Qui-Tam Lawsuit Against Celgene for Off-Label Marketing of Drugs Will Proceed
A qui-tam lawsuit brought against Celgene Corporation for two of its cancer drugs will proceed, according to a judge that refused to throw the lawsuit out.
Sales representative Beverly Brown filed a whistleblower lawsuit against Celgene, claiming that the pharmaceutical company had put “an old, highly toxic drug” on the market and began selling it for “all types of cancer without any of the research the US Food and Drug Administration (FDA) requires or the oversight it provides.”
The drugs involved in the qui-tam lawsuit are thalidomide, marketed as Thalomid, and a newer analogue lenalidomide, marketed as Revlimid. Both drugs were widely used in the marketing of multiple myeloma, but Brown claimed in her off-label marketing whistleblower lawsuit that the company began marketing the drugs to oncologists before they were approved for use against cancer.
“The essential allegation is that the drugs were marketed off-label, and safety risks and kickbacks were not disclosed,” explained Reuben Guttman, JD, who is representing Brown. “This falls under the federal and state False Claims Acts, which are statutes that allow an individual whistleblower — who has independent or nonpublic knowledge of a wrongful act — to bring suit in the name of the government.”
Brown worked as a pharmaceutical sales rep for Celgene between 2001 and 2011 in Los Angeles. She was not fired by the company for filing the whistleblower lawsuit, but left of her own volition.
The whistleblower lawsuit for off-label marketing includes not only the federal government, but redress for 28 states, the City of Chicago, Washington, DC, and private health insurers in California.
“There was no profit in treating a disease that affects less than a few hundred people a year in the United States. So Celgene never developed substantive marketing materials about ENL or trained its sales representatives to sell [thalidomide] to physicians who treat leprosy,” Brown’s whistleblower case alleges.
The off-label marketing of the thalidomide-based drugs “violated explicit FDA regulations prohibiting misbranding, including off-label marketing: Celgene flooded the country with sales representatives” who were pressured to sell the drugs to oncologists; Celgene continued these off-label marketing actions despite warning letters from the FDA in 1998 and 2000.
“Celgene’s initial marketing efforts for [thalidomide] were tantamount to ongoing human experimentation,” the whistleblower case claims. The FDA did not approve the drugs to treat multiple myeloma until 2006.
The Strom Law Firm Can Help Protect Whistleblowers with the False Claims Act
The False Claims Act, also known as the Whistleblower Act or a qui tam lawsuit, is intended to encourage people to come forward with information and assist the government in stopping the waste of Government funds.
Common whistleblower actions include:
- Medicare fraud,
- defense contractor fraud, and
- other kinds of fraud.
If you are personally aware of a fraud that has been committed by your current or former employer, a competitor or otherwise, contact the Qui Tam attorneys at the Strom Law Firm today for a no cost consultation to discuss the facts of your case and whether filing a whistleblower lawsuit may be appropriate. We understand the complexity of the False Claims Act, and can help you with your case. We offer free, confidential consultations so contact us for help today. 803.252.4800.