FAYETTEVILLE, Ark. — The United States Supreme Court last week cited the research of Robert B. Leflar, Arkansas Bar Foundation Professor of Law at the University of Arkansas School of Law.

The Supreme Court’s Feb. 20 decision in Riegel v. Medtronic, Inc. addressed the question of whether federal Food and Drug Administration approval of a medical device that later causes injury preempts lawsuits by injured patients claiming the device was defective. The court held that most patients are barred from recovering for injuries caused by these medical devices.

Justice Ruth Ginsburg, dissenting, wrote that Congress intended no such thing in passing the medical device law. She quoted Leflar’s conclusion in his 1997 Tennessee Law Review article "The Preemption Pentad," co-authored by Robert Adler: “Surely a furor would have been aroused by the very suggestion that . medical devices should receive an exemption from products liability litigation while new drugs, subject to similar regulatory scrutiny from the same agency, should remain under the standard tort law regime.” Justice Antonin Scalia's opinion for the Supreme Court also cited the Leflar-Adler article, while implicitly disagreeing with its conclusions.

The case involved Charles Riegel, a heart attack patient who suffered serious injury when his balloon catheter burst while he was undergoing an angioplasty procedure. He and his wife sued the device’s manufacturer, Medtronic Inc. The defense argued that since the FDA had approved the device, Medtronic should not be held liable under state law for its malfunction, and the Supreme Court agreed.

Leflar, who teaches product liability and other courses relating to personal injury and health law at the law school and at the medical school in Little Rock, said the court’s decision will have unfortunate effects where the FDA “blows the call” in its judgment about a product’s safety or effectiveness.

“I’ve served on FDA committees reviewing these products, and the FDA doesn’t always get it right,” he said. “Sometimes the product manufacturer doesn’t give FDA all the adverse data. Sometimes the FDA has to reverse course and pull a product that it’s already approved off the market. Juries ought to be able to hear those cases.”

The Riegel decision was front-page news because of the hundreds of similar medical device cases now in the courts that will be affected. The decision may also be a signpost indicating the court’s intention to restrict or eliminate liability of drug manufacturers for injuries and deaths suffered by patients taking prescription drugs. The court has two drug liability cases on its docket now, one of them argued just this week.

For more information about the case, read the New York Times article at http://www.nytimes.com. And for more about federal preemption of product liability claims, Leflar’s article appeared in the fall 1997 issue of the Tennessee Law Review, which is at http://www.law.utk.edu/departments/lawrev/lawreviewhome.htm.