$1 million added to estate of asthma study victim

Hopkins reached private accord with dead woman's family

November 28, 2001|By Walter F. Roche Jr. | Walter F. Roche Jr.,SUN STAFF

The estate of a woman who died in a Johns Hopkins asthma experiment grew by more than $1 million soon after the medical school reached a confidential settlement with her family.

The increase in the estate of Ellen M. Roche was recorded recently in court records filed in Baltimore County.

Roche, 24, died June 2 after inhaling a chemical as part of a study of the causes of asthma. The Reisterstown woman was a laboratory technician at Hopkins' Asthma and Allergy Center at the Bayview campus.

Her death prompted a federal investigation into safety violations that led to a temporary halt in experiments on humans at Hopkins.

Investigators concluded that the Hopkins scientist conducting the asthma experiment, Alkis Togias, failed to fully research past studies on the risks of the chemical and failed to tell Roche or the university review board that an earlier volunteer in the experiment had developed a persistent cough.

Court records do not indicate the source of the $1 million increase in Roche's estate. The revised estate inventory was filed Nov. 1 in Towson, three weeks after attorneys for the family and the medical school announced that they had reached a private settlement for an undisclosed sum.

The estate lists Roche's father as the only "interested party," and it does not include a will.

The probate case is active, and nothing has been filed indicating what will be done with the proceeds. The attorney for the estate could not be reached to comment yesterday.

When the settlement was announced, attorneys for the family said the agreement would end threats of a lengthy lawsuit and provide enough money to help the family set up a scholarship program in Roche's honor.

Before the settlement, family attorneys and her father, Bernard J. Roche Jr., filed a preliminary estate inventory that listed her assets as her equity in a condominium and a savings account of $2,243. According to those filings, when Roche died she owed $74,682 on a mortgage to finance the purchase of the $83,000 Reisterstown condominium One claim, for $4,627, has been filed against the estate by the attorneys for a credit card company. The estate also lists funeral and burial expenses.

Craig Schoenfeld, attorney for Roche's family, declined to comment yesterday on the estate filing or whether it represents all, part or none of the settlement agreement. He said he considers the estate filing a private family matter.

"I'm not at liberty to talk about the settlement," Schoenfeld said.

The attorney said the scholarship fund, which will benefit students in health fields, has been established. Contributions have been accepted, he said.

Joann Rogers, a spokeswoman for the medical school, also declined to comment, noting confidentiality provisions of the settlement agreement.

Roche died while participating in an experiment in which volunteers inhaled the chemical hexamethonium. The purpose of the study was to determine what triggers asthma attacks.

In a subsequent report, federal officials concluded that information was readily available showing that several patients who had received hexamethonium to treat hypertension in the 1950s suffered respiratory failure. Some of them died, the federal report noted.

The federal reviewers also found fault with the wording of the consent form signed by Roche and other participants in the experiment. On that form, researchers called hexamethonium a "medication" though it was no longer approved by the Food and Drug Administration, the report said.

Volunteers, the report concluded, should have been told that the chemical, which lost federal approval in 1972, was being used experimentally. Even when hexamethonium was an approved medication, it was never approved for use in an inhaled form, according to the investigative report.

The federal agency also criticized the Hopkins review board that approved the experiment.

In July, the federal Office of Human Research Protection concluded that the problems at Hopkins were not limited to the asthma experiment. The report noted widespread lapses in safety procedures and a failure throughout the university to supervise experiments on humans.

Federal investigators said they found multiple instances in which different descriptions of the risks of an experiment were given to the university's institutional review board and to the volunteers participating in the studies.

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