An appeals court decision could have negative consequences for patients who are injured by medications that were unknowingly prescribed to them for off-label uses.
The Maryland Court of Appeals ruled in April that patients can provide their “informed consent” to a treatment, even if they are unaware they are being administered the drug for an unapproved use. Appeals judges said off-label uses do not reflect a drug’s risks, and therefore, whether a patient is informed about a medication’s intended use is not relevant in an informed consent lawsuit.
The appeals decision upholds a trial court ruling in favor of a physician who was sued by a patient’s family for lack of informed consent. Patient Anthony Fusco’s family said hematology/oncology specialist Kevin Shannon, MD, failed to inform Fusco of the risks that accompanied the drug, Amifostine and the material risks of administering radiation therapy. Fusco was administered Amifostine after having been diagnosed with prostate cancer. According to Dr. Shannon’s trial testimony, the drug was designed to protect the bladder and rectum from inflammation caused by radiation therapy.
Fusco was later diagnosed with Stevens-Johnson Syndrome, a disease involving skin irritations that cause the top layer of skin to die and shed. Shortly after developing the condition, Fusco died from pneumonia.
The U.S. Food and Drug Administration had not approved Amifostine to supplement radiation treatment in prostate cancer patients, a fact that Fusco’s family claimed the patient was never told. In addition, the plaintiffs said an insert contained in the Amifostine packaging advised against its use in elderly patients, because its effects on older populations were unknown. Had such full and adequate disclosures been made, Fusco’s family said he would not have given his consent to taking Amifostine. Information about the insert and the drug’s intended uses was ruled inadmissible by the trial court. A jury later returned a verdict in favor of the physician.
The Maryland Court of Appeals agreed to review the case after a conflicting decision by the state’s intermediate appeals court. In its 45-page opinion, the Maryland Court of Appeals said the precluded evidence was immaterial, thus ruling against Fusco’s family.
“The package insert’s warning, which suggested that Amifostine should not be administered to an elderly patient, may have supported a claim of negligence in the administration of the drug to Mr. Fusco,” the opinion said. “Information 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. We note, finally, with respect to this issue, that the FDA-approval status does not provide any information regarding the materiality of the risks of the administration of Amifostine; it does not inform the fact-finder of the likelihood or severity of any risk.”
The Maryland opinion could be cited in similar lawsuits to prevent plaintiffs from pursuing informed consent claims related to off-label treatments.
All patients should ensure they understand the elements of informed consent and how it pertains to their medical treatment. Informed consent is defined as the process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a medical intervention. For ethical and legal reasons, patients must be provided adequate information to be fully informed before deciding to undergo the treatment. In a study of more than 1000 patient-physician encounters, only 9% were deemed to contain all the elements of complete informed decision-making. The most common element missing was an explicit assessment of patient understanding.