Janssen Pharmaceuticals, Inc. of New Jersey, and its parent company, pharmaceutical giant Johnson & Johnson, are fighting a high-stakes legal battle against hundreds of Risperdal breast-growth victims.
Court records show the companies are seeking to avoid having to pay punitive damages in the event the cases are tried and the company loses judgments.
The lawsuits, which have been consolidated in the Philadelphia Court of Common Pleas, involve allegations that the use of Risperdal caused gynecomastia, or abnormal growth of breast tissue in adolescent boys. Read more here.
The companies are accused in the legal actions of wrongfully and aggressively marketing the anti-psychotic medication for off-label uses that caused the side effects in adolescent boys and inadequately warning of these dangerous side effects.
Large companies that named as defendants in civil lawsuits always attempt to avoid punitive damages, which punish defendants for improper behavior and to discourage future violations.
Legal experts say this is a “deep pocket” source of damages for plaintiffs and numerous multi-million dollar punitive damages have been awarded in high-profile civil cases.
Johnson & Johnson and its subsidiary Janssen Pharmaceuticals have already paid a heavy price from government prosecutions over the companies’ marketing practices involving Risperdal and other medications.
The companies recently pleaded guilty and agreed to pay more than $2.2 billion in criminal fines and civil settlements over the way they marketed and sold Risperdal for off-label uses not approved by the Food and Drug Administration.
The FDA approved Risperdal 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 JPI began in March 2002 to market the drug for the treatment of agitation associated with dementia in the elderly, representing that Risperdal was safe and effective for this unapproved indication and subpopulation.
“The FDA maintains that physicians may, within the practice of medicine, use a drug to treat patients for symptoms or diseases even when the drug is not FDA-approved for such uses,” agency officials said in a press release.
“However, if a pharmaceutical manufacturer intends its drug to be used for a new use, not approved by the FDA, and introduces the drug into interstate commerce for that use, the drug is misbranded, and introduction of that misbranded drug into interstate commerce is a violation of the law.”
The FDA said The U.S. Department of Justice action also alleged that JPI and Johnson & Johnson were 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.