Does a medical device cleared under the US Food and Drug Administration's 510(k) application mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer.
In an amicus curiae brief filed with the nation's top court last week, AdvaMed takes issue with a decision from the US Court of Appeals for the Fourth Circuit, which upheld a $3.27 million jury verdict against Johnson & Johnson subsidiary Ethicon.
That case, known as Ethicon v. Huskey, was brought by Jo Huskey, a woman implanted with an Ethicon transvaginal mesh device in 2011 to treat stress urinary incontinence but which caused severe pain. Huskey and tens of thousands of others have filed lawsuits because of pelvic mesh device issues.
But AdvaMed is taking issue with the Fourth Circuit's decision to affirm the district court's decision to exclude all evidence of the Ethicon device's 510(k) clearance, despite "Congress having mandated that principles of safety and effectiveness underlie every 510(k) review," AdvaMed says.
"The Fourth Circuit discarded FDA's own view that principles of safety and effectiveness underlie the 510(k) process, rejecting FDA's statements as ‘[b]ald assertions,'" AdvaMed writes.
The court reasoned that the 510(k)-clearance information "was of minimal probative value as to whether the TVT-O [the device] is safe because ‘the 510(k) process focuses mostly on the equivalence between the product in question and an older one, and only "tangentially" examines the safety of the product going through the process,'" AdvaMed says.
In addition, the group says the court's reasoning is from a 1982 decision and AdvaMed cited FDA publications from 2014 and 2017 that "contain many statements confirming the importance of safety and effectiveness in a 510(k) review."
FDA's "consistent position" since the Safe Medical Devices Act was enacted in 1990 is "that principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review," AdvaMed claims.
AdvaMed is calling on the Supreme Court to take up the case, not only because there are about 60,000 pelvic mesh cases pending, but because it believes the court should "clarify the bounds of its previous statements on the 510(k) process."
In addition, the organization wants the Supreme Court to clarify whether a device manufacturer can be barred from citing FDA's clearance of the device to defend against claims that the device is unsafe, and to "elucidate the limits as to when a court may disregard an agency's characterization of its own processes," among other issues.