Risperdal: In the News
With millions of prescriptions and hundreds of lawsuits filed across the county, Risperdal has a long and controversial history. If you or someone you love has suffered severe side effects from taking Risperdal, PGMBM can help.
OVERVIEW | SIDE EFFECTS | GYNECOMASTIA | FAQs | IN THE NEWS
Risperdal, an atypical antipsychotic drug, rapidly became one of the most popular and profitable drugs after its introduction to the U.S. market, but it has had a troubled history.
In 1993, the U.S. Food and Drug Administration (FDA) approved Risperdal (risperidone) for the treatment of schizophrenia in adults. The drug was developed by Janssen Pharmaceuticals, a division of Johnson & Johnson. Within three years, more than one million prescriptions had been dispensed.
By April of 2005, the use of the drug among elderly patients with dementia was found to increase the risk of sudden death and the FDA required a Black Box Warning on the drug's label. The next year, a study conducted by Duke University showed that giving Risperdal to children, which had not yet been approved by the FDA, could cause gynecomastia, or male breast growth, as well as unexpected lactation in young girls. Nevertheless, in 2007 the FDA granted approval of Risperdal for the treatment of schizophrenia in children between the ages of 13 and 17 and for bipolar disorder in children 10 to 17.
Johnson & Johnson made billions of dollars from the sale of Risperdal before it lost its patent in 2007 and generic versions of risperidone became available. Once Johnson & Johnson's best-selling drug, Risperdal generated worldwide sales of $24.2 billion from 2003 to 2010.
But consumers began to allege that Johnson & Johnson failed to properly research side effects. The company was also accused of providing monetary incentives to Omnicare, a pharmaceutical supply company, to convince doctors to prescribe Risperdal to patients.
In July of 2010, the first gynecomastia lawsuit was filed. The 21-year-old plaintiff took Risperdal from the ages of 9 to 13. At the time he was taking it, Risperdal had not been approved by the FDA for treatment of children. Johnson & Johnson settled the case for an undisclosed sum. More than 100 gynecomastia lawsuits are still pending.
Also in 2010, a Louisiana jury awarded nearly $258 million in damages because Johnson & Johnson's Ortho-McNeil Janssen unit defrauded the state's Medicaid system by claiming Risperdal was superior to competing antipsychotic drugs and minimizing its links to diabetes.
In 2011, after a jury verdict, a South Carolina judge ordered Johnson & Johnson to pay $327 million for deceptive marketing. It was the largest drug marketing award in the state's history and the largest penalty levied for violations of the South Carolina Unfair Trade Practices Act.
A Texas whistle-blower case cost Johnson & Johnson a $158 million settlement in 2012 for "making false or misleading statements about the safety, cost and effectiveness of the expensive anti-psychotic medication Risperdal, and improperly influencing officials and doctors to push the drug."
In April 2012, an Arkansas jury found that Johnson & Johnson and subsidiary Janssen Pharmaceuticals had minimized or concealed the dangers associated with Risperdal. The judge ordered the companies to pay more than $1.2 billion in fines for nearly 240,000 violations of the state's Medicaid fraud law.
In August of the same year, Johnson & Johnson arrived at a $181 million settlement with 36 states and the District of Columbia regarding the marketing of Risperdal and another antipsychotic, Invega. The prosecutors claimed that Johnson & Johnson promoted their drugs for unapproved uses and minimized the seriousness of side effects.
Only two months later, in October 2012, Johnson & Johnson agreed to settle five more Risperdal gynecomastia cases.
The Department of Justice began investigating Johnson & Johnson's practices. The pharmaceutical giant offered the feds $2.2 billion in order to halt the investigation, but only if they could avoid admitting wrongdoing, which could affect the outcome of the many personal injury lawsuits pending against them.
The DOJ continues its investigation, and J&J continues to deny liability for Risperdal injuries. They have appealed many of the judgments against them.
Filing a Risperdal Injury Lawsuit
If you or someone you love has suffered severe side effects from taking Risperdal, PGMBM can help. You may be entitled to compensation for your pain and suffering, medical expenses, and other damages. Our mission is to protect those who are injured by the negligence or misconduct of others – including pharmaceutical companies. You can reach our attorneys online or by calling: 1-888-348-6787.