Doctor's "off-label use" of medical device required his patient's consent.
A Fayette County Circuit Judge was recently reversed by the Kentucky Court of Appeals, after she wrongfully dismissed a negligence claim filed against Baptist Healthcare Systems (Central Baptist Hospital).
In Cales v. Baptist Healthcare 2015-CA-001103-MR the Plaintiff brought a product's liability claim and a medical malpractice claim against the doctor, hospital and medical device manufacturer after her surgeon implanted a medical device that caused her injury.
Mrs. Cales alleged, "Baptist Healthcare was negligent in failing to inform [Plaintiff] that the use of the BMP/Sponge with Capstone Cage had not been approved by the FDA and that Dr. Keiefer's use of the BMP/Sponge was a deviation from the standard of care in light of the information Baptist Healthcare knew or should have known at the time of the surgery."
Although the device inserted during the surgery was approved by the FDA, it was being used "off-label." In other words, it was being used in a procedure other than what it was specifically approved for by the Food and Drug Administration. This act alone does not necessarily create negligence, however, the failure to get the patient's consent did create a question of negligence as Kentucky law required her "informed consent" for this surgery. KRS 304.40-320.