KITSAP
COUNTY SUPERIOR COURT IN AND FOR THE STATE OF WASHINGTON
WILLIAM
LEE WRIGHT, Sr., individually and:
as
Personal Representative of the Estate of Becky:
Wright;
PEGGY DRAHEIM, individually and :
as
Personal Representative of the Estate of
:
Dr. John
Draheim; and all others similarly :
situated, :
:
Plaintiff, :
: CAUSE NO.: 01-2-008376
vs. :
THE FRED
HUTCHINSON CANCER : FIRST AMENDED
RESEARCH
CENTER; DR. E. DONNALL : COMPLAINT FOR
THOMAS and
JANE DOE THOMAS, and :
DAMAGES AND
the
marital community comprised thereof; : CLASS ACTION
DR. JOHN
A. HANSEN and JANE DOE :
HANSEN,
and the marital community comprised:
thereof;
DR. PAUL J. MARTIN and JANE :
DOE MARTIN
and the marital community :
comprised
thereof; DR. ROBERT DAY and :
JANE DOE
DAY, and the marital community :
comprised
thereof; and GENETIC SYSTEMS :
CORPORATION
and its PRESENTLY :
UNKNOWN
SUCCESSOR CORPORATION, :
:
Defendants. :
:
I. INTRODUCTION
1.
Plaintiffs bring this action pursuant to Rule 23 of the
Washington Rules of Civil Procedure on their own behalf and as representatives
of a class of persons consisting of:
All persons who participated in Protocol 126 at the Fred Hutchinson
Cancer Research Center between 1981 and 1993, (a "Study Participant") or their
estates, administrators or other legal representatives, heirs or beneficiaries
("Representative Claimants"), and any other persons asserting the right to sue
the defendants herein independently or derivatively by reason of their personal
relationship with a Study Participant, including without limitation, spouses,
parents, children, dependents, other relatives or "significant others" ("Derivative
Claimants").
2.
Plaintiffs bring this action individually and as class
representative to recover damages,
against the defendants identified below who created, took part in and
formulated Protocol 126.
II. PARTIES AND VENUE
3.
Plaintiff William Lee Wright, Sr., is a resident and citizen
of the State of Alabama residing at 960
Ross St., Heflin, Alabama, 36364.
4.
Plaintiff William Lee Wright, Sr. was the husband of
plaintiff's decedent Becky Wright.
5.
Plaintiff William Lee Wright, Sr. was duly appointed Administrator
of the Estate of Becky Wright.
6.
Plaintiff Peggy Draheim, is a resident and citizen of the
State of Arizona residing in
Scottsdale.
7.
Plaintiff Peggy Draheim was the wife of plaintiff's decedent
Dr. John Draheim.
8.
Plaintiff Peggy Draheim was duly appointed Administrator of
the Estate of Dr. John Draheim.
9.
The plaintiff Class consists of :
All
persons who participated in Protocol 126 at the Fred Hutchinson Cancer Research
Center between 1981 and 1993 ("Research Subjects"), or their estates,
administrators or other legal representatives, heirs or beneficiaries ("Representative
Claimants"), and any other persons asserting the right to sue the Defendants
independently or derivatively by reason of their personal relationship with a
Research Subject, including without limitation, spouses, parents, children,
dependents, other relatives or "significant others" ("Derivative Claimants").
On
information and belief, a substantial number of the putative members of the
Class were residents of the State of Washington at the time they received
services from the defendants and/or their estates were estates filed in
Washington. On information and belief,
one of the said putative members of the Class is the estate of Dr. John Draheim. Dr. Draheim was a
resident of Bremerton, Kitsap County, Washington during the relevant time
period. Venue is proper, therefore, in
Kitsap County Superior Court.
10.
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.
11.
Defendant Dr. E. Donnall Thomas is the co-founder and
clinical director of the Center and and
is a citizen of the United States and the State of Washington.
12.
Defendant Dr. John A. Hansen at all times relevant hereto
was the head of a tissue-typing lab and later clinical director at the Center
and is a citizen of the United States
and the State of Washington.
13.
Defendant Dr. Paul J. Martin at all times relevant hereto
was an oncologist employed by the Center and
and is a citizen of the United States and the State of Washington.
14.
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.
15.
Defendant Genetic Systems is a corporation incorporated on
Nov. 13, 1980, whose successor entity is presently unknown but believed to be a
corporation.
CLASS
ACTION ALLEGATIONS
16.
Plaintiffs bring this action, pursuant to Rule 23 of the
Washington Rules of Civil Procedure, on their own behalf and as representatives
of the following class of individuals:
All
persons who participated in Protocol 126 at the Fred Hutchinson Cancer Research
Center between 1981 and 1993 ("Research Subjects"), or their estates,
administrators or other legal representatives, heirs or beneficiaries ("Representative
Claimants"), and any other persons asserting the right to sue the Defendants
independently or derivatively by reason of their personal relationship with a
Research Subject, including without limitation, spouses, parents, children,
dependents, other relatives or "significant others" ("Derivative Claimants").
17.
Plaintiffs and the Class bring this action for damages
pursuant to Rule 23 of the Washington
Rules of Civil Procedure.
18.
Research Subjects have suffered personal injury and death as
a direct and proximate result of defendants' actions herein. In addition, the Derivative Claimants have
suffered damages as a direct and proximate result of the defendants' actions
for which an award of damages is appropriate.
19.
The named plaintiffs herein are members of the Class they
seek to represent.
20.
The Class includes approximately 82 individuals, and
therefore the members of the Class are so numerous that joinder is
impracticable.
21.
There are questions of law and fact common to the class
including, but not limited to:
1.
whether defendants failed to follow and abide by the
Nuremberg Code, the Belmont Report, the Declaration of Helsinki and 45 CFR '
46;
2.
whether defendants
knew of prior adverse reactions to the drugs used in Protocol 126 and failed to
inform the Research Subjects of these adverse reactions;
3.
whether the defendants failed to adequately and properly
test the drug after its design and manufacture;
4.
whether the defendants failed to investigate and analyze
prior adverse reactions information in order to warn and/or notify Research
Subjects of the dangers of participating in the program;
5.
whether defendants committed common law fraud in
intentionally misrepresenting the risks of participating in the Trial, the
nature, scope and legitimacy of the Trial, and the reason for terminating the
Trial;
6.
whether defendants' misrepresentations set forth above were
done with the knowledge that they were false when made;
7.
whether, by their actions, defendants increased the risk of
harm, thereby causing the injuries and/or death of the plaintiff and other
members of the class;
8.
whether defendants conducted adequate study, testing and
analysis to determine whether Protocol 126 was harmful to Research Subjects;
9.
whether defendants engaged in unconscionable, deceptive
and/or unreasonable business practices and conduct;
10.
whether defendants knowingly, or intentionally concealed,
suppressed or omitted material information intended to be relied upon by others
in connection with Protocol 126;
11.
whether the class has been injured by virtue of defendants
intentional, reckless, careless and/or unconscionable
and/or deceptive business practices and conduct;
12.
whether defendants falsely and fraudulently misrepresented
in its advertisements, promotional materials and other materials the safety and
adverse results of participating in Protocol 126;
13.
whether defendants knew or should have known that
participating in Protocol 126 posed a substantial increased risk of serious
adverse health effects including but not limited to death;
14.
whether defendants continued to recruit individuals to
participate in Protocol 126 notwithstanding their knowledge of the dangerous
nature of the Protocol;
15.
whether defendants earned substantial profits as a result of
their conduct herein;
16.
whether defendants knowingly omitted, suppressed or
concealed material facts about the unsafe and dangerous nature of Protocol 126
from government regulators, the Institutional Review Board, the medical
community and/or the consuming public;
17.
whether defendants wrongful conduct as described above
violated the provisions of the Washington Health Care Provider Act, RCW
7.70.030, subpart (1),(2) and (3); and,
18.
whether defendants wrongful advertising, marketing and/or
other business conduct constitute false, deceptive and/or unfair business
practices in violation of the Washington Consumer Protection Act, RCW 19.86 et
seq.
22.
These and other questions of law and/or fact are common to
the class and predominate over any
questions affecting only individual class members.
23.
The claims of the named plaintiffs are typical of the claims
of the class they seek to represent, in that the named plaintiffs and all
members of the proposed class participated in Protocol 126 and assert rights
and claims as a "Derivative Claimant" or "Representative Claimant" as these
terms are defined in the proposed class definitions.
24.
The proposed class seeks damages as a result of injuries
they or their heirs have sustained as a result of defendants' conduct. In addition, the Derivative Claimants have
suffered a loss of consortium, love, services, and affection, and have 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 were Research Participants. Thus,
the pursuit of damages by the class representative for their injuries and
losses will work to benefit the entire proposed class they seek to represent.
25.
Plaintiffs will fairly and adequately represent and protect
the interests of the members of the class they represent. The named plaintiffs
have retained counsel competent and experienced in complex class actions and
litigation involving clinical research to represent them and the members of the
class. Accordingly, the interests of
the class will be adequately protected and advanced. In addition, there is no conflict of interest between the named
plaintiffs and the members of the class.
The interests of the named plaintiffs are aligned because the members
of the class have an interest in
securing their right to compensatory damages as a consequence of any injuries
caused by defendants' conduct.
26.
Notice can be provided to class members by a combination of
published notice and first class mail since defendants are in possession of the
addresses of those individuals who participated in the Protocol 126.
27.
Certification of the class is appropriate because the questions of law and fact common
to the members of the class predominate over any questions affecting only
individual members. This class action
is superior to other available remedies for the fair and efficient adjudication
of this controversy.
FACTUAL
BACKGROUND
The
Protocol
28.
In November of 1980, defendant Genetic Systems Corporation
was formed by Mr. David Blech.
29.
The purpose of Genetic Systems was to recruit physicians who
treat cancer patients in exchange for a position on the board of Genetic
Systems and stock in the company.
30.
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").
31.
The purported goal of Protocol 126 was to prevent an
immune-system reaction known as graft-versus-host disease ("GVHD") which occurs
in approximately 50% of recipients of bone marrow transplants from
tissue-matched siblings.
32.
In approximately 95% of the patients, GVHD is not fatal.
33.
In January of 1981, one month after submitting Protocol 126
to the HSRC, defendant Genetic Systems gave to defendant Hansen 250,000 shares
of its stock and an $18,000 consulting fee.
34.
In January of 1981, Genetic Systems gave to defendant
Thomas, 100,000 shares and a $3,000 a year board position.
35.
In January of 1981, Genetic Systems gave to defendant Martin
10,000 shares of Genetic Systems stock.
36.
In January of 1981, the HSRC rejected Protocol 126 stating
that it may cause graft rejections and cancer relapses.
37.
In March of 1981, Genetic Systems signed a 20 year deal with
the Center for commercial rights to 37 substances, including three to be tested
in Protocol 126. In exchange for this
agreement, the Center received money and a royalty agreement while an affiliated
foundation received stock in Genetic Systems.
38.
In April of 1981, defendant Hansen resubmitted Protocol 126
which was approved by the HSRC.
39.
At no time was the HSRC told that defendants Hansen, Thomas,
Martin or the Center had a financial interest in Genetic Systems.
40.
At no time was the HSRC told that defendants Hansen, Thomas,
Martin or the Center had a direct financial interest in the outcome of Protocol
126.
41.
The informed consent form that the participants signed
minimized the risk of graft failure and made it sound as if a second bone
marrow transplant could be done without difficulty if the first one failed.
42.
The defendants knew that the salvage rate from second bone
marrow transplants was between 5 percent and 10 percent.
43.
In December of 1981, defendant Martin sought and obtained
approval of a revised Protocol 126 by adding agents that greatly increased the
killing power of the monoclonal antibodies used in the experiment.
44.
In March of 1983, the Center adopted a new conflict of
interest policy whereby scientists were prohibited from participating in any
research involving the Center in which the member had a financial interest.
45.
Despite this revised policy, defendants Hansen, Thomas and
Martin continued to participate in Protocol 126.
46.
In April of 1983, the interests of the individual defendants
in Genetic Systems was as follows: Thomas - $916,000; Hansen - $2,000,000;
Martin - $91,000; and the Foundation - $458,000.
47.
In April of 1983, the HSRC sought certain stopping criteria
if individuals died in the trial as well as a change in the consent form
warning of unexpected new cancers.
48.
Despite this new stopping criteria and despite the fact that
numerous patients had died while participating in Protocol 126, defendants
never reported the deaths to the HSRC.
49.
In the spring of 1983, the trial was again approved but the
consent form failed to disclose the risks of new cancers, relapse and graft
failure.
50.
During this month, defendant Hansen was named vice president
for research of Genetic Systems.
51.
In September of 1983, the HSRC was renamed the Institutional
Review Board ("IRB").
52.
In September of 1983, the IRB asked for clarification on the
animal tests, human risks and financial interests involved in Protocol 126.
53.
In response to this request, defendant Thomas denied any
conflict of interest, refused the IRB's request for separate tests on antibodies
and warned the IRB not to impede research.
54.
In January of 1984, defendant Hansen began a one year leave
from the Center to be medical director for Genetic Systems.
55.
Over the next several years, despite concerns over the
financial interests of the researchers and Protocol 126 in general, the Center
allowed Protocol 126 to continue.
56.
In March of 1984, defendant Martin failed to notify IRB or
medical examiner of treatment-caused deaths as required by law.
57.
In May of 1984, Nancy Haldeman left the IRB administrator
stating the Center did not want independent oversight.
58.
Additionally, the IRB approved the next phase of trial but
suggested that it should go through outside review.
59.
Thereafter, defendant Day refused outside review of Protocol
126.
60.
In January of 1985, the IRB approved Protocol 126.2 for
three months, excluding good-prognosis patients. The consent form still failed
to mention the known risks of participating in Protocol 126.
61.
In April of 1985, defendants Martin, Hansen and Thomas
applied for Protocol 126.3, combining T-cell depletion with other chemicals.
The IRB again asked for outside review.
62.
In October of 1985, Genetic Systems was bought out by
Bristol-Myers for $294 million, or $10.50 per share, making the original
interest of Defendant Thomas worth $1.05 million, the foundation $502,000, and
defendant Martin $105,000. Defendant, Hansen, who had sold some shares, held
stock worth $1.8 million.
63.
Prior to September
of 1985, defendant Martin told his colleagues that Protocol 126 had prevented
GVHD but caused between 35 percent and 40 percent graft failures vs. an
expected 1 percent.
64.
In April of 1988, defendant Martin presented a paper saying
T-cell depletion in certain leukemia patients led to 100 percent relapse rate
vs. expected 25 percent.
65.
In 1991, ten years after the start of Protocol 126,
defendant Martin proposed Protocol 126.7.
66.
The consent form for Protocol 126.7 finally stated:
"There is a chance that the donor marrow will fail to produce new blood
cells because of rejection or other problems. In this situation, there is a
high chance of infections, bleeding and death."
67.
Presently, the value of defendant Thomas' original stock is
about $5 million, the foundation's $2.5 million, defendant Martin's $525,000
and defendant Hansen's shares are worth $9 million.
68.
Eighty of eighty-two
patients are dead from graft failures and/or leukemic relapse
attributable to the treatment.
69.
In 1984, Dr. John
Draheim, then a resident of Bremerton, Washington came to the Fred Hutchinson
Center for chemotherapy, radiation and bone marrow transplants. His bone marrow transplant failed to engraft
and as a result he died. Based upon
information and belief, Dr. Draheim was
subjected to treatment by Fred Hutchinson Center under Protocol 126 without
adequate informed consent of the risks of the Protocol and other available
Protocols as required by Washington law. Fred Hutchinson Center concealed from
Dr. Draheim material facts relating to
the treatment and the Protocol.
70.
In 1985, plaintiff's decedent Becky Wright went to the Fred
Hutchinson Cancer Research Center to undergo a bone marrow transplant.
71.
Within weeks after receiving this transplant, Becky Wright
was dead, a direct result of the treatment she received from the defendants.
72.
At no time prior to her participation in Protocol 126 was
Becky Wright informed of the true nature of risks she was encountering by
taking part in Protocol 126.
73.
At no time prior to her participation in Protocol 126 was
Becky Wright informed that the individual defendants had a direct financial
interest in the Protocol.
74.
At no time prior to her participation in Protocol 126 was
Becky Wright informed that the salvage rate of second transplants was
approximately five-ten percent.
75.
At no time prior to her participation in Protocol 126 was
Becky Wright informed that two of the first nine patients using one of the
antibodies in Protocol 126 suffered new cancers and died.
76.
At no time prior to her participation in Protocol 126 was
Becky Wright informed that the procedure increased the chances of a relapse
because GVHD has an antileukemic effect.
77.
At no time prior to her participation in Protocol 126 was
Becky Wright informed that while GVHD was treatable, if it happened, leukemia
relapses were usually fatal.
78.
At no time prior to her participation in Protocol 126 was
Becky Wright informed that there were alternative methods for treating GVHD if
it occurred.
FIRST
CAUSE OF ACTION
BREACH OF
THE RIGHT TO BE TREATED WITH DIGNITY
79.
Plaintiffs incorporate by reference all other paragraphs of
this complaint as if fully set forth herein and further alleges as follows on
behalf of themselves and all others similarly situated.
80.
The Nuremberg Code and the Declaration of Helsinki are the
minimum United States and international standards of conduct governing
biomedical research on human subjects; they are in essence world statutes to
which the citizens of all nations are subject.
81.
The Nuremberg Code, drafted in response to the horrors of
Nazi experimentation on human subjects, set forth basic principals Ato satisfy
moral ethical and legal concepts.
82.
The Nuremberg Code provides in pertinent part:
The
voluntary consent of the human subject is absolutely essential. . . . . .
before the acceptance of an affirmative decision by the experimental subject
there should be made known to him the nature, duration, and purpose of the
experiment; the method and means by which it is to be conducted; all
inconveniences and hazards reasonably to be expected; and the effects upon his
health or person which may possibly come from his participation in the
experiment.
.
. .
The
experiment should be designed and based on the results of animal
experimentation and a knowledge of the natural history of the disease or other
problem understudy that the anticipated results will justify the performance of
the experiment.
.
. .
The degree
of risk to be taken should never exceed that determined by the humanitarian
importance of the problem to be solved by the experiment.
.
. .
Proper
preparations should be made and adequate facilities provided to protect the
experimental subject against even remote possibilities of injury, disability,
or death.
.
. .
The
experiment should be conducted only by scientifically qualified persons.
83.
The World Health Organization established the Declaration of
Helsinki to further the goals of the Nuremberg Code and to set the minimum
acceptable standards in all nations in which human clinical trials are
conducted. These include:
Biomedical
research involving human subjects must conform to generally accepted scientific
principles and should be based on adequately performed laboratory and animal
experimentation and on a thorough knowledge of the scientific literature.
.
. .
The design
and performance of each experimental procedure involving human subjects should
be clearly formulated in an experimental protocol which should be transmitted
to a specially appointed independent committee for consideration, comment and
guidance.
.
. .
Biomedical
research involving human subjects should be conducted only by scientifically
qualified persons and under the supervision of a clinically competent medical
person..
.
. .
Biomedical
research involving human subjects cannot legitimately be carried out unless the
importance of the objectives is in proportion to the inherent risk to the
subject.
.
. .
Concern
for the interests of the subject must always prevail over the interest of
science and society.
.
. .
The right
of the research subject to safeguard his or her integrity must always be
respected.
.
. .
Doctors
should abstain from engaging in research projects involving human subjects
unless they are satisfied that the hazzards involved are believed to be
predictable.
.
. .
In any
research on human beings, each potential subject must be adequately informed of
the aims, methods, anticipated benefits and potential hazards of the study and
the discomfort it may entail.
84.
The common law has recognized such standards as a source of
the right of every human subject to be treated with dignity in the conduct of a
clinical trial; such a right is a right of all citizens of the United States
under the Constitutions of the United States and the State of Washington.
85.
Defendants' actions, as set forth above, fell below the
minimum standards of conduct set forth under the Nuremberg Code and the
Declaration of Helsinki and were a breach of the right of plaintiffs and the
members of the class to be treated with dignity.
86.
As a result of defendants' actions, plaintiffs and the
members of the class have suffered damages.
SECOND
CAUSE OF ACTION
