Some may have thought the preemption debate was settled last year by the US Supreme Court, but Johnson & Johnson's McNeil PPC unit hopes to persuade the justices to take a closer at a case involving the 1999 death of a 16-year-old boy, who had taken its Tylenol Cold med, and a Florida law that does not allow a drugmaker to unilaterally change its product labeling by adding a warning.
For those unfamiliar, preemption is the notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA unsuccessfully argued last year before the US Supreme Court that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. At issue was whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. The matter was decided in lawsuit brought against Wyeth by a Vermont musician named Diana Levine, who sued for inadequate labeling and won (background here).
In the J&J case, Armando Valdes collapsed during a roller hockey game after taking the McNeil over-the-counter-med, which contained pseudoephedrine, for a head cold, along with a caffeinated beverage, earlier that day. He suffered a heat stroke and cardiorespiratory arrest that caused brain injury and hypoxic ischemic encephalopathy. He was left Armando completely disabled, so he and his parents sued McNeil, contending the product increased the heart-related risks and heat-related illness" when combined with a caffeinated beveraged and athletic activity in a hot environment. The family contends McNeil’s failure to warn of the risks breached Florida law.
Initially, the case was dismissed in McNeil's favor. As the FDA Law blog notes, federal court in Miami decided it would have been "impossible" for McNeil to comply with federal regulations covering warning labels for OTC meds including pseudeophredine and state law findings. But last December, a federal appeals court reversed the decision, citing the Wyeth v. Levine case. McNeil, by the way, argued the circumstances were different, in part, because this involved an OTC med, not a prescription drug. And so now McNeil is asking the Supreme Court to decide.
Why? The drugmaker contends the Levine ruling was misapplied. "The appellate court in Valdes ignored the fact that prescription and OTC drugs are subject to different federal regulatory regimes," the drugmaker's attorneys wrote. "The appellate court failed to recognize that federal laws applicable to manufacturers of OTC products do not provide a mechanism similar to the CBE (changes being effected) procedure that would permit a manufacturer to unilaterally change the warnings on product labeling crafted by the FDA...Without preemption, OTC drug manufacturers would be deprived of the ability to rely on FDA’s directives as to matters that Congress delegated to the agency and that fall within the agency’s unique regulatory and scientific expertise” (read the petition here).
What do you think?
Should Preemption Extend To OTC Products?
- Yes (54%, 31 Votes)
- No (46%, 26 Votes)
Total Voters: 57