臨床薬理学および生物薬剤学

抽象的な

A Survey of Lawsuits Filed for the Complaint of Tardive Dyskinesia Following Treatment with Metoclopramide

Eli D. Ehrenpreis, Asha Krishnan BS, Alexoff BSA, Smith BSD and Wilensky BAS

Background: Tardive dyskinesia (TD) is a severe neurologic adverse reaction occurring with long-term use of metoclopramide. Aim: To examine all reported legal cases involving metoclopramide-induced TD prior to June 16, 2014 in an effort to inform physicians and practitioners of the current legal risks associated with the prescription of metoclopramide. Methods: A search of the Westlaw database for cases that contained the terms metoclopramide and tardive dyskinesia was performed. This dataset was then queried for cases brought against physicians or practitioners. Full length reports were obtained and information was pulled regarding plaintiff demographics, medical specialty of the defendant, plaintiff’s TD symptoms, lawsuit claims, and case outcome. Results: There were ninety-six cases in which patients filed a claim that met our search criteria. Eighty-five cases (88.5%) were brought against the brand name and/or generic medicine manufacturers as failure to warn claims. There were eleven cases brought against physicians or practitioners. Eight of eleven lawsuits (72%), of cases were either dismissed, settled or were in the process of settlement. There has also been an increase in the number of malpractice cases filed related to metoclopramide induced TD since the FDA issued its black box warning in February, 2009. Conclusions: There have been a small number of cases directed at physicians related to the prescription of metoclopramide and the development of TD, most of which were either dismissed or settled.