Here’s a relatively unusual motion filed by the pharmaceutical company Wyeth. In the motion, Wyeth admits that Reglan & Metoclopramide cause Tardive Dyskinesia, and admits that Reglan or Metoclopramide probably caused the plaintiff’s Tardive Dyskinesia. Wyeth just wants to exclude a portion of an expert’s testimony regarding the adequacy of the Reglan warning label.
Wyeth seeks limited relief. Unlike the typical Daubert motion in a pharmaceutical product liability case, Wyeth is not seeking to exclude expert testimony about causation. Wyeth does not dispute that tardive dyskinesia (“TD”) may develop in patients treated long-term with metoclopramide, or that Plaintiff, an elderly woman, more likely than not developed TD from taking metoclopramide for 14 months, over five times longer than the 12 week maximum. The issue in this case is whether the information about TD in the Reglan(R) label is adequate. Among other things, Plaintiff claims that the Reglan(R) label understates the risk that long-term users will develop TD. In support, she offers the testimony of experts who purport to quantify the risk that a long-term metoclopramide user will develop TD (which they claim is 27-29% or one in four). Another of her experts purports to calculate the relative risk of TD with long-term use – i.e., how much taking metoclopramide long-term increases the risk of TD as compared to the risk in non-users.
Wyeth asks the Court to exclude this testimony because these experts' methodologies are based on (1) a scientifically unsound interpretation of the Ganzini and Sewell studies[FN2] and (2) unsupported extrapolation from data about other drugs. The method by which these experts reach their conclusions does not comport with Daubert. Specifically, Wyeth asks the Court to exclude: (1) Dr. Leigh Thompson and Mr. Ronald Stewart's testimony based on the Ganzini and Sewell studies that there is a 27-29%, or one-in-four, risk that a long-term user of metoclopramide will develop TD; (2) Dr. Hal Morgenstern's testimony based on Ganzini and Sewell that taking metoclopramide long-term more than doubles the risk of developing TD; and (3) Dr. Morgenstern's testimony that the risk of TD associated with long-term metoclopramide use is the same or nearly the same as the risk of TD associated with the use of antipsychotics. Wyeth further asks the Court to exclude the Ganzini and Sewell studies themselves. The limited information that these studies provide (as opposed to the conclusions that Plaintiff's experts purport to draw from them) is not relevant to whether the Reglan(R) label understates the risk of TD in long-term users. Moreover, any probative value they do have is vastly outweighed by the risk that the jury will misinterpret them as demonstrating risk or relative risk, and the Court should exclude them under Federal Rule of Civil Procedure 403.
FN2. Linda Ganzini et al., The Prevalence of Metoclopramide-Induced Tardive Dyskinesia and Acute Extrapyramidal Movement Disorders, ARCH. INTERN. MED., Vol. 153, June 28, 1993 (“Ganzini”) (App. 1-7); Daniel D. Sewell et al., Metoclopramide and Tardive Dyskinesia, SOCIETY OF BIOLOGICAL PSYCHIATRY, 1994; 36:630-632 (“Sewell”) (App. 8-10 ).
SUPPORTING BRIEF AND APPENDIX
This motion is accompanied by a brief that sets out in detail Wyeth's legal arguments and authorities, as well as an Appendix containing the evidence on which Wyeth relies.
I know quite a few lawyers who are representing people who developed movement disorders after using Reglan or Metoclopramide for long periods of time. Because Wyeth admits that Reglan causes Tardive Dyskinesia, that’s one less hurdle to bringing a Reglan lawsuit. Contact me if you’d like to speak to one of my attorney friends about filing a Reglan or Metoclopramide lawsuit.