United States District Court, S.D. Indiana, Indianapolis Division
In Re COOK MEDICAL, INC., IVC FILTERS MARKETING, SALES PRACTICES AND PRODUCT LIABILITY LITIGATION This Document Relates to Tonya Brand, No. 1:14-cv-06018-RLY-TAB
ENTRY ON THE PLAINTIFF'S MOTION TO EXCLUDE OR
LIMIT THE TESTIMONY OF RENU VIRMANI, M.D.
RICHARD L. YOUNG, JUDGE
challenges three opinions advanced by Cook's retained
expert, Dr. Renu Virmani. They are: (1) filters
“function to trap clots”; (2) “[s]mall
clots are not concerning, ” while large clots
“more likely are being caught in the filter on their
way from the pelvic and leg veins”; and (3) “the
Celect and Tulip are not inherently thrombogenic.”
(Filing No. 8639-6, Expert Report of Dr. Virmani
(“Expert Report”) at 31-32). Plaintiff argues her
opinions must be excluded because she lacks the
qualifications to offer them and the opinions are unreliable
and irrelevant. For the reasons set forth below, the court
DENIES Plaintiff's motion.
Standard for Expert Testimony
Rule of Evidence 702 and the Supreme Court's decision in
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509
U.S. 579 (1993) establish the framework for analyzing the
admissibility of expert testimony. Naeem v. McKesson Drug
Co., 444 F.3d 593, 607 (7th Cir. 2006). To be
admissible, expert testimony must satisfy four requirements
under Rule 702: (1) the expert must be qualified by
knowledge, skill, experience, training, or education; (2) the
proposed expert testimony must assist the trier of fact in
determining a relevant fact at issue in the case; (3) the
expert's testimony must be based on sufficient facts or
data and reliable principles and methods; and (4) the expert
must have reliably applied the principles and methods to the
facts of the case. Lees v. Carthage College, 714
F.3d 516, 521-22 (7th Cir. 2013) (citations omitted). As the
proponent of the expert testimony at issue, the Cook
Defendants have the burden of demonstrating the expert's
admissibility. Lewis v. CITGO Petroleum Corp., 561
F.3d 698, 705 (7th Cir. 2009).
Virmani is a cardiovascular pathologist. She currently serves
as the President of CVPath Institute, a non-profit
organization that “provides consultation, histology,
and diagnostic services to promote discoveries that advance
the diagnosis, treatment, and management of cardiovascular
diseases.” (Expert Report at 1). The organization
“possesses one of the largest and most comprehensive
repositories of diseased human tissue that is available for
investigative studies and teaching.” (Id.).
her career, she has performed pre-clinical animal studies on
cardiovascular implantable devices which were later approved
by the FDA, including pre-clinical studies on IVC filters
(Boston Scientific's Greenfield Vena Cava Filter, Novate
Medical's Sentry IVC Filter, and the Cordis OPTEASE
Filter). (Id. at 1-2). She has also observed and
evaluated tissues from patients who had IVC filters in place.
(Id. at 2).
Virmani has authored over 700 publications in peer-reviewed
journals and delivered more than 800 presentations globally.
(Id. at 1). In addition, she is familiar with
clotting as it relates to vascular devices and has given
lectures on coagulation. (Filing No. 8639-2, Deposition of
Dr. Virmani at 64). And through her study, she has
“seen filters with clots on them” and has
witnessed “clots organize over time and  shrink in
size.” (Id. at 201).
argues Dr. Virmani is not qualified because she is not an
expert in clot-trapping or a hematologist. But “Rule
702 specifically contemplates the admission of testimony by
experts whose knowledge is based on experience.”
Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th Cir.
2000) (citing Walker v. Soo Line R.R. Co., 208 F.3d
581, 591 (7th Cir. 2000)). Dr. Virmani certainly has the
background and experience to testify about the function of
medical devices in the vascular system, how animal studies
support that intended function, and whether medical devices
are thrombogenic. The court therefore finds she is qualified
to offer the challenged opinions in this case.
forming her opinion on the thrombogenicity of Cook's
filters, Dr. Virmani reviewed the animal study slides from
Cook's animal studies and “didn't see any clot
formation that occurred [in Cook's long-term animal
studies], even after 180 days, and beyond 365 days. So, if
[the filters] were still thrombogenic, we should have seen
some.” (Virmani Dep. at 204). At her deposition,
Plaintiff pressed Dr. Virmani for a more specific methodology
other than the absence of clots in Cook's animal studies.
Dr. Virmani explained “it is impossible to determine 
whether a filter is causing a clot or it's trapping the
clot. Unless and until you could visualize everything
throughout the patient's life, I don't think you can
make that decision.” (Id. at 206). Plaintiff
points to this testimony and argues Dr. Virmani's
opinions are speculative and should be excluded.
Virmani's opinion is not speculative; it is based on her
experience and knowledge gleaned from the animal studies she
has developed and performed over the course of her career,
the published literature on IVC filters in animals, and
Cook's Data Summary. (Expert Report at 32). This is an
accepted methodology for a pathologist. Wise v. C.R.
Bard, Inc., No. 2:12-cv-1378, 2015 WL 570070, at *4
(S.D. W.Va. Feb. 11, 2015) (holding a pathologist's
testimony was reliable where he “reviewed pathological
slides, compared his observations to published medical
literature, and provided diagnostic interpretations of what
he saw”); see also Eve v. Santoz Pharm. Corp.,
IP 98-1429-C-Y/S, 2001 U.S. Dist. LEXIS 4531, *72-74 (S.D.
Ind. March 7, 2001) (finding animal study evidence to be
“scientifically reliable” under Daubert
because there were “good grounds” to extrapolate
from animals to humans, such as published studies in
peer-reviewed journals). Any weaknesses in her opinion may be
addressed on cross-examination.
Plaintiff faults Dr. Virmani for citing no authority for her
opinion that “small clots are not concerning”
while large clots “more likely are being caught in the
filter on their way from the ...