Triant v. American Medical Systems Incorporated

Opinion

1 WO 2 3 4 5 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 transferred from a large multidistrict litigation proceeding (“MDL”) 17 in the United States District Court for the Southern District of West Virginia. Doc. 34. 18 The Court held a conference on July 6, 2020, and the parties stated that a number of 19 disputes remained surrounding Plaintiffs’ expert Dr. Bruce Rosenzweig. Doc. 49.1 At the 20 Court’s request, the parties filed a joint memorandum identifying the issues in dispute and 21 the relevant briefing. Doc. 50. This order resolves those disputes. The Court will not 22 repeat the factual background contained in its previous Daubert order. See Doc. 51 at 2-3. 23 I. Legal Standard. 24 Under Rule 702, an expert may offer opinions based on “scientific, technical, or 25 other specialized knowledge” if they “will assist the trier of fact to understand the 26

27 1 The parties agreed that there are no Daubert issues with respect to J. Matthew Sims, Adam Kozak, and Drs. Duane Priddy, James Coad, Karen Becker, and Stephen 28 Badylak. Doc. 49. 1 evidence,” provided the opinions rest on “sufficient facts or data” and “reliable principles 2 and methods,” and “the witness has reliably applied the principles and methods to the facts 3 of the case.” Fed. R. Evid. 702(a)-(d). The proponent of expert testimony has the ultimate 4 burden of showing by a preponderance of the evidence that the requirements of Rule 702 5 have been satisfied. See Cooper v. Brown, 510 F.3d 870, 942 (9th Cir. 2007); Fed. R. 6 Evid. 104(a). The trial court acts as a gatekeeper to assure that the testimony “both rests 7 on a reliable foundation and is relevant to the task at hand.” Daubert v. Merrell Dow 8 Pharms., Inc., 509 U.S. 579, 597 (1993). 9 II. Discussion. 10 Dr. Bruce Rosenzweig, Plaintiffs’ general causation expert, produced four Rule 26 11 expert reports in the MDL. Doc. 50-1 at 2; See Doc. 50-3 at 37, 101, 171, 237.2 AMS filed 12 a motion in the MDL to exclude his opinions under Daubert and Rules 702 and 703. 13 Doc. 50-1. AMS made six arguments: (1) he is not permitted to opine on AMS’s 14 knowledge or state of mind; (2) his legal conclusions are not proper expert testimony; (3) 15 no cancer opinion is permitted; (4) he is not qualified to opine about the design or testing 16 of medical devices or the adequacy of medical device warnings; (5) his opinions regarding 17 alternative designs are not admissible; and (6) his opinions regarding the material safety 18 data sheet (”MSDS”) are irrelevant and exceed his expertise. Doc. 50. 19 The parties acknowledge that the first three issues have been resolved. See id. at 3-4, 20 15-16, 20-21. Accordingly, Dr. Rosenzweig will not be permitted to opine on AMS’s 21 knowledge or state of mind, to offer legal opinions, or to opine that mesh causes cancer. 22 See id. The Court will address the remaining issues. 23 A. Product Design and Failure to Warn. 24 In his four reports, Dr. Rosenzweig opines that AMS “failed to conduct adequate 25 safety tests” on the mesh used in its devices, including testing to determine if mesh

26 2 Dr. Rosenzweig’s reports cover various AMS products, including its Apogee and 27 Perigree (Doc. 50-3 at 37), Elevate (id. at 101), MiniArc (id. at 171), and Sparc and Monarc (id. at 237) devices. The Elevate and MiniArc devices are at issue in this case. Docs. 1 28 at 2, 41 at 2. 1 degrades in the body and clinical trials prior to marketing its products. See Doc. 50-3 at 2 48, 111, 189, 250. The parties agree that Dr. Rosenzweig is not permitted to testify about 3 the adequacy of AMS’s testing, but disagree on whether he is qualified to opine about 4 product design and warnings. See Doc. 50 at 4-9. 5 1. Design. 6 AMS contends that because “Dr. Rosenzweig is a practicing urogynecologist” and 7 not a “biomaterials expert or pathologist,” he is unqualified to opine on the design of AMS 8 products. Doc. 50-1 at 6-7. AMS argues that “Dr. Rosenzweig admitted that he is not 9 trained in polymer chemistry, does not have a degree in engineering, and has not designed 10 a medical device to treat stress urinary incontinence or pelvic organ prolapse.” Doc. 50-2 11 at 4. 12 The Court does not find this argument persuasive. As the Supreme Court has 13 explained, some expert testimony “rests upon scientific foundations,” but in other cases 14 “the relevant reliability concerns may focus upon personal knowledge or experience. 15 Daubert makes clear that the factors it mentions do not constitute a definitive checklist or 16 test.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999) (emphasis in original; 17 citations omitted). In some cases, such as this one, “reliability depends heavily on the 18 knowledge and experience of the expert, rather than the methodology or theory behind it.” 19 United States v. Hankey, 203 F.3d 1160, 1169 (9th Cir. 2000). 20 Dr. Rosenzweig has decades of experience treating female urological conditions. 21 Doc. 50-6 at 3. He has performed over 1,000 pelvic floor surgical procedures using 22 numerous synthetic pelvis mesh products, including both pelvic organ prolapse (“POP”) 23 and stress urinary incontinence (“SUI”) products. Id. He has performed over 300 surgeries 24 dealing with complications related to synthetic mesh, including the removal of numerous 25 AMS devices. Doc. 50-7 at 27 (pages 95-96). Dr. Rosenzweig testified that his general 26 opinions are based on this clinical experience, review of the relevant literature, years of 27 explanting mesh in women with mesh-related complications, and AMS internal documents. 28 Doc. 50-7 at 36 (page 132). 1 AMS does not meaningfully address this experience, but appears to argue that 2 because Dr. Rosenzweig has never implanted any AMS device, he is unqualified to provide 3 opinions on its devices. Doc. 50 at 7-8. But Judge Goodwin made clear in the MDL that 4 a physician’s “experience removing polypropylene transvaginal mesh devices and 5 performing revision and excision procedures qualifies him [to testify on product design].” 6 Heatherly v. Bos. Sci. Corp., No. 2:13-CV-00702, 2018 WL 3797507, at *4 (S.D. W. Va. 7 Aug. 9, 2018) (emphasis in original). AMS’s attempt to differentiate between implanting 8 and explanting its medical devices are matters for cross-examination and not a valid basis 9 for exclusion under Daubert or Rule 702. 10 The Court concludes that Dr. Rosenzweig’s opinions on AMS’s design defect 11 “rest[] on a reliable foundation and [are] relevant to the task at hand.” Daubert, 509 U.S. 12 at 597; see Tyree v. Bos. Sci. Corp., 54 F. Supp. 3d 501, 565 (S.D. W. Va. 2014) (“I have 13 considered Dr. Rosenzweig as a general causation expert three times in the past, and on 14 each occasion, I have admitted his general causation testimony on the properties of 15 polypropylene mesh”); see also In re C.R. Bard, Inc., 948 F. Supp. 2d 589, 612 (S.D. W. 16 Va. 2013) (ruling that a urogynecologist was qualified to opine on product design and 17 biomaterials because he had “extensive experience with pelvic floor disorders and the use 18 of mesh to treat such disorders”). 19 2. Warnings. 20 The Court reaches the same conclusion on Dr. Rosenzweig’s opinions about product 21 warnings. Plaintiffs make clear that he will not be asked to opine on the regulatory aspects 22 of product warning: 23 [H]e is not proffered to render opinions on how AMS developed the warning 24 in the IFUs that accompanied AMS’ mesh devices. In addition, he is not offered to render opinions on the regulatory requirements or the method or 25 process that is used to develop and approve warnings. Rather, Dr. 26 Rosenzweig is opining as to the completeness and accuracy of the warnings and labels in the clinical setting of surgical treatment for incontinence and 27 pelvic organ prolapse. 28 1 Doc. 50-3 at 6. 2 As a physician who has counseled with patients in more than a thousand pelvic floor 3 surgeries, who understands the risks of mesh products from more than 300 surgeries 4 treating complications of synthetic mesh, and as a urogynecologist with years of experience 5 in reading warning labels and counseling patients, Dr. Rosenzweig is qualified to opine on 6 the completeness and accuracy of warnings and labels in a clinical setting of surgical 7 treatment for SUI and POP. See Edwards v. Ethicon, Inc., No. 2:12-CV-09972, 2014 WL 8 3361923, at *8 (S.D. W. Va. July 8, 2014) (Goodwin, J.) (finding Dr. Rosenzweig 9 “qualified to testify generally on the adequacy of the TVT-O’s product warnings and 10 marketing materials”). 11 B. Alternative Designs. 12 The parties disagree on whether Dr. Rosenzweig’s opinions regarding alternative 13 designs are admissible. Doc. 50 at 9. He opines that there are a number of feasible 14 alternatives that are as effective as, and safer than, AMS’s polypropylene mesh products. 15 These include the Burch procedure; autologous fascia slings; an allograft sling; a lighter 16 weight, larger pore mesh material; a midurethral sling device; and a mesh sling with less 17 polypropylene and sealed edges. Doc. 50-3 at 225. AMS does not challenge Dr. 18 Rosenzweig’s qualifications to give these opinions, but contends instead that they are 19 irrelevant because the proposed alternatives either are unavailable in the United States or 20 are surgical techniques and not products at all. Docs. 50-1 at 8-10, 50-2 at 5. AMS argues 21 that “the MDL court has embraced the general rule that an alternative design for the product 22 in issue cannot be a different product altogether or a different surgical procedure.” Doc. 50 23 at 13. The Court concludes that the parties have not provide sufficient briefing to rule on 24 this issue, and will defer the issue to a motion in limine or trial. 25 Whether this alternative design testimony is relevant will depend on the claims 26 asserted by Plaintiffs under Arizona law – a topic to which the parties give scant attention. 27 In Golonka v. General Motors Corporation, 65 P.3d 956 (Ariz. Ct. App. 2003), the Arizona 28 Court of Appeals noted that a risk/benefit analysis may be used in design defect and strict 1 liability cases, and that the factors to be considered by the jury include the usefulness and 2 desirability of the product and the availability of other and safer products to meet the same 3 need. Id. at 962 & n.2. The Court is inclined to agree with Judge Goodwin that an 4 alternative surgical procedure cannot be used to show a defective design of a product. See 5 Mullins v. Johnson & Johnson, 236 F. Supp. 3d 940, 942-43 (S.D. W. Va. 2017) 6 (alternative designs “must be examined in the context of products – not surgeries or 7 procedures”). But Plaintiffs have also asserted strict liability claims (Doc. 11-1 at 3), and 8 it is possible that alternative procedures may be admitted to show that a product is 9 unreasonably dangerous. The parties do not address this distinction or its treatment under 10 Arizona law. 11 Nor can the Court conclude at this stage that an alternative product cannot be cited 12 unless it is licensed in the United States. The parties do little to brief this issue, but it seems 13 the relevant question is whether a safer design was available for AMS to use in this product 14 (whether or not it had been placed in another product being marketed), not whether a safer 15 product was available on the market for consumers. AMS’s motion will be denied and 16 these issues will be deferred for later consideration. 17 C. Material Safety Data Sheet. 18 Dr. Rosenzweig opines that AMS should not have used polypropylene mesh in its 19 products because the manufacturer of the resin used in the mesh issued a “medical 20 application caution” in its MSDS stating that the material should not be permanently 21 implanted in the human body. Doc. 50-3 at 50, 113, 191, 252. Specifically, Dr. 22 Rosenzweig noted that MSDS warnings are: 23 especially important when considering permanent implantation of the 24 material in the pelvis, and thus are of special importance to physicians like myself and patients considering pelvic mesh, as the applicable MSDSs state 25 in a section entitled “Stability and Reactivity” and under the heading entitled 26 “Incompatibility with Various Substances” that Total 3365 is “[i]ncompatible or reactive with… oxidizing agents.” It is well known that 27 the vagina is naturally occurring oxidizing agents, like peroxides in a woman’s pelvis. 28 1 Id. at 51, 114, 192, 253. Dr. Rosenzweig further suggests that the MSDS should have led 2 AMS to do additional product testing. Id. at 52, 115, 193, 254. The parties agree that Dr. 3 Rosenzweig is not permitted to testify that AMS should have performed additional testing 4 based on the MSDS, but disagree about whether he may use the MSDS as the basis for his 5 opinion that polypropylene mesh should not be used in humans. Doc. 50 at 16-17. 6 AMS argues that Judge Goodwin excluded Dr. Rosenzweig’s opinions related to 7 the MSDS because it is a subject on which he is not qualified to testify. Doc. 50 at 18 8 (citing Griffin v. Bos. Sci. Corp., No. 2:13-cv-11876, 2016 WL 3031700, at *12 (S.D. W. 9 Va. May 25, 2016)). But Judge Goodwin excluded Dr. Rosenzweig’s opinion only as it 10 relates to whether AMS should have done additional testing, finding that “Dr. Rosenzweig 11 lacks the experience and knowledge necessary to opine on what testing a manufacturer 12 should perform on his products.” Id. Judge Goodwin did not address Dr. Rosenzweig’s 13 concerns about the use of polypropylene mesh in the vagina. 14 The Court does not find that Dr. Rosenzweig is unqualified to provide testimony 15 using the MSDS – specifically the MSDS’ statement that polypropylene is incompatible 16 with oxidizers – to support his opinion that the mesh at issue should not be used in the 17 vagina. See In re Ethicon Inc. Pelvic Repair Sys. Prods. Liab. Litig., No. MDL 2327, 2016 18 WL 8788207, at *4 (S.D. W. Va. Aug. 26, 2016) (“A urogynecologist does not need to be 19 an expert in crafting MSDS warnings to use the substance of such warnings in forming 20 opinions about how mesh reacts in the human body.”). AMS otherwise presents no 21 argument that Dr. Rosenzweig is unqualified to provide opinions about how mesh reacts 22 in the human body, or that his opinions are unreliable under Rule 702. 23 IT IS ORDERED: 24 1. Dr. Rosenzweig will not be permitted to testify on AMS’s knowledge or state 25 of mind, to offer legal conclusions, or to opine that mesh causes cancer. 26 2. Dr. Rosenzweig will be permitted to testify on AMS’s design defect and 27 failure to warn, insofar as his testimony is premised on the characteristics of 28 1 polypropylene and the injures that can result from its implantation in humans. 2 He will not be permitted to testify about the adequacy of AMS’s testing. 3 3. The Court will defer ruling on Dr. Rosenzweig’s alternative design 4 testimony. 5 4. Dr. Rosenzweig will be permitted to rely on the MSDS for his opinion that 6 that polypropylene mesh should not be used in humans, but will not be 7 permitted to testify that AMS should have performed additional testing based 8 on the MSDS. 9 Dated this 28th day of July, 2020. 10 aur 6 Cour 12 David G. Campbell 13 Senior United States District Judge 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

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