Reglan & Tardive Dyskinesia Lawyer Blog

Georgia Reglan Lawsuit Alleges That Metoclopramide Causes Tardive Dyskinesia

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.

35.

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.

36.

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.

37.

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."

38.

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."

39.

Wyeth reviewed the epidemiological study published in the medical literature,
specifically the Archives of Internal Medicine, in June of 1993, and written by
Linda Ganzini.

Metoclopramide Attorney Files Movement Disorder Lawsuit In West Virginia

The following lawsuit was filed on behalf of Amanda Kimble in West Virginia.  It alleges that the manufacturers of Reglan (and its generic form Metoclopramide knew) failed to adequately warn of the risks of developing movement disorders from long-term use of the drug.

22. Defendant WYETH and its predecessors in interest had actual knowledge, through
their own studies and studies by independent investigators, that doctors
frequently prescribed Reglan(R)/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(R)/ metoclopramide received
it on doctor's 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 dyskinesia and other extrapyramidal side
effects of Reglan(R)/metoclopramide in patients who receive the drug for 12 weeks
or longer is approximately 100 times greater than disclosed in WYETH's package
insert for Reglan(R) and the Physician's Desk Reference monograph for Reglan(R)
brand metoclopramide. Defendant WYETH also knew, or through the exercise of
reasonable care should have known, that many patients who use Reglan
(R)/metoclopramide are not able to effectively metabolize Reglan(R)/metoclopramide
and that as a foreseeable consequence of their inability to effectively metabolize
Reglan(R)/ 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(R)/metoclopramide by a
physician who was not aware of this information. By failure to disclose this
information to the medical community and the generic pharmaceutical industry,
Defendant WYETH acted in willful and wanton disregard for the rights of persons in
the Plaintiffs class, and this conduct caused serious injury to the Plaintiff.

23. 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(R)/metoclopramide, as more particularly alleged above. Despite this
knowledge, assuming it was transmitted to Schwarz by Wyeth as contemplated in the
Asset Purchase Agreement, Schwarz failed to disclose this information to the
medical community and the generic pharmaceutical industry and thereby acted in
willful and wanton disregard for the rights of persons in the Plaintiff Amanda
Kimble's class, and this conduct caused serious injury to Plaintiff.

24. PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 chose to rely on Defendant
WYETH, and its predecessors in interest, to keep abreast of current medical
literature concerning metoclopramide and to inform them concerning its knowledge
of how physicians were using Reglan(R)/metoclopramide and any dangers that were
associated with that use, by properly reporting their knowledge to the PDA,
despite the fact that PLIVA, PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 knew, or
should have known, that WYETH and its predecessors in interest had a history of
failing to adequately warn physicians about other dangerous products. PLIVA,
PUREPAC and DRUG COMPANY DOES 1 THROUGH 6 failed to exercise reasonable care to
independently monitor their sales of metoclopramide and the medical literature,
which would have alerted them to the fact that Reglan(R)/ metoclopramide was
widely overprescribed as a result of inadequate warnings in the package inserts
and PDR monographs for Reglan(R) brand and generic metoclopramide. PLIVA, PUREPAC
and DRUG COMPANY DOES 1 THROUGH 6 also knew, or should have known in the exercise
of reasonable care, that the package insert for metoclopramide substantially
understated the prevalence of acute dystonic reactions and other acute side
effects of metoclopramide, and failed to use reasonable care to modify the package
insert, and/or seek PDA approval to modify the package insert, in order to
adequately warn physicians and consumers.