Vaccine Liability in the Era of Bioterrorism

Liability Protection Under Section 304 of the Homeland Security Act for Participants in the National Smallpox Vaccination Program

Section 304 provides liability protection to a range of participants involved in the administration of the smallpox vaccine, including manufacturers, distributors, hospitals, physicians, nurses, and others. The Act refers to these participants as "covered persons" and deems them federal employees of the U.S. Public Health Service (PHS) for liability purposes,^[47] subject to a few modifications.^[48] Lawsuits alleging personal injury and death against PHS employees who were acting within the scope of their office or employment are not allowed under the Public Health Service Act (PHSA). Instead, as discussed above, the federal government substitutes itself as defendant, accepting liability on behalf of the participants through the FTCA,^[49] also subject to a few modifications.^[50] Thus, Section 304 amends and modifies the liability section of the PHSA, which, in turn, modifies the FTCA.

For liability protection to occur under Section 304, six requirements must be met. If one of the requirements is missing, there is no protection. Liability protection is afforded to (1) a "covered person" while acting within the scope of such person's office or employment with respect to (2) claims alleging personal injury or death arising out of administration of a "covered countermeasure against smallpox" that is (3) used to prevent or treat smallpox, or used to control or treat the adverse effects of vaccinia inoculation or of administration of another covered countermeasure, and if administered by (4) a qualified person to (5) specified categories of people during

(6) a time period specified in a declaration issued by the Secretary of Health and Human Services.^[51] The Secretary's declaration, which triggers liability protection, must conclude that "an actual or potential bioterrorist incident or other actual or potential public health emergency makes advisable the administration of a covered countermeasure to a category or categories of individuals."^[52] Thus, a bioterrorism attack does not have to take place to trigger the Act, nor is bioterrorism even required, although the agent must be smallpox. On January 24, 2003, Secretary Tommy Thompson issued the first such declaration ("the Declaration")^[53] and published it in the Federal Register as required (see Appendix A).^[54]

By its express wording, the Act protects only against vaccines and treatments considered "covered countermeasures against smallpox."^[55] If the same vaccines and treatments are used for a pathogen other than smallpox -- for example, to prevent the spread of monkeypox^[56] -- Section 304 does not apply. Moreover, if vaccines or treatments are developed or used for other possible bioterrorism agents (e.g., bacteria such as plague, toxins such as botulinum, viruses such as ebola, etc.), the Act must be amended or a new law enacted.

A covered countermeasure can be any substance (1) used to prevent or treat smallpox, including vaccinia^[57] or another vaccine; or (2) "used to control or treat the adverse effects^[58] of vaccinia inoculation or of administration of another covered countermeasure."^[59] With respect to the first category, while vaccination given within the first few days after exposure to smallpox can prevent or ameliorate the subsequent illness,^[60] currently there are no treatments for smallpox approved by the Food and Drug Administration.^[61] The second category is potentially much broader since the April 2003 amendments^[62] and could include such treatments as vaccinia immune globulin (VIG), Cidofovir, antibiotics, vidarabine, trifluridine, and those used in supportive care.^[63] If VIG and Cidofovir, for example, qualify as covered countermeasures, the "substances" used to treat their adverse effects could also be included.

To qualify as a covered countermeasure, the "substance" must also be explicitly identified in the Secretary's declaration.^[64] The current declaration identifies only three countermeasures: (1) vaccinia (smallpox) vaccines, including Dryvax; (2) Cidofovir and derivatives thereof; and (3) VIG.^[65] As it is silent with respect to all other substances that would otherwise qualify under the Act, their administration is not covered at this time.

In addition, liability protection only applies to claims "arising out of the administration of a covered countermea-sure."^[66] This phrase was not initially defined in the Homeland Security Act, and this ambiguity caused tremendous concern among healthcare providers. The April 2003 amendments define this phrase broadly to include four types of activities: (1) determining whether or under what conditions an individual should receive a covered counter-measure; (2) obtaining the individual's informed consent to administer a covered countermeasure; (3) monitoring, management, or care of the immediate site of administration on the body of a covered countermeasure or evaluation of whether the countermeasure's administration has been effective; or (4) transmission of the vaccinia virus by an individual vaccinated according to the Act.^[67]

Only those considered "covered persons" are protected from liability under the Act.^[68] The term initially only included four categories of individuals or entities, but the April 2003 amendments added four more categories, as well as making modifications to some of the original four. A "covered person" now includes: (1) manufacturers and distributors of a covered countermeasure; (2) healthcare entities involved in the administration of a covered countermeasure broadly defined;^[69] (3) a "qualified person" who administers the countermeasure;^[70] (4) a state, its political subdivisions, and agencies and officials of both providing guidance, advice, or assistance to a program administering covered countermeasures or otherwise supervising or administering that program; (5) individuals vaccinated according to the Act, who unintentionallytransmit vaccinia to someone else, or the entities that employ those individuals or where those individuals are otherwise authorized to provide healthcare;^[71] (6) officials, agents, and employees of a person described in categories (1), (2), (3), or (4); (7) contractors and volunteers working for and performing the function of a covered person in categories (1), (2) or (4); and (8) individuals authorized to provide healthcare for the healthcare entities in category (2) or the entities described under category (5).^[72] (See Appendix B for exact statutory language.) Public safety personnel who are not healthcare providers (such as police officers and fire-fighters) but who are eligible to get vaccinated under the Declaration (see below) would likely have to qualify as covered persons under category (6) or (7).

Before the April 2003 amendments, the Declaration also clarified the definition of "covered person"^[73] to address concerns that the term would be interpreted too narrowly.^[74] The Declaration's definitions should be considered superseded by the April 2003 amendments, which were specifically enacted by Congress.^[75]

The government waives its immunity and agrees to substitute itself as defendant only during the effective period of a declaration^[76] -- currently specified from January 24, 2003, until and including January 23, 2004.^[77] A provider will not be protected from liability if the provider administers a vaccine or other countermeasure before or after that period. The Act provides no time constraints on how short or long that effective period can be, and, therefore, the Secretary has complete discretion to decide on the timeframe unless other laws limit that discretion. All that is required from the Secretary on this point is that the declaration explicitly state the beginning and ending dates of its effective period.^[78] The Secretary also has authority to shorten or extend that period.^[79]

Exactly when to administer a covered countermeasure during the effective period of the Declaration will be an important consideration for providers and hospitals. Adverse events following vaccination might not present themselves until weeks after vaccination,^[80] and complications could last for months.^[81] Depending on what particular "substances" qualify as covered countermeasures, the effective period needs to be at least long enough to vaccinate all those eligible for vaccination and long enough to control or treat the adverse events. Clearly, hospitals should not vaccinate anyone in the last few weeks of the effective period to allow for any adverse events to become apparent.

The Declaration lists four categories of individuals eligible to receive covered countermeasures: (1) healthcare workers who monitor or treat individuals eligible to receive a countermeasure under the Declaration, or individuals who contracted vaccinia unintentionally and are deemed to have been vaccinated according to the Act; (2) members of smallpox response teams or teams identified as such by state or local government entities or DHHS; (3) public safety personnel, including law enforcement officers, firefighters, security personnel, and emergency medical personnel, who assist these teams; and (4) personnel associated with certain federal government facilities abroad.^[82] The government has agreed to assume liability on behalf of covered persons only if the vaccine or other countermeasure is administered by a "qualified person"^[83] to an individual within one of these categories (or if the qualified person has reasonable grounds to believe that the individual is within one of the categories).^[84]

Therefore, if a provider mistakenly believes that a patient is eligible to receive a smallpox vaccine and that belief is reasonable (which a federal court would ultimately determine), the provider will have liability protection, assuming that the other requirements of the Act have been met. A provider will not have liability protection if the provider vaccinates a friend, family member, or other medical professional who is not within a category of individuals specified in the Declaration.

Even though a person is eligible to get vaccinated under the Declaration, it does not mean that the individual should get vaccinated. For example, at this time individuals with eczema, a compromised immune status, or other identified contraindications should not be vaccinated, because there is no "confirmed, imminent, or likely exposure to the smallpox virus" and the potential for serious adverse reactions exists.^[85] A potential vaccine recipient must understand these and other risks, as well as the benefits and alternatives to vaccination, in order to make an informed decision about whether or not to get vaccinated. Thus, before administering any medical treatment or procedure in a clinical setting, including vaccines, a health-care provider has a legal duty to obtain "informed consent" from the patient. Informed consent is a complicated area of law and state laws vary considerably, although there are two broad standards: the physician standard and the patient standard. In general, the physician standard looks to what a reasonable physician would disclose to a patient under the same circumstances, whereas the patient standard looks to what a reasonable patient would consider material in order to make an informed decision.^[86] Indiana law, for example, appears to combine the two: "a physician must disclose the facts and risks of a treatment which a reasonably prudent physician would be expected to disclose under like circumstances, and which a reasonable person would want to know."^[87]

Under the FTCA, federal courts apply "the law of the place where the act or omission occurred."^[88] This language means that the federal court hearing a case under Section 304 will apply the tort law of the state in which the suit was brought, which includes whether informed consent was given (at least with respect to licensed vaccines).^[89] Common sense might suggest that if a person files suit in a federal court, federal law would apply and, if brought in a state court, state law would apply, but in fact federal courts often apply state law.

The CDC requires states to provide more than 30 pages of information and a video to help potential vaccine recipients decide whether or not to get vaccinated.^[90] This voluminous material likely meets the informed consent standard of most states. Obviously, this package would be impractical for mass vaccination of the general public, so the CDC is currently developing shorter, more appropriate material. To limit its liability exposure, the federal government should determine if this shorter version will comply with the various states' informed consent laws with respect to mass vaccination programs.

The fact that federal courts apply state tort law under the FTCA means that liability and compensation may often depend on where an individual alleging a vaccine-related injury files a lawsuit. In practical terms, this means that the same set of facts in one state could require a provider to reimburse the government for a damage award, whereas if the suit was brought in another state, the provider might be held liable but owe nothing (see discussion below on gross and simple negligence). Likewise, an injured party may receive a huge award in one state and comparatively little in another. Inconsistent court decisions were made under the Swine Flu Act,^[91] and it is likely that that would happen again under the Homeland Security Act.

Different courts interpreting the same law differently encourages "forum shopping." For example, if a person knows that one state has a cap on damages, that person might choose to get vaccinated in another state where damages are unlimited. The Washington, DC, metropolitan area (covering DC, Northern Virginia, and Maryland) as well as the two Kansas Cities (Kansas City, Kansas, and Kansas City, Missouri) are just two examples of places where forum shopping could easily occur.

Perhaps there is no better illustration of this point than the doctrine of contributory negligence. Although defined differently among the states, the concept of contributory negligence basically means that the plaintiff's (i.e., the person bringing the suit) own negligence contributed to his or her injuries, and that that contribution has legal consequences. In some states, if the plaintiff and defendant are found negligent, damages against the negligent defendant are reduced (referred to as comparative negligence). In other states, the plaintiff may be barred from all recovery (i.e., the defendant is held not liable, and the plaintiff receives no compensation).^[92] For example, with respect to medical negligence claims in Virginia and Maryland, if the plaintiff's contributory negligence is concurrent with the physician's negligence, the physician may be absolved of any liability.^[93] Concurrent contributory negligence barring recovery has been found when a patient fails to disclose an accurate medical history to a physician and suffers an adverse reaction to medication the physician prescribes.^[94] It is not difficult to imagine that, in the context of a national smallpox vaccination program, an individual might fail to disclose past eczema or other skin conditions that pose a risk of serious adverse reactions.^[95] In the litigation under the Swine Flu Act, the government raised the defense of contributory negligence,^[96] and it should be anticipated that it would do so again under Section 304.

Three immediate questions flow from this broader one. First, if a physician is vaccinated and unintentionally transmits the vaccinia virus to a patient or someone else, does that physician and the facility where he or she provides healthcare have liability protection? Second, if a physician vaccinates a patient and that patient unintentionally transmits the virus to someone else, are the physician and the facility protected? Third, if the patient who was vaccinated infects someone else, who infects someone else, who infects someone else, is protection afforded? Although the language in the Act is cumbersome, even as amended, the answer to all three questions appears to be "yes," in most cases, provided the requirements of the Act were met.

Several provisions in the Act -- three of which were added by the April 2003 amendments -- address "accidental vaccinia inoculation"^[97] or contact vaccinia, defined as "an inadvertent vaccinia virus infection in a person other than the vaccine recipient."^[98] The main provision^[99] works by making a presumption (under two sets of circumstances) that an individual with contact vaccinia contracted it from someone who was properly vaccinated under the Act. If that presumption is not rebutted (i.e., proven to be false), the individual with the contact vaccinia will then be deemed for purposes of liability to have been eligible to get vaccinated and to have been properly vaccinated under the Act. In practical terms, this means that the individual with contact vaccinia alleging complications must sue the federal government under Section 304, and not the provider or other covered person. If, however, the presumption is shown to be false -- for example, a provider vaccinated a family member who was not in a category of eligible vaccine recipients identified in the Declaration -- the government will not accept liability on behalf of that provider and the provider could be sued directly.

The two sets of circumstances under which the presumption applies are broad and would likely cover most cases of contact vaccinia: (1) the individual contracts vaccinia during the effective period of the Declaration or by 30 days after the period ends; or (2) the individual has resided with, or has had contact with, a person properly vaccinated under the Act and contracts vaccinia after the date that person was vaccinated.

Before the government substitutes itself as defendant, the U.S. Attorney General must certify that the action or proceeding is (1) against a covered person and (2) is based on a claim alleging personal injury or death arising out of the administration of a covered countermeasure.^[100] The Attorney General's decision to certify or not has several likely implications.^[101] Suppose the Attorney General certifies that a provider is a covered person and that the claim arises out of the administration of a covered countermeasure, resulting in the government's substituting itself as defendant. If the plaintiff does not think that the provider should be considered a covered person or that the claim does not arise out of the administration of a covered countermeasure, that plaintiff could ask a federal court to review the Attorney General's certification, and a federal court will review it. If the court agrees with the plaintiff that the provider is not a covered person or that the claim does not arise out of the administration of a covered countermeasure, the government will not be allowed to substitute itself as defendant, but the case still will proceed against the provider in federal court. The case remains in federal court, even though under other circumstances a state court would preside over the case against the provider.^[102] This provision is significant, in part, because federal and state courts have different rules of procedure that govern the conduct of trials. Depending on the state, some state rules may be more favorable to plaintiffs than the federal rules or vice versa. In addition, if the Attorney General refuses to certify that the claim arises out of the administration of a covered countermeasure or that the provider is a covered person, the provider can contest that decision, but the vaccine recipient cannot.^[103]

Yes. If the provider or other covered person does not cooperate with the government, the government does not have to accept liability on behalf of that person. It is unreasonable to assume that the government will agree to substitute itself as defendant if it cannot defend the case properly. Section 304 explicitly requires covered persons to cooperate with the government in the processing and defense of a claim or action.^[104] Under the FTCA, the person alleging a vaccine-related injury must exhaust administrative remedies before filing suit in federal court.^[105] Therefore, the covered person must cooperate with the government at both the agency and court levels. Cooperation may include such things as answering lengthy interrogatory questions, furnishing internal documents, sitting for depositions, or appearing as a witness at trial or a hearing. If a federal court finds that a provider or other covered person has failed to cooperate, it will substitute that person as the defendant in the lawsuit in place of the government. The government then will no longer be obliged to defend the claim or incur any liability on behalf of the covered person.^[106]

The Act also has a specific provision granting the government financial recourse against a covered person in a few instances, even if the government remains as defendant in the lawsuit. The government can recover from the covered person that portion of the payment (whether by administrative determination, settlement, or court judgment), including interest and costs of litigation, resulting from the covered person's gross negligence, reckless or illegal conduct, or willful misconduct.^[107] This means that if a court finds a provider's actions only negligent in the administration of a vaccine and awards damages to the plaintiff, the provider does not have to reimburse the government any money related to that award. Covered persons are therefore financially protected from their own negligence. If, however, the provider is deemed grossly negligent, the provider must reimburse the government for that conduct. Negligence is a complicated area of law, and the difference between gross and simple negligence is not always clear, even in a single state.^[108] Consider additionally that what is deemed negligent conduct in the administration of a vaccine pre-attack might not be considered negligence post-attack. That there are 50 states and the District of Columbia with their own negligence laws is nothing short of daunting.

The government also can recover from a covered person that portion of the payment, including interest and costs of litigation, resulting from the covered person's failure to carry out any contractual obligations assumed with the government.^[109]

Section 304 provides liability protection for vaccine manufacturers, providers, and other participants in the smallpox vaccination program, but it does not directly set forth compensation for vaccine recipients. Even though the Act does not address compensation directly, it does explain the procedures that a vaccine recipient must follow in order to pursue compensation. A vaccine recipient must first apply for compensation available under Part C of the Smallpox Emergency Personnel Protection Act before pursuing a claim under Section 304.^[110] If the adverse event is recognized as a "covered injury" and the vaccine recipient is a "covered individual" (i.e., a member of a smallpox emergency response plan),^[111] compensation will be provided without the vaccine recipient's having to prove that the provider or other covered person did something wrong (i.e., no-fault compensation). If the Secretary fails to make a final determination as to compensation within 240 days or if the individual is dissatisfied with the award after a determination has been made, the individual can then pursue a claim under the FTCA through Section 304.^[112] Because the amount of compensation is limited (e.g., presently capped at $262,100 for death benefits and for loss of employment income for those temporarily disabled),^[113] it may not adequately compensate serious adverse reactions of the smallpox vaccine.

If a particular case eventually does end up in federal court, the FTCA changes some of the rules of litigation, making it more difficult for a plaintiff to prove the case. For example, the FTCA does not allow claims based on strict liability.^[114] In general, strict liability means that the plaintiff does not have to prove fault by the defendant because the law imposes liability just by virtue of the activity that the defendant engages in (e.g., the use of explosives in a residential area). Thus, under Section 304, the plaintiff must prove culpability equal to or rising above the level of negligence to receive compensation above what may be offered by Part C. This means that even when all of the requirements of Section 304 are met, no matter how severe the personal injury, including death, there is no further compensation beyond what may be available under Part C unless there is a finding of fault.^[115]

Also, under the FTCA, attorneys' fees are paid out of the award and are limited,^[116] and the government will not pay interest accumulated prior to judgment or, with a minor exception, punitive damages (i.e., those that punish intentional or egregious conduct).^[117] Because only punitive damages are prohibited, courts can award damages that exceed actual monetary loss.^[118] What those damages are depends on state law. For example, Pennsylvania law holds (although it will likely change) that "damages are to be compensatory to the full extent of the injury sustained."^[119] In a 1983 decision under the Swine Flu Act applying Pennsylvania law, damages included past and future medical expenses; past lost earnings; lost future earning capacity; and past, present, and future pain and suffering (physical pain and suffering, mental anguish, inconvenience, disfigurement, humiliation, and the loss of enjoyment of life) resulting in an award of nearly $4 million.^[120] By contrast, in a late 1990 evaluation, at least 35 states had placed a cap on compensatory damages, which varied substantially as to the types of actions and damages capped as well as the total dollar amount.^[121]

No. Section 304 states: "The remedy provided by sub-section (a) [i.e., FTCA] shall be exclusive of any other civil action or proceeding for any claim or suit this sub-section encompasses, except for a proceeding under part C of this title."^[122] This so-called "exclusivity" provision likely prohibits any other lawsuit if Section 304 applies. However, the phrase "this subsection encompasses," which refers to Section 304, should allow lawsuits based on the administration of the smallpox vaccine or other covered countermeasure when Section 304 is not implicated (e.g., the use of smallpox vaccines to prevent the spread of monkeypox)^[123] or if the vaccine is provided on the black market or otherwise in violation of Section 304. In such cases, the normal rules of litigation would apply. Unfortunately, there is no Congressional record on this provision, and the language differs slightly from the exclusivity language that applies to regular PHS employees,^[124] so its reach is not entirely clear.

For those cases that do fall within the purview of Section 304, the issue of exclusivity has tremendous implications for potential plaintiffs. If the federal government has been substituted as defendant under the Homeland Security Act, the claim is brought pursuant to the FTCA. The FTCA has 13 enumerated exceptions in which the government will not accept liability for the acts or omissions of its employees.^[125] The result is that when the government substitutes itself as defendant for one of its employees, but one of the exceptions applies, the claim against the government is dismissed and the plaintiff is prevented from suing the employee as well.^[126] Two of the exceptions -- the so-called discretionary function exception^[127] and the intentional torts/misrepresentation exception^[128] -- may be particularly problematic to individuals hoping to recover against the government under the Homeland Security Act. Although a discussion of these exceptions is beyond the scope of this article, many claims alleging negligence in the administration of the smallpox vaccine that would have been allowed if a vaccine manufacturer or provider had remained defendant may never see a day in court because the government becomes the defendant under the FTCA.^[129]

Biosecur Bioterror. 2003;1(3) © 2003 Mary Ann Liebert, Inc.

Cite this: Vaccine Liability in the Era of Bioterrorism - Medscape - Oct 01, 2003.