Class-action suit filed against 'The Hutch'

Tuesday, March 27, 2001, 01:56 a.m. Pacific

Class-action suit filed against 'The Hutch'

by Duff Wilson and David Heath

Seattle Times staff reporters

A leading patient-advocate attorney and two Seattle law firms yesterday filed a class-action suit against the Fred Hutchinson Cancer Research Center, claiming it violated laws overseeing ethics, human-subjects research and consumer protection when it conducted research involving cancer patients.

The lawsuit was filed in Kitsap County Superior Court on behalf of the families of 82 patients who participated in a clinical trial called Protocol 126, a failed blood-cancer experiment conducted at "The Hutch" between 1981 and 1993.

The Hutch had no comment on the lawsuit late yesterday. The lawsuit follows a Seattle Times series published earlier this month that reported the Hutchinson Center neither fully warned patients of the risks and alternatives nor disclosed private financial holdings in three of the eight drugs being tested.

At least 20 people died from the treatment; two of the 82 who enrolled are still alive today, despite a statistical likelihood that more might have lived.

The experiment used eight antibodies to kill white-blood T-cells in bone marrow donated by tissue-matched siblings. The researchers thought that eradicating the T-cells would eliminate a condition called graft-vs.-host-disease, thus making transplants more successful. In fact, though, with the T-cell eradication, the rate of rejection of donated marrow and of relapse of cancer increased dramatically.

Named in the suit were Hutch doctors E. Donnall Thomas, John A. Hansen, Paul J. Martin and Robert Day. Hansen and Martin were principal investigators on Protocol 126. Thomas, a 1990 Nobel laureate, was clinical-division director and also an investigator on the study. Day was president of The Hutch. Also named was Genetic Systems and its successor corporation. Genetic Systems paid royalties to The Hutch for an exclusive commercial license for three of the drugs being tested in Protocol 126; it also gave stock and positions to Hansen, Martin and Thomas, and stock and cash to a Hutch-affiliated foundation.

The lead plaintiff in the case is William Lee "Pete" Wright Sr. of Heflin, Ala., whose wife, Becky, died in 1984 after her leukemia returned despite a bone-marrow transplant at The Hutch.

Wright was unavailable for comment yesterday but confirmed last week he would be a party to the action.

The lawsuit accuses the Hutchinson Center of violating "the right to be treated with dignity" as stated in the Nuremberg Code of 1949 and the 1964 Declaration of Helsinki from the World Medical Association.

In addition, it claimed The Hutch violated federal laws controlling investigational drugs and protection of human-research subjects; breached the Belmont Report guidelines on ethics in human research in the United States; committed "fraud in intentionally misrepresenting the risks... "; assault and battery; product liability; and violation of the state health-care-provider and consumer-protection laws.

The lead attorney in the case is Alan Milstein of Pennsauken, N.J., who represented the family of Jesse Gelsinger, a young Arizona man who died in a botched gene-therapy experiment in 1999. The lawsuit was settled out of court.

In that suit, 18-year-old Gelsinger agreed to participate in a gene-therapy trial at the University of Pennsylvania even though it offered him no benefits. He slipped into a coma after being infused with a gene-therapy substance and died four days later.

Unknown to Gelsinger, the researcher, Dr. James Wilson, owned 30 percent of Genovo, whose gene-therapy substance he was testing. Wilson reportedly made $13.5 million when the company was later sold to Targeted Genetics of Seattle.

Milstein also recently sued the University of Oklahoma Health Sciences Center on behalf of 19 patients in a melanoma study suspended last year. Yesterday, Milstein said the Hutchinson Center case would be the broadest yet in an emerging area of damage claims by people in clinical trials. "The issue of whether or not the experiment here conformed with these worldwide ethical standards is a perfect issue for a class action," Milstein said.

Joining Milstein in the suit were attorney David Breskin of Short Cressman & Burgess of Seattle, which handles class-action and medical-malpractice cases; and Thomas Dreiling of Seattle. The case was filed in Kitsap County Superior Court because one of the patients who died, Dr. John Draheim, was a resident of Bremerton, Breskin said. Peggy Draheim of Scottsdale, Ariz., Draheim's widow, said yesterday she had not been contacted by the attorneys; she said she would likely support the suit.

Milstein said he would use Hutch records to locate and notify other families.

The Times, in its investigation, identified 36 of the 82 people enrolled but was unable to identify the other 46. The Fred Hutchinson Cancer Research Center is the leading bone-marrow transplant center in the world and receives more funding from the National Cancer Institute than any other research institution. Last week, the Hutchinson Center announced formation of a committee to evaluate how it handles informed-consent and conflict-of-interest issues. The center has challenged some of The Times' findings. Duff Wilson can be reached at 206-464-2288 or dwilson@seattletimes.com. David Heath can be reached at 206-464-2136 or dheath@seattletimes.com.