AdvaMed, the industry association of manufacturers of medical devices, diagnostic products and health information systems, has just released a statement with comments concerning the Senate Judiciary Committee's hearings last week on the Food and Drug Administration's (FDA) federal preemption authority for certain medical devices approved through the agency's pre-market approval (PMA) process.

AdvaMed's remarks continue an ongoing debate over regulatory preemption of litigation. Christopher White, executive Vice President and general counsel for AdvaMed, says, "Allowing state court lay juries to serve as secondary regulatory bodies would interfere with FDA's extensive oversight of medical devices, delay or deny patient access to life-saving treatments and increase the costs to the health care system....the Supreme Court's 8-1 decision in Riegel vs. Medtronic re-affirmed the two previous lower court rulings in this case, consistent with a 30-year history of jurisprudence, and once again made clear that the Medical Device Amendments to the Federal Food Drug and Cosmetic Act expressly provide for FDA's ultimate regulatory authority in these matters."

White refers to Riegel v. Medtronic, one of the most significant legal cases in the healthcare industry this year. The Supreme Court decision in February 2008 held that the law providing authority for the FDA to regulate devices also significantly limits the right of patients to sue manufacturers of medical devices which caused injuries. The Medical Device Amendments to the Food, Drug, and Cosmetics Act contains explicit preemption language that prohibits states from establishing requirements different from, or in addition to requirements in the federal statute that relate to the safety or effectiveness of the device.
In the U.S. Constitution Supremacy Clause, federal laws are "supreme" over state laws. If federal and state law conflict the federal law rules, and the state law is unenforceable. In Riegel, the Medical Device Amendments of 1976 was argued to preempt the area of device regulation - and preclude private litigation. The Justices voted eight to one in favor of the FDA's preemption. (In the fall, the Supreme Court will hear a similar case of preemption regarding prescription medication, Wyeth v. Levine, cert. granted 128 S.Ct. 1118 (2008))

Senator Patrick Leahy (D-VT), Chairman of the Judiciary Committee, had a different take in his statement during the June 11 hearings: "The Supreme Court has narrowly interpreted another law designed to protect Americans who rely on medical devices to keep them alive. Unfortunately, here again, the Supreme Court's interpretation has transformed the law into one that takes away protections from people by extinguishing long-standing state law remedies which hold corporations accountable when they are aware of potential dangers but hide them from consumers. As a result, Americans are not only deprived of a remedy under state law but are offered no replacement remedy under Federal law."

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