Posted by Bill Sandweg on 28 January 2019.
Off-label use is the use of a medication or a medical device for a purpose other than the purpose the Food and Drug Administration has approved for it. Doctors sometimes prescribe a medication originally developed to treat one medical condition to treat a completely different condition. This usually takes place after studies have shown that the drug has some benefit for the new use. The same goes for medical devices. Sometimes, they can be successfully used for a purpose other than the one for which they received FDA approval.
It is not always malpractice to use a drug or a medical device for a purpose other than the one approved by the FDA. It is definitely not illegal. Once the FDA has approved a drug or device, it can be lawfully prescribed for other uses. On the other hand, this off-label use of a drug or device may be malpractice in certain situations.
The definition of medical malpractice is conduct which falls below the standard of care for the physician or other health care professional in question. The standard of care is defined as that minimum level of care that would be provided in the same or similar circumstances by a reasonable health care provider in the same specialty as the provider in question. So if the doctor in question is a Board Certified Cardiologist, the issue is what would a reasonable Board Certified Cardiologist do in the same or similar circumstances. The standard of care is almost never written down. It is what doctors and other health care providers say it is.
Using the definition of standard of care, if a reasonable physician would prescribe the medication or use the medical device to treat the problem, then it is not medical malpractice for another physician to do the same thing, even if the use is not the one for which the FDA approved the drug or device. In deciding whether something is what a reasonable doctor would do, it is not a counting contest. Something can be disapproved by a majority of doctors but still be within the standard of care if a “respected minority” of doctors would do it that way or if there can be a reasonable disagreement about how to do it.
Of course, in a trial, the jury does not get to hear what a majority of doctors would do. The patient gets to bring in one expert per medical defendant to offer an opinion that the defendant doctor fell below the standard of care. The defendant doctor gets to testify that he or she acted reasonably in using the drug or device AND gets to bring in an independent expert to say the same thing. Bottom line is that the defendant always gets two witnesses to say the standard of care was met and the patient only gets one to say it wasn’t.
When the FDA approves a drug or a device, there is a label that goes along with the approval. It describes the approved use and gives warnings and advice about possible adverse outcomes and reasons not to use the drug. Any time a provider is prescribing a drug or device for a different use, he or she is taking a chance that the jury will conclude that there was not enough basis for the off-label use and that it was malpractice to use it that way. This is most likely to happen if the use is one that the manufacturer includes in the warnings or in the adverse outcomes.
As always, make sure you understand what your doctor is doing with your care. Learn about the medications being prescribed for you. Read the labels and the package insert. You can find these on line. Read about any devices your doctor intends to use before you agree to have them placed in or on your body. Don’t be a guinea pig by mistake. If they are going to experiment on you, make sure you know about it in advance and approve.