The United States Court of Appeals for the Seventh Circuit recently clarified, in its decision in Robinson v. McNeil Consumer Healthcare, 2010 WL 3156548, No. 09-4011 (7th Cir. Aug. 11, 2010), a defense left open by the Supreme Court of the United States last year in Wyeth v. Levine—implied preemption of state law when the FDA has expressly rejected a proposed warning. The Supreme Court suggested in Levine that a drug manufacturer can establish that it is impossible to comply with inconsistent federal and state regulations if it proves by clear evidence that the FDA would not have approved the change to the warning that a plaintiff suggests would have prevented her injury. Robinson clarifies that defense.

Levine involved a failure-to-warn claim in which a Vermont jury had awarded a $7.4 million verdict to the plaintiff. The Supreme Court affirmed, holding that neither FDA approval of a drug’s label, specifically, nor the labeling regime created by the Food, Drug, and Cosmetic Act, generally, preempted a state-law claim of failure to warn. 129 S. Ct. 1187, 1191 (2009). The Court also stated that a drug manufacturer cannot prove impossibility of compliance with both state and federal regulation “absent clear evidence that the FDA would not have approved a change to [the drug]’s label.”

Robinson is an important decision because it clarifies that rejection by the FDA of a proposed change to a drug label is “clear evidence” that compliance with inconsistent federal and state regulations is impossible. The case involved a failure-to-warn claim about Children’s Motrin in which the plaintiff alleged that she experienced an allergic reaction to the ibuprofen in the drug and developed toxic epidermal necrolysis (TEN), “a rare but life-threatening disease that causes severe blistering and consequent sloughing off of skin over much of the body,” and Stevens-Johnson syndrome (SJS). The plaintiff argued at trial that the drug label, which warned that the drug could cause “a severe allergic reaction which may include: hives, facial swelling, asthma (wheezing), shock,” should have included “rash” as a possible allergic reaction and warned of SJS/TEN.

The Seventh Circuit affirmed a defense verdict. Most importantly, the court rejected the argument of the plaintiff that the failure to warn of SJS/TEN was an implied warranty that the drug would not cause SJS/TEN. Not only did the drug manufacturer not have a duty to “guarantee against every conceivable adverse consequence of taking the drug,” but also the manufacturer proved that it had no duty to warn against SJS/TEN because the FDA explicitly rejected a proposed warning about SJS/TEN. The court, citing Levine, stated that “a court cannot order a drug company to place on a label a warning if there is ‘clear evidence’ that the FDA would not approve it.” The clear evidence that the drug manufacturer presented was “the agency’s refusal to require a reference to SJS/TEN on the label of over-the-counter drugs containing ibuprofen, when it had been asked to do so in the submission to which the agency was responding.”  

Drug manufacturers should keep Robinson in their toolbox when litigating failure-to-warn cases. If the FDA has expressly refused to require the very warning that a plaintiff argues would have made the drug safer, implied preemption is a viable defense.