Faulty pacemaker case may set
precedent for implant patients

Medical Devices

April 24, 1996
Web posted at: 8:35 a.m. EDT

WASHINGTON (CNN) -- Supreme Court justices took a skeptical view Tuesday of a company's claim that it can't be sued for allegedly making a faulty heart pacemaker. The court's ruling in the case, due by July, could have a broad impact on many lawsuits involving medical devices.

The plaintiff in the case, Lora Lohr, has something special in common with 11 million Americans: she has an implanted medical device. Lohr, who has a bad heart, had a pacemaker installed when she was just 27. She did not think she was taking a gamble. The pacemaker, she says, failed three years later.

Lora Lohr

"There is no stranger feeling than trying to take your own pulse and not having one," she said.

Now she is in the middle of a suit that has ramifications for every person with any sort of implant. After having the pacemaker replaced, she tried to sue for damages, accusing the makers of the device of faulty manufacturing and design. Her case may determine whether implant recipients are already protected enough by federal regulators, or if they can get additional protections in court.


"We wanted just basically compensation for what insurance didn't cover and, you know, at that time, suffering or whatever, the time I missed from work," Lohr said.

But Medtronic Inc., the company that made the pacemaker, won a lower court ruling that threw out most of Lohr's lawsuit. A lawyer for the company said that because federal regulators already check on the safety of many medical devices, no company that makes them can be sued in a state court.


"To allow juries and plaintiffs' lawyers in 50 different states to try and get 50 different interpretations of what the federal statute means simply would drive up the cost of products," argued Arthur Miller, the attorney for Medtronic.

He had trouble convincing several skeptical justices that people injured by medical devices can never sue. As Chief Justice William Rehnquist put it, "That's an extraordinary sweep."

The Supreme Court's ruling could affect how easily people can sue in thousands of other cases involving medical devices, such as breast implants. If Medtronic wins, consumer advocacy groups fear, many companies might use the case to try to avoid costly lawsuits.

"We want to be sure that consumers can use the legal marketplace to go after negligent behavior and recover for injuries caused to them," said Gene Kimmelman of the group Consumers Union.

On the other side, business groups say too many lawsuits could stifle innovation.

"I just saw on TV, a new artificial heart has been made. If the people who are making that device know that juries around the country can redesign it if something goes wrong, (consumers) may never get the product," said Victor Schwartz, an attorney for the National Association of Manufacturers.

For Lora Lohr, the issue is simple. "I want my day in court. That's all I want," she said.

From Correspondent Anthony Collings

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