Risperdal Settlements and Verdicts

These drugs are known as atypical antipsychotics because they target both dopamine and serotonin receptors in the brain.

Risperdal Settlements and Verdicts

A number of lawsuits have been filed over Risperdal and/or Invega, atypical antipsychotic medications manufactured by Johnson & Johnson (J&J) and subsidiary Janssen. These drugs have been linked to a number of side effects, including gynecomastia (male breast growth), movement disorders (tardive dyskinesia, tardive dystonia and parkinsonism), heart problems and diabetes. There has also been litigation involving the off-label promotion of these drugs.

RSeveral large settlements and verdicts have emerged from the litigation. A number of plaintiffshave been awarded for their damages and settlements have been paid to resolve allegations. In fact, Janssen has even pled guilty to misbranding Risperdal in response to government allegations.

Settlements and Verdicts

In November 2013 J&J agreed to pay over $2.2 billion to resolve allegations involving Risperdal, Invega and Natrecor. The government alleged, among other things, that the companies marketed these drugs for off-label use in patients and paid illegal kickbacks to promote their use. Janssen pled guilty to misbranding Risperdal and paid a criminal fine of $400 million. In particular, the government alleged that J&J marketed Risperdal for elderly patients with dementia despite the fact that it was not approved for this purpose. The company allegedly offered incentives to salespeople who for marketed this product for both approved and non-approved uses. The government alleged in a civil complaint that Janssen promoted Risperdal for use in the most vulnerable populations, including elderly nursing home patients, children and individuals with mental disabilities. It was also alleged that J&J knew that the use of Risperdal could increase the risk of strokes in the elderly, but downplayed these dangers.

Attorney General Eric Holder commented on the issue in a Department of Justice press release dated November 4, 2013. “The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” he stated, according the release. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”

“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” Director of the FDA’s Office of Criminal Investigations John Roth said in the DOJ press release. “Today’s settlement demonstrates thegovernment’s continued focus on pharmaceutical companies that put profits ahead of the public’s health. The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”

In May 2012, 36 state attorneys general and the District of Columbia alleged that the companies illegally promoted Invega and Risperdal for unapproved uses between 1998 and 2004. The separately filed state lawsuits alleged, among other things, that J&J marketed Risperdal off-label for children as well as patients with Alzheimer’s disease, dementia, depression and anxiety. In August 2012, J&J agreed to pay $181 million to resolve these allegations.

In July 2010, a lawsuit was filed on behalf of a 21-year old man who developed breast growth,allegedly due to Risperdal. He used the antipsychotic drug from 1999 to 2004, between the ages of 9 and 14. During this time, the FDA had not approved Risperdal for use in children. J&J agreed to settle on the first day this case went to trial in September 2012.

J&J agreed to settle five Risperdal gynecomastia cases in October 2012. The cases were filed in Pennsylvania state court. By September 2012, the company faced over 130 lawsuits alleging that Risperdal or Invega caused gynecomastia.