Beverly Brown, an employee of Celegene, manufacturer of a drug previously removed from circulation because of its toxicity; thalidomide. Brown’s whistleblower suit against the company was recently unsealed by the District Court.
Brown claims Celgene marketed the drugs to cancer patients and their physicians for indications that had not been approved by the FDA. She alleges that Celgene defrauded government-funded healthcare programs – including Medicare, Medicaid, TRICARE, the Veterans Administration, and the Federal Employees Health Benefits Program – by promoting the drugs for non-approved uses and paying illegal kickbacks to providers.
In her lawsuit, Brown states that Celgene’s unlawful promotion of the drugs for off-label uses caused “federal, state, and local government healthcare programs…to pay for millions of prescriptions that never would have been submitted for reimbursement but for Celgene’s activities.”
The drug, though toxic and withdrawn from use with pregnant women remained interesting to drug companies because of its immunimodulatory properties.
The drug was initially approved for use with leprosy patients. But leprosy, though devastating, wasn’t a profitable venture for the company. So they began looking at other ways to make money on it.
Brown says, “”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 (leprosy treatment) or trained its sales representatives to sell [thalidomide] to physicians who treat leprosy,” Brown’s alleges.
Instead of marketing the drug for this limited indication, Celgene instead “violated explicit FDA regulations prohibiting misbranding, including off-label marketing: Celgene flooded the country with sales representatives” who were under heavy pressure to sell thalidomide and later lenalidomide to oncologists. Celgene continued these actions even after receiving warning letters from the FDA in 1998 and 2000.
Once the case was unsealed, Celgene was given access to the complaint and filed a motion to dismiss. The Judge denied the motion noting that “Celgene cannot reasonably suggest that the 100-plus pages in the [complaint] do not give adequate notice of the misconduct alleged – as a direct participant in Celgene’s off-label promotion, Brown ‘sets out the particular workings of a scheme that was communicated directly to [her] by those perpetrating the fraud’.”
Hopefully the case goes well for Brown from this point on and the government comes to its senses. If the case settles or proceeds to trial and ends up in Brown’s favor, she stands to recover a substantial sum of money, under the False Claims Act’s (both state and federal) recovery sharing provisions.
And if the case does resolve itself in her favor, hopefully the media takes notice and brings to light the shady dealings surrounding this dangerous drug.