“Our drug industry has been disastrous. And the other thing we have to do is create new bidding procedures for the drug industry, because they are getting away with murder.”
President Donald Trump.
“He’s right – and I have been saying that for years. Pharma does get away with murder. Literally murder. People die because they can’t get the prescription drugs they need.” Sen. Bernie Sanders.
Forbes magazine claims this is the only thing where Trump and Sanders agree.
Our favorite quote comes from author and physician Ben Goldacre, “It is clear from the evidence presented… that the pharmaceutical industry does a biased job of disseminating evidence – to be surprised by this would be absurd – whether it is through advertising, drug reps, ghostwriting, hiding data, bribing people or running education programs for doctors.”
We happen to love the pharmaceutical industry and the people who dedicate their lives to saving lives and reducing suffering. Unfortunately, many times the people running the industry – pharmaceutical company executives – lose their way.
They cut corners in manufacturing, push drugs for off label uses not approved by the FDA, engage in illegal “pay to delay” tactics to prevent lower priced generics from entering the market. Many bribes physicians to push their drugs over that of a rival even if their rival makes a better product.
It’s difficult for the line worker in a drug company to fix all the problems that plague the industry. Heck, even when the politicians agree that there is a problem they can’t seem to agree on a solution.
Pharmaceutical workers aren’t as powerless as they may think, however. An underutilized 19th century law makes it easier than one may think for David to take on Goliath and win.
We have spoken with many quality assurance professionals and drug company sales reps. They become disillusioned when complaints to higher ups are ignored. (Unfortunately, many find themselves ostracized and punished for internally blowing the whistle.)
A few become so disillusioned and feel so powerless that they contact the FDA. Yet still nothing happens.
So how does the researcher, factory worker in India or QA professional make a difference.
How Pharmaceutical Whistleblowers Can Best Make a Difference
The answer is easier than you may believe assuming the right facts. And the answer goes all the way back to the U.S. Civil War.
Back in the 1860’s, vendors were selling the U.S. Army lame mules and uniforms filled with moth holes. Since the government didn’t have many resources back then, Lincoln and Congress passed the False Claims Act, a law that allows private citizens to prosecute fraud cases on behalf of the government.
There are a couple catches but before you roll your eyes, those catches aren’t all that onerous.
First, there has to be a loss to the government. Since most prescription medicines are paid Medicare, Tricare and a portion of Medicaid. Defrauding those programs gives rise to a False Claims Act violation. (We will explain why that is so important in a minute.)
The next “catch” is that whistleblowers must be the original source of the information. That is a fancy way of saying you must possess inside knowledge and not file a claim bases on speculation or information form public sources.
Finally, expect that only the first to file will receive a reward. Wait too long and you may get nothing.
Pharmaceutical Whistleblowers Get Rewards
When we were in high school, winning a tournament or excelling in sports might get you an award. Something you could put on a shelf and remember how well you performed. Under the false claims act, whistleblowers are entitled to huge cash rewards.
Often we read headlines as to how this drug company or that one had to pay $250 million to settle charges. Usually these cases are brought under the False Claims Act, a law that authorizes the Justice Department to pay a reward of up to 30% on what the collect.
In the example above, that could mean a reward of $83,325,000.00. Not a bad day. [The bottom end rewards are 15% meaning a reward of “just” $41 million.]
Are these rewards real? Our clients have walked away with $100 million in rewards. So, yes!
We are living in interesting political times today. Like Trump and Sanders agreeing on drug prices being too high, most prosecutors, regulators and judges also believe that adulterated drugs, increasing sales through the payment of bribes and kickbacks, lying / omitting information in safety studies and hiding newly discovered side effects are still bad.
The off-label use arguments aren’t as powerful as they once were but if the claims are false we can still build a case. Pay to delay cases often require a whistleblower in management or close to the CFO.
There is a separate reward program if you happen to work for a pharmaceutical company that is bribing foreign public officials. Big pharma has certainly been caught doing that lately too.
If you are considering blowing the whistle, contact us first. Many people try to fix problems internally first. We certainly understand that but if we get involved early enough we can better protect you from illegal retaliation.
How Do I Blow the Whistle?
Blowing the whistle and collecting a reward requires filing a sealed lawsuit in federal court. The case is filed under seal meaning it is secret while the government investigates. If the government doesn’t intervene, in most instances the whistleblower’s own attorney can continue to prosecute in the name of the government.
Some question whether they want to get involved or if filing of a lawsuit is too much of a hassle. Great questions.
As experienced whistleblower lawyers, we do all the heavy lifting. You don’t owe us any moment unless we first recover money for you.
Is it worth it? Only you can answer that. Whether you are motivated by the cash reward or saving lives, that choice is very personal. We can certainly outline the plusses and minuses so you can make an informed decision.
To learn more, visit our pharmaceutical fraud whistleblower page. Ready to see if you qualify for a reward? Just contact us directly. We can be reached online, by email or by phone . Foreign callers? Add +1 before the number.