Pre-emption opponents work to overturn ruling

WASHINGTON—Backers of a bill that would end federal pre-emption of state tort law regarding medical devices say they think the political winds have turned in their favor.

They hope to overturn last year's U.S. Supreme Court decision in Donna S. Riegel vs. Medtronic Inc. by passing the Medical Device Safety Act of 2009, which was introduced in both houses of Congress earlier this month. The decision held that the pre-emption clause in the Medical Device Amendments of 1976 bars common law claims that challenge the safety and effectiveness of a medical device that has received premarket approval from the Food and Drug Administration (BI, Feb. 25, 2008).

Bills to void the ruling were introduced in both houses last year, but failed to move out of committee. But supporters are trying again, buoyed by the Supreme Court's recent ruling in Wyeth vs. Diana Levine that circumscribed implicit federal pre-emption of state product liability laws (BI, March 9).

"I am glad the court spoke clearly and decisively on this issue," Sen. Patrick Leahy, D-Vt., said upon introduction of the medical device bill in the Senate. "The court's decision was not only a vindication of Congress' primary authority to pre-empt state law, but a victory for every American who relies upon pharmaceutical drugs and entrusts the manufacturers of those drugs with ensuring their safety." The bill "is another important step to correct an erroneous reading by the court of Congress' intent in enacting the Medical Device Amendments of 1976," Sen. Leahy said.

The bills, S. 540 and H.R. 1346, would amend the Federal Food, Drug and Cosmetic Act to say that nothing in the section that deals with state and local requirements concerning medical devices "shall be construed to modify or otherwise affect any action for damages or the liability under the law of any state."

Supporters say changed political circumstances favor their cause.

"The odds are better this year because there's a different administration," said Allison Zieve, senior attorney at Public Citizen in Washington. She said the Bush administration reversed a longtime federal view that federal device laws did not pre-empt damage claims under state law.

But times have changed. Both houses of Congress have larger Democratic majorities and, Ms. Zieve pointed out, then-Sen. Barack Obama, D-Ill., "was a co-sponsor of the act when it was introduced in the Senate last July."

"Consumers' ability to hold manufacturers accountable for injuries caused by their products is important because it is the sole means consumers have of getting compensation for their injuries," Ms. Zieve said. "The existence of state tort law provides a powerful incentive for companies to make their products as safe as they can be and to improve their products as soon as they become aware that the design or labeling is inadequate."

The president of a group of medical device makers said there is no blanket pre-emption for such devices, which undergo exhaustive scrutiny.

Products that go through the FDA's premarket approval process undergo clinical trials and generate "an extraordinary amount of data that is exhaustively reviewed by scientists and others," said Mark Leahey, president and chief executive officer of the Medical Device Manufacturers Assn. in Washington. "We feel that those FDA experts are in a better position to determine the safety and efficacy of a device than a lay jury," he said.

"It's looking to trump the highest court in the land, who ruled that federal law trumps state law in medical device cases," said Anthony Wisniewski, executive director-health care policy for the U.S. Chamber of Commerce in Washington. "This is a direct shot over the bow of Riegel vs. Medtronic."

Mr. Wisniewski said if the measure became law, there could be 50 different state standards. "There needs to be one FDA and one FDA only. They are the gold standard in approving medical devices," he said. "Congress should be focusing a lot more on trying to promote medical innovation in this country."

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