92 N.E.3d 1205
Mass.2018Background
- Plaintiff Brian Rafferty ingested generic finasteride and alleges persistent sexual dysfunction; he sued brand-name manufacturer Merck for failure to warn and under G. L. c. 93A.
- Rafferty did not take Merck’s brand drug (Proscar); under federal law generic labels must match the brand label.
- Rafferty alleges Merck knew or should have known of persistent adverse effects and had updated labels in foreign markets but not in the U.S.
- Trial judge dismissed Rafferty’s negligence and c. 93A claims on the ground Merck did not manufacture the drug that injured him and thus owed no duty.
- Appeal: whether a plaintiff injured by a generic drug can bring (a) a common-law negligence claim or (b) a G. L. c. 93A claim against the brand-name manufacturer that controlled the label.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether brand manufacturer owes common-law duty to users of generic drug for failure to warn | Merck controlled the generic label by law; thus Rafferty can sue Merck in negligence for failure to warn | Duty in products/liability and negligence should be limited to manufacturer of the product that caused the injury; imposing duty on brand would upset Hatch‑Waxman balance and chill innovation | A limited duty exists: brand may be liable only for reckless (not merely negligent) failure to warn of an unreasonable risk of death or grave bodily injury; negligence claim may proceed only if amended to plead recklessness |
| Whether G. L. c. 93A, § 9 claim lies against brand for failure to warn about a drug the brand did not advertise, offer, or sell | Rafferty contends Merck’s failure to warn is an unfair/deceptive act that caused his injury | Merck argues its alleged omission was not in the course of trade or commerce as to the drug Rafferty used | c. 93A claim dismissed: failure to warn a user of a drug Merck never advertised, offered, or sold is not conduct "in the conduct of any trade or commerce" under § 1(b) |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (federal preemption bars state-law failure-to-warn claims against generic manufacturers)
- Wyeth v. Levine, 555 U.S. 555 (state-law failure-to-warn claims can coexist with FDA regulation; federal scheme may supplement but not always preempt state law)
- Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (design-defect claims preempted where federal requirements prevent state-law compliance)
- Mathers v. Midland-Ross Corp., 403 Mass. 688 (manufacturer liability generally tied to the product made by that manufacturer)
- Mitchell v. Sky Climber, Inc., 396 Mass. 629 (a manufacturer cannot be held liable for risks created solely by another manufacturer's product)
- Jupin v. Kask, 447 Mass. 141 (general tort principle: duty owed to those foreseeably endangered; duty remains subject to public policy limits)