the manufacturers and distributors of the bone screws, but also against other manufacturers, doctors, and organizations that were not directly responsible for the implantation of the bone screws but who, according to the Plaintiffs, conspired to unlawfully and fraudulently promote and market the devices. The instant action, along with several other bone screw cases, was remanded to this Court by the Judicial Panel on Multidistrict Litigation. By Memorandum Opinion and Order dated October 1, 1998, this Court dismissed the Plaintiffs' claims against the "Omni Defendants," those Defendants whose sole potential liability arose out of the claims of conspiracy to fraudulently promote and market the devices. The remaining claims of the Complaint allege that the remaining Defendants improperly marketed and promoted the bone screws, which had been approved by the FDA for certain uses but not for pedicle fixation. In addition to her claims of fraudulent marketing and promotion, Plaintiff Marilyn Greiner ("Greiner") alleges that the bone screws were defectively designed and manufactured, that the manufacturers are strictly liable and are liable per se for violations of the Food, Drug, and Cosmetic Act ("FDCA"), and that the manufacturers made negligent misrepresentations that caused her injuries. Currently before the Court are the Defendants' Motions for Summary Judgment. For the reasons set forth below, the Court will grant the Defendants' Motions for Summary Judgment. 2 Background 2 Bone screws are devices that are attached to the spine in certain types of spinal surgery in order to stabilize the spine and to aid in the fusion of vertebrae. To achieve this end, the bone screws are implanted in the vertebral pedicles to immobilize the spine after surgery. For the procedural history of the bone screw litigation and the general WEST LA © 2016 Thomson Reuters. No claim to original U.S. Government Works. 3 Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 4 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 background of these cases, the Court has relied on the prior rulings of United States District Judge Louis C. Bechtle, who presided over the multidistrict proceedings. In particular, the Court has relied on Judge Bechtle's Memorandum and Order dated April 16, 1997, accompanying PTO 861, in which he included a general discussion of the bone screw cases before dismissing certain of the Plaintiffs' claims, as well as on the subsequent opinion of the Third Circuit. See In re Orthopedic Bone Screw Prods. Liab. Litig., MDL Docket No. 1014, 1997 WL 186325 (E.D.Pa. Apr. 16, 1997); see also In re Orthopedic Bone Screw Prods. Liab. Litig., 159 F.3d 817 (3d Cir.1998). A. Greiner's Medical History Greiner has had back problems from at least the age of fifteen, when she was diagnosed with lumbar scoliosis. (Sanderson 2/3/98 Dep. at 66.) The discomfort in her lower back continued and worsened throughout her teen years and thereafter and, in 1984, she underwent her first surgical procedure to treat her condition. (Id at 67.) The 1984 surgery was a laminectomy discectomy VV :TLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 5 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 at the L4-5 and L3-4 levels. (Svitak Aff. Ex. A-15 (medical records).) She continued to have pain in her lower back and continued to seek medical treatment for her condition. In 1988, Dr. David L. Hoversten of Dakota Orthopedics took x-rays of her lumbosacral spine and, from them, concluded that Greiner had "severe degenerative disc disease" and stated his belief that "she will ultimately need a stabilizing fusion in order to have any kind of reasonable result." (Id.) Slightly more than three years after this diagnosis, Greiner decided to undergo a three-level spinal fusion surgery, which was performed by Dr. John Lonstein ("Lonstein") on April 24, 1992. (Id Ex. A-2.) Prior to the surgery, Lonstein diagnosed Greiner as suffering from degenerative disc disease at the L-3-S1 levels, and he confirmed this diagnosis after the operation. (Id) Lonstein used the Cotrel-Dubousset ("CD") instrumentation for the L-3 to S-1 fusion. (Id at A-2 to A-7.) When it was determined several days later that two of the bone screws had been improperly implanted, Lonstein's colleague, Dr. Manuel Pinto, removed them. (Id at A-5 to A-8.) B. Dr. Lonstein's Background *2 Lonstein received his medical degree from the University of Witswatersrand in Johannesburg, South Africa, in 1964. (Svitak Aff. Ex. B (curriculum vitae).) He then performed a surgical internship and a medical internship at Johannesburg General Hospital until January 31, 1966. (Id) After leaving South Africa, Lonstein was a surgical resident at Boston University Medical Center from 1967 until 1969 and then received special orthopedic training at the University of Minnesota from 1969 until 1972. (Id.) He has been board-certified by the American Board of Orthopedic Surgeons since 1973, and has taught at the University of Minnesota's Department of Orthopedic Surgery, in various capacities, from 1972 until the present. (Id) He is currently a clinical associate professor in that department. (Id) During his medical career, he has performed over 2,200 spinal fusion surgeries. (Svitak Aff. Ex. C (Lonstein letter).) He has made many presentations on the topic of pedicle screw fixation-including at the seminars that the Plaintiffs allege were part of the conspiracy in the instant cases- and is the author of an article entitled, "Pedicle Fixation of the Lumbar Spine," which was published in 1992 as a chapter in a book. (Id. Ex. B.) Along with several of his colleagues at the Minnesota Spine Center, Lonstein conducted a review of the 875 patients who had bone screws implanted in their pedicles between 1984 and 1993. (Id Ex. C.) He and his colleagues determined that insertion of bone screws was generally safe and did not cause pain, and they continue to regularly perform surgeries involving pedicle fixation. (Id) Lonstein himself continues to use pedicle screw instrumentation in spinal fixation surgeries. (Lonstein 11/15/95 Dep. at 27-30.) Lonstein was aware that the bone screws had not been approved by the FDA for implantation into the lumbar spine at the time of Greiner's surgery and has testified that knowledge of the financial arrangements between the presenters and the sponsors of the bone screw seminars would not have affected his decision to use bone screws in his treatment of Greiner. (See 10/14/98 Mem. Op. & Order at 14; Lonstein 11/15/95 Dep. at 132-36.) Analysis I. Standard of Review Summary judgment is warranted if, "after viewing the evidence in the light most favorable to the nonmoving party, there exists no genuine issue of material fact and the moving party is entitled to judgment as a matter of law." FDIC v. Bell, 106 F.3d 258, 263 (8th Cir.1997). After the movant has satisfied its burden of identifying those portions of the record which show the absence of any genuine issue of material fact, the nonmoving party may not rest upon the allegations contained in its pleadings, but "rather must set forth specific facts, by affidavit or other evidence, showing that a genuine issue of material fact exists." Chisrn v. W.R. Grace & Co., 158 F.3d 988, 990 (8th Cir.1998). To survive a motion for summary judgment, the nonmoving party must support its case with "more than a scintilla of evidence." Bell, 106 F.3d at 263 (quotation omitted). "Where the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no genuine issue for trial." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 1356 (1986) (quotation omitted). *3 Ordinarily, the court does not weigh facts or evaluate the credibility of affidavits and other evidence on a motion for summary judgment. The nonmovant cannot, however, avoid summary judgment in favor of the movant merely by pointing to some alleged factual dispute between the parties. Instead, any fact alleged to be in dispute must be WEST LA © 2016 Thomson Reuters. No claim to original U,S. Government Works. 5 Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 6 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 "outcome determinative under prevailing law," that is, it agency must be material to an essential element of the specific states its theory of recovery at issue. See Get Away Club, Inc. v. finding Coleman, 969 F.2d 664, 666 (8th Cir.1992). Essentially, that the court performs the threshold inquiry of determining "the whether there is a need for a trial. Anderson v. Liberty data, reviewed Lobby, Inc., 477 U.S. 242, 250, 106 S.Ct. 2505, 2510 (1986). as a whole, II. Design Defect corroborated the The Defendants contend that the Plaintiffs' design defect results claims fail because they do not point to any particular of other design defect and because they fail to offer any evidence available of an alternative, safer design. They also argue that the data FDA's recent determination regarding the effectiveness sets of pedicle fixation with screws lends support to their demonstrating contention that there is nothing defective in the design of the the bone screws. 3 The Plaintiffs do not respond to either safety of these criticisms in any substantive way, but simply and effectiveness restate their allegation that there is no proven benefit to of pedicle screw fixation. pedicle screw 3 See spinal generally systems"). "Orthopedic In Mozes v. Medtronic, Inc., 14 F.Supp.2d 1124 Devices: (D.Minn.1998), this Court summarized the requirements Classification under Minnesota law for a claim of design defect as and Reclassification of Under Minnesota law, in order Pedicle Screw to establish a products liability Spinal claim based upon a defective design, Systems," a plaintiff must show that: 1) 63 the defendant's product was in Fed.Reg. a defective condition unreasonably 40025 dangerous for its intended use; 2) (July 27, the defect existed when the product 1998) left the defendant's control; and (attached 3) the defect was the proximate as Ex. cause of the injury sustained. Bilotta A-2 to v. Kelley Co., 346 N.W.2d 616, Kliebenstein 623 n.3 (Minn.1984); Marcon v. Aff.) Kmart Corp., 573 N.W.2d 728, 731 (final rule (Minn.Ct.App.1998), review denied, issued Apr. 14, 1998. by the Mozes, 14 F.Supp.2d at 1127. The first element described FDA, in which above-that the product is in a defective condition the VII © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 7 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 unreasonably dangerous for its intended use-is satisfied if the manufacturer fails to exercise that degree of care in his plan or design so as to avoid any unreasonable risk of harm to anyone who is likely to be exposed to the danger when the product is used in the manner for which the product was intended, as well as an unintended yet reasonably foreseeable use. What constitutes "reasonable care" will, of course, vary with the surrounding circumstances and will involve a balancing of the likelihood of harm, and the gravity of harm if it happens, against the burden of the precaution which would be effective to avoid the harm. Bilotta, 346 N.W.2d at 621, quoted in Mozes, 14 F.Supp.2d at 1127. In Kallio v. Ford Motor Co., 407 N.W.2d 92, 95- 96 (Minn.1987), the Minnesota Supreme Court held that certain rare cases may exist in which a plaintiff bringing a claim of design defect need not prove the existence of a safer alternative design. Id. at 97 & n.8. This qualification, however, does not alter the general rule that *4 Minnesota ... maintains the requirement in a strict liability products case that a plaintiff must establish not only that the product was in a defective condition, but also that it was unreasonably dangerous. Obviously, a factor bearing upon the latter requirement will be the existence or nonexistence of a feasible alternative design. To satisfy that requirement, the plaintiff ordinarily has the burden of showing the existence of an alternative design that was safer.... To establish a prima facie case that [the product in question] was unreasonably dangerous normally requires production of evidence of the existence of a feasible, alternative safer design. Id. at 96 (internal citations omitted). In the instant case, the Plaintiffs have presented no evidence of a feasible alternative design, and have failed to show how this could be one of those "rare cases" mentioned in Kallio when such evidence is unnecessary. Any argument that the Defendants' device should be removed from the market (thereby bringing it within the scope of the Kallio exception) is foreclosed by the uncontradicted evidence of the Plaintiffs' experts that the device in question does have valid uses. Several of the Plaintiffs' generic experts have testified that these devices are effective under certain circumstances and should not be taken off of the market altogether. Harold Alexander, one of the Plaintiffs' generic experts, stated that he wouldn't ban them entirely. I think there's been adequate experience over the years in their use. And there's enough indication that surgeons tell me they have patients who have been helped by these devices that I wouldn't say, you know, that they are absolutely dangerous, horrible devices and they should all be banned. (Alexander 6/14/96 Dep. at 285.) In addition to Alexander's testimony, Dr. John Esterhai, another of the Plaintiffs' generic experts, testified during his deposition that "I am not saying that these devices should never be used." (Esterhai Dep. at 371; see also Alexander 6/14/96 Dep. at 367 ("I'm not in general critical of pedicle fixation devices overall for all indications. I said there might be a situation where a device is appropriate for a particular indication."); Peyster 7/15/96 Dep. at 278 (‘I think that the answer is not in, that the subject should be studied further. They may have a real role in these situations, and I'm not going to get up there and say that they should be thrown in the garbage. That's not what I'm here about"); Sanderson 2/3/98 Dep. at 97 ("It's not my opinion that pedicle screws ought to be outlawed. My opinion is they are likely to have an appropriate place in an orthopedic surgeon[']s or neurosurgeonns armamentarium....").) Because the Plaintiffs have not shown that the instant case is one of those "rare cases" discussed in Kallio, in which a plaintiff can show that a device should be taken off the market altogether (and, in fact, because the uncontradicted testimony of the Plaintiffs' experts establishes just the opposite), they must present evidence of an alternative safer design in order to succeed on their claim for design defect. The Plaintiffs have not made such a showing, however, and they have failed to identify any defect in the Defendants' product or even to attempt to make such a showing. See Elliott v. Acromed Corp., et al., vnSTLAW 0 2016 Thomson Reuters. No claim to original U.S. Government Works. 7 Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 8 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 No. 94-2683 (E.D.La. Feb. 13, 1998), at 8-10 (in another bone screw case, under Louisiana law, granting summary judgment on the plaintiffs' design defect claim because of the plaintiffs' failure to identify an alternative safer design) (attached as Ex. 10 to Kliebenstein Aff.). Rather than identifying any particular defect in the design of the Defendants' device, the Plaintiffs merely point out that use of the devices involves some measure of risk, a statement that could be made about virtually any medical device or product. Conclusory statements that a device was defectively designed do not constitute sufficient evidence to withstand summary judgment on a claim for design defect. See Mozes, 14 F.Supp.2d at 1128 (citing Patton v. Newmar Corp., 538 N.W.2d 116, 120 (Minn.1995)). Because of their failure to identify any defect in the design of the device in question, the Plaintiffs have failed to create a genuine issue of material fact with regard to whether the device manufactured by the Defendants was unreasonably dangerous. Accordingly, the Court will grant summary judgment on the Plaintiffs' claim for design defect, for failure to satisfy the first criterion identified in Mozes. III. The "Learned Intermediary" Doctrine and the Claims for Failure to Warn, Fraudulent Marketing and Promotion, and Negligent Misrepresentation *5 The Defendants argue that they are entitled to summary judgment on the Plaintiffs' claims of failure to warn, fraudulent marketing and promotion, and negligent misrepresentation, because of the "learned intermediary" doctrine. 4 The Plaintiffs have presented no evidence that Greiner's treating physician was misled by the Defendants or the seminars and promotions in which the Defendants took part, or that he relied on any of the Defendants' representations to the detriment of the Plaintiffs. Because the Plaintiffs cannot show any reliance by Greiner's treating physician, the Court finds that the Defendants are entitled to summary judgment on the Plaintiffs' claims of failure to warn, fraudulent marketing and promotion, and negligent misrepresentation. 4 "To prevail on [a claim of fraudulent promotion or marketing], each plaintiff has the burden of showing that ... Sofamor promoted/ marketed its medical device to plaintiff s particular doctor or surgeon for use in the pedicles of the spine, and that such promotion caused the surgeon to decide that surgical implantation of the particular device was the best procedure for improving plaintiffs condition." In re Orthopedic Bone Screw Prods. Liab. Litig., MDL 1014, WESTLA► © 2016 Thomson Reuters. No claim to original U.S. Government Works. 8 Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 9 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 1995 WL 273597, at * 11 n.13 (E. D.Pa. Feb. 22, 1995) (PTO 8). The "learned intermediary" doctrine was addressed by this Court in Mozes. Ordinarily Minnesota law imposes on manufacturers a duty to warn users of its products of any dangers associated with those products about which it knows or should know. Mozes, 14 F.Supp.2d at 1129 (citing Gryc v. Dayton-Hudson Corp., 297 N.W.2d 727, 739 (Minn.1980)). "Failure to provide such a warning will render the product unreasonably dangerous and will subject the manufacturer to liability for damages under strict liability in tort ." Id (quoting Gryc, 297 N.W.2d at 739). Where the product at issue is a medical device or product, however, the manufacturer's duty to warn does not run to the lay public but to the medical professional who will be using the product or device. Id (citing Mulder v. Parke Davis & Co., 288 Minn. 332, 335 n.1, 181 N.W.2d 882, 885 n.1 (1970)). Because the treating physician or other medical professional acts as the learned intermediary between the manufacturer and the ultimate consumer, courts have held that he or she "is in the best position to understand the patient's needs and assess the risks and benefits of a particular course of treatment." Brooks v. Medtronic, Mc., 750 F.2d 1227, 1231 (4th Cir.1984). Whether the Defendants are entitled to summary judgment on these claims, therefore, turns not on whether they warned the individual Plaintiffs who received treatment with the Defendants' products, but whether they warned those Plaintiffs' treating physicians. The Plaintiffs allege that the Defendants failed to provide Lonstein adequate information on their devices' use for pedicle screw fixation. What the Plaintiffs never address, however, and what is a fatal problem with this claim, is the lack of any evidence tending to show that Lonstein would have altered his recommended course of treatment for Greiner if he had been given any additional information by the Defendants. The evidence before the Court suggests just the opposite-Lonstein was aware of the risks attendant in the use of instrumented spinal fixation surgery, believed them to be outweighed by the potential benefits, and would render the same recommendation to Greiner today that he did in 1992. This Court has previously dismissed the Plaintiffs' claims against certain Defendants that they engaged in a conspiracy to conceal the FDA status of the bone screws and other safety-related issues. In granting summary judgment on those claims in the instant case and the Bruzer case, the Court held that the Plaintiffs failed to introduce any evidence that any conduct on the part of the Defendant manufacturers "affected the manner in which the Plaintiffs' surgeons would have treated them." (10/1/98 Mem. Op. & Order at 14.) The Court reviewed not only the familiarity that both Bruzer's and Greiner's treating physicians had with the devices in question but also the lack of any testimony or evidence of reliance. For the same reasons, the Plaintiffs cannot show any reliance on the part of Lonstein that would support a claim for failure to warn, fraudulent marketing and promotion, or negligent misrepresentation. Put another way, the warnings provided Lonstein were adequate as a matter of law because the Plaintiffs have not identified any piece of information that would have convinced him to alter his recommended course of treatment with regard to Greiner. See Balder v. Haley, 399 N .W.2d 77, 81-82 (Minn.1987) (holding that the plaintiff had failed to show a causal relationship between the alleged failure to warn and the injury sustained when the plaintiff had been aware of the dangers presented); see also Holowaty v. McDonald's Corp., 10 F.Supp.2d 1078, 1085-86 (D.Minn.1998) ("The alleged failure to warn is not the cause of injury when the product user is actually aware of the danger associated with use of the product.") The Plaintiffs have presented no evidence that Lonstein was defrauded in any way by any of the Defendants or their agents, or that he took or refrained from taking any action because of the Defendants' statements or omissions. Accordingly, based on the application of the learned intermediary doctrine and the lack of any evidence of reliance on the part of Lonstein, Greiner's treating physician, the Court will grant the Defendants' Motion for Summary Judgment on the Plaintiffs' claims of failure to warn, fraudulent marketing and promotion, and negligent misrepresentation. IV. Causation *6 For the foregoing reasons, the Court finds that the Defendants are entitled to summary judgment on each of the Plaintiffs' claims. Regardless of these grounds, however, each of the Plaintiffs' claims would fail for a separate and alternative reason: their failure to show that WESTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 9 Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 10 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 any of the Defendants proximately caused their injuries. plaintiff With regard to the issue of whether the Defendants' must device proximately caused Greiner's injuries, the Plaintiffs prove rely on the testimony and report of Dr. Douglas "negligence, Sanderson, their case-specific causation expert. In his not at report, however, Sanderson does not identify any defect large or in the design of the Defendants' device or any conduct in the abstract, on the part of any Defendant that caused injury to but in Greiner. Rather, he concludes in his report that "the relation use of pedicle screws in this case was the proximate to the cause of right-sided radiculopathy because of pedicle plaintiff...." penetration at the L3 level. This complication not only Palsgraf necessitated additional surgery with its inherent risks v. Long and expense but also caused prolonged neurologic deficit Island and associated disability." (Svitak Aff. Ex. D (Sanderson R. R. letter).) (emphasis added). The Plaintiffs' only case- Co., 248 specific causation expert, therefore, attributes the cause of N.Y. Greiner's injury not to any defect in the Defendants' device 339, or any conduct or representations by the Defendants, but 346, 162 to a complication that took place during the implantation N.E. 99, 101 surgery. (1928) (Cardozo, As another judge considering similar testimony in a J.) related bone screw case put it, "the court does not understand how the surgery's asserted failure to alleviate Even if the Plaintiffs in the instant case had been able to show some causal connection between the Defendants' the plaintiffs problems ... establishes the required connection between the fixation device and the plaintiffs device and Greiner's injuries, the Defendants would still be entitled to summary judgment on all of the Plaintiffs' present condition." West v. Danek Med., Inc., No. 97- 575-T, at 6 (W.D.Okla. Dec. 28, 1998). Because the claims that are based on a failure to warn, fraud, or Plaintiffs have presented no evidence from which a negligence (including negligence per se ), 6 because the reasonable jury could conclude that Greiner's pain was Plaintiffs have presented no evidence of reliance by caused by the Defendants' device, the lack of any evidence Lonstein on any representation (or omission) of the showing proximate causation provides a separate and Defendants. 7 alternative ground on which the Defendants are entitled to summary judgment on each of the Plaintiffs' claims. 5 6 Even assuming 5 that theIt is a central principle of American tort law that, to show liability on the part of a defendant, a Plaintiffs have shown negligence per se (a proposition about which the Court is extremely skeptical), this WESTLA I n 2016 Thomson Reuters. No claim to original U.S. Government Works.. 10 Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 11 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 would (applying not Kentucky excuse substantive them law); from Kronzer their v. First burden Nat'l of Bank, showing 305 that the Minn. Defendants' 415, negligence 421, 235 proximately N.W.2d caused 187, 191 their (1975). injuries. Because See the Kipp v. Plaintiffs United have States, presented 88 F.3d no 681, 685 evidence (8th that any Cir.1996) alleged ("[T]he violations negligence of the per se FDCA principle by the only Defendants establishes proximately the duty caused and their breach injuries, of duty the elements Defendants of a are negligence entitled claim.... to [The summary plaintifffs judgment arguments on the as to Plaintiffs' negligence negligence per se per se are of claims. no avail 7 in Because proving the the Plaintiffs essential have element failed to of present causation.") any WEST © 2016 Thomson Reuters. No claim to original U.S. Government Works. 11 Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 12 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 evidence Defendants of said to causation him or or concealed reliance from by him. Lonstein Even if on any the alleged Court representation, were to omission, assume, or false therefore, representation that the made by Defendants any of violated the the Defendants, FDCA the in their Court promotion need and not marketing address of the the issue devices, of there is whether no a evidence private that cause of such action conduct exists proximately for caused violations the of the Plaintiffs' FDCA. injuries. The Summary uncontradicted judgment testimony on this before claim is the appropriate Court because shows the that Plaintiffs Lonstein have did not simply base his failed to decision present to use any the CD evidence instrumentation of a on causal anything connection. that any The Plaintiffs have failed to show that any of the misrepresentations, concealments, or failures to warn had WIEST © 2016 Thomson Reuters. No claim to original U.S. Government Works. 12 Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 13 of 14 Greiner v. Sofamor, S.N.C., Not Reported in F.Supp.2d (1999) 1999 WL 716891 any effect whatsoever on the treatment that Greiner received. Although the Plaintiffs' causation expert, Dr. Sanderson, may testify that the procedure resulted in injury to Greiner, he has not offered any testimony or evidence establishing a causal link between any conduct on the part of the Defendants and her injury, or the Defendants' device and her injury. As stated above, the Plaintiffs have presented no evidence that the product was defectively designed or manufactured. Another district court, addressing the same issue in a bone screw case, held that: *7 It is not enough to show that the fusion surgery caused the injury since plaintiff and his doctors, not defendant, chose fusion surgery as the treatment. There is no basis to conclude that plaintiff and his doctors chose fusion surgery as the treatment for his back pain because of defendant's device. Smith v. Sofamor, S.N.C., Civ. No. 96-C-956-S, at 8 (W.D.Wis. May 11, 1998) (attached as Ex. 24 to Kliebenstein Aff ) Similarly, another court found that, even if it had allowed the plaintiffs' causation experts to testify, the defendants would be entitled to summary judgment because the experts could not testify that any defect in the bone screws caused the plaintiffs' injuries. In Conger, et al v. Danek Medical, Inc., et al., Civ. No. 4:96- CV-739-A (N.D.Tex. Dec. 14, 1998), the court granted the defendants' motion to exclude the proposed expert testimony pursuant to Daubert and went on to state: Even were the court to allow [the plaintiffs' causation experts] to testify, plaintiffs are still not home free. [The experts] could only testify that [the plaintiffs] experienced some type of hardware- related pain. Plaintiffs cannot show, however, that the pain experienced by them was caused by a defect in the implants themselves, as opposed to negligence of the doctor who implanted the devices or some other cause. Movants have shown that plaintiffs' surgeon based his decision on his best medical judgment and that he was not influenced by packaging of the devices of their lack of FDA clearance. Plaintiffs have not raised a genuine issue of fact as to causation. Conger, slip op. at 16-17. The treating physician in the instant case was aware of the FDA status of the devices and, therefore, any attempted concealment of this fact by the Defendants could not have affected his recommendations for treatment of Greiner. V. Loss of Consortium Because Emil Greiner's claim for loss of consortium is derivative of Plaintiff Marilyn Greiner's other claims, on each of which the Defendants are entitled to summary judgment, the Court will grant the Defendants' Motion for Summary Judgment with regard to the claim for loss of consortium. Conclusion For the foregoing reasons, and based upon all of the files, records and proceedings herein, IT IS ORDERED that: (a) Defendant Sofamor-Danek Group's Motion for Summary Judgment (Doc. No. 185) is GRANTED IN ITS ENTIRETY; (b) Defendant Youngwood Medical Specialties, Inc.'s Motion for Summary Judgment (Doc. No. 187) is GRANTED IN ITS ENTIRETY; and (c) the Complaint is DISMISSED WITH PREJUDICE. LET JUDGMENT BE ENTERED ACCORDINGLY. All Citations Not Reported in F.Supp.2d, 1999 WL 716891 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. \NESTLAW CO 2016 Thomson Reuters. No claim to original U.S. Government Works. 13 Case 4:13-cv-00321-CDL Document 40-15 Filed 08/29/16 Page 14 of 14 EXHIBIT M Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 1 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 1 of 20 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 Docket No. 2004 4:08-MD-2004 (CDL) * Case Nos. • 4:13-cv-00017 4:13-cv-00339 • 4:13-cv-00464 4:13-cv-00485 • 4:14-cv-00060 4:14-cv-00062 (Bromley) (Larranaga) (Kaiser) (Hill) (Burt) (Alexander) ORDER Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiffs Lisa Bromley, Maria Larranaga, Marian Kaiser, Sandy Anne Hill, Barbara Burt, and Leslie Alexander were implanted with ObTape and assert that they suffered injuries caused by ObTape. Each Plaintiff brought a product liability action against Mentor, contending that ObTape had design and/or manufacturing defects that proximately caused her injuries. Plaintiffs also assert that Mentor did not adequately warn their physicians about the risks associated with ObTape. Mentor seeks partial summary judgment on several of Plaintiffs' claims. For the reasons set forth below, Mentor's partial summary judgment motions are granted as to Bromley, Larranaga, and Hill. The motions are granted in part and denied in part as to Kaiser, Burt, and Alexander. Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 2 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 2 of 20 SUMMARY JUDGMENT STANDARD Summary judgment may be granted only "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). In determining whether a genuine dispute of material fact exists to defeat a motion for summary judgment, the evidence is viewed in the light most favorable to the party opposing summary judgment, drawing all justifiable inferences in the opposing party's favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). A fact is material if it is relevant or necessary to the outcome of the suit. Id. at 248. A factual dispute is genuine if the evidence would allow a reasonable jury to return a verdict for the nonmoving party. Id. FACTUAL BACKGROUND I. Lisa Bromley (ECF No. 45 in 4:13-cv-17) On October 18, 2005, Dr. Fawad Zafar implanted Bromley with ObTape to treat her stress urinary incontinence. In 2007, Bromley's husband began to experience comfort during sex, "like he was hitting some type of plastic or something that was hard." Bromley Dep. 93:10-21, ECF No. 45-5. The problem worsened, and Bromley's husband "said he could actually, you know, see [the ObTape], that it was actually -- that it looked like it was not supposed to be coming out, but it looked like it was -- you know, it was falling apart." Id. at 96:20-97:7. 2 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 3 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 3 of 20 In September 2008, Bromley went to Dr. Priscilla Ruhe with complaints of burning with urination. At the time, according to Bromley, "you could see the actual mesh falling out." Id. at 106:14-18. Dr. Ruhe saw an exposed piece of ObTape in Bromley's vagina, and she told Bromley that "it looked like it was part of the bladder sling" and "that it shouldn't have been falling out." Id. at 105:18-106:4. Dr. Ruhe told Bromley that the "excess material" was "causing [Bromley] pain in the vagina from the irritation." Id. at 107:15-23. Dr. Ruhe removed the eroded portion of ObTape. Bromley contends that she did not connect her complications to ObTape until she consulted another doctor in 2011 and learned that the remainder of the ObTape would have to be removed. Bromley is an Iowa resident whose ObTape-related treatment took place in Iowa. She filed her action in Hennepin County District Court of the State of Minnesota and served Mentor with the Complaint on December 21, 2012. Bromley brought claims for strict liability and negligence. II. Maria Larranaga (ECF No. 29 in 4:13-cv-339) Larranaga saw her gynecologist, Dr. Steve Vouis, for treatment of stress urinary incontinence. Dr. Vouis implanted Larranaga with ObTape on December 29, 2005. Larranaga did not see any materials from Mentor regarding ObTape, and she did not speak with any representatives of Mentor about the product. Larranaga 3 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 4 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 4 of 20 asserts that Mentor misrepresented to Dr. Vouis (or 'concealed from him) an accurate complication rate for ObTape, the severity of known ObTape complications, and true information about ObTape's physical characteristics. She also contends that if Dr. Vouis had known the true risks of ObTape, he would not have implanted it in Larranaga. But Larranaga did not point the Court to any evidence on this point.1 Larranaga returned to Dr. Vouis in October 2008 complaining of recurrent incontinence and dyspareunia. Dr. Vouis did not connect Larranaga's symptoms with ObTape. Larranaga currently attributes several symptoms-including dyspareunia, pain, and incontinence-to ObTape. Larranaga is a California resident whose ObTape-related treatment took place in California. She filed her action in Hennepin County District Court of the State of Minnesota on July 3, 2013. Larranaga brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. Larranaga asserts that Dr. Vouis testified that he would not have used ObTape if he had known of its true risks. Larranaga cites several pages of Dr. Vouis's deposition in support of these assertions (108, 119-121), but she did not include those pages in the deposition excerpt of Dr. Vouis that she submitted to the Court, so the present record does not support her assertions. "Material facts not supported by specific citation to particular parts of materials in the record . . . will not be considered by the court." M.D. Ga. L.R. 56. 4 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 5 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 5 of 20 III. Marian Kaiser (ECF No. 29 in 4:13-cv-464) Kaiser sought treatment for stress urinary incontinence from Dr. David Guthman. Dr. Guthman implanted Kaiser with ObTape on May 16, 2005. Kaiser did not see any materials from Mentor regarding ObTape, and she did not speak with any representatives of Mentor about the product. Kaiser asserts that she suffered various injuries caused by ObTape. Kaiser asserts that Mentor misrepresented to Dr. Guthman (or concealed from him) an accurate complication rate for ObTape, the severity of known ObTape complications, and true information about ObTape's physical characteristics. E.g., Guthman Dep. 42:8-43:22, ECF No. 31-3. She also pointed to evidence that if Dr. Guthman had known the true risks of ObTape, he would not have implanted it in Kaiser. Id. at 38:19-21 ("[I]n pursuit of the health of our patient, we always try to use the safest, lowest-risk device possible."); id. at 78:14-19 (stating that Dr. Guthman would always choose the safer alternative product); id. at 85:17-86:2 (stating that if Mentor had provided him with additional information suggesting that ObTape had a higher risk than other products, he "would probably have searched out an alternative"). Kaiser is an Illinois resident whose ObTape-related treatment took place in Illinois. She filed her action in Hennepin County District Court of the State of Minnesota and served Mentor with the Complaint on September 10, 2013. Kaiser brought claims for 5 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 6 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 6 of 20 strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. IV. Sandy Anne Hill (ECF No. 29 in 4:13-cv-485) Hill saw Dr. Clifford Sarnacki for treatment of stress urinary incontinence. Dr. Sarnacki diagnosed Hill .with bladder prolapse and recommended surgery. On July 30, 2004, Dr. Sarnacki implanted Hill with ObTape, although Hill claims that she did not learn about the implanted device until sometime later. Hill did not see any materials from Mentor regarding ObTape, and she did not speak with any representatives of Mentor about the product. Hill asserts that the ObTape did not cure her incontinence and that it caused her abdominal pain. Hill appears to assert that Mentor misrepresented to Dr. Sarnacki (or concealed from him) an accurate complication rate for ObTape, the severity of known ObTape complications, and true information about ObTape's physical characteristics. She also appears to assert that if Dr. Sarnacki had known the true risks of ObTape, he would not have implanted it in Hill. But Hill did not point the Court to any evidence on this point.2 2Dr. Sarnacki passed away before his deposition could be taken. Hill did not point to any evidence that Dr. Sarnacki relied on information from Mentor in deciding to implant Hill with ObTape or that he would have made a different decision if he had been given different information. The Court cannot speculate as to what Dr. Sarnacki might have said had he been able to testify. 6 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 7 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 7 of 20 Hill is a Texas resident whose ObTape-related treatment took place in Texas. She filed her action in Hennepin County District Court of the State of Minnesota and served Mentor with the Complaint on September 27, 2013. Hill brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. V. Barbara Burt (ECF No. 27 in 4:14-cv-60) Burt sought treatment for stress urinary incontinence from Dr. Thomas Truluck. Dr. Truluck implanted Burt with ObTape on April 24, 2006. Burt did not see any materials from Mentor regarding ObTape, and she did not speak with any representatives of Mentor about the product. Burt asserts that she suffered various injuries caused by ObTape. Before he implanted Burt with ObTape, Dr. Truluck received training from Mentor and reviewed the ObTape product information data sheet. Truluck Dep. 26:6-17, ECF No. 29-3. A Mentor representative told Dr. Truluck that the approach for implanting ObTape was a new and safer approach. Dr. Truluck testified that if he had known that ObTape had a higher rate of extrusion than other slings, he would not have implanted Burt with it. Id. at 42:3-9. Burt is a North Carolina resident whose ObTape-related treatment took place in North Carolina. She filed her action in Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 8 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 8 of 20 Hennepin County District Court of the State of Minnesota and served Mentor with the Complaint on February 3, 2014. Burt brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. VI. Leslie Alexander (ECF No. 27 in 4:14-cv-62) Dr. Thomas Phillips implanted Alexander with ObTape on September 27, 2004. Alexander did not see any materials from Mentor regarding ObTape, and she did not speak with any representatives of Mentor about the product. Dr. Phillips testified that if he had known that ObTape had a higher rate of infection than other slings, he would not have implanted ObTape in his patients. Phillips Dep. 20:9-19, ECF No. 29-3. Alexander suffered recurrent incontinence in 2007 and sought treatment from Dr. Roberto Ferraro in 2008. Dr. Ferraro conducted exploratory surgery in June 2008 and discovered that Alexander's ObTape had eroded through her vaginal wall. Dr. Ferraro removed the portion of ObTape that he could remove. Alexander acknowledges that Dr. Ferraro told her in 2008 that she suffered a vaginal erosion of the ObTape. Alexander Dep. 21:21-22:9, ECF 27- 5. Alexander contends that she did not connect her complications to ObTape until she saw a television commercial regarding mesh injuries in 2013. 8 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 9 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 9•of 20 Alexander is a North Carolina resident whose ObTape-related treatment took place in North Carolina. She filed her action in Hennepin County District Court of the State of Minnesota and served Mentor with the Complaint on February 3, 2014. Alexander brought claims for strict liability, negligence, breach of express warranty, breach of implied warranty, common law fraud, constructive fraud, and negligent and intentional misrepresentation. DISCUSSION Each Plaintiff filed her action in Minnesota state court, and Mentor removed each Plaintiff's action to the United States District Court for the District of Minnesota. The cases were later transferred to this Court as part a multidistrict litigation proceeding regarding ObTape. The parties agree for purposes of summary judgment that Minnesota law applies to Plaintiffs' claims. See In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., No. 4:08-md-2004, 2013 WL 286276, at *7 (concluding that Minnesota law applied to claims of non-Minnesota ObTape plaintiffs who brought their actions in Minnesota). I. Strict Liability Claims Mentor contends that Bromley and Alexander's strict liability claims are time-barred under Minnesota law. The statute of limitations for a strict liability claim is four years. Minn. Stat. § 541.05 subd. 2 ("[A]ny action based on the strict 9 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 10 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 10 of 20 liability of the defendant and arising from the manufacture, sale, use or consumption of a product shall be commenced within four years."). Under Minnesota law, "a claim involving personal injuries allegedly caused by a defective product accrues when two elements are present: '(1) a cognizable physical manifestation of the disease or injury, and (2) evidence of a causal connection between the injury or disease and the defendant's product, act, or omission.'" Klempka v. G.D. Searle & Co., 963 F.2d 168, 170 (8th Cir. 1992) (quoting Hildebrandt v. Allied Corp., 839 F.2d 396, 398 (8th Cir. 1987)) (applying Minnesota law). "A plaintiff who is aware of both her injury and the likely cause of her injury is not permitted to circumvent the statute of limitations by waiting for a more serious injury to develop from the same cause." Id. For example, in Klempka, the plaintiff suffered injuries and was diagnosed with chronic pelvic inflammatory disease, which her doctor said was caused by the plaintiff's intrauterine device. Id. at 169. Several years later, the plaintiff was told that she was infertile and that the intrauterine device caused her infertility. Id. Applying Minnesota law, the Eighth Circuit concluded that the plaintiff's cause of action accrued when she first learned that she had an injury (chronic pelvic inflammatory disease) that was caused by the intrauterine device. Id. at 170. 10 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 11 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 11 of 20 Bromley cannot seriously deny that she knew she suffered some injuries caused by ObTape in September 2008 when Dr. Ruhe told Bromley that her pain was caused by the exposed ObTape. And Alexander cannot seriously dispute that she knew she suffered some injuries caused by ObTape in June 2008 when Dr. Ferraro told her that her ObTape had eroded through her vaginal wall. Bromley argues, however, that her claims did not accrue until she consulted a different doctor in 2011 and learned that the remainder of her ObTape would have to be removed. And Alexander asserts that her claims did not accrue until she saw an advertisement regarding mesh injuries in 2013. Bromley and Alexander did not point to any Minnesota authority holding that a plaintiff must be on actual notice that her specific injuries were caused by a defect. Rather, the precedent establishes that a claim accrues when the plaintiff becomes aware of an injury and a causal connection between the injury and the defendant's product. Klempka, 963 F.2d at 170. Bromley and Alexander nonetheless contend that one Eighth Circuit case and one Minnesota District Court case support denial of summary judgment in this case. The Court disagrees. First, they point to Tuttle v. Lorillard Tobacco Co., 377 F.3d 917 (8th Cir. 2004). In Tuttle, the district court found that the decedent's smokeless tobacco product liability action accrued when the decedent discovered a lump in his cheek. The Eighth Circuit 11 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 12 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 12 of 20 reversed because the decedent's doctor initially told the decedent that the lump was caused by an oral infection and was treatable with antibiotics-not that it was oral cancer caused by the tobacco. Id. at 922. Second, Bromley and Alexander point to Huggins v. Stryker Corp., 932 F. Supp. 2d 972 (D. Minn. 2013). In Huggins, the plaintiff asserted that the defendant's pain pump caused a condition that resulted in degeneration of his cartilage. The plaintiff's doctor discovered the loss of cartilage in 2002, but he did not connect the condition to the pain pump or tell the plaintiff that there was such a connection. The district court noted that the "first article recognizing a potential causal link between pain pumps" and the plaintiff's condition was not published until 2007. Id. Tuttle and Huggins are both distinguishable from Bromley and Alexander's cases. Unlike in Tuttle and Huggins, there is no dispute that Bromley and her doctor connected Bromley's injuries to ObTape in September 2008, and there is no dispute that Alexander and her doctor connected Alexander's injuries to ObTape in June 2008. Bromley and Alexander argue that even if Minnesota's discovery rule does not save their strict liability claims, the statute of limitations should be tolled by fraudulent concealment. "Fraudulent concealment, if it occurs, will toll the running of the statute of limitations until discovery or reasonable opportunity for discovery of the cause of action by the exercise 12 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 13 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 13 of 20 of due diligence." Holstad v. Sw. Porcelain, Inc., 421 N.W.2d 371, 374 (Minn. Ct. App. 1988); accord Hydra-Mac, Inc. v. Onan Corp., 450 N.W.2d 913, 918 (Minn. 1990). "The party claiming fraudulent concealment has the burden of showing that the concealment could not have been discovered sooner by reasonable diligence on his part and was not the result of his own negligence." Wild v. Rarig, 234 N.W.2d 775, 795 (Minn. 1975). As discussed above, Dr. Ruhe told Bromley in September 2008 that her pain was caused by ObTape and that the mesh "shouldn't have been falling out." Bromley Dep. 105:18-106:4. And Dr. Ferraro told Alexander in June 2008 that her ObTape had eroded through her vaginal wall. A reasonable person in that situation would take some action to follow up on the cause of her injuries and try to find out whether the injuries were caused by a problem with ObTape, a problem with the implant surgery, or some other problem. But Bromley and Alexander pointed to no evidence that they took any action to investigate their potential claims even though they knew there was a connection between their injuries and the ObTape. Under these circumstances, the Court concludes that fraudulent concealment does not toll the statute of limitations. Bromley's strict liability claim accrued in September 2008, and Alexander's accrued in June 2008. Neither filed her Complaint within four years of the accrual. The strict liability claims of Bromley and Alexander are therefore time-barred. 13 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 14 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 14 of 20 II. Misrepresentation and Common Law Fraud Claims Larranaga, Kaiser, Hill, Burt, and Alexander assert claims for common law fraud, negligent misrepresentation, and intentional misrepresentation. Mentor seeks summary judgment on these claims, contending that Minnesota law requires each Plaintiff to prove that she was injured because she relied on a misrepresentation from Mentor. But under Minnesota law, a misrepresentation claim in a medical device case can be premised on the manufacturer's alleged misrepresentations to a physician-not just misrepresentations directly to the patient. Kociemba v. G.D. Searle & Co., 707 F. Supp. 1517, 1525 (D. Minn. 1989); accord In re Minnesota Breast Implant Litig., 36 F. Supp. 2d 863, 879 (D. Minn. 1998) ("Statements made by a pharmaceutical representative directly to a physician should be expected to be relied upon[.]"). Thus, if a plaintiff can establish that the manufacturer made misrepresentations to her physician regarding the risks of product and that the physician would not have recommended the product for the plaintiff had he known the product's true risks, then the reliance and causation elements are satisfied.3 3 Mentor seeks summary judgment on Plaintiffs' "negligent misrepresentation" claims because Minnesota has not expressly recognized the tort of negligent misrepresentation involving the risk of physical harm. See Smith v. Brutger Cos., 569 N.W.2d 408, 413 (Minn. 1997) (declining to recognize the tort of negligent misrepresentation with physical harm but stating that the decision did "not foreclose the possibility of recognizing in Minnesota the tort of negligent misrepresentation involving the risk of physical harm" under a different factual scenario-with an actionable misrepresentation, reasonable reliance, and a causal connection). In support of their "negligent 14 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 15 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 15 of 20 Here, Plaintiffs assert that Mentor, intending to defraud them and induce them to undergo the ObTape procedure, made misrepresentations to their physicians that induced the physicians to recommend ObTape to Plaintiffs. Plaintiffs further contend that they relied on their doctors in deciding to proceed with the ObTape procedure. Kaiser, Burt, and Alexander each produced evidence that their physicians would not have implanted them with ObTape had they known its true risks. Thus, for Kaiser, Burt, and Alexander, the Court is satisfied that a genuine fact dispute exists on the justifiable reliance and causation elements, and Mentor is not entitled to summary judgment on their fraud and misrepresentation claims. Larranaga and Hill, however, did not point the Court to any evidence that their physicians relied on a misrepresentation from Mentor in selecting ObTape or that the physicians would not have recommended ObTape had they known its true risks. They contend that the Court should apply a "heeding presumption"-a "rebuttable presumption that the injured person would have heeded an adequate warning, had one been provided," which Minnesota has recognized in certain product cases. Prairie v. Mio Mech. Corp., No. 27-CV-12- 14077, 2013 WL 3869264, at *6 (Minn. Dist. Ct. June 25, 2013). misrepresentation" claims, Plaintiffs allege that Mentor did not exercise reasonable care in providing warnings to their doctors about ObTape. See, e.g., Burt Compl. IT 100-104, ECF No. 1-1 in 4:14-cv-60. Thus, Plaintiff's "negligent misrepresentation" claims are simply failure to warn claims, which Minnesota does recognize, so the Court declines to grant summary judgment on this basis. 15 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 16 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 16 of 20 For example, in Prairie, the Minnesota trial court presumed that a window washer who died after falling from the defendant's roof rigger platform product would have heeded an adequate instruction regarding the proper way to secure the platform had one been given. Id. But all Prairie allows the Court to presume is that Plaintiffs' physicians would have paid attention to an additional warning about the risks of ObTape. In other words, Prairie allows the Court to presume that the physicians would have considered the infection and erosion rates-among other considerations-in determining which product to select for their patients. The cases do not, however, permit the Court to speculate about how the physicians would have weighed the additional warnings. For this reason, the heeding presumption does not apply. Larranaga and Hill did not point to sufficient evidence to create a fact dispute on reliance and causation, so Mentor is entitled to summary judgment on their misrepresentation and fraud claims. III. Constructive Fraud Claims Larranaga, Kaiser, Hill, Burt, and Alexander brought "constructive fraud" claims. Mentor contends that Plaintiffs' constructive fraud claims fail because Mentor did not owe fiduciary duty to Plaintiffs; under Minnesota law, "[c]onstructive fraud reposes exclusively in the context of fiduciary obligations and is simply a characterization of a breach of such a duty." 16 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 17 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 17 of 20 Perl v. St. Paul Fire & Marine Ins. Co., 345 N.W.2d 209, 213 (Minn. 1984). The crux of Plaintiffs' "constructive fraud" claims is that Mentor had certain information about the risks of ObTape but intentionally concealed it from Plaintiffs' physicians. See, e.g., Burt Compl. 92-98, ECF No. 1-1 in 4:14-cv-60. In other words, Plaintiffs are asserting a classic fraudulent concealment claim, which is recognized under Minnesota law. See Flynn, 627 N.W.2d at 350 ("Under Minnesota law, fraudulent misrepresentation based on the concealment of a material fact occurs when one party knowingly conceals a material fact that is 'peculiarly within his own knowledge,' and the other party relies on the presumption that the fact does not exist.") (quoting Richfield Bank & Trust Co. v. Sjogren, 309 Minn. 362, 364, 244 N.W.2d 648, 650 (1976)). As discussed above, Kaiser, Burt, and Alexander each produced evidence that their physicians would not have implanted them with ObTape had they known its true risks, which Mentor concealed from them. Therefore, the Court denies summary judgment as to their fraudulent concealment claims. But Larranaga and Hill did not point to sufficient evidence of causation and reliance, so Mentor is entitled to summary judgment on their fraudulent concealment claims. 17 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 18 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 18 of 20 IV. Breach of Warranty Claims Larranaga, Kaiser, Hill, Burt, and Alexander brought breach of warranty claims. Mentor contends that the warranty claims are time-barred. Larranaga, Kaiser, Burt, and Alexander do not contest summary judgment as to their breach of warranty claims, so Mentor's motion as to those claims is granted. Hill contests summary judgment on her breach of warranty claims. Mentor argues that her claims are time-barred. But even if Hill's breach of warranty claims are not time-barred, Hill's breach of warranty claims fail for the same reasons her fraud and misrepresentation claims fail: Hill did not point to any evidence that any breach of warranty by Mentor caused her injuries. "To establish a warranty claim the plaintiff must basically prove: the existence of a warranty, a breach, and a causal link between the breach and the alleged harm." Daigle v. Ford Motor Co., 713 F. Supp. 2d 822, 825 (D. Minn. 2010) (quoting Peterson v. Bendix Home Sys., Inc., 318 N.W.2d 50, 52-3 (Minn. 1982)). Hill did not point to any evidence that Mentor made warranties directly to her. She also did not point to any evidence of a causal link between any representation Mentor made to Dr. Sarnacki and the alleged harm to Hill. The Court thus concludes that Mentor is entitled to summary judgment on Hill's breach of warranty claims. 18 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 19 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 19 of 20 CONCLUSION As discussed above, the Court makes the following rulings on Mentor's partial summary judgment motions: Lisa Bromley. Mentor's motion for summary judgment (ECF No. 45 in 4:13-cv-17) is granted. Only Bromley's negligence claim remains pending for trial. Maria Larranaga. Mentor's motion for partial summary judgment (ECF No. 29 in 4:13-cv-339) is granted. Only Larranaga's negligence and strict liability claims remain pending for trial. Marian Kaiser. Mentor's motion for summary judgment (ECF No. 29 in 4:13-cv-464) is granted as to Kaiser's breach of warranty claims. Mentor's motion is denied as to Kaiser's intentional misrepresentation, negligent misrepresentation, fraud, and fraudulent concealment claims. Those claims, along with her strict liability and negligence claims, remain pending for trial. Sandy Anne Hill. Mentor's motion for summary judgment (ECF No. 29 in 4:13-cv-485) is granted. Only Hill's negligence and strict liability claims remain pending for trial. Barbara Burt. Mentor's motion for summary judgment (ECF No. 27 in 4:14-cv-60) is granted as to Burt's breach of warranty claims. Mentor's motion is denied as to Burt's intentional misrepresentation, negligent misrepresentation, fraud, and fraudulent concealment claims. Those claims, along with her strict liability and negligence claims, remain pending for trial. 19 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 20 of 21 Case 4:13-cv-00017-CDL Document 50 Filed 11/19/15 Page 20 of 20 Leslie Alexander. Mentor's motion for summary judgment (ECF No. 27 in 4:14-cv-62) is granted as to Alexander's strict liability claim and breach of warranty claims. Mentor's motion is denied as to Alexander's intentional misrepresentation, negligent misrepresentation, fraud, and fraudulent concealment claims. Those claims, along with her negligence claim, remain pending for trial. Within seven days of the date of this Order, the parties shall notify the Court whether the parties agree to a Lexecon waiver. IT IS SO ORDERED, this 19th day of November, 2015. S/Clay D. Land CLAY D. LAND CHIEF U.S. DISTRICT COURT JUDGE MIDDLE DISTRICT OF GEORGIA 20 Case 4:13-cv-00321-CDL Document 40-16 Filed 08/29/16 Page 21 of 21 EXHIBIT N Case 4:13-cv-00321-CDL Document 40-17 Filed 08/29/16 Page 1 of 7 In re Guidant Corp. Implantable Defibrillators Products..., Not Reported in... 2007 WL 2023569 2007 WL 2023569 Only the Westlaw citation is currently available. United States District Court, D. Minnesota. In re GUIDANT CORP. IMPLANTABLE DEFIBRILLATORS PRODUCTS LIABILITY LITIGATION. This Document Relates to: Leopoldo Duron, Jr., Plaintiff, v. Guidant Corporation, Guidant Sales Corporation, Boston Scientific Corp., and Cardiac Pacemakers, Inc., Defendants. MDL No. 05-1708 (DWF/AJB). Civil No. 06-25 (DWF/AJB). July 6, 2007. Attorneys and Law Firms Charles S. Zimmerman, Ronald S. Goldser, Zimmerman Reed, PLLP, Gale D. Pearson, Pearson, Randall & Schumacher, PA, Michael K. Johnson, Goldenberg & Johnson, PLLC, Minneapolis, MN, Elizabeth J. Cabraser, Lieff Cabraser Heimann & Bernstein, San Francisco, CA, Richard J. Arsenault, Neblett, Beard & Arsenault, Alexandria, LA, Seth R. Lesser, Locks Law Firm, PLLC, New York, NY, Thomas A. Schultz, Kyle E. Lakin, Lopez Hodes Restaino Milman & Skikos, Newport Beach, CA, for Plaintiffs. Timothy A. Pratt, Michael D. Moeller, Shook Hardy & Bacon LLP, Kansas City, MO, Joseph M. Price, Faegre & Benson LLP, Minneapolis, MN, V. Scott Williams, Hazelwood & Weber, LLC, St Charles, MO, David P. Burke, Neil, Dymott, Frank, Harrison & McFall, APLC, Thomas J. Stoddard, Gordon & Rees, San Diego, CA, for Defendants. Paul R. Hannah, Kelly & Berens, PA, Minneapolis, MN, Gene F. Price, Frost Brown Todd LLC, Louisville, KY, for Intervenors. MEMORANDUM OPINION AND ORDER DONOVAN W. FRANK, United States District Judge. *1 This matter came before the Court pursuant to a Motion for Summary Judgment on Plaintiff Leopoldo Duron, Jr.'s Failure-to-Warn Claims Based on the Learned Intermediary Doctrine brought by Guidant Corporation, Guidant Sales Corporation, Boston Scientific Corp., and Cardiac Pacemakers, Inc. (collectively, "Guidant"). For the reasons set forth below, the Court grants in part and denies in part the motion. BACKGROUND The factual background and procedural history of this case are fully set forth in the Court's May 22, 2007 and June 12, 2007 Orders. Briefly, in March 2002, Dr. Steven Higgins, an electrophysiologist, 1 surgically implanted an implantable cardioverter defibrillator ("ICD"), the VENTAK PRIZM 2 DR, Model 1861 (the "Prizm 2"), in Duron after an electrophysiology study showed that he needed an ICD. Guidant manufactured the Prizm 2. Prior to the surgery, Guidant provided Dr. Higgins with a copy of the Prizm 2's Physician Technical Manual and System Guide. In that manual and/or guide, Guidant warned that Prizm 2 devices were "subject to random component failure" and that "[s]uch failure could cause inappropriate shocks, induction of arrhythmias or inability to sense arrhythmias, and could lead to the patient's death." 2 1 An electrophysiologist is a cardiologist who has had additional education and training in the diagnosis and treatment of abnormal heart rhythms. Although WESTLAW © 2016 Thomson Reuters, No claim to original tiS. Governmen Works. Case 4:13-cv-00321-CDL Document 40-17 Filed 08/29/16 Page 2 of 7 In re Guidant Corp. Implantable Defibrillators Products..., Not Reported in... 2007 WL 2023569 2 the of the parties quotations. did not In June 2005, Guidant recalled Prizm 2 devices, including provide Duron's device, which were manufactured prior to any actual April 2002. Shortly thereafter, the Food and Drug numbers, Administration classified Guidant's recall as a Class the I recall. A Class I recall is reserved for devices that Court create a reasonable probability of serious adverse health notes consequence or death. On August 19, 2005, Dr. Sardul there is Singh explanted Duron's Prizm 2 and replaced it with a a different Guidant-manufactured ICD. Subsequently, relatively Duron commenced an action against Guidant based on small alleged injuries he suffered as a result of the Prizm 2. number (1,000- 2,000 range) ARGUMENT of electrophysiologists I. Motion for Summary Judgment in the Summary judgment is proper if there are no disputed United issues of material fact and the moving party is entitled States. to judgment as a matter of law. Fed.R.Civ.P. 56(c). The Court must view the evidence and the inferences, Guidant which may be reasonably drawn from the evidence, in did not provide the light most favorable to the nonmoving party. Enter. the Bank v. Magna Bank of Mo., 92 F.3d 743, 747 (8th Court Cir.1996). As the United States Supreme Court has stated, with a "[s]ummary judgment procedure is properly regarded not copy of as a disfavored procedural shortcut, but rather as an the integral part of the Federal Rules as a whole, which manual; are designed 'to secure the just, speedy, and inexpensive instead, determination of every action.' " Celotex Corp. v. Catrett, these 477 U.S. 317, 327 (1986) (quoting Fed.R.Civ.P. 1). quotes are The moving party bears the burden of showing that there taken is no genuine issue of material fact and that it is entitled to from judgment as a matter of law. Enter. Bank, 92 F.3d at 747.Dr. Higgins' The nonmoving party must demonstrate the existence of Affidavit. specific facts in the record that create a genuine issue for (Guidant's trial. Krenik v. County of Le Sueur, 47 F.3d 953, 957 (8th Summ. Cir.1995). A party opposing a properly supported motion J. for summary judgment may not rest upon mere allegations Mem., or denials of his pleading, but must set forth specific facts Ex. I.) showing that there is a genuine issue for trial. Anderson v. Duron Liberty Lobby, Inc., 477 U.S. 242, 256 (l 986). does contest *2 Guidant moves for summary judgment on Duron's the failure-to-warn claims based on the learned intermediary accuracy doctrine. The parties agree that the learned intermediary doctrine applies to Duron's failure-to-warn claims and WESTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 2 Case 4:13-cv-00321-CDL Document 40-17 Filed 08/29/16 Page 3 of 7 In re Guidant Corp. Implantable Defibrillators Products..., Not Reported in... 2007 WL 2023569 on the standard used for failure-to-warn claims under his California law. They disagree about the impact of that failure- doctrine and standard on Duron's claims. 3 to-warn claims as those 3 It is claims unclear that which "sound exact in fraud counts or in something Duron's akin to Amended fraud or Complaint- negligence." by- (Id. at Adoption 63 .) the Given parties this, classify Counts as the I, III, "failure- VI, and to- VIII are warn" likely claims. implicated. Guidant The classifies standards the for such claims claims "as are strict quite liability different. warning See and Carlin v. negligent Superior failure Court, to warn, 13 [and] ... Ca1.4th the 1104, consumer 1112-13 protection (Cali 996) claims (discussing to the differences extent between they are negligent based failure- on a to-warn failure claims to warn and 106M9607 strict Tr. at liability 58.) failure- Duron to-warn classifies claims). WESTLAW CO 2016 Thomson Reuters. No claim to original U,S. Government Works. 3 Case 4:13-cv-00321-CDL Document 40-17 Filed 08/29/16 Page 4 of 7 In re Guidant Corp. Implantable Defibrillators Products..., Not Reported in... 2007 WL 2023569 Because the focus of the parties' briefing is on the "known or knowable" aspect of failure to warn, which is derived from strict liability cases, the focus of this Order is on that standard. Under California law, it is well-settled that a manufacturer of medical devices or prescription drugs owes to the medical profession the duty of providing adequate warnings if it knows, or has reason to know, of any dangerous side effects of its devices or drugs. See Carlin, 13 Cal.4th at 1112-13. California follows the learned intermediary doctrine, which provides that the duty to warn "runs to the physician, not to the patient." Id. at 1116. Thus, a manufacturer discharges its duty to warn if it provides adequate warnings to the physician about any known or reasonably knowable dangerous side effects, regardless of whether the warning reaches the patient. The adequacy of a warning is controlled by comment k of the Restatement (Second) of Torts, § 402A, and it requires that a manufacturer's device be accompanied with warnings of a devices "dangerous propensities that were either known or reasonably scientifically knowable at the time of distribution." Brown v. Superior Court, 44 Cal.3d 1049, 1061 (Ca1.1988). The Court assumes, and the parties appear to agree, that under California law, a plaintiff asserting failure-to-warn claims must prove not only that no warning was provided or the warning was inadequate, but also that the inadequacy or absence of the warning caused the plaintiffs injury. Motus v. Pfizer, Inc., 196 F.Supp.2d 984, 993 (C.D.Ca1.2001) (applying California law and concluding that California courts would likely not apply a reputable presumption for causation in failure-to- warn claims) Using these standards, Guidant asserts that it is entitled to summary judgment on Duron's failure-to-warn claims for three primary reasons. The Court will discuss each in turn. A. Pre-Implant Warning Dr. Higgins implanted the Prizm 2 in Duron on March 9, 2002. Prior to that time, Guidant had received one report on February 1, 2002, involving arcing in the header of a Prizm 2. Guidant received that device on February 12, 2002, and its engineers analyzed the device and determined that the incident was caused by a short circuit within the header. The parties dispute the result of those findings and whether, at that time or before, Guidant knew or should have known that there was a potentially systematic problem in the Prizm 2s, whether that problem is with polyimide or with the placement of the DF-feed through wire. Guidant asserts that it had no duty to warn Duron's doctor of the February 1, 2002 incident because, at that time, it did not know the cause of the problem; therefore, it contends that it could not have given an accurate warning. And, Guidant argues that its warning about "random component failure" covers the February 1, 2002 incident. Guidant also asserts that over-warning doctors carries with it a risk that the warnings will go unheeded. In addition, Guidant contends that, at that time, the FDA precluded it from giving a warning because there was no significant medical evidence to suggest there was a possible health hazard to Prizm 2 patients. Finally, Guidant characterizes Duron's failure-to-warn claims as a back-door way to get to design defect claims, which are unavailable to him under California law. *3 Duron responds that Guidant did have a duty to warn of the February 1, 2002 incident because it knew or should have known that the device defect at issue was a systematic, as opposed to a random, defect that could lead to death or serious injury. He points out that Guidant's own Independent Panel concluded that reports of single events should be communicated to doctors if (a) there is a risk of death or serious injury; (b) there is a suspected or defined basis for the malfunction or failure; and (c) the failure is likely to be systematic and to occur in other patients. (Duron's Ex. 66. at 19.) Moreover, even WESTLAW 0 2016 Thomson Reuters. No claim to original U.S. Government Works. 4 Case 4:13-cv-00321-CDL Document 40-17 Filed 08/29/16 Page 5 of 7 In re Guidant Corp. Implantable Defibrillators Products..., Not Reported in... 2007 WL 2023569 if Guidant did not know the "root cause" of the February incident, Duron points to several scientific authorities published years before Duron's implant surgery to show that Guidant should have known of the problems created by polyimide when it is placed in contact with bodily fluids. The Court agrees with Duron. It is true that medical device manufacturers may not have a duty to warn after receiving every single incident report, depending on the circumstances underlying the incident report and the cause of that report. Here, however, there are genuine issues of material fact with respect to what Guidant knew or should have known after receiving the February 1, 2002 report and what Guidant knew or should have known about polyimide prior to Duron's implant. The FDA's actions or inactions may be admissible to show whether these risks were known or reasonably scientifically knowable. 4 Carlin, 13 Ca1.4th at 1111. These genuine issues of material fact need to be resolved before determining whether Guidant should have issued specific warnings that the Prizm 2 may malfunction as a result of polyimide degradation. Guidant's boilerplate warnings of random failures or potential mortality due to failure to defibrillate do not cover failures caused by specific, known or knowable, causes and do not insulate Guidant from potential liability. For these reasons, the Court denies Guidant's motion with respect to whether its warnings were adequate prior to Duron's implant surgery. See id. at 1116-17. 4 The June 29, 2007 Daubert Order addresses the evidentiary implications of the FDA actions or inactions. B. Post-Implant Warning The parties agree that California law imposes a continuous post-sale duty to warn so long as the device remains in use. See Valentine v. Baxter Healthcare Corp., 81 Cal.Rptr.2d 252, 262 (Cal.Ct.App.1999). Guidant moves for summary judgment on any claims involving post-implant warnings because it asserts that Duron cannot show that any post-implant warnings caused his injuries. Duron's alleged injuries stem from the June 2005 recall and his subsequent explant surgery in August 2005. Duron does not specifically respond to this argument; instead he focuses on what Guidant knew or should have known post-implant surgery. The Court agrees with Guidant that Duron's post-implant warning claims must fail because there is no causal link between those warnings and his alleged injuries. Accordingly, the Court grants Guidant's motion with respect to this aspect of Duron's failure-to-warn claims. C. Causation *4 As stated earlier, the Court assumes, and the parties appear to agree, that under California law, a plaintiff must show that the inadequacy or lack of warning caused the plaintiffs injury. Motus, 196 F.Supp.2d at 995. In connection with its summary judgment motion, Guidant submitted Dr. Higgins' affidavit, in which he avers that his decision to implant the Prizm 2 in Duron would not have changed had Guidant warned him of the February 1, 2002 incident. Dr. Higgins further states that prior to Duron's implant surgery, he was aware that "electrical arcing and short circuiting in ICDs may occur." (Guidant's Summ. J. Mem. Ex. I, ¶ 10.) Dr. Higgins does not state if he knew why the arcing and short circuiting might occur, but he does state that "these risks have been generally known in the medical community for over twenty years." ( Id. at 1111.) He further explains that he would not want or expect to be notified every time an ICD fails. Dr. Higgins does not discuss polyimide degradation. Based on Dr. Higgins' affidavit, Guidant asserts that it is entitled to summary judgment because Duron cannot establish causation, given that Dr. Higgins would have implanted Duron's Prizm 2 even if he had the warnings Duron says Guidant should have given. Both before and after Duron's implant, Dr. Higgins had a long-standing relationship with Guidant. Not surprisingly, the parties characterize the Dr. Higgins- Guidant relationship differently. Guidant asserts that Dr. Higgins was simply reasonably compensated for consulting work that he performed for Guidant and for his service as a member of Guidant's Medical Advisory Board. It contends that Dr. Higgins merely "thinks Guidant is a great company because Guidant makes WESTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00321-CDL Document 40-17 Filed 08/29/16 Page 6 of 7 In re Guidant Corp. Implantable Defibrillators Products..., Not Reported in... 2007 WL 2023569 great devices that save people's lives." (6/19/07 Tr. at 52.) Guidant further asserts that Dr. Higgins has no bias for Guidant because many other electrophysiologists in the United States have relationships with medical device companies similar to Dr. Higgins' relationship with Guidant. According to Guidant, Dr. Higgins' "admiration for Guidant is entirely understandable and pretty typical of the vast majority of [electrophysiologists]." (Id at 54.) In response, Duron points out that, among other things, Guidant paid for Dr. Higgins, Guidant's Cardiac Rhythm Management Division President Fred McCoy, and other top Guidant executives to travel to Ireland for a golf trip to celebrate Dr. Higgins' birthday. He also points out that top Guidant executives regularly visited Dr. Higgins at his home and went on golfing trips in the United States. He notes that in e-mails to Guidant, Dr. Higgins described himself as Guidant's "alter ego" and as a "hit man." (Id. at 73-74.) In addition, Duron states that on-going, past- due discovery will show that Guidant paid Dr. Higgins very large sums of money for his various consulting and study activities. Finally, Duron points to other doctors' testimony to demonstrate that other doctors would not have implanted the Prizm 2 in their patients had they been properly warned of the risks of arcing and polyimide degredation. *5 Guidant's causation argument is that there is no way for Duron to succeed on his failure-to-warn claims because his implanting doctor, despite his relationship with Guidant, averred that he would have implanted the Prizm 2 in Duron independent of any additional or different warnings. Guidant also argues that other doctors' opinions are irrelevant. But the law does not turn a blind eye to an implanting doctor's bias or interest. Rather, Dr. Higgins' statements must be viewed in conjunction with his ties and/or relationship to Guidant. See, e.g., Stevens v. Parke, Davis, & Co ., 9 Ca1.3d 51, 66-67 (Ca1.1973) (explaining that the evidence supported the jury's inference that the doctor was induced to prescribe a drug based on defendant's overpromotion); see also Motus, 196 F.Supp.2d at 997 (explaining that summary judgment would not be warranted if plaintiff had presented evidence putting the physician's credibility in question). Contrary to Guidant's assertions, the Court doubts that Guidant provides European-birthday-golfing-trips to most electrophysiologists in the United States, that top Guidant executives frequently visit electrophysiologists' homes, and that Guidant or other ICD manufacturers pay electrophysiologists the sums Guidant paid Dr. Higgins. If this is true, at a minimum, it creates an appearance of bias and interest that the jury is entitled to consider and that certainly deserves an explanation. Given this, summary judgment is inappropriate because, as discussed above, genuine issues of material fact exist concerning Dr. Higgins' credibility and whether Duron can establish causation. Therefore, the Court denies Guidant's motion with respect to causation. CONCLUSION Based on the foregoing, it is HEREBY ORDERED that: 1. Guidant's Motion for Summary Judgment on Plaintiff Leopoldo Duron, Jr.'s Failure-to-Warn Claims Based on the Learned Intermediary Doctrine (MDL No. 05-1708 (DWF/AJB), Doc. No. 1458; Civ. No. 06-25 (DWF/AJB), Doc. No. 25) is GRANTED IN PART AND DENIED IN PART as follows: a. Guidant's Motion for Summary Judgment with respect to Post-Implant Warnings is GRANTED. b. Guidant's Motion for Summary Judgment with respect to Pre-Implant Warnings and Causation is DENIED. A11 Citations Not Reported in F.Supp.2d, 2007 WL 2023569 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. litYESTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 Case 4:13-cv-00321-CDL Document 40-17 Filed 08/29/16 Page 7 of 7 EXHIBIT 0 Case 4:13-cv-00321-CDL Document 40-18 Filed 08/29/16 Page 1 of 8 Allstate Ins. Co. v. General Motors Corp., Not Reported in N.W.2d (2005) 2005 WL 264276, 56 UCC Rep.Serv.2d 241 2005 WL 264276 District Court of Minnesota, Fourth Judicial District, Hennepin County.. ALLSTATE INSURANCE COMPANY, as subrogee of Arnold Gronke, Plaintiff, v. GENERAL MOTORS CORPORATION, Defendant. No. PD 04-12393. Jan. 24, 2005. Attorneys and Law Firms Authony U. Wacker, Minneapolis, MN, for Allstate Insurance Company, as subrogee of Arnold Gronke. Mickey W. Greene, Hanson Marek Bolkom & Greene, Ltd., Minneapolis, MN, for General Motors Corporation. ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT DUFRESNE, J. *1 The above-entitled matter came duly on for hearing before Judge Mary Steenson DuFresne on January 10, 2005. Based upon the evidence adduced, the argument of counsel, and all of the files, records, and proceedings herein, THE COURT FINDS: 1 Defendant brings this motion for summary judgment and asserts that Plaintiffs claims are barred by Minnesota's adoption of the Uniform Commercial Code's four-year statute of limitations applicable to a breach of warranty as codified in Minnesota Statutes Section 336.2-725. Defendant asserts that Section 336.2-725 requires an action for breach of warranty to be brought within four years of the breach and Plaintiff brought his action on April 23, 2004, more than five years after the warranty on his 1999 Cadillac Seville began and nearly fifteen months after the statute of limitations period expired. Defendant asserts further that the four-year statute of limitations period did not begin tolling when the Cadillac Seville was damaged because its warranty merely covered repair and replacement and did not extend to the Cadillac Seville's future performance. 2. Plaintiff opposes Defendant's motion for summary judgment and asserts, inter alia, that the Cadillac Seville's warranty was an explicit warranty of future performance because it covered the Cadillac Seville for 4 years or 50,000 miles, whichever occurred first. As a warranty of future performance, Plaintiff alleges that the 4- year statute of limitations period did not begin to toll until the Cadillac Seville's axle and rotor plate failed on May 7, 2002; therefore, Plaintiffs April 23, 2004 Summons and Complaint is not barred by Minnesota Statutes Section 336.2-725 because the statute of limitations period does not expire until May 7, 2006. IT IS ORDERED: 1. Let the attached Memorandum of Law be incorporated by reference herein. 2. Defendant's motion for summary judgment is GRANTED. LET JUDGMENT BE ENTERED ACCORDINGLY. I. FACTS Although the parties do not dispute the facts of this matter they have each developed opposing interpretations of how the facts apply to Minnesota Statutes Section 336.2-725(2). Plaintiffs insured, Arnold Gronke, purchased and took delivery of a 1999 Cadillac Seville (the "Cadillac") on February 5, 1999. The Cadillac was manufactured by Defendant and came with a "New Vehicle Limited Warranty" (the "Warranty"). The Warranty states that Defendant "will provide for repairs to the vehicle during the warranty period[.]" Under the heading "Repairs Covered" the Warranty states that it "covers repairs to correct any vehicle defect related to materials or workmanship occurring during the Warranty period." The Warranty states further that "[t]he Warranty Period for all coverages begins on the date the vehicle is first delivered or put into use and ends at the expiration WESTLAW CO 2016 Thomson Reuters. No claim to original U.S. Government Works. 1 Case 4:13-cv-00321-CDL Document 40-18 Filed 08/29/16 Page 2 of 8 Allstate Ins. Co. v. General Motors Corp., Not Reported in N.W.2d (2005) 2005 WL 264276, 56 UCC Rep.Serv.2d 241 of the coverage period" and that "[t]he complete vehicle is covered for 4 years or 50,000 miles, whichever comes first [.1" Lastly, and under the heading "Other Terms," the Warranty states that "[p]erformance of repairs and needed adjustments is the exclusive remedy under this written warranty or any implied warranty. [Defendant] shall not be liable for incidental or consequential damages ... resulting from the breach of this written warranty or any implied warranty." The Warranty expired by its own terms four years after Mr. Gronke took delivery of the Cadillac on February 5, 2003. *2 Mr. Gronke was involved in an accident on May 7, 2002 while driving the Cadillac westbound on Minnesota Highway 7. Plaintiff alleges in its April 23, 2004 1 Complaint that the Cadillac's left rear axle and rotor plate "broke" and caused the Cadillac to rollover several times and incur damage totaling $29,229.58. Given the fact that Mr. Gronke had covered the Cadillac with one of Plaintiffs automobile insurance policies, Plaintiff paid the cost of the damage to Mr. Gronke and subrogated itself to his claims. 1 The parties stipulated to amend the Summons and Complaint in August 2004. The Amended Complaint appears to only have removed Plaintiff s claims regarding a 1999 Chevrolet Suburban owned by another one of its insureds named Kimberly Collins. II. STATEMENT OF CLAIMS Defendant brings this motion for summary judgment and asserts that Plaintiffs claims are barred by Minnesota's adoption of the Uniform Commercial Code's four-year statute of limitations applicable to a breach of warranty as codified in Minnesota Statutes Section 336.2-725. Defendant asserts that Section 336.2-725 requires an action for breach of warranty to be brought within four years of the breach and Plaintiff brought his action on April 23, 2004, more than five years after the Warranty began and nearly fifteen months after the statute of limitations period expired. Defendant asserts further that the four-year statute of limitations period did not begin tolling when the Cadillac was damaged because the Warranty merely covered repair and replacement and did not extend to the Cadillac's future performance. Plaintiff opposes Defendant's motion for summary judgment and asserts, inter alia, that the Warranty was an explicit warranty of future performance because it covered the Cadillac for 4 years or 50,000 miles, whichever occurred first. As a warranty of future performance, Plaintiff alleges that the 4-year statute of limitations period did not begin to toll until the Cadillac's axle and rotor plate failed on May 7, 2002; therefore. Plaintiffs April 23, 2004 Summons and Complaint is not barred by Minnesota Statutes Section 336.2-725 because the statute of limitations period does not expire until May 7, 2006. III. SUMMARY JUDGMENT STANDARD Summary judgment is appropriate "if the pleadings ... answers to interrogatories, and admissions on file, together with the affidavits ... show that there is no genuine issue as to any material fact and that either party is entitled to a judgment as a matter of law." Minn. R. Civ. P. 56.03. The party moving for summary judgment "has the burden of proof and ... the nonmoving party has the benefit of that view of the evidence which is most favorable to him." Sauter v. Sauter, 70 N.W.2d 351, 353 VITSTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00321-CDL Document 40-18 Filed 08/29/16 Page 3 of 8 Allstate Ins. Co. v. General Motors Corp., Not Reported in N.W.2d (2005) 2005 WL 264276, 56 UCC Rep.Serv.2d 241 (Minn.1955). There is no genuine issue of material fact " ̀[w]here the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party." ' DLH, Inc. v. Russ, 566 N.W.2d 60, 69 (Minn.1997) (quoting Matsushita Elec. Indus. Co. v. Zenith Radio Corp. 475 U.S. 574, 587 (1986)). The nonmoving party must " 'do more than simply show that there is some metaphysical doubt as to the material facts." ' Id. at 70 (quoting Matsushita, 475 U.S. at 586). A district court's "function on a motion for summary judgment is not to decide issues of fact, but solely to determine whether genuine factual issues exist." DLH, 566 N.W.2d at 70. This court cannot "weigh the evidence on a motion for summary judgment;" however, "when determining whether a genuine issue of material fact for trial exists, th[is] court is not required to ignore its conclusion that a particular piece of evidence may have no probative value, such that reasonable persons could not draw different conclusions from the evidence presented." Id. IV. LEGAL ANALYSIS *3 The Uniform Commercial Codes ("U.C.C.") provision governing statutes of limitations in contracts for sale has been adopted in Minnesota and states, in relevant part, that "[a]n action for breach of any contract for sale must be commenced within four years after the cause of action has accrued." Minn.Stat. § 336.2-725(1) (2004). The parties do not dispute that the sale of the Cadillac was a contract for sale. See Minn.Stat. § 336.2-106(1) (2004) (defining a "contract for sale" as a "present sale of goods and a contract to sell goods at a future time" and a "sale" as "the passing of title from the seller to the buyer for a price"). That portion of Section 336.2-725 that the parties have found reason to quarrel over states that [a] cause of action accrues when the breach occurs, regardless of the aggrieved party's lack of knowledge of the breach. A breach of warranty occurs when tender of delivery is made, except that where a warranty explicitly extends to future performance of the goods and discovery of the breach must await the time of such performance the cause of action accrues when the breach is or should have been discovered. Id at § 336.2-725(2) (emphasis added). This matter turns on whether or not the Warranty explicitly extends to the future performance of the Cadillsc, Plaintiff asserts that the Warranty's "bumper-to-bumper coverage" for four years or 50,000 miles explicitly warrants the future performance of the Cadillac, and, as such, Defendant's breach did not occur until the left rear axle and rotor plate failed on May 7, 2002. Pursuant to Plaintiffs interpretation of Section 336.2-725(2), the statute of limitations does not expire until May 7, 2006-two full years after Plaintiff brought this action. Contrariwise, Defendant asserts that the Warranty merely covered repair and replacement of the Cadillac's defective parts, if any, and the statute of limitations began tolling when the Cadillac was tendered to Mr. Gronke on February 5, 1999. Pursuant to Defendant's interpretation of Section 336.2-725(2), the four-year statute of limitations expired on February 5, 2003-fifteen months before Plaintiff brought this action. Pursuant to the U.C.C., a "warranty must 'explicitly extend( ] to future performance of the goods,' or else the buyer's breach of warranty action accrues on tender of delivery." Marvin Lumber and Cedar Co. v. PPG Industries, Inc., 223 F.3d 873, 879 (8th Cir.2000) (quoting Section 336.2-725(2)). Courts throughout the United States have "vigorously enforced the U.C.C.'s statutory explicitness requirement." Id (citing Standard Alliance Industries, Inc. v. Black Clawson, Co., 587 F.2d 813, 820 (6th Cir.1978)). In Standard Alliance, the Sixth Circuit Court of Appeals concluded that [m]ost courts have been very harsh in determining whether a warranty explicitly extends to future performance. Emphasizing the word "explicitly," they have ruled that there must be specific reference to a future time in the warranty. As a result of this harsh construction, most express warranties cannot meet the test and no implied warranties can since, by their very nature, they never "explicitly extend to future performance." 2 WESTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00321-CDL Document 40-18 Filed 08/29/16 Page 4 of 8 Allstate Ins. Co. v. General Motors Corp., Not Reported in N.W.2d (2005) 2005 WL 264276, 56 UCC Rep.Serv.2d 241 2 Although not addressed in its motion papers, Plaintiff seemed to assert at oral argument that Defendant's various Cadillac advertising campaigns amounted to implied warranties of future performance. The court does not decide here whether such advertising does amount to an implied warranty but notes in passing that at least two Minnesota courts have concluded that implied warranties do not extend to future performance. See Nelson v. International Harvester Corp., 394 N.W.2d 578, 582 (Minn.Ct.App.1986) overruled on other grounds by Lloyd F. Smith Co., Inc. v. Den- Tal-Ez, Inc., 491 N.W.2d 11, 17 (Minn.1992) (endorsing the rule adopted in courts throughout the country that "the words `implied' and `explicit' are contradictory and it would be illogical to hold that an implied warranty can explicitly extend to WEST AW © 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00321-CDL Document 40-18 Filed 08/29/16 Page 5 of 8 Allstate Ins. Co. v. General Motors Corp., Not Reported in N.W.2d (2005) 2005 WL 264276, 56 UCC Rep.Serv.2d 241 future N.W.2d 302, 314 n. 25 (Minn.2000). Warranties of future performance"); performance differ from those that merely offer to repair Muzzy or replace defective parts. Anderson v. Crestliner, v. E. I du 564 N.W.2d 218, 222 (Minn.Ct.App.1997) (citing Ontario Pont de Hydro v. Zallea Systems, Inc., 569 F.Supp. 1261, 1266 Shell for future performance guarantees the performance of the Oil Co., 725 product itself for a stated period of time." ' Id. (emphasis A.2d in original). 431, 436 (Del.Super.Ct.198) The (stating warranty that at issue "[a]n in implied Ontario warranty, Hydro by its stated, very in part, nature, that "[i]f cannot at any extend time up to to future twelve... performance months. because any it makes defect no or explicit deficiency representations should concerning appear longevity"). due to *4 Standard Alliance, 587 F.2d at 820. faulty workmanship, A warranty explicitly extending to future performance material Nemours & Co., (D.De1.1983)). 3 A warranty of future performance " 1993 'must expressly provide some form of guarantee that the WL product will perform in the future as promised." ' Id. A 76191, warranty to repair or replace " 'does not, warrant how *2 the goods will perform in the future. Rather, [it] simply (Minn.Dist.Ct.lfiMides that if a product fails or becomes defective, See also the seller will replace or repair within a stated period." S & R Id. The distinction between these two warranties " is Associates, that a repair or replacement warranty merely provides a L. P. v. remedy if the product becomes defective, while a warranty "presents an exception to the normal rule as to when or design... a cause of action for breach of warranty accrues." the Marvin Lumber, 223 F.3d at 878. A warranty of future sChoamllpanyperformance guarantees that a particular product will perform in the future as promised. Church of the Nativity restore of Our Lord v. WotPro, Inc., 491 N.W.2d 1, 6 (Minn.1992) the overruled on other grounds by Ly v. Nystrom, 615 Equipment WESTLAW 2016 Thomson Reuters. No claim to original U.S. Government Works. Case 4:13-cv-00321-CDL Document 40-18 Filed 08/29/16 Page 6 of 8 Allstate Ins. Co. v. General Motors Corp., Not Reported in N.W.2d (2005) 2005 WL 264276, 56 UCC Rep.Serv.2d 241 to joints satisfactory were condition defective. by Id. at making 1266. good The warranty in Crestliner concerned a 21-foot fiberglass every boat and stated, in relevant part, that "Crestliner such defect[.]"warrants ... that each new retail boat ... shall be free Ontario from any defect in material or workmanship according Hydro, to the following guidelines.... The warranty period for 569 defects in material or workmanship of the hull and deck F . Supp . at structure is 5 years." Crestliner, 564 N.W.2d at 220. The 1264. warranty also indicated that the original purchaser's sole Interpreting and exclusive remedy was "repair or replace[ment] without U. C. C. charge" of any part covered by the warranty. Id. Holding Section that the boat's warranty guaranteed that the hull and deck 2-725(2), structure would be free from material or workmanship the defects for a period of five years, the Court concluded that Court the warranty "explicitly extends to future performance." concluded Id at 221. that the warranty was a Unlike the warranty that presented itself for adjudication repair in Crestliner, and despite Plaintiffs assertion to the Or contrary, the Warranty does not anywhere state, explicitly replacement or otherwise, that it extends to the Cadillac's future warranty performance or that the Cadillac is guaranteed to be free because from defects for four years or 50,000 miles; rather, the it did Warranty merely states that the Cadillac is covered for not "4 years or 50,000 miles, whichever comes first." The warrant Warranty's four-year or 50,000 mile coverage must be read how the in conjunction with the explicit recitation that it "covers product- repairs to correct any vehicle defect related to materials expansion or workmanship occurring during the Warranty Period." joints- would Like the warranty at issue in Ontario Hydro above, the perform Warranty merely provides the Cadillac's owner with the in the remedy of "correct[ing] any defect related to materials or future; workmanship occurring during" the first four years or rather, 50,000 miles. The Warranty merely provided Mr. Gronke the with a remedy, not, as Plaintiff asserts, a guarantee of warranty the Cadillac's performance. Although " ̀[t]he presence of merely language limiting the remedy to replacement of defective provided materials, by itself, is [not] determinative of the exact a nature of the [W]arrant[y]," ' Id at 222 (quoting R. W. remedy Murray Co. v. Shatterproof Glass Corp., 697 F.2d 818, for 823 (8th Cir.1983)), the Warranty also states under the repair within heading "Other Terms" that "[p]erformance of repairs one year and needed adjustments is the exclusive remedy[.]" This if the limiting language, although not dispositive, adds weight expansion WESTLAW 2016 Thomson Reuters. No claim to original U.S. Government Works. 6 Case 4:13-cv-00321-CDL Document 40-18 Filed 08/29/16 Page 7 of 8 Allstate Ins, Co. v. General Motors Corp., Not Reported in N.W.2d (2005) 2005 WL 264276, 56 UCC Rep.Serv.2d 241 to the court's conclusion that the Warranty is one of repair or replacement, not of future performance. V. CONCLUSION *5 The court finds, and the parties agree, that there are no genuine issues of material fact. The court's conclusion that the Cadillac was covered by a repair or replacement warranty is fatal to Plaintiffs claims because Section 336.2-725's four-year statute of limitations began tolling when the Cadillac was tendered to Mr. Gronke on February 5, 1999 and expired on February 5, 2003-fifteen months before Plaintiff commenced this action. Section 336.2-725's statute of limitations for breach of a contract for sale bars Plaintiffs claims and Defendant is, therefore, entitled to judgment as a matter of law. All Citations Not Reported in N.W.2d, 2005 WL 264276, 56 UCC Rep.Serv.2d 241 End of Document © 2016 Thomson Reuters. No claim to original U.S. Government Works. WESTLAW © 2016 Thomson Reuters. No claim to original U.S. Government Works. 7 ase 4:13-cv-00321-CDL Document 40-18 Filed 08/29/16 Page 8 of 8
