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“Legal Issues in Transfusion Medicine”

“THE most recent, and potentially most dangerous, disease of the twentieth century, AIDS.” Thus Dr. L. A. Laskey (Senior Scientist, Genentech Corp.) described a problem that led to a conference on September 19-20, 1985, in Washington, D.C., U.S.A.

You likely know that AIDS (Acquired Immune Deficiency Syndrome) has been linked to blood products and to transfusions. The printed program put it this way:

“No single health concern in our memory has created as much discussion and fear among the general public. AIDS cases may double in the next year, and as many as one million Americans [and countless more in other lands] may be affected. The potential legal liability flowing from AIDS, therefore, is great.”

Some 200 doctors, lawyers, and blood-bank personnel gathered for the conference on “Legal Issues in Transfusion Medicine.” The jobs or careers of most of these were linked to blood transfusions. But some of Jehovah’s Witnesses also attended. Let us share with you excerpts from what the speakers revealed.

The main concerns were the risk of spreading AIDS by blood and the legal risks for those in their industry who collect, process, or sell blood. This latter concern was evident from the first talk, on the ‘organization, economics, and regulation of the blood-banking system.’ Such regulation, Dr. P. J. Schmidt said, dates to the 1600’s. French physician Denis was involved “in the first malpractice suit in transfusion” history, for giving “lamb’s blood to a young man, who died.” Is regulation still needed? Schmidt admitted: “I think there are a lot of unknowns. Still, the very act of transfusion is an enormous day-in-day-out challenge. A million times a month in this country it is an experiment in immunology, in epidemiology, often without legal precedent.”

Later, Dr. Paul Ness (The Johns Hopkins Hospital) spoke on “What Can Go Wrong With Transfusion.” He felt that in just “a half of an hour it is very difficult to talk about all of what can go wrong with blood transfusion.” In fact, he intended to show a slide that said, “Warning,” as if it were a label, “the following can go wrong with blood transfusion,” listing “about 50 different things . . . [But] I knew that list wouldn’t be complete in any way.”

Dr. Johanna Pindyck (Greater New York Blood Program) said that ‘non-A non-B hepatitis is the most pressing transfusion-transmitted disease problem confronting us in the transfusion field.’ This form of hepatitis “is thought to be caused by at least two viral agents, but their exact nature has not been identified. Study has been going on for many years​—a good 10 to 15—​but we haven’t discovered the cause yet.” Concerning the best testing available to screen blood for this hepatitis, she commented: “I’d say, probably 10 percent of the blood supply is currently being tested, or maybe even slightly less than that.”

When discussing AIDS, Dr. Pindyck and others expressed the hopeful view that current screening tests now enable blood banks almost to eliminate “blood product transfusion as a source of AIDS transmission.” Can they? Dr. Laskey later stated that present tests ‘are incredibly expensive, are dangerous to produce, and are not completely accurate.’ What about a newly developed method that he feels is superior? He told of experiments with patients having AIDS or the AIDS Related Complex. With a number of them, the tests failed to reveal the AIDS connection. ‘Nobody [that is, none of the tests] would have [detected]’ the AIDS, he said.

You can thus understand why many are considering storing their own blood or accepting blood only from a friend or a relative. But Dr. Joseph Bove (Yale-New Haven Hospital) opposed this, holding that it would be expensive and would lead to shortages. He added: “One of the major causes of transfusion-related fatalities is administrative error​—getting the wrong blood into the wrong person. I’m embarrassed to . . . say that in 1985, with all the technology we have, with computers and everything else, we can’t get the right unit of blood into the right patient. But the truth of the matter is, we don’t always do it, and that’s how we kill people.”

As a result, the conferees had much to say about legal issues. How can a blood bank protect itself against malpractice suits? Now that tests are available, if a donor’s blood tests positive for AIDS antibodies, should the blood bank notify those who received his blood in the last few years? Dr. Schmidt (director of a blood bank) said: “I am an anti-notifier at the moment. We’re doing just what we have to, and no more than that.” Should court orders be obtained to force blood on those refusing it, such as Jehovah’s Witnesses who refuse for religious reasons?

Actually, Jehovah’s Witnesses were considered in Dr. William Dornette’s talk, “Negligence and Liability Issues.” He explained that one basis for Witnesses’ refusal of blood “is this chapter from Genesis [9:3, 4]. And it specifically says that ‘I do give it all to you. Only flesh with its soul​—its blood—​you must not eat.’” How reasonable is that position, and what legal right do Witnesses have to refuse blood?

Dornette, a doctor both of medicine and of law, advised: “For many, many years the members of the Jehovah’s Witnesses faith have been considered a bunch of oddballs who don’t know what they’re doing, because ‘I the medical profession​—the doctor—​know everything.’ We have to realize that, first of all, they are deeply religious. Secondly, they are American citizens . . . Third, they do have the right to practice religion, and they are interested in getting well . . . They believe in medical care. And I think we’ve got to respect their rights as individuals to practice religion freely.” He added: “Failure to obtain any consent at all is a battery. Failure to obtain consent for a transfusion is a battery. . . . If you obtain a competent patient’s informed refusal, you have absolved yourself from exposure to liability in a court of law.”

Another speaker, lawyer Susan Lentz, stressed this, saying: “It’s important to understand that informed consent is really meaningful only if you recognize that it includes not only the right to give consent but also the right to withhold consent.” She added that “in this very year there have been three or four [court] decisions affirming rights of Jehovah’s Witness patients to decline transfusions.” She concluded: “As what you’ve been hearing about for the last day and a half regarding AIDS and related problems become more of a problem, at least in the mind of the public, problems related to refusal may also increase.”

(Additional useful information on AIDS will appear in Awake! of April 22, 1986.)

[Box on page 26]

Can patients trust that a blood bank will be able to detect AIDS-contaminated blood? Dr. Myron Essex, chairman of the department of cancer biology at Harvard School of Public Health, recently said: “It’s extremely unlikely that the test is picking up more than 90 percent, and my best guess is it’s 75 to 80 percent. I’d be shocked if it’s any better than that.”​—The New York Times, October 4, 1985.

[Box on page 27]

“The new blood test, approved last April and used by all blood banks, detects only antibody to the AIDS virus, HTLV-III. What it, unfortunately, does not detect are people who harbor infectious AIDS virus and who have not as yet produced antibody to the AIDS virus . . . Therefore, a small but significant number of the approximately one million people harboring the AIDS virus will not yet reveal antibodies to the virus on current routine testing at blood banks.”​—Sanford F. Kuvin, M.D., Jerusalem, November 17, 1985.