Risperdal Gynecomastia Lawsuit
Janssen-Cilag, a subsidiary of pharmaceutical company Johnson & Johnson, produced Risperidone, a drug marketed under the name Risperdal. This drug is identified as an atypical anti-psychotic medication where the mechanism of action alters certain chemicals in the patient’s brain. The U.S. Food and Drug Administration (FDA) approved Risperdal for use in adults with schizophrenia, schizoaffective disorder, bipolar disorder, or irritability from autistic disorders. Janssen allegedly started promoting the drug to physicians for use in children and teenagers. Subsequently, the company paid fines for promoting risperidone for off-label uses including for dementia, anger management, and anxiety. Recent evidence indicates Johnson & Johnson is responsible for a significant number of possible life-threatening side effects from Risperdal.
Johnson & Johnson is accused of failing to warn consumers and physicians about the high risks of gynecomastia. Gynecomastia is a condition among adolescent and young male patients resulting in abnormal breast growth or development. Studies also found a number of young girls taking Risperdal lactate before reaching puberty. Risperdal-Gynecomastia lawsuits filed against Johnson & Johnson allege the drug causes hormonal imbalances in the body via elevated levels of the lactation hormone, Prolactin. Prolactin stimulates breast growth development and milk production. The condition requires patients to undergo mastectomies because of abnormal breast size. Signs and symptoms of gynecomastia include breast pain, breast enlargement, and nipple discharge. This leads to physical and emotional trauma in patients who experience these symptoms. Kershaw, Cook & Talley is filing lawsuits on behalf of victims with gynecomastia secondary to Risperidone use.
The side effects of Risperdal, in addition to gynecomastia, include:
These side effects led to a significant number of lawsuits with allegations against Johnson & Johnson. The number of victims increases with time. There are multiple lawsuits alleging severe personal damages filed against Johnson & Johnson. The FDA issued several warnings related to Risperidone. Furthermore, Johnson & Johnson were penalized and paid billions of dollars to resolve state and federal government accusations stating the company marketed several drugs illegally including Risperdal. The law requires manufacturers provide factual information to their consumers concerning their products. Every consumer has the right of knowledge pertaining to a certain product. Tax payers can help ensure federal health care finances are spent suitably. The FDA aggressively pursues companies attempting to corrupt the health care system. All Risperdal lawsuits demonstrate Johnson & Johnson fell short in providing sufficient warning labels concerning the drug’s side effects.
In August 2012, Johnson & Johnson agreed to pay $181 million to resolve claims by 36 states for the promotion of Risperdal for unverified uses. The provisions of drug manufacturers restricts marketing and sales personnel from distributing peer reviewed prints of journal articles containing off- label information. On November 4, 2013, Johnson & Johnson agreed to pay over $2.2 billion, one of the highest penalties ever charged against a corporation for healthcare deception. This fine resolves criminal and civil investigations into the selling and marketing of Risperdal, and other extensively off label marketed products. The agreement requires Johnson & Johnson’s Janssen division plead guilty to misbranding Risperdal for unapproved uses. In addition, the company was accused of paying kickbacks to physicians and Omnicare Inc., the chief pharmacy for treatment prescriptions. This resolution subjects Johnson & Johnson to stern requirements under a Corporate Integrity Agreement obtained under the department of Health and Human Services Office of the Inspector General (HHSOIG). The agreement ensures accountability and intelligibility to curb future abuse and fraud.
Many law firms are dedicated to helping victims suffering from Risperdal, both physically and emotionally. For instance, a lawsuit filed in Philadelphia involved a 21 year old man who alleged Johnson & Johnson knew about the side effects of Risperdal before the company marketed the drug. The man stated he developed breasts after taking Risperdal for about five years, beginning at the age of nine. Not only did he suffer from psychological trauma but was also forced to have his breasts surgically removed. Johnson & Johnson secretly settled the case prior to the trial date. This sheds light on just one of the hundreds of lawsuits filed against Johnson & Johnson and it’s subsidiary, Janssen.
If you, or a loved one, were diagnosed with gynecomastia secondary to Risperdal use, call Kershaw, Cook & Talley for a free case consultation. Fill out the contact form on this page, or call toll free at (888) 997-5170.