Publically available FDA documents, such as a new drug application (“NDA”) or a recall notice, are frequently relied on as evidence in products liability cases. But, as a recent case out of the U.S. District Court for the Southern District of Mississippi illustrates, to be relevant those documents must relate to the actual product at issue.
In Chatman v. Zimmer Inc., plaintiff complained of injuries allegedly suffered as a result of a defective “Zimmer NexGen System, Posterior Stabilized Knee with Cement Components.” She identified no experts and produced no expert reports speaking to the alleged defect or to medical causation. Instead, in response to Zimmer’s summary judgment motion, she alleged that she could prove her case with her own accounting of events, her medical records, and a Recall Notice from the FDA.
The Recall Notice did not involve the Zimmer product that the plaintiff received. Relying on cases involving accidents with cranes and hanging meat trailers, Chatman argued the Recall Notice was relevant and admissible as evidence of other accidents occurring under substantially similar circumstances. The district court made quick work of this argument. Unlike the cases cited by plaintiff, which involved evidence of other accidents involving the same product and occurring under the same or substantially similar circumstances, Chatman’s case involved an entirely different product than the one identified in the Recall Notice. “Thus, the Recall Notice is irrelevant and not evidence of a defect in the product at issue in this case.” Chatman v. Zimmer Inc., 2016 WL 3365456, *2 (S.D. Miss., June 16, 2016).
Without the Recall Notice, the heart of plaintiff’s evidence was a post-operative diagnosis of “Failed Right Knee Total Arthroplasty.” As the court observed, cases involving complicated medical devices require expert testimony that the device is defective and that the defect caused the alleged injuries. Because the diagnosis, without more, did not prove that the device was defective, plaintiff could not survive summary judgment.
The full Chatman v. Zimmer opinion can be found here.