Reglan & Tardive Dyskinesia Lawyer Blog

California Reglan Lawsuit Discusses Side Effects of Reglan and Metoclopramide

The following lawsuit was filed by Elizabeth Conte in California.  It alleges that Metoclopramide is a defective drug because it can cause a variety of movement disorders:

38. Metoclopramide was "defective" and "unreasonably dangerous" when the product
initially was patented, and subsequently when it was promoted and entered into the
stream of commerce and was received by Elizabeth Conte, in one or more of the
following respects:

(a) At the time metoclopramide left the control of TEVA, PLIVA, PUREPAC, and DRUG
COMPANY DOES 1 THROUGH 6 it was defective and unreasonably dangerous due to a
failure to contain adequate warnings or instructions, or, in the alternative,
because it was designed in a defective manner, or, in the alternative, because the
product breached an express warranty or failed to conform to other expressed
factual representations upon which Elizabeth Conte's physicians justifiably
relied, or because it breached an implied warranty, all of which proximately
caused the damages for which Plaintiff seek recovery herein.

(b) Metoclopramide was not reasonably safe as designed, taking into account the
foreseeable risks involved in its use at the time the product left the possession
of TEVA, PLIVA, PUREPAC, and DRUG COMPANY DOES 1 THROUGH 6 and that such risks
clearly outweighed the utility of the product or its therapeutic benefits.

(c) Metoclopramide was not reasonably safe due to inadequate or defective warnings
or instructions that were known or reasonably scientifically knowable at the time
the product left the possession of the Drug Company Defendants. Specifically,
although TEVA, PLIVA, PUREPAC, and DRUG COMPANY DOES 1 THROUGH 6 were well aware
that metoclopramide could potentially cause central nervous system side effects,
depression with suicidal ideation, akathisia, akinesia, tardive dyskinesia,
tardive dystonia, visual disturbances and interference with the metabolism of
other prescription drugs and in fact, had significantly greater prevalence and
severity of these side effects in patients with diabetes mellitus, warnings of
such adverse health conditions were either not included on the package insert for
these products or they were not adequate to inform reasonably prudent physicians
and consumers.

(d) The warnings or instructions of TEVA. PLIVA, PUREPAC, and DRUG COMPANY DOES 1
THROUGH 6 were not of a nature that a reasonable prudent drug company in the same
or similar circumstances would have provided with respect to the danger. There
were no warnings or instructions that communicated sufficient information on the
dangers and safe use of the product taking into account the characteristics of the
product, and/or the ordinary knowledge common to the physician who prescribes and
the consumer who purchases the product, such as the Plaintiff Elizabeth Conte.

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.

Reglan Attorney Alleges that Reglan Manufacturers Knowingly Sell a Defective Product

In this document, which was filed in Mensing v. Wyeth, the Reglan lawyer representing the plaintiff alleges that manufacturers of Reglan or its generic form, Metoclopramide, are knowingly selling a defective product with an inadequate warning label:

The position created by the melding of the Defendants' arguments here creates a “Catch-22” for any plaintiff who is permanently injured by the misrepresented adverse effects of the drug MCP. The name brand manufacturer, Schwarz contends that it owes no duty regarding its misrepresentations in the label of its name brand drug that misstates the actual risk of developing EPS, because Plaintiff did not consume its pills, and only direct product liability claims should be recognized against it. Then, to complete the ironic situation, generic manufacturers argue that the drugs they made that were consumed by Plaintiff - - even if defective for their own misstatements - - are not susceptible to suit either, because their “hands were tied”[FN21] by having to follow the false statements of the name brand manufacturer.

FN21. Unfortunately, the generic manufacturers choose to continue to keep manufacturing and selling generic MCP in light of their knowledge that the label is false.

If the Defendants' arguments, taken as a whole, are correct, Plaintiff would have no remedy for developing tardive dyskinesia, a life-altering, permanent injury that could have been avoided with a simple, accurate statement about the dangers associated with MCP, rather than misstatements. As a result, if the Defendants are correct, the tort system will not only have failed Plaintiff, but it will fail every doctor who prescribes MCP in the future or their patient who will needlessly develop EPS because none of the Defendants will have been found to have a legal duty to accurately state the risks associated with MCP. However, this result should not be the case in light of the duties continued in the Restatement and Minnesota law. In turn, Schwarz's motion should be denied.

Movement Disorder Attorneys List Metoclopramide Side Effects In Reglan Lawsuit

The association between Reglan and movement disorders has long been known.  This lawsuit, Mensing v. Wyeth, alleges that the manufacturers of Reglan and its generic form, metoclopramide, should have done more to warn patients of the risks of developing movement disorders:

26. On or about March 23, 2001, Plaintiffs physician prescribed Reglan at a dosage of 5 mg, b.i.d., to treat Plaintiffs diabetic gastroparesis.

27.The active ingredient, metoclopramide and metoclopramide HCl is a dopamine antagonist.

28.Subsequently, Plaintiffs physician increased Plaintiffs dosage to 10 mg to be taken four (4) times a day.

29. Subsequently, Plaintiffs physician increased the dosage of Plaintiffs prescription for Reglan, metoclopramide, and/or metoclopramide HCl, and prescribed it to Plaintiff for several years thereafter.

30. Upon information and belief, in prescribing the Reglan, metoclopramide, and/or metoclopramide HCl drugs to Plaintiff on a long-term basis, Plaintiffs physicians relied upon information published in the package inserts and/or the Physician's Desk Reference (hereinafter “PDR”) or otherwise disseminated by the Reference Listed Drug Company (hereinafter “RLD”) and/or the New Drug Application Holder (hereinafter “NDA holder”), in particular, that information disseminated by Defendants Wyeth and Schwarz.

31.Plaintiff ingested Reglan, metoclopramide and/or metoclopramide HCl, as prescribed.

32.Plaintiffs long term ingestion of Reglan, metoclopramide and/or metoclopramide HCl caused her injuries.

33. Plaintiffs physicians were not aware of information different from or contrary to the inaccurate, misleading, materially incomplete, false and/or otherwise inadequate information disseminated in the PDR.

34. Wyeth and Schwarz, as the RLD and/or NDA holders, provided misleading information about the true risks associated with the use of Reglan, metoclopramide, and/or metoclopramide HCl to the medical community, Plaintiffs Physician, and Plaintiff (and other foreseeable users similarly situated).

35. On or about March of 2005, Plaintiff was taken to Plaintiffs physician, who discontinued Plaintiffs Reglan, metoclopramide, and/or metoclopramide HCl prescription due to the clinical presentation of lip smacking and tongue thrusting movements.

36. On or about September of 2005, Plaintiff was examined by Dr. Bruce A. Evans, Department of Neurology, Mayo Clinic, who diagnosed her as suffering from drug induced Tardive Dyskinesia related to her long-term use of Reglan, metoclopramide, and/or metoclopramide HCl.

37. Plaintiff used the pharmaceutical drugs Reglan, metoclopramide, and/or metoclopramide HCl without substantial change in condition of the drugs between the time of design and manufacture of the drugs and the time Plaintiff used the drugs as directed.

38. Plaintiffs use of Reglan, metoclopramide, and/or metoclopramide HCl drugs, as prescribed, resulted in overexposure to the drugs Reglan, metoclopramide, and/or metoclopramide HCl which caused Plaintiff to suffer serious, permanent and disabling injuries, including but not limited to injuries of or associated with the central nervous and extrapyramidal motor systems, specifically Tardive Dyskinesia, a severe and often permanent disfiguring neurological movement disorder.

39. Plaintiffs serious and permanent injuries, as described above, came about as a foreseeable and proximate result of the RLD and/or NDA holder and the ANDA holders dissemination of inaccurate, misleading, materially incomplete, false, and otherwise inadequate information concerning the potential effects of exposure to Reglan, metoclopramide, and/or metoclopramide HCl and the ingestion of Reglan, metoclopramide, and/or metoclopramide HCl drug to the medical community, physicians, Plaintiffs physician, Plaintiff and other foreseeable users of the drug.