Trial Begins in Texas Lawsuit Alleging Manufacturer Fraudulently Promoted Antipsychotics

By January 12, 2012 Dangerous Drugs

I’ve written here many times from my perspective as a dangerous drug attorney about the problems with atypical antipsychotic drugs. These newer drugs were originally hailed as an improvement over older antipsychotics, but their use has become controversial because they were widely prescribed for “off-label” uses until fairly recently. In fact, drug makers including Janssen, a subsidiary of Johnson & Johnson, have been accused of illegally promoting atypical antipsychotics for off-label uses, particularly dementia. That use has fallen out of favor after studies showed that antipsychotics actually increased dementia patients’ risk of death; Johnson & Johnson announced a $1 billion settlement of related charges this month. Now, according to Bloomberg News, the company is accused of paying kickbacks to a former Texas state official for giving its drugs prescribing preference.
In the lawsuit, the state of Texas accused Janssen of defrauding it paying a mental health official to give its drugs priority in prescribing. As head of the Texas Department of Mental Health and Mental Retardation, Steven Shon helped develop the Texas Medication Algorithm Project, a computer program that provided prescribing guidelines to state doctors. Shon testified that he accepted payments from Janssen to fly to other states to promote the project as a model, once or twice a month over several years. Shon also served on Janssen advisory boards and the board for a Janssen publication, and served as a continuing medical education speaker for the company. Though he testified that these trips happened on his own time, the state cited at least one instance where he stayed on the clock despite being in Arizona. He retired involuntarily in 2006.
Shon and Janssen deny the allegation that they conspired to promote drugs like Risperdal illegally. Texas is also alleging that Janssen’s illegal over-promotions overbilled the state’s Medicare program. That is one of at least 12 similar claims in state and federal lawsuits, according to the Associated Press. Jury verdicts and settlements against the drug manufacturer for its Risperdal marketing practices include a $327 million award in South Carolina in 2011 and a 2010 award of $258 in Louisiana. In addition to alleging that Janssen marketed Risperdal for dementia and, before FDA approval for this purpose, bipolar patients, states also claim that the pharmaceutical company promoted it for use in children despite no approval for that use. The FDA itself ordered Janssen at least three times, in 1994, 1999 and 2004, to stop making false marketing claims about Risperdal.
This is especially concerning to defective drug lawyers like me because Risperdal has serious side effects. In particular, it and other atypical antipsychotics have a known risk of weight gain, diabetes and related metabolic problems such as high blood pressure. In addition, studies over the past decade have revealed that they may also increase the risk of stroke and heart problems in dementia patients or other older people. Those studies that gave rise to the FDA’s decision to include a “black box” warning, the agency’s strongest, advising against their use in dementia patients. More rarely, but also more seriously, antipsychotics like Risperdal can cause life-altering neurological problems including neuroleptic malignant syndrome and tardive dyskinesia. As a pharmaceutical liability attorney, I support these lawsuits and look forward to anything else they may reveal about these apparently widespread illegal marketing practices.


Based in St. Louis, Carey, Danis & Lowe represents clients across the United States who have been seriously hurt by a defective or unreasonably dangerous pharmaceutical. To tell us about your case and learn more about your options, call us today for a free consultation at 1-877-678-3400 or send us a message online.
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