Rose et al v. Boston Scientific Corporation, No. 2:2020cv00716 - Document 72 (W.D. Wash. 2020)
Court Description: ORDER granting in part and denying in part Plaintiffs' 42 Motion to Exclude Certain Opinions and Testimony; denying Defendant's 44 Motion to Exclude Certain Opinions and Testimony. Signed by Judge Barbara J. Rothstein. (PM)
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Rose et al v. Boston Scientific Corporation Doc. 72 Case 2:20-cv-00716-BJR Document 72 Filed 07/21/20 Page 1 of 9 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF WASHINGTON AT SEATTLE ) ) ) Plaintiffs, ) ) v. ) ) BOSTON SCIENTIFIC CORPORATION, ) ) Defendant. ) ____________________________________) ALICIA ROSE and LARRY DUNNING, I. CASE NO. 2:20-cv-00716-BJR ORDER GRANTING IN PART AND DENYING IN PART MOTION TO EXCLUDE CERTAIN OPINIONS AND TESTIMONY AND EXCLUDE CERTAIN OPINIONS AND TESTIMONY INTRODUCTION Before the Court are two motions to exclude expert opinions and testimony. Plaintiffs 17 18 19 move to exclude certain opinions of Dr. Steven Swift. Dkt. Nos. 42, 43. Defendants move to exclude certain opinions of Dr. Neeraj Kohli. Dkt. No. 44. Having reviewed the motions, the 20 oppositions thereto, the record of the case, and the relevant legal authorities, the Court will grant 21 . The reasoning for the 22 23 24 II. BACKGROUND The Court laid out the background of this case in its recent Order Granting in Part and 25 1 Dockets.Justia.com Case 2:20-cv-00716-BJR Document 72 Filed 07/21/20 Page 2 of 9 See Dkt. No. 71. In brief, the case 1 2 3 involves the transobturator midurethral sling, known as the Obtryx Device, which Ms. Rose had surgical implanted to treat her stress urinary incontinence, but now complains is defective. Both 4 case-specific expert. 5 III. LEGAL STANDARD 6 7 8 9 10 11 knowledge, skill, experience, training, or education at testimony meets certain indicia of relevance and reliability. FED. R. EVID. 702;1 see also United States v. Ruvalcaba-Garcia, 923 F.3d 1183, 1188 (9th Cir. 2019) (quoting Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 597 (1993)) ( 12 13 ). Testimony is relevant wher 14 15 16 Estate of Barabin v. AstenJohnson, Inc., 740 F.3d 457, 463 (9th Cir. 2014) (quoting Cooper v. Brown, 510 F.3d 870, 942 (9th Cir. 2007)), and reliable where a reliable basis in the knowledge and experie 17 18 id. (quoting Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 149 (1999)). 19 20 21 22 23 24 25 1 In full, Rule 702 provides A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case. FED. R. EVID. 702. 2 Case 2:20-cv-00716-BJR Document 72 Filed 07/21/20 Page 3 of 9 while the Supreme Court has suggested 1 2 several factors helpful in determining reliability, see Daubert, 509 U.S. at 592 94, District Courts 3 broad latitude in determining the appropriate form of the inquiry, United States v. 4 Wells, 879 F.3d 900, 934 (9th Cir. 2018) (quoting Kumho Tire, 526 U.S. at 150); see also Barabin, 5 740 F.3d at 463. 6 7 8 9 10 haky but admissible evidence is to be attacked by cross examination, contrary evidence, and attention to the burden of proof, not exclusion. Primiano v. Cook, 598 F.3d 558, 564 (9th Cir. 2010) (citing Daubert, 509 U.S. at 596). The party proffering the expert testimony has the burden of establishing its admissibility under a preponderance of the evidence standard. Daubert, 509 U.S. at 592 n.10. IV. 11 PLAINTIFF 12 Plaintiffs 13 14 MOTION TO EXCLUDE TESTIMONY OF STEVEN SWIFT, M.D. -specific expert, Dr. Steven Swift,2 15 Directions for Use 16 physical properties of the polypropylene mesh used in the Obtryx Device. Dkt. No. 42 at 1. 17 A. D 18 Plaintiffs seek to exclude the opinions and testimony of Dr. Swift as to the adequacy of the 19 20 21 ; (2) complication rates of patients in his own practice; and (3) the DFU, or the warnings therein, claiming that he has conceded to not being qualified to offer such expertise. Dkt. No. 42 at 1; Dkt. No. 43 at 4 6. As evidence of this claimed 22 23 24 25 2 Dr. Swift is a board-certified urogynecologist and is currently the Director of the Division of Urogynecology, Vice Chair of the Institutional Review Board for investigator-initiated studies, and a tenured Professor in the Department of Obstetrics and Gynecology at the Medical University of South Carolina. See Dkt. No. 42-3 (Curriculum Vitae of Steven Swift, M.D.). 3 Case 2:20-cv-00716-BJR Document 72 Filed 07/21/20 Page 4 of 9 1 concession to lack of expertise, Plaintiffs point to statements Dr. Swift made during his deposition, DFU is for because prior to this litigation, 2 3 heard the term, Dkt. No. 42-2 at 63:7 9, and 4 mean 5 statements in 6 7 8 9 10 id. at 63:17 64:23. Plaintiffs also point to six relevant Defendant contends that the opinions and testimony that Dr. Swift will proffer on this subject are well within his expertise. Dkt. No. 46 at 3 6. Defendant points out that Dr. Swift will not be testifying on the adequacy of the DFU in general, but, rather, he will complications alleged by Plaintiffs or their experts and opine that such complications are included Id. at 4. 11 12 13 14 15 16 17 -1). Dkt. No. 43 at 4. The Court has . Dr. Swift is a highly qualified and experienced doctor in this field which, according to the MDL that preceded this Court, makes him c mesh surgery and whether those risks were adequately expressed [i]n the [ DFU]. Ethicon, Inc., 29 F. Supp. 3d 691, 704 (S.D. W. Va. 2014). As that Court held, Huskey v. need 18 not be an expert on product warnings per se 19 implanting the [Obtryx Device] and whether those risks were adequately expressed [i]n the 20 [ 21 22 and is qualified to testify about the risks of the completeness and accuracy of it follows from that warning the extent to which any inaccuracies or omissions could either deprive a reader or mislead a reader of what the risks and benefits of the Obtryx Device was when the 23 24 25 warnings were published. Id. at 719 (quoting In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Prods. Liab. Litig., MDL 1203, 2000 WL 876900, at *11 (E.D. Pa. June 20, 4 Case 2:20-cv-00716-BJR Document 72 Filed 07/21/20 Page 5 of 9 1 2 2000)); see also Tyree v. Bos. Sci. Corp., No. 12-cv-08633, 2014 WL 5486694, at *47 (S.D. W. Va. Oct. 29, 2014). Reviewing the statements identified by 3 , and the report as a 4 whole, the Court concludes that Dr. Swift has not strayed into regulatory interpretation but, instead, 5 has expressed an opinion as to what other doctors and surgeons would find relevant in the DFUs. 6 7 B. 8 11 Complication Rates of Patients in His Practice Plaintiffs argue that Dr. Swift should not be permitted to testify on complication rates in 9 10 .3 As his own practice. Dkt. No 42 at 1; Dkt. No. 43 at 6 8. Plaintiffs take issue with several statements in his practice, complications with the Obtryx Device 12 13 14 15 16 17 18 consistent with complications reported in the clinical literature. Dkt. No 43 at 6 (quoting 42-1 at 5, 6, 7, 8 9, 11). Such testimony, according to Plaintiffs, is inappropriate because it lacks a verifiable methodology a database tracking patient outcomes and he is, therefore, unable to provide a concrete complication rate. Defendant opposes and argues that Dr. Swift should be permitted to testify on opinions developed based on his own experience. Dkt. No. 46 at 8 10. It is well established that 19 20 Kumho Tire relevant reliability concerns may focus upon personal 21 22 23 24 25 3 should be excluded because the MDL Court excluded his testimony on Flores-Banda v. Bos. Sci. Corp., No. 13-cv-04434, 2016 WL 2939522, at *17 (S.D. W. Va. May 19, 2016), the Court agrees with Defendant that Dr. Swift has not limited his testimony in this case as he did there. See Flores-Banda [i]n his deposition, Dr. Swift stated that he had no intention of opining on the DFU 5 Case 2:20-cv-00716-BJR Document 72 Filed 07/21/20 Page 6 of 9 1 2 knowledge or experience ; see also FED. R. EVID. knowledge, skill, experience, training, or education may testify ; In re: Ethicon, Inc. Pelvic Repair Sys. Prod. Liab. 3 Litig., No. MDL 2327, 2016 WL 4944331, at *3 (S.D. W. Va. Aug. 31, 2016) ( 4 general complications opinions based on [their] clinical ). At the same time, expert 5 testimony should FED. R. EVID. 702(c). Thus, 6 7 8 9 the product of reliable principles and methods as the MDL Court has already established, experts cannot testify on personal complication rates where they have no objective data to back up [such] assertion Eghnayem v. Bos. Sci. Corp., 57 F. Supp. 3d 658, 701 (S.D. W. Va. 2014). That Court consistently prohibited experts 10 from testifying on specific personal complication rates where the expert was unable to provide 11 verifiable data 12 Inc. Pelvic Repair Sys. Prod. Liab. Litig., No. 2327, 2016 WL 4958312, at *3 (S.D. W. Va. Aug. 13 25, 2016); Eghnayem, 57 F. Supp. 3d at 701; Tyree v. Bos. Sci. Corp., 54 F. Supp. 3d 501, 521, 14 15 16 17 18 See Ethicon, 2016 WL 4944331, at *3; In re: Ethicon, 523 (S.D. W. Va. 2014), as amended (Oct. 29, 2014); Huskey, 29 F. Supp. 3d at 721; In re C.R. Bard, Inc., 948 F. Supp. 2d 589, 606 07 (S.D. W. Va. 2013), on reconsideration in part (June 14, 2013). Based on these principles, the Court will exclude 19 rates in his personal practice. 20 inadmissible as both unsupported by verifiable data and irrelevant to the questions at hand. There 21 22 are are only two reasons why Defendant would want to introduce such testimony. The first, as Dr. Swift provided in his report, is to relate his complications rates with those occurring in the general 23 24 25 population as expressed in medical literature. He may not do so, however, because he has not provided the data from his practice to quantify his actual rates. 6 Case 2:20-cv-00716-BJR Document 72 Filed 07/21/20 Page 7 of 9 vague and unverifiable. 1 The second reason to introduce such testimony is to provide observations limited only to 2 3 his own practice 4 experience. Again, however, such terms are devoid of relevance without quantifiability. Further, 5 observations from his own practice are not relevant to the trier of fact as his own practice is not 6 7 8 the subject of this litigation. See FED. R. EVID. ... knowledge will help the trier of fact to understand the evidence or to determine a fact in issue . 9 10 11 C. he Physical Properties of Polypropylene Mesh 12 Plaintiffs urge the Court to exclude testimony by Dr. Swift as to the physical properties of 13 the polypropylene mesh used in the Obtryx Device, including that it does not degrade, contract, or 14 15 16 17 18 19 elicit a continual foreign body response. Dkt. No. 42 at 1; Dkt. No. 43 at 8 9. According to Plaintiffs, Dr. Swift lacks expertise in biomaterials, biomedical engineering, and medical device manufacture and design. Defendant counters that Dr. Swift is qualified to opine on the polypropylene as a medical expert who frequently sees the material in his practice as well as medical literature. Dkt. No. 46 at 6 8. 20 As stated above, Dr. Swift is qualified by experience to discuss the cases he has treated 21 involving degradation, contraction, and continual foreign body response. His report does not offer 22 23 24 25 opinions pertinent to biomedical engineering, but, instead, observations rooted in his experience as a practitioner. See Dkt. No. 42-1 at 11 ( I have not seen evidence of polypropylene degradation, systemic infection, mesh shrinkage/contracture, or other unexpected adverse outcomes following 7 Case 2:20-cv-00716-BJR Document 72 Filed 07/21/20 Page 8 of 9 I see no evidence of mesh degradation, contracture or 1 emphasis added). 2 The Court is also mindful that the MDL Court reserved judgment on this question. See 3 4 Flores-Banda, 2016 WL 2939522, at *16 17 without 5 6 7 8 9 10 ions on the physical properties of mesh. Id. at *17. this Court is convinced that his experience with such materials based on personal observation is relevant and would be helpful to the jury. See FED. R. EVID. 702(a). The Court will, therefore, allow Dr. Swift to testify on this subject. V. 11 12 O EXCLUDE TESTIMONY OF DR. NEERAJ KOHLI, M.D. Kohli,4 13 and attributes them to the Obtryx 14 15 Device. Dkt. No. 44. Defendant claims Dr. Kohli conceded in his deposition that he does not have 16 17 dysfunction and hypertonic pelvic floor. Id. at 2.5 Plaintiffs explain that Dr. Kohli will not testify 18 19 20 21 22 23 24 25 4 Dr. Kohli is a board certified obstetrician-gynecologists specializing in urogynecology and currently serves as Medical Director for Boston Urogyn. He also maintains an academic teaching appointment at Harvard Medical See Dkt. No. 44-1 at 2 4. 5 Q. Just so I have it clear you're not offering an opinion to a reasonable degree of medical certainty as to the s defecatory dysfunction, correct? A. Correct. Q. And you're not offering an opinion to a reasonable degree of medical certainty as to the cause of her 8 Case 2:20-cv-00716-BJR Document 72 Filed 07/21/20 Page 9 of 9 1 2 as to the cause of these conditions, but, rather, that the Obtryx Device exacerbated them. Dkt. No. 47 at 3 5. 3 As Plaintiffs point out, in his expert report, Dr. Kohli does not address the root causes of 4 ations, but, instead, concentrates on his contention that the Obtryx Device had 5 a worsening effect on her condition. Id. at 4 5. Dr. Kohli deposition testimony is consistent with 6 this. See Dkt. No. 47-2 at 38:11 23. The Court, therefore, will deny Defe 7 8 9 10 VI. CONCLUSION For the foregoing reasons, the Court ORDERS as follows: 1. testimony on the adequacy of the Obtryx 2. testimony on complication rates of patients in 11 12 13 14 his practice is GRANTED; 3. 15 polypropylene mesh is DENIED; and 16 17 18 physical properties of 4. DATED this 21st day of July, 2020. 19 _______________________________ BARBARA J. ROTHSTEIN UNITED STATES DISTRICT JUDGE 20 21 22 23 24 hyper tonic pelvic floor, correct? A. Correct. 25 Dkt. No. 44-2 at 58:4 14. 9
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