Risperdal Lawsuit Lawyers
Risperdal has been linked to gynecomastia, a painful condition in which males develop female breasts. If you or a loved one has been injured by Risperdal, contact an experienced Risperdal Lawyer for a free legal consultation. The first Risperdal verdict (Feb. 2015) resulted in a $2.5 million award to a minor and his family.
Risperdal (Risperidone) is used to treat schizophrenia, bipolar disorder, and autism. Johnson & Johnson and Janssen, the makers of Risperdal, have been sued by several state attorneys general for improperly marketing the drug to minors for unapproved uses.
Risperdal marketed illegally to Children
Risperdal is not approved to treat whole Autism Spectrum Disorder, though it was approved in 2006 to treat irritability in autistic children. Johnson & Johnson and Janssen, however, did not wait for final approval before marketing the drug to doctors for children.
Johnson & Johnson asked the FDA to approve Risperdal for children in the 1990s, but the agency determined in 1997 that no clinical evidence supported such approval. FDA warned J&J that “vague reference to the safety and effectiveness in pediatric patients (would) serve only to promote the use of the drug in pediatric patients without any justification.”
J&J Guilty on Criminal, Civil Grounds
On Nov. 4, 2013, the U.S. Department of Justice – on behalf of FDA – announced a guilty plea by Janssen Pharmaceuticals, Inc. The Big Pharma giant from Titusville, N.J. pleaded guilty. Fines levied against it include a $400 million criminal penalty for putting misbranded Risperdal into interstate commerce. Janssen also agreed to pay $1.25 billion under a separate civil settlement. The combined criminal plea and civil settlement for Risperdal totals more than $1.67 billion. Janssen and J&J were found guilty of marketing Risperdal to minors even while knowing minors were at increased risk for developing gynecomastia from Risperdal. J&J and Janssen, meanwhile, face thousands of individual Risperdal lawsuits across the country.
Risperdal Side Effects
Risperdal can increase the production of a hormone called prolactin, which stimulates breast growth and can even cause lactation, or Hyperprolactinemia. Gynecomastia is usually permanent. Victims need painful breast reduction surgery to correct it. The condition can also cause serious emotional damage. Risperdal nevertheless remains on the market. Risperdal side effects include:
- Weight gain
- Gynecomastia (development of breasts in males)
- Galatorrhea (lactation)
- Cardiovascular problems
• goes by the generic name risperidone™
• contains the active ingredient risperidone
• was first approved in 1994 for schizophrenia, bipolar disorder
• is made by J&J subsidiary Janssen Pharmaceuticals
• has been the subject of several multi-billion-dollar lawsuits filed by state attorneys general*
Complaints about Risperdal
Complaints filed by state and federal officials and people injured by Risperdal charge that Janssen began promoting Risperdal for children as early as 1994. They also claim the drug maker illegally promoted Risperdal for a variety of off-label uses among elderly and pediatric patients, including ADHD (a fictitious “disease”), depression, Alzheimer’s, anxiety, obsessive compulsive disorder, post-traumatic stress disorder, conduct disorder.
Complaints also allege Johnson & Johnson planned an aggressive marketing campaign targeting doctors to prescribe Risperdal for unapproved purposes. The company:
- gave doctors thousands of free samples.
- created sales goals and incentives to motivate sales people to promote unapproved uses to elderly dementia patients and children with mental disabilities.
- paid kickbacks to the country’s largest pharmacy for nursing homes for promoting Risperdal to doctors treating nursing home patients.
- paid doctors to learn about the drug’s unapproved uses in a sham of a consulting program.
- gave doctors rewards like “lucrative consulting agreements,” speaker fees, and retreats at a luxury hotel to support unapproved uses and to increase their Risperdal prescriptions.
Risperdal captures Antipsychotic Drug Market
Johnson & Johnson’s aggressive, illegal marketing strategy helped Risperdal capture at least half of the dementia and pediatric markets for antipsychotics. But complaints allege the strategy was misleading, that it failed to disclose serious and potentially permanent side effects associated with use by elders and children.
FDA Warnings for Risperdal
In 2003 the FDA issued a strongly-worded warning letter to Johnson & Johnson announcing an increased risk of cerebrovascular adverse events for people taking Risperdal, including an increased risk of stroke in elderly patients. In 2004 the FDA sent another warning letter to healthcare professionals to announce an increased risk of hyperglycemia for Risperdal users. This condition can lead to serious complications such as ketoacidosis, diabetes, coma, even death.
2003 FDA Warning Letter to J&J, Janssen
The FDA told Johnson & Johnson that the company wrote physicians a false or misleading “Dear Healthcare Provider” letter on Nov. 10, 2003. FDA wrote that the letter violated Sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. 352(a) and 321(n)). The letter failed to disclose information “relating to hyperglycemia and diabetes mellitus to the approved product labeling (PI), minimizes the risk of hyperglycemia-related adverse events, which in extreme cases is associated with serious adverse events including ketoacidosis, hyperosmolar coma, and death, fails to recommend regular glucose control monitoring to identify diabetes mellitus as soon as possible, and misleadingly claims that Risperdal is safer than other atypical antipsychotics.”
FDA in April 2005 announced that patients with dementia-related psychosis treated with atypical (second generation) antipsychotic medications such as Risperdal increase their risk of dying compared with a placebo. FDA requested that the package insert for Risperdal be updated to include a black box warning to describe this risk and also noted Risperdal is not approved for this indication.
Risperdal causes Boys to Develop Breasts
Contraindications for Risperdal
Drugs.com reports that Risperdal use is usually contraindicated for anyone with liver, kidney or heart disease, high blood pressure, heart rhythm problems; high cholesterol or triglycerides (certain fats in the blood); a history of heart attack, stroke or low white blood cell (WBC) counts; a history of breast cancer; seizures or epilepsy; diabetes (risperidone can increase blood sugar); a history of suicidal thoughts; Parkinson’s disease; or trouble swallowing.
Johnson & Johnson’s Risperidone patent expired in 2004. Teva Pharmaceuticals then started to make and distribute a generic version of Risperdal. The only thing worse than brand name Risperdal might be the generic version of the drug.
Off-label Uses of Risperdal
Despite severe Risperdal “side effects,” some doctors prescribed it for:
• Generalized anxiety disorder
• Social Phobia
• Attention-deficit hyperactivity disorder
• No co-occuring disorders
• Bipolar Children
• Mentally retarded children
• Adjunctive treatment
• Eating disorders
• Obsessive-compulsive disorder
• Augmentation with SSRI
• Augmentation of citalopram
• Personality disorder
• Borderline personality disorder
• Schizotypal personality disorder
• Post-traumatic stress disorder
• Moderate or high evidence of efficacy
• Substance abuse (Alcohol, Cocaine, Methamphetamine, Methadone)
• Tourette’s syndrome
Risperdal Side Effects
Risperdal side effects range from minor to severe. More than ten percent of Risperdal patients have reported side effects that include headaches, sleeping problems, tremors. Other Risperdal patients may experience back pain, blurred vision, coughing, dizziness, fever, indigestion, and many more side effects. Rispersal Side Effects include:
• aggressive behavior
• changes in vision
• decreased sexual desire or performance
• difficulty concentrating
• difficulty speaking or swallowing
• inability to move the eyes
• loss of balance control
• mask-like face
• memory problems
• menstrual changes
• muscle spasms of the face, neck, and back
• problems with urination or increase in the amount of urine
• restlessness or need to keep moving (severe)
• shuffling walk
• skin rash or itching
• stiffness or weakness of the arms or legs
• tic-like or twitching movements
• trembling and shaking of the fingers and hands
• trouble sleeping
• twisting body movements
More Risperdal Side Effects
Other Risperdal side effects include back pain, chest pain, speech or vision problems, sudden weakness or numbness in the face, arms, or legs, unusual secretion of milk, confusion, dizziness, drowsiness, extreme thirst, fast or shallow breathing, fast and weak heartbeat, headache, increased thirst, lip smacking or puckering, loss of appetite, muscle cramps, pale, clammy skin, poor coordination, prolonged and painful and inappropriate erection of the penis, puffing of the cheeks, rapid or worm-like movements of the tongue, shivering, talking and acting with uncontrollable excitement, uncontrolled twisting movements of neck, trunk, arms, or legs, unusual bleeding or bruising,unusual facial expressions or body positions.
FDA Alerts for Risperdal
FDA Drug Safety Communication included a warning in June 2011 of Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip). FDA alerted the public “to medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.” See this link: Risperdal confused with Requip.
Advice to 18-Year-Old with Gynecomastia
Risperdal Medication Guide & Resources
Risperdal Settlements and Legal Fines
Janssen Pharmaceuticals, Inc. has plead guilty and been fined millions of dollars to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal.
Risperdal Lawsuit Information
If you or a loved one has experienced adverse side effects from the use of Risperdal, you may qualify for compensation to help with the cost of your medical expenses, as well as your pain and suffering. To contact a Risperdal lawyer for a free legal consultation and Risperdal lawsuit information, call Matthews and Associates toll free at 1-888-520-5202 or email us now.
• Risperdal Lawsuit Lawyer
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* U.S. Government prosecutors alleged that Johnson & Johnson promoted Risperdal for boys suffering from mental disabilities despite knowing that the drug could raise levels of a hormone known to stimulate the development of breasts.