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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. Darren Hurst. Doc. 7302. The motion is fully briefed, and the Court heard arguments on January 19, 2018. The Court will deny the motion.

         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 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. Hurst, an interventional radiologist, as an expert witness on various issues in each of the five cases selected for bellwether trials. He has prepared case-specific reports that share certain opinions in common. Doc. 7306. Defendants ask the Court to exclude three categories of opinions: (1) Bard filters have higher complication rates than other filters and an “unacceptable risk” of caudal migration; (2) Bard ignored safety signals, failed to perform additional studies, and misrepresented the safety and performance of its filters; and (3) Bard failed to communicate to doctors that the Meridian filter should be used instead of the G2X or Eclipse. Doc. 7302 at 2.[1] The Court will address each category.[2]

         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). 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 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. Higher Complication Rates and “Unacceptable Risk” of Migration.

         Dr. Hurst is a full time physician who received fellowship training in the field of interventional radiology at the University of Michigan Medical Center. Doc. 7306 at 4, 23. He has been the chief of vascular and interventional radiology for St. Elizabeth Health System in northern Kentucky for nearly 15 years, and serves the greater Cincinnati area through his private medical practice. Id. He is board certified in both general diagnostic radiology and specialized interventional radiology. Id. at 25. He regularly implants and removes IVC filters as part of his clinical practice, including filters manufactured by Bard. Id. at 4. He states that he is familiar with the medical literature concerning IVC filter issues, including filter complications and the risks and benefits associated with the devices. Id.

         In each bellwether case, Dr. Hurst opines that Bard failed to notify the implanting physician of the “higher complication rates associated with the Recovery, G2, and Eclipse filters in comparison to the original predicate device, the Simon Nitinol Filter, and competitor filters.” See, e.g., Doc 7306 at 10. Dr. Hurst also opines that “Bard's own internal risk analysis deemed the G2 filter . . . to pose an ‘unacceptable risk' of caudal migration.” Id. at 11. Defendants contend that Dr. Hurst is not qualified to opine that their filters had higher complication rates than other filters or posed an “unacceptable risk” of caudal migration. Doc. 7302 at 4-7.

         The Court concludes that the admissibility of such testimony will depend on the manner in which it is given. Dr. Hurst's reports state that physicians reasonably expect medical device manufacturers such as Bard to design, test, manufacture, warn, and market in a manner that will enable the physicians to select appropriate IVC filters and make correct therapeutic decisions. Doc. 7306 at 8. He states that patients reasonably expect sufficient information to make an informed decision. Id. Dr. Hurst quotes the AMA Code of Medical Ethics on informed consent to support these assertions. Id. at 9. As an experienced interventional radiologist with ...

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