Hutch Settles consent Case out of court – Seattle Times

Thu, 16 Jan 2003

The Fred Hutchinson Cancer Center has settled a lawsuit that charged the institution with ethical/legal violations in a fatal cancer trial. The case was brought to light in a superb, 5-part, prize winning series by David Heath and Duff Wilson of The Seattle Times.

The March 2001 series documented an intricate web of medical ethics violations and colossal failure of the entire research protection system. The series documented how lives had been sacrificed by doctors whose financial interests and those of the institution conflicted with medical ethics and patient safety standards. Although federal oversight authorities had been informed about the wrongdoing, neither the FDA, nor the (then) Office of Protection from Research Risks conducted a credible investigation.

After the Times series laid out in detail the numerous egregious federal violations n March 2001, Hutch officials assumed a defiant aggressive stance. Federal oversight agencies failed to act– the (current) Office of Human Research Protection stood idly by and did nothing.

Only the prospect of an open court trial brings mighty research centers– such as the University of Pennsylvania and Johns Hopkins University–to the negotiating table. Often the damaging facts remain shielded from public view. The cost of these individual legal settlements has been borne by tax exempt, publicly supported medical research institutions. Ultimately, taxpayers foot the bill.

Until wrongdoers are also held personally accountable– as is mandated under The Nuremberg Code– people who volunteer for clinical trials are unsafe.

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http://seattletimes.nwsource.com/cgibin/PrintStory.pl?document_id=134615684&zsection_id=268448406&slug=hutch15&date=20030115
15, 2003, 08:34 a.m. Pacific
Hutch settles consent case out of court

By David Heath
Seattle Times staff reporter

A week before trial, the Fred Hutchinson Cancer Research Center has reached an out-of-court settlement with the husband of Kathryn Hamilton, a breast-cancer patient who died in a controversial clinical trial.

U.S. District Judge Robert Lasnik ruled in August that the Hutchinson center was liable for not telling Hamilton that an intravenous drug meant to protect her was no longer available. Judges rarely rule in favor of medical malpractice claims before they get to trial.

His decision reduced the center’s chief defense to arguing that Hamilton’s husband, Allan Berman of Spokane, had waited too long before filing his lawsuit. The settlement means the case is resolved and will never go before a jury.

Both sides agreed to keep the terms of the settlement secret. Berman said he was “delighted” that the case was finally over but that he could say nothing else because of a confidentiality clause in the agreement.

In March 2001, The Seattle Times told the story of Hamilton’s death in an investigative series titled, “Uninformed Consent: What patients at ‘The Hutch’ weren’t told about the experiments in which they died.” Berman filed his lawsuit two months after the series appeared.

Since the series’ publication, The Hutch has steadfastly denied any wrongdoing. Officials of the center would not comment yesterday.

Hamilton’s oldest son, Seattle attorney Chris Addicott, said that the settlement “means that Judge Lasnik’s original ruling — that my mother would not have participated and died in The Hutch’s experiment if she had been told the facts she was entitled to know — will always stand as testament to the defendants’ misconduct. With Judge Lasnik’s ruling against The Hutch, the defendants can no longer credibly maintain that they did nothing wrong.”

Addicott was expected to testify during the trial, but he was not a party in the lawsuit with his stepfather. He said he was relieved not to have to relive his mother’s death by testifying.

Hamilton was a 48-year-old health-care administrator from Spokane who turned to doctors at The Hutch when her breast cancer returned for the second time in 1992. The Hutch was experimenting with stem-cell transplants for terminally ill breast-cancer patients.

Hamilton was told half of the patients in an earlier, related experiment had died from high doses of chemotherapy. In her trial, however, doctors added two drugs they hoped would protect patients from the potentially fatal side effects.

Given her bad experience with chemotherapy, Hamilton feared she’d throw up the potentially life-saving pills, according to her son. But Hutch doctors told her that if that happened, she would be given the drugs intravenously.

In truth, The Hutch no longer had the IV drug. Two months earlier, the supplier notified The Hutch that it was cutting off the drug. The director of clinical research sent out a memo telling doctors to cross out any reference of the IV in patient-consent forms.

In pretrial testimony, Dr. William Bensinger, who headed the study, acknowledged that he had not crossed out the references to the IV drug.

“I didn’t feel that that was part of my job, number one, and number two, I’m not sure this follows institutional guidelines,” he testified. “I can’t just cross out things willy-nilly.”

The Hutch has since argued that it didn’t matter that Hamilton didn’t get the drug because there’s evidence it would not have worked. But Lasnik said that argument misses the point: Patients evaluate whether to sign up for a trial based on what’s known at the time.

If Hamilton had known the drug was unavailable, Lasnik wrote, she “would not have agreed to the treatment which ultimately killed her.”

During the experiment, Hamilton threw up the pills repeatedly and eventually gave up taking them. She died from the effects of the high-dose chemotherapy 44 days after being admitted to The Hutch.

She had been expected to live another year or two.

At least 10 other family members of patients treated at The Hutch have sued over the deaths of their relatives in another cancer experiment. In that set of clinical trials, called Protocol 126, nearly all of more than 80 leukemia patients died. Trials for those malpractice cases, alleging lack of informed consent under state law, are set to start later this year.

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