January 20, 2012: J&J’s Risperdal Sales May Have Violated Pact, Witness Said

Johnson & Johnson’s Janssen unit may have violated the drug maker’s agreement with Texas by marketing Risperdal (an antipsychotic) to mentally ill children, a use that was not approved by the FDA until 2006. This issue deals with a push by the Janssen unit to increase Risperdal prescriptions to children and adolescents prior to approval in 2006. The New York Times reported that this push may have broken the drug maker’s promises to “comply with all state and federal laws” in exchange for having the drug covered by the Texas Medicaid program, Billy Milwee, the state Medicaid director, told a jury today.

Lawyers for Texas are asking an Austin jury to make Johnson & Johnson and Janssen pay at least $579 million in damages over the companies’ Risperdal marketing practices. According to the New York Times,  Texas state Medicaid director testified: The state’s Medicaid program “would not have engaged as great a cost as it did” if Janssen officials hadn’t misled doctors and regulators about Risperdal’s superiority to other antipsychotics and avoided marketing the drug for unapproved uses. The state claims to have spent 45 times more than they otherwise would have had they not accepted Janssen’s claims that the drug is superior to others like it.

The jury also heard from children psychiatrist Valerie Robinson and Tone Jones a former Janssen executive. Robinson testified to “numerous visits” by Janssen sales people pushing the benefits of Risperdal for use in children. Jones’ testimony included claims that company officials pushed salespeople to step up visits to child psychologists in hopes of pumping up Risperdal sales.

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