Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Reglan Lawsuit Filed in Louisiana Against Wyeth

Posted in Reglan / Metoclopramide

This Reglan lawsuit was filed in Louisiana, and it alleges that Wyeth purposely concealed the side effects of long term usage of Reglan or Metoclopramide.

35. 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 12 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 Patricia Tarver's class, and this conduct caused serious injury to the Plaintiffs.

Please contact me if you think you’ve developed a movement disorder after taking Reglan or Metoclopramide for longer than 12 weeks.  I know several attorneys who handle these cases and perhaps one of them can help you.

PARTIES AND JURISDICTION

1. Plaintiff Patricia Tarver is an individual and is, and at all times relevant to this Complaint was, a resident of Caldwell Parrish, Louisiana.

2. Plaintiff Glenn Tarver is an individual and is, and at all times relevant to this Complaint was, a resident of Caldwell Parrish, Louisiana.

3. Defendant WYETH, INC. (“WYETH”) is a Delaware corporation with its principal place of business in New Jersey. WYETH is the successor in interest to A.H. Robins Company, Inc., a Virginia corporation, which first obtained approval by the Food and Drug Administration to distribute metoclopramide, under the brand name of Reglan, in the United States. Until December 27, 2001, Wyeth manufactured and distributed Reglan through its Wyeth-Ayerst Laboratories Division in St. Davids, Pennsylvania. Metoclopramide is the active ingredient of Reglan. WYETH also manufactures and distributes generic metoclopramide through its ownership of ESI LEDERLE, INC. (“ESI”), which was formerly a subsidiary of WYETH and was merged into WYETH on December 15, 1998. On December 27, 2001, WYETH sold the rights and liabilities associated with Reglan tablets and Reglan syrup to Schwarz Pharma, Inc., a Delaware corporation with its principal place of business in Wisconsin. WYETH regularly transacts business in Louisiana. References in this Complaint to WYETH include both WYETH individually and as successor in interest to A.H. ROBINS, INC., AMERICAN HOME PRODUCTS CORPORATION, and ESI.

4. As a successor in interest to A.H. Robins, Inc., American Home Products Corporation and ESI, Wyeth is legally responsible for the actions taken by those companies.

5. Plaintiffs are informed and believe that WYETH, ESI, or a related entity whose identity is presently unknown to Plaintiffs, manufactured, distributed or contracted for the manufacture and distribution of generic metoclopramide in the State of Louisiana that was identified with an NDC number assigned to ESI Lederle and ingested by Plaintiff Patricia Tarver.

6. Plaintiffs are informed and believe that at all times relevant to this lawsuit, Defendant WYETH, ESI and/or one of its predecessors in interest and/or one of its family of wholly owned divisions did business in the State of Louisiana by selling Reglan brand metoclopramide and/or generic metoclopramide in the State of Louisiana.

7. Schwarz Pharma, Inc. (“SCHWARZ”) is a Delaware corporation with its principal place of business in Mequon, Wisconsin. On December 27, 2001, SCHWARZ purchased the rights and liabilities associated with Reglan tablets and Reglan syrup from Wyeth pursuant to an Asset Purchase Agreement executed on that date which obligated it to be responsible for claims relating to or arising out of the ingestion or use of Reglan from and after March 31, 2002, subject to a right to indemnification by Wyeth up to an amount not presently known by Plaintiffs. Plaintiffs are informed and believe that at all times relevant to this lawsuit, Defendant SCHWARZ and/or one of its predecessors in interest and/or one of its family of wholly owned divisions did business in the State of Louisiana by selling Reglan brand metoclopramide in the State of Louisiana.

8. Plaintiffs are informed and believe that Defendant PLIVA, INC. (“PLIVA”) is a New Jersey Corporation with its principal place of business in East Hanover, New Jersey, and is a wholly owned subsidiary of PLIVA D.D., a Croatian corporation with its principal place of business in Zagreb, Croatia. Plaintiffs are further informed and believe that PLIVA, or a related entity whose identity is presently unknown to Plaintiffs, manufactured, distributed or contracted for the manufacture and distribution of a generic form of metoclopramide in the State of Louisiana that was identified with an NDC number assigned to Pliva, Inc. and that was ingested by Plaintiff Patricia Tarver.

9. Plaintiffs are further informed and believe that PLIVA is subject to suit in the State of Louisiana, because at all times relevant to this Complaint, PLIVA regularly conducted business in this State, receiving substantial revenues in this State, and manufactured and/or distributed products in this State which have caused injury to Plaintiffs.

10. Plaintiffs are informed and believe that Defendant UNITED RESEARCH LABORATORIES, INC. (“URL”) is a Pennsylvania corporation with its principal place of business in Philadelphia, Pennsylvania. Plaintiffs are informed and believe that URL, or a related entity whose identity is presently unknown to Plaintiffs, manufactured, distributed, or contracted for the manufacture and distribution of a generic form of metoclopramide in the State of Louisiana that was identified with an NDC number assigned to United Research Laboratories, Inc. and that was ingested by Plaintiff Patricia Tarver.

11. Plaintiffs are further informed and believe that URL is subject to suit in the State of Lousiana because, at all times relevant to this Complaint, it regularly conducted business in this State, receiving substantial revenues in this State, and manufactured and/or distributed products in this State which have caused injury to Plaintiffs.

12. Plaintiffs are informed and believe that Defendant DURAMED PHARMACEUTICALS, INC. (“DURAMED”) is a Delaware corporation with its principal place of business in Cincinnati, Ohio. Plaintiffs are informed and believe that DURAMED, or a related entity whose identity is presently unknown to Plaintiffs, manufactured, distributed, or contracted for the manufacture and distribution of a generic form of metoclopramide in the State of Louisiana that was identified with an NDC number assigned to Duramed Pharmaceuticals, Inc. and that was ingested by Plaintiff Patricia Tarver.

13. Plaintiffs are further informed and believe that DURAMED is subject to suit in the State of Louisiana because, at all times relevant to this Complaint, it regularly conducted business in this State, receiving substantial revenues in this State, and manufactured and/or distributed products in this State which have caused injury to Plaintiffs.

14. Plaintiffs hereby incorporate by reference all above allegations as if fully set forth herein. With respect to each of the above allegations that the above entities manufactured, distributed or contracted for the manufacture and distribution of a generic form of metoclopramide in the State of Louisiana, Plaintiffs are informed and believe that DRUG COMPANY DOES 1 THROUGH 6 also manufactured, distributed or contracted for the manufacture and distribution of a generic form of metoclopramide in the State of Louisiana that was ingested by Plaintiff Patricia Tarver. Plaintiffs are further informed and believe that DRUG COMPANY DOES 1 THROUGH 6 are subject to suit in the State of Louisiana, because at all times relevant to this Complaint, they each regularly conducted business in this State, receiving substantial revenues in this State, and manufactured and/or distributed products in this State which have caused injury to Plaintiff Patricia Tarver.

15. Plaintiffs do not know the true names of DRUG COMPANY DOES 1 THROUGH 6 inclusive, and therefore sue them by those fictitious names.

16. For purposes of this Complaint WYETH, ESI, SCHWARZ, PLIVA, URL, DURAMED and DRUG COMPANY DOES 1 THROUGH 6 are sometimes referred to as the “Drug Company Defendants.”

17. This Court has jurisdiction pursuant to 28 U.S.C. § 1332, as the matter in controversy exceeds the sum or value of $75,000, and is between citizens of different states.

18. Venue is proper in this judicial district pursuant to 28 U.S.C. § 1391 because a substantial part of the events giving rise to Plaintiffs' causes of action arose in Caldwell Parrish, Louisiana in this judicial district.

FACTUAL BACKGROUND

19. From on or about July 23, 1998 until on or about October 2003, Plaintiff Patricia Tarver took metoclopramide manufactured and distributed by WYETH, PLIVA, URL, DURAMED, and/or metoclopramide manufactured and distributed by DRUG COMPANY DOES 1 THROUGH 6, for the treatment of gastroesophageal reflux.

20. From on or about July 23, 1998 until on or about February 2000, Dr. Gregory Boyce prescribed Reglan to Plaintiff Patricia Tarver for gastroesophageal reflux.

21. From on or about February 2000 until on or about October 2003, Dr. John Hull prescribed Reglan to Plaintiff Patricia Tarver for gastroesophageal reflux.

22. When Plaintiff Patricia Tarver filled her prescriptions for Reglan, the pharmacy substituted generic metoclopramide manufactured and/or distributed by the DRUG COMPANY DEFENDANTS.

23. Because of the misleading information that the DRUG COMPANY DEFENDANTS, and each of them, provided to physicians and the FDA about the true risks associated with the use of Reglan/metoclopramide and because of the failure of the DRUG COMPANY 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, at all times relevant to this lawsuit, while Plaintiff Patricia Tarver was taking Reglan/metoclopramide, her physicians never informed her of any side effects associated with Reglan/metoclopramide or that Reglan/metoclopramide was only approved for short term use (up to 12 weeks).

24. Ms. Tarver took metoclopramide as prescribed by throughout the period from on or about July 23, 1998 until on or about October 2003.

25. In or about June 2002, Ms. Tarver began to experience jaw and mouth movements. Her symptoms got progressively worse and she developed constant involuntary jaw movements, mouth movements, and tongue movements; she also developed severe jaw pain and foot and toe movements, among other movement problems. On October 13, 2003, Dr. Paul Riley, a TMJ specialist, diagnosed Ms. Tarver with tardive dyskinesia, probably related to Reglan.

26. Tardive dyskinesia is a debilitating neurological disorder that often results in involuntary and uncontrollable movements of the head, neck, face, arms, legs, and trunk, in addition to grotesque facial grimacing and open-mouthed, uncontrollable tongue movements, tongue thrusting, tongue chewing, and other involuntary movements. Tardive dyskinesia is often permanent. There is no cure for tardive dyskinesia.

27. Use of metoclopramide caused Ms. Tarver 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 Ms. Tarver suffered from the use of Reglan/metoclopramide, Ms. Tarver 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.

28. Reglan/metoclopramide is approved for short-term use up to twelve weeks in adults.

29. 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 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.

30. At all times material hereto, WYETH and the other Drug Company Defendants knew or should have known that most physicians were not aware of or did not fully appreciate the seriousness of the risks associated with use of Reglan/metoclopramide and that consequently there was a widespread tendency for physicians to prescribe Reglan/metoclopramide for inappropriate long-term use. Therefore, WYETH and the other Drug Company Defendants also knew or should have known that the package insert and the Physician Desk Reference monograph for Reglan/metoclopramide did not adequately inform physicians about the risks associated with Reglan/metoclopramide, particularly for patients whose bodies do not metabolize metoclopramide effectively.

31. WYETH also had access to knowledge concerning the side effects of Reglan/metoclopramide, the manner in which physicians were prescribing Reglan/metoclopramide and the fact that physicians did not fully understand the risks associated with Reglan/metoclopramide through its participation in or its ability to review data from clinical studies that were not publicly available, through its review of domestic and international medical literature concerning Reglan/metoclopramide and through ongoing litigation. Yet, WYETH failed to adequately warn physicians about the risks associated with Reglan/metoclopramide, despite the fact that WYETH knew that physicians and the generic pharmaceutical industry relied on WYETH to disclose what it knew and what it should have known from a prudent review of the information that it possessed or to which it had access.

32. Defendant WYETH's predecessor in interest, A.H. Robins Company, Inc., expressly warranted to some physicians that Reglan/metoclopramide is safe in long-term use. When A.H. Robins made those representations, Robins knew that those physicians would share that information with other physicians in their community and that eventually many physicians would come to rely on Robins' express warranties about Reglan/metoclopramide's safety in long-term use. Robins' express warranties about the safety of Reglan/metoclopramide in long-term use were false.

33. As successor in interest to A.H. Robins Company, Inc., Wyeth is legally responsible for representations and warranties made by A.H. Robins Company, Inc. concerning the safety and adequacy of Reglan/metoclopramide.

34. Defendant WYETH knew, or should have known through the exercise of reasonable care, that the package insert for Reglan/metoclopramide substantially understated the prevalence of acute and long-term side effects of Reglan/metoclopramide. WYETH failed to use reasonable care to modify the package insert to adequately warn physicians about the true risks of both short-term use and long-term use, even after several injured patients filed lawsuits alleging inadequate warnings and produced competent expert testimony supporting their allegations.

35. 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 12 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 Patricia Tarver's class, and this conduct caused serious injury to the Plaintiffs.

36. 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. 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 of the rights of persons in Plaintiff Patricia Tarver's class, and this conduct caused serious injury to the Plaintiffs.

37. Defendants PLIVA, URL, DURAMED, 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 Reglan/metoclopramide and to inform them concerning its knowledge of how physicians were using Reglan/metoclopramide and any dangers that were associated with that use, by properly reporting their knowledge to the FDA, despite the fact that PLIVA, URL, DURAMED, 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. Defendants PLIVA, URL, DURAMED, 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/metoclopramide was widely overprescribed as a result of inadequate warnings in the package inserts and PDR monographs for Reglan brand and generic metoclopramide. Defendants PLIVA, URL, DURAMED, and DRUG COMPANY DOES 1 THROUGH 6 also knew, or should have known in the exercise of reasonable care, that the package insert for Reglan/metoclopramide substantially understated the prevalence of acute dystonic reactions and other acute side effects of Reglan/metoclopramide, and failed to use reasonable care to modify the package insert, and/or seek FDA approval to modify the package insert, in order to adequately warn physicians and consumers.

38. As a result of the misrepresentations, breach of express and implied warranties and negligence occasioned by the DRUG COMPANY DEFENDANTS, Ms. Tarver was prescribed excessive amounts of metoclopramide which caused her to suffer serious and permanent injuries as described above.

39. All Defendants are jointly and severally liable to Plaintiffs for all damages claimed.

INTERRUPTION OF PRESCRIPTION

40. Prescription as to the Plaintiffs has been interrupted and tolled. Plaintiff Patricia Tarver's tardive dyskinesia is a long-latency disease that only manifested after long-term exposure to metoclopramide. Plaintiff Patricia Tarver did not become aware of the connection between her injury and the Defendants' tortuous and wrongful actions until she was diagnosed with tardive dyskinesia on October 13, 2003, at which time she first learned of the connection between metoclopramide and her tardive dyskinesia. Until October 13, 2003, Plaintiffs' causes of action against the Defendants were not known or reasonably knowable by Plaintiffs, Plaintiffs had no reasonable basis to pursue a claim against Defendants, and Plaintiffs specifically plead the doctrine of contra non valentem agere nulla currit praescripto as tolling or suspending the applicable prescription.

FIRST CAUSE OF ACTION

Strict Products Liability: (As against DRUG COMPANY DEFENDANTS)

41. Plaintiffs hereby incorporate by reference all above allegations as if fully set forth herein.

42. At all relevant times the DRUG COMPANY DEFENDANTS were engaged in the business of manufacturing, designing, testing, marketing, promoting, distributing, and/or selling metoclopramide.

43. At all times mentioned in this Complaint, metoclopramide was defective and/or unreasonably dangerous to Patricia Tarver and other foreseeable users at the time it left the control of the DRUG COMPANY DEFENDANTS.

44. 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 Patricia Tarver, in one or more of the following respects:

(a) At the time metoclopramide left the control of the Drug Company Defendants 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 Patricia Tarver's physicians justifiably relied, or because it breached an implied warranty, all of which proximately caused the damages for which Plaintiffs 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 the Drug Company Defendants, and that such risks clearly outweighed the utility of the product or its therapeutic benefits.

(c) At the time metoclopramide left the control of the Drug Company Defendants it possessed a dangerous characteristic that may cause damage, and it 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 the Drug Company Defendants 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. The Drug Company Defendants failed to use reasonable care to provide an adequate warning of these dangerous characteristics to handlers and users of metoclopramide.

(d) The Drug Company Defendants' warnings or instructions were not of a nature that a reasonably 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 Patricia Tarver.

(e) The metoclopramide manufactured and supplied by the Drug Company Defendants was further defective due to inadequate post-marketing warning or instruction because, after the Drug Company Defendants knew or should have known of the risks of injury from metoclopramide associated with long-term use as commonly prescribed, they failed to promptly respond to and adequately warn about extrapyramidal side effects, among other adverse reactions.

45. The DRUG COMPANY DEFENDANTS knew or in light of reasonably available scientific knowledge should have known about the danger that caused the injuries for which Plaintiffs seek recovery. A reasonably competent physician who prescribed metoclopramide and a reasonably competent plaintiff who consumed metoclopramide would not realize its dangerous condition.

46. The DRUG COMPANY DEFENDANTS knew or in light of reasonably available scientific knowledge should have known about the danger associated with use of metoclopramide that caused the damages for which Plaintiffs seek recovery.

47. The reasonably foreseeable use of metoclopramide, that is ingestion as treatment for gastritis/gastroesophageal reflux on a long term basis, involved substantial dangers not readily recognizable by the ordinary physician who prescribed metoclopramide or the patient, like Plaintiff Patricia Tarver, who consumed metoclopramide.

48. The DRUG COMPANY DEFENDANTS knew that the metoclopramide was to be prescribed by physicians and used by consumers without inspection for defects in the product or in any of its components or ingredients and that metoclopramide was not properly prepared nor accompanied by adequate warnings of its dangerous propensities that were known or reasonably scientifically knowable at the time of distribution.

49. Plaintiff Patricia Tarver and her physicians did not know, nor had reason to know, at the time of the use of metoclopramide, or at any time prior to its use, of the existence of the above-described defects and inadequate warnings.

50. These defects caused serious injuries to Plaintiff Patricia Tarver when the product was used in its intended and foreseeable manner, and in the manner recommended by the DRUG COMPANY DEFENDANTS or in a non-intended manner that was reasonably foreseeable.

SECOND CAUSE OF ACTION

Negligence (As against DRUG COMPANY DEFENDANTS)

51. Plaintiffs hereby incorporate by reference all above allegations as if fully set forth herein.

52. At all times mentioned in this Complaint, the DRUG COMPANY DEFENDANTS had a duty to properly manufacture, compound, test, inspect, package, label, distribute, market, examine, maintain, supply, provide proper warnings, and prepare for use and sell metoclopramide.

53. The DRUG COMPANY DEFENDANTS knew or should have known that use of metoclopramide created an unreasonable risk as a result of its design, testing, and/or manufacturing, including an unreasonable risk of central nervous system side effects, depression, akathisia, akinesia, tardive dyskinesia, tardive dystonia, visual disturbances and/or interference with drug metabolism, especially in female patients diagnosed with diabetes mellitus and more particularly in patients who are poor metabolizers of metoclopramide.

54. The DRUG COMPANY DEFENDANTS were negligent, and breached duties owed to Plaintiff Patricia Tarver with respect metoclopramide in one or more of the following respects:

(a) Despite knowledge of hazards and knowledge that the product was frequently prescribed for long-term use, they failed to accompany the product with adequate warnings and instructions regarding the adverse and long-lasting side effects associated with the use of metoclopramide and particularly with foreseeable long-term use;

(b) They failed to conduct adequate testing;

(c) Despite knowledge of hazards, they failed to conduct adequate post-marketing surveillance to determine the safety of the product;

(d) Despite knowledge of hazards, they failed to adequately warn Plaintiff Patricia Tarver's physicians or Plaintiff Patricia Tarver that the use of metoclopramide could result in depression with suicidal ideation, akathisia, akinesia, tardive dyskinesia, tardive dystonia, visual disturbances and interference with drug metabolism; and

(e) Despite the fact that the Drug Company Defendants knew or should have known that metoclopramide caused unreasonably dangerous side effects, they failed to adequately disclose the known or knowable risks associated with metoclopramide as set forth above; they willfully and deliberately failed to adequately disclose these risks, and in doing so, acted with a conscious disregard of Plaintiff Patricia Tarver's safety or welfare.

55. As a result of the negligence of the DRUG COMPANY DEFENDANTS and their willful and wanton misconduct, metoclopramide was prescribed to Plaintiff Patricia Tarver for long-term use and was used long-term by her, thereby causing her to sustain reasonably foreseeable serious and permanent damages and injuries as alleged in this Complaint.

56. The negligence and the willful and wanton misconduct of the DRUG COMPANY DEFENDANTS was a proximate cause of Plaintiff Patricia Tarver's harm and injuries that Plaintiff Patricia Tarver has suffered and will continue to suffer as previously described.

THIRD CAUSE OF ACTION

Negligence Per Se (As against DRUG COMPANY DEFENDANTS)

57. Plaintiffs hereby incorporate by reference all above allegations as if fully set forth herein.

58. The product label and package insert for metoclopramide is misbranded within the meaning of 21 U.S.C. § 352(a) and (f) because it was false and misleading and failed to give adequate warnings and directions for use by physicians who prescribe metoclopramide. Because DRUG COMPANY DEFENDANTS, and each of them, had a statutory duty under 21 U.S.C. § 352(a) and (f), not to misbrand metoclopramide and because each of them violated this duty, they were guilty of negligence per se. In addition, and more particularly, because the DRUG COMPANY DEFENDANTS knew, or should have known, that physicians commonly prescribed metoclopramide for long-term use, beyond the 12 week intended use that was approved by the FDA, pursuant to 21 CFR 201.128, long-term use became an “intended use” which required the defendants, and each of them, to provide adequate labeling for such a drug which accords with such other uses to which the article was commonly prescribed. Their failure to adequately warn about the magnitude of the risk associated with long-term use constitutes negligence per se.

59. Defendants' negligence per se proximately caused injury to the Plaintiff Patricia Tarver as described more fully herein.

FOURTH CAUSE OF ACTION

Fraud (As against Defendant WYETH)

60. Plaintiffs hereby incorporate by reference all above allegations as if fully set forth herein.

61. As set forth above, WYETH and its predecessors falsely and fraudulently represented to Plaintiff Patricia Tarver's physicians, and through them to Plaintiff Patricia Tarver and members of the general public, that Reglan/metoclopramide was safe for use to treat gastritis/gastroesophageal reflux and that central nervous system side effects and extrapyramidal symptoms were comparatively rare. These representations were, in fact, false. The true facts were that Reglan/ metoclopramide was not safe for that purpose and was, in fact, dangerous to the health and body of Plaintiff Patricia Tarver.

62. WYETH and its predecessors made other representations about the safety and efficacy of Reglan/metoclopramide, and its minimal side effects, all as set forth above and incorporated here by reference.

63. These representations were, in fact, false. The true facts were that Reglan/metoclopramide causes central nervous system side effects, and extrapyramidal symptoms, among other side effects, far more frequently than represented, and WYETH and its predecessors did not disclose or warn physicians about the actual prevalence of known side effects of Reglan/metoclopramide, particularly when Reglan/metoclopramide is used on a long-term basis or when used in patients who are poor metabolizers of metoclopramide, all of which were foreseeable. WYETH and its predecessors misrepresented the safety of Reglan/metoclopramide and withheld warnings of the known side effects of Reglan/metoclopramide when used as commonly prescribed by physicians, as specifically required by 21 CFR 201.128.

64. When WYETH and its predecessors made these representations, they knew that they were false. WYETH made these representations with the intent to defraud and deceive Plaintiff Patricia Tarver's physicians and through them to defraud and deceive Plaintiff Patricia Tarver, and with the intent to induce her and her physicians to act in the manner alleged in this Complaint, that is, to use Reglan/metoclopramide as pharmaceutical treatment for gastritis/gastroesophageal reflux for a period of time that far exceeded the FDA's approved indicated duration of use.

65. At the time WYETH and its predecessors made the above-described representations, and at the time Plaintiff Patricia Tarver and her physicians took the actions alleged in this Complaint, Plaintiff Patricia Tarver and her physicians were ignorant of the falsity of the representations and reasonably believed them to be true. In reliance upon the representations, Plaintiff Patricia Tarver's physicians were induced to, and did, prescribe Reglan/metoclopramide as described in this Complaint and Plaintiff Patricia Tarver did use Reglan/metoclopramide as described in this Complaint.

66. If Plaintiff Patricia Tarver's physicians had known the actual facts, they would not have prescribed Reglan/metoclopramide in the manner that they prescribed it and Plaintiff Patricia Tarver would not have taken Reglan/metoclopramide in the way that it was prescribed.

67. The reliance of Plaintiff Patricia Tarver and her physicians upon the representations of WYETH and its predecessors was justified because the representations were made by individuals and entities that appeared to be in the position to know the true facts.

68. As a proximate result of the fraud and deceit of WYETH and its predecessors, Plaintiff Patricia Tarver sustained the injuries and damages described in this Complaint.

69. In doing the acts alleged in this Complaint, Wyeth and its predecessors acted with oppression, fraud, and malice and Plaintiffs are therefore entitled to punitive damages to deter WYETH and others from engaging in similar conduct in the future. This wrongful conduct was done with the advance knowledge, authorization, or ratification of an officer, director, or managing agent of each of WYETH and its predecessors.

FIFTH CAUSE OF ACTION

Negligent Misrepresentation (As against Defendants WYETH and SCHWARZ)

70. Plaintiffs hereby incorporate by reference all above allegations as if fully set forth herein.

71. WYETH and SCHWARZ had actual knowledge of facts which demonstrated that representations in the Reglan package insert, the PDR monograph for Reglan and literature that they distributed concerning Reglan/metoclopramide to physicians were false and misleading. WYETH and SCHWARZ had an absolute duty to disclose the true facts regarding the safety of Reglan to physicians and their patients, pharmacists, and the generic metoclopramide industry, which they negligently failed to do. Furthermore, WYETH and SCHWARZ had a duty to ensure that they had a reasonable basis for making the representations described above, to exercise reasonable care in making those representations, to accurately make those representations, and to not make misrepresentations, all of which they negligently failed to do.

72. Important information regarding metoclopramide's risks was in the exclusive control of WYETH and SCHWARZ and was exclusively known by them. As part of their business, and in the furtherance of their own interests, WYETH and SCHWARZ disseminated information regarding metoclopramide to physicians and their patients, pharmacists, and the generic metoclopramide industry, and did so knowing that the safety of metoclopramide users depended on the accuracy of that information. Further, WYETH and SCHWARZ knew and expected that recipients of that information would rely on it, that they would take action based upon it, that individuals would be put in peril by such action, and that those individuals would suffer physical harm as a result.

73. WYETH and SCHWARZ expressly and/or impliedly represented to Plaintiff Patricia Tarver, her physicians, pharmacists, the generic metoclopramide industry and members of the general public that Reglan/metoclopramide was safe for use to treat nausea and/or esophageal reflux for durations of use that exceeded the 12 week duration indicated in WYETH and SCHWARZ'S package inserts and in the PDR. The representations by WYETH and SCHWARZ, and the lack of them were, in fact, false. The true facts were that Reglan/metoclopramide was not safe for use in the manner in which it was prescribed and was, in fact, dangerous to the health and body of Plaintiff Patricia Tarver.

74. WYETH and SCHWARZ made the above-described representations with no reasonable grounds for believing them to be true. WYETH and SCHWARZ did not have accurate or sufficient information concerning these representations and they failed to exercise reasonable care both in ascertaining the accuracy of the information contained in those representations and in communicating the information. Further, WYETH and SCHWARZ were aware that without such information, they could not accurately make the above-described representations.

75. The above misrepresentations or omissions were made to Plaintiff Patricia Tarver, her physicians, pharmacists, the generic pharmaceutical industry and the general public, all of whom justifiably and forseeably relied on those representations or omissions. Plaintiff Patricia Tarver would not have suffered her injuries but for the above misrepresentations or omissions. WYETH and SCHWARZ'S misrepresentations or omissions were a cause in fact and a proximate cause of Plaintiffs' damages.

SIXTH CAUSE OF ACTION

Fraud by Concealment (As against Defendant WYETH)

76. Plaintiffs hereby incorporate by reference all above allegations as if fully set forth herein.

77. At all times mentioned in this Complaint, WYETH and its predecessors had the duty and obligation to disclose to Plaintiff Patricia Tarver and to her physicians, the true facts concerning Reglan/metoclopramide, that is, that Reglan/metoclopramide was dangerous and defective, and how likely it was to cause serious consequences to users, including injuries as described in this Complaint, and the true level of risk involved in prescribing Reglan/metoclopramide for the purposes indicated. WYETH and its predecessors made the affirmative representations set forth above to Plaintiff Patricia Tarver, her prescribing physicians, and the general public prior to the day Plaintiff Patricia Tarver was first prescribed and used Reglan/metoclopramide, while concealing the material facts set forth below.

78. At all times mentioned in this Complaint, WYETH and its predecessors had the duty and obligation to disclose to Plaintiff Patricia Tarver and to her physicians the true facts concerning Reglan/metoclopramide, that is, that long term use and exposure could cause central nervous system side effects, depression with suicidal ideation, akathisia, akinesia, tardive dyskinesia and tardive dystonia. At all times mentioned in this Complaint, WYETH and its predecessors intentionally, willfully, and maliciously concealed or suppressed the facts set forth above from Plaintiff Patricia Tarver's physicians, and therefore from Plaintiff Patricia Tarver, with the intent to defraud as alleged in this Complaint.

79. At all times mentioned in this Complaint, neither Plaintiff Patricia Tarver nor her physicians were aware of the facts set forth above. Had they been aware of those facts, they would not have acted as they did, that is, would not have utilized Reglan/metoclopramide in the treatment of Plaintiff Patricia Tarver's gastritis/gastroesophageal reflux for periods of time that exceeded 12 weeks duration.

80. As a proximate result of the concealment or suppression of the facts set forth above, Plaintiff Patricia Tarver was prescribed and took Reglan/metoclopramide and subsequently became ill, thereby sustaining the injuries and damages as set forth in this Complaint.

81. In doing the acts alleged in this Complaint, WYETH and its predecessors acted with oppression, fraud, and malice, and Plaintiffs are therefore entitled to punitive damages in an amount reasonably related to Plaintiffs' actual damages and to WYETH's wealth, and sufficiently large to be an example to others, and to deter WYETH and others from engaging in similar conduct in the future.

SEVENTH CAUSE OF ACTION

Breach of Express Warranties (As against DRUG COMPANY DEFENDANTS)

82. Plaintiffs hereby incorporate by reference all above allegations as if fully set forth herein.

83. The DRUG COMPANY DEFENDANTS represented to the medical community that the most common extrapyramidal side effect of metoclopramide, acute dystonic reactions, only occurred in one in every 500 patients, despite the fact that from no later than June 1993 DRUG COMPANY DEFENDANTS knew, or should have known, that published studies had established that the risk was 100 times greater than disclosed in the package inserts and the PDR monograph for Reglan brand and generic metoclopramide. Metoclopramide is not safe for long-term use and the risk of dystonic reactions, including tardive dyskinesia from long-term use is much greater than warranted, given the conditions Reglan/metoclopramide is used to treat.

84. The above-described manufacturing, compounding, packaging, designing, distributing, testing, constructing, fabricating, analyzing, recommending, merchandizing, advertising, promoting, supplying, and selling of metoclopramide was expressly warranted by DRUG COMPANY DEFENDANTS to be safe and fit for use by Plaintiff Patricia Tarver and other members of the general public.

85. At the time of the making of the express warranties, DRUG COMPANY DEFENDANTS had knowledge of the purpose for which metoclopramide was to be used and warranted it to be, in all respects, fit, safe, and effective and proper for such purpose. metoclopramide was not properly prepared nor accompanied by adequate warnings for its dangerous propensities that were either known or reasonably scientifically knowable at the time of distribution.

86. Plaintiff Patricia Tarver and her physicians reasonably relied upon the skill and judgment of DRUG COMPANY DEFENDANTS and upon the above-described express warranties in using metoclopramide. The warranties and representations were untrue in that metoclopramide was far more likely to cause injury than represented by DRUG COMPANY DEFENDANTS, it caused severe injury to Plaintiff Patricia Tarver and was unsafe and, therefore, unsuited and unfit for the use for which it was intended. The breach of the express warranties made by DRUG COMPANY DEFENDANTS about metoclopramide could and did thereby proximately cause Plaintiff Patricia Tarver to sustain damages and injuries as alleged in this Complaint.

87. As soon as the true nature of metoclopramide and the fact that the warranties and representations were false, were ascertained by Plaintiff Patricia Tarver, DRUG COMPANY DEFENDANTS were notified of the breach of their express warranties.

EIGHTH CAUSE OF ACTION

Breach of Implied Warranties / Redhibition (As against DRUG COMPANY DEFENDANTS)

88. Plaintiffs hereby incorporate by reference all above allegations as if fully set forth herein.

89. The DRUG COMPANY DEFENDANTS knew that most physicians who prescribed metoclopramide were not aware the drug is a dopamine antagonist and/or a neuroleptic agent, which is just as likely to cause serious extrapyramidal side effects as other dopamine antagonists and/or other neuroleptic drugs. DRUG COMPANY DEFENDANTS also knew that the risks of potentially irreversible neurological side effects when metoclopramide is used long-term were much greater than most physicians realized. By failing to give adequate warnings about the dopamine antagonist and/or neuroleptic properties of metoclopramide and the risk of long-term use that is associated with those properties, DRUG COMPANY DEFENDANTS, and each of them, breached implied warranties of merchantability and fitness for the ordinary use of metoclopramide, and the warranty against redhibitory defects.

90. At all times mentioned in this Complaint, DRUG COMPANY DEFENDANTS manufactured, compounded, packaged, distributed, recommended, merchandised, advertised, promoted, supplied, and sold metoclopramide, and prior to the time it was used by Plaintiff Patricia Tarver, DRUG COMPANY DEFENDANTS impliedly warranted to Plaintiff Patricia Tarver and to her physicians that the product was of merchantable quality and safe and fit for the use for which it was intended, and that it was free from redhibitory defects.

91. Plaintiff Patricia Tarver relied on the skill and judgment of DRUG COMPANY DEFENDANTS in using metoclopramide.

92. Metoclopramide was unsafe and unfit for its intended use, nor was it of merchantable quality, nor was it free from redhibitory vices or defects, as warranted by DRUG COMPANY DEFENDANTS, in that it had very dangerous propensities when put to its intended use and would cause severe injury to the user. Metoclopramide's qualities constitute a redhibitory vice or defect, rendering it useless or so inconvenient that it must be presumed that Plaintiff Patricia Tarver would not have bought it had she known of the defect. Metoclopramide was not properly prepared nor accompanied by adequate warnings of its dangerous propensities that were either known or reasonably scientifically knowable at the time of distribution. As a result, metoclopramide proximately caused Plaintiff Patricia Tarver to sustain damages and injuries as alleged in this Complaint by virtue of causing Plaintiff Patricia Tarver's illness.

93. After Plaintiff Patricia Tarver was made aware of her injuries as a result of metoclopramide, notice was duly given to DRUG COMPANY DEFENDANTS of the breach of the above-described warranties.

NINTH CAUSE OF ACTION

Consumer Protection (As against Defendant Wyeth)

94. Plaintiffs hereby incorporate by reference all above allegations as if fully set forth herein.

95. By reason of their conduct as alleged herein, WYETH and its predecessors violated the provisions of the Louisiana Unfair Trade Practices and Consumer Protection Law, La. Rev. Stat. Ann. § 51:1401, et seq, by inducing the Plaintiff and Plaintiff's physicians to use and/or prescribe the drugs Reglan/metoclopramide through the use of false and/or misleading advertising, representations and statements.

96. By engaging in the conduct described above, WYETH and its predecessors violated the Louisiana Unfair Trade Practices and Consumer Protection Law, La. Rev. Stat. Ann. § 51:1401, et seq, by, among other things:

(a) Engaging in unfair trade practices as defined in this statute by making false and misleading oral and written statements that had the capacity, tendency or effect of deceiving or misleading consumers;

(b) Engaging in unfair trade practices as defined in this statute by making representations that their products had an approval, characteristic, ingredient, use or benefit which they did not have, including but not limited to statements concerning the health consequences of the use of these drugs;

(c) Engaging in unfair trade practices as defined in this statute by failing to state material facts, the omission of which deceived or tended to deceive, including but not limited to, facts relating to the health consequences of the use of these drugs; and

(d) Engaging in unfair trade practices as defined in this statute through deception, fraud, misrepresentation, and knowing concealment, suppression and omission of material facts with the intent that consumers rely upon the same in connection with the use and continued use of the drugs.

97. The violations of the Louisiana Unfair Trade Practices and Consumer Protection Law, La. Rev. Stat. Ann. § 51:1401, et seq, by WYETH and its predecessors proximately caused injury to Plaintiff Patricia Tarver.

98. As a result of the aforesaid statutory violations, Plaintiff is entitled to relief, as allowed by statute and prayed for below.

TENTH CAUSE OF ACTION ELEVENTH CAUSE OF ACTION

Loss of Consortium (As against all Defendants)

99. Plaintiffs hereby incorporate by reference all above allegations as if fully set forth herein.

100. Plaintiff Glenn Tarver is the husband of Plaintiff Patricia Tarver.

101. As a direct and proximate result of the injuries to Plaintiff Patricia Tarver set forth above, Plaintiff Glenn Tarver was deprived, and will in the future, be deprived of the companionship, society, guidance, material services and consortium of his spouse.

JURY DEMAND

Plaintiffs demand that all issues of fact in this case be tried to a properly empanelled jury.

  • Angelina

    To see dystonic reaction (oculogyric crisis with retrocollis within hours of receiving Haldol) in autistic patient, see “Autistic Patient In Crisis Goes Unnoticed” on you tube. Dystonic reaction in this patient was quickly reversed with ‘cogentin” and ‘benadryl”. Interesting.