Trial Update: A continuance has been granted; this trial will now begin Sept. 12, 2016.
Gynecomastia Injury alleged
Mr. Moore, represented by Houston law firm Matthews & Associates, is suing J&J’s Ortho-McNeil and Janssen for the case of gynecomastia he says he developed as a minor. Gynecomastia is a painful condition in which males develop female breast tissue. The petition alleges that the J&J companies illegally marketed the drug to Mr. Moore’s doctor for off-label use in minors despite knowing that the drug raised the risk of gynecomastia.
Risperdal is a powerful atypical antipsychotic developed by Janssen-Cilag, a subsidiary of Johnson & Johnson. It was approved by FDA in 1993 for the treatment of schizophrenia in adults.
Released in 1994, Risperdal became one of the most profitable drugs in history, bringing billions of dollars in profits.
In 2003, FDA approved risperidone, the chemical name for Risperdal, for the short-term treatment of the mixed and manic states associated with bipolar disorder in adults.
“But,” the petition reads, “many executives, marketing professionals, and even sales representatives were more interested in its unapproved use in children.”
Although the FDA never approved Risperdal for use in children and adults, in 2003 unapproved prescriptions accounted for most Risperdal sales.
J&J failed to Warn
The petition reads: “Johnson & Johnson and Janssen by and through its agents, servants, directors, officer(s) and employees knew, or should have known, about the devastating side effects that Risperdal could bring to children, but they failed to inform or to adequately inform physicians, including the Physician Defendant about this vital information.”
Jacoby Moore was a 7-year-old boy living in Beaumont in 2003 when he was prescribed Risperdal for Attention Deficit Hyperactiity Disorder (ADHD) and behavioral problems. Though Risperdal was not approved for use in children, Mr. Moore was prescribed it by his doctor, who had been encouraged by J&J to subscribe the drug to children.
The petition reads: “But for the Manufacturer Defendants’ off-label marketing, recommending, advertising, and promoting, the Physician Defendant would not have prescribed Risperdal to Plaintiff for off-label use. The Physician Defendant prescribed Risperdal to Plaintiff Jacoby Moore as it was recommended, promoted, and advertised to him by the Janssen Defendants.”
Risperdal Trial in Texas
The trial, the third to try J&J for Risperdal in civil court, is expected to last three weeks.
In the first Risperdal trial in February 2015, a jury hit J&J’s Janssen with a $2.5 million verdict. In the second Risperdal trial, in March 2015, a Philadelphia jury found Janssen had failed to warn that Risperdal could cause male breast growth, but awarded no damages to a young man for whom the jury found no direct link to his condition.
J&J, Janssen fined $2.2 Billion +
In 2013, Johnson & Johnson and Janssen paid more than $2.2 billion to resolve civil and criminal investigations by the U.S. Department of Justice into the marketing of Risperdal and several other drugs.