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Executive Summary and Recommendations
Introduction
Smallpox Vaccine
Vaccine Complications
Legal Liability for Vaccine Complications
Furloughing Employees
The Homeland Security Act Provisions for Legal Immunity
Risk Management
Non-Participating Hospitals
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
How the President Can Provide Proper Compensation
Coordination with Public Health Officials
Is the Current Vaccination Plan Worth the Risks?
Senate Bill 15
Summary
On 13 Dec 2002 the White House announced its smallpox vaccination plan and the White House Smallpox Vaccination FAQ. 500,000 military personnel were to be vaccinated immediately, and 500,000 hospital and health care workers were to follow within a few weeks. It was said that the vaccine would be be available to the general public in 2004, that there were no plans to encourage universal immunization. President Bush was immunized first, and there were no reported ill effects. The military vaccinations have slowed after initial complications, and the health care community refused to participate until the liability provisions of the Homeland Security Act took effect on 24 Jan 2003.
At this point in time (2 Feb 2003), the vaccination plan for health care workers is stalled over several critical issues:
1) What is the real complication rate and who is at greatest risk for complications?
This information is critical to establishing the proper informed consent to vaccination. Two missing pieces of information are how much vaccine immune globulin (VIG) is available for treating complications, and what is true complication rate for persons with HIV.
2) Is the vaccine being administered in a safe manner?
Several health care worker groups have raised questions about whether the bifurcated needles being used for vaccinations meet federal safety standards, and over whether the vaccine is contaminated with latex.
3) Will worker's compensation cover worker injuries and lost time?
The Homeland Security Act does not give employer's immunity from worker's compensation claims. Some worker's compensation carriers are raising questions about whether vaccine related injuries are covered by their plans. Irregardless of coverage, employers are concerned about the costs of compensating workers for illness and lost time from work.
4) Are all members of the health care team protected by the legal immunity provisions of the Homeland Security Act?
The language of Homeland Security Act does not cover independent contractors unless they are administering countermeasures or are themselves vaccinated. This would exclude physicians and other contractors who, for example, care for vaccine complications or otherwise are involved with the vaccination program but without directly administering the countermeasures. The Secretary of HHS has attempted to broaden the statutory coverage with his Declaration, but there are serious questions about whether the courts will find that he has the authority to do this.
5) How will persons injured by the vaccine be compensated?
While employees will be covered by workers compensation (even if the insurance does not pay, the employer will probably have to), workers compensation is a meager recovery and will not provide full compensation for serious injuries. Family members of employees and patients have no recourse for compensation.
6) Is this plan epidemiologically sound, i.e., does it improve smallpox preparedness sufficiently to be worth the risks?
This is the fundamental question all health care providers and their employers must answer to their own satisfaction. Many hospitals have decided that this plan is epidemiologically flawed and thus is not worth the risks that it poses to workers.
Health care workers considering vaccination should read the CDC's Smallpox Vaccination and Adverse Reactions Guidance for Clinicians (PDF - large), the Recommendations of the Advisory Committee on Immunization Practices (ACIP) - Smallpox, and the label for the vaccine, which contains information that has been left out of the CDC and ACIP materials.
Health care employers must set up surveillance systems to assure that they are aware of every vaccinated employee so that they can monitor the employee's vaccine sore and control the exposure of at-risk patients. Without such a system, employers will not know if an employee has been vaccinated at another site, such as on reserve duty, and is returning to work while infectious.
Health care employers who participate in the vaccine program should identify all independent contractors in their system who might have contact with vaccinated persons or who otherwise might be a legal risk for vaccine-related injuries. The employer should either enter into agency agreements with their contractors to make them the hospital's agents for the vaccine program, or, better, get the local health department to sign agency agreements with the contractors so they become agents of the health department. While such agreements are not certain to bring these contractors under the Act, they will give the hospital and the contractor a strong argument for immunity.
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 be 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 vaccinate 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 a 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.)
Part of the recommendation for caring for individuals who have been vaccinated is that the vaccination should be covered a bandage and that the health care provider should wear long sleeves to cover the bandage. This is to prevent the vaccine virus from spreading to other parts of the body or to other people. The recommended bandage is a combination of gauze to absorb the fluids from the vaccination sore and a covering that will keep these fluids and the virus they contain from getting out of the bandage. The problem is that the sore needs to dry out in order to heal properly and any bandage that keeps the virus from getting out will keep the sore wet. In practice, there is only one way to keep a wet sore covered and dry for long periods of time. You have to change the bandage every time it begins to be wet, usually several times a day. This involves more work and more potential spread of vaccinia than the current recommendations acknowledge. There are anecdotal reports that vaccinations that are being covered with the recommended bandage are creating larger vaccination sores ("robust takes") which may heal more slowly and leave more scaring than those that are properly covered.
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.
This section reviews the potential liability for vaccine-related injuries in the absence of any legal immunity from the Homeland Security Act. Immunity under the Act is discussed in a later section.
The first level of risk is the primary immunization of hospital personnel. It is anticipated that state worker's compensation laws will require employers to pay worker's compensation for all vaccine-related injuries to their employees who are participating in the vaccine program at the hospitals request. Workers who are vaccinated as part of their military duty will be covered by the military's benefits program. Workers at hospitals who do not participate in the vaccination plan but who are vaccinated elsewhere may not be covered by worker's compensation and may not have any source of compensation if they are injured. 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. Workers compensation claims could be significant if a person with contraindications to vaccination is inadvertently immunized. There are also conflicting reports about whether the vaccine is contaminated with latex, which would pose a significant risk to health care workers with latex allergies. (Dryvax label precautions.) Some workers compensation insurance plans are questioning whether they will cover vaccine-related injures because they are part of a national defense program rather than a workplace activity. Irrespective of whether the insurance carrier pays the claim, the employer will probably be liable for the compensation.
If hospital personnel vaccinate any non-employees, the hospital will be open to the full spectrum of medical malpractice tort liability, in particular failure of informed consent and failure to screen adequately before vaccination. 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. However, an immunosuppressed person who suffered a vaccine injury could still 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 a family 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. Leaving them in the workplace risks spread to patients and other workers. Even if 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. The Act went into effect on 24 Jan 2003 and the Secretary of HHS has issued a Declaration 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)."
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.
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).
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 CDC later issued a revised QA and a Guidance for the Healthcare Community Concerning Section 304 of the Homeland Security Act, which track the Secretary's views.) In addition, a group of Democratic senators has filed Senate Bill 6 in the 108th Congress which claims, as a sense of the Congress, that this language only includes hospitals that have their own staff administer the vaccine. This same bill also asserts that the vaccinated health care worker him/herself is not covered by the Act. Such a reading of (iv) is very strained: any health care worker who is vaccinated under the current plan should be an agent or employee of a covered hospital or health department. It is unclear whether this "sense of the Congress" provision really reflects the legislative history of the Act or whether it is an attempt to undermine the immunity provisions to enable tort actions to be filed against hospitals who participate in the smallpox immunization program.
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.
The Declaration by the Secretary of HHS attempts to deal with the coverage of the Act in two ways. First, by broadening the definition of a covered countermeasure:
Administration of a countermeasure such as smallpox vaccine is necessarily more involved than the act of placing a drop of vaccine on a two-pronged needle and inoculating a person's arm. Determining who is contraindicated; monitoring, management, and care of the countermeasure site; evaluation of countermeasure "takes;" and contact transmission of vaccinia, among other things, all arise out of and are directly related to and part of the administration of the countermeasure. All such acts also potentially give rise to legal liability that, without sufficient protections, may significantly discourage participation in the smallpox vaccination program.
This provision of the declaration must be read in conjunction with the language of the enabling statute giving the Secretary the authority to issue this part of the declaration:
(ii) COVERED COUNTERMEASURE- The Secretary shall specify in such declaration the substance or substances that shall be considered covered countermeasures (as defined in paragraph (8)(A)) for purposes of administration to individuals during the effective period of the declaration.
The referenced paragraph (incorrectly referenced in the statute as (8)(A), which does not exist, rather than (7)(A)), uses a much narrower definition of covered measure:
Reading these together, the Homeland Security Act seems to limit covered countermeasures to the vaccine, vaccine immunoglobulin, and other substances used to to prevent or treat smallpox. Covered countermeasures seems to refer only to substances (drugs and vaccines), not to the service of administering them. Referring now to the definition of a person who gets immunity, there is a service based component: "a qualified person who administered such countermeasure." The Secretary's definition of administer includes every conceivable health care services related to a vaccinated person. There are problems with this broad definition. There are plain language meanings for administer:
1. To manage or conduct, as public affairs; to direct or superintend the execution, application, or conduct of; as, to administer the government or the state.
2. To dispense; to serve out; to supply; execute; as, to administer relief, to administer the sacrament.
[Let zephyrs] administer their tepid, genial airs. --Philips. Justice was administered with an exactness and purity not before known. --Macaulay.3. To apply, as medicine or a remedy; to give, as a dose or something beneficial or suitable. Extended to a blow, a reproof, etc.A noxious drug had been administered to him. --Macaulay.Webster's Revised Unabridged Dictionary, © 1996, 1998 MICRA, Inc.
While the first definition would seem to work for the Secretary, the Act does not say the administration of the vaccination program but the administration of a countermeasure, i.e., a drug or vaccine. This fits definition three much more closely - to give or apply a medicine. In no other context would we equate administering a drug to treat or prevent a disease with the entire bundle of services involved with managing the disease. For example, would a law giving immunity for administering insulin be taken to protect every aspect of caring for a diabetic? The Secretary's reading of the Act might be found permissible, but could as easily be rejected.
The Secretary then tries to modify the statutory language itself:
"Official, agent, or employee" as used in Section 224(p)(7)(B)(iv) of the PHS Act and with respect to health care entities under whose auspices covered countermeasures are administered, includes health care workers who share any employment or other staffing relationship with the health care entity.
"Staffing relationship" is not defined in the statute or in health care law more generally. If it means agent or official, it is just circular and does nothing to resolve the problem of independent contractor physicians. If it is an attempt to include independent contractor physicians by including medical staff members, then a court would have to read it against the plain language of the statute which limits coverage to officials, agents, and employees. This might be a permissible broadening in states that do not recognize the independence of medical staff members. In most states, however, a court will read this provision in the light of specific state case law that says that medical staff members are not agents or officials or employees of hospitals. Those courts are unlikely to find that the secretary has the power to change the legally established standards for agent, official, or employee. This construction problem will be exacerbated by the policy arguments of the plaintiffs. They will argue that the Act's plain language says it protects vaccine manufacturers, persons vaccinating other persons, persons treating vaccine complications, and the hospitals they work for. It was never meant to cover the careless spread of vaccinia to innocent third parties and following the Secretary's interpretation will deny compensation to deserving persons.
The simplest way to manage the problem of independent contractor risk is to sign agency agreements with them and bring them under the clear language of the Act. 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 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.
These agreements should be signed before the hospital participates in the plan. Ideally, the agreement will be between the health department and the contractors. This will prevent the agreements from being used as evidence of a general agency relationship in vicarious liability cases alleging that a negligent physician was an agent of the hospital.
Many hospitals have chosen to defer their participation in the smallpox vaccination program. These decisions are based on many factors, including the continuing ambiguity over the legal protections provided by Sec. 304, the problem of compensating injured workers and others, and fundamental questions about the epidemiological soundness of the program. These hospitals need to develop a policy to deal with health care workers who are vaccinated during military reserve duty or who want to be vaccinated outside the hospital's own program.
Workers vaccinated by the military are covered by the military's compensation program rather than the hospital's workers compensation insurance. This program probably does not provide protection for the hospital for if a patient or co-worker catches vaccinia from a vaccinated reservists who has returned to the hospital before the vaccine sore has healed. Ideally these vaccinated persons will be removed from patient care until they are no longer infectious, but many hospitals cannot afford the financial or staffing problems this creates.
Employees of a non-participating hospital who seek vaccination on their own pose more difficult issues. Arguably, if these persons suffer a vaccine-related injury, they will not be covered by the hospital's workers compensation program because they were vaccinated outside of work and there is no benefit to the employer. A non-participating hospital could establish a policy that any employee who accepts vaccination must take personal time off from work until the vaccine sore heals. Such a decision could have adverse public relationship consequences - the hospital might be seen as unpatriotic. It is possible in some states that the person could sue under state law to be paid for the lost time, but that depends on specific state provisions that are beyond the scope of this publication. This should be explored with local counsel.
If the hospital wants to prevent vaccinated workers from returning until they are non-infectious, it should have a clearly argued policy statement about why the institution is not participating in the program and why vaccinated employees pose a threat to patients and other workers. This will be critical to defending claims for lost wages by furloughed employees.
If the hospital wants to allow these vaccinated workers to return to the workplace, it should enter into an agreement with the local or state health department. This agreement should outline that while the hospital is not recommending that its employees be vaccinated at this time, it is participating in the smallpox immunization plan by allowing employees who have been vaccinated away from work to continue working in the facility. The purpose of this agreement is to deflect later arguments that hospitals that do not recommend vaccinations are not covered by Sec. 304.
The Act's immunity 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 is a case 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. (CDC Claims Flowchart) 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 get compensation 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?
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 smallpox, 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 close contacts. 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.
On March 11, 2003, Senators Gregg, Frist, Alexander, Warner, Enzi, Sessions, Roberts, and Graham introduced Senate Bill 15, which, among other things, establishes a smallpox vaccine injury compensation fund. This fund is intended to encourage smallpox vaccinations by addressing the fears of health care workers and others that they will not have any insurance coverage if they are injured by the smallpox vaccine. As discussed below, the fund proposed by this bill is very restrictive and may not go far enough to address the concerns of health care providers and their institutions.
Until the 1970s, there was no expectation of compensation if someone was injured by a vaccine. There had been some tort claims based on impure vaccines, but these were exceptional. Most people supported vaccinations for themselves and their children because they were frightened of catching the diseases for the vaccines were developed. While there have always been persons who opposed vaccination, they were in the minority and legal policy reflected the majority view that vaccine injuries were the cost of reducing one's risk of contracting a deadly disease. As these diseases were eradicated or reduced to only sporadic outbreaks, people became less tolerant of vaccine injuries, which lead to the discontinuance of smallpox vaccinations in the early 1970s. As these diseases faded from memory, tort lawyers and vaccine opponents convinced people that vaccines were dangerous, fueling resistance to vaccinations and a tsunami of litigation. Congress responded with the National Childhood Vaccine Injury Compensation Fund, which provided compensation for children allegedly injured by vaccines. This fund was good politics, if not good policy, and created the expectation that the federal government should provide compensation if it wants people immunized for communicable diseases. This expectation of compensation was heightened for the smallpox vaccine, which is much more dangerous than any other approved vaccine. Most health care providers have baulked at being vaccinated because of their own fear of injury and because patients inadvertently injured through secondary transmission have no avenue for compensation under the Homeland Security Act.
S15 begins with the definition of a covered person:
(i) a health care worker, a law enforcement officer, a firefighter, a security-related worker, an emergency medical worker, or a public safety worker who is identified in a State, local, or Department of Health and Human Services plan that is approved by the Secretary; or
(ii) an individual with respect to whom the Secretary determines and declares that it is advisable to administer the vaccine (not including any individual to whom the Secretary determines only that such vaccine should be made available)
Section (i) raises the issue of what is an approved plan and what does identification mean - must each vaccinated person be identified, and what if the plan is not approved? Section (ii) appears to cure this by expanding the class of covered persons to at least cover all those described in the Secretary's declaration, but it clearly excludes persons for whom vaccination is available but not recommended by the Secretary.
The definition of a covered injury is handled effectively and the Secretary is directed to flesh this out with regulations. The next problem is in Section 5, the definition of an eligible individual, i.e., those covered persons with covered injures who are eligible for compensation. The problem comes for persons who are secondarily infected by vaccinia, which can include fellow health care workers, patients, and family members. Compensation is only available for one:
"who has resided with, or has been in close contact with, a covered individual"
This is based on the CDC's view that vaccinia is hard to transmit and thus only close contacts can catch it. The literature on vaccinia does not support this, finding instances of casual transmission. More importantly, since the government controls all the vaccine, the only way an injured person could be exposed to vaccinia is through contact with a person immunized under the program. This provision would exclude most patients and fellow workers injured by secondary spread.
S15 provides that the Secretary of HHS may review and approve, deny, or modify determinations of eligibility under the Act and that the Secretary's decision is final and unreviewable:
Section (b) (5) REVIEW OF DETERMINATION.
(A) SECRETARY'S REVIEW AUTHORITY - The Secretary may review a determination under this subsection at any time on the Secretary's own motion or on application, and may affirm, vacate, or modify such determination.
(B) SECRETARY'S ACTION NOT JUDICIALLY REVIEWABLE. - The determinations of the Secretary under this subsection shall not be subject to review by another official of the United States or by a court by mandamus or otherwise.
The medical benefit is limited. It is second dollar coverage, paying only what is left after other insurance plans , including worker's compensation, or any other payer (including tort awards or settlements) has contributed. There are no payments at all for persons who are eligible for Medicare, despite the many expenses left to patients by the Medicare system.
The lost wages benefit is paid at 2/3 of the monthly wage, with no payments for the first 5 days of lost wages, and a cap on all payments of $50,000. As with the medical benefit, this is second dollar coverage and payment from any other sources will be deducted.
S15 provides a death benefit and a benefit for total and permanent disability equal to the benefits paid under the Public Safety Officers' Benefits Program, which, according to an announcement by the Secretary of HHS, are $262,100. This appears to be in addition to any other benefits that the individual receives, except for benefits from the Public Safety Officers' Benefits Program. It appears that there can also be benefits for partial disability, but this is unclear from the Act.
S15 represents an attempt to draft a compensation act that
will not attract fraudulent claims while taking the fears of health care
workers and others
seriously. It is unclear how well it succeeds. It provides inadequate
compensation for serious injuries, it does not address the worker's compensation
gap,
and it potentially excludes most injured patients. Smallpox is a deadly
threat and smallpox vaccinations may be a necessary part of domestic policy.
So
far, the federal funding for smallpox vaccinations for health care workers
is much less than the total costs for health departments and health care
institutions. Should the vaccinees also absorb the costs of injury or
should these be part of the defense budget? S15 goes part way to solving
this
problem. It will be up to health care providers and others to decide if
this is far
enough or if they want to be financially protected fully. If S15 were
coupled with a better plan for handling a smallpox outbreak and more
information
about the probability of a smallpox outbreak, health care providers might
be more willing to accept the risk of vaccination.
It is now national policy that we should be prepared for the use of smallpox as an agent of bioterrorism and that our preparations should include immunization of specific groups of people with vaccinia virus to make them immune to smallpox. National security policy may well require reinstituting smallpox vaccinations. However, there are some serious medical, administrative and legal problems that should be addressed before large numbers of people receive the vaccine.
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