Johnson and Johnson, makers of the anti-psychotic drug Risperdal, apparently are not appalled as they continue to sell the drug and promote it for off-label use knowing it causes Gynaecmastia – abnormal enlargement of male breast tissues.
The only treatment is to surgically remove the oversized breasts with a mastectomy.
The emotional distress to these grade school and high school boys means nothing to big pharma as long as their profits far exceed the fines and settlements paid out in lawsuits over this side effect. (Derogatory nicknames for this condition include “moobs” for “male boobs” and “bitch tits”)
Risperdal, known generically as risperidone and manufactured by Johnson & Johnson’s Janssen Pharmaceuticals Inc. subsidiary, was approved by the U.S. Food & Drug Administration (FDA) in 1993 to treat schizophrenia in adults. In April 2005 the FDA added a Black Box Warning to the label for elderly dementia patients as the drug’s use caused increased deaths.
In June 2006 Duke University researchers found that the risk of male breast growth was stronger with Risperdal than with the other atypical antipsychotics – it accounted for 70% of the Gynaecmastia cases studied.
Despite these findings the FDA in August of 2007 approved it for ages 13-17 for schizophrenia and for ages 10-17 for bipolar disorder.
Once the drug became a best seller and was prescribed widely by psychiatrists for off-label use in children labeled with “Attention Deficit Hyperactivity Disorder”, the lawsuits began to roll in.
On 6 November 2008 The Wall Street Journal reported that the drug can stimulate the production of prolactin, a hormone involved in lactation and that a lawyer was now representing several boys in Risperdal (Risperidone) gynecomastia lawsuits. He told the Journal that two of his clients required mastectomies to correct Risperdal male breast development.
In July 2010 a 21-year old man, Aaron Banks,who was treated with Risperdal between 1999 and 2004 filed a Risperdal (Risperidone) gynecomastia lawsuit in Pennsylvania, alleging he suffered emotional trauma from the breast growth he experienced. He had been given the drug before it was approved for use in children.
In 2011 a South Carolina judge levied civil penalties of $327 million against Janssen, the Johnson and Johnson subsidiary that markets Risperdal.
In April of 2012 an Arkansas jury found J&J company officials guilty of misleading doctors and patients about the risks of Risperdal and Judge Tim Fox ordered the company to pay more than $1.1 billion in fines. (Janssen committed over 238,000 violations of the state’s Medicaid fraud laws by illegally marketing Risperdal over a four year period. Each violation carried a $5,000 fine.)
Another $181,000 million was paid in August of 2012 for consumer fraud involving 36 states and the District of Columbia.
In Sept of 2012 the Aaron Banks case was about to come to trial in a Pennsylvania court room. Johnson and Johnson avoided seeing Mr. Banks take the stand by quickly settling out of court. By settling the case, J&J avoided having Alex Gorsky called to the stand. Gorsky was VP of marketing at the J&J Janssen unit that sold the antipyschotic. And from October 2001 to early 2003 he was the Janssen president, during which time he was responsible for selling Risperdal.
Aaron’s lawyer, Stephen Sheller said “It’s been a disaster for him and many others who suffered from this. There are boys who grew breasts as large as ‘D’ cups. There’s a major design defect here, which the judge was going to allow us to pursue, not just the fact that labeling understated risks.”
Sheller explained that Risperdal stimulated the production of prolactin, which is a hormone released by the pituitary gland that stimulates breast development. The initial Risperdal labeling downplayed the risk of adverse events resulting from increased prolactin levels and failed to suggest that a test should be used as well. “If your prolactin goes up, you have a higher chance of developing adverse events and kids are much more subject to this,” he said.
“Risperdal should be a drug of last resort. The adverse event profile is so significant; you don’t want to use it except as a last resort. There are many alternatives to these kinds of drugs. But ‘big pharma’ and the FDA have failed to protect the public”
Aaron was one of the cases that had to have his breasts surgically removed.
In Oct of 2012 the former commissioner of the U.S. Food and Drug Administration, David Kessler, submitted a 92 page report for a trial scheduled in Common Pleas Court in Philadelphia. Kessler stated that Johnson & Johnson and its Janssen subsidiary broke the law in marketing the antipsychotic drug Risperdal for use in children and adolescents and that “In my opinion, Janssen promoted Risperdal for non-approved uses in violation of the Federal Food, Drug, and Cosmetic Act.”
Faced with the possibility of Kessler’s appearing on the witness stand, J&J settled this and 4 other lawsuits for undisclosed amounts.
These fines and lawsuit payments for Risperdal side effects like Gynaecomastia are clearly “cost of doing business” for Johnson and Johnson. Millions paid in claims are a drop in their profit bucket.
In a recent lawsuit, The Kentucky attorney general filed a Risperdal suit in Jefferson County Court on June 14, 2013 against Janssen Pharmaceuticals and Johnson & Johnson, claiming the companies concealed the harmful side effects of the drug. According to their filing “Risperdal is the most widely used atypical antipsychotic in the world, with $4.5 billion in sales in 2007.”
Kentucky is arguing that this case should be taken to the Federal level as it deals with missing warning labels and the FDA’s role in protecting citizens.
It will take a major Federal case and lots of media attention to force the FDA and Johnson and Johnson to pull this drug from the market as they continue to defend it despite all evidence of terrible side effects.
The J&J spokesman when asked about the Aaron Banks settlement made this statement, “Since the early 1990s, Risperdal has and continues to improve the lives of countless people throughout the world who suffer from debilitating mental illnesses.”
Alex Gorsky, who avoided the witness stand in the Aaron Banks case has now been promoted to CEO at Johnson and Johnson. He tells us on their website:
“I am honored to be just the seventh CEO in our long history and proud to continue to lead our legacy of commitment to sustainable ideals, born from Our Credo commitments and in line with our purpose of caring for the world, one person at a time. I am privileged to work alongside the talented and dedicated people of Johnson & Johnson who have long demonstrated the passion to do well and do good. We emphasize the importance of doing the right thing well, in all that we do, and of never being satisfied when there is more to be done to deliver real solutions—not just treatments—for people all over the world.”
These words ring a bit hollow for Risperdal victims.