Shook Brief Explains Importance of Allowing Jury to Hear Evidence of Compliance with FDA Regulations

Shook has filed an amici brief with the New Jersey Superior Court in a product liability case in which the trial court prevented the jury from hearing evidence of a surgical mesh manufacturer’s interactions with the U.S. Food and Drug Administration (FDA) and compliance with the FDA clearance process for the device.  

The brief explains that the FDA cleared the device for sale through the 510(k) process. But without hearing that critical information, the jury found that the manufacturer’s decision to sell the device was unreasonable and awarded punitive damages to the plaintiff. The brief also details the FDA’s 510(k) process, explaining how it evaluates the safety and effectiveness of the device as well as the reasonableness of manufacturer’s conduct in bringing the device to market. In the brief, Shook argues that such information is essential to a fair determination of whether a product is defective or punitive damages are appropriate.

The amici brief was filed by Phil Goldberg, Partner and co-chair of Shook’s Public Policy Group; Dan Rogers, Partner and chair of the firm’s Florida/Eleventh Circuit Appellate Practice Team; and Associate Katherine Mastrucci. The attorneys filed the brief on behalf of AdvaMed, the U.S. Chamber of Commerce and the National Association of Manufacturers.
The case is McGinnis v. C.R. Bard, Inc., No. A-001083-18T1 (N.J.).