109-148 , which was signed into law on December 30, 2005, and which limits liability with respect to pandemic flu and other public health countermeasures. Division C, which is titled the "Public Readiness and Emergency Preparedness Act," (PREP Act) created § 319F-3 of the Public Health Service Act, which provides that, except in one circumstance (discussed below under "New Federal Cause of Action"), a "covered person" would be immune from suit and liability for "all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration ... has been issued with respect to such countermeasure." The declaration referred to is a declaration by the Secretary of Health and Human Services (HHS) of a public health emergency or the credible risk of such emergency. Immunity from Liability

Division C defines a "covered person" to include the United States and a (i) manufacturer, (ii) distributor, (iii) program planner, (iv) qualified person who prescribed, administered, or dispensed a covered countermeasure, or (v) official, agent, or employee of (i) through (iv). Since then, the Secretary of HHS has issued additional declarations covering various countermeasures against anthrax, botulism, acute radiation syndrome, smallpox, and various strains of influenza. Comparison with Existing Federal Tort Reform Statutes

Congress has enacted other tort reform statutes to limit liability under state law. Division C eliminated tort liability except for willful misconduct, and therefore falls in between these two categories. In addition, Division C would allow injured persons to recover compensation from the Covered Countermeasure Process Fund, if Congress appropriates money for it.
Division C of P.L. 109-148 (2005), 42 U.S.C. §§ 247d-6d, 247d-6e, also known as the Public Readiness and Emergency Preparedness Act (PREP Act), limits liability with respect to pandemic flu and other public health countermeasures. Specifically, upon a declaration by the Secretary of Health and Human Services of a public health emergency or the credible risk of such emergency, Division C would, with respect to a "covered countermeasure," eliminate liability, with one exception, for the United States, and for manufacturers, distributors, program planners, persons who prescribe, administer or dispense the countermeasure, and employees of any of the above. The exception to immunity from liability is that a defendant who engaged in willful misconduct would be subject to liability under a new federal cause of action, though not under state tort law, if death or serious injury results. Division C's limitation on liability is a more extensive restriction on victims' ability to recover than exists in most federal tort reform statutes. However, victims could, in lieu of suing, accept payment under a new "Covered Countermeasure Process Fund," if Congress appropriates money for this fund.
The first PREP Act declaration was issued on January 26, 2007, to limit liability for the administration of the H5N1 influenza vaccine. Since then, declarations have been issued covering countermeasures against other strains of influenza (including H1N1), anthrax, botulism, small pox, and acute radiation syndrome.