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Can someone sue a doctor for off-label drug recommendations?

On Behalf of | Nov 20, 2023 | Medical Malpractice

It takes a lot of research, financial investment and time for a drug company to develop a new medication. Not only do they need to develop a concept for a drug to meet patient needs, but they also need to complete testing and submit records to the Food and Drug Administration (FDA).

The testing that a drug company performs needs to show that the medication is more effective than a placebo at addressing someone’s symptoms and that the medication is reasonably safe. It is typical for companies to only seek FDA approval for a single use of a medication.

However, doctors might then prescribe the drug to a patient with a totally different medical condition. An example would be the very trendy drug Ozempic. This drug received approval from the FDA for Type 2 diabetes management. Doctors may also prescribe this drug to those trying to lose weight. Is it medical malpractice to recommend a drug for a purpose that the FDA has not approved?

Off-label prescribing is a common practice

It would be cost-prohibitive for medication manufacturers to test a drug for every possible use. Therefore, the FDA and medical licensing boards recognize off-label prescribing is a reasonably safe practice. Physicians can assume that a drug approved for one purpose is reasonably safe to use for other medical purposes as well.

There are times when off-label prescribing can constitute medical malpractice. One of the most common would involve a situation where the medication has warnings about use in certain situations. The drug Cytotec, for example, bears a prominent warning advising doctors that it is not safe to use for pregnant women. If a doctor then gave someone the drug during labor, as some physicians do, their choice could constitute medical malpractice if the patient has an adverse reaction to the drug.

Physicians generally need to understand the risks and side effects that a medication has. They must evaluate the appropriateness of prescribing a medication based on current research about the drug and their knowledge of a patient’s medical history. When a doctor prescribes a drug for use in an inappropriate situation or to a patient who is at increased risk of serious side effects, that decision could constitute medical malpractice.