Supreme Court Places New Limits on Products Liability Lawsuits Filed Against Medical Device Manufacturers

February 20, 2008, by Michael A. DeMayo

Now, more than ever, it is important to speak with an experienced defective medical device attorney to discuss your case. In an 8-1 vote today, the U.S. Supreme Court voted to place new limits on defective medical device lawsuits filed against Medtronic Inc. and other medical device manufacturers: Patients cannot sue a medical manufacturer if the product that caused the injury was cleared by a strict federal review process.

In this latest case, the Supreme Court barred a lawsuit filed by the widow of a man who was permanently injured when his Medtronic heart catheter burst while he underwent angioplasty surgery. The Medtronic product had been gone through the U.S. Food and Drug Administration’s pre-market approval process. When the device burst, the patient developed a complete blockage and had to undergo emergency bypass surgery. He died three years ago.

The Bush administration and medical device manufacturers had both argued in favor of precluding state law claims with the more rigorous pre-market review process.

This new ruling could work in favor of medical devices makers that have been named as defendants in the thousands of defective products lawsuits that are still pending. It could also work in favor of drug manufacturers. Drug makers are also trying to get the U.S. Supreme Court to place limits on lawsuits filed by people injured from taking a dangerous or defective drug.

Lawsuits that will be most impacted by the ruling are cases involving medical devices that have undergone the FDA’s yearlong pre-market approval process. This is an arduous process, which is why only 43 new applications were filed in 2005. A fast-track review is available to new devices that are similar to products that are already being sold in the marketplace.

The Supreme Court’s ruling does leave room for defective medical device lawsuits filed under state rules that are considered parallel to federal requirements.

Our North Carolina and South Carolina defective products law firm has helped many injured patients and their families recover compensation from medical device makers and drug manufacturers. We have the experience and resources to help you explore your options and take the necessary and available steps to pursue your case.

Patient Medical-Device Suits Curbed by Top U.S. Court,, February 20, 2008

Justices Make It Tougher to Sue Medical Device Makers, The New York Times, February 20, 2008

Related Web Resources:

Read the Supreme Court Decision, Justia & Oyez

Medtronic, Inc.


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