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Medicolegal Considerations in the Treatment of Psychosis With Second-Generation Antipsychotics

Medicolegal Considerations in the Treatment of Psychosis With Second-Generation Antipsychotics


Psychiatric Times December 2004
Vol. XXI
Issue 14


A quick Internet search using the terms "lawsuits and atypical antipsychotic medications," also known as second-generation antipsychotics (e.g., aripiprazole [Abilify], clozapine [Clozaril], olanzapine [Zyprexa], risperidone [Risperdal], quetiapine [Seroquel] and ziprasidone [Geodon]), returns hundreds of hits. Mostly, these hits are law firms seeking clients to sue physicians and/or pharmaceutical companies for serious side effects that may be linked with these medications. Top complaints of plaintiffs are diabetes, pancreatitis and wrongful death.

This wave of legal actions is occurring as a consequence of the marketing success of these compounds and amid the growing recognition, even among the general public, of the increased metabolic liabilities associated with them. It is likely that there will be many thousands of such diabetes cases in the United States. Several hundred will make it to the desk of a capable plaintiff's attorney, and several dozen will be so compelling that the painful sojourn through the tort system will be started in earnest. The astute among these attorneys will soon discover the need to apportion causality because of etiological vagueness and the enormous rates of obesity and diabetes that are unrelated to any introduced pharmaceutical. The goal for such attorneys is to causally tie the untoward outcome for a given patient to the manufacturer's negligence in either insufficient testing or inadequate labeling.

Both obesity and, as a direct consequence, diabetes are at epidemic crisis levels in this country and, of most concern, appear to be accelerating at a rate that is literally without precedent. Although the details accounting for and contributing to this pandemic among the general populace are not entirely known, the very existence of the pandemic has caused (or in some cases, has been used to promote) a delay in our collective recognition and acceptance of the substantial additional burden imposed by many second-generation antipsychotics on our already challenged patients. Our field is currently grappling (with insufficient information to date) to determine their impact on weight gain and diabetes, the liability with second-generation antipsychotics in comparison to (and in synergy with) other known risk factors, and the potential for differential risk between each second-generation antipsychotic. Much of our decision making at present is based on short-term clinical studies and epidemiological analyses. More informative, long-term, pharmacovigilant studies are awaited.

What is the reasonable psychiatrist supposed to do to optimize patient care and avoid the malpractice minefield? First and foremost, we must prioritize our relationship with the patient and do what is reasonable to inform patients about the risks of second-generation antipsychotics. Equally important, we must also monitor for side effects, keep ourselves informed, and try to prevent untoward events. Patients who wish to sue a doctor must prove that the doctor was negligent, and through this negligence, caused an injury.

Adverse drug reactions are a common reason for liability claims against physicians. The growing literature that associates second-generation antipsychotics with weight gain, obesity and its metabolic legacies (e.g., diabetes and changes in cholesterol and triglycerides) may be used as "evidence" that such adverse reactions can occur. Thus, clinicians must be familiar with the relative side-effect profiles of available second-generation antipsychotics and carefully weigh the risks and benefits of them before prescribing them. Unfortunately, the alternative of selecting first-generation antipsychotics, with their greater risk of tardive dyskinesia, a potentially irreversible movement disorder, also lands psychiatrists and patients squarely into further risk-benefit analyses. Tardive dyskinesia lawsuits were the second most frequent cause of legal action against psychiatrists in recent years, the first being suicide. New tardive dyskinesia lawsuits are less common now and they may be surpassed by the growing number of legal actions regarding what we now call "the tardive dyskinesia of the SGAs"--weight gain, diabetes and dyslipidemias (Wirshing et al., 2002). The Table explains a few of the current and proposed lawsuits regarding these side effects.

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