Compliance With FDCA May Not Preclude State Law Product Liability Claims
Recent decisions by the United States Supreme Court and the United States Court of Appeals for the Third Circuit (which includes Pennsylvania) signal that pharmaceutical manufacturers may have a difficult time arguing that compliance with federal regulations, including the Food, Drug and Cosmetic Act (FDCA), precludes state law product liability claims. See Wyeth v. Levine, 129 S. Ct. 1187 (2009); and Holk v. Snapple Beverage Corp., ___ F.3d ___, 2009 WL 2449561 (3d Cir. 2009).
In Wyeth, a patient, Levine, brought a claim against Wyeth under state law for failure to warn of the dangers of administering an antihistamine using an IV-push, rather than IV-drip method. The drug, promethazine hydrochloride, sold by Wyeth under the brand name Phenergan, is used to treat nausea, but directly injecting the drug into a patient's vein creates a significant risk of catastrophic consequences, in Levine's case irreversible gangrene, which lead to the amputation of her arm. She brought an action for damages against Wyeth asserting state law claims predicated on negligence and strict (product) liability theories.
Phenergan's labeling, which had been deemed sufficient by the federal Food and Drug Administration (FDA), warned of the danger of gangrene and amputation from inadvertent intra-arterial injection, but Levine alleged that the labeling was defective because it failed to instruct clinicians to use the IV-drip method of intravenous administration rather than the high risk IV-push method. Wyeth filed a motion for summary judgment, arguing that Levine's state law based failure to warn claims were preempted by federal law.
The trial court denied the motion, and a five-day jury trial was held. The jury found that Wyeth was negligent and that Phenergan was a defective product due to inadequate warnings and instructions. The trial court then issued an opinion denying a motion by Wyeth for judgment as a matter of law, and the Vermont Supreme Court affirmed.
On appeal to the U.S. Supreme Court, Wyeth argued that it would have been impossible for it to modify Phenergan's labeling without violating federal law and that recognition of Levine's state tort action would create an unacceptable "obstacle to the accomplishment and execution of the full purposes and objectives of Congress."
In rejecting these arguments, the Supreme Court noted that an FDA regulation permits a manufacturer to change its label to "add or strengthen a contraindication, warning, precaution, or adverse reaction" or to "add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product." It need not wait for FDA approval. Further, it can do so, not only based upon newly acquired information, but also based upon a new analysis of previously submitted data. The court also found that strengthening the warning would not have made Phenergan a new drug, nor would it have rendered Phenergan misbranded. Thus, the court said that, absent evidence that the FDA would not have approved the label change, it would not conclude that it was impossible for Wyeth to comply with both federal and state law.
Likewise, the court found no merit in Wyeth's argument that a state law duty to provide a stronger warning would obstruct "Congress's purpose to entrust an expert agency to make drug labeling decisions that strike a balance between competing objectives." The court noted that the FDA itself stated that, in establishing "minimum standards" for drug labels, it did not intend "to preclude the states from imposing additional labeling requirements."
This notion that compliance with the Food, Drug and Cosmetic Act (FDCA) and FDA regulations may not protect a manufacturer from state law product liability claims was recently applied by the Third Circuit in the Snapple case. There, Snapple marketed drinks as "All Natural" when, in fact, they contained high fructose corn syrup, an ingredient manufactured from processed cornstarch. Following Wyeth, the Third Circuit began its analysis with a presumption against preemption of state tort law claims in areas traditionally regulated by the states, including food labeling. As the Third Circuit explained, federal law may be held to preempt state law where any one of three forms of preemption apply: express preemption, field preemption and implied conflict preemption.
The Third Circuit found that Snapple had waived its argument that its use of the term "All Natural" was expressly preempted by the FDCA by not properly preserving the issue for appeal. Then the court explained that field preemption occurs when state law occupies a field reserved for federal regulation, leaving no room for state regulation, i.e., where Congressional intent to supersede state law is clear and manifest. The Third Circuit rejected field preemption in the Snapple case because there was no express preemption provision in the FDCA prior to the enactment of the Nutrition Labeling and Education Act (NLEA) and Congress was cognizant of the operation of state law and regulation in the food and beverage industry but only enacted limited exceptions in NLEA to the operation of both federal and state law.
Lastly, the Third Circuit described implied conflict preemption as when it is impossible for a party to comply with both state and federal requirements. As to that theory, the Third Circuit held that Snapple's use of the term "All Natural" was not impliedly preempted by an FDA policy statement regarding the use of the term "natural" or by an enforcement letter from the FDA indicating that some forms of high fructose corn syrup could be classified as "natural."
The Wyeth and Snapple decisions indicate that it may become more difficult to persuade trial courts that state law product liability claims are preempted by federal law or, stated differently, that compliance with the FDCA protects a manufacturer from tort claims under state law.