Two New Jersey Pelvic Mesh Verdicts Overturned

While Covid-19 continues to be a dominant national topic, including with the recent approval of the Johnson & Johnson vaccine, there are other developments of note for the life sciences industry. One of those came on March 2, 2021, when the New Jersey Appellate Division—New Jersey’s intermediate appellate court—I issued a lengthy opinion reversing two multi-million dollar verdicts in favor of plaintiffs in pelvic mesh product liability cases. (Actually, the court issued two lengthy opinions, a long published opinion and an even longer unpublished opinion that addressed additional issues.)

Readers who have a more substantial interest in medical device litigation and product liability law will want to read both opinions issued by the court because the panel address a number of recurrent issues in such cases, including plaintiff’s obligation to offer proof of a reasonable and practical alternative design, defendant’s state of the art defense, and the learned intermediary. This brief post will simply highlight the key reason for the reversal of these verdicts: the trial judges’ erroneous decisions, as confirmed by the panel, to preclude defendants from offering evidence of the Section 510(k) clearances associated with the pelvic mesh products at issue.

The two verdicts—one in the Hrymoc case and one in the McGinnis case—were the second and third cases, respectively, tried from among the cases centralized as part of New Jersey’s multicounty litigation involving pelvic mesh devices. The Hrymoc case involved an Ethicon mesh device and resulted in a verdict for $5 million compensatory damages and $10 million punitive damages, while the McGinnis case involved a Bard mesh device and resulted in a verdict for $33 million compensatory damages (plus stipulated medical expenses) and another $35 million in punitive damages.

The defendants in each case appealed, raising a number of issues, some of which overlapped. The appellate panel rejected all of the defendants’ challenges except for one: the defendants’ argument that the respective trial judges erred in precluding them from offering evidence that the respective medical devices had received Section 510(k) clearance from the FDA for being substantially equivalent to other approved medical devices on the market.

In reaching its decision, the panel noted that this issue had been addressed in prior pelvic mesh cases in other jurisdictions, including at the federal MDL and before several United States Courts of Appeals. While noting that the majority of those decisions reached the conclusion that evidence of Section 510 (k) clearance should be excluded, the panel nevertheless concluded, in a significant victory for defendants, that a per se rule of exclusion was improper. Instead, recognizing that the excluded evidence would have some relevance and probative value, particularly in light of the plaintiffs’ arguments focusing on the defendants’ lack of testing and clinical studies, the court determined that the trial judges should conduct evidentiary hearings and adopt procedures to allow for some limited presentation of this evidence to afford defendants a fair opportunity at trial.

The panel remanded both cases to the respective trial courts to conduct new trials, but our expectation is that the plaintiffs—who are represented by the same law firm—will instead seek further review of this decision before the New Jersey Supreme Court. The submissions before the Appellate Division drew the interest of several amicus, all on the defense side, and if the Supreme Court accepts certification, we anticipate further amicus involvement on this issue.

We will continue to follow this issue and report to this audience on future developments. But for now, this goes in the win column for defendants.

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