January 26, 2015 — Attorneys representing a boy who developed enlarged breast tissue (gynecomastia) after taking Risperdal have presented opening arguments to a jury in Philadelphia, in one of the first cases to go to trial.
The case concerns a 20 year-old from Alabama, who was prescribed Risperdal in July 2002, when he was 8 years old.
The prescription was “off-label,” meaning it was not approved by the FDA. At the time, Risperdal was only approved for adults with severe psychotic disorders, such as schizophrenia. Risperdal was approved for the treatment of irritability associated with certain intellectual disorders in 2006.
Attorneys told Law360 that former FDA commissioner David Kessler is expected to testify today regarding efforts by Janssen Pharmaceuticals to obscure the safety risks associated with Risperdal.
Janssen and its parent company, Johnson & Johnson, paid a $2.2 billion settlement with the U.S. Department of Justice (DOJ). The settlement resolved civil and criminal allegations that Risperdal and several other drugs were illegally marketed.
Prosecutors accused Johnson & Johnson of instructing sales representatives to target child psychiatrists when promoting Risperdal. They claim Risperdal was illegally promoted “off-label” for children between 1999-2005.
The FDA repeatedly warned the company against promoting Risperdal for use in children. Risperdal was known to elevate levels of prolactin, a hormone that could stimulate breast growth and milk production.
Approximately 1,250 Risperdal lawsuits have been filed in the Philadelphia Court of Common Pleas. Another 700 cases have been consolidated in California.
Although several cases have been set for trial, Johnson & Johnson has consistently settled them before a jury could make a decision. One of the first settlements was awarded in 2012 to a 21 year-old man who started taking Risperdal when he was just 9 years old.