Risperdal: A dangerous drug with a troubled past

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Risperdal has been linked to dangerous side effects, particularly in children and the elderly. Read more about recent legal victories in holding the drug's manufacturer accountable.

The Food and Drug Administration (FDA) exists to protect us from unsafe products, including pharmaceuticals. When drug companies ignore FDA regulations or prioritize profits over safety, innocent people suffer the consequences.

One example of a prescription drug with a troubled legacy is Risperdal (also known as risperidone). Launched in 1994 by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, the drug is an antipsychotic medication approved to treat schizophrenia and acute mania in bipolar disorder.

Reich & Binstock partner Dennis Reich was appointed in 2014 by the Honorable Carl Highberger of The Superior Court of Los Angeles County to serve on the Plaintiffs' Steering Committee, which provides the leadership and financial resources to prosecute cases involving a condition known as gynecomastia (development of female breasts in boys and men) from the ingestion of Risperdal. The first trial in California will begin in the summer of 2015.

Dangers to the elderly

Over the last decade, the drug has been at the center of billion-dollar litigation involving allegations of misbranding, inappropriate marketing, promotion of off-label uses and failure to fully disclose dangerous side effects. Janssen actively marketed the drug as an effective treatment for agitation, anxiety, hostility, depression and dementia in the elderly, even though the FDA never approved these uses. The company allegedly provided sales incentives for off-label promotion and engaged in illegal kickbacks to push the drug into nursing homes.

Meanwhile, evidence continued to mount that Risperdal increased the risk of death, stroke, heart disease and other serious health problems in the elderly. Janssen was aware of these dangers but downplayed them.

An alarming side effect in children

Janssen also allegedly marketed the drug as a treatment for various mental disorders in children, including attention deficit disorder, obsessive compulsive disorder, oppositional defiant disorder and autism. At the time, the FDA had not approved Risperdal for any use in children, and it repeatedly warned the company not to market it for children. Nonetheless, Janssen made it a business goal to increase the drug's market share among children and adolescents. The company paid speaker fees and provided other incentives for health care providers to issue prescriptions for children.

Risperdal use in children has been linked to elevated levels of the hormone prolactin, which stimulates the growth of breast tissue and milk production. An alarming side effect is the development of breasts in males. Called gynecomastia, this condition takes a serious physical and emotional toll, and may require surgery to treat.

Pursuing accountability

The legal system has begun to hold Janssen accountable. In November 2013, Janssen entered a guilty plea agreement with the U.S. Department of Justice surrounding many of these allegations. The company paid out more than $2.2 billion in civil and criminal penalties. Last year, a Philadelphia jury awarded a $2.5 million verdict against Janssen for failing to warn about the risk of gynecomastia. In December, the company reached a $15.5 million settlement with the Kentucky Attorney General regarding off-label marketing and failure to fully disclose side effects of the drug.

The litigation surrounding Risperdal remains ongoing, with more than 1,600 cases still pending. In the latest round of litigation, the U.S. Supreme Court declined to hear an appeal challenging a $124 million penalty against the company for mismarketing, overstating the benefits of Risperdal and downplaying its risks.

For those who have suffered harm as a result of Risperdal use, the takeaway is that multiple legal options are available for holding the drug company accountable. It's not too late to seek guidance from an experienced product liability attorney. Contact the experienced lawyers at Reich & Binstock (713-352-7883 or toll free 877-643-3099) to discuss your options.