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OFF LABEL USE IN THE NEWS AND IN THE COURTS

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. One reason for the massive lack of information is that drug and device companies benefit financially from off-label use because it expands the market for their narrowly approved drug or device. Imagine how much extra money the makers of aspirin have made since the world began using it to prevent heart attacks! The makers of Chloroquine could not make it fast enough once President Trump recommended it for COVID treatment from his presidential podium. It’s a whole new market. A whole world of profit awaits the company whose drugs or devices are used for unintended purposes! It is easy to see who wins.

But who loses?

What happens if the uninformed doctor is a surgeon who permanently implants a medical device “off-label” in a patient without knowing it was not FDA-approved for that use? Permanently implanting an “off label” device is different from prescribing Chloroquine for COVID, because the patient can stop taking a drug when they have side effects or realize it is not working. Patients can’t simply try something else if they are unhappy with an implanted medical device.

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. The company who sold it for an off-label use and the sales rep who knowingly watched it happen during surgery lose money if they intervene. Sales reps risk losing commission. Manufacturers are watching their bottom lines. Who’s looking out for the patients?

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. Unfortunately, pharmaceutical companies are masters of regulatory manipulation.

My firm is representing people injured by off label use of permanently implanted hip implants, and so far, every surgeon has testified that they were unaware that their use of the implants was off label. All of my clients were unaware at the time of surgery.

And they are understandably angry when they learn their implants were not approved for their particular surgeries. Why was I given this if it was not approved? What was wrong with using approved devices? What was the surgeon thinking? The answer is usually that the company and sales rep knew but did not tell the surgeon because that is bad for business. Instead of taking the time to read the material accompanying the components of each device, surgeons rely on the expertise of those most familiar with it: the sales representatives and the manufacturer. It’s a broken system!

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 them, but the company peddled them to doctors who implanted them in patients anyways. To use the Chloroquine for COVID as an example, that would be like promoting the drug after the FDA had specifically rejected it for COVID treatment.

The company obviously knew about each rejection but kept surgeons in the dark. What surgeon would use such implants? Most say that, had they known, they would have used something else. What patient would want rejected implants in their body?

However, Surgeons are usually very busy people. Surgeons are human. Surgeons make mistakes. Manufacturers take advantage of that by building a rapport with surgeons and then convincing them to use unapproved devices, knowing that many of these doctors are too busy to seriously double-check. A surgeon’s job is to treat patients. The medical device company’s job is to sell devices, not help patients. Companies like Smith & Nephew might pay lip service to patient safety, but their focus is ultimately on making money, and that means somehow getting the shiniest, newest device into surgeon hands no matter what.

Why? Greed. Pure and simple. In the early 2000s, metal-on-metal was the hot new thing and every surgeon wanted it—and every company wanted to sell it, including Smith & Nephew. 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.

Typically, the FDA provides a safety net by only approving devices for limited, proven uses. The FDA’s safety net is compromised when the manufacturer promotes a device off-label. That’s why the FDA has created strict rules about what a company must do if they promote something off-label to a surgeon: the company must tell the surgeon that it is off label use. The FDA’s prohibition against off label promotion applies whether the surgeon is in Washington D.C., Beaumont, Texas, or anywhere else in the U.S. But enforcement is difficult; the FDA relies on honesty. Companies are expected to follow the rules.

A patient who sues Smith & Nephew for injuries from unapproved hip implants may think they are “pursuing justice.” But many fail to hold the sales rep accountable. This well-informed professional knowingly sold a device for off label use and then watched the unapproved surgery, usually saying nothing about the FDA’s rejection. The FDA has long recognized that it is the surgeon’s responsibility to know what a device is intended for, and they are responsible if they use a product off label without disclosing that. Ultimately, he or she is the one performing the surgery and the only one capable of reading all the accompanying materials.

You are going to a court battle against the company with only one-third of your weapons – if you don’t sue everyone involved in your surgery with FDA-rejected Smith & Nephew parts. More than two hundred people nationwide have done exactly that in pending lawsuits. And more cases were filed just this week! In my opinion, these folks are leaving some of their strongest weapons at home.

I have previously blogged about how medical device cases are like a three-legged stool. It’s a sturdy stool – or case. You sue the sales rep, who knew the device was being peddled for off label use but said nothing. You sue the manufacturer, who knew but who was enjoying healthy profits. And you consider suing the doctor, who is too busy to read about your product, but is the only one standing between you and a bad implant.

My next blog will discuss the specifics of a Smith & Nephew metal hip implant case with examples from cases I am involved in now.