Shapira v. Christiana Care Health Services, Inc., — A.3d — (2014)
This case implicated a “On–Q procedure” that treats pain caused by rib fractures. The procedure involves the insertion of a special “On-Q” catheter that secures the infusion of liquid analgesic to soak the nerves around the fractured rib and thereby relieve the patient’s pain. The “On–Q” procedure has not been approved by the FDA and thus involved an “off-label” use of the “On–Q” catheter.
The physician in charge failed to inform the patient that he had an independent interest in the “On–Q” procedure. He had a contract with the On–Q’s manufacturer, I–Flow Corporation, that made him a paid member of the manufacturer’s speaker’s bureau. I–Flow paid the physician to give presentations to other doctors about the “On–Q” procedure and to create a patient database and promotional pamphlet.
Based on these facts, the Delaware Supreme Court held that the physician “had a strong incentive to play down the risks of the On–Q procedure and play up the problems with alternative treatments.” Whether the physician satisfied Delaware’s informed consent requirements thus turns into a jury question. Evidence showing the physician’s conflict of interests consequently becomes “relevant to the informed consent claim and admissible.”