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August 14, 2018

Legal Liability of Generic vs Brand Drug Manufacturers for Inadequate Product Labels

Author Affiliations
  • 1Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts
  • 2Program on Regulation, Therapeutics, and Law (PORTAL), Brigham and Women’s Hospital, Boston, Massachusetts
  • 3Deputy Editor, JAMA, Chicago, Illinois
JAMA. 2018;320(6):547-548. doi:10.1001/jama.2018.8408

Massachusetts is the latest of state highest courts to address the issue of “innovator liability”: brand-name pharmaceutical manufacturers who are exposed to legal liability for generic forms of their brand products that cause injuries to consumers. In Rafferty v Merck & Co Inc (2018),1 the Massachusetts Supreme Judicial Court addressed a claim against Merck based on failure to warn of an adverse drug effect brought by a patient, Brian Rafferty, who took finasteride, a generic version of Merck’s brand-name drug Proscar. Generic finasteride was prescribed to the plaintiff to treat an enlarged prostate. Almost immediately after starting the drug, Rafferty experienced symptoms of erectile dysfunction and decrease in libido, and despite weaning of finasteride, the symptoms persisted. The product label for finasteride warned of the potential adverse effect of sexual dysfunction but also reported that it would resolve if the drug were discontinued. Rafferty alleged that Merck had information in its possession that the adverse effect could persist even if the drug were discontinued and had even changed the label for Proscar in several non-US markets but failed to do so in the United States. The legal question in the case is: Should brand companies be held liable for harm resulting from a generic counterpart that they did not produce?