title: Rethinking blood shield statutes in view of the hepatitis C pandemic and other emerging threats to the blood supply.
abstract: Researchers have identified at least twenty-five pathogens that can be transmitted through blood transfusions. Four percent of patients who receive the average amount of blood during a transfusion are at risk of being infected with a contaminated unit, and exposed to the danger of serious adverse reactions, including future debilitating conditions. Victims of transfusion-related diseases, however, generally have been unsuccessful when making claims against the purveyors of blood products because of blood shield statutes that were initially enacted in response to unknown pathogens that made the blood an "unavoidably unsafe" product. Today, blood purveyors are aware of the possibility of epidemics from unsafe blood and have continued to research and supervise the blood supply to create mechanisms that detect and inactivate various blood-borne pathogens. In response to the current and advancing methods of blood purification, this Article suggests that a hybrid strict liability/negligence standard be implemented to ensure advancements in safety of blood transfusions. A strict liability standard should attach for infections that can be detected and eliminated through current testing and inactivation methods. A negligence standard should govern infections for which no current test or inactivating method is available. Under this approach, blood purveyors would be compelled to take account of the risks of any manufacturing decisions that they make, and they would not enjoy the freedom from liability that the blood shield statutes now provide. The costs necessary to ensure compliance with this hybrid structure are small in comparison to the social and economic costs exacted by thousands of transfusion-related diseases.
authors.affiliation: ruedaa_andres@hotmail.com
authors.forename: A
authors.initials: A
authors.lastname: Rueda
mesh_terms: D001771:Blood Banks / Q000331:legislation & jurisprudence* / Q000592:standards; D001782:Blood Donors / Q000331:legislation & jurisprudence*; D001803:Blood Transfusion / Q000592:standards; D017848:Blood-Borne Pathogens; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control / Q000635:transmission; D006526:Hepatitis C / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission; D006801:Humans; D016365:Liability, Legal; D008318:Malpractice / Q000331:legislation & jurisprudence; D017751:Safety Management / Q000331:legislation & jurisprudence*; D065227:Transfusion Reaction; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration