Dr. Michael Halpern, an expert witness retained by First DataBank, disputes that Reglan can cause tardive dyskinesia. This report was prepared in 2005, well before the Reglan Black Box Warning came out. The Black Box warning confirms that Reglan does in fact cause tardive dyskinesia if taken for long periods of time. Still, it is interesting to review an expert witness report in a Reglan lawsuit:
Thus, using the class of evidence rated most highly by the Oxford University Centre for Evidence Based Medicine, systematic reviews of clinical trials, rates for depression, Parkinsonism, tardive dyskinesia, and suicidality among patients receiving Reglan are similar to or lower than the rates of these symptoms spontaneously occurring in the elderly population. It can therefore be concluded that there is no evidence that Reglan causes these symptoms in general. Dr. Breggin's conclusion of general causation (that is, that Reglan causes depression, Parkinsonism, tardive dyskinesia, and suicidality) is not supported by the scientific evidence.
The expert who prepared this report works for a company called Exponent, which is generally well-regarded.
Probably the most famous Reglan lawsuit is that of Conte v. Wyeth. It’s famous among Reglan attorneys because that case established that the brand name manufacturer of a drug can be held liable for injuries that occur when someone takes a generic version of the drug. That rule (so far) only applies in California Reglan litigation, but I am hopeful the rule will be extended further. This is a copy of the actual lawsuit that culminated in the decision in Conte v. Wyeth.
29. 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 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 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 in patients who receive the drug for weeks or longer 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 are not able to effectively metabolize Reglan/ metoclopramide and that as a foreseeable consequence of their inability to effectively metabolize Reglan/ 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 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 Elizabeth Conte's class, and this conduct caused serious injury to the Plaintiffs.
In part because of this case, many Reglan lawyers try to file their Reglan cases in California. And for the same reason, most Reglan defendants try and make sure that Reglan lawsuits aren’t filed in California.
As a rule of thumb, Reglan lawyers prefer to file their Reglan lawsuits in state court, instead of federal court. That’s because it is generally cheaper and easier to prosecute a Reglan lawsuit in a state court than in a federal court. But sometimes, due to procedural rules that are beyond the scope of this blog, a Reglan attorney will have to file in federal court. This is an example of a Reglan lawsuit filed in a California federal court.
35. The Plaintiff's use of metoclopramide products, as prescribed by his physicians, resulted in his overexposure to the drug metoclopramide, which caused him 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 (for the past approximately 20 years) tardive dyskinesia and (for the past several years) consequent clinical depression. The Plaintiff discovered the cause of the afflictions from which he has been suffering, as confirmed by Veterans Administration doctors in April 2009, only this year, after happening upon publicity in the media concerning the connection between various movement disorders and long term therapy using Reglan and/or other metoclopramide products.
36. Because of these injuries the Plaintiff has experienced and will continue to experience disfigurement, disability, embarrassment, loss of ability to provide household services for himself, pain and suffering, medical and related expenses, and other damages.
37. The Plaintiff's serious and permanent injuries, as described above, came about as a foreseeable and proximate result of Wyeth's dissemination to physicians of inaccurate, misleading, materially incomplete, and otherwise false information concerning the potential effects of exposure to metoclopramide through the ingestion of a metoclopramide product such as Reglan.
Regardless of whether the lawsuit is filed in a state or a federal courthouse, the allegations will be the same: That the manufacturers of Reglan knew that long-term use of the drug could cause movement disorders like tardive dyskinesia.
Yet another movement disorder lawsuit was filed against the various manufacturers of the brand-name drug Reglan and its generic equivalent, Metoclopramide. Hundreds of Reglan lawyers across the country are filing lawsuits similar to this one, which alleges that long-term use of Reglan leads to movement disorders. Ever since the FDA issued its black box warning for Reglan, there has been little scientific debate over whether users of Reglan could develop movement disorders like tardive dyskinesia. The legal battle is waged over whether the manufacturers adequately warned Reglan users of the risks of developing movement disorders.
44. This case involves, in part, Defendants' failure to warn doctors and patients of information within their knowledge or possession which indicated that the subject Reglan/metoclopramide, when taken for long periods of time, caused serious, permanent and debilitating side effects, including tardive dyskinesia.
45. Defendants jointly and severally marketed, manufactured and distributed Reglan/metoclopramide and encouraged the long term use of these drugs, misrepresented the effectiveness of these drugs and concealed the drug's dangerous side effects.
46. Reglan/metoclopramide is indicated as short-term therapy for symptomatic gastroesophageal reflux and acute and recurrent diabetic gastric stasis.
47. Reglan/metoclopramide is indicated for use for no greater than twelve weeks; however, Defendants represented that Reglan/metoclopramide was safe for use to treat nausea and/or esophageal reflux for durations that exceed twelve weeks.
48. Patients who use Reglan/metoclopramide for long periods are at a significantly increased risk of developing a severe and permanent neurological movement disorder.
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.
Reglan lawyers are allowed to file what is called a motion for summary judgment. In that motion, the lawyers tell the court that there are no factual issues to decide, but only legal issues. If there truly are no factual issues, then the court may decide the summary judgment motion. The loser is “thrown out of court.” In this case, the Reglan lawyers representing the Reglan manufacturers filed this motion:
This is a products liability case. Plaintiff Shirley Brinkley alleges that she suffered injuries after ingesting the prescription drug metoclopramide. Cmplt. PP 8-10, 15-16.[FN1] After the completion of product identification discovery, Plaintiff conceded that she did not ingest any product manufactured by Wyeth or Schwarz. Nonetheless, Plaintiff asserts numerous claims against these defendants, arguing that Wyeth and Schwarz (who, at different times manufactured the name brand version of the drug) can be held liable for allegedly failing to adequately warn Plaintiff and her doctors about the risks associated with generic drugs manufactured by other companies. Because Plaintiff never purchased or ingested a Wyeth or Schwarz metoclopramide product, these claims fail as a matter of law.
FN1. Citations to Plaintiffs Complaint, Doc. No. 2, filed 1/7/08, shall take the form "Cmplt. P [ ]."
Under well-settled Missouri law, a plaintiff asserting products liability claims must establish, among other things, that the defendant manufactured or distributed the specific product that injured the plaintiff. A defendant cannot be liable for any harm allegedly caused by another manufacturer's product. In line with this well-settled principle, no Missouri authority -- case law, statute or otherwise -- requires a name brand drug manufacturer (such as Wyeth and Schwarz) to warn about the risks associated with the use of a generic drug manufactured and distributed by another company.
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 Linda Ganzini.
In this report, an expert witness retained by Pliva expresses the opinion that Pliva's metoclopramide warning label was adequate.
9. However, because of how the FDCA was structured, companies that wanted to market generic versions of drug products approved under NDAs after 1962, such as Reglan brand of metoclopramide, would have had to duplicate the expensive animal and clinical studies the innovator did, even though the patent protection had ended. This situation had the consequence of providing a virtual monopoly for drugs first approved after 1962, because generic drug manufacturers did not have the financial resources to perform extensive clinical and animal studies and to prepare and submit NDAs to the FDA. The Congress remedied this situation in 1984, when the Hatch-Waxman amendments to the FDCA extended a simplified administrative process the FDA used for generic versions of older drugs, called an Abbreviated NDA (ANDA) to generic versions of drugs first approved after 1962. The public policy arguments for the Hatch-Waxman amendments included the following:
This motion was filed in the Louisiana Reglan lawsuit of Tarver v. Wyeth. The motion asks the court not to allow Dr. Daniel Sewell to testify about the association between Reglan and movement disorders like tardive dyskinesia.
On behalf of Wyeth, Mr. Reilly contacted Dr. Sewell in early 1999 to ask him about his paper on Tardive Dyskinesia and to investigate his willingness to consult with Wyeth on the Woodworth matter. Dr. Sewell informed Mr. Reilly that he was not working with plaintiff's counsel in Woodworth and that he did not have any conflicts that would prohibit him from working for Wyeth. Mr. Reilly eventually scheduled an in-person meeting with Dr. Sewell. At their meeting, which took place on or about April 27, 1999, Mr. Reilly and other counsel for Wyeth met with Dr. Sewell for three-and-a-half hours. Dr. Sewell spent another hour-and-a-half reviewing medical records and a videotape related to the plaintiff in Woodworth.
During this lengthy meeting, counsel for Wyeth shared confidential information regarding the Woodworth case, including their thoughts on the merits of plaintiff's claims and the adequacy of the Reglan(R) label. In the course of that meeting, Dr. Sewell provided his assessment of plaintiff's condition; his thoughts about the use of Reglan(R) for gastrointestinal disorders; his opinions about the adequacy of the Reglan(R) label, especially in light of his paper on the use of Reglan(R) in the VA center; and general defense strategies. It is important to emphasize that the plaintiff in Woodworth was represented by the same attorney in this case -- Mr. Ralph Pittle. Indeed, plaintiffs theories of liability in the instant case are similar if not identical to those pursued in Woodworth by Mr. Pittle.
From this point forward, Mr. Reilly and Wyeth reasonably believed that Wyeth had established a confidential relationship with their new consultant, Dr. Sewell. In fact, following this meeting, Dr. Sewell sent Mr. Reilly "an invoice for my consultation with you and Stuart Gordon in San Diego." This invoice clearly demonstrated that, from Dr. Sewell's perspective, a consultation had occurred. See Affidavit of James R. Reilly in Support of Wyeth's Motion to Exclude Plaintiffs' Expert Daniel Sewell at "Exhibit A." This confidential relationship was further confirmed by Mr. Reilly's payment to Dr. Sewell for his services.
This lawsuit is a little unusual because it is a wrongful death lawsuit. James Willett developed Tardive Dyskinesia while taking Metoclopramide, and as such, he was unable to receive a transplant. This is a lawsuit filed against the manufacturer and the seller of the Metoclopramide he ingested.
14. The drug in question was an unreasonably dangerous product, subject to strict product liability in tort, because it presented an unreasonable risk of the development of tardive dyskinesia and other injuries and, in fact, caused the injuries and the damages which Plaintiffs have suffered. The drug was unsafe for its intended purposes at the time it left the control of Defendant TEVA and was sold. The foreseeable risks of the drug exceeded the benefits associated with its formulation. The drug was more dangerous than an ordinary consumer would expect.
15. The drug in question was unaccompanied by proper warnings regarding the degree of risk for tardive dyskenisia. The warnings accompanying the drug in question did not accurately reflect the nature, scope, or severity of the potential for injury from the use of the drug.
16. Metoclopramide, as manufactured and/or supplied, by Defendants is a defective product due to inadequate post-marketing warnings and instructions. After Defendants knew or should have known that metoclopramide posed dangers and risks to potential patients, Defendants failed to take steps to warn and/or cause consumers, potential consumers, and health care professionals to be advised of such dangers and risks.
17. The defective and unreasonably dangerous drug metoclopramide and the described defects were a producing cause of the damages and injuries suffered by Plaintiffs set out hereinbelow. Defendants are liable to Plaintiffs under the doctrine of strict liability as contained in s402A of the Restatement Second of the Law of Torts as adopted by the Supreme Court of Texas.
(Filling out this form does not create an attorney-client relationship.)
Reglan & Metoclopramide Videos
How To Report Adverse Events To The FDA
If you think you've suffered from a side effect from a prescription drug, you can voluntarily choose to report your symptoms to the FDA. This video from the FDA tells you how to do so. Reporting an injury to the FDA is not the same as hiring an attorney.
Safety Alert From The FDA
The FDA issued the following safety alert to warn the public about the dangers of using Reglan or Metoclopramide for a long period of time. Do not make any decisions about whether you should stop taking your medication without consulting your doctor.
What Movement Disorders Look Like
This video shows what movement disorders like Tardive Dyskinesia look like. If you or someone you love has similar symptoms, you might want to consider consulting with a Reglan lawyer.