Once again, generic drug makers have Kirkland & Ellis partner Jay Lefkowitz to thank for closing off one of the few remaining avenues for plaintiffs to bring product liability claims against them in state court.
On Monday, almost two years to the day after the U.S. Supreme Court ruled 5-4 in Pliva v. Mensing that generic drug makers are exempt from state tort lawsuits accusing them of failing to provide adequate warning labels on their products, the same five justices handed another victory to Lefkowitz and the generic drug industry. In Monday's ruling in Mutual Pharmaceutical Co. v. Bartlett, the Supreme Court extended Mensing to cover state design defect claims against generics, reversing a 2012 decision from the U.S. Court of Appeals for the First Circuit.
In doing so, the Supreme Court also vacated a $21 million New Hampshire verdict in favor of Karen Bartlett, a woman who claims that generic sulindac, an anti-inflammatory drug, caused her to sustain burns to over 60 percent of her body and left her almost completely blind. Bartlett was represented by Kellogg, Huber, Hansen Todd, Evans & Figel; Shaheen & Gordon; and Jensen & Associates.
Writing for Chief Justice John Roberts and Justices Antonin Scalia, Anthony Kennedy, and Clarence Thomas, Justice Samuel Alito concluded that Bartlett's lawyers were merely bringing forth a failure-to-warn case under the guise of a design-defect claim. Holding that all state law design-defect claims "that turn on the adequacy of a drug's warnings are preempted by federal law under Mensing," Alito found that Mutual was in an impossible situation. On the one hand, federal statute required Mutual to produce generic drugs that were identical to their brand name counterparts in both chemical composition and packaging. On the other hand, New Hampshire state law required Mutual to make its warnings more conspicuous or else it would face liability under state design defect products liability laws. Because it would have been impossible for Mutual Pharmaceutical to strengthen its warnings without altering its label in violation of federal law, Alito held that the New Hampshire law was preempted.
Bartlett's lawyers had argued that Mutual could have avoided this problem by pulling its product from the shelves once it realized it was selling a potentially dangerous drug. Alito, however, found that this argument was irrelevant, and he noted that the court turned down the same argument in Mensing.
"[Bartlett's] situation is tragic and evokes deep sympathy, but a straightforward application of pre-emption law requires that the judgment below be reversed," Alito wrote in Monday's 53-page opinion.
In a dissent, Justice Sonia Sotomayor, who was joined by Justice Ruth Bader Ginsberg, criticized the court for extending Mensing and giving pharmaceutical companies license "to sell a federally approved drug free from common-law liability." In a separate dissent, Justice Stephen Breyer, joined by Justice Elena Kagan, agreed with Bartlett's argument that Mutual could have decided not to sell its product in New Hampshire.
Kirkland's Lefkowitz told us Monday that the decision was the only logical outcome. "Fundamentally, the regime Congress created requires generic drugs to be the same as their brand equivalents," said Lefkowitz. "To have generic drugs alter their labels unilaterally would cause tremendous confusion." Lefkowitz also said that, between Bartlett and Mensing, the Supreme Court reinforced the notion that the Food and Drug Administration, not states, have exclusive authority to determine the safety and efficacy of drugs.
David Frederick of Kellogg Huber, who argued for Bartlett before the high court, did not respond to a request for comment.
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