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Lawyers Deny Culpability in Risperdal Case

If you’ve spent enough time on our blog, you might have read about Risperdal, the popular antipsychotic. Approved in 1993, it was originally only for use in adults, though it was offered “off-label” for children with behavioral disorders and bipolar disorder. However, in 2006 a study from Duke University linked Risperdal use to abnormal breast growth on young men when taken as a child, also known as gynecomastia.

After multiple recalls, government investigations, and a growing volume of lawsuits, Janssen Pharmaceuticals began settling cases with plaintiffs to avoid testimony from the FDA commissioner, and even paid the Department of Justice $2.2 billion to halt an investigation. Regardless, in 2013 the company pled guilty to issuing kickbacks to doctors who prescribed Risperdal and marketing the drug for off-label use.

Our Current Lawsuit Against Janssen Pharmaceuticals

Today, Janssen Pharmaceuticals is facing 1,750 Risperdal lawsuits—all of which have been consolidated into a Multi-District Litigation (MDL) in Philadelphia. One of those lawsuits is our own: Arnold & Itkin is representing a young man who began taking Risperdal at age five to treat a mental disorder that causes violent behavior.

Opposing counsel contends that our client took Risperdal with his doctor monitoring for gynecomastia, indicating that the doctor knew the risks. However, that’s not the whole story. Janssen withheld vital documents that would show a strong link between use of Risperdal and abnormal breast tissue growth.

Here’s what we contend:

Janssen has always wanted to aggressively find a way to expand the use of Risperdal—particularly by expanding into the children’s prescription market. At the time that our client began taking Risperdal (2003), Janssen was studying the effect of Risperdal on children, but it had not been approved nor were the documents released.

When their findings discovered the risk of abnormal breast growth, Janssen manipulated the numbers in order to make the risk seem smaller than it was. Calculated more accurately, the incidence of gynecomastia is “frequent,” not rare. Though Janssen issued a warning in 2006 admitting there was a potential for gynecomastia for young Risperdal users, it was already too late for our client—he began growing breast tissue in 2004 at the age of 6.

The years between the updated label and our client’s Risperdal usage (2003, 2004, and 2005) were years that doctors could have been informed of the much stronger link between gynecomastia. Possibly due to Janssen’s ambitions for an expanded market, this information was never disseminated.

What We’re Fighting For

As a result, we believe our client and his family deserve compensation for:

  • Our client’s childhood spent bearing the burden of a visible deformity.
  • His medical care, should our client seek surgical correction for his condition.
  • The emotional scarring that comes from a socially traumatic condition.

More than that, our client still has to contend with his psychological condition, a condition that compels him to violent behavior that is no fault of his own. Due to his physical condition, our client’s mother had tried several other medications besides Risperdal to address her son’s psychiatric needs, but none were as effective.

Opposing counsel believes this makes the family responsible for their son’s condition. We believe that such a choice is not a choice at all—who would prioritize a boy’s physical appearance over mental health? The issue on the table is this: our client’s doctor and parents were not nearly as informed as Janssen says they were.

With a history of halting investigation and resisting probes into their drug’s documentation, Janssen Pharmaceuticals argues that they hid nothing from our client’s family. We believe they did. More importantly, we believe that the withholding of information led directly to our client’s harm.

That’s what our pharmaceutical injury lawyers intend to prove in court.


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