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 for treating any conditions not specified 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 stated it should be used to 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 Caused Devastating Side Effects in Young Men
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 of heart-related diseases and strokes. Lack of substantial studies in addition to noted serious side effects meant J&J wasn’t supposed to 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 kept promoting it to children.
One jury recently ruled that 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
Risperdal was originally approved only for adult use, and the FDA often reminded J&J of that fact. Still, Johnson & Johnson ignored warnings and increased Risperdal promotion to children, adolescents and the elderly. 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.