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Risperdal settlement occurs amid growing litigation

Risperdal lawsuits continue to be filed in regard to the antipsychotic drug's side effects to male patients. Meanwhile, several defendants, including Janssen Pharmaceuticals, the manufacturer of Risperdal (risperidone), agreed May 18 to pay the State of Arkansas nearly $7.8 million to settle litigation in regard to the marketing of the drug. The agreement is contained in a May 18 order handed down by the state's Sixth Division Circuit Court of Pulaski County.

The state alleged in the original lawsuit, which it filed in 2007, the defendants engaged in false and deceptive practices in the marketing of Risperdal, for which the state paid $8.1 million in Medicaid claims during a period identified in the state's litigation. The state claimed that Risperdal's label understated certain risks and that the manufacturer's letter to health care providers did the same thing.

At the insistence of the U.S. Food and Drug Administration, Janssen and other makers of so-called second-generation antipsychotics in 2003 had to send letters to health care providers explaining those drugs' risks of hyperglycemia and diabetes mellitus. Risperdal was one of those drugs. Janssen said in the 2003 letter that the FDA directed it to inform about those risks, but the manufacturer had the audacity to debunk those risks in the very same letter.

In 2004, the FDA reminded Janssen that its Dear Health Care Provider Letter minimized the risks, after which Janssen sent a letter that directed health care providers to the drug's updated prescribing information concerning diabetes and hyperglycemia.

Then in 2007, Arkansas took Janssen to court because, according to Supreme Court documents, it "knowingly made false statements or representations of material fact in its Risperdal label," in violation of Medicaid fraud laws.

This was not Janssen's first run-in with governments.

By 2012, the dam of state-sponsored litigation broke loose. Janssen announced that year a settlement and consent decree with 36 states and the District of Columbia in regard to its Risperdal marketing practices. Arkansas was not in that settlement.

Moreover, in November 2013 Johnson & Johnson, which owns Janssen, agreed to pay the U.S. government more than $2.2 billion to resolve criminal and civil liability for promoting Risperdal and other drugs "for uses not approved as safe and effective by the Food and Drug Administration and payment of kickbacks to physicians and to [nursing home pharmacies]," according to the U.S. Justice Department. The agreement included allegations that the corporations marketed drugs to the elderly and to others despite health risks that they knew about.

Risperdal Gyne Illustration.jpgOne of those risks was gynecomastia, which is the abnormal development of breasts in males. Young men and adolescents are particularly at risk. Risperdal lawsuits have been filed across the country as a result of the alleged unreasonable risk of gynecomastia, which has been linked to breast growth so enormous in many cases that the male victims had to undergo the expense and suffering of surgery to correct the problem.

As the Justice Department's statement read, "from 1999 through 2005 [prior to FDA approval to market the drug to children], Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities. The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production."

More than 1,300 Risperdal gynecomastia lawsuits have been filed at the Mass Tort docket of the Philadelphia-based First Judicial District of Pennsylvania. There is still time to file. Young men and, through their parents, male children who used Risperdal and since have been diagnosed with gynecomastia should consult an attorney.

Reich & Binstock handles Risperdal gynecomastia lawsuits. Its skilled Risperdal Litigation Team at no charge will analyze a potential client's circumstances and determine all of the legal options. The law firm operates in all 50 states.

For a free consultation, contact Reich & Binstock either by calling the toll-free number, 1-866-LAW-2400, or by submitting an electronic message through this web page.

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