No Pain, No Claim: The False Claims Act and the Use of Painkillers in the NFL
Sports and Health Care are both businesses, in case you had not noticed. Law, I guess makes it a trifecta. We work on False Claims cases in part as a business, but we also like to think that the work improves practices and holds big players accountable for when medical judgment gets played by money.
I was reminded of this while reading an article forwarded to me on the continual problems of using painkilling drugs in the NFL.
This is a pretty extreme example of the kinds of problems inherent in using drugs and especially when medical decision-making is compromised by business.
Those of us who file false claims cases are constantly fighting those who believe that the FDA should not be able to regulate advertising for drugs. It has gotten more and more difficult to bring cases based on theories of false advertising and promoting off-label use of drugs.
Off-label promotion has gotten harder to detect, but it was the basis for some of the largest False Claims Cases. What happens though when there is tremendous pressure to use drugs for off-label uses? What happens when money messes with medical judgment?
Football provides a parable for the problem we all may face. The story about the NFL takes for granted that money was also involved in the fact that players performing meant huge money to the league and to the players too.
So, they used Toradol according to the article as follows:
After clinical trials, Toradol was approved for sale…. It was indicated specifically for the relief of severe post-operative pain. Its regular use — say, 16 times a year for several years — has never been clinically studied as a result. Toradol was contraindicated for use beyond five continuous days, reduced to two in its 2015 updated monograph. It comes with a black box warning from the FDA, the strongest that the administration requires, prohibiting its use in patients with preexisting renal problems or….
Well, you get the idea. This drug at least arguably was indicated to treat pain. We have seen cases where the drug was being advertised for or recommended for an indication for which its efficacy is not even established. Here the drug was effective in treating pain but that was as much as those using seemed to know or care about it.
Yes, in this case, the pressure and money came from the need to have athletes perform. Yes, in this case, the drug was not used in a hospital setting, which usually would mean better care. Still, the pressure at the root of all this is the same.
There was a huge financial incentive at stake and so athletes allegedly were given a drug outside of its normal use. Then it turned out the drug may have caused serious health problems.
For drug companies, the sale of a product, which has a limited shelf life for its patent price means they are under pressure to sell. We are, most of us anyway, not multi-million dollar athletes.
We have to rely on the judgment of the medical world. The money pressure is still there though. We have limited protections from this in the form of the False Claims Act sometimes fortified by regulations and law such as the Anti-Kickback Statute, Stark Law, and FDA regulations.
The money available creates similar pressures, even though we are not NFL players who are trying to make a game day. Overall, however, the financial stakes to medical device manufacturers, drug companies, and medical providers are huge.
Once you understand it is all about money, or at least a lot about money, as it is with the NFL, you start to want to see these laws enforced. You want medical judgment to be on one side divorced completely from these financial pressures. That is what these laws are designed to protect.
That is why False Claims Cases used to enforce these principles do matter. Otherwise, even if we are not football players, we will find ourselves taking a prescription or having an operation for the wrong reasons, with some serious consequences.