Chemical Restraints as an Easily Hidden Form of Egregious Nursing Home Abuse: A Problem that Is Further Magnified by the Unethical Marketing Practices of Anti-Psychotic Drug Manufacturers Such as Astra Zeneca.
As a Florida law firm involved in nursing home negligence and abuse litigation, we are well-acquainted with the acts and omissions on the part of nursing homes which often result in serious harm to vulnerable nursing home residents. Once in a while we, however, can still be astounded by the actions of nursing home administrators and staff members, including doctors, which are so egregious in nature that they rise to the level of criminal conduct.
Take, for example, the recent matter involving nursing home residents at the Kern Valley Nursing Home in California. Various residents had supposedly complained to the nursing home director about certain matters. As reprisal, she chemically restrained them with powerful anti-psychotic drugs, there being no showing that these residents were psychotic. The drugs’ effects were so severe that three (3) of the residents died. The director, an administrator, and staff physician have been charged with criminal violations by the State of California.
Certainly the care of nursing home residents is demanding because the residents are more likely than not suffering from some stage of Alzheimer’s and/or dementia and often physical problems as well. In understanding just why the "Kern's" trio's conduct was criminal in nature, one needs to understand that FDA has approved certain drugs for treating Alzheimer’s, but has never approved any drugs whatsoever specifically for the treatment of dementia, generally associated with confusion and anxiety. Therefore, the prescribers of these anti-psychotic drugs for dementia are knowingly administering these drugs under a practice known as “off label” usage.
Furthermore, the FDA issued warnings in June 2008 to medical providers that anti-psychotic drugs used to treat dementia in the elderly are associated with a high risk of death. Therefore those healthcare providers who violate the warnings of the FDA and use anti-psychotic drugs on the elderly cannot claim ignorance as to the potentially dangerous consequences of their actions.
One of the anti-psychotic drugs on the FDA's June 2008 "dangerous drug" warning list is Seroquel, a drug manufactured and marketed by AstraZeneca. Seroquel has recently received considerable negative press because of AstraZenaca's suspect marketing activities. Seroquel has been approved by the FDA only for the treatment of short term bipolar disorder and schizophrenia. Despite that “limited” approval, AstraZeneca had engaged in a calculated effort to “expand” the deliverance of this drug to the elderly despite the known, potentially life-threatening risk factors. To accomplish this suspect objective, the drug was marketed to geriatric physicians and primary care physicians who treat elderly patients, not psychiatrists. Psychiatrists are the doctors who generally diagnose and treat schizophenia and bipolar disorder, not primary care physicians.
Interestingly, a 2005 British Medical Journal report showed that Seroquel actually made cognitive functioning worse in elderly patients with dementia! So not only was the drug ineffective, but it also can cause harm to the patient! Not surprisingly, class action civil lawsuits have been filed against AstraZeneca on behalf of the victims harmed of the company’s questionable marketing practices
Why would drug manufacturers such as AstraZeneca “push” the usage of drugs to unsuspecting elderly patients through cooperative physicians? Think about it. Seroquel and other antipsychotic drugs have a relatively small market compared to the burgeoning “elder” market. Indeed a member of our law firm had personal experience with a situation where a physician prescribed Seroquel to an elderly family member, who was not in a nursing home at time, and after the FDA’s warning to healthcare providers in 2008. The elderly family member began experiencing excessive thirst and other “new” symptoms associated with diabetes, one of Seroquel’s well-known risk factors. The elderly person had none of the risk factors associated with diabetes and in fact had hever had a "bad" glucose test reading in her life. After several conversations with the doctor, the elderly person’s caregiver gradually “weaned” the patient off of Seroquel and changed doctors. Her entire medication schedule has been changed, and considering her age, she is doing remarkably well.
And who pays for the prescriptions for the elderly? Medicare and Medicaid. Indeed the U.S. Department of Justice filed an action against AstraZeneca for among other things, Medicare and Medicaid fraud in 2009. On April 27, 2010, AstraZeneca agreed to settle the case for $ 520 million.
