More than 6,200 Risperdal lawsuits are now pending in the mass tort program underway in Pennsylvania’s Philadelphia Court of Common Pleas, up from just 1,945 filings in January 2017.
The new figures were reported this week by Law.com, which noted that the state’s Risperdal litigation has grown 219% in a little more than a year.
Risperdal lawsuits now make up about 56% of the total mass tort inventory in Philadelphia.
According to a Risperdal lawyer interviewed by Law.com, the significant growth in Risperdal filings can be attributed to Janssen Pharmaceutical’s decision to end a tolling agreement, which required many plaintiffs to file before the statute of limitations governing their cases ran out.
Risperdal is an atypical antipsychotic medication approved to treat adult and adolescent schizophrenia, bipolar disorder in adults and children ages 10-to-17, and irritability in children (5-to-16 years of age) with autistic disorder. It is also frequently prescribed off-label to treat children with ADHD.
The majority of Risperdal lawsuits pending in Pennsylvania were filed on behalf of men and boys who developed gynecomastia (excessive male breast growth) while taking the medication. Many of these plaintiffs were allegedly prescribed the drug as children, before the U.S. Food & Drug Administration (FDA) approved Risperdal’s first pediatric indications in October 2006.
The Risperdal label was also modified in October 2006 to note that gynecomastia had occurred in 2.3% of male adolescents prescribed the drug. Prior to the modification, the label described the condition as a rare side effect affecting just 1 in 1,000 patients.
Plaintiffs accuse Janssen and its parent company, Johnson & Johnson, of concealing the potential for Risperdal to cause excessive breast growth in men and boys. They also contend that, prior to October 2006, the companies illegally marketed Risperdal for use in children without FDA approval.
The Philadelphia mass tort program began a series of Risperdal gynecomastia trials in February 2015. Out of seven cases that have made it before a jury, five have resulted in plaintiffs’ verdicts, with compensatory damage awards ranging from $2.5 million to $70 million.
While a handful of Risperdal breast growth lawsuits have also settled out of court, Janssen and Johnson & Johnson have not indicated any desire to negotiate a global settlement of all claims.
Last month, a ruling from a 3-judge panel of the Pennsylvania Superior Court opened the door for Risperdal plaintiffs to seek punitive damages against the defendants.
While some have speculated that the development could increase pressure for a settlement, a spokesperson for Janssen told Law.com that the company plans to “continue to defend this litigation and will try cases where appropriate.”