Once again the drug giant Johnson & Johnson has been ordered to pay out for its mishandling of the marketing of its drug Risperdal. In early November 2013, the company has plead guilty to a misdemeanor charge of misbranding and has been ordered to pay fines, forfeit profits and settle some pending civil suites to the tune of over $2.2 billion. This is one of the largest payout settlements ever reached between the U.S. government and a pharmaceutical company.
Decades Of Profiting From Risperdal
Risperdal, an atypical antipsychotic, was first approved in 1993 for use in schizophrenia and was manufactured by Jassen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson. Over the next two decades, the drug would be also used to treat many other mental health issues, some approved by the FDA, others not. The drug was very profitable for J&J, with peak sales in 2007 of $4.5 billion, making up over 5% of the companies sales even in 2008.
Risperdal has been linked to many harmful side-effects, including diabetes, stroke, breast development in young males and even death. Although some of these side-effects were known, J&J allegedly downplayed these to the companies and health care providers they marketed to, even being reprimanded by the FDA for improper disclosure back in 2003 and 2004 regarding diabetes. In addition, the company is accused of issuing kick-backs to physicians and Omnicare, the largest pharmacy used by nursing homes as well as marketing the drug without approval for use in children and the elderly.
Accepting Accountability But Not Liability
Even with this record-breaking settlement, Johnson & Johnson is still not admitting wrongdoing in civil allegations. While they agreed to the misdemeanor charges in their plea and have agreed to pay out to settle civil suites to the U.S. Department of Justice and 45 states, they deny liability. Three of the civil suites settled were whistle-blower lawsuits, including a former sales representative that claimed the company ordered her to sell the drug to doctors for mental illness in children, which was not an approved application of the drug at the time.
The settlement reached does not include the previous court cases in three other states that are possibly pending appeal by J&J. Arkansas, Louisiana and South Carolina all have judgments against the company for its misleading marketing of Risperdal. These three states have over $1.8 in settlements that it is suspected that J&J will appeal. Add this to the $2.2 billion and the company is looking at over $4 billion in settlement costs, larger than the $3 billion pharmaceutical agreement in 2012 by GlaxoSmithKline over its marketing of their drugs.
The injuries and harm that have been caused by Risperdal due to the greed of J&J is unquestionably heinous. The company knowingly marketed the drug for uses it was not approved for and even paid off health care entities to prescribe the drug to children, the mentally ill and the elderly. The billions that they will pay out is nothing compared to the suffering they have caused for the hundreds, if not thousands, of people that they have harmed chasing after profits.