Brief Fact Summary. A woman lost her hand and forearm to gangrene when she was injected with Phenergan, an anti-nausea drug made by Wyeth. She won a jury verdict in Vermont under a theory Wyeth had failed to include an adequate warning on the drug’s label.
Synopsis of Rule of Law. Congress did not expressly intend for the FDCA to preempt all state common law tort claims, and with respect to prescription drugs, state tort law claims offer an additional important layer of consumer protection which complements, and does not obstruct, FDA regulation.
Facts. Plaintiff Levine was treated for a migraine in an emergency room with an injection of the drug Phernergan manufactured by Defendant Wyeth, which can be injected intramuscularly or intravenously (IV-push), or put into an IV-drip. The drug is corrosive and causes irreversible gangrene if it enters a patient’s artery. While administering the IV into Plaintiff’s vein, the drug somehow entered into an artery (either because it penetrated an artery or escaped the vein and mixed with arterial blood). Consequently, Plaintiff’s forearm had to be amputated. After settling medical malpractice claims, Plaintiff brought common law negligence and strict liability claims for failure to provide an adequate warning of the risks of the drug. The FDA approved Defendants label in its new drug application, as well as in a subsequent revision of the labeling. The trial court jury found in favor of Plaintiff and awarded damages and disregarded Defendant’s preemption arguments. The Vermont Supreme Court affirmed because federal labeling requirements create a âfloor, not a ceilingâ for state regulation and Defendant could have provided an additional warning for IV-push administration.
Issue. If a drug meets the labeling requirements of the FDA, does that give rise to federal preemption of state law regarding inadequate labeling?
Held. No, state common law claims do not provide an obstacle to the accomplishment of Congressional purposes in the FDCA.
Discussion. Â [Justice Stevens] Defendant raised two arguments in favor of FDA preemption: a) impossible for it to comply with both state-law duties and federal labeling regulations, because the latter forbids it from changing its label without FDA approval; and b) allowing states to require stronger warnings creates an unacceptable âobstacle to the accomplishment and execution of the full purposes and objectives of Congress,â because it substitutes a lay jury’s decision about drug labeling for the expert judgment of the FDA.
The Court noted that in all preemption cases, the ultimate touchstone is the purpose of Congress, particularly where Congress has legislated in a field which the States have traditionally occupied. However, this must be balanced against the powers of the States, which shall not be superseded by a federal act unless that was the clear and manifest purpose of Congress.
Defendant’s âimpossibility preemptionâ argument that it cannot change its label after FDA approval is off-base, as there exists an FDA regulation (âchanges being effectedâ or âCBEâ) which allows a manufacturer to make certain changes to its label that âadd or strengthen a contraindication, warning, precaution, or adverse reactionâ or to âadd or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product.â Defendant misplaces responsibility on the FDA, whereas it is always the manufacturer’s responsibility to craft an adequate label and ensure that its warnings remain adequate as long as the drug is on the market. Moreover, the FDA retains authority to reject CBE changesâso absent evidence that the FDA would not have approved a change to the drug’s label, it was not impossible for Defendant to comply with both federal and state requirements here.
The argument that the state law duty obstructs the FDA regulation holds no merit, and is an overbroad view of an agency’s power to preempt state law. If Congress thought state claims posed an obstacle to its objectives, it could have expressly preempted such claims. Citing Riegel, Congress only included a preemption provision which relates to medical devices, not prescription drugs. Its silence and knowledge of state tort litigation must mean that Congress did not intend FDA oversight to be the only means of ensuring drug safety.
The FDA’s opinion (in its 2006 agency preamble) that state law frustrates the agency’s implementation of its statutory mandate does not merit deference either, because the Court has never deferred to an agency conclusion regarding preemption. Furthermore, the FDA for decades has relied on state tort claims to assist in uncovering unknown drug hazards and provide incentives to disclose safety risks promptly. The longstanding coexistence of state tort law and FDA regulation clearly undercuts the FDA’s recent change of heart.