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Major Setback for Consumers Hurt By Faulty Medical Devices

Posted by Jane Akre
Wednesday, February 20, 2008 6:49 PM EST
Category: Major Medical, Protecting Your Family
Tags: Medical Devices, Wrongful Death, Product Liability

If a manufacturer makes it and the government approves it – then injured consumers are out of luck if they want to take the maker of an unsafe medical device to court.   


Today’s Supreme Court decision was a victory for the $75 billion medical device industry.

If a manufacturer makes it and the government approves it – then injured consumers are out of luck if they want to take the maker of an unsafe medical device to court under state law.

That’s the sort of blanket immunity manufacturers of federally approved medical devices were given by the highest court in the land, the Supreme Court in an 8-1 decision Wednesday. 

The court ruled against the family of a man who suffered serious injury when a catheter burst during angioplasty surgery. Charles Riegel sued Medtronic Inc. of Fridley, Minnesota saying it had a defective design and it carried an inadequate warning label.

Medtronic moved to dismiss the lawsuit, arguing that the Food, Drug, and Cosmetic Act expressly preempts state-law damages brought by injured consumers. Lawyers for Medtronics argued that a patient is precluded from seeking state court remedies since the FDA had approved the device after the company documented its safety and effectiveness. The court agreed and dismissed the case.  

Public Citizen represented the Riegels on appeal and then before the Supreme Court.  

The Evergreen Balloon catheter is no longer manufactured by Medtronic.

Riegel had permanent disabilities resulting from his surgery to unclog an artery. He died in 2004.

Last Sunday, an exchange on 60 Minutes might make consumers less confident about the FDA’s role in overseeing safety. A medical researcher was asked whether the FDA assured the safety of drugs, which receive federal approval as do medical devices.

Scott Pelley, correspondent, talking to Dr. Dennis Mangano, a medical researcher about drug safety.  

“Doesn't a drug have to be proven safe before the FDA allows it on the market?" Pelley asks Mangano.

Mangano: "No," he replies. "The trials that are constructed before a drug is marketed and given approval to be marketed generally address effectiveness of the studies."

Pelley:  "Make sure I understand. If the FDA is not certifying a drug as safe, before it goes on the market, what is it doing?" Pelley asks.

Mangano: "It's certifying that the drug is effective and that within the small numbers studied, relatively small, it doesn't appear to be unsafe," Mangano says. (editors notations)

Voicing its opinion for the majority, the Bush administration agreed with the Supreme Court saying that unfavorable jury verdicts would end up altering the design already approved by the FDA. 

The one dissenting vote came from Justice Ruth Bader Ginsburg who said that Congress never intended “a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labeled medical devices.”

Riegels’ lawyers argued that FDA procedures are less rigorous than Medtronic lawyers argued.

The medical device industry makes everything from toothbrushes to pace makers. There have been 100 safety complaints before federal regulators over the last three months.

But speaking to the Business Journals, a Massachusetts medical device maker insists the review process for approval is “the gold standard”.

"In bringing a medical product to market in this country, medical device manufacturers comply with the most rigorous review process in the world," said Thomas Sommer, president of MassMedic.

As it stands now, only the 11th U.S. Circuit Court of Appeals in Atlanta and the Illinois Supreme Court have sided with consumers in these cases. #


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