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In re Bard IVC Filters Products Liability Litigation

United States District Court, D. Arizona

February 8, 2018

IN RE Bard IVC Filters Products Liability Litigation


          David G. Campbell, United States District Judge

         This multidistrict litigation proceeding (“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 Robert Ritchie, Ph.D. Doc. 7316. The motion is fully briefed, and the parties agree that oral argument is not necessary. 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. IVC filters, such as Bard's Simon Nitinol Filter (“SNF”), originally were designed to be implanted permanently. Because some patients need only temporary filters, however, medical device manufacturers such as Bard developed retrievable filters.

         Bard retrievable filters are spider-shaped devices with multiple limbs fanning out from a cone-shaped head. The limbs consist of legs with hooks that attach to the IVC wall, and shorter curved arms that serve to catch or break up blood clots. Seven different versions of Bard retrievable filters are at issue in this MDL - the Recovery, G2, G2 Express, G2X, Eclipse, Meridian, and Denali. Each of these filters is a variation of its predecessor. Bard first obtained Food and Drug Administration (“FDA”) clearance to market the Recovery in 2003. The last-generation Denali received FDA clearance in 2013.

         Each Plaintiff in this MDL was implanted with a Bard filter and claims it is defective and has caused serious injury or death. Plaintiffs, among other things, allege that Bard filters are more dangerous than other IVC filters because they have a higher risk of tilting, perforating the IVC, or fracturing and migrating to vital organs. 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 Bard filters are not defective and their overall complication rates are comparable to those of other IVC filters.

         Plaintiffs have identified Dr. Ritchie, a mechanical engineer and materials scientist, as an expert witness on the design and manufacture of certain Bard filters. Dr. Ritchie received a bachelor's degree in physics and metallurgy, a master's degree in materials science, and a doctorate degree in materials science, all from Cambridge University. He has taught engineering courses at Massachusetts Institute of Technology, and currently teaches materials science as a distinguished professor at the University of California, Berkeley. He is a member of prestigious science and engineering academies, has published hundreds of peer-reviewed articles in the technical literature, and is highly regarded for his research in the fields of fatigue and fracture mechanics. With respect to medical devices, Dr. Ritchie has testified before the FDA about device fatigue and fracture and has served as a consultant to leading manufacturers of medical implants. Docs. 7319-1 at 3, 7319-2 at 49-50.[1]

         Dr. Ritchie has authored a report assessing the structural integrity of Bard's G2, G2 Express, and Eclipse filters. He examined more than two dozen Bard filters that had experienced fractured limbs and other failures while implanted. Doc. 7319-1 at 3. He also reviewed internal Bard documents, medical records, medical and technical literature, other expert reports, and certain deposition testimony. Id. at 3-4. He opines that the fractures resulted from high cycle fatigue, which is the failure of a metal component over time due to cyclically varying physiological loading. Id. at 4, 25-30, 35-38. He further opines that contributing factors to the fatigue and resulting fractures include the lack of a chamfered filter head, poor surface conditions, rough grinding markings, and increased stress due to filter tilt and migration. Id.

         Defendants do not challenge Dr. Ritchie's qualifications to opine about the manufacture and design of Bard filters from a technical perspective, nor do they seek to exclude his opinions about filter fatigue and fracture. Rather, Defendants ask the Court to exclude several categories of opinions: (1) Bard filters have “unacceptably high” complication rates; (2) one filter complication leads to others in a “vicious circle” of adverse events; (3) Bard's testing was insufficient; and (4) the SNF is a safer, alternative device. Doc. 7316 at 2. The Court will address each category.

         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 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).

         III. Discussion.

         A. Bard Filters Have “Unacceptably ...

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