In one of the biggest settlements of a healthcare fraud case ever, biotechnology giant Johnson and Johnson (J&J) has agreed to pay $2.2 billion to settle charges over how it marketed three of its highly-profitable prescription medications in the late 90s and early 2000s. J&J is accused of marketing Risperdal (risperidone) and Invega (paliperidone) as a way to treat anxiety among elderly people with dementia, even though the medicines increased their risk of death. In a separate civil complaint, the government alleged that J&J and its subsidiary Scios promoted its heart failure drug Natrecor (nesiritide) as a weekly treatment for patients, despite no scientific evidence to support this approach.
Free Dementia Class Action Lawsuit Evaluation: If one of your parents or family members was prescribed Risperdal, Natrecor, or Invega for the treatment of Dementia while living in a nursing home or assisted living facility, you may be entitled to compensation. To see if you qualify, please contact our law firm immediately by filling out the Free Confidential Case Evaluation form below or by calling us toll free 24/hrs a day by dialing (866) 588-0600.
J&J Will Pay More Than $2.2 Billion to Settle Risperdal, Invega, Natrecor Lawsuits
Under the terms of the plea deal, Johnson & Johnson’s Janssen unit will plead guilty to a misdemeanor criminal charge of misbranding Risperdal for uses not approved by the FDA, including for the treatment of elderly patients with dementia. The company will reportedly pay $334 million in fines and forfeit $66 million.
Janssen also settled civil claims that it marketed Risperdal for unapproved uses to the elderly, children, and mentally disabled, and that it paid kickbacks to doctors and to Omnicare Inc., the largest pharmacy for nursing homes in the United States. The civil accord covered ‘off-label’ marketing of Risperdal and Invega, as well as for Natrecor, a heart failure medicine.
“These companies lined their pockets at the expense of the American taxpayers, patients and the private insurance industry,” Attorney General Eric Holder said. Johnson & Johnson “recklessly put at risk the health of some of the most vulnerable members of our society — including young children, the elderly, and the disabled.”
“Today we reached closure on complex legal matters spanning almost a decade,” Michael Ullmann, J&J’s general counsel, said in a statement. “This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world.”
Settlement Doesn’t End State Risperdal Lawsuits
The new settlement doesn’t end Risperdal lawsuits filed in a number of states including Louisiana and South Carolina. The civil settlement, which involves the Department of Justice (DOJ) and 45 U.S. states, resolves several claims filed by whistleblowers under the False Claims Act, which lets citizens sue on behalf of the government and join in any settlement. The DOJ has joined those lawsuits.
While physicians have the authority to prescribe a medication for any reason, pharmaceutical companies can only market them only for indications authorized by the FDA. From 2003 to 2010, Risperdal was one of J&J’s biggest sellers, generating worldwide sales of nearly $25 billion. After that, the company lost patent protection and sales declined.
Risperdal was approved in 1993 for the treatment of psychotic disorders including schizophrenia. This market is relatively limited, so J&J sought to expand Risperdal’s uses to include bipolar disorder, dementia, mood and anxiety disorders, and other unapproved indications. The drug was later approved for other uses.
Like Risperdal, Invega is a second-generation atypical antipsychotic drug used to treat schizophrenia and other serious psychological disorders. Invega suppresses the effects of dopamine and serotonin, neurotransmitters in the brain that tend to be elevated in schizophrenics. Invega is manufactured by ALZA Corporation or Janssen-Cilag Manufacturing, LLC, and marketed and distributed by Janssen.
Natrecor is prescribed to patients with congestive heart failure. This condition occurs when the heart is unable to sufficiently transport blood to different parts of the body. Natrecor was approved by the FDA in 2001, even though Janssen may have marketed the drug for non-purposes.
Risperdal Linked to Gynecomastia
In addition to the marketing problems with Risperdal, the drug has been linked to gynecomastia. This condition causes young men to develop or grow breasts. Signs and symptoms of Risperdal-induced gynecomastia may include:
- Swollen breast gland tissue
- Breast tenderness
- Nipple discharge in one or both breasts
While generally caused by either hormone imbalance or certain health conditions, Risperdal Gynecomastia lawsuits allege that the drug causes an increase in the levels of prolactin, a lactation hormone that stimulates breast growth development. The lawyers at Schmidt & Clark, LLP, are evaluating potential Risperdal gynecomastia lawsuits for individuals who developed male breasts, or gynecomastia, after taking the drug.
Do I Have a Dementia Class Action Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Risperdal, Natrecor, and Invega lawsuits. We are handling individual litigation nationwide and currently accepting new Drug lawsuits in all 50 states.
Free Dementia Class Action Lawsuit Evaluation: Again, if one of your parents or family members was prescribed Risperdal, Natrecor, or Invega for the treatment of Dementia while living in a nursing home or assisted living facility, you may be entitled to compensation. To see if you qualify, please contact our law firm immediately by filling out the Free Confidential Case Evaluation form below or by calling us toll free 24/hrs a day by dialing (866) 588-0600.