On November 4, 2011, the U.S. Department of Justice (DOJ) announced that Johnson & Johnson (J&J) and some of its subsidiaries will pay over $2.2 billion due to allegations regarding several prescription drugs. On November 7, 2013, as part of this settlement agreement, Janssen Pharmaceuticals Inc. (a J&J subsidiary) pled guilty to a misdemeanor charge for misbranding a drug that was at one time J&J’s largest seller. This criminal charge included promotion of the drug to the elderly for uses which have not been approved as safe and effective by the Food and Drug Administration. As commented by the U.S. District Judge Timothy Savage, who approved Janssen’s guilty plea, Janssen “acted in a ‘calculated manner’ with intent to ‘maximize profits with no regard to risk.'”
Under the plea agreement, J&J’s subsidiary Janssen will pay $400 million, of which $336 million are for criminal fines, and $66 million are forfeited to the U.S. government. According to Zane Memeger, U.S Attorney for the Eastern District of Pennsylvania, the settlement is the largest in U.S. history involving a single drug.