By Chris Battiloro (Syracuse College of Law Class of 2019)
https://www.jdsupra.com/legalnews/legal-black-holes-proliferate-after-73441/https://www.jdsupra.com/legalnews/rafferty-v-merck-expands-potential-17387/
On March 16, 2018, Massachusetts’s Supreme Judicial Court, the highest court in the state, issued a ruling that will likely increase product liability exposure for pharmaceutical companies within the state. In Rafferty v. Merck, the court ruled that a consumer was not permitted to bring a simple negligence claim against a brand-name manufacturer on the basis of a failure to warn. However, a consumer was permitted to bring a failure to warn claim, against a brand name manufacturer, if it could show that the manufacturer intentionally failed to update one of its drug labels. The consumer would have to show that the manufacturer had reckless intent; meaning, they knew or had reason to know“ of an unreasonable risk of death or grave bodily injury associated with its use.” This imposes a higher standard of proof than a mere negligence claim.
In Rafferty, the plaintiff, Brian Rafferty, was prescribed finasteride to treat an enlarged prostate. Rafferty began taking finasteride, which is the generic version of the brand-name drug Proscar; a drug manufactured by Merck & Co, Inc. At the time Rafferty was prescribed finasteride, the label warned for potential side effects, but informed these side effects would subside after discontinuing use. Rafferty began experiencing symptoms and started weaning himself off the drug, but instead of improving his symptoms continued to worsen. Subsequently, he was diagnosed with hypogonadism (gonad failure) and androgen deficiency. Plaintiff alleged that, at the time he had been prescribed finasteride, several studies and reports had been released stating that side effects could, in fact, persist after ceasing use.
This case differed from other duty to warn cases because of the Hatch-Waxman Act; a federal law which established the modern system of generic drug regulation. The Hatch-Waxman amendments require that the warning label of a generic drug be identical to the warning label of its brand-name affiliate.
While the Rafferty decision is in the minority of most courts who have ruled on this issue, the Massachusetts court wished to provide balance to the Pliva Inc. v. Mensing Supreme Court ruling. The Plivacase established that generic drug makers could not be sued for failing to warn about potentially dangerous side effects as their labels are only required to match their brand-name equivalent. Moreover, the court forbids generic drug manufacturers from independently revising their warning labels and creating contradicting warnings. Thus, the ruling of the Massachusetts case bridged a gap that now holds brand name manufacturers liable for recklessly failing to warn users of the generic drug’s associated risks.
As a matter of public policy, the Supreme Court concluded permitting generic drug consumers to bring general negligence claims, on a theory of failure to warn, posed too great of a risk for pharmaceutical innovation. However, they also concluded public policy would be harmed if generic drug consumers had no remedy for failure to warn cases resulting in death or grave bodily injury. Thus, the reckless intent standard strikes an appropriate balance between the competing public policy interests.