J&J Settles Law Suit Regarding Male Breasts

J&J Settles Law Suit Regarding Male Breasts

September 12th, 2012 // 5:18 pm @ jmpickett

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Was Johnson & Johnson worried what would happen when Aaron Banks took the stand to testify that its Risperdal antipsychotic allegedly caused him to grow breasts? Just as a trial in a Pennsylvania state court was about to begin, the health care giant settled the case, the first of dozens of such lawsuits charging the pill has caused gynecomastia – the abnormal development of large mammary glands in males – but labeling lacked sufficient warnings.

“It’s been a disaster for him and many others who suffered from this,” says his lawyer, Stephen Sheller, who has filed about 120 such lawsuits and is scheduled to take another to trial later this month. “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.”

The plaintiff, 21-year-old Aaron Banks, alleged that he suffered psychological trauma after growing breasts while taking Risperdal between 1999 and 2004, starting when he was nine years old, says Sheller, who added that the antipsychotic was not approved for use in children in the US at the time. Banks later had the breasts surgically removed (read the lawsuit here and here). As for the settlement, the terms are being kept confidential.

Sheller explains that Risperdal stimulated the production of prolacting, which is a hormone released by the pituitary gland that stimulates breast development. The initial Risperdal labeling, he says, 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 says.

By settling the case, J&J (JNJ) avoided having ceo Alex Gorsky called to the stand. Banks’ lawyers were seeking his testimony because from October 1998 to October 2001, 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.

The US Department of Justice, in fact, cited his same responsibilities in an effort earlier this year to depose Gorsky in connection with a widely publicized kickback case involving the Omnicare nursing home pharmacy (back story). However, Gorsky may escape being deposed if J&J settles various civil and criminal probes in to Ripserdal marketing and pay as much as $2.2 billion as reported (see this).

Nonetheless, Sheller says he plans to continue pursuing Gorksy and hopes the court will rule that the J&J ceo will be required to provide testimony during the upcoming trial later this month, although he says J&J is fighting his effort. Separately, he has filed a citizen’s petition with the FDA to revoke approval for Risperdal, its generic versions and the Invega antipsychotic “unless and until the long-term safety” can be demonstrated or labeling that includes a Black Box warning on insufficient safety data is added (read it here).

Meanwhile, J&J had little to say about the settlement. A spokeswoman sent us this: “Since the early 1990s, Risperdal has and continues to improve the lives of countless people throughout the world who suffer from debilitating mental illnesses.”

Last month, J&J agreed to pay $181 million to resolve claims by 36 states for promoting the Risperdal and Invega pills for unapproved uses (see here). The deal includes provisions that are more specific than the sort of restrictions that the Feds often impose on drug makers, such as agreeing not to misuse continuing medical education programs for marketing or awarding grants to doctors based on their prescribing habits. One provision restricts the ability of drug makers to use sales and marketing personnel to distribute peer reviewed reprints of journal articles that contain off-label information.