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In re Cook Medical Inc. IVC Filters Marketing, Sales Practices and Product Liability Litigation

United States District Court, S.D. Indiana, Indianapolis Division

November 7, 2018




         The 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 Plaintiff's Motion.

         I. Standard for Expert Testimony

         Federal 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).

         II. Discussion

         A. Qualifications

         Dr. 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[1] 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, 114-15).

         Plaintiff 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.”).

         B. Methodology

         Next, 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[2] of Scott Robertson (“Robertson Dep.”) at 51, 246-47, 426, 445-448). This methodology is also espoused in the peer-reviewed Morales paper.[3]

         In 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)).

         1. Analysis of Benefit

          Dr. 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[4] 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).

         The 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 ...

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