Bill would limit FDA pre-emption

Chris Rizo Sep. 29, 2008, 2:39pm

Jeffrey Axelrad

WASHINGTON (Legal Newsline)-A push in Congress to broaden product liability to federally approved medical devices could threaten future development of live-saving technology, a legal expert told Legal Newsline.

Jeffrey Axelrad, adjunct law professor at George Washington University School of Law, said the Democrat-backed proposal would allow state courts to impose varying requirements on so-called sophisticated medical devices, including stents and balloon catheters.

The bill would allow plaintiffs to sue manufacturers even though requirements of the U.S. Food and Drug Administration had been met, said Axelrad, who served as director of the U.S. Department of Justice's Torts Branch from 1977 to 2003.

"It's predictable that the bill over time would discourage American manufacturers from putting resources into developing and selling the devices," he said Monday. "That means that people would not have the benefit of the devices they need to save their lives."

If approved, the Medical Device Safety Act of 2008 additionally would effectively overturn a Supreme Court decision issued this year that barred people injured by defective medical devices from suing in state courts so long as the device was approved by the FDA.

Axelrad said if enacted, the legislation could create a hodgepodge of state regulations.

"Manufacturers wouldn't have one set of requirements, and the rules might be different in Virginia from West Virginia; the rules might be different between Arizona and New Mexico," he said. "You wouldn't have one roadmap that a manufacture needs to follow to market one of these very sophisticated medical devices."

Axelrad added that under current law litigants can pursue damages for defective medical devices that didn't follow FDA requirements.

However, the aim of the legislation backed by Democratic presidential nominee Sen. Barack Obama of Illinois and Democratic Sen. Ted Kennedy of Massachusetts, among others, is just to expand manufacturers' exposure to tort liability.

"This means people won't have the benefits of the devices and many more people will be injured by the lack of devices," Axelrad said.

As for its passage, he said it is not likely this year given the upcoming election.

"This is a stalking horse, but who knows what the Congress will look like next year," he said. "You have a powerful group of special interests that want to be able to bring these lawsuits, and you've got a rather dramatically powerful support in introducing the bill."

From Legal Newsline: Reach reporter Chris Rizo at

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