There has been a lot of talk in the news lately about “off-label use” of various medicines for treatment of COVID-19. Just yesterday, the FDA’s “FDA MedWatch Drug Safety Communication” arrived in my inbox. Receiving an email from the FDA about injuries from unapproved uses of drugs or devices is not unusual for me. But yesterday’s FDA Notice was different because the one promoting off label use was not a sales rep or pharmaceutical company. It was the President of the United States!
“Off Label Use” of a drug or device refers to using that product in a way that is different from FDA specifications. The idea is that there is a “Label” for every drug or device and the FDA approves the product only for that specific use. An over the counter example of this is aspirin. It is approved to treat minor pain, but it is used “off label” to help prevent heart attacks. A prescription drug example of that is what President Trump has been discussing lately: Chloroquine for treatment of Coronavirus.
The FDA’s announcement yesterday was a public health advisory to warn the public that promotion of the off-label use of Chloroquine was dangerous. It is not a recommended or approved medical strategy to treat or prevent COVID; every doctor who recently prescribed it for COVID knew it was an experiment – an act of desperation. They almost certainly told their patients it was off-label as well.
But what happens when the situation is different, and the doctor does not know he or she is using a drug or device off label? Everything changes when that happens. How can the patient make an informed decision about an off-label use if the doctor is uninformed? Who benefits from that lack of knowledge? Who is harmed? This blog and my next one later this week will help explain all this in the context of medical devices that are permanently implanted in people when neither the doctor nor patient knows it is off label.
It may seem hard to believe that a doctor would not know what is on the label of a drug or device he or she prescribes, but it unfortunately happens all the time in America. One government-sponsored survey concluded that over forty percent of physicians were unaware that at least one combination of drugs they “commonly prescribed” was not FDA approved. See https://www.ncbi.nlm.nih.gov/pubmed/19697444.
What exactly happens when a patient is implanted with a medical device that was not FDA approved for that purpose? Nothing, usually, unless there are problems. Off-label prescription of a drug or device can have deadly consequences. That is why the FDA only approves devices for certain, limited uses. The company has to submit scientific data showing the device is safe and effective for the “intended uses” spelled out in its application for approval. There is a short cut that allows clearance of the device if it is similar to already-approved devices, but FDA clearance or approval is still needed before a device can be legally marketed in America. To me, that all sounds like a reasonably good system—if the rules are followed.
My firm is representing people injured by off label use of permanently implanted hip implants.
My law firm is focusing on helping people who were implanted with unapproved hip implants. I am focusing exclusively on Smith & Nephew metal hip implants because the FDA specifically rejected certain metal-on-metal components for total hip replacement surgeries.
Smith & Nephew is the only major implant maker that never could secure FDA clearance for using a metal on metal implant in a routine total hip replacement surgery. The company was required to disclose that to surgeons before giving them access to their metal devices.