As a Pennsylvania nursing home lawyer, I have watched with interest the progress of multiple lawsuits over the antipsychotic drug Risperdal (riperidone). The drug, made by Johnson & Johnson's Janssen subsidiaries, is the subject of a federal lawsuit based in Massachusetts and numerous state lawsuits, all alleging that Janssen paid kickbacks to medical providers to promote the drug, thus defrauding Medicare and Medicaid, and downplayed negative safety information. This is especially disturbing because post-approval studies have shown that Risperdal carries a high risk of stroke, weight gain and related metabolic problems like diabetes. For this reason, it is no longer widely used off-label in dementia patients -- one of the uses Janssen is alleged to have illegally promoted.
According to the Morristown, N.J., Daily Record, Pennsylvania Inspector General's investigator Allen Jones noticed in 2002 that a computer program used by the state seemed to recommend Risperdal even when a less expensive medication would be appropriate. Jones couldn't find any independent studies suggesting that Risperdal or other Janssen drugs were more effective than older generics, but the computer program, which doctors used to prescribe drugs, mandated them. Jones went public with his claims in 2004 and was fired. He is now an expert witness in a Texas state lawsuit alleging that the drug company defrauded the state's Medicaid program out of many millions of dollars, through a similar computer program and questionable payments to doctors. A similar Pennsylvania lawsuit is on appeal, and ten other states and the federal government are also pursuing claims.
By the time Risperdal's patent expired in 2007, it had generated $25 billion in profits for Janssen. It is approved for the treatment of patients with schizophrenia and bipolar disorder, and sometimes with autism. As a Philadelphia injury lawyer, I'm interested in the nursing home safety aspects of this story. The drug's use to control dementia symptoms is off-label to start with, which means the company may not promote it for that use but doctors are free to prescribe it. This means offlabel marketing, including but certainly not limited to the Omnicare kickbacks, is already a violation of the law. However, independent studies have shown that Risperdal may increase the risk of death when used in dementia patients. In most cases, the death was cardiovascular in nature, which means heart failure, stroke or another serious medical emergency. As a result, the FDA required a black box warning on Risperdal's label in early 2011. As a Philadelphia medical malpractice lawyer, I'm not sorry to see that the rate of new prescriptions for this purpose has plummeted since then. Not only is the risk too great, but the use to calm irritable dementia patients could be considered a form of Pennsylvania nursing home abuse -- chemical restraints.