The Law: Medical Equipment Makers' Liability

The issue: Does federal law block a victim's right to sue medical equipment makers?

Charles Riegel of Albany, N.Y., was optimistic when he underwent an angioplasty in 1996. His arteries would be cleaned, a balloon catheter would be inserted and inflated and Riegel, who had been plagued with heart problems for several years, would go on to live a healthy life. Then, the unthinkable happened.

During surgery, the catheter burst, and Riegel lost consciousness, was placed on advanced life support and rushed to the emergency room. Riegel survived, but he suffered severe disabilities. He died in 2004.

The question now is whether Riegel's family can sue Medtronic, manufacturer of the catheter, for damages or whether federal approval of the device insulates the product's maker from liability if it proves defective.

So far, several courts considering the same question have decided the issue differently, and the U.S. Supreme Court has agreed to resolve the dispute. AARP lawyers have filed a friend of the court brief, siding with Riegel's family.

The Riegels are appealing a May 2006 ruling supporting Medtronic's claim that since the U.S. Food and Drug Administration had approved as safe the device used in Riegel's case, then federal law superseded state law, and the patient couldn't sue the manufacturer.

The Supreme Court will examine 1976 amendments to the federal Food, Drug and Cosmetic Act, which allowed regulation of medical devices in addition to drugs and food. AARP senior attorney Bruce Vignery says two points may help the Riegels. First, the court may decide that the FDA approval process is not sufficiently rigorous to screen out all defective devices. Second, the court could rule that Congress did not intend to displace state law. That would give people the right to sue the maker of an allegedly defective product.

"AARP believes that the federal approval process wasn't intended to replace traditional state law claims," says Vignery. The Bush administration has filed a brief supporting Medtronic. Lawyers for the company would not discuss the case, although the firm has suggested that the incident was caused by the surgeon's decisions, rather than the medical device.

Emily Sachar is a journalist and author based in Brooklyn, N.Y.