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Supreme Court will consider medical devices suit

By Janet Moore

McClatchy Newspapers

MINNEAPOLIS — In a case that could give patients the right to pursue product-liability lawsuits against medical device companies, the U.S. Supreme Court on Monday agreed to hear an appeal against Medtronic Inc.

If the high court decides against the Fridley, Minn.-based medical technology giant, it would have broad implications for the med-tech industry.

The appeal stems from a New York case that began as an angioplasty procedure gone awry in 1996.

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After Charles Riegel suffered a heart attack, a doctor inserted a Medtronic catheter into his badly blocked right coronary artery. But when the catheter’s balloon was expanded to restore blood flow to the heart, it burst. Riegel suffered "severe complications," according to his lawyer.

With almost any other consumer product, an injured party could sue the manufacturer for damages in state court. But that’s not the case with many medical devices.

Medtronic argues that it is pre-empted from being sued because the device was first cleared for sale by the Food and Drug Administration. Lower courts have agreed.

Should the Supreme Court rule against Medtronic, "It could really change the legal landscape for med-tech companies," said Sarah Brew, an attorney with the Minneapolis-based law firm Greene Espel, who has represented Medtronic and other device firms in the past.

"These companies will be caught between a rock and a hard place — they have to do what the government says for pre-market (FDA) approval in a very involved and costly process. But to think that later a jury can say, ‘No, you didn’t design the device correctly or failed to warn us properly on the label,’ puts them at a lot of risk."

But if patients injured by a medical device can’t sue under state law, "there’s no means of getting any compensation for an injury that wasn’t the patient’s fault," said Riegal’s attorney, Allison Zieve, of the Public Citizen Litigation Group in Washington, D.C.

A lawsuit holding manufacturers accountable for injuries caused by their products "provides a very powerful incentive for companies to make their products as safe as possible," Zieve said.

The Medtronic device used in Riegel’s angioplasty procedure, the Evergreen balloon catheter, was approved for use by the FDA after an extensive "pre-market" review, a process that involves submission of detailed information regarding the device’s safety and effectiveness. (The product is no longer made by the company.)

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Once the angioplasty balloon burst during Riegel’s May 1996 procedure, he lost consciousness and required emergency bypass surgery.

In a statement Monday, Medtronic said that Riegel’s doctor inflated the device’s balloon beyond limits spelled out on its FDA-approved product labeling, and that Riegel was not a proper candidate for the procedure involving the device.

Riegel and his wife, Donna, sued the company, but a trial kourt in Albany, N.Y., dismissed the case. That decision was upheld by the Second Circuit Court of Appeals. The high court will hear arguments in the case late this year, with a decision in 2008.

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