Pzifer’s off-label marketing of their anti-inflammatory drug Bextra will cost the pharmaceutical company a record-breaking $2.3 billion, $102 million of which will be split by five qui tam relators (whistleblowers). This most recent whistleblower lawsuit is the fourth illegal marketing lawsuit Pzifer’s settled since 2002. Of the $2.3B, $1B is in civil penalties with the remaining $1.195B as the largest criminal fine in U.S. history. This settlement is part of a four-year federal investigation into the business practices of the world’s largest pharmaceutical company.
At issue, this and previous lawsuits against the drug company allege marketing Bextra for “off-label,” or non FDA-approved, uses. In 1991, Bextra received FDA approval as a treatment for arthritis and menstrual cramps. In April 2005, Bextra was recalled after FDA officials received mounting evidence that the painkiller increased risks of heart attack, stroke, pulmonary embolism, and Stevens-Johnson Syndrome, a serious and sometimes fatal skin reaction.
During these nearly 14 years of distribution, Pfizer allegedly marketed the drug to doctors as a treatment for acute pain, a treatment the FDA never approved and one which required large doses of Bextra, an increase that would accordingly raise the health risks posed by Bextra. While it is not illegal for doctors to treat patients with drugs as they see fit, it is illegal for drug companies to market off-label uses.
Part of this illegal marketing included, according to the whistleblower lawsuit, kickbacks, perks, and incentives.
In addition to the fine, Pfizer must pledge to improve its corporate behavior, including marketing practices, as part of the settlement. This is the third such pledge Pfizer has made since 1999, signing such agreements in 2002 for Lipitor and in 2004 for Neurontin. The government has also accused Pfizer of illegally marketing the antipsychotic Geodon.
Because one of the parties defrauded by Bextra’s off-label marketing was the federal government, whistleblowers were eligible to take qui tam action and receive a portion of the funds from the government lawsuit. Qui tam lawsuits require a special knowledge of False Claims laws and should be pursued through an experienced whistleblower attorney, such as my colleagues at Higgins Firm.
For more information on qui tam lawsuits, explore my TN law firm’s employment law pages on False Claims Whistleblower / Qui Tam lawsuits.