ST. LOUIS (Legal Newsline) – Nebraska law doesn’t require medical device manufacturers to directly warn users of potential dangers.
The U.S. Court of Appeals for the Eighth Circuit reached that conclusion Feb. 8 in Stephanie Ideus’ lawsuit against Teva Pharmaceuticals. It noted the learned-intermediary doctrine, which requires health care professionals to pass on warnings to patients, is in place in the state when it comes to prescription drugs.
But it is not clear whether the doctrine would apply to medical devices like the intrauterine device at issue in Ideus’ case, so the Eighth Circuit predicted what the Nebraska Supreme Court would do.
It looked at a Nebraska Supreme Court ruling in a case regarding Accutane, an acne medication. It adopted the Third Restatement of Torts when ruling against the plaintiff.
The Third Restatement says the learned-intermediary doctrine should apply to “a prescription drug or medical device.”
“Although Freeman involved a ‘prescription drug,’ the Restatement treats ‘medical device[s]’ no differently, which suggests that the Nebraska Supreme Court would, if faced with the question, apply the learned-intermediary doctrine to devices like ParaGard,” Judge David Stras wrote.
Ideus’ lawyers could only point at cases from Massachusetts and Michigan that required direct warnings to consumers. But the decision noted at least 15 states that rejected that theory.
“Every indication is that the Nebraska Supreme Court would follow what has become an ‘overwhelming majority’ rule,” Stras wrote. “After all, by adopting the Restatement and noting that the learned-intermediary doctrine has been widely adopted, it has already signaled its hesitance to become an outlier.”
Judge Jane Kelly dissented, arguing the Eighth Circuit lacked enough guidance from the Nebraska Supreme Court to make the decision. She would have rather her court certified the question to the Nebraska Supreme Court.
“Though a federal court sitting in diversity generally has a duty to resolve state-law issues properly before it, in my view, this case presents one of the unusual circumstances where certification is necessary,” Kelly wrote.