Risperdal Gynecomastia Risk Was Known to J&J by 2001, Former FDA Chief Testifies

According to testimony presented by a former commissioner of the FDA during an on-going drug liability trial in Philadelphia, Johnson & Johnson knew as early as 2001 that side effects of Risperdal may cause gynecomastia, potentially leaving young boys using the atypical antipsychotic with abnormal breast growth.

David Kessler, who led the FDA from 1991 to 1997, testified in a Risperdal trial in Philadelphia yesterday, telling jurors that a 2001 study by Johnson & Johnson’s Janssen unit showed a link between Risperdal and gynecomastia. However, Kessler indicated that despite what he considered to be a “red flag,” the company chose not to update warnings provided to parents about the male breast growth risks associated with the medication until 2006, the same year it was approved for sale to children. Even then, many critics say the warning did not go far enough.

Kessler’s testimony was presented on behalf of Austin Pledger, a 20 year old man with claims that use of Risperdal as a child for autism left him with female breasts that may now require surgical removal.

The trial is the first Risperdal case to go before a jury in Pennsylvania, where more than 1,250 similar Risperdal gynecomastia lawsuits are currently centralized in the Philadelphia Court of Common Pleas as a mass tort.

Gynecomastia is a medical disorder associated with the growth of breast tissue among males. In many of the Risperdal cases, plaintiffs allege that the breast development caused by the medication resulted in the need for surgical treatment to remove the breasts, which will leave them with scarring and other physical injury, as well as severe psychological damage from Risperdal breast growth.

All of the claims involve similar allegations the Johnson & Johnson and Janssen knew about the potential risk that young boys may develop breasts while using the medication, yet withheld information from consumers and the medical community.

Johnson & Johnson has been quietly dealing with breast growth litigation over Risperdal for years, but the number of cases has continued to grow as more families and young adults learn that there may be a link between problems suffered following a diagnosis of gynecomastia and Risperdal use as a child.

The study Kessler referred to was conducted by Janssen in 2001 and found that about 3.8% of boys taking Risperdal suffered breast growth. He also pointed out that the company was illegally marketing Risperdal for children long before it got approval by the FDA to do so.

In November 2013, Johnson & Johnson agreed to pay the federal government $2.2 billion for illegally marketing Risperdal and several other drugs. The settlement, one of the largest on record for a pharmaceutical company, included $485 million in criminal fines and forefeitures, as well as civil settlements of $1.72 billion split between the federal government, states, and whistleblowers within the company who revealed the illegal activities to federal investigators.

One key whistleblower said she was personally urged to push Risperdal off-label and that sales reps were given bonuses for their off-label sales. She secretly wore a recording device provided by federal agents to a meeting of Johnson & Johnson sales representatives and recorded evidence of the illegal sales operations.