Reglan & Tardive Dyskinesia Lawyer Blog

Plaintiff In Reglan Lawsuit Argues That Her Case Should Not Be Dismissed

One of the biggest issues in Reglan litigation is whether the manufacturer of a generic version of Reglan can be held liable for not updating the warning label included with the drug.  In most cases, the generic version of a label is identical to that of the brand-name.  However, the law requires all manufacturers to adequately warn of the risks of their products.  Generic drug manufacturers argue that they are not legally allowed to change the label of their drug, while injured plaintiffs argue that generic drug manufacturers are in fact allowed to do so.  My analysis is that generic manufacturers are so allowed.

1. Wyeth is the innovator and original manufacturer of REGLAN(R), a medication
which has been on the market for more than 20 years and which is used primarily
for gastroenterological purposes. Reglan's generic name is metoclopramide. A
prescription drug is accompanied by a label, often referred to as a "package
insert," which includes drug indications, contraindications, instructions for use,
WARNINGS and similar information.[FN1] Wyeth is also the author/manufacturer of
the deficient and misleading product information by which the drug is
prescribed-whether it be brand name or generic-and that has been continuously
published in the Physicians Desk Reference (PDR) from 1990 to 2002 (a marketing
privilege for which Wyeth paid handsomely).[FN2] Plaintiffs Complaint does not
relate to the composition or manufacture of the metoclopramide pills she ingested,
but rather focuses on the inaccurate and insufficient (mis)information promulgated
by Movants and by which the pills were prescribed (and the false sense of security
and safety regarding metoclopramide that was created thereby)-all of which caused
or contributed to its misuse by Plaintiffs prescribing doctor and, consequently
led directly to the severe damages sustained by Plaintiff.

      FN1. The regulations governing the approval of drug products includes the
      submission and approval of all labeling of the drug product, including the
      actual package insert as well as all accompanying labeling (i.e. boxes,
      cartons, package insert), and all advertising and promotional materials used
      to advertise or promote the sale and distribution of the product. See
      Section 505(b)(1) of the Food and Drug Cosmetic Act.

      FN2. See e.g. Wyeth's package inserts (labeling) which were published in the
      Physician's Desk Reference and are attached as Exhibits 1 to 11.

2. As a direct result of the Plaintiff's 44 weeks of exposure to metoclopramide
spanning from May 2008 March 2009, Plaintiff developed severe and persistent TD-to
include the variants, tardive dystonia and tardive akathesia (herein collectively
referred to as "TD").

3. TD, by definition, is a drug induced neurological disease permanently affecting
the patients' brain chemistry and loosely resembling a drug induced Parkinson's
disease and/or Tourrette's condition. The disease is disfiguring and debilitating
and affects the patient physically, emotionally, vocationally and socially.

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.

Expert Witness In Metoclopramide Lawsuit Discusses Tardive Dyskinesia At Length

Dr. Robert Nelson filed the following expert witness report in the case of Swicegood v. Pliva.  In it, he suggests that the manufacturers of Metoclopramide (the generic form of Reglan) have not lived up to their duty to sell a safe product:

There was an understanding by the FDA in the early 1980s that MCP, a dopaminergic agent, had the potential for TD given LT exposure. Initially its use was limited to inpatients and severe DG. However, it was eventually approved for up to 12 weeks treatment of GERD.

The reports of MCP-TD presented in Section X of this report all attribute TD as a consequences of off-label long-term use. Grimes (1982b) and Wiholm (1984) were the first to analyze the signal and publish the problem.

Miller and Jankovic (1989) found the TD emerges, on average, 12 months of exposure and that treatment was continued for an average of 6 months AFTER involuntary movements had started. Sewell (1992a) reviewed the reports in the literature and found 67 cases of MCP-TD with 20 months duration of exposure.

Stewart (1992b) analyzed “inappropriate” long-term use of MCP in the elderly. This descriptive study identified 34 exposed to MCP from 4515 (2898 females; 1617 males) patients who participated in a health screening research program in Florida, 11 (32.4%) were long-term users. The study was initiated because two patients presented to the University hospital with MCP-induced TD within the prior year. Both had taken MCP for longer than 8 years for GERD. Only three of the 34 participants had diabetes mellitus (DM), so GERD or heart-burn-like ailments and not DG was their likely treatment diagnosis. This small study signaled that LT-MCP was a substantial component of MCP use in the elderly.

These published cases and the studies of Stewart, Ganzini, and Sewell made the problem of long-term off-label use visible and highlighted its unique consequences.

To assess risk factors for TD in MCP exposed persons, Schaffer et.al. (2004) reviewed the reports in the FDA Adverse Reaction Reporting System (AERS) through June 2003. They also used the IMS Health data to evaluate MCP prescribing patterns before and after the withdrawal of cisapride from the US marketplace. They extracted a case-series of 87 reports from AERS with TD as the adverse outcome and MCP as an exposure. Each case was re-evaluation for validity of both exposure and outcome. Data regarding prescription utilization (via National Prescription Audit, NPA) and demographics of patients (National Disease & Therapeutic Index, NDTI) treated with MCP, between 1/1992 - 6/2003, were obtained from IMS Health. The mean age for the case-series was 60 years and 2/3 were female. The mean dose was 33 mg/day with mean duration of 753 days (-108 weeks). Most of the known use was for GERD (gastroesophageal reflux disease), or acid reflux, whose main symptom is heartburn. Only 14% of use was for gastroparesis.

The marketing of cisapride for GERD in 1993 had an inverse impact on the sales of MCP, which reversed when cisapride was withdrawn from the market due to QT wave prolongation. Nearly 1/4 of MCP use was in persons, mostly females, over 70 years of age. This descriptive analysis reinforced the fact that a meaningful percentage ( 15-20%) of MCP is used long-term (off-label) in persons (elderly females) who are at the highest risk of TD. The authors reflect on the impact of these prescribing practices given the ‘paucity of evidence that MCP improves the quality of life” and the risk of a life-changing, potentially irreversible neurological disorder.

….

It is my opinion that the defendants have not acted as a reasonable and prudent drug manufacturer and breached their standard of care. Given clear evidence of causality, the well-documented use greater than 12 weeks, and given the strong probability of increased risk for TD conditional on that greater exposure the defendants, should, at a minimum (1) assess the risk of TD beyond 12 weeks of exposure to determine if it is no different than that seen within the approved shorter termed exposure where the benefit-risk balance is considered by the FDA to be acceptable; (2) affirm efficacy beyond 12 weeks for the relevant indication(s) and reestablish that benefit - risk balance with the results from choice #1. The defendants had a responsibility to petition the FDA to update the label and reflect new information. Yet, the defendants have chosen to do neither. As a result, persons continue to be harmed to this day as demonstrated by Kenney (2008). The defendants fell below its standard of care in not reporting to the FDA and treating physicians the data available regarding long term use of metoclopramide. If the defendants would properly inform the FDA and the prescribers about the risk of TD then thousands of injuries from this drug could be prevented. Metoclopramide - as it was marketed and distributed by defendants at the time of Mr. Burnett's ingestion of the drug - was unreasonably dangerous and the information and warnings supplied with the drug were inadequate.”

Georgia Reglan Lawsuit Alleges Wyeth and Schwarz Pharma Did Not Accurately Disclose Side Effects of Reglan

In May of 2009, attorneys filed the lawsuit of Forrester v. Wyeth in the U.S. District Court for the Northern District of Georgia.  The lawsuit alleges that Wyeth, the manufacturer of Reglan, and Schwarz, the manufacturer of a generic Metoclopramide product, concealed the side effects of Reglan:

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 HC1 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 HC1 and/or 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, metoclopramide HC1 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 Physician's 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 HC1 and/or metoclopramide are not able to effectively metabolize Reglan, metoclopramide HC1 and/or metoclopramide and that as a foreseeable consequence of their inability to effectively metabolize Reglan, metoclopramide HC1 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 HC1 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 Plaintiffs class, and this conduct caused serious injury to the Plaintiff.

33.

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 HC1 and/or metoclopramide, as more particularly alleged above.

34.

Defendant SCHWARZ purchased from WYETH the rights and liabilities associated with Reglan, metoclopramide, metoclopramide syrup and metoclopramide HC1 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 HC1, subject to a right of indemnification from WYETH up to a certain dollar amount.[FN2]