McNeil Brings Failure-to-Warn Preemption Issue to Supreme Court

Dec 09, 2010   

McNeil, the manufacturer of Tylenol Cold, has asked the U.S. Supreme Court to decide whether federal law, which imposes certain requirements for labeling on makers of over-the-counter (OTC) drugs, preempts state law thereby precluding product liability actions for failure-to-warn. The case originated in 1999, when sixteen year old Armando Valdes suffered a heat stroke during a roller hockey game after ingesting McNeils product, along with a caffeinated beverage, earlier that morning. Having suffered permanent disability in connection with this incident, the Valdes family brought suit against McNeil under a state law failure-to-warn theory.
The suit alleged that McNeil was negligent and/or strictly liable for failing to warn of the increased risks involved with taking the product when ingested with caffeinated drinks and coupled with strenuous physical activity. While the Miami-Dade County Circuit Court granted summary judgment in favor of McNeil, finding federal law impliedly preempted state law products liability actions in this context, the Third District Court of Appeal reversed this ruling. Found here, the Third District found that the Federal Food, Drug, and Cosmetic Act (the FDCA) neither expressly nor impliedly preempted state law and that the Supreme Courts recent decision in Wyeth v. Levine was controlling.

In Wyeth, the Court found that the FDCAs provisions for prescription drugs did not preempt state law failure-to-warn claims because Congress did not expressly preempt such claims in the revisions to the Act. The Supreme Court reasoned that because Congress expressly provided for such preemption in the case of medical devices, any failure to include the same for other types of products was not due to oversight. This is the reasoning that the Third District used in reaching its decision concerning preemption and OTC drugs.

In its recent petition for certiorari filed with the Supreme Court, the drug manufacturer argues that the Third District Court of Appeal erred in failing to consider that the product in Wyeth was a prescription drug. Rather, McNeil argues that Wyeth is distinguishable because McNeils product, Tylenol Cold, is an OTC drug and thus subject to different provisions under the FDCA. As McNeil argues, the granting of its petition would enable the Supreme Court “to resolve the overbroad and conflicting application of Wyeth” and decide whether Congress, by adopting less stringent processes for OTC drugs when compared to prescription drugs, intended to preempt state law failure-to-warn claims.

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