Two more families have sued the Fred Hutchinson Cancer Research Center and three of its leading doctors over the deaths of patients in a 1980s leukemia experiment.

The new lawsuit, filed in King County Superior Court, brings to 14 the total number of families accusing "the Hutch" of misconduct in a series of clinical trials known as Protocol 126. The first five of those cases are scheduled for a consolidated trial in February.

The patients who died included a Navy doctor from Bremerton, an insurance agent from Pennsylvania, a computer analyst from California, and a city attorney and an anthropology professor, both from New York.

The latest suit was filed in September by Lynn Kohlhagen, a Florida retiree whose son died in 1986, and Zita Schneider, a Michigan secretary whose husband died in 1986. Their complaint says the Hutchinson Center knew or should have known the risks of the experiment outweighed the possible benefits, yet pushed ahead.

Protocol 126 aimed to prevent a sometimes-fatal side effect of bone-marrow transplants known as graft-versus-host-disease, but ended with extraordinary numbers dying from graft failures and cancer relapses.

Dr. Paul Martin, the principal investigator, said in a court filing that his latest audit of records showed that 85 people had enrolled and 84 of them had died. Previously, Martin had said 80 of 82 people had died.

Dr. E. Donnall Thomas was a senior investigator on Protocol 126 and Dr. John Hansen was a principal investigator.

With either graft failure or relapse, patients faced almost certain death.

Many of the patients in Protocol 126 were critically ill, but at least 20 of them — including the professor, lawyer and computer analyst in the first suits coming to trial — had an early form of leukemia that was roughly 50 percent curable then and 90 percent curable now.

The family members who are suing include 10 former spouses, three parents, a sister and a son.

Attorney Tom Dreiling, Seattle co-counsel for the family members, said they were inadequately informed about the risks, alternatives and financial conflicts of interest in the treatment. Some of the doctors who treated these patients held stock in a company that owned rights to some of the chemicals tested, as did the center itself.

Dreiling said they didn't realize this until a Seattle Times investigative series in 2001, titled "Uninformed Consent: What patients at 'The Hutch' didn't know about the experiments in which they died."

Some of the family members said the Hutch scared them with graphic images of graft-versus-host-disease (GVHD) while downplaying the risks of rejection and relapse.

Marian Dagosto is the widow of Paul Mahler, who taught anthropology at Queens College in New York. Dagosto teaches anatomy to first-year medical students at Northwestern University in Chicago, and said in an interview, "I'm a research scientist myself, and I don't see how they can justify what they did."

The Hutchinson Center denies all the charges and insists its doctors could not have profited from the experiment.

Dr. David Nathan, president emeritus of the Dana-Farber Cancer Institute in Boston, said in a deposition last month that Protocol 126 was "totally appropriate" and Martin "is a wonderful scientist." Nathan is expected to testify for the Hutch as an expert in transplants in the 1980s.

George Mernick, an attorney for the Hutch, said he will prove at trial that the center and its physicians "acted at all times in the best interests of their patients."

Pretrial rulings

Judges have made important pretrial rulings for each side over the past year.

U.S. District Judge Robert Lasnik denied the plaintiffs class-action status last November, ruling the cases were too individually distinct. Lasnik also denied novel claims under the Nuremberg Code and the Declaration of Helsinki, which set international standards for human experiments.

The federal judge ordered the cases moved to state court.

In August, King County Superior Court Judge Douglas McBroom dismissed claims under state consumer-protection and product-liability laws, leaving the cases focused on medical malpractice. (One product-liability claim remains.)

In September, McBroom granted partial summary judgment on one important element of malpractice — whether the Hutch's treatment caused deaths — for four of the cases set for the first trial.

To prove malpractice under the state Health Care Provider Act, the families still must show that the Hutch failed to follow the standard of care and that the patients did not give informed consent to the treatment.

In the fifth case set for the first trial, the judge also ruled that the Hutch had been negligent, leaving only the issue of damages for trial.

In that case, David Yingling, a Pennsylvania insurance agent, died from graft failure after the Hutch mishandled his brother's bone marrow in a centrifuge, according to deposition testimony. The Hutch changed procedures after that.

On the issue of damages to Yingling, the Hutch says he would have died from liver failure.

McBroom threw out one malpractice claim, brought by Pete Wright of Heflin, Ala., whose wife's case had been featured in the newspaper series. The judge said Wright missed a one-year statute of limitations to file suit.

Wright had been the first family member to learn about the alleged misconduct when a Times reporter in January 2000 sent him a copy of a letter from Dr. John Pesando, a former Hutch scientist who repeatedly blew the whistle on Protocol 126. Wright didn't file suit until March 2001, shortly after The Times series. He said it had been too painful to think about.

Wright had been unique among families so far identified in possessing a tape recording of the consent conference, in which a Hutchinson doctor told his wife, "It's not that risky."

The judge turned back a statute-of-limitations challenge against Annmarie Ridings, a Massachusetts woman whose sister in 1985, saying Elizabeth Almeida did not know enough details about the case until the articles were published.

In other pretrial rulings, McBroom refused a motion by the Hutch's lawyers to dismiss claims of fraud and negligent infliction of emotional distress, in addition to the malpractice claim. Wright is still pursuing a fraud case. There is court hearing Nov. 12 in Seattle.

Depositions

Protocol 126 used then-new chemicals called monoclonal antibodies to remove a type of red blood cells, known as T-cells, from a donor's marrow, in an effort to prevent GVHD. The T-cell-depleted marrow was then injected into leukemia patients to restore the immune systems that had been wiped out by radiation and chemotherapy.

In the end, Hutch researchers learned that T-cells were also necessary for the bone-marrow graft to take and that some GVHD reaction helped kill stray cancer cells and avoid a relapse of the leukemia.

Many cancer centers were pursuing T-cell depletion in the early 1980s but the Hutch's cocktail of antibodies was unique and most potent.

It ended with what Hutch co-founder Dr. Rainer Storb would term "disastrous results."

Scores of affidavits and more than 50 depositions, or testimony under pretrial questioning from lawyers, have shed new light on Protocol 126 during the past year. Lawyers for each side are claiming small victories as the testimony emerges.

F. William Dommel, former assistant director of the federal Office for Protection from Research Risks, said in an affidavit for the families that his office would have sanctioned the Hutch for misconduct if he had known what The Seattle Times reported.

Instead, in 1995, the office dismissed the whistle-blower's complaint without interviewing anyone.

In pretrial depositions, lawyers for the Hutch asked surviving family members whether they knew the center was engaged in research trials or experiments rather than just standard treatment. They pointed out, research is part of the center's name.

Some agreed, but said they thought they'd get the best available treatment.

Others said they had no idea, when they checked their relatives in to the most experienced transplant center in the world, that they were signing up for an early-stage human experiment.

Duff Wilson: 206-464-2288 or dwilson@seattletimes.com