Johnson & Johnson announced Tuesday that it reached an agreement
in principle to settle a misdemeanour criminal charge in the US related
to the marketing of Risperdal (risperidone), Bloomberg reported. The
agreement in principle on the criminal charge, which includes
allegations that the drugmaker marketed the antipsychotic for unapproved
uses and downplayed its risks, is “pursuant to a single misdemeanour
violation of the Food, Drug and Cosmetic Act,” the company said.
The drugmaker indicated that “discussions have been ongoing in an
effort to resolve criminal penalties under the Food, Drug and Cosmetic
Act related to the promotion of Risperdal,” adding that “certain issues
remain open before a settlement can be finalised.” Johnson & Johnson
noted that it had “adjusted the accrued amount in the second quarter of
2011 to cover the financial component of the proposed criminal
settlement,” and that the settlement “is not expected to have a material
adverse effect on the company’s financial position.”
Johnson & Johnson also said that the justice department and the
US attorney in Philadelphia “are continuing to pursue both criminal and
civil actions” against the company over Risperdal. The two groups
indicated that they will either intervene or join multiple lawsuits
filed by whistleblowers over the drug’s marketing.
The company said it is also in negotiations to settle civil
investigations against the company’s Janssen Pharmaceuticals unit
related to the marketing of the antipsychotic, as well as Invega
(paliperidone), but said it wasn’t sure a settlement could be reached on
those issues. “The attorneys general of approximately 40 other states
have indicated a potential interest in pursuing similar litigation
against” Janssen, Johnson & Johnson noted.
Last year, jurors in Louisiana ordered Johnson & Johnson to pay nearly $258 million
to state officials for making misleading claims about Risperdal’s
safety. The drugmaker is currently appealing the verdict. In addition, a
South Carolina judge in June ordered the drugmaker to pay $327 million
over claims that it deceptively marketed the drug, a verdict that
company executives said they have asked the judge to throw out.