NEW BRUNSWICK, NJ–Johnson and Johnson, the pharmaceutical giant based in New Brunswick, will agree to pay $2.2 billion in legal fees to US and state government entities to settle outstanding lawsuits.
The decision has come after a drawn out legal battle over unlawful drug marketing on the part of J&J.
Risperdal, an anti-psychotic drug manufactured by J&J's Jannsen division, had been advertised to treat disorders such as Attention Deficit Hyperactive Disorder (ADHD), autism, dementia in the elderly, and pediatric uses for children.
The Federal Drug Administration (FDA) only approved the drug for the treatment of psychotic disorders like schizophrenia.
However, according to the federal Department of Justice, the company has been involved in numerous, unlawful promotional practices for the drug.
From 1999 to 2005, Johnson and Johnson created a sales force known as “ElderCare”, which sought to promote Risperdal to the elderly for an array of unapproved illnesses, such as dementia and agitation.
The company also pushed the drug on child psychiatrists and pediatricians, as a treatment for ADHD, autism, and Obsessive-Compulsion Disorder (OCD).
Risperdal has been found to have number of negative, or even lethal side effects. These include weight gain and diabetes, but also the promotion of a hormone in young males that causes breast growth.
The company has also promoted two other drugs, Natrecor and Invega, for treatments outside of approved uses.
In recent years, Johnson and Johnson has come under fire for numerous similar violations of the federal and international law, as well as dozens of recalls.
In 2010, the company issued recalls on more than 40 over-the-counter drugs.
Many of these drugs, designed for infants and young children, had failed to meet manufacturing standards.
In total, Johnson and Johnson will pay $2.2 billion in the Risperdal lawsuit. Nearly $1.72 billion will go towards federal and state lawsuits against the company.
The company will plead guilty to violations of the U.S. Food, Drug and Cosmetics Act, and pay over $400 million in criminal fees and profit forfeiting.
Several whistleblowers involved in the controversy will receive payments totaling at around $167.7 million.