The nine-year legal saga over fraudulent behaviour and dubious sales and marketing practices by Johnson & Johnson in the US regarding its antipsychotic Risperdal (risperidone) and other medicines has finally been laid to rest with a massive $2-billion-plus settlement.
The drug giant has confirmed that, alongside subsidiaries Janssen and Scios, it has now finalised previously disclosed agreements with the US Department of Justice and 45 US states to put an end to federal investigations and state Medicaid claims related to past promotional practices of Risperdal from 1999 through 2005, as well as other claims.
Under the resolution, a total settlement of around $2 billion to the federal government and state Medicaid programmes has been agreed, though as this has previously been accrued no additional charge to the company’s earnings will be recorded in connection, J&J stressed.
Specifically, Janssen has pleaded guilty to a single misdemeanor violation of the Food, Drug and Cosmetic Act for past promotional practices of Risperdal, but the overall settlement also resolves allegations related to the sales and marketing of Invega (paliperidone), Natrecor and those related to Janssen’s alleged 'kickbacks' to pharmacy giant Omnicare.
Risperdal was approved by the US Food and Drug Administration in 2002 for the treatment of schizophrenia and in 2003 for the short-term treatment of acute mania and for mixed episodes associated with bipolar 1 disorder.
But, according to the FDA, in March 2002 Janssen began to market the drug for the treatment of agitation associated with dementia in the elderly, claiming Risperdal was safe and effective for this unapproved indication and subpopulation.
Doctors can use a drug 'off-label' to treat patients for symptoms or diseases even when it is not specifically approved for such uses, but if a pharmaceutical firm intends its drug to be used for a new use not approved by the FDA, and introduces it into interstate commerce for that use, then the drug is misbranded and laws are violated.
The US DoJ also alleges that J&J was aware that Risperdal posed serious health risks for the elderly, including increased risk of stroke, but that the companies downplayed those risks by combining negative data with other studies in order to support a perception of decreased risk from using the drug.
“When pharmaceutical companies ignore the FDA’s requirements, they not only risk endangering the public’s health but also damaging the trust that patients have in their doctors and their medications,” said FDA Commissioner Margaret Hamburg, adding that the settlement "demonstrates that pharmaceutical manufacturers that ignore the FDA’s regulatory authority do so at their own peril".
In a statement, J&J said "the settlement of the civil allegations is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations".
But the resolution "allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world,” noted Michael Ullmann, general counsel at J&J.