PERSPECTIVE: EMPHASIZING THE FUNCTION OF THE FEDERAL DRUG ADMINISTRATION (FDA) IN WYTHE v. DIANA LEVINE
The Food and Drug Administration (FDA), a regulatory agency within the Department of Health and Human Services, regulates the safety and effectiveness of drugs sold in the United States [1]. The FDA plays a crucial role in ensuring drug safety in the United States by issuing recalls of unsafe drugs and label changes. The Federal Food and Drug Act was enacted in 1906 and “prohibited the manufacture or interstate shipment of adulterated or misbranded drugs, supplemented the protection for consumers already provided by state regulation and common-law liability [2]. “In 1938 Congress enacted the Federal Food, Drug, and Cosmetic Act (FDCA) that included a provision requiring premarket approval of new drugs. It required every manufacturer to submit a new drug application to the FDA for review [3].” Before 1962, the FDA had the burden of proof in proving harm to keep a drug out of the market; however, Congress amended the (FDCA) to shift the burden of proof from the FDA to the manufacturer. Now the manufacturer is required to demonstrate that its drug is “safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling” before distribution of the drug [4].
The case of Wythe v. Diana Levine raised the question of whether federal preemption can be used as a defense to state regulation of drug safety. The issue presented to the Supreme Court is whether petitioner Wyeth, a drug manufacturer, should be held liable for strict product liability and/or negligence state law claims for failure to provide adequate warning labels despite FDA approval of their drug labeling. A strict product liability (failure-to-warn) cause of action governs most legal claims for injury caused by dangerous or defective products.
Respondent, Diana Levine, was treated for a medical condition with the drug Phenergan, which is manufactured by the petitioner Wythe. According to the drug label the drug can be administered either through the (1) IV push method or (2) IV drip method.
The facts show the respondent was treated with the IV push method. The respondent received a greater dose than the label prescribed and the drug may have been inadvertently injected into an artery rather than a vein, causing gangrene which ultimately led to amputation of her forearm.
State claims were filed in Vermont state court. “Wyeth was found negligent as well as strictly liable, the jury also determined that Levine’s injury was foreseeable; the inadequate label was both a but-for and proximate cause of Levine’s injury,” awarding damages [5].
The Vermont Supreme Court affirmed the state court’s verdict rejecting Wythe’s preemption defense. Wythe appealed and the Supreme Court granted Wythe’s petition for certiorari.
Respondent argues the labeling of the drug by the drug company was defective because there was an inadequate warning of the IV push method being of higher risk than the IV drip method. The petitioner filed a motion for summary judgment as a matter of law. The Supreme Court held that federal law does not preempt the respondent’s state law claim shielding petitioner from liability and affirmed the judgment of the Vermont State Court.
The Court reasoned that drug manufacturers are always responsible for the content of their labels when new risks emerge. They reasoned “[t]here was no direct conflict between FDA regulations and respondent’s state-law claims because those regulations permit strengthened warnings before FDA approval on an interim basis so long as it later submits the revised warning for review and approval [6].” The Court’s reasoning is based on the 1962 amendments of the FDCA that added a saving clause, indicating that a provision of state law would only be invalidated upon a “direct and positive conflict” with the FDCA [7]. This amendment set a high standard for federal preemption of state law. In short, the Supreme Court concluded the respondent’s state law claims do not obstruct the federal objectives of the FDCA.
The FDA provides an essential function in ensuring the drug market is safe and effective. Wythe v. Diane Levine reiterates that this function is done with auxiliary help from common law and state regulation to ensure optimal compliance.
[1] CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul.
[2] Wythe v Levine, 555 U.S. 555 (2009).
[3] Id.
[4] Id.
[5] Id.
[6] Id.
[7] Id.