Julie A. Steinberg Washington Reporter Steven Patrick Washington
Merck & Co., maker of the branded drug Proscar, doesn’t have to face negligence claims by a plaintiff who used a generic version of the drug, Massachusetts’s top court said March 16.
As a matter of Massachusetts tort law and public policy, a plaintiff who used a generic drug can’t bring a general negligence claim against the maker of the corresponding brand-name product for failure to warn, the court said.
Nor can a plaintiff harmed by a generic drug bring a claim under Massachusetts consumer protection law against the maker of the corresponding branded product, it said.
However, a branded drugmaker could be held liable to someone who used a generic drug if it recklessly failed to update its warning, the court said.
Brian Rafferty alleged he suffered sexual dysfunction side effects caused by a generic version of Merck & Co.'s drug Proscar, a drug used to treat an enlarged prostate.
He alleged Merck owed him a duty because as the brand-name manufacturer, Merck created the warning that the generic drugmaker was required by federal law to use.
Allowing a generic drug consumer to bring a general negligence claim poses too great a risk of chilling drug innovation, the Massachusetts Supreme Judicial Court said.
That’s contrary to the public policy goals embodied in the Hatch-Waxman amendments that cleared the way for inexpensive generic drugs, it said.
But public policy isn’t served if generic drug consumers have no remedy for a brand-name manufacturer’s failure to warn in cases where such failure rises to the level of recklessness, the court said.
But a generic drug consumer may bring a claim against a brand-name manufacturer that intentionally fails to update the label, knowing or having reason to know an unreasonable risk of death or serious injury.
Because Merck owed Rafferty a limited duty to warn, the top court remanded his case and directed the trial court to allow Rafferty to amend his complaint if he believes that he can state facts sufficient to support such a claim.
Rafferty’s attorney said she sees the decision as “a step in the right direction.”
The decision “at least creates some form of remedy” for people who used generic drugs, who are injured because of conduct by the branded drugmaker, Emily E. Smith-Lee of Smith Lee Nebenzahl Law LLC in Sharon, Mass., told Bloomberg Law.
Rafferty plans to file an amended complaint, alleging a failure to warn on Merck’s part that fits the court’s carve-out, Smith-Lee said.
Merck said in a statement that the court agreed with its arguments that Rafferty can’t bring negligence and consumer law claims. The company said it was disappointed with the aspects of the ruling that created a claim for intentional failure to update a drug warning, but “appreciates the court’s careful analysis.”
Some 90 percent of prescriptions in the U.S. are for generic drugs. However, plaintiffs generally can’t sue generic drugmakers.
The majority of courts to consider whether brand-name companies can be held liable to plaintiffs who used generics haven’t allowed liability.
However, California’s top court recently said Novartis Pharmaceuticals Corp. can be held liable for alleged injuries linked to another company’s generic version of its former branded drug Brethine.
West Virginia’s top court is mulling the issue of brand-name maker liability.
And GlaxoSmithKline is challenging a $3 million verdict at the U.S. Court of Appeals for the Seventh Circuit, saying it shouldn’t have been held liable for the death of an attorney who used a generic version of its Paxil antidepressant.
Smith Lee Nebenzahl Law LLC represents Rafferty.
Morrison Mahoney LLP represents Merck.
The case is Rafferty v. Merck & Co. , 2018 BL 90182, Mass., SJC-12347, 3/16/18 .
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