Fosamax is a drug used to treat osteoporosis that is manufactured by Merck. The drug works by inhibiting bone loss, but also, in the process, it slows bone repair. Over time, that can lead to bones breaking due to normal, everyday activities. Those fractures are called atypical femoral fractures (AFF). Merck sought to update the warning labeling on Fosamax to include the risk of AFFs, but the FDA twice rejected the proposed label as misleading.
Merck was sued in state court by a group of patients who suffered AFFs while on Fosamax. While the FDA regulates drug approval and labeling at the federal level, that doesn’t mean state court systems don’t also play a role. The relevant constitutional question, however, is whether the FDA has “preempted” state-law tort claims, such as the failure-to-warn claim alleged here. FDA preemption means that federal law overrides state law and can extinguish a tort lawsuit in state courts. Merck argued that the FDA’s rejection of Merck’s proposed warning labels as misleading should preempt the failure-to-warn tort claims because the FDA would have also rejected an accurate label at the time. The Third Circuit didn’t agree, however, and rightly held that speculation about what an agency would have done should not be allowed to preempt state tort law.
The Supreme Court took Merck’s appeal, and Cato has filed an amicus brief in support of the injured patients. We argue that merely possible agency actions should not be allowed to preempt state law because such actions are not “Laws of the United States” under the Supremacy Clause of Article VI. The Supremacy Clause says that the “the Laws of the United States which shall be made in Pursuance” of the Constitution shall be the “supreme Law of the Land.” As the original sovereigns in our constitutional system, states retain broad powers over their tort systems, and Congress has repeatedly said federal drug laws would preempt state laws only when they’re in “direct and positive conflict.” State laws should not be preempted by inapt speculation about what an agency would have done in different circumstances. Something an agency might have done is not only not in “direct and positive” conflict with state law, it is not a “Law” under the Constitution. We also argue that allowing speculative agency actions to preempt state law would encourage drug companies to create delays by proposing inadequate warnings designed to be rejected, creating a win-win for drug companies but a lose-lose for state law and the consumers such law seeks to protect.