Teva Pharmaceutical Industries subsidiary Cephalon Inc. on Thursday settled a False Claims Act (FCA) lawsuit filed by a former sales representative who accused the drugmaker of pushing its narcolepsy drug Provigil for unapproved, off-label uses.
Whistleblower Bruce Boise, who filed the original complaint against Cephalon in 2008, alleged that the company rewarded physicians who prescribed Provigil and another narcolepsy drug, Nuvigil, for uses not approved by the U.S. Food and Drug Administration (FDA), including attention deficit disorder, hyperactivity disorder, multiple sclerosis, Parkinson’s disease, jet lag, and depression, according to Law360.
A number of patients who had been prescribed the drugs for off-label uses joined the lawsuit.
The parties settled the lawsuit on March 16 and U.S. Magistrate Judge Carol Sandra Moore Wells approved the settlement March 20, but the terms have not yet been made public.
The settlement concludes protracted litigation that spanned nearly a decade. Law 360 reports an amended complaint was unsealed in 2013, but it stalled as the U.S. Supreme Court mulled a case with first-to-file implications relevant to the Cephalon suit.
According to Law360, the Supreme Court shot down Cephalon’s contentions later that year. The case advanced, but in 2016, U.S. District Judge Thomas N. O’Neill Jr. pared a year of claims from the suit, finding the U.S. government’s decision to not intervene in the case triggered a six-year statute of limitations.
Then a week before the settlement, Judge Wells “denied the plaintiffs’ request to extend the claims period up to the date of a trial in the case, but said they could renew their motion at the end of discovery if they produced evidence showing culpable conduct continued past March 2014, when the second amended complaint was filed,” according to Law360.