Supreme Court Shields Medical-Device Makers
Decision Rules Out State Lawsuits Over Products That Meet FDA's Highest Standards

By Robert Barnes
Washington Post Staff Writer
Thursday, February 21, 2008

The Supreme Court yesterday protected the makers of medical devices that have passed the most rigorous federal review standards from lawsuits by consumers who allege that the devices caused them harm.

The court ruled 8 to 1 against the estate of a New York man who was seriously injured when a balloon catheter manufactured by Medtronic burst during an angioplasty in 1996. Charles Riegel, who died three years ago, and his wife sued under New York law, alleging that the device's design was faulty and its labeling deficient.

Justice Antonin Scalia, writing for the majority, said federal law preempts the imposition of liability under state laws for devices that have undergone the Food and Drug Administration's pre-market approval process, the most rigorous of the FDA's testing procedures.

Justice Ruth Bader Ginsburg was the lone dissenter. Congress did not intend the preemption clause, Ginsburg wrote, "to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices."

Courts are filled with lawsuits over preemption, which New York University law professor Catherine M. Sharkey called "the fiercest battle in products liability litigation today."

The Supreme Court this year took several cases that invoke federal preemption. Cases still to be heard include lawsuits in state courts that seek to punish cigarette makers and drug manufacturers.

The court ruled in 1996 that devices approved by the FDA under a less-rigorous process were not protected from state lawsuits. The agency agreed with that.

In 2004 the government reversed its position, and when the case decided yesterday was argued in December, the government said such suits undermine the FDA's authority.

Yesterday's decision seemed in step with the court's recent rulings favoring business and expressing skepticism about the role of civil lawsuits in disciplining corporations.

But Sharkey said the fact that eight of the nine justices joined yesterday's decision in Riegel v. Medtronics underscored what she viewed as a "narrow, textual interpretation" of federal law specific to the preemption clause in the Medical Device Amendments of 1976.

That law, Scalia noted, was passed in response to the "thousands of tort claims" resulting from the problems caused by the Dalkon Shield intrauterine device. It set up a detailed federal regime for the FDA to test medical devices and precluded states from imposing "any requirement which is different from, or in addition to, any requirement applicable under this chapter."

The court has held a "requirement" to mean a state tort award.

Scalia wrote that devices such as Medtronic's catheter are subjected to nearly a year of study. Because they are designed to be used on people with the most serious medical conditions, Scalia wrote, they can carry great risks for patients and thus the FDA plays an important role in weighing the benefits against the potential costs.

Allowing juries to award damages when something goes wrong, Scalia wrote, would be unfair. A jury "sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court," Scalia wrote. Patients "would suffer without new medical devices if juries were allowed to apply the tort law of 50 states to all innovations."

But Ginsburg, in her dissent, wrote that she doubted Congress meant to foreclose consumers injured by FDA-approved devices that "nevertheless prove unsafe.

"The MDA's failure to create any federal compensatory remedy for such consumers further suggests that Congress did not intend broadly to preempt state common-law suits grounded on allegations independent of FDA requirements."

The decision upset some Democrats on Capitol Hill.

"The Supreme Court's decision strips consumers of the rights they've had for decades," said Rep. Henry A. Waxman of California, the chairman of the House Committee on Oversight and Government Reform. "This isn't what Congress intended, and we'll pass legislation as quickly as possible to fix this nonsensical situation."

The American Association for Justice, a group of trial lawyers, said in a statement attributed to chief executive Jon Haber that the decision "limits the rights of people to receive justice through the legal system when they are injured by the negligence or misconduct of others."

But, like Sharkey, the association pointed out that the decision was narrowly tailored to apply only to Class III medical devices -- those that have received the highest level of FDA scrutiny.

And Scalia's opinion said the law "does not prevent a state from providing a damages remedy for claims premised on a violation of FDA regulations.''

Scalia also noted that the preemption clause passed by Congress refers to medical devices approved by the FDA, not drugs, leaving that question for another day.

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