The U.S. Supreme Court has issued a new opinion which clarifies the standard drug makers must meet to establish a federal “pre-emption” defense, which is often used by pharmaceutical companies to try to escape liability for failing to warn about known risks associated with medications they sell, arguing that the FDA would not have permitted a label update.
All nine justices joined or concurred in the decision, which found that a judge, not a jury, must determine that there is “clear evidence” the drug maker fully informed the FDA about the justifications for adding such a warning, and that the FDA, in turn, informed the drug maker that the agency would not approve a change to include that warning.
As a result of the ruling, the nation’s highest court remanded hundreds of Fosamax lawsuits over failure to warn about the risk of atypical bone fractures. The cases will be sent back to a lower appeals court to determine whether Merck can establish the pre-emption defense under the newly articulated standards.
Each of the claims involve allegations that side effects of Fosamax caused users to suffer a sudden femur fracture, which typically occur with little or no trauma. Plaintiffs claim that the drug maker knew about the bone fracture risk for years after Fosamax was introduced, but withheld information from consumers and the medical community until the FDA required a label update in 2010.
Merck has attempted to defend the case by arguing that the FDA would not have allowed a warning update before 2010, since the agency previously rejected a proposed label update about the risk of “stress fractures”. However, it will be a judicial question to determine whether that prior action would pre-empt claims for failure to warn about the more serious atypical femur fractures at issue in the case.
In the majority opinion, Justice Stephen Breyer pointed out that Merck once again proposed a “stress fracture” warning in 2010, which the FDA rejected again when it required the stronger warning about atypical fractures.
“Merck was initially resistant to the [2010 FDA label] change, proposing revised language that, once again, referred to the risk of ‘stress fractures’,” Justice Breyer wrote. “But the FDA, once again, rejected that language. And this time, the FDA explained that ‘the term ‘stress fracture’ was considered and was not accepted’ because, ‘for most practitioners, the term ‘stress fracture’ represents a minor fracture and this would contradict the seriousness of the atypical femoral fractures associated with bisphosphonate use.”
While the justices remanded the case to the Court of Appeals for further proceedings consistent with the opinion, Justice Clarence Thomas suggested in a concurring opinion that the Court should have rejected Merck’s pre-emption defense as a matter of law, indicating that Merck has been unable to point to any statute, regulation or other agency action that provides the force of federal law necessary to prohibit the drug maker from adding warning.
The Fosamax lawsuits will now be remanded back to the U.S. Court of Appeals for the Third Circuit for further proceedings.