Risperdal update

Lawsuits over Risperdal continue to move forward. The Arkansas Supreme Court has scheduled oral arguments in Johnson & Johnson’s request to overturn a verdict and $1.2 billion fine over the marketing of the antipsychotic drug Risperdal.

Oral arguments are set for Feb. 27 in Little Rock for the appeal from Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. Attorney General Dustin McDaniel successfully sued the companies, claiming they downplayed and hid risks associated with taking Risperdal.

The Risperdal lawsuit in Arkansas accused Johnson & Johnson and its Janssen Pharmaceuticals unit of concealing the risks associated with the medication. The state also charged that the companies had deceptively marketed Risperdal as being better and safer than competing medications. In 2012, the Arkansas state court judge overseeing the case levied a $5,000 fine against the drug makers for each Risperdal prescription purchased through the state Medicaid program over a 3 ½ year period. The companies were also ordered to pay a fine of $2,500 for each of the more than 4,500 letters Janssen sent to Arkansas doctors to promote the use of Risperdal.

This appeal comes after the makers of Risperdal, the global health-care giant Johnson & Johnson, agreed to pay more than $2.2 billion in November 2013 to settle allegations with the U.S. Department of Justice that it misrepresented drugs and used kickbacks to promote their sales.

That was one of the largest health-care fraud settlements in US history. According to the Justice Department, the criminal and civil fine covered allegations that J&J promoted the antipsychotic drugs Risperdal and Invega — as well as the heart drug Natrecor and other Johnson & Johnson products – for uses not approved as safe and effective by the Food and Drug Administration (FDA).
With Risperdal Johnson & Johns actively pursued the market for geriatric patients even after the FDA rejected efforts by the company to expand the drug’s use to older dementia patients. The company even went so far as to create a dedicated sales force, ElderCare, to promote the drug and others to doctors who primarily treated older patients. In sales literature the company claimed Risperdal could address symptoms that made treating elderly patients a challenge, especially in a nursing home setting. However, while the sales literature highlighted the drugs ability to treat agitation, confusion, hostility and impulsiveness, it scarcely mentioned that the drug was approved only to treat schizophrenia.

Federal officials also revealed that J&J knew Risperdal posed serious health risks for older adults, like an increased risk of strokes, but continued to play them down. Only later was the drug’s label updated to warn against use in older patients with dementia.

It was also revealed by Federal Officials, that Johnson & Johnson promoted the use of Risperdal in people with mental disabilities and children. This in spite of the fact that it wasn’t until 2006 the company received FDA approval to market to children. The drug was promoted as a safe treatment for ADHD and obsessive-compulsive disorder, yet J&J knew that children were susceptible to certain health risks from taking Risperdal. These included the possibility that boys could develop breasts through elevated production of the hormone prolactin.
There will be much attention paid to the Arkansas appeal. Johnson & Johnson has shown that it consistently places profits before the welfare of its patients. The company has also repeatedly shown that, even after it has been found guilty in the Risperdal case, it will go to great lengths to keep justice from being served.