As applies to this Motion, the Hutchinson Center is a medical facility that
conducts medical therapy and research for cancer patients. Defendant Dr. E.
Donnall Thomas is the co-founder and clinical director; defendant Dr. John
A. Hansen at all times relevant was the head of a tissue-typing lab and later
clinical director; defendant Dr. Paul J. Martin at all times relevant was
a staff oncologist; and defendant Dr. Robert Day at all times relevant was
the Director. In November 1980, Genetic Systems Corporation ("Genetic
Systems") was formed by David Blech. Genetic Systems recruited physicians
who treat cancer patients in exchange for a position on the board of Genetic
Systems and stock in the company.
In December 1980, defendants Hansen, Thomas and Martin submitted Protocol
126 to the Institutional Review Board ("IRB"). 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. In January 1981,
one month after defendants Hansen, Thomas and Martin submitted Protocol 126
to the IRB, Genetic Systems provided defendant Hansen 250,000 shares of its
stock and an $18,000 consulting fee, defendant Thomas, 100,000 shares of stock
and a $3,000 a year board position, and provided defendant Martin 10,000 shares
of Genetic Systems stock.
Under Protocol 126, defendants proposed to use "monoclonal antibodies"
to remove the "T-cells" from the donor's bone marrow prior to transplantation,
on the assumption that these cells contributed to a complication known as
"graft-versus-host disease," or GVHD. Defendants knew, however,
that T-cells were necessary to engraftment of the donor's marrow. See deposition
transcript of Paul Martin, attached as Exhibit "A." T-cell depletion
in bone marrow transplants actually increased the risk of graft failure or
graft rejection. Defendants at all times understood that the experiment needed
to be designed in accordance with the ethical standards governing human research
and that, among other things, this involved weighing the risks to the subjects
against the potential benefits.
In January 1981, the Institution Review Board ("IRB") at the Hutchinson
Center rejected Protocol 126 because the increased risk of graft failure and
cancer relapses did not outweigh the potential benefit of decreasing the incidence
of GVHD. While this calculus never changed, and indeed was ultimately affirmed
numerous times over the course of the next decade, defendants proceeded to
conduct this experiment on unwitting subjects who came to the Hutchinson Center
for one reason and one reason alone: to get well. In March 1981, Genetic Systems
signed a 20 year deal with Hutchinson Center for commercial rights to 37 substances,
including three to be tested in Protocol 126. In exchange for this agreement,
Hutchinson Center received money and a royalty agreement while an affiliated
foundation received stock in Genetic Systems. In April 1981, defendant Hansen
resubmitted Protocol 126, which was approved. 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.
The informed consent form that the participants signed prior to formal participation
in Protocol 126 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. The defendants knew, but did not advise the participants, that
the salvage rate from second bone marrow transplants was between 5 percent
and 10 percent. In addition, the informed consent form did not disclose that
the Hutchinson defendants possessed a direct financial interest in Protocol
126.
In March 1983, the Hutchinson Center adopted a new conflict of interest policy
whereby scientists were prohibited from participating in any research involving
the Hutchinson Center in which the member had a financial interest. Despite
this revised policy, defendants Hansen, Thomas and Martin continued to participate
in Protocol 126. In April 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 Hutchinson Center - $458,000.
In April 1983, the IRB imposed a two death by graft rejection stopping criteria
for the experiment, understanding that a substantially increased risk of graft
failure, normally one percent, would outweigh any potential benefit to the
subject and render the experiment unethical. To get around this new stopping
criteria, however, defendants simply added successive decimal points each
time two graft failures would occur.
During the Spring of 1983, the IRB approved renewing the experiment though
the informed consent form failed to disclose the risks of new cancers, relapse
and graft failure. Nor did the informed consent form reveal that the Hutchinson
defendants had a direct financial interest in the outcome of Protocol 126.
In September 1983, the IRB asked for clarification on the animal tests, human
risks and financial interests involved in Protocol 126. 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. In May of 1984, Nancy Haldeman left the IRB administrator position
stating the Hutchinson Center did not want independent oversight.
In January 1984, defendant Hansen began a one year leave from the Hutchinson
Center to become medical director for Genetic Systems. Over the next several
years, despite concerns over the financial interests of the researchers and
Protocol 126 in general, the Hutchinson Center allowed Protocol 126 to continue.
Additionally, the IRB approved the next phase of the experiment but suggested
that it should go through outside review. Thereafter, defendant Day refused
outside review of Protocol 126. In March 1984, defendant Martin failed to
notify IRB or medical examiner of treatment-caused deaths as required by law.
In January 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 the experiment. In April 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.
In October 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, FHCRC $502,000, and defendant Martin $105,000. Defendant,
Hansen, who had sold some shares, held stock worth $1.8 million.
In April 1988, defendant Martin presented a paper saying T-cell depletion
in certain leukemia patients led to 100 percent relapse rate vs. expected
25 percent. This of course was never disclosed to the participants in Protocol
126. In 1991, ten years after the start of Protocol 126, defendant Martin
proposed Protocol 126.7. 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." 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.
Some eighty of eighty-five patients are dead from graft failures and/or leukemic
relapse attributable to the treatment.
The Hutchinson defendants now move to dismiss plaintiffs' causes of action
seeking damages for violations of the Constitutions of the United States,
21 C.F.R. § 210, 211/21 C.F.R. § 601, 610/45, and for failing to
follow the ethical principals in the Belmont Report and the requirements of
45 C.F.R. § 46. The entire motion rests on the contention that plaintiffs
have no right, under any circumstances, to sue under these authorities. The
defendants' motion should be denied.
III. LEGAL ARGUMENT
A. STANDARD OF REVIEW
Defendants move to dismiss Counts One through Four of the Second Amended Complaint
pursuant to Federal Rule of Civil Procedure 12(c). The parties agree that
the standard to be followed pursuant to Rule 12(c) is the same standard as
Rule 12(b)(6). In reviewing a Rule 12(b)(6) motion, a court accepts the allegations
in the complaint as true and views them in the light most favorable to the
non-moving party; a court, thus, does not weigh potential evidence. Regence
Blueshield v. Philip Morris, Inc., 40 F.Supp.2d 1179, 1181 (W.D. Wash. 1999).
To that end, a motion predicated on Rule 12(b)(6) shall not be granted unless
it "appears beyond doubt that the plaintiff can prove no set of facts
in support of his claim which would entitle him to relief." Levine v.
Diamanthuset, Inc., 950 F.2d 1478, 1482 (9th Cir, 1991) (citation omitted).
B. DEFENDANTS IMPROPERLY RELY UPON AN UNPUBLISHED OPINION
As an initial matter, plaintiffs submit that all references by defendants
to unpublished opinions, specifically Robertson v. McGee, No. 01-CV-60-C (N.D.
Okla. Jan. 28, 2002), a case also involving plaintiffs' counsel, Alan Milstein,
should be disregarded. Despite the clear rules of this Circuit, defendants
have boldly sought to rely upon a matter that is unpublished, out of jurisdiction,
and on appeal. Defendants have compounded this error by attaching the Robertson
case to their brief.
The Ninth Circuit has held that counsel may not rely upon unpublished decisions
for the precedential value that defendants seek to attach to the Robertson
decision. In Hart v. Massanari, 266 F.3d 1155 (9th Cir. 2001), the issue was
whether counsel should have been disciplined for violating Ninth Circuit Rule
36-3, which provides that "[u]npublished dispositions and orders of this
Court are not binding precedent . . . [and generally] may not be cited to
or by the courts of this circuit . . . "Id. at 1159. The respondent in
Hart raised the defense that the Circuit's rule was unconstitutional. The
Court went through a detailed analysis of the development and application
of establishing case precedent before holding that its rule prohibiting citation
to unpublished decisions did not violate the constitutional article governing
the judiciary. Id. at 1180.
In addition, the Court discussed why an opinion in one circuit is not binding
on other courts throughout the country:
[A]n opinion of our court is binding within our circuit, not elsewhere in
the country. The courts of appeals, and even the lower courts of other circuits,
may decline to follow the rule we announce-- and often do. This ability
to develop different interpretations of the law among the circuits is considered
a strength of our system. It allows experimentation with different approaches
to the same legal problem, so that when the Supreme Court eventually reviews
the issue it has the benefit of "percolation" within the lower
courts.Id. at 1172-73.
The Court also explained the meaning and value of a non-precedential opinion:
That a case is decided without a precedential opinion does not mean it is
not fully considered, or that the disposition does not reflect a reasoned
analysis of the issues presented. What it does mean is that the disposition
is not written in a way that will be fully intelligible to those unfamiliar
with the case, and the rule of law is not announced in a way that makes
it suitable for governing future cases . . . An unpublished disposition
is, more or less, a letter from the court to parties familiar with the facts,
announcing the results and the essential rationale of the court's decision.
Hart, supra, 266 F.3d at 1177-78. In addition, should a court permit these
non-precedential opinions to be cited, "zealous counsel would be tempted
to seize upon superficial similarities between their clients' cases and unpublished
dispositions." Id. at 1178.
Thus, the Robertson decision, a non-precedential opinion generated by a district
court in a different circuit, cited throughout defendants' brief and attached
to their motion package, must be disregarded. Had the Court in the Robertson
matter expected or wanted its opinion to be relied upon by others it would
have published it. It was in clear error for defendants' counsel to rely upon
and attach the Robertson decision.
C. THE RIGHTS TO BODILY INTEGRITY AND TO BE TREATED WITH DIGNITY ARE PROTECTED
WITHIN THE FOURTEENTH AMENDMENT TO THE UNTIED STATES CONSTITUTION
Defendants argue that plaintiffs' first cause of action, breach of the right
to bodily integrity and the right to be treated with dignity, should be dismissed
solely because "there is no private right of action under the Nuremberg
Code or the Declaration of Helsinki." This argument misses the point.
Plaintiffs do not claim a private right of action under either the Nuremberg
Code, which is a decision by three United States judges sitting as an international
tribunal, or the Helsinki Declaration, which is simply a recommended standard
of conduct adopted by the World Medical Association. Instead, plaintiffs claim
rights under the Fourteenth Amendment to the United States Constitution; plaintiffs
offer the Nuremberg Code and the Declaration of Helsinki merely as evidence
of this Nation's - and indeed the World's - recognition that such rights are
fundamental human rights essential to an ordered society. Both history and
an emerging body of law suggest that plaintiffs should succeed on these claims.
The constitutional right to bodily integrity is a long standing right. In
addition to seeking redress for the violation of the right to bodily integrity,
the plaintiffs seek recognition of a right that is equally important. What
is at stake in this litigation is whether individuals have a Constitutional
right to human dignity so as not to be the subjects of an unethical human
experiment. Such a right, reflected in the Nuremberg Code and in the federal
regulations known as the Common Rule, is a fundamental right of all citizens
of the world and, thus, must be a right of the citizens of the United States,
a Constitutional right.
The Fourteenth Amendment provides that no State shall "deprive any person
of life, liberty, or property, without due process of law." This clause
"guarantees more than fair process, and the 'liberty' it protects includes
more than the absence of physical restraint." Washington v. Glucksberg,
521 U.S. 702, 719 (1997). Rights are protected under the Due Process Clause
of the Fourteenth Amendment if they are "so rooted in the tradition and
conscience of our people as to be ranked as fundamental" or if such rights
reflect "basic values implicit in the concept of ordered liberty"
such that "neither liberty nor justice would exist if they were sacrificed."
See Moore v. City of East Cleveland Ohio, 431 U.S. 494, 503 (1977); Griswold
v. Connecticut, 381 U.S. 479, 500 (1965); Palko v. Connecticut, 302 U.S. 319,
325 (1937); Snyder v. Massachusetts, 291 U.S. 97, 105 (1934).
The right to bodily integrity has long been recognized as a fundamental right
protected by the Constitution. See Albright v. Oliver, 510 U.S. 266 (1994)
(due process accorded to matters involving marriage, family, procreation and
the right to bodily integrity); Planned Parenthood of Southeastern Pennsylvania
v. Casey, 505 U.S. 833 (1992), (Constitutional liberty interest includes right
to bodily integrity, a right to control one's person); Schmerber v. California,
384 U.S. 757 (1966) (integrity of an individual's person is cherished value
of our society); Union Pacific R. Co. v. Botsford, 141 U.S. 250 (1891) (no
right held more sacred or more carefully guarded than right of every individual
to be in possession and control of his own person, free from restraint or
interference of others). Courts have particularly recognized such Constitutional
autonomy rights in the medical context. See, e.g., Cruzan v. Director, Missouri
Department of Health, 497 U.S. 261 (1990) (Constitution grants competent person
right to refuse lifesaving hydration and nutrition); Roe v Wade, 410 U.S.
113 (1973) (women have Constitutional right to control decision on whether
to obtain an abortion); Griswold v. Connecticut, 381 U.S. 479 (1965) (restriction
on citizens from receiving contraceptives from their physician an unconstitutional
intrusion); Rochin v. California, 342 U.S. 165 (1952) (forcible stomach pumping
of accused violates due process and is conduct which: "shocks the conscience");
Skinner v. State of Oklahoma, 316 U.S. 535 (1942) (sterilization performed
without consent deprives individual of basic liberty). As Justice Cardoza
stated in Schloendorff v. The Society of New York Hospital, 211 N.Y. 125,
105 N.E. 92, 93 (1914), a case against a surgeon for performing an operation
without consent: "Every human being of adult years and sound mind has
a right to determine what shall be done with his own body." 211 N.Y.
at 129-130.
Thus, this Court should easily find that the right at issue here, the right
to be free from unethical human experimentation, is within the right to bodily
integrity. Such a right has similarly already been recognized under the Constitution
and defendants do not appear to dispute this. Accordingly, there can be no
dispute that plaintiff's federal constitutional claims remain before this
Court.
Defendants appear to object only to plaintiffs' claim that there exists an
independent right to human dignity. This is, and has already been considered,
a distinct fundamental right of all human beings. To best understand the nature
of this right, it is important to understand both the historical context in
which the Nuremberg Code arose and the post-Nuremberg controversies involving
human subject protection. That understanding is necessary because an examination
of "our Nation's history, legal traditions and practices" is critical
in determining the scope of the right to liberty under the Due Process Clause.
Washington v. Glucksberg, 521 U.S. 702 (1997); Collins v. Harker Heights,
503 U.S. 115, 125 (1992); Cruzan, supra, at 269-70; Moore, supra, at 503.
After the Nazi holocaust, a series of twelve unprecedented war crimes trials
took place at the Palace of Justice in Nuremberg, Germany. In the first trial,
later the subject of numerous books and movies, the allies designated four
judges from the United States, Great Britain, the Soviet Union, and France
to sit and render judgement under international law on the leaders of the
Third Reich. Thereafter, the United States proceeded with the other prosecutions
including with what became known as the "Doctors Trial," whose verdict
included what is now known as the "Nuremberg Code." See Jay Katz,
"The Nuremberg Code and the Nuremberg Trial," JAMA 1996; 276:1662-1666,
a copy of which is attached as Exhibit "I."
The Doctors Trial, captioned United States v. Karl Brandt et al., was conducted
by three United States judges. The trial began on December 9, 1946, under
the authority of the United States Military pursuant to United States rules
of procedure with United States lawyers as prosecutors. Karl Brandt, Hitler's
personal physician, and twenty two other medical doctors were charged with
war crimes, membership in criminal organizations, and crimes against humanity.
See "From the Indictment," United States Holocaust Memorial Museum
archives, reprinted at www.ushmm.org/research/doctors/persons.htm, a copy
of which is attached as Exhibit "J." The first two charges concerned
acts intended to aid the Third Reich's military aims; the third charged the
physicians with acts undertaken under the guise of human experimentation either
in the reckless pursuit of scientific knowledge or for sadistic torture. The
experiments included studies on the tolerance of human beings to adverse conditions
such as high altitudes, freezing temperatures and ingestion of sea water,
tests involving the inoculation of prisoners with infectious diseases, pathogens
and new vaccines, and gruesome physiological studies involving mutilations
and transplants. See "The Brutalities of Nazi Physicians," JAMA,
1946; 132: 714-715, Editorial, a copy of which is attached as Exhibit "K."
Telford Taylor's opening statement for the prosecution underscores the point
that the wrongs at issue in the Doctors Trial were breaches of the fundamental
rights of all human beings under American jurisprudential principles. Mr.
Taylor stated:
The charges against these defendants are brought in the name of the United
States of America. They are being tried by a court of American judges. The
responsibilities thus imposed upon the representatives of the United States,
prosecutors, and judges alike, are grave and unusual. . . The mere punishment
of the defendants, or even of thousands of others equally guilty, can never
redress the terrible injuries which the Nazis visited on these unfortunate
people. For them it is far more important that these incredible events be
established by clear and public proof so that no one can ever doubt that
they were fact and not fable; and that this Court as the agent of the United
States and as the voice of humanity, stamp these acts, and the ideas which
engendered them, as barbarous and criminal.
Trials of War Criminals Before the Nuremberg Military Tribunals Under Control
Council Law, Vol. I, No. 10, Washington D.C.: U.S. Government Printing Office;
1946-1949, reprinted at www.ushmm.org/research/doctors/telford.htm, a copy
of which is attached as Exhibit "L."
A principal defense, as articulated by Dr. Brandt's counsel, the eminent jurist
Robert Servatius of Cologne, was that the scientific and medical community
at large and particularly in the United States had long been conducting human
experiments on prisoners, vulnerable populations and uninformed subjects.
Sadly, this charge was quite accurate, though certainly never to the extreme
as practiced by the Nazis.
After 139 court sessions, 62 witnesses, and 901 written exhibits, Chief Judge
Walter B. Beals, who was the Chief Justice of the Supreme Court of the State
of Washington, announced the verdict of the court. Sixteen of the defendants
were convicted of war crimes against humanity and seven were condemned to
death. Though nothing else was required, the court did far more, perhaps because
of the troubling defense testimony with respect to unethical scientific and
medical experiments occurring outside of the Third Reich. The court held:
The great weight of the evidence before us is to the effect that certain
types of medical experiments on human beings, when kept within reasonably
well defined bounds, conform to the ethics of the medical profession generally.
The protagonists of the practice of human experimentation justify their
views on the basis that such experiments yield results for the good of society
that are unprocurable by other means of study. All agree, however, that
certain basic principals must be observed in order to satisfy moral and
legal concepts:
1. The voluntary consent of the human subject is absolutely essential. This
means that the person involved should have legal capacity to give consent;
should be so situated as to be able to exercise free power of choice, without
the interventions of any elements of force, fraud, deceit, duress, over
reaching, or other ulterior form of constraint or coercion; and should have
sufficient knowledge and comprehension of the elements of the subject matter
involved as to enable him to make an understanding and enlightened decision.
This latter element requires that 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 duty and responsibility for ascertaining the quality of the consent
rests upon each individual who initiates, directs, or engages in the experiment.
It is personal duty and responsibility which may not be delegated to another
with impunity.
2. The experiment should be such as to yield fruitful results for the good
of society, unprocurable by other methods or means of study and not random
and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal
experimentation . . .
4. The experiment should be conducted so as to avoid all unnecessary physical
and mental suffering and injury.
5. No experiment should be conducted where there is a priori reason to believe
that death or disabling injury will occur. . .
6. The degree of risk to be taken should never exceed that determined by
the humanitarian importance of the problem to be solved by the experiments.
7. Proper preparations should be made and adequate facilities provided to
protect the experimental subject against even remote possibilities of injury,
disability, or death.
8. The experiment should be conducted only by scientifically qualified persons
. . .
9. During the course of the experiment the human subject should be at liberty
to bring the experiment to an end . . .
10. During the course of the experiment the scientist in charge must be
prepared to terminate the experiment at any stage, if he has probable cause
to believe, in the exercise of the good faith, superior skill and careful
judgment required of him that a continuation of the experiment is likely
to result in injury, disability, or death to the experimental subject.
Id., reprinted at www.ushmm.org/research/doctors/nuremberg_code.htm, a copy
of which is attached as Exhibit "M."
These ten points constitute what is now known as the Nuremberg Code. They
were not promulgated as new legislation to be applied retroactively to the
defendants then in the dock. They were an articulation of what these United
States judges believed "all agree" were the fundamental rights of
every human being. See Affidavit prepared for the case of Michael Grodin,
M.D., a leading authority on the Nuremberg Code and one of plaintiffs' bioethics
experts. A copy of his Affidavit and C.V. is attached as Exhibit "R."
The Code set forth two equally important requirements of ethical human experimentation,
both of which are at issue in this case. The first is the requirement of voluntary
consent of the subjects after being informed of all material information about
the experiment. The second, often overlooked but no less significant, is that
such experiments must comport to certain ethical and scientific standards
even if subjects have given their informed consent to participate. The Code
did not just look backward at the events that gave rise to the Doctors Trial
but looked forward to postwar research on human beings. As stated by Dr. Leo
Alexander, one of the prosecution's key expert witnesses and the man many
credit as the author of the Code:
[The Nuremburg Code] is a useful measure by which to prevent in less blatant
settings the consequences of more subtle degrees of contempt for the rights
and dignity of certain classes of human beings, such as mental defectives,
people presumably dying from incurable illnesses, and other people disenfranchised,
such as prisoners or other inarticulate public charges whose rights might
be easily disregarded for the apparently compelling reason of an urgent
purpose.
Michael Grodin, "Historical Origins of the Nuremberg Code," in
Annas and Grodin, The Nazi Doctors and the Nuremberg Code: Human Rights
in Human Experimentation (1992) at p. 139, a copy of which is attached as
Exhibit "N."
The World Medical Association, which includes representatives of the American
Medical Association, was founded in 1947 soon after the Doctors Trial. In
1954, the Eighth General Assembly of the World Medical Association adopted
a resolution on human experimentation based largely on the Nuremberg Code.
The resolution contained the basic principles that "it is the duty of
the physician in medical research to protect the life, health, privacy and
dignity of the human subject." After several revisions, this document
now known as the Declaration of Helsinki was adopted by the 18th World Medical
Assembly in Helsinki in 1964. It was revised again in 1975 to include a requirement
for ethical review committees, such as Institutional Review Boards and adopted
most recently by the 52nd General Assembly of the World Medical Association
in Edinburgh Scotland in October 2000.
In the fifty years after Nuremberg, outrage over a series of public scandals
involving human experiments in the United States have reaffirmed this Nation's
commitment to human subject protection and the right to basic human dignity.
The first two public scandals were revealed in a landmark article by Harvard
physician and Medical School Professor Henry Beecher in the New England Journal
of Medicine. See H. K. Beecher, Ethics and Clinical Research, New England
Journal of Medicine, Vol. 274 (June 16, 1966) , pp. 1354-60, a copy of which
is attached as Exhibit "O." One occurred at New York's Sloan Kettering
Institute for Cancer Research where a researcher working on the immune system's
ability to fight cancer convinced the director of the Jewish Chronic Disease
Hospital in Brooklyn to allow him to inject unwitting patients with live cancer
cells. The second was the Willowbrook study, in which researchers at an institution
for mentally disabled children sought to develop a hepatitis vaccine by studying
children whom they had deliberately infected with isolated strains of the
virus. In the conclusion of Dr. Beecher's article, he cautioned that no research
should be conducted without the informed consent of the subject and that the
risks in any experiment must be commensurate with the benefits.
It was the third scandal, with racial overtones all too reminiscent of Nazi
atrocities, that generated federal action to regulate human subject research.
The infamous Tuskegee Syphilis Study conducted by physicians of the U.S. Public
Health Service was halted in 1972, nearly 40 years after it began while 200
African-American subjects with syphilis were allowed to remain untreated despite
the availability of therapeutic measures. In 1973, the Ad Hoc Advisory Panel
issued its Final Report of Tuskegee Syphilis Study, concluding "society
can no longer afford to leave the balancing of individual rights against scientific
progress to the scientific community." See Final Report, Department of
Health Education and Welfare (Washington, D.C.: G.P.O. 1973), a copy of which
is attached as Exhibit "P."
Public concern over the rights of research subjects have increased within
the decade subsequent to the passage of the Common Rule, published in 1991,
detailing conditions required for obtaining informed consent. See Part C,
infra. Particularly within the last few years media reports detailed the tragic
consequences of failed human experiments, including the one at issue here.
One question for this Court is, in light of this history, whether the principles
of the Nuremberg Code have any present day applicability to American law and
the rights of American citizens or whether they are simply wartime relics
applicable only to understanding the Nazi horrors. Given that the Code emerged
from the judgment of United States judges in a United States military tribunal,
if any country is bound by the legal precepts of the Nuremberg Code, it is
the United States. As George Annas, one of the leading authorities on the
Nuremberg Code, has opined,
The most complete and authoritative statement of the law of informed consent
to human experimentation is the Nuremberg Code... This Code is part of international
common law and may be applied in both civil and criminal cases covered by
state, federal and municipal courts in the United States.
George J. Annas, et al., Informed Consent to Human Experimentation: The Subject's
Dilemma 21 at 1 (1997). A number of evolving opinions support this view.
The first opinion to suggest that the Nuremberg Code has a place in American
jurisprudence is the dissent in the Kentucky case of Strunk v. Strunk, 445
S.W. 2D 145 (Court of Appeals of Kentucky, 1969), in which the court by a
vote of four to three authorized the removal of a kidney from a mentally retarded
institutionalized adult for transplantation into his ailing mentally sound
brother. In an eloquent dissent, Justice Samuel Steinfeld wrote:
Apparently because of my indelible recollection of a government which, to
the everlasting shame of its citizens, embarked on a program of genocide and
experimentation with human bodies, I have been more troubled in reaching a
decision in this case than in any other. My sympathies and emotions are torn
between a compassion to aid an ailing young man and a duty to fully protect
unfortunate members of society.... Regretfully, I must say, no."
445 S.W.2d at 149-51.
In Whitlock v. Duke University, 637 F. Supp. 1463 (M.D.N.C. 1986), aff'd,
829 F. 2d 1340 (4th Cir. 1987), a subject in a non-therapeutic, deep-diving
experiment sustained severe brain damage. In dismissing the action because
of a finding that the plaintiff had consented to participate in the experiment
with full knowledge of the risks, the court stated that the Nuremberg Code
provided persuasive guidance on the standard of care in the context of human
experimentation. The court stated:
The United States Military Tribunal at Nuremberg adopted the Nuremberg Code
as a proper statement of the law of informed consent in connection with the
trials of German scientists for human experimentation after World War II.
Id. at 1471.
One year later, the United States Supreme Court considered the case of James
B. Stanley, a Master Sergeant who had been surreptitiously dosed with LSD
as part of a mind control experiment conducted by the United States Army.
United States v. Stanley, 483 U.S. 669 (1987). Mr. Stanley became aware that
he had been a guinea pig in such an experiment when he received a letter almost
20 years later soliciting his cooperation in a study of the long-term effects
on such "volunteers." The Supreme Court in a narrow 5 to 4 ruling
reaffirmed the decision dismissing the plaintiff's complaint under the Feres
Doctrine which holds that a serviceman can not sue the government for putting
him in harm's way. In so holding, the Court impliedly acknowledged that Stanley
would have had a constitutional claim, if not for the Feres Doctrine and Stanley's
status as a serviceman during the experiment.
In dissent, Justice Brennan noted the importance of placing the government's
conduct in historical context:
The medical trials at Nuremberg in 1947 deeply impressed upon the world that
experimentation with unknowing human subjects is morally and legally unacceptable.
The United States Military Tribunal established the Nuremberg Code as a standard
against which to judge German scientists who experimented with human subjects.
Its first principle was: the voluntary consent of the human subject is absolutely
essential.
Id. at 687. Justice Brennan then concluded that "the United States Military
developed the Code which applies to all citizens--soldiers as well as civilians."
Id.
Justice Brennan characterized the government's experimentation on an unknown
human subject as "an intentional Constitutional tort" and ended
his opinion with a phrase that would thereafter be associated with the right
to be free from unethical experimentation: "Soldiers ought not be asked
to defend a Constitution indifferent to their essential human dignity."
Id.
Justice O'Connor, also dissenting, stated: "No judicially crafted rule
should insulate from liability the involuntary and unknowing human experimentation
alleged to have occurred in this case." Id. at 709-10. Justice O'Connor
noted that the United States Military played an instrumental role "in
the criminal prosecution of Nazi officials who experimented with human subjects
during the Second World War... and the standards of the Nuremberg Military
Tribunal used to judge the behavior of the defendants stated that the 'voluntary
consent of a human subject is absolutely essential... to satisfy moral, ethical
and legal concepts'." Accordingly, Justice O'Connor reasoned:
If this principle is violated the very least that society can do is to see
that the victims are compensated, as best they can be, by the perpetrators.
I am prepared to say that our Constitution's promise of due process of law
guarantees this much.
Id. at 711.
In re Cincinnati Radiation Litigation, 874 F. Supp. 796 (S.D. Ohio), is the
first case to expressly hold that Nuremberg may be applied in the courts of
the United States. Plaintiffs who had been the unknowing subjects in experiments
on radiation exposure brought suit against investigators and institutions
involved in the study. In rejecting a motion for summary judgment, the court
held that such claims were cognizable under the Due Process Clause of the
United States Constitution.
In a section titled, "The Nuremberg Code," the court examined the
history of the Doctors Trial, stating:
The judges appointed by President Truman to hear the medical case were all
American judges and lawyers. The Nuremberg tribunal was asked to determine
culpability . . . under "the principles of the laws of nations as a result
from the usages established among civilized people, from the laws of humanity,
and from the dictates of public conscience. . . Throughout the trial, the
question of what were or should be the universal standards for justifying
human experimentation recurred. "The lack of a universal principle for
carrying out human experimentation was the central issue pressed by the defendant
physicians throughout their testimony."
Id. quoting, United States of America v. Karl Brandt, et al., I Trials of
War Criminals, Vo., II at 181 (1909).
After quoting the first principle of the Nuremberg Code, the court concluded:
"The Nuremberg Code is part of the law of humanity. It may be applied
in both civil and criminal cases by the federal courts in the United States."
The court thus held:
If the Constitution has not clearly established a right under which these
clients may attempt to prove their case, then a gaping hole in that document
has been exposed. The subject of experimentation who has not volunteered is
merely an object. The plaintiffs in this case must be afforded at least the
opportunity to present their case.
Id. at 822.
The next case to invoke Nuremberg was Stadt v. University of Rochester, 921
F.Supp. 1023 (W.D.N.Y. 1996). In this case, plaintiff brought an action under
the Federal Tort Claims Act claiming she had been the subject of testing by
physicians who had injected her with plutonium without her informed consent.
In rejecting a motion that the Constitutional claims should be dismissed,
the court stated: "This case does not involve the right to refuse medical
treatment, but instead the right to be free from non-consensual experimentation
on one's body . . . the right to bodily integrity . . . a right which has
been recognized throughout this nation's history." Id. at 1027. In support,
the court reviewed the long line of cases holding that the right to bodily
integrity, which would include the right to be free from unethical human experimentation,
was a fundamental right under the United States Constitution. Id. at 1027-28,
citing Albright v. Oliver, 510 U.S. 266 (1994); Schmerber v. California, 384
U.S. 757 (1966); Skinner v. State of Oklahoma, 316 U.S. 535 (1942); Union
Pacific R. Co. v. Botsford, 141 U.S. 250 (1891). The court thus held: "The
Constitution and, more specifically, the due process clause of the Fifth Amendment,
clearly established the right to be free from non-consensual government experimentation
on one's body." 921 F. Supp. at 1027-28.
The next case and the one most similar to the factual issues here is Heinrich
v. Sweet, 62 F. Supp. 2d 282 (D. Mass., 1999), where family members brought
an action based on allegations that various government doctors conspired to
conduct extensive, unproven, and dangerous medical experimentation on 140
terminally ill patients without their informed consent. The court stated that
the issues presented must be understood in their historical context and then
proceeded to describe the background of the Doctors Trial and the Nuremberg
Code. The court then adopted the reasoning and holding of In re Cincinnati
Radiation Litigation that a breach of the principles of the Nuremberg Code
by a government actor would violate the Due Process Clause of the United States
Constitution. In language particularly relevant here, the court stated: "Similar
conduct that "shocks the conscience" includes the use of false promises
of therapeutic hope to terminally ill patients in order to lure them into
becoming human subjects . . . for the benefit of curious scientists rather
than the health of test subjects." 62 F. Supp. 2d at 320.
The culmination of this body of emerging law is Grimes v. Kennedy Krieger
Institute, Inc., 366 Md. 29 (2001). A research institution affiliated with
Johns Hopkins University created a research program to determine the effectiveness
of lead paint abatement procedures. Certain homes were selected to receive
only partial lead abatement modifications. The research institute encouraged
and, in one situation, required, the landlords of the homes to rent the premises
to families with young children. The children were examined and tested to
determine whether, and to what extent, their blood became contaminated with
levels of lead dust in the home. Id. at 36-37.
Based upon a previous research program, the researchers were aware that lead
dust remained and/or returned to abated homes. It was therefore anticipated
that the human subjects of the study, the children, could accumulate lead
in their blood. This would assist the researchers in determining the extent
that the partial abatement methods succeeded. Id. at 38.
Neither the children nor their parents were advised of the risks of the study.
"There was no complete and clear explanation in the consent agreement
signed by the parents of the children that the research to be conducted was
designed, at least in significant part, to measure the success of the abatement
procedures by measuring the extent to which the children's blood was being
contaminated." Id. at 38.
At some point, the plaintiffs, two of the children in the study and their
mothers, filed lawsuits against, amongst others, the researchers. The Circuit
Court, Maryland's trial court, granted summary judgment in favor of the research
institution, finding no negligence against the research institute because
it did not owe a duty to the children or their guardians.
In a strongly worded opinion, the Court of Appeals of Maryland, the State's
highest court, vacated and remanded the trial court's decision. The Court
held that the trial court's decision that summary judgment was appropriate
and that the researchers in that case did not have the duty to warn the participants
of known potential dangers was in error.
In reaching its decision, the court analyzed the Nuremberg Code, which the
Court stated was "the result of legal thought and legal principles, as
opposed to medical or scientific principles, and thus should be the preferred
standard for assessing the legality of scientific research on human subjects.
Under it, duties to research subjects arise" Id. at 74. The court further
held:
Additionally, the Nuremberg Code, intended to be applied internationally,
and never expressly rejected in this country, inherently and implicitly, speaks
strongly to the existence of special relationships imposing ethical duties
on researchers who conduct nontherapeutic experiments on human subjects. The
Nuremberg Code specifically requires researchers to make known to human subjects
of research "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." (Emphasis added.) The breach of obligations
imposed on researchers by the Nuremberg Code, might well support actions sounding
in negligence such as those at issue here. We reiterate as well that, given
the facts and circumstances of both of these cases, there were, at the very
least, genuine disputes of material facts concerning the relationship and
duties of the parties, and compliance with the regulations.
Id. at 98-99. The court reiterated that the Nuremberg Code may be applied
in both civil and criminal courts throughout the United States. Id. at 74.
As noted by the court, the first tenet of the Nuremberg Code's ten points
is that voluntary consent by the human subject "is absolutely essential."
Grimes, supra, 366 Md. at FN 31. Even prior to the issue of consent, the court
concluded, it is the obligation of the researcher to appraise the "scientific
merits and the acceptability of risks." Id. at 79 (citation omitted).
The court further explained that the fact that the subject signed a consent
form does not affirm that the research is justified. The court stated, "Researchers
cannot ever be permitted to completely immunize themselves by reliance on
consents, especially when the information furnished to the subject, or the
party consenting, is incomplete in a material respect." Grimes, supra,
366 Md. at 101. To that end, the court held that "[a] human subject is
entitled to all material information." and that without having provided
full material information, a researcher has not obtained "informed' consent.
Id. at 90. However, the researcher's duty to the participant is independent
of obtaining consent. Id. at 101.
In determining that there was not proper consent in the matter before it,
the Grimes Court reaffirmed the right to human dignity by citing a recent
law review article: The court stated, "The question is not so much whether
we can afford to honor our commitment to human dignity, free from subterfuges
. . . but whether we can afford not to, or whether we ought to." Id.
at 113 (citation omitted).
As these cases and history make clear, and as "all agree" in the
words of the Nuremberg judges, the right to essential human dignity (as well
as the right to bodily integrity) in the context of medical experimentation
as expressed in the Nuremberg Code is a fundamental right rooted in the conscience
and history of the people of the world, in general, and of the United States,
in particular. It is a right reflecting basic human values essential to any
"concept of ordered liberty" and, if it is sacrificed, neither liberty
nor justice can exist. It is, thus, a right guaranteed by the Fourteenth Amendment
to the United States Constitution and its violation will give rise to liability
under 42 § U.S.C. 1983.
Defendants do not submit any case law in opposition to these claims. Rather,
they argue that the Nuremberg Code and the Declaration of Helsinki are not
treaties and do not provide a private right of action. Defendants miss the
point. The cause of action claimed by these plaintiffs is based not upon the
doctrines themselves but upon the principles underlying the doctrines. The
Nuremberg Code and the Declaration of Helsinki are simply the expressions
of the right to bodily integrity and the right to human dignity. Also see,
e.g., In re Cincinnati Radiation Litigation, 874 F.Supp. 796, 810-11 (S. D.
Ohio 1995), "The right to be free of state-sponsored invasion of a person's
bodily integrity is protected by the Fourteenth Amendment guarantee of due
process." The right to be treated with dignity is simply an extension
of the right to bodily integrity.
D. THE PLAINTIFFS' FOURTH CAUSE OF ACTION SHOULD NOT BE DISMISSED
1. Plaintiffs Have Stated a Cause of Action for Substantive Due Process Violations.
Plaintiffs claim that the defendants denied them the due process of law guaranteed
by the Fourteenth Amendment by enrolling them in an unethical and ill-conceived
medical experiment without their informed consent. Defendants' sole argument
regarding this claim is that it simply does not exist.
To the contrary, the federal courts have often recognized claims violations
of due process resulting from nonconsensual medical treatment. Such was the
case in White v. Napoleon, 897 F.2d 103, 113 (3rd Cir. 1990), in which the
Third Circuit held:
The Due Process clause of the Fourteenth Amendment substantively protects
certain fundamental rights. Among these are the right to be free from unjustified
intrusions into the body, Ingraham v. Wright, 430 U.S. 651, 673, 97 S.Ct.
1401, 1413, 51 L.Ed.2d 711 (1977), the related right to refuse unwanted medical
treatment, Rennie v. Klein, 653 F.2d 836, 844 (3d Cir.1981), and, as we decide
today, the right to sufficient information to intelligently exercise those
rights.
Id. at 111. The court emphasized:
A prisoner's right to refuse treatment is useless without knowledge of the
proposed treatment. Prisoners have a right to such information as is reasonably
necessary to make an informed decision to accept or reject proposed treatment,
as well as a reasonable explanation of the viable alternative treatments that
can be made available in a prison setting.
Id. (emphasis added); see also Washington v. Harper, 494 U.S. 210, 229, 110
S.Ct. 1028 (1990) ("[t]he forcible injection of medication into a nonconsenting
person's body represents a substantial interference with that person's liberty");
Zinermon v. Burch, 494 U.S. 113, 110 S.Ct. 975 (1990); United States v. Stanley,
supra; Riggins v. Nevada, 504 U.S. 127, 112 S.Ct. 1810 (1992) (holding that
a prisoner's Fourteenth Amendment rights were violated when he was forced
to ingest anti-psychotic drugs during his trial without the State demonstrating
that the medication was medically appropriate and there were not less intrusive
alternatives).
The constitutional right to informed consent is also expressly recognized
in the context of experimental treatment. See Bibeau v. Pacific Northwest
Research Foundation Inc., 188 F.3d 1105 (9th Cir. 1999); In re Cincinnati
Radiation Litigation, 874 F.Supp. 796, 811 (1995); Craft v. Vanderbilt University,
18 F.Supp.2d 786 (1998); and Henrich v. Sweet, 62 F.Supp.2d 282 (D. Mass.
1999). Thus, the defendants' assertion that substantive due process rights
do not apply in cases of informed consent involving medical treatment is false.
This constitutional right applies regardless of whether the experiment is
therapeutic or non-therapeutic. Defendants cite no legal authority for their
theory that the standards for non-therapeutic research experiments differ
from those for therapeutic research experiments, and no court has so held.
The sole case they cite, Whitlock v. Duke University, 637 F.Supp. 1463 (M.D.N.C.
1986), aff'd, 829 F. 2d 1340 (4th Cir. 1987), does not support this theory.
In fact, it supports plaintiffs' claim that the defendants had a heightened
duty, based on federal regulations and the Nuremberg Code, for obtaining informed
consent. No Section 1983 claims were alleged in Whitlock. Instead, the federal
court sitting in diversity jurisdiction was asked to determine whether an
alleged failure to obtain informed consent in a nontherapeutic experiment
would be subject to North Carolina's statutory standard of care for health
treatment, or whether a heightened standard would apply. After examining the
Nuremberg Code as "persuasive guidance," the court concluded "that
North Carolina would analyze informed consent in the nontherapeutic context
consistent with 45 C.F.R. § 46.116(a)(2)."
Moreover, plaintiffs have alleged and found that Protocol 126 was conducted
for non-therapeutic purposes. The plaintiffs contend that the purpose of the
experiment was to further the scientific and personal ambitions of the defendants,
not to provide the best known therapy to the plaintiffs. See Draheim's Motion
for Partial Summary Judgment, filed 3/21/02. To the extent the distinction
is pertinent to this motion, the defendants cannot ask this Court to determine
as a factual matter whether this case involves "therapeutic" or
"non-therapeutic" treatment, and the motion must be denied.
2. Plaintiffs' Have Stated a Cause of Action For Violations of their Procedural
Due Process Rights.
Similarly, in this case plaintiffs claim procedural due process violations
resulting from (1) defendants' failure to provide plaintiffs with an opportunity
to be heard prior to deprivation of their liberty interest in bodily integrity;
(2) defendants' failure to abide by the procedural due process standards for
human subject research defined by the federal regulations and Assurance Agreement
applicable to Protocol 126; and (3) defendants' concealment of the true facts
about the experiment.
As the U.S. Supreme Court stated in Cleveland Bd. of Educ. v. Loudermill,
470 U.S. 532, 546 105 S.Ct. 1487 (1985):
An essential principle of due process is that a deprivation of life, liberty,
or property "be preceded by notice and opportunity for hearing appropriate
to the nature of the case." We have described "the root requirement"
of the Due Process Clause as being "that an individual be given an opportunity
for a hearing before he is deprived of any significant property interest."
(emphasis in original)(citations omitted).
Where explicit procedures govern the standards for informed consent, or where
those procedures are inadequate under an Mathews v. Eldridge balancing test,
the failure to properly obtain informed consent can constitute a violation
of procedural due process rights. In Zinermon v. Burch, 110 S.Ct. 975, 494
U.S. 113 (1990), a patient who was voluntarily committed to a mental hospital
asserted that the state actors who admitted him failed to properly apply the
state statutes which would have provided him with a timely postdeprivation
hearing. The patient claimed that he lacked the mental capacity to provide
informed consent, and his admission to the hospital should have been treated
as an involuntarily commitment. Due to State's failure to abide by the involuntary
commitment procedures and provide a postdeprivation hearing, the patient claimed
that he was deprived of his procedural and substantive due process rights.
The trial court dismissed the case on a motion to dismiss on the pleadings.
On certiorari, U.S. Supreme Court reversed, holding that, based on the facts
alleged, the State's failure to implement informed consent procedures in place
to protect the substantial liberty interests at stake, either pre-deprivation
or post-deprivation, could constitute a violation of the patient's procedural
due process rights.
In addition, the federal regulations and "Assurances" related to
the policies and procedures for conducting experiments on human subjects exist
in order to ensure that procedural due process rights in experimental research
are protected. See Section C supra. In Halikas v. University of Minnesota,
856 F.Supp. 1331 (D. Minn. 1994), these federal regulations and "Assurances"
were recognized as "defin[ing] due process standards applicable to human
subjects research." Id. at 1335.
In Halikas, after an IRB shut down a researcher's experiment based upon alleged
violations of the informed consent requirements of 21 C.F.R. § 56.113,
the researcher sued for a preliminary injunction to prevent the shutdown.
The court denied his request, finding that "the IRB is in sufficient
compliance with the procedures in the University of Minnesota General Assurance
Agreement and the applicable federal regulations to satisfy the required procedural
due process." Id. at 1136 (emphasis added). Here, plaintiffs' allegations
that defendants' failure to abide by these identical standards give rise to
a procedural due process cause of action under Section 1983.
The informed consent failures in this case (i.e. intentional withholding of
information necessary to understand the proposed treatment and possible risks
and benefit of the research protocols was withheld, intentional interference
with the IRB review process, and the intentional continuation of financial
conflicts of interest, despite prohibitions on such) resulted in a breakdown
of the procedural due process protections intended to reduce the risk of erroneous
deprivation. Here, the plaintiffs' procedural due process claims arise from
defendants' failure to obtain informed consent, a direct violation of the
federal regulations intended to protect human research subjects. The consequences
of those were fatal -- 80 of 85 participants died prematurely as a result
of defendants' actions.
Finally, procedural due process rights exist in the experimental research
context where intentional withholding of information regarding the true nature
and purpose of the experimental treatments impaired the patients' rights to
seek damages for substantive due process claims. Henrich v. Sweet, 62 F.Supp.2d
282 (D. Mass. 1999). In Heinrich, it was alleged that the defendants, including
an amalgam of public and private researchers and institutions, failed to obtain
informed consent of their cancer patients by concealing the true nature and
purpose of the proposed treatments, which were primarily intended to research
the effects of radiation exposure on humans. Many years after the experiments
occurred, the patient and their survivors brought suit and alleged that their
right of access to the court to had been violated through the defendants acts
of withholding pertinent information. The Heinrich court held that the plaintiffs
had stated a cause of action for violation of procedural due process as a
result of the government's concealing information about the experiments, which,
due to the loss of evidence over the passage of time, interfered with the
plaintiffs' cause of action and "opportunity to be heard." See also
In re Cincinnati Radiation Litig., 874 F.Supp. at 825 (finding that loss of
witnesses due to concealing purpose of radiation experiments could amount
of violation of procedural due process).
Procedural due process violations in this case occurred as a result of the
defendants' failure to implement procedures which were designed to eliminate
the risk of erroneous deprivation of substantive due process rights (and which
were agreed to as a condition of obtaining authority to conduct research on
human subjects). The informed consent process was inherently flawed by the
defendants' intentional withholding of information necessary to evaluate the
nature and purpose of the proposed treatment, and the risks involved.
3. Plaintiffs Have Sufficiently Pled a Section 1985 Cause of Action
Similarly, defendants' argument that plaintiffs have no right under 42 USC
§ 1985 should be rejected. Defendants deceptively seek to dismiss the
entire Fourth Count of the plaintiffs' Second Amended Complaint pursuant to
this statute, though plaintiffs' cause of action seeks damages under both
Sections 1985 and 1983. Even if defendants were correct that Section 1985
does not apply, the Fourth Count of the pleading should not be dismissed in
its entirety.
In any event, defendants' contention should be rejected. At this stage of
the litigation, defendants' contention that plaintiffs are not a proper "class"
under the statute is not ripe. Taking plaintiffs' allegations as true, plaintiffs
have set forth a valid cause of action under 42 U.S.C. § 1985.
4. Federal Regulations Can Give Rise to Rights Subject to Section 1983
Cause of Action.
The U.S. Supreme Court has held that, to the extent federal regulations secure
a federal right guaranteed to an individual, they can form the basis of a
Section 1983 claim. Wright v. City of Roanoke Redevelopment and Housing Authority,
479 U.S. 418, 430, 107 S.Ct. 766, 93 L.Ed.2d 781 (1987). The Ninth Circuit
has upheld the following test for determining whether a particular regulation
gives rise to a federal right.
First, Congress must have intended that the provision in question benefit
the plaintiff. Second, the plaintiff must demonstrate that the right assertedly
protected by the statute is not so "vague and amorphous" that its
enforcement would strain judicial competence. Third, the statute must unambiguously
impose a binding obligation on the States . . .
San Lazaro Association, Inc. v. Connell, 278 F.3d 932, 941 (2002). See also
Williams v. Lane, 851 F.2d 867, 879-81 (7th Cir.1988), cert. denied, 488 U.S.
1047, 109 S.Ct. 879, 102 L.Ed.2d 1001 (1989) (holding that regulations requiring
equal housing and program opportunities for inmates in protective custody
can create liberty interest for purpose of a Section 1983 claim).
Thus, the court may find that certain regulations which are intended to benefit
the plaintiff and which constitute a binding obligation on the state can constitute
a right secured by federal law. In this case, plaintiffs have alleged, inter
alia, that defendants failed to abide by the highly specific federal regulations
and binding "Assurances" regarding informed consent in experimental
research on human subjects, and that this failure deprived plaintiffs of a
right secured to them under federal law that is subject to the protections
of a Section 1983 action. As discussed below, application of the federal regulations
at issue in this case to the Ninth Circuit test in San Lazaro demonstrates
that plaintiffs have stated a Section 1983 cause of action. First, the human
subject research regulations are undoubtedly intended to protect patients
undergoing experimental treatments, whether therapeutic or non-therapeutic.
Second, the requirements are not unreasonably vague or amorphous. Explicit
steps for obtaining and maintaining records of patients' informed consent
are set out in 45 C.F.R. Part 46. Third, the statutory requirements are set
out not only in the federal regulations as mandatory obligations on all researchers
conducting experimental research, but they are also repeated in "Assurance
Agreements" as a condition of federal funding for that research. Under
San Lazaro, plaintiffs are entitled to pursue Section 1983 damages for defendants'
violations of the informed consent regulations and Assurances.
5. Section 1983 Remedies are Supplemental to, Not in Place of, State Law
Remedies
The fact that state law remedies may be available is irrelevant to a Section
1983 claim. In Zimermon v. Burch, 494 U.S. 113, 110 S.Ct. 975, 982 (1990),
the U.S. Supreme Court, in quoting Monroe v. Pape, 365 U.S. 167, 81 S.Ct.
473 (1961), stated: "It is no answer that the State ha a law which if
enforced would give relief. The federal remedy is supplementary to the state
remedy, and the latter need not be first invoked." As discussed at length
in this brief, there is ample authority that substantive due process claims
based upon the Fourteenth Amendment for violation of informed consent are
well-established in U.S. jurisprudence. Defendants rely heavily on Collins
v. City of Harker Heights, 503 U.S. 115, 112 S.Ct. 1061 (1992), however that
case rejected only the argument that a municipality had a duty under the Constitution,
to provide a safe workplace, for the purpose of a Section 1983 claim. It did
not address informed consent. Federal courts are only reluctant to recognized
certain Section 1983 claims that are not based on federal law, as explained
by the D.C. Circuit as follows:
[S]ection 1983 does not provide a remedy for any and all injuries inflicted
by persons acting under color of state law. Rather, these cases draw a distinction
between those rights secured by the Constitution or federal law and those
secured only under state tort laws; section 1983 provides a remedy only for
injuries to the former.
Washington v. District of Columbia, 802 F.2d 1478, 1480 (D.C. Cir. 1986).
6. Defendants Are Not Entitled to Qualified Immunity
The defendants half-heartedly assert qualified immunity in defense of the
constitutional claims against them. Private actors engaged in public functions
generally do not enjoy qualified immunity. Richardson v. McKnight, 521 U.S.
399, 408-09, 117 S.Ct 2100 (1997); Wyatt v. Cole, 504 U.S. 158, 167-68, 112
S.Ct. 1827 (1992); Halvorsen v. Baird, 146 F.3d 680, 685 (9th Cir. 1998).
The defendants have offered no basis for qualified immunity in this case and
it must be denied.
E. THERE IS AN IMPLIED PRIVATE CAUSE OF ACTION UNDER THE FEDERAL REGULATIONS
CITED IN PLAINTIFFS' PLEADINGS
As the Amended Complaint indicates, plaintiffs also assert claims based on
21 C.F.R. § 210, 211 and 21 C.F.R. § 601, 610, which establish the
law of the United States with respect to the manufacture and control of investigational
biologics, and 45 C.F.R. Part 46, which establishes the law of the United
States with respect to the protection of human research subjects.
In 1974, Congress passed the National Research Act, which authorized the adoption
and implementation of regulations to protect research subjects. In 1991, the
regulations were integrated into the Common Rule for 17 departments and agencies,
the most familiar of which is the Department of Heath and Human Services regulations
at 45 C.F.R. Part 46, a copy of which is attached as Exhibit "S."
The Common Rule is published in the Federal Register at 56 Fed. Reg. 28, 012
(June 18, 1991). These regulations, among other things, detail the conditions
required for obtaining informed consent and the information that must be provided
under those conditions, restrict experiments to those in which risks are minimized,
require the equitable selection of research subjects and establish the requirement
for institutional review boards to oversee research at every institution subject
to the regulations.
These regulations require:
Risks to subjects are minimized: (i) By using procedures which are consistent
with sound research design and which do not unnecessarily expose subject to
risk.
. . .
Risks to subjects are reasonable in relation to anticipated benefits . . .
. . .
Selection of subjects is equitable.
. . .
Informed consent will be sought from each prospective subject or the subject's
legally authorized representative, in accordance with, and to the extent required
by § 46.116.
. . .
Informed consent will be appropriately documented, in accordance with, and
to the extent required by § 46.117.
. . .
Where appropriate, the research plan makes adequate provision for monitoring
the data collected to insure the safety of subjects.
. . .
Where appropriate, there are adequate provisions to protect the privacy of
subjects and to maintain the confidentiality of data.
. . .
Where some or all of the subjects are likely to be vulnerable to coercion
or undue influence, such as persons with acute or severe physical or mental
illness, or persons who are economically or educationally disadvantaged, appropriate
additional safeguards have been included in the study to protect the rights
and welfare of these subjects.
These regulations also require institutions to appoint an IRB to review the
design of any clinical trial protocol and to ensure that the conduct of any
clinical trial at the institution is consistent with the requirements of the
regulations. Defendants violated these and several other provisions of the
federal regulations.
Defendants contend that plaintiffs do not have a cause of action under the
Code of Federal Regulations, as there is no private right of action provided
under the sections defendants violated and that Titles 21 and 45 create enforcement
rights for the FDA.
The regulations for which plaintiffs bring causes of action are silent as
to whether a claimant may assert a private cause of action. Thus, for plaintiffs
to be able to assert a private cause of action, Congress or an administrative
agency must implicitly intended to have individuals use them to litigate.
24 Hour Fuel Oil Corp v. Long Island Rail Road Company, 903 F.Supp. 393, 397
(E.D.N.Y. 1995). In Cort v. Ash, 422 U.S. 66, 78, 95 S.Ct. 2080, 45 L.Ed.2d
26 (1975), the United States Supreme Court set forth a four part test to determine
the availability of an implied private cause of action:
(1) whether the plaintiff is one of the class for whose benefit the statute
was enacted;
(2) whether there is any indication of legislative intent, explicit or
implicit, to create or deny such a remedy;
(3) whether the private right of action would be consistent with or frustrate
the purposes of the legislative scheme; and
(4) whether the cause of action is traditionally relegated to state law
remedies, so that it would be inappropriate to infer a cause of action based
solely on federal law.
The primary factor in this analysis is whether there is any indication,
one way or another, of legislative intent. Olmsted v. Pruco Life Insurance
Company of New Jersey, 134 F.Supp.2d 508, 512 (E.D.N.Y. 2000).
A review of the Cort factors demonstrate that there is an implied private
cause of action under 45 C.F.R. Part 46, the federal regulations concerning
human experimentation. First, plaintiffs are obviously a beneficiary of the
regulations. As set forth above, the history of the regulations has been concerned
with the rights of human subjects. It is these individuals for whose benefit
the regulations were enacted. As the Memorandum titled "Review of Federal
policy for the Protection of Human Subjects" indicates, 45 C.F.R.. §
46 provides that review by the IRB for all research protocols involving human
subjects to ensure that "(1) risks are minimized and reasonable in relation
to anticipated benefits; (2) there is informed consent; and (3) the rights
and welfare of the subjects are maintained." A true and correct copy
of the February 17, 1994 Memorandum is attached hereto as Exhibit " ."
This section is designed to protect substantive rights, not simply procedural
ones. Stated differently, this is not a statute focusing on spending directives
or conditions for government grants. See Rapid Transit Advocates v. Southern
California Rapid Transit Dist., 752 F.2d 373, 377 (9th Cir. 1985).
Second, there is no legislative history expressing an intent to deny individuals
subjected to unlawful human experimentation the ability to seek redress. Had
a bar to private actions been contemplated Congress would have so stated.
The only logical presumption based upon the legislative history set forth
above is that Congress intended for individuals to seek relief under a series
of regulations designed solely to protect them.
Third, for reasons similar to what has just been asserted, the purpose of
the regulations is to ensure that unlawful human experimentation does not
occur. To allow a patient the right to be made whole, to seek a remedy for
the physical, mental and emotional damage from the experimentation advances
the goals of the regulations.
Finally, the protection of human subjects to which 45 C.F.R. § 46 applies
is a unique federal cause of action. That there are state causes of action
applicable to defendants' conduct does not negate the viability of a federal
cause of action. As stated In re Cincinnati Radiation Litigation, 874 F.Supp.
796, 817 (S.D.Ohio 1995), a case with facts similar to those in this matter,"[t]he
distinction between this case and an ordinary tort case is not one of degree,
but rather, of kind. Government actors in cases such as this violate a different
kind of duty from that owed by a private tort defendant." Thus, a cause
of action for damages from unlawful human experimentation based upon regulations
prohibiting this conduct would not interfere with state law claims, especially
considering that there is no state statute specifically barring defendants'
conduct.
Whitlock v. Duke University, supra, 637 F.Supp. 1463 (M.D.N.C. 1986) is instructive.
Whitlock concerned a subject in a non-therapeutic, deep-diving experiment
who sustained severe brain damage. The plaintiffs asserted several causes
of action, including damages for breach of 45 C.F.R. § 46. While the
court dismissed the action after finding that the plaintiff consented to participate
in the experiment with full knowledge of the risks, the court relied upon
45 C.F.R.. § 46.116 in reaching its determination. The court did not
opine whether a private cause of action exists under this section.
In addition, plaintiffs do not seek a private cause of action under the FDCA
and have never sought such relief. While the defendants have violated the
provisions of the FDCA and 21 C.F.R. Part 312, the plaintiffs claims are for
violations of 45 C.F.R. Part 46, which is not stated as under the authority
of the Food and Drug Administration, unlike the provisions of the FDCA.
None of the cases defendants cite are set forth for anything other than boilerplate
language, that there is no private cause of action under the Food, Drug and
Cosmetic Act. However, this same argument was rejected in Platzer v. Sloan-Kettering
Institute for Cancer Research, 787 F.Supp. 360, 364 (S.D.N.Y. 1992), aff'd
983 F.2d 1086 (2d Cir.), cert. den., 507 US 1006, 113 S.Ct. 1648, where the
court held that one case cited by defendants, Merrell Dow Pharmaceuticals,
478 US 804 (1986):
did not involve a direct implied right of action, but rather involved a state
law action which required interpretation of a federal statute. The importance
in this distinction can not be overemphasized. The Supreme Court stated, "This
case does not pose a [direct] federal question . . . respondents do not allege
that federal law creates any of the causes of action that they have asserted.
As such, its holding was limited to state law claims alleging violations of
federal statutes. As the plaintiffs claim in this matter are predicated on
federal claims, e.g., the Code of Federal Regulations, defendants' reliance
on Merrell Dow Pharmaceuticals and the other cases is misplaced, in addition
to being moot.
F. PLAINTIFFS ARE THIRD-PARTY BENEFICIARIES TO THE ASSURANCE AGREEMENTS,
WHICH CONTAIN THE PROVISIONS OF THE BELMONT REPORT
In the 1970's Congress appointed a federal commission to examine the system
for protecting human research subjects. The National Commission for the Protection
of Research Subjects in Biomedical and Behavioral Research was charged with
identifying the basic ethical principles underlying research on human subjects.
In 1979, it issued "The Belmont Report," a document all research
institutions promise in an Assurance Agreement to uphold in all research studies
in order to be eligible for certain grant monies. After acknowledging the
influence of the Nuremberg Code, the Belmont Report sets forth three principles
to guide human subject research: the first is respect for persons, which demands
that researchers fully inform their subjects of all material information about
the study and only then obtain their voluntary consent; the second is beneficence,
which prohibits any experiment where the risks are too great or are outweighed
by the benefits; and the third is justice, which requires equitable selection
of research subjects. Belmont Report, DHEW Pub. No. (05) 78-0012. (Washington
D.C.: G.P.O.), a copy of which is attached as Exhibit " ."
Plaintiffs are clearly third-party beneficiaries to the assurance agreements
between defendants and the government, as the purpose of these agreements
are for the protection of the human research subjects participating in clinical
trial, such as Protocol 126. An objective test is used to determine whether
a third-party beneficiary contract exists. Postlewait Constr., Inc. v. Great
American Ins. Companies, 106 Wn.2d 96, 99 (1986). If performance necessarily
and directly benefits the third-party a beneficiary contract exists. Id. It
is the participants of every human clinical research study that are protected
by the provisions of the Belmont Report. Otherwise, there is no purpose to
the Assurance Agreements. Accordingly, defendants' argument should be rejected.
IV. CONCLUSION
For the foregoing reasons, defendants' Motion to Dismiss should be denied
in its entirety.
DATED this 16th day of April, 2002.
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Alan C. Milstein
Harris L. Pogust
SHERMAN, SILVERSTEIN, KOHL,ROSE & PODOLSKY
Fairway Corporate Center
4300 Haddonfield Road, Suite 311
Pennsauken, NJ 08109
(856) 661-2078
THOMAS R. DREILING, WSBA # 4794
999 3RD AVE.
Seattle, WA 98104
(206) 624-9400
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SHORT CRESSMAN & BURGESS,
P.L.L.C._____________________________________
David E. Breskin, WSBA #10607
Attorneys For Plaintiffs
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