$327 million—that was the verdict handed down in 2011 against Johnson & Johnson’s subsidiary, Janssen Pharmeceuticals, for illegally marketing Rispderal. By 2013, various courts ordered J&J to pay upwards of $2.2 billion to settle criminal and civil investigations over illegal marketing practices. The behavior continued, so courts penalized Janssen again by ordering Risperdal payouts for misleading doctors and patients.
Risperdal Payouts and Recent Verdicts
In December 2015, the Jefferson District Court in Kentucky ordered Janssen to pay Risperdal payouts totaling $15.5 million. These damages were ordered due to misleading marketing claims about its antipsychotic drug, Risperdal. The judgment found Janssen deliberately promoted Risperdal as safe and effective for uses not approved by the Food and Drug Administration. In addition to Risperdal payouts, Janssen must update all marketing materials and labels to comply with with FDA regulations and policies by August 30, 2017.
The Risks of Risperdal
Risperdal has been under scrutiny for side effects the company didn’t disclose to patients or physicians. In 2005, the FDA issued a warning: Risperdal patients with dementia-related psychosis faced higher risk of death. (The drug isn’t approved for dementia, just for schizophrenia, and only in adults.) Risperdal has also been linked to gynecomastia, a condition in which young males develop breasts. Some cases have required surgery, and lawsuits have followed.
The Kentucky ruling focuses not so much on the side effects themselves as it does on the way Jansen markets Risperdal. The judgment’s language forces Janssen to “conspicuously” explain all of Risperdal’s associated risks. It also restricts Janssen from promoting Risperdal’s “off-label” uses.
Risperdal Payouts Can Help Educate Consumers
This penalty comes less than three years after Janssen paid more than $2.2 billion in criminal and civil fines for illegally marketing Risperdal to children and elderly patients. Allegations and findings were grave enough to warrant the Department of Justice’s involvement. In a press conference announcing the Risperdal payouts, the Attorney General said the company’s actions “recklessly put at risk the health of some of the most vulnerable members of our society–including young children, the elderly, and the disabled.” That finding, as well as the most recent judgment in Kentucky, suggest financial incentives drove Janssen pushing the drug for unapproved uses. Now, the court hopes to negate those fiscal incentives through heavy fines.
Of course, some money from the Kentucky ruling pays for court costs. The remaining Risperdal payouts are placed in a fund to help educate patients about possible risks. Additionally, that fund assists victims already suffering from adverse health complications. Other lawsuits are pending. Risperdal remains on the market today.