Risperdal, one of the new-age anti-psychotic drugs and the target of many a lawsuit, is manufactured by Janssen, a subsidiary of pharmaceutical giant Johnson & Johnson (J&J) and was originally approved by the US Food and Drug Administration (FDA) in 1993 to treat schizophrenia and bipolar disorder. Its patent expired in 2007, but not before its manufacturer racked up billions of dollars in sales—sales that some have taken exception to.
One who has asked a lot of questions is Allen Jones, at one time an investigator with the Pennsylvania Office of the Inspector General who was, according to an investigative report published November 22 in the Asbury Park Press (APP), fired from his job after going public with his concerns regarding issues surrounding the purchasing of Risperdal by the state health authority. In that case, Jones noted that a computer program employed by the state and used by doctors routinely recommended expensive, new-age anti-psychotic drugs such as Risperdal over older, less-expensive options.
And yet Jones could not source government-funded medical studies to support such a recommendation.
Pennsylvania wound up suing J&J, as have several other states attempting, by way of Risperdal lawsuits, to recover costs alleged to have been spent unwisely on an expensive drug, when a less-expensive and older generic would have worked just fine.
Jones continued to investigate the issues surrounding Risperdal despite his firing, eventually serving as the whistleblower and plaintiff for a lawsuit by the state of Texas against Janssen. That Risperdal lawsuit goes to trial January 9.
Other trials have since been dismissed or are being appealed. South Carolina and Louisiana were each awarded $250 million last year. However, the manufacturer has appealed the award in Louisiana and has signaled that it will appeal the South Carolina award as well.
In total, 12 states have launched Risperdal lawsuits against Janssen to recover public health dollars spent on a high-end drug that is allegedly no more effective than cheaper generics. At least, that's the view of the National Institute of Mental Health.
Dr. John David Abramson, a health care policy expert and author, echoes those views. "We're spending money on a drug that isn't superior and might be inferior to other drugs that cost a fraction as much," says the health care policy expert at Harvard University and author of Overdosed America, in comments published November 22 in the Asbury Park Press.
The Risperdal case is complicated to say the least, involving allegations of misleading marketing and the development of computer algorithms that were allegedly tweaked to consistently recommend top-end drugs like Risperdal. The developer of the software has denied the allegation and noted that no one drug was given preferential ranking in a system that grew out of the Texas Medical Algorithm Project.
However, according to APP, J&J was among the drug companies that helped to fund the project. When using the system that grew from it, doctors treating patients at public facilities were required to undertake the recommended drug and could not stray from that recommendation without written justification, according to the text of the Texas Risperdal lawsuit.
Johnson & Johnson maintains it has done nothing improper. However, J&J is reported to have revealed in an August filing with the US Securities and Exchange Commission (SEC) that the manufacturer is in the throes of negotiating a settlement with the US Justice Department in relation to an investigation conducted by the department into marketing practices involving Risperdal. J&J, according to the filing, has agreed to plead guilty "in principal" to a misdemeanor charge relative to an alleged violation of the Food, Drug and Cosmetic Act.
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J&J opined that the payments to Omnicare were lawful. In contrast, the US Justice Department took the view that the millions of grants, rebates, sponsorship and educational funding were in actual fact, kickbacks.
That case has yet to go to trial. However, a year earlier—in 2009—the Asbury Park Press noted that Omnicare agreed to pay $98 million to settle separate charges by the US Justice Department that it accepted kickback payments from J&J. In paying the settlement, Omnicare admitted to no wrongdoing.
J&J is reported to have earned $25 billion in sales of Risperdal before the patent expired in 2007. Various Risperdal lawsuits seek to return some of that money to public coffers.
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