A Philadelphia court has ruled in favor of Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc., in a major mass tort proceeding involving hundreds of men and their families who allege that the antipsychotic drug Risperdal caused injuries including gynecomastia, and who were seeking punitive damages for those injuries.
Earlier this year, J&J filed for summary judgment on punitive damages, arguing that because its headquarters are in New Jersey, that state’s Product Liability Law should be applied, in which no punitive damages can be awarded in lawsuits over medications that went through the premarket approval procedures of the U.S. Food and Drug Administration.
However, plaintiffs filed a response in March, arguing that up until that point, Janssen’s stance was that punitive damages should be based on the law of the state when the drug was marketed, prescribed, and ingested. Court filing show that the plaintiffs also argued that because the company has offices in Pennsylvania and company officials convened there to develop Risperdal marketing strategies, Pennsylvania law should govern punitive damages. “Here, Pennsylvania punitive damages law should apply because significant regulatory compliance, pre-approval submissions, labeling and testing for Risperdal were performed by defendants in Pennsylvania,” plaintiffs said in court documents. “Further, plaintiffs have offered extensive evidence demonstrating that wrongful conduct occurred in Pennsylvania, the state of Janssen’s incorporation,” Law 360 reported.
Last week, in the Philadelphia Court of Common Pleas, Judge Arnold New denied the plaintiffs right to seek punitive damages, and ruled in favor of Janssen’s argument that New Jersey law should apply. (Risperdal Litigation, case number 100300296).
According to court documents, about 80 Risperdal gynecomastia lawsuits filed in Pennsylvania have been settled for an undisclosed amount. Risperdal complaints continue to be filed, and the court’s website shows that a meeting has been scheduled for May 13 regarding the mass tort proceedings currently underway. (courts.phila.gov/common-pleas/trial/civil/clc.asp)
Many of the lawsuits filed in the mass tort allege that Risperdal caused male patients to develop breasts, a condition known as Gynecomastia. Some of these men had to undergo mastectomies or liposuction to eliminate the breast tissue and most allege they suffered severe emotional and mental distress. The lawsuits claim that J&J knew and hide the risk of Gynecomastia from patients and their physicians. Plaintiffs also allege that pharmaceutical giant began marketing the drug for use in children prior to the drug being approved by the FDA for that use.
The first Risperdal bellwether trails were set to begin in 2012 however, Janssen settled the first case the morning trial was to start, the second case was settled the week it went to trial, and the four other cases were settled the same day. A new set of bellwether cases are expected to be heard starting in July.
In March, J&J agreed to pay $5.9 million to settle a Montana lawsuit filed in 2008 by the state’s Attorney General which accused the drug makers of unfair, illegal and deceptive marketing practices. J&J did not admit to any wrongdoing in that case.