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Bar News - July 19, 2013

US Supreme Court Reverses NH Jury Award


With its June 24 decision in the case of Mutual Pharmaceutical Co. v. Barlett, the US Supreme Court reversed one of the largest jury awards in New Hampshire history.

Karen Bartlett of Plaistow, NH, suffered horrific injuries, including near blindness and burns over most of her body, in 2004 after taking a generic pain medication manufactured by Mutual Pharmaceutical Co. Barlett sued the company in federal court in Concord and was awarded $21 million in damages.

Mutual Pharmaceutical appealed, arguing in part that the doctrine of federal preemption should override New Hampshire tort laws, because the generic drug was made to the exact specifications as the FDA-approved brand name version. The First Circuit Court of Appeals upheld the jury verdict.

The case before the Supreme Court was set against the backdrop of two similar cases that came before it: Wyeth v. Levine, in which the court ruled that manufacturers of brand name drugs could be held liable in state courts for inadequate drug warnings, even if the labels used were approved by the FDA; and PLIVA Inc. v. Mensing, in which it ruled that generic drug manufacturers, which cannot legally change FDA-approved labels, are excluded from liability in state courts in claims related to inadequate warnings.

The decision in Mutual Pharmaceutical echoed the PLIVA decision, with the court ruling 5-4 that the pharmaceutical claim could not be held liable for drug defects, because the composition of the generic version was the same as the brand name drug.

Bartlett’s attorney, David Frederick, contended that the Mutual case was different from PLIVA, because it relied on a claim of strict liability, according to analysis by Ronald Mann of Because the recovery did not depend on negligence, he argued, it should be regarded more as cost-shifting than conduct-altering, Mann wrote.

Mutual Pharmaceutical’s counsel, Jay Lefkowitz, argued that the New Hampshire tort depends on a finding that the product is “unreasonably” dangerous. Justice Alito, writing for the majority, honed in on Lefkowitz’s point. Mann writes: “Because the tort turned on ‘unreasonable’ danger, it involved an assessment of the product’s quality, not simply a shifting of the risks associated with the product. In the Court’s view, there were only three bases for assessing liability under the New Hampshire standard: that the product was not sufficiently beneficial to patients, that it was excessively dangerous, or that the warning was inadequate. Because the Court held in PLIVA that the generic manufacturer had no discretion to change any of those three product attributes, the Court held the claim pre-empted. Justice Alito buttressed

Mann also opined on the impact of the case.

“Presumably the most important jurisprudential impact of the case will be on the ‘impossibility’ doctrine of pre-emption. Bartlett had argued that it was not ‘impossible’ for the manufacturer to comply with both state and federal law – it could simply stop selling the product in New Hampshire,” he wrote. “The Court firmly rejected Bartlett’s argument, stating that prior cases ‘presume’ that the actor ‘is not required to cease acting altogether in order to avoid liability.’ In the Court’s view, a narrower reading would render the impossibility pre-emption doctrine ‘all but meaningless.’ As Justice Breyer emphasized in his concurrence, it certainly would have been reasonable under prior cases to reach the opposite conclusion on that point.”

Mutual Pharmaceutical Co. v. Bartlett was one of two federal preemption cases from New Hampshire considered by the US Supreme Court during its 2013 term. In the other case, Dan’s City Used Cars Inc. v. Pelkey, the justices found unanimously for respondent Robert Pelkey, whose Honda Civic was towed from his Manchester apartment complex and sold while he was ill. In that case, the High Court ruled that federal trucking regulations did not supersede Pelkey’s claim under state consumer protection laws.

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