Medical research has found a connection between Risperdal and adolescent male breast enlargement (gynecomastia). If you or someone you know has taken Risperdal and developed gynecomastia, you need a sympathetic advocate who will represent only your interests—and who will make the process of obtaining compensation for your injuries as painless as possible. The Rottenstein Law Group knows this, and we want you to believe it. We might be the Risperdal law firm you are looking for.
What Is Risperdal and What Is Prescribed For?
Risperdal is the brand name for the drug risperidone. Made and sold by the Johnson & Johnson subsidiary Ortho-McNeil-Janssen, this prescription medication is used to treat schizophrenia in teenagers and adults, Bipolar I Disorder in those aged 10 and older, and irritability associated with autistic disorder in children aged 5-16 years. The U.S. Food and Drug Administration (FDA) approved it in late 1993.
Ortho-McNeil-Janssen’s risperidone patent expired in 2004, and in 2008, Teva Pharmaceuticals began selling a generic equivalent in the U.S.
According to the drug’s label, scientists do not understand Risperdal’s mechanism of action, though this is not uncommon for drugs designed to treat schizophrenia. Medical experts speculate that Risperdal blocks dopamine Type 2 receptors and serotonin Type 2 receptors in the brain. It’s less likely than some antipsychotic drugs to cause involuntary body movements at low doses. Risperdal is sold in various forms including tablets, orally disintegrating tablets, oral solutions, and intramuscular injections.
Controversy Has Surrounded Risperidone
The manufacturers of risperidone are not strangers to controversy. In January 2010, whistleblowers, state attorneys general, and the Department of Justice filed a Risperdal lawsuit against Johnson & Johnson based on the False Claims Act. The government claims that between 1999 and 2004 Johnson & Johnson paid $50 million in kickbacks to a pharmaceutical supply company, Omnicare, to sell Risperdal to nursing homes. The kickbacks appeared as payments to Omnicare for sham services, and Omnicare used the money to initiate programs aimed at convincing doctors to prescribe Risperdal to nursing home residents. Omnicare settled its own lawsuit against the government for $112 million.
In 2010, investors became so angry over the Risperdal controversies that they filed a derivative lawsuit against the Johnson & Johnson’s executives in New Jersey federal court. In July 2012, that case settled for $2.2 billion.
In August 2011, Massachusetts filed suit against J&J claiming the drug company promoted Risperdal for off-label uses and failed to disclose serious Risperdal side effects including diabetes and an increased risk of death in elderly patients. Several other states have filed similar suits against J&J, with mixed results. A Risperdal-related suit brought by the State of West Virginia was dismissed, but South Carolina secured a judgment against J&J for $347 million—an amount that included $4,000 for each of 7,142 letters the drug company sent to South Carolina doctors for marketing purposes. J&J has reportedly earmarked significant funds for Risperdal-related liability. In January 2012, Bloomberg Businessweek reported that J&J settled a Risperdal fraud lawsuit brought by Texas on behalf of its Medicaid program for $158 million.
Due to the alleged marketing tactics Johnson & Johnson used, U.S. Securities and Exchange Commission filings indicate that the government has been investigating the company’s sales practices. In August 2012, per a settlement agreement, it entered a guilty plea for a misdemeanor.
In November 2013, the New York Times reported that J&J settled with the Justice Department for $2.2 billion in civil and criminal fines because J&J improperly marketed Risperdal to children, the elderly, and people with disabilities between 1999 and 2005. It is the third-largest pharmaceutical settlement in U.S. history. In January 2014, the Louisiana Supreme Court reversed a $257.7 million jury verdict in favor of the state because the attorney general failed to show that J&J and Janssen had misrepresented the drugs efficacy to recover money from a state medical program.
In June 2011, Ortho-McNeil-Janssen recalled roughly 16,000 bottles of Risperdal due to a musty odor emanating from a pesticide contained in the wooden pallets used to transport the drug. Around the same time, the FDA issued a drug safety communication alerting the public and physicians that some doctors and pharmacists had mistaken Risperdal for Requip, a drug for treating Parkinson’s disease.
Risperdal Might Cause Life-Threatening Side Effects in the Elderly
The FDA does not approve Risperdal for the treatment of dementia in the elderly, and it requires a black box Risperdal warning on the product’s label informing users that the drug carries an increased risk of death in elderly users. The FDA determined that elderly people with dementia who used Risperdal were 1.6—to—1.7 times more likely to die of various ailments, including heart disease and pneumonia.
Risperdal Might Cause Neuroleptic Malignant Syndrome and Tardive Dyskinesia
Medical resources on the Web report that Risperdal is a potential cause of Neuroleptic Malignant Syndrome (NMS). NMS is a potentially fatal disorder with the following symptoms:
- Muscle rigidity;
- Altered mental status; and
- Autonomic instability (irregular heartbeat or blood pressure, excessive sweating).
Medical resources on the Web report that Risperdal is also a potential cause of Tardive Dyskinesia, a potentially irreversible condition characterized by involuntary facial movements such as:
- Puckering and pursing of the lips;
- Tongue protrusion;
- Lip smacking; and
- Rapid eye blinking.
Risperdal Might Cause Male Breast Growth
Although Risperdal wasn’t approved for treating children between 2000 and 2004, some doctors prescribed it to boys, some of whom developed gynecomastia. Doctors simply attributed the breasts to weight gain and not a unique side effect of the drug. In April 2013, the medical journal Plastic and Reconstructive Surgery published an article finding that gynecomastia has “a significant negative impact on primarily the psychosocial well-being of affected adolescent patients, specifically in regard to social functioning, mental health, and self-esteem.” In September 2012, one 21-year-old plaintiff’s case settled on the first day of trial for an undisclosed amount. Five more Risperdal breast growth lawsuits settled in October 2012, leaving more than 100 lawsuits that have not been resolved.
Risperidone Might Cause Other Harmful Side Effects
Like many antipsychotics, Risperdal carries a suicide warning in its “Warnings and Precautions” section.
The “Pregnancy” section of Risperdal’s label now informs doctors and women who are about to become pregnant that Risperdal causes withdrawal symptoms in infants in the form of abnormal muscle movements (called extrapyramidal signs (EPS)). In February 2011, the FDA required Ortho-McNeil-Janssen to include information about risperdone’s potential to cause EPS on the drug’s label.
Symptoms of EPS include:
- Hypertonia (excessive muscle rigidity);
- Hypotonia (excessive muscle elasticity);
- Somnolence (sleep disturbances);
- Respiratory distress; and
- Feeding disorder.
Most EPS withdrawal symptoms pass after a few days.
There is also concern that Risperdal, like other atypical antipsychotic drugs, has the potential to cause metabolic disorders, particularly hyperglycemia (excess sugar) and diabetes. Atypical antipsychotics cause the body to metabolize fat instead of carbohydrates, leading to insulin resistance to the excess carbohydrates. At the same time they promote fat accumulation.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that getting satisfaction from the company that harmed you shouldn’t be just more hardship. That’s why we do everything we can to streamline the process, and we will file a Risperdal lawsuit on your behalf if necessary.
If you believe you have experienced adverse side effects as a result of taking Risperdal, submit this simple secure form for a free and confidential evaluation of your eligibility to file a Risperdal lawsuit.