Louisiana Supreme Court Overturns $258M Award in Risperdal Lawsuit

The Louisiana Supreme Court has reversed a $257 million verdict entered against Johnson & Johnson, which was awarded to the state several years ago over illegal marketing of the drug maker’s antipsychotic Risperdal.  

In a ruling (PDF) issued on Tuesday, Louisiana’s highest court determined that the state attorney general’s office failed to establish that Johnson & Johnson’s Janssen Pharmaceutical Inc. subsidiary broke state laws by misrepresenting the potential side effects of Risperdal.

Although Johnson & Johnson recently agreed to pay $2.2 billion to settle Risperdal marketing charges brought by the U.S. Department of Justice, Louisiana’s claims were excluded from the deal based on the prior damage award in this case.

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Risperdal Lawsuits

Side effects of Risperdal linked to risk of breast growth among young boys, or gynecomastia.

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The basis of the state’s charges against the pharmaceutical giant was that because of off-label marketing and misrepresentation of the health risks, the company received fraudulent medical reimbursements. However, the Louisiana Supreme Court determined that the state never actually showed evidence of Janssen or J&J receiving such fraudulent payments based on the Risperdal misrepresentations, overturning the verdict in the 2010 case.

“Even if the defendants misrepresented the efficacy or safety of their product to Louisiana doctors, there is simply no evidence in this record, and moreover no allegation, that this misrepresentation in fact caused any health care provider or his billing agent to knowingly present a claim for payment that is false, fictitious, untrue, or misleading in regard to any material information,” the court ruled.

Louisiana was one of several states that have pursued Risperdal lawsuits against Johnson & Johnson. Arkansas and Texas courts also leveled fines of hundreds of millions of dollars against the company.

In addition to the DOJ settlement and the Louisiana verdict, there was also a $327 million damage award the company was ordered to pay South Carolina for illegally promoting the drug and overstating its benefits. Johnson & Johnson has appealed that verdict as well, arguing that the damages are unfair because it was never shown that anyone was harmed due to its actions.

Risperdal Risks

One of the largest concerns over the use of Risperdal raised in the government cases involve the use of the antipsychotic in nursing homes, where it has often been given to elderly patients with dementia as a form of chemical restraint. The FDA and other health officials have repeatedly warned that Risperdal has little or no effect on dementia, and actually appears to increase the risk of death. As a result, many critics consider using Risperdal as a chemical restraint to be a form of nursing home abuse.

In addition to claims alleging that the drug makers illegally marketed their product, Johnson & Johnson and its Janssen subsidiary also face a growing number Risperdal lawsuits brought in recent years by young males who were given the drug as children, alleging that use of the antipsychotic as young boys caused them to develop male breasts, involving a serious medical condition known as gynecomastia.

Those complaints allege that the drug makers provided inadequate warnings for consumers or the medical community about the risk of boys developing breasts from Risperdal. In some cases, plaintiffs alleged that boys developed breasts measuring as large as a 38D cup size after using the medication, with many cases resulting in the need for breast removal surgery.

The psychological effects of Risperdal breast growth can have a devastating impact on the boys, greatly impacting their overall quality of life. Lawsuits allege that Johnson & Johnson placed their desire for profits before the health of consumers by withholding information about this potential risk for young males prescribed Risperdal.

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