In the Ashe v. Radiation Oncology case: Legal Aspect Health
Analyze the case and commentary
Decision-making capacity
Informed consent and
How you'd implement a policy in hospitals/clinics that would make you feel assured about a patient receiving informed consent.
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: ?
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