In an 8–1 ruling in favor of Medtronic, the Supreme Court decided on February 20, 2008, that most state lawsuits are preempted by the federal government's regulatory scheme.
The Supreme Court ruled that premarket approval of new medical devices by the U.S. Food and Drug Administration preempts most personal injury lawsuits seeking monetary damages under state law claims. In other words, medical device manufacturers are immune from liability for personal injury claims as long as those devices are approved for market by the FDA.
The Court's ruling in Riegel v. Medtronic came in the context of a lawsuit brought by a patient who was injured by a medical device during a medical procedure. In 1996, a balloon catheter burst and severely injured Charles Riegel while he was undergoing an angioplasty. Mr. Riegel sued the company, contending that the catheter had been designed, labeled, and manufactured in a manner that violated New York state law, and that those defects had caused severe and permanent injuries to him. Both a federal district court and the United States Court of Appeals for the Second Circuit dismissed Riegel's suit on the ground that the catheter had been given premarket approval by the FDA, thus protecting the manufacturer from liability under state law. The Supreme Court upheld the lower federal courts, with Justice Scalia writing for the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which bars states from imposing on medical devices any requirement which is different from, or in addition to, any applicable requirement.
In affirming the ruling of the two lower courts, the Supreme Court focused on the plain meaning of the 1976 law, which bars states from imposing "any requirement" related to a medical device that was "different from, or in addition to" the federal requirements. According to the Court, "any requirement" encompasses state tort law claims that seek to saddle manufacturers with additional duties of care not mandated by the federal law.
The case impacts only those medical devices that received premarket approval under the process outlined in the Medical Device Amendments of 1976. Devices receiving premarket approval are distinguishable from devices that reach the market because of their "substantial equivalence" to devices that existed on the market before the enactment of the 1976 law. Substantially-equivalent devices undergo a less rigorous approval process. As a result, the Supreme Court ruled in 1996 that the substantially-equivalent process does not preempt state damage suits.
However, not all state damage suits are precluded under the premarket approval process. Suits contending that the device was manufactured in violation of FDA specifications are still permitted, as are suits brought under state laws that parallel FDA regulations, as opposed to supplementing them. Manufacturers of medical devices subject to the FDA's rigorous premarket approval process can now take comfort in knowing that successful navigation of that process could yield the added benefit of immunity from personal injury suits. In keeping the federal regulatory scheme intact, the Court's ruling affords manufacturers peace of mind while curtailing their susceptibility to damage suits.
Manufacturers need to continue to ensure that their premarket-approved devices remain compliant with the FDA's regulations while on the market. All changes in manufacturing process, labeling, or any other attribute that would affect safety or effectiveness require FDA permission. Manufacturers also need to ensure that they continue to follow FDA-mandated reporting requirements once premarket approval is obtained. Strict adherence to the FDA's post-premarket-approval and reporting regulations will likely reduce exposure from state lawsuits based on claims that mirror the FDA's regulations.
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