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Medical Malpractice – Off Label Use of Medical Devices and Drugs

The Food and Drug Administration (FDA) regulates prescription drugs and medical devices to ensure that these products are safe and effective for their intended use. Frequently, medical professionals see clinical uses for medical devises that lie outside of the FDA-approved labeling. This is a practice known as “off label use.”

While off label use of a medical device may be legal, a prescription drug or medical device should not be used “off label” without a patient’s consent. In Maryland, and in most states, the medical malpractice doctrine of “informed consent” requires that doctors (in a non-emergency setting) present the patient with important information about the nature of their ailment, the nature of the proposed treatment, the probability of success of contemplated therapy and its alternatives, and the risk of unfortunate consequences associated with such treatment. This information allows the patient to decide which course of action to pursue.

In the recent Maryland case of Fusco v Shannon, the Court of Special Appeals held that a pharmacist was qualified to testify regarding off label use of a prescription drug in an medical malpractice informed consent case. The case involved an 82-year old man, Mafalda Fusco, who was diagnosed with prostate cancer and elected to undergo radiotherapy treatment. The physician 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 causally contributed to his death.

The trial court excluded the testimony of the plaintiff’s expert who sought to introduce evidence concerning, among other things, the FDA-approved uses of Amifostine, which 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 constitute a material consideration in a patient’s decision 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 court’s decision can be found here.

Using medical devices or drugs that are not approved to treat a certain condition (off label use) 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 physician failed to provide adequate information. Nevertheless, patients who have been adversely affected as a result of off label medical device or drug use should seek the counsel of one of our experienced medical malpractice attorneys.

As an experienced Baltimore, Maryland medical malpractice lawyer, I have handled a number of medical malpractice cases involving involving informed consent. These are complicated cases that require a medical malpractice specialist. To see some of the cases I have handled, click here.