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, 1:14-cv-06018-RLY-TAB
ENTRY ON PLAINTIFF'S MOTION TO EXCLUDE THE
TESTIMONY OF SCOTT W. ROBERTSON, PH.D.
RICHARD L. YOUNG, JUDGE
Cook Defendants offer the expert testimony of Scott W.
Robertson, Ph.D. Dr. Robertson is a mechanical and materials
science engineer who offers three opinions in this case.
Plaintiff challenges only one of them: his Opinion 2 that the
Celect IVC filter design is not defective and the benefits of
the filter or utility far outweigh the risks. For the reasons
explained below, the court DENIES
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).
Robertson has a Master of Science and Doctor of Philosophy in
Materials Science & Engineering from the University of
California in Berkley, and a minor in Biomedical Engineering.
(Expert Report of Dr. Scott Robertson at ¶ 2). Of
particular relevance to the present case, from 2009-2011, Dr.
Robertson served as General Manager of Teneo Medical
Development, whose sole product was an optionally-retrievable
IVC filter. (Id. at 32). As General Manager, he
“led all engineering activities for both the implant
and delivery system, designed and performed both benchtop and
animal experiments to evaluate the safety and efficacy of the
system, and managed the quality and regulatory functions of
the company.” (Id.). As part of his work
developing the Teneo IVC filter, Dr. Robertson studied many
other IVC filters and performed comparative bench experiments
and analysis on Cook IVC filters. (Robertson Dep. at 45,
argues Dr. Robertson is not qualified to offer an opinion on
the medical benefits of Cook's IVC filters. But he is not
offering an opinion on the benefits of an IVC filter from a
medical perspective; rather, he is opining on them from an
engineering perspective. And from that perspective,
the court easily finds he is qualified, based on his
education and experience developing the Teneo IVC filter, to
offer an opinion on the benefits of an IVC filter. See
Smith v. Ford, 215 F.3d 713, 721 (7th Cir. 2000)
(“[A] court should consider a proposed expert's
full range of practical experience as well as academic or
technical training when determining whether that expert is
qualified to render an opinion in a given area.”).
Plaintiff challenges the methodology supporting Dr.
Robertson's risk-benefit analysis. He identified the
primary performance feature or benefit of the Celect IVC
filter to be the ability to capture clots. He then considered
the performance features or risks to include migration
resistance, fracture resistance, perforation resistance, tilt
resistance, optional retrievability, and occlusion
resistance. (Expert Report at 27-31). Dr. Robertson testified
that he used this same methodology to design and develop the
Teneo IVC filter. (Deposition of Scott Robertson
(“Robertson Dep.”) at 51, 246-47, 426, 445-448).
This methodology is also espoused in the peer-reviewed
forming his opinions, Dr. Robertson reviewed the available
data regarding IVC filters, including MAUDE data. (Expert
Report at ¶ 15). He also considered peer-reviewed
literature, Cook's testing records, Cook's design and
engineering records, the opinions and testimony of other
experts, and the depositions of Cook employees. (Id.
at ¶ 1-F31). This is an acceptable methodology. See,
e.g., Tucker v. SmithKline Beecham Corp., 701 F.Supp.2d
1040, 1062-63 (S.D. Ind. 2010) (finding expert's
“review of experimental, statistical or other
scientific data gathered by others may suffice as a
reasonable methodology upon which to base an opinion”)
(quoting Walker v. Consolidated Rail Corp., 111
F.Supp.2d 1016, 1017 (N.D. Ind. 2000)).
Analysis of Benefit
Robertson testified that the primary benefit of IVC filters
is to prevent pulmonary embolism. (Robertson Dep. at 230-31).
But, Plaintiff argues, Dr. Robertson failed to provide any
data or studies demonstrating whether, or the extent to
which, pulmonary embolism is actually prevented by
Cook filters. (Id. at 323 (“Q: What percentage
of the hundreds of thousands of what you call successful
Celect  implantations actually prevented a pulmonary
embolism? A: I don't know.”)). The court does not
agree. Dr. Robertson's Expert Report, as noted above,
states that the primary performance benefit of an IVC filter
is its ability to capture clots; this is the means by which
pulmonary embolism is prevented. To quantify that benefit,
Dr. Robertson “relied upon the publications that were
done by numerous authors using numerous clot sizes,
individual clot -- individual clots, a cascade of clots,
tilted filters, centered filters, and comparing those filters
from Cook to other filters that are on the market that have a
proven effectiveness in preventing PE.” (Id.
at 249; see also Expert Report at 27 (“When
compared statistically against the Gunther Tulip predicate
device, the Celect maintained or exceeded the clot trapping
characteristic under simulated single clots, cascade of
multiple clots, eccentric and concentric deployment, and
large and small IVC diameters. This robust testing covered
all foreseeable permutations of deployment and clot
type”)). Dr. Robertson also relied upon the PRECIP I
study, a randomized clinical trial “that demonstrates
that IVC filters are capable of preventing PE versus a
randomized control group.” (Robertson Dep. at 243-44).
court finds Dr. Robertson's inability to quantify the
number of Cook IVC filters which have actually prevented
pulmonary embolism from the hundreds of thousands that have
been successfully implanted in patients does not warrant the
exclusion of his testimony. Rather, it goes to the weight of
his testimony. Metavante Corp. v. Emigrant Sav.
Bank, 619 F.3d 748, 762 (7th Cir. 2010) (criticisms of
the quality of an expert's ...