6th Circuit Backs Preemption in Abbott Drug Case
The 6th Circuit Court of Appeals has affirmed a lower court decision preempting a strict liability claim for failing to conform to representations of a prescription anti-seizure medication that the plaintiff said caused physical deformities and cognitive disabilities in her child who was born while she was taking the medication. Attorney Eric Alexander (Reed Smith) writes in an online blog post that the labeling for the unnamed Abbott drug had long contained a Boxed Warning and other warnings about birth defects that discouraged used of the drug during pregnancy unless its use was shown to be essential to managing the patient’s seizures. In addition, he writes, the plaintiff’s prescriber said that she was aware of the labeling, would have relayed the information to the plaintiff, and would not have relied on other materials outside the label.
Alexander suggests that the failure to warn claims should not have made it to trial, but since they did, he appreciates the court’s action in preempting them. “Because FDA twice refused Abbott’s attempts to strengthen [the drug’s] label,” the appeals court said, “based on its own review of the evidence that the drug adversely affected the development of children exposed to it in utero, [the] failure-to-warn claim is preempted by federal drug labeling law.” The court also found a preemptive line barring all plaintiffs who used a drug before an FDA insufficient evidence decision concerning the risk at issue.
Finally, the court cited ample evidence on the record that Abbott had followed up on new data about developmental delay and its association with the drug and had contacted FDA multiple times to propose label changes to reflect the data. Each time, however, FDA reviewed the data and said that changes were inappropriate at that time, the court found.