Risperdal was pushed as an off-label ADHD treatment by Johnson & Johnson, according to a former FDA commissioner. But for years it came without a warning that it could develop breasts in prepubescent boys and girls.
Risperdal, Johnson & Johnson’s big money antipsychotic pill, was their No. 1 product for over a decade, and it’s one they have settled over 1,300 lawsuits to protect. The latest came just days ago from a young man growing female breasts of sizes up to a 46DD without warning. The drug maker settled out of court for an undisclosed amount.
The drug itself, which is prescribed to treat schizophrenia but has been used off-label for sufferers of ADD and ADHD, has a long and sordid history. Its maker backed Harvard child psychologist Joseph Biederman’s research institute for child psychotherapy at Massachusetts General Hospital, in exchange “to move forward the commercial goals of J&J,” according to internal emails and internal documents obtained by the New York Times. Biederman was disciplined by his employer, Massachusetts General Hospital, in 2011 for failing to reveal that many of his studies were funded by drug companies, who gave him and coworkers as much as $4.2 million.
Second, biochemist Ivo Caers, a vice president of J&J subsidiary Janseen Research & Development, who has worked for the company for 36 years and on Risperdal for 18 years, testified in court that the FDA was never given information on an internal study that showed direct links between breast growth in boys and Risperdal—despite the study having existed for years.
In 2012, a Texas judge finalized Johnson & Johnson’s Janssen Pharmaceuticals unit’s settlement of $158 million for improperly marketing Risperdal in the state, after a whistleblower outed them for pushing the drug for unapproved uses to both children and the elderly.
Then, in 2013, J&J was ordered to fork over more than $2.2 billion to resolve criminal and civil investigation surrounding the drug, one of the largest healthcare fraud penalties ever.
And Risperdal was certainly profitable, accounting for 97 percent of J&J’s sales, $28.9 billion, from 1994-2010. It wasn’t approved for any use in minors until as late as 2006, after which it was issued a new label warning—noting the possibility of gynemecostia, or breast development.
Even former FDA commissioner David Kessler took the stand this year in Philadelphia, testifying that the company pushed for doctors through marketing to prescribe the drug of “off-label”—or for uses it wasn’t formally tested and approved—claiming that J&J "knew by 2001 that Risperdal could cause abnormal breast development in boys."
This is exactly what it did for 20-year-old autistic man Austin Pledger, who grew size 44DD breasts as a result of taking the drug since age eight—and who won $2.5 million this past January, the first of 1,200 pending Risperdal cases filed in Philadelphia alone to see a jury. Just last week, the drug maker settled yet another case mere hours before opening arguments were slated to begin, in which Christopher Walker found himself also facing abnormal breast growth.
Attorneys for Johnson & Johnson have claimed, such as they did with Pledger, that the so-called “man-boobs” were the result of obesity and puberty.
Another case is slated in Philly for June 22.
By James Joiner - The Daily Beast/June 15, 2015