Supreme Court Got It Wrong in Wyeth v. Levine

In Vermont, a jury awarded Diana Levine $7.4 million in damages against Wyeth. Levine claimed that Wyeth, which manufactures the drug Phenergan, failed to put an adequate warning label on the drug regarding its use intravenously. As a result of a physician's assistant blatant disregard of the warning labels on Phenergan, Levine developed gangrene that necessitated her forearm be amputated. Relying on common-law negligence and strict-liability theories, the jury found that Wyeth was negligent, that Phenergan was a defective product because of inadequate warnings and instructions, and that no intervening cause had broken the causal connection between the product defects and the Levine’s injury.

Under the Federal Food, Drug, and Cosmetic Act (FDCA), The FDA has the responsibility for making sure manufacturers place adequate warning labels on their medications. These regulations setting forth labeling obligations are set forth in an entire part of the Code of Federal Regulations, see 21 CFR pt. 201. Under those regulations, the FDA must be satisfied that a drug’s warning label contains, among other things, “a summary of the essential scientific information needed for the safe and effective use of the drug,” §201.56(1), including a description of “clinically significant adverse reactions,” “other potential safety hazards,” “limitations in use imposed by them, . . . and steps that should be taken if they occur,” §201.57(c)(6)(i). Neither the FDCA nor its implementing regulations suggest that juries may second-guess the FDA’s warning labeling decisions. Thus, the FDCA clearly pre-empts a state common-law tort actions in which a plaintiff claims that the defendant was not in compliance with the these regulations. Therefore, the Court should have concluded that the FDCA pre-empts the state court lawsuit.

The Supremecy Clause clause provides that: "This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any state to the Contrary notwithstanding." Art. VI, cl. 2 The FDA's drug-approval determinations consider the interests of all potential users of a drug. If juries in all 50 States are free to contradict the FDA’s expert determinations, like the one in Vermont, and if local medical communities are allowed to present potentially conflicting ones, then pharmaceutical companies will be subject to the local whims and interests of the adequacy of a warning labels in each of the 50 states. In conclusion, the FDA, through the FDCA, has the regulatory authority in pharmaceutical labeling to avoid these conflicts that will arise after this unsound ruling.