Patterson v. Covidien, Inc., et al.

Summary

The United States District Court for the District of Massachusetts denied the plaintiffs’ motion to exclude the testimony of Dr. Corey Deeken under Federal Rule of Evidence 702. The court held that Dr. Deeken’s review of preclinical and clinical data concerning the Symbotex hernia mesh reflected a reliable methodology, and that challenges concerning adverse-event data, extrapolation, and the scope of her analysis were matters for cross-examination. The court limited her testimony regarding regulatory sufficiency but permitted her to testify about testing from the perspective of a biomaterials expert.

Holdings

1. An expert’s methodology is not unreliable merely because it relies on scientific judgment or lacks a formal consensus standard, cutoff, or fixed set of criteria, when the expert surveys a broad range of directly relevant preclinical and clinical data and applies relevant expertise to that data.
2. An expert may consider studies of component parts and related products, including products with a different but comparable barrier, when those studies are considered as part of a broader review that also includes data specifically involving the product at issue.
3. An expert’s failure to comprehensively consider adverse-event reports is grounds for cross-examination rather than exclusion when the reports themselves do not establish causation and the expert otherwise reviews relevant evidence.
4. A biomaterials expert may testify about the sufficiency of Covidien’s testing from the perspective of biomaterials science, including the expert’s understanding of Symbotex’s clinical outcomes, but may not testify as a regulatory expert concerning the sufficiency of the testing for regulatory purposes.

Questions Presented

1. Whether Dr. Deeken’s testimony regarding the safety of Symbotex was based on a reliable methodology under Federal Rule of Evidence 702.
2. Whether Dr. Deeken’s reliance on component studies, studies involving bovine collagen barriers, and incomplete adverse-event data created an impermissible analytical gap requiring exclusion.
3. Whether Dr. Deeken could testify about the sufficiency of Covidien’s testing from the perspective of a biomaterials expert without offering impermissible regulatory or legal conclusions.

Disposition

other