Is it medical malpractice in Pennsylvania if injury occurs due to an off-label medication? The practice is a slippery medical slope. Taking a misappropriated drug for what it was not intended sounds wrong. But it is relatively common in medical communities. It’s not unusual for a clinician to prescribe a drug for a use that manufacturers never intended, and it’s not unusual for that unapproved purpose to harm the patient.
Is it malpractice whenever you use an off-label drug?
A doctor who gives you an off-label medication is not outright guilty of medical malpractice. The application needs the support of science that falls under the standard of care. If there are side effects, the doctor should inform you. That’s especially true if the meds were not tested for the use given.
But responsible doctors do not do this unless they have sound reasons. A good example is Viagra. The medication was originally designed as an application to treat high blood pressure. Reported side effects in those cases also uncovered another side effect. That resulted in off-label prescribing for impotence.
What if there weren’t sound reasons?
Should a clinician prescribe off-label medications where better alternatives are readily available or if there was no medical reason for the action, a malpractice claim is feasible if you experience harm. Legally, you have to evidence how the chosen prescription caused harm and that there were other (ignored) options. Only then is malpractice a consideration.
Is the manufacturer liable?
Theoretically, drug manufacturers are not held accountable when your doctor purposes their product outside its intended use. The company is responsible for the standards and testing approved by the FDA. Any use outside of the drug’s approved and intended purpose falls out of the manufacturer’s jurisdiction.
According to the Agency for Healthcare Research and Quality, one in five prescriptions is off-label. It’s a common, legal practice. But a clinician is still responsible for their actions and any medical malpractice.
