You asked for information on the recently passed federal “Public Readiness and Emergency Preparedness Act. ” You are interested in its liability protections for vaccine manufacturers and distributors, its preemption provisions, and the arguments for and against the legislation.

SUMMARY

This federal act was passed as part of the Department of Defense Appropriations bill for FY 06 (Division C of H. R. 2863; P. L. 109-148) and signed into law on December 30, 2005. It provides immunity from lawsuits under state and federal law for manufacturers and distributors of pandemic and epidemic products (including vaccines) and security countermeasures, in the event that the Health and Human Services Department (HHS) secretary declares a public health emergency as a result of a disease or other health condition. The only exception to this immunity is in the case of “willful misconduct. ”

The act prohibits any federal or state court from reviewing the HHS secretary's action in declaring an emergency. Also, it preempts any conflicting state or local communities' laws during the effective period of the declaration.

The legislation also provides a process for establishing an emergency compensation fund to compensate individuals whose injuries or death are directly caused by the administration or use of a product covered by an emergency declaration. But it does not provide any specific funding for this.

FEDERAL PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT

Immunity from Lawsuits

Under the legislation, a covered person (the United States or countermeasure manufacturer or distributor) is immune from suit and liability under Federal and State law concerning all claims for loss caused by, arising out of, or resulting from the administration to or the use by an individual of a covered countermeasure if a public health emergency declaration has been issued with respect to the countermeasure (§ 319F-3. (a)(1) of Division C of H. R. 2863; see below for discussion of declaration of an emergency).

The act defines “loss” as death; physical, mental, or emotional injury, illness, disability, or condition; fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and loss or damage to property, including business interruption loss (§ 319F-3. (a)(2)).

Declaration of a Public Health Emergency/Court Review

The HHS secretary triggers the liability protections by declaring a public health emergency if he determines that a disease or other health threat represents an emergency or may constitute an emergency in the future. The law does not list any criteria for determining the existence of an emergency. But the declaration must list the diseases, populations, and geographic areas covered and when the emergency would end (§ 319F-3. (b)).

The secretary's declaration is not subject to review by any U. S. or state court, whether by mandamus (a writ by which a court commands the performance of a particular act) or otherwise (§ 319F-3. (b)(7)).

Willful Misconduct

The law provides an exception to the immunity protection in the case of “willful misconduct. ” This is defined as an act or omission that is taken (1) intentionally to achieve a wrongful purpose; (2) knowingly without legal or factual justification; and (3) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. The legislation goes on to state that the above criterion “shall be construed as establishing a standard for liability that is more stringent than a standard of negligence in any form or recklessness” (§ 319F-3. (c)(1)(A),(B)).

The plaintiff has the burden of proving by clear and convincing evidence willful misconduct by each covered person sued and that the willful misconduct caused death or serious physical injury (§ 319F-3. (c)(3)).

Preemption

The legislation prohibits a state or a political subdivision of a state from establishing, enforcing, or continuing in effect with respect to a covered countermeasure any requirement that:

1. differs from or conflicts with any requirement applicable under this section; and

2. relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use or any other aspect of safety or efficacy; the prescribing, dispensing, or administration by qualified persons of the covered countermeasure; or to any matter included in a requirement applicable to the covered countermeasure under this act or under the federal Food, Drug, and Cosmetic Act (§ 319F-3. (b)(8)).

Preemption applies during the effective period of the secretary's declaration, or at any time with respect to conduct taken in accordance with the declaration.

Compensation Fund

The legislation provides for establishment of a “Covered Countermeasure Process Fund” in the Treasury when the HHS secretary issues a declaration. The fund's purpose is to provide “timely, uniform, and adequate compensation to eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure according to the declaration. ” The legislation does not appropriate any money for the fund at this time (see § 319F-4. (a)).

A person claiming injury from a covered treatment may not sue without first trying to collect from the compensation fund. That requirement applies only if the compensation program has been funded. A person can sue if HHS fails to act on the request for compensation within 240 days. If a plaintiff accepts an award from the fund, he is barred from suing anyone (see § 319F-4. (d)).

Supporters and Opponents of the Legislation

U. S. Senate Majority Leader Bill Frist was supportive of the legislation, believing that real, imminent dangers posed by diseases like avian flu underscore the serious need to bolster U. S. preparedness by enacting meaningful liability reform. He commented that the measure “extends limited protections to manufacturers, distributors, and first-responders, so that life-saving countermeasures, such as an H5N1 avian flu vaccine, will be developed, deployed, and administered. ” Senator Frist continued that the bill “strikes a reasonable balance where those who are harmed will be fairly compensated and life-saving products will be available in ample supply to protect and treat as many Americans as possible” (see LexisNexis News, January 6, 2006).

Those arguing against the legislation include Senator Edward Kennedy, as well as consumer and advocacy groups such as Public Citizen and the National Autism Association. Senator Kennedy tried to strip the liability protection provisions because he believed the accompanying compensation plan did not ensure that those who may be hurt by the products would be paid for their injuries. Kennedy stated that he supported liability protections for both avian flu and biodefense products, but he wanted the compensation program funded ahead of time. He commented, “there is no guarantee that any victim of a faulty or negligently made drug or vaccine will receive any compensation

whatsoever. ” He also complained that the emergency countermeasures were so broadly defined that even products that mitigate side effects of a biodefense product are covered. (see LexisNexis News, December 23, 2005).

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