AdvaMed Amicus Brief Urges High Court Review of 510(k) Evidence
The Advanced Medical Technology Association (AdvaMed) has filed an amicus curiae brief urging the U.S. Supreme Court to hear the case of Ethicon v. Huskey in order to correct lower courts’ refusal to allow 510(k) clearance requirements as evidence in product liability cases. The case involves a Fourth Circuit appellate decision that earlier this year affirmed a $3.27 million verdict in the second Ethicon pelvic mesh bellwether trial.
“Representing much more than a disagreement over what evidence is admissible, the case provides a chance to restore fundamental principles of fairness and transparency in fact-finding efforts at trial,” AdvaMed says. “We are asking the court to grant a writ of certiorari to hear the case, which could reverse a trend of evidentiary decisions in the Fourth Circuit and beyond that prohibit defendants in medical product liability cases from presenting evidence of a product’s 510(k) premarket clearance. In effect, such decisions prevent juries from hearing the full story, which is fundamentally unfair. Worse, it can result in FDA’s assessment of a product’s safety and effectiveness being supplanted by a court ruling.”
In its brief, AdvaMed notes that the lower court reasoned that the pelvic mesh’s 510(k) clearance was of “minimal probative value” as to whether 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’s brief argues that the Fourth Circuit erred by relying on a “statutory analysis that mischaracterizes the 510(k) review process.” It questions the court’s conclusion that the 510(k) process only “tangentially” examines safety that was based on its previous decision in Cisson, which was based on the court’s decision in Medtronic, Inc. v. Lohr, “wherein the court held that the 510(k) process in 1982 was insufficiently tied-up with safety to preempt state tort actions.” However, the Ethicon mesh product was cleared in 2013, AdvaMed contends, “after Congress enacted the Safe Medical Devices Act (SMDA), Pub. L. 101-629, 104 Stat. 4511 (1990), which was introduced “to modify the underlying law in ways that will result in greater protection of the public health.”
Additionally, the brief urges the Supreme Court to hear the case “because this issue — whether a medical device manufacturer can be barred from citing FDA’s clearance of the device to defend against claims that the device is unsafe — is vital to a sizable number of cases. Currently, 60,000 cases are pending in the pelvic mesh [multi-district litigation]. And, with the overwhelming majority of medical devices reaching the market through the 510(k) process, this issue is sure to affect a substantial number of future cases.”