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.
The Solicitor General argued that the promulgation of the Federal Motor Vehicle Safety Standard (FMVSS) 208 embodied a policy judgment that safety would be best promoted if manufacturers installed alternative protection systems in their fleets rather than one particular system in every car.View Full Point of Law
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. [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 obstacle to the accomplishment and execution of the full purposes and objectives of Congress, 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 However, this must be balanced against the powers of the States, which shall not be superseded by a federal act unless that was the clear and manifest purpose of Congress.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 impossibility preemption argument that it cannot change its label after FDA approval is off-base, as there exists an FDA regulation (changes being effected or CBE) which allows a manufacturer to make certain changes to its label that 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. 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 changes”so 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.