Federal Invega Lawsuit Leads to $1.6 Billion Settlement, Corporate Integrity Agreement


Health care giant, Johnson & Johnson, recently settled a Risperdal and Invega lawsuit for $1.6 billion. State and federal regulators charged that Johnson & Johnson engaged in improper off-label marketing of the two antipsychotic drugs.

Medications are released to the market once the U.S. Food and Drug Administration (FDA) grants approval for their use. Although physicians may prescribe medications for whatever purposes they deem appropriate, drug makers are not permitted to market their drugs for any non-approved—off-label—use. The FDA approves medications only following appropriate clinical testing.

Invega Lawsuit Claims Include Allegations of Kickbacks, Off-Label Promotion

The Invega lawsuit against Janssen Pharmaceuticals Inc., and its parent company, Johnson & Johnson, involved allegations that the antipsychotics, Invega and Risperdal, were marketed for off-label uses; that the drug makers made false, misleading statements about the drugs’ safety; and that the drug makers paid kickbacks to doctors and pharmaceuticals that serve nursing homes and other long-term care facilities to induce them to use the drugs for off-label uses, including the treatment of pediatric patients and elderly dementia patients. Risperdal and Invega were not approved for pediatric uses until 2006, and neither is currently approved for age-related dementia.

The federal government was joined in the Invega lawsuit, which settles civil and criminal allegations, by a number of states, including New York.

Invega Lawsuit Settlement Should Be Greater, Says Consumer Group

Over $523 million of the civil portion of the settlement will be used to reimburse state Medicaid programs for Risperdal and Invega prescriptions. Another $749,240,137 is earmarked for federal health care programs. The companies have also entered into a Corporate Integrity Agreement that will allow U.S. Department of Health and Human Services, Office of the Inspector General to monitor their marketing and sales practices.

According to consumer group, Public Citizen, the settlement should have been larger. One official with the group asserted that without bigger fines, as well as jail time for top executives, pharmaceutical companies will continue to flout the law.  Among other things, Sammy Almashat, a researcher with Public Citizen pointed out that between 2003 and 2010, Risperdal sales amounted to 10 times the amount Risperdal and Invega lawsuit settlement.

Considering an Invega Lawsuit? File a Claim Today

Bernstein Liebhard LLP is investigating Invega lawsuits on behalf of men and boys who developed gynecomastia, or male breast growth due to its use. To obtain a free case review, please call (855) 511-1001.

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