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J&J pays $158m to settle Risperdal marketing suit in Texas

Practices led to "excessive reimbursements" by the state's Medicaid programme claims lawsuit

Johnson & Johnson has agreed to pay $158m to settle a Texas lawsuit accusing it of mismarketing its schizophrenia drug Risperdal.

Such practices led to "excessive reimbursements" by the state's Medicaid programme, according to the prosecution.

The lawsuit accuses the company of promoting Risperdal for patient populations and disease states "for which it had no FDA-approved indication, including in the child and adolescent population", according to the lawsuit, which had sought up to $1bn from the pharma company.

J&J's Janssen Pharmaceuticals subsidiary will pay the settlement, and insisted in a statement that it did not accept any wrongdoing in the affair.

The suit was first filed in 2004 by whistleblower Allen Jones, a former employee of the Office of the Inspector General in Pennsylvania who claimed that J&J had bribed a Texas official to get Risperdal included in a preferred medication formulary operated by the state.

Under recently-introduced whistleblower rules in the US, Jones will receive a portion of the settlement.

In December, the US Department of Justice said that it had secured over $3bn in settlements and civil lawsuits involving alleged defrauding of government bodies, with $2.2bn raised from pharmaceutical companies.

Last year, J&J reached an agreement to settle a misdemeanour criminal charge brought by the US Department of Justice related to mismarketing of Risperdal.

At the time the company indicated that a number of other civil suits were still active, and Bloomberg has indicated the total civil liability faced by the company is around $1bn.

Other states that have brought action against the company over Risperdal mismarketing include West Virginia, Massachusetts, Montana, New Mexico, Pennsylvania, South Carolina and Louisiana, although the suits in Pennsylvania and West Virginia found in favour of the company.

Meanwhile, Janssen recently received an 'untitled letter' from the FDA admonishing it for an incident in which one of its sales reps made statements promoting an unapproved use of its Nucynta (tapentadol) pain drug at a pharmacy conference, reports the Washington Drug Letter.

20th January 2012

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