December 5th, 2007

"Defective Heart Catheter Made by Medtronic Lawsuit Goes to High Court"

The Supreme Court heard arguments in a controversial case involving a defective heart catheter made by Medtronic on Tuesday. At issue is whether or not the manufacturer can be held liable under state law for the plaintiff’s injuries since the device had been approved for sale by the Food and Drug Administration.

Charles R. Riegel and his wife filed a suit against Medtronic after he suffered serious injury due to an Evergreen catheter that burst during an angioplasty. The device, which gained approval for the market in 1994, is no longer manufactured.

Federal “Premarket Approval”

Two lower federal courts have dismissed the suit, citing a medical device maker’s exemption from liability in a state court in cases involving devices that had “premarket approval” from the FDA, a federal government agency.

In 1996, the Supreme Court took up another medical device case and ruled that devices approved under a different and more expedited process were not exempt from state liability. The federal government agreed with the decision at that time.

However, the government reversed its opinion in 2004 and began to side with the manufacturer. The government reasoned that to allow a manufacturer to be held liable under state law would essentially undermine consumer faith in the FDA and its approval process.

Sometimes Problems Arise after Approval

Allison M. Zieve, an attorney with the Public Citizen Litigation Group, raised concerns about the FDA’s premarket approval process, asking whether it was rigorous enough to justify protecting manufacturers from liability in state courts.

She granted that states should not be able to impose a premarket approval process different from the federal one, but reminded the court that premarket approval is merely an initial assessment of the safety and effectiveness of a device.

According to Zieve, manufacturers should still be obligated to make their devices safer and better in light of post-marketing evidence of a problem. Several Supreme Court justices raised similar concerns about shielding manufacturers from liability.

“There could be a newly discovered risk that the FDA never knew about and, nevertheless, the claim would be pre-empted?” asked Justice John Paul Stevens.

Theodore B. Olson, lawyer for Medtronic, replied, “Yes, and that’s a judgment that Congress has made.”

(Source: New York Times online)

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