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# Let Juries Hear ‘510(k) Evidence’: Attorney
- URL: https://www.fdaweb.com/let-juries-hear-510-k-evidence-attorney/
- Published: 2021-12-02T12:00:00.000Z
- Updated: 2026-09-14T17:24:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150682

The New Jersey Supreme Court has an opportunity to make a decision 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.” That’s the position explained by attorney **Phil Goldberg** (Shook, Hardy & Bacon) in a Washington Legal Foundation *Legal Opinion Letter* involving two pelvic mesh devices implanted in women who allege complications from the device.

In both cases, Goldberg [writes](ttps://www.wlf.org/wp-content/uploads/2021/12/12032021Goldberg%5FLOL.pdf), the trial courts agreed with the plaintiffs’ lawyers and withheld information from the juries that FDA had cleared the devices for implantation.

On appeal, the New Jersey Appellate Division said the trial courts “erred by categorically excluding” the evidence. Goldberg says that understanding how a device was brought to market includes FDA’s role in permitting the manufacturer to market it. The appellate court also said that withholding the information undermines juries’ ability to do their jobs.

Goldberg says that some federal appeals court decisions have set a precedent that judges can deny juries so-called 510(k) evidence and says the precedents are “outdated” and the New Jersey Supreme Court should follow the Appellate Division and take a fresh look at the evidentiary question.

“Trial courts can trust juries with 510(k) evidence, including why FDA required some tests, but not others, or why the device’s Warnings did or did not contain certain information,” Goldberg concludes. “Only then can juries properly facilitate the pursuit of justice.”