A version of this article was published by The Daily Record on April 21, 2015.
In April, Maryland's highest court laid down a seminal opinion restating the doctrine of informed consent in Maryland, while addressing important issues of proof in informed consent lawsuits.
The decision is a mixed bag for health care providers in Maryland. On the one hand, the decision helpfully makes expert testimony a legal requirement for informed consent cases, and sets a bar for that testimony to clear. On the other hand, that bar is set low, and can now be cleared by a wider range of experts.
A. The Case
Shannon v. Fusco arose when the family of an elderly patient sued the patient?s physician, alleging that the physician failed to apprise the patient of the risks of Amifostine, a drug the physician prescribed to prevent inflammation that could result from radiation therapy for the patient?s prostate carcinoma. The family alleged that Amifostine caused the patient to develop Stevens-Johnson Syndrome and die.
The court considered whether the family could use any of the following evidence to prove its case: (1) the testimony of a professor of pharmacy establishing the risks of Amifostine, (2) evidence that the Food and Drug Administration had not approved Amifostine for use as an anti-inflammatory, or (3) the portion of Amifostine?s package insert warning against use by the elderly.
B. The Law
In a prelude to its ruling, the court restated Maryland?s informed consent law.
The court explained that Maryland generally imposes a duty on physicians to obtain the informed consent of their patients prior to treatment (even non-invasive treatment). Consent is not ?informed? unless the physician discloses material risks of the treatment to the patient. Risks are ?material? if they ?would be significant to a reasonable person in the patient?s position in deciding whether or not to submit to a particular medical treatment or procedure.? In practice, whether a risk is material turns on:
1. The nature of the risk (that is, the type of injury that could occur);
2. The severity of the risk; and
3. The likelihood the risk will be realized.
A risk must also be weighed against the likelihood of success of the treatment, available treatment alternatives, and whether disclosure would harm the patient. Nevertheless, consent and good care are distinct. A physician may obtain informed consent to a contra-indicated treatment, or may fail to obtain informed consent to the best available treatment.
C. Who May Testify?
The court agreed with the family that the professor of pharmacy ? a specialist in oncology drugs ? could testify as to the material risks of Amifostine.
The court rejected the defendant physician?s argument that non-physicians are unqualified to testify in informed consent cases because they are ignorant of physician standards of care. The court noted that Maryland defines informed consent not by what physicians think is sufficient information, but rather by what a reasonable patient would think is sufficient information to consent, including information about material risks. Also, a pharmacist may have expertise necessary to establish the existence of a material risk.
D. Family Still Loses
Although the family won the battle to qualify the pharmacist to testify, it lost the war to make that testimony relevant. The court held that the testimony, Amifostine?s package insert, and Amifostine?s FDA status did not combine to prove the case.
First, the pharmacist?s testimony only identified Stevens-Johnson Syndrome as a risk of Amifostine use, not a material risk. The pharmacist did not spell out the likelihood that Stevens-Johnson Syndrome would develop or its severity, or the relative weight of that risk against the risks associated with other available treatments or with non-treatment.
Neither was the package insert specific enough to establish materiality. Although the insert?s warning against use by the elderly was evidence that Amifostine was contraindicated, it was not evidence of the existence, severity, or likelihood of any particular risk.
The FDA?s non-approval was similarly irrelevant. ?The category into which the FDA places? the drug ?for marketing and labeling purposes simply does not enlighten the patient? about the drug or its risks.
The court clarified that an informed consent lawsuit will only succeed if supported by an expert opinion that a provider failed to disclose a significantly likely or severe risk of treatment to a patient. The expert here failed to offer that support, ignoring likelihood and severity entirely.
But future experts may be better prepared. In addition, since the court did not say that one must show a particular likelihood, or severity, of risk, future experts may simply cite existing medical literature to establish that the injury suffered is a known risk, and has a chance of occurring within some specific probabilistic range.