In a Tennessee case formerly part of multidistrict litigation targeting Novartis for failing to warn physicians that its Aredia and Zometa biophosphonate drugs could cause osteonecrosis of the jaw (ONJ), the Sixth Circuit Court of Appeals has reversed a district court’s grant of summary judgment for Novartis and remanded the causation issue for a jury to decide. Payne v. Novartis Pharm. Corp., No. 13-6266 (6th Cir., decided August 18, 2014).

The plaintiffs, a cancer patient and her husband, alleged that if Novartis had notified her physician and he had then warned them of the ONJ risks purportedly associated with Aredia and Zometa, she would not have taken the drugs and would not have had part of her jaw removed as a result of ONJ. In dismissing the claims, the district court looked to Tennessee’s “learned intermediary doctrine,” under which the question was “whether a jury could find that [the physician] would have done something differently had he known about the risk of ONJ and, if so, whether that difference could have prevented [the plaintiff’s] ONJ.” It then dismissed as “entirely speculative” the plaintiff’s statement that she would not have taken the biophosphonates if she had been warned about the ONJ risk.

The Sixth Circuit disagreed. It found that the district court erred in disregarding the testimony offered by the plaintiff’s physician, who said that he now warns patients about the ONJ risk. Tennessee law only requires “evidence that a warning would have altered the doctor’s actions and that the change in the doctor’s actions would have averted the patient’s injury,” the court said, and the testimony from the plaintiff’s physician should have been sufficient to forestall summary judgment. The plaintiffs argued that Tennessee “explicitly allows such testimony to show causation in informed consent cases,” and the court found “no indication that the Tennessee Supreme Court would adopt a different standard of proof for essentially the same link in the causal chain” of this failure-to-warn case.