By its opinion filed on August 7, 2014, the Supreme Court of the State of Delaware (“Delaware Supreme Court”) upheld a Delaware medical malpractice jury verdict in favor of the plaintiffs in the amount of $4.4 million ($3.75 million to the injured man and $650,000 to the man’s wife for her loss of consortium claim) after an eight-day trial. The jury found the defendant physician to be 65% at fault and the defendant hospital to be 35% at fault for the man’s injuries and damages.
The Alleged Underlying Facts
The man had fallen off a ladder and suffered multiple non-displaced rib fractures and other injuries. He was admitted to the defendant hospital where he had severe chest pain not controlled by oral pain medication. The defendant physician (a thoracic surgeon associated with the defendant hospital) offered the man an “On-Q procedure” that involves the insertion of a catheter, known as the “On-Q,” that is about five inches long and contains holes through which a liquid analgesic is infused to continuously soak the nerves around the ribs with analgesic in order to relieve the pain associated with rib fractures. Use of the On-Q catheter in such a manner is an off-label use of the catheter because the On-Q procedure has not received FDA approval.
The defendant physician performed the On-Q procedure on the man after which the man inadvertently removed the catheters. A second surgery was performed by the defendant physician to insert two new On-Q catheters, one of which became displaced and perforated some of the man’s internal organs, requiring significant additional time in the hospital and several surgeries to remove the catheter and repair the organ damage.
The Medical Malpractice And Informed Consent Contentions
The man and his wife filed a medical malpractice lawsuit against the physician and the hospital, alleging that the physician had negligently performed the On-Q procedure and that the defendant physician failed to obtain his informed consent for the procedure.
The plaintiffs alleged that the defendant physician breached the standard of care for informed consent by failing to adequately disclose the risks and alternatives of the On-Q procedure, including the fact that the On-Q procedure was “experimental” and that an epidural was a viable alternative, and by failing to disclose to the plaintiffs his significant personal conflicts of interest regarding the On-Q procedure, including his business relationship with the manufacturer of On-Q, which included being a member of the manufacturer’s speaker’s bureau and being paid by the manufacturer to give presentations to other physicians about the On-Q procedure.
The defendant physician conceded at trial that he never presented the plaintiff with the option to receive an epidural rather than undergo the On-Q procedure, which the defendant physician acknowledged can be a “very effective” treatment method for rib fracture pain, despite Delaware’s informed consent statute that expressly requires a physician to disclose “alternatives to treatment . . . which a reasonable patient would consider material to the decision whether or not to undergo the treatment . . . ”
Delaware’s Informed Consent Law
Delaware’s informed consent statute defines informed consent as: ” . . . the consent of a patient to the performance of health care services by a health care provider given after the health care provider has informed the patient, to an extent reasonably comprehensible to general lay understanding, of the nature of the proposed procedure or treatment and of the risks and alternatives to treatment or diagnosis which a reasonable patient would consider material to the decision whether or not to undergo the treatment or diagnosis.” 18 Del. C. § 6801(6).
Therefore, a physician must provide the patient with information necessary to understand (1) the nature of the proposed procedure, and (2) the material risks and alternatives to the procedure – information “to the extent [that it is] customarily given to patients . . . by other licensed health care providers in the same or similar field of medicine as the defendant.” Such required information includes information about a doctor’s inexperience with a procedure, a hospital being understaffed on the day of the procedure, and the existence of a nearby hospital in which the procedure also could be performed. Whether a physician has met the standard of care required by the informed consent statute is a question of fact for the jury.
The Delaware Supreme Court held that the defendant physician’s relationship with the On-Q manufacturer directly related to the procedure he performed and that the conflict information was relevant because it bears on “risks and alternatives” (the conflict created a risk that the defendant physician wanted to perform the procedure because it would benefit him personally, and not because it was the most appropriate procedure for the plaintiff, and created a risk that the defendant physician did not disclose or consider all reasonable alternatives). The Delaware Supreme Court stated that the conflict evidence was relevant to the informed consent claim and was admissible, and that the trial court properly permitted the jury to consider this evidence when reaching its determination as to whether the defendant physician met the standard of care under Delaware’s informed consent statute.
Nadiv Shapira, M.D. and Nadiv Shapira, M.D., LLC, Defendants Below v. Christiana Care Health Services, Inc., Defendant Below and John Houghton and Evelyn Houghton, His Wife, Plantiffs Below. No. 392, 2013. Read the opinion of the Delaware Supreme Court by clicking here.
If you were seriously injured as a result of medical negligence in Delaware or in another U.S. state, you should promptly seek the advice of a Delaware medical malpractice attorney or a medical malpractice attorney in your state who may investigate your medical malpractice claim for you and represent you in a medical malpractice lawsuit, if appropriate.
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