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On March 16, 2018, Massachusetts’s highest court , the Supreme Judicial Court, issued a ruling that we believe will increase the product liability risk exposure for pharmaceutical manufacturers in the state. In the case of Rafferty v. Merck & Co., SJC-12347 (March 16, 2018), the Supreme Judicial Court held that a user of a generic drug may not bring a simple negligence claim against the brand-name manufacturer for failure to warn, but the user could bring a failure to warn claim against the brand-name manufacturer if it could show that that the brand name manufacturer intentionally failed to update a label on its drug, “knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use.” The Supreme Judicial Court’s holding requires a plaintiff to show that the brand-name manufacturer’s actions were reckless, as opposed to only negligent, which is a more stringent standard to prove. The Court’s decision sought to balance protection for the consumers of generic drugs in light of the U.S. Supreme Court decision in Pliva Inc. v. Mensing,[1] while taking into account the burden on brand-name manufacturers. However, by its own admission, this latest decision from Massachusetts’s highest Court stands in the minority of courts that have ruled on this issue. The decision is an important one, however, because brand-name manufacturers can now be held liable to the users of the generic versions of its drug under a theory of reckless failure to warn. It will be interesting to see if other jurisdictions that have not addressed the issue will follow the Massachusetts high court.
Continue Reading Rafferty v. Merck Expands Potential Liability for Drug Manufacturers in Massachusetts