Supreme Court hears appeal that may prohibit suits for FDA-cleared devices

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Supreme Court ruling affects medical device industry.

Dec. 6 – The Supreme Court on Tuesday heard the case of Medtronic and other medical devices manufacturers that are appealing to shield themselves from product liability lawsuits against FDA-approved devices. 

The case, Riegel v. Medtronic, was brought by Charles Riegel, who was injured when a Medtronic catheter burst during a 1996 angioplasty procedure. Riegel died in 2004. His widow now represents her husband’s case, asserting that the catheter had design flaws and carried misleading labeling instructions.

The Boston Globe reported that Medtronic’s attorney, Theodore Olsen, told the justices that a product in compliance with the FDA should not be found liable for negligence by a jury in a state tort lawsuit. “The FDA is the right place for these decisions,” Olsen said.

Olsen, a former U.S. Solicitor General who was considered by the Bush administration for the post of Attorney General to succeed Alberto Gonzales, now represents Medtronic.

Justices Stephen Breyer and Antonin Scalia appeared to agree that juries should not be empowered to question the FDA, according to The Boston Globe. In fact, Scalia said that if a jury rules against a company like the Minneapolis-based Medtronic, that “manufacturer is placed at risk in selling a device that scientists at the FDA have said is OK. I find that extraordinary.”

Justice Anthony Kennedy, a potential swing vote on the court, expressed skepticism that Medtronic should face a lawsuit over the catheter that was approved for sale by the FDA, The Financial Times reported. Several justices said the experts at the FDA, and not lay jurors, should determine safety and effectiveness.

Riegel’s lawyer, Allison M. Zieve, argued that many device defects only become known after a device gets FDA approval and is on the market, The Boston Globe reported.

Zieve of the Public Citizens Litigations Group, specializes in public health law, and successfully defended an appeal against Medtronic in 1999.

The Boston Globe also reported that if the Supreme Court rules in Medtronic’s favor, it would not necessarily prohibit all future suits; lawsuits alleging that a product was not designed or manufactured as specified during the FDA approval process could still proceed, Olsen explained.

The Supreme Court is expected to make a decision on the case by July 2008.