In Rafferty v. Merck & Co., 2016 Mass. Super. LEXIS 48 (Mass. Super. Ct. May 23, 2016), plaintiff sued his prescribing physician and a pharmaceutical manufacturer for injuries allegedly suffered from use of the drug finasteride, the generic equivalent of a brand name medication manufactured by defendant. Plaintiff brought claims for negligence and violation of Mass. Gen. Laws Ch. 93A (the state's unfair and deceptive practices statute), alleging defendant failed to warn that sexual dysfunction was a potential side effect. Defendant moved to dismiss, arguing Massachusetts does not recognize an "innovator liability" theory that would extend a brand name, i.e., innovator, drug manufacturer's duty to warn beyond users of its product to individuals who use a generic equivalent that copies the manufacturer's labeling. 

The court acknowledged that this was an issue of first impression in Massachusetts. The court noted that the federal Food, Drug and Cosmetics Act ("FDCA") established an "onerous and lengthy" process for the approval of a new branded drug by the United States Food & Drug Administration ("FDA"), including approval of its label, while a chemically and biologically equivalent generic drug may be approved through an abbreviated process so long as its label follows that of the branded drug. And under the United States Supreme Court's rulings in PLIVA, Inc. v. Mensing, 564 U.S. 604, 613 (2011) (see July 2011 Foley Hoag Product Liability Update), and Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2476 (2013) (see July 2013 Foley Hoag Product Liability Update), failure-to-warn and design defect claims against generic manufacturers are preempted because the FDCA prohibits the manufacturer from departing from the FDA-approved branded drug's design and labeling, leaving the branded manufacturer as the only possible defendant. 

Against this background, the court concluded that holding defendant liable as an innovator would be inconsistent with fundamental principles of Massachusetts product liability law, under which a plaintiff must prove that the product he claims caused his injury is traceable to the defendant. Merely issuing instructions about how to use a category of products is too attenuated a relationship to warrant imposing liability. Although defendant generated the information used in the generic drug's warning label, defendant did not affirmatively supply that information to the generic manufacturer, which merely copied the information on its own. In addition, defendant's warning label could be analogized to a non-defective component part, and in Massachusetts manufacturers are not liable for a failure to warn of risks created solely by the use or misuse of their products with those of another manufacturer.

Further, looking to out-of-state case law, the court held that imposing liability would conflict with general principles of negligence law and public policy. Innovator liability would alter the relationship between brand name and generic drug manufacturers under the FDCA, and the FDA, not the judiciary, was best qualified to balance the policy considerations relevant to possible changes in this relationship. (Indeed, the court noted that that the agency was at that time considering amendments to FDA regulations that would allow a generic drug manufacturer to revise its label to depart from that of the branded manufacturer under certain circumstances). Lastly, negligence liability has historically followed control, and a branded manufacturer neither controls a generic manufacturer's conduct nor profits from its sales. Accordingly, the court granted defendant's motion to dismiss.

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