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In re Bard IVC Filters Products Liability Litigation

United States District Court, D. Arizona

January 22, 2018

IN RE Bard IVC Filters Products Liability Litigation,



         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 a motion to exclude the opinions of Dr. Mark Eisenberg. Doc. 7291. The motion is fully briefed, and the Court heard arguments on January 19, 2018. The Court will grant the motion 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 Plaintiff in this MDL was implanted with a Bard IVC filter and claims it 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 overall 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.

         Plaintiffs have identified Dr. Eisenberg as an expert witness on various issues, including concerns about the safety and efficacy of Bard filters, Bard's obligations to perform safety studies and inform physicians and patients about them, whether the filters were as safe and effective as their predicate devices, and the interpretation of certain clinical studies. Dr. Eisenberg is a board-certified interventional cardiologist. He regularly treats patients with deep vein thromboses and pulmonary emboli, including patients implanted with IVC filters and those who may be candidates for implantations, although he does not implant filters himself. He is also a clinical epidemiologist, having obtained a master's degree from the Harvard School of Public Health. Doc. 7293 at 4-5.[1]

         Defendants challenge Dr. Eisenberg's opinions on several grounds. Defendants contend that his opinions about Bard's responsibilities and alleged unethical conduct are not the proper subject of expert testimony, and that he is not qualified to render such opinions. Doc. 7291 at 3-4, 6-11. Defendants make the same arguments as to opinions regarding Bard's knowledge, motives, intent, and state of mind. Id. at 11-13. Defendants further argue that factual narratives and “common sense” opinions will not assist the jury. Id. at 13-18. Finally, Defendants argue that Dr. Eisenberg cannot speak on behalf of all physicians and patients. Id. The Court will address each argument.

         II. Legal Standard.

         Under Rule 702, a qualified 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). An expert may be qualified to testify based on his or her “knowledge, skill, experience, training, or education.” Id.

         The proponent of expert testimony has the ultimate burden of showing that the expert is qualified and the proposed testimony is admissible under Rule 702. See Lust v. Merrell Dow Pharm., Inc., 89 F.3d 594, 598 (9th Cir. 1996). 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 v. Merrell Dow Pharm., Inc., 509 U.S. 579, 597 (1993). Rule 702's requirements, and the court's gatekeeping role, apply to all expert testimony, not only to scientific testimony. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147 (1999).

         III. Discussion.

         A. Opinions Regarding Ethics and State of Mind.

         Plaintiffs agree that Dr. Eisenberg may not opine on Bard's “ethics, motivations, intentions, and state of mind” (Doc. 7810 at 2), but the parties disagree on whether Plaintiffs intend to have him testify on those topics. Plaintiffs assert that his 47-page report contains no opinion that Bard's conduct was unethical, but instead states opinions on “the evidence concerning safety and efficacy of Bard's filters, the information that physicians and patients need for proper informed consent and medical decision-making, and an evaluation of Bard's disclosures of the information it had.” Doc. 7810 at 2. Defendants counter that Plaintiffs are attempting to recast Dr. Eisenberg's report and sworn testimony as anything other than ethics opinions, and note that another court has rejected a similar attempt. Doc. 8222 at 2; In re Trasylol Prod. Liab. Litig., No. 08-MD-1928, 2010 WL 1489793, at *8-9 (S.D. Fla. Feb. 24, 2010).

         The Court does not find it helpful to cast the issue in terms of ethics vs. non-ethics, but instead will focus on Dr. Eisenberg's specific assertions and the bases for them. He opines that, in light of various “safety signals, ” Bard had a responsibility to perform large prospective safety studies and randomized controlled clinical trials. Doc. 7293 ¶¶ 30, 34, 197-98, 202, 207, 213. He devotes an entire section of his report to Bard's responsibility to do safety studies. Id. ¶¶ 193-210 (§ IV.K). He asserts that Bard did not conduct such studies, but instead “downplayed the documented high rates of adverse events with the Recovery and G2 filters” and had a “corporate policy to not share any of these complication rate analyses with anyone outside the company.” Id. ¶¶ 85-86, 173. He opines that Bard looked “for ways to avoid being forthright” and spent “time, money and company resources on a media company and PR for ‘spin control.'” Id. ΒΆ ...

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