On Tuesday, March 19, 2013, the Supreme Court heard arguments on the question whether state law can require drug makers to compensate patients injured by drugs that the Food and Drug Administration (FDA) has approved. Would such a requirement make it impossible for the manufacturer to comply with both state and federal law or allow juries to second-guess the judgment of the FDA?
The Injuries and the Evidence
In 2004, Karen Bartlett’s doctor prescribed Clinoril®, a brand name non-steroidal anti-inflammatory drug (NSAID), to relieve shoulder pain. Her pharmacist substituted sulindac, a generic version of the drug. In 2005, the drug caused Bartlett to suffer Stevens Johnson Syndrome and a related disease, toxic epidermal necrolysis (SJS/TEN); more than 60 percent of the outer skin layer on the surface area of her body was deteriorated, burned off, or an open wound, twice the percentage required for a TEN diagnosis. It was established that SJS/TEN was a rare side effect of sulindac.
The trial court limited Bartlett’s case to the theory that sulindac was unreasonably dangerous because of defective design. It ruled that the adequacy of the warning label was relevant only to limit or mitigate the risk. The FDA had approved sulindac as safe and effective, but Bartlett’s expert pharmacologist/toxicologist testified that sulindac presented a greater risk of SJS/TEN than other NSAIDs and that its safety profile was similar to another generic NSAID withdrawn in 2005.
The Manufacturer’s Case
Mutual Pharmaceutical Co., Inc. (Mutual), the manufacturer, chose not to present any evidence in its defense. Rather, Mutual cross-examined Bartlett’s experts and raised legal defenses. Its primary defense was preemption, i.e., that the Food, Drug and Cosmetic Act (FD&C Act) superseded state tort law, so that the FDA’s approval barred Bartlett’s claims. The trial court rejected the preemption defense, following the Supreme Court’s March 2009 ruling in Wyeth v Levine, which held that FDA approval does not protect the manufacturer of a brand name drug from liability under state tort law. It also it refused to set aside the jury’s verdict finding that the drug was defective because the risks outweighed the benefits.
The Changing Law
The Supreme Court’s decisions on the preemption of state law tort actions against drug manufacturers changed the law again after the trial. In PLIVA, Inc. v Mensing, the Court held that manufacturers of generic drugs could not be held liable for failure to provide adequate warnings because the FD&C Act required them to use the labels approved by the FDA. Only the brand name manufacturer could change the label before the FDA approved the change. Because it was impossible for the manufacturer to comply with both federal law and state law requiring better warnings, the federal law preempted state law.
The Supreme Court Arguments
Oral arguments focused on preemption, primarily whether it was impossible for the generic maker to comply both with state and federal law. The manufacturer and the FDA argued that Mensing controlled the decision because the inadequacy of the warning was the heart of Bartlett’s case. Justice Sotomayor asked whether Mensing preempted tort actions based on defective design, where the inadequate warning was not an essential element of the plaintiff’s case. Mutual’s counsel would not accept that premise. However, Justice Sotomayor questioned whether the brand name and the generic manufacturers were in the same position with respect to the design of the drug.
Justices Ginsburg and Alito both focused on the premise that the New Hampshire law imposed strict liability on the manufacturers. Would it be impossible to comply if the effect of state law was to require them to pay for the harm their drugs caused whether or not they were at fault, to “spread the cost”? Chief Justice Roberts asked similar questions of the FDA’s counsel, who supported Mutual’s arguments, perhaps indicating that the Court would not consider a requirement to pay damages as a duty conflicting with federal law.
The FDA’s Role
The Court asked the FDA’s counsel whether states could impose any legal duty at all with respect to dangerous drugs. Counsel argued that the FDA approval shielded the makers from liability and that juries should not be allowed to second-guess the FDA. A brand name manufacturer could not be held liable unless new scientific evidence showed that the brand name drug maker should have made changes to the label. However, he conceded in response to questions that in a case not involving labeling, both the brand name and the generic makers could be sued.
Counsel for the plaintiff contended that the state law duty was not to change the design or the label of the drug, but not to market the drug at all if the risks outweighed the benefits and caused egregious injury. He emphasized that Mutual had chosen not to present any evidence of the benefits of the drug in this case, so that it had waived the argument that the drug was unavoidably unsafe. He noted that the jury’s verdict would not prevent Mutual from presenting evidence of the benefits of the drug in other cases.