Allegations of Failure to Obtain Informed Consent in Otolaryngology: Evidenced-Based Recommendations for Sinus Surgeons.

BACKGROUND: Informed consent requires preoperative discussion of surgical risks, complications, and alternative treatment options. Allegations of incomplete informed consent are common in the field of otolaryngology.

OBJECTIVES: Analyze outcomes and case variables in cases of alleged informed consent failure involving otolaryngologists.

METHODS: A legal research database containing state and federal case records from across the United States was retrospectively reviewed for malpractice claims involving informed consent and otolaryngology.

RESULTS: Among the 128 informed consent cases identified, 72.6% resulted in favorable verdicts for otolaryngologists. Functional endoscopic sinus surgery (FESS) was the most common source of informed consent litigation in the field of otolaryngology, with an incidence four-fold higher than the next most litigated procedure of uvulopalatopharyngoplasty (21.9% vs 5.4%). The top four factors cited in FESS-related cases were CSF leak (10), inadequate discussion of alternative therapies (4), diplopia (3), and meningitis (3). Cases resulting in a transient injury were significantly less likely to result in a payment from a plaintiff verdict or settlement (9.1%) as compared to payment-rates among cases involving permanent complications (34.6%) ( p  = 0.005).

CONCLUSIONS: Failure to obtain informed consent is an important factor in medical malpractice litigation. This report identifies specific, actionable recommendations aimed at protecting sinus surgeons from liability and ensuring that patients are better informed.