Justices: FDA OK No Shield for Medical Device Makers

In a setback for the makers of heart pacemakers, silicone breast implants and other medical devices, the U.S. Supreme Court ruled Wednesday that injured consumers can sue them for damages even though their products are screened for use by the federal Food and Drug Administration.

The 5-4 decision revives a damage suit brought by a Florida woman who nearly died in 1993, allegedly because of a wiring defect in her heart pacemaker.

In recent years, many judges have dismissed such state damage suits on grounds that Congress brought medical devices under federal regulation in 1976.

The issue has been a recurring question in the law. For example, do federal auto safety regulations bar lawsuits over cars that lack air bags, or do federal cigarette warning labels forbid lawsuits by lung cancer victims?

In recent years, however, the consistent answer from the Supreme Court has been no.

Justice John Paul Stevens, writing for the court, relied on the states’ rights rhetoric that has been so popular among conservatives.

“Because the states are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly preempt state-law causes of action,” he said.

Typically, state laws allow injured consumers to sue for damages if they can show they were hurt by a product that was defectively designed or negligently manufactured. While Congress has the power to block all damage suits against medical device manufacturers, Stevens said, it did not do so in the 1976 law.

The ruling in the case (Medtronic vs. Lohr, 95-754) returns the case to a Florida court, where attorneys for Lora Lohr will try to convince a jury that her pacemaker was defectively designed or poorly made.

Trial lawyers and consumer advocates said they were delighted with the decision.

“This is a major victory for consumers,” said Arthur Bryant, president of Trial Lawyers for Public Justice. “They are saying this was a law enacted to protect consumers from medical devices, not to protect manufacturers of medical devices from consumers.”

Stevens noted that the Dalkon shield disaster helped bring about the law. Put on the market in 1970 as a safe contraceptive, the Dalkon shield instead caused infections, sterilizations and a few deaths among young women.

Safety concerns were also voiced in the early 1970s over the first generation of artificial heart valves, pacemakers and defibrillators. The FDA was authorized to regulate these products through “pre-market approvals.”

Even today, however, most medical devices on the market have not gone through the full approval process. Because they are “substantially equivalent” to devices that were on the market in 1976, the FDA has cleared their use without forcing manufacturers to go through the rigorous appraisal contemplated by the law.

Still, the makers of medical devices say their companies produce innovative products that save or extend lives. Sometimes new devices will be used by only a few thousand patients. It is unfair, they say, to subject these firms to the potential of crushing lawsuits if a regulated product is later shown to have a defect.

“We are certainly disappointed,” said William George, the president of Minneapolis-based Medtronic, the leading maker of pacemakers, defibrillators and heart valves. “The court did not act in the best interests of medical innovation or in the best interest of patients who need these devices.”

The company has eight manufacturing facilities in California, George noted. Orange County in particular has been seen as a center of medical device technology.

The Medtronic president said Wednesday’s ruling will have “an adverse financial impact” on the company. It has never been hit with a major jury verdict, he said. He expressed hope that the court might change its view if faced with a product that had gone through the entire approval process.