A jury found J&J’s Janssen liable for $150 million in damages in New Jersey federal court last week, ruling that the company owed $120 million for violating the False Claims Act and $30 million for the same violations in dozens of states, in a case regarding their HIV medicines.
According to court documents, Janssen — now known as Johnson & Johnson Innovative Medicine — caused 159,574 false claims to be filed with both federal and state governments through the promotion of its HIV/AIDS drugs Prezista and Intelence. However, the jury did not find that Janssen violated the Anti-Kickback Statute.
The case has been going on since 2012, when two whistleblowers and former Janssen employees, Jessica Penelow and Christine Brancaccio, sued on behalf of 26 states and the federal government, alleging 56 counts under the federal and state False Claims Act and the Federal Anti-Kickback Statute.
With respect to Prezista, the lawsuit alleged that Janssen misled physicians about the drug by “misstating Prezista’s superiority, efficacy, and potency.” With Intelence, the whistleblowers claimed that Janssen promoted it for once-daily dosing, contrary to its FDA-approved label for twice-daily dosing, and also promoted it for patients who had never taken a treatment before, even though it’s indicated for treatment-experienced patients.
As for the kickback scheme, the lawsuit alleged that Janssen “made unlawful payments to physicians and other health care professionals in connection with dinner and speaker programs and provided other things of value” in order to get them to prescribe Prezista or Intelence.
In 2021, Janssen attempted to file a summary judgment in the case, arguing that there wasn’t enough evidence to prove the claims. The judge denied the motion and the case continued.
A representative for J&J told Endpoints News that the company plans to appeal the verdict, adding that the company continues “to believe that Janssen’s marketing and promotion of these life-saving medications has always been consistent with the FDA approved labels. The decision on the promotional claims is predicated on a clearly erroneous jury instruction that is contrary to the law and we are confident will be reversed on appeal.”