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Is off-label drug use a form of medical malpractice?

When a doctor diagnosed your spouse with cancer, you knew you would seek out any treatment that would improve their prognosis. A doctor eventually recommended that your spouse try not traditional treatments like chemotherapy but a drug often used for a different kind of cancer.

Your spouse agreed, but the treatment was not effective. Now, they require even more aggressive therapy or have fewer treatment options because of the delay. Was the off-label administration of that drug a form of medical malpractice?

Off-label drug administration is common

The process of getting Food and Drug Administration (FDA) approval for a medication is lengthy and expensive. Pharmaceutical companies need to fund studies that show a new medication or treatment is effective and reasonably safe. When the FDA believes that the evidence supports the claims made by the manufacturer, they can approve the use of the drug in specific circumstances.

All FDA-approved drugs should be safe for human use. While some drugs may have limitations regarding your use in specific populations, like pregnant women, you can generally expect drugs approved to treat one condition to be safe to use in people with other medical conditions. The simple act of using a drug for an unapproved purpose or off-label is not inherently medical malpractice.

However, general safety does not equate to effectiveness nor to safety in a specific situation. Especially if a doctor fails to notice a possible drug interaction or uses a medication for a purpose that other doctors believe is questionable, their choice could constitute medical malpractice.

Expert medical testimony can help those hurt by malpractice

Often, to build an effective and convincing claim of medical malpractice, you will need to show that what a doctor did is not what another reasonable physician with a similar education would do. While the simple act of administering a drug for a purpose other than its FDA-approved uses isn’t malpractice, the treatment decisions made could still be malpractice.

If there were other, more effective treatments that the doctor ignored in favor of a questionable prescription, that could be malpractice. Giving a drug to someone who is an at-risk population for that medication or who takes other drugs that may interact with the treatment could also be malpractice.

Determining what another doctor would have done in the same situation is often a starting point for a medical malpractice claim based on poor decisions about medications.