Nearly two years ago, the Supreme Court ruled that manufacturers of generic drugs were immune from liability in "failure to warn" lawsuits in state courts, in part because under federal law, generics are powerless to have warnings or labels that are different from their brand-name counterparts.
On Tuesday, it was unclear whether the court would extend that protection from Pliva v. Mensing to generics manufacturers in a different kind of suit—namely a claim of harmful "design defects" in the generic drug. The stakes are high for generics, which account for more than 80 percent of all prescriptions.
Several justices seemed interested in distinguishing between the Mensing case and the one before them Tuesday: Mutual Pharmaceutical v. Bartlett. The suit was brought in a New Hampshire court by Karen Bartlett, who had a severe and debilitating reaction to generic sulindac, an anti-inflammatory drug. The case was removed to federal court, where she won a $21 million verdict after the judge rejected Mutual‘s claim that the suits were pre-empted by federal law.
The U.S. Court of Appeals for the 1st Circuit upheld the verdict and said the case differed from Mensing. It reasoned that, while generics must have the same labels as their brand-name counterparts, nothing would keep the generics companies from withdrawing an unsafe product from the market. As a result, the court said there was no federal pre-emption because it was not impossible for drug makers to abide by both federal and state law requirements.
At the Supreme Court Tuesday, Kirkland & Ellis partner Jay Lefkowitz, who won the case for generics in Pliva, ran into trouble as he argued that "there is no principled basis for treating design defect claims differently from failure to warn claims." Justice Elena Kagan seemed to pick up on the 1st Circuit’s reasoning, suggesting that approval of a drug under the federal Food Drug and Cosmetic Act "says you can sell this. But it does not say you must sell it." She added that under court precedents, "when a federal law permits something, typically, a state can do more if it wants to."
Chief Justice John Roberts Jr. made a similar point when Anthony Yang, assistant to the solicitor general argued on the side of generics manufacturers. Roberts suggested that a state could impose strict liability and force manufacturers to pay damages without being pre-empted by federal law. Both Lefkowitz and Yang asserted that the Mensing rule should apply.
"What we’re trying to do is preserve the FDA’s role here, not have juries second-guess on a case-by-case and state-by-state basis imposing different safety obligations on manufacturers," said Yang.
David Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel, represented plaintiff Bartlett. Frederick did not argue in Mensing, but has had a winning streak before the high court representing plaintiffs in other pharmaceutical and securities cases, among others. He asserted that Mensing notwithstanding, tort suits based on design defects were not pre-empted by federal law. "I don’t think anybody here can argue with a straight face that simply paying a judgment in strict liability is impossible in light of the federal regime." Frederick also cited another case he argued, Wyeth v. Levine, which allowed state lawsuits against brand-name drug manufacturers. "In Wyeth, I think six justices said there is no obstacle under the FDCA of having state law remedies to compensate injured patients."
The argument Tuesday also included another instance in which Justice Sonia Sotomayor’s intrusive style of questioning seemed to rankle. Sotomayor asked Yang several questions in rapid succession, interrupting his answers. "If I might just finish," Yang finally said to the justice. And Justice Antonin Scalia, sounding irritated, told Yang, "I would like to hear your answer."
Tony Mauro can be contacted at email@example.com.