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Ruling may aid drug firms

A former U.S. official said a high-court finding on devices could be applied to pharmaceuticals.

Former U.S. Solicitor General Paul Clement told a gathering of lawyers in Philadelphia yesterday that a Supreme Court decision in February shielding medical-device makers from legal liability could foreshadow sweeping protections for pharmaceutical makers.

Clement, who stepped down in June as the U.S. government's chief lawyer before the Supreme Court, said the issues in the medical-device case bear striking similarities to a case involving drug-maker liability that the court will review in the fall.

In the medical-device case, the Supreme Court ruled, 8-1, that even though a patient was injured by a balloon catheter made by Medtronic Inc., the company was protected from liability because the device met specifications of the U.S. Food and Drug Administration

In the pharmaceutical case, a patient sued Wyeth, alleging the company was liable for injuries she suffered from its anti-nausea drug Phenergan.

Madison, N.J.-based Wyeth, which employs roughly 5,300 at its pharmaceutical headquarters in Collegeville, contends the drug was administered in a way that was unsafe and violated FDA rules.

"What caught most people by surprise [in the Medtronic case] was the margin," Clement said.

Clement, who filed a brief as solicitor general in favor of liability protections for drug manufacturers, said the Medtronic ruling might be read to suggest that the Supreme Court would adopt similar protections for drug makers - a principle known as preemption - because the court relied heavily on the finding that the FDA extensively tested the medical devices.

Similar testing is used on pharmaceuticals, he said.

Clement spoke to a luncheon meeting of the Philadelphia chapter of the Federalist Society, a conservative legal group that has supplied many of the Bush administration's top executive branch and judicial nominees.

Both Supreme Court Chief Justice John Roberts and Justice Samuel A. Alito Jr. were active in the society.

In the last term, the Supreme Court continued to increase its focus on business, with much of its docket devoted to commercial and employment matters, Clement said.

But he contended it would be a mistake to assume the court under Roberts is pro business, as is widely assumed. On the contrary, the court has ruled against corporate defendants in several high-profile employment cases, Clement said.


Contact staff writer Chris Mondics at 215-854-5957 or cmondics@phillynews.com.

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