Off-Label Marketing

Pharmaceutical industry fraud, including off-label marketing, costs the government millions of dollars each year. Qui tam lawyer James T. Ratner understands the complexities of off-label lawsuits, and is committed to helping you navigate these intricate cases successfully and confidentially.

If you have documented information regarding off-label marketing fraud and wish to come forward, please contact James Ratner today by calling (845) 688-5222 or by completing the form on this page to schedule a consultation.

What Is Off-Label Marketing?

The Food and Drug Administration (FDA) necessitates that drugs be proven safe and effective for a specific use before being marketed to the public. Drug manufacturers are required to provide evidence of extensive clinical testing to prove that a drug’s proposed use is safe and effective.

However, following FDA approval, some companies begin to promote drugs for uses other than which they were approved. This is referred to as off-label marketing.

It is important to note that the FDA regulates manufacturers, not hospitals or doctors. While it is legal for physicians to use their professional discretion to prescribe drugs for off-label uses, it is not legal for drug companies to promote a drug for an unapproved purpose.

Medicare and Medicaid Fraud

While doctors may prescribe off-label medication without violating their medical licenses, it is generally illegal for anyone to knowingly bill a government health care program for an off-label use. When drug manufacturers promote their medications for off-label purposes, they violate the rules of the FDA. However, these companies may also violate the False Claims Act by influencing physicians to prescribe drugs for off-label uses, and causing pharmacies to bill Medicare and Medicaid for off-label use of their drugs.

The FDA doesn’t have adequate resources to investigate all of the companies potentially involved in this nefarious practice. Due to a lack of resources, courts allow whistleblowers to bring claims against drug companies on behalf of the government. In these cases, the whistleblower is protected from retaliation by the drug company, and could share in the money subsequently recovered by the government.

Government Rewards

Violating the False Claims Act carries harsh penalties for pharmaceutical companies. If found guilty, these organizations could face fines of $10,000, plus three times the amount of damages that the government incurred as a result of their fraudulent actions. In addition to these fines, companies could face punitive damages.

If a whistleblower brings a suit on behalf of the government against a company, the whistleblower could collect between 25 percent and 30 percent of the damages, in addition to attorney’s fees and costs.

Begin Building Your Off-Label Marketing Case

If you wish to come forward with information regarding off-label marketing practices, please contact qui tam lawyer James Ratner today by calling (845) 688-5222 or by completing the form on this page to schedule a consultation. Mr. Ratner serves clients in New York and throughout the U.S.

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