Johnson & Johnson Reaches Agreement On Risperdal Misdemeanor Charge

Healthcare giant Johnson & Johnson has reached an agreement to settle a single misdemeanor charge related to its antipsychotic treatment Risperdal, the company said in a regulatory filing Tuesday.

"An agreement in principal on key issues relevant to a disposition of criminal charges pursuant to a single misdemeanor violation of the Food Drug and Cosmetic Act has been reached, but certain issues remain open before a settlement can be finalized,"J&J said. The company added that it has adjusted the accrued amount in the second quarter to cover the financial component of the proposed criminal settlement.

Sales practices for the drug have been under the scanner since 2004. J&J said its Janssen unit received a subpoena from the Office of the Inspector General of the United States Office of Personnel Management in that year seeking documents concerning sales and marketing of the drug from 1997 to 2002, among others.

Documents subsequent to 2002 were also requested by the Department of Justice. An additional subpoena seeking information about marketing of, and adverse reactions to Risperdal was issued by the United States Attorney's Office for the Eastern District of Pennsylvania in November 2005.

J&J said the Department of Justice and the Attorney's Office for the Eastern District of Pennsylvania are continuing to actively pursue both criminal and civil actions. The company also noted that discussions have been going on with state and federal government representatives to resolve the separate civil claims related to the marketing of Risperdal and another drug Invega, including those under the False Claims Act.