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In re Bard IVC Filters Products Liability Litigation

United States District Court, D. Arizona

December 21, 2017

IN RE Bard IVC Filters Products Liability Litigation


          David G. Campbell United States District Judge

         This multidistrict litigation (“MDL”) involves thousands of personal injury cases related to inferior vena cava (“IVC”) filters manufactured and marketed by Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, “Bard”). Bard has filed motions to exclude the opinions of two regulatory experts, Drs. Suzanne Parisian and David Kessler. Docs. 7308, 7309. The motions are fully briefed, and the Court heard arguments on December 15, 2017. The Court will grant the motions in part.

         I. Background.

         The IVC is a large vein that returns blood to the heart from the lower body. IVC filters are small metal devices implanted in the IVC to catch blood clots before they reach the heart and lungs. This MDL involves seven different versions of Bard IVC filters - the Recovery, G2, G2 Express, G2X, Eclipse, Meridian, and Denali. Each filter received premarket clearance from the Food and Drug Administration (“FDA”).[1]

         Each Plaintiff in this MDL received an implant of a Bard IVC filter and claims that the filter is defective and has caused serious injury or death. Plaintiffs allege that Bard filters tilt, perforate the IVC, or fracture and migrate to neighboring organs. Plaintiffs claim that Bard filters are more dangerous than other IVC filters, and that Bard failed to warn about the higher risks. Plaintiffs assert a host of state law claims, including manufacturing and design defects, failure to warn, breach of warranty, and consumer fraud and unfair trade practices. Doc. 303-1.

         Bard disputes Plaintiffs' allegations, contending that complication rates for Bard filters are comparable to those of other IVC filters, and that the medical community is aware of the risks associated with IVC filters. Bard contends that the FDA's premarket clearance of its IVC filters and labels shows that the filters are safe and effective, and that Bard provided adequate warnings to implanting physicians.

         The parties intend to use various expert witnesses at trial, including engineers, medical professionals, and regulatory experts. Plaintiffs have identified Drs. Parisian and Kessler as FDA regulatory experts. Dr. Parisian is a board-certified pathologist with a master's degree in biology. She served as an FDA medical officer in the early 1990s. Dr. Kessler is a former FDA Commissioner who holds a medical degree from Harvard Medical School and a law degree from the University of Chicago Law School. He is a professor of food and drug law, and serves as an advisor to pharmaceutical and biomedical companies.

         Defendants agree that Drs. Parisian and Kessler are qualified, based on their knowledge, experience, and training, to serve as experts regarding the FDA regulatory process for medical devices. Defendants also agree that the FDA process is complex and beyond the experience of the average juror, and that opinions of regulatory experts therefore may prove helpful to the jury. Defendants argue, however, that the specific opinions and proposed testimony of Drs. Parisian and Kessler are inadmissible under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

         II. Legal Standard.

         Under Rule 702, an expert may testify on the basis of “scientific, technical, or other specialized knowledge” if it “will assist the trier of fact to understand the evidence, ” provided the testimony rests on “sufficient facts or data” and “reliable principles and methods, ” and “the witness has reliably applied the principles and methods to the facts of the case.” Fed.R.Evid. 702(a)-(d). The proponent of expert testimony has the ultimate burden of showing, by a preponderance of the evidence, that the proposed testimony is admissible under Rule 702. See Lust v. Merrell Dow Pharm., Inc., 89 F.3d 594, 598 (9th Cir. 1996). But the trial court acts as a gatekeeper to assure that expert testimony “both rests on a reliable foundation and is relevant to the task at hand.” Daubert, 509 U.S. at 597. Rule 702's requirements, and the court's gatekeeping role, apply to all expert testimony, not solely to scientific testimony. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147 (1999).

         III. Dr. Parisian.

         Dr. Parisian presents a difficult challenge. Her report is 257 pages long, unwieldy, often unfocused, and poorly organized. As another court aptly observed, “Dr. Parisian's report is a labyrinth that the Court cannot navigate.” Lopez v. I-Flow Inc., CV 08-1063-PHX-SRB, 2011 WL 1897548, at *10 (D. Ariz. Jan. 26, 2011). Numerous courts have excluded her FDA-related testimony because she fails to identify a clear methodology, engages in lengthy factual narratives, opines on subjects well outside her area of expertise, and often acts more as an advocate than an expert.

         And yet Dr. Parisian appears to have FDA expertise, and some of her opinions are relevant to this case. Because it is not possible to address everything in her expert report, the Court is forced to paint with broad strokes.

         A. Difficulties Presented by Dr. Parisian's Report.

         Dr. Parisian's report lists hundreds of documents, deposition transcripts, and expert reports she reviewed in preparing her opinions. Doc. 7312 ¶¶ 10-14. Dr. Parisian provides an overview of the FDA's 510(k) clearance process in general and as it relates to IVC filters. Id. ¶¶ 17-76. Then, over the next 200 or so pages, she states the following opinions:

. Opinion 1: Bard's premarket actions with design and development of the Recovery filter as a permanent filter were inadequate (¶¶ 77-210);
. Opinion 2: Bard obtained FDA clearance to market the Recovery filter as both a permanent and retrievable IVC filter yet failed to provide physicians and patients with adequate warnings (¶¶ 211-346);
. Opinion 3: Bard's actions for post-market oversight continued to permit marketing of the flawed Recovery filter (¶¶ 347-456);
. Opinion 4: Bard developed its “next generation” of IVC filters based on piecemeal reactive modifications to its flawed Recovery filter platform rather than use of quality science and design principles (¶¶ 457-651);
. Opinion 5: Bard's quality systems and post market monitoring procedures were flawed, helped underestimate risk, and permitted continued commercial release of misbranded and dangerous products as supported by Bard's receipt of an FDA 2015 warning letter (¶¶ 652-673);
. Opinion 6: Bard engaged in aggressive off-label promotions which overstated benefits, downplayed risks, expanded the implanted patient population, and failed to adequately warn physicians, patients, and its own sales force of the risks (¶¶ 674-742);
. Opinion 7: Bard marketed the Recovery Cone Retrieval System as part of the Recovery IVC filter system to facilitate filter retrieval without having obtained 510(k) clearance (¶¶ 743-758).[2]

         Each of these opinions is followed by a string cite of various FDA regulations, without explanation, and by a lengthy discussion of documents, depositions, events, and other facts regarding alleged flaws in Bard IVC filters, what Bard knew or should have known about those flaws, and what Bard failed to disclose to the FDA and the medical community. Doc. 7312 at 37-255. Dr. Parisian largely fails to explain how her factual recitations relate to or support her opinions. Nor does she explain how the facts relate to her string cites of regulations. On the rare occasion where she states that Bard violated a specific regulation with some specific action, she fails to explain why that regulation was violated. See Doc. 7312 ¶¶ 343, 665.

         Other courts have encountered similar problems with Dr. Parisian's opinions. In Trasylol, the court found that “[a]ll of Dr. Parisian's opinions suffer from this fatal flaw: she recounts [the] regulatory history, the contents of [defendants'] internal documents and e-mails, and the findings of scientific studies; she then offers a broad opinion, often outside her scope of expertise, that is not connected to the underlying facts in any apparent way and that lacks regulatory analysis.” In re Trasylol Prods. Liab. Litig., 709 F.Supp.2d 1323, 1347 (S.D. Fla. 2010); see also Lopez, 2011 WL 1897548, at *10 (“Dr. Parisian's report simply presents a narrative of selected regulatory and corporate events and quotations and then leaps to a conclusion without sufficient explanation”); Miller v. Stryker Instruments, No. CV-09-813-PHX-SRB, 2012 WL 1718825, at *11 (D. Ariz. Mar. 29, 2012) (Dr. Parisian provides “no analysis or explanation of [her] conclusory opinion” that the defendant violated FDA regulations); Kaufman v. Pfizer Pharm., Inc., No. 1:02-CV-22692, 2011 WL 7659333, at *9 (S.D. Fla. Aug. 4, 2011) (“Dr. Parisian generally takes a collection of facts, imputes [defendants'] motive and knowledge to those facts, and draws unsupported conclusions that are unrelated to any regulatory experience that she has”); Hines v. Wyeth, No. 2:04-0690, 2011 WL 2680842, at *5 (S.D. W.Va. July 8, 2011) (Dr. Parisian's testimony is “riddled with conclusory statements lacking either analysis or explanation; improperly touches on issues well beyond [her] qualifications; and at times, merely regurgitates factual information that is better presented directly to the jury”); In re Prempro Prods. Liab. Litig., 554 F.Supp.2d 871, 887 (E.D. Ark. July 8, 2008) (Dr. Parisian ‚Äútestified to the bottom line ...

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