Mass Immunization Cases: Drug Manufacturers\u27Liability for Failure to Warn

In recent years, the manufacturers of polio\u27 vaccines, administered in mass immunization programs at public health clinics, have been beseiged with a flurry of cases in which they have been held liable for failing adequately to warn of the dangers inherent in the use of an otherwise pure, unadulterated drug. As a result of the relatively large judgments awarded in these cases and the almost insurmountable practical problems of preventing further liability, drug manufacturers have ceased, or are threatening to cease, production of these essential, life-saving vaccines. Consequently, these recoveries threaten the effectiveness of the nation\u27s preventative health care programs and contravene the strong public policy of combating infectious disease through widespread vaccination campaigns. Furthermore, as community health care centers increase in number and expand in function to meet the emerging needs of the nation\u27s medical patients, the drug manufacturer\u27s potential liability is multiplied. In addition, although the scenario for most of the mass immunization cases thus far has been the administration of polio vaccine at a public health clinic, the holdings foreshadow the extension of their rationale to other immunization agents or drugs distributed at a clinic, or at any in-patient or out-patient facility,in an impersonal assembly-line fashion in which nurses perform important dispensing functions without direct physician supervision. Because the primary mass immunization cases have involved the imposition of liability for injuries resulting from the administration of a polio vaccine, this Note initially will discuss the history of the development of this vaccine to provide a more complete understanding of the factual background surrounding these cases. The holdings of the mass immunization cases and the rationales proffered to support the imposition of liability on the drug manufacturers will be examined. Further, this Note will investigate in depth the practical problems faced by drug manufacturers because of these cases and, lastly, will propose possible solutions to those problems