Drug prescription labels are a little different than, say, the nutrition label on a bag of potato chips. Prescription drug labels are thick, multi-page documents doctors use to learn about a drug before prescribing it. The label explains how each drug is used, potential side effects, warnings, appropriate dosage, etc. The Food and Drug Administration approves all labels and works closely with manufacturers to ensure they aren’t misleading. Additionally, it’s a crime for pharmaceutical companies to promote drugs to treat conditions not on the drug’s label. This is called “off-label marketing.” Despite the possible legal repercussions and damage to consumers, Johnson & Johnson promoted its antipsychotic medication Risperdal for off-label use. Plaintiffs now allege Risperdal marketed illegally to pediatric physicians without performing clinical trials had devastating side effects in young men.
Risperdal Marketed Illegally to Children and Elderly Patients Without FDA Approval
Approved in 1993, Risperdal’s original label says it can manage psychotic disorders (such as hallucinations and delusions) in adults. It warned that too few clinical trials existed to know how Risperdal would affect the elderly and children. Despite this, J&J tried to get promotional materials for doctors who treat the elderly approved by the FDA a year later. The FDA said that promoting to the elderly would be misleading, since Risperdal wasn’t deemed safe or effective for them. J&J also wanted to say children could benefit from Risperdal, but this addition was denied. The FDA’s response stated “you have not provided substantial evidence from adequate and well-controlled trials to support any pediatric indications.” J&J then began paying nursing homes and doctors to speak in Risperdal’s favor in an attempt to circumvent the FDA’s label limitations.
Risperdal Marketed Illegally to Young Men With Devastating Side Effects
J&J knew from initial Risperdal clinical trials that it could cause significant weight gain, sleepiness, headaches, and sickness in children. Elderly patients showed increased risk for heart-related diseases and strokes. Without substantial studies, J&J legally couldn’t market Risperdal to these patient populations. In the late 1990s, medical studies showed young boys taking Risperdal could develop breasts (a condition known as gynecomastia). Despite knowing 5.5% of boys taking Risperdal might develop breasts, the company promoted it to children anyway.
One jury ruled J&J failed to properly warn consumers about abnormal breast development in boys taking Risperdal. The 20-year-old Alabama plaintiff won $70 million in damages. The court also determined that J&J purposefully “falsified, destroyed, or concealed records” regarding Risperdal’s potential gynecomastia side effect.
Speak Up About Your Risperdal Case
The FDA approved Risperdal for adult use, and J&J knows that. Still, the company ignored warnings and promoted Risperdal to children, adolescents and elderly patients anyway. When confronted in court, the drug giant feigned ignorance about Risperdal’s terrible side effects. If you or a loved one suffered serious side effects after taking Risperdal, fill out a free case review form today. An attorney will review your claim to see if you may be eligible for financial compensation.
Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as Match.com, Yahoo!, MSN, AOL, Xfinity, Mail.com, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.