BOSTON — The thinking behind a Massachusetts ruling that brand-name manufacturers can he held liable for injuries suffered by patients who take generic versions of the drug those manufacturers innovate could have bearing in a case before a federal appeals court in Chicago.
It could come down to what duty pharmaceutical company GlaxoSmithKline holds to maintain the warning label for its antidepressant drug Paxil, said Tarifa B. Laddon, an attorney at Faegre Baker Daniels in Los Angeles.
Stewart Dolin, a 57-year-old former attorney at Reed Smith LLP in Chicago, was taking a generic version of Paxil in July 2010 when he committed suicide by stepping into the path of a Chicago Transit Authority train in the Loop.
His widow. Wendy Dolin, then sued, asserting GSK should be held liable for Dolin's death, because the warning label for Paxil, which was approved by the U.S. Food and Drug Administration and also serves as the warning label for generic equivalents of the drug, did not sufficiently disclose suicide risk.
GSK fought the lawsuit, including at trial, asserting the law does not allow it to be held liable for injuries suffered by someone taking a drug they did not make - a concept known as innovator liability.
A federal jury in Chicago, however, sided with Dolin, awarding $3 million to the widow. GSK has appealed that decision, and the appeal is pending before the U.S. Seventh Circuit Court of Appeals.
"The threshold question in all innovator liability cases, including the Dolin case before the Seventh Circuit, is whether or not a duty exists," Laddon said. "That is, does a name-brand manufacturer have a duty to warn users of generic drugs that these manufactures did not make? Courts in four states so far—California, Vermont, Illinois and Massachusetts—have answered affirmatively."
However, the courts that recognize that a duty exists for those manufacturers differ on the scope of that duty, Laddon said.
Last month, the Massachusetts Supreme Judicial Court handed down its ruling on the subject in the case, Rafferty v. Merck, holding that in the absence of negligence and traditional product liability claims, brand-name manufacturers can be held liable for injuries causes by generic medication.
"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," Supreme Judicial Court Chief Justice Ralph D. Gants wrote. "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 plaintiff in the case, Brian Rafferty, alleges he suffered injuries in 2010 after he began taking a generic version of the drug Finasteride as prescribed by his physician to treat an enlarged prostate, according to the background portion of the Massachusetts high court's decision. Rafferty claimed that his injury arose from the "inaccurate or inadequate drug warning label" written by Merck for the drug.
In its ruling, the Massachusetts Supreme Judicial Court found Raffery could not bring a common-law general negligence claim against Merck, but he could bring a common-law recklessness claim against the company if he could show that the label had intentionally not been updated.
"This allocation of labeling responsibilities under federal law has proved difficult to reconcile with the duties required of generic drug manufacturers under state tort law," Chief Justice Gants wrote. "Many states, including this one, impose on manufacturers a duty to warn consumers of dangers arising from the use of their products where the manufacturers know or should have known of the dangers."
Laddon said the Massachusetts court "recognized a narrower version of innovatory liability than we have seen [in] other states by requiring recklessness, not negligence."
Massachusetts is half a country away and an entirely different state jurisdiction, but the March 16 ruling could be applicable in GlaxoSmithKline's appeal before the Seventh Circuit, Laddon said.
"The parties in the Dolin case seem think so, albeit for different reasons," she said. "The appellant, GlaxoSmithKline (GSK), already filed supplement authority, arguing that the Rafferty decision supports its position that Illinois, like Massachusetts, should not recognize innovator liability based in negligence. The plaintiff, Wendy Dolin, argued in response that the Rafferty decision undermines GSK's position because Massachusetts to some extent recognized that a duty exists. In any event, Dolin argued, GSK's behavior rose to the level of recklessness."
However, other states may not necessarily follow the lead of the Massachusetts high court, Laddon said.
"It is important not to lose sight that the overwhelming majority of courts continue to reject innovator liability based on well-settled law," she said. "In fact, no federal circuit court has yet recognized innovator liability under any state law. It would be a sign of bad things to come if the conservative Seventh Circuit became the first federal circuit court to do so, under Illinois law."