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Is the recommendation of off-label drug use medical malpractice?

On Behalf of | Jul 12, 2023 | Medical Malpractice

Sometimes, medical treatment that should help or heal someone causes negative medical consequences instead of improving their condition. Occasionally, such issues are simply the result of someone’s unique biology, as they may have a previously-unknown allergy or sensitivity. Other times, the poor outcomes people experience during medical treatment directly relate to mistakes amount to unprofessional conduct on the part of medical care providers.

When doctors cut corners or don’t follow best practices for their area of specialization, their patients may be at elevated risk of an adverse outcome. There are many ways in which doctors could deviate from best practices and professional standards. Would the decision to administer a medication for an off-label purpose constitute a professional error that could potentially be medical malpractice?

Off-label recommendations are not automatically malpractice

The Food and Drug Administration (FDA) requires that pharmaceutical companies conduct studies looking at the efficacy of drugs for any treatment claims that the manufacturer makes. Studies have to establish that the drug has a medical effect on patients and also that it is reasonably safe.

If the FDA reviews the information submitted by the drug company and determines that the studies do show the drug is a viable treatment option for certain conditions, the FDA will approve the drug only for those specified uses validated by the study that the manufacturer conducted. However, that does not inherently mean that the medication is only safe or useful for that purpose.

Instead, there is a presumption that the medication is generally safe when used in appropriate circumstances. Doctors might choose to use a drug approved for one form of cancer to treat another form of cancer. They could use medications recommended for one neurological condition to control the symptoms of a totally different health issue.

Provided that their patient does not have any known contraindications, an off-label drug recommendation is not inherently a form of malpractice. Still, patients can potentially put together a malpractice claim if they can show that they had a known contraindication for that kind of medication or that the doctor deviated from the best prescribing practices regarding the dosage of the drug, the other medications someone was on or other crucial factors.

When a medical professional does not do their due diligence or when they make a mistake by recommending a medication to someone for whom it is not appropriate, they may sometimes incur liability for doing so. Discussing what seems like a medical error with another physician – and with a legal professional who handles medical malpractice cases – can be a good way to evaluate whether a doctor’s decisions significantly deviated from established best practices and could, therefore, constitute actionable medical malpractice.