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Risperdal, an atypical antipsychotic, has been on the market since 1993. Antipsychotics, in general, have come under fire, both for the number and severity of side effects and for drug companies’ disingenuous marketing tactics. Over the past few years, Johnson & Johnson and subsidiary Ortho-McNeil-Janssen Pharmaceuticals have been involved in several lawsuits concerning both issues.
The FDA approved Risperdal in 2003 for adult treatment of schizophrenia. A decade later, its benefits further spread to adult treatment of bipolar disorder. It wasn’t until 2006 that Risperdal and generic equivalent Risperidone were approved to treat irritability in children with autism, and by 2007, it was recommended for patients under 16 with bipolar disorder.
However, since Risperdal entered the market, the FDA has issued warnings concerning such serious side effects as neuroleptic malignant syndrome (NMS), tardive dyskinesia, diabetes, and increased risk of death in elderly patients, attributed to stroke and stroke-like conditions.
The drug generated $24.2 billion in sales per year from 2003 to 2010. However, losing patent protection caused figures to drop to $358 million by 2012.
A side effects occurring only in children – gynecomastia, or male breast development – has received a significant amount of attention.
Breast tissue develops naturally in women when levels of hormone prolactin increase. However, studies have shown that boys taking Risperdal are more predisposed to developing this condition. Associated with it is pain, psychological trauma, and nipple discharge.
A 2006 study published in the Journal of Clinical Psychopharmacology established a correlation between Risperdal usage and increased prolactin levels. The article further pointed out that researchers have not documented the drug’s long-term effects into adolescence. As a result, the study recommended that Risperdal not be given to children and teens.
A 2009 study published in the Journal of Child and Adolescent Psychopharmacology confirmed the initial findings and further stated that elevated prolactin levels continue for up to two years.
Other Side Effects
Along with gynecomastia, other side effects associated with Risperdal have included metabolic syndrome, pancreatitis, Hyperprolactinemia, weight gain, movement issues, stroke risks, and diabetes.
Diabetes: Studies have shown that Risperdal usage increases a patient’s risk of developing diabetes by 50 percent, when compared to other antipsychotics.
Strokes: Since the drug became available, 37 reports of strokes or stroke-like conditions have been filed, including 16 deaths. As a result, Johnson & Johnson informed doctors of this risk, particularly for elderly patients.
Movement Issues: Risperdal may cause a patient to develop NMS, a condition characterized by muscle stiffness and irregular blood pressure and pulse, or TD, a central nervous system disorder resulting in involuntary limb movement and facial and tongue twitching.
Lawsuits and Legal Action
Johnson & Johnson has been plagued with litigation issues since the early 2000s. They’re not the first antipsychotic drug manufacturer to be faced with lawsuits, however, and in fact, Eli Lilly and Pfizer, for Zyprexa and Geodon, respectively, preceded them.
Johnson & Johnson is the defendant in roughly 420 cases at the state level, with 130 concerning gynecomastia. Although certain issues, such as diabetes side effects, have been consolidated into mass tort litigation, no multidistrict class action lawsuit has been filed.
Regarding gynecomastia, plaintiffs experienced psychological trauma and required surgery to remove breast tissue. Depending upon severity, procedures ranged from liposuction to a mastectomy. Further, they allege Johnson & Johnson failed to warn about breast development side effects, did not fully research potentially-developing conditions, and provided kickbacks to Omnicare.
As well, a handful of plaintiffs claim Johnson & Johnson’s marketing practices resulted in being prescribed Risperdal before the FDA approved it for children in 2006. In court, a sales manager alleged Johnson & Johnson trained its representatives to promote the drug for treating children as early as 2003.
For these cases, plaintiffs have sought compensation for medical expenses, trauma, and other damages.
While Johnson & Johnson reached a settlement concerning some gynecomastia cases in a Pennsylvania court in 2012, several other state- and federal-level lawsuits have targeted its marketing practices, which, according to statements, claimed Risperdal has fewer side effects than other antipsychotics and has a zero-percent diabetes risk. For this group of claims, Johnson & Johnson reached the following settlements:
- $181 billion in 2012 for misconduct in 36 states.
- $2.2 billion for false marketing and kickbacks.
- $257.7 million in Louisiana for defrauding the state Medicare program and misleading regulators.
- $1.2 billion in Arkansas for improper marketing
- $158 million in Texas for marketing tactics.
- $327 million in South Carolina from letters Johnson & Johnson sent that overstated Risperdal’s safety.