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Dagosto, Marian v. FHCRC

Superior Court For The State of Washington
At King County

MARIAN DAGOSTO, individually and as Personal Representative of the Estate of Paul Mahler

and

PAULA CARRICO, individually and as Personal Representative of the Estate of Norman Carrico

and

MALATHI SARMA, individually and as Personal Representative of the Estate of Mohan Sarma

and

CATHY YINGLING, individually and as Personal Representative of the Estate of David Yingling

and

ROBERT and CAROL RUSSELL, individually and as Personal Representative of the Estate of Lynne Russell

and

DIANE FENDER, individually and as Personal Representative of the Estate of George Fender

and

RANDALL G. OBERMEYER, individually and as Personal Representative of the Estate of Carolyn Obermeyer

Plaintiffs,v.

THE FRED HUTCHINSON CANCER RESEARCH CENTER

and

DR. E. DONNALL THOMAS and JANE DOE THOMAS, and the marital community comprised thereof

and

DR. JOHN a. HANSEN and JANE DOE HANSEN, and the marital community comprised thereof

and

DR. PAUL J. MARTIN and JANE DOE MARTIN and the marital community comprised thereof

and

DR. ROBERT DAY and JANE DOE DAY and the marital community comprised thereof

Defendants.

: NO. 02-2-06303-9SEAFIRST AMENDED COMPLAINT FOR DAMAGES

I. INTRODUCTION

Plaintiffs bring this action to recover damages against the defendants identified below caused by defendants' formulation, adoption, implementation and administration of human research clinical trials commonly referred to as "Protocol 126." Plaintiffs allege as follows:

II. PARTIES

1. Plaintiff Marian Dagosto is a resident and citizen of the State of Illinois.

2. Plaintiff Marian Dagosto was the wife of plaintiff's decedent, Paul Mahler.

3. Plaintiff Paula Carrico is a resident and citizen of the State of Tennessee.

4. Plaintiff Paula Carrico was the wife of plaintiff's decedent, Norman Carrico.

5. Plaintiff Paula Carrico represents the Estate of Norman Carrico.

6. Plaintiff Malathi Sarma is a resident and citizen of the State of Utah.

7. Plaintiff Malathi Sarma was the wife of plaintiff's decedent, Mohan Sarma.

8. Plaintiff Cathy Yingling is a resident and citizen of the State of Pennsylvania.

9. Plaintiff Cathy Yingling was the wife of plaintiff's decedent, David Yingling.

10. Plaintiffs Robert and Carol Russell are residents and citizens of the State of California.

11. Plaintiffs Robert and Carol Russell were the parents of plaintiffs' decedent, Lynne Russell.

12. Plaintiff Diane Fender is a resident and citizen of the State of California.

13. Plaintiff Diane Fender was the wife of plaintiff's decedent, George Fender.

14. Plaintiff Randall G. Obermeyer is a resident and citizen of the State of Indiana.

15. Plaintiff Randall G. Obermeyer was the son of plaintiff's decedent Carolyn Obermeyer.

16. Defendant The Fred Hutchinson Cancer Research Center ("the Center") is a medical facility organized and existing under the laws of the State of Washington with its principal office and place of business located at 110 Fairview Ave. N., Seattle, Washington 98109.

17. Defendant Dr. E. Donnall Thomas is the co-founder and clinical director of the Center and is a citizen of the United States and the State of Washington.

18. Defendant Dr. John A. Hansen at all times relevant hereto was a principal investigator of Protocol 126 and later clinical director at the Center and is a citizen of the United States and the State of Washington.

19. Defendant Dr. Paul J. Martin at all times relevant hereto was an oncologist employed by the Center and a principal investigator of Protocol 126 is a citizen of the United States and the State of Washington.

20. Defendant Dr. Robert Day at all times relevant hereto was the Director of the Center and is a citizen of the United States and the State of Washington.

III. FACTS

21. Each of the plaintiffs' decedents ["decedents"] was enrolled by the defendant Center in "Protocol 126." Each of the decedents received a bone marrow transplant administered by the defendant Center during his or her participation in Protocol 126. Per the provisions of the written protocol, the defendant depleted T-cells from the transplanted marrow supplied by the decedent's marrow donor prior to the decedent's transplant. The defendant Center performed each of these marrow transplants at a time when the defendants knew or should have known that results from prior human research by defendant involving T-cell depleted marrow had shown no improvement in survival of the defendant's human subjects because of an increase of graft failure. At the time that each of the decedent's marrow transplants were performed by the defendant Center, the defendants believed that the most likely explanation for the unusually high rate of graft failure in their prior human subjects was due to depletion of the T-cells from the donor's marrow. Each of the individually named defendants was involved in the development, adoption, implementation and/or administration of Protocol 126 on behalf of the defendant Center.

22. Each of the individually named defendants knew or should have known of the decedents' participation in Protocol 126 at a time when the defendant believed that T-cell depletion was the most likely cause of graft failure experienced by the research subjects prior to defendant enrolling the plaintiffs' decedents in Protocol 126. None of the individually named defendants did anything to halt or terminate the defendant Center's continued enrollment of human subjects in Protocol 126 during the time that plaintiff's decedents were enrolled by defendant in Protocol 126. Nor did any of the individually named defendants do anything to prevent the defendant Center from enrolling the plaintiffs' decedents in Protocol 126 or to prevent the injury and/or damages sustained by the decedents as a result of their participation in Protocol 126.

23. Each of the decedents died after participating in Protocol 126 and receiving a T-cell depleted marrow transplant administered by the defendant Center.

24. Each of the decedents suffered personal injury and death as a direct and proximate result of defendants' acts and omissions related to Protocol 126 and plaintiffs' decedents participation in Protocol 126. In addition, the plaintiffs suffered damages as a direct and proximate result of the defendants' actions for which an award of damages is appropriate.

25. The plaintiffs seek damages as a result of injuries they or their heirs have sustained as a result of the defendants' conduct. In addition, plaintiffs have suffered a loss of consortium, love, services, and affection, and has incurred financial expenses and economic losses as a direct and proximate result of the personal injuries and damages suffered by their spouses or significant others who participated in Protocol 126.

26. In December of 1980, defendants Hansen, Thomas and Martin submitted Protocol 126 to the Human Subjects Review Committee ("HSRC") of the Fred Hutchinson Cancer Research Center (the "Center").

27. Defendants knew or should have known that the risks posed by Protocol 126 were greater than the benefits anticipated.

28. Defendants Hansen, Thomas, and Martin and the Center had financial stakes in Genetic Systems, Inc., which licensed the antibodies used in Protocol 126.

29. In April of 1981, Protocol 126 was approved by the HSRC and defendants began to enroll research subjects, including the plaintiffs' decedents.

30. The HSRC was not fully informed of the risks, benefits, results, and financial conflicts of interest in Protocol 126.

PAUL MAHLER

31. In 1984, Paul Mahler went to the Fred Hutchinson Cancer Research Center for treatment of his leukemia.

32. Defendants enrolled Paul Mahler on Protocol 126 without his informed consent.

33. Defendants failed to properly inform Paul Mahler of Protocol 126's risks, benefits, purposes, procedures, and alternatives. Defendants failed to properly inform Mahler of the prior results of Protocol 126 clinical trials and/or other prior cancer research involving T-cell depleted marrow transplantation. Defendants failed to inform Mahler of their personal, proprietary or financial interest in conducting Protocol 126 and/or in seeking to enroll Mahler in the protocol as a human subject. None of the defendants disclosed to Mahler that their personal, proprietary or financial interest in the success of Protocol 126 as a scientific or experimental research project might conflict with Mahler's interest in obtaining the most beneficial or superior therapy or treatment for his disease.

34. Within weeks after receiving a bone marrow transplant under Protocol 126 and as a direct result of his participation in Protocol 126, Paul Mahler suffered a relapse of his cancer.

35. Seven months after the first transplant, Paul Mahler received a second bone marrow transplant from the defendants.

36. Due to this second transplant, Paul Mahler developed Graft versus Host Disease and died of graft failure.

NORMAN CARRICO

37. In 1984, Norman Carrico went to the Fred Hutchinson Cancer Research Center to receive treatment for his leukemia.

38. Defendants enrolled Norman Carrico in Protocol 126 without his informed consent.

39. Defendants failed to properly inform Norman Carrico of Protocol 126's risks, benefits, purposes, procedures, and alternatives. Defendants failed to properly inform Carrico of the prior results of Protocol 126 clinical trials and/or other prior cancer research involving T-cell depleted marrow transplantation. Defendants failed to inform Carrico of their personal, proprietary or financial interest in conducting Protocol 126 and/or in seeking to enroll Carrico in the protocol as a human subject. None of the defendants disclosed to Carrico that their personal, proprietary or financial interest in the success of Protocol 126 as a scientific or experimental research project might conflict with Carrico's interest in obtaining the most beneficial or superior therapy or treatment for his disease.

40. Within weeks after receiving a bone marrow transplant under Protocol 126, Norman Carrico relapsed and eventually died, a direct result of the treatment he received from the defendants.

MOHAN SARMA

41. In 1985, Mohan Sarma went to the Fred Hutchinson Cancer Research Center to receive treatment for his leukemia.

42. Defendants enrolled Mohan Sarma in Protocol 126 without his informed consent.

43. Defendants failed to properly inform Mohan Sarma of Protocol 126's risks, benefits, purposes, procedures, and alternatives. Defendants failed to properly inform Sarma of the prior results of Protocol 126 clinical trials and/or other prior cancer research involving T-cell depleted marrow transplantation. Defendants failed to inform Sarma of their personal, proprietary or financial interest in conducting Protocol 126 and/or in seeking to enroll Sarma in the protocol as a human subject. None of the defendants disclosed to Sarma that their personal, proprietary or financial interest in the success of Protocol 126 as a scientific or experimental research project might conflict with Sarma interest in obtaining the most beneficial or superior therapy or treatment for his disease.

44. After receiving a bone marrow transplant under protocol 126, Mohan Sarma relapsed, a direct result of the treatment he received from the defendants.

DAVID YINGLING

45. In 1983, David Yingling went to the Fred Hutchinson Cancer Research Center to receive treatment for his leukemia.

46. Defendants enrolled David Yingling in Protocol 126 without his informed consent.

47. Defendants failed to properly inform David Yingling of Protocol 126's risks, benefits, purposes, procedures, and alternatives. Defendants failed to properly inform Yingling of the prior results of Protocol 126 clinical trials and/or other prior cancer research involving T-cell depleted marrow transplantation. Defendants failed to inform Yingling of their personal, proprietary or financial interest in conducting Protocol 126 and/or in seeking to enroll Yingling in the protocol as a human subject. None of the defendants disclosed to Yingling that their personal, proprietary or financial interest in the success of Protocol 126 as a scientific or experimental research project might conflict with Yingling's interest in obtaining the most beneficial or superior therapy or treatment for his disease.

48. Less than fifteen days after receiving a bone marrow transplant under Protocol 126, David Yingling developed graft failure and died, a direct result of the treatment he received from the defendants.

LYNNE RUSSELL

49. In 1984, Lynne Russell went to the Fred Hutchinson Cancer Research Center to receive treatment for her leukemia.

50. Defendants enrolled Lynne Russell in Protocol 126 without her informed consent.

51. Defendants failed to properly inform Lynne Russell of Protocol 126's risks, benefits, purposes, procedures, and alternatives. Defendants failed to properly inform Russell of the prior results of Protocol 126 clinical trials and/or other prior cancer research involving T-cell depleted marrow transplantation. Defendants failed to inform Russell of their personal, proprietary or financial interest in conducting Protocol 126 and/or in seeking to enroll Russell in the protocol as a human subject. None of the defendants disclosed to Russell that their personal, proprietary or financial interest in the success of Protocol 126 as a scientific or experimental research project might conflict with Russell's interest in obtaining the most beneficial or superior therapy or treatment for his disease.

52. After receiving a bone marrow transplant under Protocol 126, Lynne Russell relapsed and died, a direct result of the treatment she received from the defendants.

GEORGE FENDER

53. In 1984, George Fender went to the Fred Hutchinson Cancer Research Center to receive treatment for his leukemia.

54. Defendants enrolled George Fender in Protocol 126 without his informed consent.

55. Defendants failed to properly inform George Fender of Protocol 126's risks, benefits, purposes, procedures, and alternatives. Defendants failed to properly inform Fender of the prior results of Protocol 126 clinical trials and/or other prior cancer research involving T-cell depleted marrow transplantation. Defendants failed to inform Fender of their personal, proprietary or financial interest in conducting Protocol 126 and/or in seeking to enroll Fender in the protocol as a human subject. None of the defendants disclosed to Fender that their personal, proprietary or financial interest in the success of Protocol 126 as a scientific or experimental research project might conflict with Fender's interest in obtaining the most beneficial or superior therapy or treatment for his disease.

56. After receiving a bone marrow transplant under Protocol 126, George Fender relapsed and developed GVHD, a direct result of the treatment he received from the defendants.

CAROLYN OBERMEYER

57. In March 1984, Carolyn Obermeyer went to the Fred Hutchinson Cancer Research Center to Receive treatment for her leukemia.

58. Defendants enrolled Carolyn Obermeyer in Protocol 126 without her informed consent.

59. Defendants failed to properly inform Carolyn Obermeyer of Protocol 126's risks, benefits, purposes, procedures, and alternatives. Defendants failed to properly inform Obermeyer of the prior results of Protocol 126 clinical trials and/or other prior cancer research involving T-cell depleted marrow transplantation. Defendants failed to inform Obermeyer of their personal, proprietary or financial interest in conducting Protocol 126 and/or in seeking to enroll Obermeyer in the Protocol as a human subject. None of the defendants disclosed to Obermeyer that their personal, proprietary or financial interest in the success of Protocol 126 as a scientific or experimental research project might conflict with Obermeyer's interest in obtaining the most beneficial or superior therapy or treatment for her disease.

60. After receiving a bone marrow transplant under Protocol 126, Carolyn Obermeyer relapsed, required a second bone marrow transplant and died, a direct result of the treatment she received from the defendants.

IV. FIRST CAUSE OF ACTION
ASSAULT, BATTERY, AND VIOLATION OF
HEALTH CARE PROVIDER ACT

61. Plaintiffs incorporate by reference all other paragraphs of this complaint as if fully set forth herein.

62. Defendants, and each of them respectively, failed to obtain the Plaintiffs' decedents' informed consent to their treatment in Protocol 126 in violation of the Washington Health Care Provider Act, RCW 7.70.030(3); thus, the treatment the Plaintiffs' decedents received constituted a battery.

63. Defendants, and each of them, through their negligent and wrongful conduct, as described herein, and through their assurances and promises of treatment under Protocol 126 violated the Washington Health Care Provider Act, RCW 7.70.030(1) and (2).

V. SECOND CAUSE OF ACTION
STRICT PRODUCTS LIABILITY

64. Plaintiffs incorporate by reference all other paragraphs of this complaint as if fully set forth herein.

65. Defendants designed, manufactured and supplied the biologics, which caused great physical and emotional damage to the Plaintiffs' decedents.

66. Defendants breached their duties and obligations to the Plaintiffs' decedents by various sections of the Revised Code of Washington, Section 7.72 and Restatement of Torts, 2d, including Section 402(a) and are liable for causing injuries to the Plaintiffs' decedents.

67. By conducting themselves as aforesaid, defendants increased the risk of harm, thereby causing the death of the plaintiffs' decedents.

VI. THIRD CAUSE OF ACTION
VIOLATION OF CONSUMER PROTECTION ACT

68. Plaintiffs incorporate by reference the above stated paragraphs as if fully set forth at length herein.

69. Defendants' wrongful conduct in advertising and marketing Protocol 126, in pre-enrolling the plaintiffs' decedents in Protocol 126 without their knowledge, and in failing to disclose their personal, proprietary, financial and business interests in the sale and marketing of the Protocol to patients, including the plaintiffs' decedents, constitutes false, deceptive and/or unfair conduct in violation of the Washington Consumer Protection Act, RCW 19.86 et seq.

70. Defendants' wrongful conduct in violation of the Washington Consumer Protection Act caused economic injury to the plaintiffs.

VII. FOURTH CAUSE OF ACTION
INFLICTION OF EMOTIONAL DISTRESS

71. Plaintiffs incorporate by reference all other paragraphs of this complaint as if fully set forth herein.

72. Defendants' wrongful conduct in subjecting the plaintiffs and their decedents to the treatment regime in Protocol 126 was outrageous and unconscionable and constitutes negligent and/or intentional infliction of emotional distress.

73. As a result of defendants' conduct, plaintiffs and their decedents suffered damages.

VIII. DAMAGES

74. Plaintiffs incorporate by reference all other paragraphs of this complaint as if fully set forth herein.

75. As a direct and proximate result of defendants' acts, omissions and conduct as set forth above, the plaintiffs and their decedents have suffered personal injury, wrongful death, pain and suffering, loss of consortium and/or economic loss. Plaintiffs, on behalf of themselves and in their representative capacities, request an award of damages to fully compensate them for the injuries sustained.

IX. PRAYER FOR RELIEF

WHEREFORE , Plaintiffs pray for relief as follows:

1. That plaintiffs be awarded their above claimed damages;

2. That plaintiffs be awarded their actual and reasonable attorneys' fees, expenses and costs of this action, as provided by applicable law;

3. That plaintiffs be awarded interest on their damages; and

4. That plaintiffs be awarded any other relief in law or equity to which the plaintiffs are entitled.


DATED: May ___, 2002.

SHORT CRESSMAN & BURGESS, P.L.L.C.

__________________________
David E. Breskin, WSBA #10607
Daniel F. Johnson, WSBA #27848
Attorneys for Plaintiffs