Objective: This paper seeks to explore whether prescribing the drug Donepezil carries a risk of liability for failure to warn of aggressive side effects.
Design: Medical literature regarding reported aggressive behavior associated with Donepezil was reviewed, as well as legal precedent involving acetylcholinesterase inhibitors and the drug Prozac.
Materials and Methods: PubMed was searched using the terms Donepezil, Acetylcholinesterase Inhibitor, Side Effects, Adverse Outcome, and Aggression. Westlaw was searched using the terms Donepezil, Acetylcholinesterase Inhibitor, Involuntary Neurotoxic Damage Defense, and Prozac. Findlaws class action database was searched using the terms Donepezil and Aricept.
Results: There is a growing body of medical literature calling into question the efficacy of Donepezil, and noting problematic behavioral side effects. While there has been no litigation regarding Donepezil to date, case law in the criminal domain establishing a causal link between acetylcholinesterase inhibitors and violent behavior make Donepezil a potential risk for legal liability. In addition, in the Prozac precedent, the duty to warn was shifted from the prescriber to the manufacturer based on results of clinical trials, but the basis for the shift is absent in Donepezil clinical trials.
Conclusion: Physicians should utilize caution when serving as the learned intermediary in prescribing Donepezil. In effectuating the duty to warn, physicians should not filter out too many of the adverse side effects in their warnings to patients in an effort to maximize compliance with the drug. Physicians cannot effectively rely on legal precedent in which physicians have typically been successful in shifting liability back to the drug manufacturer. The manufacturer has absolved itself of liability by listing aggression as a frequent side effect on the package insert and the PDR. Physicians should be aware that many of the obstacles plaintiffs encountered in similar failure to warn cases have already been removed with regard to Donepezil. The shroud of doubt that hovered over Prozac litigation with regard to the causal link component of the claims is filmy at best with regard to Donepezil. Looking to precedent in the criminal domain, one may even say it has been removed. Plaintiffs will have little trouble in establishing a causal connection between violent behavior and Donepezil, thus proving the breach of the duty to warn proximately caused the plaintiff’s damages.
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