July 29, 2013 Articles

The FDA's 510(k) Approval Process in Medical-Device Litigation

By Troy Roberts

Any litigator knows evidence makes or breaks a case. One piece of admissible evidence may not determine a matter outright, but it may be that crucial nudge for a jury to tip the scales of justice for one side or the other. In medical-device trials, Food and Drug Administration (FDA) 510(k) regulatory approval may be that evidence. This dynamic was never more evident when two separate juries, one in March and one in April, determined whether or not DePuy's ASR XL metal hip implants caused injuries to the plaintiffs. At the conclusion of the March trial, the first in the ongoing ASR XL metal-hip litigation, a Los Angeles jury awarded the plaintiff an $8.3 million verdict because the hip was defective and negligently manufactured. The next month, in Chicago, DePuy's second ASR XL hip trial resulted in a full defense verdict.

What made the difference? In Chicago, where the jurors found for the defense, the judge allowed evidence and testimony that DePuy fully complied with the FDA's 510(k) regulatory approval process. In Los Angeles, where the jurors found for the plaintiff, the judge did not. However, surely the respective cases did not hinge solely on the 510(k) evidence. Opposing sides presented weeks of evidence on many evidentiary issues, such as the plaintiffs' past medical history. But equally as sure, the 510(k) evidence (or lack thereof) played a role in determining the divergent outcomes. This article's purpose is to revisit the status of the FDA's 510(k) medical device approval process and to address related legal considerations.

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