On April 24th, Maryland’s highest court ruled that it is acceptable for patients to give their informed consent to drug treatment even if they are not informed that a drug is being prescribed for an off-label use because such information does not reveal anything about the risks of using the drug.

The Maryland Court of Appeals reached this ruling in the case of Shannon, et al. v. Fusco, et al., No. 57 (Apr. 24, 2014). In the case, the estate of Anthony Fusco brought suit against Dr. Kevin Shannon for failing to provide Mr. Fusco with information as to the material risks of the drug, Amifostine, which was used to treat Mr. Fusco’s prostate cancer. Without such information, the plaintiff alleged that Mr. Fusco was unable to provide informed consent to the use of the drug. Because Amifostine had not been approved by the FDA to treat prostate cancer, its use in Mr. Fusco’s case was off-label.

The Court of Appeals agreed with the trial court, finding that references to the fact that Dr. Shannon had prescribed Amifostine for an off-label use were inadmissible at trial. Specifically, the court stated that “[i]nformation pertaining to an ‘off-label’ use provides the patient with no information about the treatment itself. . . . Because it provides no information regarding the medical treatment, it cannot, therefore, be considered material information to an informed consent discussion.”

Review the court’s opinion.

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