United States District Court, D. Arizona
IN RE Bard IVC Filters Products Liability Litigation,
G. CAMPBELL, UNITED STATES DISTRICT JUDGE.
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
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.
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.
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
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 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).
Higher Complication Rates and “Unacceptable Risk”
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.
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.
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 ...