TortsProf Blog

Editor: Christopher J. Robinette
Southwestern Law School

Tuesday, December 7, 2021

Goldberg on 510(k) Evidence

Phil Goldberg discusses two cases before the New Jersey Supreme Court on the issue of 510(k) evidence, i.e., whether courts should allow juries to hear evidence regarding the FDA's review of medical devices when determining whether those devices are defective.  The lede:

  The New Jersey Supreme Court has agreed to hear a pair of cases that will have a major impact on medical
device liability and, in turn, the availability of important new devices that offer technological advances over
previous products. The issue is over the admissibility of evidence that the manufacturer received the U.S. Food
and Drug Administration’s (FDA) clearance before bringing the device to market. Plaintiffs’ lawyers want juries
to decide core liability issues—whether a medical device is defective or its manufacturer should be subject to
punitive damages for how it brought the device to market—as if the FDA did not exist.

The piece is here:  Download Goldberg 510(k) Article for WLF

Products Liability | Permalink


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