May 14, 2014 — Hundreds of people who have filed lawsuits involving Risperdal (risperidone) will not be allowed to seek punitive damages against Janssen Pharmaceuticals or Johnson & Johnson, according to a ruling from a Pennsylvania judge.
Judge Arnold New indicated that plaintiffs will only be allowed to seek compensatory damages, removing the possibility that drug-makers will face punitive damages to punish them for gross negligence or recklessly failing to warn about side effects.
The judge agreed with defendants that the New Jersey Product Liability Act applies in the lawsuits because Janssen is headquartered in the state. The Act prohibits punitive damages in cases involving pharmaceutical drugs approved by the U.S. Food and Drug Administration (FDA).
Plaintiffs argued that Pennsylvania law should apply to the litigation, which currently involved about 500 Risperdal lawsuits in the Philadelphia Court of Common Pleas. Judge New disagreed and issued an Order on May 2.
Johnson & Johnson and Janssen are accused of concealing risk information linking Risperdal and gynecomastia, a disfiguring medical condition in which imbalanced hormones cause male breast tissue to enlarge. Severe cases often require surgery to excise abnormal tissue and improve cosmetic appearance.
In November 2013, the U.S. Department of Justice announced a $2.2 billion settlement with Johnson & Johnson and Janssen. The drug-makers agreed to resolve civil and criminal charges that they illegally marketed Risperdal and two other drugs to children, the elderly, and the disabled.
Lawsuits accuse the companies of improperly marketing Risperdal for “off-label” uses, including the treatment of children. Risperdal was not approved for pediatric uses until 2006. It now carries a Boxed Warning about the risk of stroke and death in elderly dementia patients.
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