What's the difference between the cautious use of a medication or medical device "off-label" and carelessly exposing a patient to unnecessary medical risks?
Using a medical product off-label means using it in a way that isn't approved or recommended by the Food and Drug Administration (FDA). The off-label use of drugs and medical devices is a perfectly acceptable practice that's actually led to a lot of progress. For example, Botox injections made the leap from cosmetic surgery to use for everything from migraines to cervical dystonia over time through its careful off-label applications.
Doctors are given a wide latitude to make decisions about the off-label use of medical products, as long as the use is deemed to be appropriate based on his or her professional opinion. However, the boundary line between what's appropriate and what's not rests on a basic standard. The physician must ask, "Is this what other similarly-trained physicians would do in the same situation for this patient?"
If not, that's a violation of standard medical care and malpractice.
For example, a Chicago hospital just settled a $30 million lawsuit with the family of a young child who underwent 24 surgeries in 17 months, several of which involved procedures that were unproven. In one case, a stent was used to fix a leak in the child's esophagus. In another surgery, a suturing device was used to attempt to repair the esophagus in a move that was deemed to be both off-label and "inappropriate." The physician ended up puncturing the child's pulmonary artery and the child will now require lifelong care.
When a physician takes too many liberties and disregards his or her patient's safety, the patient can end up suffering a lifetime of complications that never should have happened. There's a huge difference between a surgery or treatment that's merely risky and one that's medically careless.
If you suffered an injury from the off-label use of a drug or medical device that you believe was inappropriate or irresponsible, consider contacting an attorney for advice and the possibility of a medical malpractice suit.
Source: Chicago Tribune, "$30M malpractice settlement against doctor who worked at Chicago hospitals," Ameet Sachdev, Feb. 22, 2017