# Homeland Security Act of 2002: Tort Liability Provisions

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URL: https://www.frixlaw.com/law-library/documents/crs%3ARL31649

## Record

- **Collection:** Congressional research report
- **Document type:** CRS Report
- **Published:** May 9, 2008
- **Citation:** RL31649

## Text

Homeland Security Act of 2002:
Tort Liability Provisions
-name redactedLegislative Attorney
May 9, 2008

Congressional Research Service
7-....
www.crs.gov
RL31649

CRS Report for Congress
Prepared for Members and Committees of Congress

Homeland Security Act of 2002: Tort Liability Provisions

Summary
The Homeland Security Act of 2002, P.L. 107-296 (H.R. 5005), contains the following provisions
that limit tort liability, and this report examines each of them.
•

Section 304 immunizes manufacturers and administrators of smallpox vaccines
from tort liability. It makes the United States liable, but not strictly liable, as
manufacturers and administrators would be under state law. Rather, the United
States will be liable only for the negligence of vaccine manufacturers and
administrators.

•

Section 863 limits the tort liability of sellers of anti-terrorism technologies. It
prohibits punitive damages, joint and several liability for noneconomic damages,
and application of the collateral source rule; in addition, it permits the
government contractor defense. Section 864 limits the tort liability of sellers of
anti-terrorism technologies to the amount of liability insurance required by the
Secretary of Homeland Security.

•

Section 890 limits the tort liability of air transportation security companies and
their affiliates for claims arising from the September 11, 2001 air crashes. It
limits it to the amount of their liability insurance coverage on that date.

•

Section 1201 limits the tort liability of air carriers for acts of terrorism committed
on or to an air carrier. If the Secretary of Homeland Security certifies that an act
of terrorism occurred, then air carriers shall not be liable for losses that exceed
$100 million for all claims, but the government shall be liable for losses above
that amount.

•

Section 1402 immunizes air carriers from liability arising out of a Federal flight
deck officer’s use or failure to use a firearm, and immunizes Federal flight deck
officers from liability, except for gross negligence or willful misconduct, for acts
or omissions in defending the flight deck of an aircraft.

•

Sections 1714-1717 limit the tort liability of manufacturers and administrators of
the components and ingredients of various vaccines. They require victims to file
a petition for limited no-fault recovery under the National Vaccine Injury
Compensation Program before they may sue. These sections reportedly were
designed to benefit pharmaceutical manufacturer Eli Lilly in suits against it
concerning Thimerosal. Sections 1714-1717 were repealed by P.L. 108-7 (2003),
Division L, §102.

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Homeland Security Act of 2002: Tort Liability Provisions

Contents
Introduction ..........................................................................................................................1
Smallpox Vaccine Manufacturers and Administrators ............................................................1
No Strict Liability ...........................................................................................................2
Some Other Features of Section 304................................................................................3
Sellers of Anti-Terrorism Technologies: The SAFETY Act ....................................................3
Exceptions to the Application of State Law .....................................................................4
Liability Insurance ..........................................................................................................6
Air Transportation Security Companies .................................................................................6
Air Carriers...........................................................................................................................6
Federal Flight Deck Officers .................................................................................................7
Vaccine Components and Ingredients Manufacturers and Administrators...............................8
National Childhood Vaccine Injury Act of 1986...............................................................8
Homeland Security Act Amendments ..............................................................................9

Contacts
Author Contact Information ...................................................................................................... 10

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Homeland Security Act of 2002: Tort Liability Provisions

Introduction
Tort liability is traditionally governed by state law, but Congress has the power to regulate it
when it affects interstate commerce. Past instances in which Congress has limited tort liability
include the National Childhood Vaccine Injury Act of 1986, which is discussed below, and the
September 11th Victim Compensation Fund of 2001.1 The Homeland Security Act of 2002, P.L.
107-296, contains the following provisions that limit tort liability, and this report examines each
of them.
•

Section 304 immunizes manufacturers and administrators of smallpox vaccines
from tort liability.

•

Sections 863 and 864 limit the tort liability of sellers of anti-terrorism
technologies.

•

Section 890 limits the tort liability of air transportation security companies and
their affiliates for claims arising from the September 11, 2001 air crashes.

•

Section 1201 limits the tort liability of air carriers for acts of terrorism committed
on or to an air carrier.

•

Section 1402 immunizes air carriers from liability arising out of a Federal flight
deck officer’s use or failure to use a firearm, and immunizes Federal flight deck
officers from liability, except for gross negligence or willful misconduct, for acts
or omissions in defending the flight deck of an aircraft.

•

Sections 1714-1717 limit the tort liability of manufacturers and administrators of
the components and ingredients of various vaccines; these sections reportedly
were designed to benefit pharmaceutical manufacturer Eli Lilly in suits against it
concerning Thimerosal. These section were repealed by P.L. 108-7 (2003).

Smallpox Vaccine Manufacturers and Administrators
Section 304(c) of the Homeland Security Act of 2002 amended the Public Health Service Act by
adding 42 U.S.C. § 233(p), which provides that “a covered person shall be deemed to be an
employee of the Public Health Service with respect to liability arising out of administration of a
covered countermeasure [e.g., a vaccine] against smallpox to an individual during the effective
period of a declaration [of a public health emergency] by the Secretary ....” This language
immunizes from tort liability any “covered person,” which the statute defines to include
manufacturers and distributors of a smallpox vaccine, health care entities under whose auspices a
smallpox vaccine is administered, and licensed health professionals or other individuals who are
authorized to administer the vaccine. The Secretary of Health and Human Services issued the
specified declaration, making it effective as of January 24, 2003.2
The reason that the provision just quoted immunizes covered persons from tort liability is that it
deems such persons to be employees of the Public Health Service for tort liability purposes. The
Public Health Service is a federal agency, and the Federal Tort Claims Act (FTCA) makes all
1
Others are listed in CRS Report 95-797, Federal Tort Reform Legislation: Constitutionality and Summaries of
Selected Statutes.
2
68 Fed. Reg. 2121 (January 28, 2003).

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federal employees immune from liability for torts they commit within the scope of their
employment. 3 They are immune, that is, from liability under state tort law; they may be held
liable for violating the U.S. Constitution or a federal statute that authorizes them to be sued.
At the same time that the FTCA immunizes federal employees (and those deemed federal
employees for liability purposes) from liability for torts they commit within the scope of their
employment, it makes the United States government liable for such torts, under the law of the
state where the tort occurred, in the same manner that private employers are generally liable for
the torts of their employees. 4 The FTCA, however, does not permit awards of punitive damages,
and does not allow jury trials. It also contains exceptions under which the United States may not
be held liable even though a private employer in the same situation could be held liable under
state law. Even when one of these exceptions precludes the United States from being held liable,
the FTCA continues to immunize federal employees from liability for torts they commit within
the scope of their employment. 5

No Strict Liability
The exceptions under which the United States may not be held liable include suits by military
personnel for injuries sustained incident to service (the Feres doctrine), suits based on the
performance of a discretionary function (i.e., a policy judgment), suits for assault or battery or
specified other intentional torts, claims arising out of combatant activities, claims arising in
foreign countries, and others.
For present purposes, however, the FTCA’s most significant exception to federal government
liability is that the United States may not be held liable in accordance with state law imposing
strict liability.6 Strict liability means liability regardless of negligence, and manufacturers and
sellers of defective products, including vaccines, may be held strictly liable under state law.7 A
product may be found defective under state law not only when it was defectively manufactured,
but when it was defectively designed in the sense that it feasibly could have been designed to be
safer, or when a warning that might have prevented injury was not provided. The fact that the
FTCA does not permit strict liability apparently means that, under the Homeland Security Act of
2002, the government will not be liable for injuries caused by a smallpox vaccine unless the
plaintiff proves that the vaccine manufacturer or other “covered person” had been negligent, in
which case the government may be held liable, if no other exceptions in the FTCA preclude
liability.

3

28 U.S.C. § 2679(b). See CRS Report 97-579, Making Private Entities and Individuals Immune from Tort Liability by
Declaring Them Federal Employees.
4
28 U.S.C. §§ 1346(b), 2674. Because the United States is liable under the law of the state where the tort occurred,
state tort reform statutes, such as those imposing caps on noneconomic damages, apply in suits under the FTCA. For
general information on the FTCA, see CRS Report 95-717, Federal Tort Claims Act.
5
United States v. Smith, 499 U.S. 160 (1991).
6

Under 28 U.S.C. § 1346(b), liability must be based on a “negligent or wrongful act or omission,” and the Supreme
Court has construed this to preclude strict liability. See, Dalehite v. United States, 346 U.S. 15, 44-45 (1953).
7
In the case of some vaccines, not including smallpox, one may not file a civil action for damages in an amount greater
than $1,000 against a vaccine or administrator until one first files a petition for compensation under the National
Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa-11(a)(2), and the United States Court of Federal Claims
issues a judgment on the petition. This statute is discussed below, under “Vaccine Components and Ingredients.”

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Some Other Features of Section 304
Section 304 also provides that the United States may be held liable for injuries caused by a
smallpox vaccine only if the vaccine was administered by a “qualified person” (a person
authorized by state law to administer the vaccine) during the effective period of a declaration of a
public health emergency by the Secretary of Homeland Security, and only if the person receiving
the vaccine “was within the category of individuals covered by the declaration” or the person
administering the vaccine “had reasonable grounds to believe” he was.
If a person who did not receive the vaccine contracts vaccinia (the smallpox virus), and resides
with an individual who did receive the vaccine, then he shall be “rebuttably presumed” to have
contracted vaccinia from the individual who received the vaccine. This means that, unless the
government proves that the person who did not receive the vaccine contracted vaccinia from a
source other than the individual who did receive the vaccine, the person who contracted vaccinia
may sue the government as if he had contracted vaccinia from the vaccine.

Sellers of Anti-Terrorism Technologies: The SAFETY Act
Section 863 of the Homeland Security Act of 2002, titled “Litigation Management” is part of the
Support Anti-terrorism by Fostering Effective Technologies Act of 2002, or the SAFETY Act.8
Section 863 created a federal cause of action against sellers of anti-terrorism technologies for
claims arising out of “an act of terrorism when qualified anti-terrorism technologies have been
deployed in defense against or response or recovery from such an act ....” Prior to enactment of
this section, suits against sellers of qualified anti-terrorism technology would have been brought
under state law, but the new federal cause of action apparently precludes suits from being brought
under state law. 9 Under the new federal cause of action, liability against qualified sellers of antiterrorism technologies is more limited than it generally is under state law. The Secretary of
Homeland Security shall determine whether an anti-terrorism technology qualifies for liability
protection, and shall place each technology that does on an “Approved Product List for Homeland
Security” and issue it a “certificate of conformance.” The Department of Homeland Security
issued a proposed rule to implement the SAFETY Act,10 then an interim rule, which took effect
on October 16, 2003,11 and then a final rule, which took effect July 10, 2006.12
Under the new federal cause of action, the substantive (as opposed to procedural) law that
governs liability is the law of the state in which the acts of terrorism occur, except for the federal
liability limitations discussed below.13 The significance of creating a federal cause of action is
8

For additional information, see http://www.safetyact.gov.
The SAFETY Act does not explicitly preempt state causes of action, but appears to do so implicitly. Section 863(a)(2)
gives federal district courts exclusive jurisdiction, but the statute does not state that the federal cause of action is
exclusive. It would not seem reasonable, however, to construe the statute not to preempt state causes of action because,
if it did not preempt them, then, because state causes of action in some states do not include liability limitations similar
to those in the SAFETY Act, plaintiffs in those states would bring state causes of action (albeit in federal court) and the
SAFETY Act would have no effect in those states.
10
68 Fed. Reg. 41419-41432 (July 11, 2003), 6 C.F.R. Part 25.
11
68 Fed. Reg. 59684-59704 (October 16, 2003), 6 C.F.R. Part 25.
12
71 Fed. Reg. 33147-33168 (June 8, 2006), 6 C.F.R. Part. 25.
13
This includes “choice of law principles,” which means that, under section 863, if a state’s law calls for the
application of another state’s law, then the first state may apply the second state’s law.
9

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that suits may be brought in federal court regardless of the domicile of the parties and regardless
of the amount of damages that the plaintiff seeks.14 In fact, section 863 requires that suits be
brought in federal court; though federal causes of action generally may also be brought in state
court, this particular cause of action may not be, as section 863 provides that the “appropriate
federal district court” shall have “exclusive jurisdiction.”15

Exceptions to the Application of State Law
Although the substantive law of the state in which the acts of terrorism occur governs the new
federal cause of action, section 863 prescribes some rules that preempt state law.
•

Section 863 prohibits awards of punitive damages and of interest prior to
judgment.

•

Section 863 prohibits joint and several liability for noneconomic damages.
Noneconomic damages are damages for pain and suffering and other losses that
do not constitute monetary expenses, such as medical bills and lost wages. Joint
and several liability is the rule that, if more than one defendant is found liable for
a plaintiff’s injuries, then each defendant may be held 100 percent liable. (The
plaintiff may not recover more than once, but he may recover all his damages
from one defendant, with that defendant then entitled to seek contribution from
other liable defendants.) The reason for joint and several liability is that the
common law viewed it as preferable for a wrongdoer to pay more than his share
of the damages than for an injured plaintiff to recover less than the full
compensation to which he is entitled. Under section 863, in lieu of joint and
several liability for noneconomic damages, “[n]oneconomic damages may be
awarded against a defendant only in an amount directly proportional to the
percentage of responsibility for the harm to the plaintiff.” Joint and several
liability will continue to apply to economic damages, except when state law
provides otherwise.

•

Section 863 eliminates the collateral source rule. This is the rule that allows an
injured party to recover damages from the defendant even if he is also entitled to
receive them from a third party (a “collateral source”), such as a health insurance
company or an employer. The collateral source rule may allow double recovery
for the plaintiff, but the common law viewed it as better for the victim than for
the wrongdoer to profit from the victim’s prudence (as in buying health
insurance) or good fortune (in having some other collateral source available).
Section 863 provides: “Any recovery by a plaintiff .... shall be reduced by the
amount of collateral source compensation, if any, that the plaintiff has received or
is entitled to receive....”

•

Section 863 permits the government contractor defense. This is a defense, created
by the Supreme Court pursuant to “federal common law,” that product

14

28 U.S.C. § 1332 allows state causes of action to be brought in federal court only if the plaintiffs and defendants are
from different states and the amount in controversy exceeds $75,000.
15
The reason that the statute created a federal cause of action, rather than simply requiring state causes of action to be
brought in federal court, may be that it might have been unconstitutional to allow state causes of action between
plaintiffs and defendants from the same state to be brought in federal court. See, In re TMI Litigation Cases Consol. II,
940 F.2d 832, 848-851 (3d Cir. 1991).

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manufacturers may use in products liability cases that allege a design defect or a
failure to warn.16 These are cases, brought under state law, in which the plaintiff
alleges that his injuries were caused by a product that was defective in that the
manufacturer failed to use the safest feasible design for the product or failed to
provide adequate warnings of a product hazard that could not be eliminated by a
feasible safer design. In its defense, the manufacturer may assert that it
manufactured the product pursuant to a government contract and that the design
or warning it used was required by contract specifications. When it successfully
asserts this defense, it may not be held liable. Under section 863, however, as
interpreted by the Department of Homeland Security, “[s]ellers of qualified antiterrorism technologies need not design their technologies to federal government
specifications in order to obtain the government contractor defense under the
SAFETY Act. Instead, the Act sets forth criteria for the Department’s
Certification of technologies [that are eligible for the defense].”17
Under section 863, that is, the government contractor defense would be available “when qualified
anti-terrorism technologies approved by the Secretary” have been deployed, and “[t]he Secretary
will be exclusively responsible for the review and approval of anti-terrorism technology for
purposes of establishing a government contractor defense . . . .” This indicates that the Secretary’s
approval of anti-terrorism technology for purposes of establishing a government contractor
defense is separate from his determination that anti-terrorism technology qualifies to be subject to
suit under section 863 instead of under state law.
Section 863(d) provides:
Should a product liability or other lawsuit be filed ... relating to ... qualified anti-terrorism
technologies approved by the Secretary ... there shall be a rebuttable presumption that the
government contractor defense applies in such a lawsuit. This presumption shall only be
overcome by evidence showing that the Seller acted fraudulently or with willful misconduct
in submitting information to the Secretary ... This presumption of the government contractor
defense shall apply regardless of whether the claim against the Seller arises from a sale of the
product to Federal Government or non-Federal Government customers.”

On its face, this language seems to immunize government contractors from liability for injuries
caused by defects that were not necessarily required by contract specifications, including defects
that were not even design defects but that occurred in the manufacturing process. In other words,
it appears to provide immunity to sellers in all cases in which the seller did not engage in the
specified fraud or misconduct. One might argue, however, that, when section 863 says that “the
government contractor defense applies,” it means only that it applies in the general circumstance
in which it ordinarily applies, namely in design defect cases in which the defendant followed
government contract specifications. The Department of Homeland Security apparently takes this
position when it states that, except when the presumption in favor of the government contract is
rebutted, it is “clear that any Seller of an ‘approved’ technology cannot be held liable under the
Act for design defects or failure to warn claims.... The Department believes that Congress
incorporated the Supreme Court’s Boyle line of cases as it existed on the date of enactment of the

16
Boyle v. United Technologies Corp., 487 U.S. 500, 504 (1988) (design defect); Densberger v. United Technologies
Corp., 297 F.3d 66, 75 n.11 (2d Cir. 2002) (failure to warn).
17
71 Fed. Reg. 33149.

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SAFETY Act, rather than incorporating future developments of the government contractor
defense in the courts.”18

Liability Insurance
Section 864(a) of the Homeland Security Act of 2002 provides that sellers of anti-terrorism
technology to federal and non-federal government customers must obtain liability insurance in
such amounts as the Secretary shall require, and such insurance shall protect, in addition to the
seller, “contractors, subcontractors, suppliers, vendors and customers of the Seller,” and
“contractors, subcontractors, suppliers, and vendors of the customer.” Section 864(b) provides
that “[t]he Seller shall enter into a reciprocal waiver of claims with its contractors, subcontractors,
suppliers, vendors and customers, and contractors and subcontractors of the customers ... under
which each party to the waiver agrees to be responsible for the losses ... that it sustains ....”
Section 864(c) provides that a seller’s liability shall be limited to the amount of liability insurance
coverage that it is required to maintain under section 864(a).

Air Transportation Security Companies
Section 890 of the Homeland Security Act of 2002 limits the liability of air transportation security
companies and their affiliates for claims arising from the September 11, 2001, air crashes. It
limits their liability to the amount of liability insurance they had on that date.
Section 890, more precisely, limits the liability of “persons engaged in the business of providing
air transportation security and their affiliates,” if they are employees or agents of “a citizen of the
United States undertaking ... to provide air transportation” and, if agents, “have contracted
directly with the Federal Aviation Administration on or after and commenced services no later
than February 17, 2002, to provide such security and have not been or are not debarred for any
period within six months from that date.” Section 890 limits the liability of such persons (i.e., air
transportation security companies and their affiliates) only for claims “arising from the terroristrelated crashes of September 11, 2001,” and it limits it to the “amount of liability insurance
coverage maintained by that ... person.”19
The September 11th Victim Compensation Fund of 200120 already provides this liability limitation
for air carriers. What section 890 of the Homeland Security Act of 2002 does is to redefine “air
carrier” to include the persons referred to in the preceding paragraph.

Air Carriers
Section 1201 of the Homeland Security Act of 2002, 49 U.S.C. § 44303(b), limited the liability of
air carriers “[f]or acts of terrorism committed on or to an air carrier” through 2003, and it has
18

Id.

19

It is not apparent the circumstances in which an air transportation security company would both be an agent of a
citizen of the United States who provides air transportation and have contracted directly with the FAA. It is also not
apparent why companies who provided air transportation security on September 11, 2001 are required to have
contracted with the FAA by February 17, 2002 in order to benefit from the liability limitation.
20
49 U.S.C. § 40101 note; P.L. 107-42, title IV, as amended by P.L. 107-71, title II. See CRS Report RL31179, The
September 11th Victim Compensation Fund of 2001.

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been extended through 2008. This section, in effect, reenacted section 201(b)(2) of the Air
Transportation Safety and System Stabilization Act, P.L. 107-42, which was enacted on
September 22, 2001. (Title IV of this act created the September 11th Victim Compensation Fund
of 2001.)
Section 201(b)(2) of P.L. 107-42 conferred a liability limitation on air carriers for terrorist attacks
that might have occurred after September 11, 2001. It provides that,
[f]or acts of terrorism committed on or to an air carrier during the 180-day period following
the date of enactment of this Act, the Secretary of Transportation may certify that the air
carrier was a victim of an act of terrorism and ... shall not be responsible for losses
suffered by third parties (as referred to in section 205.5(b)(1) of title 14, Code of Federal
Regulations) that exceed $100,000,000, in the aggregate, for all claims by such parties
arising out of such act.

If the Secretary so certifies, making the air carrier not liable for an amount that exceeds $100
million, then “the Government shall be responsible for any liability above such amount. No
punitive damages may be awarded against an air carrier (or the Government taking responsibility
for an air carrier under this paragraph) under a cause of action arising out of such act.”
The section in the Code of Federal Regulations that section 201(b) mentions refers to “persons,
including non-employee cargo attendants, other than passengers”; these are apparently the “third
parties” to whom section 201(b) refers, for whose losses above $100 million the government, but
not an air carrier, would be responsible. P.L. 107-42, as noted, was enacted on September 22,
2001, which means that it sunset on March 21, 2002.
Section 1201 of the Homeland Security Act of 2002 extended the period during which section
201(b) would apply to December 31, 2003. It also gave certifying authority for operation of the
liability limitation to the Secretary of Homeland Security instead of the Secretary of
Transportation, and it codified the section in 49 U.S.C. § 44303(b). P.L. 110-161, §114(b)
extended the liability limitation to December 31, 2008.21

Federal Flight Deck Officers
Section 1402 of the Homeland Security Act of 2002 created 49 U.S.C. § 44921 to “establish a
program to deputize volunteer pilots of air carriers providing passenger air transportation or
intrastate passenger air transportation as Federal law enforcement officers to defend the flight
decks of aircraft of such air carriers against of criminal violence or air piracy. Such officers shall
be known as ‘Federal flight deck officers.’” Subsection (h) of section 44921 provides: “(1) An air
carrier shall not be liable for damages in any action ... arising out of a Federal flight deck officer’s
use of or failure to use a firearm,” and “(2) A Federal flight deck officer shall not be liable for ...
acts or omissions ... in defending the flight deck of an aircraft unless the officer is guilty of gross
negligence or willful misconduct.”
Subsection (h)(3) provides: “For purposes of an action against the United States with respect to
acts or omissions of a Federal flight deck officer in defending the flight deck of an aircraft, the
21

For prior extensions, see P.L. 110-116, §§ 101 and 102 (specifically, the new § 156 of P.L. 110-92 added by § 102 of
P.L. 110-116).

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officer shall be treated as an of the Federal Government.” This means (as explained above under
“Smallpox Vaccines”) that the federal government may be sued under the Federal Tort Claims
Act. This is apparently the case even when a Federal flight deck officer is guilty of gross
negligence or willful misconduct, except that, among the FTCA’s exceptions to government
liability is that the government may not be held liable for claims based on assault or battery.
Note that, ordinarily, when a person is treated as a federal employee for liability purposes, he
becomes totally immune from tort liability. Section 1402 makes Federal flight deck officers an
exception, as it leaves them liable for gross negligence or willful misconduct. Subsection (h)(3)
recognizes this by treating Federal flight deck officers’ as federal employees only “[f]or purposes
of an action against the United States”; it does not treat them as federal employees for purposes of
an action against themselves.

Vaccine Components and Ingredients Manufacturers
and Administrators
Sections 1714-1717 of the Homeland Security Act of 2002 amended the National Childhood
Vaccine Injury Act of 1986,22 which is part of the Public Health Service Act. We first explain the
1986 act and then the Homeland Security Act’s amendments to it. Note: sections 1714-1717 were
repealed by P.L. 108-7 (2003), Division L, §102; see the end of this report for details.

National Childhood Vaccine Injury Act of 1986
This statute created the National Vaccine Injury Compensation Program and provides that one
may not sue a vaccine manufacturer or administrator for more than $1,000, for death or injury
caused by vaccines set forth in the statute’s Vaccine Injury Table, unless one first files a petition
for compensation under the Program, and the United States Court of Federal Claims issues a
judgment on the petition. The Program, which is funded by a tax on vaccines, provides more
limited recovery than is generally allowed under state tort law, but provides relatively fast, nofault compensation. It was hoped that “the relative certainty and generosity of the system’s
awards will divert a significant number of potential plaintiffs from litigation.”23
Recovery under the Program is limited to actual unreimbursable expenses, up to $250,000 for
pain and suffering and emotional distress, $250,000 in the event of a vaccine-related death, actual
and anticipated loss of earnings, and attorneys’ fees and other costs, but no punitive damages. A
petitioner dissatisfied with his recovery under the Program may sue a vaccine manufacturer or
administrator under state tort law, with some limitations. Manufacturers are not liable for failure
to provide warnings directly to the injured party, as a warning to the vaccine administrator is
deemed sufficient. There are rebuttable presumptions that manufacturers who comply with
federal regulations are not subject to suit for failure to warn or to punitive damages.

22
23

42 U.S.C. §§ 300aa-1—300aa-34.
H.Rept. 99-908, Part I, 99th Cong., 2d Sess. 13 (1986); reprinted in 1986 U.S.C.C.A.N. 6354.

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Petitions for compensation under the Program are filed for “a vaccine-related injury or death,”
and that “term does not include an illness, injury, condition, or death associated with an adulterant
or contaminant intentionally added to such vaccine.”24

Homeland Security Act Amendments
Sections 1714-1716 of the Homeland Security Act of 2002 made the Program applicable not only
to vaccines in the Vaccine Injury Table, but to “any component or ingredient of any such
vaccine.” Section 1717 made sections 1714-1716 applicable “to all actions or proceedings
pending on or after the date of enactment of this Act,” which was November 25, 2002. An action
or proceeding is no longer pending when a court has entered a judgment that entirely disposes of
it, regardless of whether the time for appeal has expired.
Section 1715 added a sentence to the section quoted above that provides that the Program does
not cover “an adulterate or contaminant.” The new sentence provides that the term “adulterate or
contaminant shall not include any component or ingredient.”
The statute does not state whether a claim that was pending on November 25, 2002 may be
pursued if the statute of limitations in the National Childhood Vaccine Injury Act of 1986 had
already run on that date.25
Although sections 1714-1717 apply to the components and ingredients of every vaccine listed in
the Vaccine Injury Table, press reports indicate that this provision was intended to benefit
pharmaceutical manufacturer Eli Lilly, which has been “a major target in a spate of lawsuits filed
since 2000” concerning Thimerosal, which is a preservative used in some childhood vaccines.
Thimerosal contains mercury, which allegedly has caused autism in some vaccinated children. 26
Courts, however, have held that Thimerosal is not an “adulterant” or “contaminant” as used in the
statute (as quoted above), but is a vaccine “component”27 and therefore was covered by the
Program before enactment of the Homeland Security Act of 2002. A case decided in September
2002 stated:
It appears that every federal court to have ruled on the issue has held that injuries resulting
from Thimerosal contained in vaccines are vaccine-related under the meaning of the Act. See
Liu v. Aventis Pasteur, No. A-02-CA-395-SS, 2002 WL 31007709 (W.D.Tex. August 23,
2002) (holding the injuries were vaccine related in a motion to dismiss); Owens v. Am. Home
Prods. Corp. 203 F. Supp.2d 748 (S.D. Tex. 2002); see also McDonald v. Abbott Labs, 0277 (S.D. Miss. Aug. 1, 2002); Collins v. Am. Home Prods. Corp., 01-979 (S.D.Miss. Aug. 1,
2002); Stewart v. Am. Home Prods. Corp., 02-427 (S.D. Miss. Aug. 1, 2002)(denying motion
to remand and granting motion to dismiss); Strauss v. American Home Prod. Corp., 208 F.
24

42 U.S.C. § 300aa-33(5).
The statute of limitations is three years from “the date of the occurrence of the first symptom or manifestation of
onset or of the significant aggravation of such injury,” except that if a death occurred as a result of the vaccine, then the
statute of limitations is two years from the date of death and four years from “the date of the occurrence of the first
symptom or manifestation of onset or of the significant aggravation of the injury from which the death resulted.” 42
U.S.C. § 300aa-16(a)(2),(3).
26
“Homeland Bill Rider Aids Drugmakers,” Washington Post, November 15, 2002, p. A7.
27
Leroy v. Secretary of the Department of Health and Human Services, No. 02-392, 2002 U.S. Claims LEXIS 284
(October 11, 2002).
25

Congressional Research Service

9

Homeland Security Act of 2002: Tort Liability Provisions

Supp.2d 711 (S.D. Tex., 2002) (finding injuries from Thimerosal are “vaccine-related” under
the Vaccine Act); Blackmon v. American Home Prod. Corp., Cause No. G-02-179 (S.D. Tex.
May 8, 2002) (same); Owens v. American Home Prod. Corp., 203 F. Supp.2d 748 (S.D. Tex.
2002)(same). Additionally, the Department of Health and Human Services has taken the
position that Thimerosal is not an adulterant or contaminant of vaccines.28

It appears, therefore, that, with respect to Thimerosal, sections 1714-1717 would have made a
difference only to the extent that they would have precluded future court decisions that disagree
with these.
P.L. 108-7 (2003), Division L, §102, repealed sections 1714-1717, and provided that the Vaccine
Program “shall be applied and administered as if the sections ... had never been enacted. . . . No
inference shall be drawn from enactment of sections 1714 through 1717 ... or from this repeal,
regarding the law prior to enactment of sections 1714 through 1717. ... Further, no inference shall
be drawn that [this repeal] affects [sic] any change in that prior law, or that Leroy v. Secretary of
Health and Human Services [supra, note 22] was incorrectly decided.”
P.L. 108-7 (2003), Division L, §102, also provides that it is the sense of Congress that, not later
than six months after the date of its enactment, which was February 20, 2003, the Senate
Committee on Health, Education, Labor, and Pensions; and the House Committee on Energy and
Commerce, “should report a bill addressing the issues” of ensuring an adequate supply of
vaccines, developing new vaccines, and liability for vaccine-related injuries.

Author Contact Information
(name redacted)
Legislative Attorney
[redacted]@crs.loc.gov, 7-....

28
Bertrand v. Aventis Pasteur Laboratories, Inc., 226 F. Supp.2d 1206, 1213 (D. Ariz. 2002). This quotation names
eight cases, and the cases cited in this footnote and the previous footnote make a total of ten that have ruled the same
way.

Congressional Research Service

10

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/crs%3ARL31649. Public record. Not legal advice.
