The pharmaceutical company Celgene has settled a lawsuit with a former sales representative, in which she alleged that the company marketed two of its products, Revlimid® (lenalidomide) and Thalomid® (thalidomide), for unapproved uses.
The company will pay a total of $280 million ($259.3 million to the federal government and $20.7 million to 28 states and Washington, DC) to settle the charges – making this one of the largest settlements involving a cancer drug.
Both agents were approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma; Revlimid was also approved for the treatment of mantle cell lymphoma. However, Celgene was accused of marketing the treatments for a broad range of cancers that were not included in the approved indication.
The plaintiff claimed that the pharmaceutical company’s marketing was inappropriate because it “exposed patients to heightened risks that included potentially fatal blood clots and other side effects.” The side effects were not listed on the warning label until after the drugs were approved by the FDA.
Reuben A. Guttman, a representative for the plaintiff, said, “At the end of the day, what this is about is that even when you’re on life’s edge, [a company] can’t break the law by off-label marketing a drug.”
A Celgene spokesman noted that the company denied any wrongdoing but chose to settle “to avoid the uncertainty, distraction, and expense of protracted litigation.”
Source: The New York Times, July 25, 2017.