Several U.S. Supreme Court justices questioned Tuesday whether the importance placed on a generic drug's warning label at trial suggests design defect claims against its manufacturer are preempted by federal law, in a high-stakes showdown over generic-drug makers' liability for users' injuries.
The high court heard argument in Mutual Pharmaceutical Co. Inc.'s challenge to a $21 million jury award for plaintiff Karen Bartlett, who suffered a near-fatal reaction after taking the generic anti-inflammatory drug sulindac. The case centers on whether the court's Mensing ruling, which held that federal law preempts state-law failure-to-warn claims against generics makers, extends to design defect claims.
The court's justices peppered the attorneys for Mutual and Bartlett with questions about the role played by the warning for sulindac at trial. Justice Elena Kagan noted that the adequacy of the warning was raised in expert testimony, the judge's jury instructions and closing statements before a New Hampshire federal jury.
"There's just, all over, this stuff about adequacy of the warning, which does suggest that this is sort of within the four corners of Mensing," Justice Kagan said.
Justice Stephen Breyer added that Bartlett's complaint repeatedly referenced the inadequacy of the warning for sulindac. Justices Breyer and Kagan were two of the four judges who dissented in the Mensing decision. Much of the questioning during the hourlong session came from the two justices and their fellow Mensing dissenters, Justices Sonia Sotomayor and Ruth Bader Ginsburg.
Kellogg Huber Hansen Todd Evans & Figel PLLC partner David Frederick, the attorney for Bartlett, maintained the allegations were not preempted because the design defect claim was not tied to Mutual's warning for the drug.
The day before the trial started, Mutual abandoned its so-called comment k defense, which holds that a company sold an unsafe drug but adequately warned of its risks, Frederick said. The judge told the jury it was not to decide the adequacy of the warning, according to Frederick. In fact, the jury's consideration of the warning could only benefit Mutual, because "liability was going to be found in spite of the warning and not because of the warning," he said.
Jay Lefkowitz of Kirkland & Ellis LLP, the attorney for Mutual, contended the case presented a "classic case of impossibility preemption," meaning Bartlett's claims are preempted because Mutual could not possibly comply with both state and federal law. In upholding the jury award, the First Circuit had ruled the claims were not preempted because, even if Mutual couldn't change the drug's labeling and design, it could decide to stop selling the drug.
Justice Kagan pointed out that Lefkowitz said federal law "authorizes" drugmakers to market drugs. It is possible for someone to comply with state and federal laws that appear to conflict when the federal law only authorizes, or permits, an activity, she said. By contrast, impossibility preemption comes into play when the federal law requires an activity or gives a company the right to perform an activity, according to Justice Kagan.
Later, when Frederick was speaking, Justice Samuel Alito presented a hypothetical in which the U.S. ordered that cars nationwide stay on the right side of the road, but New Hampshire ordered that cars in the state stay on the left. When he asked Frederick whether such a scenario was an example of impossibility preemption, Frederick replied that it was.
"But you could comply with both rules by not driving," Justice Alito said.
A few minutes later, Frederick said that Mutual and the federal government, which joined the drugmaker in contending Bartlett's claims were preempted, were arguing for obstacle preemption, which holds that state-law claims are preempted where they create an obstacle to lawmakers' intentions in enacting a federal statute, in addition to impossibility preemption. But Mutual waived obstacle preemption because it asked the court only to review whether it was impossible to comply with both state and federal law in Bartlett's case, he said.
Frederick told Law360 after the hearing that he believed the justices asked tough questions of both sides.
"They shouldn't [find] preemption, because there's no duty to change the warning under New Hampshire liability law. I hope they understand that," he said.
Mutual is represented by Jay Lefkowitz, Michael McConnell, Michael Shumsky and John Crisham of Kirkland & Ellis LLP.
Bartlett is represented by David Frederick, Brendan Crimmins and Joshua Branson of Kellogg Huber Hansen Todd Evans & Figel PLLC; Keith Jensen of Jensen & Associates PLLC; and Steven Gordon and Christine Craig of Shaheen & Gordon.
The case is Mutual Pharmaceutical Co. Inc. v. Bartlett, case No. 12-142, in the U.S. Supreme Court.
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