In discussing a surgical procedure, the phrase œoff-label use refers to the use of medical devices for an unapproved indication or an unapproved form of administration. Generally speaking, off-label use is legal unless it violates the standard of care to the patient, a specific ethical guideline or any safety regulations. Even thought it is legal, it does carry significant health risks and differences in legal liability. If a physician uses a device for a medical ailment that is not in the approved or cleared labeling, a pysician is required to: (1) evaluate whether there is sufficient evidence to justify the off-label use; (2) press for additional information and research when adequate evidence is lacking; and (3) inform patients about the uncertainties and potential risks associated with off-label prescribing.
In the case of Patricia Lancaster, Dr. Quadri & the staff at Orange Park Medical Cener (OPMC) used a polyflex stent to attempt to open her colon, which is considered an off-label use of this stent. The FDA has only approved the polyflex stent for esophageal indications, not colorectal conditions. Nevertheless, it can be used for colorrectal conditons but only in an experimental fashion.
When a product such as a polyflex stent is used in an experimental fashion, the patient should be fully informed of the procedure and associated risks. The patient should have a full understanding that the endoscopic stenting for his or her condition is experimental and the patient must then give full informed consent before the procedure is conducted. The patient must understand the potential complications and that there may be a need for multiple endoscopic reinterventions. The patient must also be aware of the training, qualifications and experience of the physician related to the experimental procedure. Also, the patient should be made aware that there is a lack of data in the literature on the short and long-term outcome of the off-label procedure. Unfortunately, in Mrs. Lancaster’s case, none of this was done by Dr. Quadri or by OPMC.
When a physician does not have the experience to use a medical device for an off-label use, the effects to the patient can be significant. Patricia Lancaster experienced this first hand. The polyflex stent tore a hole in her colon, and she now has a permanent colostomy bag that she will wear for the rest of her life. This procedure also caused her to have her leg amputated.
We don’t disagree that there can be a benefit for off-label treatments. However, Patricia Lancaster had the right to know that the procedure that OPMC allowed Dr. Quadri to perform was off-label so that she could make an informed decision as to her own care and treatment. Mrs. Lancaster was never informed that this procedure involved the off-label use of a stent, which was meant to be inserted in a person’s throat and not his or her colon. Mrs. Lancaster was never informed about the inherent risks of this procedure. Mrs. Lancaster was never informed as to whether Dr. Quadri was qualified to perform this procedure. Mrs. Lancaster trusted Dr. Quadri and OPMC to protect her and to put her safety first and they did not.