How is a generic drug's label different from the drug itself? That was one of the many questions posed yesterday as the generics-liability case had its Supreme Court airing.
And it's one of the key questions, given the court's previous ruling in PLIVA v. Mensing. The court's decision in that case turned on FDA's requirement that generic-drug labels be identical to those accompanying the branded versions. If a generics company has to use the brand label, then it shouldn't be held liable for failing to warn patients or doctors about a drug's risks, the court determined.
This new case, Mutual Pharmaceutical Company v. Bartlett, adds a wrinkle to the labeling argument. Bartlett suffered a severe skin reaction three weeks after starting therapy with a generic version of the pain reliever Clinoril. She is now legally blind, unable to drive, and probably unable to return to her previous job, The Wall Street Journal notes. She claimed not only that Mutual didn't adequately warn of its drug's dangers, but that the product was defective and shouldn't have been sold. A jury awarded her $21 million for her injuries.
"Here, no words would have made any difference," said David Frederick, who argued on Bartlett's behalf (as quoted by The Hill).
But Mutual argues that its product was FDA-approved and so was its label, and those approvals preempt Bartlett's state-court claims. The Justice Department backs that view. "What we're trying to do is protect the FDA's role here," said Anthony Yang, who represented the federal government.
As the WSJ reports, Mutual's lawyer, Jay Lefkowitz, said during the hearing that separating a defective label from a defective product is "a distinction without a difference in real life," because "the lack of a clearer warning made the product itself more dangerous."
According to Reuters, Chief Justice John Roberts said he saw some differences between Bartlett's case and the PLIVA case, including a provision in New Hampshire law that imposes liability on products that are "unreasonably dangerous."