Triant v. American Medical Systems Incorporated

• Court: District Court, D. Arizona
• Decided: July 20, 2020
• Docket: 2:12-cv-00450
• Status: Unknown

Opinion

1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA 8 No. CV-12-00450-PHX-DGC 9 Mimi Triant and Stavros Triant, ORDER 10 Plaintiffs, 11 v. 12 American Medical Systems Inc., 13 Defendant.

14 15 16 This case was originally filed on March 2, 2012, and was transferred by the Judicial 17 Panel on Multidistrict Litigation (“JPML”) to Judge Joseph Goodwin in the Southern 18 District of West Virginia on April 11, 2012, for inclusion in a large multidistrict litigation 19 (“MDL”) proceeding. Docs. 1, 8 (MDL No. 2325). On April 1, 2020, Judge Goodwin 20 advised the JPML that consolidated pretrial proceedings had been completed and that 21 remand to this District, as provided in 28 U.S.C. § 1407(a), was appropriate. Doc. 34. The 22 JPML remanded the case to the undersigned judge with the motions addressed in this order 23 already pending. 24 Plaintiffs Mimi and Stavros Triant allege that Ms. Triant was injured by three of 25 Defendant American Medical Systems, Inc.’s (“AMS”) medical devices which were 26 implanted to treat her pelvic organ prolapse (“POP”) and stress urinary incontinence 27 28 1 (“SUI”). Docs. 1 at 2, ¶¶ 5-7; 41 at 2.1 AMS moves for partial summary judgment on 2 Plaintiffs’ manufacturing defect, breach of warranty, and punitive damages claims. 3 Doc. 12. The parties have also filed four Daubert motions. Docs. 13, 15, 17, 19. The 4 motions are fully briefed, and no party requests oral argument. For reasons stated below, 5 the Court will grant the motions in part and deny them in part. 6 I. Background. 7 The following facts are undisputed unless otherwise noted. On March 3, 2010, Ms. 8 Triant underwent a procedure at Banner Good Samaritan Medical Center to treat her SUI 9 and POP. Doc. 1 at 2, ¶¶ 6-7. Dr. Scott Crawford implanted three pelvic mesh products 10 manufactured, marketed, and sold by AMS: Elevate Anterior & Apical Prolapse Repair 11 System and Mesh, Elevate Apical & Posterior Prolapse Repair System and Mesh, and 12 MiniArc Sling (the “Devices”). Id.; Doc. 41 at 2. Ms. Triant suffered complications and 13 underwent three additional surgeries to remove portions of the Devices on July 2, 2010, by 14 Dr. Crawford at Phoenix Surgicenter; on December 29, 2011, by Dr. Jeffrey Cornella at 15 the Mayo Clinic; and on March 21, 2012, by Dr. Felicia Lane at the UC Irvine Women’s 16 Health Care Center. Doc. 11-1 at 46. 17 The Devices has been cleared through the Food and Drug Administration’s (“FDA”) 18 510(k) clearance process, and AMS voluntarily ceased their manufacture and sale when it 19 ended operation of its women’s health business. Docs. 12 at 2, ¶ 5; 41 at 2.2 Plaintiff 20 alleges that the Devices were defective and have caused her chronic and severe pelvic pain, 21 urinary problems, bowel dysfunction, nerve damage, infections, bleeding, and painful 22

23 1 Citations to documents filed in the Court’s docket are denoted “Doc.,” and pin 24 cites are to page numbers placed at the top of each page by the Court’s electronic system. 25 2 The FDA applies different levels of scrutiny to medical devices before approving or clearing them for market. See In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15- 26 02641-PHX DGC, 2017 WL 5625547, at *2 (D. Ariz. Nov. 22, 2017). A 510(k) review is a premarket submission process made to FDA to demonstrate that the device is 27 substantially equivalent to a legally marketed predicate device already on the market. 21 U.S.C. § 360c(f)(1)(A)). A 510(k) review is less rigorous than the FDA’s “premarket 28 approval” process. See 21 U.S.C. § 360e(a). 1 intercourse. Docs. 1 at 3, ¶ 14; 41 at 2. AMS denies that the Devices are defective and 2 that they caused Ms. Triant’s injuries. Doc. 41 at 3; see also Doc. 292 (MDL No. 2325). 3 II. Daubert Motions. 4 The parties have filed four Daubert motions. Under Rule 702, an expert may offer 5 opinions based on “scientific, technical, or other specialized knowledge” if they “will assist 6 the trier of fact to understand the evidence,” provided the opinions rest on “sufficient facts 7 or data” and “reliable principles and methods,” and “the witness has reliably applied the 8 principles and methods to the facts of the case.” Fed. R. Evid. 702(a)-(d). The proponent 9 of expert testimony has the ultimate burden of showing by a preponderance of the evidence 10 that the requirements of Rule 702 have been satisfied. See Cooper v. Brown, 510 F.3d 870, 11 942 (9th Cir. 2007); Fed. R. Evid. 104(a).3 The trial court acts as a gatekeeper to assure 12 that the testimony “both rests on a reliable foundation and is relevant to the task at hand.” 13 Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597 (1993). 14 A. Dr. Saad Juma. 15 Dr. Saad Juma, a board-certified urogynecologist, produced a case-specific expert 16 report for AMS that opines on the safety and efficacy of polypropylene mesh, the causes 17 of Ms. Triant’s injuries, and her prognosis. Docs. 22 at 1; 13-1. Plaintiffs argue that Dr. 18 Juma improperly opines on (1) general causation, (2) the safety and efficacy of the Devices 19 based on his own clinical practice, (3) the adequacy of AMS’s product warnings and 20 instructions for use, (4) the cause of Ms. Triant’s injuries, and (5) the oxidative degradation 21 of polypropylene, and provides opinions not adequately contained in his report. Doc. 14. 22 1. General Causation. 23 Plaintiffs contend that because AMS failed to designate Dr. Juma as a general 24 causation expert, he is precluded from providing general opinions in his Rule 26 report. 25 Id. at 4. Plaintiffs challenge the following opinions:

26 3 Because the Daubert motions were filed in the MDL, they cite the federal law of 27 the Fourth Circuit. See In re Gen. Am. Life Ins. Co. Sales Practices Litig., 391 F.3d 907, 911 (8th Cir. 2004). Now that the case has been returned to its original jurisdiction, 28 however, the Court will apply Ninth Circuit law, as it would have originally. 1 • “in my experience, there are actually fewer adverse events associated with the use of these products[.]” Doc. 13-1 at 9; 2 3 • “[t]he safety of polypropylene in the body is beyond reproach . . . These basic facts are proof that oxidative degradation is not clinically 4 relevant when polypropylene is used in humans for indicated surgical 5 procedures.” Id. at 8-9; 6 • “[t]he Elevate is a safe and useful device . . . [with] appropriately 7 designed mesh . . . whose benefits far outweigh their risks,” and “[t]he MiniArc sling was a highly effective treatment for SUI and its benefits 8 outweigh its risks.” Id. at 8, 24; 9 • “the IFUs provide adequate warnings of associated risks . . . [and] 10 present[] an excellent narrative of the risks and potential complications known about the device and provides an adequate 11 warning of associated risks.” Id. 12 Plaintiffs argue that Dr. Juma cannot give these general opinions because the MDL 13 court distinguished between general and specific causation experts and AMS did not 14 designate Dr. Juma as a general causation expert. The basis for this argument is not entirely 15 clear. In their motion, Plaintiffs cite MDL Pretrial Order 251 (Doc. 14 at 4), but in their 16 reply they cite MDL Pretrial Order 274 (Docs. 27 at 1). AMS addresses MDL Pretrial 17 Order 274. Doc. 22 at 2. 18 MDL Pretrial Order 274, which has been placed in the docket in this case (Doc. 10), 19 does mention general and specific causation experts, but it does not state that a single expert 20 is limited to one or the other. To the contrary, it recognizes that a single expert may state 21 general and specific causation opinions. Id. at 6. The order does say that parties are limited 22 to five experts per case (id. at 4), but Plaintiffs do not contend that AMS has violated this 23 limitation. The Court cannot conclude that AMS violated a pretrial order in the MDL and 24 that Dr. Juma’s general causation opinions are inadmissible on this basis.4 25

26 4 Nor is the Court persuaded by AMS’s argument that Plaintiffs’ objection is 27 untimely because it was filed 15 days after the local-rule deadline for raising discovery issues in the Southern District of West Virginia. See Doc. 22 at 3. A Daubert motion is 28 not clearly a discovery issue. The Court also notes, however, that its practice is to allow 1 Plaintiffs also argue that Dr. Juma’s entire report should be excluded under Daubert 2 because it lacks reliable scientific support. Doc. 14 at 5. Without specifically addressing 3 any of the more than 40 articles cited by Dr. Juma (Doc. 13-1 at 66-69), Plaintiffs contend 4 that there “is only one single item on his reliance list total that even specifically discusses 5 prolapse mesh at all and there is merely a press release that doesn’t specifically mention 6 Elevate or any data on Elevate” (Doc. 14 at 5). But Dr. Juma’s report refers to a number 7 of peer-reviewed articles on mesh degradation and the safety of polypropylene, including 8 articles published in the Journal of Urology, the International Urogynecology Journal, and 9 the American Journal of Obstetrics and Gynecology. See Doc. 13-1 at 67, 69. AMS notes 10 this fact in its response (Doc. 22 at 4) and Plaintiffs say nothing in reply. 11 Plaintiffs further assert that Dr. Juma’s opinions should be excluded because, 12 “[f]rom reading his report, it doesn’t even appear Dr. Juma used both the Elevate devices 13 at issue in this case in his practice.” Doc. 14 at 5. AMS responds that “Dr. Juma has ample 14 experience both implanting and explanting transvaginal mesh devices, including MiniArc 15 and Elevate” (Doc. 22 at 4-5), and Plaintiffs do not address this issue in their reply. Dr. 16 Juma specifically states that he is familiar with both the benefits and the risks of the 17 MiniArc and Elevate products (Doc. 13-1 at 7-8), and his report establishes that he has 18 substantial experience in female pelvic medicine and reconstructive surgery, and how the 19 Devices work in practice. 20 The Court finds that Dr. Juma is qualified to render opinions in this case. He is a 21 board-certified urologist with clinical and research interests in female pelvic medicine and 22 pelvic reconstructive surgery, including minimally invasive treatment for urinary 23 incontinence. Doc. 13-1 at 3. Dr. Juma founded the Incontinence Research Institute in 24 Encinitas, California, and has served as its director since 2002. Id. The Institute “advances 25 health care for women through research in diseases including urinary incontinence and 26 pelvic organ prolapse” – the conditions from which Ms. Triant suffered. Id. Dr. Juma is

27 only one expert per issue per side at trial. If the parties disagree and intend on presenting more than one expert per issue, they should raise this matter with the Court at the final 28 pretrial conference. 1 also a member of several urological associations, has served as an expert reviewer for a 2 number of urological journals, and serves on the American Urological Association 3 Guidelines Update Panel for the “surgical Management of Female Stress Urinary 4 Incontinence.” Id. 5 Dr. Juma provides six pages of treatment options for SUI and POP – including 6 descriptions of the MiniArc and Elevate devices – with explanations of the procedures and 7 their risks based on his experience. Doc. 13-1 at 4-9. Plaintiffs present no evidence that 8 he is unqualified to opine on the efficacy of the Devices in treating SUI and POP – areas 9 in which he clearly is an expert. See Fed. R. Evid. 702.5 10 2. Safety and Efficacy. 11 Plaintiffs argue that Dr. Juma should not be permitted to opine on the basis of his 12 personal clinical experience related to the safety and efficacy of the Devices because they 13 have no way of testing such an opinion. Doc. 14 at 6. Plaintiffs note, correctly, that Dr. 14 Juma does not include in his report any information about his personal safety or efficacy 15 rates. Id. 16 In response, AMS asserts that the MDL court has repeatedly held that experts are 17 entitled to opine on the basis of their clinical experience, and that Dr. Juma’s opinions are 18 not based solely on his clinical experience. Doc. 22 at 5. The Court agrees with the second 19 half of AMS’s argument – Dr. Juma’s opinions are not based solely on his clinical 20 experience. He relies on his “education, training and experience as a medical researcher, 21 educator, physician, and surgeon, as well as [his] ongoing review of medical literature and 22 participation on medical expert panels and committees . . . and other sources of medical 23 and scientific information obtained throughout the course of [his] career.” Doc. 13-1 at 3. 24 Dr. Juma’s report provides general opinions on the safety of the Devices: 25 26 27 5 Plaintiffs assert that “several of Dr. Juma’s opinions do not relate to any case- specific issue and address conditions and complications that are not reflected in [Ms. 28 Triant’s] records,” but they never identify those opinions. Doc. 14 at 5. 1 The Monarc and Miniarc products were FDA-cleared, appropriately-designed [mid-urethral slings (“MUS”)] indicated for the treatment of SUI. MUS 2 techniques in which polypropylene mesh is used are the most commonly-used 3 techniques for the surgical management of stress incontinence and continue to be the standard of care. I am familiar with both the benefits and the risks 4 of the Monarc and the Miniarc products. These products are highly effective 5 treatment for SUI whose benefits far outweigh its risks. 6 * * * 7 The Elevate Apical and Posterior Prolapse Repair System was an FDA- 8 cleared, appropriately designed mesh indicated for the treatment of pelvic organ prolapse in the posterior area of the pelvis. The Elevate is a safe and 9 useful device for the treatment of pelvic organ prolapse. 10 * * * 11 These products are highly effective treatment for POP whose benefits far 12 outweigh their risks. 13 * * * 14 The Elevate and the Miniarc products consist of polypropylene mesh. The 15 safety of polypropylene in the body is beyond reproach . . . Its long track 16 record for safety is well established. . . . This extensive record of safety is unique among the many synthetic materials that are used in surgical 17 procedures daily worldwide. With that record of safety, polypropylene has 18 proven its safety in humans in clinical practice. 19 Doc. 13-1 at 7-9. The Court concludes that these general opinions are admissible under 20 Rule 702. 21 But the Court cannot conclude that Dr. Juma should be permitted to testify about 22 outcomes from his own clinical experience. Rule 26 requires an expert’s report to contain 23 a “complete statement of all opinions the witness will express and the basis and reasons for 24 them.” Fed. R. Civ. P. 26(a)(2)(B)(i). Dr. Juma’s report provides no information about 25 his own clinical experience with the Devices. He does not describe the extent to which he 26 has used them, his complication rates, or any other information to support opinions based 27 on his own clinical experience. Because such information is not provided in his report, he 28 1 cannot testify about it at trial. As a result, he cannot provided a basis for the Court to 2 conclude by a preponderance of the evidence that Rule 702 is satisfied. See Fed. R. 3 Evid. 104(a); see also In re: Ethicon, Inc., No. 2327, 2016 WL 4958312, at *3 (S.D.W. Va. 4 Aug. 25, 2016) (holding that defense expert could not discuss personal complication rates 5 or compare those rates to the complication rates found in medical literature because he 6 failed to include those rates in his expert report). Plaintiffs’ motion is granted on this issue.6 7 3. Product Warnings. 8 Plaintiffs argue that Dr. Juma has no expertise in the area of warnings and 9 instructions and it is not clear whether he has used the Devices in his practice. Doc. 14 10 at 7-8. Plaintiffs also argue the he does not explain the basis for the opinions he renders 11 on AMS’s warnings. Id. AMS contends that Dr. Juma has decades of clinical experience 12 and training in the surgical repair of pelvic floor disorders and the treatment of patients 13 with SUI, and “knows whether the information necessary to obtain proper patient informed 14 consent is contained in relevant IFUs.” Doc. 22 at 7. 15 Dr. Juma states in his report that the “Instructions for Use (IFU) which accompany 16 the [Devices] presents excellent narrative of, among other things, how to properly place 17 and tension the products (where appropriate) and the risks and potential complications 18 known about the devices; the IFUs provide adequate warnings of associated risks.” 19 Doc. 13-1 at 7-8. He provides a similar one-sentence opinion later in his report. Id. at 24. 20 Dr. Juma does not address the content of the IFUs or the risks they address, and he does 21 not explain why he thinks the IFUs provide adequate warnings of relevant risks. Nor does 22 he say anything about the kinds of warnings expected by physicians or the standards he 23 applied in concluding that the warnings in this case were adequate. Because Dr. Juma will 24 not be permitted to provide explanations at trial that are not in his report (unless, as noted

25 6 Plaintiffs filed their Daubert motion before they deposed Dr. Juma. The Court’s 26 practice is to limit an expert’s testimony to information disclosed in the expert’s report (consistent with Rule 26(a)(2)) and information elicited by the opposing party in the 27 expert’s deposition. If Plaintiffs elicited testimony in Dr. Juma’s deposition about his clinical experience with the Devices, that information may provide a basis for a different 28 outcome on this issue. AMS can raise this issue in a motion in limine, if warranted. 1 above, those explanations were elicited by Plaintiffs’ counsel in his deposition), he has 2 provided no evidence to satisfy the requirements of Rule 702 by a preponderance of the 3 evidence with respect to his warning opinions. See Fed. R. Evid. 104(a). Further, 4 “[w]ithout additional expertise in the specific area of product warnings, a doctor, such as 5 an urogynecologist, is not qualified to opine on the adequacy of a product warning IFU 6 merely because he is familiar with the products in question in his own practice.” In re C. 7 R. Bard, Inc., Pelvic Repair Sys. Prods. Liab. Litig., No. MDL 2187, 2018 WL 605064, at 8 *4 (S.D.W. Va. Jan. 29, 2018), reconsideration denied in part, No. MDL 2187, 2018 WL 9 774068 (S.D.W. Va. Feb. 7, 2018). Plaintiffs’ motion will be granted with respect to Dr. 10 Juma’s adequacy-of-warning opinions. 11 4. Specific Causation. 12 Plaintiffs move to exclude Dr. Juma’s opinion as to the cause of Ms. Triant’s injuries 13 because he purportedly failed to perform a reliable differential diagnosis. Doc. 14 at 8. 14 Plaintiffs contend that Dr. Juma reached his opinion that Ms. Triant’s injuries were caused 15 by irritable bowel syndrome without considering the Devices as a cause. Id. 16 “A differential diagnosis [or etiology] is ‘a patient-specific process of elimination 17 that medical practitioners use to identify the most likely cause of a set of signs and 18 symptoms from a list of possible causes.’” Stanley v. Novartis Pharm. Corp., 11 F. Supp. 19 3d 987, 1000 (C.D. Cal. 2014) (quoting Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 20 254 (2d Cir. 2005)). To perform such a diagnosis, an expert must identify “all of the 21 potential hypotheses that might explain a patient’s symptoms, [and] must then engage in a 22 process of elimination, eliminating hypotheses on the basis of a continuing examination of 23 the evidence so as to reach a conclusion as to the most likely cause of the findings in that 24 particular case.” Clausen v. M/V NEW CARISSA, 339 F.3d 1049, 1058 (9th Cir. 2003). 25 Plaintiffs claim that Dr. Juma did not rule out the Devices or the subsequent surgeries they 26 allegedly made necessary as causes of Ms. Triant’s injuries. The Court does not agree. Dr. 27 Juma addressed the various conditions from which Ms. Triant suffers, and ruled out the 28 Devices as a cause of each. 1 For dyspareunia, which is difficult or painful sexual intercourse, Dr. Juma reviewed 2 various studies and Ms. Triant’s medical history and then stated this opinion: 3 Taking into account the totality of Ms. Triant’s history, and the reviewed 4 medical records, it is clear that she has multiple causes of dyspareunia. One cannot simply blame the mesh and exclude all the numerous other cases of 5 dyspareunia that she has. In fact, when one looks at the chronology of her 6 symptoms, it is clear that the removal of the different mesh components did not contribute in any significant or durable way to the resolution of her stated 7 symptoms of dyspareunia and pelvic pain. This evidence suggests that other causes of dyspareunia that she has, are significant contributing factors to her 8 dyspareunia. It is my opinion that the mesh, particularly after its removal, is 9 not the cause nor a substantial contributing factor to her dyspareunia. 10 Doc. 13-1 at 27. 11 Similarly, Dr. Juma ruled out the MiniArc as a contributing cause of Ms. Triant’s 12 dyspareunia based on Dr. Dionysios Veronikis’s physical exam: 13 [Dr. Veronikis’s exam] documents the absence of tenderness over the bladder 14 and urethra, and no evidence of erosion or extrusion of the sling was noted. 15 Despite the absence of objective evidence of extrusion, erosion, tenderness over the urethra, and SUI, Dr. Veronikis removed the right arm of the 16 MiniArc sling. The lack of tenderness over the MiniArc indicates it is not 17 the cause, nor is it contributing to her dyspareunia. 18 Id. at 27. 19 Dr. Juma next addressed Ms. Triant’s bowel dysfunction, fistula, and perineal 20 abscess. He noted that a known cause of each of these conditions is inflammatory bowel 21 disease (“IBD”), a condition from which Ms. Triant suffers. He stated that “[t]here is no 22 credible scientific evidence to suggest that the mesh cause[s] inflammatory bowel disease.” 23 Id. at 28. He also noted that Ms. Triant’s conditions are associated with the J-pouch surgery 24 she underwent. Id. 25 Dr. Juma next addressed Ms. Triant’s pain and pudendal neuralgia. He noted that 26 she underwent a pudendal block to reduce or eliminate the pain, and that it actually 27 increased her pelvic pain. He concluded: “This pattern of increased pelvic pain after 28 1 pudendal nerve block . . . , and in association with recurrent pouchitis indicates the pain is 2 caused by the pouch/pouchitis and not caused by the pudendal nerve.” Id. at 29. He found 3 it “more likely that the IBD and the J-pouch are the source of her pelvic pain[.]” Id. He 4 noted that a subsequent examination by a pain specialist, after the mesh was removed, 5 identified pain in various points, but that “none of the points of tenderness are in the vicinity 6 of the previously placed mesh[.]” Id. 7 Finally, Dr, Juma addressed Ms. Triant’s autoimmune dysfunction. He reviewed a 8 large study of patients who suffer from various conditions, including patients who 9 underwent mesh-based POP surgery. The study found no association between pelvic mesh 10 surgery and autoimmune dysfunction. Id. at 30. Based on the study, Dr. Juma opined that 11 Ms. Triant’s pelvic mesh implants were not the cause of her autoimmune dysfunction. Id. 12 In short, Dr. Juma provided a basis for his conclusion that the mesh did not cause 13 Ms. Triant’s conditions. He did not phrase his report in terms of a differential diagnosis, 14 but he provided a basis for ruling out the Devices as a cause of each condition he addressed. 15 Plaintiffs do not contend that he omitted any of Ms. Triant’s conditions. 16 The Court finds by a preponderance of the evidence that each of the Rule 702 factors 17 is satisfied in Dr. Juma’s specific causation opinions. As a trained and experienced 18 urologist who regularly diagnoses and treats SUI and POP, he is qualified to opine on 19 factors that caused Ms. Triant’s injuries. 20 5. Oxidative Degradation. 21 Plaintiffs move to exclude Dr. Juma’s opinion that he has “not seen clinical evidence 22 that polypropylene degrades in the human body nor is there any reliable evidence in support 23 of this position.” Doc. 13-1 at 9; see Doc. 14 at 10-11. Plaintiffs contend that because Dr. 24 Juma “does not have a background in chemical engineering, has never studied biomaterials, 25 and has never done any bench research or lab research with respect to polypropylene,” he 26 cannot provide this opinion. Doc. 14 at 10. 27 Plaintiffs’ factors are neither exclusive nor dispositive in a Rule 702 inquiry, see 28 Daubert, 509 U.S. at 593-94, and “may not be pertinent in assessing reliability, depending 1 on the nature of the issue, the expert’s particular expertise, and the subject of his 2 testimony,” Primiano v. Cook, 598 F.3d 558, 565 (9th Cir. 2010) (quoting White v. Ford 3 Motor Co., 312 F.3d 998, 1007 (9th Cir. 2002)). As the Supreme Court has explained, 4 although some expert testimony “rests upon scientific foundations,” in other cases “the 5 relevant reliability concerns may focus upon personal knowledge or experience. Daubert 6 makes clear that the factors it mentions do not constitute a definitive checklist or test.” 7 Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999) (emphasis in original; citations 8 omitted). The Ninth Circuit likewise holds that “[t]he Daubert factors (peer review, 9 publication, potential error rate, etc.) simply are not applicable to [testimony] whose 10 reliability depends heavily on the knowledge and experience of the expert, rather than the 11 methodology or theory behind it.” United States v. Hankey, 203 F.3d 1160, 1169 (9th Cir. 12 2000). 13 Dr. Juma has decades of experience treating urological conditions and has specific 14 clinical and research interests in female pelvic reconstructive surgery, including minimally 15 invasive treatment for urinary incontinence. Doc. 13-1 at 3. Dr. Juma has also provided a 16 number of peer-reviewed articles upon which he bases his opinions on mesh degradation 17 and the safety of polypropylene, including those published in the Journal of Urology, the 18 International Urogynecology Journal, and the American Journal of Obstetrics and 19 Gynecology. See Doc. 13-1 at 67, 69. 20 The Court concludes that Dr. Juma’s opinions on oxidative degradation “rest[] on a 21 reliable foundation and [are] relevant to the task at hand.” Daubert, 509 U.S. at 597; see 22 also In re C.R. Bard, Inc., 948 F. Supp. 2d 589, 612 (S.D.W. Va. 2013) (ruling that a 23 urogynecologist was qualified to opine on product design and biomaterials because he had 24 “extensive experience with pelvic floor disorders and the use of mesh to treat such 25 disorders”). 26 B. Dr. Brian Raybon. 27 Dr. Brian Raybon is a board-certified female pelvic specialist and reconstructive 28 surgeon, and Plaintiffs’ expert on the cause of Ms. Triant’s injuries. Doc. 15-1 at 2. He 1 has produced an expert report opining, among other things, that the Devices are responsible 2 for Ms. Triant’s gastrointestinal surgeries and colorectal problems, that polypropylene 3 degrades and shrinks in the human body, that Ms. Triant’s injuries were caused by the 4 Devices, and that Ms. Triant will need ongoing medical care for the rest of her life. See 5 Doc. 15-1. AMS contends that Dr. Raybon’s opinions are unreliable, he is unqualified to 6 opine on polypropylene, and that his prognosis opinion is speculative. Doc. 15 at 1. 7 1. Gastrointestinal Health. 8 Dr. Raybon opines that the Devices are responsible for Ms. Triant’s alleged injuries 9 and that “her doctors began to consider the mesh devices and the reaction to them as causes 10 of her colorectal symptoms.” Doc. 15-1 at 18-19. AMS contends that there is no reliable 11 basis for this conclusion and that Ms. Triant’s “treating physicians have actually rejected 12 this theory of mesh-related gastrointestinal issues.” Doc. 16 at 4. AMS points to Dr. 13 Cornella’s deposition, where he testified “there is no literature suggesting that 14 polypropylene results in a systemic immune reaction that would be responsible for her 15 symptoms related to inflammatory bowel disease,” and that Ms. Triant’s husband “agreed 16 that currently there is no scientific evidence of the relationship between polypropylene and 17 immune disease.” Doc. 15-1 at 35-36. Dr. Lane, one of Ms. Triant’s explanting 18 physicians, similarly testified that there “is no level 1 evidence that supports the claim that 19 vaginal mesh can cause colitis,” and Dr. Raybon himself noted that there is no “smoking 20 gun” in the medical literature that supports his position. Id. at 39, 43. AMS further 21 contends that “Dr. Raybon has not performed any tests or experiments to confirm that 22 pelvic mesh causes these conditions, nor can he point to any level 1 scientific literature 23 documenting the same[.]” Doc. 30 at 3. 24 In reaching his conclusion, Dr. Raybon conducted a differential diagnosis, 25 incorporating his experience, peer-reviewed scientific literature, corporate documents, 26 testimony from corporate officials and treating physicians, his review of the medical 27 records, and his examination of Ms. Triant. As required in a differential diagnosis, Dr. 28 Raybon explained that “it is necessary to ‘rule in’ potential causes of the injury, and then 1 by process of elimination, to ‘rule out’ the least likely causes to arrive at the most likely 2 cause.” Doc. 15-1 at 17. Dr. Raybon ruled in mesh as a possible cause of Ms. Triant’s 3 injuries and ruled out a host of other possible causes, including inflammatory bowel 4 disease, Crohn’s disease, ulcerative colitis, auto accident, pre-existing prolapse, pre- 5 existing pressure, and pre-existing stiff neck and back as the cause of her injuries. See id. 6 at 18. He explained how he reached these conclusions: 7 I considered each of the conditions listed in Mrs. Triant’s past medical 8 history and concluded that they were not the cause of her listed injuries as they would not present so severely and so related to the unique mesh 9 complications of mesh shrinkage, mesh contract and severe and chronic 10 pelvic pain (secondary to the tender mesh areas and mesh attachment points). I specifically ruled out GI disorders including IBD, Chron’s, ulcerative 11 colitis. The chronicity and severity of her symptomatology are not consistent 12 with these potential causes and are similar to the complications reported in the medical literature and that I see in my own practice that are caused by 13 transvaginal mesh devices that are life-long and not subject to complete 14 resolution. In fact, there are reports in the medical literature of these conditions being caused by mesh. I was also able to rule these out due in part 15 to the refractory nature of her complications – simply put, treatments offered 16 by her GI doctors and colorectal surgeons that would treat these conditions have not resolved her complications. If any of these conditions were the sole 17 cause of her symptoms she would have seen resolution of her underlying symptoms with her treatments. Moreover, the response noted repeatedly in 18 her chart that relates to her pelvic, vaginal, rectovaginal and colorectal area 19 is consistent in the nature, severity and timing of the chronic inflammation, dense scarring and granulation, bleeding, infections, foreign body response, 20 bleeding, drainage, discharge and chronic/severe pain – they are all 21 consistent in that they occurred after the implantation of her three AMS transvaginal mesh devices and were not present prior to her implants – they 22 are all consistently noted in her chart as being associated with a chronic and 23 persistent inflammatory response and mesh related responses by her body as described more below and throughout my report. Moreover, the lack of any 24 definitive diagnoses by her GI doctors and inconsistent findings by her GI 25 doctors support a differential that the GI related physicians were effectively ruling out these causes over time and shown through the lack of a clear 26 etiology and lack of efficacy of treatments for these proposed and potential 27 causes. Eventually, her doctors began to consider the mesh devices and the reaction to them as causes of her colorectal symptoms. 28 1 Doc. 15-1 at 18-19. 2 Dr. Raybon additionally refers to a number of peer-reviewed journals as support for 3 his conclusions, including the conclusion that Ms. Triant’s “tissue and body were under 4 attack and constantly trying to fight back against the inflammation and foreign body 5 reaction caused by the three mesh devices, and, as such, Mrs. Triant’s vagina, pelvis and 6 colorectal area was consistently in a state of chronic inflammation and scarring and subject 7 to acute, chronic and subclinical infections.” Id. at 20.7 8 The Court finds by a preponderance of the evidence that Dr. Raybon is qualified to 9 opine on the causes of Ms. Triant’s injuries, that his opinions are based on sufficient facts 10 and data, that differential diagnosis is a reliable principle and method for determining 11 cause, and that he has applied the method reliably to the facts of this case. Fed. R. 12 Evid. 104(a), 702. The Court will deny AMS’s motion to exclude his specific causation 13 opinion.8 14 2. Mesh Shrinkage, Contraction, and Degradation. 15 AMS contends that because Dr. Raybon is a urogynecologist and not a biomaterials 16 expert or pathologist, he cannot provide opinions on polypropylene as a possible cause of 17 Ms. Triant’s injuries. Doc. 16 at 5. Among other things, AMS challenges Dr. Raybon’s 18 conclusions that there “is a correlation between the shrinkage and contraction documented 19 in Mrs. Triant’s medical records and the shrinkage and contraction documented by” AMS 20 21 7 AMS points to a case from 2014 where the court excluded Dr. Raybon’s general causation opinions as not meeting Daubert’s reliability requirement. See Doc. 30 at 3 22 (citing Eghnayem v. Boston Sci. Corp., 57 F. Supp. 3d 658, 701 (S.D.W. Va. 2014)). But in that case Dr. Raybon based his opinion solely on his personal experience, and conceded 23 that he did not reference any articles in reaching his opinion. See id. Dr. Raybon’s report in this case does not rely on the same basis. 24 8 At times it appears that AMS conflates Dr. Raybon’s qualification with the 25 reliability of his conclusions. See Doc. 30 at 3 (“Dr. Raybon is simply not qualified to opine that [AMS’s] mesh devices caused Ms. Triant’s gastrointestinal, colorectal, and 26 immunologic issues[.]”) (emphasis added). Dr. Raybon is qualified as an expert in female pelvic medicine and reconstructive surgery to offer expert opinions on potential causes of 27 Ms. Triant’s injuries. He has extensive experience implanting pelvic floor mesh products, including AMS’s Elevate devices, and has been retained by AMS as a consultant in product 28 development. 1 in its internal documents, that the “uneven stretching, pulling and tightening across the 2 arms and central portion of the Elevate mesh due to the contraction and shrinkage . . . 3 caused extreme pain in Mrs. Triant,” and that “[d]egredation of the mesh material in the 4 [Devices] caused additional inflammation and foreign body reaction and has contributed 5 to [Ms. Triant’s] injuries.” Doc. 15-1 at 21, 23-24. AMS argues that Dr. Raybon “has no 6 basis for concluding the Plaintiff’s mesh actually degraded, shrunk, or contracted.” Id. 7 The Court does not agree. 8 An expert may be qualified “by knowledge, skill, experience, training, or 9 education.” Fed. R. Evid. 702. Dr. Raybon has extensive experience with polypropylene 10 used in pelvic reconstructive surgery. Docs. 15-1 at 2, 23-1 at 85. He also has extensive 11 experience with POP – one of Ms. Triant’s conditions – and the use of mesh to treat it. See 12 Wise v. C.R. Bard, Inc., No. 2:12-CV-01378, 2015 WL 521202, at *1 (S.D.W. Va. Feb. 7, 13 2015) (finding Dr. Raybon qualified to opine on product design based on his vast 14 experience with mesh in treatment and his background in testing and training on such 15 products). 16 AMS argues that Dr. Raybon never personally examined Ms. Triant and therefore 17 “cannot opine as to the ‘mechanisms’ of mesh complications purportedly related to mesh 18 characteristics, such as shrinkage, contraction, and degradation.” Doc. 30 at 4. But Dr. 19 Raybon relied on Ms. Triant’s medical records, and AMS does not dispute that explanting 20 physicians concluded that the mesh in Ms. Triant had contracted. See Doc. 23 at 8-9. Dr. 21 Raybon also cites medical literature and AMS’s own documents in support of the 22 proposition that polypropylene shrinks and contracts in the body. Doc. 23-1 at 48. The 23 Court concludes that Dr. Raybon has provided adequate foundation for his opinions. His 24 opinions are based on his “education, training, and experience in treating patients with 25 incontinence/prolapse with or without mesh, educating physicians on prolapse surgery and 26 mesh use, and reviewing mesh related legal cases, as well as [his] familiarity with 27 published medical and scientific literature relating to mesh complications.” Doc. 15-1 28 at 24. 1 3. Specific Causation. 2 AMS asserts that because Dr. Raybon is a clinician, “his understanding of certain 3 ‘clinical properties of mesh’ does not qualify him to speculate about supposed 4 ‘mechanisms’ about which he has no expertise. Doc. 16 at 6. As the Court concluded 5 above, however, Dr. Raybon provided a sufficient basis for his opinion on the effects of 6 mesh shrinkage in Ms. Triant, and his differential diagnosis provides a sufficient basis for 7 his opinion regarding the cause of her conditions. AMS presents no other colorable 8 argument that Dr. Raybon’s specific-causation opinions are unreliable, and does not further 9 address this argument in reply. See Doc. 30. 10 4. Future Complications. 11 AMS challenges Dr. Raybon’s opinion that Ms. Triant’s prognosis is poor and that 12 she will need medical treatment “for the rest of her life.” Doc. 16 at 6; see Doc. 15-1 at 13 25. AMS’s sole basis for challenging this opinion is that it is speculative. Id. Plaintiffs 14 contend that because Ms. Triant has continued to receive treatment and has suffered 15 additional complications, Dr. Raybon’s opinion is not speculative. Doc. 23 at 11. 16 Dr. Raybon’s prognosis opinion is based on his examination of Ms. Triant, her 17 medical records, his substantial experience treating similar patients and conditions, and 18 medical literature cited in his report. The Court finds his general prognosis opinion 19 admissible under Rule 702. Dr. Raybon also opines that Ms. Triant will need future surgery 20 and plastic surgery, but he provides no explanation for this opinion. Doc. 23-1 at 52. 21 Because he provides no basis for this opinion that satisfies Rule 702, and he cannot testify 22 beyond his report (unless AMS elicited such testimony in his deposition), the Court will 23 exclude his opinions about the need for future surgeries. 24 C. Dr. Richard Trepeta. 25 Dr. Trepeta, a board-certified pathologist, has produced a seven-page report 26 concluding that mesh caused and will continue to cause Ms. Triant physical and emotional 27 injuries. See Doc. 17-1. AMS contends that Dr. Trepeta is unqualified and that his opinions 28 are unreliable. Doc. 18 at 3-6. 1 1. Qualification. 2 AMS contends that as a pathologist, Dr. Trepeta is not qualified to opine about Ms. 3 Triant’s current and future physical and emotional injuries. Doc. 18 at 3. AMS argues that 4 Dr. Trepeta’s work is done in a lab, examining tissue and other specimens under a 5 microscope, and that he is not qualified to opine on current and future conditions 6 experienced by patients. Id. at 4. The Court agrees in part. 7 “A pathologist is a clinician who provides diagnoses for patient care based on the 8 examination of specimens they receive and relevant clinical information.” Heinrich v. 9 Ethicon, Inc., No. 2:20-cv-00166-APG-VCF, 2020 WL 1914812, at *2 (D. Nev. Apr. 17, 10 2020) (citing Eghnayem v. Bos. Sci. Corp., 57 F. Supp. 3d 658, 712 (S.D.W. Va. 2014)). 11 Dr. Trepeta has more than three decades of experience as a pathologist, and has reviewed 12 hundreds of mesh and non-mesh pathological specimens from every organ and tissue in 13 the body. Doc. 25-1 at 22-23. He serves on the Pathology Committee of the International 14 Society for the Study of Vulvovaginal Disease, which establishes the criteria and 15 terminology for the diagnosis of vulvar and vaginal diseases. Doc. 17-1 at 3. He also has 16 specific experience with the pathology and injuries related to the implantation of 17 polypropylene mesh to treat prolapse and SUI among women. Id. Dr. Trepeta is qualified 18 to opine on the basis of his experience and knowledge as a pathologist, and the results of 19 his pathology examination of specimens from Ms. Triant, about what the specimens show 20 regarding her physical conditions, including those caused by her mesh implants.9 21 22 23 9 AMS’s reply highlights a number of statements by Dr. Trepeta from another case that, among other things, he has never studied or published on mesh, has never published 24 on the foreign body reaction to biomaterials, and does not diagnose pain disorders in his clinical practice. Doc. 28 at 2-3. Even if these statements are true, Dr. Trepeta based his 25 conclusions in this case on a review of Ms. Triant’s medical records and pathology reports, including Ms. Triant’s pathological specimen taken from her December 2011 revision 26 surgery. He concluded that the implantation of the polypropylene mesh directly resulted in significant physical damage to Ms. Triant, and that “the body’s reaction to the implanted 27 mesh was predictable and the resulting complications expected.” Doc. 17-1 at 6; see Doc. 25 at 5. These opinions about what he observed as a pathologist have a sufficiently 28 reliable basis to be admissible under Rule 702. 1 The Court does not find, however, that Dr. Trepeta is qualified to provide expert 2 opinion on the emotional harm suffered by Ms. Triant. When asked what emotional 3 damage he attributed to the mesh, he testified: 4 The emotional damage that would seem to be self-evident. That a woman 5 who is of sexual activity age is no longer able to have sexual activity in the routine degree that she once did, and she has a husband who would be 6 interested, unless there’s some problem, with having relationships with her 7 and her ability to have relationships. A sexual relationship has been altered. To think that there isn’t emotional damage going on between her and her 8 husband or her husband and her due to that absence in their life would be unreasonable. But there is [sic] just certain things in life that you know to be 9 true. Like the sun will come up tomorrow. 10 11 Doc. 28 at 7. Dr. Trepeta provides no additional support for his opinion that Ms. Triant 12 has suffered and will suffer emotional damage. 13 Dr. Trepeta will not be permitted to provide expert testimony based on what he 14 views as self-evident. Such testimony would not be helpful to the jury – which can make 15 its own assessment of what is self-evident – and would not be based on expertise. See In 16 re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2018 WL 495187, 17 at *4 (D. Ariz. Jan. 22, 2018); see also Stephenson v. Caterpillar, Inc., No. 2:16-CV-00071- 18 JRG-RSP, 2018 WL 5831314, at *4 (E.D. Tex. Nov. 7, 2018) (“Common sense testimony 19 falls within the common knowledge of the jury, and, without more, this testimony is neither 20 reliable nor helpful to the trier of fact.”). 21 The Court will grant AMS’s motion with respect to Dr. Trepeta’s testimony on 22 emotional injury, and deny it on his opinions about physical injury caused by AMS’s 23 products. 24 2. Alleged Sample Selection Bias. 25 AMS argues that because Dr. Trepeta’s opinions were based on pathology 26 specimens and reports provided by Plaintiffs’ attorneys, the opinions must be excluded as 27 unreliable because he provides no explanation of the standards used to select the specimens 28 and does not explain how the specimens correlate to the Devices implanted in this case. 1 Doc. 18 at 4. AMS’s argument, Plaintiffs’ response, and Dr. Trepeta’s report create 2 confusion on this issue, which the Court has attempted to sort out. 3 There are at least three different sets of pathology reports discussed in Dr. Trepeta’s 4 report. First, he notes that he has reviewed over 100 pathology samples confirming that 5 polypropylene mesh causes injuries in women. Doc. 17-1 at 3. His report does not identify 6 the source of these samples, but he testified in his deposition that they all came from 7 surgeries performed at St. Joseph’s Hospital in Phoenix, Arizona, where Dr. Trepeta 8 practices as a pathologist. Doc. 25-1 at 16 (page 52). He states in his report that he has 9 seen an alarming increase in these injuries during the last eight years of his practice. 10 Doc. 17-1 at 3. The Court does not find Dr. Trepeta’s reliance on these samples to be 11 problematic. They were generated in the course of his medical practice, rather than being 12 selected by Plaintiffs’ counsel, and his clinical experience provides a reliable basis for him 13 to develop expertise in and testify about the effects of polypropylene mesh in women. 14 Second, Dr. Trepeta states that “pathology reports of AMS mesh” were “provided 15 for review,” and that they are consistent with the disease processes addressed in his report. 16 Id. Again, his report provides no description of the source of these pathology reports, but 17 he testified in his deposition that they all came from Ms. Triant’s mesh-removal surgeries. 18 Doc. 25-1 at 17 (page 54). Reliance on these plaintiff-specific reports is appropriate. Dr. 19 Trepeta reviewed the pathology reports from Ms. Triant to determine whether she suffers 20 from conditions he has observed in other mesh-implant patients in his clinical practice. It 21 is appropriate and consistent with Rule 702 for a doctor who has developed expertise in his 22 clinical practice to examine samples from the plaintiff and opine on the conditions revealed 23 by the samples. AMS cites no case law indicating otherwise, and does not argue that Dr. 24 Trepeta’s review of Ms. Triant’s pathology reports is unreliable. See Daubert, 509 U.S. at 25 597; see also Kumho, 526 U.S. at 152 (“[W]e conclude that the trial judge must have 26 considerable leeway in deciding in a particular case how to go about determining whether 27 particular expert testimony is reliable.”). Because this second category of samples all came 28 from Ms. Triant, there is no concern about selection bias. 1 Third, Dr. Trepeta’s report states – several pages later on page 7 – that he “was 2 provided pathology reports from the Wagstaff and Cartmell, LLP law firm,” and that “these 3 reports correlate to AMS products MiniArc and Elevate” and “are consistent with the 4 medical knowledge and reports of tissue interactions, injury, deformation and degradation 5 related to polypropylene mesh implants.” Doc. 17-1 at 7. This same opinion has been 6 excluded by Judge Goodwin because the reports on which Dr. Trepeta relied were provided 7 by plaintiffs’ counsel and Dr. Trepeta appeared to be using them as the basis for a general 8 causation opinion that AMS mesh products cause injuries, and yet he could provide no 9 assurance that they were selected properly and did not suffer from selection bias. See In 10 re Bos. Sci. Corp. Pelvic Repair Sys. Prods. Liab. Litig., No. MDL 2326, 2018 WL 11 8131708, at *2 (S.D.W. Va. May 30, 2018) (“Dr. Trepeta’s review of the pathology reports 12 has a fatal deficiency – it lacked standards to govern the process of selecting the sample of 13 pathology reports to be evaluated.”); Sanchez v. Bos. Sci. Corp., No. 2:12-CV-05762, 2014 14 WL 4851989, at *22 (S.D.W. Va. Sept. 29, 2014) (excluding Dr. Trepeta’s opinions 15 because there is “no way to ensure that the plaintiffs’ counsel did not provide Dr. Trepeta 16 with only those pathology reports that tended to strengthen, rather than refute, Dr. Trepeta’s 17 opinions.”); Frankum v. Bos. Sci. Corp., No. 2:12-CV-00904, 2015 WL 1976952, at *26 18 (S.D.W. Va. May 1, 2015) (excluding Dr. Trepeta’s opinions because his report “lacked 19 standards to govern the process of selecting the sample of pathology reports to be 20 evaluated’). 21 The Court agrees with these cases. To the extent Dr. Trepeta is relying in this case 22 on pathology reports selected by Plaintiffs’ counsel to form opinions about the general 23 effect of AMS products once implanted, the Court will exclude those opinions because the 24 Court cannot rule out selection bias. Although the language from Dr. Trepeta’s report 25 tracks the language of his opinions that have been excluded in other cases, Dr. Trepeta 26 testified in his deposition that the third category of reports all came from the explant 27 surgeries of Ms. Triant. See Doc. 25-1 at 22 (page 76). If this is true, then it appears Dr. 28 Trepeta’s testimony at page 7 of his report is nothing more than a restatement of his earlier 1 plaintiff-specific testimony, which the Court finds admissible. Thus, to be clear, Dr. 2 Trepeta will not be permitted to give a general causation opinion with respect to AMS 3 products based on a sampling of pathology reports selected by Plaintiffs’ counsel, but he 4 will be permitted to give plaintiff-specific causation testimony based on his review of 5 pathology reports from Ms. Triant’s explant surgeries and his general clinical experience 6 at St. Joseph’s Hospital.10 7 D. Dr. Colleen Fitzgerald. 8 Dr. Fitzgerald is a board-certified physical medicine and rehabilitation doctor 9 specializing in the etiology and treatment of female pelvic pain. Doc. 19-1 at 16. She 10 conducted an independent medical evaluation of Ms. Triant on May 28, 2019, and prepared 11 a report in which she opines, among other things, on the cause of Ms. Triant’s injuries. 12 AMS makes two arguments: (1) there is no reliable foundation for her specific causation 13 opinion, and (2) she failed to employ a reliable methodology. See Doc. 20. 14 1. Specific Causation. 15 Dr. Fitzgerald opines that Ms. Triant has developed pelvic peripheral sensitization 16 and chronic central sensitization, which are lifelong conditions “requiring ongoing pain 17 medication management and surgical/GI management.” Doc. 19-1 at 43. She further 18 concludes that “these diagnoses occurred as a result of multiple ongoing vaginal mesh 19 complications[.]” Id. AMS argues that this conclusion is unreliable because Dr. Fitzgerald 20 “could not point to any research at all on mesh-related pelvic pain and quantitative sensory 21 testing” and she failed to provide a list of literature in her report upon which she relied. 22 Doc. 20 at 4. 23 Rule 26 requires that an expert disclose “the facts or data considered by the witness 24 in forming” his or her opinions (Fed. R. Civ. P. 26(a)(2)(B)(ii)), and Rule 702 requires that 25 26 10 AMS also argues that Dr. Trepeta’s opinions should be excluded because he did not conduct a differential diagnosis. As noted above, however, it is appropriate and 27 consistent with Rule 702 for a doctor who has developed expertise in his clinical practice to examine samples from the plaintiff and opine on the conditions revealed by those 28 samples. 1 the opinions be “based on sufficient facts or data” (Fed. R. Evid. 702(b)). Dr. Fitzgerald’s 2 report does not contain a list of articles or other publications she relied on in reaching her 3 opinions, even though her report states that she plans to use “[e]xcerpts from medical 4 articles and learned treatises” to support her opinions. Doc. 19-1 at 44. When asked during 5 her deposition to identify the specific literature she relied on, Dr. Fitzgerald was unable to 6 identify any specific articles, stating only that she relied on “[t]he entire body of literature 7 that I look at really that’s pelvic pain, including the mesh related items.” Doc. 24-1 at 13 8 (page 40). 9 Plaintiffs make no attempt in their reply to explain why they did not have Dr. 10 Fitzgerald disclose the literature she relied on in forming her opinions as required by 11 Rule 26. They do, for the first time with their reply brief, provide an exhibit titled “List of 12 Mesh-Related Literature” which contains 41 articles with no indication of whether Dr. 13 Fitzgerald relied on them in forming her opinions for this case. Doc. 24-1 at 32-34. This 14 is a wholly inadequate effort to comply with Rule 26, and, more importantly, it has deprived 15 AMS of the opportunity to learn the literature-related basis for Dr. Fitzgerald’s opinions. 16 The Court will not preclude Dr. Fitzgerald from testifying entirely because of this 17 failure – the Court concludes that she is qualified by training and experience to render her 18 opinions11 – but she will not be permitted to testify about medical literature before the jury. 19 She will not be permitted to testify that she relied on medical literature or that medical 20 literature supports her opinions, and she will not be permitted to identify any specific article 21 or other literature source during her testimony before the jury. Having deprived AMS of 22 the opportunity to prepare for such testimony, Dr. Fitzgerald will not be permitted to give 23 it.12

24 11 Dr. Fitzgerald’s knowledge, training, and experience as a board-certified physical 25 medicine and rehabilitation doctor specializing in the etiology and treatment of female pelvic pain, her examination of Ms. Triant, and her review of Ms. Triant’s medical history 26 and ongoing symptoms show by a preponderance of the evidence that her opinion on the cause of Ms. Triant’s injuries is sufficiently reliable to be admissible under Rule 702. 27 12 Nor will Dr. Fitzgerald be permitted to testify about future surgeries Ms. Triant 28 might need in the absence of a clear explanation, in her report or her deposition, as to how 1 2. Methodology. 2 AMS argues that Dr. Fitzgerald’s differential diagnosis is flawed because she failed 3 to give serious consideration to inflammatory bowel disease as a potential cause of Ms. 4 Triant’s injuries. Docs. 20 at 5-6, 29 at 3. Plaintiffs contend that because there was no 5 definitive diagnosis of this condition in the record, Dr. Fitzgerald was not required to 6 consider it. Doc. 24 at 10. Plaintiffs further contend that Dr. Fitzgerald’s review “of the 7 documentary evidence, her familiarity with relevant published medical and scientific 8 literature, the depositions of treating physicians, as well as her own clinical experience,” 9 make her differential diagnosis reliable. Id. at 10-11. 10 The first step in a proper differential diagnosis “is to compile a comprehensive list 11 of hypotheses that might explain the set of salient clinical findings under consideration.” 12 Clausen, 339 F.3d at 1057. To perform such a diagnosis, Dr. Fitzgerald must identify “all 13 of the potential hypotheses that might explain [Ms. Triant’s] symptoms, [and] must then 14 engage in a process of elimination, eliminating hypotheses on the basis of a continuing 15 examination of the evidence so as to reach a conclusion as to the most likely cause of the 16 findings in [this] case.” Id. at 1058 (emphasis added). 17 Dr. Fitzgerald failed to account for an important aspect of Ms. Triant’s medical 18 history in conducting her differential diagnosis. Inflammatory bowel disease can be a 19 significant cause of pelvic pain, and yet she did not consider it. See Doc. 24-1 at 14-15. 20 Plaintiffs highlight the fact that Ms. Triant had not been conclusively diagnosed with 21 inflammatory bowel disease (Doc. 24 at 10; see Doc. 24-1 at 14-15), but, as noted above, 22 Ninth Circuit law requires her to consider all “potential hypotheses” that could reasonably 23 cause her condition. Clausen, 339 F.3d at 1058. There was evidence in Ms. Triant’s 24 medical record suggesting that inflammatory bowel disease could be a contributing factor 25 to her condition. In fact, there were at least three instances in which Ms. Triant’s treating 26 physicians stated that they could not rule our inflammatory bowel disease as the cause of 27 her issues. See Doc. 15-1 at 7-8 (Dr. Heigh Russel), 9 (Dr. Anitha Yadav), 10 (emergency

28 she can conclude that specific surgeries will be required. 1 room physician at Gilbert Mercy Medical Center and Dr. Elisabeth McLemore). Looking 2 at the same medical record, Dr. Juma reached the conclusion that “Ms. Triant was 3 diagnosed with inflammatory bowel disease.” Doc. 13-1 at 25. Likewise, Dr. Raybon, 4 also a specialist in women’s pelvic issues, specifically considered inflammatory bowel 5 disease and ulcerative colitis in his differential diagnosis. See Doc. 15-1 at 18. Yet Dr. 6 Fitzgerald failed to consider inflammatory bowel disease because it was “not within the 7 scope of [her] own specialty.” Doc. 24-1 at 14. 8 A reliable differential diagnosis “must provide reasons for rejecting alternative 9 hypotheses ‘using scientific methods and procedures’ and the elimination of those 10 hypotheses must be founded on more than ‘subjective beliefs or unsupported speculation.’” 11 Clausen, 339 F.3d at 1058 (quoting Claar v. Burlington N. R.R. Co., 29 F.3d 499, 502 (9th 12 Cir. 1994)). Dr. Fitzgerald has not done so. As a result, Plaintiffs have not shown by a 13 preponderance of the evidence that Dr. Fitzgerald’s causation opinions are based on 14 sufficient facts or data to which reliable principles and methods have been applied reliably. 15 Dr. Fitzgerald’s opinions on AMS’s mesh products as the specific cause of Ms. Triant’s 16 injuries are not admissible under Rule 702(b)-(d). See Doc. 19-1 at 43 (“It is my medical 17 opinion that these diagnoses occurred as a result of multiple ongoing vaginal mesh 18 complications as delineated above.”). 19 III. Summary Judgment. 20 AMS moves for summary judgment on Plaintiffs’ claims for manufacturing defect, 21 breach of express and implied warranty, and punitive damages. Doc. 11. Plaintiffs state 22 in response that they no longer intend to pursue the manufacturing defect and breach of 23 warranty claims. Doc. 21 at 3-4. The only issue, therefore, is whether AMS is entitled to 24 summary judgment on punitive damages. 25 Under Arizona law, punitive damages are available when the plaintiff proves by 26 clear and convincing evidence that the defendant engaged in reprehensible conduct and 27 acted with an “evil mind.” Rawlings v. Apodaca, 726 P.2d 565, 578 (Ariz. 1986); see 28 Anderson, 477 U.S. at 254 (the substantive evidentiary burden of proof – including the 1 heightened clear and convincing burden – applies on summary judgment). An evil mind 2 is established with evidence that the defendant: (1) intended to cause injury; (2) engaged 3 in wrongful conduct motivated by spite or ill will; or (3) acted to serve its own interests, 4 having reason to know and consciously disregarding a substantial risk that its conduct 5 might significantly injure the rights of others, even though defendant had neither desire nor 6 motive to injure. Bradshaw v. State Farm Mut. Auto. Ins. Co., 758 P.2d 1313, 1324 (1988). 7 A. A.R.S. § 12-689. 8 The Court must first determine whether A.R.S. § 12-689 bars punitive damages in 9 this case. The statute provides that “[a] manufacturer, service provider or seller is not liable 10 for exemplary or punitive damages if . . . [t]he product alleged to have caused the harm 11 was designed, manufactured, packaged, labeled, sold, or represented in relevant and 12 material respects according to the terms of an approval, conditional approval, clearance, 13 license or similar determination of a government agency.” A.R.S. § 12-689(A)(1). AMS 14 contends that the FDA cleared the Devices for manufacturing and sale, making punitive 15 damages unavailable under the statute. Docs. 12 at 6-7, 26 at 1-3. Plaintiffs argue that the 16 statute did not go into effect until August 2, 2012, five months after this action was filed, 17 and therefore does not apply to this case. Doc. 44. The Court agrees.13 18 Under Arizona law, “[n]o statute is retroactive unless expressly declared therein,” 19 A.R.S. § 1-244, and a statute “will have prospective operation only, unless it plainly 20 indicates an intent that it have retrospective effect,” Rodriquez v. Terry, 290 P.2d 248, 249 21 (Ariz. 1955) (citation omitted). The Arizona Legislature passed § 12-689 in May 2012, 22 and it went into effect on August 2, 2012. See A.R.S. § 12-689; Arizona Legislature, 23 General Effective Dates, https://www.azleg.gov/general-effective-dates (last visited 24 25 26 13 Plaintiffs initially argued that § 12-689 did not apply because AMS intentionally withheld information from the FDA. Doc. 21 at 6-7; see A.R.S. § 12-689(B)(2). Plaintiffs 27 later learned that § 12-689 became effective five months after their action was filed and sought leave to file a supplemental brief. Doc. 31. The Court permitted the supplemental 28 brief (Doc. 43) and a response (Doc. 45). 1 June 23, 2020). Plaintiffs filed this action on March 2, 2012 (Doc. 1), five months 2 before § 12-689 became effective. 3 AMS contends that the prohibition on retroactive statutes found in § 1-244 is not 4 absolute, and that courts allow for an exception where statutes are “merely procedural.” 5 Doc. 45 at 2. But AMS makes no argument that § 12-689 is merely procedural, and the 6 Arizona Supreme Court has held that a rule affecting the measure of damages is 7 substantive. Hall v. A.N.R. Freight Sys., Inc., 717 P.2d 434, 442, 444 (Ariz. 1986). Nor 8 does AMS point to anything in § 12-689 suggesting that the Arizona Legislature intended 9 it to apply retroactively. Because this case was filed before the statute became effective, 10 and the Court cannot conclude that the statute applies retroactively, it does not bar punitive 11 damages in this case.14 12 B. Availability of Punitive Damages. 13 Plaintiffs argue that AMS acted with an “evil mind” because it knew the Devices 14 “would pose an unjustifiable significant risk of harm to others but chose to consciously 15 disregard those risks for its own economic benefit.” Doc. 21 at 6. Plaintiffs contend that 16 they have “produced evidence showing that [AMS] either withheld or intentionally 17 misrepresented information that is directly relevant to the harm Plaintiffs suffered and 18 would be material to the FDA’s clearance of its” Devices. Id. at 7. AMS argues that 19 Plaintiffs cannot satisfy the high standard for punitive damages, but does not directly 20 address the evidence Plaintiffs cite. Because AMS fails to address Plaintiffs’ evidence, the 21 Court finds the evidence sufficient to create a genuine dispute of material fact, even under 22 a clear and convincing standard, on whether AMS acted with an evil mind. 23 Plaintiffs assert that AMS knew polypropylene was unsuitable for use in human 24 implants and disregarded that fact for its own economic gain. Doc. 21 at 8. They present 25 evidence that decades of medical literature provided notice to AMS about issues related to 26 the use of polypropylene in implantable medical devices. Doc. 21-1 at 22. Plaintiffs also

27 14 AMS cites several cases discussing § 12-689, but none discusses whether the 28 statute is retroactive. See Doc. 45 at 2-4. 1 assert that as early as 2004, AMS knew of a potential 30% complication rate for POP mesh 2 products, and that it was warned of polymer degradation related to oxidation in 2005 by 3 Dr. Duane Priddy and Norber Maecker of Polymer Failure Lab. Id. at 24, 144. 4 Plaintiffs assert that Total Petrochemical – the supplier of AMS’s 5 polypropylene – did not know its polypropylene was being used to manufacture AMS’s 6 pelvic mesh products, and that AMS was concerned it would stop providing the materials 7 if it learned of that use. Doc. 21 at 8; see Doc. 21-1 at 19. Plaintiffs highlight Total 8 Petrochemical’s material safety data sheet, which did not indicate that the polypropylene 9 was suitable or intended for use in permanently implantable medical devices. Doc. 21-1 10 at 19. Rather, the data sheet recommended that the polypropylene be used for carpet 11 backing and ropes. Total Petrochemical specifically disclaimed warranties regarding the 12 safety of the material in implantable medical devices. Id. at 19. In fact, Total 13 Petrochemical sent out warnings against the use of its polypropylene in medically 14 implantable devices, stating: “Under no circumstances are any products sold by Total 15 Petrochemicals suitable for human or animal implants.” Id. at 20. Plaintiffs contend that 16 the “FDA likely would not have cleared [AMS’s] mesh devices had it known about 17 [AMS’s] decision to use the polypropylene material in its products without conducting the 18 appropriate clinical studies despite having knowledge of the substantial risk of harm that 19 polypropylene poses when implanted in the human body.” Doc. 21 at 10.15 20 Plaintiffs also present evidence that AMS’s management disregarded concerns 21 about the use of polypropylene and sought to go to market without adequately studying or 22 warning physicians of its substantial risks. As Dr. Raybon testified: 23 I remember the president or the VP of the division asked me, you know, what 24 would you think if we went ahead and got it on the market and didn’t study

25 15 In 2012 the FDA issued “522 Orders” to all pelvic mesh manufacturers requiring 26 companies either to conduct additional safety studies to support the use of their product, or to withdraw the product from the market, and later banned transvaginal mesh POP kits 27 from the market. See FDA’s Activities: Urogynecologic Surgical Mesh, https://www. fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities- 28 urogynecologic-surgical-mesh (last visited June 24, 2020). 1 it, and I’m, like, are you serious, and he goes yeah. I said, you want my honest opinion, and he said yeah, and I said, you’re – you’d be a blanking 2 idiot if you did that because we need some – none of these meshes have had 3 appropriate research on them, you know, to get to the market in my opinion at that point. 4 5 Doc. 21-1 at 187. 6 Plaintiffs further note that AMS was working on a so-called “Truth-Seeking 7 Project” before Ms. Triant’s implant, and yet failed to warn her implanting physician. 8 Doc. 21-1 at 197-98. The Project concluded that there was a biomechanical mismatch 9 between the Devices and the pelvic anatomy and that the Devices shrunk, contracted, and 10 deformed in the patients’ bodies, resulting in chronic dyspareunia, vaginal scarring, chronic 11 foreign body response, and other complication – the precise injuries Ms. Triant sustained. 12 Id. 13 Construing this evidence in the light most favorable to Plaintiffs, the Court 14 concludes that a reasonably jury could find the requisite evil mind by clear and convincing 15 evidence. “While any single piece of evidence, taken alone, might not be clear and 16 convincing evidence of an ‘evil mind,’ several such pieces of evidence, taken together, 17 might clear the evidentiary hurdle.” Thompson v. Better-Bilt Aluminum Prod. Co., 832 18 P.2d 203, 211 (Ariz. 1992); Quintero v. Rogers, 212 P.3d 874, 879 (Ariz. Ct. App. 2009) 19 (“A court will allow a jury to consider a punitive damages award if sufficient 20 ‘circumstantial’ evidence exists” (citation omitted)). The Court will deny AMS’s motion 21 for summary judgment on punitive damages. 22 IT IS ORDERED: 23 1. Plaintiffs’ motion to exclude the opinion of Dr. Saad Juma (Doc. 13) is 24 granted in part and denied in part as set forth above. 25 2. Defendant’s motion to exclude the opinion of Dr. Brian Raybon (Doc. 15) is 26 granted in part and denied in part as set forth above. 27 28 1 3. Defendant’s motion to exclude the opinion of Dr. Richard Trepeta (Doc. 17) 2 is granted in part and denied in part as set forth above. 3 4. Defendant’s motion to exclude the opinion of Dr. Colleen Fitzgerald 4 (Doc. 19) is granted as set forth above. 5 5. Defendant’s motion for summary judgment (Doc. 11) is denied as to the 6 punitive damages claim, and granted as to the manufacturing defect and 7 breach of express and implied warranty claims. 8 6. The Court has scheduled the trial in this case for January 2021. Doc. 21. The 9 Court will issue a separate order setting the final pretrial conference and the 10 motions deadlines that will precede the final pretrial conference. 11 7. The Court will rule on the Rosenzweig expert issues in a separate order. 12 Dated this 20th day of July, 2020. 13 . + 14 pureed 6, Cane 15 David G. Campbell 16 Senior United States District Judge 17 18 19 20 21 22 23 24 25 26 27 28

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