Failure to obtain informed consent: $400,000 verdict
By Jan J. Gorrie, Esq., and Blake J. Delaney, Summer Associate
Buchanan Ingersoll Professional Group, Tampa, FL
News: A patient successfully underwent aortic value replacement surgery; however, it had the adverse side effects of causing her to lose her sight and sustain a hand injury. Two years later, the surgery was unsuccessfully repeated and the patient died. The family brought suit against the hospital and doctors alleging malpractice and the failure to obtain informed consent. The jury found in favor of the physicians, but awarded the plaintiffs $400,000 against the hospital for failure to obtain informed consent from the patient prior to undergoing the first procedure.
Background: A 56-year-old certified nurse’s aide was admitted to the hospital to undergo a Ross procedure, which is a form of aortic value replacement surgery. The plaintiffs claimed that as a result of the procedure, the patient went blind and sustained a debilitating hand injury. The plaintiffs also alleged that the procedure was incorrectly performed and resulted in a prolapsed aortic value two years later, which necessitated repeat surgery from which the patient did not survive.
The plaintiffs alleged medical negligence on the part of the physicians, violations of informed consent procedures by the hospital, and wrongful death against both the hospital and physicians. All of the defendants maintained they committed no negligence in the care of this patient and asserted they met applicable standards of care in their diagnoses, care, and treatment of the patient. The defendants also claimed that the patient was fully informed of all material risks, available alternatives, and benefits of the initial aortic value replacement procedure, as well as the risks and benefits expressly associated with the Ross procedure.
The jury returned a verdict awarding the plaintiffs $400,000 against the hospital for the failure to obtain informed consent and defense verdict in favor of the treating physicians.
What this means to you: Informed consent is a process of effective communication or exchange of information between the physician and patient regarding the intended procedure, risks, benefits, alternative treatment, expected outcome, and consequences for refusal of treatment.
"The physician has the ultimate duty to obtain informed consent from the patient or legally authorized representative; however, the hospital may, as this case demonstrates, still find itself liable if something goes wrong," says Patti L. Ellis, RN, BSN, LHRM, corporate risk manager, Pediatrix-Obstetrix Medical Group of Sunrise, FL.
"The patient’s signature or that of a legally authorized representative does not constitute informed consent. The written consent form serves only to prove that informed consent took place. While the hospital and it nurses are not responsible for obtaining informed consent, the hospital usually through its nurses does have the duty to ensure that informed consent has been properly obtained and documented. Proof of informed consent is evidenced by a properly executed consent form placed in the patient’s medical record. Many states, such as Florida, have specific laws on informed consent. Every risk manager should be well versed on their state’s requirements governing informed consent and include it as part of their risk management education," she adds.
While the circumstances in this particular case are not known, "in the scenario where a hospital fails to have the patient/legally authorized representative sign a written consent form prior to surgery when dictated by hospital policy, where it can be proven that the patient was under the effects of sedation or duress when signing the form, when the signed form is in a language other than the patient’s and where the failure of the hospital staff/ nurse to intervene on the patient’s behalf and the patient sustains injury, one can understand how the jury might find the hospital liable for failure to obtain informed consent," notes Ellis.
"While unforeseen conditions can occur during the course of surgery that may require an additional procedure; it is obviously the surgeon’s responsibility to address this with the patient during the informed consent process. In addition, this should be included on the consent form itself," she says.
"Every risk manager should have the overall responsibility for policy and procedure development for informed consent with direct involvement from the medical staff and nursing. Physician and nursing education is most important for avoiding litigation related to failure to obtain informed consent. As part of the your facility’s quality improvement program, consider periodic chart audits to monitor consent form compliance, for as this facility found — even though obtaining informed consent is the physician’s responsibility, if the hospital is unable to show that informed consent was documented they may be liable," concludes Ellis.
• King County (WA) Superior Court, Case No. 98-2-28165-1.