AdvaMed Participates in Oral Arguments in McGinnis v C.R. Bard
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 yesterday’s oral arguments in front of the New Jersey Superior Court Appellate Division in the case of McGinnis v C.R. Bard:
“AdvaMed believes standards the FDA developed for allowing a specific medical device on the market is essential to any fair determination of whether that device can be considered defective or the company subject to punitive damages for how it brought the product to market. Here, the trial court mischaracterized the 510(k) clearance process in determining that evidence was inadmissible. We are heartened that the New Jersey appellate court is carefully studying this issue, including asking AdvaMed to participate in the oral argument.
“Congress and the FDA established the 510(k) process to ensure the safety and effectiveness of Class II medical devices, which includes the mesh device in this case.
“The interaction between a manufacturer and the FDA in gaining FDA’s clearance to market a medical device is so inextricably intertwined with allegations of defect or misconduct that one story cannot be told without the other. Juries must be able to hear why a manufacturer conducted some tests but not others, why a manufacturer did not conduct certain clinical trials, and why its device’s warnings did or did not contain certain information. The manufacturer-FDA communications during this 510(k) process informs these inquiries. Otherwise, plaintiffs will always be able to argue that an additional test would have prevented their harm, and there will be no context for why FDA did not ask for that test.
“We hope the amicus brief we filed with the National Association of Manufacturers and the U.S. Chamber of Commerce – supported by our oral argument – will encourage the New Jersey Superior Court Appellate Division to give medical device manufacturers a fair shake in defending themselves by reversing the ruling of the trial court and allowing 510(k) evidence to be admissible at trial. The bottom line is that without such a ruling, juries will be left to speculate about FDA’s involvement and could make decisions in a vacuum that undermines the FDA’s ability to give the American people access to important medical devices.”