Pharmaceutical fraud costs the federal government billions of dollars and jeopardizes public safety. Fortunately, the False Claims Act allows individuals to initiate a qui tam lawsuit to help the government combat pharmaceutical fraud in exchange for a whistleblower reward. If you have knowledge of pharmaceutical fraud against the government, you should consult an experienced whistleblower lawyer.
Newman & Shapiro has extensive experience handling pharmaceutical fraud cases brought under the False Claims Act (FCA). Given that the government has recovered billions from pharmaceutical companies in FCA actions, you may be entitled to a significant financial reward. When you partner with us, we will thoroughly assess your evidence of pharmaceutical fraud, help you file the required declaration, and guide you through the legal system. Together, we can hold big pharma and other responsible parties accountable for pharmaceutical fraud. Above all, our whistleblower attorneys will help you obtain the reward you have earned.
What is pharmaceutical fraud?
Pharmaceutical fraud involves a wide range of fraudulent activity engaged in by pharmaceutical manufacturers, pharmacies or other healthcare providers. Some of the most common pharmaceutical fraud schemes include:
Medical Trial Fraud
This type of fraud involves pharmaceutical manufacturers providing false data to, or withholding negative data from, the Food and Drug Administration (FDA) in connection with clinical research trials about the efficacy of drugs or medical devices to obtain FDA approval to sell and market the products.
Failure to Report Adverse Events
Under the Federal Food, Drug, and Cosmetic Act (FD&C), holders of drug applications, certain pharmaceutical manufacturers, packers and distributors of prescription and non-prescription medications are required to report adverse events of medications to the FDA.
Contaminated Pharmaceutical Products
Pharmaceutical manufacturers are required to adhere to Current Good Manufacturing Practice (CGMP) regulations, which govern the design, monitoring and control of processes and facilities used to manufacture pharmaceutical products. The sale of pharmaceuticals that have not been manufactured according to CGMP regulations is prohibited by the FD&C.
Pharmaceutical kickbacks involve illegal payments made by pharmaceutical companies to physicians, clinics, pharmacies and other healthcare providers in return for prescribing certain drugs. These schemes may also involve pharmaceutical companies encouraging physicians to seek reimbursement from Medicare or Medicaid for free samples of drugs so that both the company and the doctor make a profit at the government’s expense. These schemes are a violation of the False Claims Act as well as other laws such as the federal Anti-kickback Statute.
Best Price Fraud
This form of pharmaceutical fraud occurs when a pharmaceutical company manipulates the data currently available on the open market (the Best Price) and intentionally provides Medicare, Medicaid or another government program with incorrect information on the price of the medication. These assistance programs ensure that enrollees pay the lowest price possible for their prescription medications.
Medicaid achieves the Best Price through a rebate program that requires pharmaceutical companies to provide the government with the lowest fee throughout the drug marketplace. If an enrollee pays more than the agreed-upon price, Medicaid covers the price difference, and the drug’s manufacturer is required to reimburse Medicaid the additional costs in the form of a rebate, based on difference or spread between the Best Price (BP) and the Average Wholesale Price (AWP) of the product. Best price fraud is a violation of the False Claims Act.
Off Label Marketing
This illegal practice involves marketing healthcare products for uses that have not been determined safe and effective by the FDA. Although Medicare and Medicaid will not pay for prescription medications for uses that have not been FDA-approved, manufacturers often market their products for off label uses and incentivize salespeople to promote off label uses to prescribers. This may cause doctors and pharmacies to bill Medicare and Medicaid for the off label use of these drugs. Ultimately, a pharmaceutical company can be held liable under the False Claims Act for promoting the use of prescription drugs for unapproved conditions to beneficiaries of federal healthcare programs.
How To Combat Pharmaceutical Fraud
Given the billions of dollars in losses that result from pharmaceutical fraud and because of the government’s limited ability to detect fraud, it takes brave whistleblowers to come forward. Under the qui tam provisions of the False Claims Act, individuals can file a lawsuit on behalf of the government against companies, pharmacies, doctors, and other healthcare professionals who engage in pharmaceutical fraud.
If you are an employee in the pharmaceutical industry and fear retribution by your employer, you should know that the FCA contains protections against employment retaliation. An employer who fires, demotes or takes any other adverse action against an employee for reporting pharmaceutical fraud can be held liable in a civil lawsuit.
Contact Our Pharmaceutical Fraud Whistleblower Lawsuit Lawyers
From our offices in Boston and Marblehead, Massachusetts, Newman & Shapiro represents whistleblowers throughout the nation. Well-versed in the False Claims Act and other statutes applicable to pharmaceutical fraud, we will provide you with informed representation and work to protect your rights and your reputation.
If the government intervenes in a qui tam lawsuit, you may be entitled to a significant whistleblower award. If your employer takes an adverse action against you for reporting pharmaceutical fraud, you take take legal action to recover damages such as back pay, attorneys fees and costs. Don’t let pharmaceutical fraud and its lasting repercussions go unchecked. Contact our office today in confidence for a free consultation.