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Brand-Name Pharmaceutical Companies Can Be Liable to Generic Drug Users for Recklessly Providing Inadequate Warnings on Brand-Name Drugs

Chief Justice Ralph D. Gants of the Supreme Judicial Court of Massachusetts wrote for the Court on March 16, 2018 that a generic drug user’s negligence claim against Merck had been properly dismissed by the Judge Kenneth J. Fishman of the Middlesex County Superior Court.

Brian Rafferty had been prescribed the generic version of Merck’s brand-name drug Proscar, which was a finasteride for treatment of his enlarged prostate. However, Rafferty developed side effects that included hypogonadism and erectile dysfunction. He asserted that Merck’s warnings on its own drugs, which warnings had been used for the generic drug as well, were inadequate.

In 2011, the U.S. Supreme Court decided in Pliva Inc. v. Mensing that product liability and other claims against generic drug manufacturers were preempted by federal law mandating they copy brand-name warning labels. Thirty-six other courts have ruled that brand-name manufacturers were not liable for claims arising from generic products.

The Massachusetts Supreme Court held that a brand-name manufacturer could not be held liable under a negligence theory for failure to warn with respect to a generic drug user. However, the Court determined that if properly amended, a claim could be brought against a brand-name manufacturer for common-law recklessness if it intentionally failed to update the drug label, despite knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with the drug's use. The Court noted that the benefits of imposing that liability outweighed the risks and provided financial incentive for brand-name drug manufacturers to revise warning labels. 

Lexis Advanced subscribers can access the full opinion at:   Rafferty v. Merck & Co., 479 Mass. 141, 2018 Mass. LEXIS 161

Lexis subscribers can access the full opinion at:  Rafferty v. Merck & Co., 479 Mass. 141, 2018 Mass. LEXIS 161

Author:  Sheri Steinmetz, Lexis-Nexis Case Law Editor


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