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LAWSUIT SETTLED; U.S. Pays $450,000 for Drug-Study Death

Posted on: Friday, 3 March 2006, 12:00 CST

By Sue Reinert; SUE REINERT

The Patriot Ledger

The federal government has paid $450,000 to settle a wrongful death lawsuit filed by the family of a Massachusetts woman who died in a National Institutes of Health drug study.

Jamie Jackson, 42, of Plainville, a mother of three, died in June 1999 at the NIH hospital in Bethesda, Md. Doctors there said she developed a rare, fatal blood disease after receiving several blood transfusions at the now-closed Southwood Hospital, where she worked as a nurse.

The lawsuit said NIH researchers and Jackson's own doctor in Norwood should have ordered irradiated blood transfusions to prevent the disorder, but they didn't. The label of the chemotherapy drug that NIH was testing in lupus patients like Jackson recommended irradiated blood.

"I do think it was an unnecessary death," said Leslie McGrath, Jamie Jackson's sister. "She was probably going to see her kids grow up and have babies."

Michael Mone, the Boston lawyer who represented Jackson's family, said settlements typically don't admit liability "but obviously there is some recognition by the government that there was a serious issue."

Mone, a malpractice specialist, said he had never before filed suit against the NIH. The agency, the nation's top research center, has settled at least one set of suits involving research: cases involving a study of fialuridine for hepatitis B patients. Ten of the 15 patients in the NIH study died. Terms of the agreement were not available yesterday. Jackson's physician, Dr. Philip Weinstein, also reached a settlement with the Jackson family. Mone declined to disclose the terms and Weinstein's attorney could not be reached.

The Patriot Ledger obtained a copy of the government settlement agreement under the Freedom of Information Act after Asst. U.S. Attorney James J. McGovern at first refused to disclose it.

A NIH spokeswoman referred questions yesterday to the U.S. Attorney's office, which declined to comment. The government had denied any wrongdoing.

McGrath, Jackson's sister, said ending the case without a trial brought closure for the family but also crushed their hopes.

"For seven years we waited and waited to get our day in court and then it just ended," she said. "I would have liked to see (the NIH researchers) say they did something wrong, and the doctor in Norwood, too."

Jackson suffered from lupus, a treatable but potentially fatal disease that mainly afflicts young women. Conventional drugs were not working and the disease had attacked her kidneys.

NIH scientists wanted to see whether a potent chemotherapy drug that suppresses the immune system, fludarabine, would help lupus patients. The drug had been approved to treat leukemia. Drug maker Berlex had warned of the danger of graft-versus-host disease after reports of the disease in a small number of leukemia patients.

Graft-versus-host disease connected with transfusions occurs when immune system cells from a blood donor attack a recipient whose immunity is weak. The disorder kills more than 90 percent of victims when it is caused by a transfusion. Treating donated blood with radiation prevents the transfusion reaction by disabling immune cells in the blood.

Aside from the drug label warning, Jackson needed treated blood because of her extremely weak immune system when she got the transfusions, Mone said.

NIH scientists didn't believe the warning applied to lupus patients.

After Jackson's death, the NIH told study participants to get irradiated blood if they needed a transfusion. The government ended the study in 2000 after another patient developed a milder reaction to the drug.

Sue Reinert may be reached at sreinert@ledger.com.

Source: Patriot Ledger, The; Quincy, Mass.

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