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Can off-label prescribing constitute medical malpractice?

On Behalf of | May 9, 2025 | Medical Malpractice |

Medical doctors are subject to many professional standards. They have to attend years of post-secondary schooling and complete state testing to work in medicine. They must commit to continued education throughout their careers. They need to remain up to date on cutting-edge treatments in their area of specialization and observe their employers’ standards when providing care to patients.

Sometimes, doctors make decisions that significantly deviate from best practices. Their choices may put their patients at unnecessary risk. In some cases, the questionable decisions made by doctors directly cause harm to their patients.

There are certain medical habits that could lead to negative outcomes for patients who trust their doctors. For example, doctors may make mistakes when prescribing medications to their patients. In some cases, they may prescribe a medication for an off-label use. Can an off-label prescription justify a claim of medical malpractice?

Doctors must use their discretion when choosing treatments

There are a variety of different interventions and drugs that can help people control different medical conditions and symptoms. In some cases, doctors may choose to use a medication for a purpose other than its approved medical function.

When drug companies develop new medications, they have to test the drug to ensure that it is reasonably safe and that it is more effective than a placebo for treating certain symptoms. Once the FDA approves the drug for one purpose, doctors can then prescribe the medication to their patients.

It is reasonable for a physician to assume that a drug approved by the FDA is safe for patients to take in most scenarios. Off-label prescribing is common in part because drug testing is quite costly. Companies that secure FDA approval for one use of a medication may not want to invest in seeking approval for other uses. However, the existing research into the medication may make it clear that the drug could help those with certain symptoms or conditions.

Provided that there are no clear contraindications, off-label prescribing is a reasonable practice. However, some types of off-label prescribing can be downright dangerous. For example, doctors may administer the drug Cytotec, or misoprostol, during labor and delivery to assist with cervical dilation in a basement.

However, the drug bears a warning label that it can cause uterine rupture and miscarriage in pregnant women. In scenarios where doctors miss obvious contraindications or recommend drugs that could be dangerous for a particular patient, then off-label prescribing could constitute medical malpractice.

Learning more about best practices for different medical matters can help people determine whether they may have grounds to take action against a doctor after a poor treatment outcome. Pursuing a medical malpractice lawsuit can help people address the medical and financial aftermath of a prescribing error.

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