Off-Label Use: Lack of FDA Approval Not Relevant to Informed Consent, Maryland High Court Holds

October 1, 2014 | Health System Risk Management


In a case involving the administration of amifostine, a cytoprotective agent used to ameliorate the harmful effects of radiation treatment and chemotherapy drugs, the Maryland Court of Appeals, the state's highest court, held that while lack of U.S. Food and Drug Administration (FDA) approval may be relevant to a claim of medical negligence, it is not relevant to a claim for lack of informed consent. In so ruling, the court held that expert opinion testimony from a pharmacist is relevant only in establishing the severity of a drug's risk and the likelihood of its occurrence but may not be used to establish a claim of lack of informed consent or negligent use of the drug. The plaintiff, the estate of the deceased patient, alleged that had the patient known that the drug was not approved by FDA for use in prostate cancer, he would not have consented to its use. The patient allegedly developed a serious adverse skin reaction to the drug, which allegedly contributed to his death.

Maryland's legal standard for informed consent requires physicians to disclose material information that the physician knows or ought to know would be significant to a reasonable person in the patient's condition in deciding whether to submit to a proposed medical treatment or procedure. Materiality, the court explained, refers to the severity and likelihood of risk. The drug at issue in this case was approved by FDA only for use in head, neck, or kidney cancer and not for prostate cancer. The court stated that information about the FDA status of a drug provides no information about the treatment itself. Whereas the court noted that in Maryland a physician may be required to disclose his or her HIV status to a patient or relative inexperience in performing a complex surgical procedure, it concluded that a physician's use of a drug or device in a manner not specified in the FDA's approved packaging label or insert is not "material information" relevant to a patient's informed consent. Concurring with a Pennsylvania Supreme Court opinion regarding a medical device, the Maryland court noted that the FDA label does not constitute a material fact,...

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