Posted On: June 12, 2013 by Andrew G. Slutkin

Medical Malpractice and Informed Consent Involving Off-Label Use Of Medical Devices and Drugs

The U.S. Food and Drug Administration regulates medical devices and prescription drugs to make sure that they are safe and effective for their intended use. Frequently, doctors see clinical uses for medical devices and drugs that lie outside of the FDA-approved labeling. This is a practice known as “off-label use.” The off-label use of a medical device is, in most cases, completely legal. The FDA understands that doctors have the right to make their own treatment decisions, including decisions about off-label uses, based on clinical experience and knowledge. However, the off-label use of medical devices can be a source of increased liability when such use falls short of patients’ expectations.

All doctors engaged in medical practice are liable for damages from negligent injury to patients due to medical malpractice. In such cases, the key question is whether the medical procedure or service at issue met the standard of care. The standard of care generally is defined as what a reasonable doctor would do under the same or similar circumstances.

If a patient brings a malpractice claim against a doctor who uses a medical device for an allegedly improper off-label use, the patient may claim that the doctor failed to obtain the patient’s “informed consent.” The doctrine of informed consent mandates that a doctor must present the patient with material information about the procedure’s risks, benefits, and alternatives, and holds a doctor for any patient injury that results. This information allows the patient to decide which course of action to pursue.

In a recent Maryland court decision, the Court of Special Appeals held that a pharmacist was qualified to testify regarding off label use of a prescription drug in an informed consent case. Fusco v. Shannon, 210 Md.App. 399, 63 A.3d 145 (2013). The case involved an 82-year old man, Mafalda Fusco, who was diagnosed with prostate cancer and elected to undergo radiotherapy treatment. The doctor to whom he was referred for this treatment explained the nature of radiation, including the need for a commonly used radiation protectant, Amifostine. Mr. Fusco underwent 23 injections of Amifostine and later suffered from a serious reaction, which contributed to his death.

The trial court excluded the testimony of the plaintiff’s expert who sought to introduce evidence that the FDA-approved uses of Amifostine did not include use on patients undergoing radiation therapy for prostate cancer. The Court of Special Appeals recognized that information concerning recommended and FDA-approved uses of a drug may be something that he patient would want to know in deciding whether to consent to treatment. The court went on to hold that the failure to present such evidence to the jury was not harmless error, and accordingly reversed and remanded the case for reconsideration including such evidence. A copy of the case can be found here.


Using medical devices or drugs that are not approved to treat a certain condition can be extremely dangerous. In general, the more information doctors provide patients about alternative therapies or treatments and their risks and benefits, the less likely it is that patients successfully can assert that the doctor failed to provide adequate information. Patients who have suffered injury because an off-label medical device or drug was used on them should seek the counsel of an experienced medical malpractice attorney.

As an experienced Baltimore, Maryland medical malpractice lawyer, I have handled a number of medical malpractice and wrongful death cases involving off-label use of medical devices and drugs. Off-label use of devices of medical devices or drugs can cause serious injuries. Frequently, we have found, the doctor using a device or drug off label is doing a study on the effectiveness of the device or drug. Doctors should tell patients if they are studying the effectiveness of a device or drug, as that is information that most patients would want to know. To see some of the cases I have handled, click here.

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