In restating his decision, Judge Arnold New confirmed that patients who allege they were harmed by the use of Risperdal will not be able to obtain punitive damages from their lawsuits. Earlier in 2014, Judge New ruled that New Jersey law regarding punitive damages would be applied to the lawsuit. New Jersey law does not allow punitive damages in claims involving drugs that required pre-market approval by the FDA.
The judge agreed with Janssen Pharmaceuticals that because Janssen has two facilities in New Jersey, where marketing for the drug was developed, the New Jersey Product Liability Act would apply to the lawsuit. Plaintiffs had argued that because they were treated with Risperdal for uses not approved by the FDA, the law barring punitive damages should not apply.
Approximately 600 plaintiffs are involved in the lawsuit (In re: Risperdal Litigation, case number 100300296). So far, approximately 80 lawsuits have reportedly been settled. Lawsuits allege that patients were not adequately warned about the potential for side effects such as gynecomastia when they took the medication. Some lawsuits also allege male patients suffered emotional trauma as a result of the development of breast tissue.
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Risperdal has been linked to an increased risk of weight gain. That weight gain can result in other issues such as increases in cholesterol and triglycerides, which may come with their own health problems. Many doctors, however, feel that the risk of weight gain is not as significant as the benefits of using Risperdal.
In 2013, Johnson & Johnson agreed to pay more than $2.2 billion to settle allegations the company marketed Risperdal, Invega and Natrecor for unapproved uses. Although it is not illegal for doctors to prescribe medications for unapproved uses, it is illegal for companies to market drugs for unapproved use.