Johnson & Johnson has agreed to pay more than $2.2 billion to resolve government charges over a drug now at the center of Risperdal lawsuit claims, as well as Invega, another anti-psychotic medication, and Natrecor, a heart drug, according to Bloomberg.com.
According to an article published November 4th, the U.S. government investigation partially involves the company’s marketing of Risperdal to elderly patients with dementia, as well as children and individuals with mental disabilities for uses not approved by the U.S. Food and Drug Administration (FDA). A plea agreement announced on that date indicates that Janssen, the Johnson & Johnson subsidiary responsible for marketing these medications, will pay a $334 million fine and forfeit $66 million. Meanwhile, plaintiffs in lawsuits over the anti-psychotic drug continue to file Risperdal gynecomastia claims.
Civil claims indicate that Johnson & Johnson and Janssen paid kickbacks to physicians and Omnicare Inc., a pharmacy that sells to nursing homes in its off-label promotion of the above medications.
According to a statement heard Monday at a news conference in Washington, the U.S. Attorney General said, “These companies lined their pockets at the expense of the American taxpayers, patients and the private insurance industry.”
Despite this multi-billion dollar settlement agreement, however, Johnson & Johnson stressed that its decision did not necessarily admit to fault related to liability or wrongdoing, but “accepts accountability” for its actions and “expressly denies the government’s civil allegations.”
In October 2012, Johnson & Johnson settled five Risperdal lawsuits filed over the anti-psychotic drug approved to treat adults and adolescents with schizophrenia, bipolar disorder in children and adults ages 10 to 17, and irritability in children. Its off-label uses also include the treatment of ADHD, research indicates.
Risperdal lawsuits involved in last year’s settlement included claims of gynecomastia, or male breast growth, from men and boys who took the medication. These cases had originally been filed in Pennsylvania’s Philadelphia Court of Common Pleas. Among the allegations included in these Risperdal lawsuits, plaintiffs claim that Johnson & Johnson failed to properly warn consumers about this particular risk, and trained sales representatives marketing the product to downplay the potential for this side effect to occur.
These cases further allege that liposuction procedures and mastectomies may be necessary to reverse Risperdal gynecomastia side effects, which may manifest in pain, swelling, tenderness and nipple discharge.
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