Kentucky’s Informed Consent Law
A new opinion by the Kentucky Supreme Court has altered the application of informed consent in medical malpractice lawsuits in Kentucky. This opinion will likely impact your approach to discussing the risks and benefits of medical procedures performed on your patients. Prior to August 2015, the Kentucky Supreme Court gauged an informed consent lawsuit based upon what a reasonable physician would do under the same or similar circumstances. This is the same standard for a medical malpractice lawsuit in general: did the treatment provided by the physician meet the standard of care of what a reasonable physician would do under the same or similar circumstances?
The Supreme Court’s latest opinion, in a medical malpractice lawsuit Sargent v. Shaffer, 2013‑SC‑111, highlights that physicians must conduct the informed consent dialogue from the perspective of the patient. Failing to do so may open the door for a lawsuit based upon an alleged lack of informed consent.
Kentucky’s Informed Consent Law is found in the Kentucky Revised Statutes, in particular KRS 304.40‑320. This statute provides the parameters of an informed consent lawsuit against physicians. This type of lawsuit often alleges that the physician was negligent in informing the patient of the risks of the procedure, and if the patient had known all of the risks, he or she would not have agreed (or consented) to the procedure.
In particular, KRS 304.40-320 states informed consent for a procedure “shall be deemed to have been given” when the physician provides the consent according to “the accepted standard . . . among members of the profession with the similar training and experience.” Moreover, the informed consent must provide to “a reasonable individual” (1) “a general understanding of the procedure”; (2) medically accepted alternative treatments; and (3) the “substantial risks” of the procedure as “recognized among other health care providers.” The Kentucky General Assembly has carved an exception for emergency situations, “where the consent of the patient cannot reasonably be obtained.”
The Sargent v. Shaffer case involved a lumbar laminectomy and decompression, which required removal of bone and scar tissue. Shortly after surgery, the patient experienced weakness in her lower extremities, and she eventually ended up paralyzed below the waist and incontinent. The patient sued alleging, among other things, that she had not been informed that paralysis and incontinence were potential risks to the procedure. According to the written informed consent document, the patient was warned of the risks of “infection, bleeding, nerve damage, dural leak, injury to the nerve, and destabilization of the scoliosis requiring fusion.” The patient was also warned of the risk of injury to adjacent structures along with the risks associated with anesthesia.
The surgeon admitted that he never used the words “paralysis,” “incontinence,” or “loss of bowel and bladder control” when discussing the risks of the procedure. At trial, the surgeon’s position, and the position of the surgeon’s experts, was that the phrase “nerve damage” encompassed all of these risks. At trial, the jury found in favor of the surgeon.
The Kentucky Supreme Court reversed the jury’s verdict on the informed consent claim because the jury was only instructed that the informed consent must be provided based upon what a reasonable physician would do under the same or similar circumstances. However, the Supreme Court held that proper jury instructions must be based on KRS 304.40-320, and include the informed consent discussion from the perspective of the patient; that is, would “a reasonable individual,” following the discussion with his or her physician, have an understanding of (1) the procedure; (2) the medically accepted alternative treatments; and (3) the “substantial risks” of the procedure as “recognized among other health care providers.” In reaching its decision the Supreme Court went on to say the main question to be asked of the jury in the Sargent case was “whether a ‘reasonable individual’ would generally understand that ‘nerve injury’ included the possibility of permanent paralysis below the waist.”
So what does this case mean in a practical sense for the physician having an informed consent dialogue with his or her patient? First, continue the practice of fully explaining the risks and benefits of the procedure with your patients using clear, understandable language. Second, physicians obtaining informed consent must (1) consider whether the information shared with the patient will be understood by a reasonable person (someone not medically trained); and (2) write on the informed consent document almost every reasonable adverse outcome related to the proposed procedure. As an example of what a lay person would understand, consider a gastrojejunostomy where the physician warns of “bleeding, infection, and damage to adjacent structures.” Does this informed consent discussion warn a reasonable, non-medically trained person of the risk that the anastomosis may break down leading to sepsis and potential death? To a reasonable lay person: arguably, no. Instead, it is better practice to list “breakdown of anastomosis” in addition to “infection.”
Therefore, the written informed consent document should be as clear and explicit as possible in warning of the potential risks and in discussing possible alternatives to the proposed procedure. To avoid the possibility of confusion afterwards, the better practice will be to list out each potential risk, and each possible alternative. This may take more time initially, but it will be better documentation in case of litigation. This will require your practice group to change its consent forms to incorporate the suggested changes to its current format. While the case has altered the legal construct surrounding informed consent, the physician should continue to use best practices in obtaining the informed consent: communicate the risks and alternatives in clear language, with an opportunity for the patient to ask questions before the administration of anesthesia; and, of course, document, document, document.