Massachusetts Superior Court Rejects “Innovator Liability” Failureto-Warn Claim, Holds Branded Pharmaceutical Manufacturer Owed No Duty to Plaintiff Alleging Injury From Equivalent Generic Drug That Copied Defendant’s Labeling But Defendant Did Not Make Or Sell -

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.