Reglan & Tardive Dyskinesia Lawyer Blog

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.”

Vermont Reglan Lawsuit Alleges That Reglan Label Is False and Misleading With Respect To Reglan Side Effects

In Kellogg v. Wyeth, the Reglan attorneys representing Ethel Kellogg in her tardive dyskinesia lawsuit allege that Wyeth knowingly wrote a false and misleading label for Reglan:

23. The package inserts for metoclopramide products, and the PDR monograph for Reglan, contained false and/or misleading statements and omitted information material to the foreseeable and ordinary contemplated uses of the products. These statements and omissions include:

a) The statement that “Like the phenothiazines and related drugs, which are also dopamine antagonists, metoclopramide produces sedation and may produce extrapyramidal reactions, although these are comparatively rare (See WARNINGS).” This statement is false and misleading in light of the manufacturers' knowledge that extrapyramidal reactions are far more common, particularly when metoclopramide is used long-term and their concurrent knowledge that metoclopramide is commonly prescribed for long-term use.

b) The statement that the most common EPS occurred in approximately 1 in 500 hundred patients using metoclopramide. This statement is without scientific evidence of any sort capable of supporting it.

c) The omission of any reference to epidemiological studies and other evidence suggesting that the prevalence of tardive dyskinesia among patients exposed to metoclopramide for six months or longer is as much as 100 times greater than 1 in 500.

d) The statement that use of metoclopramide products for longer than 12 weeks “had not been evaluated” and therefore “cannot” be recommended. The statement misleadingly implies that no evaluation whatever of longer term use has been undertaken, or that use for longer than 12 weeks would be recommended if only formal evaluations or clinical studies for such periods had been performed.

e) The statement that the risk of tardive dyskinesia from exposure to metoclopramide is “believed” to increase with duration of treatment and total cumulative dose. The statement misleadingly implies that the “belief” is not supported, or not strongly supported, by scientific evidence.

f) The omission of any statement that therapy with metoclopramide should not extend beyond three months, which implies, in context, that no scientific evidence suggests, or strongly suggests, that longer term use increases substantially the risks of overexposure.

g) The statement that “Extrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30-40 mg/day of metoclopramide,” which tends to understate concerns about more serious extrapyramidal symptoms such as akathisia and tardive dyskinesia.

24. The dangerous propensities of metoclopramide products, as referenced above, were known or scientifically knowable to the drug company defendants, through appropriate research and testing, at the time they distributed, supplied, or sold the products, and not known to ordinary physicians who would be expected to prescribe the drug for their patients, or their patients.

25. In its dissemination of information to physicians concerning Reglan, Wyeth (and in particular the A. H. Robins Company, Inc. prior to its merger with and into Wyeth) promoted the idea that long-term use of metoclopramide or Reglan was both safe and effective. The promotion of such use included presentations by sales representatives (known as “detail men”) emphasizing the drug's gastroenterological effects, in particular gastric emptying, at the expense of its extrapyramidal effects; the sponsoring of talks and seminars with company sponsored speakers, who would discuss the supposed benefits and safety of longer term use; and the ghost-authoring, company-sponsored publication, and further dissemination of at least one junk science study calculated to “demonstrate” the safety of long-term metoclopramide use. Defendants Wyeth and Schwarz have never repudiated the substance of this promotion or acted to neutralize its effects.

26. Between 5/8/00 and 5/24/04, Plaintiff's physicians prescribed “Reglan” and/or “metoclopramide” for the plaintiff as treatment for gastroesophageal reflux disease (GERD).

Tardive Dyskinesia Lawyer Alleges Reglan Black Box Warning Should Have Come Sooner

In the Arkansas Reglan lawsuit of Fields v. Wyeth, the tardive dyskinesia lawyer representing Bettye Fields alleges that the black box warning Reglan has should have come sooner:

I.

INTRODUCTION

Plaintiff sued these defendants for their negligent acts, which proximately caused Plaintiff's injuries. This is a failure to warn case. Wyeth and Schwarz Pharma, Inc. claim that they cannot be liable for the warning they crafted, no matter how negligently, because they are neither the manufacturers nor suppliers of the drug Plaintiff ingested. Though they appear not to have manufactured the drug at issue here, Wyeth and Schwarz Pharma, Inc. should remain liable under claims of negligence, fraud and misrepresentation as they relate to failure-to-warn claims. Wyeth and Schwarz Pharma, Inc. are the manufacturers of name-brand Reglan(R), generically known as MCP. Ms. Fields took the generic form. MCP/Reglan(R), typically prescribed for gastroesophageal reflux disease, carries a significant risk of tardive dyskinesia, a severe drug side effect characterized by grotesque involuntary movements of the mouth, tongue, lips, and extremities, involuntary chewing movements, and a general sense of agitation, especially with extended use. Tardive dyskinesia is a terribly debilitating condition. Plaintiff contends that the various defendants failed to adequately warn of the risks of tardive dyskinesia associated with extended use of MCP/Reglan(R), that the drug, by whomever manufactured, ought to carry a black box warning of the risk of tardive dyskinesia with extended use. It was in fact the warning created and sponsored by Wyeth and Schwarz Pharma, Inc., the warning that the FDA approved, that, by law, the MCP consumed by Bettye Fields carried. In fact, as of February, 2009, MCP/Reglan(R) now carries, as mandated by the FDA, just such a “Black Box” warning.[FN1] As a result, Ms. Fields has suffered permanent, disabling and disfiguring injuries.

FN1. The newly required warning says that “Chronic treatment with [MCP] can cause tardive dyskinesia.... [MCP] therapy should routinely be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia .... Prolonged treatment (greater than 12 weeks) ... should be avoided in all but rare cases....” See Exhibit A.

A designer who is not also the manufacturer should share the same duty in design and warning.

II.

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]

Oklahoma Reglan Lawyers File Movement Disorder Lawsuit Against Wyeth, and Generic Manufacturers

The following lawsuit, filed in the U.S. District Court for the Western District of Oklahoma, alleges that users of Reglan risk developing movement disorders such as tardive dyskinesia.  Further, the lawyers allege that after showing signs of tardive dyskinesia, Susan Schrock in fact developed that movement disorder:

3.10 Upon information and belief, in prescribing the Reglan/metoclopramide to Mrs. Schrock on a long-term basis, her prescribing doctor relied upon information published in the package inserts and/or the Physicians' Desk Reference (hereinafter referred to as “PDR”) or otherwise disseminated by the Reference Listed Drug Company (hereinafter referred to as “RLD”) and/or the New Drug Application Holder (hereinafter referred to as “NDA Holder”).

3.11 Mrs. Schrock ingested the Reglan/metoclopramide as prescribed.

3.12 Mrs. Schrock used the pharmaceutical drugs Reglan/metoclopramide without substantial change in the condition of the drugs between the time of design and manufacture of the drugs and the time she used the drugs as directed.

3.13 Mrs. Schrock's long-term ingestion of the Reglan/metoclopramide caused her injuries.

3.14 Mrs. Schrock was not aware of information different from or contrary to the inaccurate, misleading, materially incomplete, false and/or otherwise inadequate information disseminated in the PDR, RLD, or by the NDA Holders.

3.15 In June of 2006, Mrs. Schrock was exhibiting abnormal movements which have since been linked to her use of Reglan/metoclopramide.

3.16 Mrs. Schrock's use of Reglan/metoclopramide, as prescribed, resulted in overexposure to the drugs which have caused her 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 Dystonia, a severe and often permanent disfiguring neurological movement disorder.

3.17 Mrs. Schrock's serious and permanent injuries, as described above, came about as a foreseeable and proximate result of Defendants' dissemination of inaccurate, misleading, materially incomplete, false and otherwise inadequate information concerning the potential effects of exposure to and long-term ingestion of Reglan/metoclopramide to the medical community, Mrs. Schrock, and other foreseeable users of the drug.

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.

Metoclopramide Attorney Files Movement Disorder Lawsuit in Illinois

In January of 2008, a metoclopramide lawyer representing Shirley Brinkely filed the following lawsuit in the U.S. District Court for the Southern District of Illinois.  The lawsuit alleges that Ms. Brinkley contracted a rare movement disorder after ingesting metoclopramide, which is the generic form of Reglan:

15. Plaintiff's long term ingestion of Reglan, metoclopramide and/or metoclopramide HC1 resulted in overexposure to the drugs Reglan, metoclopramide, and/or metoclopramide HC1 which caused her to suffer serious, permanent and disabling neurological injuries, including but not limited to, injuries of or associated with the central nervous and extrapyramidal motor systems, specifically Tardive Dyskinesia.

16. Use of Reglan, metoclopramide HC1 and/or metoclopramide 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. Because of the injuries Plaintiff suffered from the use of Reglan, metoclopramide HC1 and/or metoclopramide, Plaintiff has experienced and will continue to experience medical and related expenses, loss of ability to provide household services, disfigurement, disability, pain and suffering, psychological injury and other injuries and damages.

17. Plaintiff's serious and permanent injuries, as described above, came about as a foreseeable and proximate result of Defendant Wyeth and Defendant Schwarz (as the Reference Listed Drug and or New Drug Applicant holder and Defendant PLIVA (the abbreviated New Drug Applicant holder) dissemination of inaccurate, misleading, materially incomplete, false, and otherwise inadequate information concerning the potential effects of exposure to Reglan, metoclopramide, and/or metoclopramide HC1 and the ingestion of Reglan, metoclopramide, and/or metoclopramide HC1 drug to the medical community, physicians, Plaintiff's physician, Plaintiff and other foreseeable users of the drug.

18. Reglan, metoclopramide HC1 and/or metoclopramide was not approved by the United States Food and Drug Administration for long-term use.

19. Because of the misleading information that the Defendants provided to physicians and the FDA about the true risks associated with the use of Reglan, metoclopramide HC1 and/or metoclopramide and because of the failure of the Defendants and each of them to adequately inform physicians generally, including Plaintiff's physicians, about the true risks associated with the use of Reglan, metoclopramide HC1 and/or metoclopramide, at all times relevant to this lawsuit, while Plaintiff was taking Reglan, metoclopramide HC1, and/or metoclopramide, her physicians never informed her of any side effects associated with Reglan, metoclopramide HC1, metoclopramide or that Reglan, metoclopramide HC1 and/or metoclopramide was only approved for short term use (up to 12 weeks).

20. At all times material hereto, Defendant Wyeth, individually and as successor-in-interest to A.H. Robins Company, was aware of the serious side effects caused by Reglan, metoclopramide HC1 and/or metoclopramide including, but not limited to, central nervous system disorders, depression with suicidal ideation, akathisia, tardive dyskinesia, tardive dystonia, visual disturbances and interference with drug metabolism.

Metoclopramide Lawyers Move For Summary Judgment In Reglan Lawsuit

Wyeth’s attorneys in the case of Burnett v. Wyeth have moved for summary judgment, which means they are asking the judge to “throw the case out.”

Plaintiff and Mrs. Burnett testified that they discovered the nature of Plaintiff's injury, tardive dyskinesia, and its link to Reglan when they conducted the Internet search in Fall, 2004. Thereafter, Mr. Burnett contacted attorneys on Plaintiff's behalf, and pursuant to instructions from this counsel, Plaintiff made the Haverty's videotape in November-December 2004. On December 8, 2004, Plaintiff asked his doctor for a referral to a neurologist, by this time aware that he had a neurological condition and believing that it was caused by Reglan. By the time that Plaintiff and his wife went to see Dr. Moore in mid-December, 2004, they already believed that Plaintiff had Reglan-induced tardive dyskinesia. They knew the elements of their claims by the time that Plaintiff sought neurological treatment on December 8, 2004. Thus, more than two years before Plaintiff filed suit in Minnesota on December 15, 2006, Plaintiff knew all the elements of his claim necessary to start limitations running, but he did not sue within those two years; he conceded in Minnesota federal court that this was fatal to his claim under Texas law.[FN10] Accordingly, Plaintiffs tort claims, filed more than two years after his cause of action accrued, are barred by limitations under section 16.003(a).

Wyeth wants the case “thrown out” because the plaintiffs waited too long to file their lawsuit.  This shows the importance of contacting a movement disorder attorney quickly if you believe you have tardive dyskinesia after ingesting any gastrointestinal drugs containing metoclopramide.

Movement Disorder Lawyers Allege That FDA Alerts On Reglan Weren’t Sufficient

The movement disorder lawyers who filed the Reglan lawsuit of Carden v. Wyeth allege that neither the Reglan warning label nor the FDA alerts about Reglan were sufficient to warn users of Reglan:

By the early, 1990s, peer-risk for tardive dyskinesia or extrapyramidal reactions ratio were significantly higher than previously thought. Thus, the risk/benefit analysis for MCP had substantially changed after initial FDA approval. For instance, in other MCP litigation, Dr. Frederick Wilson, testified:

Q: Just so I'm absolutely clear on your answer - - are you telling me that it is your opinion, as Wyeth's medical monitor for Reglan, that Reglan should not be prescribed in long-term therapy for GERD, because its side effects are too dangerous, and because its efficacy in long-term use has never been established?

A: Today, as we sit here, and with the other drugs that are currently on the market, I would agree with that.

See Wilson deposition at p. 66, Appx., pp 134-143.

Moreover, two formal epidemiological studies published in peer-reviewed journals in the early 1990s specifically addressed the prevalence of tardive dyskinesia in MCP exposed patients. The article published by Linda Ganzini, et al., entitled “The Prevalence of Metoclopramide-Induced Tardive Dyskinesia and Acute Extrapyramidal Movement Disorders,” ARCH. INTERN. MED. 153:1469, 1471 (1993). Dr. Ganzini's study found that the frequency of tardive dyskinesia among her patients that were treated with MCP was over 29%, or at a frequency of about 1 in 4 - a prevalence that was 100 times higher than reported in the text of the MCP label. (See Id). A second epidemiological study (closely replicating Ganzini's) found that 27% of patients treated with MCP contracted tardive dyskinesia. (See Id. n. 6)

These same studies also found that diabetic patients exposed to MCP faced a particularly higher risk of developing tardive dyskinesia, and typically developed more severe forms of the disease than non-diabetic patients exposed to the drug. (See Gazini, fn 6). Nevertheless, the MCP label makes absolutely no reference to the particularly higher risk of tardive dyskinesia in this patient population of diabetics taking MCP.