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From Products Liability Law Daily, March 19, 2018

Brand manufacturer could be liable for ‘reckless’ failure to update generic drug labeling

By Dietrich Knauth

Drug manufacturer Merck & Co., Inc. could be liable for failing to update a warning label that also applies to generic versions of its drug Proscar®, the Massachusetts Supreme Judicial Court ruled, finding that injuries could be covered by a common-law recklessness claim even if Merck did not manufacture the actual generic drug that a consumer had taken (Rafferty v. Merck & Co., Inc., March 16, 2018, Gants, R.).

Injury and suit. The consumer had sued Merck for negligence and failure to warn consumers about the possibility that Proscar, used to treat an enlarged prostate, could cause long-term erectile dysfunction. Although the consumer took a generic version of Proscar, he argued that Merck was liable because it controlled the warning label’s language under Food, Drug, and Cosmetic Act (FDC Act) regulations that require generic drugs to use the same labeling as their name-brand counterparts. The case was dismissed by a lower court, which found that Merck could not be liable because it did not manufacture the drug that allegedly caused the plaintiff’s injury. The plaintiff appealed, and the Supreme Judicial Court took the case on its own motion, bypassing the appeals court.

Generic drugs. Generic drug consumers are generally left without recourse for alleged injuries caused by inadequate or inaccurate labels, as generic manufacturers are not responsible for the labeling, and the original manufacturers are not responsible for the manufacture of generic drugs. The U.S. Supreme Court has held that state law claims against generic drug makers for failure to warn are preempted by federal drug regulations, which leaves consumers able to bring such claims only if they ingested a brand-name version of the drug. And once generic drugs are approved, they usually make up the vast majority of the market, meaning that relatively few consumers would have the ability to sue the original manufacturer, according to the decision.

Common-law recklessness. Seeking to strike a balance between protecting generic drug consumers and maintaining the FDC Act’s goals of encouraging new drug development and speeding the approval of generic drugs, the Massachusetts high court found that Merck could not be liable for negligence or failure to warn, but it could be liable for common-law recklessness. A simple negligence standard would leave drug makers too vulnerable to paying additional costs for products they no longer produce, extending liability long after the brand-name manufacturer has moved on to focus on other patented products, according to the court. The recklessness standard, on the other hand, requires consumers to show both intent and a substantially greater risk than is required for ordinary negligence, the court found. The recklessness standard protects both drug consumers and manufacturers by creating liability only for the most serious injuries and the most dangerous forms of conduct, according to the decision. The plaintiff’s case was remanded to the lower court, with instructions that he be allowed to amend his complaint to include claims that Merck acted recklessly in its failure to update the warning label.

The Massachusetts Supreme Judicial Court acknowledged that it was going against most other states’ courts in finding that brand-name manufacturers have a duty to warn consumers of generic drugs, and said that it was the only court to apply a recklessness standard to such claims. California’s Supreme Court also recently held that brand-name manufacturers could be liable for the warning labels on generic drugs [see Products Liability Law Daily’s December 27, 2017 analysis]. In that case, the California court ruled that Novartis could be liable for a generic label even after selling the rights to its brand-name version, on the grounds that it was reasonably foreseeable that the successor drug manufacturer could continue to use the same label that Novartis created. The California decision drew a dissenting opinion that called the majority decision "a more expansive, enduring liability on drug manufacturers than has been recognized elsewhere in tort law," one that could put the original manufacturer on the hook for negligent labeling in perpetuity.

The case is No. SJC-12347.

Attorneys: Emily E. Smith-Lee (SLN Law, LLC) for Brian Rafferty. Richard L. Neumeier (Morrison Mahoney LLP) for Merck & Co., Inc.

Companies: Merck & Co., Inc.

MainStory: TopStory WarningsNews DrugsNews MassachusettsNews

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