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March 2, 2021

AdvaMed Applauds NJ Appellate Division for Reversing Trial Court Order Regarding FDA Evidence Admissibility

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from Pat Fogarty, Vice President, Assistant General Counsel, and Director, Civil Justice Policy regarding today’s decision from the New Jersey Appellate Division’s decision to remand the McGinnis case for a new trial preceded by Rule 104 hearing on the 510(k) clearance evidence.

“AdvaMed applauds the New Jersey Appellate Division for reversing the trial court order, which prevented the medical device manufacturer in the case from fully informing the jury about the process Congress and the FDA developed to assure the safety and effectiveness of medical devices. 

“As the NJ Appellate Division clearly understood, blindfolding a jury from the 510(k) clearance process can easily lead to unjust results.

“AdvaMed agrees with Appellate Division that it is better to give jurors this information and trust them to get it right. As the court stated, ‘the revelation of the FDA’s 510(k) clearance of these devices can be conveyed to the jurors effectively and plainly without extensive elaboration.  The playing field can be leveled without a dramatic alteration of the overall contest.’”

AdvaMed filed an amicus brief urging the court to allow the 510(k) evidence to be admitted. The court also invited AdvaMed’s counsel to participate in the oral argument.

For a copy of the AdvaMed amicus brief, please click here.