(The House of Representatives has passed the Homeland Security Act (the Act) and sent it to the Senate. The Senate passed version appears to be the same, at least as regards vaccine liability.(Discussion of the risk to hospitals in the absence of the Act))
On 13 Dec 2002 the White House announced its smallpox vaccination plan and the White House Smallpox Vaccination FAQ. The first persons to be vaccinated will be 500,000 military personnel. The next group will be health care workers. There will be no vaccinations of health care workers until the immunity provisions of section 304 of the Homeland Security Act are in effect. Congress will be asked to accelerate the effective date of the Act when it reconvenes on 6 Jan 2003. The vaccine will be available to the general public in 2004, but at this point there no plans to encourage universal immunization. At the same time that Congress is being asked by the White House to accelerate the effective date of the Act's immunity provisions, it will be asked by plaintiff's lawyers to limit the immunity provisions, and by representatives of health care workers to provide a federal compensation system for vaccine related injuries.
On 9 Dec 2002 the CDC posted a QA on the immunity provided by section 304 of the Homeland Security Act. Contrary to the reading of the Act by most other legal experts, the CDC has concluded that the Act would not cover most hospitals:
Q.16. Will hospitals or other institutions who employ vaccinees but who do not operate as a clinic administering countermeasures be covered by Section 304 protections?A.16. Generally, no. Only hospitals and institutions under whose auspices countermeasures are administered are covered by Section 304 protections.
While the CDC's legal interpretation is not binding on the federal courts, it is a significant red flag because it must be assumed that the CDC is privy to more information about the legislative intent of the Act than has been made generally available. It will also be given deference by any judges who want to limit the immunity under the Act.
Since the CDC is also recommending that the vaccine be administered by health departments, this would leave most hospitals subject to open-ended tort liability for all vaccine related claims. Given the high complication rate for the vaccine and the difficulty in defending vaccine-related lawsuits, hospital administrators should carefully consider whether they want any of their personnel to participate in the smallpox vaccine program until this question has been definitively addressed by Congress or by the Secretary of HHS. Even a retraction of this opinion by the CDC legal department would not resolve the issue since it would leave the question open of why the CDC changed it's mind.
The Act as passed by the House contains many provisions which are new or significantly changed from last year's version. Among these are detailed provisions for limitations of liability for persons and institutions administering smallpox vaccine. These provision could have been drafted more clearly and their plain meaning may not be what the House members intended, but that is impossible to say and of little interest to the courts.
The smallpox provisions are found in Sec. 304 of the Act: Conduct of Certain Public Health-Related Activities. This is not a self-implementing provision, the Secretary of HHS must declare that there is a public health emergency requiring countermeasures, what the countermeasures are, and who they involve. This section seems to give the Secretary broad powers to define such measures beyond the specific protections for smallpox specified in Sec. 304. Measures that are not specifically described in the Secretary's declaration are not protected under the Act.
The Act uses a strategy for legal immunity that has been used in other laws, including the immunity provisions for federally qualified community health centers:
"For purposes of this section, and subject to other provisions of this subsection, 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 against smallpox to an individual during the effective period of a declaration by the Secretary under paragraph (2)(A)."
Sec. 304 goes on to define persons as including health care institutions, so this provision applies to hospitals and health departments as well as the employees. Deeming them to be employees of the Public Health Service means that any claims against them must be filed under the Federal Tort Claims Act (FTCA), subject to its defenses as discussed below. The Federal Government is substituted for the defendant in such cases, which provides nearly complete legal protection for the hospital or individual who is the real subject of the claim. (FTCA cases in general)
The most difficult question posed by this provision is its scope. It applies to "... liability arising out of administration of a covered countermeasure against smallpox to an individual ...". This clearly applies to a person suffering a vaccine complication who wants to sue for either medical malpractice or products liability related to bad vaccine or negligent administration. It does not appear to apply to worker's compensation claims by hospital employees injured by vaccination. Worker's compensation is a not a liability claim but a statutory trading of liability claims for an insurance system that does not require a showing of fault for compensation. A court constructing this section would also have a strong policy reason for finding that it does not apply to worker's compensation clams: As discussed below, if this provision applies, the injured person will receive no compensation at all. Thus the court will likely find a manifest injustice if the employee is injured in the course and scope of his/her job yet has no avenue for compensation for medical costs and lost wages.
Other provisions of the Act create a rebuttable presumption that if there is secondary spread of vaccinia that the vaccinia originated with the vaccination of a person covered by the Act and thus is also covered by the Act. Thus patients or family members who suffer vaccine related injuries from contact with a vaccinated person will have to sue for compensation under the provisions of the FTCA.
This provision appears to anticipate the availability of black-market vaccine, which is the only way someone could be exposed to vaccinia which did not originate with the federal immunization program. Given the public demand for vaccine, it can be expected that some will be diverted and used for family members or sold. It is also relatively easy to use traditional vaccination techniques described in old texts to extract vaccinia laden tissue from an active vaccine sore and use that to immunize others. These activities are not covered by the Act and will be subject to existing state and federal tort and criminal laws.
The FCTA waives the sovereign immunity of the United States and allows certain tort claims to be made against the United States and its employees. (The FTCA does not apply to active duty military personnel - the Feres case - whose only remedies are through military compensation systems.) The FTCA applies to negligence torts and the standard for proving negligence is drawn from the state tort law where the incident happened. The FTCA is an administrative compensation system and requires that a claim be filed with the government before the plaintiff can go to court. If the government does not act on this claim or does not make a satisfactory offer of settlement, the plaintiff may then go to court. (Click here for more information on this claims process.)
As a tort claim governed by state law, the U.S. may use the tort defenses allowed by state law. The U.S. may also rely on a statutory defense provided in the FTCA, the discretionary authority provision:
"based upon an act or omission of an employee of the Government, exercising due care, in the execution of a statute or regulation, whether or not such statute or regulation be valid, or based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the discretion involved be abused." United States v. S.A. Empresa de Viacao Aerea Rio Grandense (Varig Airlines), 467 U.S. 797 (1984).
Varig Airlines was a tort claim which asserted that the FAA was negligent because it spot-checked airplanes for a particular problem rather than checking them all. The United States Supreme Court ruled that since the statute and regulations were silent on the proper way to conduct inspections, it was within the agency's discretion to select the inspection technique and that it could not be sued for this decision. In Berkovitz by Berkovitz v. U.S., 486 U.S. 531 (1988), the FDA was sued for not requiring full testing information for all batches of polio vaccine. In this case, the United States Supreme Court found that the agency regulations mandated that it have the full information and thus it had no discretion to approve vaccine without it. These two cases set out the key parameters for the discretionary authority defense: the agency must follow statutes and regulations, but if these allow a policy decision to be made by the agency, it cannot be sued because the plaintiff believes this decision was negligent.
By treating all claims for liability as claims against a U.S. Public Health Service employee, the Act adopts the FDTA as the measure of damages and liability. It is possible, but unknown, that the House intended to give the same protections to persons injured by smallpox vaccine that it gave to persons injured by swine flu vaccine. This is not the case. The language in the swine flu immunity statute was very different:
"The Swine Flu Act provides: [T]he liability of the United States arising out of the act or omission of a program participant may be based on any theory of liability that would govern an action against such program participant under the law of the place where the act or omission occurred, including negligence, strict liability in tort and breach of warranty. 42 U.S.C. § 247b(k)(2)(A)(i)." Unthank v. United States, 732 F.2d 1517 (10th Cir. 1984).
The FTCA does not recognize strict liability claims and probably does not recognize breach of warranty claims. These would not be available to persons injured by smallpox vaccine. More importantly, the court found that the legislative history indicated that this language was intended to set up a no-fault compensation scheme:
"The trial court was particularly impressed, as we are, with the explicit statements of Senator Harrison A. Williams, Jr. of New Jersey in discussing the reasons for enacting this bill establishing liability against the federal government. He said:""This is pioneering in the sense, it has never been done before, but it is in response to an emergency. That is the way the liability fixes upon the government, through the total class act, for any misfortune which would follow, as defined, the administration of the inoculation and vaccine ... 192 [sic] Cong.Rec. 26632 (August 10, 1976), 533 F.Supp. at 719.""The trial court was also impressed, as we are, with the statement of Congressman Paul G. Rogers of Florida:""[W]e have asked the drug companies to produce this vaccine. We have told them how to do it. We have told them the dosage we want, what strength. We gave them the specifications because we are the only buyers, the Government of the United States. This is not the usual process of going out and selling. But if someone is hurt, we think people ought to have a remedy. [122 Cong.Rec. at] p. 26796. 533 F.Supp. at 719."
Since the courts that considered the claims for injures caused by swine flu vaccine believed that Congress intended the unusual language in the swine flu immunity law to create a no-fault compensation system, they awarded compensation to all persons who could show that their injuries were caused by the vaccine.
In contrast with the swine flu law, the Act makes no extensions of liability or modification of the terms of the FTCA. There is also no congressional history at this point to indicate that despite this language the House intended that every injured person be compensated. Under the unmodified language of the FTCA, it is very hard to recover from the government for risks that the government knew it was exposing people to. Since most of the risks of the smallpox vaccine are very well known, by choosing to immunize a given class of persons, the government is making a discretionary decision to expose that class of persons to the risks. This decision cannot be attacked under the FTCA and thus acts as a defense to claims for smallpox vaccine injures. The best analogy is the atomic fallout cases in which persons downwind from nuclear test sites sued the government for injuries allegedly caused by exposure to fallout. The district court, in a 255 page opinion, found that there was proof that these persons had suffered injuries and that the government should be liable for exposing them to fallout. In an opinion of little more than one page, the appeals court held that since the government had decided to expose them to fallout, knowing the risks, that it was not liable under the FTCA. (Allen v. United States, 816 F.2d 1417 (10th Cir. 1987) ) The court found that while there was statutory language urging the agency to balance the risk of harm to the population against the need for testing atomic bombs, this did not prohibit the agency from deciding that testing was more important than protecting the population from fallout.
As written, without contrary legislative history, the Act appears to require that persons injured by smallpox vaccine prove that the government or persons acting on its behalf were negligent in administering the vaccine in order to recover under the FTCA. Just proving that they were injured by the vaccine will not be enough. The three areas where negligence is most likely to be alleged are: screening persons for contraindications; preventing spread to third parties; and informing persons of the risks of the vaccine. If the government is careful to document its decisions in these areas and to explain why these decisions reflect its determination of public policy, it can probably escape liability for almost all injuries. For example, while it is clear that every person being immunized should undergo clinical testing for immune status (a CBC and an HIV test would be a minimum), if the government says that such testing would interfere with the protection of the public, and that it was aware that failing to test would injure some persons, it would have no liability under the FTCA.
The Act does provide useful, but not complete, protection for hospitals whose personnel are immunized against smallpox. It is the authors' opinion that it leaves the hospital liable for worker's compensation costs for injured employees. It relieves the hospital of liability for secondary spread, which poses the greatest legal risk. It does not, however, make the government liable for such spread. Thus patients and family members injured by the vaccine will not have any recourse and will receive no compensation, even for permanent disability or death. In the worst case scenario, their private insurance carriers will deny coverage because the injures were related to the preparation for an act of terrorism or war, as specified in the required declaration by the Secretary.
The care of these injured persons will fall somewhere. Will hospitals refuse to care for their own patients or their workers' family members who are injured by the hospital's vaccination plan? Are the state and local governments prepared to bear the burdens of caring for these people?
It is right for the federal government to bear the burden of smallpox vaccine injuries, rather than hospitals and health care workers. The House has not accepted this burden. Instead, it has left the hospitals liable for worker's compensation claims and denied any compensation for all other victims of the smallpox immunization campaign. This makes it imperative that the government be as careful as possible in who it immunizes and who they might expose to others. Everyone should be tested before immunization and then isolated from contact from all persons who might be injured by exposure to vaccinia. This is different from all other immunization programs because smallpox vaccine is dramatically more dangerous than other vaccines. It is an indispensable tool in fighting smallpox, but it is a dangerous tool that must be used very carefully.
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