PHILADELPHIA (CN) – Cephalon took hundreds of millions of dollars by pushing its Provigil and Gabitril drugs for off-label uses, two unions say in a federal RICO class action.
The FDA approved Provigil for sleep disorders and Gabitril for epilepsy, plaintiffs AFSCME and Philadelphia Firefighters Union Local No. 22 say. It is legal for doctors to prescribe drugs for off-label uses, but not for the manufacturers to push them for that.
The unions claim Provigil was approved for “excessive daytime sleepiness associated with narcolepsy” and for “excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.” They say Cephalon pushed it “as a non-stimulant drug for the treatment of sleepiness, tiredness, decreased activity, lack of energy and fatigue.”
They claim the FDA approved Gabitril for epilepsy but Cephalon pushed it “to treat anxiety, insomnia, and pain.”
The unions seek punitive damages. They are represented by Stewart Cohen with Cohen, Placitella & Roth.