United States District Court, D. Arizona
IN RE Bard IVC Filters Products Liability Litigation,
G. Campbell, United States District Judge
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
McMeeking, Ph.D. Doc. 7314. The motion is fully briefed, and
the parties agree that oral argument is not necessary. The
Court will grant the motion in part.
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.
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 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.
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.
have identified Dr. McMeeking, a mechanical engineer and
materials scientist, as an expert witness on the design of
Bard filters. Dr. McMeeking received his master's and
doctorate degrees from Brown University. He currently teaches
at the University of California, Santa Barbara, as a
distinguished professor of structural materials and
mechanical engineering, and has taught in these fields for
more than 40 years. He is a member of prestigious engineering
societies, has published peer-reviewed articles and served as
an editor for engineering journals, and has received awards
and honors for his work in the field of mechanical
engineering. With respect to medical devices, Dr. McMeeking
has testified before the FDA on device design and testing
issues, and has served as a consultant to leading
manufacturers of medical implants. Doc. 7318 at 3,
McMeeking has authored a report assessing design aspects of
Bard filters. Id. at 1-175. The report provides Dr.
McMeeking's credentials and a description of the
methodology he employed, and sets forth objective industry
and engineering standards for the design of medical implants.
Id. at 3-10. The report contains a preliminary
description of each Bard filter (id. at 10-28), and
a more detailed assessment of the design, mechanical
behavior, and stress and strain characteristics of the
Recovery and G2 (id. at 28-83). The detailed
assessment includes, among other things, a discussion of
Bard's in vivo loading and finite element
analyses, its testing protocols, expected filter strains and
their effects on reliability, the impact of device geometry
and fabrication, and the risk of filter fracture, migration,
perforation, and tilt. The report concludes with a list of
documents reviewed, references, and figures and diagrams.
Id. at 81-124.
do not challenge Dr. McMeeking's qualifications to opine
about design aspects of Bard filters from an engineering
perspective, nor do they seek to exclude his opinions that
the filters are defective in various ways. Rather, Defendants
ask the Court to exclude several categories of opinions: (1)
Bard did not go far enough to reduce filter risks; (2) Bard
failed to fully communicate relevant information to the FDA;
(3) the complication rates for Bard retrievable filters are
“dangerous”; and (4) the SNF is a safer,
alternative device. Doc. 7314 at 2. The Court will address
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
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).
Bard Did Not Go Far Enough to ...