Risperdal Settlement Held Up Over Breast Growth Warnings: Report

A $2.2 billion Risperdal settlement between Johnson & Johnson and the federal government may be delayed or imperiled by Department of Justice (DOJ) demands that the drug maker acknowledge that side effects of Risperdal may increase the risk of breast growth, which has been alleged in a number of product liability lawsuits filed on behalf of young boys who used the antipsychotic drug.  

The agreement has been in the works since last year, following a federal probe into Johnson & Johnson’s activities concerning the illegal marketing of Risperdal.

As part of the settlement, the Wall Street Journal reports that the government wants Johnson & Johnson to admit it downplayed the risk of Risperdal breast growth when it sought approval to market the drug to children, which may expose the company to numerous and expensive lawsuits from former users of the drug.

Johnson & Johnson faces dozens of Risperdal breast growth lawsuits filed on behalf of teen boys who experienced abnormal development of breasts after using the atypical antispychotic drug as a kid. The complaints allege that the drug maker failed to adequately research the medication or warn about the risk of boys growing breasts if they use the medication.

In September 2012, it was reported that Johnson & Johnson settled a Risperdal breast growth lawsuit brought by a 21 year old, who alleged that the side effects caused him to suffer psychological trauma and undergo surgery to have the breasts removed. That settlement was reached before trial was to begin in the case, which was the first bellwether case scheduled to reach a jury.

Additional cases are pending in New Jersey and Pennsylvania state courts, and the number of complaints continues to increase as young men discover that their problems with breast growth may due to Risperdal use as a young child.

Illegal Risperdal Marketing Claims

The U.S. Department of Justice (DOJ) has been investigating Johnson & Johnson’s marketing of Risperdal since 2004, when it began looking into an alleged kickback scheme between the drug maker and Omnicare, the nation’s largest provider of drugs to nursing homes.

In 2009, Omnicare reached a settlement with DOJ over kickback charges. The DOJ investigators indicated that Johnson & Johnson paid Omnicare millions to push off-label use of Risperdal to nursing home doctors and hid the kickbacks as data fees, education fees and payments to attend Omnicare meetings. In January 2010, the DOJ filed a civil False Claims Act complaint against J&J.

Risperdal is frequently used as a “chemical restraint” in nursing homes, used to subdue unruly residents. However, studies have shown that the drug increases the risk of death in patients with dementia, and there have been nationwide efforts to curb its use for such off-label purposes.

Off-label marketing occurs when a drug company promotes the use of its drug for purposes other than those approved by the FDA, and is illegal. Doctors can prescribe a drug for any purpose they see fit, but companies cannot promote them for unapproved uses.