New Hampshire law applies a hybrid design-defect standard that imposes liability for harm caused by a drug product if the drug product, in light of the manufacturer’s warning on the label, is unreasonably dangerous. Does such a framework avoid federal preemption issues that have doomed failure to warn negligence claims premised on taking allegedly dangerous generic pharmaceuticals? That was the question addressed by the Supreme Court at oral argument in Mutual Pharmaceutical Co. v. Bartlett, the third in a trilogy of cases addressing preemption of state tort claims against drug manufacturers based on federal laws mandating prescription drug labeling requirements. While several justices appeared uncomfortable with the possibility of creating a system that allowed for FDA approval to serve as both a ceiling and a floor for generic drug liability, overall it appeared that the Court would find preemption, consistent with the defendant and Solicitor General’s arguments.

Three years ago in Wyeth v. Levine, the Court held that a state law failure-to-warn claim related to a branded pharmaceutical was not preempted federal drug laws. The next year in a 5-4 decision, the Court held in PLIVA, Inc. v. Mensing that a negligence claim for failure to warn by a generic manufacturer was preempted by federal law because the Hatch-Waxman Act (which sets up the generic pharma framework) allowed for no discretion in what a generic pharmaceutical manufacturer can put on its label.

Mutual comes to the Supreme Court after the First Circuit upheld a New Hampshire Federal District Court’s jury verdict premised on the finding that a generic version of sulindac was unreasonably dangerous. The arguments before the Court centered on whether a design defect claim was somehow different from a failure to warn claim, and therefore merited a different result than the one reached in PLIVA.

The defendants argued that this was a distinction without a difference, as the jury instructions stated that if the jury found that the drug was unreasonably dangerous, then the jury was required to look the label to determine whether the warning sufficient or not. Because the warning on the label was critical to the case, the defendants argued, the case is controlled by PLIVA.

The Solicitor General, as amicus, largely agreed with the defendants and stated that “when the State is imposing an obligation, they do it based on a safety standard — that is in fact second-guessing the FDA — that is preemptive.” At base, the Solicitor General’s position is that, in the absence of new and scientifically significant evidence not considered by the FDA, FDA’s approval of a drug preempts design defect claims because federal law prevents a drug company from changing the design after it was approved by FDA. Importantly, FDA, as amicus, filed a brief consistent with the position taken by the Solicitor General.

Plaintiffs attempted to distinguish PLIVA by arguing that the New Hampshire hybrid framework did not take into account the warning in the same way as PLIVA, because the New Hampshire instructions mandated that the jury first determine whether there was an “unreasonable danger” and only then was the jury allowed to consider whether the warning minimized risk. The Court struggled with where and to what extent the sufficiency of the drug’s warning label entered into the case. Plaintiff argued that while it was a “factor” to consider it was not an “element” of the claim.

Our Insight.  Your Advantage.  While likely a close case, Justice Breyer, who dissented in PLIVA seemed troubled by the plaintiffs’ position as it would apply to dangerous but necessary drugs such as chemotherapy drugs. When combined with the five justices in the majority in PLIVA (Chief Justice Roberts and Justices Scalia, Thomas, Alito, and Kennedy), it seems likely that the Court will extend PLIVA, consistent with the Solicitor General and the defendant’s position.