On November 4, 2013, Janssen Phamaceuticals (JPI) entered a guilty plea for introducing a misbranded drug, Risperdal. Part of the plea was for Janssen to pay a $400 million criminal fine. Jansen is a Johnson & Johnson Company subsidiary and the parent company agreed to pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals more than $1.67 billion.
Additional charges related to JPI’s healthcare fraud can be found at the Department of Justice website.
The FDA released a statement after the order was entered in the U.S. District Court for the Eastern District of Pennsylvania. “When pharmaceutical companies ignore the FDA’s requirements, they not only risk endangering the public’s health but also damaging the trust that patients have in their doctors and their medications,” said FDA Commissioner Margaret A. Hamburg, M.D.
The FDA approved Risperdal in 2002 for the treatment of schizophrenia for the short-term treatment of acute mania and for mixed episodes associated with Bipolar 1 Disorder. In March 2002, JPI began to market the drug for the treatment of agitation associated with dementia in the elderly. Janssen represented to the public that Risperdal was safe and effective for this unapproved indication The Department of Justice alleged that JPI and Johnson & Johnson were aware that Risperdal posed serious health risks for the elderly, including increased risk of stroke, but that the companies downplayed those risks by combining negative data with other studies in order to support a perception of decreased risk from using the drug.
The FDA maintains that physicians may use a drug to treat patients for symptoms or diseases even when the drug is not FDA-approved for such uses. However, if a the manufacturer intends its drug to be used for a new use, not approved by the FDA, and introduces the drug for that use, the drug is considered to be misbranded. Under federal law, this is a violation and a company is subject to stiff penalties.
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Risperdal causes risperdal breast growth in children which was not information provided in the warnings
Johnson & Johnson is also facing hundreds of lawsuits regarding plaintiffs who developed gynecomastia, or male breast growth, allegedly due to their use of Risperdal. In October 2012, Bloomberg News reported that Johnson & Johnson had reached Risperdal settlements in five cases. Among other things, the Risperdal lawsuits alleged that Johnson & Johnson had concealed evidence that Risperdal could cause male breast growth, and that the company had improperly marketed the antipsychotic drug for use in children. (In Re: Risperdal Litigation, Case ID. 100300296)
In November of 2008, the Wall Street Journal reported that Risperdal was found to stimulate the production of prolactin, a hormone involved in lactation. An attorney involved in the lawsuits told the paper that two of his clients have required mastectomies to correct the male breast development.