Subjects in Halted Melanoma Trial
Sue Institutional Review Board, Others
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Oklahoma recipients of an experimental cancer vaccine filed a federal
lawsuit Jan. 29 seeking damages from individuals and institutions that
allegedly failed to ensure the clinical trial followed federal regulations
for human-subject protection (Robertson v. McGee, N.D. Okla., No.
4:01-CV-60, complaint filed 1/29/01).
The University of Oklahoma Health Sciences Center in Tulsa suspended its
melanoma trial in March 2000 after an audit discovered "an egregious lack of
control" in the preparation of the vaccine, and other problems potentially
affecting patient safety, according to the U.S. Department of Health and
Human Services Office for Human Research Protection (No. 134 HCDR
/12/00 ).
A June 29, 2000, letter from OHRP cited 13 "major findings" of problems in
the melanoma study. The deficiencies ranged from inadequacies in the
manufacturing of vaccine to incomplete informed consent from subjects,
over-enrollment of participants, and lack of ongoing oversight by the
institutional review board (IRB) charged with that task under federal
regulations.
"They simply ignored the regulations that are in place to govern the conduct
of such research," said Alan C. Milstein, of Sherman, Silverstein, Kohl,
Rose & Podolsky PA, Pennsauken, N.J. Milstein represents 19 plaintiffs in
the litigation.
The lawsuit is believed to be the first against IRB members in the United
States. "The oversight [of many clinical trials] is nonexistent," Milstein
said. "People who participate in these trials are under the impression
someone is watching."
Last year, Milstein represented the family of a University of Pennsylvania
student who died during a gene therapy trial there (No. 186 HCDR 9/25/00 ).
That case was settled, although terms were not announced (No. 217 HCDR
11/8/00 ).
Defendants Named
The Oklahoma lawsuit names as defendants the trial's investigator, Dr. J.
Michael McGee, along with members of the university's IRB and others
associated with the UOHSC, including the university's president.
McGee's attorney said the actual events of the cancer study have yet to be
fully developed. "After reading the pleadings, it appears the allegations of
a whistleblower made last year, and at this point largely uninvestigated,
are being relied on as the truth," said Lynn P. Mattson, of Doerner,
Saunders, Daniel & Anderson LLP, in Tulsa. Mattson represents McGee in
employment litigation against the university.
Milstein said a companion lawsuit will be filed in state court against the
university. As a state institution, the university cannot be sued in federal
court.
UOHSC-Tulsa President Ken Lackey was not immediately available for comment.
Also named as defendants were St. John Medical Center, Hogue Cancer Center,
Cancer & Hematology Center, and Immunex Corp., which provided a drug used in
the vaccine.
91 Causes of Action
The 75-page complaint lists 91 causes of action on behalf of the
participants, family members, and estates of clinical trial participants.
The lawsuit claims the defendants' actions violated human-rights provisions
of two international treaties, the Nuremberg Code and the Declaration of
Helinski. The complaint also alleges federal civil rights violations and
violations of federal regulations governing clinical trials.
In addition to these federal claims, the complaint alleges state causes of
action for negligence, intentional and negligent infliction of emotional
distress, fraud and misrepresentation, assault and battery, lack of informed
consent, and strict products liability.
The complaint is available online at http://www.sskrplaw.com/gene/.
By Chad Bowman
Copyright (c) 2001 by The Bureau of National Affairs, Inc., Washington D.C.
