Innovator liability is an issue that civil justice reform advocates expect to advance in the state legislature this year.
“Generic drugs are being manufactured and the innovator is ultimately held liable even if the individual who took the drug, took it from a generic manufacturer,” said Rich AuBuchon, executive director of the Missouri Civil Justice Reform Coalition.
As state law currently stands, brand name drug manufacturer defendants which had nothing to do with the generic product involved in litigation can be held liable for damages of an injury party.
“There is legislation being introduced to make sure that if you ingest the generic drug, then it’s the generic drug manufacturer that you should sue not the innovator of the product,” AuBuchon told St. Louis Record. “We have been working on this even as early as two years ago but it takes about three years on average to pass a bill.”
Missouri is home to more than 168 drug manufacturers, including Sanofi-Aventis, Eli Lilly & CO, and Hoffmann-La Roche Inc.
“We've seen this litigation popping up in Missouri recently,” AuBuchon said about what is referred to as innovator liability litigation. “It has reared its head in the city of St. Louis. We're not foreclosing liability. We're just saying that plaintiffs have to sue the manufacturer of the product.”
According to a Federalist Society study, plaintiffs are targeting branded drug companies rather than companies that made the generic drug because federal law overall preempts state law but some legislatures worry that absolving generic drug companies and implicating branded drug companies will curb innovation and increase prices.
“It's been something we're seeing more in the courts nationwide,” said Tiger Joyce, president of American Tort Reform Association (ATRA). “In a way, this is articulating a policy statement so that the courts don't engage in, what we would call, judicial activism.”
Courts such as the Iowa Supreme Court and West Virginia Supreme Court have rejected innovator liability, according to the Federalist Society report.
"The Iowa Supreme Court said '[d]eep pocket jurisprudence is law without principle," the report states. "West Virginia’s highest court said that '[r]equiring the defendant in a products liability case to be either the manufacturer or the seller of the product is the majority rule in this country.'"
The report also noted, however, that the California Supreme Court and Massachusetts Supreme Court have adopted innovator liability as law.
"The Alabama Supreme Court recognized the theory in 2014, but the ruling was quickly overturned by the legislature,” wrote attorney and civil justice reform expert Mark Behrens in a Feb. 2020 Civil Justice Update. “The Massachusetts high court imposed innovator liability on branded drug manufacturers that act ‘in reckless disregard of an unreasonable risk of death or grave bodily injury.’”