A Survey of Lawsuits for Metoclopramide and Tardive Dyskinesia

Abstract

Introduction: Metoclopramide, (Reglan), is used to treat gastroparesis and other gastrointestinal disorders. In 2009, the Food and Drug Administration (FDA) issued a black box warning about the association of metoclopramide and tardive dyskinesia (TD). TD is a permanent neurological disorder characterized by involuntary muscle movements. This study examined lawsuits involving metoclopramide-induced tardive dyskinesia in an effort to inform physicians of the legal risks of prescribing metoclopramide. Methods: The Westlaw database, one of the primary online legal research services for legal professionals, was used for the study. A first search was conducted for all cases containing “metoclopramide” or “reglan” and “tardive dyskinesia” (search: “adv: metoclopramide reglan and tardive dyskinesia”). This search yielded 96 cases where patients filed a claim. All appeals were excluded from the total number of cases. Of these, 10 (11%) were filed against prescribing physicians, 1 (1%) against a pharmacist, and the remaining 85 (88%) were filed against manufacturers. Cases were commonly filed based off the following premises: fail to warn, medical malpractice. Failure to warn is defined as when a manufacturer or distributor does not provide adequate information regarding the dangers associated with the product. Medical malpractice is when a health care provider does not provide a quality level of care that usually results in harm to a patient. Results: Of the 10 cases filed against physicians, 5 were compliant for malpractice and 5 were for failure to warn. The remaining 85 cases were brought against the generic and brand manufacturers of the drug for negligence or failure to warn physicians and patients about the potential side effects of metoclopramide, including tardive dyskinesia. The number of lawsuits has increased dramatically since the black box warning (Figure 1).Figure 1Conclusion: At present, there appears to be only a small legal risk to physicians prescribing metoclopramide. However, the trends related to lawsuits against physicians need careful monitoring, as the number of suits for metoclopramide and tardive dyskinesia has increased since the FDA black box warning.