Chamber Asks High Court to Defer to FDA Drug Labeling
Federal Law Should Trump State Tort Lawsuits 

WASHINGTON, D.C.—The U.S. Chamber's National Chamber Litigation Center (NCLC) today urged the Supreme Court to reject a Vermont Supreme Court decision upholding a jury's verdict that a prescription drug manufacturer failed to adequately warn of the risks associated with an anti-nausea drug, even though the Food and Drug Administration designed the drug label. The case, Wyeth v. Levine, will be heard by the High Court this fall.

"Congress has given the FDA the authority to regulate what are the most appropriate drug labels, and states and juries shouldn't be allowed to second-guess the judgment of those expert regulators," explained Robin Conrad, executive vice president of NCLC. "This case is about leaving regulation in the hands of experts, not placing it in the hands of trial lawyers."

In its amicus brief, NCLC urged the Court to reject independent state tort liability for drug labeling. According to the brief, FDA approval of a drug reflects the agency's expert judgment that the benefits of the drug outweigh the risks. FDA-designed drug labels reflect the agency's determination that a drug is safe and effective under certain conditions of use. State laws or jury decisions that exaggerate a particular risk could harm the public by discouraging the appropriate use of an otherwise beneficial drug, according to NCLC. Moreover, if multiple regulators including federal agencies, states and juries are allowed to set different and competing labeling standards, consumers could be so overwhelmed by excessive warnings that the more meaningful risk information provided by the FDA would lose its significance.

"Drug manufacturers are subjected to multiple, competing layers of regulation, including the federal government, state governments and juries," said Conrad. "Regulation by jury is costly and unpredictable, and often forces businesses to either pull beneficial drugs off the market or pass the costs of regulation on to consumers."

NCLC is the public policy law firm of the U.S. Chamber of Commerce. The U.S. Chamber is the world's largest business federation representing more than 3 million businesses and organizations of every size, sector and region.