Johnson & Johnson is set to pay more than $2.2 billion in criminal and civil claim settlements over how antipsychotics such as Risperdal and other medicines were unethically marketed, and over claims that the company paid kickbacks to the largest pharmacy in the country. According to USA TODAY, this multi-billion dollar payout is among the biggest ever for a health care fraud settlement.
The main allegations were based on the antipsychotic drug Risperdal. The FDA's approved usage of this antipsychotic is the treatment of schizophrenia. Johnson & Johnson was marketing this drug as a regular part of treatment for elderly patients with dementia and even for children who had issues such as attention deficit disorder, obsessive-compulsive disorder, or autism—while hiding some of the possible side effects.
So what exactly did Johnson & Johnson do? According to U.S Attorney General Eric Holder, they "recklessly put at risk the health of some of the most vulnerable members of our society—including young children, the elderly and disabled."
This is worse than simply trying to wring extra profit by selling a drug for something it was not meant to do. This bad marketing translates into grave health risks, especially for the elderly. For one thing, according to Bloomberg.com, Risperdal may be associated with inordinate weight increases as well as diabetes. In children, it has been known cause side effects such as gynecomastia (breast growth in males). According to the Alzheimer's Society, elderly dementia patients who take antipsychotics can have nine times the risk of a stroke after just four weeks of medicating. One study found that antipsychotics led to 1,800 deaths every year. Even less severe complications of antipsychotics could be life-threatening for elderly nursing home residents who have dementia. If an antipsychotic is administered to an elderly patient who does not have schizophrenia, then they could feel extreme lethargy, or even a severe imbalance or dizziness that causes falls, and thus can lead to serious injuries. These drugs can also diminish the mental faculties of these elderly patients.
Risperdal and Invega were some of the drugs that a subsidiary company, Janssen Pharmaceuticals, was said to have marketed for these unapproved uses, even for use as a chemical restraint against elderly dementia patients who were disorderly or befuddled. The company pleaded guilty to misdemeanor misbranding. Johnson & Johnson and this subsidiary were further charged with offering kickbacks in the millions of dollars to the biggest pharmacy in the United States: Omnicare. These were supposed to be incentives for the pharmacy to dispense their drugs for off-label treatment. Omnicare directly provides medications to nursing home facilities.
Janssen was also charged with offering kickbacks to physicians in order to have them prescribe Risperdal. Scios, another subsidiary company, and Johnson & Johnson were also charged for how they marketed Natrecor, which is only supposed to be used by patients who have a specific type of severe congestive heart failure. Instead, this drug was being touted as treatment for other forms of heart failure too.
The pharmaceutical corporation is going to pay $485 million as part of a criminal settlement, and $1.72 billion in civil settlements. The companies have also pledged to modify their marketing approach and to be more transparent. Between 2003 and 2010, Johnson & Johnson collected $24.2 billion in Risperdal sales.
Medical malpractice can be more than negligence in a medical procedure; it could be unethical or negligent marketing as well, such as exhibited with these antipsychotic drugs. If you or a loved one have been the victim of medical or pharmacy malpractice, do not hesitate to contact an experienced medical malpractice attorney today.