Medical devices put to legal test

Protections for makers of catheters and other medical equipment are at stake as lawsuit against Medtronic goes before U.S. Supreme Court.

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By Aaron Smith, staff writer

NEW YORK ( -- The U.S. Supreme Court will hear arguments Tuesday in a case that could have major implications for Medtronic Inc. and other makers of medical devices.

The lawsuit, Riegel v. Medtronic, was brought by Donna Riegel. She says her husband, Charles, who has since died, was left severely disabled when a Medtronic-made heart catheter burst. A U.S. district court judge and then the U.S. Court of Appeals threw out her case.

But Donna Riegel has carried her fight to the Supreme Court. At issue is whether patients can sue makers of catheters and other devices through state tort law, when those devices have been approved by federal regulators.

The Riegel v. Medtronic case has "big implications for the medical device industry," said Boston University law professor Frances Miller. "If they are in fact exempt from liability here, irregardless of anything, they're going to save [the cost of] having to defend these cases."

Minneapolis-based Medtronic is one of the largest medical device makers in the world, competing against Johnson & Johnson (Charts, Fortune 500), Boston Scientific (Charts, Fortune 500), St. Jude Medical (Charts) and Abbott Labs (Charts, Fortune 500). Estimates for the size of this market vary widely, but they tend to hover around $100 billion for the U.S. industry and $200 billion worldwide.

The case before the Supreme Court dates back to 1996, when Charles Riegel underwent an angioplasty operation. The Medtronic (Charts, Fortune 500)-made Evergreen balloon catheter burst, leaving him severely injured and disabled. The Riegels sued Medtronic in 2002, but lost in a New York federal district court and then on appeal.

The two courts, siding with Medtronic, ruled that a 1976 amendment to the federal Food, Drug and Cosmetic Act protects medical device makers from being sued.

"The defendant says you can't sue us in state or federal court because it's pre-empted by the federal amendment from 1976," said Wayne P. Smith, a lawyer for Riegel. "It's a very devastating defense."

The cause of Charles Riegel's death, in 2004, was brain cancer, according to Smith. Medtronic is not being blamed for the death, but Smith said he is seeking about $5 million for injuries, including kidney damage and loss of mental function.

"Charlie was not himself ever again after the blood supply loss to his brain," said Smith.

Medtronic spokesman Robert Clark said his company will ask the Supreme Court to uphold the appeals court decision ruling against Riegel. Clark said that doctor malpractice, not device malfunction, caused the catheter to rupture because it was inflated beyond its FDA-approved limits.

"The product did not malfunction," said Clark. "The physician used the product in a manner that was outside its label and its intention. In this case, it was expanded beyond the labeled indication."

Another lawyer representing Riegel, Allison Zieve of the Public Citizen Litigation Group in Washington, D.C., explained why Charles Riegel didn't sue the doctor who performed the angioplasty and the emergency bypass procedure following the rupture.

"Mr. Riegel didn't want to sue the man who saved his life," she said. To top of page

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