Using a medication for a purpose which was never approved by the Food and Drug Administration (FDA) sounds like a recipe for disaster, but the practice is surprisingly common. As many as 40 to 60% of all prescriptions are for uses which the manufacturer never intended, but most of the time these drugs only help patients.
Sometimes, however, a doctor prescribes a drug for an unapproved purpose which ends up harming the patient. When this happens, that physician may be liable for a medical malpractice claim.
Is Off-Label Use Always Malpractice?
In most cases, a doctor who prescribes an off-label medication does so for sound medical reasons. Sometimes, new uses for a drug are discovered during the FDA approval process, or other physicians or researchers discover that a medication is helpful for a certain condition. This happens frequently—famously, the drug Viagra was not originally intended as an erectile dysfunction medication, but as a medication which treated high blood pressure. After patients reported certain side effects, it began to be prescribed for off-label treatment of impotence.
A doctor who prescribes a medication for an off-label purpose is not necessarily guilty of malpractice. If the use is supported by science, and the prescription falls within a doctor’s applicable standard of care, there will be no malpractice. Physicians still have a duty to warn the patient of any potential side effects, especially if the medication was never tested for that particular use.
If, however, the doctor prescribes an off-label medication when there are better alternatives, or when there is no medical reason to do so, then a malpractice claim might be a possibility. When a patient can show that there was a better alternative, and that the doctor’s choice of prescription led to an injury, then the doctor might have committed malpractice.
Does the Drug’s Manufacturer Have Any Liability?
In general, the drug’s manufacturer of a medication cannot be held responsible for any complications due to its off-label use. Pharmaceutical companies must put their medications through a rigorous trial and testing process to gain approval from the FDA, and they are usually only responsible for the way the drug behaves when used for its intended and approved purposes.
However, pharmaceutical manufacturers cannot promote their drugs for unapproved uses, and often face stiff sanctions and fines when they are caught doing so. In addition, the drug companies have a responsibility to report any known side effects, even when those side effects result from the off-label use of a drug. When the companies hide side effects, or promote their medications for unapproved purposes, the manufacturer may shoulder some legal responsibility for any harm their drugs cause.
It can be difficult to tell when the problems a medication causes is a known side effect or a result of negligent off-label prescribing. When your medical malpractice lawsuit relies on complicated evidence, you need an attorney who understands the medicine as well as the law. Attorney Bradley I. Kramer, M.D., is both a doctor and a lawyer. He and his team of dedicated legal and medical professionals use their expertise to help you get justice after an injury caused by medical negligence.
For a free consultation at the Trial Law Offices of Bradley I. Kramer, M.D., Esq., call us today at (310) 289-2600 or use our online contact form to have your case reviewed for free.