Risperdal Lawsuits

Johnson & Johnson agreed to pay more than $2.2 billion in criminal and civil fines to settle accusations that it improperly promoted the antipsychotic drug Risperdal (and all of its branded names) to be used for off-label uses in older adults, children, and people with developmental disabilities, and withheld known risks of taking the drug. The FDA issued a black box warning for Risperdal, stating that the drug posed a risk of death and stroke when used in elderly patients with dementia for the treatment of aggression and psychosis. It was also alleged that Johnson & Johnson manipulated and withheld data about the drug causing boys and young men to develop a condition called gynecomastia, which can cause severe psychological and physical trauma.

Many of the lawsuits filed against Johnson & Johnson are from young boys and men, and their families, who alleged that Risperdal causes gynecomastia — a condition that increases levels of the hormone prolactin in the body, leading to enlarged breasts — which in some cases required surgery to correct.

Any males who have taken Risperdal, Risperdal Consta, or generic Risperdal (risperidone) and developed gynecomastia are eligible to file a lawsuit. Some patients are also suing the manufacturers of Invega, another antipsychotic drug that is processed slightly differently by the body but causes similar physiological effects. Plaintiffs claimed that gynecomastia has required them to undergo surgical intervention, in some cases a double mastectomy, or has caused emotional and psychological trauma such as embarrassment, anxiety, despair, inhibition of intimacy, and social anxiety. In addition to pain and swelling in the chest, Risperdal users are suing for damages including medical expenses, lost work, reduced quality of life, and severe emotional and physical injuries.

The manufacturers named in the lawsuits are Janssen Pharmaceuticals Inc., which makes Risperdal, Johnson & Johnson, which makes Risperdal Consta, Patriot Pharmaceuticals Inc., which manufactures risperidone, and Janssen Research and Development, which makes Invenga. These are all subsidiaries of Johnson & Johnson.

Risperdal Litigation

It is widely reported in the press that Johnson & Johnson’s controversial and unlawful actions began when its previous psychotic medicine ended its patent life. In 1994, Johnson & Johnson released Risperdal as the successor to that drug. The FDA stated that Risperdal was effective for schizophrenia in adults, but that it wasn’t necessarily better than the previous drug. Despite that, Johnson & Johnson still marketed it to treat a broad range of issues, including problematic behavior in the elderly with dementia and children with autism.

The lawsuits allege that Johnson & Johnson and its subsidiaries falsely marketed Risperdal as a more effective and safer drug when it knew that wasn’t true. The company is accused of illegal marketing to influence physicians and patients, withholding information about known complications of taking the drug, insufficiently warning patients of its dangers and complications, and making false statements about the drug’s safety, cost, and effectiveness.

In 1999 and 2004, the FDA warned Johnson & Johnson about its marketing, stating that it was promoting Risperdal for unapproved uses and was publishing false and misleading marketing material. In 2005, the FDA issued a black box warning stating that use of Risperdal in the elderly put those patients at increased risk of death, and that the drug was not indicated for use in seniors with dementia-related psychosis.

Former FDA commissioner David Kessler testified in a gynecomastia-related lawsuit that Johnson & Johnson knew of the risks associated with Risperdal but failed to disclose the data that proved to what extent boys would develop gynecomastia. State and federal attorneys alleged that Johnson & Johnson completely disregarded FDA warnings for the unapproved use of Risperdal in children and the elderly.

In 2012, following consumer protection regulator investigations in 36 states, Johnson & Johnson agreed to a consumer fraud settlement of $181 million without any acceptance of liability or wrongdoing.

In 2013, Johnson & Johnson paid $2.2 billion to settle criminal and civil charges arising from allegations relating to Risperdal, Invega, and Natecor, including promotion for uses unapproved by the FDA and payment kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, pled guilty to misbranding the drug.

Between 2015 and 2017, jury verdicts in Philadelphia awarded $82 million to four users of Risperdal who developed gynecomastia. Johnson & Johnson settled further gynecomastia cases in 2012 and 2013, but the amounts have not been disclosed and the company denies liability and any wrongdoing.

Court awards and fines against Johnson & Johnson for their conduct — in defrauding the states’ Medicaid programs, misleading regulators and the public about health risks, improper marketing, and inaccurately reporting the safety of the drug — have been reported in South Carolina, Louisiana, Texas, Arkansas, Kentucky, and Montana.