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Introduction
Smallpox Vaccine
Vaccine Complications
Legal Liability for Vaccine Complications
Furloughing Employees
The Homeland Security Act Provisions for Smallpox Vaccine
The Legal Protections
Risk Management
Is Worker's Comp Covered?
Protections for Secondary Spread
Black-market Vaccine
Recovery under the FTCA
Contrast with the Swine Flu Legislation
Compensation under the Homeland Security Act
The CDC's Contrary View on Immunity for Hospitals
How the President Can Provide Proper Compensation
Coordination with Public Health Officials
Is the Current Vaccination Plan Worth the Risks?
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. The vaccine will be available to the general public in 2004, but at this point there are no plans to encourage universal immunization. The original plan was to start immunizing health care workers by 15 Dec 2002, but hospitals protested because the immunity provisions of section 304 of the Homeland Security Act (Act) will be in effect no earlier than 24 Jan 2003. Congress will be asked to accelerate the effective date of the Act when it reconvenes on 6 Jan 2003. 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.
This article discusses the medical risks of smallpox vaccination, how these lead to legal risks, and how the Act affects the liability of persons and institutions involved in the smallpox immunization campaign. These materials were originally directed to hospital attorneys because hospitals will bear the brunt of the legal risks. The intent of the authors is not to stop smallpox vaccinations, but to see them done in a way that will minimize both injuries and legal problems. A program with unacceptable injuries, such as happened with the Swine Flu immunization program in the 1970s, will severely damage the creditability of all vaccine programs and of public health programs in general.
Smallpox is a contagious viral disease that kills 5% - 30% of infected persons. It is spread when infected persons cough out virus particles from smallpox sores in their mouths and lungs. These particles can be inhaled, but are more commonly picked up as tiny dried droplets in the environment and inadvertently ingested or rubbed into the eyes. Persons who survive smallpox develop immunity to the disease, which lasts for many years. More than a 1000 years ago there were attempts to infect persons with a mild case of smallpox to protect them, but this was very dangerous and often resulted in a fatal illness. In the early 1800s Jenner popularized the use of cowpox to infect persons to protect them from smallpox. The cowpox virus is closely related to smallpox virus and provides some immunity to smallpox. Cowpox is usually only a mild illness in humans, but the vaccine was often contaminated with bacteria and other viruses, making the traditional immunization process dangerous. Even so, in 1905 the United States Supreme Court ruled that individuals could be punished if they refused to accept vaccination, holding that the risk of vaccination was a cost of living as a member of society. (See Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905).)
In the 1950s a purified form of smallpox vaccine that could be stored in a dry form at room temperature was marketed. This allowed vaccine to be sent to all corners of the world and allowed the process of eradication of smallpox to begin. This vaccine, called Dryvax, was manufactured by Wyeth and is the vaccine that will be used for the first smallpox vaccinations. It has been in storage for more than 30 years. It contains a live virus called vaccinia. While the vaccine was thought to contain cowpox, modern genetic analysis showed that it is not cowpox and is not any other known pox virus. (It may be the now extinct horsepox.) A person who is infected with vaccinia develops immunity to smallpox, but this immunity is not as effective as that from being infected by smallpox. Persons have to revaccinated every 5 - 10 years to keep up their immunity, and need to be revaccinated when exposed to smallpox.
Smallpox vaccine contains live virus because a person must be infected with vaccinia to develop immunity to smallpox. There is a new way of manufacturing the vaccine using cell culture that produces a vaccine with less contamination than the process used for making Dryvax, but it poses the same risks because it uses the same live virus. Dead virus vaccine has been tried, but it does not work. The objective of vaccination is to produce a small infected sore on the patient's arm. To vaccinated a patient a drop of solution containing vaccinia is put between the prongs of a very small bifurcated (two pronged) needle, which is then punched into the patient's arm 15 times. This infects the person's skin with vaccinia. For most persons the infection is limited to a small sore at the vaccination site, but the infection can be spread by scratching or other trauma. As many as 1/3 of vaccinated persons suffer fever and malaise sufficient to interfere with work or recreation, but most of these persons recover quickly without permanent sequella. The sore lasts about 2 - 3 weeks and it leaks live virus from the surface. If the person scratches the sore and then scratches his/her eye or nose or an insect bite or scratch, the virus will form sores at the scratched location. The virus can also be spread to others who come into contact with the sore or its dressing. It is assumed that people without severe vaccinia complications do not spread the vaccinia virus by coughing, but this is not clear since it has never been carefully studied. It did not matter when everyone was immunized. (For more technical information on the vaccination process, see the Dryvax label.)
Smallpox vaccinations have many complications. One of the most common serious sequella is spreading of the vaccination sore and development of sores on other parts of the body. This can happen in people with eczema and other dermatological conditions. While not usually life-threatening, this is a painful, difficult to treat complication that can leave the patients permanently scared. Others suffer neurologic sequella, which can be permanent or even fatal in a small percentage of cases. When the virus spreads from the original vaccination sore, the risk of infecting others with vaccinia through secondary spread is dramatically increased. Such persons must be managed so that they are never in contact with unvaccinated persons or persons who are susceptible to vaccinia injury. If they are treated in health care facilities or hospitals they must be put in proper isolation and be managed much as a smallpox case is managed. The only specific treatment is human vaccine globulin (VIG) which is made from the serum of persons recently vaccinated with smallpox vaccine. There is very little VIG available at this time. The government is increasing production as fast as possible, but there is a serious question of whether there will be enough VIG to treat the expected complications from vaccinating 1,000,000 persons over the next few months. While there are no antiviral drugs that are know to treat vaccinia, there are drugs that are effective against other pox viruses and it is hoped these will help cure vaccinia reactions.
The most serious complication is disseminated vaccinia. (There is some confusion about the nomenclature - disseminated vaccinia in this review means the generalized spread of vaccinia throughout the body.) Disseminated vaccinia means that the immunized person's immune system could not keep the vaccinia virus confined to the vaccination sore. The virus spreadS as a whole body illness, creating sores that look very much like smallpox. Disseminated vaccinia is often fatal. It was very rare in the 1960s and early 1970s when the last smallpox vaccinations were done in the US. It accounted for about 1 death per 1,000,000 immunizations. Studies at the time found that such cases could usually be traced to persons with defective immune systems. More importantly, the leading study determined that persons with defective cellular immunity were usually killed by the vaccine. [Freed, E. R., R. J. Duma, et al. (1972). “Vaccinia necrosum and its relationship to impaired immunologic responsiveness.” Am J Med 52(3): 411-20.]
In 1972, there were very few persons with such immune system defects. Most were children with genetic diseases, with the most severely affected dying shortly after birth because they could not fight off any infections. (The bubble baby had this condition.) The others tended to be persons with undiagnosed cancers who were inadvertently vaccinated. Since 1972, the use of powerful cancer drugs, arthritis drugs, and transplant drugs, plus the emergence of HIV/AIDS, has increased the number of immunosuppressed persons. There are at least 100 times as many immunosuppressed people in the US today as in 1972 and perhaps 1000 times as many.
We have little direct information on the consequences of vaccinating persons with pharmacologically suppressed immune systems or those suffering from HIV. There is one case reported in the literature where a person with HIV was immunized with smallpox vaccine. [Redfield, R. R., D. C. Wright, et al. (1987). “Disseminated vaccinia in a military recruit with human immunodeficiency virus (HIV) disease.” N Engl J Med 316(11): 673-6.] The victim was a healthy 19 year old soldier who been tested and found to have normal blood work before immunization. This was just before the HIV screening test was used for all military personal - one of the results of this case. Within 3 weeks of being vaccinated, the soldier became very ill with disseminated vaccinia. Despite intensive treatment, including many injections with VIG, he died after a prolonged illness. It appeared that the vaccinia virus destroyed the reserve capacity of the patient's immune system, leading to a rapidly progressive case of AIDS. His vaccinia did appear to resolve before his death. Given the lack of knowledge about AIDS and HIV at the time this happened, and the unavailability of modern anti-HIV drugs, it is unknown whether he would have had the same course with modern aggressive treatment.
Taken together, these two studies, plus the other work in the literature, must be read as finding that immunizing or exposing a person with a cellular immunity defect such as HIV to smallpox vaccine has a high probability of serious illness and death. It has been informally reported that many military personnel with HIV were vaccinated without these side-effects. If true, this data should be made available to help health care workers and others make an informed decision about accepting vaccination.
(Since the President's smallpox immunization plan is targeting hospital workers first, this discussion is about the risks to hospitals and their employees. The same risks would apply to clinics and other health care workplaces.)
The first level of risk is the primary immunization of the hospital personnel. It is anticipated that state worker's compensation law will cover all vaccine related injuries due to primary vaccination. These claims could be significant if a person with contraindications to vaccination is inadvertently immunized. A this point in time, there are no plans to use medical testing to screen employees for immunosuppressive disease or other contraindications before vaccinating them. They will be given a questionnaire about conditions such as HIV and cancer, etc., and the decision to vaccinate will be based on this self-reporting. If hospital personnel vaccinate any non-employees, the hospital will be open to the full spectrum of medical malpractice tort liability.
Smallpox vaccine was classified as an investigational new drug (an experimental drug) until recently. (Dryvax approval letter.) In the clinical trials being conducted with the vaccine, all persons are tested for HIV, their medical histories are screened, and their family members's medical conditions are evaluated. While Dryvax is now an approved drug, the level of screening done in the clinical trials arguably sets the standard of care for pre-vaccination screening. Doing any less for routine immunizations is arguably malpractice. This is a critical issue because many persons do not know that they are immunosuppressed. For example, the CDC has estimated at various times that 25-50% of persons infected with HIV do not know they are infected. Given the potential risks from inappropriate immunization, every person should tested for immune system problems before vaccination. The CDC has not required this in the Smallpox Vaccination Recommendations (Updated October 21, 2002), which makes it difficult for hospitals to require because of various state privacy laws and anti-HIV screening laws. An immunosuppressed person who suffered a vaccine injury could sue for both improper screening and improper informed consent about the risks of vaccination.
The second level risk is the spread from an immunized person to an unimmunized person. When smallpox vaccination was done routinely, such transmission was common. Vaccinia can be transferred to anyone the vaccinated person has close contact with. This can be family a member or fellow worker. Every person who is vaccinated should be counseled and educated about the possible risks to family members. If there is any question of risk, a public health investigator should review the situation and visit the family members or significant others.
The largest group at risk are patients in the hospital, especially those who are immunosuppressed. If a health care worker infects a patient with vaccinia, the patient can sue the health care worker and the employer for negligence, in the absence of any protections from the Act. The FDA warning label for the vaccine will make it hard to defend such claims. See Furloughing Employees, below.
The third level risk is spread from a secondary case of vaccinia to other third parties. A person with wide-spread vaccinia lesions secondary to eczema or disseminated vaccinia sheds large amounts of virus and is a significant risk to unimmunized persons, especially those with immunosuppression. Persons caring for vaccine complications must be immunized and must follow usual infection control guidelines. These patients must be kept away from all immunosuppressed persons, both family members and other patients in the hospital. This will be easy if they are sick enough to require hospitalization because they can then be put in a negative pressure isolation room. Many will not be very sick, but may have large and or multiple vaccine sores which will shed virus. They need to be very carefully managed, with the help of the health department, to assure that they do not come in contact with any immunosuppressed persons. It may be best to require that initial management of all vaccine complications be done at the health department rather than at the hospital, and that persons needing more intense care be sent to one designated facility which can set up appropriate isolation procedures. Depending on state informed consent law and precedent, the hospital may need to inform all patients admitted or in residence at the time of the immunization program that they may be exposed to smallpox vaccine virus.
Immunization programs pose difficult human resources issues. The military's campaign to immunize troops with anthrax vaccine, a relatively safe vaccine, resulted in many officers refusing immunization and, as reported by the GAO, some officers resigned rather than undergo immunization. (ANTHRAX VACCINE GAOs Survey of Guard and Reserve Pilots and Aircrew - Sept. 2002). It should be expected that some hospital personnel will refuse immunization and others will not be candidates for immunization. Such personnel cannot care for persons with vaccine complications and must be excluded from any situation where they can encounter a person with smallpox in an outbreak. These issues should be worked out with employee representatives and unions before immunizations are offered.
Hospitals must decide whether to furlough vaccinated employees until their vaccination heals. This is a critical problem until the Act takes effect because employees are being vaccinated during military reserve training and are returning to work. Leaving them in the workplace risks spread to patients and other workers. Later, when the Act protects against patient lawsuits, hospitals need to prevent patient injuries and the resulting adverse publicity. Furloughing employees is costly and disruptive. The Act is silent on who should pay the cost of furloughs. There is an OSHA ruling on hepatitis b immunizations that indicates that a waiver of liability would be a cost to the employee, and employees should not bear the costs of immunizations. Analogizing to smallpox, the Act's requirement that the vaccination be voluntary seems to require that the employee not bear the cost, which would include furloughs. Having the employee bear both the risk of injury and the cost of a furlough seems to undermine the intent of the Act.
Hospitals are reluctant to remove workers because of the costs of paying them and hiring others to cover their shifts. If immunized persons stay in the workplace, they pose a risk to immunosuppressed patients and immunosuppressed co-workers. Co-workers are covered by Workers Compensation Insurance, but there are no limits on liability for injuries to third parties, unless covered by the Act. Arguably, even some state caps on medical malpractice claims would not apply since this is not a medical but an administrative risk. Even with the Act's protections, the conflicting federal recommendations make this a difficult questions. The FDA approved label for Dryvax recommends:
"Recently vaccinated healthcare workers should avoid contact with patients, particularly those with immunodeficiencies, until the scab has separated from the skin at the vaccination site."
This would seem to indicate that vaccinated employees should be removed from patient care, if not from the workplace. The CDC recommendations do not require workers to be removed from the workplace and instead just recommend that the vaccination sore be carefully bandaged and that the health care workers wash their hands properly. However, the CDC recommendation provides no legal protection, implying that if there is spread, then there was negligent handwashing or vaccination care. If there is secondary spread to patients, the hospital will have to explain why it did not follow the FDA 's warnings. Even if the health care worker and employer are protected from legal liability by the Act, they will face public relations, community, and perhaps regulatory pressures if there are patient injuries.
Preventing spread from vaccinated workers to patients will demand vaccinating workers in small groups so that newly immunized persons can be assigned to work that will keep them away from immunosuppressed patients. This will also mean keeping them from answering emergency calls or other situations where they cannot control the patients that they treat. The larger the population of immunosuppressed patients, the greater the risk. Cancer hospitals and other institutions with large concentrations of immunosuppressed persons should furlough vaccinated workers.
The Homeland Security Act (Act) provides general protections for persons and institutions assisting the government during a bioterrorism incident and specific protections for smallpox vaccination programs. 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. Once the Act goes into effect on 24 Jan 2003 (unless Congress accelerates the effective date) the Secretary of HHS must declare that smallpox poses a potential public health emergency requiring smallpox vaccinations as a countermeasure. The Secretary must also decide who will be involved in providing the countermeasures. Until this declaration has been made, the Act provides no protection for persons involved with the smallpox vaccination program, and once the declaration is made, it will only cover what is specified in the declaration. This section also gives the Secretary broad powers to define countermeasures for bioterrorism threats.
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 covered persons as:
(B) COVERED PERSON- The term `covered person', when used with respect to the administration of a covered countermeasure, includes any person who is--
`(i) a manufacturer or distributor of such countermeasure;
`(ii) a health care entity under whose auspices such countermeasure was administered;
`(iii) a qualified person who administered such countermeasure; or
`(iv) an official, agent, or employee of a person described in clause (i), (ii), or (iii).
The Secretary of HHS has released a letter that contradicts the reading of the bill by the CDC and the Senators who filed S.6:
You asked whether liability protection is available under the following scenario:
Healthcare worker from Hospital A is vaccinated at Hospital B and then sheds vaccinia to a patient at Hospital A while working within the scope of employment.It is our intention to word the Section 304 Declaration to include the Secretary’s determination that hospitals that designate employees to receive smallpox countermeasures under the state’s smallpox vaccination plan are participants in the program and thus are healthcare entities under whose auspices the countermeasure is administered. After consulting with the U.S. Department of Justice, we believe that under this scenario Hospital A would be deemed a covered person under the Act.
This response makes two important points. First, that administration of countermeasures is broader than just the actual vaccination of individuals. Second, and more important, Sec. 304 of the Homeland Security Act is direction by Congress to an agency charged with protecting the public health and safety to guide the agency in developing policy. As such, the agency has some discretion to fill in missing or ambiguous parts of the statute in ways that are consistent with its intent.
Deeming covered persons to be employees of the Public Health Service means that any claims for their negligence must be filed against the Federal government 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) Under the Department of Justice's opinion, reflected in the Secretary's letter, this provision should provide complete immunity for tort claims against health care workers and their institutions, but with the CDC and a group of Senators claiming otherwise, there are certain to be courts who will reject this immunity. At this point, the only way to clarify the immunity provisions will be further legislation by Congress.
(ii) a health care entity under whose auspices such countermeasure was administered;
(iii) a qualified person who administered such countermeasure; or(iv) an official, agent, or employee of a person described in clause (i), (ii), or (iii).
The Secretary of HHS argues that all hospitals who allow employees to be vaccinated are an "entity under whose auspices such countermeasure was administered," without regard to whether the hospital actually vaccinates the employees itself or lets the health department do it. This is a reasonable reading of the Act.
Persons who actually do the vaccinations are clearly covered by (iii). The rest of the hospital's employees are covered by (iv). The problem is that most physicians who provide care in hospitals are independent contractors. Even in university teaching hospitals, where everyone appears to work for the hospital, it is common for the physicians to work for an independent company that contracts with the hospital. The law in most states recognizes this independent contractor arrangement and holds that physicians are not officials, agents, or employees of the hospital. This is a basic premise of hospital liability law: in most states a plaintiff cannot sue the hospital for the malpractice of a physician on the medical staff because the physician is not an agent or official of the hospital. Thus there is strong precedent, and even statutory law, that physicians do not meet the requirements of (iv) to be covered by the provisions of 304 unless they are personally vaccinating others. A court could rule that a vaccinated physician who spreads the virus can be sued personally and is not covered by the Act.
There are other ways to read this law which could include physicians, such as arguing that the physician practice groups is a health care entity under whose auspices such countermeasure are administered. The difficulty is that the courts are not bound by the Secretary of HHS's reading of the law, or by the Department of Justice's reading of the law. Courts may, but are not required to defer to agency interpretation of a statute. In this case, reading the law to cover physician contractors will deny compensation to innocent injured persons. It is certain that some courts will be unwilling to do this, leaving the United States Supreme Court to sort it out.
Hospitals and health departments should sign written agreements with all independent contractor physicians they will be working with or who practice in their facilities. These agreements should include:
1) that the physicians will be participating in the entity's administration of countermeasures as defined by Section 304 of the Homeland Security Act and the Declaration by the Secretary of HHS as authorized under the Homeland Security Act;
2) that for the purposes of Section 304 immunity that the physicians are acting as agents of the hospital or health department and thus are covered by Section 304 immunity and that any claims against the physicians must be brought against the Secretary of HHS as provided in the Homeland Security Act; and
3) this agency agreement for the purposes of participating in the smallpox vaccination plan does not* make these physicians agents of the hospital or health department for any other purpose. *corrected, 24 Jan 03, 11:46AM.
These agreements should be signed before the hospital participates in the plan.
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 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: if this provision blocks workers compensation claims, the injured employee 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 when there is secondary spread of vaccinia that the vaccinia originated with the vaccination of a person covered by the Act and therefore the case is 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. To rebut this presumption, the plaintiff would have to show that he/she was exposed to vaccinia through an unauthorized source of vaccine.
Sec. 304 does not apply to vaccine claims for vaccine that is administered outside the federally sponsored program. This would apply to black-market vaccine, which is the only way someone could be exposed to vaccinia which did not originate with the federal immunization program. Given public demand for vaccine, it can be expected that some will be diverted and used for family members or sold on the black-market. 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 FTCA 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 - see Feres v. U.S., 340 U.S. 135 (1950) - 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. It does not allow products or strict liability claims. 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, which is:
"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 before approving the vaccine 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 FTCA as the measure of damages and liability. This is superficially similar to the protections given the manufacturers of the swine flu vaccine. It is possible, but unknown, that Congress intended to give the same protections to persons injured by smallpox vaccine that it gave to persons injured by swine flu vaccine. In the swine flu vaccine injury cases, plaintiffs received substantial compensation. However, despite the superficial resemblance of Sec 304 to the swine flu legislation, 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).
In contrast, the FTCA does not recognize strict liability claims and probably does not recognize breach of warranty claims. These theories were used in most of the swine flu cases but would not be available to persons injured by smallpox vaccine. More importantly, the court found that the legislative history of the swine flu legislation 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 so it is a defense against 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 provides 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 does relieve 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 burden of caring for these people?
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.
The authors and most lawyers disagree with the CDC's reading of Sec. 304. However, 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 open the question of why the CDC changed its mind.
It is right for the federal government to bear the burden of smallpox vaccine injuries, rather than hospitals and health care workers. The Congress 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. The President can solve this problem by directing the Public Health Service to pay legitimate compensation claims made under the FTCA rather than taking them to court and claiming discretionary authority immunity. While the FTCA is only meant to pay for negligence, nothing prevents an agency, acting under the President's direction, from paying all just claims and not just those it cannot beat in court.
As currently structured, the Federal smallpox vaccination effort will be carried out through state and local public health agencies (LPHAs). A hospital should have a close working relationship with the LPHA. The LPHA should work with the hospital to train workers about the risks of smallpox immunization and the management of immunization complications. The LPHA should investigate home situations as appropriate to assure the safety of the family members and significant others of immunized persons. All screening and immunization should be be done by state or local health department employees, not hospital personnel. This will improve the worker's privacy protections and will shift any liability for negligent screening or unforeseen reactions to the state.
The biggest unknown about the smallpox vaccination plan is the level of risk of an outbreak of smallpox versus the risk of the vaccination plan. More importantly, the current plan is not well designed and will not significantly improve our readiness to manage an outbreak.
The US security forces have known since 1993 that the Soviet Union produced large amounts of illegal smallpox virus. It is assumed that this information was kept from the CDC and other public health experts until the late 1990s because the government did not think it posed a significant threat. Had there been a decision in 1993 that smallpox posed a threat, work should have begun then on a safe alternative vaccine. There has been almost no information made available on why smallpox is now a priority, necessitating a massive vaccination plan. This is important information because once smallpox vaccinations are begun, they have to be continued until the threat is gone. It may be that we will never be comfortable with the risk of smallpox and that smallpox vaccinations will become a routine part of life again. If a safe vaccine is developed, this will pose little problem. With the current vaccine it challenges many assumptions about privacy for immunosuppressed persons - will it really be possible to protect immunosuppressed persons from vaccination and secondary spread while keeping their immune status secret? Can it be possible at all for the persons who refuse testing and do not know their immune status?
The current plan assumes a large smallpox outbreak with patients rushing to hospitals to be treated. The vaccinated health care workers will care for these patients in their hospitals. This plan makes no provision for the other patients in the hospital. Hospitals have a very limited number of isolation beds suitable for smallpox, and almost no hospitals have a safe way to get patients from the front door into those rooms without exposing others. If there are more than a small number of smallpox cases, a hospital will no longer be able to isolate them. At that point all the other patients and unvaccinated staff must be moved out and the facility converted to a smallpox hospital, or the smallpox patients must be sent away.
The current plan also fails to deal with the health care workers who cannot be immunized. These workers will have to be kept away from any possible smallpox cases, for their own safety and, more importantly, because unimmunized health care workers are a prime way to spread smallpox. If we are in a constant state of readiness for a smallpox outbreak, does this mean that these workers cannot be in any jobs where they might encounter an undiagnosed smallpox case? If there is a case identified in the community, should all unimmunized workers be sent home? Who will cover their duties? What about health care workers outside of hospitals? Patients are as likely to go to private physicians as hospital based clinics. How should these facilities handle potential smallpox cases?
It makes sense to vaccinate front line emergency health care workers who are at the highest risk of encountering a smallpox case. Hospitals with emergency rooms and outpatient clinics are at risk in this scenario, and ambulance workers are at high risk. Yet this does not mean that the entire hospital staff needs to vaccinated. Smallpox cases should not be admitted or treated in every hospital in the community. They should be sent to a designated regional smallpox hospital. To minimize the risk of secondary spread of vaccinia, the regional smallpox hospital should not be a hospital with a significant number of immunosuppressed persons. There should be a plan for how to evacuate all patients and unimmunized staff to other facilities should smallpox be identified in the community. Ideally the regional hospital should be a hospital run by a government entity that is shielded from lawsuits by sovereign immunity. This will allow compensation under a tort claims act procedure. Ideally this should be a federal hospital such as a Veterans Administration hospital because the federal government has the best tort law protection and the best ability to adsorb other costs such as workers compensation claims. More importantly, a federal facility will be able to absorb the tremendous financial risks of treating smallpox cases, including the potential closing of the facility if decontamination proves impossible. This is important even if the Homeland Security Act immunity is in place to prevent tort claims.
A go-slow approach in the designated hospitals will allow the screening of employees for all causes of immunosuppression and will allow better investigation of potential risk of spread among family and significant others. It will also allow careful isolation of recently vaccinated employees from immunosuppressed patients. This will build up a cadre of immunized persons to manage a potential outbreak in the medically and legally safest way. While such a delay does, in theory, increase the risks associated with a smallpox outbreak, in practice it may not matter. If there is an outbreak, it is likely that political concerns will demand a mass immunization campaign, sweeping away the advantages of a narrowly targeted smallpox vaccination program.
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