False Off-Label Pharmaceutical Marketing: How Our Whistleblower Attorneys Can Help

Pharmaceutical manufacturers have often illegally marketed their drugs as “off-label.” These methods violate federal and state False Claims Act laws. Violations of the False Claims Act result in penalties which include treble damages and penalties of between $5,500 and $11,000 per false claim. Each prescription filled can be viewed as a false claim. Our whistleblower attorneys represent clients in New Jersey and Pennsylvania who have knowledge of these illegal violations of the False Claims Act.

Clients who report these violations by having a Qui Tam lawyer are whistleblowers who are known as Relators. Relators are entitled to between 15 and 30 percent award of all moneys collected by federal and/or state governments as a result of the False Claims Act lawsuit brought on the Relators behalf by his or her Qui Tam Attorney.

Off-label marketing means that a drug manufacturer promotes the use of a drug or drugs for purposes that were not approved by the Food and Drug Administration. These drugs were tested and approved for particular illnesses or conditions and proved to have some useful purpose and some level of acceptable safety.

When drug manufacturers sell drugs off-label, they are promoting these drugs for untested and unapproved purposes and therefore not the purpose that Medicare or Medicaid or any other federal health plan such as TriCare intended, who had agreed to reimburse pharmacies for the sale of these drugs to Medicare, Medicaid or recipients of other government healthcare programs recipients. This conduct is Medicare or Medicaid Fraud and is a violation of the False Claims Act.

Contrary to the illegal nature of off-label marketing, doctors can prescribe off-label at any time. Because doctors can prescribe off-label, pharmaceutical manufacturers often provide inducements to these doctors to prescribe such as gifts, speaking opportunities, free vacations or other inducements. These inducements are kickbacks and are violations of the Anti-Kickback Statute. Violations of the Anti-Kickback Statute are also violations of the False Claims Act and entitle clients who file Qui Tam suits to the same awards or Relator’s Share as any other violation of the False Claims Act.

While the off-label marketing schemes described above have resulted in collections for the federal government of billions of dollars, an often overlooked fraud, which is a variant of off-label marketing, is called off-branding fraud or off-packaging fraud. These type of frauds are also actionable under the False Claims Act.

When a drug is “off-branded,” it is, in fact, “off-labeled.” The label has an improper dose and is marketed at a dose that has not been approved by the Food and Drug Administration. Just like marketing for an unapproved illness or condition is a violation of the False Claims Act, by changing the approved dose so the drug may become more competitive in the marketplace, it is not being marketed is nor being sold as deemed safe and effective by the FDA and therefore is being marketed to Medicare or Medicaid illegally and “off-label.”

The Consumer Product Safety Commission also approves drug packaging for safety and drug preservation. When a drug is marketed in packaging that has not been approved, the drug is likewise illegal and “off-label.” Such marketing of off-packaged drugs can be called “off-packaging/off-label marketing” and is also a violation of the False Claims Act. Such marketing is a violation of Statutes such as the Consumer Product Safety Act, Poison Control Act and the Food Drug and Cosmetic Act. Violations of these Statutes like the Anti Kickback Statute are also violations of the False Claims Act.

Begelman & Orlow, P. C. has experience pursuing these violations under the False Claims Act. We are experienced Qui Tam attorneys located near Philadelphia in Southern New Jersey in Cherry Hill and and Conshohocken, Pennsylvania. We have represented Relators/clients from across the United States and are available to provide experienced Qui Tam / False Claims / Whistleblower advice to you. For a free consultation with one of our experienced attorneys, please call us at 866-627-7052 or fill out our online form today.


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