Johnson & Johnson to Pay $2.2B in Risperdal Misbranding Settlement

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Johnson & Johnson has agreed to pay $2.2 billion to settle charges with the U.S. Department of Justice (DOJ) over its alleged illegal marketing of Risperdal, Invega and Natrecor. It is the largest payout for misbranding and unapproved use in history.  It is also the third largest settlement involving one company.

Johnson & Johnson will pay criminal fines and forfeiture of $485 million and civil penalties of $1.72 billion  to resolve alleged misbranding of Risperdal and paying kickbacks. The State of New Jersey will receive $18 million for participating in the settlement. The settlement does not impact hundreds of consumer lawsuits consolidated into multidistrict litigation alleging that Risperdal caused adolescent boys to develop enlarged breasts, a condition known as gynecomastia. The pharmaceutical giant has already paid millions of dollars in state fines for allegedly misrepresenting the risks of Risperdal side effects and marketing it for off-label uses.

Risperdal is a drug approved by the U.S. Food & Drug Administration (FDA) to treat management and manifestation of psychotic disorders. In March 2002, its use was limited to treatment of schizophrenia. The Risperdal settlement will also resolve accusations that the company inappropriately promoted the heart-failure drug Natrecor and the newer antipsychotic drug Invega.

The Risperdal settlement would cover allegations that the Johnson & Johnson misbranded Risperdal for uses not approved by the FDA, including treatment of elderly patients with dementia and children. On the contrary, the drug was never approved for treating dementia for the elderly and was only approved for certain pediatric uses in 2006.

The settlement also included the allegations that Johnson & Johnson paid kickbacks to physicians and Omnicare Inc., the largest pharmacy for nursing homes to drive sales of Risperdal.

“These companies lined their pockets at the expense of the American taxpayers, patients and the private insurance industry,” U.S. Attorney General Eric Holder said. He also asserted that Johnson & Johnson “recklessly put at risk the health of some of the most vulnerable members of our society, including young children, the elderly, and the disabled.”

Johnson & Johnson is currently facing hundreds of Risperdal lawsuits in a consolidated litigation in Pennsylvania Court of Common Pleas in Philadelphia. Most of these cases alleged that the company concealed evidences that the drug could cause male breast growth, and improperly marketing the drug for use in children.

Despite the settlement and the hundreds of Risperdal lawsuits, Johnson & Johnson said that it stands by the safety and efficacy of Risperdal and is trying to put the chapter to rest.

Help for Victims of Risperdal Side Effects

If you or a loved one took Risperdal between the ages of 10 and 18 years old and suffered gynecomastia (male breast growth), male breast pain, nipple pain or nipple discharge, you may be able to take legal action against the drug’s manufacturer. Johnson & Johnson has already paid out millions of dollars in settlements for Risperdal lawsuits. See if you qualify to pursue compensation for medical bills, pain and suffering, and other damages by filling out the short form at the Risperdal Class Action Lawsuit Investigation.