January 13, 2017
In an opinion issued today, the Kentucky Court of Appeals reversed a decision by the Fayette Circuit Court that a hospital had no duty to advise a patient before surgery of the FDA regulatory status of a medical device intended for use in the surgery. Cales v. Baptist Healthcare System, Inc., 2015-CA-1103. The Court of Appeals held that whether the hospital breached the standard of care by failing to inform the patient of off-label use of a medical device is a question of fact for the jury. The Court of Appeals, however, upheld the trial court's ruling that the plaintiff had not stated a product liability claim against the hospital. The Court noted that the FDA's approval of the medical device would preempt any claim that the device was defectively designed. In addition, the Court noted that the plaintiff's claims about how the hospital used the device could only be considered medical negligence claims, not product liability claims.