Subjects in Halted Melanoma Trial Sue Institutional Review Board, Others
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, Moorestown, 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.