Gomez v. American Medical Systems Incorporated ( 2021 )

1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA 8 9 Shannon Gomez, No. CV-20-00393-PHX-ROS 10 Plaintiff, ORDER 11 v. 12 American Medical Systems Incorporated, 13 Defendant. 14 15 Pending before the Court are eight Daubert motions. Defendant American Medical 16 Systems (“AMS”) filed motions seeking to exclude the general causation opinions of Dr. 17 Bruce Rosenzweig (Doc. 104), the specific causation opinions of Dr. Bruce Rosenzweig 18 (Doc. 61), the expert opinions of Dr. Vladimir Iakovlev (Doc. 67), the specific causation 19 opinions of Dr. Jerry Blaivas (Docs. 72), and the expert opinions of Drs. Scott Guelcher 20 and Jimmy Mays (Doc. 74). Plaintiff Shannon Gomez (“Gomez”) filed motions seeking to 21 exclude the expert opinions of Dr. Debora L. Joslin (Doc. 70), Dr. Karen Becker (Doc. 22 106), and Dr. Stephen F. Badylak (Doc. 107). 23 For the reasons below, the motion concerning Dr. Rosenzweig’s general causation 24 opinions will be granted in part and denied in part; the motion concerning Dr. 25 Rosenzweig’s specific causation opinions will be denied; the motion concerning Dr. 26 Iakovlev’s expert opinions will be granted; the motion concerning Dr. Blaivas’s specific 27 causation opinions will be denied; the motion concerning Drs. Guelcher and Mays’ expert 28 opinions will be granted in part and denied in part; the motion concerning Dr. Joslin’s 1 expert opinions will be denied; the motion concerning Dr. Becker’s expert opinions will 2 be denied; and the motion concerning Dr. Badylak’s expert opinions will be denied. The 3 Court will then set this matter for trial. 4 BACKGROUND This case originated in one of seven multidistrict litigations (“MDLs”), totaling 5 more than 100,000 cases, concerning products liability for pelvic repair systems, that is, 6 vaginal mesh. (Doc. 52 at 1). All MDL cases were initially before Judge Joseph R. 7 Goodwin in the Southern District of West Virginia.1 Plaintiff Shannon Gomez filed her 8 Amended Short Form Complaint on June 28, 2013 alleging, as a result of the implantation 9 of two American Medical Systems (“AMS”) vaginal mesh products, negligence; gross 10 negligence; design defect; manufacturing defect; failure to warn; defective product; breach 11 of express warranty; breach of implied warranty; violation of consumer protection laws; 12 fraudulent concealment; constructive fraud; discovery rule, tolling and fraudulent 13 concealment; negligent misrepresentation; negligent infliction of emotional distress; unjust 14 enrichment; and punitive damages. (Doc. 17). 15 While in the MDL phase, fact and expert discovery was completed. (Doc. 52 at 1). 16 The parties also were required to file dispositive and Daubert motions. (Doc. 52 at 1). In 17 Pretrial Order #255, Judge Goodwin set October 18, 2018 as the deadline for Daubert 18 motions. (Doc. 35). AMS filed four timely Daubert motions challenging the opinions and 19 testimony of Dr. Bruce Rosenzweig; Dr. Jerry Blaivas; Dr. Vladimir Iakovlev; and Drs. 20 Scott Guelcher and Jimmy Mays. (Docs. 58-6 at 1; 58-18 at 1; 58-21 at 1; 58-31 at 1). On 21 November 9, 2018, Gomez filed her own Daubert motion, seeking to exclude the testimony 22 of Dr. Debora L. Joslin. (Doc. 58-11 at 1–2). On November 16, 2018, AMS moved to strike 23 Gomez’s Daubert motion as untimely. (Doc. 58-16 at 1). In AMS’s Motion to Strike, AMS 24 also responded to the merits of Gomez’s motion regarding Dr. Joslin. (Doc. 92 at 3–8). 25 Gomez never responded to AMS’s Motion to Strike nor replied to AMS’s argument on the 26 merits. The Daubert motions were not resolved by Judge Goodwin. 27 28 1 In prior MDL cases, Judge Goodwin ruled on Daubert motions regarding some of the experts in this case. If applicable, the Court will rely on Judge Goodwin’s prior rulings. 1 This case was eventually transferred to the District of Arizona. In the order 2 transferring the case, Judge Goodwin ordered the parties to designate relevant documents 3 from the MDL in order to constitute an appropriate record for this Court. (Doc. 52 at 2). 4 On February 19, 2020, parties filed the Joint Designation of Record for MDL Transfers. 5 (Doc. 53). In it, Gomez included a Notice of Adoption, purporting to adopt prior Daubert 6 motions filed in separate cases for some of AMS’ experts (Dr. Stephen Badylak, Dr. Karen 7 Becker, Adam Kozak, and Dr. James Coad). (Docs. 53 at 3; 81 at 3). The Notice of 8 Adoption did not cite specific prior motions but claimed to “hereby adopt and incorporate 9 by reference all prior Daubert Motions filed in this MDL and related MDLs” for the four 10 witnesses. (Doc. 53-35 at 1). Additionally, the Notice of Adoption was filed in a later 11 “wave” of cases in the AMS MDL, not the “wave” that included Gomez’s case.2 (Doc. 53- 12 35 at 1). 13 On February 20, 2020, the case was transferred to the District of Arizona. (Doc. 52 14 at 2). And Judge Diane J. Humetewa ordered the parties to “refile Daubert motions to only include factual information relevant to this Plaintiff and not other plaintiffs who are not 15 present in this case” by March 20, 2020. (Docs. 56; 60). On March 20, 2020, AMS filed its 16 four Daubert motions and Gomez filed three motions. (Docs. 61; 67; 72; 74). Gomez filed 17 responses to each of the four motions, and AMS failed to file replies.3 (Docs. 80; 82; 83; 18 84). 19 In support of her motions, Gomez filed a variety of briefs taken from other MDLs 20 concerning different mesh products and manufacturers. Although the defendants in the 21 other MDLs relied on the same experts, the experts submitted different reports in each 22 MDL. Gomez filed three separate briefs4 regarding a single witness, Dr. Badylak, and a 23 24 2 The MDL has consisted of numerous “waves” of cases. Each “wave” is virtually its own 25 MDL with motions and orders that only apply to parties in that “wave.” Later “waves” sometimes adopted motions from earlier “waves” to preserve legal resources. Here, 26 however, Gomez attempts to include a Notice of Adoption from Wave 5 when Gomez’s case was included in Wave 3 of the MDL. (Docs. 53 at 1; 35 at 1). 27 3 AMS filed at least three replies in the MDL court but failed to refile the replies in this Court. (Docs. 58-9; 58-30; 58-34). 28 4 Two of the briefs were taken from a separate MDL and one from an early “Bellwether” case in this MDL, which featured an expert report not relevant to this case. 1 brief taken from a separate MDL regarding Dr. Becker. In short, Gomez paid little attention 2 to what she was filing and disregarded the order requiring the motions be updated to reflect 3 information specifically relevant to this case. 4 On April 3, 2020, AMS filed a Motion to Strike the Daubert motions related to Dr. 5 Badylak and Dr. Becker. (Doc. 81). On August 31, 2020, AMS filed the Motion to Strike 6 the Dr. Joslin Daubert motion. (Doc. 91). Consistent with the motion to strike filed at the 7 MDL phase, the motion included a response on the merits of Gomez’ motion to exclude 8 Dr. Joslin. (Doc. 92 at 3–8). Gomez never responded to AMS’s Motion to Strike regarding 9 Dr. Joslin nor replied to AMS’s argument on the merits. 10 On September 1, 2020, this case was reassigned from Judge Humetewa to this 11 Court. (Doc. 93). And on December 11, 2020, the Court granted AMS’s Motion to Strike 12 Gomez’s irrelevant Daubert motions for Dr. Badylak and Dr. Becker. (Doc. 94). The Court 13 denied AMS’s Motion to Strike Gomez’s Daubert motion for Dr. Joslin and construed 14 AMS’s motion as a response to the original Daubert motion. (Doc. 94). The Court allowed Gomez to file new, relevant Daubert motions for Dr. Badylak and Dr. Becker, and the 15 Court also ordered all parties to file all papers, including missing replies, relevant to the 16 pending Daubert motions. (Doc. 94). Because both parties had failed to adhere to previous 17 Court Orders and rules, the Court instructed the parties shall “strictly comply with all Local 18 and Federal Rules as well as the Orders of this Court.” (Doc. 94 at 6). The Court warned 19 the parties, that “[f]ailure to comply with all orders, rules, and procedures will result in 20 sanctions, which may include granting or denying motions, dismissal of claims or defenses, 21 default judgment, or awards of attorneys’ fees.” (Doc. 94 at 6). 22 On December 18, 2020, AMS filed four replies to Daubert motions and a motion 23 for leave to file another Daubert motion that had been filed at the MDL phase but had not 24 been refiled in this Court. (Docs. 95–99). The same day, Gomez filed a motion for 25 extension of time to file the new Daubert motions. (Doc. 100). The Court granted AMS’s 26 motion for leave to file and Gomez’s motion for an extension of time. (Doc. 101). 27 On January 4, 2021, AMS filed a motion followed by an amended motion to limit 28 the general causation opinions and testimony of Bruce Rosenzweig, MD. (Docs. 102, 104). 1 Because Gomez failed to respond, the motion was granted as unopposed. (Doc. 113). 2 Gomez then filed a motion to vacate the order granting the unopposed motion. (Doc. 114). 3 That motion to vacate was granted, proper papers were filed, and all pending Daubert 4 motions are now fully briefed.5 (Doc. 119). 5 ANALYSIS 6 Expert testimony is governed by Federal Rule of Evidence 702, 703, and Daubert 7 and its progeny. Daubert v. Merrell Dow Pharm., 509 U.S. 579, 592 (1993). The first 8 inquiry asks whether a witness is qualified as an expert. Fed. R. Evid. 702. An expert is 9 qualified by “knowledge, skill, experience, training, or education.” Id. This is not to be 10 construed in a “narrow sense.” Id. Advisory Committee’s note to 1972 Proposed Rules 11 (explaining the Rule includes “skilled” witnesses, such as a landowner testifying to land 12 values, as an expert and is not limited to those with formal credentials); see also Thomas 13 v. Newton Int’l, 42 F.3d 1266, 1269–70 (9th Cir. 1994) (holding a longshoreman with 29 14 years of experience was an expert as to the working conditions of longshore personnel). 15 “Ordinarily, courts impose no requirement that an expert be a specialist in a given field, although there may be a requirement that he or she be of a certain profession, such as a 16 doctor.” Doe v. Cutter Biological, a Div. of Miles Labs., 971 F.2d 375, 385 (9th Cir. 1992). 17 “[L]ack of particularized expertise goes to the weight accorded her testimony, not to the 18 admissibility of her opinion as an expert.” United States v. Garcia, 7 F.3d 885, 890 (9th 19 Cir. 1993). 20 Courts then conduct a two-step inquiry. Daubert, 509 U.S. at 592. First, does the 21 testimony amount to scientific knowledge? Id. Second, is the knowledge relevant or does 22 it assist the trier in understanding or determining a fact in issue? Id. If so, the testimony is 23 admissible. Id. To be scientific knowledge, the testimony must be based on sufficient facts 24 or data. Fed. R. Evid. 702(b). And the testimony must be the product of reliable principles 25 and methods, which in turn must be reliably applied to the facts of the case. Fed. R. Evid. 26 27 5 The Court sanctioned Gomez’s counsel and required him to reimburse AMS’s reasonable attorneys’ costs and fees incurred in litigating the motion to vacate. (Doc. 119). Separately, 28 Gomez failed to file a reply to her Daubert motion regarding Dr. Joslin. The Court will rule on the motion nonetheless. 1 702(c)–(d). The non-exhaustive factors to determine whether testimony is valid scientific 2 knowledge include “(1) whether the expert's technique or theory can be or has been 3 tested—that is, whether the expert’s theory can be challenged in some objective sense, or 4 whether it is instead simply a subjective, conclusory approach that cannot reasonably be 5 assessed for reliability; (2) whether the technique or theory has been subject to peer review 6 and publication; (3) the known or potential rate of error of the technique or theory when 7 applied; (4) the existence and maintenance of standards and controls; and (5) whether the 8 technique or theory has been generally accepted in the scientific community.” Fed. R. Evid. 9 702 Advisory Committee’s note to 2000 amendments. Not every factor is relevant to 10 reliability in every case and the significance of each factor is case-dependent. Murray v. S. 11 Route Mar. SA, 870 F.3d 915, 924 (9th Cir. 2017). “District courts have broad range to 12 structure the reliability inquiry and may choose not to comment on factors that would not 13 inform the analysis.” Id. For example, where there is an absence of peer-reviewed studies, 14 an expert may proffer a diagnostic hypothesis “so long as [the expert] relied upon a variety of objective, verifiable evidence.” Clausen v. M/V NEW CARISSA, 339 F.3d 1049, 1060– 15 61 (9th Cir. 2003), as amended on denial of reh'g (Sept. 25, 2003) (internal quotation and 16 citation omitted). “It is well-established that expert testimony concerning an ultimate issue 17 is not per se improper.” Hangarter v. Provident Life & Acc. Ins., 373 F.3d 998, 1016 (9th 18 Cir. 2004) (internal quotations and citation omitted). “That said, an expert witness cannot 19 give an opinion as to her legal conclusion, i.e., an opinion on an ultimate issue of law.” Id. 20 (internal quotations and citation omitted). The party offering the expert testimony must 21 establish it as qualified and reliable by a preponderance of the evidence. Daubert, 509 U.S. 22 at 593 n.10. 23 24 I. Dr. Bruce Rosenzweig’s General Causation Opinions 25 AMS seeks to exclude Dr. Bruce Rosenzweig’s general causation opinions. (Docs. 26 104; 61). Dr. Rosenzweig is a urogynecologist, who has provided causation opinions in a 27 number of AMS MDL cases. (Doc. 105 at 2). Here, he provides general causation opinions 28 related to AMS’s Monarc and Miniarc products, both of which were implanted here, and 1 specific causation opinions related to Gomez’s medical records. (Docs. 105 at 2; 65 at 1). 2 A. Corporate Conduct, Knowledge, and State of Mind 3 AMS seeks to exclude Dr. Rosenzweig’s opinions about AMS’s corporate conduct, 4 knowledge, and state of mind. Regarding AMS’s conduct, AMS argues Dr. Rosenzweig 5 “merely repeat[s] language from AMS (or other company) documents” in his expert 6 reports. (Doc. 105 at 3). AMS complains Dr. Rosenzweig “quotes company documents at 7 length, at times even reproducing them wholesale.” (Doc. 105 at 3). Gomez acknowledges 8 Judge Goodwin’s “prior orders precluding experts from providing narrative summaries” of 9 corporate conduct as unhelpful to the jury. (Doc. 120 at 12). But Gomez argues Dr. 10 Rosenzweig relies on these documents in forming his opinion that AMS should have 11 provided more information to physicians and patients so they could make an informed 12 decision about the mesh. (Doc. 120 at 12). 13 With regard to Dr. Rosenzweig’s expert report in a different manufacturer’s vaginal 14 mesh litigation, Judge Goodwin reasoned, “a narrative review of corporate documents . . . 15 is not helpful to the jury.” Huskey v. Ethicon, 29 F. Supp. 3d 691, 706 (S.D.W. Va. 2014). 16 Other courts have held similarly, “an expert cannot be presented to the jury solely for the 17 purpose of constructing a factual narrative based upon record evidence” Johns v. Bayer 18 Corp., No. 09CV1935 AJB DHB, 2013 WL 1498965, at *28 (S.D. Cal. Apr. 10, 2013) 19 (citation and internal quotation marks omitted); see also id. (citing In re Rezulin Prods. 20 Liab. Litig., 309 F.Supp.2d 531, 551 (S.D.N.Y.2004)) (“rejecting portions of plaintiffs' 21 expert's testimony that was ‘a narrative reciting selected regulatory events’ because ‘[s]uch 22 material, to the extent it is admissible, is properly presented through percipient witnesses 23 and documentary evidence’”). 24 As Judge Goodwin recognized, “an expert may testify about his or her review of 25 internal corporate documents solely for the purpose of explaining the basis for his or her 26 opinions—assuming the opinions are otherwise admissible—a party’s knowledge, state of 27 mind, or other matters related to corporate conduct and ethics are not appropriate subjects 28 of expert testimony because opinions on these matters will not assist the jury.” Tyree v. 1 Bos. Sci. Corp., 54 F. Supp. 3d 501, 517–18 (S.D.W. Va. 2014), as amended (Oct. 29, 2 2014). The Court agrees an expert may not testify to corporate conduct but notes AMS’s 3 documents may otherwise be admissible. 4 Regarding state of mind opinions, AMS provides a sampling offered by Dr. 5 Rosenzweig in his expert report: 6 That a supplier of the resin used for AMS’s mesh “was unaware” that the resin was being used in pelvic mesh devices. 7 That AMS “knew or should have known that polypropylene 8 mesh is not inert and is subject to degradation inside the body. 9 That AMS “knew” that mesh could degrade, could “shrink in vivo,” and had insufficient pore size. 10 11 (Doc. 105 at 3). 12 Courts have repeatedly recognized “the opinions of expert witnesses on the intent, 13 motives, or states of mind of corporations, regulatory agencies and others have no basis in 14 any relevant body of knowledge or expertise.” See, e.g., Aya Healthcare Servs. v. AMN 15 Healthcare, No. 17CV205-MMA (MDD), 2020 WL 2553181, at *5 (S.D. Cal. May 20, 16 2020) (citations and internal quotation marks omitted); see also In re Bos. Sci. Corp. Pelvic 17 Repair Sys. Prod. Liab. Litig., No. MDL 2326, 2018 WL 2426159, at *2 (S.D.W. Va. May 18 29, 2018). 19 Judge Goodwin held similarly in a different manufacturer’s vaginal mesh litigation: 20 “experts may not testify about what other parties did or did not know. However, to the 21 extent [Defendant] seeks to exclude Dr. Rosenzweig’s testimony about factual issues or 22 the knowledge of the medical community in general, . . . [e]xpert witnesses may properly 23 offer opinions on these topics.” In re Bos. Sci. Corp., 2018 WL 2426159 at *2. Gomez 24 acknowledges Judge Goodwin’s prior rulings as to corporate state of mind and states 25 “Plaintiff will not offer Dr. Rosenzweig to testify as to AMS’[s] state of mind.” (Doc. 120 26 at 12). The Court will thus grant AMS’s motion to the extent that it seeks to exclude 27 opinions regarding AMS’s conduct, knowledge, or state of mind. 28 B. Medical Device Testing 1 AMS seeks to exclude Dr. Rosenzweig’s opinions that “AMS ‘failed to conduct 2 adequate safety tests’ on its mesh as it developed and sold its devices, including testing to 3 determine if mesh degrades in the body and clinical trials prior to marketing its products 4 and that the testing that AMS did perform was deficient.” (Doc. 105 at 4). AMS argues Dr. 5 Rosenzweig has no specialized training or education that qualifies him to offer such 6 opinions. (Doc. 105 at 5). Gomez only counterargues that “Dr. Rosenzweig is qualified to 7 render opinions regarding the adequacy of AMS’ testing from perspective of a clinician 8 based on his knowledge of and clinical experience with the risks of pelvic mesh products.” 9 (Doc. 120 at 10). 10 Judge Goodwin has repeatedly held Dr. Rosenzweig does not have the “experience, 11 education, or knowledge about the appropriate testing that a medical device manufacturer 12 should perform on its products prior to sale.” In re Bos. Sci. Corp. Pelvic Repair Sys. Prod. 13 Liab. Litig., No. MDL 2326, 2018 WL 2426159, at *2 (S.D.W. Va. May 29, 2018); see 14 also Griffin v. Bos. Sci. Corp., No. 2:13-cv-11876, 2016 WL 3031700, at *12 (S.D. W. Va. 15 May 25, 2016) (“Dr. Rosenzweig lacks the experience and knowledge necessary to opine 16 on what testing a manufacturer should perform on his products.”). 17 Gomez fails to provide sufficient evidence of Dr. Rosenzweig’s qualifications to 18 opine on the adequacy of medical device testing. As such, AMS’s motion will be granted 19 to the extent it seeks to exclude Dr. Rosenzweig’s opinions regarding the adequacy of 20 device testing. 21 C. Medical Device Design and Warnings 22 AMS also seeks to exclude Dr. Rosenzweig’s opinion that “AMS should have 23 designed its polypropylene mesh implants differently.” (Doc. 105 at 4; see, e.g., Doc. 105 24 at 4–5 (“resin used to manufacture polypropylene pelvic mesh ‘should never have been 25 used in a medical implant’ and ‘[t]he design of the Monarc . . . is inherently flawed’ because 26 of the risk of nerve damage and other complications; . . . ‘[t]he resin used to manufacture 27 polypropylene mesh in MiniArc Products should never have been used to manufacture a 28 medical implant.’”)). AMS also seeks to exclude Dr. Rosenzweig’s opinions that “AMS 1 should have provided additional warnings about the rate, severity, or duration of potential 2 risks associated with its pelvic mesh.” (Doc. 105 at 5; see, e.g., Doc. 105 at 5 (“‘AMS 3 failed to disclose pertinent adverse risk information, pertinent information about the defects 4 in the properties of the mesh.’”)). As with device testing, AMS argues Dr. Rosenzweig has 5 no specialized training or education that qualifies him to offer such opinions. (Doc. 105 at 6 5). 7 AMS reasons Dr. Rosenzweig’s design opinions rely on his mesh degradation and 8 contraction opinions, which are unqualified because he is not a biomaterials expert or 9 pathologist. (Doc. 105 at 5). However, Judge Goodwin held at least four separate times that 10 Dr. Rosenzweig’s general causation testimony on mesh degradation and contraction based 11 on the physical properties of polypropylene mesh are qualified and admissible. See Tyree 12 v. Bos. Sci. Corp., 54 F. Supp. 3d 501, 565 (S.D. W. Va. 2014). 13 AMS specifically argues Dr. Rosenzweig is not qualified to opine about “the 14 regulatory aspects of medical device warnings, including their adequacy vis-à-vis FDA 15 regulations, or their development by device manufacturers in accordance with those 16 regulations.” (Doc. 105 at 2). Gomez makes clear Dr. Rosenzweig is not offered for those 17 purposes; 18 [Dr. Rosenzweig] is not proffered to render opinions on how AMS developed the warning in the IFUs that accompanied 19 AMS’ mesh devices. In addition, he is not offered to render opinions on the regulatory requirements or the method or 20 process that is used to develop and approve warnings. Rather, Dr. Rosenzweig is opining as to the completeness and accuracy 21 of the warnings and labels in the clinical setting of surgical treatment for incontinence and pelvic organ prolapse. His 22 opinions are based on his knowledge, education, training and experience, his thorough review of the medical literature and 23 Instructions for Use that he has reviewed. 24 (Doc. 120 at 5) (emphasis in original). 25 Judge Goodwin also made clear a physician’s “experience removing polypropylene 26 transvaginal mesh devices and performing revision and excision procedures qualifies him” 27 “to opine on the design or adequacy of warnings of polypropylene transvaginal mesh 28 devices.” Heatherly v. Bos. Sci. Corp., No. 2:13-CV-00702, 2018 WL 3797507, at *4 (S.D. 1 W. Va. Aug. 9, 2018) (emphasis in original). And Judge Campbell noted in a similar case, 2 “Dr. Rosenzweig has decades of experience treating female urological conditions.” Triant 3 v. Am. Med. Sys., No. CV-12-00450-PHX-DGC, 2020 WL 4333645, at *2 (D. Ariz. July 4 28, 2020). He has performed over a thousand pelvic floor surgeries. (Doc. 120 at 3). He 5 has performed over 300 surgeries dealing with complications related to synthetic mesh, 6 including numerous AMS device removals. (Doc. 120 at 3). He testified that his opinions 7 are based on his clinical experience, a review of the relevant literature, years of explanting 8 mesh from women with mesh complications, and AMS internal documents. (Doc. 120 at 9 3–4). He has also counseled more than a thousand patients undergoing pelvic floor 10 surgeries, including hundreds involving mesh complications. 11 Based on his extensive gynecological experience, the Court finds Dr. Rosenzweig 12 qualified to opine on medical device design and warnings and AMS’s motion will be 13 denied on this issue. 14 D. Alternative Design 15 AMS seeks to exclude Dr. Rosenzweig’s opinions regarding “a number of ‘feasible 16 alternatives’” to AMS’s mesh because none of the alternatives are “alternative pelvic mesh 17 implant[s] available in the United States.” (Doc. 105 at 6). In particular, AMS claims Dr. 18 Rosenzweig’s alternatives are either: 19 surgical techniques . . . (the Burch procedure, suturing a sling made of the patient’s own tissue, suturing a sling made of 20 cadaveric tissue, suturing a patient’s tissues together, or an abdominal sacralcolpopexy incorporating a polypropylene 21 mesh graft), or they are products not approved or cleared for sale in the United States (the “Dynamesh” sling made of 22 polyvinylidene difluoride or “PVDF”), or hypothetical products that do not exist (“mesh sling with less polypropylene 23 and sealed edges” or “lighter weight, larger pore mesh sling [with] a shorter piece of mesh.” 24 25 (Doc. 105 at 6–7). AMS argues these opinions will not help the jury “evaluate the safety 26 and efficacy of AMS’s pelvic mesh product designs.” AMS also argues the alternative 27 design opinions constitute “design opinions that exceed the scope of Dr. Rosenzweig’s 28 expertise.” (Doc. 105 at 6). 1 But Dr. Rosenzweig is qualified to opine on device design. The question then is 2 whether his alternative opinions are admissible because they are helpful to the jury. Judge 3 Campbell deferred ruling on the same question in Triant until trial, but noted he was 4 “inclined” to find “an alternative surgical procedure cannot be used to show a defective 5 design of a product.” Triant, 2020 WL 4333645, at *3. Judge Campbell also included a 6 discussion of Arizona law: 7 Whether this alternative design testimony is relevant will depend on the claims asserted by Plaintiffs under Arizona law 8 – a topic to which the parties give scant attention. In Golonka v. General Motors Corporation, 65 P.3d 956 (Ariz. Ct. App. 9 2003), the Arizona Court of Appeals noted that a risk/benefit analysis may be used in design defect and strict liability cases, 10 and that the factors to be considered by the jury include the usefulness and desirability of the product and the availability 11 of other and safer products to meet the same need. Id. at 962 & n.2. . . . Plaintiffs have also asserted strict liability claims [], 12 and it is possible that alternative procedures may be admitted to show that a product is unreasonably dangerous. 13 14 Id. Arizona’s law provides a starting point but it does not yet directly address this question. 15 The parties each cite cases from other jurisdictions in support of their positions. Again, 16 AMS argues only available products, not procedures or unavailable products, are relevant 17 to products liability. (Doc. 122 at 5–7). Gomez argues an effective substitute, including 18 surgical procedures, is relevant. (Doc. 120 at 14–16). Presently, the Court is persuaded by 19 the latter. The benefit of a product directly relates to its value compared to alternative 20 options, including alternative procedures. See, e.g., Messina v. Ethicon, No. 21 620CV1170ORL40LRH, 2020 WL 7419586, at *4 (M.D. Fla. Dec. 17, 2020) (“Dr. 22 Rosenzweig's opinion that alternate medical procedures were safe and effective—that is, 23 they are safer than the accused product and were feasible for [Plaintiff]—are relevant to 24 demonstrating that the [product’s] inherent risks outweigh its benefits.”) (footnote 25 omitted). And in any event, Dr. Rosenzweig will be subject to cross-examination. 26 Accordingly, the Court will deny AMS’s motion on this issue. Dr. Rosenzweig will be 27 allowed to testify about alternative design opinions regarding alternative surgical 28 procedures. 1 Separately, as was the case in Triant, the parties have not sufficiently briefed the 2 question of whether hypothetical products or products not available in the United States 3 are relevant and admissible. See Triant, 2020 WL 4333645, at *3 (“T]he Court [cannot] 4 conclude at this stage that an alternative product cannot be cited unless it is licensed in the 5 United States.”). The Court will defer the issue for later consideration if appropriate. The 6 AMS’s motion on this issue is denied without prejudice. 7 E. Legal Conclusions 8 AMS also seeks to exclude Dr. Rosenzweig’s opinions that “constitute improper 9 legal conclusions.” (Doc. 105 at 7). Gomez acknowledges “the scope of permissible expert 10 testimony articulated by the MDL Court with respect to ‘legal conclusions,’” and will “not 11 [to] elicit legal conclusions from [her] experts.” (Doc. 120 at 14) Accordingly, AMS’s 12 motion will be denied as moot on this issue. 13 F. Material Safety Data Sheet (“MSDS”) 14 AMS seeks to exclude Dr. Rosenzweig’s opinions “AMS products should not have 15 incorporated polypropylene mesh because the manufacturer of the resin used in the mesh . 16 . . included a . . . ‘medical application caution’ in its material safety data sheet [] stating 17 that the material should not be permanently implanted in the human body.” (Doc. 105 at 18 7). AMS also objects to Dr. Rosenzweig’s suggestion that the MSDS should have led AMS 19 to do different product testing. (Doc. 105 at 7). 20 Judge Goodwin held in a separate litigation, “[a] urogynecologist does not need to 21 be an expert in crafting MSDS warnings to use the substance of such warnings in forming 22 opinions about how mesh reacts in the human body.” In re Ethicon Inc. Pelvic Repair Sys. 23 Prods. Liab. Litig., No. MDL 2327, 2016 WL 8788207, at *4 (S.D. W. Va. Aug. 26, 2016). 24 Judge Campbell similarly found Dr. Rosenzweig qualified to rely on the MSDS to support 25 his opinion that the mesh at issue should not be used in the vagina. Triant, 2020 WL 26 4333645, at *4. Both parties acknowledge two additional cases where Dr. Rosenzweig was 27 qualified to rely on the MSDS. (See, e.g., Doc. 122 at 8–9). AMS provides no authority 28 otherwise. The Court will allow Dr. Rosenzweig to rely on the MSDS as the basis for his 1 opinions and will deny AMS’s motion on this issue. 2 G. Cancer 3 AMS seeks to exclude Dr. Rosenzweig’s opinions about the possible association 4 between cancer and polypropylene mesh, which he has not offered here but has in other 5 pelvic mesh MDL cases. (Doc. 105 at 8). And Gomez will not offer such opinions from 6 Dr. Rosenzweig. (Doc. 120 at 14). The motion is denied as moot on this issue. 7 II. Dr. Bruce Rosenzweig’s Specific Causation Opinions 8 A. General Causation Opinions 9 AMS seeks to exclude all of Dr. Rosenzweig’s specific causation opinions as based 10 only on his general causation opinions which AMS contends are unreliable. (Doc. 65 at 2). 11 Gomez notes, Dr. Rosenzweig relies on, in addition to his general causation opinions, 12 deposition materials, medical records, scientific literature, and corporate documents to 13 form his specific causation opinions. (Doc. 84 at 4). As held above, Dr. Rosenzweig’s 14 general causation opinions are essentially qualified and reliable. As such, AMS’s motion 15 will be denied on this issue. 16 B. Degradation and Contraction 17 AMS seeks to exclude Dr. Rosenzweig’s opinions that degradation and contraction 18 of Gomez’s mesh caused her injuries as without reliable foundation that the mesh actually 19 degraded or contracted. (Doc. 65 at 3–4). AMS complains that Dr. Rosenzweig, a urologist, 20 has not examined any pathology specimens from Gomez’s explant procedures, such that 21 his opinions are mere speculation and without evidentiary support. (Doc. 65 at 3–4). 22 Gomez was first implanted with a MiniArc device. That device was explanted and 23 replaced with a Monarc device. The Monarc appears to remain implanted. (See Doc. 84-1 24 at 36). 25 AMS does admit Dr. Rosenzweig has evidence that Gomez’s MiniArc degraded and 26 contracted. According to Dr. Rosenzweig, a new MiniArc device is 1 to 1.1 centimeters 27 wide, but the device was only 0.5 centimeters wide when explanted from Gomez. (Doc. 84 28 at 7). Dr. Rosenzweig opines this is evidence of “contraction, deformation, degradation, 1 roping, and curling.” (Doc. 84 at 7). AMS does not dispute this but claims because this is 2 Dr. Rosenzweig’s only evidence of degradation and contraction, the opinion is 3 inadmissible. (Doc. 99 at 3). AMS also claims its expert and other medical records show 4 no signs of degradation. (Doc. 99 at 3). However, that goes to weight, not admissibility, 5 and Dr. Rosenzweig’s opinion will be allowed. 6 AMS also states Dr. Rosenzweig has no evidence of degradation or contraction of 7 Gomez’s Monarc device, as Gomez’s Monarc device remains in her body. (Doc. 99 at 3, 8 22). Dr. Rosenzweig obviously cannot opine on the Monarc’s present and actual 9 degradation or contraction. However, Dr. Rosenzweig will be allowed to testify to the 10 likelihood of contraction or degradation of the Monarc device to the extent possible without 11 the specimen having been observed, as discussed in the next section. Accordingly, AMS’s 12 motion will be denied on this issue. 13 C. Opinions Regarding Defectiveness and Causation 14 AMS seeks to exclude Dr. Rosenzweig’s opinion that the mesh products were 15 defective and caused Gomez’s injury because his differential diagnosis is unreliable. (Doc. 16 65 at 5). A differential diagnosis “is a standard scientific technique of identifying the cause 17 of a medical problem by eliminating the likely causes until the most probable one is 18 isolated.” Clausen v. M/V NEW CARISSA, 339 F.3d 1049, 1057 (9th Cir. 2003), as 19 amended on denial of reh'g (Sept. 25, 2003) (citation and internal quotation marks 20 omitted). “[A] reliable differential diagnosis passes muster under Daubert.” Id. at 1058. 21 AMS claims, unlike an arguably typical differential diagnosis, Dr. Rosenzweig did 22 not conduct a physical exam and only reviewed Gomez’s medical history. (Doc. 65 at 5). 23 AMS contends Dr. Rosenzweig’s opinion is based on “little more than timing—that Ms. 24 Gomez’s complaints followed an implant procedure” and thus “succumb to the logical 25 fallacy of post hoc ergo propter hoc.” (Doc. 65 at 5 (citation and internal quotations 26 omitted)). 27 A physical exam is not always necessary to reach a differential diagnosis. “A doctor 28 using a differential diagnosis grounded in significant clinical experience and examination 1 of medical records and literature can certainly aid the trier of fact.” Messick v. Novartis 2 Pharm., 747 F.3d 1193, 1199 (9th Cir. 2014). 3 In fact, Dr. Rosenzweig reliably ruled out or found other causes less likely after 4 Gomez’s fibroids, ovarian cysts, adenomyosis, and the ovaries that stimulate endometriosis 5 were removed and pain persisted. (Doc. 84 at 7). And Dr. Rosenzweig relied on the 6 evidence of degradation and contraction to support his opinion. (Doc. 84 at 7). Dr. 7 Rosenzweig’s opinion was based on his clinical experience, an examination of the medical 8 records, and the literature. (Doc. 65-1 at 19). 9 Whether Dr. Rosenzweig’s opinion is persuasive after cross-examination will be 10 determined at trial. The Court finds Dr. Rosenzweig’s opinion that the mesh products were 11 defective and caused Gomez’s injuries are reliable and the motion will be denied on this 12 issue. 13 D. Future Harm 14 AMS seeks to exclude Dr. Rosenzweig’s opinions that Gomez may have future 15 symptoms and complications as speculation. (Doc. 65 at 6). Gomez identifies the evidence 16 Dr. Rosenzweig relied upon as medical records and deposition testimony that includes that 17 Gomez’s pain is chronic and ongoing, which is reliable enough to be presented to the jury 18 and his opinions will be the subject of cross-examination. (Doc. 84 at 8). The Court will 19 deny AMS’s motion on this issue. 20 III. Dr. Vladimir Iakovlev’s Opinions 21 AMS seeks to exclude the general causation opinions of Dr. Vladimir Iakovlev, an 22 anatomical pathologist. (Doc. 68 at 2). AMS does not challenge Dr. Iakovlev’s 23 qualification. 24 A. General Causation 25 AMS seeks to exclude Dr. Iakovlev’s general causation opinions because of the 26 methodologies and the scientific literature he relies upon are unreliable. (Doc. 68 at 2). 27 Judge Goodwin has repeatedly found Dr. Iakovlev’s methodologies related to his mesh 28 studies unreliable. For example, Judge Goodwin reasoned: 1 Dr. Iakovlev’s general causation opinions are based largely on his examination of the mesh explant samples in his personal 2 data pool. However, Dr. Iakovlev provides no information on how the mesh explants were chosen or prepared for 3 examination. Indeed, Dr. Iakovlev testified that plaintiffs’ counsel provided approximately seventy percent of the 4 transvaginal mesh explants, but he does not know how those explants were chosen or what methodology counsel employed. 5 6 In re Bos. Sci. Corp. Pelvic Repair Sys. Prod. Liab. Litig., No. MDL 2326, 2018 WL 7 2419058, at *2 (S.D.W. Va. May 30, 2018). Judge Goodwin has also excluded Dr. 8 Iakovlev’s opinions for lack of sample size, error rate, written protocol, and standardized 9 methodology. See, e.g., Edwards v. Ethicon, No. 2:12-CV-09972, 2014 WL 3361923, at 10 *23 (S.D.W. Va. July 8, 2014). 11 Here, Dr. Iakovlev’s specimens are from his hospital, referring hospitals, and 12 medico-legal consultations. (Doc. 68-1 at 7). He received about 60 specimens, almost all 13 related to this MDL. (Doc. 68 at 5). He does not know how mesh specimens were selected. 14 (Doc. 68 at 4). Some were pre-stained, others he stained himself. (Doc. 68 at 4). Dr. 15 Iakovlev’s report then only included specimens which demonstrated scarring or foreign 16 body response. (Doc. 68 at 5). He had no standardized process for obtaining, preparing, or 17 selecting specimens for inclusion in his report. (Doc. 68 at 4). He did not use a control 18 group, instead he referenced samples “embedded in [his] head.” (Doc. 68 at 5). He failed 19 to track which specimen photographs captured. (Doc. 68 at 5). When presented with 20 photographs during his deposition, Dr. Iakovlev could not replicate the results in his report. 21 (Docs. 68 at 5; 99 at 5). As the Judge Goodwin repeatedly held, Dr. Iakovlev’s opinions 22 cannot be reliable because he provides no reliable methodology to support his conclusions. 23 With regard to the Dr. Iakovlev’s “stretch test,” Judge Goodwin found it unreliable 24 because Dr. Iakovlev failed to standardize his method or results and conducted the test 25 outside of the body, which is not sufficiently similar to the way mesh would exist within 26 the body. Eghnayem v. Bos. Sci. Corp., 57 F. Supp. 3d 658, 709–10 (S.D.W. Va. 2014). 27 The Court agrees and Dr. Iakovlev’s opinions will be excluded to the extent they rely on 28 1 his study of AMS mesh specimens and the “stretch test.” The motion will be granted.6 2 AMS also seeks to preclude all other experts from relying on Dr. Iakovlev’s 3 unreliable opinions. (Doc. 68 at 10). Presently, other experts will not be allowed to rely on 4 Dr. Iakovlev’s opinions and bases to the extent they have been found unreliable here. The 5 parties give scant and insufficient attention to other opinions relying upon Dr. Iakovlev’s 6 opinions, so the motion is denied without prejudice on this issue. 7 IV. Dr. Jerry Blaivas’s Opinions7 AMS seeks to exclude the specific causation opinions and testimony of Dr. Jerry 8 Blaivas because it argues his methods are unreliable and he is not qualified to offer these 9 opinions. (Doc. 73 at 1–2). AMS specifically seeks exclusion of improper legal 10 conclusions, opinions about AMS’s state of mind, opinions that AMS did not adequately 11 test its products and did not provide adequate warning with the products, and opinions 12 about the “degradation” and “shrinkage” of AMS’s mesh. (Doc. 73 at 2–3). 13 Dr. Blaivas is a urologist, who teaches medicine and practices surgery in 14 Massachusetts and New York. (Doc. 73-1 at 3). Dr. Blaivas helped develop the techniques 15 for sling surgery for women suffering incontinence. (Doc. 73-1 at 3). He has experience 16 implanting and explanting both autologous and synthetic slings. (Doc. 73-1 at 3–4). 17 A. Mesh Degradation 18 AMS argues Dr. Blaivas is not qualified to opine that polypropylene mesh degrades 19 in vivo and is subject to degradation and deformation, which causes pain, contracture, and 20 other complications because he lacks specialized knowledge in biomedical engineering and 21 biomaterials.8 (Doc. 73 at 3). In response, Gomez provides Dr. Blaivas’ credentials. He is 22 a board-certified clinical and academic urologist and has performed around 1,500 23 procedures to treat stress urinary incontinence, pelvic organ prolapse, or both. (Doc. 80 at 24 3–4). Most often, Dr. Blaivas used autologous tissue in these procedures, but he also 25 6 Because the motion is granted on the unreliability of Dr. Iakovlev’s study, the Court will 26 not address Dr. Iakovlev’s reliance on scientific literature. 7 AMS may have attempted to file a reply regarding Dr. Blaivas but filed its reply for Dr. 27 Rosenzweig’s specific causation opinions a second time. (Doc. 97). 8 AMS claims that Dr. Blaivas agreed he is unqualified to opine on the subject and admitted 28 all his information comes from Gomez’s expert, Dr. Iakovlev, but this is false. (Docs. 73 at 3; 73-2 at 29). 1 implanted around twelve synthetic mesh slings and explanted over 100 mesh slings. (Docs. 2 80 at 4; 80-1 at 4). Like Dr. Rosenzweig, Dr. Blaivas’ clinical and professional experience 3 qualifies him to opine about vaginal mesh and its complications. What he lacks in expertise 4 in biomedical engineering goes to the weight of his testimony, not the admissibility. See 5 United States v. Garcia, 7 F.3d 885, 890 (9th Cir. 1993) (“lack of particularized expertise 6 goes to the weight accorded [the expert’s] testimony, not to the admissibility of [their] 7 opinion as an expert”). AMS’s motion will be denied on this issue. 8 B. Device Design 9 AMS seeks to exclude Dr. Blaivas’ opinion that AMS’s mesh devices “should not 10 have been designed for placement in a surgically contaminated field” because he is 11 unqualified to opine on the design of mesh devices. (Doc. 73 at 4). AMS argues Dr. 12 Blaivas’ criticism of the transvaginal surgical approach does not equate to relevant 13 experience in device design, he has never designed a medical device to treat stress urinary 14 incontinence or pelvic organ prolapse, and he has never designed a mesh device. (Doc. 73 at 4). In response, Gomez cites Dr. Blaivas’ years of experience with gynecological 15 surgeries and surgical fields. (Doc. 80 at 6). As mentioned above, Dr. Blaivas has implanted 16 around twelve synthetic mesh slings and explanted over 100 mesh slings. (Docs. 80 at 4; 17 80-1 at 4). Although Dr. Blaivas does not have experience with mesh design, his extensive 18 experience with gynecological surgery including at least 100 mesh explant procedures 19 qualifies him to opine about device design. A surgeon’s opinion may be less valuable than 20 a biochemical engineer’s but that does not disqualify the surgeon. As with Dr. Rosenzweig, 21 Dr. Blaivas is qualified to offer this opinion and AMS’s motion will be denied on this issue. 22 C. Device Testing 23 AMS seeks to exclude Dr. Blaivas’ opinion that AMS did not perform adequate 24 testing on its mesh products because he is unqualified to opine on appropriate testing for 25 mesh devices. (Doc. 73 at 4–5). Gomez concedes the point. (Doc. 80 at 2 n.1). AMS’s 26 motion will be denied as moot. 27 D. Device Marketing 28 AMS seeks to exclude Dr. Blaivas’ opinion that “synthetic slings were revived, 1 reinvented and promoted by industry through pervasive advertising inducements to 2 physicians to perform such surgeries” because he is unqualified to offer “marketing” 3 opinions. (Doc. 73 at 5). Gomez concedes the point. (Doc. 80 at 2 n.1). AMS’s motion will 4 be denied as moot on this issue. 5 E. Mesh Complication Rate 6 AMS seeks to exclude Dr. Blaivas’ opinion that “the overall risk of a negative 7 outcome after SMUS implantation surgery is greater than or equal to 15 percent” because 8 the opinion is speculative and unreliable. (Doc. 73 at 5). AMS argues Dr. Blaivas admits 9 the complication rate is imprecise. (Doc. 73 at 5–6). But Dr. Blaivas explains the reason 10 this calculus is imprecise, that is, underreporting is well-documented. (Doc. 73-1 at 15). 11 Dr. Blaivas’ findings were published in Nature Reviews Urology, a peer-reviewed 12 publication. (Doc. 73-1 at 15; Nature Research: Peer-review policy, 13 https://www.nature.com/nature-research/editorial-policies/peer-review#selecting-peer- 14 reviewers (last accessed December 1, 2020)). These findings may be used where relevant to challenge his opinion, but AMS did not do so.9 Instead, AMS quotes Dr. Blaivas’ 15 deposition in which he explains the imprecise nature of calculating complication rates. 16 (Doc. 73 at 5–6). Because AMS does no more than summarily allege unreliable methods, 17 AMS’s motion will be denied on this issue. 18 F. Warnings 19 AMS seeks to exclude Dr. Blaivas’ opinion that the mesh “should not have been 20 designed for placement in a surgically contaminated field . . . without a clear warning about 21 the possibility of short and long term complications” and that the Monarc (a particular mesh 22 product) Instructions for Use (“IFU”) did “not even mention the severity and life style 23 altering nature of some of these complications” because he is not a regulatory expert and 24 the opinions are unreliable. (Doc. 73 at 6). Judge Goodwin recognized Dr. Blaivas, as a 25 urologist, is qualified to testify about the risks of devices and whether IFUs adequately 26 express those risks. Huskey v. Ethicon, 29 F. Supp. 3d 691, 719 (S.D.W. Va. 2014). The 27 28 9 Again, rather than file a reply relevant to this motion, AMS appears to have filed its reply to the Dr. Rosenzweig specific causation motion twice. (Doc. 97). 1 Court agrees and AMS’s motion will be denied on the issue. 2 G. Corporate State of Mind 3 Finally, AMS seeks to exclude Dr. Blaivas’ opinions that AMS “knew” or “should 4 have known” about complications with its devices and those of its competitors because of 5 problems associated with predicate devices as “state of mind” testimony. (Doc. 73 at 7). 6 Gomez concedes the issue. (Doc. 80 at 2 n.1). AMS’s motion will be denied as moot on 7 this issue. 8 V. Drs. Scott Guelcher and Jimmy Mays’ Opinions 9 AMS moves to exclude Drs. Scott Guelcher and Jimmy Mays’ general causation 10 opinions, “state of mind” opinions, and legal conclusions. (Doc. 75 at 2). Additionally, 11 AMS seeks to exclude Dr. Guelcher’s opinions on proposed alternative designs and the 12 adequacy of AMS’s testing on its pelvic mesh devices. (Doc. 75 at 2). 13 Dr. Guelcher holds a Ph.D. in chemical engineering and a post-doctoral degree in 14 biomedical engineering. (Doc. 75-1 at 1). He is currently a professor of chemical and 15 biomolecular engineering. (Doc. 75-1 at 1). Dr. Mays has a Ph.D. in Polymer Science and worked for four years as a research chemist for a manufacturer of polypropylene. (Doc. 75- 16 2 at 2–3). He is currently a professor of chemistry and scientist at the Oak Ridge National 17 Laboratory. (Doc. 75-2 at 2). 18 A. In Vivo Degradation 19 AMS seeks to exclude as unreliable Drs. Guelcher and Mays’ opinions that mesh 20 degrades in vivo. (Doc. 75 at 5). Central to AMS’s argument is the fact that in vivo mesh 21 degradation is “merely a hypothesis in need of further study.” (Doc. 75 at 5). The parties 22 primarily dispute whether the methods in the proverbial “Talley study” (also known as 23 “Oxidation and degradation of polypropylene transvaginal mesh” found in the 2017 24 Polymer Edition of the Journal of Biomaterials Science). (Doc. 75 at 6–7). The study was 25 subject to peer-review and published. (Doc. 83 at 5). AMS accuses the Talley study of 26 lacking any protocol. (Doc. 75 at 8). Yet, the Talley study contains a detailed materials and 27 methods section, which AMS fails to address. (Doc. 75-3 at 5–7). AMS criticized the study 28 for its small sample size and the materials used, none of which were AMS mesh. (Doc. 96 1 at 3). But Drs. Guelcher and Mays seek to use this study to support their opinion that 2 polypropylene mesh, generally, degrades in vivo. The details of the study go to weight, not 3 admissibility of the opinions. In short, the Court finds no reason to find the Talley study 4 unreliable as a matter of law. AMS’s motion will be denied on this issue. 5 AMS also argues other studies relied upon are flawed as only putting forth 6 hypotheses in need of further study. (Doc. 75 at 8). However, the studies highlighted by 7 AMS provide evidence to support the hypothesis that mesh degrades in vivo. See, e.g., 8 Materials Characterization of Explanted Polypropylene Hernia Meshes (Doc. 82-7 at 2) 9 (“Overall, the results supported our hypothesis that oxidation is involved with the 10 degradation of polypropylene hernia mesh materials.”). Moreover, all the studies are 11 published in peer-reviewed publications. (Doc. 83 at 3–4). AMS “is right that none of the 12 studies establish all aspects of [Drs. Guelcher and Mays’] opinions, which is why [their] 13 report is necessary to connect them.” Zeiger v. WELLPET, No. 3:17-CV-04056-WHO, 14 2021 WL 756109, at *6 (N.D. Cal. Feb. 26, 2021). A study admitting a hypothesis requires further study does not make it unreliable. Offering a hypothesis as an opinion goes to 15 weight, not admissibility, so long as there is support in objective evidence. AMS does not 16 argue there is no support for these theories. The concerns AMS has with the studies can be 17 addressed on cross-examination, as AMS demonstrated in its deposition of Dr. Mays. (Doc. 18 75-3 at 7). Experts may hypothesize “so long as [the expert] relied upon a variety of 19 objective, verifiable evidence.” Clausen, 339 F.3d at 1060–61. AMS’s motion will be 20 denied on this issue. 21 AMS again notes that many of the authors of these studies are Gomez’s designated 22 experts in this litigation, limiting their independence and credibility. (Doc. 75 at 5). 23 However, several of the articles’ authors are not experts in vaginal mesh cases, providing 24 evidence of some independence and credibility. Again, an accusation of bias is an issue for 25 cross-examination. 26 B. Medical Causation 27 AMS seeks to exclude Drs. Guelcher and Mays’ opinions that in vivo degradation 28 of mesh causes pain, scarring, and inflammation because they are not medical doctors. 1 (Doc 75 at 9). Both Drs. Guelcher and Mays have strong credentials in polymer science. 2 Much of their research looks at effects of polypropylene in the body. Their review of the 3 literature led to their opinions that in vivo degradation can cause negative effects in the 4 body. (E.g., Doc. 75-1 at 18). As chemists and engineers, they are qualified to opine that 5 “mesh is not inert and its properties change after implantation, which can lead to adverse 6 events in the implantee.” (Doc. 83 at 6). However, they are not medical professionals, have 7 not examined patients, and have not conducted differential diagnoses. Thus, as Judge 8 Goodwin held, they are unqualified to offer opinions regarding the medical complications 9 that mesh degradation can cause. In re: Ethicon Inc. Pelvic Repair Sys. Prod. Liab. Litig., 10 No. 2327, 2016 WL 4547055, at *3 (S.D.W. Va. Aug. 31, 2016). To the extent Gomez 11 attempts to offer Drs. Guelcher and Mays for their opinions regarding medical 12 complications, AMS’s motion will be granted. 13 C. Improper Legal Conclusions 14 AMS argues Guelcher and Mays’ opinions that AMS created an “unreasonable risk” of oxidation and degradation and that the products are “unreasonably dangerous” and 15 “defective” are improper legal conclusions. (Doc. 75 at 9). Gomez agrees that Drs. 16 Guelcher and Mays will not testify to any improper legal conclusions. (Doc. 83 at 7). 17 Accordingly, AMS’s motion will be denied as moot on this issue. 18 D. Corporate State of Mind 19 AMS argues Guelcher and Mays’ expert report speculates as to AMS’s state of 20 mind, intent, knowledge, and corporate conduct. (Doc. 75 at 10). Gomez agrees Drs. 21 Guelcher and Mays will not testify to AMS’s knowledge, state of mind, or corporate 22 conduct. (Doc. 83 at 7). AMS’s motion will be denied as moot on this issue. 23 E. Safer Alternative Design Opinions 24 AMS argues Dr. Guelcher does not offer proper a safer alternative design because 25 he only proposes alternative surgeries or procedures, not products. (Doc. 75 at 10–11). As 26 discussed above with regard to Dr. Rosenzweig, safer alternative surgeries or procedures 27 are permissible and relevant to the Arizona state benefit/risk analysis for products liability. 28 According, AMS’s motion will be denied on this issue. 1 F. Testing Opinions 2 AMS seeks to exclude Dr. Guelcher’s opinions that AMS failed to perform adequate 3 testing on its pelvic mesh device. (Doc. 75 at 11). AMS argues that Dr. Guelcher is “neither 4 a medical doctor nor a medical device engineer.” (Doc. 75 at 11). (Doc. 73 at 4–5). AMS 5 claims Dr. Guelcher “has no experience in designing or testing medical devices.” (Doc. 75 6 at 11). Gomez failed to respond to this argument. As such, AMS’s motion will be granted 7 on this issue. 8 VI. Dr. Debora Joslin’s Opinions10 9 Gomez seeks to exclude Dr. Debora Joslin’s opinions. Dr. Joslin has a Ph.D. in 10 Metallurgical Engineering and is a research scientist, with expertise in electron beam 11 microanalysis. (Doc. 92 at 3). 12 A. Reliance on Wayne Niemeyer’s Reports 13 Gomez seeks to strike Wayne Niemeyer’s testing reports, on which Dr. Joslin relied, 14 because he is not an expert in this case. (Doc. 71-1 at 2). If the Court agrees, Gomez then 15 seeks to exclude all of Dr. Joslin’s opinions because they lack support without Mr. 16 Niemeyer’s reports. (Doc. 71-1 at 2). Federal Rule of Evidence 703 does not require an 17 expert to create their own data. Rather, it allows an expert to rely on data “the expert has 18 been made aware of . . . [that] experts in the particular field would reasonably rely on.” 19 Fed. R. Evid. 703. Dr. Joslin reached her conclusions “based on [her] review of the original 20 data.” (Doc. 92 at 5). There is nothing in the record to establish this is data an expert would 21 not reasonably rely on. (Doc. 71-1 at 3–4). Accordingly, Gomez’s motion will be denied 22 on this issue. 23 B. Reliance on Mr. Niemeyer’s Data and Methodology 24 Gomez seeks to exclude Dr. Joslin’s opinions because “she did not perform an 25 independent analysis and instead merely adopted Mr. Niemeyer’s work without any 26 knowledge of the underlying methods.” (Doc. 71-1 at 6). Dr. Joslin testified repeatedly the 27 analysis was her own. (Doc. 92 at 5). The Court finds no evidence to the contrary. 28 10 Gomez failed to file a reply related to her motion to exclude Dr. Joslin’s opinions. 1 As to Mr. Niemeyer’s methodologies, Gomez again argues the report lacks 2 reliability. (Doc. 71-1 at 5–6). The findings and conclusions in Mr. Niemeyer’s report go 3 to weight, not admissibility. Any problems with the underlying data will be subject to 4 cross-examination. As such, Gomez’s motion will be denied on this issue. 5 C. Manufacturing Process and Testing 6 Gomez seeks to exclude Dr. Joslin’s opinions as unqualified regarding the 7 manufacturing process and Niemeyer’s testing process. Gomez argues Dr. Joslin is not 8 familiar with the manufacturing process of mesh. (Doc. 71-1 at 10.) AMS agrees it will not 9 have Dr. Joslin opine about the manufacturing process. (Doc. 92 at 7 n.23). Accordingly, 10 Gomez’s motion will be denied as moot on this issue.. 11 Gomez also argues Dr. Joslin is not an expert in the analytical tests conducted by 12 Mr. Niemeyer. (Doc. 71-1 at 10). However, Dr. Joslin is specifically an expert in the type 13 of microscopy that Mr. Niemeyer used in his testing. As such, Gomez’s motion will be 14 denied on this issue. 15 D. Discovery Violations 16 Gomez seeks to exclude Dr. Joslin’s opinions for an alleged discovery violation. 17 Discovery was completed at the MDL stage. (Doc. 71-1 at 10). Gomez alleges Dr. Joslin 18 failed to produce the underlying data and notes she reviewed in support of her expert report. 19 (Doc. 71-1 at 10). The proper vehicle for a discovery dispute is a discovery motion, not a 20 Daubert motion. As discovery and its disputes have long been closed, Gomez’s motion 21 will be denied on this issue.11 22 VII. Dr. Karen Becker’s Opinions 23 Gomez seeks to exclude Dr. Karen Becker’s expert opinions because they relate to 24 the FDA’s 510(k) process. Both parties agree Judge Goodwin repeatedly found this type 25 of testimony excludable as unrelated to safety or efficacy. (Doc. 110 at 3). See, e.g., Lewis 26 v. Johnson & Johnson, 991 F.Supp.2d 748, 753–56 (S.D.W. Va. 2014). This is best 27 resolved on a motion for limine, although the parties appear open to a stipulation on the 28 11 If at trial it is learned that AMS has failed to produce the material data requested, the Court will consider sanctions. 1 matter. (Doc. 110 at 3). Accordingly, the Court will deny Gomez’s motion without 2 prejudice. The Court encourages the parties to discuss a stipulation on such testimony. 3 VIII. Dr. Stephen Badylak’s Opinions 4 Gomez seeks to exclude Dr. Stephen Badylak’s opinions as unreliable and 5 unqualified. (Doc. 107 at 2). Dr. Badylak has degrees in medicine, pathology, and 6 veterinary medicine and specializes in biomaterials and tissue scaffolds such as surgical 7 mesh. (Doc. 109 at 3). 8 A. Contradictory Research 9 Gomez seeks to exclude all of Dr. Badylak’s opinions as contradicted by his own 10 prior research rendering them unreliable. (Doc. 107 at 4). Specifically, Gomez asserts Dr. 11 Badylak’s prior research supports the hypothesis that polypropene mesh can wrinkle and 12 degrade after implantation, which can lead to complications. (Doc. 107 at 3). The Court 13 agrees with Judge Goodwin that “[a]lleged inconsistencies in a witness’s testimony go to 14 credibility, rather than Daubert’s standard of admissibility.” Wise v. C.R. Bard, No. 2:12- 15 CV-01378, 2015 WL 521202, at *13 (S.D.W. Va. Feb. 7, 2015) (citation and internal 16 quotation marks omitted). The credibility of Dr. Badylak’s opinions are best addressed 17 through cross-examination. Accordingly, Gomez’s motion will be denied on the issue. 18 B. Steady State Foreign Body Reaction 19 Gomez seeks to exclude Dr. Badylak’s opinions regarding a steady state foreign 20 body reaction to mesh because he fails to cite specific research but instead relies on his 21 own experience and the entire body of available literature. (Doc. 107 at 5). Gomez also 22 states a publication referenced by Dr. Badylak in his deposition contradicts his opinion and 23 is not cited in his expert report. (Doc. 107 at 7). Looking to Dr. Badylak’s deposition, he 24 extensively explains the research he relies on, including citing specific publications to 25 support his opinions. (Doc. 107-2 at 158–166; see, e.g., “Well, there are several studies. . . 26 . probably the most convincing early set of studies was conducted by Jim Anderson.”). 27 With regard to the allegedly contradictory publication, Gomez is mistaken that Dr. Badylak 28 fails to cite the publication he references in his deposition. (Doc. 109-2 at 3). And Dr. 1 Badylak does not rely on the publication Gomez accuses Dr. Badylak of relying upon to 2 form an opinion contradictory to the publication. Gomez is engaging in cross-examination 3 by paper, nothing else. Accordingly, Gomez’s motion will be denied on this issue. 4 C. Toxicity, Design, and Resin 5 Gomez seeks to exclude Dr. Badylak’s toxicity, design, and resin opinions as 6 unqualified or unreliable. (Doc. 107 at 8). It is unclear whether Gomez is challenging Dr. 7 Badylak’s qualifications or methodology. Gomez asserts these opinions “exceed his 8 expertise” without ever addressing his qualifications or the qualifications required. As 9 such, the Court will only address Dr. Badylak’s methodology. Gomez states the opinions 10 are “not based in testing, literature or other reliable means.” (Doc. 107 at 8). AMS responds 11 by putting forth the biocompatibility and toxicity testing, as well as peer-reviewed 12 literature, Dr. Badylak relied upon. (Doc. 109 at 10). In her reply, Gomez then argues the 13 testing completed does not prove the biocompatibility of AMS’s products. (Doc. 111 at 5). 14 Gomez does not argue the testing conducted was unreliable. 15 AMS has shown Dr. Badylak’s opinions have enough reliable support to be 16 presented to the jury. The extent of that support can be best addressed on cross- 17 examination. Thus, Gomez’s motion will be denied on this issue. 18 D. Corporate State of Mind 19 Gomez seeks to exclude Dr. Badylak’s opinions that opine as to AMS’s state of 20 mind or intent. (Doc. 107 at 9). Although AMS asserts, Dr. Badylak did not offer any state 21 of mind opinions, AMS agrees that state of mind opinions should generally be excluded. 22 (Doc. 109 at 11). Moreover, the MDL Court excluded Dr. Badylak’s opinions, similar to 23 the testimony offered here, as a corporate state of mind opinion. Tyree v. Bos. Sci. Corp., 24 54 F. Supp. 3d 501, 576 (S.D.W. Va. 2014), as amended (Oct. 29, 2014). Gomez’s motion 25 will be denied as moot on this issue. 26 This matter is now ready for trial. Accordingly, 27 IT IS ORDERED AMS’s motion to limit the general causation opinions and 28 testimony of Bruce Rosenzweig, MD (Doc. 104) is GRANTED IN PART and DENIED 1 IN PART. Dr. Rosenzweig’s general causation opinions will be excluded to the extent the 2 motion seeks to exclude opinions regarding AMS’s conduct, knowledge, or state of mind 3 and opinions regarding the adequacy of device testing. 4 IT IS FURTHER ORDERED AMS’s motion to exclude specific causation 5 opinions and testimony of Bruce Rosenzweig MD (Doc. 61) is DENIED. 6 IT IS FURTHER ORDERED AMS’s motion to exclude testimony of Vladimir 7 Iakovlev MD (Doc. 67) is GRANTED. Dr. Iakovlev’s opinions will be excluded. 8 IT IS FURTHER ORDERED AMS’s motion to exclude the specific causation 9 opinions and testimony of Jerry Blaivas MD (Docs. 72) is DENIED. 10 IT IS FURTHER ORDERED AMS’s motion to exclude the opinions and 11 testimony of Scott Guelcher PhD and Jimmy Mays PhD (Doc. 74) is GRANTED IN 12 PART and DENIED IN PART. Drs. Guelcher and Mays’ opinions will be excluded to 13 the extent the motion seeks to exclude opinions regarding medical complications mesh 14 degradation may cause and opinions about AMS’s testing. 15 IT IS FURTHER ORDERED Gomez’s motion to exclude the testimony of Debora 16 L. Joslin, Ph.D (Doc. 70) is DENIED. 17 IT IS FURTHER ORDERED Gomez’s motion to exclude the opinions and 18 testimony of Karen Becker, PH.D. (Doc. 106) is DENIED. 19 IT IS FURTHER ORDERED Gomez’s motion to exclude the opinions and 20 testimony of Dr. Stephen F. Badylak, DVM, PH.D., M.D. (Doc. 107) is DENIED. 21 IT IS FURTHER ORDERED the pretrial deadlines set in the Court’s January 8, 22 2021 Order (Doc. 108) are VACATED. 23 IT IS FURTHER ORDERED all Motions in Limine are due April 6, 2021. 24 Responses are due seven days afterward. No replies are permitted unless ordered by the 25 Court. Prior to filing any Motion in Limine, the parties must confer and discuss the contents 26 of each planned motion. No Motion in Limine should be filed if the other party does not 27 oppose the relief requested. 28 IT IS FURTHER ORDERED the Joint Proposed Pretrial Order, if not already 1 filed, is due April 6, 2021. 2 IT IS FURTHER ORDERED the parties shall review the Court’s standard Juror 3 Questionnaire (available on the Court’s website) and submit NO MORE THAN FIVE 4 STANDARD PROPOSED QUESTIONS EACH to be added to the standard Juror 5 Questionnaire with the Court’s approval no later than April 6, 2021. Each proposed 6 question shall stand alone and shall not contain sub-parts. 7 IT IS FURTHER ORDERED the parties shall submit a Joint Statement of the 8 Case, of no more than a few short sentences for the Juror Questionnaire, no later than April 9 6, 2021. 10 IT IS FURTHER ORDERED the parties shall submit a second Joint Statement of 11 the Case, of no more than two short paragraphs to be read to the jury, no later than April 12 20, 2021. 13 IT IS FURTHER ORDERED no later than April 20, 2021, the parties shall file 14 and submit via email (silver_chambers@azd.uscourts.gov) in Word format proposed Jury 15 Instructions in compliance with the procedures available on the Court’s website, including 16 but not limited to: 1) a joint set of proposed jury instructions where the parties’ instructions 17 agree; 2) a separate set of instructions (one for each party) where the parties do not agree; 18 and 3) legal authority supporting all proposed instructions whether the parties agree or not. 19 Where the parties do not agree, the opposing party shall clearly state its objection to the 20 proposed instruction and the proposing party shall clearly state its response. 21 IT IS FURTHER ORDERED the parties will jointly file a proposed form of 22 verdict, or if the parties do not agree, they may separately file proposed forms of verdict 23 no later than April 20, 2021. 24 IT IS FURTHER ORDERED no later than April 20, 2021, the parties shall deliver 25 to chambers excerpts of the deposition testimony they propose to present at trial, in 26 compliance with the procedures available on the Court’s website (found in Deposition 27 Designation Procedure for Judge Silver), including but not limited to: Plaintiffs 28 highlighting in yellow the portions they wish to offer and Defendants highlighting in blue 1 || those portions they wish to offer. If either party objects to the proposed testimony, a 2|| specific and concise objection (e.g., “Relevance, Rule 402’) shall be placed in the margin 3 || adjacent to the proposed testimony. 4 IT IS FURTHER ORDERED a final pretrial conference is set for May 11, 2021 || at 11:00 a.m., at which time the Court will review Juror Questionnaires. The parties shall 6|| meet and confer prior to this date regarding the Juror Questionnaires and email to the || Courtroom Deputy no later than noon on May 10, 2021 a list of any jurors they agree 8 || should be stricken for cause, along with any objections to jurors they do not agree should 9|| be stricken for cause. The parties shall not file this list. The Court will rule on any 10 || disputed jurors at the final pretrial conference. 11 The parties will be supplied a disk containing the questionnaires approximately || one week prior to the final pretrial conference. Counsel shall bring a copy of the 13 || questionnaires to the conference for review. Counsel are required to return the disk to the Courtroom Deputy and destroy all copies of the questionnaires no later than 15 || the last day of trial. 16 IT IS FURTHER ORDERED trial to a jury is set for May 18, 2021 at 8:30 a.m. 17 || Estimated length of trial is 10 days. 18 IT IS FURTHER ORDERED the parties shall comply with the Exhibit Procedures || found on the Court’s website at www.azd.uscourts.gov / Judges’ Information / Orders, 20 || Forms & Procedures for Hon. Roslyn O. Silver. 21 Dated this 26th day of March, 2021. 22 fo . 23 ( — 24 5 Senior United States District Judge 26 27 28 - 30 -