In the Ashe v. Radiation Oncology case: Legal Aspect Health Analyze the case and commentary Decision-making...

Ms. Ashe sustained “radiation myelitis” caused by a permanent radiation injury to her spinal cord. She became a paraplegic.   The plaintiff alleged Ms. Ashe’s doctor did not inform Ms. Ashe that the radiation treatment might result in a permanent injury to her spinal cord. According to her doctor, the risk that she would sustain a spinal cord injury was less than one percent. Mrs. Ashe proffered the testimony of her expert, Dr. Carlos Perez. Dr. Perez opined that the risk of spinal cord injury was one to two percent. Dr. Perez testified that the applicable standard of care required physicians to warn patients about the risk of radiation injury to the spinal cord.

At trial, Ms. Ashe testified that she would not have consented to the radiation therapy had she been informed of the risk of paralysis.

Trial Court ruling

The trial court found that the plaintiff’s trial testimony conflicted with her deposition testimony regarding whether she would have consented to the procedure had she been warned of the risk of spinal cord injury. The trial court, therefore, struck the trial testimony and granted the defendant a directed verdict on the informed consent claim. The plaintiff’s malpractice claim went to the jury. The jury was unable to reach a verdict, and a mistrial was declared.

The plaintiff appealed to the Court of Appeals. The Court of Appeals held that as part of the plaintiff’s informed consent claim she was required to prove that a reasonable person knowing of the risk for spinal cord injury would have decided not to have had the procedure performed. The Court held that the discrepancy between the trial testimony and deposition testimony went to the issue of credibility and that the trial testimony should not have been stricken. The Court of Appeals reversed the trial court’s grant of a directed verdict on the informed consent claim and remanded the case for a new trial.

Ruling in the Tennessee Supreme Court

On appeal, the Tennessee Supreme Court affirmed the Court of Appeals. The Supreme Court first noted the distinction between a lack of informed consent case and a pure medical battery case. In Blanchard v. Kellum, the Supreme Court defined a medical battery as a case in which a doctor performs an unauthorized procedure. . A medical battery may typically occur when: (1) a professional performs a procedure that the patient was unaware the doctor was going to perform; or (2) the procedure was performed on a part of the body other than that part explained to the patient (i.e., amputation of the wrong leg). Id. A lack of informed consent claim typically occurs when the patient was aware that the procedure was going to be performed but the patient was unaware of the risk associated with the procedure. Id.

The Court observed that because Ms. Ashe had authorized the radiation treatment, the case concerned lack of informed consent, rather than medical battery.

Proving causation in an informed consent lawsuit

The question before the Supreme Court thus became what standard to adopt for assessing causation in an informed consent case. Prior to Ashe, the Supreme Court had not clearly ruled on this issue.

One approach, termed the “subjective” approach, focuses solely on patient testimony. Under this approach, Patients must testify and prove that they would not have consented to the procedures had they been advised of the particular risk in question. The Court held that the subjective approach was potentially unfair to physicians: “the subjective test potentially places the physician in jeopardy of the patient’s hindsight and bitterness.”

A second approach, the so-called “objective” standard, analyzes causation in terms of what a “prudent person in the patient’s position would have decided if suitably informed of all perils bearing significance.” Id.  Under this approach, he patient’s testimony is relevant under an objective approach, but the testimony is not controlling.

A third approach, known as the “modified objective” standard, determines causation “from the viewpoint of the actual patient acting rationally and reasonably.” Id. at 123. The Court noted that this standard is unduly complex and onerous to apply. Id.  Citing with approval a case from the Hawaii Supreme Court, the Tennessee Supreme Court agreed that the objective standard provides a better, simpler, and more equitable analytical process.

Applying the objective approach to informed consent causation

Adopting the objective approach, the Court explained how the test should be applied:

“The finder of fact may consider and give weight to the patient’s testimony as to whether the patient would have consented to the procedure upon full disclosure of the risks. When applying the objective standard, the finder of fact may also take into account the characteristics of the plaintiff including the plaintiff’s idiosyncrasies, fears, age, medical condition, and religious beliefs.” Id. at 123-124.

In applying this test to Ms. Ashe’s case, the Court held:

“Under the objective analysis, the plaintiff’s testimony is only a factor when determining the issue of informed consent. The dispositive issue is not whether Ms. Ashe would herself have chosen a different course of treatment. The issue is whether a reasonable patient in Ms. Ashe’s position would have chosen a different course of treatment. The jury, therefore, should have been allowed to decide whether a reasonable person in Ms. Ashe’s position would have consented to the radiation therapy had the risk of paralysis been disclosed.”

The case was remanded for a new trial consistent with the Court’s ruling. The parties then reached a confidential settlement.

Open questions after Ashe for Tennessee informed consent lawsuits

After Ashe, there remains an unanswered legal question regarding causation in informed consent cases. The question concerns whether a plaintiff in an informed consent must prove (in addition to the “Ashe causation” that a reasonable patient in the plaintiff’s position would have chosen a different course of treatment) that the failure to disclose the risk proximately caused the injury to the plaintiff. There is support for the proposition that the answer is no, that “Ashe causation” is all that is required. In Shadrick v. Coker, the Tennessee Supreme Court observed:

“When the health care provider performs the treatment or procedure without the requisite informed consent of the patient, liability attaches for the resulting injuries regardless of whether those injuries resulted from negligence . . .This is because the doctrine of lack of informed consent is based upon the tort of battery, not negligence, since the treatment or procedure was performed without having first obtained the patient’s informed consent.

For informed consent to be effectively obtained, the law requires that physicians notify patients of the nature, risks, benefits and alternatives of a medical procedure before the procedure is performed. If a physician fails to do so, the physician may be subject to liability for failure to obtain informed consent, even if the physician complies with the recognized standard of acceptable professional practice (“the standard of care”) in the performance of the procedure itself. Errors in obtaining informed consent may subject the physician to liability under one of two legal theories: the tort of failure to obtain informed consent, or medical battery. A failure to obtain informed consent occurs when a patient consents to the treatment but later claims the physician failed to advise the patient of the risks and benefits of the treatment and alternative treatments in accordance with the standard of care. A medical battery occurs when a patient does not consent to the treatment provided, such as operating on a different body part or performing a procedure that was not authorized. This paper reviews the tort of failure to obtain informed consent.

INFORMED CONSENT EXPLAINED
The tort of failure to obtain informed consent . It states that in a malpractice action, the plaintiff shall prove by evidence “that the defendant did not supply appropriate information to the patient in obtaining informed consent … in accordance with the recognized standard of acceptable professional practice in the profession and in the specialty, if any, that the defendant practices in the community in which the defendant practices and in similar communities.” A claim of failure to obtain informed consent is a type of medical malpractice claim requiring proof of the applicable recognized standard of acceptable professional practice.

A claim of failure to obtain informed consent is established when a physician fails to disclose a particular risk of a procedure, which the standard of care required her to disclose, the risk occurs, and the physician’s failure to disclose the risk is found to be the cause of the patient’s damages.2 When proving the element of causation, the patient must establish that a reasonable person in the patient’s position would not have consented to the treatment if the physician had explained the risks, benefits, and alternatives in compliance with the standard of care. In Ashe v. Radiation Oncology Associates, the Court established that the causation standard to be applied is an objective standard. In other words, would a reasonable person in the patient’s position have chosen a different course of treatment? Under this standard “patients must prove that the physician’s conduct fell below the applicable standard of care and that a reasonably prudent person in the patient’s position would not have consented to the procedure if they had been suitably informed of the risks, benefits, and alternatives.” The finder of fact presented with a claim of failure to obtain informed consent must inquire whether the patient was provided sufficient information to allow him or her to make an intelligent and informed decision. Expert testimony is required for the patient to prove his or her case.

Generally, a hospital cannot be held liable for a failure to obtain informed consent of the patient for a physician-performed treatment. Frequently, physicians rely on hospital personnel to obtain a patient’s signature on an informed consent form and presume that informed consent has been obtained once the form has been signed. A signature on a form alone will not defeat a claim of failure to obtain informed consent; nor will failure to obtain a signature on a form result in liability. In Bryant v. HCA Health Services of Tennessee, Inc.,4 the Tennessee Supreme Court determined that a hospital, as opposed to a physician, is not required to obtain the informed consent of a patient before the commencement of a medical procedure. The decision was based on T.C.A. § 29-26-118. The statute was found by the Court to refer to the physician performing the procedure and not to the hospital. The Court stated that the large majority of states that have considered this issue have reached the same conclusion. However, the Bryant Court recognized a narrow circumstance in which a hospital may adopt an independent legal duty to obtain a patient’s informed consent. Such a duty may be adopted when a hospital participates in a clinical study monitored by the FDA and is required by FDA regulations to obtain the informed consent of patients for certain experimental treatments under the supervision of an Institutional Review Board. The implication is that summary judgment will be appropriate for the hospital as to the informed consent portion of medical malpractice claims because the responsibility to obtain informed consent falls on the physician. Unless the hospital undertakes some independent duty, such as with FDA-monitored clinical studies, it has no liability exposure for failure to obtain the patient’s informed consent to a physician-performed procedure. Similarly, a signed consent form will not absolve a physician of liability. The physician has a duty to explain the risks, benefits, and alternatives of a treatment to the patient as required by the recognized standard of acceptable professional practice. Boilerplate hospital consent forms alone rarely satisfy this standard even when a short description of the procedure, usually paraphrasing the patient’s description, is written on the form.

The information that must be disclosed to obtain a patient’s informed consent is governed by the recognized standard of acceptable professional practice in the applicable specialty in the community in which the physician practices, which includes available treatment modalities and facilities, and by the circumstances of the patient’s condition, which include the patient’s capacity to understand details of the risks, benefits and alternatives. While a physician is not required to disclose every aspect of the proposed procedure or every inherent risk, “a physician should disclose the nature of the patient’s ailment; the nature of and the reasons for the treatment or procedure; the risks involved with such treatment or procedure; whether such procedure is experimental; alternative methods of treatment along with the risks and benefits associated with it; and the patient’s prospects for success.” Further, performing the procedure itself in accordance with the standard of care will not absolve a physician of liability for a claim of failure to obtain informed consent. Tennessee cases addressing the tort of failure to obtain informed consent have established that the skill with which the procedure at issue is performed is not relevant. The tort focuses only on how the physician obtained the patient’s consent to perform the procedure.6 Thus, a procedure could be performed perfectly, a patient experience a complication, and the physician still be liable for failure to obtain informed consent. ?When a physician makes a thorough disclosure of benefits, risks and alternatives but misrepresents information in the disclosure, medical battery rather than failure to obtain consent occurs, because there is no effective consent and, thus, no authorization for the procedure. In Holt v. Alexander, the patient relied on her surgeon, who represented that her urologist approved the surgical procedure. However, the urologist was not even aware the procedure was going to be performed. Thus, the Court of Appeals found a claim for medical battery.

INFORMED CONSENT GUIDELINES
The following guidelines should be considered by physicians when obtaining a patient’s informed consent: ?

• Obtain a signed informed consent form from the patient before each invasive procedure. Document any disagreement with a patient over the treatment protocol recommended. ?Keep the informed consent form with the patient’s medical record.? Disclose what a reasonable person would want to know about the procedure proposed. ?Be aware of the consent laws for minors. ?Do not pressure, manipulate or coerce the patient toward a particular decision.?Review the record carefully to make sure competency is not an issue. ?Make sure the patient understands the explanation of his or her options.?For an informed consent form, contact your liability carrier.
• Document the actual risks and benefits of the procedure that were stated to the patient.
• Document the actual alternative treatments that were explained to the patient and the risks and benefits of those alternatives.
• Document the patient’s propensity to receive the information.
• Make documentation unique to the patient.
• Document questions by the patient.