When patients are faced with life-threatening injuries or diseases, they sometimes rely on blood donations to save their lives. What happens when the blood they rely on to save them actually makes them sicker?

FDA Oversight

In the United States, the Food and Drug Administration (FDA) is charged with overseeing the safety of the blood supply. The FDA licenses and registers blood collection facilities, develops policies and regulations for the manufacture of blood products, and enforces regulations concerning the blood supply. Despite the government's efforts to protect the nation's blood supply, tainted blood enters the market. Tainted blood can enter the blood supply through negligent screening of donors or negligent testing of blood. In the absence of negligence, blood may be tainted because a disease contained in the blood is not something blood banks are aware to test for. For example, at the beginning of the AIDS epidemic, thousands of people were infected with the disease through blood tainted with the disease.

Blood Shield Laws

Litigation against the suppliers and distributors of contaminated blood products has sometimes held these parties strictly liable for injuries sustained as the result of the contaminated blood. In addition, sometimes hospitals and other health care providers have been held liable for providing patients with contaminated blood or blood products. In response to these lawsuits and as a means to prevent blood banks, suppliers, and distributors from paying claims from HIV/AIDS litigation, hepatitis litigation, and other tainted blood claims, the vast majority of states have passed "blood shield" laws. While these laws vary depending on the jurisdiction, in general, they are designed to prohibit the imposition of strict liability against blood suppliers, blood product manufacturers, and health care workers in cases involving the inadvertent use by healthcare providers of defective blood products. These laws state that blood and blood products are not "products" subject to strict product liability if they are defective.

The blood shield laws provide a great deal of protection to the blood and blood product industry. However, this protection is not absolute. Manufacturers of blood products, such as plasma factor concentrate used to treat hemophilia, can be held liable for negligence if a plaintiff can prove that the manufacturer was actually negligent. Thus, plaintiffs must show that the manufacturer knew or should have known of the risk of injury to the plaintiff and unreasonably failed to protect against such risk. As the burden of proof is much higher than that needed to establish strict product liability, the manufacturers often prevail.

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