Abstract
Infectious diseases have caused widespread misery, and have wreaked havoc physically, mentally, economically, politically, and socially. Fortunately, in more recent years, scientists have developed vaccines. Vaccines are generally very safe, but cause side effects in a small percentage of cases. The United States Congress has passed two major pieces of legislation that provide sweeping tort immunity to vaccine manufacturers and others. In 1986 Congress passed the National Childhood Vaccine Injury Act (NCVIA) and in 2005 it passed the Public Readiness and Emergency Preparedness Act (PREP ACT). Both Acts were passed to encourage manufacturers to develop vaccines, particularly in times of public emergencies, in exchange for expansive liability protection. Both Acts established no-fault type compensation schemes to compensate those suffering injury or death from vaccines without having to resort to typical litigation. The author discusses both Acts in detail, in the context of the current Covid-19 crisis.
Highlights
1.1 Sooner or Later, Everything Old is New Again.1 A Brief Timeline of PandemicsInfectious diseases have plagued mankind for thousands of years
The balance that must be struck, from a public policy standpoint, is how best to promote the widespread use of vaccinations, that have been proven effective in, if not eradicating diseases, at least largely keeping them at bay, while at the same time ensuring that those unfortunate persons that have adverse reactions to the vaccines receive fair compensation
This Article will address the legislation that has been enacted in the United States by the Congress to deal with these complicated issues, namely the 1986 National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. §300aa-1 to 34 (2012)); the 2005 Public Readiness and Emergency Preparedness Act (42 U.S.C. §247d-6d (2012)); as well as one of the key legal cases that has interpreted the legislation, in particular, the Supreme Court’s ruling in Bruesewitz v
Summary
The most recent, and perhaps the most important, legislative enactment providing nearly blanket immunity to manufacturers, distributors and others of vaccines is the Public Readiness and Emergency Preparedness Act (42 U.S.C. §247d-6d) (hereinafter PREP Act). They characterized the PREP Act as a “travesty of the legislative process,” and stated that it could be “used to allow manufacturers of virtually any drug or vaccine to escape responsibility for gross negligence or even criminal acts.” They accused the law’s sponsors of creating “an empty shell of a compensation program for injured patients with none of the funding needed to make compensation a reality.” 49 Public Readiness and Emergency Preparedness Act, 42 U.S.C. The PREP Act authorized the HHS Secretary to issue a Declaration to provide liability immunity to certain individuals and entities (“Covered Persons”) against any claim for loss cause by, arising out of, relating to, or resulting from the manufacture distribution, administration, or use of certain medical countermeasures (“Covered Countermeasures”), except for claims involving “willful misconduct.”. Article will draw heavily upon the OAO in order to explain how the PREP Act works.
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