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Supreme Court of New Jersey to AABB: 'You're guilty and that's final.' (American Association of Blood Banks)

The launch of the American Revolution in 1775 came with the shot heard 'round the world. British attempts to control colonial trade and to tax the colonists to pay for the costs of colonial administration and defense went against the traditions of local self-government. This eventually incited the colonies to rebellion. If the premise is true that those who do not learn from history are doomed to repeat it, then the recent shot taken by the New Jersey judicial system at the American Association of Blood Banks (AABB) could provoke a revolution among standard-setting organizations nationwide.

The Supreme Court of New Jersey recently upheld a lower court ruling that found the AABB negligent for failing to recommend surrogate testing (for antibody to hepatitis B core antigen). The AABB, therefore, was held responsible for 30% of the $1.35 million in damages awarded to William Snyder, who contracted AIDS from a transfusion during open-heart surgery in 1984 from blood supplied by the Bergen Community Blood Center, a nonprofit blood bank and member of the AABB. While there was no direct test available at the time to determine whether blood was infected with HIV, the court deemed other methods of making that determination were available.

Despite the AABB's defense that it used all the best scientific knowledge available at the time to determine the quality of the blood used, and regardless of the fact that the AABB cannot enforce AABB members to follow all of its guidelines and standards, the AABB is being held responsible for some $460,000 in damages.

Seeking other remedies

After the New Jersey Supreme Court upheld the lower court ruling, the AABB filed a motion for reconsideration, but it was denied recently. "So we're not going to get the case reheard," said Eric R. Slayton, division director, strategic planning and communications for the Bethesda, Md.-based AABB. "This left us no legal remedies through the judiciary system in New Jersey, and it's not the type of case that would be heard at the U.S. Supreme Court level," he said.

"So we have opted to seek a remedy through the legislature," Slayton continued. "We're in only the formulation stage right now, but we're putting together a process by which we will present a bill that would grant some type of 'qualified' immunity to voluntary standard setters. Such a piece of legislature might be worded to say that from this date forward voluntary standard setters will be exempt from a standard of ordinary care for their standard-setting activities."

"The AABB is a professional association that develops voluntary standards based on the best available scientific and medical information," said AABB General Counsel Philip Schiff. "To impress a duty on the AABB for failing to propose a standard that was not supported by the scientific data available at the time makes all standard setting impossible."

"We need to be put into a position that if we haven't committed gross negligence, we can't be held liable," Slayton added. "In the normal course of setting standards, to hold someone liable for something that a jury says 'should' have existed 10 years ago is not practical."

Another allegation of the Snyder ruling was that the AABB did not provide public input into its standard-setting process. Slayton responded, "So we decided to provide a mechanism of allowing public input into our standard-setting process. Our biggest fear, however, is that this could compromise the process."

How wide a ripple effect?

While it is still unclear exactly what impact this ruling will have on standard-setting organizations, Snyder said, "The concern is now that this case is on the books, it is going to have a potentially serious impact on all standard setters, such as the American College of Gynecologists, the American Association of Tissue Banks, and the American Society of Association Executives."

At a meeting Oct. 16, the AABB board of directors reaffirmed the AABB's commitment to standard setting as a core activity of the Association. The board reaffirmed its responsibility to enhance the quality of all aspects of blood services and transfusion practices by setting standards based on good medical practice and available scientific data.

Roger K. Svoboda, AABB president, said, "The AABB should not retreat from its role as a voluntary standard-setting organization ... We will continue to monitor our standard-setting process and revise it as necessary to continue that role and still protect our association."

The sole dissenting judge in the 6-1 ruling disagreed with the majority's denial of qualified immunity to the AABB. "When a private organization performs a quasi-governmental task that the state would otherwise have to perform, public policy requires a grant of immunity," stated Justice J. Garibaldi. "Otherwise, the private organization 'might well refuse' to perform the task at all, thereby 'increas[ing] the load on the strained resources' of the state .... Granting immunity to nonprofit associations who have assumed some governmental duties will ensure that, undaunted by the prospect of litigation expense and potential damage awards, they will continue to perform the essential public service that they alone are well-positioned to undertake: the good-faith development of industry standards to protect the public health and safety."
COPYRIGHT 1996 Nelson Publishing
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Copyright 1996 Gale, Cengage Learning. All rights reserved.

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Author:Zacharia, Mark
Publication:Medical Laboratory Observer
Date:Dec 1, 1996
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