Hutch opposes class action

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In their first response to a federal class-action suit, lawyers for the Fred Hutchinson Cancer Research Center say doctors gave patients "full disclosure of the material risks ... known at the time" in a controversial clinical trial.

In a court filing yesterday, The Hutch also argued that the suit brought by five people whose spouses died in the blood-cancer experiment should not be certified as a class action but broken into individual cases.

Hutch attorneys said each patient in the experiment - conducted by the Seattle facility between 1981 and 1993 - had a unique situation.

"The adequacy of disclosure to each patient presents an individual question," the 21-page filing says. "The results of each patient's treatment, and the question of whether (The Hutch) caused any injury, much less a wrongful death, is an individual issue with respect to each patient."

The lawsuit, in U.S. District Court in Seattle, was filed in March shortly after publication of a Seattle Times investigative series, "Uninformed consent: What patients at `The Hutch' weren't told about the experiments in which they died."

The newspaper reported more than 20 blood-cancer patients died prematurely in a test of experimental drugs in which Hutchinson Center doctors held financial interests. Patient records and interviews with survivors indicated that patients weren't fully informed of risks and alternatives.

The experiment, known as Protocol 126, was an attempt to prevent graft-versus-host-disease (GVHD) after radiation, chemotherapy and a bone-marrow transplant for blood cancers. Almost every stage of Protocol 126 tested the same eight drugs and attempted to prevent GVHD by killing white blood cells known as T-cells.

The patient-consent form was similar through most years of the experiment, typically failing to emphasize the fatal risks of graft failure, or to mention the risks of relapse and new cancers, or to tout a safer alternative.

But Hutch attorneys said the forms were just a start. They said all of the patients and their families were given full information during face-to-face medical conferences that lasted about an hour in each case.

"No two of these discussions were the same," the attorneys added. "The adequacy of disclosure to each patient presents an individual question."

The attorneys also said Protocol 126 was not a single experiment, but "numerous separate clinical trials that differed from each other in significant respects."

Dr. John Pesando, the former Hutchinson Center doctor and internal-review-board member who complained to government agencies about Protocol 126, said the researchers should have gone back to the lab or animal tests after seven out of 20 human patients suffered fatal graft failures. Such failures were expected only 1 percent of the time.

But the researchers said they thought they could solve the problem in people. Each new arm of the experiment added or subtracted radiation or other drugs affecting the immune system while maintaining the major part of the regimen.

Yesterday's filing says the allegations in the lawsuit "are fundamentally inconsistent with the pertinent patient records."

Alan Milstein, lead attorney for the families suing The Hutch, said of yesterday's filing: "I find it incredible, at this point, that they are denying any wrongdoing whatsoever. That's what this litigation's going to be about."

Milstein asserts that The Hutch violated the Nuremberg Code, the 1949 international standard for the treatment of humans in medical experiments.

Milstein said he has not yet identified the 82 people The Hutch says were enrolled in Protocol 126. The Hutch says it cannot disclose their identifies without permission of their families. Last year, Dr. Paul Martin, principal investigator in Protocol 126, said only two of the 82 remained alive, but more recently a Hutch spokeswoman said the number of survivors, if any, was not confirmed.

While many of the patients in Protocol 126 had a form of blood cancer with only a 15 to 20 percent chance of survival, about 20 of them had a form with a 50 percent or better chance of survival with the standard treatment at the time.

Bennett Bigelow & Leedom of Seattle and Hogan & Hartson of Washington, D.C., are representing the Hutchinson Center and four doctors.

The patients' survivors are represented by Milstein; David Breskin of Short Cressman & Burgess in Seattle; and Thomas Dreiling of Seattle.

Dreiling said he expects the first battle, over class-action certification, to last into the fall. No schedule has been set.

Lis Wiehl, a University of Washington law professor not involved in the case, said it would be much harder for The Hutch to fight a class action because it enables the plaintiffs to pool their resources.

"If you've got one large group that you are fighting, that's much more difficult generally, even if you've got a hundred parties and you have to litigate one small suit at a time," Wiehl said. "Each of those parties has less resources. That's the reason for a class action, that it helps the little guy to bring a claim."