For centuries, the primary rule for healthcare providers was "First, do no harm." Respect for human life demanded caution from anyone offering a remedy for an illness. Unfortunately, healthcare has since become big business, and the corporations behind the supposed remedies have become more interested in profit than patients.
Today when it comes to fraud in healthcare, the pharmaceutical industry is the major offender. Fraudulent schemes designed to boost drug sales and profit margins put hundreds of thousands of patients at risk and drain public resources from essential programs like Medicaid, Medicare and TRICARE.
Because pharmaceutical fraud is so widespread in the healthcare industry, the various government departments cannot catch al the illegal activity. The U.S. Department of Justice is tasked with prosecuting offenders but cannot act without the assistance of insiders like you.
The Most Successful Pharma Whistleblowers Typically Fall
Into These Categories
- Drug Sales Reps
- Quality Control Pros
- Fired or At-Risk of Firing Employees
- Pharmaceutical and Financial Insiders
- Both U.S. and Foreign Nationals
If you are in pharmaceutical sales, research and development, corporate management, production, or accounting, you may have vital information necessary to expose criminal fraud putting patients' lives at risk.
People who come forward are known alternately as qui tam plaintiffs, relators and whistleblowers. Each of these terms has significance.
As a qui tam plaintiff, you are suing on behalf of the government, which is the party injured by the fraud. As a relator, you provide pertinent information to the U.S. Department of Justice, and the law entitles you to collect a substantial reward if the information leads to a recovery. And as a whistleblower, you are entitled to various protections.
You can file anonymously ("under seal"), and you are protected against retaliation from your employer.
What Does Pharmaceutical Fraud Look Like?
Typical Schemes Prosecuted Under the False Claims Act Include:
- Adulterated and Substandard Drugs
- Manufacturers often ignore FDA current good manufacturing practices (cGMP) and neglect quality control. Thus, pharma plants, especially overseas, produce drugs that do not have standard amounts of active ingredients or are contaminated. Adulterated, substandard drugs put patients at enormous risk.
- Price-Fixing Schemes
- Collusion among companies to inflate drug prices forces the government to pay more than the true market value of the drugs.
- Illegal Kickbacks
- Pharma companies pay healthcare providers to promote their drugs and/or prescribe them for their patients. As a result, medical decisions are made for personal gain rather than the patient's best interests.
- Off Label Marketing
- Drugs are approved to treat specific conditions. Off-label marketing refers to sales and promotions geared towards convincing providers to prescribe drugs for uses the FDA has not approved. This allows the drug company to reap profits while giving useless or even harmful medications to vulnerable patients.
- Pay to Delay
- When a patent for a drug expires, companies can offer a generic alternative at a lower cost to patients. To prevent generics from cutting into their profits, patent owners will pay companies to delay production of generics.
- Best Price Fraud
- The Center for Medicare and Medicaid Services uses a company's best price for its drugs to calculate rebates under the Medicaid Rebate Program. Companies use false reporting to lower their rebate obligations.
- Clinical Trial Fraud
- Companies often misrepresent data in their FDA approval applications, downplaying adverse effects and playing up the drug's effectiveness. Schemes often enlists the assistance of prominent doctors who position themselves as authors of clinical research they have not participated in. Other schemes use flimsy trials to market drugs for off-label uses rather than actually testing the drug's efficacy and safety.
- Pharmacy Fraud
- Parties who manage pharmacy benefits under programs, such as Medicare Part D Prescription Drug Plans, Medicare Advantage Plans, Federal Medicaid programs, are obligated to act in the best interests of the beneficiaries. Unfortunately, too many abuse their positions for self-enrichment.
Our attorneys are prepared to help you take the information you possess and make an effective case that maximizes your potential reward.
Halperin Bikel lawyers know how to prepare, package and present your
case to catch the eyes of federal prosecutors who must sift through
thousands of complaints each year. Our highest duty is to ensure that
you receive the maximum return on the information you provide.
A Civil War Era Law Allows You to Take Action
If you have inside information about a scheme to defraud the U.S government as in the case of pharmaceutical fraud, the federal False Claim Act allows you to take action.
The law originated during the Civil War, when President Lincoln was concerned that fraud by civilian military contractors was undermining the war effort. FCA, also known as the Lincoln Law, allows citizens with unique knowledge of fraud to come forward, sue on behalf of the U.S. government, and claim a reward when the government recovers its losses.
Because much pharmaceutical fraud targets patients enrolled in government programs like Medicaid, Medicare or TRICARE, the FCA often covers these schemes.
Further because of the success of the Lincoln Law, many states have adopted their own False Claims Act statutes to recover for fraud against state programs. Many pharmaceutical fraud cases implicate state and federal law and can proceed on dual tracks in state and federal court.
When You Blow the Whistle on Pharma Schemes Your Reward Can Be Substantial
The False Claims Act allows relators to obtain a reward ranging from 15 to 30 percent of the amount the government recovers through settlement or at trial.
In most successful cases, the Department of Justice chooses to intervene, meaning U.S. Attorneys take over the investigation, prosecution and settlement negotiations with the defendants. The higher the amount recovered, the higher your reward.
But the amount of your reward also depends greatly on the percentage of the recovery the DoJ decides your help was worth. There are many factors that could increase or decrease your percentage of the recovery.
Generally, the cleaner your hands are and the more actively you participate in the case, the higher will be your percentage of the reward.
For example, if the DoJ declined to intervene in your case, but you and your private attorney decided to go forward and were able to win, you would be entitled to a higher-end percentage. On the other hand, if you didn't assist the U.S. Attorneys at all after your initial filing of the complaint, your percentage would be on the lower end.
Nevertheless, even 15 percent of what could be a multi-million-dollar recovery is a substantial reward.
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Skilled Attorney Services are Essential for Maximizing Your Reward
If the Department of Justice chooses to intervene, your case gets an enormous boost. Suddenly, you've got the investigative and prosecutorial resources of the government behind you. Unfortunately, the Department of Justice only chooses to intervene in about 25 percent of filed cases.
To get the attention your case deserves, you need the assistance of a skilled and knowledgeable attorney who can draft your Complaint and assemble your evidence persuasively for maximum impact. Then use back channel communications with various Department of Justice regional offices to determine the optimal venue for your case.
An experienced attorney can also boost the percentage of your reward by counseling you on how to best assist the investigation and by drafting a detailed and compelling report that highlights the ways your information was instrumental in an ultimate favorable outcome.
Recent Pharmaceutical Fraud Recoveries Under the False Claims Act
In 2019, the U.S. Department of Justice settled False Claims Act cases for more than $3 billion. The lion's share of those recoveries, more than $2.6 billion, came from healthcare fraud, including these pharmaceutical cases:
- Kickbacks and Off-Label Marketing
- Insys Therapeutics paid $195 million to settle allegations of fraud that illegally boosted sales of Subsys, a sublingual form a fentanyl, exposing vulnerable patients to a fast-acting, highly addictive opioid painkiller.
- Off-Label Marketing, Price Manipulation and False Claims
- Reckitt Benckiser Group plc paid $1.4 billion to resolve criminal and civil liability related to its marketing of Suboxone, an opioid addiction treatment, for unsafe uses.
- Kickbacks and False, Misleading Marketing
- Avanir Pharmaceuticals paid more than $95 million to settle allegations of kickbacks and false, misleading marketing that promoted off-label use of its drug Neudexta for dementia patients.
- Price Fixing
- Seven companies paid more than $624 million to resolve claims of illegally raising prices. The offending companies were Actelion Pharmaceuticals US Inc., Amgen Inc., Astellas Pharma US Inc., Alexion Pharmaceuticals, Inc., Jazz Pharmaceuticals Inc., Lundbeck LLC, and US Worldmeds LLC.
The dollar amounts of the recoveries are staggering, but don't seem to have not deterred fraud. Recoveries for healthcare fraud have topped $2 billion for six consecutive years.
Quick Facts about Being a Pharma Whistleblower
If you are ready to step forward as a pharmaceutical fraud whistleblower, there are a few points you need to know:
- You Must Be the First to File
- The FCA only pays for unique information. If someone at your company has access to the same data and files before you, you are disqualified from receiving a reward.
- Your Information Must Be New
- If the information your complaint relies on is known to the public, or has already been discovered by authorities, you cannot receive a reward.
- You Can File Anonymously
- You can blow the whistle without your employer knowing, because your attorney files the complaint "under seal." Your identity is secret until your Complaint is unsealed, typically after a settlement has already been negotiated.
- You Are Protected from Retaliation
- Your employer is prohibited from taking adverse actions against you, such as firing, demoting or harassing you. If an employer retaliates, a whistleblower may be entitled to remedies, including monetary damages and reinstatement.
All this means that time is of the essence and there is no risk to you.
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