Do You Have Information about Pharmaceutical Fraud? Drug Company Kickbacks, Off-Label Marketing, or FDA Quality (CGMP) Violations?
Our Pharma Fraud Attorneys can help you Become a False Claims Act Whistleblower and Earn a Whistleblower Cash Award.
The MahanyLaw team of experienced False Claims Act whistleblower lawyers and investigators help pharmaceutical fraud whistleblowers report drug company misconduct and obtain cash rewards from the U.S. government. Our mission is simple, we help whistleblowers:
- Protect Their Anonymity and Job
- Investigate and Prepare a Whistleblower Claim
- Maximize Federal and State Cash Rewards
- Stop Dangerous Conduct
To date, we have helped clients report fraud and claim more than $100 million in rewards. Recently we helped the government recover a record $16.65 billion against just one wrongdoer.
The whistleblower (or “qui tam”) provision of federal and state False Claims Acts offers a money incentive for people with private information on FDA pharmaceutical fraud or clinical trial violations, pharma company kickback or pricing schemes, or off label marketing activities to step forward and report these False Claims Act violations.
Whistleblowers who report under the Federal Anti-Kickback Statute, the Federal False Claims Act, or any state False Claims Act are critical to uncovering these frauds, recovering taxpayer money lost to the offending pharmaceutical companies, stopping unsafe pharma production and flawed clinical trials.
Common Pharmaceutical Fraud Schemes
- Unlawful Kickbacks – Violations of the Anti-Kickback Statute (see below)
- Failure to Comply with FDA Current Good Marketing Practices – cGMP (see below)
- Off Label Marketing Schemes (see below)
- False Reporting of Clinical Trials Results (see below)
- Medicare Part D Fraud Schemes (see below)
- Compounding Pharmacy Frauds
- Importing Unapproved Drugs or API
- Misuse of the 340B Drug Discount Program
- Violation of Medicaid Best Price Rules
- Pharmacy Benefit Managers (PBMs) Schemes
Anti-Kickback and False Claims Act Whistleblower Lawsuits
It is illegal for drug firms or other healthcare companies to influence a physician’s judgment on what is best for their patient through pharmaceutical kickback fraud. Such actions violate the Federal Anti-Kickback Statute and if Medicare, Medicaid, TRICARE, or other state or federal healthcare program is financially harmed, it is also a Federal False Claims Act violation. Your report could stop these activities and earn an award.
Rarely are kickbacks paid as cash. Giving anything of value can be considered a kickback. Pharmaceutical kickbacks are often disguised as something else, but Anti-Kickback Statute and False Claims Act prosecutors look past the surface, often with the help of a whistleblower insider. Financial inducements have included:
- Payments to physicians for attending “meetings” or speaking;
- False research funding or educational grants;
- Vacations, dinners, entertainment or sports event tickets;
- Bonus payments to physicians, practice groups, or hospitals;
- Sham joint ventures, clinical trials, or advisory board appointments.
These are some of the many ways pharmaceutical firms have acted fraudulently to circumvent the basic rule that physician’s judgement about what is best for their patient should never be clouded by kickbacks in any form. Kickbacks are bad for Medicare, Medicaid, TRICARE or any healthcare program and the practice is bad for the patient. Any of these actions, or similar schemes, violate the Federal Anti-Kickback Statute and all state and federal False Claims Acts.
For a confidential conversation with an experienced False Claims Act whistleblower lawyer to discuss how to maximize your whistleblower claim potential and protect yourself, call MahanyLaw now: 202.800.9791 or Report Online
cGMP Fraud, Adulterated or Impure Drug Production
We rarely think twice about what is in our medicine cabinet. Unfortunately, there have been too many instances of under-potent, adulterated or contaminated pharmaceuticals entering the stream of commerce. Current Good Manufacturing Practice or cGMP fraud takes place when a pharmaceutical company does not follow current guidelines for quality of products and manufacturing process integrity to assure FDA requirements are met and safe drugs are produced and distributed.
When drugs are manufactured in a way that does not meet FDA requirements or the products are impure or fail to meet the safety or strength characteristics they claim, and those drugs find their way into the U.S. healthcare system involving Medicare, Medicaid, TRICARE or other federal health program, there is a strong False Claims Act violation claim. In fact, your report can go a long way to stopping this potentially deadly health risk.
Pharmaceutical cGMP fraud cases are complex, requiring pharma expertise to make a strong False Claims Act case. MahanyLaw has both healthcare and pharmaceutical industry experts to assess your information and discuss your reporting options; they speak your language.
To connect with a MahanyLaw pharmaceutical cGMP violation lawyer about your potential whistleblower report and claim, call us. The first to report has a big advantage on claiming cash awards: 202.800.9791 or Report Online
Off-Label Drug Marketing
Pharmaceuticals must meet state and federal guidelines before they are approved; those FDA and other guidelines include what medical conditions those drugs are approved to treat. While physicians may use these products for any additional use in the treatment of their patient, pharmaceutical manufacturers are not allowed to promote a use beyond those approved by the FDA.
When pharmaceutical companies encourage “off-label”, i.e. unapproved use of their products, they are violating federal law and federal and state False Claims Acts.
Clinical Drug Trial Fraud – False Reporting to the FDA
Drug makers need FDA approval before marketing a new drug. Those approvals can require years of clinical trials and testing to ensure that they are safe, effective and only marketed for approved proper uses. The FDA also seeks to ensure that new drugs have appropriate warning labels.
Pharmaceutical companies have a legal duty to properly document their trials and report any adverse incidents. Unfortunately, a few pharmaceutical companies make false statements to the FDA, fail to report adverse events or lie about the drug’s effectiveness. All of these things can give rise to whistleblower rewards under the False Claims Act.
We are currently seeing a spike in pharmaceutical fraud cases involving drug companies who are fudging test results in order to be the first to develop a COVID-19 vaccine.
Medicare Part D Pharmaceutical Fraud
Medicare Part (also called the Medicare Prescription Drug Program) provides prescription drugs for millions of older Americans. Under Part D, private insurance companies provide prescription drugs to eligible beneficiaries. Medicare then pays for the costs of those drugs.
Common Medicare Part D fraud includes:
- Billing for brand name drugs but dispensing generics
- Billing for drugs never dispensed or provided.
- Billing for drugs not covered by Medicare.
- Schemes involving Illegal diversion of narcotics
- Billing for prescriptions without a valid prescription*
*Regarding billing for prescriptions without a valid prescription, we are currently litigating one of the largest pharmacy companies in the United States over prescriptions refilled for assisted living facility patients without a valid prescription. Not only are taxpayers paying tens of millions of dollars for unnecessary drugs, patients may also be in danger if they are taking a drug no longer prescribed by their doctor.
Act Quickly to Protect Your Award Rights and Protect Your Job
In Pharmaceutical Fraud cases, the Federal False Claims Act has led to many multi-million dollar cash awards and for that reason, reporting has become competitive – the FCA strongly favors the first whistleblower to report a fraud when it comes to determining whose information helped recover taxpayer money and stop the fraud. Timing is therefore critical for making your claim.
Pharmaceutical fraud whistleblowers should also know that the False Claims Act provides for strong anti-retaliation protection for employees who report fraud to their bosses or the authorities. This anti-retaliation provision provides for substantial damages for harassment at your job and also reinstatement if you are fired.
For any False Claims Act whistleblower claim, it is critical to prepare and plan your case in advance of reporting. The FDA, Department of Justice and other agencies receive thousands of complaints and only select a small percentage for prosecution. At MahanyLaw our industry leading experts and investigators work hand-in-hand with our pharmaceutical fraud lawyers to prepare the strongest possible ready-to-go case before filing to maximize your chances and maximize your reward. Call us for a confidential discussion: 202.800.9791 or Report Online
Additional Pharmaceutical Fraud Whistleblower Reward Links: