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U.S.D.C. - Eastern District of Pennsylvania

This case marked the largest single drug settlement in United States history. The matter was resolved a host of civil and criminal charges against the maker of the blockbuster anti-psychotic, Risperdal.

The product in question, Risperdal, is an anti-psychotic manufactured by Janssen Pharmaceuticals, a division of pharmaceutical giant Johnson & Johnson. From ________ until ________, Risperdal was responsible for $24.2 billion in global sales, with $4.5 billion in ________ alone. Generic versions of the drug became available in ________. Risperdal was originally approved by the FDA exclusively for schizophrenia, and later to treat specific types of bipolar mania.

The plaintiffs, primarily men and boys who were treated with Risperdal, charged that J&J marketed the drug in ways inappropriate to this approval, which included promoting it for unapproved uses in children and adolescents, including conduct disorders and attention deficit hyperactivity disorders, as well as for behavioral disturbances in elderly dementia patients. One example involved selling it to nursing homes and nursing home physicians as a chemical restraint. Multiple patients represented in subsequent litigation alleged that they have developed gynecomastia, a serious condition where young boys and men have developed large or female-shaped breasts after taking Risperdal. Treatment for this condition in some cases included boys undergoing mastectomies to correct the condition.

The first complaint was filed in ________ by Sheller, P.C., a mass torts and whistleblower/qui tam law firm, on behalf of a former J&J pharmaceutical sales representative acting as a whistleblower. The suit named as defendant healthcare giant Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals. The plaintiffs sought action under a qui tam False Claims Act, including civil and criminal remedy for violation of state and federal law regarding off-label marketing. Specifically, the United States Government contended that, in addition to making false and misleading statements about the safety of Risperdal, Janssen also paid "kickbacks" to doctors to induce them to prescribe the drug.The suits were subsequently resolved via settlement, with the J&J agreeing to pay the federal government more than $2 billion in civil settlement and criminal fines to settle charges against it.

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