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J&J to pay $181m to settle Risperdal off-label promotion lawsuits in the US

Company's Janssen subsidiary looks to draw a line under mis-marketing claims filed in 36 US states

Johnson and Johnson - Risperdal

Johnson & Johnson faces a payout of $181m to 36 US states and the District of Columbia to settle claims it misled consumers through the marketing of its antipsychotic Risperdal (risperidone).

The healthcare giant's US pharma subsidiary Janssen Pharmaceuticals had faced accusations it promoted the drug for uses not approved by the Food and Drug Administration (FDA) and made false claims about Risperdal's effects.

However, the company denied these claims, saying the settlement was “not an admission of wrongdoing or violation of any law or regulation” and instead was to resolve concerns of attorney generals and to avoid unnecessary expense and a lengthy legal battle.

“We have chosen this path to achieve a prompt and full resolution of these state claims,” said Michael Yang, president, Janssen.

The company said it had already set aside money to cover the settlement earlier in the year, and each state will receive a portion of the total amount.

The $181m cost is still a fraction of what the company had to pay the state of Arkansas in April, 2012, when J&J was fined $1.1bn after a jury determined that the company misled the government run Medicaid health insurance programme and hid risks of its antipsychotic drug. The company seeking a new trial for that case, and said it will appeal if this is denied.

J&J also paid a settlement charge of $158m to the state of Texas in January, 2012, for a case that again involved allegations concerning the marketing of Risperdal.

In addition, the company recorded a separate $600m charge in June to cover a settlement as part of an 'agreement in principle' with the US Department of Justice.

This last involves three civil claims pending in US courts that cover marketing practices for J&J's Risperdal, Invega (paliperidone) and Natrecor (nesiritide), in addition to allegations involving care home pharmacy service Omnicare.

31st August 2012

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