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
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.
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 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.
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. 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
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.
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.
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 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 Filters Have “Unacceptably ...