Order Code RS22327
November 18, 2005
CRS Report for Congress
Received through the CRS Web
Pandemic Flu Liability Limitation Legislation
Henry Cohen
Legislative Attorney
American Law Division
Summary
S. 1873, 109th Congress, the Biodefense and Pandemic Vaccine and Drug
Development Act of 2005, as reported, would eliminate liability, with one exception,
for manufacturers, distributors, administrators, and health care providers, of a security
countermeasure or a qualified pandemic and epidemic product. The exception would
be when the defendant violated the Federal Food, Drug, and Cosmetic Act and, in doing
so, engaged in willful misconduct. This would be a more severe restriction on victims’
ability to recover than exists in most federal tort reform statutes.
Pending Legislation
This report analyzes the pandemic flu liability limitation legislation pending in the
109th Congress, and compares it with existing federal tort reform statutes. At present,
only the Senate has been actively considering a bill on this issue. Section 6 of S. 1873,
the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, as reported
on October 24, 2005, by the Committee on Health, Education, Labor, and Pensions,
would create § 319F-3 of the Public Health Service Act, which would provide that, except
in one circumstance, “a manufacturer, distributor, or administrator of a security
countermeasure, or a qualified pandemic and epidemic product . . . or a health care
provider shall be immune from suit or liability caused by or arising out of the design,
development, clinical testing and investigation, manufacture, labeling, distribution, sale,
purchase, donation, dispensing, prescribing, administration, or use of a security
countermeasure pandemic and epidemic product . . . .”1
The bill defines or amends existing definitions of some of the terms used in the
above quotation. A “security countermeasure” is defined in § 319-F-2(c)(1) of the Public
Health Service Act,2 as it would be amended by § 4(b) of S. 1873, as a drug, biological
1 All references in this report to S. 1873 are to the reported version.
2 Section 319F-2 was enacted by the Project Bioshield Act of 2004, P.L. 108-276, § 3, and is
codified at 42 U.S.C. § 247d-6b.
Congressional Research Service ˜ The Library of Congress

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product, or device (as those terms are defined in the Federal Food, Drug, and Cosmetic
Act) that the Secretary of Health and Human Services approves as necessary to diagnose,
mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear
agent.3
A “qualified pandemic or epidemic product” is defined in § 319L of the Public
Health Service Act, which would be created by § 4 of S. 1873, as having “the meaning
given the term in section 319F-3(c)(5).” This should say “319F-3(d)(5),” as that provision
defines a “qualified pandemic or epidemic product” as a drug, biological product, or
device (as those terms are defined in the Federal Food, Drug, and Cosmetic Act) designed,
developed, modified, or procured to diagnose, mitigate, prevent, or treat or cure a
pandemic or epidemic that the Secretary approves.4
The immunity from suit or liability that S. 1873 would provide with respect to
security countermeasures and qualified pandemic and epidemic products would not apply
in one circumstance, which would be when an HHS administrative law judge finds clear
and convincing evidence that the defendant violated a provision of the Federal Food,
Drug, and Cosmetic Act and in doing so “acted with willful misconduct,” and that such
willful misconduct “caused the product to present a significant or unreasonable risk to
human health; and . . . proximately caused the injury alleged by the party.”5 If an
administrative law judge makes this finding, then the defendant would have a right to
judicial review by the U.S. District Court for the District of Columbia.6 If the
administrative law judge’s finding stands, then the defendant would be liable under
relevant state law; i.e., there would be no caps on non-economic or punitive damages, for
example, except as provided by state law.
In sum, S. 1873 would provide total immunity from liability, except in cases of
willful misconduct that violates the Federal Food, Drug, and Cosmetic Act, for certain
manufacturers, distributors, administrators, and health care providers. Congress has
enacted other tort reform statutes to limit liability under state law, and these are briefly
summarized in the appendix to CRS Report 95-797, Federal Tort Reform Legislation:
Constitutionality and Summaries of Selected Statutes, by Henry Cohen.7 The rest of this
report will describe the broad categories into which these statutes may be placed, so that
S. 1873 can be compared with them.
Comparison with Existing Federal Tort Reform Statutes
S. 1873 is most similar to federal statutes that eliminate liability (usually with
exceptions) and do not provide for an alternate means of recovery by victims. The
General Aviation Revitalization Act, enacted in 1994, for example, bars, without
exception, products liability suits against manufacturers of small planes more than 18
3 This is a summary of a more complex definition.
4 This is a summary of a more complex definition.
5 Section 319F-3(b)(1)(C) and (D), as added by S. 1873, § 6.
6 Section 319F-3(b)(1)(D)(4), as added by S. 1873, § 6.
7 Includes citations to all statutes mentioned in this report.

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years old. The Protection of Lawful Commerce in Arms Act, enacted in October 2005,
bars, with exceptions, suits against manufacturers and sellers of firearms or ammunition,
and trade associations, for damages resulting from the criminal or unlawful misuse of a
firearm or ammunition. The exceptions in the Protection of Lawful Commerce in Arms
Act, include, but are not limited to, violations of law.
With some statutes, Congress has eliminated the right to sue for ordinary negligence,
but not eliminated it for gross negligence or for intentional or willful misconduct.
Examples include the Bill Emerson Good Samaritan Food Donation Act, the Volunteer
Protection Act, the Aviation Medical Assistance Act of 1998, the Cardiac Arrest Survival
Act of 2000, and the Paul D. Coverdell Teacher Protection Act of 2001. S. 1873, by
eliminating liability for gross negligence and retaining it only for willful misconduct that
violates a federal law, would go further in preempting state law than the statutes cited in
this paragraph do.
More than fifty federal statutes provide total immunity to particular private parties,
but make the U.S. government liable, under the Federal Tort Claims Act, in their stead.8
An example of such a statute is section 304 of the Homeland Security Act of 2002, which
immunizes from liability manufacturers and administrators of smallpox vaccine.9 There
are situations, however, in which the U.S. government may not be held liable under the
FTCA, and, in those situations, victims may be left without a remedy.10 Even when the
United States may be held liable under the FTCA, it may never be held liable for punitive
damages.
Occasionally Congress immunizes private parties but establishes a federal
compensation program. Examples include the Radiation Exposure Compensation Act,
which immunized government contractors who carried out atomic weapons testing
8 These statutes make private parties immune from suit by declaring them federal employees for
liability purposes, as the Federal Tort Claims Act makes federal employees immune from liability
for torts they commit in the course of employment. For additional information, see CRS Report
97-579, Making Private Entities and Individuals Immune From Tort Liability by Declaring Them
Federal Employees, by Henry Cohen.
9 The Project BioShield Act of 2004, P.L. 108-276, which enacted § 319F-1(d)(2) of the Public
Service Health Act, 42 U.S.C. § 247d-6a(d)(2), provides that a person carrying out a personal
service contract under the statute, “and an officer, employee, or governing board member of such
person shall, subject to a determination by the Secretary, be deemed to be an employee of the
Department of Health and Human Services for purposes of [the FTCA].” The section, however,
contains exceptions to the immunity from liability that the FTCA otherwise grants to federal
employees: “Should payment be made by the United States to any claimant . . . , the United States
shall have . . . the right to recover against [the person deemed a federal employee] for that portion
of the damages so awarded or paid, as well as interest and any costs of litigation, resulting from
the failure . . . to carry out any obligation or responsibility . . . under a contract with the United
States or from any grossly negligent or reckless conduct or intentional or willful misconduct. . . .”
10 Federal employees, civilian or military, may not sue under the FTCA, but may receive federal
benefits if injured on the job. Plaintiffs who may sue under the FTCA nevertheless may not
recover, and be left without a remedy, if one of the FTCA’s exceptions applies. These include
the discretionary function exception and the exception for claims arising in a foreign country.
For additional information, see CRS Report 95-717, Federal Tort Claims Act: Current
Legislative and Judicial Issues, by Henry Cohen.

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programs from 1946 to 1962, as well as the National Childhood Vaccine Injury
Compensation Act of 1986 and the September 11th Victims Compensation Fund of 2001.
These three programs differ in various ways. Only the radiation law precludes lawsuits.
The vaccine law requires that victims first apply for no-fault, limited compensation under
the National Vaccine Injury Compensation Program (which is funded by a manufacturers’
excise tax on certain vaccines). Claimants, however, may reject what they are offered
under the program and sue under state law, though with some limitations on their rights
under state law. The September 11th fund did not limit the right to sue unless one chose
to file for compensation under the fund, but, with respect to lawsuits, it capped airlines’
liability at the limits of their liability insurance coverage.
Finally, some federal tort reform statutes do not eliminate the right to sue and do not
establish alternative compensation mechanisms. Rather, they cap noneconomic and
punitive damages, limit each defendant’s share of the total liability to its share of
responsibility for the plaintiff’s injuries, or take other steps to limit recovery. Examples
include the Y2K Act, which limited liability for Y2K failures, and the SAFETY Act,
which limits the liability of sellers of anti-terrorism technologies. The SAFETY Act
substitutes a federal cause of action for state causes of action, but continues to apply state
law.11 Capping damages and otherwise limiting liability while retaining the right to sue
is also the approach taken by pending medical malpractice legislation, such as H.R. 5,
109th Congress, which the House passed on July 28, 2005.
11 For additional information on the SAFETY Act, see CRS Report RL31649, Homeland Security
Act of 2002: Tort Liability Provisions, by Henry Cohen.

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