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. Mark Eisenberg. Doc.
7291. The motion is fully briefed, and the Court heard
arguments on January 19, 2018. 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. 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 IVC 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. Eisenberg as an expert witness on various
issues, including concerns about the safety and efficacy of
Bard filters, Bard's obligations to perform safety
studies and inform physicians and patients about them,
whether the filters were as safe and effective as their
predicate devices, and the interpretation of certain clinical
studies. Dr. Eisenberg is a board-certified interventional
cardiologist. He regularly treats patients with deep vein
thromboses and pulmonary emboli, including patients implanted
with IVC filters and those who may be candidates for
implantations, although he does not implant filters himself.
He is also a clinical epidemiologist, having obtained a
master's degree from the Harvard School of Public Health.
Doc. 7293 at 4-5.
challenge Dr. Eisenberg's opinions on several grounds.
Defendants contend that his opinions about Bard's
responsibilities and alleged unethical conduct are not the
proper subject of expert testimony, and that he is not
qualified to render such opinions. Doc. 7291 at 3-4, 6-11.
Defendants make the same arguments as to opinions regarding
Bard's knowledge, motives, intent, and state of mind.
Id. at 11-13. Defendants further argue that factual
narratives and “common sense” opinions will not
assist the jury. Id. at 13-18. Finally, Defendants
argue that Dr. Eisenberg cannot speak on behalf of all
physicians and patients. Id. 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). 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).
Opinions Regarding Ethics and State of Mind.
agree that Dr. Eisenberg may not opine on Bard's
“ethics, motivations, intentions, and state of
mind” (Doc. 7810 at 2), but the parties disagree on
whether Plaintiffs intend to have him testify on those
topics. Plaintiffs assert that his 47-page report contains no
opinion that Bard's conduct was unethical, but instead
states opinions on “the evidence concerning safety and
efficacy of Bard's filters, the information that
physicians and patients need for proper informed consent and
medical decision-making, and an evaluation of Bard's
disclosures of the information it had.” Doc. 7810 at 2.
Defendants counter that Plaintiffs are attempting to recast
Dr. Eisenberg's report and sworn testimony as anything
other than ethics opinions, and note that another court has
rejected a similar attempt. Doc. 8222 at 2; In re
Trasylol Prod. Liab. Litig., No. 08-MD-1928, 2010 WL
1489793, at *8-9 (S.D. Fla. Feb. 24, 2010).
Court does not find it helpful to cast the issue in terms of
ethics vs. non-ethics, but instead will focus on Dr.
Eisenberg's specific assertions and the bases for them.
He opines that, in light of various “safety signals,
” Bard had a responsibility to perform large
prospective safety studies and randomized controlled clinical
trials. Doc. 7293 ¶¶ 30, 34, 197-98, 202, 207, 213.
He devotes an entire section of his report to Bard's
responsibility to do safety studies. Id.
¶¶ 193-210 (§ IV.K). He asserts that Bard did
not conduct such studies, but instead “downplayed the
documented high rates of adverse events with the Recovery and
G2 filters” and had a “corporate policy to not
share any of these complication rate analyses with anyone
outside the company.” Id. ¶¶ 85-86,
173. He opines that Bard looked “for ways to avoid
being forthright” and spent “time, money and
company resources on a media company and PR for ‘spin
control.'” Id. ¶ ...