Families are filing legal claims against Johnson & Johnson and its Janssen unit, alleging that atypical antipsychotic drugs Risperdal and Invega cause male breast tissue enlargement. Known as gynecomastia, the emotionally damaging condition can lead to boys needing 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. Risperidone is also available in a long-acting injection called Risperdal Consta and a generic version manufactured by Patriot.
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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Thousands of lawsuits were filed on behalf of injured boys and young men in several states. Risperdal has already been the subject of several lawsuits over diabetes risks, prompting New Jersey to centralize Risperdal diabetes cases under mass tort procedures. State and federal courts may also centralize Risperdal gynecomastia cases as those claims continue to rise.
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.
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.
In November 2013, Johnson & Johnson agreed to pay $2.2 billion to settle criminal and civil claims involving Risperdal marketing. At the time, U.S. Attorney General Eric Holder said Johnson & Johnson "recklessly put at risk the health of some of the most vulnerable members of our society."
Complaints filed by state and federal officials and injured people across the country allege Janssen promoted Risperdal for children as early as 1994, despite the FDA deciding there was no supporting clinical evidence.
According to complaints, the drugmaker illegally promoted the drug for various off-label uses among elderly and pediatric patients, such as ADHD, depression, Alzheimer’s disease, anxiety, obsessive compulsive disorder, post-traumatic stress disorder, and conduct disorder.
|Federal lawsuits said Johnson & Johnson planned an aggressive marketing campaign to get doctors to prescribe Risperdal for unapproved purposes. The plan involved:|
|Giving doctors thousands of free samples.|
|Creating sales goals and incentives to motivate sales representatives to promote unapproved uses to elderly dementia patients and children with mental disabilities.|
|Paying kickbacks to the country’s largest pharmacy for nursing homes for promoting Risperdal to doctors treating nursing home patients.|
|Paying doctors to learn about the drug’s unapproved uses as part of a “sham” consulting program.|
|Giving doctors rewards like “lucrative consulting agreements,” speaker fees, and retreats at a luxury hotel to support unapproved uses and to increase their Risperdal prescriptions.|