The US Supreme Court decided to intervene in several important business disputes, on Friday, including lawsuits that could be worth billions of dollars to pharmaceutical and tobacco companies.
The court will decide whether to shield drugmakers from many costly patient lawsuits, agreeing to hear Wyeth v Levine, a case that tests whether companies are protected from liability when federal regulators have approved the label on a drug. The Vermont Supreme Court upheld a $6.8m damages award against Wyeth over the use of its anti-nausea drug.
But Wyeth is not the only drug company facing lawsuits that question the adequacy of federally approved drug labels. Wyeth, Merck and other drugmakers face thousands of such suits potentially worth billions of dollars. The issue in the case is whether state law claims are pre-empted under federal law.
Wyeth said in court papers that the Vermont ruling “would empower courts to review and override FDA’s careful and comprehensive balancing of safety and effectiveness concerns in prescription drug labelling.’’
US drug law forbids states from making rules that create a “direct and positive conflict’’ with federal requirements.
The US Chamber of Commerce had urged the Supreme Court to take up the case, which is expected to be heard either in April, or early in the court’s next term which begins in October.
The court is already considering a similar case involving federal pre-emption, which will test whether medical device makers can be shielded from lawsuits over products cleared for sale by the Food and Drug Administration.
Robin Conrad of the National Chamber Litigation Center, the US Chamber of Commerce’s legal arm, welcomed the decision to hear the Wyeth case and other business cases on Friday.
“The court is taking so many important business cases and particularly in the area of federal pre-emption,” she said. “The court seems to understand the impact of these issues on a global economy.”
The court also agreed to hear another pre-emption case involving cigarettes on Friday. That case, Altria Group v Good, could determine whether tobacco companies are shielded from lawsuits seeking billions of dollars over the marketing of “light” cigarettes.
The case involves Maine smokers’ claims that Philip Morris, the largest US cigarette maker, fraudulently portrayed light cigarettes as safer than others. It could determine the fate of some 30 other similar lawsuits against other cigarette-makers.
Philip Morris says federal law pre-empts the suit, which was brought under state consumer protection law.
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