As readers of this blog know, your two cohosts met more than a decade ago, when they were toiling side by side in the Orthopedic Bone Screws wars. We hope you’ll forgive a moment’s reflection about what those cases taught us about the informed consent process.
In 1993, the FDA-approved labels for “bone screws” indicated the devices for use in the “bones,” but not specifically for use in the “bones of the spine.” Although the surgical standard of care required using bone screws in spinal surgery, that constituted an off-label use of a medical device.
Spine surgery was, before 1993 (and to some extent remains today), a problematic medical procedure. Spinal fusion surgery was a last-ditch effort to help patients who didn’t benefit from less drastic treatments. For some patients, fusion surgery worked like a charm and cured what ailed them; for others, the surgery achieved nothing or actually made things worse. This was no surprise; everyone knew this going into the surgery.
After Barbara Walters did her thing on 20/20 (on December 17, 1993, the day we became conservatives), the mass tort bar filed thousands of Bone Screw lawsuits on behalf of patients who claimed that spinal fusion surgery had not cured their ills. One key piece of the claims rested on a supposed lack of informed consent: “My doctor never told me that the FDA had not approved using bone screws in spinal fusion surgery. If I had only been warned, I would never have consented to the operation!”
This is ridiculous, of course, for endless reasons. Here are a few:
1. Everyone puts medical devices to off-label uses. Q-tips (“cotton-tipped swabs”) are not labeled for removing wax from ears; does that give anyone a moment’s pause?
2. People consenting to spine surgery signed consent forms that said things like, “The risks of surgery include paraplegia, quadriplegia, brain damage, and death.” The patients consented. How many people would have refused consent if they had only been told that, “The risks of surgery include paraplegia, quadriplegia, off-label use of bone screws, brain damage, and death”?
3. If a physician explained that the off-label use of bone screws had not been approved by the FDA, but the technique was widely used, recognized as the standard of care, and the most likely cure for the patient’s ills, would any patient truly have rejected the treatment?
And so on.
Happily, we won the bone screw wars, and the case law now overwhelmingly holds that off-label use of a drug or device is not a “risk” of medical treatment that must be disclosed during the informed consent process.
But what would have happened if the plaintiffs had won? Anything useful? We see only two results.
First, there would have been a massive transfer of wealth from medical device companies, physicians, and insurance companies to plaintiffs’ lawyers and to people with bad backs who had knowingly undergone a dangerous last-choice therapy.
Second, health care providers across the country would have re-written their informed consent forms to tell every patient undergoing any treatment that off-label use is always a possibility. The long, dense, informed consent form would then have included another sentence explaining that “standard of care medical treatment often requires that medicines or medical devices be used for indications not approved by the FDA. As part of your medical treatment, you hereby consent to undergo off-label treatment.”
How could we have spent the better part of a decade battling over that?