Reporting Pharmaceutical Frauds and Acts of Misrepresentation

There have been some large cases filed under the False Claims Act related to the Opioid crisis. A few billion-dollar settlements have hit so far. Here’s hoping they as well as the cases now 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 trying to argue 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.

The State of Oklahoma v. Johnson & Johnson

Just last week 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 Mark Hunter v. Purdue Pharma et. al.  Case No. CJ-2017-816 ¶ 3.)

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 that harm.

This set of cases is only the worst and latest example to demonstrate who really was greedy and the consequences. We can’t make everyone whole or be sure this kind of thing will never happen. We do hope that the False Claims Act continues to be used and 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 this Judge’s opinion to see what can happen and think about that when they rule on a case.