In this case, the plaintiffs attempted to hold the manufacturer of a unicondylar knee replacement device liable for injuries they sustained following knee replacement surgery.  Plaintiffs asserted claims for negligence, strict liability, misrepresentation, and violation of the Florida Deceptive and Unfair Trade Practices Act (FDUTPA), alleging they were improper candidates for surgical implantation of the unicondylar knee replacement device based on their activity level and weight. In response to defendant’s motion to dismiss plaintiffs’ consolidated complaints, plaintiffs attempted to invoke the little-used over promotion exception and the “direct-to consumer” marketing exception to the learned intermediary doctrine, as recognized in Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245 (N.J. 1999). Plaintiffs also encouraged the district court to apply a novel and as yet unrecognized “doctor as agent of the manufacturer” exception to the learned intermediary doctrine.

The district court ultimately held that because the basis of plaintiffs’ claims was the manufacturer’s alleged failure to warn plaintiffs’ physician of the risks associated with the unicondylar knee replacement device, the learned intermediary doctrine barred each of the plaintiffs’ claims. The court thus granted summary judgment in the defendant’s favor with respect to the entirety of the complaint.

This decision was an important victory for medical device manufacturers, because had the plaintiffs succeeded and the suit been allowed to proceed, the litigation potentially would have opened the floodgates to a wave of suits against medical device manufacturers based on the patient selection decisions of physicians using their products.

Given the increasing popularity and importance of marketing medical devices directly to consumers, medical device manufacturers are likely to see an increase in these types of lawsuits in the future. This significant decision has cross-jurisdictional application and its impact on the continuing viability of the learned intermediary doctrine is not limited to Florida law.

Carlton Fields has significant experience defending claims related to medical devices. Our Pharmaceutical and Medical Device Practice Group focuses extensively on defending drug and medical device manufacturers in individual, mass tort, class action, and other complex litigation matters in state and federal courts, from inception through appeal. Carlton Fields' attorneys work on these types of matters on a daily basis, and are able to put together teams of experienced lawyers in multiple jurisdictions dedicated to the defense of a single product or set of claims.