Informed consent Is evolving: Now what?

Dr. Surgery completed his dermatology residency three years ago. He has a combined medical/surgical practice. Two years ago, he undertook a weekend blepharoplasty course at a well-respected, nationally recognized occuloplastic surgery program. Last year, he performed a lower eyelid transconjunctival blepharoplasty. Prior to the procedure, he provided both oral and written consent. Among the documented risks was retrobulbar hematoma and blindness. Unfortunately, on his third ever procedure, his patient suffered this rare complication. Dr. Surgery is clearly upset but feels comfortable, from a legal perspective, because he warned the patient of this risk.

Ultimately, the patient sues Dr. Surgery. The gist of the lawsuit does not surround the discussion of risks. Instead it focuses on the fact that Dr. Surgery never informed his patient that he was recently trained to do blepharoplasty and his patient was only the third patient on which he had ever performed this procedure. The patient contends that had she known of Dr. Surgery’s inexperience, she never would have consented to the procedure.

Should Dr. Surgery be concerned?         

The fundamental law of informed consent is familiar to all dermatologists.  The basic requirement of consent before a surgical operation was set forth in the 1914 legal case of Schloendorff v Society of New York Hospital. In Schloendorff, a woman consented to having a fibroid tumor examined under anesthesia to see if it was malignant. The doctor, on finding that the tumor was malignant, chose to remove it contrary to the patient’s wishes. Justice Benjamin Cardozo agreed that “Every human being of adult years and sound mind has a right to determine what shall be done with his own body. The 1972 legal case of Canterbury v Spence expanded the scope of informed consent by focusing on information disclosure. In Canterbury v Spence, the Court of Appeals in the District of Columbia considered the complaint of a patient who was seriously injured after elective thoracic spine surgery for a herniated disc. The surgeon had chosen not to tell the patient about the risk of paralysis; he argued that the risk was small enough and that disclosure might provoke unnecessary patient anxiety that could result in the harmful postponement of a medically necessary procedure. The court disagreed; its opinion clarified the disclosure requirement that is now a well -recognized element of the informed consent process.

With dramatic advances in information technology, patients now have easier access to medical information. The emerging model of patients as consumers of medical services has led to a reexamination of what needs to be disclosed during the informed consent process. Traditional informed consent has focused on the risks, benefits, and alternatives to a planned procedure. Physician disclosure has never addressed the quality of the physician and/or physician experience.

The American Medical Association (AMA) characterizes informed consent as requiring a “dialogue between patient and physician in which both parties exchange information and questions.   Beyond dialogue, however, the AMA states that informed consent requires voluntary disclosure of information by the physician, even absent patient inquiry. However, AMA opinions on this matter have not required member physicians to disclose personal physician experience. In contrast to the AMA, the American College of Surgeons (ACS) has addressed such variables related to choice of surgeon and surgeon experience. From the physician standpoint, the informed consent doctrine, even in the ACS model, remains limited to disclosure of the classic procedure-related risks, benefits, and results; the ACS simply encourages the patient to inquire further if so desired

Meaningful disclosure of physician experience would address how many times a surgeon has performed a procedure and the attendant success rate of that surgeon with the procedure. In Degennaro v Tandom, a defendant dentist neglected to tell the patient that she had no experience with the equipment used. The Connecticut court held that provider-specific information such as inexperience must be disclosed to obtain consent.

What has become clear is that recent judicial rulings have left the door open to future expansion of the informed consent doctrine and that failure to disclose information related to surgeon experience may constitute a deviation from the standard of care. In practice, however, the definition of physician experience or inexperience is fraught with practical difficulty; for example, a surgeon may be well experienced in performing surgery around a given anatomic location although he or she may not have performed the specific procedure in question.

As relates to Dr. Surgery, recent case law suggests that disclosure of surgeon experience is not always necessary, but in cases of substantial inexperience lack of disclosure may be construed as a breach of informed consent.