Pharmaceutical Qui Tam Whistleblower Lawsuits: Billions Of Dollars At Stake

Qui Tam, or whistleblower, lawsuits have increased dramatically over the past few years – especially in the pharmaceutical industry for off-label drug uses not approved by the U.S. Food & Drug Administration (FDA). Whistleblowers, also known as relators, have collected billions of dollars for reporting fraudulent activity against the government – and billions more are at stake.

Whistleblower lawsuits increasing

The number of whistleblower, or Qui Tam lawsuits, is on the rise – especially in the pharmaceutical industry. It's no secret that some corporations have taken advantage of the FDA's limited abilities to monitor them when it comes to promoting their products for off-label uses – a practice that, while not allowed, is quite common. However, due to substantial Qui Tam settlements and verdicts which have exposed corporate fraud against the government and taken billions of dollars out of their corporate purses, the number of whistleblower lawsuits are increasing. In fact, the government now has approximately 150 pharmaceutical whistleblower lawsuits pending – with over 500 different drugs.

What constitutes off-label use?

An off label use of a product is a use that is not approved by the FDA. According to Qui Tam lawyers/, pharmaceutical companies often do whatever they can to entice doctors to use their drugs – such as:

  • Distributing fraudulent or less-than-truthful clinical studies to doctors that support the efficacy of their products
  • Visiting doctors' offices who they know treat patients that may use their products – even when those products are considered safe to use
  • Convincing doctors to try or prescribe their products and report any adverse effects to the pharmaceutical company

These types of practices have not only resulted in an increase in Qui Tam lawsuits, but have caused the Obama Administration to expand the False Claims Act (also known as the Qui Tam statute) and the Department of Justice to actively pursue violations. In fact, Tony West, the Assistant Attorney General for the Civil Division of the Department of Justice, was quoted as saying: Pharmaceutical companies must not promote their drugs for uses that have not been proven to be safe and effective. We are committed to pursuing False Claims Act violations and recovering taxpayer dollars lost to off-label marketing. And that they have. Here are some of the recent Qui Tam settlements and obtained against some of America's largest pharmaceutical companies:

  • Pfizer. Pfizer will pay $704 million after it was charged with promoting Serostin for off-label uses, paying doctors to prescribe the drug and making false representations to healthcare professionals about the product. It will also pay $2.3 billion to settle accusations that it marketed Bextra for off-label uses.
  • Eli-Lilly. Eli-Lilly will pay $1.4 billion to settle allegations that it illegally marketed Zyprexa.
  • AstraZeneca. AstraZeneca will pay $520 million to settle allegations that it payed kickbacks to doctors to illegally market several drugs.
  • Johnson & Johnson. J&J, along with AstraZeneca, Topamax, Ortho-McNeil and Novartis, will pay $72.5 million to settle allegations that they promoted the cystic fibrosis drug TOBI for unapproved uses and that Novartis caused false claims to be submitted to federal healthcare programs.

Qui Tam lawsuits: What's in it for relators?

Along with the satisfaction of knowing that you've helped to stop fraudulent activity against the government, one word – money. Whistleblowers receive 15 – 25 % of a Qui Tam settlement. Considering the settlement amounts of the Qui Tam lawsuits above, that's a lot of money. If you've witnessed fraud against the government, contact a Qui Tam lawyer today to discuss you situation – but keep in mind that filing a Qui Tam lawsuit requires the assistance of an experienced Qui Tam attorney.