In a 6-3 decision on Wednesday, the Supreme Court of the United States held that federal law and regulation does not pre-empt state personal injury actions against drug manufacturers whose products cause injury because of inadequate labeling. The ruling in essence makes drug companies responsible for the content of their warning labels. The decision stems from a Vermont lawsuit in which Diane Levine sued Wyeth Pharmaceuticals after she received an IV-push of the drug company's anti-nausea drug, Phenergan, which ultimately led to the amputation of her right arm. Levine was awarded $6.7 million (after court-ordered reductions) by a Vermont jury that found Wyeth failed to adequately warn of the dangers of it product.
After the verdict, Wyeth appealed and ultimately argued to the Supreme Court that Levine's lawsuit was pre-empted by federal law because "it would have been impossible for it to comply with its state law duty to modify Phenergan's label without violating federal law" and "that requiring it to comply with a state-law duty to provide a stronger warning about IV-push administration would obstruct the purposes and objectives of federal drug labeling regulation." The Court's opinion rejected both arguments basing part of its decision on the fact that Food and Drug Administration (FDA) regulations permit a manufacturer to make certain changes to its label before receiving agency approval, and without evidence that the FDA would have rejected such changes, the court refused to find the claim was pre-empted because of impossibility of compliance.
The Court also rejected Wyeth's obstruction claim that argued "[o]nce the FDA has approved a drug's label, a state-law verdict may not deem the label inadequate, regardless of whether there is any evidence that the FDA has considered the stronger warning at issue." The Court found that Wyeth's argument was completely contrary to congressional intent and reasoned that "[i]f Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision" within the controlling federal law. The Court also noted that although the FDA has recently taken the position that its regulations pre-empt state law, "[n]ot once prior to Levine's injury did the FDA suggest that state tort law stood as an obstacle to its statutory mission."
In an amazing denunciation of the FDA's 2006 change in philosophy and in support of state tort claims, the Court noted that "[s]tate tort claims uncover unknown drug hazards and provide incentives for drug manufactures to disclose safety risks promptly" and "serve a distinct compensatory fucntion that may motivate injured persons to come forward with information."
The decision helps pave the way for others in Florida and throughout the US to bring suits for injuries sustained as a result of pharmaceutical companies' failures to adequately label and warn of known dangers.
After the verdict, Wyeth appealed and ultimately argued to the Supreme Court that Levine's lawsuit was pre-empted by federal law because "it would have been impossible for it to comply with its state law duty to modify Phenergan's label without violating federal law" and "that requiring it to comply with a state-law duty to provide a stronger warning about IV-push administration would obstruct the purposes and objectives of federal drug labeling regulation." The Court's opinion rejected both arguments basing part of its decision on the fact that Food and Drug Administration (FDA) regulations permit a manufacturer to make certain changes to its label before receiving agency approval, and without evidence that the FDA would have rejected such changes, the court refused to find the claim was pre-empted because of impossibility of compliance.
The Court also rejected Wyeth's obstruction claim that argued "[o]nce the FDA has approved a drug's label, a state-law verdict may not deem the label inadequate, regardless of whether there is any evidence that the FDA has considered the stronger warning at issue." The Court found that Wyeth's argument was completely contrary to congressional intent and reasoned that "[i]f Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision" within the controlling federal law. The Court also noted that although the FDA has recently taken the position that its regulations pre-empt state law, "[n]ot once prior to Levine's injury did the FDA suggest that state tort law stood as an obstacle to its statutory mission."
In an amazing denunciation of the FDA's 2006 change in philosophy and in support of state tort claims, the Court noted that "[s]tate tort claims uncover unknown drug hazards and provide incentives for drug manufactures to disclose safety risks promptly" and "serve a distinct compensatory fucntion that may motivate injured persons to come forward with information."
The decision helps pave the way for others in Florida and throughout the US to bring suits for injuries sustained as a result of pharmaceutical companies' failures to adequately label and warn of known dangers.
Gabriel Mejia is a personal injury attorney handling accident and
injury cases in Florida for Law Offices Cytryn and Velazquez, P.A.
