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Thousands are filing suit against Johnson & Johnson for not disclosing side effects of antipsychotic drug
The company stands by the drug and said it has helped millions of patients
When teenage Eddie Bible looked in the mirror, he didn’t see a boy. It was too difficult for him to look past the large breasts on his chest.
“I had bigger boobs than the girls in (high) school,” he said. “I thought, ‘Am I going to have to get a training bra?’ “
At 13 years old, Bible was suffering a side effect – not disclosed at the time – of medication he was taking for anxiety and bipolar disorder.
“They put me on this Risperdal. The doctors said, ‘Well, Risperdal was helping some.’ To me, it didn’t really help, because a year and a half later, I had gynecomastia.”
Gynecomastia is a condition that causes teen boys or men’s breast tissue to grow. Bible and thousands of others are preparing to sue Johnson & Johnson for damages, claiming the company did not disclose this possible side effect in a timely manner.
Though it’s not uncommon for teen boys to develop some breast tissue during puberty, this is different. This, Bible says, was humiliating.
At first, Bible thought his breasts were a result of weight gain, also something many who take Risperdal go through. So, at least initially, he overlooked it.
“If I knew what the side effects would be of the medication, I would have never taken it,” Bible said of Risperdal, which he took in the early 2000’s.
Soon after his breasts became noticeable, Bible stopped going outside with his friends. Most days, he’d retreat to his room and play video games to block out the world. When he was forced to go outside to attend school, he had to deal with “the looks,” he says.
And, of course, the comments.
“I’d go to the locker room, and people would point and stare,” he said.
Psychologically, he says, dealing with the side effects of Risperdal was worse than the bipolar disorder.
“They took advantage of me,” Bible, now 26, said of the drug’s maker, Johnson and Johnson, and its subsidiary Janssen, which marketed the medication.
“Everybody picking on you for being a boy with boobs. … It’s just … depressing.”
In 2006, after the drug spent more than a decade on the market, available to teens like Bible, the company placed the gynecomastia side effect on Risperdal labels.
For Bible, it was too late.
“Looking back on it, I feel like an experiment,” he said.
In a statement to CNN, Johnson & Johnson said on behalf of Janssen that it considers Risperdal a useful drug, “essential to helping those affected by mental illness. … Physicians decide how best to treat their patients.”
The World Health Organization includes risperidone, the chemical name for Risperdal, on its list of “essential medicines,” meaning the drug is “one of the minimum medicines needed for a basic healthcare system.”
But since 1994, when J&J put Risperdal on the market, the drug has drawn a significant amount of attention and controversy, beyond undisclosed side effects.
The company has had to pay more than $2 billion in penalties and settlements to state and government entities as a result of lawsuits relating to Risperdal and two other drugs, as well as civil and criminal complaints over their usage.
In 2013, in one of the largest health care fraud settlements in US history, the Department of Justice said Risperdal and two other Johnson & Johnson drugs were promoted for dementia patients when Risperdal was approved only to treat schizophrenia. This use was not approved as safe and effective by the Food and Drug Administration.
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said then-Attorney General Eric Holder.
The department also alleged that Janssen promoted the drug for use in children and people with mental disabilities, despite knowing the health risks, and said it was even one of the company’s base business goals.
The agency also alleged that Janssen’s sales representatives told doctors that they needed to increase their Risperdal prescriptions in order to receive speaking fees for speeches set up by Janssen. Janssen agreed to the settlement and fines.
In a statement, the company blamed the sales representatives.
Responding to accusations that it inappropriately marketed the drug to children, J&J said Janssen “did not direct sales representatives to promote Risperdal for use in children or adolescents, and it did not approve sales materials aimed at treating children or adolescents.”
J&J insists, “Risperdal is a safe and effective medication that has helped millions of people live better lives for more than two decades.”
The fact that doctors continue to prescribe Risperdal today is concerning for Jason Itkin, a lawyer who represents Eddie Bible and “13,000 victims like him who were injured by the drug.”
They are suing J&J for financial damages related to “disfigurement caused by Risperdal.”
“Unfortunately, past fines that J&J has already paid did nothing to help those who directly suffered through the bullying and shaming after developing female breasts,” Itkin said.
“In the mid-’90s, early 2000s, Johnson & Johnson made a conscious decision that they were going to withhold important information about their drug so that they could essentially increase their profits by selling it to kids,” Itkin said. “J&J went out of their way to hurt these kids, and now the information has come to light.”
Arturo Carino took Risperdal for a mental illness as a teen, only to develop large breasts. He was so embarrassed by his condition, he left high school after a bullying incident and never graduated. Unable to afford breast reduction surgery, the 23-year-old still suffers from gynecomastia.
“I try to act like they’re not there, but every time I look in the mirror, they are,” Carino said. “In the car, you hit a bump, and you feel it. Children grab you to try to figure out what you are. If I have this for the rest of my life, I’m probably not going to have a significant other,” he said.
For Bible, suing J&J won’t bring back his past. Nor will it erase the scars from the surgery to remove his breasts. But perhaps, he says, if he can just show those at Johnson & Johnson what the drug did, he could help them understand what he went through.
“I want to tell them to put themselves in my shoes at that age,” he said.
In late October, a Philadelphia judge granted a summary judgment in J&J’s favor for an outstanding lawsuit related to Risperdal and gynecomastia.
A separate case scheduled to start at the end of October was also resolved.
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But money will not stop “the bullying, the shaming, the deformity of being a boy growing female breasts,” Itkin said.
Getting J&J to financially compensate victims is one goal for Itkin. But he has another.
“Part two is to hopefully help J&J to find its way back,” Itkin said. “I mean, this is a company that’s supposed to help people and instead has gone out of their way to hurt kids.”
But Johnson & Johnson insists that Risperdal has helped millions and will continue to help many more.