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Is writing an off-label prescription a form of medical malpractice?

On Behalf of | Apr 3, 2024 | Medical Malpractice

People who seek out medical care generally expect that treatments should improve their symptoms. Unfortunately, some people have adverse reactions to medical treatment and could end up in a worse condition than they were in when they initially sought care.

The average individual has a hard time determining when the medical professional overseeing their treatment could be to blame for their unfavorable outcome. For example, someone who experienced severe side effects from a medication may wonder if the doctor’s decision to prescribe that medication may have been malpractice. One of the scenarios that leads to such questions involves a doctor prescribing a medication for off-label use.

Off-label prescribing is common

When drug manufacturers seek approval for new medications, they have to conduct rigorous testing. The testing process typically needs to show that the medication is reasonably safe when taken appropriately and that the medication is more successful than a placebo at treating certain symptoms.

Once the FDA approves a medication for a particular use, there is an assumption that the drug is reasonably safe to use for other purposes as well. Off-label prescribing occurs when a physician writes a prescription for a medication with the intent to use it for an unapproved medical purpose. Off-label prescribing is not automatically medical malpractice but can sometimes constitute malpractice.

When could off-label prescribing become malpractice?

There are several scenarios in which people may reasonably claim that a doctor’s prescribing habits did not conform with current best practices. For example, perhaps the doctor failed to check someone’s medical record and prescribed them a medication to which an adverse reaction was easily predictable given their response to prior treatments.

Maybe the physician failed to notice crucial contraindications that make certain medications dangerous for specific people. If a physician ignored current best practices for a specific type of drug or made another error in judgment when prescribing a medication for off-label use, then the situation could potentially constitute medical malpractice.

The first step for someone questioning whether a doctor erred in recommending a certain medication to them involves talking to another physician to evaluate what best practices currently require for that specific medication. In scenarios where other physicians with similar training would recognize that giving someone a specific prescription was a dangerous choice, the patient affected by that decision may have grounds for a medical malpractice lawsuit.

Filing a medical malpractice lawsuit could lead to financial compensation. A patient taking legal action could also lead to changes in how one professional or business practices medicine. As such, those affected negatively by prescribing practices may benefit from learning more about their rights and options under the law.