The 11th Circuit on Thursday affirmed summary judgment for the defendants in a case filed by an individual against Ethicon Inc. over an allegedly faulty mesh pelvic implant, declining to create an exception to state doctrine that says medical device manufacturers must only warn physicians, not patients, of possible adverse effects.
Charlotte Salinero and her husband originally sued Ethicon and its parent company, Johnson & Johnson, in the Southern District of Florida after Salinero experienced adverse health effects purportedly resulting from a surgery implanting Ethicon’s Artisyn Y-Mesh device. The defendants moved for summary judgment — and won — because of the learned intermediary doctrine governing communication between medical device makers and physicians.
Under this doctrine, the medical device companies are only responsible for informing physicians of health risks of their devices, who then are required to use their best judgment in deciding whether to warn patients. Invoking the doctrine and having it recognized by the court as correctly applied means a defendant is protected from failure-to-warn claims related to product liability.
However, Salinero argued that the learned intermediary doctrine should not apply in this case because her physician, Dr. Jaime Sepulveda, “has a long-standing financial relationship with both defendants and thus it was not reasonable for them to expect him to adequately communicate the risks surrounding an Artisyn Y-Mesh implant,” the court explained. The court said this claim is a big ask: one that, if granted, would create a “financial bias” exception to the longstanding state doctrine that Florida courts have never upheld, “much less discussed.” According to the court, such a “sea change” would have major implications for Florida product liability law, and it does not wish to rock the boat.
“Until Florida’s appellate courts tell us otherwise, as we see it, a physician who has significant education and training and understands the complexity of a medical drug or device is in a profoundly different position than an intermediary manufacturer,” the court reasoned. “In this case, and on this record, we are satisfied that Dr. Sepulveda did just what is expected of physicians. He used his individualized medical judgment to determine what treatment to offer Mrs. Salinero.”
The court acknowledged that Salinero invoked a Florida Supreme Court product liability case in which a financial bias exemption was created — Aubin v. Union Carbide Corp. — but said the example is inadequate given that the case did not involve a medical device recommended by a physician to a patient; instead, the case revolved around a supplier of bulk asbestos to intermediary manufacturers. In addition to the “sharply different context” under which Aubin arose, the court said the Florida Supreme Court did not suggest that the asbestos supplier-intermediary manufacturer relationship was analogous to a physician-patient relationship nor did it operationalize any of Florida’s medical learned intermediary case law in its analysis, further widening the gap between Salinero’s claims and Aubin.
The Ferraro Law Firm and The Saade Law Firm P.A. represent the plaintiffs. Butler Snow LLP, Thomas Combs & Spann PLLC, Goldman Ismail Tomaselli Brennan & Baum LLP, Saul Ewing Arnstein & Lehr LLP, and Squire Patton Boggs represent the defendants.