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By Samantha Skolnick
In a recent decision by the U.S. Court of Appeals for the Eleventh Circuit, the Court upheld almost $27 million in judgments against Boston Scientific Corporation (BSC). The consolidated cases stemmed from women who claimed to have had complications from their surgeries using BSC’s Pinnacle Pelvic Floor Repair Kit to correct pelvic organ prolapse. The complications included exposure of pieces of mesh requiring further surgical procedures, loss of vaginal sensitivity, pelvic pain and pressure, incontinence and painful intercourse.
After a jury trial in 2014, each woman was awarded more than $6 million dollars. On appeal, the Eleventh Circuit held that the district court exercised the appropriate amount of discretion when it consolidated the actions and when it disallowed certain FDA evidence. The FDA evidence was related to the regulatory scheme and clearance of the Pinnacle for sale pursuant to the 510 (k) “substantial equivalence” process. The Court excluded this evidence under Fed. R. Evid. 402 and 403 on the basis that it was irrelevant and prejudicial. In so doing, the Court found that positive completion of the Section 510(k) process was immaterial to the product’s safety. The Court cited to the district court’s explanation that “[i]f 510(k) does not go to a product’s safety and efficacy — the very subjects of the plaintiffs’ products liability claims — then evidence of BSC’s with 510(k) has no relevance to the state law claims in this case.” The Court found that the concern with prejudice and confusion substantially outweighed the probative value of the evidence, which separated from any clear showing of safety review for the device or a device of a similar nature was minimal. The evidence had diminished probative value because 510(k) “operate[s] to exempt devices from rigorous safety review procedures.”
The key take away: the Federal Rules of Evidence and the ever-present 403 balancing test must always be in the back of your mind, especially in products liability cases. An entire case can fall apart at the stitches (or sutures) when evidence is deemed inadmissible when the probative value does not outweigh the prejudice.
If you have any questions or would like more information, please contact Samantha Skolnick at [email protected]