Johnson & Johnson revealed in a regulatory filing that it reached an “agreement in principle” with the U.S. Department of Justice and some states to settle investigations into marketing practices for Risperdal (risperidone) and two other products. “We won’t speculate on when a settlement will be finalized,” said Johnson & Johnson spokesman Al Wasilewski.
Specifically, the drugmaker indicated that it has reached a deal to settle three pending civil False Claims Act matters that are pending with authorities in Pennsylvania, California and Massachusetts related to the sales and marketing of Risperdal, Invega (paliperidone) and Natrecor (nesiritide). The settlement would also cover allegations that Johnson & Johnson provided pharmacy operator Omnicare with rebates and other payments linked to Risperdal.
The company added that it has also reached a tentative deal with representatives of a group of 38 states and the District of Columbia to settle non-Medicaid actions in connection with the sales and marketing of Risperdal and Invega. Johnson & Johnson said that for all of the preliminary agreements, “issues remain open that must be resolved before the settlements can be finalized.”
Johnson & Johnson noted that the settlements will not resolve all pending state litigation matters regarding Risperdal, adding that “some states may elect to opt out.” According to the drugmaker, among other states, Arkansas, Louisiana and South Carolina are not expected to participate in the settlements.
Recent reports suggested that Johnson & Johnson and the Department of Justice concluded an agreement for up to $2.2 billion, resolving probes into the company’s drug marketing practices. However, the final amount, which reportedly includes a criminal fine of about $400 million for the illegal promotion of Risperdal, is expected to be dependent on which states suing the drugmaker agree to the deal.
