Below, a seasoned False Claims Act attorney talks about how handling pharmaceutical industry False Claims Act cases are different from bringing a False Claims Act case in other industries. If you need to retain legal counsel for your case, feel free to call Tony Munter for a free evaluation.
Some pharmaceutical companies are so big that they have the capacity to compartmentalize issues with pharmaceutical whistleblowers and not necessarily immediately crackdown on them. Aside from that, being a whistleblower in the pharmaceutical industry is not necessarily different for the whistleblower’s experience than other industries.
How Big is the Pharmaceutical Industry?
The pharmaceutical industry is a big industry making an awful lot of money off the government. Prescriptions are a big part of what the government pays for under the Medicare and Medicaid and medical devices are also a big part of what the government pays for under Medicare and Medicaid.
Another interesting aspect of being a whistleblower in this industry is that if you have a strong pharmaceutical industry False Claims Act fraud case, then the case will likely apply to practices across the country. If you are marketing a pharmaceutical illegally in Washington DC, you are probably doing the same thing in Massachusetts, so that can be a very large case very quickly. In terms of how the whistleblower might be treated within their own company, that is a question of going from company to company. A company that is committing fraud in the first place is unlikely to be happy with the whistleblower. Fortunately, the success of various False Claims Act cases against the pharmaceutical industry in the past 10 to 15 years has improved some practices.
The Pharmaceutical Industry Is Highly Regulated
The pharmaceutical industry is highly regulated, from how a drug comes to market to what you can say about a drug in marketing materials, to what you can do to encourage doctors to prescribe a drug. Because drugs are also paid for largely through government programs if something is wrong there is a high degree of likelihood that it can create a False Claims Act case and it can also be violating regulations in law. That is perhaps a little unusual compared to other industries.
Pharmaceuticals are highly regulated for obvious reasons. If you take a drug that is unsafe or bad for you, it can become a very serious medical issue indeed. If drugs are distributed improperly, that can become a very serious medical issue and a public safety issue.
So there are a lot of laws and regulations to support whistleblowers if they are bringing False Claims Act cases in the pharmaceutical industry, assuming of course that the whistleblower’s complaint has merit. So to that extent, it may be a little different.
Making the Decision to Blow the Whistle on Pharmaceutical Companies
The first question when dealing with pharmaceutical whistleblowers is to figure out what is really wrong and sort of narrowing that down. For whistleblowers in the pharmaceutical industry and in other industries, there is usually a bit of an emotional issue as to whether or not the whistleblower has personally been retaliated against. They may see that as a major issue or they may see public safety as a major issue.
Deciding what is really the problem with the pharmaceutical product or the pharmaceutical company and what is actionable under the False Claims Act is really a process that requires the whistleblower to talk to a DC lawyer and explain the facts of what has happened so they can determine what kind of a case they really have. That is really the first step towards filing a case and also towards the whistleblower understanding what they should do about the information they have.
Alternatives to Filing a Pharmaceutical Company Whistleblower Claim
The first thing that anyone can do under these circumstances is to call a lawyer because you may think you do not have a whistleblower case but then figure out that you do after talking with legal counsel. It is hard to know in isolation without talking to someone. If you do not have a case, there is always the Food & Drug Administration and other government agencies that a person can still report to, but I think determining whether or not you have got a whistleblower case with an attorney in Washington, D.C. is the smartest move first of all.
If it is a major issue, such as an issue of safety, and it is a False Claims Act case, that is usually the best way to get the government involved in dealing with the safety issue too. So typically, the first thing to do would be is to talk to a lawyer in Washington, D.C. and see what you have got and go from there.
How Do Employers in Big Pharmaceutical Companies Treat Whistleblowers?
I do not know of an industry as a whole that really has an outstanding record of protecting whistleblowers from retaliation and taking the concerns of whistleblowers seriously, of management trying to fix those problems and promoting the whistleblower or having the whistleblower become a manager because they were the person that figured out that something was wrong. There just isn’t an industry that comes to mind that fits that description.
Now admittedly, I hear from the people who have been upset because of their company’s unwillingness to fix the problems. So I guess I am not representative of polling data on which companies are great for whistleblowers and which industries are great for the whistleblowers. But my sense of it is that there really isn’t an industry to which you could point to and say, “Well, they are just the greatest whistleblower people and the most supportive to whistleblowers in the world.” It just is not the usual situation.
If someone blows the whistle on a company because they are doing something bad, chances are that they are doing something bad and they know they are doing something bad, so they pretty much don’t want anyone telling on them. That is the nature of whistleblowing, I’m afraid.
Prescription Drug Fraud and the False Claims Act
This area of litigation has involved some of the largest rewards to successful False Claims Act whistleblowers. Marketing abuses and manufacturing issues with pharmaceuticals have resulted in high profile cases that you may already have read about. These cases involve massive amounts of drugs sold. Therefore, when the drugs were sold illegally, the cases resulted in huge settlements under the False Claims Act (FCA). There are many reasons why these cases are both important to our health and involve large recoveries. The first is that prescription drugs in this country are a huge business. Once a drug enters the marketplace it can be sold and charged to a government program in seemingly endless quantities. The temptation to make money off such prescriptions is always present. However, the legal requirements for selling such drugs are spelled out carefully and when they are violated create major liability under the FCA.
Prescription drugs are subject to approval by the FDA to be sold in the United States. The point of this regulation is to protect us all from the many harms, which could arise from selling powerful pharmaceuticals without appropriate oversight. The FDA has broad authority to be sure that the products sold are safe to use and achieve some results in line with the manufacturer’s claims. Because of this, prescription drugs are subject to a lengthy review process involving clinical trials and approval by the U.S. Food and Drug Administration (FDA).
FCA and Off-Label Prescription Drug Use
When the FDA approves a new drug for sale, it is limited to specified uses of the drug. One drug may be approved to treat acute pain, but not chronic pain, while another drug is approved as a general muscle relaxant, but not to treat high blood pressure. Prescribing a drug for a use not approved by the FDA is known as “off-label” use.
Doctors are generally permitted to prescribe patients whatever drug they think will most effectively treat their conditions, including for off-label uses. Drug companies, however, are only permitted to market their drugs for approved uses. Off-label marketing or promotion is strictly forbidden. Courts have held that, if a company promotes a particular off-label use for one of its drugs, then any claims presented to the government for prescriptions for such use may be false claims. So when a company is found to have improperly promoted off-label use of a particular drug, then it can be liable for every single claim submitted to a federal healthcare program for such use.
Of course the terms, “marketing” or “promotion” can mean many things but, any communication by a drug company to a doctor that is intended to induce the doctor to prescribe for an off-label use could be sufficient to create liability under the False Claims Act. Usually, the case must also include misrepresentations about the drug to create liability in an off-label marketing issue. Drug companies have been accused of engaging in all kinds of practices to promote the use of their products and have had to pay major awards to the government as a result.
The point of all these laws is not just to create liability for pharmaceutical companies under the False Claims Act. Promoting a drug for an unapproved use has the potential to create considerable patient harm through the side effects of the drug. The FDA was created to ensure that drugs can be prescribed as safely as possible, which is why promoting a drug for an unapproved use may be both dangerous and likely to create liability under the FCA.
FDA and Adulterated Prescription Drugs
FDA regulations extend to the quality of manufacturing of the drug. “Adulterated” drugs have been exposed in several major cases involving generic drug companies. Since adulterated drugs can be especially harmful to patients, and can also involve huge sales in the marketplace, these cases have also created some of the largest collections on behalf of the government.
Most importantly, the illegal marketing of prescription drugs and the sale of adulterated drugs creates the possibility of significant patient harm.
Seeking Help with a Pharmaceutical Industry False Claims Act Case
The large collections awarded under the False Claims Act for cases against members of the pharmaceutical industry are also meant to deter such practices and, hopefully, have helped provide an incentive for pharmaceutical companies to adhere to the law. For more information on pharmaceutical industry False Claims Act cases, call our team of dedicated DC attorneys today