This lawsuit alleges that the manufacturers of Reglan and Metoclopramide knew for years that the risk of developing tardive dyskinesia while taking Reglan was much higher than they reported to the FDA.
Defendant Wyeth and its predecessors in interest had actual knowledge, through
their own studies and studies by independent investigators, that doctors
frequently prescribed Reglan, metoclopramide HCl and metoclopramide for long term
use that was not safe for patients. Defendant Wyeth and its predecessors in
interest had actual knowledge, through their own studies and studies by
independent investigators, that nearly one-third of all patients who used Reglan,
metoclopramide HCl and/or metoclopramide received it on doctors' prescriptions for
12 months or longer, rather than 12 weeks or less. Defendant Wyeth also had actual
knowledge, through research by independent investigators, that the risk of tardive
dystonia and other extrapyramidal side effects of Reglan, metoclopramide HCl
and/or metoclopramide in patients who receive the drug for long term use is
approximately 100 times greater than disclosed in Wyeth's package insert for
Reglan and the Physicians Desk Reference monograph for Reglan brand
metoclopramide. Defendant Wyeth also knew, or through the exercise of reasonable
care should have known, that many patients who use Reglan, metoclopramide HCl
and/or metoclopramide are not able to effectively metabolize Reglan,
metoclopramide HCl and/or metoclopramide and that as a foreseeable consequence of
their inability to effectively metabolize Reglan, metoclopramide HCl and/or
metoclopramide, those patients have a greater risk of developing serious and
permanent injuries. Defendant Wyeth failed to disclose this information to the
medical community and failed to adequately disclose this information to the
generic pharmaceutical industry. Defendant Wyeth was aware that its failure to
disclose this information to the medical community and its failure to disclose it
to the generic pharmaceutical industry would probably result in serious injury to
patients who were prescribed Reglan, metoclopramide HCl and/or metoclopramide by a
physician who was not aware of this information. By failing to disclose this
information to the medical community and the generic pharmaceutical industry,
Defendant Wyeth acted in willful and wanton disregard of the rights of persons in
the Plaintiff's class, and this conduct caused serious injury to the Plaintiff.
On or about December 27, 2001, Defendant Schwarz became entitled to access to all
of the information and knowledge then possessed by Defendant Wyeth concerning
Reglan/ metoclopramide, as more particularly alleged above.
Defendant Schwarz purchased from Wyeth the rights and liabilities associated with
Reglan, metoclopramide and metoclopramide HCl tablets, upon information and
belief, the terms of which obligated Schwarz to be responsible for claims related
to the ingestion or use of Reglan, metoclopramide and metoclopramide HCl, subject
to a right of indemnification from Wyeth up to a certain dollar amount.[FN2]
FN2. Plaintiff does not have information regarding the maximum amount of
liability under the defendants' indemnification agreement.
Wyeth reviewed the article published in the Archives of Internal Medicine, in
1989, and written by Joseph Jankovic, entitled "Metoclopramide-Induced Movement
Disorders: A Review of the Literature."
Wyeth reviewed the article published in the Annals of Pharmacology, in 1992,
written by Dr. Ronald Stewart, entitled "An Analysis of Inappropriate Long-Term
Use in the Elderly."
Wyeth reviewed the epidemiological study published in the medical literature,
specifically the Archives of Internal Medicine, in June of 1993, and written by