We trust our doctors’ judgment when they prescribe medications. But what if their prescription isn’t necessarily approved by the Food and Drug Administration? Known as off-label drug use, this practice can raise important questions about patient rights and legal recourse.
What is off-label drug use?
Off-label drug use is when physicians prescribe medications for purposes not included in the “Indications for Use” section of your medicine’s packaging. Doctors often turn to off-label prescribing when standard treatments fail. They also prescribe drugs off-label for rare conditions without approved therapies, usually based on emerging evidence.
Although the practice is common, it still carries many potential risks. As such, you need to receive full disclosure about the treatment and all its possible side effects.
The importance of following standard of care
Off-label drug use itself isn’t automatically illegal or a form of malpractice. In fact, it’s accepted as standard practice in certain situations.
You may still potentially sue for malpractice if you suffered harm from the off-label drug use. You may have grounds to sue if your doctor was negligent about prescribing the drug, such as if they failed to inform you that the use was off-label or there was no accepted practice to use the drug that way.
The key factor is whether the prescribing physician followed the accepted standard of care. The standard considers what a reasonable, similarly trained doctor would do in the same situation.
Proving an off-label drug use malpractice claim
To establish a valid claim, you typically have to prove:
- A doctor-patient relationship existed
- Your doctor breached the standard of care
- This breach directly caused harm
- The harm resulted in specific damages
Proving malpractice in off-label cases presents unique challenges, often requiring expert testimony to establish the appropriate standard of care.
The path forward for affected patients
You have the right to pursue justice and compensation for any injuries resulting from medical negligence. Remember to seek immediate medical care, not only for your health concerns but also to document your symptoms. This documentation can strengthen potential legal claims later. Moreover, working with experienced legal counsel may further help you. They can guide you through filing the medical malpractice claims and help you fight for your due compensation.
