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.
Now back to the Kerns case. Is the Kerns case an isolated incident? Unfortunately the answer is “no.” Further research into the practice of using anti-psychotic drugs has revealed that such drugs are administered to one in four nursing home residents. The issue that must be considered in such cases is whether such drugs are being used as a means simply to discipline the resident or staff convenience or whether they do have some beneficial medical effect as determined by an ethical physician, preferably a physician who understands the challenges of “old age” health problems.
It must be emphasized that both physical and chemical restraint of nursing home patients is generally illegal, including in the State of Florida. In fact, as discussed in previous blogs, Florida has a very detailed Nursing Home Bill of Rights intended to protect the physical and mental well- being of its thousands of nursing home residents. One provision of this “rights bill” provides that a nursing home resident has
The right to be free from mental and physical abuse, corporal punishment, extended involuntary seclusion, and from physical and chemical restraints, except those restraints authorized in writing by a physician for a specified and limited period of time or as are necessitated by an emergency. In case of an emergency, restraint may be applied only by a qualified licensed nurse who shall set forth in writing the circumstances requiring the use of restraint, and, in the case of use of a chemical restraint, a physician shall be consulted immediately thereafter. Restraints may not be used in lieu of staff supervision or merely for staff convenience, for punishment, or for reasons other than resident protection or safety.
The foregoing provision is very clear that physical and chemical constraints, if used at all, are to be used only under very limited circumstances and pursuant to carefully documented procedures. Otherwise informed consent is required, and it is most likely that this informed consent would have to be obtained from the nursing home resident’s legal representative since the nursing home patient is likely mentally incompetent and therefore incapable of giving informed consent.
One obvious difference between a physical and chemical restraint is that physical restraints can be readily observed and reported. On the other hand, the chemical restraint of nursing home residents via the administration of anti-psychotic drugs, such as those used in the Kerns case, can be difficult to detect. Most nursing home residents do not have any clear idea as to the medications they are even rightly be given. Also, even the most attentive legal representative or family member cannot be on site 24/7 to observe the loved one and monitor his/her day-to-day care. Abusive chemical restraint of nursing home residents and/or assisted living facilities can thus be very difficult to detect.
Cases of this nature and other widespread forms of neglect and abuse described in previous blogs point to the necessity of having relatives of nursing home and ALF residents keep a vigilant eye out for the possibility of chemical restraints. In particular, the family members should look for sudden changes in their loved one’s behavior and other factors which may be indicative of chemical restraint. For example, has the resident become more lethargic, less interested in the outside world, even catatonic? Prior to a noticeable change in “personality,” had the patient ever complained to the family member of problems at the facility (e.g., rough treatment by a staff member)? Has a previously physically healthy patient (e.g., a non-diabetic), started complaining of excessive thirst or more frequent urination? Has the resident been recently examined by a physician, and what was the prognosis?
Furthermore, a family member who is involved in admitting their loved one to a nursing home. should keep a written list of all of the medications with specified dosages the nursing home resident was taking at the time of admission. Once the person is admitted, the family member should periodically request a copy of the nursing home’s “prescription administration” records. Any changes to that list compared to the list retained by the family member should be questioned.
Finally, if the family member is asked to give consent to chemical restraint, the family member should ask questions to determine if the so-called unmanageable behavioral changes could be medically related. For example, agitation could be the result of pain. An elderly patient who has problems communicating may be unable to properly articulate the “pain” problem and may become increasingly agitated by the “non-response” to his/her problem.
We hope the foregoing discussion emphasizes that the proper care of our elderly population requires a team approach for ensuring that our vulnerable nursing home and ALF residents suffering from dementia are not subjected to dangerous chemical restraint. Sometimes, consistent with the confines of the law, chemical or physical restraint may be proper to protect the resident from danger to himself/herself or to protect another resident from harm (e.g., where a resident and a roommate have a “combative” relationship) where no other reasonable alternatives have worked or are available. Any nursing home administrator or attending physician involved in making a decision related to restraint and considers himself or herself to be an ethical, caring provider will make the decision on the basis of the best interests of the resident and not the "best interests of the nursing home (e.g., as a means to minimize staff requirements by keeping the resident in a "manageable" state or to keep the resident from reporting neglect to his/her family member).
In closing, we would like to emphasize that caring for the elderly can be extremely demanding. Many families attempt to care for their elderly loved one at home, only to become worn out from dealing day to day with their lover one's mental and physical problems. Many families eventually make the difficult decision to institutionalize their loved one in nursing homes for that very reason. "Old age" promises to become a public health issue as our population continues to age, and this time the treatment options for dealing with progressive dementia are few. Nevertheless, as a society, we must make every effort to protect our elderly citizens, who, like, children, are vulnerable to exploitation and mistreatment, and, who, like children, can do little to protect themselves from those who would do them harm
DISCLAIMER. THE FOREGOING IS NOT LEGAL ADVICE NOR SHOULD YOU CONSIDER IT SUCH. YOU SHOULD CONSULT WITH AN ATTORNEY OF YOUR CHOOSING WHEN CONTEMPLATING ANY ACTION WHICH HAS LEGAL CONSEQUENCES.
