Johnson & Johnson says it has set aside funds for a potential settlement with the U.S. government. The settlement would resolve an investigation into J&J's marketing of the antipsychotic Risperdal that involved possible violations of the Food, Drug and Cosmetic Act, Dow Jones reports. And more legal reserves could be coming. The company says it hasn't yet earmarked money to cover whistleblower lawsuits related to the Risperdal probe.
According to the news service, J&J disclosed the reserve in a recent SEC filing without saying just how much money was involved. The company announced last month that it had taken litigation-related charges of $271 million against its first-quarter results, but it's unclear how much of that charge relates to the Risperdal probe.
Meanwhile, the company says whistleblowers have filed lawsuits alleging violations of the False Claims Act, claiming that J&J marketed Risperdal for off-label use--and the government intends to intervene. By throwing its weight behind those suits, the feds would be amping up the pressure on J&J to resolves those claims, too.
In recent years, government settlements with drugmakers have grown increasingly common. Big Pharma companies have agreed to pay civil and criminal penalties to resolve allegations of off-label marketing, kickbacks and other violations. So far, the biggest settlement has been Pfizer's $2.3 billion deal, which wrapped up claims that it improperly marketed its pain drug Bextra and several other meds.
- read the Dow Jones story