Risperdal Lawsuits
Risperidone; Patent expired June 29, 2008. Johnson & Johnson subsidiary Ortho-McNeil-Janssen Pharmaceuticals, Inc. (formerly Janssen Pharmaceutical, Inc.) The abnormal development of breasts in males. Swelling of the breast tissue in males. Caused by an imbalance of the hormones estrogen and testosterone. Can effect one or both breasts, sometimes unevenly. Symptoms include swollen breast gland tissue, breast tenderness, swelling, pain, tenderness, nipple discharge. Recent Plastic & Reconstructive Surgery study concluded recently that gynecomastia has a significant negative impact on the psychosocial wellbeing of affected adolescent patients. Initial tests to determine the cause may include blood tests, mammograms, chest x-rays, CT scans, testicular ultrasounds, and tissue biopsies. Medications used to treat breast cancer. Surgery to remove excess breast tissue – liposuction or mastectomy. Background:
Regulatory History: Approved in 1993 for treatment of schizophrenia. FDA granted approval to Teva to market the first generic version June 30, 2008. J&J launched its own generic around the same time. Schizophrenia, Manic/mixed episodes of bipolar I disorder, Autism spectrum disorders. Major depressive disorder, Behavioral disturbances related to dementia. Metabolic disturbances, weight gain, extrapyramidal symptoms, hyperprolactinemia. Risk of death and stroke when used in older adults with dementia. One of the oldest and least expensive second-generation antipsychotics. One of the few antipsychotics approved for use in children. Litigation
Jury in Louisiana orders J&J to pay $257.7M for making misleading safety claims + 73M in legal fees added South Carolina judge orders J&J to pay $327M for deceptive marketing J&J agrees to pay $158M to settle lawsuit brought by Texas attorney general. Settlement resolved claims brought by the state in 2004 for alleged Medicaid overpayment during the years 1994-2008. J & J settled 5 pending cases. Former litigation has centered on promotion of the drug to adolescents when it was not approved for adolescent use at the time. Philadelphia lawyer Stephen Sheller petitions the FDA to release documents that purportedly detail gynecomastia side effects. These documents were sealed as part of ongoing litigation. Sheller was deposed in 2013. His transcript is one of the documents Sheller seeks. November 2013:
J&J agrees to pay more than $2.2B in criminal and civil fines. This is the 3rd largest pharmaceutical settlement in US history. As part of the settlement, J&J agreed to plead guilty to a criminal misdemeanor, acknowledging that it improperly marketed Risperdal to older adults for unapproved uses. It did not admit to wrongdoing for the civil portion of the settlement, which involves claims that the company promoted the drug’s use in children and developmentally disabled. J&J will pay criminal fines and forfeiture of $485M and civil penalties of $1.72M. The civil settlement also resolves similar accusations brought by 45 states. Support:
Former FDA Commissioner David Kessler opines that J&J broke the law
by promoting Risperdal for use in children. Kessler submitted a 92-page
report to the FDA in 2011 as part of the litigation. We have the report. In
2003, Kessler reviewed a study in the Journal of Clinical Psychiatry that
was funded by a J&J unit. The meta-analysis determined that long-term
Risperdal treatment in children did not demonstrate a correlation between
elevated prolactin levels and gynecomastia in boys. Several of the co-
authors were J&J employees. In the 2003 report, Kessler maintained that
J&J failed to present the data in an objective fashion (ex: J&J altered the
results by ignoring all adverse events in boys 10 years or older).
Other drugs can cause gynecomastia, including anti-androgens used to treat prostate enlargement or cancer (like Proscar), anabolic steroids, AIDS medications, anti-anxiety medications (like Valium), tricyclic antidepressants, antibiotics, ulcer medications, chemotherapy, and heart medications (like Digoxin and calcium channel blockers). Some street drugs like alcohol, amphetamines, marijuana, heroin and methadone can also cause gynecomastia. Can also be caused by breast cancer, fatty breast tissue, or breast abscess (infection in the breast tissue.



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