Off-Label Marketing

Before a company can market a drug or device in the United States, it must subject the drug or device to clinical trials.  The Food and Drug Administration (“FDA”) evaluates the research and data from the trials to determine whether the drug or device is safe and effective for treating the medical condition.  If approved, the manufacturer, along with the FDA, work together to create a label (or in the case of a device, a device label), which contains a specific set of instructions on how that medication or device should be used.  Notwithstanding the FDA-approved label, physicians and healthcare providers can use the approved drug or device to treat any condition or disease a doctor determines is medically appropriate. Using a drug or device in ways not approved by the FDA is called “off-label” use.  Although healthcare providers are permitted to prescribe off-label use, it is illegal for manufacturers to promote off-label uses through off-label marketing.  Nevertheless, manufacturers often promote off-label uses through off-label marketing in order to squeeze more money from their top-selling products.  They do so through, among other practices, inducements, kickbacks, quid-pro-quo payments, Medicaid and Medicare formulary manipulation (i.e., the use of forms to conceal or exaggerate the symptoms or side effects suffered by the patient in order to ensure payment through the Medicare and Medicaid programs), and sham education and research programs.

Whistleblowers have exposed these and other fraudulent practices, and have achieved huge recoveries on the government’s behalf in qui tam lawsuits brought against drug and device manufacturers for off-label marketing.

For example:

  • In April 2010, AstraZeneca agreed to pay the federal government $520 million in civil fines to settle charges of off-label marketing of the antipsychotic drug Seroquel.
  • In April 2010, Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., both subsidiaries of Johnson & Johnson, agreed to pay more than $81 million to resolve criminal and civil liability arising from the illegal promotion of the epilepsy drug Topamax.  The whistleblowers who brought the qui tam action were awarded payments totaling more than $9 million from the federal share of the civil recovery.
  • In September 2009, Pfizer agreed to a $2.3 billion settlement of civil and criminal charges involving the off-label marketing of the FDA-approved Bextra, which was meant to treat arthritis, as well as menstrual pain in very limited doses. The whistleblower who brought the qui tam action received $51.5 million as a reward.
  • In January 2009, Eli Lilly agreed to pay $1.4 billion to settle claims (of which approximately $615 million was earmarked to settle criminal charges) that it illegally promoted its antipsychotic medication Zyprexa.
  • In September 2008, Cephalon agreed to pay $475 million in civil and criminal penalties to settle the off-label whistleblower lawsuits involving three of its drugs – Actiq, Gabitril and Provigil.  The whistleblowers who brought the qui tam actions were awarded $46.4 million.

Acting as whistleblower exposes healthcare fraud, and ensures that drugs and medical devices are marketed only for the uses for which they were approved.  If you know or suspect that a pharmaceutical company or device manufacturer is engaged in unlawful sales practices, including Medicaid and/or Medicare fraud and/or promoting drugs or devices for off-label purposes, please contact Michael S. Bigin or Laurence J. Hasson.