New wave of tainted blood litigation: hepatitis C liability issues.

• Author: Reser, R. Jo

Both individual cases and class actions are raising multiple issues of liability and the bases on which damages may be imposed

A NEW wave of tainted blood litigation caused by the hepatitis C virus (HCV) has begun. Thousands of patients in the United States are receiving HCV "look-back" notifications that they may have been exposed to hepatitis C. Plaintiffs' lawyers are beginning to advertise for people who have contracted hepatitis C through a blood transfusion, organ transplant or the use of any blood products.

The hepatitis C epidemic in the United States has created international litigation. A group of Canadians, claiming that they were infected by tainted blood products collected from prisoners in the United States, have filed a $ 660 million lawsuit against the Canadian government and several private companies for failing to adequately safeguard the blood supply. This class action suit charges Ottawa with neglect for failing to set aside blood plasma collected in Arkansas prisons in the early 1980s after U.S. health officials already had determined that using the product was "imprudent" because of the high risk of infection. At the time, there was no test to indicate the presence of Hepatitis C. The plasma should not have been collected from inmates who tested positive for hepatitis B.

TREATMENTS FOR HEPATITIS C

While there is no known cure for hepatitis C, in January 1999, the U.S. Department of Veterans Affairs announced plans to offer a costly new drug treatment to former military personnel suffering from hepatitis C. Kenneth W. Kizer, the department's undersecretary for health, was quoted in the Washington Post as stating that the department's package, costing $12,000 to $15,000 a year per patient, is a harbinger of costly medical treatments to come as new drugs become available to treat chronic ailments in veterans. Kizer said the costs of the HCV initiative--$250 million to $300 million this year alone--have provoked questions outside the V.A. about the necessity of this effort.

He said the cost should rise next fiscal year to $400 million to $500 million. Even "at government prices," he maintains the HCV initiative is a cost-effective way to fight a disease that V.A. surveys have found is widespread among veterans. HCV can lead to other costly medical treatments including liver transplants.

Veterans who choose the new treatment face a difficult program. Side effects of the drugs involved--interferons and ribavirin --are said to be serious, and include depression, anemia and flu-like symptoms. Only half of those who take the treatments improve, and those who do are not said to have been cured, but only to have eliminated signs of active liver disease.

HCV LOOK BACK

In 1989, Texas enacted Section 162.008 of the Texas Health and Safety Code, which enumerates "procedures for notifying blood recipients." This statute provides:

Each hospital, physician, health agency and other transfuser of blood shall strictly follow the official "Operation Look Back" procedure of the American Association of Blood Banks (AABB) or the American Red Cross Blood Services in notifying past and future recipients of blood. The only exception to notifying a recipient of blood is if the recipient is dead or cannot be located. Physicians and hospitals thus must take seriously the FDA's recent look back "recommendations." The FDA recommended that blood establishments begin by March 1999 to look back whenever a donor tests positive for HCV virus. The look back is a retest of samples from all previous donations by such individuals, going back 10 years, followed by notice to hospitals and physicians, who must in turn inform patients who received this reactive blood or blood products.

The FDA required that this take place as soon as possible and be completed by March of this year. Blood consignees, which include hospital and transfusion services, have one year from the date of their notification to attempt to notify recipients of the infected blood.

A minimum of three attempts must be made to notify the recipients of HCV-infected blood. The notification can be carried out in two ways: (1) by notifying the patient and concurrently the physician who ordered the blood or blood products, or (2) by notifying the physician who ordered the blood products, who is then to notify the patient. If the physician fails to notify the patient, the hospital or transfusion service should notify the patient. The patient's medical record must documents all attempts at notification, even unsuccessful efforts.

Compliance with the FDA's recommendations is likely to be adopted by the U.S. Health Care Financing Administration (HCFA). Development of a compliance plan, as well as the education of physicians, clinical staff, management and directors and/or trustees, is essential for any provider.

While compliance with industry standards has not allowed defendants an out in litigation, the failure to comply with such standards usually proves fatal. Jury research has shown that jurors were not impressed with claims of compliance with government standards. Where industry standards were at issue, compliance was even less of a factor in favorably impressing jurors.

There is strong evidence that a defense based on compliance will elicit no more than a neutral reaction among jurors, according to Donald Vinson's research in his book Jury Trials: The Psychology of Winning Strategy. However, when the defendant is a non-complier, evidence suggests the jurors will be quick to form a negative opinion. In fact, non-compliance has potentially disastrous consequences. On the same approval ratings scale, defendants in non-compliance cases scored very low and were regarded as unbearable by jurors. In fact, if the plaintiffs pursue a strategy of demonstrating that the defendant is in noncompliance with established standards, defense counsel will have a difficult time bringing jurors up to a position of mere neutrality.

With the U.S. government recommending and offering expensive HCV treatment to thousands of veterans, it would be difficult to explain a failure to follow an FDA or HCFA recommended look back program in the private sector.

Hernandez v. Nueces County Medical Society Community Blood Bank,(1) decided by the Texas Court of Appeals, dealt specifically with hepatitis C infection caused by transfusion after the delivery of a baby by ceasarian section. The court examined the new screening procedures being used by other blood banks and held that "since, in the instant case, there is evidence that the blood bank may have unduly lagged in the adoption of new screening procedures, we hold that evidence of compliance with federal and minimum licensing standard does not conclusively insulate the blood bank from liability."

The court cited Learned Hand's Second Circuit opinion in The T.J. Hooper:

Indeed in most cases reasonable prudence is in fact common prudence; but strictly it is never its measure; a whole calling may have unduly lagged in the adoption of new and available devices. It never may set its own tests, however persuasive be its usages. Courts must in the end say what is required; there are precautions so imperative that even their universal disregard will not excuse their omission.(2) These are the tasks that risk managers, counsel and physicians are face in dealing with the HCV look-back recommendations of the FDA and other future regulations. To understand the way courts will look at the duties of the physicians, hospitals and their staff, one must examine how the courts in the past have assessed their various responsibilities in similar cases of tainted blood.

LEGAL ISSUES

Cases involving blood products are personal injury cases, so many of the legal principles to be applies are similar to or the same as those used in cases of general negligence, products liability and medical malpractice.

1. Parties

   Blood product cases can be divided generally into two types: (1) those involving the donation, preparation and transfusion of human blood; and (2) those involving the donation, manufacture and administration of blood products.

   In most cases involving the donation and administration of human blood, the donation is obtained by a blood bank or transfusion service from a voluntary donor, who typically (but not always) gives for altruistic reasons. The blood is fractionated into two to three separate components (platelets, red blood cells, cryoprecipitate, fresh frozen plasma, etc.) and then shipped to a hospital, where the blood is transfused under the specific orders of a physician.

   In the second category of cases, blood is obtained from an altruistic, voluntary donor or from a paid donor. The second category of cases usually involves a process known as "apheresis" (literally--to take away), in which a specific component is removed from the blood and the remainder of the blood is transfused back into the donor. In most instances, the component withdrawn is plasma, white blood cells or platelets. The component is then sold to a manufacturing company, which turns the donated material into a usable end product through specific manufacturing processes. The end product is sold to doctors and hospitals, who prescribe it as needed. These types of cases typically involve factor VIII and factor IX concentrates. Hemophiliacs are usually dependent on factor VIII and factor IX concentrates to clot their blood.

   Who is a necessary party in a blood products case depends on the type of case and the nature of the injury. Physicians have a duty to order a transfusion only when it is medically necessary. Nurses and nurses' assistants usually are responsible for the actual transfusion. Hospitals are responsible for obtaining and maintaining a supply of safe blood and for monitoring its use by physicians who have privileges at the hospital. Hospital laboratories (and pathologists) type and cross-match the blood in order to determine whether the blood ordered for transfusion...