May 14, 2014 — The Pennsylvania judge overseeing more than 500 lawsuits involving Risperdal (risperidone) has banned plaintiffs from seeking punitive damages, ruling that a New Jersey Product Liability Act applies in the cases.
The ruling was issued on May 2 by Judge Arnold New. It is a win for defendants Johnson & Johnson and Janssen Pharmaceuticals, who are headquartered in New Jersey. The act prohibits punitive damages in lawsuits involving FDA-approved pharmaceutical drugs, which removes the possibility that plaintiffs will be allowed to seek damages that punish drug-makers for gross negligence or reckless behavior.
Plaintiffs argued that Pennsylvania law should apply because the litigation is located in the Philadelphia Court of Common Pleas. Now, they will only be allowed to seek compensation for claims like medical expenses.
Johnson & Johnson and Janssen are accused of hiding information about the risk of side effects from Risperdal, including gynecomastia (male breast growth). This complication occurs when Risperdal disrupts levels of the pregnancy hormone prolactin, resulting in the growth of glandular male breast tissue. The disfiguring, embarrassing condition often requires surgery.
Last November, the drug-makers agreed to pay $2.2 billion to settle criminal and civil charges of illegally marketing Risperdal and two other drugs. The U.S. Department of Justice (DOJ) accused the companies of “off-label” marketing of Risperdal for use in children, although Risperdal was not approved for pediatric purposes until 2006.
The drug-makers were also accused of marketing Risperdal, a powerful anti-psychotic, for use in elderly people with dementia. The DOJ cited internal memos indicating that studies linking Risperdal and stroke in these patients were concealed. The label on Risperdal now carries a “Black Box” warning about the increased risk of death when it is used in elderly dementia patients.
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