Transfusion-associated HIV infection: the legal legacy.
We learned soon enough. The direct and indirect impact of AIDS on blood service has been staggering. The situation, although referred to as a national epidemic, would be more accurately described as a series of subepidemics.
The battle against the transfusion-associated sub-epidemic that struck blood recipients is almost over, and the winners are patients who rely on blood service. Events changed dramatically in March 1985, when the FDA licensed the first HIV testing kits for screening donated blood.
One painful reminder of this subepidemic is the series of transfusion-associated AIDS lawsuits on file across the country. The battle between blood bankers and HIV seems to be nearly over-at least, for now-but the battle between lawyers and medical expert witnesses has just started.
* Major arguments. The allegations in most of these suits boildown to the following points:
Failure to use the antibody to hepatitis B core antigen test, known as core-antibody, as a surrogate for AIDS testing before the latter was licensed.
2. Inadequate donor screening and selection.
3. Inadequate sharing of blood bankers' knowledge with physicians and patients.
In a few isolated cases, issues included directed donations and failure to test blood inventory adequately when HIV screening became available. In the main, however, the three allegations listed above are the basic claims used in transfusion-associated cases.
* Delayed outcry. A small group of medical expert witnesses, mostly from California, seems to pop up all over. They have cited negligence by individual blood banks, national organizations, and the Federal Government. Yet from 1983 to 1985, the crucial "war years" against transfusionassociated HIV infection, these same experts failed to alert the blood banking community that screening procedures were insufficient. They never appeared at American Association of Blood Banks (AABB) meetings, wrote letters to medical journals, or petitioned the FDA to require surrogate testing and more specific screening of male donors. If they had, this information would now serve as evidence in lawsuits.
The Federal Government can be proud of the roles played by the CDC and the FDA in the war against transfusion-associated HIV infection. Instead of voicing that pride, authorities seemed intent on insuring that the same criticisms, valid or invalid, were never raised again.
*Bureaucratic demands. One example of the Government's overreaction took place shortly after plaintiff experts started givingtestimony by deposition in some West Coast lawsuits. As if in response to their allegations, the FDA issued a memorandum in 1986 to the blood banking community. The memo recommended "voluntary, confidential, self-exclusion" programs for high-risk individuals.
The FDA told us to create a system in our blood banks wherein high-risk individuals who wanted to donate blood could appear to do so. We were told to let them donate blood and then prohibit its transfusion by a system so confidential that not a single person working in any blood bank could ever know who donated that dangerous unit of blood-which would be immediately destroyed.
The memo describing this new requirement exemplified the late Dean Acheson's Rule of the Bureaucracy: "A memorandum "is written not to inform the reader but to protect the writer." The cost of introducing to our system the self-exclusion program recommended by the FDA was astronomical. Yet the mandated routine had no definable value to anyone except persons wishing to give the impression of being at no risk by donating during a company or community blood drive.
Many such programs existed before the 1986 recommendation. The only blood banks affected by the memo were those whose managers had already considered and rejected the concept.
Any blood program that wanted a confidential self-exclusion policy needed no authorization from the FDA. Thus, we can assume the memo was written not to inform the reader but to protect the writers from further criticisms by plaintiff experts.
In following the recommendation, we are deliberately introducing high-risk units of blood to our inventory-units we can only hope will be detected by the system before they find their way to the operating room. We are also submitting our blood bank staff to an unnecessary risk of exposure. The cost of processing these units can be recaptured only by passing it along to recipients.
The worst aspect of this system is that it violates the integrity of the donor interview process. Essentially we are telling donors that they may lie to the interview nurse when giving a health history or describing their life-style. We are implying that it is fine to ignore the AIDS information that identifies high-risk individuals-a dangerous message indeed.
If high-risk donors can confidentially prohibit the transfusion of their blood, then our entire donorscreening process applies only to the no-risk individuals we needn't have been concerned about in the first place. It is surely time for the FDA to reconsider its 1986 memo on confidential selfexclusion.
The Federal bureaucracy is not alone in overreacting to the allegations of medical expert witnesses in HIV Infection-related lawsuits. Blood bank management will never again allow logic, economics, efficiency, or increased productivity to override the medicolegal aspects of decision making.
*Sequelae. Because of fallout from these suits, blood banks are now adding staff without regard to productivity, designing new and expensive computer systems without regard to need, and redesigning donor and patient consent forms so complex that few persons will agree to donate blood and even fewer will agree to accept a transfusion.
We will continue to add testing procedures each year until few units will test non-reactive for every procedure. We will then be providing a unit of blood so safe that it can never harm a recipient-and so expensive that no patient could ever afford to be transfused with it.
More than five decades have been dedicated to developing the world's finest blood supply and transfusion system. Yet hysteria by blood bankers and Government officials induced by HIV lawsuits has brought the system to a crisis in less than five years.
Nearly all lawsuits filed to date against blood banks involve blood transfusions that took place between late 1982 and March 1985, before tests for HIV began. Early legal decisions repeatedly found in favor of blood banks. Judges and juries seemed sympathetic to the blood bank's dilemma in combating this new risk to the blood supply. After all, the cause of AIDS had not yet been determined, the virus had not yet been identified, and no appropriate laboratory test had been licensed.
A precedent was set when a Federal judge in the District of Columbia issued a summary judgment in favor of the Red Cross Blood Center and Georgetown Hospital (Kozup v Red Cross and Georgetown Hospital). An infant in critical condition at birth had received a contaminated transfusion in January 1983 and later died of AIDS at age 2 before the case was brought to trial.
The judge ruled tha"foresight and not hindsight must be the guide." He further noted that the CDC meeting on Jan. 3, 1983, "had reached no consensus" on the best method of preventing the spread of AIDS by blood transfusion, The judgment, in favor of the blood bank, was appealed. The higher court upheld it in the summer of 1987 .
At approximately the same time, Borchelt v Irwin Blood Bank went to trial in San Francisco. The case, which was settled in mid-tria], involved a patient who later developed AIDS. The blood bank was determined to have failed in following its own guidelines for preventing the transmission of a dangerous blood-borne disease.
The blood bank had sent a unit of blood to the hospital for transfusion even though a question on the donor form regarding hepatitis exposure was blank. This violated the blood bank's policy against distributing blood when the donor interview form was incomplete. The blood bank now says, however, it had evidence that the donor had answered "no" twice before and twice after that history.
*Other decisions. Since those two early cases, rulings favorable to blood banks have been made in Colorado (Quintana v UBS), Arkansas (Kirkendall v Harbor Insurance Co.), Texas (Baker v Wadley Blood Center), and Atlanta (Jones v Miles Laboratories).
The Atlanta case, although against a pharmaceutical company rather than a blood bank, has important implications for the blood banking industry. The trial judge overruled the jury, saying that the verdict, in favor of the plaintiff, was based on neither the law nor the facts.
A San Francisco jury found a blood bank guilty of negligent failure to inform and awarded $750,000 in a transfusion-associated AIDS case (Osborn v Irwin Blood Bank). The plaintiffs said they had been refused the option of using directed donor blood. The jurors later said they felt the blood bank had inconsistently applied its own policy of allowing directed donations under certain conditions. The blood bank, now appealing the case, avers that it had allowed directed donations only as rare exceptions and that the jury did not understand the difference between a general policy and a procedure to handle exceptions. Since no family member could have donated blood for the child, the blood bank adds, refusing this option was not the proximate cause of injury.
Soon after the San Francisco verdict, a jury in Milwaukee found a blood bank negligent and awarded the plaintiff $3.9 million (J.A.C. v The Blood Center (of Southeastern Wisconsin). The main issue in this lawsuit was inventory testing at the start of HIV screening in March 1985.
The blood bank began HIV testing in March but continued to provide blood components from units drawn previously without testing those units. The plaintiff, who had been transfused one month after the start of HIV screening, argued that the blood bank should have organized a mandatory recall of untested components rather than allowing the hospital to decide whether to return such units.
While these two verdicts in favor of plaintiffs have alarmed blood bankers, it's important to understand the issues. In Milwaukee, the transfusion of an untested unit one month after the start of testing represented an unusual, although not unique, situation. In San Francisco, although a putatively inconsistent directed donation policy was cited, the jury was probably swayed by the condition of the patient-a five-year-old boy with little chance of having a normal life or reaching adulthood.
Since few transmission cases involve children and even fewer involve the transfusing of untested blood after official testing began, these two cases should not strongly affect the 200 or more transfusion-associated suits cur
rently on file around the country.
* Confidentiality. A side issueraised in lawsuits in New York, Florida, Texas, Illinois, Washington, Ohio, and Pennsylvania-involves donor privacy and the confidentiality of blood bank records. The specter of a single volunteer donor's testifying in court or becoming involved in civil litigation is enough to cause sleepless nights for blood bankers everywhere. In one case, lawyers for the plaintiff actually took a donor's anonymous telephone call as a deposition.
Most of the judicial decisions to date have favored the blood bank's position on the need for donor confidentiality. In so ruling, judges have recognized society's need for a free flow of volunteer blood and perceived the chilling effect disclosure would have on donors everywhere. In most cases, while still protecting donor confidentiality, judges are no longer basing their decisions on physician-patient confidentiality, a form of protection on which blood bankers have long celled.
While blood bankers may be winning the confidentiality battle with anonymous donors, they are losing on the broader issue: the right to claim a physician-patient relationship. Fortunately, judges continue to agree that donors have a right to privacy. Their rationale, however, is no longer that a physician-patient confidentiality relationship exists between blood banks and donors but that a breach of confidentiality could diminish the nation's blood supply.
In taking the history, blood bank interviewers try to get donors to tell the truth. If confidentiality can no longer be assured, donors may begin to lie about present and past conditions. The full impact of these rulings may be felt well into the next century. If blood bank records are not confidential, we can no tonger assure donors anonymity.
* Strange wars. Any transfusionassociated AIDS lawsuit quickly becomes a battle-not between blood bank and patient but between lawyers and expert witnesses . In many cases the blood bank has no attorney. The lawyer defending the suit is usually working for the insurance company covering the blood bank rather than for the blood bank itself. This can represent a conflict of interest for the defending lawyer. A successful defense for the blood bank might cost half a million dollars, whereas losing the case in an outof-court settlement might cost only one-fourth of that amount. The insurance company might find it less expensive to lose four cases out of court than to win just one case in court.
The three basic allegations in such suits are essentially hindsight by experts employed by plaintiff's attorneys. Expert witnesses have the advantage of being able to determine what blood banks should have been doing years before.
The surrogate test for AIDS usually cited in these suits as not having been used is the core-antibody. The logic behind using this test-which was available before the HIV test for AIDS was licensed-was that many gay men have been exposed to hepatitis B. If a donor had been exposed to hepatitis B because of sexual activity, then he might also have been exposed to AIDS in the same way. Therefore, as a surrogate test, core-antibody would have excluded many high-risk donors.
Extending this logic would suggest that blood bankers should have used core-antibody not as a surrogate test for AIDS but rather as a surrogate test for homosexuality. Would a physician expert, then, testify with a reasonable degree of medical certainty that any man who is core positive is probably homosexual? That would no doubt be news to the thousands of recently discovered core-positive blood donors throughout the country.
The San Francisco expert physician noted that blood banks don't use core-antibody because it is costly and would cause too many existing donors to be lost. That is not the real reason. The private and Government agencies that set standards of care are not concerned about cost and donor recruitment, yet the core-antibody test was not part of the established standard of care.
Few blood banks in the United States used the core test as a surrogate for AIDS testing-with the important exception of those in the San Francisco Bay area, which began to do so in mid1984. A study of 8,000 blood donors by the Irwin Memorial Blood Bank in San Francisco showed that such testing was useless and confusing. Researchers reported greater differences based on ethnic origin than on sexual preference.
None of the 1983 tests demonstrated an ability to recognize the carrier state of AIDS. That's why we didn't use them-and why no Government or private agency ever established a standard of care on the matter. The experts are accusing blood banks of violating a policy that did not actually exist.
As for the second allegation, inadequate donor screening: One of the plaintiff experts stated that blood banks weren't specific enough in donor screening questions and that the AIDS information material was inadequate. The logic of this allegation is difficult to follow.
The Government disseminated AIDS information based on guidelines provided by the Federal Government and private blood banking organizations. Blood banks that followed the nationally established policies on standards of care for screening donors are involved in the current suits, which allege a failure to interview donors properly.
Can one San Francisco physician, who is not involved in blood banking, be allowed to set a hindsight standard of care for the whole country? Are we really expected to believe that a donor who gave blood after reading the AIDS information material recommended by Govemment and blood banking organizations would have declined to do so if we had asked whether he had ever participated even once in male-to-male anal sex?
The final allegation-failure to share our knowledge of AIDS with physicians and patients-is perhaps the biggest smokescreen of all. It is as though we are being accused of a conspiracy of silence, as if only blood bankers understood AIDS and its possible transmission by transfusion.
Is there a physician in the country today who would deny knowing about this in 1983 and 1984? Was there not a virtual explosion of media information on AIDS during those years? The mass and medical media presented it regularly; television networks, leading magazines, medical journals, radio stations, and daily newspapers jumped on the story. Yet plaintiff experts are saying that if blood bank personnel had explained the dangers of AIDS to physicians and patients, blood transfusions would not have been given.
Lost in all the legal maneuverings, deposition taking, and side issues are the very real problems faced by this innocent group of transfusion-associated AIDS victims. They must anticipate horrendous medical expenses and live with the knowledge that they have been exposed to a virus that leads to a terrible disease. Society must devise solutions for these people-solutions that should represent more than obscene cash awards for trial lawyers and the so-called medical expert consultants they employ. At the very least, we need a method of paying for legitimate medical expenses without bankrupting the entire blood banking system, which plays so vital a role in restoring patients to good health.
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|Author:||Crowley, Richard D.|
|Publication:||Medical Laboratory Observer|
|Date:||Sep 1, 1989|
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