The mother of a severely autistic man who allegedly developed gynecomastia due to his use of Risperdal as a child was reportedly brought to tears, following trial testimony of a former U.S. Food & Drug Administration (FDA) commissioner who was called as an expert witness on her son’s behalf.
“I’m just having a hard time right now hearing what the pharmaceutical company was doing,” she told a reporter from the Philadelphia Inquirer last Thursday. The exchange took place outside the Philadelphia, Pennsylvania court room where the case was being heard.
At the time, former FDA commissioner Dr. David Kessler had just finished his second day of testimony, telling a 16-member jury that Johnson & Johnson and its Janssen Pharmaceuticals unit tried to manipulate data in a number of company-funded reports to conceal evidence of Risperdal’s association with excessive breast growth in young boys. According to Bloomberg.com, Dr. Kessler also testified that while the drug companies knew as early as 2001 that Risperdal could cause breast development in boys, they didn’t include a warning on the safety label until 2006.
That year, the FDA approved Risperdal to treat autism and certain mental disorders in children. Before the drug’s approved uses were expanded to include these pediatric indications, Dr. Kessler said Janssen pushed doctors to prescribe the medication through “off-label” marketing. The Plaintiff in this case was first prescribed Risperdal in 2002 to help control symptoms of autism.
On Friday, Dr. Kessler was cross examined by the defense. According to the Philadelphia Inquirer, he continued to maintain that the companies were misleading when they told the FDA in 2005 that there was no correlation Risperdal and gynecomastia in boys.
This trial if the first to involve Risperdal gynecomastia allegations in the Pennsylvania mass tort litigation established for claims alleging injury due to the medication. As a bellwether trial, it could provide valuable insight into how juries might rule in other Risperdal lawsuits involving male breast growth.