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Lawsuit Against Teva and Wal-Mart Alleges that Metoclopramide Causes Tardive Dyskinisia

Posted in Reglan / Metoclopramide

The following lawsuit, filed against Teva (the maker of Metoclopramide, a generic form of Reglan) and Wal-Mart, alleges that extended use of Metoclopramide causes Tardive Dyskinesia.

If you think you have a movement disorder and you’re taking Reglan or Metoclopramide, why not contact me to have me put you in touch with a Reglan attorney who will investigate your claim?

I.

PARTIES

1. Plaintiffs MARY WILLET, Individually and as Representative of the Estate of JAMES E. WILLETT, JR., DECEASED, MAURISSA DEE WILLETT, and JAMES RAUGHN WILLETT are individuals residing in Navarro County, Texas.

2. Defendant TEVA PHARMACEUTICAL S USA INC. [hereinafter “TEVA”] is a corporation that has appeared and answered in this action.

3. Defendant WAL-MART STORES, INC. is a corporation that has appeared and answered in this action.

4. Defendant WAL-MART STORES EAST, INC. is a corporation that has appeared and answered in this action.

Defendants WAL-MART STORES, INC., and WAL-MART STORES EAST, INC., are hereinafter collectively referred to as WAL-MART.

II.

JURISDICTION

5. Defendant TEVA removed this case to this Court based on diversity jurisdiction.

III.

CONDITIONS PRECEDENT

6. All conditions precedent have been performed or have occurred. FED.R.CIV.PROC. 9(c).

IV.

FACTUAL BACKGROUND

7. Decedent JAMES E. WILLETT, JR., received medical treatment from various health care providers for interstitial pneumonitis/pulmonary fibrosis. In this connection, he was placed on the transplant list at UNIVERSITY OF TEXAS SOUTHWESTERN – ST. PAL L LUNG TRANSPLANT CLINIC. Plaintiff MARY WILLETT is the widow of Decedent JAMES E. WILLETT, JR. Plaintiffs MAURISSA DEE WILLETT, and JAMES RAUGHN WILLETT are the children of Decedent JAMES E. WILLETT, JR.

8. In an attempt to solve issues with gastric emptying, Decedent JAMES E. WILLETT was prescribed metoclopramide 10 mg. In August or September, 2004, Plaintiff JAMES E. WILLETT, JR., began suffering the symptoms of tardive dyskenisia which has become a permanent condition. Due to this condition, Decedent JAMES E. WILLETT, JR., was removed from the transplant list and lost transplant eligibility.

9. The metoclopramide which Decedent JAMES E. WILLETT, JR., was provided was designed, manufactured, and/or marketed by Defendant TEVA PHARMACEUTICAL S USA INC.

10. Decedent JAMES E. WILLETT, JR., died on March 8, 2007.

V.

CORPORATE RESPONSIBILITY

11. Whenever it is alleged herein that any of the corporate entities or businesses engaged in an act or omission, it is alleged that such act or omission was that of an officer, employee, or other agent of the corporate entity or business.

VI.

ALLEGATIONS

A.

PRODUCT LIABILITY

12. Defendant TEVA is the “manufacturer,” under Chapter 82 of the TEXAS CIVIL PRACTICE & REMEDIES CODE, of the drug metoclopramide at issue in this litigation and placed the drug, which had defects in design and marketing, in the stream of commerce.

13. Defendant WAL-MART was the “seller,” under Chapter 82 of the TEXAS CIVIL PRACTICE & REMEDIES CODE, that provided the drug in question to Plaintiff JAMES E. WILLETT, JR., and is liable to Plaintiffs in strict liability under Sec. 82.003 (4)and/or (6).

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 §402A of the Restatement Second of the Law of Torts as adopted by the Supreme Court of Texas.

B.

NEGLIGENCE

18. Defendant TEVA was negligent in the following particulars:

a. Failing to conduct adequate testing of metoclopramide before marketing the drug.

b. Failing to adequately consider prior testing and study of the effects of metoclopramide.

c. Failing to adequately warn physicians and the general public of the known potential danger of metoclopramide and the continuing findings regarding danger and degree of risk.

d. Failure to use reasonable care in formulating and manufacturing metoclopramide so as to avoid the described risks to individuals who were prescribed the drug.

19. Defendant WAL-MART was negligent in the following particulars:

a. Failing to adequately warn the general public of the known potential danger of metoclopramide.

b. Utilizing a “monograph” warning regarding metoclopramide which failed to adequately warn and advise the general public regarding metoclopramide.

20. Defendant TEVA engaged in acts and/or omissions in connection with the product labeling of metoclopramide which constituted negligence per se as that term is understood under Texas law, as follows:

a. The labeling did not state that there was a lack of evidence to support the common belief of the safety and efficacy of metoclopramide, in violation of 21 CFR §201 .57(C)(3)(i) and/or (iv) anchor (c)(2);

b. There was inadequate information for patients for the safe and effective use of metoclopramide in combination, in violation of21 CFR §201.57(f)(2);

c. There was inadequate information regarding special care to be exercised by physicians for safe and effective use of metoclopramide in combination, in violation of21 CFR §201.57(f)(1); and

d. he labeling of metoclopramide was misleading and/or promotional in part, in violation of 21 CFR §201.56(b).

21. The acts and omissions of Defendants TEVA and WAL-MART. constituting negligence described hereinabove, taken separately and collectively, constitute direct and proximate causes of the injuries and damages set forth below.

C.

WARRANTY

22. Defendant TEVA made the following warranties to Plaintiffs:

a. The express warranty that metoclopramide was a safe and effective drug.

b. The implied warranty that metoclopramide was safe when in fact said Defendant knew that the drug was not safe for all foreseeable uses.

c. The implied warranty that metoclopramide was of merchantable quality and fit for its intended uses. The users of metoclopramide and the physicians prescribing it reasonably relied upon the skill and judgment of Defendant TEVA as to whether metoclopramide was of merchantable quality and fit for its intended uses.

23. These warranties were breached because metoclopramide was not a safe and effective drug, was not safe for foreseeable and/or intended uses, and was not of merchantable quality.

24. These breaches of warranty were legal causes of the injuries and damages set forth below.

VII.

DAMAGES

A.

WRONGFUL DEATH

25. This cause of action arises under Section 71.004 of the Texas Civil Practice and Remedies Code.

26. Decedent is JAMES E. WILLETT, JR.

27. The wrongful death beneficiaries of JAMES E. WILLETT, JR., under the Wrongful Death statute are as follows:

Name

Relationship to Decedent

MARY WILLET

Wife

MAURISSA DEE WILLETT

Daughter

JAMES RAUGHN WILLETT

Son

JENNIFER ANNE WILLETT

Daughter

ANDREA LYNNE WILLETT

Daughter

28. The wrongful death of Decedent occurred as a proximate result of the negligence and unreasonably dangerous products set out hereinbelow.

29. Decedent JAMES E. WILLETT, JR., was 60 years of age at the time of his death.

30. Plaintiffs MARY WILLETT, MAURISSA DEE WILLETT, and JAMES RAUGHN WILLETT have suffered pecuniary loss as a result of the death of their husband and father, including losses of care, maintenance, support, services, advice, counsel, and contributions of a pecuniary value that they would, in reasonable probability, have received from their husband and father during their lifetimes, had he lived. Plaintiffs MARY WILLETT, MAURISSA DEE WILLETT, and JAMES RAUGHN WILLETT have suffered additional losses by virtue of the destruction of the husband-wife and parent-child relationship including the right to love, affection, solace, comfort, companionship, society, emotional support, and happiness. They have suffered and will continue to suffer mental anguish, grief, and sorrow as a result of the death of their husband and father well into the future.

31. For these losses, Plaintiffs MARY WILLETT, MAURISSA DEE WILLETT, and JAMES RAUGHN WILLETT seek damages.

B.

SURVIVAL ACTION

32. As a legal result of the product, the described breaches of warranty, and the acts and/or omissions of all Defendants, Decedent endured severe bodily injury and conscious pain and suffering. Additionally, the estate of such Decedent has incurred reasonable and customary charges for medical treatment, funeral and burial.

33. As a legal result of all of the above and foregoing, the Estate of JAMES E. WILLETT, JR., has been damaged in an amount for which MARY WILLET as Representative of the Estate of JAMES E. WILLETT hereby sues.

34. By reason of all the above and foregoing, Plaintiffs have suffered losses and damages, for which they hereby sue.

VIII

JURY DEMAND

Plaintiffs hereby request a trial by jury on all issues in this case.

IX

PRAYER

WHEREFORE, Plaintiffs request that Defendants be cited to appear and answer, and that on final trial, Plaintiffs have judgment against Defendants for an amount in conformity with the evidence presented, together with prejudgment and post-judgment interest at the legal rate, costs of court, and for such other and further relief to which Plaintiffs may be justly entitled.
I.

PARTIES

1. Plaintiffs MARY WILLET, Individually and as Representative of the Estate of JAMES E. WILLETT, JR., DECEASED, MAURISSA DEE WILLETT, and JAMES RAUGHN WILLETT are individuals residing in Navarro County, Texas.

2. Defendant TEVA PHARMACEUTICAL S USA INC. [hereinafter “TEVA”] is a corporation that has appeared and answered in this action.

3. Defendant WAL-MART STORES, INC. is a corporation that has appeared and answered in this action.

4. Defendant WAL-MART STORES EAST, INC. is a corporation that has appeared and answered in this action.

Defendants WAL-MART STORES, INC., and WAL-MART STORES EAST, INC., are hereinafter collectively referred to as WAL-MART.

II.

JURISDICTION

5. Defendant TEVA removed this case to this Court based on diversity jurisdiction.

III.

CONDITIONS PRECEDENT

6. All conditions precedent have been performed or have occurred. FED.R.CIV.PROC. 9(c).

IV.

FACTUAL BACKGROUND

7. Decedent JAMES E. WILLETT, JR., received medical treatment from various health care providers for interstitial pneumonitis/pulmonary fibrosis. In this connection, he was placed on the transplant list at UNIVERSITY OF TEXAS SOUTHWESTERN – ST. PAL L LUNG TRANSPLANT CLINIC. Plaintiff MARY WILLETT is the widow of Decedent JAMES E. WILLETT, JR. Plaintiffs MAURISSA DEE WILLETT, and JAMES RAUGHN WILLETT are the children of Decedent JAMES E. WILLETT, JR.

8. In an attempt to solve issues with gastric emptying, Decedent JAMES E. WILLETT was prescribed metoclopramide 10 mg. In August or September, 2004, Plaintiff JAMES E. WILLETT, JR., began suffering the symptoms of tardive dyskenisia which has become a permanent condition. Due to this condition, Decedent JAMES E. WILLETT, JR., was removed from the transplant list and lost transplant eligibility.

9. The metoclopramide which Decedent JAMES E. WILLETT, JR., was provided was designed, manufactured, and/or marketed by Defendant TEVA PHARMACEUTICAL S USA INC.

10. Decedent JAMES E. WILLETT, JR., died on March 8, 2007.

V.

CORPORATE RESPONSIBILITY

11. Whenever it is alleged herein that any of the corporate entities or businesses engaged in an act or omission, it is alleged that such act or omission was that of an officer, employee, or other agent of the corporate entity or business.

VI.

ALLEGATIONS

A.

PRODUCT LIABILITY

12. Defendant TEVA is the “manufacturer,” under Chapter 82 of the TEXAS CIVIL PRACTICE & REMEDIES CODE, of the drug metoclopramide at issue in this litigation and placed the drug, which had defects in design and marketing, in the stream of commerce.

13. Defendant WAL-MART was the “seller,” under Chapter 82 of the TEXAS CIVIL PRACTICE & REMEDIES CODE, that provided the drug in question to Plaintiff JAMES E. WILLETT, JR., and is liable to Plaintiffs in strict liability under Sec. 82.003 (4)and/or (6).

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 §402A of the Restatement Second of the Law of Torts as adopted by the Supreme Court of Texas.

B.

NEGLIGENCE

18. Defendant TEVA was negligent in the following particulars:

a. Failing to conduct adequate testing of metoclopramide before marketing the drug.

b. Failing to adequately consider prior testing and study of the effects of metoclopramide.

c. Failing to adequately warn physicians and the general public of the known potential danger of metoclopramide and the continuing findings regarding danger and degree of risk.

d. Failure to use reasonable care in formulating and manufacturing metoclopramide so as to avoid the described risks to individuals who were prescribed the drug.

19. Defendant WAL-MART was negligent in the following particulars:

a. Failing to adequately warn the general public of the known potential danger of metoclopramide.

b. Utilizing a “monograph” warning regarding metoclopramide which failed to adequately warn and advise the general public regarding metoclopramide.

20. Defendant TEVA engaged in acts and/or omissions in connection with the product labeling of metoclopramide which constituted negligence per se as that term is understood under Texas law, as follows:

a. The labeling did not state that there was a lack of evidence to support the common belief of the safety and efficacy of metoclopramide, in violation of 21 CFR §201 .57(C)(3)(i) and/or (iv) anchor (c)(2);

b. There was inadequate information for patients for the safe and effective use of metoclopramide in combination, in violation of21 CFR §201.57(f)(2);

c. There was inadequate information regarding special care to be exercised by physicians for safe and effective use of metoclopramide in combination, in violation of21 CFR §201.57(f)(1); and

d. he labeling of metoclopramide was misleading and/or promotional in part, in violation of 21 CFR §201.56(b).

21. The acts and omissions of Defendants TEVA and WAL-MART. constituting negligence described hereinabove, taken separately and collectively, constitute direct and proximate causes of the injuries and damages set forth below.

C.

WARRANTY

22. Defendant TEVA made the following warranties to Plaintiffs:

a. The express warranty that metoclopramide was a safe and effective drug.

b. The implied warranty that metoclopramide was safe when in fact said Defendant knew that the drug was not safe for all foreseeable uses.

c. The implied warranty that metoclopramide was of merchantable quality and fit for its intended uses. The users of metoclopramide and the physicians prescribing it reasonably relied upon the skill and judgment of Defendant TEVA as to whether metoclopramide was of merchantable quality and fit for its intended uses.

23. These warranties were breached because metoclopramide was not a safe and effective drug, was not safe for foreseeable and/or intended uses, and was not of merchantable quality.

24. These breaches of warranty were legal causes of the injuries and damages set forth below.

VII.

DAMAGES

A.

WRONGFUL DEATH

25. This cause of action arises under Section 71.004 of the Texas Civil Practice and Remedies Code.

26. Decedent is JAMES E. WILLETT, JR.

27. The wrongful death beneficiaries of JAMES E. WILLETT, JR., under the Wrongful Death statute are as follows:

Name

Relationship to Decedent

MARY WILLET

Wife

MAURISSA DEE WILLETT

Daughter

JAMES RAUGHN WILLETT

Son

JENNIFER ANNE WILLETT

Daughter

ANDREA LYNNE WILLETT

Daughter

28. The wrongful death of Decedent occurred as a proximate result of the negligence and unreasonably dangerous products set out hereinbelow.

29. Decedent JAMES E. WILLETT, JR., was 60 years of age at the time of his death.

30. Plaintiffs MARY WILLETT, MAURISSA DEE WILLETT, and JAMES RAUGHN WILLETT have suffered pecuniary loss as a result of the death of their husband and father, including losses of care, maintenance, support, services, advice, counsel, and contributions of a pecuniary value that they would, in reasonable probability, have received from their husband and father during their lifetimes, had he lived. Plaintiffs MARY WILLETT, MAURISSA DEE WILLETT, and JAMES RAUGHN WILLETT have suffered additional losses by virtue of the destruction of the husband-wife and parent-child relationship including the right to love, affection, solace, comfort, companionship, society, emotional support, and happiness. They have suffered and will continue to suffer mental anguish, grief, and sorrow as a result of the death of their husband and father well into the future.

31. For these losses, Plaintiffs MARY WILLETT, MAURISSA DEE WILLETT, and JAMES RAUGHN WILLETT seek damages.

B.

SURVIVAL ACTION

32. As a legal result of the product, the described breaches of warranty, and the acts and/or omissions of all Defendants, Decedent endured severe bodily injury and conscious pain and suffering. Additionally, the estate of such Decedent has incurred reasonable and customary charges for medical treatment, funeral and burial.

33. As a legal result of all of the above and foregoing, the Estate of JAMES E. WILLETT, JR., has been damaged in an amount for which MARY WILLET as Representative of the Estate of JAMES E. WILLETT hereby sues.

34. By reason of all the above and foregoing, Plaintiffs have suffered losses and damages, for which they hereby sue.

VIII

JURY DEMAND

Plaintiffs hereby request a trial by jury on all issues in this case.

IX

PRAYER

WHEREFORE, Plaintiffs request that Defendants be cited to appear and answer, and that on final trial, Plaintiffs have judgment against Defendants for an amount in conformity with the evidence presented, together with prejudgment and post-judgment interest at the legal rate, costs of court, and for such other and further relief to which Plaintiffs may be justly entitled.