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Johnson & Johnson’s Janssen unit decided to plead guilty to charges by federal prosecutors that it illegally marketed its antipsychotic medication Risperdal for off-label uses. As part of the guilty plea, J&J has agreed to pay $2.2 billion to settle claims related to its mislabeling, the largest settlement ever for a single drug.

The settlement with J&J is the third largest with a drug company in history and began thanks to the actions of several concerned whistleblowers. The case includes $1.6 billion in civil payments that will be made to the federal government as well as 45 states. In the case, Janssen pled guilty to marketing its powerful antipsychotic medication to elderly individuals with dementia for uses that were never approved by the FDA.

The J&J subsidiary also settled claims that that it marketed Risperdal to children, the mentally disabled and those with mood disorders. J&J also paid out to settle claims that it gave kickbacks to doctors and to Omnicare, the country’s largest pharmacy for nursing homes, something J&J still denies. Experts say that J&J wanted to market its drug for far wider purposes than it was given FDA permission to, and actively sought out larger markets for its drug such as those individuals suffering from bipolar disorder, dementia or various mood conditions.

The plea agreement states that J&J’s Janssen unit acted in a “calculated manner” and intended to maximize the drug’s profits with little concern for the risks its off-label marketing might pose to patients. Janssen’s tactics appeared to work, as Risperdal was once the company’s top selling drug, generating global sales of nearly $25 billion between 2003 and 2010.

Prosecutors praised the settlement saying that it is the largest ever involving a single drug. The final agreement was only achieved thanks to the actions of four whistleblower who filed lawsuits against J&J under the False Claims Act. The False Claims Act is a piece of legislation that allows private citizens to sue companies on behalf of the government and later share in the recovery.

Patient advocates have also applauded prosecutors for going after companies like Johnson & Johnson who for years have quietly marked drugs to doctors and patients for off-label uses. A study in the Archives of Internal Medicine found that about 21 percent of all uses for commonly prescribed medications were off-label, and that 15 percent of these were completely lacking in scientific evidence of any useful or beneficial effect. While off-label use by doctors is permitted under the law, off-label marketing is strictly forbidden, something that J&J will now pay dearly for.


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