In Knight v. Boehringer Ingelheim Pharmaceuticals, Inc., No. 19-1636 (4th Cir. January 6, 2021) the Fourth Circuit reversed the district court’s order denying Boehringer’s post-trial motion for judgment as a matter of law, finding that the plaintiff?s state-law fraud claim is preempted.
After defendant Boehringer developed a drug called Pradaxa to help reduce the risk of stroke, the FDA approved the drug and its label. Betty Knight suffered complications from taking the drug and eventually died. Betty’s children filed suit against Boehringer asserting a variety of state-law claims alleging Boehringer failed to adequately warn about the risks associated with taking Pradaxa. Boehringer argued that federal law preempted the claims, the district court agreed with plaintiffs, and then the jury returned a mixed verdict.
The mixed verdict included a finding for Boehringer on all claims except fraud. The jury also found that Knight would not have taken Pradaxa absent the fraud, and the drug proximately caused her injuries, but not her death. It awarded the Knights $250,000 in compensatory damages and $1,000,000 in punitive damages. Boehringer appealed, claiming that plaintiffs’ fraud claim based on the physician label was preempted.
The Fourth Circuit reversed the district court’s order denying Boehringer’s post-trial motion for judgment as a matter of law. The court held that there is no bright-line, one-size-fits-all line marking the moment when an analysis reveals new information. A careful review of the record is needed to determine whether a conclusion has been reached. Applying careful review here, the court concluded that Boehringer did not have “newly acquired information” regarding an optimal Pradaxa blood concentration level which would have warranted a unilateral change to the physician label. Therefore, the state-law fraud claim is preempted.
“Under the preemption doctrine, a state-law challenge to federally approved pharmaceutical warning labels may only proceed when the pharmaceutical company has the unilateral ability to change that labeling. * * * * But companies can change the physician label under the CBE regulation ?if the change is designed to ?add or strengthen a . . . warning? where there is ?newly acquired information? about the ?evidence of a causal association? between the drug and a risk of harm.”
Ultimately, the Fourth Circuit determined that a study at issue in the case did not provide the required new information. It was able to make this determination because preemption is a question of law which the Court can review de novo.