As someone without a medical education, it can be hard for you to understand when your doctor’s behavior might be medical malpractice. After all, malpractice occurs when someone fails to meet the established standard for their industry or fails to do what another reasonable professional in the same field would do in the same situation.
When you don’t understand what a doctor should do or what a doctor would do, you will have a hard time judging your own physician’s behavior and decisions. For example, your doctor may have recommended that you take a medication for an off-label purpose.
If you later had an adverse reaction to that medication or if it failed to treat your condition, you may wonder if their decision to give you the drug for an unapproved purpose constitutes medical malpractice.
Off-label drug use is not always medical malpractice
The Food and Drug Administration (FDA) carefully evaluates claims made by drug manufacturers for accuracy and for safety. Manufacturers can only make claims about the medical effects of a drug when they have research to support those claims. They can then produce and market the drug for the FDA-approved purpose backed by their research.
Given that the FDA considers approved drugs to be generally safe when properly administered, it is possible for a doctor to administer a drug for another purpose other than the approved one safely. Off-label drug use occurs when a physician decides to use an approved medication for a completely different purpose than the one(s) for which the manufacturer sought approval. Whether or not the decision to give a drug off-label is medical malpractice will largely depend on the circumstances.
When is off-label administration a form of malpractice?
One of the most obvious reasons that off-label drug use could constitute malpractice is when a doctor intentionally ignores a safety warning, possibly by using a drug for a woman who is pregnant when that medication has an explicit warning against using it for pregnant women. Additionally, the doctor needs to have sound reasoning to justify their decision to use the drug the way they did.
Reviewing your medical records can be a good starting point if you think you may have a medical malpractice claim based on a doctor giving you a drug for an inappropriate or unapproved purpose.