Reporting Pharmaceutical Frauds and Acts of Misrepresentation
There have been some large cases related to the Opioid crisis. A few half-billion-dollar settlements have hit so far. Here’s hoping they, as well as the new cases being litigated and settled, provide a reminder to the industry about what they should and should not be doing when marketing drugs.
Not long ago, drug companies were almost effectively arguing that their right to say almost anything about any product was protected by the First Amendment. The current state of Opioid addiction and resulting litigation belies such a notion. These Opioid cases also have some interesting applications with regard to the False Claims Act. Many of the defenses cited in the Opioid prosecutions have also been used in False Claims Act cases and, they are proving not to be very persuasive to the Judges in this context.
The State of Oklahoma v. Johnson & Johnson
Just recently a Judge ordered Johnson & Johnson to pay Oklahoma $572 Million for failing to inform consumers about the dangers of opioid use and exaggerating the benefits of opioids. That is for one State’s worth of the drug.
The Decision is still subject to appeal. It was decided based on Oklahoma’s public nuisance law, not the False Claims Act. Yet, the Judge discusses arguments familiar to False Claims Act litigants. The agreed facts as presented by the Judge are staggering. They include that that from 1994 to 2006, prescription opioid sales increased fourfold. In addition, from 2011-2015, more than 2,100 Oklahomans died of an unintentional prescription opioid overdose. Also undisputed is that in 2015, over 326 million opioid pills were dispensed to Oklahoma residents, enough for every adult to have 110 pills. Perhaps most disturbing in 2017, 4.2% of babies born covered by SoonerCare were born with Neonatal Abstinence Syndrome (also called NAS), a group of conditions caused when a baby withdraws from certain drugs it’s exposed to in the womb before birth.
(See, Judgment State of Oklahoma Ex. Rel Mike Hunter v. Purdue Pharma et. al. Case No. CJ-2017-816 ¶ 3.) Mr. Hunter is the Oklahoma Attorney General filing the case on behalf of the State.
Arguments about the idea that the First Amendment protects commercial speech in making false marketing statements were rejected in this Judge’s decision as the Court found the statements to be misrepresentations. There are still thousands of cases in litigation as a result of this crisis and reports of multi-billion-dollar settlements in the offing. None of that money would make anyone harmed entirely whole, of course.
When those of us working in this area complain about the misleading promotion of drugs or medical devices or services, we rarely can point to the extent of that harm to patients or refer to as many patients harmed as presented by this crisis. The point is though, such misleading marketing of medical products always puts the patient last and the dollars first.
Reward for Reporting Medical and Pharmaceutical Frauds
Relators who point out allegations regarding the misrepresentation and or illegal marketing in this field, and attempt to obtain a reward under the False Claims Act for making such reports, often face being called greedy. Yet, if they shut down the dangerous use of a medical drug or device being marketed for an improper use or being marketed to be used in situations for which it is not appropriate, not only do they recover money lost by the Government, but also they may save people from serious harm.
The Opioid litigation is only the latest example to demonstrate who really was greedy and the consequences of that greed. We can’t make everyone whole or alas even be sure this kind of thing will never happen.
We do hope that among other tools used, the govenrment will aggressively use the False Claims Act. It should be cherished as a way to fight fraud under such circumstances.
We hope that when those reporting fraud in medicine attempt to make their cases, people including people in decision making roles, will look at the Judge’s opinion in State of Oklahoma Ex Rel Mike Hunter v. Purdue Pharma et al. to see what can happen and think about that when they rule on a case.