Thursday, March 21, 2013
The Supreme Court heard oral arguments earlier this week in Mutual Pharmaceutical v. Bartlett, a case testing whether the federal Food, Drug, and Cosmetic Act (and in particular the Hatch-Waxman Act) preempts a state design-defect claim against a generic drug manufacturer.
The case is important because of the large and increasing role that more affordable generics play in the prescription drug market. But as Justice Kagan pointed out early in the argument, the case may also affect branded drugs. That's because both branded and generics need to get FDA approval for new or changed formulas, and yet they both could be subject to state-law design-defect claims, as in this case. If so, depending on the nature of the state law claim, the state court ruling could set a different standard than the FDA standard--making it impossible for a manufacturer, branded or generic, to comply with both. But again: that depends on the nature of the state-law claim.
Recall that the Court just two years ago ruled in PLIVA v. Mensing that the FDCA did preempt a state failure-to-warn claim against a generic manufacturer. The reason: Under the FDA's process for generic approval (under Hatch-Waxman), a generic has to bear the same label as its branded counterpart. Under the federal FDCA, the generic has no control over the label, and so the Court said that it can't be held to a higher labeling requirement under state tort law. In other words, the requirement under federal law (to bear the same label as its branded counterpart) conflicted with duties set by the state tort suit (to include different warnings).
But that was a failure-to-warn claim. Bartlett involves a design-defect claim, going to the generic's design, not (or maybe not) its label.
Still, the label was one sticking point, maybe the most important sticking point, at argument this week. The justices struggled to figure out whether the plaintiff's design-defect claim turned at all on faulty labeling. (If it did, the case would more likely be governed by Mensing, and the claim more likely to be preempted.) The plaintiff argued that the trial court judge carefully distinguished between considering the label for its adequacy as opposed to its effectiveness. According to the plaintiff, the judge ruled out the former consideration, because the defendants waived a defense that would have turned on adequacy. Moreover, according to the plaintiff, the label's effectiveness goes to limiting the danger of an inherently dangerous drug--and is therefore not a consideration of labeling in its own right, but rather a consideration of labeling as related to a pure design-defect claim. It's not clear that the Court bought this distinction, however, and the defendant argued strenuously against it.
Another and related sticking point was the nature of the state design-defect claim. Was it a pure strict liability claim, in which the plaintiff simply received compensation for injuries resulting from an inherently dangerous drug? If so, the claim operated more like a drug compensation fund, and even the defendant said there was no preemption. That's because the defendant could comply with both the federal requirements for generics and the state duty to pay. Stated differently, the state tort suit wouldn't set a new standard of care; instead, it would simply require compensation. But if the label was relevant to the design-defect claim--and if, as the Court held in Mensing, the defendant had no control over the label--the state tort suit could be understood as setting a new standard (in the same way the failure-to-warn claim did in Mensing)--and the FDCA would preempt.
Yet another sticking point was the FDA approval process as opposed to the process of state-court juries. The FDA puts new drugs through a rigorous ringer to weigh the costs and benefits before approval. But state court juries grant damage awards based on the judgments of a handful of lay individuals. The question is: If the FDA approves a drug and thus its counterpart generic--based on thorough and expert cost-benefits analyses--why should a state court lay jury be able to second-guess and even overrule it?
The Court divided 5-4, along conventional ideological lines, in Mensing. That seems like a plausible, even likely, result here, too.