Angle v. Mentor Worldwide Llc

MOTION for Partial Summary Judgment

M.D. Ga.April 24, 2017

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. 4:16-cv-00035 (Angle) DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR PARTIAL SUMMARY JUDGMENT AGAINST PLAINTIFF DOROTHY ANGLE Pursuant to Rule 56 of the Federal Rules of Civil Procedure and Local Rule 56, Defendant Mentor Worldwide LLC (“Mentor”) respectfully moves this Court for partial summary judgment against Plaintiff Dorothy Angle. Plaintiff’s claims for strict liability- design defect (Count II) and breach of warranty (Counts V and VI) fail as a matter of law. Additionally, to the extent Plaintiff relies on a continuing duty to warn theory, her negligence and strict liability-failure-to-warn claims (Counts I and IV) fail because she has no evidence that her doctors would have treated her differently had they received more or different post-implant warnings from Mentor. The grounds for this Motion are set forth in more detail in the accompanying memorandum in support. Dated: April 24, 2017 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 4:16-cv-00035-CDL Document 12 Filed 04/24/17 Page 1 of 2 2 012813\003576\3136204.1 IN RE: MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL NO. 2004 CERTIFICATE OF SERVICE A copy of the foregoing was served via ECF on the following counsel this 24th day of April 2017: Caroline C. Pace cpace@arnolditkin.com D. Doug Mena doug@haunmena.com J. Steve Mostyn jsmostyn@mostynlaw.com Jason A. Itkin jitkin@arnolditkin.com Kurt B. Arnold karnold@arnolditkin.com Laura Stehr Peters lpeters@arnolditkin.com Micajah D. Boatright cboatright@arnolditkin.com Noah M. Wexler nwexler@arnolditkin.com Rebecca L. Adams radams@arnolditkin.com Attorneys for Plaintiff Dorothy Angle s/ John Q. Lewis John Q. Lewis Designated Lead Counsel for Defendant Mentor Worldwide LLC Case 4:16-cv-00035-CDL Document 12 Filed 04/24/17 Page 2 of 2 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 No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:16-cv-00035 (Angle) DEFENDANT MENTOR WORLDWIDE LLC’S MEMORANDUM IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT AGAINST PLAINTIFF DOROTHY ANGLE Mentor is entitled to partial summary judgment on Plaintiff’s claims for the following reasons: • The strict liability-design defect (Count II) and breach of warranty claims (Counts V and VI) fail as a matter of law because California law prohibits strict liability and related warranty liability for design defects in medical device cases. • The implied warranty claim (Count V) further fails for lack of privity. • The breach of express warranty claim (Count VI) further fails because Plaintiff failed to give Mentor pre-lawsuit notice of her claim. • The negligence and strict liability-failure-to-warn claims (Counts I and IV) fail to the extent Plaintiff alleges a post-sale or continuing duty to warn because there is no evidence that any post-implant warning would have changed the care and treatment Plaintiff received from her physicians. For these reasons, Mentor respectfully requests that this Court enter summary judgment in its favor on Counts II, V, and VI of Plaintiff’s Complaint and on Counts I and IV to the extent based on a continuing or post-sale duty to warn. UNDISPUTED FACTS RELEVANT TO THIS MOTION This Court previously described general facts related to ObTape (e.g., Order, Apr. 22, 2010, Doc. No. 241 at 4-5); Mentor will not restate them here as this motion is premised on undisputed facts unique to Plaintiff Dorothy Angle. Case 4:16-cv-00035-CDL Document 12-1 Filed 04/24/17 Page 1 of 11 2 On November 29, 2004, Dr. Chris Threatt implanted Plaintiff with ObTape in Turlock, California. (Separate Statement of Materials Facts ((“SSMF”) ¶ 1.) Dr. Threatt never gave Plaintiff any written materials about ObTape. (Id. ¶ 2.) Plaintiff relied on Dr. Threatt to decide what type of sling to use for her implant, and she did not know that she received a Mentor ObTape until the day of her deposition. (Id. ¶ 3.) Plaintiff never returned to Dr. Threatt with a complication from her ObTape. (Id. ¶ 4.) In 2015, Plaintiff treated with Dr. Alberto Corica for urinary issues. (SSMF ¶ 5.) During his care and treatment of Plaintiff, Dr. Corica never diagnosed her with a complication that he attributed to her ObTape. (Id. ¶ 6.) Plaintiff’s ObTape has never been removed. (Id. ¶ 7.) Dr. Corica testified that if Mentor recommended removing the entire ObTape upon seeing erosion or infection, he would not have treated Plaintiff any differently because the symptoms she presented with were not specific to mesh. (Id. ¶ 8.) Dr. Corica learned in residency-not from Mentor-that the standard of care for an eroded mesh was to remove the entire sling. (Id. ¶ 9.) Likewise, Dr. Threatt testified that he understood that when an erosion occurred, he should remove the tape to minimize the risk of infection and that his practice with eroded slings was to remove the mesh as far as he could get to it. (Id. ¶ 10.) After seeing a television advertisement in 2015, Plaintiff obtained counsel and direct-filed her lawsuit against Mentor on February 24, 2016. (SSMF ¶ 11.) Plaintiff testified that she believes she began having problems that she now attributes to her sling in 2005. (Id. ¶ 12.) Plaintiff moved from California to Idaho in 2006 and was an Idaho resident when she filed her Complaint. (Id. ¶ 13.) Case 4:16-cv-00035-CDL Document 12-1 Filed 04/24/17 Page 2 of 11 3 LAW AND ARGUMENT Summary judgment is appropriate where “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). 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). 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. California Law Applies to Plaintiff’s Claims. Per this Court’s direct-filing Order, Idaho choice-of-law rules apply to Plaintiff’s claims because she was an Idaho resident when she filed her Complaint. (Direct Filing Order, Doc. 446; SSMF ¶ 13.) Idaho applies the “most significant relationship test” from the Restatement (Second) of Conflict of Laws § 145. Grover v. Isom, 137 Idaho 770, 772- 73, 53 P.3d 821, 823-24 (2002). In tort cases, the relevant considerations are “(a) the place where the injury occurred, (b) the place where the conduct causing the injury occurred, (c) the domicile, residence, nationality, place of incorporation and place of business of the parties, and (d) the place where the relationship, if any, between the parties is centered.” Id. at 773 (citing Seubert Excavators, Inc. v. Anderson Logging Co., 126 Idaho 648, 651, 889 P.2d 82, 85 (1995)). The most important factor is the place where the injury occurred. Id. Applying these factors shows that California has the most significant relationship to this case. The first factor, the place where the injury occurred, points to California, where Plaintiff resided when her alleged injuries developed. (SSMF ¶¶ 12-13); see In re Case 4:16-cv-00035-CDL Document 12-1 Filed 04/24/17 Page 3 of 11 4 Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., No. 4:13-cv-127 (Stelling), 2016 WL 1578752, at *2 & n.2 (applying most significant relationship test under Idaho law and holding Idaho, where plaintiff lived and her symptoms arose, was place of injury) (attached as Ex. D to Decl. of John Q. Lewis (“Lewis Decl.”)). The second factor, the place where the conduct allegedly causing the injury occurred, points to California and Minnesota, where key decisions about ObTape’s design and warnings were made and where Plaintiff’s ObTape was sold to her doctor. See Stelling, 2016 WL 1578752 at *2. The third factor, the domicile, residence, nationality, place of incorporation, and place of business of the parties, points to Idaho (Plaintiff’s current residence), New Jersey (Mentor’s state of incorporation), and California and Minnesota (states where Mentor had significant operations). Id.; (SSMF ¶ 13). The fourth factor, the place where the relationship, if any, between the parties is centered, is not a major consideration in this case because there is no direct relationship between the parties, and Plaintiff did not know that Mentor manufactured her sling until the day of her deposition. (SSMF ¶ 3.) Dr. Threatt, who selected ObTape for Plaintiff, practices in California. (See id. ¶ 1.) As in Stelling, numerous states have connections to this lawsuit. But because the place of injury is the dominant factor under the Second Restatement, California has the most significant relationship to this case, and California substantive law applies. Stelling, 2016 WL 1578752 at *2. B. California Bars Strict Liability for Design Defect in Medical Device Cases. California prohibits strict liability for design defect in drug and device litigation. California’s bright-line rule emerged decades ago, when the California Supreme Court- concerned that strict liability would discourage research and development and drive up Case 4:16-cv-00035-CDL Document 12-1 Filed 04/24/17 Page 4 of 11 5 costs-determined that “a drug manufacturer’s liability for a defectively designed drug should not be measured by the standards of strict liability.” Brown v. Superior Court, 751 P.2d 470, 477 (Cal. 1988). Medical device decisions soon followed, with California’s appellate courts finding that “the important considerations underlying Brown apply with equal force to implanted medical devices.” Hufft v. Horowitz, 4 Cal. App. 4th 8, 18 (Cal. Ct. App. 1992); see Garrett v. Howmedica Osteonics Corp., 214 Cal. App. 4th 173, 184 (Cal. Ct. App. 2013); see also Rhynes v. Stryker Corp., No. 10-5619 SC, 2011 WL 2149095, at *6 (N.D. Cal. May 31, 2011) (granting motion to strike because “controlling California law unequivocally prohibits strict liability claims for design defect against manufacturers of prescription implantable medical devices”) (attached as Ex. E to Lewis Decl.). Judge Goodwin has applied California law to grant summary judgment on a strict liability-design defect claim in a mesh case because “California does not recognize strict liability for defective design of implantable medical devices.” Sanchez v. Boston Scientific Corp., 38 F. Supp. 3d 727, 736 (S.D. W. Va. Aug. 18, 2014) (citing Hufft, 4 Cal. App. 4th 8; Armstrong v. Optical Radiation Corp., 50 Cal. App. 4th 580 (Cal. Ct. App. 1996)); see also In re Pradaxa (Dabigatran Etexilate) Prods. Liab. Litig., No. 3:12-CV- 60092, 2014 WL 114480, at *5 (S.D. Ill. Jan. 11, 2014) (attached as Ex. F to Lewis Decl.). Plaintiff’s strict liability-design defect claim likewise fails here, and Mentor is entitled to summary judgment. C. Plaintiff’s Warranty Claims Fail as a Matter of Law. 1. Plaintiff’s Design-Based Warranty Claims Are Barred Under Brown. Plaintiff’s warranty claims fail for the same reason. The Brown court, having barred strict liability for design defect, did the same for design-based warranty claims Case 4:16-cv-00035-CDL Document 12-1 Filed 04/24/17 Page 5 of 11 6 because they “would obviously be incompatible with our determination regarding the scope of a drug manufacturer’s liability for product defects.” Brown, 751 P.2d at 484; see also id. at 484 n.14 (“[A] cause of action for breach of warranty does not lie against a prescription drug manufacturer” because of “the inconsistency between such claims and our conclusion that prescription drugs are not subject to strict liability for design defects.”). The Brown court recognized that warranty claims like Plaintiff’s, which attack a product’s safety generally, are essentially strict liability claims for design defect. “[T]he manufacturer’s representation, express or implied, that a drug may be prescribed for a particular condition amounts to a warranty that it is ‘fit’ for and will accomplish the purpose for which it is prescribed.” Id. at 484. In a pre-Brown decision in which the Court of Appeal rejected strict liability and warranty claims for blood transfusions, that court likewise explained that “the liability imposed by strict liability in tort and breach of express and implied warranties is virtually the same, i.e., a form of liability without fault.” Shepard v. Alexian Bros. Hosp., 33 Cal. App. 3d 606, 614 (Cal. Ct. App. 1973). Brown bars Plaintiff’s design-based warranty claims. She alleges that Mentor warranted that her ObTape device “was of merchantable quality and safe and fit for the use for which it was intended,” but that the device instead “was unsafe for its intended use” and “had very dangerous propensities when used as intended.” (Compl. ¶¶ 61, 66, 69.) It is undisputed that Plaintiff did not receive any materials or representations from Mentor before her surgery, that Plaintiff relied on her surgeon, not Mentor, to select her sling, and that she did not know the name of the product implanted in her until the day of her deposition. (SSMF ¶¶ 2-3.) In essence, her claims bear the “magic words” of a Case 4:16-cv-00035-CDL Document 12-1 Filed 04/24/17 Page 6 of 11 7 warranty claim but in fact attack ObTape’s design and safety. Brown therefore controls, and her breach of warranty claims fail as a matter of law. 2. Plaintiff’s Implied Warranty Claim Fails for Lack of Privity. Plaintiff’s implied warranty claim also fails on additional, independent grounds: lack of privity. As this Court previously recognized in granting summary judgment on implied warranty claims under Georgia law, Mentor does not sell ObTape directly to patients. In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., 711 F. Supp. 2d 1348, 1366 (M.D. Ga. 2010) (“It is undisputed that Mentor did not sell ObTape directly to any patient; therefore, there is a lack of privity between Mentor and Plaintiffs.”) Here, Plaintiff did not even know she received a Mentor ObTape until the day of her deposition. (SSMF ¶ 3.) Lack of privity is fatal to Plaintiff’s implied warranty claim. California courts recognize that medical device manufacturers and patients do not have the relationship needed to support an implied warranty claim. “In the context of prescription medical devices and pharmaceuticals, the transaction is between the manufacturer and the physician, not the patient.” Adams v. I-Flow Corp., No. CV09-09550 R SSX, 2010 WL 1339948, at *4 (C.D. Cal. Mar. 30, 2010) (attached as Ex. G to Lewis Decl.). As a result, “[i]n the implantable medical product context, a patient lacks the privity required to establish a claim for breach of implied warranty.” Currier v. Stryker Corp., No. 2:11- CV-1203 JAM-EFB, 2011 WL 4898501, at *4 (E.D. Cal. Oct. 13, 2011) (attached as Ex. H to Lewis Decl.); see also Quatela v. Stryker Corp., 820 F. Supp. 2d 1045, 1047-48 (N.D. Cal. 2010). So it is here. Plaintiff did not purchase her ObTape from Mentor, did not rely on Mentor to select the appropriate device for her surgery, and did not even know that she Case 4:16-cv-00035-CDL Document 12-1 Filed 04/24/17 Page 7 of 11 8 received a Mentor ObTape until the day of her deposition. (SSMF ¶¶ 2-3.) In other words, she is not in privity with Mentor. Because privity is lacking, Mentor is entitled to summary judgment on Plaintiff’s breach of implied warranty claim. 3. Plaintiff Did Not Comply with California’s Requirement of Pre-Litigation Notice for Express Warranty Claims. Mentor is likewise entitled to summary judgment on Plaintiff’s express warranty claim, independent of Brown, because Plaintiff did not comply with California’s pre- litigation notice requirement. To recover for breach of express warranty, Plaintiff was required “within a reasonable time after . . . she discover[ed] or should have discovered any breach, [to] notify the seller of breach or be barred from any remedy.” See Cal. Com. Code § 2607(3)(A). Plaintiff has the burden of showing she gave notice to Mentor within a reasonable time after the alleged breach and before filing this lawsuit. Cardinal Health 301, Inc. v. Tyco Elecs. Corp., 169 Cal. App. 4th 116, 135-37 (Cal. Ct. App. 2008); see Alvarez v. Chevron Corp., 656 F.3d 925, 932-33 (9th Cir. 2011); Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1181 (C.D. Cal. 2013) (dismissing medical device warranty claim for lack of allegations showing pre-suit notice). When confronted with this issue before, this Court held that Mentor was entitled to summary judgment because plaintiffs failed to provide the required statutory notice. In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., No. 4:13-cv-225 (Brenner), 2015 WL 6134397, at *2 (M.D. Ga. Oct. 19, 2015) (attached as Ex. I to Lewis Decl.); In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., No. 4:12-cv-238 (D. Escalera), 2015 WL 5468791, at *2 (M.D. Ga. Sept. 16, 2015) (attached as Ex. J to Lewis Decl.). Here, Plaintiff has no evidence that she gave such notice before filing her lawsuit, and Mentor is entitled to summary judgment on her express warranty claim. Case 4:16-cv-00035-CDL Document 12-1 Filed 04/24/17 Page 8 of 11 9 Accordingly, under Brown and California’s privity and notice requirements, Mentor is entitled to summary judgment on Plaintiff’s warranty claims. D. Plaintiff Cannot Establish Breach of a Continuing or Post- Sale Duty to Warn as a Matter of Law. Although Plaintiff has not expressly alleged a post-sale duty to warn, this Court should nevertheless grant summary judgment to the extent she relies on such a theory to support her claims, specifically for negligence and strict liability-failure-to-warn (Counts I and IV). Because Plaintiff cannot establish that a breach of such a duty caused her claimed injuries, Mentor is entitled to summary judgment as a matter of law. Under the learned intermediary doctrine (which California courts apply), Mentor’s duty to warn ran to Plaintiff’s physician, not to Plaintiff herself. See, e.g., Andren v. Alere, Inc., 207 F. Supp. 3d 1133, 1144 (S.D. Cal. 2016) (citing cases); Carlin v. Superior Court, 13 Cal. 4th 1104, 1116 (1996) (holding “the duty to warn runs to the physician, not to the patient”). As such, proving causation requires Plaintiff to put forth evidence that her treating physicians would have treated her differently in light of different, stronger warnings. See Andren, 207 F. Supp. 3d at 1144 (citing Motus v. Pfizer Inc., 358 F.3d 659, 661 (9th Cir. 2004).) For an alleged breach of a continuing or post-sale duty to warn, that requires evidence that physicians who treated her after her ObTape implant would have done something differently. See In re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig., MDL No. 05-1708, 2007 WL 2023569, at *3 (D. Minn. July 6, 2007) (applying California law) (attached as Ex. K to Lewis Decl.). Indeed, this Court has dismissed claims based on an alleged continuing duty to warn where a plaintiff has failed to “argue or point to any evidence that her post-implant treatment would have been different if Mentor had provided a post-implant warning to” an implanting physician. In re Mentor Corp. ObTape Transobturator Sling Prods. Case 4:16-cv-00035-CDL Document 12-1 Filed 04/24/17 Page 9 of 11 10 Liab. Litig., No. 4:12-cv-245 (Clinton), 2016 WL 822945, at *4 (M.D. Ga. Feb. 29, 2016) (attached as Ex. L to Lewis Decl.); see also In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., No. 4:14-cv-113 (Morgan), 2016 WL 7209431, at *3 (M.D. Ga. Dec. 9, 2016) (granting summary judgment on continuing duty to warn claim where plaintiffs “did not point to any evidence of how a different warning regarding delayed onset ObTape-related infections would have affected [the doctor’s] treatment of” the plaintiff) (attached as Ex. M to Lewis Decl.); In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., No. 4:12-cv-276 (Burch), 2015 WL 5722799, *4 (M.D. Ga. Sept. 29, 2015) (granting summary judgment on continuing duty to warn claim where “there is absolutely no evidence in the present record suggesting that additional warnings about the ObTape infection rate” would have changed the implanting physician’s post-implant actions or otherwise averted the plaintiff’s alleged injuries) (attached as Ex. N to Lewis Decl.). Here, the record confirms that neither Dr. Threatt, who implanted Plaintiff’s ObTape, or Dr. Corica, who provided later treatment, would have provided different treatment to Plaintiff had they been provided more or different information about ObTape after her implant surgery. Plaintiff never returned to see Dr. Threatt with any ObTape complications. (SSMF ¶ 4); see also Burch, 2015 WL 5722799, at *4 (dismissing continuing duty to warn claim where it was undisputed that the plaintiff never sought medical treatment from her implanting physician after her ObTape implant). Moreover, he testified that he understood that if an erosion occurred, he should remove the tape to minimize the risk of infection and that his practice with eroded slings was to remove the mesh as far as he could get to it. (SSMF ¶ 10.) Likewise, a post-implant warning would not have changed Dr. Corica’s treatment of Case 4:16-cv-00035-CDL Document 12-1 Filed 04/24/17 Page 10 of 11 11 012813\003576\3129826.1 Plaintiff because he testified that he never diagnosed her with a complication related to her ObTape, that a recommendation to remove the entire sling would not have changed his treatment of Plaintiff because her symptoms were not specific to mesh, and that he understood from his training in residency-not from Mentor-that the standard of care for an erosion was to remove the entire sling. Id. ¶¶ 8-9. In short, Plaintiff lacks any evidence that her physicians would have treated her differently had they received other information from Mentor following her 2004 implant. Consequently, Plaintiff lacks any evidence to support a continuing duty to warn claim as a matter of law, and Mentor is entitled to summary judgment. CONCLUSION Plaintiff cannot prevail as a matter of law on her claims for strict liability-design defect (Count II) and breach of warranty (Counts V and VI). Additionally, to the extent Plaintiff relies on a continuing duty to warn theory, her negligence and strict liability- failure-to-warn claims (Counts I and IV) fail because she has no evidence that her doctors would have treated her differently had they received more or different post- implant warnings from Mentor. Accordingly, Mentor respectfully requests that this Court grant Mentor’s Motion for Partial Summary Judgment and dismiss those claims. Dated: April 24, 2017 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 4:16-cv-00035-CDL Document 12-1 Filed 04/24/17 Page 11 of 11 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. 4:16-cv-00035 (Angle) DEFENDANT MENTOR WORLDWIDE LLC’S SEPARATE STATEMENT OF MATERIAL FACTS IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT AGAINST PLAINTIFF DOROTHY ANGLE Pursuant to Rule 56 of the Federal Rules of Civil Procedure and Local Rule 56, Defendant Mentor Worldwide LLC (“Mentor”) submits this Separate Statement of Material Facts in support of its Motion for Partial Summary Judgment against Plaintiff Dorothy Angle. 1. On November 29, 2004, Dr. Chris Threatt implanted Plaintiff with ObTape in Turlock, California. (Dep. of Dorothy Angle (“Pl. Dep.”) 23:22-24:5, 32:7-11, attached as Ex. A to Decl. of John Q. Lewis (“Lewis Decl.”); Dep. of Dr. Chris B. Threatt (“Dr. Threatt Dep.”) 85:20-24, attached as Ex. B to Lewis Decl.) 2. Dr. Threatt never gave Plaintiff any written materials about ObTape. (Dr. Threatt Dep. 85:14-17, 192:12-193:12; Pl. Dep. 55:17-24.) 3. Plaintiff relied on Dr. Threatt to decide what type of sling to use for her implant, and she did not know that she received a Mentor ObTape until the day of her deposition. (Pl. Dep. 84:17-85:15, 87:2-8.) 4. Plaintiff never returned to Dr. Threatt with a complication from her ObTape. (Dr. Threatt Dep. 92:25-93:3.) Case 4:16-cv-00035-CDL Document 12-2 Filed 04/24/17 Page 1 of 3 2 5. In 2015, Plaintiff treated with Dr. Alberto Corica for urinary issues. (Dep. of Dr. Alberto G. Corica (“Dr. Corica Dep.”) 24:5-25:18, attached as Ex. C to Lewis Decl.) 6. During his care and treatment of Plaintiff, Dr. Corica never diagnosed her with a complication that he attributed to her ObTape. (Dr. Corica Dep. 38:18-39:4, 44:20-45:13, 83:3-15, 85:10-18.) 7. Plaintiff’s ObTape has never been removed. (Pl. Dep. 32:22-33:6.) 8. Dr. Corica testified that if Mentor recommended removing the entire ObTape upon seeing erosion or infection, he would not have treated Plaintiff any differently because the symptoms she presented with were not specific to mesh. (Dr. Corica Dep. 69:14-70:22.) 9. Dr. Corica learned in residency-not from Mentor-that the standard of care for an eroded mesh was to remove the entire sling. (Dr. Corica Dep. 83:16-84:4.) 10. Likewise, Dr. Threatt testified that he understood that if an erosion occurred, he should remove the tape to minimize the risk of infection and that his practice with eroded slings was to remove the mesh as far as he could get to it. (Dr. Threatt Dep. 175:17-176:8.) 11. After seeing a television advertisement in 2015, Plaintiff obtained counsel and direct-filed her lawsuit against Mentor on February 24, 2016. (Pl. Dep. 19:9-19; Compl., Doc. 1.) 12. Plaintiff testified that she believes she began having problems that she now attributes to her sling in 2005. (Pl. Dep. 144:1-145:15.) 13. Plaintiff moved from California to Idaho in 2006 and was an Idaho resident when she filed her Complaint. (Pl. Dep. 23:9-21, 37:11-21.) Case 4:16-cv-00035-CDL Document 12-2 Filed 04/24/17 Page 2 of 3 3 012813\003576\3129571.1 Dated: April 24, 2017 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 4:16-cv-00035-CDL Document 12-2 Filed 04/24/17 Page 3 of 3 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA COLUMBUS DIVISION IN RE MENTOR CORP. OBTAPE TRANSOBTURATOR SLING PRODUCTS LIABILITY LITIGATION MDL No. 2004 Master Case No. 4:08-md-2004-CDL Individual Case No. 4:16-cv-00035 (Angle) DECLARATION OF JOHN Q. LEWIS IN SUPPORT OF DEFENDANT MENTOR WORLDWIDE LLC’S MOTION FOR PARTIAL SUMMARY JUDGMENT AGAINST PLAINTIFF DOROTHY ANGLE 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 are true and correct copies of excerpts from the February 16, 2017 Deposition of Dorothy Angle. 3. Attached as Exhibit B are true and correct copies of excerpts from the March 14, 2017 Deposition of Dr. Chris B. Threatt. 4. Attached as Exhibit C are true and correct copies of excerpts from the March 15, 2017 Deposition of Dr. Alberto G. Corica. 5. Attached as Exhibit D is a true and correct copy of this Court’s decision in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 4:13-cv-127 (Stelling), 2016 WL 1578752 (M.D. Ga. Apr. 19, 2016). Case 4:16-cv-00035-CDL Document 12-3 Filed 04/24/17 Page 1 of 3 2 6. Attached as Exhibit E is a true and correct copy of an unreported case, Rhynes v. Stryker Corp., No. 10-5619 SC, 2011 WL 2149095 (N.D. Cal. May 31, 2011). 7. Attached as Exhibit F is a true and correct copy of an unreported case, In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, No. 3:12-CV-60092, 2014 WL 114480 (S.D. Ill. Jan. 11, 2014). 8. Attached as Exhibit G is a true and correct copy of an unreported case, Adams v. I-Flow Corp., No. CV09-09550 R SSX, 2010 WL 1339948 (C.D. Cal. Mar. 30, 2010). 9. Attached as Exhibit H is a true and correct copy of an unreported case, Currier v. Stryker Corp., No. 2:11-CV-1203 JAM-EFB, 2011 WL 4898501 (E.D. Cal. Oct. 13, 2011). 10. Attached as Exhibit I is a true and correct copy of this Court’s decision in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 4:13-cv-225 (Brenner), 2015 WL 6134397 (M.D. Ga. Oct. 19, 2015). 11. Attached as Exhibit J is a true and correct copy of this Court’s decision in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 4:12-cv-238 (D. Escalera), 2015 WL 5468791 (M.D. Ga. Sept. 16, 2015). 12. Attached as Exhibit K is a true and correct copy of an unreported case, In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, MDL Docket No. 05-1708, 2007 WL 2023569 (D. Minn. July 6, 2007). Case 4:16-cv-00035-CDL Document 12-3 Filed 04/24/17 Page 2 of 3 3 012813\003576\3136205.1 13. Attached as Exhibit L is a true and correct copy of this Court’s decision in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 4:12-cv-245 (Clinton), 2016 WL 822945 (M.D. Ga. Feb. 29, 2016). 14. Attached as Exhibit M is a true and correct copy of this Court’s decision in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 4:14-cv-113 (Morgan), 2016 WL 7209431 (M.D. Ga. Dec. 9, 2016). 15. Attached as Exhibit N is a true and correct copy of this Court’s decision in In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, MDL Docket No. 2004, No. 4:12-cv-276 (Burch), 2015 WL 5722799 (M.D. Ga. Sept. 29, 2015). I declare under penalty of perjury under the laws of the United States that the foregoing is true and correct. Executed this 24th day of April 2017 in Cleveland, Ohio. s/John Q. Lewis John Q. Lewis Case 4:16-cv-00035-CDL Document 12-3 Filed 04/24/17 Page 3 of 3 Exhibit A Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 1 of 37 1 IN THE UNITED STATES DISTRICT COURT 2 FOR THE MIDDLE DISTRICT OF GEORGIA 3 COLUMBUS DIVISION 4 * * * * * 5 6 IN RE MENTOR CORP. OBTAPE ) MDL CASE NO.: TRANSOBTURATOR SLING ) 4:08-MD-2004 (CDL) 7 PRODUCTS LIABILITY LITIGATION ) ) Individual Case No. 8 ) 4:16-CV-00035 ______________________________) Angle, D.) 9 10 11 VIDEOTAPE DEPOSITION OF DOROTHY ANGLE 12 Thursday, February 16, 2017; 9:07 o'clock a.m. 13 14 15 BE IT REMEMBERED that the videotape deposition of DOROTHY ANGLE was taken by the 16 attorney for the defendant at the LaQuinta Hotel, 1440 Bench Road, The Meeting Room, Pocatello, Idaho, 17 before DiAnn Erdman Prock, Court Reporter and Notary Public, in and for the State of Idaho, in the 18 above-entitled matter. 19 20 21 22 23 24 25 Job No. CS2537674 Page 1 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 2 of 37 1 A P P E A R A N C E S 2 For the Plaintiff: ARNOLD & ITKIN LLP 3 BY: EMILY N. HILLIARD 6009 Memorial Drive 4 Houston, Texas 77007 (713) 222-3800 5 E-mail: ehilliard@arnolditkin.com 6 For the Defendant: TUCKER ELLIS LLP 7 BY: JEFFREY C. SINDELAR, JR. 950 Main Avenue 8 Suite 1100 Cleveland, Ohio 44113 9 (216) 592-5000 E-mail: jeffrey.sindelar@tuckerellis.com 10 The Videographer: 11 T&T REPORTING C. JOHN TERRILL 12 477 Shoup Avenue P.O. Box 51202 13 Idaho Falls, Idaho 83405 (208) 529-5491 14 E-mail: office@ttreporting.com 15 16 17 18 19 20 21 22 23 24 25 Page 2 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 3 of 37 1 I N D E X 2 E X A M I N A T I O N 3 WITNESS PAGE 4 DOROTHY ANGLE 5 Examination by Mr. Sindelar . . . . . . . . . 7 6 Examination by Ms. Hilliard . . . . . . . . . 164 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 3 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 4 of 37 1 I N D E X 2 E X H I B I T S 3 NUMBER PAGE 4 1 Notice of Deposition for Plaintiff. . . . 20 5 Dorothy Angle 6 2 Complaint . . . . . . . . . . . . . . . . 22 7 3 Plaintiff, Dorothy Angle's, Answers . . . 25 8 to Mentor Worldwide, LLC's First Set of 9 Interrogatories 10 4 Plaintiff, Dorothy Angle's, Responses . . 28 11 to Mentor Worldwide, LLC's First 12 Requests for Admissions 13 5 Plaintiff, Dorothy Angle's. Responses . . 28 14 to Mentor Worldwide, LLC's First Set of 15 Requests for Production 16 6 Plaintiff's First Amended Fact Sheet. . . 30 17 7 Emanuel Medical Center Medical Records. . 97 18 8 Sutter Health Medical Records . . . . . . 120 19 9 Sutter Health Medical Records . . . . . . 127 20 10 Dictation and Reports (Continued) 1-9-15. 129 21 11 Dictation and Reports (Continued) 2-3-15. 132 22 12 Progress Notes, Portneuf Medical Practice 136 23 Division, 3-16-15 24 13 Progress Notes, Portneuf Medical Practice 139 25 Division, 4-2-15 Page 4 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 5 of 37 1 I N D E X 2 E X H I B I T S (CONTINUED) 3 NUMBER PAGE 4 14 Progress Notes, Portneuf Medical Practice 141 5 Division, 4-15-15 6 15 Dictation and Reports (Continued) 4-28-15 142 7 16 Progress Notes, Portneuf Medical Practice 143 8 Division, 5-28-15 9 17 Progress Notes, Portneuf Medical Practice 146 10 Division, 7-6-15 11 18 Progress Notes, Portneuf Family Medicine. 148 12 8-8-15 13 19 Dictation and Reports (Continued) 6-1-16. 151 14 15 16 17 18 19 20 21 22 23 24 25 Page 5 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 6 of 37 1 (The videotape deposition proceeded at 2 9:07 a.m. as follows:) 3 * * * * * * 4 THE VIDEOGRAPHER: We will now go on the 5 record. 6 My name is John Terrill, the video 7 technician, and DiAnn Prock is the court reporter 8 from T&T Reporting at 477 Shoup Avenue, Suite 105, 9 Idaho Falls, Idaho, contracted by Veritext Legal 10 Solutions out of New Jersey. 11 We are here today February 16th, 2017, 12 at approximately 9:07 a.m. Mountain Time, at the 13 La Quinta at 1440 Bench Road, Pocatello, Idaho, to 14 videotape the deposition of Dorothy Angle, being 15 taken at the instant of the defendant in the matter 16 of Mentor Corp. ObTape Transobturator -- 17 Transobturator? 18 MR. SINDELAR: Transobturator. 19 MS. HILLIARD: Transobturator. 20 THE VIDEOTECHNICIAN: Okay. 21 -- Sling Products liability litigation, 22 Case Number 4:08-MD-2004 (CDL) in the United States 23 District Court for the Middle District of Georgia, 24 Columbus Division. 25 The court reporter will now swear in the Page 6 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 7 of 37 1 witness, then counsel will introduce themselves and 2 the parties they represent. 3 THE COURT REPORTER: Raise your right 4 hand, please. 5 You do solemnly swear the testimony you 6 are about to give in this matter will be the truth, 7 the whole truth, and nothing but the truth, so help 8 you God? 9 THE WITNESS: Yes. 10 THE COURT REPORTER: Thank you. 11 12 WHEREUPON, 13 DOROTHY ANGLE, having been first duly 14 sworn to tell the truth, the whole truth and nothing 15 but the truth, testified as follows: 16 * * * * * * 17 MS. HILLIARD: My name is Emily Hilliard 18 on behalf of the plaintiff. 19 MR. SINDELAR: And this is Jeff Sindelar 20 here on behalf of the defendant, Mentor Worldwide, 21 LLC. 22 23 EXAMINATION 24 BY MR. SINDELAR: 25 Q. Good morning. Could you please state Page 7 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 8 of 37 1 Q. And I may ask, if we go through -- as 2 we're going through records, I may ask if any of 3 those documents are things that you reviewed 4 yesterday to refresh your memory. 5 A. Yes, it did. 6 Q. Do you remember which -- which documents 7 refreshed your memory of certain things? 8 MS. HILLIARD: Object to form. 9 Q. (BY MR. SINDELAR:) Your attorney may 10 have objections to the phrasing or the basis of my 11 questions. You can -- unless she instructs you not 12 to answer, you can go ahead and answer those, but 13 if -- 14 A. Would you ask the question again? 15 Q. No, certainly. And just so you 16 understand better so you know what's going on, later 17 on we may make motions before the court on the 18 phrasing of the question, and that's just why your 19 attorney has to lodge her objection, so -- 20 A. No problem. 21 Q. -- unless she says don't answer after 22 she states her objection, you can go ahead and 23 answer. 24 So my question was, do you remember -- 25 of the documents you reviewed yesterday, do you Page 18 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 9 of 37 1 remember which ones refreshed your memory of the 2 facts around this case? 3 A. The complaint and -- and dates, that 4 sort of stuff. 5 Q. Okay. Did you prepare anything in 6 advance of your deposition, or is it just notes and 7 a chronology of when things happened? 8 A. No, just memory. 9 Q. Do you recall how you first found the 10 attorneys who are representing you in this 11 lawsuit? 12 A. I happened to see an advertisement on 13 TV. 14 Q. Do you recall when you saw that 15 advertisement? 16 A. I think it was in 2015. 17 Q. How long after you saw that ad did you 18 call the number to find -- 19 A. Almost immediately. 20 Q. Other than the attorney with you here 21 today, have you met with any other attorneys 22 representing you in this case? 23 A. No. 24 Q. Prior to calling the attorneys after you 25 saw that ad in 2015, did you do any Internet Page 19 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 10 of 37 1 searches or any research about mesh slings and -- 2 A. No. 3 Q. -- incontinence products? 4 Other than E-mails you exchanged with 5 your attorney or their assistants or the law firms, 6 not talking about E-mails with the law firm or 7 attorneys, did you send any E-mails to other people 8 about the ObTape sling you had -- 9 A. No. 10 Q. -- or any complications you thought you 11 had? 12 A. Huh-uh. 13 Q. Do you have any social networking 14 accounts such as Facebook, Pinterest, or Twitter? 15 A. Don't want to be bothered. 16 Q. I want to take a look at some of the 17 documents filed and discovery exchanged in this case 18 now. First I just want to mark a copy of your 19 notice for this deposition so -- just so it's part 20 of the record. 21 (Deposition Exhibit 1 was marked for 22 identification.) 23 THE COURT REPORTER: Exhibit 1. 24 MR. SINDELAR: Thank you. 25 Q. (BY MR. SINDELAR:) I'm handing you a Page 20 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 11 of 37 1 that was filed in this lawsuit. 2 (Deposition Exhibit 2 was marked for 3 identification.) 4 MS. HILLIARD: Thanks. 5 THE COURT REPORTER: Exhibit 2. 6 MS. HILLIARD: That could be an issue. 7 Is that in your way? 8 THE VIDEOGRAPHER: (Shakes head.) 9 MS. HILLIARD: Okay. 10 Q. (BY MR. SINDELAR:) I've handed you a 11 copy of what has been marked as Exhibit 2 which is 12 the complaint in this lawsuit. 13 Have you reviewed this document prior to 14 today? 15 A. Yes, I have. 16 Q. Okay. And if you look at the top, 17 there's a heading that the court system puts on 18 these documents when they're filed, and this 19 document indicates it was filed on February 24th, 20 2016. 21 Do you see where I'm looking? 22 A. Yes. 23 Q. Okay. And did you review this document 24 prior to it being filed on February 24th, 2016? 25 A. I don't recall. Page 22 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 12 of 37 1 Q. Okay. I want to go through a few things 2 just to verify if they're accurate or if there are 3 certain things in here that are not accurate. 4 The first one is -- you notice there are 5 numbered paragraphs? 6 A. Uh-huh. 7 Q. So number one says: The plaintiff is a 8 resident in the State of California. 9 In February of 2016, were you a resident 10 of California or were you living in Idaho? 11 A. I lived in Idaho. 12 Q. Okay. What was your address on 13 February 24th, 2016? 14 A. The same as it is now, 32 Rutgers. 15 Q. You agree with me that the paragraph one 16 saying that you're a resident of the California is 17 not accurate; is that -- 18 A. It's not accurate. 19 Q. Okay. So paragraph one should say: 20 Plaintiff is a resident of the state of Idaho? 21 A. That's correct. 22 Q. Okay. And if we could turn to the third 23 page, I want to look on paragraph 13. The first 24 sentence starts off: Plaintiff was implanted with 25 an ObTape Sling on November 29th, 2004, in Turlock, Page 23 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 13 of 37 1 California. 2 Is that your understanding that the 3 product this lawsuit was about was implanted in you 4 on November 29th, 2004, in Turlock, California? 5 A. Yes. 6 Q. Okay. If you'd turn with me to page 7 number 12, I want to look at paragraph fifty-seven. 8 A. Okay. 9 Q. It states: If plaintiff received 10 adequate warnings regarding the risks of the ObTape 11 Sling she would not have used it. 12 Are there any specific warnings you wish 13 you would have received prior to having the ObTape 14 implanted that you did not receive? 15 MS. HILLIARD: Object to form. 16 THE WITNESS: Pardon me, I didn't hear 17 her. 18 MR. SINDELAR: She's objecting to form. 19 Go ahead and answer. 20 THE WITNESS: Oh, I'm sorry. I didn't 21 hear. 22 MS. HILLIARD: You don't need to hear 23 me. 24 THE WITNESS: Okay. 25 MS. HILLIARD: I'll speak up and tell Page 24 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 14 of 37 1 you not to answer -- 2 THE WITNESS: Okay. 3 MS. HILLIARD: -- if I need to, but 4 otherwise I'm just going to give my objections to 5 the court reporter for the record. 6 THE WITNESS: Okay. 7 Q. (BY MR. SINDELAR:) Do you want me to 8 ask the question again? 9 A. Yes, please. Sorry. I got 10 distracted. 11 Q. So paragraph seven says that you did not 12 receive adequate warnings about the risks of ObTape. 13 Are there any specific warnings that you 14 did not receive prior to having the ObTape implant 15 that would have caused you not to have had the 16 ObTape? 17 A. No. 18 MS. HILLIARD: Object to form again on 19 that one. 20 Q. (BY MR. SINDELAR:) Okay. That's all of 21 the questioning that I have regarding Exhibit 22 Number 2. 23 (Deposition Exhibit 3 was marked for 24 identification.) 25 THE COURT REPORTER: Exhibit 3. Page 25 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 15 of 37 1 attached -- authorization attached to this 2 declaration. 3 And if you look below that, it's dated 4 August 20th, 2016, and next to that is what appears 5 to be your signature. 6 A. Uh-huh. 7 Q. So my question is first: Is that your 8 signature on this page? 9 A. Yes, uh-huh. 10 Q. And did you sign this page on 11 August 30th, 2016? 12 A. Yes. 13 Q. And in signing this verification page, 14 were you confirming that the information contained 15 in what has now been marked as Exhibit 6 was true 16 and accurate to the best of your knowledge? 17 A. Yes. 18 Q. Okay. And I wanted to go through -- I 19 don't want to -- you provided all the information, 20 so I don't want to ask about everything -- 21 A. Okay. 22 Q. -- otherwise that would kind of defeat 23 the purpose of you filling out the form, but there's 24 a few things I want to follow up on and confirm 25 throughout the document. Page 31 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 16 of 37 1 So starting on page 2, there are a few 2 questions there about the product implant, and it 3 indicates, based on your responses to questions one 4 through four, that Dr. Chris Threatt, do you 5 pronounce that -- 6 A. Threatt. 7 Q. Threatt. That Dr. Chris Threatt 8 implanted you with the ObTape, November 29th, 2004, 9 at Emanuel Medical Center in Turlock, California; is 10 that correct? 11 A. Yes, uh-huh. 12 Q. Okay. And then based on your answers to 13 questions five through nine, it indicates that the 14 ObTape product has never been removed; is that 15 correct? 16 A. No. 17 Q. Okay. And was the ObTape product 18 removed after you signed this -- 19 A. No. 20 Q. -- verification? 21 A. No. 22 Q. Have you had a surgery where any doctor 23 has removed the ObTape? 24 A. No. 25 Q. Okay. I'm sorry, I think I may have Page 32 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 17 of 37 1 phrased a question a way that produced a double 2 negative. That's my mistake. 3 So I want to make sure it's clear in the 4 record. As of today, your ObTape has never been 5 removed; is that correct? 6 A. That's correct. 7 Q. Okay. And I apologize, if I phrase a 8 question in a way that calls for a double negative 9 and you're confused, let know and I may re-ask a 10 question just because on the record things don't 11 come out clear sometimes -- 12 A. Okay. 13 Q. -- with a double negative. 14 A. No problem. 15 Q. And turning to the next page, which is 16 page 3 -- 17 A. Uh-huh. 18 Q. -- question eleven asks: Has any doctor 19 told you that those portions of the ObTape still in 20 your body need to be removed, and you indicate, yes. 21 And it says: Possible surgery soon. 22 A. Uh-huh. 23 Q. And did -- is your testimony that Dr. -- 24 is it Corica? 25 A. Corica. Page 33 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 18 of 37 1 Q. -- Corica, did he tell you that the mesh 2 may need to be removed? 3 A. Yes. 4 Q. Okay. And when did he tell you that? 5 A. Oh, I don't know. More than a year 6 ago. 7 Q. Is Dr. Corica still practicing -- 8 A. Yes. 9 Q. -- in Idaho? 10 A. No. 11 Q. Do you know where he practices now? 12 A. In New Mexico. 13 Q. Okay. And do you know when he -- when 14 he moved from Idaho to New Mexico? 15 A. Seems like it's been at least a year -- 16 Q. Okay. 17 A. -- if not more. 18 Q. Did he ever schedule a surgery to remove 19 your ObTape? 20 A. No. 21 Q. Did he tell you for certain that the 22 ObTape had to come out, or did he just present that 23 as a possible option? 24 A. A possible option. 25 MS. HILLIARD: Object to form. Page 34 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 19 of 37 1 addresses and the residencies for the past ten -- I 2 guess it goes back to twenty years now. 3 It looks like you lived in Modesto, 4 California, from 1997 through 2002; is that 5 correct? 6 A. You're talking about just California or 7 that town? 8 Q. Well, just based on number four it gives 9 an address in -- in Modesto -- 10 A. Okay. 11 Q. -- from '97 to 2000. 12 A. That's right. 13 Q. And then from 2002 to 2006 you lived in 14 Atwater, California? 15 A. That's right. 16 Q. And then it gives your current address 17 starting in November of 2015 to the present, it 18 says, and I just want to fill in from 2006 until 19 November of 2015, where you lived or what your 20 address was. 21 A. I lived at where I live now, 22 32 Rutgers. 23 Q. And when did you first start living at 24 that 32 Rutgers? 25 A. November, '15. Page 36 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 20 of 37 1 Q. Okay. And from 2006 until 2015, where 2 did you live? 3 A. I think I had a couple of addresses. 4 Q. Okay. 5 A. One on Poplar Street and one on 6 McKinley -- 7 Q. Okay. 8 A. -- in Pocatello. 9 Q. Okay. Those were all in Pocatello? 10 A. Right. Here, uh-huh. 11 Q. Is 2006 when you moved from California 12 to Idaho? 13 A. That's right. 14 Q. Okay. Do you remember what month you 15 moved to Idaho? 16 A. In March, 2006. 17 Q. And from March, 2006, up until today, 18 even though you moved to different places in 19 Pocatello, have you lived in Pocatello, Idaho 20 continuously from March of 2006 to the present? 21 A. That's right. 22 Q. Okay. And then on the next page, which 23 is page 4, question nine asks for names of former 24 spouses and dates of marriage. 25 A. Uh-huh. Page 37 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 21 of 37 1 Q. And it looks like there might be a typo 2 with the dates here, so it looks like you were 3 married to Dennis is it Gillard? 4 A. Gillard. 5 Q. Dennis Gillard. I'm, like, oh for three 6 on names here. I apologize. You were married to 7 Dennis Gillard June of 1964 through January of 1970; 8 is that correct? 9 A. Thereabouts, uh-huh. 10 Q. And then for your second and third 11 husbands it looks like there's an overlap in the 12 dates, which I think might be a typo. For Larry, 13 can you just walk me through the names of your 14 husbands? 15 A. Larry Vermilyea. 16 Q. Larry Vermilyea. And what years were 17 you married to him? 18 A. I think it was -- I think it was in 19 1971, but I'm not positive of that. 20 Q. Okay. And the two of you divorced in 21 1997? 22 A. Yes, uh-huh. 23 Q. And then for Joe Soares? 24 A. Soares. 25 Q. Soares. So I was pretty close on that Page 38 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 22 of 37 1 A. I hope I answered that right. It's 2 confusing. 3 Q. That's all right. 4 Did Dr. Threatt or any other doctor, 5 before you had the ObTape put in, did they suggest 6 any other treatment options to cure the stress 7 incontinence? 8 A. Not that I recall. It's been so long. 9 Q. In discussing stress incontinence and 10 different types of incontinence, there are a few 11 different types of incontinence, but the two primary 12 ones that we see in these cases are stress urinary 13 incontinence and urge incontinence. 14 I will represent to you that stress 15 urinary incontinence is the involuntarily losing of 16 urine with different stresses in the abdomen or the 17 body that will occur with things such as coughing, 18 laughing, sneezing, jumping. Those sorts of 19 activities will cause a person to involuntarily lose 20 urine. 21 And then urge incontinence is described 22 more as a sudden feeling that you have to go to 23 the -- go to the restroom very suddenly. You have a 24 sudden onset where you feel like you have to go to 25 the bathroom very badly. Page 54 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 23 of 37 1 Do you have an understanding of those 2 two different types of incontinence? 3 A. Yes, I do, and I had both of them. 4 Q. Okay. That's what I was going to ask. 5 Can you distinguish between the stress urinary 6 incontinence symptoms and the urge incontinence 7 symptoms that had you experienced? 8 A. Sure. 9 Q. Okay. And question number three on 10 page 10 asks: Did you see, read, or rely upon any 11 documents or other information from Mentor in making 12 your decision to have the ObTape implanted, and you 13 indicate yes. 14 A. I don't see that. I'm not quite sure 15 how to answer that because it's kind of confusing a 16 little bit. 17 Q. Okay. Do you recall receiving any 18 written materials from your doctor about the ObTape 19 product prior to the implant? 20 A. He didn't give me anything. He just 21 talked to me about it. 22 Q. Okay. You just had a conversation -- 23 A. Yeah. 24 Q. -- with your doctor? 25 Okay. If we could jump ahead to page Page 55 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 24 of 37 1 number 12. Question three asks: Do you claim any 2 psychological or psychiatric injury, other than 3 garden variety emotional distress, as a consequence 4 of having the ObTape? And the response indicates 5 no. 6 Do you see that portion? 7 A. Yes. 8 Q. And is that answer correct that other 9 than garden variety emotional distress, you're not 10 claiming any -- 11 A. No. 12 Q. -- psychological or psychiatric 13 injury? 14 I'm sorry? 15 A. I said no. Sorry. 16 Q. Okay. And I think we have a double 17 negative problem. Just to be clear, you're saying, 18 No, you are not claiming psychological or 19 psychiatric injury other than garden variety 20 emotional distress. 21 Is that -- is that accurate? 22 A. I think that's accurate. 23 Q. Okay. And then you're not making a 24 claim for lost wages or lost earning capacity 25 either; is that correct? Page 56 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 25 of 37 1 had to go pee? 2 A. Oh, yes. 3 Q. Do you remember how many times you did 4 that type of testing? 5 A. I think I did it a couple types. 6 Q. Did he do any testing with a Q-tip and 7 ask you to bear down to see how the Q-tip reacted? 8 A. I somewhat remember that. 9 Q. Okay. Do you recall any discussions 10 with Dr. Threatt about what those tests were 11 intended to figure out? 12 A. He tried to explain to me why he was 13 doing it and that sort of thing. 14 Q. Okay. Sitting here today, do you have 15 any recollection of what exactly those tests 16 meant? 17 A. I personally think that they were just 18 to test me whether I needed to have surgery, or I 19 didn't need to have it, that sort of thing. That's 20 what I remember. 21 Q. Okay. So you do remember in general 22 that whatever testing he did indicated that surgery 23 would be a good option for you? 24 A. Yes. 25 Q. Okay. Page 83 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 26 of 37 1 A. Well, that was what was suggested to 2 me. 3 Q. Okay. And based -- and you don't 4 remember specifically what -- what exactly the 5 testing was demonstrating, though, or how it would 6 show your body was working? 7 A. It's hard to remember that, yeah. 8 Q. Okay. 9 A. The whole time. 10 Q. And we've been talking about you 11 using -- him using the Mentor ObTape product on you. 12 Going into the surgery, do you recall 13 what he told you the surgery would involve? 14 A. I think that he said the sling would 15 bring up the bladder and help that part of it. 16 That's basically what I remember. 17 Q. And then you said he said sling, and I 18 think you referred to it before. Is that how he 19 described it to you as a sling? 20 A. From what I remember what he said, seems 21 like that's what it was. 22 Q. Okay. Do you remember him talking about 23 Mentor or ObTape in particular? 24 A. I don't remember that. 25 Q. Okay. Do you know when -- let me Page 84 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 27 of 37 1 rephrase that. 2 When did you first come to have an 3 understanding that the product that Dr. Threatt 4 implanted you with was called ObTape? 5 A. I don't remember that at all, to be 6 honest with you. 7 Q. Okay. Coming into this deposition today 8 prior to us talking about it here, did you know that 9 that was the name of the product? 10 A. No, not really. 11 Q. Okay. 12 A. It didn't mean anything to me. 13 Q. Okay. And do you know what the name of 14 the company is that made the ObTape? 15 A. No. 16 MR. SINDELAR: We're getting kind of 17 close to the hour mark again, and we're probably 18 running a little close to the tape, so why don't we 19 go ahead and take another break. 20 THE VIDEOGRAPHER: We're now off the 21 record. 22 (A brief recess was had.) 23 THE VIDEOGRAPHER: This is recording 24 number two. We are now on the record. 25 Q. (BY MR. SINDELAR:) We're kind of in the Page 85 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 28 of 37 1 middle of a section, and I was asking you about a 2 discussion you had with your doctor, Dr. Threatt, 3 prior to the ObTape implant. So this is going to 4 kind of continue where we left off. 5 Did you understand going into the ObTape 6 implant surgery that Dr. Threatt would be operating 7 in the area of your vagina? 8 A. Uh-huh. 9 Q. And did you understand that the surgery 10 would involve making some incisions in the area of 11 your vagina and putting an implant in your body? 12 A. He explained it to me. 13 Q. Okay. 14 A. I don't know if I understood it totally, 15 but I -- you know, he told me. 16 Q. Okay. And you -- you understood that he 17 was planning to leave a sling in your body? 18 A. Yes. 19 Q. Did you have an understanding as to what 20 the sling was made out of? 21 A. No. I don't think we really ever went 22 through that. 23 Q. Okay. 24 A. Just -- I didn't ask -- to be honest 25 with you, I should have asked more questions, but I Page 86 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 29 of 37 1 didn't. 2 Q. Okay. Did you rely on Dr. Threatt in 3 deciding what type of sling to use? 4 A. Yes. 5 Q. Okay. Did you have any discussion with 6 him about different types or brand names of 7 slings? 8 A. No. We didn't discuss any of that. 9 Q. Okay. 10 A. I probably wouldn't have understood him 11 anyway. 12 Q. Did you have a discussion with 13 Dr. Threatt about how common the surgery was or how 14 many times he had performed it? 15 MS. HILLIARD: Object to form. 16 THE WITNESS: I don't recall that. 17 Q. (BY MR. SINDELAR:) Okay. Did you 18 consider the ObTape implant surgery an invasive 19 procedure? 20 MS. HILLIARD: Object to form. 21 THE WITNESS: Yes. 22 Q. (BY MR. SINDELAR:) Were you reluctant 23 at all to undergo surgery? 24 A. Yes. 25 Q. What -- what things made you Page 87 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 30 of 37 1 reluctant? 2 A. I just -- in that area, per se, that 3 kind of scared me. 4 Q. Okay. 5 A. So I think that's why I was very 6 reluctant, plus I also wanted to go home and discuss 7 it with my husband. 8 Q. Okay. And was there anything in 9 particular you remember about an operation in the 10 area of the vagina that made you a little hesitant 11 to undergo surgery? 12 MS. HILLIARD: Object to form. 13 THE WITNESS: I just didn't know whether 14 it was going to eventually damage me in that area. 15 Q. (BY MR. SINDELAR:) Uh-huh. 16 A. Which, you know, you take all that stuff 17 into consideration -- 18 Q. Uh-huh. 19 A. -- and that's mainly what bothered me is 20 that. 21 Q. Did you ask Dr. Threatt any questions 22 about those concerns? 23 A. I just said, could -- in the long run 24 could it damage me or anything, and I don't remember 25 his answers, but I did ask those questions because Page 88 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 31 of 37 1 study you had done, but since Corica is apparently 2 leaving this week permanently. 3 Does that refresh your memory -- 4 A. Yes. 5 Q. -- of Dr. Corica? 6 A. Yes. 7 Q. So you started seeing Dr. Corica, and he 8 was leaving after a couple of visits. Okay. 9 And if we turn over to the back page of 10 Exhibit 15, it indicates that you had, looks like, a 11 new onset of a hernia? 12 A. Uh-huh. 13 Q. Do you recall what that hernia was and 14 where it was located? 15 A. It was a hiatal hernia. 16 Q. That's in the upper abdominal area? 17 A. Uh-huh. 18 Q. Did you have you any surgical treatment 19 for that? 20 A. No. They did a scope and that was it. 21 MR. SINDELAR: Okay. We can set 15 to 22 the side. 23 (Deposition Exhibit 16 was marked for 24 identification.) 25 THE COURT REPORTER: Exhibit 16. Page 143 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 32 of 37 1 Q. (BY MR. SINDELAR:) I handed you a copy 2 now of what has been marked as Exhibit 16, and this 3 is a May 26, 2015, follow-up visit with Dr. Peter 4 Jones, the urologist, and it indicates that you were 5 here to discuss CMG, which is a abbreviation for the 6 urodynamic testing that he had done on you. 7 And it says: Dorothy is a 8 sixty-eight-year-old female who returns in follow-up 9 today. She has a history of having a sling placed a 10 few years ago and since that time has had nothing 11 but problems per her report. She has near constant 12 pelvic pain. 13 Do you remember reporting that to 14 Dr. Jones -- 15 A. Yes. 16 Q. -- during this visit? 17 A. Uh-huh. 18 Q. If we turn over a few pages, then, I 19 want to look at the Bates number 34. It looks like 20 he reviewed the urodynamic studies with you and down 21 under the plan, he says: Given her history of 22 having a sling placed really is essential that we 23 perform a cystoscopy. We will also send again a 24 request to obtain her outside records so that we can 25 review the op. report. We will get her scheduled Page 144 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 33 of 37 1 for urodynamics. Also her history of hematuria and 2 back pain, we will obtain a renal ultrasound just to 3 rule out any other issues. 4 Do you recall having a discussion with 5 Dr. Jones that he wanted to perform a cystoscopy 6 where he could look up in your bladder to see if 7 there were any issues -- 8 A. I remember that conversation. 9 Q. Okay. And when you reported to 10 Dr. Jones that you had nothing but problems since 11 the time of your sling implant, do you recall when 12 it was you first felt that you had continuous 13 problems with the sling implant? 14 A. Seems like it was, like, 2005, but I'm 15 not positive of that. 16 Q. Okay. And then whenever you went to see 17 Dr. Sauervine -- how do you pronounce his name? The 18 doctor who moved to Montana? 19 A. Sauervine. 20 Q. Sauervine. 21 A. They've got his name spelled wrong. 22 Q. Oh, okay. Is that why it's -- 23 A. Yeah. It's S-a-u-e-w-i-n-e or 24 w-e-i-n-e. 25 Q. Okay. Do you remember what his first Page 145 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 34 of 37 1 name was? 2 A. Boris, I think. 3 Q. Boris? 4 A. Because he's from Germany, I think. 5 Q. Okay. I'll have to figure out who that 6 is and where he is now. 7 Is Dr. Sauervine the first doctor you 8 saw after your follow-up appointment with the 9 implanter who -- 10 A. I think so. 11 Q. Okay. And you don't have a specific 12 memory of the first time that you saw 13 Dr. Sauervine? 14 A. No. 15 MR. SINDELAR: Okay. Set Exhibit 16 to 16 the side. 17 (Deposition Exhibit 17 was marked for 18 identification.) 19 THE COURT REPORTER: Exhibit 17. 20 Q. (BY MR. SINDELAR:) I've handed you a 21 copy of what has been marked as Exhibit Number 17. 22 This is a July 6th, 2015, follow-up note from a 23 visit you had with the urologist, Peter Jones, and 24 it indicates you were in for cystoscopy to check 25 mesh. Page 146 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 35 of 37 1 THE COURT REPORTER: Repeat it. 2 MR. SINDELAR: Object to form and 3 foundation. 4 If you can just give me a second like we 5 did with your attorney. 6 THE WITNESS: Sure. 7 MR. SINDELAR: Sorry about that. 8 MS. HILLIARD: That was my last 9 question, so we're done. 10 MR. SINDELAR: Nothing else from me. 11 THE VIDEOGRAPHER: This concludes 12 today's videotape deposition. We're now off the 13 record. 14 (Whereupon, the videotape deposition 15 concluded at 1:36 p.m.) 16 * * * * * * 17 18 19 20 21 22 23 24 25 Page 166 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 36 of 37 Page 167 Case 4:16-cv-00035-CDL Document 12-4 Filed 04/24/17 Page 37 of 37 Exhibit B Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 1 of 23 1 UNITED STATES DISTRICT COURT 2 MIDDLE DISTRICT Of GEORGIA 3 COLUMBUS DIVISION 4 5 6 DOROTHY ANGLE, 7 Plaintiff, MDL Case No. 4:08-MD-2004 (CDL) 8 vs. Individual Case No. 9 MENTOR WORLDWIDE LLC, 4:16-CV-00035 10 Defendant. 11 12 13 14 VIDEO DEPOSITION OF CHRIS B. THREATT, M.D. 15 16 Date: Tuesday, March 14, 2017 17 Time: 1:56 p.m. 18 Location: SEQUOIA UROLOGY CENTER 2900 Whipple Avenue 19 Suite 130 Redwood City, California, 94O62. 20 Reported by: Howard Schroeder, CSR 21 License Number 1123 22 23 24 25 Job No. CS2561428 Page 1 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 2 of 23 1 A P P E A R A N C E S: 2 For the Plaintiff HAUN MENA 3 Dorothy Angle: BY: D. DOUGLAS MENA, Esq. 3006 Brazos Street 4 Houston, Texas 77006 (713) 781-8600 5 6 For the Defendant TUCKER ELLIS, LLP Mentor Worldwide, BY: JEFFREY C. SINDELAR, JR., Esq. 7 LLC: 950 Main Avenue Suite 1100 8 Cleveland, Ohio, 44113-7213 (216) 696-3697 9 Videographer: Veritext Legal Solutions 10 BY: Brandon Miller 101 Montgomery Street #450 11 San Francisco, CA 94104 (415) 274-9977 12 Reported by: Creekside Court Reporting 13 BY: Howard Schroeder, CSR 1123 2425 Porter Street 14 Suite 9 Soquel, CA 95073 15 (831) 426-5767 16 17 18 19 20 21 22 23 24 25 Page 2 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 3 of 23 1 I N D E X O F E X A M I N A T I O N 2 Page: 3 By Mr. Sindelar 5, 180 224 4 By Mr. Mena 102, 222 5 6 7 I N D E X O F E X H I B I T S 8 Plaintiff: Page: 9 1 Curriculum vitae 63 10 2 Set of records from Emanuel Medical Center 64 11 3 Mentor ObTape Trans-Obturator 12 Surgical Kit 116 13 4 Controlling Urine Leakage 135 14 5 Email, 12/7/03 151 15 6 Email chain, 3/28/04 156 16 7 Email chain, 3/25/04 157 17 8 ObTape conference call 160 18 9 In-house minute meeting from conference call 162 19 10 Bates 030805 and 806 166 20 11 Position Statement from the 21 American Urogynecologic Society 211 22 12 Journal article 213 23 24 25 Page 3 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 4 of 23 1 P R O C E E D I N G S 2 3 VIDEOGRAPHER: All right. Stand by. 4 Good afternoon. We're now on the record. 5 Please note that the microphones are sensitive 6 and may pick up whispering and private conversations. 7 Please silence all cellphones and place them away from 8 the microphones as they can interfere with deposition 9 audio. Recording will continue until all parties agree 10 to go off the record. 11 My name is Brandon Miller, representing 12 Veritext Legal Solutions. 13 Today's date is March 14, 2017. The time is 14 approximately 1:56 p.m. 15 This deposition is being held at Sequoia 16 Radiology Center, located at 2900 Whipple Avenue, Suite 17 132 -- 18 THE WITNESS: 130. 19 VIDEOGRAPHER: Redwood City, California, 20 94O62. Suite 130. 21 The caption of this case, in re Mentor Corp. 22 This case is being held in the United States 23 District Court for the Middle District of Georgia, 24 Columbus Division. 25 The case numbers: 4:08-MD-2004 (CDL). Page 4 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 5 of 23 1 Individual case number 4:16-CV-00035. 2 The name of the witness is Dr. Chris Threatt. 3 At this time, will the attorneys present in 4 the room please identify themselves and the parties they 5 represent. 6 Our Court Reporter, Howard Schroeder, 7 representing Veritext Eagle Solutions, will swear the 8 witness and we may proceed. 9 MR. SINDELAR: Jeff Sindelar here on behalf of 10 the defendant, Mentor Worldwide, LLC. 11 MR. MENA: Doug Mena on behalf of the 12 plaintiff. 13 THE REPORTER: Howard Schroeder, Court 14 Reporter. 15 VIDEOGRAPHER: Swear in the witness. 16 17 CHRIS B. THREATT, M.D., 18 being first duly sworn by the Certified Shorthand 19 Reporter to tell the truth, the whole truth, and nothing 20 but the truth, testified as follows: 21 22 EXAMINATION BY MR. SINDELAR: 23 Q Good afternoon, Dr. Threatt. Is Threatt the 24 correct pronunciation? 25 A That's correct. Page 5 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 6 of 23 1 A Yes. 2 Q And do you know how many times you would have met 3 with her or approximately how many times, given your 4 practice back in 2004? 5 A At least three times, excluding the urodynamic 6 testing, it would have been an initial visit. It would 7 have been a visit after the urodynamics. 8 There would have been probably a preop visit. 9 And then the surgical visit. And typically there is a 10 postop visit day three and then a two-week, a six-week, 11 three-month and six-month visits in my practice. 12 Q Regarding the visits prior to the implant, is there 13 a reason you schedule multiple visits with the patient 14 prior to the surgery? 15 A It's difficult to get everything in a 15, 20 minute 16 visit. And there's a lot when it comes to preparing 17 anybody for surgery, especially these surgeries. 18 Q Do you have -- I guess I should have asked this 19 earlier. Do you have any independent recollection of 20 any of the -- of your visits with Mrs. Angle? 21 A None. 22 Q Do you -- do you have any, any independent memory 23 of who Mrs. Angle is today? 24 A No. 25 Q If you were out at a Starbucks or a restaurant this Page 84 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 7 of 23 1 evening and Mrs. Angle was in line next to you, do you 2 think you would recognize her? 3 A You could be Mrs. Angle and I wouldn't know. 4 Q Prior to performing the ObTape implant on Mrs. 5 Angle would you have provided her the opportunity to ask 6 any questions that she had of you about the procedure or 7 the product you were implanting in her? 8 A Yes. 9 Q And if she had had questions, would you have 10 answered them as fully for her as possible about the 11 procedure she was about to undergo? 12 MR. MENA: Objection to form. 13 THE WITNESS: Yes. 14 Q BY MR. SINDELAR: Do you know whether you provided 15 Mrs. Angle any written materials about ObTape prior to 16 her surgery? 17 A I don't recall. 18 Q I want to turn over to your operative report now. 19 That is at PLF Angle D six and seven. 20 And, Doctor, does this operative report 21 confirm to you that you implanted the plaintiff in this 22 lawsuit, Dorothy Angle, with an ObTape on November 29th, 23 2004? 24 A Yes. 25 Q And, Doctor, there's a listing at the top of the Page 85 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 8 of 23 1 operative report of preoperative diagnosis, 2 postoperative diagnosis and procedure performed? 3 A Uh-huh. 4 Q Can you explain for the members of the jury, what 5 those sections of an operative report are and what you 6 indicated for the plaintiff in this lawsuit? 7 A It's the -- well, it says what I plan to do, what I 8 did, and the procedure performed as we discussed. 9 It's -- I fixed the bladder, fixed the floor of the 10 vagina, and then put the sling in. 11 Q And were there any complications during the 12 operations that you performed on Miss Angle? 13 A No. 14 Q And then, can you just walk us through in layman's 15 terms what procedures you performed, specifically what 16 you did during those procedures? 17 A Sure. Well, according to the notes, I made an 18 incision in the top of the vagina. And I placed a piece 19 of tissue that helped to bring the bladder back up. And 20 I closed that incision. 21 And then I made another incision in the floor 22 of the vagina. And I fixed the part that was tinting 23 up, which is called a rectocele and closed that back up. 24 And then I made a small incision in the -- in the, a 25 little further up in the, underneath the urethra. And I Page 86 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 9 of 23 1 us through what interval you would see a patient after a 2 sling implant? 3 A Usually three days, two weeks, six weeks, three 4 months, six months. 5 Q And you don't have any independent memory of those 6 visits with Miss Angle? 7 A No. 8 Q Okay. And do you know if you would have provided 9 any discharge instructions to her upon her being 10 discharged from the hospital? 11 A Everyone should receive discharge paperwork 12 instructions. 13 Q Okay. Do you know what those instructions would 14 have been for a patient in November of 2004? 15 A No. 16 Q Okay. I just have a series of questions now just 17 to rule out qualifications in certain areas. And then I 18 believe I'll be done with my questioning for today. 19 First of all, is there anything that a 20 representative from Mentor ever told you about the 21 ObTape that, that you knew to be a false statement? 22 MR. MENA: Objection, form. 23 THE WITNESS: Not that I recall. 24 Q BY MR. SINDELAR: Okay. Did anyone from Mentor 25 ever promise you some form of compensation in exchange Page 91 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 10 of 23 1 for using the ObTape? 2 A No. 3 Q Was your decision to use the ObTape product based 4 on what you thought was the best treatment option for 5 Miss Angle? 6 A Yes. 7 Q Okay. Have you ever assisted in the design of a 8 mesh product? 9 A No. 10 Q Do you have any training or experience in the 11 characteristics of polypropylene? 12 A I'm sorry, ask me that again. 13 Q Do you have any training or experience in the 14 characteristics of polypropylene? 15 A No. 16 Q Have you ever done any comparative scientific study 17 on success and/or complication rates of mesh slings? 18 A No. 19 Q Do you know how many ObTapes were implanted in 20 patients in the United States? 21 A No. 22 Q Do you know how many ObTapes were implanted in 23 patients Worldwide? 24 A Nope. 25 Q In your care and treatment of the plaintiff in this Page 92 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 11 of 23 1 lawsuit, do you have any memory of her ever returning to 2 you with a complication from the ObTape? 3 A Nope. 4 Q Do you have any memory of any other patient you 5 implanted with an ObTape returning to you with 6 complications? 7 A I couldn't say the ObTape specifically. 8 Q Uh-huh. 9 A But I remember complications from mesh, but not the 10 ObTape specifically. 11 Q And in your experience with different mesh products 12 over the years, did the ObTape product have a different 13 rate of complications from other products other than the 14 TVT and bladder perforation discussed earlier? 15 A No. 16 Q Based on what you know to date, would you hold 17 yourself out as an expert or as an expert qualified to 18 offer an analysis of ObTape complications versus 19 complications with other surgical treatments for stress 20 urinary incontinence? 21 A I'm sorry, ask me the question again. 22 Q Yeah. Based on -- based on your knowledge today, 23 would you hold yourself out as being qualified to offer 24 an analysis of complications experienced with the ObTape 25 product versus complications experienced with other Page 93 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 12 of 23 1 surgical treatments for stress urinary incontinence? 2 A Yes. 3 Q And what would be the basis of your qualification 4 in that field? 5 A It would be experience with performing the 6 procedures. 7 Q Uh-huh. 8 A Experience with treating my complications. 9 Experience with treating other patients. I mean, other 10 physicians' complications from urethral suspension 11 procedures and my reading and knowledge and training. 12 Q Okay. And -- and based on that experience that you 13 cited, do you believe the ObTape has any different rate 14 of complication from other mesh slings on the market? 15 MR. MENA: Objection, form. 16 THE WITNESS: Today or back then? 17 Q BY MR. SINDELAR: Both, actually. 18 A Today I think it would -- the fact at that time 19 that the mesh doesn't breathe, and it doesn't allow for 20 tissue to incorporate would put it at a slightly higher 21 risk for complications. 22 I think the TOT, not necessarily the Mentor 23 TOT would. That procedure places patients at a slightly 24 higher risk of complications than a single incision 25 procedure. Page 94 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 13 of 23 1 urologists in the nation. One guy who kind of stands 2 out who does something better than most and will -- is 3 -- his comments will usually influence how people might 4 -- might -- might manage a patient. 5 Q Maybe like the gentleman you were speaking of 6 earlier for the penile implants? 7 A Yeah. Like Perito. 8 Q Okay. Would you consider the opinions of a key 9 opinion leader in your field to be valuable in your 10 practice? 11 MR. SINDELAR: Object to form. 12 THE WITNESS: Yeah, I would. 13 Q BY MR. MENA: Did anyone from Mentor tell you that 14 in November 2004, or any time thereafter, that the 15 company was informed by key pin leaders in Europe that 16 it should withdraw the ObTape from the market due to the 17 seriousness of infections from the material? 18 A No. 19 MR. SINDELAR: Object to form and foundation. 20 Q BY MR. MENA: If Mentor had told you that their key 21 opinion leaders had recommended withdrawal of the 22 ObTape, would you have reconsidered whether to implant 23 the ObTape in Miss Angle or not? 24 THE WITNESS: I would have. 25 MR. SINDELAR: Object to form and foundation, Page 174 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 14 of 23 1 and calls for speculation. 2 Q BY MR. MENA: You would have reconsidered? 3 A Yes. 4 Q Did Mentor ever tell you that they were 5 recommending yearly follow-ups for ObTape patients to 6 make sure they were not having complications? 7 A No. 8 MR. SINDELAR: Object to foundation, assumes 9 facts not in evidence. 10 Q MR. MENA: Did Mentor ever tell you that their own 11 consultants were terminating their consulting agreements 12 with Mentor due to their own experience with ObTape 13 complications? 14 A No. 15 MR. SINDELAR: Object to foundation. Assumes 16 facts not in evidence. 17 Q BY MR. MENA: Did anyone from Mentor ever tell you 18 that when an erosion occurred with ObTape it was 19 important to remove the tape to minimize the risk of 20 infection? 21 MR. SINDELAR: Object to foundation. 22 THE WITNESS: I knew that. I just -- I don't 23 know if Mentor told me that or it was something I 24 learned somewhere else. 25 Q BY Mr. MENA: In the rare instance when, if you Page 175 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 15 of 23 1 ever saw erosion with a Monarc or a SPARC or Ethicon 2 TVT, how would you have corrected it? 3 A Usually -- 4 MR. SINDELAR: Object to foundation. 5 THE WITNESS: -- remove the sling as far 6 --remove the mesh as far as I can get to it and I don't 7 replace it with another mesh. I usually will leave it 8 to heal. 9 Most patients tend not to leak after you 10 remove the mesh. Those that do, I give them six months 11 before I consider doing something else. The few I have 12 had, I think I have gone to like a cadaveric sling. 13 Q MR. MENA: Have you ever heard of Dr. Andrew Segal? 14 A No. 15 Q Did Mentor ever tell you not to implant the ObTape 16 in a patient that was having or had had a hysterectomy? 17 A No. 18 Q Is it fair to say that when you were discussing 19 ObTape with your patients, like Miss Angle, when you 20 were going through your risk/benefit analysis, that you 21 were not aware of any manufacturing or design defects of 22 the ObTape? 23 A That's correct. I was not aware. 24 Q And it's safe to assume you didn't actually 25 discuss those manufacturing or design defects risks with Page 176 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 16 of 23 1 Miss Angle when you were doing your informed consent? 2 A Correct. 3 MR. SINDELAR: Object to form and foundation. 4 THE WITNESS: That's correct. 5 Q BY MR. MENA: And any consent that you would have 6 obtained from Miss Angle would have been based on your 7 implanting a nondefective sling? 8 A Correct. 9 Q Do you remember -- again, I know it's been a long 10 time. Do you remember if you provided Miss Angle with 11 any brochures or literature from Mentor before 12 performing the surgery? 13 A I don't. 14 Q Okay. Having looked at the documents that we've 15 looked at today, do you think that you were in a 16 position to fully inform Miss Angle of all the risks and 17 complications associated with ObTape prior to her 18 surgery? 19 MR. SINDELAR: Object to foundation. 20 Q BY MR MENA: And not just with the documents that 21 we have looked at, but also the information that you 22 have obtained on doing your own due diligence and your 23 own research since then. 24 MR. SINDELAR: Object, foundation. 25 THE WITNESS: Rephrase your question. Page 177 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 17 of 23 1 A Yes. 2 Q Okay. Are you aware of any way that a company 3 could have a one hundred percent reporting of 4 complications with its products? 5 A It would be pretty hard to do. 6 Q Do you -- do you have any recollection of how 7 Mentor's efforts to follow up on ObTape in patients who 8 have ObTape compared with other sling manufacturers? 9 A There's no big difference. 10 Q Okay. And there were questions about, do you 11 expect to receive -- to receive all information or 12 complete information from medical device companies.? 13 Do you expect a medical device company to copy 14 you on all its emails? 15 A I do. I'm just teasing. Of course not. 16 Q There are tens of thousands of pages produced in 17 this discovery. Do you expect any medical device 18 company to send you every single internal memo that it 19 has? 20 A I would hope not, no. 21 Q Would you have time to practice medicine if you had 22 to review all the internal documents from every medical 23 device company whose products you use? 24 A No. 25 Q Okay. Have you ever had other medical device Page 191 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 18 of 23 1 companies come to you with internal emails and people 2 owes to share them with you? 3 A I have. 4 Q Okay. And what was that in relation to? 5 A It was more in relations to the company potentially 6 winding down, or a few products coming out on the 7 market. Or a change in pricing. Things like that. 8 Q Okay. And were those -- were those communications 9 designed for doctors then that they sent you? 10 A Some were and some were just reps giving me some 11 insight into what was to -- what was ahead. 12 Q Okay. And the next exhibit that you looked at 13 was -- it was marked as number four. It was the 14 brochure, the front page entitled "Controlling Urine 15 Leakage." 16 A Uh-huh. 17 Q Prior to today, do you ever recall seeing the 18 document? 19 A Nope. No. 20 Q It's fair to say, you didn't rely on this document 21 in any way in deciding to use the ObTape product? 22 A No. 23 Q I am sorry, we may have a double negative. 24 Did you rely on this product in deciding to 25 use ObTape? Page 192 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 19 of 23 1 A No, I didn't. 2 Q And if you look at this document briefly, does this 3 appear to be the type of document that is provided to 4 doctors to educate them on the product or does it appear 5 to be the type of document provided to patients about a 6 product? 7 A The patient, it says, "Speak to your Doctor". So 8 I'm assuming it's a patient document. 9 Q Because you never recall seeing the document prior 10 to today, would it be fair to say that you did not 11 provide this document to your own patients? 12 A It would be fair to say. 13 Q Okay. And, Doctor, you discussed some of the other 14 emails that you saw regarding an individual doctor 15 having an adverse event with the product. 16 Do medical device companies typically come to 17 you and share every time they get a report from a doctor 18 that they have a complication with their products? 19 A No. 20 Q And are you able to form an opinion as to whether 21 or not a product is -- is safe and effective, based on a 22 single outcome of a single patient? 23 A No. 24 Q Doctor, would it be fair in deciding to use a 25 product, what you look primarily to published journal Page 193 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 20 of 23 1 articles and the urological associations to which you 2 belong? 3 A Correct. As well as peers. 4 Q Okay. And in terms of what information you receive 5 from a company, do you -- do you value that more or less 6 with the same as information you receive from your peers 7 and articles, and urological associations? 8 A It would be less. Unless they are going to report 9 all the bads. 10 Q Okay. 11 With regard to the information you expect to receive 12 from medical device companies, do you expect them to 13 provide you information about known risks and then leave 14 it to you to make an informed decision about whether to 15 integrate that product into your own practice? 16 A I do. 17 Q Okay. Then in addition to relying on the 18 information you received from prior sources, do you rely 19 at all on the FDA 510(K) approval process in determining 20 whether to use a product? 21 A Absolutely. I mean, if it's 510(K) approved, it 22 shouldn't even come across my desk or the operating 23 room. 24 Q Did you ever request a copy of the 510(K) 25 application that Mentor submitted to the FDA? Page 194 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 21 of 23 1 A I didn't have a reason. 2 MR. SINDELAR: Thank you. I have no further 3 questions. 4 THE WITNESS: Okay. 5 MR. MENA: I have got nothing. 6 THE WITNESS: So does that mean we're really 7 done? 8 MR. SINDELAR: We're really done. 9 MR. MENA: Really done. 10 VIDEOGRAPHER: This concludes today's 11 deposition of Dr. Chris Threatt. Total number media 12 used is four. 13 Going off the record at 8:21 p.m. 14 15 (Deposition of Chris B. Threatt, M.D. was 16 concluded at 8:21 p.m.) 17 18 19 --o0o-- 20 21 22 23 24 25 Page 230 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 22 of 23 Page 231 Case 4:16-cv-00035-CDL Document 12-5 Filed 04/24/17 Page 23 of 23 Exhibit C Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 1 of 29 1 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF GEORGIA 2 COLUMBUS DIVISION 3 ) MDL CASE NO. 4:08-MD-2004 IN RE: MENTOR CORP. ) (CDL) 4 OBTAPE TRANSOBTURATOR ) SLING PRODUCTS LIABILITY ) Individual Case No. 5 LITIGATION ) 4:16-CV-00035 ) (Angle, D.) 6 7 8 9 10 11 12 VIDEOTAPED DEPOSITION OF ALBERTO G. CORICA, M.D. March 15, 2017 13 4:07 p.m. Albuquerque Marriott Pyramid North 14 5151 San Francisco Road Northeast Albuquerque, New Mexico 87109 15 PURSUANT TO THE NEW MEXICO RULES OF CIVIL 16 PROCEDURE, this deposition was: 17 TAKEN BY: MR. JEFF SINDELAR, ESQ. ATTORNEY FOR DEFENDANT MENTOR 18 REPORTED BY: ANNE D. WIESE, RPR, NM CCR #301 19 VIDEOGRAPHER: SCOTT SAIZ TRATTEL COURT REPORTING 20 609 12TH STREET NW ALBUQUERQUE, NEW MEXICO 87102 21 22 23 24 25 Job No. CS2562979 Page 1 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 2 of 29 1 A P P E A R A N C E S 2 FOR THE PLAINTIFF: 3 MR. DUANE DOUGLAS "DOUG" MENA II, ESQ. Haun Mena PLLC 4 3006 Brazos Street Houston, Texas 77006 5 doug@haunmena.com 6 FOR THE DEFENDANT MENTOR: 7 MR. JEFFREY SINDELAR, ESQ. 8 Tucker Ellis LLP 950 Main Avenue 9 Suite 1100 Cleveland, Ohio 44113 10 jeffrey.sindelar@tuckerellis.com 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 2 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 3 of 29 1 INDEX PAGE 2 EXAMINATION OF ALBERTO G. CORICA, M.D. By Mr. Sindelar............................... 4 3 By Mr. Mena................................... 45 By Mr. Sindelar............................... 74 4 By Mr. Mena................................... 85 5 SIGNATURE/CORRECTION PAGE..................... 88 CERTIFICATE OF COMPLETION OF DEPOSITION....... 89 6 7 EXHIBITS MARK/ID 8 NO. DESCRIPTION 1 Progress Notes from Portneuf 14 9 Medical Practice Division dated 3/16/15 10 2 Progress Notes from Portneuf 24 11 Medical Practice Division dated 3/16/15 12 3 Progress Notes from Portneuf 30 13 Medical Practice Division dated 4/2/15 14 4 Progress Notes from Portneuf 33 15 Medical Practice Division dated 4/15/15 16 5 Progress Notes from Portneuf 35 17 Medical Practice Division dated 5/26/15 18 6 Progress Notes from Portneuf 38 19 Medical Practice Division dated 7/6/15 20 7 Progress Notes from Portneuf 39 21 Family Medicine dated 11/30/16 22 23 24 25 Page 3 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 4 of 29 1 VIDEOGRAPHER: Stand by. 2 Okay. Good afternoon. Today is March 15, 3 2017. The time is 4:07. Location is the Marriott 0 4 Hotel, Albuquerque -- Marriott Pyramid Hotel, 5 Albuquerque, New Mexico. My name is Scott Saiz, a legal 6 video specialist. 7 The case number is CS2562979. It was 8 filed in -- Alberto Corica, M.D. is the deponent. 9 Will the attorneys please introduce 10 themselves. 11 MR. SINDELAR: Jeff Sindelar from Tucker 12 Ellis, LLP, here on behalf of the defendant, Mentor 13 Worldwide, LLC. 14 MR. MENA: Doug Mena, Haun Mena, PLLC for 15 the plaintiff, Dorothy Angle. 16 VIDEOGRAPHER: Will you please swear in the 17 witness. 18 ALBERTO CORICA, M.D., 19 having been first duly sworn, testified as follows: 20 EXAMINATION 21 BY MR. SINDELAR: 22 Q. Good evening, Dr. Corica. How are you doing? 23 A. Good. 24 Q. And I apologize -- am I pronouncing your name 25 correctly? Page 4 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 5 of 29 1 Q. And do you rely on the accuracy of your medical 2 records for the ongoing care and treatment of your 3 patients? 4 A. I do. 5 Q. Okay. Now, with regard to the medical records 6 that you brought with you, can you just explain for us 7 how -- what you had to do to obtain those records. 8 A. You mean the ones I -- 9 Q. Yes, the ones you brought with you. Do you 10 have access to those or did someone send them to you? 11 A. I believe your practice sent them to me -- or 12 to my office, and then they eventually got to me. 13 Q. Okay. So when you found out that your 14 deposition was requested, your office requested that we 15 send the records pertaining to your care and treatment 16 of Ms. Angle? 17 A. Correct. 18 Q. Okay. I want to start with what I believe is 19 the first encounter that you had with the plaintiff, 20 which, according to the records I've seen, was on March 21 16th, 2015. 22 A. Correct. 23 Q. And you probably have the records in front of 24 you. I'm going to go ahead and mark an additional copy 25 of the records from that encounter as Exhibit No. 2 and Page 23 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 6 of 29 1 hand you a copy just so we can be sure that we're all 2 looking at the same document, on the same page. 3 (Deposition Exhibit 2 was marked for 4 identification.) 5 Q. (By Mr. Sindelar) First of all, Doctor, does 6 what has been handed to you marked as Exhibit No. 2 7 appear to be a record from an encounter that you had 8 with Ms. Angle on March 16th, 2015? 9 A. It does. 10 Q. Okay. And was this -- does this appear to be 11 the first time that you saw Mrs. Angle? 12 A. Yes. 13 Q. Okay. And Doctor, the record is several pages 14 long. That is one of the functions of electronic 15 medical records, is that they -- every time you print a 16 record, they provide a great deal of information. So I 17 don't want to read through the entire record in detail, 18 but can you explain to us why it is that Mrs. Angle came 19 to see you on March 16th, 2015. 20 A. Yes. So this patient was coming to see us due 21 to her voiding issues. At that point, she had been 22 complaining that she had been experiencing worsening 23 urge, as well as urge incontinence. 24 She did mention that she had had a complex 25 prior medical and surgical history as well. She did Page 24 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 7 of 29 1 mention that at that point, she had had a sling and 2 possibly a cystocele repair sometime -- and she recalled 3 that might have been 2004 or 2005, in California. 4 She also said that even after the 5 procedure, she still had some stress incontinence, which 6 led to pervasively worsening of her urge and urge 7 incontinence on top of that as well. There's also some 8 evidence of frequent urinary tract infections at the 9 time of the initial encounter. She had some issues with 10 constipation that she had been treating with stool 11 softeners and, according to her indications, those were 12 working well for her. 13 At that point, that first visit, she was 14 found to have a urine analysis that was suggestive of a 15 urinary tract infection, so we followed protocol, and 16 then at that point, she might have been started on oral 17 antibiotics and that urine would have been sent to be 18 cultured. We'd discuss her findings. 19 Do you want me to keep going or -- 20 Q. No, that's good. Can -- I just have 21 some -- ask you some follow-up questions on a few of 22 those. 23 First of all, with regard to the patient's 24 surgical history and the prior sling placement and 25 possible cystocele repair, who was the source of that Page 25 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 8 of 29 1 information? 2 A. At that point, the patient. 3 Q. Okay. Did -- do you know whether Mrs. Angle 4 had ever had any prior cystocele repairs or stress 5 incontinence surgeries prior to the 2005 -- or 2005 6 procedures that she mentioned to you? 7 A. She did not mention that to me. 8 Q. Do you know whether Mrs. Angle experienced urge 9 incontinence prior to her sling placement which she 10 reported to you took place in 2004 or 2005? 11 A. She did not report that to me. 12 Q. It notes in the record that there's a "PVR that 13 was minimal at 5 cc today." Can you explain what a PVR 14 is and what it means if she had a 5-cubic-centimeter 15 PVR. 16 A. Correct. So PVR stands for post-voided 17 residual. It's the amount of urine that she would -- 18 that would have been left behind in her bladder after 19 she voided, and a 5 cc is a minute amount. 20 Q. From a clinical perspective, is there a concern 21 that she has 5 centimeters -- 5 cubic centimeters of 22 post-void residual? 23 A. No. 24 Q. And then there's a note in here about being 25 "unable to inspect the vagina due to complete Page 26 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 9 of 29 1 record, there's another visit where she goes in on May 2 the 26th, 2015, and I believe this is where she 3 discusses with Dr. Jones the results of that urodynamic 4 testing that we looked at from April. And I think there 5 might be some more details in here. Can you just walk 6 us through what the results of that testing showed. 7 A. Sure. Let me read it up a little bit. 8 Q. Okay. 9 A. I don't see a formal report of her urodynamic 10 testing. There's a summary, what it seems to be, that 11 Dr. Jones went over with her, but there -- I can't find 12 any mention of what exactly was found or what was 13 discussed from those results. 14 Q. Okay. 15 A. Oh, here we go; I found it. I apologize. It 16 says here under "Diagnostic Studies" that ^ the 17 urodynamics were reviewed with the patient. She had 18 retention of 250 ccs and there were some low-amplitude 19 involuntary detrusor contractions. 20 Q. Then was the plan at this point to perform a 21 cystoscopy on the patient? 22 A. Correct -- 23 Q. Okay. 24 A. -- it looks that way. 25 Q. It looks like she was back in -- we can set Page 37 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 10 of 29 1 Exhibit No. 5 to the side. 2 I'm going to mark as Exhibit 6 -- I believe 3 this is the last visit she had at Portneuf before she 4 transferred her care back to you, and I just want to 5 make sure we cover her treatment in that area. 6 (Deposition Exhibit No. 6 was marked for 7 identification.) 8 THE WITNESS: Before she transferred her 9 care back to where? 10 Q. (By Mr. Sindelar) Before she came to see you 11 that one time when you were at Bingham Urology. 12 A. I don't have that record. 13 Q. Oh, when she came back to Bingham? 14 A. Did she? Did I see her at Bingham? I don't 15 recall any of that. 16 Q. There's a record that indicates you did. We'll 17 check -- look at that one next. 18 So what was the purpose of Mrs. Angle's 19 visit to Portneuf medical practice on July 6, 2015? 20 A. To get her cystoscopy performed. 21 Q. Okay. And we've returned to the second-to-last 22 page of the exhibit. Near the bottom of the ^ "Plan," 23 it goes through the results of that cystoscopy. What 24 were the findings from her cystoscopy in July of 2015? 25 A. They were all essentially normal findings. Page 38 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 11 of 29 1 Q. Was there any evidence of mesh erosion or 2 extrusion? 3 MR. MENA: Form. 4 A. According to Dr. Jones, no. 5 Q. (By Mr. Sindelar) Did you ever review results 6 of her cystoscopy? 7 A. No, up until I got her records -- 8 Q. Okay. 9 A. -- from you guys. 10 Q. Okay. We could set No. 6 aside, then. 11 I am going to mark as Exhibit 7 what 12 appears to be a note from your office for a visit with 13 Mrs. Angle on August the 6th, 2015. 14 (Deposition Exhibit No. 7 was marked for 15 identification.) 16 Q. (By Mr. Sindelar) Take a moment to familiarize 17 yourself with the note. 18 A. Yeah, I was not given -- I was not given this 19 before. 20 Q. Oh, I'm sorry about that. I think it was 21 labeled as being from Bingham Urology. There's another 22 set that was labeled as being from you. 23 A. Oh. 24 Q. So if you want to take a minute to review 25 that -- I'm sorry you didn't get that one in advance -- Page 39 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 12 of 29 1 please do it. Let me know when you're ready. 2 MR. SINDELAR: Why don't we take a quick 3 break, go off the record right now. 4 VIDEOGRAPHER: The time is 6:01 p.m. We're 5 off the record. 6 (Recess taken - five minutes.) 7 VIDEOGRAPHER: Stand by. 8 Okay. The time is 6:06 and we're back on 9 the record. 10 Q. (By Mr. Sindelar) Okay. Doctor, have you had 11 a chance to review the record that appears to be an 12 office visit that you had with Mrs. Angle on August 6, 13 2016? 14 A. Correct. 15 Q. Does that appear to be a record from another 16 visit that you did have with her in August of 2016? 17 A. Yes. 18 Q. Doctor, can you just walk us through why 19 Mrs. Angle came in to see you that day. 20 A. Basically because of the same problems that she 21 had in the past: Pelvic pain, urge incontinence. I do 22 make a mention that she had been seen by me a few months 23 back. I did obtain some records from Dr. Jones's office 24 regarding her urodynamic findings, and I do mention 25 those findings. Page 40 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 13 of 29 1 this patient? 2 MR. MENA: Objection, form. 3 A. I don't see that being the case. More -- what 4 are you referring to? 5 Q. (By Mr. Sindelar) No, I was just asking you if 6 you did make any determination? 7 A. No, no. 8 Q. And I believe this is the last record that I've 9 seen of you treating Mrs. Angle. Do you have any 10 independent memory, now that we've gone through the 11 records that we have today, of ever seeing Mrs. Angle 12 again after this August 6, 2015 visit? 13 A. I don't recall. 14 Q. And do you know when you moved from Idaho to 15 New Mexico? 16 A. That would have been probably October, November 17 of 2015. 18 Q. So within two or three months of this 19 encounter, you relocated to Albuquerque? 20 A. Correct. 21 Q. Okay. And other than the records for the 22 visits that we've reviewed today, do you have any 23 independent recollection of any other time that you 24 treated Mrs. Angle? 25 A. I don't. Page 43 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 14 of 29 1 Q. Do you have any knowledge of Mrs. Angle's 2 medical care and treatment after you last saw her August 3 the 6th, 2016? 4 A. I don't. 5 Q. I just want to ask a few more questions to kind 6 of close out here on my end. First of all, were you the 7 doctor who implanted Mrs. Angle with her ObTape? 8 A. No. 9 Q. Do you know the name of the doctor who did 10 implant her with her ObTape? 11 A. Apparently, I made a note here that we would 12 try to get records from Dr. Carlson. 13 Q. Okay. And do you know today if that's the 14 doctor who implanted her with the ObTape? 15 A. I don't know who that doctor is. 16 Q. Okay. Would it be fair to say, then, that you 17 played no role whatsoever in deciding to implant 18 Mrs. Angle with ObTape? 19 A. I did not. 20 Q. And based on your review of the records and 21 your care and treatment of Mrs. Angle, did you ever 22 diagnose her with a complication that you attributed to 23 her ObTape? 24 A. Say that again. 25 Q. Yeah. Based on your review of the records Page 44 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 15 of 29 1 today and your care and treatment of Mrs. Angle, did you 2 ever diagnose her with a complication that you 3 attributed to her ObTape? 4 A. No. 5 Q. Okay. Did you ever determine that Mrs. Angle's 6 ObTape needed to be removed or further operated on in 7 any way? 8 A. It doesn't seem that way. Again, I don't 9 recall our conversations, so I'm remitting to my charts. 10 Q. Okay. If you had made that determination or 11 recommendation, is that the type of thing that you would 12 have noted in your records? 13 A. Of course. 14 MR. SINDELAR: Okay. Thank you very much 15 for your time today, Doctor. I do not have any further 16 questions. I believe the plaintiff's counsel will have 17 some questions for you, but I'm all done asking you 18 questions for now. 19 EXAMINATION 20 BY MR. MENA: 21 Q. Good evening, Doctor. My name is Doug Mena and 22 I represent Ms. Angle. Do you understand that? 23 A. Yes. 24 Q. You did a really good job earlier when you were 25 speaking with Mentor's counsel about kind of following Page 45 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 16 of 29 1 the rules that he had mentioned early on. Can we have 2 the same agreement to do the same thing with me? 3 A. Yes. 4 Q. Thank you. 5 Doctor, one of the things that you 6 mentioned earlier is that during your residency, you 7 actually had implanted ObTape before? 8 A. Yes. 9 Q. But now you don't use mesh implants at all? 10 A. Correct. 11 Q. And you said it was because of the lawsuit and 12 the FDA, the complications that you had read about; is 13 that correct? 14 A. Yes. 15 MR. SINDELAR: Object to form, misstates 16 prior testimony. 17 Q. (By Mr. Mena) Can you tell me why it is that 18 you no longer use mesh implants, please. 19 A. They're too controversial. 20 Q. What about them have you learned since you 21 stopped using the mesh implants is it that you believe 22 is controversial? 23 MR. SINDELAR: Objection to form and 24 foundation. 25 A. What is my personal take about it or -- Page 46 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 17 of 29 1 Q. And have you seen or treated Ms. Angle since 2 August 6, 2015? 3 A. I have not. 4 Q. Do you know anything about her care from that 5 point forward? 6 A. I do not. 7 Q. Do you know anything about her signs or 8 symptomology related to what we're here to talk about 9 today from that time forward? 10 A. No. 11 Q. Okay. Do drug -- or I'm sorry, not drug 12 manufacturers -- do product manufacturers ever send you 13 letters about their products? 14 A. They do. 15 Q. Okay. Have you received any of those letters 16 from Mentor about the ObTape? 17 A. Not that I can recall. 18 Q. Okay. Do you recall if Mentor ever sent you a 19 letter advising you to remove the entire ObTape upon 20 seeing erosion or infection in order to diminish your 21 patients' complications? 22 A. No. It is standard of care, though. 23 Q. Has Mentor ever sent you a letter informing you 24 that there were changes that were being made for the 25 ObTape? Page 68 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 18 of 29 1 MR. SINDELAR: Objection to foundation, 2 assumes facts not in evidence. 3 A. No. 4 Q. (By Mr. Mena) If Mentor had passed along the 5 information that Mentor is recommending removal of the 6 entire ObTape upon seeing erosion or infection in order 7 to diminish the patient's complications, and if you knew 8 that Ms. Angle had been implanted with ObTape, having 9 seen the records and seen the signs and symptomology, 10 what would you have done? 11 MR. SINDELAR: Object to foundation, calls 12 for speculation. 13 A. I don't understand the question. 14 Q. (By Mr. Mena) If Mentor had sent you the 15 information that they were recommending removal of the 16 entire ObTape on seeing erosion or infection in order to 17 diminish the patient's complications, would you have 18 conveyed that to your patients that had mesh slings like 19 Ms. Angle? 20 MR. SINDELAR: Object to form, foundation, 21 calls for speculation. 22 A. In the presence of symptoms or no symptoms? 23 Q. (By Mr. Mena) The presence of symptoms. 24 A. Not necessarily, no. 25 Q. So if the product manufacturer gave you Page 69 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 19 of 29 1 information that says that you should have the product 2 removed if the patient is showing symptoms and you saw 3 symptoms in the patient, you would not convey that 4 information to your patient? 5 A. No. The symptoms that I found and I saw in 6 Mrs. Angle were very inspecific and they could have been 7 caused from many other reasons, not necessarily her 8 potential sling, which, again, at the point of all of 9 these visits that we had done, we only assumed that 10 that's what she had. 11 At that point, I was not sure exactly what 12 type of mesh, if mesh, she had implanted, whether that 13 was just a urethral sling or was an interior repair for 14 a cystocele. So that always was in my mind. 15 The myriad of symptoms I saw in her was, 16 you know, not specific. I would have removed the sling 17 if I would have seen extrusion into the vagina or the 18 urethral lumen or to the bladder, yes. Or at some 19 point, if symptoms would have been some other, then, you 20 know, sometimes you -- it's also indicated that you may 21 just release the tension of it but not remove the entire 22 sling. 23 Q. Doctor, we went over a list earlier about some 24 of the signs and symptoms that you can associate with 25 the use of ObTape in females like Ms. Angle. Do you Page 70 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 20 of 29 1 remember that? 2 A. Yes. 3 Q. One of those signs and symptoms was bleeding? 4 A. Yes. 5 Q. And Ms. Angle, towards the end of her care with 6 you and Dr. Jones, showed blood in her urine; is that 7 true? 8 A. Correct. 9 Q. Okay. One of the signs and symptoms was 10 urinary incontinence; is that right? 11 A. Yes. 12 Q. And for her entire care with you, Ms. Angle was 13 complaining of urinary incontinence; is that true? 14 A. Yes. 15 Q. One of the other ones was urinary tract 16 infections? 17 A. Yes. 18 Q. And through her entire care with you, Ms. Angle 19 was complaining of urinary tract infections; is that 20 true? 21 A. Yes. 22 Q. One of them was extreme pain during sexual 23 intercourse? 24 A. She did not mention that to me, but that was 25 noted on the previous system. Page 71 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 21 of 29 1 A. You're asking me what -- which came first, the 2 chicken or the egg. I don't know if I can answer that 3 question. I don't know if it is lack of usage that may 4 have contributed, you know, to the scar tissue on top of 5 all of her surgeries, on top of the atrophic vaginitis. 6 It's a continuum, it's not either/or. 7 She's had, obviously, evidence of prior surgeries, many 8 surgeries, many pelvic surgeries that could have 9 contributed to that, and then after that, the lack of 10 use of the vagina could have also contributed for -- to 11 form scar tissue and contract. 12 Q. (By Mr. Sindelar) When a patient has atrophic 13 vaginitis, and they have de-estrogenation of the vaginal 14 tissue, what are the effects on the quality of the 15 vaginal tissue from a lack of estrogen? 16 A. Well, it makes it thinner and more prone to 17 get, you know, scar tissue and contract. 18 Q. Okay. And is atrophic vaginitis associated 19 with pain with intercourse? 20 A. Yes. 21 Q. You also mentioned one of your thoughts was 22 that a cystocele repair product may have caused some of 23 Mrs. Angle's pain; isn't that correct? 24 A. Yes. 25 Q. Do you know whether she had a -- any product Page 82 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 22 of 29 1 used in her cystocele repair? 2 A. I don't. That was always a question. 3 Q. Okay. Did you ever diagnose Mrs. Angle with an 4 erosion of her ObTape? 5 A. No. 6 Q. Did you ever diagnose Mrs. Angle with an 7 extrusion of her ObTape? 8 A. No. 9 Q. Did you ever diagnose Mrs. Angle with a 10 urethral stricture caused by her ObTape? 11 A. No. 12 Q. Did you ever diagnose Mrs. Angle with an 13 infection caused by her ObTape? 14 A. I can't prove cause on that answer there, but 15 it may seem now. 16 Q. Okay. And you mentioned that the standard of 17 care with an eroded mesh was to remove the entire sling; 18 is that correct? 19 A. Yes. 20 Q. Okay. You did not learn that information from 21 Mentor; is that correct? 22 A. No. 23 Q. How did you learn that information if a medical 24 device company didn't come and tell you? 25 A. How did I learn it? In residency. Page 83 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 23 of 29 1 Q. Are doctors trained on how to perform surgery 2 and practice medicine without medical device companies 3 teaching them? 4 A. Of course. 5 Q. Do medical device companies practice medicine? 6 A. No. 7 Q. Okay. You also mentioned that Mrs. Angle 8 reported burning or painful urination. Is burning and 9 painful urination associated with a urinary tract 10 infection? 11 A. Yes. 12 Q. And a patient who's never had a sling implant 13 can experience a urinary tract infection, correct? 14 A. Yes. 15 Q. A patient who's never had a sling implant can 16 experience burning and pain with urination? 17 A. Yes. 18 VIDEOGRAPHER: Five-minute media warning. 19 MR. SINDELAR: Okay. I don't think I'm 20 going to go that long, so I'm going to see -- 21 (Discussion off the record.) 22 Q. (By Mr. Sindelar) Doctor, do you remember 23 being asked questions about Dr. Jones saying it was 24 critical or essential that Mrs. Angle had a cystoscopy 25 performed? Page 84 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 24 of 29 1 A. Did I discuss this with Dr. Jones? 2 Q. Do you remember your questioning earlier today, 3 you were asked about where Dr. Jones noted that because 4 Mrs. Angle had a mesh, she should have a cystoscopy 5 performed? 6 A. Yes. 7 Q. Okay. Could you turn with me to Exhibit 6, 8 Page 5, which is Bates-numbered 26. 9 A. Uh-huh (yes). 10 Q. Okay. And when Dr. Jones actually performed 11 that cystoscopy, what were his findings as they relate 12 to Mrs. Angle's mesh? 13 A. Everything was normal. 14 Q. Okay. So after Dr. Jones did perform the 15 cystoscopy, he determined that he couldn't find any 16 problems associated with her mesh; is that fair to say? 17 MR. MENA: Objection, form. 18 A. That would be the case. 19 MR. SINDELAR: That's all the questions I 20 have, Doctor. 21 FURTHER EXAMINATION 22 BY MR. MENA: 23 Q. Doctor, just quickly, you were asked if you had 24 ever made any diagnoses related to Ms. Angle's ObTape at 25 all. And I believe your answer to each one of those Page 85 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 25 of 29 1 questions was no, you did not make a diagnosis directly 2 related to the ObTape; is that correct? 3 A. What do you mean, a diagnosis related to the 4 ObTape? 5 Q. Mentor's counsel asked you if you associated 6 any of the signs or symptomology that we discussed 7 earlier with the ObTape implanted into Ms. Angle. Do 8 you remember that line of questioning? 9 A. Uh-huh (yes). 10 Q. Okay. And I believe your answer to each one of 11 those was that you didn't associate any of those signs 12 or symptoms at that time to the use of the ObTape with 13 Ms. Angle; is that true? 14 A. Well, yes and no. The process of ruling out a 15 problem is not a one-day visit. That's why the patient 16 subsequently came to visit us and we continued to order 17 tests to start ruling out some of her symptoms from what 18 the source of those symptoms might be. 19 Q. Okay. At the time that you were -- is that 20 what's called a differential diagnosis? 21 A. Correct. 22 Q. At the time that you were performing your 23 differential diagnosis on Ms. Angle, is it true that you 24 did not know that she had the ObTape implanted in her? 25 A. Correct. So initially, I was not sure that Page 86 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 26 of 29 1 that's exactly what she had implanted. 2 Q. Okay. So when you're doing your differential 3 diagnosis, you didn't know at the time that she had the 4 ObTape implanted for stress urinary incontinence? 5 A. Correct. I mean, it was highly suspicious that 6 she had, according to what she told us, but, you know, 7 sometimes patients, they get confused as to what exactly 8 is being done to them, and that's why we order to get 9 records so that we know specifically which type, what 10 approach, and what exactly had happened. 11 MR. MENA: Okay. This is just for the 12 record. Objection, nonresponsive. 13 Doctor, I appreciate you being here today. 14 I think I am done. 15 MR. SINDELAR: No further questions from me 16 either. 17 MR. MENA: We're done. 18 VIDEOGRAPHER: Okay. This concludes 19 today's videotaped deposition. Today's date is March 20 15th, 2017. The approximate time is 7:11 p.m. The 21 master recording of today's testimony will remain in the 22 custody of Trattel Court Reporting and Videography 23 located at 609 12th Street, Albuquerque, New Mexico 24 87102. 25 We are off the record. Page 87 Veritext Legal Solutions 800-567-8658 973-410-4040 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 27 of 29 Page 89 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 28 of 29 Page 90 Case 4:16-cv-00035-CDL Document 12-6 Filed 04/24/17 Page 29 of 29 Exhibit D Case 4:16-cv-00035-CDL Document 12-7 Filed 04/24/17 Page 1 of 5 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) © 2017 Thomson Reuters. No claim to original U.S. Government Works. 1 2016 WL 1578752 Only the Westlaw citation is currently available. United States District Court, M.D. 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-127 (Stelling) | Signed 04/19/2016 ORDER CLAY D. LAND CHIEF, U.S. DISTRICT COURT JUDGE *1 Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiff Ramona Stelling was implanted with ObTape and asserts that she suffered injuries caused by ObTape. Mrs. Stelling brought a product liability action against Mentor, contending that ObTape had design and/or manufacturing defects that proximately caused her injuries. Mrs. Stelling also asserts that Mentor did not adequately warn her physicians about the risks associated with ObTape. Her husband Fred brought a loss of consortium claim. Mentor seeks summary judgment on the Stellings' claims, contending that they are time- barred. For the reasons set forth below, Mentor's summary judgment motion (ECF No. 44 in 4:13- cv-127) is granted. 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 On November 8, 2004, Dr. Robert Mairs implanted Mrs. Stelling with ObTape to treat her stress urinary incontinence. Mrs. Stelling did not know which kind of sling Dr. Mairs implanted in her, and she did not receive or rely on any information from Mentor regarding ObTape. Mrs. Stelling developed malodorous vaginal discharge, and in January 2005 she consulted with Dr. Mairs about her symptoms. By May 2005, Dr. Mairs was concerned that Mrs. Stelling's sling had become exposed, and he recommended exploratory surgery. Mrs. Stelling told Dr. Mairs that she wanted the sling removed because she understood it was causing her discharge symptoms. On May 27, 2005, Dr. Mairs performed surgery on Mrs. Stelling, found an extrusion of her ObTape, and removed the eroded portions of her sling. He told Mrs. Stelling that he had removed the eroded portions of her ObTape; she was disappointed because she wanted him to remove the entire sling. All of Mrs. Stelling's treatment from Dr. Mairs occurred in Oregon. Mrs. Stelling's symptoms continued, and she sought treatment from Dr. Derke Sypherd in Idaho. Dr. Sypherd recommended complete removal of the sling “because it was just going to keep rotting.” Stelling Dep. 79:17-19, ECF No. 44-5 in 4:13- cv-127. Dr. Sypherd removed the remainder of Mrs. Stelling's ObTape in November 2005. After the removal surgery, Mrs. Stelling's discharge and odor symptoms went away, although she contends she continues to experience symptoms she attributes to ObTape. Case 4:16-cv-00035-CDL Document 12-7 Filed 04/24/17 Page 2 of 5 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) © 2017 Thomson Reuters. No claim to original U.S. Government Works. 2 *2 The Stellings are Idaho residents. Mrs. Stelling's ObTape implant procedure and her first excision procedure took place in Oregon. Mrs. Stelling's subsequent treatment took place in Idaho. Mrs. Stelling asserts claims for negligence, strict liability - design defect; strict liability -manufacturing defect; strict liability - failure to warn; breach of express warranty; breach of implied warranty; fraudulent concealment; constructive fraud; discovery rule, tolling, and fraudulent concealment; negligent misrepresentation; negligent infliction of emotional distress; violation of consumer protection laws; gross negligence; unjust enrichment; and punitive damages. Mr. Stelling asserts a loss of consortium claim. Mrs. Stelling did not respond to Mentor's summary judgment motion on her “consumer protection laws” claim, and the Court finds that she implicitly conceded that Mentor is entitled to summary judgment on that claim. Accordingly, the Court grants Mentor's summary judgment motion as to that claim. 1 1 Even if Mrs. Stelling had not conceded this claim, Mentor would be entitled to summary judgment for the same reasons it is entitled to summary judgment on her other claims. DISCUSSION The Stellings filed their action on April 4, 2013 by filing a short form complaint in In Re: Coloplast Corp. Pelvic Support System Products Liability Litigation, MDL No. 2387. The Stellings stated that the proper venue for their action is the U.S. District Court for the District of Idaho. Compl., ECF No. 1 in 4:13-cv-127. The Judicial Panel on Multidistrict Litigation transferred the action to this Court for pretrial proceedings. I. Idaho Law Applies to Plaintiffs' Claims The parties agree that Idaho's choice-of-law rules apply. Mentor argues that under these rules, Idaho law applies to the Stellings' claims. The Stellings argue that Oregon law applies. “Idaho applies the 'most significant relation test' as set forth in the Restatement (Second) of Conflict of Laws § 145 in determining the applicable law.” Grover v. Isom, 53 P.3d 821, 823-24 (Idaho 2002). The following four considerations are taken into account: “(a) the place where the injury occurred, (b) the place where the conduct causing the injury occurred, (c) the domicile, residence, nationality, place of incorporation and place of business of the parties, and (d) the place where the relationship, if any, between the parties is centered.” Id. (quoting Seubert Excavators, Inc. v. Anderson Logging Co., 889 P.2d 82, 85 (Idaho 1995)). The “most important” consideration is “the place where the injury occurred.” Id. (quoting Seubert Excavators, 889 P.2d at 85). Here, Mrs. Stelling's injury occurred in Idaho, where she lives and where her symptoms arose. 2 The conduct causing the injury occurred in California and Minnesota, where ObTape was manufactured and where key decisions about ObTape's design and warnings were made, and in Oregon, where Mrs. Stelling's ObTape was sold to her doctor. Mrs. Stelling is an Idaho resident, and Mentor is a New Jersey corporation that has had significant operations in California and Minnesota. There was no direct relationship between Mrs. Stelling and Mentor, but Mrs. Stelling's doctor recommended ObTape and implanted it in Oregon. In summary, two of the factors-place of injury and residence of the plaintiff-weigh in favor of applying Idaho law, while two factors-place of conduct and center of relationship-weigh in favor of applying Oregon law. As discussed above, the most important consideration is the place where the injury occurred. Here, that is Idaho. The Court will therefore apply Idaho law. 3 2 Mrs. Stelling argues that her injury occurred in Oregon because that is where her ObTape was implanted and where she received some medical treatment related to ObTape. These facts relate, however, relate to the place where the conduct causing the injury occurred and the place where the relationship between the parties is centered. 3 The Court notes that the Stellings' claims would also be barred under Oregon law, which has a two-year statute of limitations that applies to all product liability civil action claims, regardless of the theory. Case 4:16-cv-00035-CDL Document 12-7 Filed 04/24/17 Page 3 of 5 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) © 2017 Thomson Reuters. No claim to original U.S. Government Works. 3 Simonsen v. Ford Motor Co., 102 P.3d 710, 721 (Or. Ct. App. 2004). Under that statute, “a product liability civil action for personal injury or property damage must be commenced not later than two years after the plaintiff discovers, or reasonably should have discovered, the personal injury or property damage and the causal relationship between the injury or damage and the product.” Or. Rev. Stat. 30.905(1). Here, Mrs. Stelling knew of (or had enough information to know of) a connection between ObTape and at least some of her injuries by November 2005, when her sling was removed and her discharge and odor symptoms were resolved. The Stellings did not bring their action within two years, so their claims are time-barred under Oregon law. II. Plaintiffs' Personal Injury Claims are Time- Barred *3 Under Idaho law, a product liability claim must be brought within two years “from the time the cause of action accrued.” Idaho Code § 6-1403(3). A cause of action for any injury to the person (including warranty claims) must also be brought within two years after it accrues unless “the fact of damage” has been “fraudulently and knowingly concealed from the injured party,” in which case the cause of action “shall be deemed to accrue when the injured party knows or in the exercise of reasonable care should have been put on inquiry regarding the condition or matter complained of” and must be commenced within one year of accrual. Idaho Code § 5-219(4). And an unjust enrichment claim must be brought within four years. Idaho Code § 5-217. Idaho does not have a discovery rule except in cases “involving a foreign object unintentionally left in the body or fraudulent concealment.” Theriault v. A.H. Robins Co., 108 Idaho 303, 305, 698 P.2d 365, 367 (1985); accord Stuard v. Jorgenson, 249 P.3d 1156, 1161 (Idaho 2011) (“To allow for accrual to begin only once the parties have been put on notice of the damage, or in other words, once the damage is actually 'ascertained' would effectively create a discovery rule, which the legislature has rejected.”). In most cases, a cause of action accrues when “some damage” that is caused by the defendant's act or omission occurs. Id.; accord Davis v. Moran, 735 P.2d 1014, 1019-20 (Idaho 1987) (finding a factual dispute on when the plaintiff's physical injury due to radiation exposure occurred). Thus, unless the fraudulent concealment exception applies, Mrs. Stelling's cause of action accrued in 2005, when her sling eroded, caused her discharge and odor symptoms, and had to be removed. At that time, Mrs. Stelling had sustained some damage related to the ObTape that was objectively ascertainable. Mrs. Stelling argues that the fraudulent concealment exception applies and that her claims did not accrue until 2011 when she saw a television commercial regarding mesh complications. But the fraudulent concealment exception does not apply here. The exception only applies “when the fact of damage has, for the purpose of escaping responsibility therefor, been fraudulently and knowingly concealed from the injured party.” Idaho Code Ann. § 5-219(4). Here, there is no evidence that Mentor concealed “the fact of damage” from Mrs. Stelling or made any false representations to Mrs. Stelling that lulled her into inaction. See Theriault v. A.H. Robins Co., 698 P.2d 365, 369 (Idaho 1985) (concluding that fraudulent concealment exception did not apply because there was no evidence of fraudulent concealment; the plaintiff was on notice of a connection between her intrauterine device and her injuries more than two years before she filed suit). Mrs. Stelling's was aware of the “fact of damage” by November 2005, when Mrs. Stelling and her doctors connected at least some of her injuries to ObTape. The doctors recommended removal of the ObTape, and Mrs. Stelling wanted the ObTape removed. After the ObTape removal in November 2005, Mrs. Stelling's discharge and odor symptoms went away, suggesting that they had been caused by the ObTape. For all of these reasons, Mrs. Stelling sustained some damage related to the ObTape that was objectively ascertainable by November 2005, and her cause of action accrued then. She did not bring her tort claims within two years or her unjust enrichment claims within four years, so her claims are all time-barred. Mr. Stelling's loss of consortium claim fails because Mrs. Stelling's claims fail. Runcorn v. Shearer Lumber Prods., Inc., 690 P.2d 324, 329 (Idaho 1984) (“The claim for loss of consortium is a wholly derivative cause of action Case 4:16-cv-00035-CDL Document 12-7 Filed 04/24/17 Page 4 of 5 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) © 2017 Thomson Reuters. No claim to original U.S. Government Works. 4 contingent upon a third party's tortious injury to a spouse.”). CONCLUSION *4 As discussed above, Mentor's summary judgment motion (ECF No. 44 in 4:13-cv-127) is granted. IT IS SO ORDERED, this 19th day of April, 2016. All Citations Slip Copy, 2016 WL 1578752 End of Document © 2017 Thomson Reuters. No claim to original U.S. Government Works. Case 4:16-cv-00035-CDL Document 12-7 Filed 04/24/17 Page 5 of 5 Exhibit E Case 4:16-cv-00035-CDL Document 12-8 Filed 04/24/17 Page 1 of 7 Rhynes v. Stryker Corp., Not Reported in F.Supp.2d (2011) 2011 WL 2149095 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 1 2011 WL 2149095 Only the Westlaw citation is currently available. United States District Court, N.D. California. Gloria RHYNES, individually and on behalf of the General Public, and Darrell Jenkins, Plaintiffs, v. STRYKER CORPORATION; Stryker Orthopedics; and Does 1 through 30, inclusive, Defendants. No. 10-5619 SC. | May 31, 2011. Attorneys and Law Firms Steven R. Anthony, Jane Louise Trigero, Anthony & Associates, Oakland, CA, for Plaintiffs. James Nelson, Mario Horwitz, Rafael A. Campillo, Sedgwick LLP, Los Angeles, CA, for Defendants. ORDER GRANTING DEFENDANTS' MOTION TO DISMISS AND MOTION TO STRIKE SAMUEL CONTI, District Judge. I. INTRODUCTION *1 Before the Court is a combined Motion to Dismiss and Motion to Strike filed by Defendants Stryker Corporation and Stryker Orthopedics (“Defendants” or “Stryker”). ECF No. 14 (“Mot.”). The Motion is fully briefed. ECF No. 21 (“Opp'n”), 22 (“Reply”). Pursuant to Civil Local Rule 7-1(b), the Court finds the Motion suitable for determination without oral argument. For the reasons stated below, the Court GRANTS Stryker's Motion. II. BACKGROUND This action concerns alleged defects in a medical device known as a Trident acetabular shell (“the prosthesis”) that was allegedly implanted in Plaintiff Gloria Rhynes (“Rhynes”) as part of hip replacement surgery in August 2005. 1 ECF No. 1 (“Not. of Removal”) Ex. A (“Compl.”) ¶ 5. Rhynes alleges that Stryker manufactured and designed the prosthesis, and together with Doe Defendants, marketed and sold the prosthesis. Id. ¶¶ 3- 5. She alleges that the prosthesis was defective “because, among other things, manufacturing contamination, design defects, and manufacturing discrepancies caused the loosening of the shell.” Id. ¶ 5. She alleges that she was injured by the prosthesis when it was implanted on August 15, 2005, but that she was unaware of the injury until February 2009. Id. 1 In their Opposition, Plaintiffs state that the prosthesis was part of a knee replacement, while in their Complaint they allege it was part of a hip replacement. The Court takes well-pleaded factual allegations as true when considering a Motion to Dismiss and will therefore assume the veracity of Plaintiffs' allegation in the Complaint that the prosthesis was implanted as part of a hip replacement. On September 30, 2010, Rhynes and her husband, Plaintiff Darrell Jenkins (“Jenkins”) (collectively, “Plaintiffs”), filed this action in Superior Court for the County of San Francisco. See Compl. Rhynes asserts claims for (1) strict liability for defective product; (2) negligence; (3) violation of California Business and Professions Code § 17200; and (4) wanton and reckless misconduct. See id. Jenkins asserts a claim for loss of consortium. Id. Defendants removed the case to this Court on December 10, 2010, on the basis of diversity jurisdiction under 28 U.S.C. §§ 1332(a)(1) and 1441(a). See Not. of Removal. III. LEGAL STANDARD A. Motion to Dismiss A motion to dismiss under Federal Rule of Civil Procedure 12(b) (6) “tests the legal sufficiency of a claim.” Navarro v. Block, 250 F.3d 729, 732 (9th Cir.2001). Dismissal can be based on the lack of a cognizable legal theory or the absence of sufficient facts alleged under a cognizable legal theory. Balistreri v. Pacifica Police Dep't, 901 F.2d 696, 699 (9th Cir.1990). “When there are well- pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief.” Ashcroft v. Iqbal, --- U.S. ----, ----, 129 S.Ct. 1937, 1950, 173 L.Ed.2d 868 (2009). However, “the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Iqbal, 129 S.Ct. at 1950 (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). A Case 4:16-cv-00035-CDL Document 12-8 Filed 04/24/17 Page 2 of 7 Rhynes v. Stryker Corp., Not Reported in F.Supp.2d (2011) 2011 WL 2149095 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 2 complaint need not contain “detailed factual allegations,” but it must provide more than an “unadorned, the- defendant-unlawfullyharmed-me accusation.” Id. at 1949. The allegations in the complaint “must be enough to raise a right to relief above the speculative level.” Twombly, 550 U.S. at 555. Thus, a motion to dismiss should be granted if the plaintiff fails to proffer “enough facts to ... nudge[ ] [its] claims across the line from conceivable to plausible.” Id. at 570. B. Motion to Strike *2 Rule 12(f) provides that “[t]he court may strike from a pleading an insufficient defense or any redundant, immaterial, impertinent, or scandalous matter.” Fed.R.Civ.P. 12(f). Motions to strike are generally regarded with disfavor. Ganley v. County of San Mateo, No. 06-3923, 2007 WL 902551, at *1 (N.D.Cal. Mar.22, 2007). The essential function of a Rule 12(f) motion is to “avoid the expenditure of time and money that must arise from litigating spurious issues by dispensing with those issues prior to trial.” Fantasy, Inc. v. Fogerty, 984 F.2d 1524, 1527 (9th Cir.1993), rev'd on other grounds, 510 U.S. 517, 114 S.Ct. 1023, 127 L.Ed.2d 455 (1994). IV. DISCUSSION A. Motion to Dismiss 1. Strict Liability and Negligence Claims Defendants contend that Rhynes's first claim for strict liability and second claim for negligence are barred by the applicable statute of limitations because they were not brought within two years of the date on which Rhynes was allegedly injured. Mot. at 3. They also contend that Plaintiffs have pleaded insufficient facts to state plausible claims for strict liability and negligence under Iqbal. Id. at 3-4. Plaintiffs argue that the statute of limitations did not begin to run until Rhynes discovered her injury in February 2009 and that they have included sufficient facts to withstand a motion to dismiss. Reply at 2. The California Code of Civil Procedure provides that the applicable statute of limitations for a personal injury action is two years. Cal.Civ.Proc.Code § 335.1. However, California law includes a discovery rule that delays the accrual of a cause of action until a plaintiff either became aware of the injury and its cause or could have discovered the injury and cause through reasonable diligence. Fox v. Ethicon Endo-Surgery, Inc., 35 Cal.4th 797, 808, 27 Cal.Rptr.3d 661, 110 P.3d 914 (2005). In order to rely on the discovery rule, “a plaintiff whose complaint shows on its face that his claim would be barred without the benefit of the discovery rule must specifically plead facts to show (1) the time and manner of discovery and (2) the inability to have made earlier discovery despite reasonable diligence.” Id. (internal quotation omitted). “In assessing the sufficiency of the allegations of delayed discovery, the court places the burden on the plaintiff to show diligence; conclusory allegations will not withstand demurrer.” Id. (internal quotations omitted). Here, Rhynes alleges that she was injured by the prosthesis when it was implanted during hip surgery on August 15, 2005. She seeks to rely on the discovery rule because she allegedly did not discover the injury until February 2009. However, Rhynes has not pleaded specific facts to show the manner in which she discovered her injury or her inability to have discovered it earlier. Rather, she has merely stated in conclusory fashion, “[t]he plaintiff was unaware of the injury from the defect until February 2009.” Compl. ¶ 5. Such conclusory allegations do not suffice to invoke the discovery rule under Fox. Absent proper invocation of the discovery rule, the statute of limitations for Rhynes's first and second claims expired on August 15, 2007. *3 The Court also agrees with Defendants' contention that Rhynes has not alleged sufficient facts in support of her first and second claims to make the claims plausible under Iqbal. Most notably, Rhynes has not alleged any facts in support of the allegation that she was injured by the prosthesis. Rather, she alleges only that: “plaintiff was injured by the [prosthesis] when it was surgically implanted during hip surgery, in that said device has failed to perform its intended purpose.” Compl. ¶ 5. She further alleges that design and manufacturing defects “caused the loosening of the [prosthesis].” Id. However, she does not allege facts indicating how the loosening of the prosthesis has caused her harm. This pleading deficiency should be easy for Rhynes to cure if she chooses to file an amended complaint. Accordingly, the Court DISMISSES Plaintiff's strict liability claim and negligence claim WITH LEAVE TO AMEND. Case 4:16-cv-00035-CDL Document 12-8 Filed 04/24/17 Page 3 of 7 Rhynes v. Stryker Corp., Not Reported in F.Supp.2d (2011) 2011 WL 2149095 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 3 2. Third Claim for Violation of California Business and Professions Code § 17200 Rhynes's third claim alleges that Stryker and Doe defendants violated California's Unfair Competition Law (“UCL”) as set forth in California Business and Professions Code § 17200 et seq. Compl. ¶¶ 18-28. Rhynes alleges that Defendants engaged in unlawful, unfair, and fraudulent business practices by, among other things, “[p]roviding insufficient, misleading, and deceptive information to patients and their doctors” and “concealing the existence of patient complaints.” Id. ¶ 22. Rhynes seeks restitution and injunctive relief for this claim. She seeks restitution “to Plaintiff (and others) of the amounts retained by said defendants for the sale of said defective products.” Id. ¶ 27. She seeks injunctive relief “to prevent the continuation of such unfair business practices by said defendants, and to require said defendants to notify patients and their physicians of the true, scientifically based parameters of the quality and efficacy of the product.” Id. Stryker argues that Rhynes's UCL claim should be dismissed with prejudice because the equitable relief she seeks is unavailable as a matter of law. Stryker notes that equitable relief is only available where there is no adequate remedy at law and contends that in this case money damages will provide Plaintiffs with an adequate remedy if they prevail on their products liability claims. Plaintiff's only argument in response is that “[o]bviously, if the claims for damages are dismissed as lacking merit, there is no adequate remedy at law.” Opp'n at 3. Plaintiffs provide no authority supporting their position. The Court agrees with Stryker. The UCL only provides equitable remedies. Madrid v. Perot Systems Corp., 130 Cal.App.4th 440, 30 Cal.Rptr.3d 210, 218 (Ct.App.2005) (“[T]he UCL limits the remedies available for UCL violations to restitution and injunctive relief.”). A plaintiff seeking equitable relief must establish that there is no adequate remedy at law available. Philpott v.Super. Ct., 1 Cal.2d 512, 517, 36 P.2d 635 (1934) (holding injunctive relief not available where legal remedy was adequate); Knox v. Phoenix Leasing, Inc., 29 Cal.App.4th 1357, 1368, 35 Cal.Rptr.2d 141 (Ct.App.1994) (holding restitution not available where statute provides for money damages). The California Court of Appeal extended this principle to actions under the UCL in Prudential Home Mortgage Company v. Superior Court, 66 Cal.App.4th 1236, 1249, 78 Cal.Rptr.2d 566 (Ct.App.1998) (holding that statutory relief under the UCL “is subject to fundamental equitable principles, including inadequacy of the legal remedy.”) *4 The Central District of California has applied this rule to strike a plaintiff's request for injunctive relief under the UCL in a medical device products liability action similar to this one. See Adams v. I-Flow Corp., No. CV09- 09550, 2010 WL 1339948, at *7 (C.D.Cal. Mar.30, 2010) (striking with prejudice plaintiff's request for injunction prohibiting pain pump and anesthetic manufacturers from false advertising). The Court concludes that in this case, as in Adams, the compensatory damages Plaintiffs seek provide an adequate remedy at law to redress their alleged injuries. Plaintiffs' argument that they will have no adequate remedy at law if their other claims fail is unavailing. Where the claims pleaded by a plaintiff may entitle her to an adequate remedy at law, equitable relief is unavailable. See, e.g., Adams, 2010 WL 1339948, at *7 (“Should plaintiffs ultimately prevail on their claims, they will be adequately compensated for their alleged injuries by an award of damages.”) (emphasis added); Stationary Eng'rs Local 39 Health & Welfare Trust Fund v. Philip Morris, Inc., No. C-97-01519, 1998 U.S. Dist. LEXIS 8302, at *56 (N.D.Cal. Apr. 30, 1998) (“Because plaintiffs may be able to state claims for fraud and misrepresentation and negligent breach of intentional duty, plaintiffs cannot show that there is no adequate remedy at law.”) (emphasis added). Moreover, to the extent that Plaintiffs seek injunctive relief on behalf of the general public, 2 Plaintiffs' request fails as a matter of law. The 2004 amendments to the UCL provide that a party seeking relief on behalf of the public must satisfy class action pleading requirements. Cal. Bus. & Prof.Code § 17203. Plaintiffs' Complaint lacks the requisite class allegations. See Netscape Commc'ns. Corp. v. Fed. Ins. Co., No. 06-00198, 2006 U.S. Dist. LEXIS 9569, at *12-13 (N.D.Cal. Feb. 22, 2006). Furthermore, even if the Complaint contained the proper class allegations, Rhynes would not be entitled to seek injunctive relief on behalf of the public because she is not individually entitled to such relief. See Hodgers- Durgin v. De La Vina, 199 F.3d 1037, 1045 (9th Cir.1999) (“Unless the named plaintiffs are themselves entitled to seek injunctive relief, they may not represent a class seeking that relief.”). Case 4:16-cv-00035-CDL Document 12-8 Filed 04/24/17 Page 4 of 7 Rhynes v. Stryker Corp., Not Reported in F.Supp.2d (2011) 2011 WL 2149095 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 4 2 Plaintiffs do not argue this point in their Oppo their Complaint alleges that “[a] legal remedy is protect others among the public from being harmed such unfair business practices,” and they purport action “individually and on behalf of the general public.” Compl. at ¶ 27. Accordingly, the Court DISMISSES Rhynes's third claim for violations of the UCL WITHOUT LEAVE TO AMEND. 3. Fourth Claim for Punitive Damages Rhynes's fourth claim alleges wanton and reckless misconduct. The tort of wanton and reckless misconduct occurs when “a person with no intent to cause harm intentionally performs an act so unreasonable and dangerous that he knows, or should know, it is highly probable that harm will result.” Nolin v. Nat'l Convenience Stores, Inc., 95 Cal.App.3d 279, 286, 157 Cal.Rptr. 32 (Ct.App.1979). A showing of wanton and reckless misconduct entitles a plaintiff to punitive damages, and Plaintiffs therefore seek punitive damages on the basis of this claim. Compl. at 10. Both parties refer to the claim as Plaintiffs' “punitive damages claim.” E.g., Mot. at 7; Opp'n at 4. *5 Stryker moves to dismiss Plaintiffs' punitive damages claim on the ground that it is insufficiently pleaded under Twombly and Iqbal. Rhynes disagrees. California Civil Code § 3294(a) allows for the recovery of punitive damages only where a plaintiff shows the defendant acted with malice, oppression, or fraud in connection with the tortious conduct at issue. Under § 3294(b), malice is defined as either: (1) conduct which is intended by the defendant to cause injury to the plaintiff or (2) “despicable conduct which is carried on by the defendant with a willful and conscious disregard of the rights or safety of others.” Cal. Civ.Code § 3294(b). Here, Plaintiffs do not allege that Stryker intended to cause injury; rather they allege that Stryker engaged in “despicable conduct.” See Compl. ¶¶ 30, 32. California courts have defined “despicable conduct” as conduct which is “so vile, base, contemptible, miserable, wretched or loathsome that it would be looked down upon and despised by ordinary people.” See Mock v. Mich. Millers Mut. Ins. Co., 4 Cal.App.4th 306, 331, 5 Cal.Rptr.2d 594 (Ct.App.1992). Thus, in order for Plaintiffs' punitive damages claim to survive a motion to dismiss, Plaintiffs must allege sufficient facts to state a plausible claim that Stryker engaged in vile, base, and contemptible conduct. Stryker argues that Rhynes has failed to meet this standard. The Court agrees. Rhynes accurately summarizes the various allegations that form the basis for her punitive damages claim as follows: “Defendants knew that their product was defective and could cause injury, and not only allowed it to be used in Plaintiff's surgery anyhow-through their authorized agents, they promoted the use of their product and actively concealed their knowledge of its known performance problems.” Opp'n at 4; See Compl. ¶¶ 22, 29, 30. The Court finds that Plaintiffs' claim for punitive damages is devoid of factual support. Plaintiffs' allegations that Stryker “provid[ed] insufficient, misleading and deceptive information” to patients and doctors, “fail[ed] to promptly and fairly investigate and identify the causes of the design [and manufacturing] defects,” “concealed the existence of patient complaints,” and was “well aware of numerous instances of product failure ... at the time of Plaintiff's surgery” are merely conclusory statements not entitled to the presumption of truth under Iqbal and Twombly. Plaintiffs have alleged no facts that support a plausible inference in support of these conclusions. See Compl. ¶¶ 22, 30. Plaintiffs also allege that a Doe Defendant engaged in the distribution of Stryker products “was in the operating room and discussed the use of the Stryker product with the physicians and concealed information regarding the difficulties with the manufacturing processes and the design even though problems had been reported many months before.” Compl. ¶ 5. Absent are any alleged facts in support of the allegations that problems with the product had been reported months before and that the individual concealed such information. *6 Stryker further contends that Plaintiffs' allegations are insufficient to support a punitive damages claim against a corporate entity. Again, the Court agrees. California law provides that an employer may be liable for punitive damages in an action arising from the tortious conduct of its employee in three situations: “(1) when an Case 4:16-cv-00035-CDL Document 12-8 Filed 04/24/17 Page 5 of 7 Rhynes v. Stryker Corp., Not Reported in F.Supp.2d (2011) 2011 WL 2149095 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 5 employee was guilty of oppression, fraud or malice, and the employer with advance knowledge of the unfitness of the employee employed him or her with a conscious disregard of the rights or safety of others; (2) when an employee was guilty of oppression, fraud or malice, and the employer authorized or ratified the wrongful conduct; or (3) when the employer was itself guilty of the oppression, fraud or malice.” Weeks v. Baker & McKenzie, 63 Cal.App.4th 1128, 1151, 74 Cal.Rptr.2d 510 (Ct.App.1998). For corporate employers, such as Stryker, the advance knowledge and conscious disregard, authorization, ratification or act of oppression, fraud, or malice must be on the part of an officer, director, or managing agent of the corporation. See Cal. Civ.Code § 3294(b). 3 3 Cal. Civ.Code § 3294(b) states: “An employer shall not be liable for [punitive damages], based upon acts of an employee of the employer, unless the employer had advance knowledge of the unfitness of the employee and employed him or her with a conscious disregard of the rights or safety of others or authorized or ratified the wrongful conduct for which the damages are awarded or was personally guilty of oppression, fraud, or malice. With respect to a corporate employer, the advance knowledge and conscious disregard, authorization, ratification or act of oppression, fraud, or malice must be on the part of an officer, director, or managing agent of the corporation.” Rhynes contends that paragraph thirty-one of the Complaint contains sufficient allegations to support an award of punitive damages against Stryker. That paragraph states: [The acts giving rise to punitive damages] were either the acts of an officer, director, or managing agent of said defendants, or said acts were those of an employee of said defendants under circumstances where said defendants had advance knowledge of the unfitness of the employee and employed him or her with a conscious disregard of the rights and safety of others, or authorized or ratified the wrongful conduct as herein alleged. Compl. ¶ 31. These conclusory allegations of authorization or ratification fail to satisfy federal pleading standards. Plaintiffs have not alleged a single fact tending to show that any officer, director, or managing agent took any action amounting to authorization or ratification of the alleged misconduct or had knowledge of the unfitness of any employee. Paragraph 31 merely parrots the language of § 3294(b) 's corporate ratification provisions. Under Iqbal, threadbare recitals of statutory elements are insufficient to withstand a motion to dismiss. 129 S.Ct. at 1950. See also Kelley v. Corr. Corp. of Am., 750 F.Supp.2d 1132, 1145-48 (E.D.Cal.2010) (finding similar language insufficient to state a claim for punitive damages under Twombly and Iqbal standard). Accordingly, Stryker's Motion to Dismiss Rhynes's fourth claim for punitive damages is GRANTED WITH LEAVE TO AMEND. B. Motion to Strike Stryker asks the Court to strike Plaintiffs' strict liability design defect allegations. As Stryker notes, controlling California law unequivocally prohibits strict liability claims for design defect against manufacturers of prescription implantable medical devices. See Brown v.Super. Ct., 44 Cal.3d 1049, 1061, 245 Cal.Rptr. 412, 751 P.2d 470 (1988) (“[A] drug manufacturer's liability for a defectively designed drug shall not be measured by the standards of strict liability.”); Hufft v. Horowitz, 4 Cal.App.4th 8, 19-20, 5 Cal.Rptr.2d 377 (Ct.App.1992) (“[T]he rule of Brown ... immunizing manufacturers of prescription drugs from strict liability for design defects, should be extended to manufacturers of implanted prescription medical devices.”); Artiglio v.Super. Ct., 22 Cal.App.4th 1388, 1395, 27 Cal.Rptr.2d 589 (Ct.App.1994) (applying Hufft to hold that manufacturer of breast implants was immune from strict liability for design defects). In Artiglio, the court expressly held that this determination can be made as a matter of law without the need for fact-finding, except for the sole factual determination that the device at issue is physician-directed and physician-applied (i.e., a “prescribed device”). 22 Cal.App.4th at 1397, 27 Cal.Rptr.2d 589. Here, it is undisputed that Rhynes's hip implant prosthesis was obtained through a physician and qualifies as a prescribed device. Case 4:16-cv-00035-CDL Document 12-8 Filed 04/24/17 Page 6 of 7 Rhynes v. Stryker Corp., Not Reported in F.Supp.2d (2011) 2011 WL 2149095 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 6 *7 Plaintiffs argue that Hufft limited immunity to cases where the product has been properly made and distributed with adequate warnings of potential risks. Opp'n at 5. They rely on language in Hufft stating: “We hold that a manufacturer is not strictly liable for injuries caused by an implanted prescription medical product which has been (1) properly made and (2) distributed with information regarding risks and dangers of which the manufacturer knew or should have known at the time.” 4 Cal.App.4th at 20, 5 Cal.Rptr.2d 377. They argue that because the instant Complaint contains manufacturing defect and improper warning allegations Stryker is not immune from strict liability for design defects. Opp'n at 5. Plaintiffs misconstrue the quoted language from Hufft to suggest that a manufacturer is only immune from strict liability for defective design if there are no allegations of manufacturing defects or inadequate warning labels. Properly read, and as the rest of Hufft makes clear, this statement means that a manufacturer of prescription medical devices can be held strictly liable only for manufacturing defects or inadequate warnings-it may not be held strictly liable for design defects. In Hufft, as here, there were allegations of manufacturing defects and improper warnings; indeed, the court reversed the grant of summary judgment in favor of the manufacturer because triable issues of fact existed as to the adequacy of the warnings provided. Id. at 23, 5 Cal.Rptr.2d 377. California law categorically protects manufacturers of prescription medical devices from strict liability for design defects. Striking Plaintiff's strict liability design defect allegations would therefore serve the general purpose of Rule 12(f) by “avoid[ing] the expenditure of time and money that must arise from litigating spurious issues by dispensing with those issues prior to trial.” Fogerty, 984 F.2d at 1527. Accordingly, the Court GRANTS Stryker's motion to strike Plaintiff's strict liability design defect allegations. V. CONCLUSION For the reasons stated above, the Court GRANTS Defendant Stryker's Motion and DISMISSES Plaintiffs Gloria Rhynes and Darrell Jenkins's first, second, and fourth claims WITH LEAVE TO AMEND. The Court DISMISSES Plaintiffs' third claim WITHOUT LEAVE TO AMEND. The Court STRIKES Plaintiffs' strict liability design defect allegations WITHOUT LEAVE TO AMEND. If Plaintiff chooses to file an amended complaint, it shall be filed within thirty (30) days of this Order. Failure to do so will result in dismissal of the above claims in their entirety. IT IS SO ORDERED. All Citations Not Reported in F.Supp.2d, 2011 WL 2149095 End of Document © 2017 Thomson Reuters. No claim to original U.S. Government Works. Case 4:16-cv-00035-CDL Document 12-8 Filed 04/24/17 Page 7 of 7 Exhibit F Case 4:16-cv-00035-CDL Document 12-9 Filed 04/24/17 Page 1 of 9 In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, Not Reported in... 2014 WL 114480 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 1 2014 WL 114480 Only the Westlaw citation is currently available. United States District Court, S.D. Illinois. In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation This Document Relates to: Thelma Butner, Clifton Fitzsimmons, John Wilchinski, George Fletcher, and Pauline Aldridge, Plaintiffs, v. Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Pharma GmbH & Co. Kg, Boehringer Ingelheim International GmbH, Bidachem S.P.A., and Does 1-100, Defendants. MDL No. 2385 | 3: 12-md-02385-DRH-SCW | Case No. 3:12-cv-60092-DRH-SCW | January 11, 2014 Attorneys and Law Firms Mark R. Niemeyer, Onder, Shelton et al, Webster Groves, MO, Michael A. London, Douglas & London PC, New York, NY, Mikal C. Watts, Watts Guerra Craft, LLP, San Antonio, TX, Roger C. Denton, Schlichter, Bogard et al., St. Louis, MO, Seth A. Katz, Burg Simpson Eldridge et al, Englewood, CO, Steven D. Davis, Tor A. Hoerman, Torhoerman Law LLC, Edwardsville, IL, for Plaintiff. Dan H. Ball, Bryan Cave, St. Louis, MO, Eric E. Hudson, Butler Snow LLP, Memphis, TN, Paul W. Schmidt, Covington & Burling LLP, Washington, DC, Beth S. Rose, Sills Cummis & Gross P.C., Newark, NJ, for Defendants. ORDER HERNDON, Chief Judge: I. INTRODUCTION *1 Presently before the Court is Boehringer Ingelheim Pharmaceuticals, Inc's (“BIPI”) motion to dismiss and motion to strike pursuant to Federal Rule of Civil Procedure 12(b) and (f) (Doc. 17). On March 28, 2013, the plaintiffs filed their initial response to BIPI's motion to dismiss (Doc. 34). Shortly thereafter, the plaintiffs sought leave to file an amended responsive pleading (Doc. 35). The plaintiffs stated that the initial responsive pleading was an “older working draft” that was inadvertently filed (Doc. 35). Therefore, the plaintiffs asked for permission to file an amended responsive pleading that would replace the original responsive pleading (Doc. 35). The Court granted the plaintiffs' motion and the plaintiffs' filed their amended responsive pleading on April 1, 2013 (Doc. 37). Accordingly, the only responsive pleading before the Court is the amended responsive pleading (Doc. 37). BIPI filed a reply brief, stating exceptional circumstances, on April 11, 2013 (Doc. 38). The reply brief indicates that BIPI is withdrawing its motion to dismiss as to certain claims and is withdrawing two of its motion to strike arguments. It further contends that the plaintiffs have abandoned certain claims. Finally, in August 2013, the Court directed the plaintiffs to file supplemental briefing for the purpose of clarifying jurisdictional facts (Doc. 39, 40, 41, 42). In its initial motion to dismiss and/or strike, BIPI contends that the plaintiffs' claims for Failure to Warn (First Cause of Action), Strict Products Liability-Design Defect (Second Cause of Action), Negligence (Third Cause of Action), Breach of Implied Warranty (Fourth Cause of Action), Breach of Express Warranty (Fifth Cause of Action), Negligent Misrepresentation (Sixth Cause of Action), Fraud by Concealment (Seventh Cause of Action), Deceit by Concealment-California Civil Code Sections 1709 and 1710 (Eighth Cause of Action), Violation of California Business & Professions Code Section 17200 (Ninth Cause of Action), Violation of California Business & Professions Code Section 17500 (Tenth Cause of Action), Violation of California Civil Code Section 1750 (Eleventh Cause of Action), and Loss of Consortium (Twelfth Cause of Action) fail to state a claim for relief under the applicable legal standards and are barred as a matter of law. BIPI further moves to dismiss the plaintiffs' punitive damages claim, the loss of consortium plaintiffs' claims, as well as the claims of the Tennessee and Louisiana plaintiffs under their respective state laws and statutes. Additionally, BIPI asks the Court for an Order pursuant to Rule 12(f) of the Federal Rules of Civil Procedure, Case 4:16-cv-00035-CDL Document 12-9 Filed 04/24/17 Page 2 of 9 In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, Not Reported in... 2014 WL 114480 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 2 striking all allegations that BIPI failed to warn “plaintiff” or the “public,” all fraud on the FDA claims, and any alleged violations of the Food, Drug and Cosmetic Act as immaterial and barred as a matter of law. Finally, in its reply brief, BIPI informed the Court as follows: BIPI withdraws its challenge to Cause of Action 1 (Failure to Warn) as to all Plaintiffs; Cause of Action 2 (Design Defect) as to Tennessee and Louisiana Plaintiffs; Cause of Action 3 (Negligence) as to Tennessee and California Plaintiffs; Count 4 (Breach of Implied Warranty) as to Tennessee Plaintiffs; Count 5 as to all Plaintiffs; Counts 9-10 as to California Plaintiffs. BIPI further withdraws the first two arguments in its Motion to Strike. Also, in light of this Court's recent ruling in Hale v. State Farm Mut. Auto. Ins. Co., 2013 U.S. Dist. LEXIS 44270, 29-30 (S.D.Ill. Mar. 28, 2013), BIPI withdraws its statute of limitations challenge at this time. The consortium claims (Cause of Action 12) stand only to the extent of their spouses' viable claims. *2 (Doc. 38 p. 2 n.1). The Court has reviewed BIPI's motion to dismiss and/ or strike (Doc. 17), the plaintiffs' amended responsive pleading (Doc. 37), BIPI's reply (Doc. 38), and the plaintiffs' supplemental briefing regarding citizenship (Doc. 40, Doc. 42). For the reasons discussed herein, BIPI's motion is GRANTED in part and DENIED in part. II. BACKGROUND A. Procedural Background This multi-plaintiff action was originally filed in the Superior Court of the State of California for the County of San Francisco (Doc. 1-1). The plaintiffs' state court complaint directed claims against various entities allegedly involved in the development, sale, manufacture, promotion, and/or distribution of the prescription pharmaceutical Pradaxa. One of the defendants, BIPI, removed the action to the United States District Court for the Northern District of California on the basis of diversity jurisdiction (Doc. 1). Thereafter, the Judicial Panel on Multidistrict Litigation transferred the action to this Court for inclusion in MDL 2385. In its notice of removal, BIPI argued that complete diversity was present because the two nondiverse defendants, Boehringer Ingelheim Fremont, Inc. (“BIF”) and McKesson Corporation (“McKesson”) (both citizens of California) were fraudulently joined (Doc. 1). The plaintiffs moved to remand (Doc. 14). On February 22, 2013, the Court reviewed the issue of fraudulent joinder and concluded that BIF and McKesson had been fraudulently joined. Accordingly, the Court dismissed the non-diverse defendants and denied the plaintiffs' motion to remand. B. The Plaintiffs The caption of the complaint identifies only five plaintiffs: Thelma Butner, Clifton Fitzsimmons, John Wilchinski, George Fletcher, and Pauline Aldridge. However, the body of the complaint asserts consortium claims on behalf of four of the named plaintiffs' spouses: Jennifer Ruth Fitzsimmons, Judy Wilchinski, Charles Aldridge, and Marvin Butner. The plaintiffs and the spouses identified in the body of the complaint are citizens of Tennessee (Clifton Fitzsimmons, Jennifer Ruth Fitzsimmons, John Wilchinski, Judy Wilchinski, and George Fletcher), Louisiana (Pauline Aldridge and Charles Aldridge), and California (Thelma Butner and Marvin Butner) (Doc. 42). The named plaintiffs are in no way connected-each received medication prescribed at different times, by different doctors, and in different locations (Doc. 40, Doc. 42). The Tennessee and Louisiana plaintiffs have no connection with California (the forum). With respect to each plaintiff, potentially relevant plaintiff-specific choice-of-law factors (e.g., where Pradaxa was prescribed and purchased, location of prescribing physician, location of injury, and location of treatment) occurred in the plaintiff's state of citizenship (Doc. 40; Doc. 42). Case 4:16-cv-00035-CDL Document 12-9 Filed 04/24/17 Page 3 of 9 In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, Not Reported in... 2014 WL 114480 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 3 III. PRELIMINARY MATTERS A. Correction of Caption As noted above, in the body of the complaint, though not in the caption, the plaintiffs Thelma Butner, Clifton Fitzsimmons, John Wilchinski, George Fletcher, and Pauline Aldridge assert claims on behalf of their spouses. Naming a plaintiff in the body of a complaint but not in the caption violates Rule 10(a) of the Federal Rules of Civil Procedure. *3 For the purpose of clarity, the Court is ORDERING the plaintiffs to file an amended complaint, correcting the technical errors in the caption, within 7 days of the filing of this Order. B. Allegations as to Improper Removal In their statement of facts, the plaintiffs state that the action was improperly removed from California State Court (Doc. 37 p. 3 n. 1). This Court has already ruled on the issue of removal and fraudulent joinder. The Court found that the non-diverse defendants were fraudulently joined and concluded that removal was proper (Doc. 31). C. Controlling Law 1. Procedural and Substantive Law In assessing the motion to dismiss, the Court applies state substantive law and federal procedural law. See Erie R.R. Co. v. Tomplins, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938). 2. Controlling State Law As a preliminary matter, the Court must determine which state's law applies to each plaintiff's claims. BIPI contends the claims of (1) Clifton Fitzsimmons, Jennifer Ruth Fitzsimmons, John Wilchinski, Judy Wilchinski, and George Fletcher (the “Tennessee Plaintiffs”) are governed by Tennessee law; (2) Pauline and Charles Aldridge ( the “Louisiana Plaintiffs”) are governed by Louisiana law; and (3) Thelma and Marvin Butner (the “California Plaintiffs”) are governed by California law. BIPI's contention is based on the following: There are significant conflicts between the relevant foreign laws and the law of the forum; the Tennessee and Louisiana plaintiffs have no connection with California (the forum); and the relevant plaintiff- specific choice-of-law factors (e.g., where Pradaxa was prescribed and purchased, location of prescribing physician, location of injury, and location of treatment) occurred in each plaintiff's state of citizenship (Doc. 40; Doc. 42). The plaintiffs seem to contend that California law should apply to all of the plaintiffs' claims. The following is a relevant excerpt from the plaintiffs' briefing: Defendants cannot choose which laws will apply to certain Plaintiffs. It is an unnecessary expenditure of time and judicial resources since applying different state laws would require educating the jury on the relevant underlying theories of law and the applicable laws of three different states. It is evident that both the parties and the Court stands to conserve significant resources and can avoid duplication of efforts if the case proceeds as is, under California law only. As much as Defendants may complain, there is no disputing that one of the Plaintiffs, Thelma Butner, is absolutely a California resident. The remaining Plaintiffs were included because their injuries were similar, as were the allegations against the Defendants. Therefore, California Superior Court was selected as an appropriate venue. (Doc. 37 p. 11). The plaintiffs' argument is hardly the bedrock of sound legal reasoning. As the Court has previously explained to the plaintiffs, in this case, choice of law is governed by California choice of law principles. 1 Considering those principles it is clear that BIPI is correct. Tennessee law applies to the claims of the Tennessee Plaintiffs, Louisiana law applies to the claims of the Louisiana plaintiffs, and California law applies to the claims of the California plaintiffs. 1 On February 22, 2013, the Court addressed the plaintiffs' motion to remand. In that order the Court explained the steps for conducting a choice of law analysis in the instant case. The Court specifically noted that California's governmental interest approach would govern and discussed the relevant principles associated with California's governmental interest approach. See In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, 2013 WL 656822, * 1 (S.D.Ill.2013) (Herndon, Case 4:16-cv-00035-CDL Document 12-9 Filed 04/24/17 Page 4 of 9 In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, Not Reported in... 2014 WL 114480 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 4 C.J.). Id. at *1-*2. The Court also addressed issues pertaining to the law that governs procedural and substantive issues. In addition, the Court addressed its rules with regard to citing district court opinions. Id. at 2. It seems that plaintiffs' counsel failed to consider the Court's guidance on any of these issues. IV. MOTION TO DISMISS-LEGAL STANDARD *4 A Rule 12(b)(6) motion challenges the sufficiency of the complaint to state a claim upon which relief can be granted. Hallinan v. Fraternal Order of Police Chicago Lodge 7, 570 F.3d 811, 820 (7th Cir. 2009). The Supreme Court explained in Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007), that Rule 12(b)(6) dismissal is warranted if the complaint fails to set forth “enough facts to state a claim to relief that is plausible on its face.” Even though Twombly (and Ashcroft v. Iqbal, 556 U.S. 662 (2009)) retooled federal pleading standards, notice pleading remains all that is required in a complaint. “A plaintiff still must provide only ‘enough detail to give the defendant fair notice of what the claim is and the grounds upon which it rests and, through his allegations, show that it is plausible, rather than merely speculative, that he is entitled to relief.’ “ Tamayo v. Blagojeuich, 526 F.3d 1074, 1083 (7th Cir. 2008) (citations omitted). In making this assessment, the district court accepts as true all well-pled factual allegations and draws all reasonable inferences in the plaintiff's favor. See Rujawitz v. Martin, 561 F.3d 685, 688 (7th Cir.2009); St. John's United Church of Christ v. City of Chicago, 502 F.3d 616, 625 (7th Cir. 2007). With these principles in mind, the Court turns to analyzing the plaintiffs' complaint. V. MOTION TO DISMISS-ANALYSIS A. Abandoned Claims In its Motion to Dismiss, BIPI moved to dismiss, inter alia, the following: • Count 6: Negligent Misrepresentation. (Doc. 17 at pp. 19-20) • Count 7: Fraud by Concealment. (Id.) • Count 8: Deceit by Concealment. (Id.) • Count 11: Violation of Cal. Civ.Code § 1750 (Id. at pp. 1-2) • Punitive Damages. (Id. at 22-23.) In their Amended Opposition, the plaintiffs do not respond to BIPI's request for dismissal as to these claims. Accordingly, BIPI contends, these claims have been abandoned. The Court agrees. See Alioto v. Town of Lisbon, 651 F.3d 715, 721 ( 7th Cir. 2011) (waiver rule applies “where a litigant effectively abandons the litigation by not responding to alleged deficiencies in a motion to dismiss”); Lekas v. Briley, 405 F.3d 602, 614 (7th Cir. 2005) (claim waived where Plaintiff “did not present legal arguments or cite relevant authority ... in responding to defendants' motion to dismiss or in his own Rule 59(e) motion to alter or amend the judgment). Therefore, Counts 6, 7, 8, and 11 are DISMISSED. Any requests for punitive damages are likewise DISMISSED. B. Motion to Dismiss Count 1 (Failure to Warn) and Count 5 (Express Warranty) Withdrawn as to All Plaintiffs BIPI withdraws its challenge to Count 1 (Failure to Warn) and Count 5 (Express Warranty) as to all Plaintiffs (Doc. 38 p. 2 n.1). Accordingly, Count 1 (Failure to Warn) and Count 5 (Express Warranty) are no longer in issue. C. Remaining Claims 1. Louisiana Plaintiffs (Pauline Aldridge and Charles Aldridge) a. Motion to Dismiss Count 2 (Design Defect) is Withdrawn as to Louisiana Plaintiffs As to the Louisiana plaintiffs, BIPI withdraws its motion to dismiss Count 2 (Design Defect) (Doc. 38 p. 2 n.1). Accordingly, this claim is no longer in issue. b. Exclusivity of the LPLA and Non-Cognizable LPLA Claims Case 4:16-cv-00035-CDL Document 12-9 Filed 04/24/17 Page 5 of 9 In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, Not Reported in... 2014 WL 114480 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 5 The LPLA provides “the exclusive theories of liability for manufacturers for damage caused by their products.” La.Rev.Stat. Ann. § 9:2800.52. “A claimant may not recover from a manufacturer for damage caused by a product on the basis of any theory of liability that is not set forth in [the LPLA].” Id. (emphasis added). See also Stahl v. Novartis Pharms. Corp., 283 F.3d 354, 261 (5th Cir. 2002) (non-LPLA causes of action are not available against the manufacturer of a product for damages caused by that product). *5 The claims for Negligence and Breach of Implied Warranty are not cognizable under the LPLA and therefore must be dismissed. See In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, 2013 WL 3791509, 6-9 (S.D.Ill. July 18, 2013) (Herndon, C.J.). Accordingly, as to the Louisiana plaintiffs, Count 3 (Negligence) and Count 4 (Breach of Implied Warranty) are DISMISSED With Prejudice. c. Violations of California Business & Professions Code § 17200 (Count 9) and § 17500 (Count 10) As noted above, the Louisiana plaintiffs' claims are governed by Louisiana law and not California law. Accordingly, as to the Louisiana plaintiffs Count 9 (California Business & Professions Code § 17200) and Count 10 (California Business and Professions Code § 17500) are dismissed WITH PREJUDICE. 2. Tennessee Plaintiffs (Clifton Fitzsimmons, Jennifer Ruth Fitzsimmons, John Wilchinski, Judy Wilchinski, and George Fletcher) a. Motion to Dismiss Count 2 (Design Defect), Count 3 (negligence) and Count 4 (Breach of Implied Warranty) is Withdrawn as to Tennessee Plaintiffs As to the Tennessee plaintiffs, BIPI withdraws its motion to dismiss Count 2 (Design Defect), Count 3 (negligence) and Count 4 (Breach of Implied Warranty) (Doc. 38 p. 2 n. 1). Accordingly, these claims are no longer in issue. BIPI has also withdrawn its statute of limitations argument (at this time) as to the Tennessee plaintiffs (Doc. 38 p. 2 n. 1). b. Violations of California Business & Professions Code § 17200 (Count 9) and § 17500 (Count 10) As noted above, the Tennessee plaintiffs' claims are governed by Tennessee law and not California law. Accordingly, as to the Tennessee plaintiffs, Count 9 (California Business & Professions Code § 17200) and Count 10 (California Business and Professions Code § 17500) are dismissed WITH PREJUDICE. 3. California Plaintiffs (Thelma Butner and Marvin Butner) a. Motion to Dismiss Count 3 (Negligence), Count 9 (California Business & Professions Code § 17200) and Count 10 (California Business and Professions Code § 17500) are Withdrawn as to the California Plaintiffs As to the California plaintiffs, BIPI withdraws its motion to dismiss Count 3 (Negligence), Count 9 (California Business & Professions Code § 17200), and Count 10 (California Business and Professions Code § 17500) (Doc. 38 p. 2 n.1). Accordingly, these claims are no longer in issue. b. Count 2-Design Defect The plaintiffs' third cause of action alleges strict liability under a design defect theory. However, the California Supreme Court has held that a manufacturer of prescription drugs is exempt from strict liability claims premised on design defect. Brown v. Superior Court, 44 Cal.3d 1049, 1061, 245 Cal.Rptr. 412, 751 P.2d 470 (1988) (“[A] drug manufacturer's liability for a defectively designed drug should not be measured by the standards of strict liability[.]”); Anderson v. Owens-Corning Fiberglas Corp., 53 Cal.3d 987, 995, 281 Cal.Rptr. 528, 810 P.2d 549 (1991) (“[A] manufacturer of prescription drugs is exempt from strict liability for defects in design[.]”). Accordingly, as to the California plaintiffs, Count 2 (Strict Product Liability-Design Defect) is DISMISSED WITH PREJUDICE. Case 4:16-cv-00035-CDL Document 12-9 Filed 04/24/17 Page 6 of 9 In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, Not Reported in... 2014 WL 114480 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 6 c. Count 4-Breach of Implied Warranty *6 BIPI contends that California law requires privity between the parties for implied warranty and that privity does not exist in the prescription pharmaceutical context (Doc. 17 p. 19). Accordingly, BIPI argues, the plaintiffs' claim for breach of implied warranty is not legally viable (Doc. 17 p. 19). The plaintiffs respond arguing under Evraets v. Intermedics Intraocular, Inc.29 Cal.App.4th 779, 34 Cal.Rptr.2d 852 (1994), privity is not a requirement for actions based on express warranty. The California Appellate Court in Evraets did note that California case law generally has abolished the requirement of privity for express warranty claims. Evraets, 29 Cal.App.4th at 789 n. 4, 34 Cal.Rptr.2d 852 (citing Seely v. White Motor Co., 63 Cal.2d 9, 45 Cal.Rptr. 17, 403 P.2d 145 (1965) and Rodrigues v. Campbell Industries, 87 Cal.App.3d 494, 151 Cal.Rptr. 90 (1978)). However, as to implied warranty, the court in Evraets concluded lack of privity was fatal. In so holding, the court stated as follows: Evraets did not rely on [ the defendants'] judgment that an intraocular device was appropriate for him. Rather, he relied upon his physician's skill or judgment to select or furnish a suitable product. Thus, Evraets cannot sue the manufacturers, suppliers or distributors of the lens on an implied warranty of fitness theory. 29 Cal.App.4th at 788, 34 Cal.Rptr.2d 852. Considering the above, it appears that BIPI is correct. Under California law, privity between the patient and the manufacturer of a pharmaceutical product is a necessary component of breach of implied warranty claims. See alsoBlanco v. Baxter Healthcare Corp.,158 Cal.App.4th 1039, 1058-59, 70 Cal.Rptr.3d 566 (2008). It further appears that under California law, in the context of prescription pharmaceuticals, the transaction is between the manufacturer and the physician, not the patient. Therefore, the plaintiffs cannot maintain claims based on breach of implied warranty. Accordingly, as to the California plaintiffs, Count 4 (Breach of Implied Warranty) is DISMISSED WITH PREJUDICE. VI. MOTION TO STRIKE-ANALYSIS A. Legal Standard BIPI has also moved to strike certain allegations in the plaintiffs' complaint under Federal Rule of Civil Procedure 12(f). Federal Rule of Civil Procedure 12(f) provides that “[t]he Court may strike from a pleading an insufficient defense or any redundant, immaterial, impertinent, or scandalous matter. It is, of course, “the general rule that motions to strike are disfavored. This is because motions to strike potentially serve only to delay.” Heller Fin., Inc. v. Midwhey Powder Co.,883 F.2d 1286, 1294 (7th Cir. 1989). 2 2 In their amended response, the plaintiffs cite to California civil procedure rules and California state court cases in relation to the motion to strike (Doc. 37 pp. 11-12). These state court rules are wholly inapplicable here. B. Motion to Strike Certain Allegations Withdrawn BIPI's motion to strike is divided into three sections (in the following order): (1) Allegations that BIPI failed to warn the plaintiff or the public; (2) allegations that BIPI made misrepresentations to the FDA (fraud on the FDA); and (3) allegations that BIPI violated the Food, Drug and Cosmetic Act. In its reply brief, BIPI states that it is withdrawing “the first two arguments in its Motion to Strike” (Doc. 38 p. 2 n. 1). The Court concludes this means BIPI is withdrawing its motion to strike as to the first two sections of its motion to strike: (1) Allegations that BIPI failed to warn the plaintiff or the public and (2) allegations that BIPI made misrepresentations to the FDA (fraud on the FDA) (it would have been helpful for BIPI to expressly identify the arguments it intended to withdraw). 3 3 The Court notes that BIPI also contends, in its reply brief, that the plaintiffs have abandoned any “fraud on the FDA” claims (Doc. 38 p. 3). This is not consistent with BIPI's following claim that it is withdrawing the “first two arguments” in its motion to strike. The Court will not attempt to resolve the discrepancy for BIPI. For the time being, the Court Case 4:16-cv-00035-CDL Document 12-9 Filed 04/24/17 Page 7 of 9 In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, Not Reported in... 2014 WL 114480 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 7 presumes that BIPI intended to withdraw is motion to strike these allegations. *7 Accordingly, these two issues are no longer before the Court. C. Motion to Strike all Claims Based on Alleged Violations of the Food, drug, and Cosmetic Act The plaintiffs make various allegations relating to alleged violations of the federal and state Food, Drug and Cosmetic Acts. BIPI contends that any such claims are barred because there is no private cause of action under the FDCA (Doc. 17 p. 26). The plaintiffs disagree citing to Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009) (Doc. 37 p. 13). BIPI is correct, there is no private cause of action under the FDCA. See 21 U.S.C. § 337(a). However, this fact does not necessarily require striking allegations related to alleged violations of the FDCA. Although there is no private cause of action under the FDCA, the plaintiff has not brought suit directly under the FDCA or its accompanying regulations. Instead, the plaintiff has asserted independent state law claims. The references to alleged FDCA violations appear to be offered to establish the standard or duty that BIPI allegedly failed to meet in relation to those independent state law claims. BIPI has not cited to any authority demonstrating that the plaintiffs are prohibited from referencing alleged FDCA violations to (for instance) merely establish the standard or duty which BIPI allegedly failed to meet. Accordingly, the motion to strike allegations relating to alleged violations of the FDCA is DENIED. VII. CONCLUSION For the reasons discussed herein, BIPI's motion to dismiss and/or strike is DENIED in part and GRANTED in part. In summary, the Court ORDERS as FOLLOWS: • ALL PLAINTIFFS: Count 6 (Negligent Misrepresentation), Count 7 (Fraud by Concealment), Count 8 (Deceit by Concealment), Count 11 (Violation of Cal. Civ.Code § 1750), and any requests for punitive damages are DISMISSED as to ALL PLAINTIFFS (the plaintiffs do not respond to BIPI's request for dismissal as to these claims and these claims are deemed abandoned). • LOUISIANA PLAINTIFFS: Count 3 (Negligence), Count 4 (Breach of Implied Warranty), Count 9 (California Business & Professions Code § 17200), and Count 10 (California Business and Professions Code § 17500) are DISMISSED WITH PREJUDICE as to the LOUISIANA PLAINTIFFS. • TENNESSEE PLAINTIFFS: Count 9 (California Business & Professions Code § 17200) and Count 10 (California Business and Professions Code § 17500) are dismissed WITH PREJUDICE as to the TENNESSEE PLAINTIFFS. • CALIFORNIA PLAINTIFFS: Count 2 (Strict Product Liability - Design Defect) and Count 4 (Breach of Implied Warranty) are DISMISSED WITH PREJUDICE as to the CALIFORNIA PLAINTIFFS. • Count 12 (Loss of Consortium) stands only to the extent of the spouses viable claims. • The motion to strike allegations relating to alleged violations of the FDCA is DENIED. • WITHDRAWN ARGUMENTS: BIPI withdrew its motion to dismiss the following: Count 1 (Failure to Warn) and Count 5 (Breach of Express Warranty) as to ALL PLAINTIFFS; Count 2 (Design Defect) as to the Louisiana and Tennessee plaintiffs; Count 3 (Negligence) as to the California and Tennessee plaintiffs; Count 4 (Implied Warranty) as to the Tennessee plaintiffs; Count 9 (California Business & Professions Code § 17200) as to the California plaintiffs; and Count 10 (California Business and Professions Code § 17500) as to the California plaintiffs. In addition, BIPI withdrew its motion to strike as to (1) allegations that BIPI failed to warn the plaintiffs or the public and (2) allegations that BIPI made misrepresentations to the FDA (committed fraud on the FDA). *8 SO ORDERED: All Citations Not Reported in F.Supp.2d, 2014 WL 114480 Case 4:16-cv-00035-CDL Document 12-9 Filed 04/24/17 Page 8 of 9 In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, Not Reported in... 2014 WL 114480 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 8 End of Document © 2017 Thomson Reuters. No claim to original U.S. Government Works. Case 4:16-cv-00035-CDL Document 12-9 Filed 04/24/17 Page 9 of 9 Exhibit G Case 4:16-cv-00035-CDL Document 12-10 Filed 04/24/17 Page 1 of 8 Adams v. I-Flow Corp., Not Reported in F.Supp.2d (2010) 2010 WL 1339948 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 1 2010 WL 1339948 Only the Westlaw citation is currently available. United States District Court, C.D. California, Western Division. Eric ADAMS, et al., Plaintiffs, v. I-FLOW CORPORATION, et al., Defendants. No. CV09-09550 R(SSx). | March 30, 2010. Attorneys and Law Firms Peter A. Strotz, William E. Steimle, Filice Brown Eassa & McLeod LLP, for Defendants Astrazeneca LP and Astrazeneca Pharmaceuticals LP. ORDER GRANTING DEFENDANTS' MOTIONS TO DISMISS PURSUANT TO F.R.C.P. 12(B)(6); AND MOTIONS TO STRIKE PURSUANT TO F.R.C.P. 12(F) MANUEL REAL, District Judge. *1 This matter comes before the Court on the motions to dismiss and/or strike of Defendants AstraZeneca Pharmaceuticals LP, AstraZeneca LP, Breg Inc., DJO Incorporated, DJO, LLC, I-Flow Corporation, Moog Inc., McKinley Medical, LLC, Curlin Medical Inc., Sorenson Medical Products Inc., Stryker Corporation, and Stryker Sales Corporation (collectively “Defendants”). For the reasons set forth below, the motions to dismiss and strike are GRANTED. Defendants Abbott Laboratories, Hospira, Inc., APP Pharmaceuticals, LLC, APP Pharmaceuticals, Inc., Abraxis BioScience, LLC, Abraxis BioScience, Inc., and Pacfic Medical, Inc. also filed motions to dismiss and/or strike based on the same grounds as the instant motions. Those motions were scheduled to be heard on April 5, 2010, and May 3, 2010. Because these motions present the same issues as the instant motions and because the Court has ordered plaintiffs' claims severed with each plaintiff to file his or her own individual complaint, the Court orders the motions scheduled for April 5, 2010, and May 3, 2010, OFF CALENDAR AS MOOT; and therefore, this case, CV-09-9550-R, is now closed without prejudice to individual plaintiffs filing separate actions against specific defendants under new case numbers, as further indicated in this order. I. FACTUAL AND PROCEDURAL BACKGROUND This case involves a so-called “mass action” product liability lawsuit removed from the Superior Court of the State of California for the County of Los Angeles pursuant to 28 U.S.C. sections 1332(d) and 1453. As alleged in the Complaint, one-hundred, forty-one (141) plaintiffs underwent separate shoulder surgeries at different times, in different hospitals, in thirty- seven (37) states and Canada, that were performed by different doctors, to treat different injuries to plaintiffs' respective shoulders, over the span of a ten (10) year period. Following each plaintiff's respective surgery, an unidentified pain pump was used to administer an unidentified pain relief medication into the plaintiff's shoulder joint. Plaintiffs claim injury as a result of the unidentified pain pumps' administration of the unidentified anesthetics. Plaintiffs sue twenty-two (22) defendants who they allege manufactured and distributed either pain pumps or anesthetics, presumably of the type used following plaintiffs' surgeries. Nowhere in their Complaint does even one of the plaintiffs identify the particular pain pump or anesthetic used following his or her specific surgery or the manufacturers of those products. Instead, the Complaint uses generalized terms to identify these products, such as “pain pump” and “local anesthetic.” See, e.g., Complaint, ¶ 1. Plaintiffs allege the following causes of action against all defendants generally: negligence (and negligence per se), strict products liability, breach of express warranty, breach of implied warranty, negligent misrepresentation, and fraudulent concealment. Plaintiffs assert an additional cause of action for violation of state consumer fraud and deceptive trade practices acts against a group of the defendants, which plaintiffs call the “Defendant Pain Pump Manufacturers” 1 Case 4:16-cv-00035-CDL Document 12-10 Filed 04/24/17 Page 2 of 8 Adams v. I-Flow Corp., Not Reported in F.Supp.2d (2010) 2010 WL 1339948 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 2 1 Plaintiffs define “Defendant Pain Pump Manufacturers” to include Defendants I-Flow Corporation, Stryker Corporation, Stryker Sales Corporation, McKinley Medical, LLC, Moog Inc., Curlin Medical Inc., DJO Incorporated, DJO, LLC, Reable Therapeutics, Inc., Pacific Medical, Inc., Breg Inc., Orthofix, Inc., Sgarlato Laboratories, Inc ., Sorenson Medical Products Inc. *2 In their Oppositions to the several defendants' motions, plaintiffs admit that, at the time they filed the Complaint, they did not know the identity of the manufacturer of the pain pump or the anesthetic that was used in any of their respective surgeries. See, e.g., Plaintiffs' Opposition to Defendants AstraZeneca LP and AstraZeneca Pharmaceuticals LP's Motion to Dismiss; and Motion to Strike Pursuant to F.R.C.P. 12(b)(6) [Document 39] at 3:5-7, 7:9-13. However, in Oppositions to defendants' motions and at oral argument, plaintiffs' counsel represented that they have obtained information that will permit some, but not all, plaintiffs to identify the manufacturer of the pain pump that was used in the surgeries of the individual plaintiffs. See, e.g., id. at 7:7-9. The plaintiffs who do not know the identity of the pain pump or anesthetic used following their surgery request discovery to ascertain this information. See, e.g., id. at 7:9-13. II. MOTION TO DISMISS A. Plaintiffs' Entire Complaint Fails to State a Claim 1. Legal Standard A defendant may move to dismiss for failure to state a claim upon which relief can be granted. Fed.R.Civ.P. 12(b)(6). Rule 8 requires that a complaint set forth “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). To survive a motion to dismiss, “[f]actual allegations must be enough to raise a right to relief above the speculative level” and must state “enough facts to state a claim to relief that is plausible on its face.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). The complaint need not contain detailed factual allegations, but it must provide more than “a formulaic recitation of the elements of a cause of action.” Id. at 555. A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference the defendant is liable for the misconduct alleged. The plausibility standard is not akin to a “probability requirement,” but it asks for more than a sheer possibility that a defendant has acted unlawfully. Where a complaint pleads facts that are “merely consistent with” a defendant's liability, it “stops short of the line between possibility and plausibility of ‘entitlement to relief.’ “ Ashcroft v. Iqbal, --- U.S. ----, ----, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (emphasis added). In resolving a 12(b)(6) motion, the Court must construe the complaint in the light most favorable to the plaintiff and must accept all well-pleaded factual allegations as true. Cahill v. Liberty Mutual Ins. Co., 80 F.3d 336, 337-338 (9th Cir.1996). The Court must also accept as true all reasonable inferences to be drawn from the material allegations in the complaint. Pareto v. F .D.I.C., 139 F.3d 696, 699 (9th Cir.1998). Assertions that are mere “legal conclusions,” however, are not entitled to the assumption of truth. Iqbal, 129 S.Ct. at 1950, citing Twombly, 550 U.S. at 555. *3 When granting a motion to dismiss, a court has discretion to allow leave to amend the complaint pursuant to Federal Rule of Civil Procedure 15(a). When it is clear the complaint cannot be saved by amendment, dismissal without leave to amend is appropriate. See Eminence Capital, L.L. C. v. Aspeon, Inc., 316 F.3d 1048, 1052 (9th Cir.2003). 2. Discussion The Complaint fails to state a claim against Defendants under Rule 8, Twombly, and Iqbal. To state a claim against any of the defendants, each plaintiff must allege that each defendant caused his or her alleged injuries. Specifically, in an action such as this, a plaintiff must allege the identity of the particular defendant who manufactured the pain pump and the particular defendant who manufactured the anesthetic that allegedly injured plaintiff. See Timmons, et al. v. Linvatec Corporation, et al., 263 F.R.D. 582, 2010 WL 476661 *2 (C.D.Cal.2010). The Complaint does not allege that any particular plaintiff was administered a particular drug through a particular Case 4:16-cv-00035-CDL Document 12-10 Filed 04/24/17 Page 3 of 8 Adams v. I-Flow Corp., Not Reported in F.Supp.2d (2010) 2010 WL 1339948 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 3 pain pump that was manufactured by a particular defendant. Instead, plaintiffs plead only generally that they were injured by pain pumps and anesthetics of the type made by defendants. By suing fourteen (14) “Defendant Pain Pump Manufacturers” and eight (8) “Defendant Anesthetic Manufacturers,” the Complaint at most alleges that the individual defendants theoretically could have been the one who manufactured the pain pump or anesthetic used following each plaintiff's surgery. But, the Complaint never specifies that any one of the defendants, as opposed to the 21 other defendants, caused each plaintiff's claimed injury. As such, plaintiffs plead nothing more than the sheer possibility that any particular defendant might have manufactured the product that allegedly injured each plaintiff. This sort of speculative pleading is not permitted under the plain text of Rule 8, which requires a “statement of the claim showing that the pleader is entitled to relief.” See Ashcroft v. Iqbal, --- U.S. ----, 129 S.Ct. 1937, 173 L.Ed.2d 868; see also Timmons, et al. v. Linvatec Corporation, et al., 263 F.R.D. 582, 2010 WL 476661 *2 (C.D.Cal.2010). Accordingly, plaintiffs' Complaint must be dismissed for failure to state a claim. However, as plaintiffs' counsel has represented to the Court that some of the plaintiffs have the requisite evidentiary support under Rule 11 to plead the identity of some of the manufacturers of the pain pumps used following their surgeries, the Court cannot conclude that leave to amend would be futile as to all of the one- hundred, forty-one (141) plaintiffs. Compare, Timmons, et al. v. Linvatec Corporation, et al., 263 F.R.D. 582, 2010 WL 476661 at *4. Accordingly, and as explained in more detail below, plaintiffs are granted leave to amend to identify (1) the particular pain pump used, (2) the particular anesthetic they received, and (3) the manufacturer of those products. B. Statute of Limitations In a federal diversity action based on alleged violations of state law, the state statute of limitations controls. Bancorp Leasing and Financial Corp. v. Agusta Aviation Corp., 813 F.2d 272, 274 (9th Cir.1987). The present action was removed to this Court pursuant to 28 U.S.C. 1332(d), a subsection of the diversity jurisdiction statute. *4 California has a two-year statute of limitations with respect to plaintiffs' claims based on negligence and strict product liability theories. Cal.Code Civ. Proc., §§ 335 and 335.1. California law includes a discovery rule that delays the accrual of a cause of action until a plaintiff either became aware of the injury and its cause or could have discovered the injury and cause through reasonable diligence. Jolly v. Eli Lilly & Co., 44 Cal.3d 1103, 245 Cal.Rptr. 658, 751 P.2d 923. Plaintiff, however, must specifically plead facts to show the time and manner of discovery and the inability to have made an earlier discovery despite reasonable diligence. Fox v. Ethicon Endo-Surgery, Inc., 35 Cal.4th 797, 808, 27 Cal.Rptr.3d 661, 110 P.3d 914 (2005). Plaintiffs filed this lawsuit on October 28, 2009. Therefore, several of plaintiffs' claims are facially time-barred based on the dates of their surgeries and corresponding injuries. For example, any claim based on negligence or strict product liability theories for an injury that occurred prior to October 28, 2007, is facially barred by the two- year statute of limitations of California Code of Civil Procedure section 335.1. Plaintiffs' Complaint generically alleges on behalf of all one-hundred, forty-one (141) plaintiffs that they were unaware of a causal link between their alleged injuries and defendants' products until less than one year prior to filing the Complaint. See Complaint, ¶ 144. This conclusory allegation fails to state when and how each plaintiff discovered his or her alleged injuries were caused by defendants' products. It also fails to provide any facts that support their assertion as to why each plaintiff could not have discovered this information earlier. Accordingly, plaintiffs have not pled facts that are sufficient to invoke the discovery rule to delay the accrual of their individual causes of action, as required under California law. Thus, several of the plaintiffs' claims, including the negligence and strict product liability claims of the plaintiffs who underwent surgery prior to October 28, 2007, are facially time-barred and are dismissed. Plaintiffs are given leave to amend to state, if they can, the information required under Fox v. Ethicon Endo-Surgery, Inc., 35 Cal.4th 797, 27 Cal.Rptr.3d 661, 110 P.3d 914 to delay the accrual of their causes of action. C. Plaintiffs' Breach of Warranty Claims Plaintiffs' Third and Fourth Causes of Action for breach of warranty cannot be maintained under California law and are dismissed with prejudice. Under controlling California law, privity between the patient and the manufacturer of medical device or pharmaceutical product is a necessary component of breach of Case 4:16-cv-00035-CDL Document 12-10 Filed 04/24/17 Page 4 of 8 Adams v. I-Flow Corp., Not Reported in F.Supp.2d (2010) 2010 WL 1339948 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 4 warranty claims. See Blanco v. Baxter Healthcare Corp., 158 Cal.App.4th 1039, 1058-59, 70 Cal.Rptr.3d 566 (2008). In the context of prescription medical devices and pharmaceuticals, the transaction is between the manufacturer and the physician, not the patient. Id. Plaintiffs' Complaint is devoid of any facts suggesting that plaintiffs relied upon anything other than their physicians' skill and judgment in selecting and prescribing the anesthetics and pain pumps. Indeed, because the Complaint alleges that the local anesthetics and pain pumps were administered post-surgery in a hospital environment, no plausible inference can be drawn that any purchase of a product at issue was based on a warranty from the manufacturer to the plaintiff. There was simply no relationship between the defendant manufacturers and the plaintiffs. Under these circumstances, plaintiffs cannot maintain claims based on breach of express or implied warranty and these claims are dismissed with prejudice. D. Plaintiffs' Fraud and Misrepresentation Claims *5 A cause of action for negligent misrepresentation or fraudulent concealment must be pled with heightened specificity. Fed.R.Civ.P. 9(b); Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1107 (9th Cir.2003); Meridian Project Sys., Inc. v. Hardin Constr. Co., 404 F.Supp.2d 1214, 1219 (E.D.Cal.2005). Thus, a plaintiff must plead “the who, what, when, where and how” of the fraud or misrepresentation. Vess, 317 F.3d at 1106. Moreover, when a plaintiff sues multiple defendants, “Rule 9(b) does not allow a complaint to merely lump multiple defendants together but require(s) plaintiffs to differentiate their allegations when suing more than one defendant ... and inform each defendant separately of the allegations surrounding his alleged participation in the fraud.” Swartz v. KPMB LLP, 476 F.3d 756, 764-65 (9th Cir.2007). Thus, in order to state a valid fraud or misrepresentation claim, plaintiffs must identify the alleged misrepresentations made to them by each defendant with heightened specificity. The Fifth and Sixth Causes of Action of the Complaint fail to satisfy the heightened pleading requirements of Rule 9(b). The one hundred, forty-one (141) plaintiffs impermissibly lump together their allegations against all defendants. Further, the allegations fail to set forth any facts concerning the “who, what, when, where, and how” with respect to the alleged fraud and misrepresentations. Accordingly, the Fifth and Sixth Causes of Action for fraud and misrepresentation are dismissed. Plaintiffs are permitted leave to amend these claims in conformity with Rule 9(b) and this order. E. Fraud and Deceptive Trade Practices Act Claims Plaintiffs assert a Seventh Cause of Action for Violation of State Consumer Fraud and Deceptive Trade Practices Act against the defendants they group together as “Defendant Pain Pump Manufacturers.” Although not clearly stated, it appears plaintiffs are attempting to allege a claim for violation of California Business and Professions Code sections 17200, et seq., typically referred to as the Unfair Competition Law. Section 17200, et seq. prohibits unfair competition, which includes any unlawful, unfair or fraudulent business act or practice and unfair, deceptive, untrue or misleading advertising. To plead such a claim, however, a plaintiff must allege with reasonable particularity facts to support the statutory elements of the violation. Khoury v. Maly's of California, Inc., 14 Cal.App.4th 612, 17 Cal.Rptr.2d 708 (1993). Plaintiffs, however, fail to offer any particularity with respect to the alleged violations by each “Defendant Pain Pump Manufacturer.” Plaintiffs offer no particularity with respect their Seventh Cause of Action. They allege no facts as to which misrepresentations were made by which defendants. They have not alleged that any of the “Defendant Pain Pump Manufacturers” conducted any specific business activity or advertising, unfair or not, which in any way caused any loss of money or property to any plaintiff. Thus, plaintiffs' Seventh Cause of Action fails to state a claim on behalf of any particular plaintiff against any particular defendant. Accordingly, the Seventh Cause of Action is dismissed. Plaintiffs are given leave to amend to adequately plead plausible claims of relief on behalf of each individual plaintiff against each individual defendant. III. MOTION TO STRIKE *6 Federal Rule of Civil Procedure 12(f) provides that a court “may order stricken from any pleading ... any redundant, immaterial, impertinent, or scandalous matter.” “[T]he function of a 12(f) motion to strike is to avoid the expenditure of time and money that must arise from litigating spurious issues by dispensing with those Case 4:16-cv-00035-CDL Document 12-10 Filed 04/24/17 Page 5 of 8 Adams v. I-Flow Corp., Not Reported in F.Supp.2d (2010) 2010 WL 1339948 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 5 issues prior to trial....” See Fantasy, Inc. v. Fogerty, 984 F.2d 1524, 1527 (9th Cir.1993) (reversed on other grounds sub nom. Fogerty v. Fantasy, Inc., 510 U.S. 517, 114 S.Ct. 1023, 127 L.Ed.2d 455 (1994)). “ ‘Immaterial’ matter is that which has no essential or important relationship to the claim for relief or the defenses being pleaded” and “ ‘[i]mpertinent’ matter consists of statements that do not pertain, and are not necessary, to the issues in question.' “ Id . (citing 5 Charles A. Wright & Arthur R. Miller, Federal Practice and Procedure § 1382, at 706-07, 711 (1990)). A. Design Defect Allegations Controlling California law unequivocally bars strict liability claims for design defect against pharmaceutical manufacturers. See Brown v. Superior Court, 44 Cal.3d 1049, 1061, 245 Cal.Rptr. 412, 751 P.2d 470 (1988) (“[A] drug manufacturer's liability for a defectively designed drug shall not be measured by the standards of strict liability.”); see also Artiglio v. Superior Court of San Diego County, 22 Cal.App.4th 1388, 1392-93, 27 Cal.Rptr.2d 589 (1994). In Brown, the California Supreme Court held that both of the tests for establishing design defect in California-i.e., the consumer expectations test and the risk-benefit test-are inappropriate in the context of prescription pharmaceutical products. Plaintiffs' Complaint contains allegations asserting a design defect theory, including allegations concerning the tests for design defect liability. Inasmuch as these allegations are related only to design defect theories of products liability that are unequivocally barred by California law, they are stricken without leave to amend as immaterial and impertinent. B. Allegations of Failure to Warn Plaintiffs, the Public, and the FDA In personal injury cases involving prescription medications and devices, a manufacturer's duty to warn runs only to the physician or other “learned intermediary”-not to the patient or the general public. See Carlin v. Superior Court, 13 Cal.4th 1104, 1116, 56 Cal.Rptr.2d 162, 920 P.2d 1347 (1996) (“in the case of prescription drugs, the duty to warn runs to the physician, not to the patient”). “In the case of medical prescriptions ... ‘there is no duty by the drug manufacturer to insure that the warning reaches the doctor's patient for whom the drug is prescribed.’ “ Stevens v. Parke, Davis & Co. ., 9 Cal.3d 51, 65, 107 Cal.Rptr. 45, 507 P.2d 653 (1973) (internal quotations and citation omitted). The patient is presumed to have learned “through the physician ... of the properties and proper use of the drug or implant.” Valentine v. Baxter Healthcare Corp., 68 Cal.App.4th 1467, 1483, 81 Cal.Rptr.2d 252 (1999). (emphasis in original); see also Sherman v. Stryker Corp., 2009 WL 2241664, *4 (C.D.Cal. March 30, 2009). *7 Furthermore, state-law claims predicated on allegations that a manufacturer made misrepresentations to the Food and Drug Administration (“FDA”) are prohibited by federal law. See Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350, 353, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (barring state-law “fraud-on- the-FDA” claims because they “inevitably conflict with the FDA's responsibility to police fraud consistently with the Administration's judgment and objectives”); see also Kimmel, Inc. v. DowElanco, 275 F.3d 1199, 1204-07 (9th Cir.2002) (applying Buckman to preclude a California state law claim for intentional interference with a prospective economic advantage premised on the allegation that defendant knowingly submitted false information to the EPA). Plaintiffs' Complaint contains allegations that Defendants failed to warn plaintiffs, the public, and the FDA. As these allegations are unequivocally barred under California and federal law, leave to amend would be futile. The Court strikes these improper allegations without leave to amend. C. Plaintiffs' Request for a Constructive Trust Over Defendants' Profits Based on their Seventh Cause of Action for Violation of State Consumer Fraud and Deceptive Trade Practices Act, Plaintiffs pray for the “[i]mposition of a constructive trust over and restitution of the monies collected and profits realized by the DEFENDANT PAIN PUMP MANUFACTURERS.” However, “nonrestitutionary disgorgement of profits is not an available remedy in an individual action under the [Unfair Competition Law].” Korea Supply Co. v. Lockheed Martin Corp., 29 Cal.4th 1134, 131 Cal.Rptr.2d 29, 63 P.3d 937 (2003). Plaintiffs do not contend that, as a result of the alleged unfair, deceptive, and illegal practices, they gave money or property to any of the Defendant Pain Pump Manufacturers. Thus, plaintiffs impermissibly seek non-restitutionary disgorgement of profits. Accordingly, plaintiffs' prayer for “imposition of a constructive Case 4:16-cv-00035-CDL Document 12-10 Filed 04/24/17 Page 6 of 8 Adams v. I-Flow Corp., Not Reported in F.Supp.2d (2010) 2010 WL 1339948 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 6 trust over and restitution of the monies collected and profits realized by the DEFENDANT PAIN PUMP MANUFACTURERS” is stricken without leave to amend. D. Plaintiffs' Request for Injunctive Relief Based on their Seventh Cause of Action for Violation of State Consumer Fraud and Deceptive Trade Practices Act, Plaintiffs seek to enjoin Defendant Pain Pump Manufacturers from engaging in unspecified acts of unfair competition. Injunctive relief under the Unfair Competition Law, however, is available only to plaintiffs who can establish that they have no adequate remedy at law for damages available to them. Philpott v. Superior Court, 1 Cal.App.2d 512, 517, 36 P.2d 1093 (1934); Knox v. Phoenix Leasing Inc., 29 Cal.App.4th 1357, 35 Cal.Rptr.2d 141 (1994); Prudential Home Mortgage Company, Inc. v. Superior Court, 66 Cal.App.4th 1236, 78 Cal.Rptr.2d 566 (1998). Should plaintiffs ultimately prevail on their claims, they will be adequately compensated for their alleged injuries by an award of damages. Accordingly, plaintiffs' request for injunctive relief is improper and is stricken without leave to amend. IV. MISJOINDER OF CLAIMS *8 Rule 20 of the Federal Rules of Civil Procedure specifies when parties plaintiff may be joined in one action. In pertinent part, it provides: Persons may be joined in one action as plaintiffs if: (A) they assert any right to relief jointly, severally, or in the alternative with respect to or arising out of the same transaction, occurrence, or series of transactions or occurrences; and (B) any question of law or fact common to all parties will arise in the action. Fed. R. Civ. P 20(a)(1). The California rule on joinder of parties plaintiff is practically identical to Rule 20. See Cal.Code Civ. Proc. § 378(a)(1) (“All persons may join in one action as plaintiffs if: [¶] (1) They assert any right to relief jointly, severally, or in the alternative, in respect of or arising out of the same transaction, occurrence, or series of transactions or occurrences and if any question of law or fact common to all these persons will arise in the action”). Plaintiffs' claims do not arise out of the same transaction, occurrence, or series of transactions or occurrences. As alleged in the Complaint, one-hundred, forty-one (141) plaintiffs underwent separate shoulder surgeries that were performed at different times over the span of a ten (10) year period. These surgeries were performed in different hospitals located in thirty-seven (37) states and Canada. There are numerous different surgeons, anesthesiologists, and other physicians involved with these surgeries who are unlikely to have any common link to any two (2) of these plaintiffs, let alone one-hundred, forty-one (141) of them. Further, the medical histories of the plaintiffs that necessitated the procedures are certainly diverse and likely share no commonality. Moreover, the surgeries at issue apparently involved different pain pumps and anesthetic drugs, as well as numerous other surgical products, risk factors, and circumstances unique to each plaintiff. When faced with the same misjoinder of plaintiffs in different regions, other district courts have severed the claims of multiple plaintiffs, finding that the sole common allegation of pain pump or anesthetic use did not constitute a same transaction, occurrence, or series of transactions or occurrences. See Warner v. Stryker Corp. ., 2009 WL 1773170 (D.Or. June 22, 2009); Frobes v. Stryker Corp. ., 2009 WL 3387037 (E.D.N.Y. August 5, 2009). Based on the above, the Court finds that the claims of these one-hundred, forty-one (141) plaintiffs are misjoined in this single action. Accordingly, the Court hereby severs plaintiffs' claims. The Court retains jurisdiction over these claims pursuant to 28 U.S .C. § 1332(d) (see Cooper v. R.J. Reynolds Tobacco Co., 586 F.Supp.2d 1312 (M.D.Fla.2008)) and the claims for which the Court has dismissed with leave to amend may only be maintained going forward, if at all, in individual actions. V. FURTHER PROCEEDINGS As stated above, each individual plaintiff is provided leave to amend to state, in a separate action and under a new case number, his or her claims for negligence, strict products liability, fraudulent concealment, negligent Case 4:16-cv-00035-CDL Document 12-10 Filed 04/24/17 Page 7 of 8 Adams v. I-Flow Corp., Not Reported in F.Supp.2d (2010) 2010 WL 1339948 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 7 misrepresentation, and violations of state fraud and deceptive practices acts in conformity with this order- i.e., each complaint must specifically identify the actual product(s) alleged to have injured the plaintiff and name only the defendant(s) responsible for manufacturing such product(s). In addition, each plaintiff whose claims are facially barred by the statute of limitations must also adequately plead the applicability of the delayed discovery rule concerning the accrual of their claims. *9 IT IS SO ORDERED. All Citations Not Reported in F.Supp.2d, 2010 WL 1339948 End of Document © 2017 Thomson Reuters. No claim to original U.S. Government Works. Case 4:16-cv-00035-CDL Document 12-10 Filed 04/24/17 Page 8 of 8 Exhibit H Case 4:16-cv-00035-CDL Document 12-11 Filed 04/24/17 Page 1 of 5 Currier v. Stryker Corp., Not Reported in F.Supp.2d (2011) 2011 WL 4898501, Prod.Liab.Rep. (CCH) P 18,716 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 1 2011 WL 4898501 Only the Westlaw citation is currently available. United States District Court, E.D. California. Travis J. CURRIER, an individual, Plaintiff, v. STRYKER CORPORATION; Stryker Sales Corporation; Howmedica Osteonics Corp, dba Stryker Orthopaedics and Does 1-20, Defendants. No. 2:11-CV-1203 JAM-EFB. | Oct. 13, 2011. Attorneys and Law Firms David A. Valerio, Auburn, CA, William F. Wright, Law Office of William F. Wright, Sacramento, CA, for Plaintiff. Alicia Jane Donahue, Amir M. Nassihi, Shook Hardy and Bacon LLP, San Francisco, CA, for Defendants. ORDER GRANTING IN PART AND DENYING IN PART DEFENDANTS' MOTION TO DISMISS JOHN A. MENDEZ, District Judge. *1 This matter is before the Court on Defendants' Stryker Corporation (“Stryker”) and Howmedica Osteonics Corp (“Howmedica”) (collectively “Defendants”) Motion to Dismiss (Doc. # 16) Plaintiff Travis Currier's (“Plaintiff”) First Amended Complaint (“FAC”) (Doc. # 8). This matter was removed to this court from the Superior Court of the County of Sacramento on grounds of diversity jurisdiction (Doc. # 1). Defendants move to dismiss the FAC pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. Plaintiff opposes the motion. For the reasons set forth below, the Motion to Dismiss is GRANTED in part and DENIED in part. 1 1 This matter was determined to be suitable for decision without oral argument. E.D. Cal. L.R. 230(g). Oral argument was originally scheduled for September 7, 2011. I. FACTUAL ALLEGATIONS AND PROCEDURAL BACKGROUND This action arises from a medical device that was surgically implanted in Plaintiff's leg. The FAC alleges that a portion of Plaintiff's left femur was removed due to sarcoma and replaced with femoral endoprothesis (a femoral stem and jointed pieces), in December 1994. Am. Compl., ¶ 11. Plaintiff alleges that the femoral endoprothesis was Defendants' product, and was dangerous and defective when it was inserted into Plaintiff's femur. Am. Compl., ¶ 12. Plaintiff was 15 at the time of the surgery. Am. Compl., ¶ 11. The FAC alleges that despite Defendants' representations to Plaintiff, Plaintiff's physician and Plaintiff's parents that the product was of superior quality and would last for Plaintiff's lifetime, the product failed and broke in February 2010, causing injury and necessitating surgery to replace portions of the product that broke. Am. Compl., ¶ 13. The FAC contains three claims against Defendants for Strict Liability, Negligence and Breach of Warranty. Plaintiff seeks general damages, medical expenses and lost wages. Defendants move to dismiss the FAC in its entirety. Defendants contend that the FAC does not meet federal pleading standards and pleads claims that are unavailable under California law. II. OPINION A. Legal Standard A party may move to dismiss an action for failure to state a claim upon which relief can be granted pursuant to Federal Rule of Civil Procedure 12(b)(6). In considering a motion to dismiss, the court must accept the allegations in the complaint as true and draw all reasonable inferences in favor of the plaintiff. Scheuer v. Rhodes, 416 U.S. 232, 236, 94 S.Ct. 1683, 40 L.Ed.2d 90 (1975), overruled on other grounds by Davis v. Scherer, 468 U.S. 183, 104 S.Ct. 3012, 82 L.Ed.2d 139 (1984); Cruz v. Beto, 405 U.S. 319, 322, 92 S.Ct. 1079, 31 L.Ed.2d 263 (1972). Assertions that are mere “legal conclusions,” however, are not entitled to the assumption of truth. Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1950, 173 L.Ed.2d 868 (2009), (citing Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). To survive a motion to dismiss, a plaintiff needs to plead “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 Case 4:16-cv-00035-CDL Document 12-11 Filed 04/24/17 Page 2 of 5 Currier v. Stryker Corp., Not Reported in F.Supp.2d (2011) 2011 WL 4898501, Prod.Liab.Rep. (CCH) P 18,716 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 2 U.S. at 570. Dismissal is appropriate where the plaintiff fails to state a claim supportable by a cognizable legal theory. Balistreri v. Pacifica Police Department, 901 F.2d 696, 699 (9th Cir.1990). *2 Upon granting a motion to dismiss for failure to state a claim, the court has discretion to allow leave to amend the complaint pursuant to Federal Rule of Civil Procedure 15(a). “Dismissal with prejudice and without leave to amend is not appropriate unless it is clear ... that the complaint could not be saved by amendment.” Eminence Capital, L.L.C. v. Aspeon, Inc., 316 F.3d 1048, 1052 (9th Cir.2003). B. Claims for Relief 1. Strict Liability, First Claim for Relief The FAC alleges that Defendants designed, researched, formulated, tested, inspected, manufactured, produced, created, assembled, prepared, packaged, labeled, supplied, distributed, marketed, and/or sold the femoral stem product in a defective and dangerous condition. Am. Compl., ¶ 17. The FAC alleges that the product was defective and dangerous because it did not perform as anticipated and broke into pieces. Id. Plaintiff alleges that he sustained both physical and emotional injury, incurred medical expenses, and was unable to work in his usual occupation. Am. Compl., ¶¶ 19-21. Defendants argue that these allegations fail to state a claim because they do not differentiate between Stryker, Howmedica and Stryker Sales Corporation (not a party to this motion) and they fail to state how the product is defective. Further, to the extent that Plaintiff is attempting to assert a design defect claim, Defendants contend that such a claim is unavailable against manufacturers of medical implant devices. California recognizes three theories of product liability: design defect, manufacturing defect, and failure to warn. Yalter v. Endocare, 2004 WL 5237598 at *3 (C.D.Cal. Nov.8, 2004). The first claim in the FAC is captioned “strict liability” and does not indicate if Plaintiff is attempting to bring a products liability claim for design defect, manufacturing defect, or both. Accordingly, the Court will discuss both the design defect and manufacturing defect theories. The FAC does not contain any allegations of failure to warn, accordingly it does not appear that the “strict liability” claim is based on a failure to warn theory. Under the manufacturing defect theory, generally a manufacturing or production defect is readily identifiable because a defective product is one that differs from the manufacturer's intended result or from other ostensibly identical units of the same product line. Lucas v. City of Visalia, 726 F.Supp.2d 1149, 1154 (E.D.Cal.2010) (internal citations omitted). The manufacturing defect theory posits that a suitable design is in place, but that the manufacturing process has in some way deviated from that design. Id. California law prohibits strict liability claims for design defect against manufacturers of prescription implantable medical devices. See e.g. Hufft v. Horowitz, 4 Cal.App.4th 8, 19-20, 5 Cal.Rptr.2d 377(1992) (holding that a manufacturer is not strictly liable for injuries caused by an implanted prescription medical product which has been (1) properly made and (2) distributed with information regarding risks and dangers of which the manufacturer knew or should have known at the time); Rhynes v. Stryker Corp., 2011 WL 2149095 (N.D.Cal. May 31, 2011) (striking medical implant strict liability design defect allegations because the barred by California law), Adams v. I-Flow Corp., 2010 WL 1339948, *8 (C.D.Cal. Mar.30,2010) (same). Plaintiff argues, without citation to authority, that this rule does not apply to the implanted medical device at issue in this case, because it is not alleged to be inherently dangerous. However, given the bright line rule set forth in Hufft and recognized by California courts and federal courts, Plaintiff's argument is not persuasive. *3 Here, the allegations of the FAC are simply too vague and conclusory to state a claim for strict products liability. To the extent that Plaintiff's claim rests on the manufacturing defect theory, the FAC does not contain allegations of how the femoral stem product deviated from the manufacturer's original design or from other seemingly identical models. See Lucas, supra, at 1155. To the extent that Plaintiff's claim rests on the design defect theory, such a claim is prohibited under California law. See Rhynes, supra. Finally, since no facts are alleged regarding failure to warn, Plaintiff's strict liability claim cannot rest on that theory. Accordingly, the strict liability claim is dismissed, with leave to amend to state a claim for manufacturing defect. 2. Negligence, Second Claim for Relief Case 4:16-cv-00035-CDL Document 12-11 Filed 04/24/17 Page 3 of 5 Currier v. Stryker Corp., Not Reported in F.Supp.2d (2011) 2011 WL 4898501, Prod.Liab.Rep. (CCH) P 18,716 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 3 The FAC alleges that Defendants negligently designed, researched, formulated, tested, inspected, manufactured, produced, created, assembled, prepared, packaged, labeled, supplied, distributed, marketed, and/or sold the femoral stem product, so that the product failed. Am. Compl. ¶ 25. The FAC alleges that Defendants' negligence resulted in the product not being fit for its intended use. Id. Plaintiff alleges he suffered injury, incurred medical expenses, and was unable to attend to his usual occupation, due to Defendants' negligence. Am. Compl. ¶¶ 26-28. As Plaintiff noted in his opposition to the motion to dismiss, Defendants did not address the negligence claim. Though Defendants' Reply brief asserts that “Defendants have moved to dismiss Plaintiff's entire product liability claim, in other words, his entire complaint (which includes the strict liability, negligence and warranty claims), based on the failure to meet the requisite pleading standards,” Reply, p. 3, the motion to dismiss does not discuss the negligence claim. The motion to dismiss does not set forth the elements that must be plead to state a claim for negligence, does not argue how the allegations of the FAC fail to plead the necessary elements, and does not set forth any other theory for dismissal of the negligence claim. Accordingly, the motion to dismiss the negligence claim is DENIED. 3. Breach of Warranty, Third Claim for Relief The FAC alleges that Defendants expressly and impliedly warranted and/or represented to Plaintiff's physician and to Plaintiff, that the femoral stem product was of superior quality and would last for Plaintiff's lifetime, Am. Compl., ¶ 13, that the product was of good and merchantable quality, and that the product was fit and safe for its ordinary, intended use, Am. Compl., ¶ 31, including the use for which it was used in Plaintiff. Id. However, the FAC alleges that the product was defective; therefore, it did not conform to Defendants' warranties and/or representations. Am. Compl ., ¶ 32. Defendants argue that Plaintiff does not state a claim for breach of warranty because of a lack of privity between Plaintiff and Defendants. *4 To plead a cause of action for breach of express warranty, one must allege the exact terms of the warranty, plaintiff's reasonable reliance thereon, and a breach which proximately caused plaintiff injury. Williams v. Beechnut Nutrition Corp., 185 Cal.App.3d 135, 142, 229 Cal.Rptr. 605 (1986). As a general rule, privity of contract is required in an action for breach of either express or implied warranty, and there is no privity between the original seller and a subsequent purchaser who is in no way a party to the original sale. All West Electronics, Inc. v. M-B-W-, Inc., 64 Cal.App.4th 717, 725, 75 Cal.Rptr.2d 509 (1998) (citing cases). In the implantable medical product context, a patient lacks the privity required to establish a claim for breach of implied warranty. Blanco v. Baxter Healthcare Corp., 158 Cal.App.4th 1039, 1058- 59, 70 Cal.Rptr.3d 566 (2008). See also Adams, 2010 WL 1339948 at *4 (dismissing breach of warranty claim with prejudice, because the complaint was devoid of facts suggesting that plaintiffs relied upon anything other than their physician's skill and judgment in selecting and prescribing the anesthetics and pain pumps); Evraets v. Intermedics Intraocular, Inc., 29 Cal.App.4th 779,788 (1994) (same). Here, Plaintiff's vague allegations that unidentified “Defendants” made unspecified “representations” to Plaintiff, Plaintiff's parents and Plaintiff's physician are insufficient to state a claim for breach of warranty. Moreover, the FAC is devoid of allegations that Plaintiff relied on the representations that were allegedly made. Because this is a medical implant case, and the FAC alleges that the product was surgically inserted in a hospital, the Court cannot plausibly infer from the FAC that Plaintiff relied on anything other than his physician's skill and judgment in selecting the femoral stem product, nor that any purchase of the product was based on a warranty from the manufacturer to Plaintiff. See Adams, 2010 WL 1339948 at *4. The Court cannot plausibly infer that there is a relationship between the Defendants and Plaintiff that would allow Plaintiff to state a breach of warranty claim. See Id. Accordingly, the breach of warranty claim is DISMISSED, WITH PREJUDICE. III. ORDER Defendants' motion to dismiss the FAC is GRANTED in part and DENIED in part, as set forth below: 1. The motion to dismiss the first claim for relief for strict liability is GRANTED. The allegations of design defect are dismissed, with prejudice. Plaintiff is given leave to amend the allegations of manufacturing defect. Case 4:16-cv-00035-CDL Document 12-11 Filed 04/24/17 Page 4 of 5 Currier v. Stryker Corp., Not Reported in F.Supp.2d (2011) 2011 WL 4898501, Prod.Liab.Rep. (CCH) P 18,716 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 4 2. The motion to dismiss the second claim for relief for negligence is DENIED. 3. The motion to dismiss the third claim for relief for breach of warranty is GRANTED. The breach of warranty claim is dismissed, with prejudice. Plaintiff is ordered to file a Second Amended Complaint within twenty-one (21) days of the date of this order. IT IS SO ORDERED. All Citations Not Reported in F.Supp.2d, 2011 WL 4898501, Prod.Liab.Rep. (CCH) P 18,716 End of Document © 2017 Thomson Reuters. No claim to original U.S. Government Works. Case 4:16-cv-00035-CDL Document 12-11 Filed 04/24/17 Page 5 of 5 Exhibit I Case 4:16-cv-00035-CDL Document 12-12 Filed 04/24/17 Page 1 of 3 In re Mentor Corp. Obtape Transobturator Sling Products..., Not Reported in... 2015 WL 6134397 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 1 2015 WL 6134397 Only the Westlaw citation is currently available. United States District Court, M.D. Georgia, Columbus Division. In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation MDL Docket No. 2004 4:08-MD-2004 (CDL) | Case No. 4:13-cv-225 (L. BRENNER) | Signed 10/19/2015 ORDER CLAY D. LAND CHIEF U.S. DISTRICT COURT JUDGE MIDDLE DISTRICT OF GEORGIA *1 Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiff Lisa Brenner was implanted with ObTape and asserts that she suffered injuries caused by ObTape. Brenner brought this product liability action against Mentor, contending that ObTape had design and/or manufacturing defects that proximately caused her injuries. Brenner also asserts that Mentor did not adequately warn her physicians about the risks associated with ObTape. Mentor seeks summary judgment on several of Brenner's claims. For the reasons set forth below, Mentor's Motion for Partial Summary Judgment (ECF No. 30 in 4:13-cv-225) is granted. 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 Viewed in the light most favorable to Brenner, the record reveals the following. Brenner is a California resident, and all of her medical treatment relevant to this action occurred in California. She consulted Dr. Eric Shepard for treatment of her stress urinary incontinence, and Dr. Shepard implanted Brenner with ObTape in 2004. Brenner began experiencing recurrent incontinence in 2010, and she developed pelvic pain and dyspareunia in 2013. Brenner attributes these symptoms to ObTape. Brenner filed her Complaint on July 5, 2013. See generally Compl., ECF No. 1 in 4:13-cv-225. Brenner brought claims for personal injury under a variety of theories, including negligence, strict liability design defect, strict liability manufacturing defect, strict liability failure to warn, breach of implied and express warranties, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. Mentor seeks summary judgment on her claims for strict liability design defect, strict liability manufacturing defect, and breach of implied and express warranties. Brenner does not contest summary judgment on her claims for strict liability design defect, strict liability manufacturing defect, and breach of implied warranties. Summary judgment is therefore granted as to those claims. The only remaining question raised by Mentor's partial summary judgment motion is whether Brenner's breach of express warranty claim survives summary judgment. DISCUSSION Brenner filed her action in this Court under the Court's direct filing order. The parties agree 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 parties also agree that California law applies to Brenner's claims because Brenner is a California resident and all of her medical treatment relevant to this action occurred in California. ase 4:16-cv-00035-CDL Document 12-12 Filed 04/24/17 Page 2 of 3 In re Mentor Corp. Obtape Transobturator Sling Products..., Not Reported in... 2015 WL 6134397 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 2 *2 Brenner asserts a breach of express warranty claim based on Mentor's alleged failure to warn of ObTape's “dangerous side effects.” See Compl. ¶¶ 69, 74 (alleging that Mentor warranted that ObTape “did not produce any dangerous side effects” even though it did). Mentor contends that Brenner's breach of express warranty claim fails because she did not notify Mentor of the alleged breach before filing her lawsuit. California's commercial code requires a buyer to notify the seller of a breach within a reasonable time after discovering the breach; if such notice is not given, the buyer is “barred from any remedy.” Cal. Com. Code § 2607(3)(A). Brenner argues that there is no warranty notice requirement for remote buyer breach of warranty claims. This is the same argument the Court recently rejected in Escalera v. Mentor Corporation, No. 4:12-cv-238, 2015 WL 5468791, at *2 (M.D. Ga. Sept. 16, 2015). Like Escalera, Brenner did not point the Court to any authority that California's adoption of strict liability in tort in Greenman v. Yuba Power Products, Inc., 59 Cal.2d 57 (1963) removes the warranty notice requirement for a plaintiff attempting to proceed under a contract theory of recovery. In the absence of such authority, the Court concludes that Brenner's breach of express warranty claim fails for failure to provide the required statutory notice, and summary judgment is therefore granted on her breach of express warranty claim. CONCLUSION As discussed above, Mentor's Motion for Partial Summary Judgment (ECF No. 30 in 4:13-cv-225) is granted. Only the following claims remain pending for trial: negligence, strict liability failure to warn, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. 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. All Citations Not Reported in F.Supp.3d, 2015 WL 6134397 End of Document © 2017 Thomson Reuters. No claim to original U.S. Government Works. ase 4:16-cv-00035-CDL Document 12-12 Filed 04/24/17 Page 3 of 3 Exhibit J Case 4:16-cv-00035-CDL Document 12-13 Filed 04/24/17 Page 1 of 3 In re Mentor Corp. ObTape Transobturator Sling Products..., Not Reported in... © 2017 Thomson Reuters. No claim to original U.S. Government Works. 1 2015 WL 5468791 Only the Westlaw citation is currently available. United States District Court, M.D. Georgia, Columbus Division. In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation. MDL Docket No. 2004 | Case Nos. 4:12-cv-238 (D. ESCALERA), 4:08-MD-2004 (CDL) | Signed 09/16/2015 ORDER CLAY D. LAND, Chief U.S. District Court Judge *1 Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiff Debra Escalera was implanted with ObTape and asserts that she suffered injuries caused by ObTape. Escalera brought this product liability action against Mentor, contending that ObTape had design and/or manufacturing defects that proximately caused her injuries. Escalera also asserts that Mentor did not adequately warn her physicians about the risks associated with ObTape. Mentor seeks summary judgment on several of Escalera's claims. For the reasons set forth below, Mentor's Motion for Partial Summary Judgment (ECF No. 38 in 4:12-cv-238) is granted. 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 Viewed in the light most favorable to Escalera, the record reveals the following. Escalera is a California resident, and all of her medical treatment relevant to this action occurred in California. In 2004, Escalera saw Dr. Eric Shepard for treatment of stress urinary incontinence and decided to undergo a mesh implant surgery. Dr. Shepard implanted ObTape in Escalera on September 25, 2004. Escalera's ObTape was later removed in 2011. Escalera contends that she suffered various injuries caused by ObTape. Escalera filed her Complaint on September 11, 2012. See generally Compl., ECF No. 1 in 4:12-cv-238. Escalera brought claims for personal injury under a variety of theories, including negligence, strict liability design defect, strict liability manufacturing defect, strict liability failure to warn, breach of implied and express warranties, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. Mentor seeks summary judgment on her claims for strict liability design defect, strict liability manufacturing defect, and breach of implied and express warranty. Escalera does not contest summary judgment on her claims for strict liability design defect, strict liability manufacturing defect, and breach of implied warranties. Summary judgment is therefore granted as to those claims. The only remaining question raised by Mentor's partial summary judgment motion is whether Escalera's breach of express warranty claim survives summary judgment. DISCUSSION ase 4:16-cv-00035-CDL Document 12-13 Filed 04/24/17 Page 2 of 3 In re Mentor Corp. ObTape Transobturator Sling Products..., Not Reported in... © 2017 Thomson Reuters. No claim to original U.S. Government Works. 2 *2 Escalera filed her action in this Court 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 parties agree that California law applies to Escalera's claims because Escalera is a California resident and all of her medical treatment relevant to this action occurred in California. Escalera asserts a breach of express warranty claim based on Mentor's alleged failure to warn of ObTape's “dangerous side effects.” See Compl. ¶¶ 69, 74 (alleging that Mentor warranted that ObTape “did not produce any dangerous side effects” even though it did). Mentor contends that Escalera's breach of express warranty claim fails because she did not notify Mentor of the alleged breach before filing her lawsuit. California's commercial code requires a buyer to notify the seller of breach within a reasonable time after discovering the breach; if such notice is not given, the buyer is “barred from any remedy.”Cal. Com.Code § 2607(3)(A). Escalera argues that the seminal case of Greenman v. Yuba Power Products, Inc., 59 Cal.2d 57 (1963) stands for the proposition that the warranty notice requirement does not exist for “remote buyer” breach of warranty claims. But what Greenman really did was adopt the doctrine of strict liability and conclude that the procedural requirements of a warranty claim cannot defeat strict products liability in tort. Id. at 61-62 (explaining that strict liability in tort is not based on the law of contract warranties). Escalera did not point the Court to any authority that California's adoption of strict liability in tort removes the warranty notice requirement for a plaintiff attempting to proceed under a contract theory of recovery. In the absence of such authority, the Court concludes that Escalera's breach of express warranty claim fails for failure to provide the required statutory notice, and summary judgment is therefore granted on her breach of express warranty claim. As a practical matter, Escalera's breach of express warranty claim appears to be nearly identical to her strict liability failure to warn claim, and Mentor did not move for summary judgment on that claim. CONCLUSION As discussed above, Mentor's Motion for Partial Summary Judgment (ECF No. 38 in 4:12-cv- 238) is granted. Only the following claims remain pending for trial: negligence, strict liability failure to warn, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. 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. All Citations Not Reported in F.Supp.3d, 2015 WL 5468791 End of Document © 2017 Thomson Reuters. No claim to original U.S. Government Works. ase 4:16-cv-00035-CDL Document 12-13 Filed 04/24/17 Page 3 of 3 Exhibit K Case 4:16-cv-00035-CDL Document 12-14 Filed 04/24/17 Page 1 of 6 In re Guidant Corp. Implantable Defibrillators Products..., Not Reported in... 2007 WL 2023569 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 1 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 the parties did not provide any actual numbers, the Court notes there is a relatively small number (1,000-2,000 range) of electrophysiologists in the United States. 2 Guidant did not provide the Court with a copy of the manual; instead, these quotes are taken from Dr. Higgins' Affidavit. (Guidant's Summ. J. Mem., Ex. I.) Duron does contest the accuracy of the quotations. In June 2005, Guidant recalled Prizm 2 devices, including Duron's device, which were manufactured prior to April 2002. Shortly thereafter, the Food and Drug Administration classified Guidant's recall as a Class I recall. A Class I recall is reserved for devices that create a reasonable probability of serious adverse health consequence or death. On August 19, 2005, Dr. Sardul Singh explanted Duron's Prizm 2 and replaced it with ase 4:16-cv-00035-CDL Document 12-14 Filed 04/24/17 Page 2 of 6 In re Guidant Corp. Implantable Defibrillators Products..., Not Reported in... 2007 WL 2023569 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 2 a different Guidant-manufactured ICD. Subsequently, Duron commenced an action against Guidant based on alleged injuries he suffered as a result of the Prizm 2. ARGUMENT I. Motion for Summary Judgment Summary judgment is proper if there are no disputed issues of material fact and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c). The Court must view the evidence and the inferences, which may be reasonably drawn from the evidence, in the light most favorable to the nonmoving party. Enter. Bank v. Magna Bank of Mo., 92 F.3d 743, 747 (8th Cir.1996). As the United States Supreme Court has stated, “[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 Corp. v. Catrett, 477 U.S. 317, 327 (1986) (quoting Fed.R.Civ.P. 1). The moving party bears the burden of showing that there is no genuine issue of material fact and that it is entitled to judgment as a matter of law. Enter. Bank, 92 F.3d at 747. The nonmoving party must demonstrate the existence of specific facts in the record that create a genuine issue for trial. Krenik v. County of Le Sueur, 47 F.3d 953, 957 (8th Cir.1995). A party opposing a properly supported motion for summary judgment may not rest upon mere allegations or denials of his pleading, but must set forth specific facts showing that there is a genuine issue for trial. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 256 (1986). *2 Guidant moves for summary judgment on Duron's failure-to-warn claims based on the learned intermediary doctrine. The parties agree that the learned intermediary doctrine applies to Duron's failure-to-warn claims and on the standard used for failure-to-warn claims under California law. They disagree about the impact of that doctrine and standard on Duron's claims. 3 3 It is unclear which exact counts in Duron's Amended Complaint-by-Adoption the parties classify as the “failure-to-warn” claims. Guidant classifies the claims “as strict liability warning and negligent failure to warn, [and] ... the consumer protection claims to the extent they are based on a failure to warn theory.” (6/19/07 Tr. at 58.) Duron classifies his failure-to-warn claims as those claims that “sound in fraud or something akin to fraud or negligence.” (Id. at 63 .) Given this, Counts I, III, VI, and VIII are likely implicated. The standards for such claims are quite different. See Carlin v. Superior Court, 13 Cal.4th 1104, 1112-13 (Cal.1996) (discussing differences between negligent failure-to-warn claims and strict liability failure-to-warn claims). 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 device's “dangerous propensities that were either known or reasonably scientifically knowable at the time of distribution.” Brown v. Superior Court, 44 Cal.3d 1049, 1061 (Cal.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 plaintiff's injury. Motus v. Pfizer, Inc., 196 F.Supp.2d 984, 993 (C.D.Cal.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 ase 4:16-cv-00035-CDL Document 12-14 Filed 04/24/17 Page 3 of 6 In re Guidant Corp. Implantable Defibrillators Products..., Not Reported in... 2007 WL 2023569 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 3 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 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 Cal.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 plaintiff's injury. Motus, 196 F.Supp.2d at 995. In ase 4:16-cv-00035-CDL Document 12-14 Filed 04/24/17 Page 4 of 6 In re Guidant Corp. Implantable Defibrillators Products..., Not Reported in... 2007 WL 2023569 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 4 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 ¶ 11.) 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 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 Cal.3d 51, 66-67 (Cal.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 ase 4:16-cv-00035-CDL Document 12-14 Filed 04/24/17 Page 5 of 6 In re Guidant Corp. Implantable Defibrillators Products..., Not Reported in... 2007 WL 2023569 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 5 (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. All Citations Not Reported in F.Supp.2d, 2007 WL 2023569 End of Document © 2017 Thomson Reuters. No claim to original U.S. Government Works. ase 4:16-cv-00035-CDL Document 12-14 Filed 04/24/17 Page 6 of 6 Exhibit L Case 4:16-cv-00035-CDL Document 12-15 Filed 04/24/17 Page 1 of 5 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) 2016 WL 822945 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 1 2016 WL 822945 Only the Westlaw citation is currently available. United States District Court, M.D. Georgia, Columbus Division. In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation. MDL Docket No. 2004 | 4:08-MD-2004 (CDL) | Case Nos. 4:12-cv-245 (Clinton) | 4:12-cv-252 (Woolf) | Signed 02/29/2016 ORDER CLAY D. LAND CHIEF U.S. DISTRICT COURT *1 Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiffs Andrea Clinton and Bobbie Jo Woolf 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 summary judgment on several of Plaintiffs' claims. For the reasons set forth below, Mentor's partial summary judgment motions are is granted in part and denied in part. 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. Andrea Clinton (ECF No. 49 in 4:12-cv-245) Plaintiff Andrea Clinton visited Dr. John Saba for treatment of stress urinary incontinence. Dr. Saba recommended a sling implant, and he showed Clinton a “binder” of materials regarding the procedure. Clinton Dep. 87:9-16, ECF No. 50-3. The binder contained a diagram of the female anatomy and explained the basics of the transobturator process. Id. at 88:2-20. It also stated that “there was a chance of rare infection.” Id. at 87:23-25. Clinton decided to go ahead with the sling procedure, and Dr. Saba implanted Clinton with ObTape on December 2, 2004. In 2005, Clinton had severe left groin and leg pain, and she visited multiple physicians for treatment of these symptoms. None of the doctors connected the symptoms to Clinton's ObTape. One of the doctors Clinton visited was Dr. John Mazuski, a general surgeon with a specialty in infectious disease. Like the other doctors, Dr. Mazuski did not connect Clinton's symptoms to her ObTape, and it is not clear from the present record whether Dr. Mazuski even knew that Clinton had been implanted with ObTape when he treated her in 2005. Dr. Mazuski testified that if Mentor had provided information to him clearly associating ObTape with a problem in the thigh and if he knew that Clinton had been implanted with ObTape, then he would have known that it was “at least an option” to remove the ObTape. Mazuski Dep. 92:6-93:6, ECF No. 50-3. Dr. Mazuski is not a urologist or a gynecologist, and he has no expertise in urology or gynecology. Mazuski Dep. 13:3-16, ECF No. 51-3. Dr. Mazuski has no clinical experience with suburethral slings like ObTape. Id. 68:5-20, ECF No. 51-3. *2 In December 2007, Clinton went to the hospital complaining of groin pain and swelling, as well as foul- smelling vaginal discharge. She also said that she could feel the ObTape in her vagina. Dr. Arnold Bullock diagnosed Clinton with an infection of her ObTape and a vaginal ase 4:16-cv-00035-CDL Document 12-15 Filed 04/24/17 Page 2 of 5 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) 2016 WL 822945 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 2 erosion, and he told her that she needed to have a revision surgery. Dr. Bullock performed a revision surgery on December 24, 2007, and he removed as much of the ObTape as he could. Clinton went back to Dr. Bullock with additional complaints, and he performed a second revision surgery to remove additional ObTape from Clinton's body. Clinton's adverse symptoms continued, and Dr. Bullock performed exploratory surgery in February 2008 but could not find any additional tape. Clinton then visited Dr. Carl Klutke, who performed a fourth revision surgery in March 2008 and removed additional infected pieces of ObTape from Clinton's body. Clinton's symptoms improved after the fourth revision surgery. During each revision surgery, both Dr. Bullock and Dr. Klutke attempted to remove as much of the ObTape as possible. Clinton is a Missouri resident whose ObTape-related treatment took place in Missouri. She filed her action in this Court pursuant to the Court's direct filing order on September 20, 2012, asserting claims for negligence, strict liability-design defect, strict liability - manufacturing defect, strict liability - failure to warn, breach of implied warranties, breach of express warranties, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. II. Bobbie Jo Woolf (ECF No. 43 in 4:12-cv-252) Dr. Carl Klutke diagnosed Plaintiff Bobbie Jo Woolf with stress urinary incontinence. Dr. Klutke testified that he would have shared information from the ObTape product data insert sheet with patients like Woolf. Klutke Dep. 33:10-16, ECF No. 44-3. The product information sheet states that the risk of certain complications is very rare. Woolf testified that if Dr. Klutke had told her that the risks were not very rare or that she could develop complications years after the surgery, she would not have consented to the ObTape procedure. Woolf Dep. 120:1-121:8, ECF No. 44-3. Dr. Klutke implanted Woolf with ObTape on December 9, 2004. After the procedure, Woolf's urinary leakage improved, but it returned in mid-2007. And in November 2008, after Woolf began experiencing vaginal discomfort, Woolf saw Dr. Salina Green. Dr. Green told Woolf that “mesh had fallen and was growing inside” her. Woolf Dep. 97:3-5. Woolf was referred to Dr. Dionysios Veronikis, who recommended surgical removal of Woolf's ObTape. On January 6, 2009, Dr. Veronikis removed as much of the ObTape as he could. Woolf is a Missouri resident whose ObTape-related treatment took place in Missouri. She filed her action in this Court pursuant to the Court's direct filing order on September 20, 2012, asserting claims for negligence, strict liability-design defect, strict liability - manufacturing defect, strict liability - failure to warn, breach of implied warranties, breach of express warranties, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. Woolf does not contest summary judgment as to her claims for breach of implied warranty, fraudulent misrepresentation, and negligent misrepresentation, so Mentor's partial summary judgment motion is granted as to those claims. DISCUSSION Clinton and Woolf filed their actions in this Court 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. Clinton and Woolf are Missouri residents whose ObTape-related treatment took place in Missouri, and the parties agree that Missouri law applies to their claims. Mentor seeks summary judgment on both Plaintiffs' claims for breach of express warranty and fraudulent concealment. Mentor also seeks summary judgment on Clinton's breach of the continuing duty to warn claim. The Court will evaluate each of Mentor's summary judgment arguments in turn. I. Breach of Express Warranty *3 Missouri has a four-year statute of limitations for breach of express warranty claims. Mo. Ann. Stat. § 400.2-725(1). “A cause of action accrues when the breach occurs, regardless of the aggrieved party's lack of knowledge of the breach.” Id. § 400.2-725(2). If this statute of limitations applies to Plaintiffs' breach of express warranty claims, the claims are time-barred because Plaintiffs' ObTape was delivered in December 2004 and neither Plaintiff filed her action within four years. ase 4:16-cv-00035-CDL Document 12-15 Filed 04/24/17 Page 3 of 5 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) 2016 WL 822945 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 3 Plaintiffs argue that the four-year statute of limitations does not apply to their breach of express warranty claims. In support of this argument, Plaintiffs point to Missouri case law following Greenman v. Yuba Power Products, Inc., 59 Cal.2d 57 (1963) and adopting strict liability in tort for products liability cases. State ex rel. Apco Oil Corp. v. Turpin, 490 S.W.2d 400, 405 (Mo. Ct. App. 1973) (“A products liability case is now considered to be tortious and any recovery is really in tort.”). They also pointed to precedent regarding the applicable statute of limitations for implied warranty cases. E.g., Witherspoon v. Gen. Motors Corp., 535 F. Supp. 432, 434 (W.D. Mo. 1982). As the Court previously observed, Greenman adopted the doctrine of strict liability and concluded that the procedural requirements of a warranty claim cannot defeat strict products liability in tort. Greenman, 59 Cal.2d at 61-62 (explaining that strict liability in tort is not based on the law of contract warranties). Plaintiffs did not point the Court to any authority that Missouri's adoption of strict liability in tort changes the applicable statute of limitations for a plaintiff attempting to proceed under a contract theory of recovery. In the absence of such authority, the Court concludes that Plaintiffs' breach of express warranty claims are time-barred, and summary judgment is therefore granted as to their breach of express warranty claims. As a practical matter, Plaintiffs' breach of express warranty claims appear to be nearly identical to their strict liability failure to warn claims, and Mentor did not move for summary judgment on those claims. II. Fraudulent Concealment Mentor also seeks summary judgment on Plaintiffs' fraudulent concealment claims, which are based on their assertion that Mentor concealed material facts about ObTape from their implanting physicians and that they would not have undergone the ObTape procedure if Mentor had disclosed ObTape's true risks to their implanting physicians. “Silence or nondisclosure becomes misrepresentation only when there is a duty to speak.” Bohac v. Walsh, 223 S.W.3d 858, 864 (Mo. Ct. App. 2007). Missouri imposes “a duty to disclose information when there is a relation of trust and confidence between the parties or when one of the parties has superior knowledge or information not within the fair and reasonable reach of the other party.” Id. Mentor asserts that there was no “duty to speak” here because no fiduciary relationship existed between Mentor and Plaintiffs. Under Missouri law, the manufacturer of a prescription device “has 'a duty to properly warn the doctor of the dangers involved and it is incumbent upon the manufacturer to bring the warning home to the doctor.”' Doe v. Alpha Therapeutic Corp., 3 S.W.3d 404, 419 (Mo. Ct. App. 1999) (quoting Krug v. Sterling Drug, Inc., 416 S.W.2d 143, 146 (Mo. 1967)). In other words, “the manufacturer of prescription ... products discharges its duty to warn by providing the physician with information about risks associated with those products.” Id. Thus, it is clear that Mentor had a duty to warn each Plaintiff's implanting physician about the risks associated with ObTape so that the physician could decide whether to implant it in his patient. The Court declines to find that Plaintiffs' fraudulent concealment claims fail for lack of a fiduciary relationship. *4 Mentor argues that even if it had a duty to disclose facts that it allegedly concealed, Woolf has not pointed to any evidence to create a genuine fact dispute on causation. The Court disagrees. Woolf pointed to evidence that Mentor provided certain information about ObTape's risks to her implanting physician, that Woolf's implanting physician routinely shared such information with his patients, and that Woolf would not have consented to the procedure had she known ObTape's true risks. For these reasons, the Court denies summary judgment as to Plaintiffs' fraudulent concealment claims. III. Continuing Duty to Warn Finally, Mentor seeks summary judgment on Clinton's continuing duty to warn claim. Mentor argues that Missouri has not recognized such a claim. Mentor also argues that even if Missouri were to recognize such a claim, Clinton has not presented sufficient evidence of causation. Pretermitting the question whether Missouri recognizes a continuing duty to warn claim, the Court finds that Clinton has not presented sufficient evidence to create a genuine factual dispute on causation. Clinton argues that if Mentor had provided adequate post-implant warnings about ObTape, one of her doctors could have removed the ObTape before they ultimately did, thus preventing some of her injuries. Clinton does not base her continuing duty to warn claim on Mentor's alleged failure to provide adequate post-implant warnings to her implanting physician, Dr. Saba. She did not argue or point to any evidence that her post-implant treatment ase 4:16-cv-00035-CDL Document 12-15 Filed 04/24/17 Page 4 of 5 In re Mentor Corp. Obtape Transobturator Sling Products Liability..., Slip Copy (2016) 2016 WL 822945 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 4 would have been different if Mentor had provided a post-implant warning to Dr. Saba-such as evidence that Dr. Saba would have taken a different approach to her treatment or evidence that Dr. Saba would have passed the warning along to Clinton and that Clinton's injuries would have been mitigated if he had done so. Rather, Clinton relies exclusively on the testimony of Dr. Mazuski to establish causation on her continuing duty to warn claim. According to Clinton, if Dr. Mazuski, a general surgeon, had known of a potential connection between ObTape and Clinton's groin and leg pain when he treated her in 2005, it would have been an option for him to remove the ObTape. Again, it is not clear from the present record whether Dr. Mazuski even knew that Clinton had been implanted with ObTape when he treated her in 2005. As discussed above, the manufacturer of a prescription medical device “has 'a duty to properly warn the doctor of the dangers involved and it is incumbent upon the manufacturer to bring the warning home to the doctor.”' Doe, 3 S.W.3d at 419 (quoting Krug, 416 S.W.2d at 146). Thus, Mentor had a duty to warn Clinton's implanting physician about the risks associated with ObTape so that he could decide whether to implant her with the product. That duty to warn would also likely extend to doctors who regularly treat patients with suburethral sling products, such as urologists and gynecologists. But Clinton did not point to any authority that Mentor had a duty to warn all physicians everywhere of the risks of ObTape. And she did not point the Court to any authority that Mentor had a duty to warn Dr. Mazuski, a general surgeon who does not have any clinical experience with suburethral slings and does not make decisions regarding the implant or explant of suburethral slings, and the Court found none. For these reasons, Clinton cannot rely on Dr. Mazuski's testimony to establish causation. Moreover, even if Missouri law did require Mentor to warn Dr. Mazuski of the risks associated with ObTape, there is no evidence that such a warning would have made a difference in Dr. Mazuski's treatment of Clinton because Clinton did not point to any evidence establishing that Dr. Mazuski knew in 2005 that Clinton had been implanted with ObTape. *5 Again, Clinton does not argue that Mentor's failure to provide adequate post-implant warnings to Dr. Saba caused her injuries. She also does not argue that Mentor's failure to provide adequate post-implant warnings to Dr. Bullock and Dr. Klutke-the two urologists who performed Clinton's revision surgeries- caused her injuries. Both Dr. Bullock and Dr. Klutke tried to remove as much of the ObTape as they could, which Clinton agrees they should have done. Clinton pointed to no evidence that Dr. Bullock and Dr. Klutke would have taken a different approach if they had been given different post-implant warnings or that a different approach by these two doctors in 2007 and 2008 would have mitigated her injuries. For all of these reasons, Clinton's continuing duty to warn claim fails. CONCLUSION Andrea Clinton. Mentor's motion for partial summary judgment (ECF No. 49 in 4:12-cv-245) is granted as to Clinton's breach of express warranty and continuing duty to warn claims. Mentor's summary judgment motion is denied as to Clinton's fraudulent concealment claim. That claim, along with her claims for negligence, strict liability-design defect, strict liability -manufacturing defect, strict liability - failure to warn, breach of implied warranties, fraudulent misrepresentation, and negligent misrepresentation remain pending for trial. Bobbie Jo Woolf. Mentor's motion for partial summary judgment (ECF No. 43 in 4:12-cv-252) is granted as to Woolf's claims for breach of express warranty, breach of implied warranty, fraudulent misrepresentation, and negligent misrepresentation. Mentor's motion is denied as to Woolf's fraudulent concealment claim. That claim, along with Woolf's claims for negligence, strict liability- design defect, strict liability - manufacturing defect, and strict liability - failure to warn, 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 29th day of February, 2016. All Citations Slip Copy, 2016 WL 822945 End of Document © 2017 Thomson Reuters. No claim to original U.S. Government Works. ase 4:16-cv-00035-CDL Document 12-15 Filed 04/24/17 Page 5 of 5 Exhibit M Case 4:16-cv-00035-CDL Document 12-16 Filed 04/24/17 Page 1 of 4 In re Mentor Corp. ObTape Transobturator Sling Products Liability..., Slip Copy (2016) © 2017 Thomson Reuters. No claim to original U.S. Government Works. 1 2016 WL 7209431 Only the Westlaw citation is currently available. United States District Court, M.D. Georgia, Columbus Division. In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation. MDL Docket No. 2004 | Case No. 4:14-cv-113 (Morgan) | 4:08-MD-2004 (CDL) | Signed 12/09/2016 ORDER CLAY D. LAND, CHIEF U.S. DISTRICT COURT JUDGE *1 Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Doris Morgan was implanted with ObTape and claimed that she suffered injuries caused by ObTape. Morgan brought a product liability action against Mentor, contending that ObTape had design and/ or manufacturing defects that proximately caused her injuries. Morgan also asserted that Mentor did not adequately warn her physicians about the risks associated with ObTape. Morgan died after she filed this action. Her daughters Vickie Thomas and Sandra F. Johnston, as representatives for the Estate of Doris Morgan, were substituted as the Plaintiffs in this action. Mentor seeks summary judgment as to Plaintiffs' breach of warranty and continuing duty to warn claims. As discussed below, Mentor's partial summary judgment motion (ECF No. 33 in 4:14-cv-113) is granted. 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 On May 9, 2005, Dr. Lane Mercer implanted Morgan with ObTape to treat her stress urinary incontinence. Dr. Mercer does not recall treating Morgan after her implant surgery. Mercer Dep. 29:9-17. According to Morgan's daughter, Morgan did follow up with Dr. Mercer a few months after the implant procedure. Johnston Dep. 16:2-21, ECF No. 35-3 in 4:14-cv-113. Morgan's daughter also testified that Morgan saw Dr. Mercer in 2009 when she began nerve stimulation treatment to treat her recurrent stress urinary incontinence. Id. at 18:6-24; accord Mercer Dep. 29:9-24, ECF No. 35-5 in 4:14-cv-113. When Morgan saw Dr. Mercer in 2009, Dr. Mercer “didn't mention the- the tape at all. He said it was more of a problem between maybe [Morgan's] brain and her bladder not communicating.” Johnston Dep. 18:6-16. 1 1 Plaintiffs assert that Morgan sought treatment from Dr. Mercer for a bladder infection, but they did not present evidence to prove this point. They cited Johnston's deposition at page 18:22-25, which states that Morgan was experiencing stress urinary incontinence in 2009. They also cited Johnston's deposition at page 19:1-6, but they did not include that page with the deposition excerpt they submitted, so the Court cannot determine whether it supports Plaintiffs' claim that Morgan sought treatment from Dr. Mercer for a bladder infection. ase 4:16-cv-00035-CDL Document 12-16 Filed 04/24/17 Page 2 of 4 In re Mentor Corp. ObTape Transobturator Sling Products Liability..., Slip Copy (2016) © 2017 Thomson Reuters. No claim to original U.S. Government Works. 2 *2 In 2013, Morgan sought treatment from Dr. Rakesh Patel. Dr. Patel diagnosed Morgan with an erosion of her ObTape. Dr. Patel removed Morgan's entire ObTape on October 25, 2013, and he was able to remove it as one piece. Dr. Patel's practice was to remove the entire ObTape in the event of an erosion. Patel Dep. 43:16-44:10, 93:18-94:17, ECF No. 33-6 in 4:14-cv-113. Dr. Mercer's practice was also to remove any eroded tape in the event of an erosion. Mercer Dep. 95:14-19, ECF No. 33-5 in 4:14-cv-113. Dr. Mercer testified that an additional warning to remove as much ObTape as possible in the event of an erosion would not have changed his practice because he would remove any eroded tape, anyway. Id. Plaintiffs assert claims for negligence, strict liability-design defect, strict liability -manufacturing defect, strict liability-failure to warn, breach of implied warranties, breach of express warranties, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. Mentor seeks summary judgment on Plaintiffs' warranty claims, as well as any claims based on Mentor's alleged breach of a post-sale duty to warn. Plaintiffs do not contest Mentor's summary judgment motion as to the warranty claims, and Mentor's summary judgment motion is therefore granted as to those claims. DISCUSSION Morgan filed her action in this Court on May 8, 2014 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. Morgan was a Florida resident, and all of her ObTape-related treatment took place in Florida. The parties agree that Florida law applies to the Plaintiffs' claims. Florida law recognizes a continuing duty to warn. See Sta-Rite Indus., Inc., v. Levey, 909 So. 2d 901, 905-06 (Fla. Dist. Ct. App. 2004) (finding that swimming pool pump manufacturer could be liable for injuries caused by inadequate warnings because it did not send updated warnings to its distributors). The Court previously concluded that to state a continuing duty to warn claim under Florida law, an ObTape plaintiff must present some evidence that a different post-sale warning would have made a difference in her treatment. Burch v. Mentor, Case No. 4:12-cv-279, 2015 WL 5722799, at *3-*4 (M.D. Ga. Sept. 29, 2015). Plaintiffs did not point to any authority suggesting that Florida courts have since adopted a different causation standard for continuing duty to warn claims. Plaintiffs do not appear to dispute that it would not have made a difference to Morgan's post-implant treatment if Mentor had instructed physicians to remove as much of the ObTape as possible in the event of an erosion. Dr. Mercer never diagnosed Morgan with an erosion of her ObTape; if he had, he would have removed any eroded ObTape. And Dr. Patel's practice was to remove the entire ObTape in the event of an erosion, which is what he did for Morgan. Rather, Plaintiffs' chief argument appears to be that Mentor should have warned Dr. Mercer of the risk of delayed onset infections and that the Court may presume that Dr. Mercer would have diagnosed Morgan with a failed sling in 2009 and taken some unspecified action to treat it. But Plaintiffs did not point to any evidence of what Dr. Mercer would have done with an additional warning. There must be some evidence that Mentor's failure to issue adequate post-sale warnings actually caused Morgan's injuries. Citing Sta-Rite, Plaintiffs contend that the Court may simply presume that a different post-sale warning would have made a difference to Morgan's treatment. As the Court previously observed, Sta-Rite “stand[s] for the proposition that under Florida law, the courts may assume that an adequate warning would have been heeded.” Id. at *3. But Sta-Rite “did not dispense with the causation requirement entirely.” Id. “In Sta-Rite, the court presumed that the pool owner would have heeded a more stringent warning regarding the hazards of a pool pump and would have fixed the grate over the pump in time to avoid the plaintiff's injuries.” Id. (citing Sta-Rite, 909 So. 2d at 906). “Thus, all Sta-Rite ... allow[s] the Court ase 4:16-cv-00035-CDL Document 12-16 Filed 04/24/17 Page 3 of 4 In re Mentor Corp. ObTape Transobturator Sling Products Liability..., Slip Copy (2016) © 2017 Thomson Reuters. No claim to original U.S. Government Works. 3 to presume is that Dr. [Mercer] would have paid attention to an additional warning that ObTape may have a higher rate of infection than other slings.” Id. Sta-Rite does not, “however, permit the Court to speculate as to what Dr. [Mercer] would have done with those warnings.” Id. *3 “[I]n Sta-Rite, there was enough evidence for a jury to find that the pool owner would have heeded a warning to fix the grate over the pump in time to prevent the plaintiff's injuries.” Id. at *4 (citing Sta-Rite, 909 So. 2d at 906). But this case, unlike Sta-Rite, involves a complex decision regarding a medical device that had already been implanted in Morgan's body. Though Plaintiffs did present evidence that Morgan had two post-implant visits with Dr. Mercer, they did not point to any evidence that he treated her for an infection. Even if they had pointed to evidence that Dr. Mercer treated Morgan for an infection, they did not point to any evidence of how a different warning regarding delayed onset ObTape-related infections would have affected his treatment of Morgan. Without such evidence, “the Court finds it highly unlikely that the Florida courts would presume causation under the circumstances of this case.” Id. “Absent a presumption that relies on pure speculation, no reasonable juror could conclude based on the present record that any post-implant failure to warn caused any of [Morgan's] injuries.” Id. For these reasons, Mentor is entitled to summary judgment on Plaintiffs' continuing duty to warn claims based on Mentor's alleged failure to provide adequate post-implant warnings to Morgan's physicians. Plaintiffs also argue that they can assert a continuing duty to warn claim based on Mentor's failure to provide an adequate post-implant warning directly to Morgan. This argument fails for two reasons. First, under Florida's learned intermediary rule, Mentor's duty to warn was directed to Morgan's physicians and not to Morgan herself; Mentor did not have a duty to warn Morgan directly. See Hoffmann-La Roche Inc. v. Mason, 27 So. 3d 75, 77 (Fla. Dist. Ct. App. 2009) (explaining Florida's learned intermediary rule). Second, though Plaintiffs speculate that Morgan might have been able to connect her infection symptoms to her ObTape and then might have sought more targeted treatment, Plaintiffs did not point to any evidence of what Morgan actually would have done with a different post- implant warning. Thus, Mentor is entitled to summary judgment on Plaintiffs' continuing duty to warn claims based on Mentor's alleged failure to provide adequate post-implant warnings directly to Morgan. CONCLUSION As discussed above, the Court grants Mentor's summary judgment motion as to Plaintiffs' warranty claims and any claims based on Mentor's alleged breach of a post-sale duty to warn. Plaintiffs' other claims remain pending for trial. This action is ready for trial. Within seven days of the date of this Order, the parties shall notify the Court whether they agree to a Lexecon waiver. IT IS SO ORDERED, this 9th day of December, 2016. All Citations Slip Copy, 2016 WL 7209431 End of Document © 2017 Thomson Reuters. No claim to original U.S. Government Works. ase 4:16-cv-00035-CDL Document 12-16 Filed 04/24/17 Page 4 of 4 Exhibit N Case 4:16-cv-00035-CDL Document 12-17 Filed 04/24/17 Page 1 of 5 In re Mentor Corp., Not Reported in F.Supp.3d (2015) 2015 WL 5722799 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 1 2015 WL 5722799 Only the Westlaw citation is currently available. United States District Court, M.D. Georgia, Columbus Division. In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation. MDL Docket No. 2004 4:08-MD-2004 (CDL) | Case No. 4:12-cv-276 (B. BURCH) | Signed 09/29/2015 ORDER CLAY D. LAND, CHIEF U.S. DISTRICT COURT JUDGE MIDDLE DISTRICT OF GEORGIA *1 Defendant Mentor Worldwide LLC developed a suburethral sling product called ObTape Transobturator Tape, which was used to treat women with stress urinary incontinence. Plaintiff Barbara Burch was implanted with ObTape and asserts that she suffered injuries caused by ObTape. Mrs. Burch brought this product liability action against Mentor, contending that ObTape had design and/ or manufacturing defects that proximately caused her injuries. Mrs. Burch also asserts that Mentor did not adequately warn her physicians about the risks associated with ObTape. Mrs. Burch's husband Rufus asserts a loss of consortium claim. Mentor seeks summary judgment on several of Mrs. Burch's claims. For the reasons set forth below, Mentor's Motion for Partial Summary Judgment (ECF No. 38 in 4:12-cv-276) is granted in part and denied in part. 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 Viewed in the light most favorable to Plaintiffs, the record reveals the following. Plaintiffs are residents of Florida, and all of Mrs. Burch's medical treatment relevant to this action occurred in Alabama. In 2004, Mrs. Burch saw Dr. John Peacock for treatment of stress urinary incontinence and other symptoms. Dr. Peacock implanted ObTape in Mrs. Burch on July 2, 2004. Mrs. Burch did not speak with any Mentor representatives or see any information from Mentor prior to the surgery. But Dr. Peacock did receive information from Mentor, including the ObTape product information sheet, which disclosed certain complication rates for ObTape. Complication rates are important to Dr. Peacock in determining whether to use a product; based on ObTape's product information data sheet, Dr. Peacock understood that erosions and infections occurred “very rarely.” Peacock Dep. 110:24-111:15, 169:25-170:2, ECF No. 43-6. Mrs. Burch pointed to several studies concluding that ObTape's complication rate exceeds 5%, and Dr. Peacock testified that complications are not “very rare” at that rate. Peacock Dep. 170:3-13. Mrs. Burch asserts that she suffered several injuries caused by ObTape. Mrs. Burch did not return to Dr. Peacock for treatment of these symptoms, and her ObTape has never been explanted. Plaintiffs filed their Complaint on October 15, 2012. See generally Compl., ECF No. 1 in 4:12-cv-276. Mrs. Burch brought claims for personal injury based upon the following theories: negligence, strict liability design defect, strict liability manufacturing defect, strict liability failure to warn, breach of implied and express warranties, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. Mr. Burch brought a loss of consortium claim. DISCUSSION ase 4:16-cv-00035-CDL Document 12-17 Filed 04/24/17 Page 2 of 5 In re Mentor Corp., Not Reported in F.Supp.3d (2015) 2015 WL 5722799 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 2 *2 Plaintiffs filed their action in this Court under the Court's direct filing order. The parties agree 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. Florida's choice of law rules thus apply. Plaintiffs contend that under Florida's choice of law rules, Florida law applies. Mentor does not seriously dispute that Florida law applies. 1 The Court recently decided a Florida choice-of-law issue under factually indistinguishable circumstances. See Taylor v. Mentor, Order Den. Mot. for Summ. J. 5-8, ECF No. 54 in 4:12- cv-176 (M.D. Ga. Aug. 4, 2015). For the reasons stated in that order, Florida law applies to Plaintiffs' claims here. 1 Mentor contends that a choice of law analysis is unnecessary because there is no conflict between Alabama and Florida law on the issues raised in Mentor's summary judgment. Plaintiffs, however, pointed out that Florida recognizes a continuing duty to warn claim, while Alabama does not. Mentor seeks summary judgment on Mrs. Burch's claims for manufacturing defect, breach of the continuing duty to warn, breach of express warranty, and fraudulent and negligent misrepresentation. The Court addresses each issue in turn. I. Manufacturing Defect Mrs. Burch asserts that her ObTape has a manufacturing defect. A manufacturing defect exists if a product “is different from its intended design and fails to perform as safely as the intended design would have performed.” In re Standard Jury Instructions in Civil Cases - Report No. 13-01 (Products Liability) § 403.7(a), 160 So. 3d 869, 874 (Fla. 2015) (adopting manufacturing defect definition in pattern jury instructions). To establish a manufacturing defect, a plaintiff must present evidence that the product did not meet manufacturing specifications and that the defect proximately caused the plaintiff's injuries. Edward M. Chadbourne, Inc. v. Vaughn, 491 So. 2d 551, 553 (11th Cir. 1986). 2 2 The Florida standard for manufacturing defect is substantially the same as the Georgia standard. See In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., 711 F. Supp. 2d 1348, 1365 (M.D. Ga. 2010) (“[I]n a manufacturing defect case, the 'product's defectiveness is determined by measuring the product in question against the benchmark of the manufacturer's designs.”') (quoting ACE Fire Underwriters Ins. Co. v. ALC Controls, Inc., No. 1:07- CV-606-TWT, 2008 WL 2229121, at *2 (N.D. Ga. May 28, 2008)). Mrs. Burch's claim for manufacturing defect is based on the same evidence that the Phase I Georgia Plaintiffs presented in opposition to summary judgment: evidence that (1) ObTape's product specifications called for pores measuring between 40 and 100 microns and (2) tests of ObTape samples revealed “nonuniform pores, some of which are closed-ended pores and the vast majority of which are smaller than 40 microns.” In re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., 711 F. Supp. 2d 1348, 1376 (M.D. Ga. 2010). Based on that evidence, the Court found a genuine fact dispute on the Phase I Georgia Plaintiffs' manufacturing defect claims. Id. Mentor contends that Mrs. Burch cannot make out a manufacturing defect claim because she did not point to any evidence that an expert examined her specific ObTape -which is still in her body-and opined that it has a manufacturing defect. One way to prove a manufacturing defect is to test the specific subject product against manufacturing standards, but Mentor did not point the Court to any authority that such testing is the only way to establish a manufacturing defect under Florida law. Here, Mrs. Burch relies on the same evidence as the Phase I Georgia Plaintiffs, whose specific ObTape was not tested, either. Rather, their experts tested a number of ObTape samples and concluded that a substantial portion of each ObTape tested had pores smaller than 40 microns. In re Mentor, 711 F. Supp. 2d at 1376. At this time, the Court remains satisfied that this evidence is sufficient to create a genuine fact dispute on Mrs. Burch's manufacturing defect claim. 3 Mentor's summary judgment motion on the manufacturing defect claim is thus denied. The Court may reconsider this issue when ruling on any motion for judgment as a matter of law that may be presented at trial. 3 Because Mrs. Burch presented sufficient evidence to establish a manufacturing defect in ObTape, it is unnecessary for the Court to apply the inference described in Cassisi v. Maytag Co., 396 So. 2d 1140, 1148 (Fla. Dist. Ct. App. 1981). ase 4:16-cv-00035-CDL Document 12-17 Filed 04/24/17 Page 3 of 5 In re Mentor Corp., Not Reported in F.Supp.3d (2015) 2015 WL 5722799 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 3 II. Misrepresentation and Breach of Express Warranty Claims *3 Mentor contends that Mrs. Burch cannot make out her misrepresentation and warranty claims because she did not rely on any misrepresentations from Mentor regarding ObTape. Mrs. Burch does not dispute that reliance is a key element of her fraudulent misrepresentation, negligent misrepresentation, and breach of express warranty claims. See, e.g., Fla. Stat. Ann. § 672.313(1)(a) (requiring that an affirmation become “part of the basis of the bargain” to create “an express warranty that the goods shall conform to the affirmation or promise”); Romo v. Amedex Ins. Co., 930 So. 2d 643, 653 (Fla. Dist. Ct. App. 2006) (requiring justifiable reliance on a misrepresentation). Mrs. Burch's fraudulent misrepresentation, negligent misrepresentation, and breach of express warranty claims are all based on her contention that Mentor misrepresented the ObTape complication rate to Dr. Peacock and Dr. Peacock relied on that misrepresentation in selecting ObTape to treat Mrs. Burch. Thus, Mrs. Burch's misrepresentation and breach of express warranty claims appear to be based on the same underlying facts as her pre-implant failure to warn claim. Mentor did not move for summary judgment on Mrs. Burch's pre-implant failure to warn claim. The Court is satisfied that a genuine fact dispute exists on whether (1) Mentor misrepresented ObTape's complication rate to Dr. Peacock and (2) Dr. Peacock relied on those misrepresentations in selecting ObTape for Mrs. Burch. At least one Florida district court has concluded that the Florida courts would apply the learned intermediary doctrine to all claims based on a medical device manufacturer's alleged failure to warn of the risks of the device, regardless of what theory those claims are brought under. Beale v. Biomet, Inc., 492 F. Supp. 2d 1360, 1373 (S.D. Fla. 2007); cf. Thursby v. Reynolds Metals Co., 466 So. 2d 245, 250 (Fla. Dist. Ct. App. 1984) (considering, in evaluating the express warranty claim of a plaintiff who was injured when a machine at his workplace malfunctioned, whether the injured plaintiff's employer's equipment procurement company relied on the seller's statements in making its decision to purchase the machine). Mentor did not point to any authority suggesting that the Florida courts would not apply the learned intermediary doctrine to Mrs. Burch's misrepresentation and breach of express warranty claims. For all of these reasons, the Court denies summary judgment as to these claims. III. Continuing Duty to Warn Mrs. Burch also contends that Mentor did not provide adequate warnings about the risks of ObTape to her doctor after she was implanted with it. Florida law does recognize a continuing duty to warn. See Sta-Rite Indus., Inc., v. Levey, 909 So. 2d 901, (Fla. Dist. Ct. App. 2004) (finding that swimming pool pump manufacturer could be liable for injuries caused by inadequate warnings because it did not send updated warnings to its distributors). Citing Sta-Rite and Munoz ex rel. Munoz v. South Miami Hospital, Inc., 764 So. 2d 854, 857 (Fla. Dist. Ct. App. 2000), Mrs. Burch argues that she need not prove that her post-implant medical care would have changed if Mentor had provided additional post-sale warnings; she appears to contend that the Court may simply presume that it would have. Sta-Rite and Munoz stand for the proposition that under Florida law, the courts may assume that an adequate warning would have been heeded. But the cases do not dispense with the causation requirement entirely. In Sta-Rite, the court presumed that the pool owner would have heeded a more stringent warning regarding the hazards of a pool pump and would have fixed the grate over the pump in time to avoid the plaintiff's injuries. 4 Sta-Rite, 909 So. 2d at 906. And in Munoz, a medical malpractice case, there was a fact question as to whether the pediatrician would have diagnosed and treated a newborn baby's kidney condition had the obstetrician or nurses notified him of a sonogram that suggested a problem with the baby's kidneys. 5 Munoz, 764 So. 2d at 856-57. Thus, all Sta-Rite and Munoz allow the Court to presume is that Dr. Peacock would have paid attention to an additional warning that ObTape may have a higher rate of infection than other slings. The cases do not, however, permit the Court to speculate as to what Dr. Peacock would have done with those warnings. 4 In Sta-Rite, there was evidence that the pool owner would have heeded a more stringent warning. 909 So. 2d at 906. 5 In Munoz, the pediatrician made inconsistent statements, and the court found a fact question on causation based on all the circumstances in that case. 764 So. 2d at 856-57. *4 The causation issue here is not as simple as it was in Munoz or Sta-Rite. In Munoz, there was enough evidence in the record for a jury to determine that the pediatrician ase 4:16-cv-00035-CDL Document 12-17 Filed 04/24/17 Page 4 of 5 In re Mentor Corp., Not Reported in F.Supp.3d (2015) 2015 WL 5722799 © 2017 Thomson Reuters. No claim to original U.S. Government Works. 4 would have made the right diagnosis had he been given the sonogram results. Id. And in Sta-Rite, there was enough evidence for a jury to find that the pool owner would have heeded a warning to fix the grate over the pump in time to prevent the plaintiff's injuries. Sta-Rite, 909 So. 2d at 906. This case, however, involves a complex decision regarding a medical device that had already been implanted in Mrs. Burch's body. The undisputed evidence in the present record is that Mrs. Burch never sought medical treatment from Dr. Peacock after her ObTape implant. Thus, there was no reason for Dr. Peacock to suspect that Mrs. Burch might have any adverse symptoms caused by ObTape and no reason for him to provide any additional treatment to her. And there is absolutely no evidence in the present record suggesting that additional warnings about the ObTape infection rate should have caused Dr. Peacock to contact his otherwise healthy patients and suggest that they undergo additional medical treatment for symptoms they did not have. In sum, the Court finds it highly unlikely that the Florida courts would presume causation under the circumstances of this case. Absent a presumption that relies on pure speculation, no reasonable juror could conclude based on the present record that any post-implant failure to warn caused any of Mrs. Burch's injuries, and her continuing duty to warn claim thus fails. CONCLUSION As discussed above, Mentor's Motion for Partial Summary Judgment (ECF No. 38 in 4:12-cv-237) is granted in part and denied in part. The Court grants summary judgment on Mrs. Burch's continuing duty to warn claim. The Court denies summary judgment on Mrs. Burch's claims for manufacturing defect, fraudulent misrepresentation, negligent misrepresentation, and breach of express warranty. Those claims, along with Mrs. Burch's claims for negligence, strict liability design defect, strict liability failure to warn, and fraudulent concealment remain pending for trial. Mr. Burch's loss of consortium claim also remains 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. All Citations Not Reported in F.Supp.3d, 2015 WL 5722799 End of Document © 2017 Thomson Reuters. No claim to original U.S. Government Works. ase 4:16-cv-00035-CDL Document 12-17 Filed 04/24/17 Page 5 of 5