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Legal guidelines for blood banking and transfusions.

In the vast majority of cases, blood banking and transfusion activities benefit patients. On rare occasions, patients or donors suffer adverse effects, some of which may have legal consequences.

It's important for blood bankers and transfusion personnel to be aware of these kinds of problems. Certainly, donors and patients are learning about them. The general public is becoming more aware of medicolegal developments and related ethical issues as these matters receive increasing attention in nonscientific as well as scentific circles.

In this article, we'll discuss issues of negligence and alternative liability theories, informed consent and privacy in blood donation and transfusion, and attempts to avoid liability by obtaining signed releases. Next month, we'll look further at negligence and consider such questions as the patient's right to refuse transfusion and the newly emerging issue of the patient's right to treatment, including access to rare donors.

Our intent is to highlight areas of legal concern for blood bankers. We won't include government regulations or try to provide a guide to state requirements. Since the law is always in flux and state laws are not uniform, our discussion can only be a prelude to, not a substitute for, appropriate legal consultation.

We will start by noting that individuals who suffer injury as a result of blood donation or transfusion can seek compensation from the persons or institutions responsible. There are many potential causes of such injury--errors in labeling and crossmatching and the use of contaminated blood are a few examples--but the legal system does not attach liability in every instance. Negligent acts or omissions must lead to the harm, generally.

To have an actionable case of negligence, the injured party must prove that a duty of care was owed, that the duty was breached, and that this breach caused damage. Because negligence involves creation of a foreseeable and unreasonable risk of injury, some possible consequences of transfusion, such as non-A, non-B hepatitis, don't ordinarily give rise to negligence liability.

A lack of care can be difficult to demonstrate in certain transfusion cases, particularly those involving hepatitis. Some courts, beginning about 30 years ago, tried to allow recovery without proof of negligence, on the basis of theories of warranty liability or strict product liability, as might be applied in the case of a defective car. Today, however, negligence is again the primary legal theory.

In addition to negligence, a second legal concept--informed consent--can have a significant impact on liability. A health care professional who does not secure consent from a donor or patient before drawing or transfusing blood may be subject to civil liability for battery. In several more recent decisions, courts hae required that the consent be informed: knowledgeably and voluntarily given by a competent individual who has been told of the risks involved.

With that much as background, let's examine some key legal considerations in the donation process first. One point to bear in mind is that a donor who gives informed consent does not forfeit the right to sue the individuals or the blood bank involved if negligence results in injury. Recovery of damages hinges on a showing that lack of due care caused the injuries.

In Brown v. Shannon West Texas Memorial Hospital, for example, the plaintiff developed an infection in he arm after she donated blood. She claimed that this injury resulted from the use of an unsterile needle, but she did not introduce any direct evidence on this point. With no evidence of causation, the court upheld a judgment for the defendants.

Hospitals and blood banks sometimes try to protect themselves from liability suits by having donors sign forms that purportedly release the institution from negligence liability. Increasingly, courts view such releases with disfavor. In Boll v. Merck, Sharpe & Dohme, Inc., a paid donor fell after donating blood and sued for injuries, even though he had signed a covenant not to sue. The claim was valid, according to the court. It saw nothing in the agreement that exempted the defendant from the obligation to use ordinary care in procedures for drawing blood.

The validity of a release was again at issue more recently. In Smith v. Hospital Authority of Walker, the plaintiff signed a release before donating blood, purportedly absolving the hospital and its personnel of liability. After the donation, and allegedly as a result of negligence in the phlebotomy, he suffered serious nerve injury in his arm.

The court held that the release's exculpatory clause was void because it violated public policy (as opposed to a particular statute). The principle used in this case might be applied against any release that tries to shield a hospital or its personnel from liability for negligence.

Even if blood drawing procedures are appropriate, blood banks have an initial duty to screen and examine donors to insure they are suitable candidates to give blood. In Bowman v. American National Red Cross, the plaintiff claimed she told the donor screening nurse that she was anemic and had recently given birth. Her blood was drawn nevertheless, and she became very ill after the phlebotomy. The court found for the plaintiff on the basis of evidence that the screening was carelessly performed.

Blood banks also have an obligation to transfusion recipients to use care in screening donors. Current concern about possible transmission of acquired immune deficiency syndrome (AIDS) by transfusion highlights the weight of this duty. Yet blood banks must walk a fine line. Barring all members of a group that is at high risk for AIDS may conflict with municipal or state anti-discrimination statutes. Right now, blood banks depend largely on self-deferral, providing information about high-risk groups to potential donors in the hope that individuals who fall into those groups will refrain from donating.

Blood banks also have some obligations of privacy and confidentiality toward donors, under state laws. This protection may grow out of definition of the physician-patient relationship or common law rights to privacy, or from specific data privacy statutes. In Head v. Colloton, for example, hospital records about a potential donor's blood type were ruled confidential and exempt from disclosure under the state's public records statute.

As with donations, informed consent is an initial issue in the transfusion process. To obtain it, physicians should explain potential complications and risks of hepatitis. The matter is not cut and dried, however; court decisions conflict on this point. Furthermore, when the patient is a minor or otherwise incompetent, a parent or guardian--as specific statutes designate--ordinarily gives consent.

Consent forms are merely evidence, not conclusive proof, of informed consent. This is important to remember because transfusions are usually an element of other medical or surgical procedures, and consent to transfuse is often obtained as part of the overall procedure. It may be more helpful to have separate, explicit transfusion consent forms for special circumstances (such as possible objections on religious grounds) or procedures (such as apheresis).

The best care taken during blood donations can't eliminate risks inherent in using material derived from human sources. Although Federal regulations require testing of donors for hepatitis and syphilis, laboratory tests do not screen out all infectious donors, even when the tests are performed scrupulously. Likewise, routine questioning of potential donors is not completely effective. They may not know they have a disease or may wish to conceal it.

What are the consequences of this impossibility of eliminating all risk? Plaintiffs suing for damages because of transfusion-related hepatitis have explored theories of liability other than negligence, which involves lack of care, to bolster their cases. As we noted earlier, the courts have had to consider whether warranty liability and strict product liability are applicable when the evidence does not support negligence.

The former theory is a provision of the Uniform Commercial Code, a set of statutes enacted in almost every state. It states that the sale of goods carries an implied warranty or contract: The goods are fit for the ordinary purposes for which they are used. If the goods are defective, the buyer may sue and recover without any need to prove negligence.

Perlmutter v. Beth David Hospital was one of the first cases in which a plaintiff attempted to recover for transfusion-related hepatitis on the basis of implied warranty. The New York Court of Appeals rejected the theory, reasoning that a transfusion could not properly be characterized as a product, but is rather a service that's part of the hospital's overall treatment.

Following Perlmutter, plaintiffs in many states sought recovery for transfusion-related hepatitis on similar theories. The suits were largely unsuccessful because most courts adopted the same reasoning as the New York court.

These cases generally focused on the dichotomy between sale and service, but the legal distinction really represents an underlying policy determination that liability shouldn't be imposed on blood banks for such unpreventable consequences. The Minnesota Supreme Court, in Balkowitsch v. Minneapolis War Memorial Blood Bank, said:

"We find it difficult to give literal application of principles of law designed to impose strict accountability in commercial transactions to a voluntary and charitable activity which serves a humane and public health purpose. The activities involved in the transfusion of whole blood, a component of the living body, from one human being to another may be characterized as sui generis in that the sequence of events involve acts common to legal concepts of both a sale and a service. Moreover, it seems to us that under the facts in the case before us it would be unrealistic to hold that there is an implied warranty as to qualities of fitness of human blood on which no medical or scientific information can be acquired and in respect to which plaintiffs' physician has the same knowledge and experience as the supplier."

Today, most states have laws that define blood transfusions as services. In a few states, however, commercial blood banks may still be subject to warranty liability through statutes or judicial decisions.

Creative plaintiffs' attorneys were not defeated by warranty liability's lack of success in most jurisdictions. About 15 years ago, plaintiffs with transfusion-related hepatitis began to argue that their cases should be decided under the theory of strict product or tort liability.

This theory makes the seller of a defective, unreasonably dangerous product liable for harm to the user. Like warranty liability, it provides recovery without proof of negligence, but it requires to implied contract between buyer and seller.

A 1970 Illinois Supreme Court decision, in Cunningham v. MacNeal Memorial Hospital, marked the first case to hold a hospital strictly liable for transfusion-transmitted hepatitis. The court reasoned that blood was a product sold by the hospital to the patient, and that other legal factors necessary for imposing strict liability were present.

Despite technical differences, little distinguishes warranty and strict product liabilities in practice. Courts have therefore since rejected strict product liability in blood bank cases for the same reasons they rejected warranty liability. Even Illinois enacted a law, after Cunningham, that placed transfusions in the category of a service. Many other states have passed laws closing off product liability as an avenue for claims arising from transfusion-related illnesses.

Transfusions are not unique in this respect. Courts recognize other exceptions for "unavoidably unsafe" products that carry risks justified by the benefits they offer and by lack of alternatives. Drugs especially fall into this category, and several courts have included blood by the same rationale: "The scientific inability to screen all carriers of viral hepatitis despite due care makes blood an unavoidably unsafe product."

Only a very few courts have allowed recovery for transfusion-related hepatitis without regard to this exception or to statutory provisions defining transfusion as a service. One case running counter to the trend was a 1981 decision of the trend was a 1981 decision of the Louisiana Supreme Court, DeBatista v. Argonaut Southwest Insurance Co. The court read the applicable state law narrowly, holding that it applied only to warranty claims only. Judgment for the plaintiff was based on strict product liability.

DeBatista notwithstanding, it's probably safe to conclude that neither warranty nor strict product liability will count as factors in lawsuits spurred by transfusion-transmitted diseases. This does not mean that physicians, blood banks, or hospitals are free from liability--but plaintiffs must prove negligence to recover. We'll discuss aspects of negligence liability in our concluding article next month.
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Title Annotation:part 1
Author:Lentz, Susan L.; Polesky, Herbert F.
Publication:Medical Laboratory Observer
Date:Oct 1, 1984
Previous Article:Changes loom for second year of DRGs.
Next Article:Controlling reference testing costs; group purchase discounts and computerized test audits helped this lab slash send-out costs.

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