The Massachusetts Supreme Judicial Court on Friday said in a decision that Merck & Co. can be sued for recklessness in failing to update the labels of generic versions of their drugs.
The decision follows a similar one made in California that said brand-name manufacturers can be liable, though both these decisions depart from other recent rulings that would not hold brand-name sponsors responsible for labels of generic versions of their drugs.
But whereas the California decision
against Novartis brought up the issue of negligence, in Massachusetts, the decision hinged on whether Merck was reckless by intentionally failing to warn the consumer of known side effects of the drug and its generic version.
The court said it concluded that “allowing a generic drug consumer to bring a general negligence claim for failure to warn against a brand-name manufacturer poses too great a risk of chilling drug innovation, contrary to the public policy goals embodied in the Hatch-Waxman amendments. But we also conclude that public policy is not served if generic drug consumers have no remedy for the failure of a brand-name manufacturer to warn in cases where such failure exceeds ordinary negligence, and rises to the level of recklessness.”
Patti Zettler, associate professor of law at Georgia State University College of Law, explained to Focus
: “In short, this opinion does seem to align with the December decision out of California ... In both cases, the courts are trying to reconcile the fundamental idea in tort law that a manufacturer generally owes a duty only to individuals who use that manufacturer’s products, with the reality that strictly applying such a rule would leave patients who are injured by generic drugs very little, if any, recourse, because their claims against generic drug manufacturers are often preempted.”
The decision also puts the US Food and Drug Administration (FDA) back in the spotlight as it has pushed back the finalization of a rule
to require generic drugmakers to update their labels when new information becomes known. But the finalization of that rule isn’t expected to be resurrected in the next year and the generic drug industry has pushed for FDA to pull it.
Zettler added: “In my view, these cases show that at least some courts are sympathetic to the plight of patients injured by generic drugs. Unless and until the FDA or Congress acts to allow injured patients greater recourse against generic drug manufacturers in the courts, these cases also may be a sign that courts increasingly will try to find creative legal arguments to allow such patients to bring suits against brand-name manufacturers.”
Under federal law, a generic drug manufacturer must provide a warning label that is identical to the label of its brand-name counterpart.
The Massachusetts case centers on Brian Rafferty, who took a generic version of Merck’s Proscar (finasteride), experienced side effects causing sexual dysfunction that did not resolve after the drug was discontinued even though the drug’s label said the side effects would resolve after the drug was discontinued.
“Rafferty alleged that by the time he was prescribed finasteride, several reports and studies had already emerged suggesting that those side effects could in fact persist even after discontinued use,” the court’s decision said.
“He also alleged that, starting in 2008, Merck changed the label for Proscar in certain foreign markets, including Sweden, the United Kingdom, and Italy, to include a warning about persistent erectile dysfunction. Nevertheless, as of 2010, when Rafferty ingested finasteride, Merck had not changed its label for Proscar in the United States to include this warning.”
Rafferty initially took action against Merck, claiming the company had been negligent, though that complaint was dismissed.
The court said that the question of whether Rafferty has stated a failure to warn claim “that meets the standard of a reckless disregard of an unreasonable risk of death or grave bodily injury must be determined by a trial judge. Because Merck owed Rafferty a limited duty to warn, and because Rafferty, to state a claim that falls within this limited duty, must allege facts supporting a finding that Merck acted recklessly, not just negligently, we vacate the dismissal of this claim and remand the case to the Superior Court.”
Merck told Focus
in a statement: “The Court agreed with Merck that Mr. Rafferty may not pursue a negligence claim for failure to warn under Massachusetts law and also affirmed the dismissal of his consumer protection act claims. The Court did, however, describe a limited course of action in which a plaintiff may pursue a common-law recklessness claim against the brand-name manufacturer if it intentionally failed to update the label on its drug, knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use. While Merck is disappointed with this aspect of the ruling, Merck appreciates the Court’s careful analysis.”
The court explained its decision by noting that in cases where a brand-name manufacturer learns that its drug is repeatedly causing death or serious injury and still fails to warn consumers of a danger, “public policy does not dictate that these consumers be left with no remedy when those risks are realized, or that the manufacturer have little financial incentive to reveal these risks.
“We therefore hold that a brand-name manufacturer that controls the contents of the label on a generic drug owes a duty to consumers of that generic drug not to act in reckless disregard of an unreasonable risk of death or grave bodily injury. This recklessness standard strikes the most appropriate balance between competing public policy interests, limiting liability for brand-name manufacturers while also providing remedies for the most serious injuries and deterring the most dangerous forms of conduct,” the decision reads.
The court also discussed the prospects of its decision increasing the risk of investments in new drugs because brand-name manufacturers would be exposed to additional liabilities.
But the court said: “We expect that this marginal risk will not materially chill innovation or increase drug prices. After all, what drug manufacturer, when deciding whether to invest in a new drug or in setting prices during its patent monopoly, would factor in substantial liability costs that might be incurred after its patent expires, premised on the probability that it will act in reckless disregard of an unreasonable risk of death or grave bodily injury?”