Hundreds of lawsuits were filed against Johnson & Johnson and its Janssen unit, alleging that Risperdal and Invega cause male breast tissue enlargement. The condition, known as gynocomastia, is so severe that some of the boys have required mastectomies (removal of the breasts).
Risperdal, also known by its generic name risperidone, and Invega, also called paliperidone, are atypical antipsychotics that change the effect of brain chemicals.
The U.S. Department of Justice said J&J illegally marketed Risperdal and Invega. According to a former Johnson & Johnson sales manager, the company didn’t wait to obtain FDA approval before promoting its use for children.
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The Risperdal gynecomastia cases are currently at various stages of the litigation process. Trials have already begun in Risperdal gynecomastia cases, resulting in some noteworthy settlements:
|Johnson & Johnson has also faced fines and court awards in other states:|
|A Louisiana jury ordered it to pay $257.7 million to the state for defrauding the state Medicaid program and misleading regulators and the public about the drug’s health risks.|
|Arkansas fined the company $1.2 billion for improper marketing.|
|Shortly after Arkansas settlement, it reached a $158 million settlement with Texas.|
|South Carolina officials won a $327 million award over claims that Johnson & Johnson sent marketing letters to doctors that overstated the safety of Risperdal.|
According to Bloomberg, the drug generated worldwide sales of $24.2 billion from 2003 to 2010. So it comes as little surprise that the company did not admit to wrongdoing in the multistate investigations. In fact, Johnson & Johnson continues to deny wrongdoing despite reaching settlements in several Risperdal personal injury lawsuits in recent months.
Settlement talks with other state are ongoing, and the drug companies are also trying to settle their fight with the Justice Department.
Yet the complaint filed by the Kentucky attorney general alleges that “despite knowledge to the contrary,” J&J represented to doctors that Risperdal had a safety profile unmatched by any other antipsychotic drug.”
It even directed salespeople to say that “Risperdal had a zero percent rate of diabetes in trials, contrary to its own study result.” These types of misrepresentations allegedly resulted in a wide range of injuries affecting populations from young boys to elderly dementia patients.
|People injured by Risperdal claim Johnson & Johnson and Janssen:|
|Illegally marketed Risperdal to children as a treatment for autism and other psychiatric disorders without FDA approval between 1993 and 2004.|
|Concealed the full extent of the drug’s health risks.|
|Misrepresented the benefits and risks for the drug in children.|
All too often, innocent consumers are left with severe physical and emotional injuries that take time and money to heal. Sometimes the injuries are permanent.
Although state enforcement actions like the Kentucky attorney general’s recent lawsuit help hold drugmakers accountable for their actions, injured people like the boys who have been hurt by Risperdal often need to file their own lawsuits.
Young men and the families of boys who have been injured by Risperdal have already filed lawsuits. People like Andrew Bentley of Houston are representative of some of the claimants who are holding Johnson & Johnson and Janssen accountable for their injuries.
The drug giants have defended themselves by claiming that their product contains adequate warnings. However, plaintiffs argue that the company did not properly disclose the health risks for a drug because it wasn’t even allowed to market to youth prior to 2006.
The defendants claim that breast development is normal for boys going through puberty. But developing a condition that requires a boy to have a mastectomy is hardly normal.
That’s what happened to Andrew, who was 17 when his case went to trial. He was prescribed Risperdal to help treat problems associated with Asperger’s Syndrome. At the time, Risperdal was not approved for use in children. Andrew developed breasts after taking Risperdal.
Another boy, Aaron Banks, was prescribed Risperdal at age 9. He suffered psychological trauma and later had his breasts surgically removed. Aaron filed a lawsuit at age 21 and argued that J&J marketed a defective drug and did not warn about the risks.