First Jury Verdict In Pelvic Mesh MDL Affirmed By Fourth Circuit

Yesterday, the Fourth Circuit affirmed a jury’s award to a plaintiff of $250,000 in compensatory damages and $1.75 million in punitive damages on a design defect and failure to warn claim against the proprietors of transvaginal mesh medical devices used to treat pelvic organ prolapse and other pelvic issues.  This award was the first of the more than 70,000 similar cases involved in multi-district litigation consolidated in the U.S. District Court for the Southern District of West Virginia to proceed to a jury trial.

The defendant manufacturer made four arguments on appeal.  First, it argued that the district court abused its discretion by granting the plaintiff’s motion in limine to exclude all evidence that the manufacturer had complied with the FDA’s 510(k) approval process.  Specifically, the manufacturer argued that compliance with the 510(k) process was important to its design defect defense because it showed that the company’s conduct was reasonable, and thus relevant to Georgia’s risk-utility test that was applicable.   The Fourth Circuit explained, however, that “[w]hile some courts have found evidence of compliance with the 510(k) equivalence procedure admissible in product liability cases, the clear weight of persuasive and controlling authority favors a finding that the 510(k) procedure is of little or no evidentiary value.”  As a result, the court concluded that the district judge did not abuse his discretion when determining that allowing the 510(k) evidence on the question of design defect would be substantially more prejudicial than probative.

The manufacturer also argued that the district court’s decision overruling its hearsay objections to the admission of a Material Safety Data Sheet (MSDS) pertaining to polypropylene, a material used in the construction of the implant, was in error.  The Fourth Circuit agreed that the district judge should not have found the MSDS admissible under the hearsay exceptions contained in Federal Rules of Evidence 803(17) (“Market Reports and Similar Commercial Publications”), 803(18) (“Statements in Learned Treatises, Periodicals, or Pamphlets”), and 807 (the “Residual Exception”), but affirmed the decision to admit the report as non-hearsay, finding that any use of the evidence by the plaintiff that went beyond the limited purpose for which it was admitted as non-hearsay resulted in harmless error and was not prejudicial to the manufacturer’s defense.

The Fourth Circuit also affirmed the district court’s jury instructions on causation and the punitive damage award that was seven times as much as the compensatory award, both of which were challenged on appeal by the manufacturer.



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