Off-Label Drug Use Comes with Risks

Prescribing medications for purposes not recommended by the manufacturer or approved by the FDA can cause harm to patients and expose physicians to malpractice liability. Off-label prescription drugs make up approximately 40 to 60 percent of all U.S. prescriptions. They are commonly used to treat illnesses and conditions such as AIDS, cancer, rare diseases, and pediatric conditions.

Experimental Research

When off-label prescriptions are used as part of experimental research on a patient, he or she may be able to hold the prescribing physician liable for damages. Physicians should only prescribe off-label medications based on their own judgment, peer-reviewed resources that display sufficient scientific evidence, opinions of colleagues, desire to benefit the patient, and documented medical practice.

Lack of Informed Consent

Patients should always be informed about and understand the medications they’re prescribed, along with the specific risks and benefits that come with them. While the rules regarding what is considered material information may vary from state to state, the “reasonable physician” standard is generally viewed as the golden standard. This standard judge the prescription based on whether or not a reasonable physician would give patients the information discussed in court. However, there are many disagreements over whether or not physicians need to disclose that a drug is “off-label.”


Patients may also have a valid medical malpractice claim due to negligence if the plaintiff can prove that the physician’s level of care strays from the hypothetically reasonable care under other physicians. Courts determine this by comparing the physician’s standard of care to that of other similarly situated physicians.

Avoiding Risks Around Off-Label Prescriptions

Generally, patients can avoid a lot of the risks associated with off-label drug use by making sure that:

  • They ask questions about new medications. Physicians may not readily inform patients that a drug is prescribed for off-label use, so it’s a good idea to ask.
  • They choose physicians who are motivated solely by a desire to properly diagnose, treat, and benefit the patient.
  • Request an expert medical opinion when in doubt about a medication prescribed.
  • Ask their doctors if the particular use is supported by sound scientific evidence.

By taking these precautions, patients can reduce their risk of suffering serious injuries, side effects or illnesses when using medications prescribed for off-label use. Medical malpractice lawyers can clarify the laws regarding liability when doctors prescribe off-label drugs.