Current tissue donation laws offer little protection - East Valley Tribune: Bodymarket

Current tissue donation laws offer little protection

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Posted: Tuesday, July 13, 2004 10:30 am | Updated: 5:50 pm, Thu Oct 6, 2011.

July 13, 2004

For the rest of his life, Greg Ramirez will think about the day his daughter died, and what the American Red Cross did with her body afterward.

He will remember that day in March 1995, when the truck 19-year-old Heather Ramirez was driving spun out of control at a bend in the road.

She was thrown through the window and died later that day.

He will remember that terrible moment when he learned that her bones had been cut out of her body by the Red Cross, even though he and his wife, Lucinda, had specifically refused to donate them to the tissue bank.

He will remember that families in Arizona have almost no recourse when they are wronged by an organ or tissue bank that improperly picks pieces from the dead.

"There’s no words for it," Ramirez told the Tribune. "It’s undescribable. There’s no regard to any other human concern or desire. I have been totally devastated over the whole thing. My wife has too, and my son.

"That’s all we can think about for the rest of our lives."

Federal regulations and state laws in Arizona are skewed to encourage organ and tissue donation. They require hospitals have procedures in place to ensure

recovery organizations are notified and allowed to solicit organ and tissue donations whenever a patient dies or is near death.

Yet those same laws afford families little protection if something goes wrong.

Organ and tissue banks, as well as hospitals and others involved in the recovery process, have near complete immunity from civil liability in Arizona and every other state.

That immunity was upheld in the state by the Arizona Court of Appeals in a case brought by the Ramirezes. That case remains the precedent here. No federal agency regulates the tissue banks, beyond health and safety issues aimed at preventing disease transmission. No state agency in Arizona regulates tissue banks.

Families are left with no where to turn when things go wrong, said Rodolfo Thomas, executive director of the Arizona Board of Funeral Directors and Embalmers, the state agency that is supposed to have jurisdiction over the disposition of the dead.

"They have no recourse," Thomas said. Tissue banks "are making millions of dollars and nobody is overseeing them."

BATTLE OVER BONES

Heather Ramirez was "a beautiful child; intelligent," and was planning to get married, Greg Ramirez said. After the crash, her body was taken to Tucson Medical Center, where her mother worked as a nursing assistant.

It took less than an hour for a social worker to approach the Ramirezes to ask them for permission to harvest Heather’s tissues. They agreed to allow her eyes, skin, heart valves, veins, ligaments and tendons to be taken, believing they could be used to ease the suffering of others, Ramirez said.

They could not bring themselves to donate Heather’s bones.

In the end, it did not matter what the Ramirezes agreed to. Heather’s bones were cut from her body, along with the other tissues, by a Red Cross recovery team. They eventually wound up in California.

There was miscommunication when the paperwork was filled out, Red Cross and hospital lawyers said in the subsequent court case.

It took two years for the Ramirezes to get Heather’s bones back. In the end, they had to sign a liability waiver to retrieve them, Greg Ramirez said. They had DNA tests done on the bones to make sure they were Heather’s. After they were cremated, her tomb had to be reopened so they could be added to the rest of her remains.

At first the Red Cross was uncooperative, Ramirez said. Red Cross lawyers "flaunted" their legal immunity from civil liability, he said.

But after he threatened to take his story to the media, the tissue bank became more cooperative, he said. Heather’s bones were re turned and the Ramirezes reached a settlement with the Red Cross, which prohibits him from disclosing the terms.

"They didn’t care a damned bit about anybody," Ramirez said. "All they cared about was their own name. They are heartless. I really don’t care to even live in this world with people like that."

Ryland Dodge, director of biomedical communication for the Red Cross in Washington, D.C., said in a written statement that the Ramirez case was "a very unfortunate incident, and an isolated one."

The Red Cross modified its consent procedures to add safeguards after the Ramirez case, Dodge said. For example, under current procedures two members of the procurement team must review the consent forms and verify, in writing, that the permission for each tissue is appropriately documented, Dodge said.

REASON FOR IMMUNITY

The Ramirezes did proceed with their lawsuit against Health Partners of Southern Arizona, the corporation that operated Tucson Medical Center at the time. There was no dispute about the facts of the case when it reached the state Court of Appeals. The issue came down to the immunity in the state’s anatomical gift law.

The court ruled in 1998 that tissue banks and hospitals are immune from civil liability unless it can be proven that tissue was improperly procured with the intent to "maliciously cause injury" to the family or the deceased. The laws on the books in Arizona since 1954 have granted immunity in organ and tissue recovery if the recovery agency acts in good faith, the court held. The law also includes a presumption that those recovering tissue are acting in good faith. Compliance with the law or procedures for obtaining consent are not required for immunity to apply, the court held.

Even the notion that the Ramirezes had any right to determine what happened to Heather’s body was called into question by the court.

Courts have given families what amount to property rights over a loved one’s body for the purpose of making funeral arrangements, the judges wrote.

"It seems reasonably obvious that such ‘property’ is something evolved out of thin air to meet the occasion, and that in reality the personal feelings of the survivors are being protected under a fiction likely to deceive no one but a lawyer," the opinion states.

There is good reason to give organ and tissue banks immunity, said Greg Harris, a lawyer who lobbies for Donor Network of Arizona, the state’s designated organ recovery agency.

To be viable for transplant, organs such as the heart, kidneys and liver must be recovered quickly, before the patient’s heart stops beating. While there is more time to recover tissues meant for transplant, that window still is tight, Harris said.

Those recovering organs and tissues cannot afford to "dillydally" if the threat of litigation arises after organs or tissues have been recovered, maybe even transplanted, he said.

"Some decisions are final and there needs to be a point at which there’s certainty," Harris said. "If we didn’t have good faith protection, people would never know whether the donation was final and whether there would be a litigation risk associated with it. We would dry up our donation process."

A study of the tissue banking industry by the inspector general of the U.S. Department of Health and Human Services found in 2001 that there are few restrictions imposed at the federal level.

FEW RESTRICTIONS

No federal agency regulates the business practices of tissue banks, including the procedures they must follow to obtain consent from family members for donation, the report found.

The Food and Drug Administration does have health and safety standards for organizations that recover tissue for human transplant. The FDA sets standards for sterilization and record-keeping aimed at preventing the transmission of disease. The regulations do not apply to tissue banks that recover whole bodies or body parts that are not used for transplants, but rather for medical education and training.

The FDA began requiring tissue banks that procure and process human tissue for transplantation to begin registering with the agency in 2001, said Lenore Gelb, spokeswoman for the agency. Prior to that, no government agency even knew how many transplant tissue banks there were in the United States.

The inspector general recommended a series of reforms by the FDA and other federal agencies that would impose some standards for how families must be treated when they agree to donate a loved one’s body parts.

Those reforms have not been implemented, according to representatives of the federal agencies specified in the report.

Arizona law mandates that consent for donation be obtained, either from the prospective donor before death or by designated legal representatives or family members after death. The law sets the order regarding who can give consent, but beyond that imposes no standards for what must be disclosed.

A person may refuse to donate, or specify how donated organs and tissues can be used, under Arizona law. A donor gift registry was authorized two years ago, which allows people to register as organ and tissue donors before they die.

If a person preregisters as a donor, the organs and tissues can still be harvested, even if the family objects, under Arizona law.

There is no mechanism in Arizona for a family that believes it has been wronged to file an official complaint against a tissue bank with any state agency.

Several industry organizations have model guidelines spelling out what family members should be told when permission is sought to recover tissues from a loved one.

However, those standards can only be enforced on tissue banks that have opted to join the accrediting organizations.

Dr. Duke Kasprisin, chief medical officer for the American Red Cross and current president of the American Association of Tissue Banks, said that while there is little government regulation of the tissue banking industry, there are ethical standards that most reputable tissue banks abide by.

"Not everybody has to follow those guidelines and rules, but most people do," Kasprisin said. "It sounds a little bit helterskelter. But it’s not as helterskelter as it sounds. It’s helterskelter from a regulation standpoint. But the industry is trying to get to the same endpoint. It doesn’t have the impact of regulation. But I don’t want it to seem like everybody is saying there’s not regulation so we won’t do it."

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