IRB e-mail of September 6, 2002
Subject: FYI - Human Subject Research Misadventure

Friday, August 09, 2002

Judge: Hutch didn't reveal study's risk to patient

By David Heath

Seattle Times staff reporter


The Fred Hutchinson Cancer Research Center suffered a major defeat in a lawsuit yesterday when a federal judge ruled that the center was liable for failing to inform a 48-year-old woman with breast cancer of the risks in a clinical trial in which she died.

In a rare summary judgment, District Judge Robert Lasnik concluded that Kathryn Hamilton would not have enrolled in a clinical trial in 1993 had she been told the facts.

The judge said a "reasonable jury" could not reach any other conclusion.

Lasnik limited his ruling to the fact that "The Hutch" had failed to tell Hamilton that a potentially lifesaving drug was not available in a form that she could tolerate. He left other issues, including the extent of monetary damages and whether The Hutch misled Hamilton in other ways, to be decided by a jury.

Hamilton's case was brought to light last year in a series in The Seattle Times, "Uninformed Consent: What patients at 'The Hutch' weren't told about the experiments in which they died." The Hutch has characterized the series as "blatantly false."

Hamilton's son, Seattle attorney Chris Addicott, said yesterday, "Since the Times story came out, it has frustrated and angered me that The Hutch has consistently tried to maintain that it did nothing wrong, in the face of such overwhelming evidence to the contrary.

"With this ruling, the court has swept aside The Hutch's arguments and vindicated what I've been saying all along, ruling as a matter of law that nobody would willingly subject themselves to an otherwise lethal dose of chemotherapy knowing that they would be denied the one drug they were told might save them."

The Hutch did not comment on the judge's ruling in Hamilton's case yesterday. The Hutch noted instead that the judge dismissed some but not all of the claims made in another lawsuit against the center brought by the family of Becky Wright, a leukemia patient who died in another experiment, Protocol 126.

"In both lawsuits, we intend to defend the remaining claims vigorously and expect to show that the center and its physicians acted in the best interest of their patients," its statement said.

The Hutch had tried to get the case dismissed on the grounds that Hamilton's husband, Allan Berman of Spokane, filed the lawsuit after the statute of limitations had passed.

Lasnik ruled against The Hutch's motion and said a jury should decide that issue.

In his 11-page decision, Lasnik said that The Hutch violated Washington's informed-consent law by telling Hamilton that a drug intended to prevent serious damage from high-dose chemotherapy was available in intravenous form. But it was not.

If The Hutch had told her the drug was unavailable, "Hamilton would not have agreed to the treatment which ultimately killed her," the judge wrote.

The Hutch was trying to find the highest dose it could safely give of two chemotherapy drugs for breast-cancer patients getting stem-cell transplants. In its first attempt, The Hutch saw two of its first four patients die from the lethal effects of this chemotherapy.

In Hamilton's cancer trial, Protocol 681, Dr. William Bensinger added two other drugs to try to prevent such lethal side effects. Hamilton was told that if she threw up the pills - which she had done often in past cancer treatments - she would be given the two drugs intravenously.

However, two months before Hamilton enrolled in the trial, the supply of the intravenous drug had been cut off. A Hutch memo told researchers to change the informed-consent statements to reflect this. However, the informed-consent statement given to Hamilton said the IV drug was available.

Hamilton repeatedly vomited the pills and died from toxic side effects of chemotherapy 44 days after entering the hospital. Without the experimental treatment, Hamilton was expected to live another year or two.

The Hutch has argued that Hamilton's not getting the drug didn't matter because it proved ineffective.

"This argument misses the point," Lasnik wrote. She was entitled to informed consent.

The Hutch also argued that Hamilton was so desperate that she would have participated in the cancer trial even if she had known that the IV drug wasn't available.

Lasnik said there was no evidence to support this argument and concluded that Hamilton would not have enrolled in the trial if she had been properly informed.

Hamilton also was given "false and misleading" information about how many patients had been enrolled and died before her in the cancer trial, Lasnik wrote.

The day before Hamilton entered the hospital, a doctor told her that "there have been no deaths" among the 15 patients in her trial.

In fact, there were 31 patients and seven had died by that day, Lasnik wrote, including one who suffered serious organ damage from the high-dose chemotherapy.

The lawsuit is set for trial on Sept. 16.

Issues for the jury will include whether The Hutch misled Hamilton by misstating the number of deaths in her trial; whether it misled her about the result of research done on the drug's effectiveness; and when Hamilton's husband first suspected The Hutch was negligent.