Johnson & Johnson lost its first case related to gynecomastia, the abnormal development of breasts in men, and the use of Risperdal, when a Philadelphia jury ruled against them on Tuesday. Attorney Steven Sheller took the case and partnered with Thomas Kline of Kline and Specter for the trial itself. Several hundred more cases are still pending, mainly in Philadelphia.
The drug maker must pay $2.5 million in damages for failing to properly warn patients of the potential side effects associated with Risperdal, an antipsychotic drug. The suit was brought by the family of an autistic boy who took the drug for five years and later developed size 46 DD breasts, according to court documents.
The case has drawn attention for a few reasons. For one, this was the first lawsuit claiming J&J hid the risks of gynecomastia to go to trial after a handful of cases were settled in recent years. The trial also served as a reminder that J&J paid $2.2 billion two years ago to resolve criminal and civil allegations of illegally marketing Risperdal to children and the elderly.
In fact, court documents showed, J&J concealed studies that showed a statistically significant association between the elevations of prolactin levels in children on Risperdal with the development of gynecomastia. Documents produced in the trial by J&J outlined the specific sales tactics of the company, which included safety information on “Leave Behind” material given to doctors that contradicted the drugs label.
While doctors can prescribe drugs “off-label” as they see fit, drug companies cannot market drugs for unapproved uses.
David Kessler, former FDA commissioner, served as a paid expert witness on behalf of the family and testified that J&J knew of the associated risks with Risperdal, but failed to disclose the data showing the extent to which young men may develop gynecomastia. In a report prepared for a 2012 case that was settled, Kessler wrote that J&J’s Janssen unit, which marketed the drug, violated the law.
Petition to Revoke FDA Approval for Risperdal Use in Children
Sheller submitted a petition to revoke Risperdal’s approval for use in children and adolescents. Documents submitted detail the severity of the drug’s side effects that were known to Sheller from depositions and discovery obtained during trial preparation, according to the petition.
Under a protective and confidentiality order, Sheller was unable to submit the documents but requested the agency to retrieve the documents directly, according to the complaint. But, the FDA denied the petition. The law firm Duane Morris has joined Sheller to appeal the agency’s decision.
Sheller’s firm has another gynecomastia Risperdal trial currently in the Philadelphia Court of Common Pleas. Six previous Sheller Risperdal trials for gynecomastia in Philadelphia ended in settlement, two were trials under way but were settled prior to conclusion.