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Vaccine Law 2.0: Mandates and Injury Compensation

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Vaccine Law 2.0: Mandates and Injury Compensation

The powerful public interest in preventing the spread of contagious diseases has led to a longstanding history of vaccination mandates being imposed as a prerequisite to access to various rights, such as education and employment. At some points in history, nonvaccination has even been punished with fines. Balancing out this imposition, systems have been established to compensate the small proportion of individuals who claim to have been harmed by an adverse reaction to a vaccination. This course will examine the legal basis and structure of vaccination mandates, including public mandates imposed by state and federal government entities and private mandates imposed by employers. The course will cover the common exemptions from vaccination and accommodations required by employers under federal law. The course will then turn to the function and operations of the National Vaccine Injury Compensation Program, and to other routes of injury compensation available for vaccines not covered under that program.

Presenters

Brian Dean Abramson
Vaccine Law Expert and Adjunct Professor of Vaccine Law
Florida International University College of Law

Transcript

Brian Dean Abramson: This is Brian Dean Abramson, author of the legal treaties, "Vaccine, Vaccination and Immunization Law," presenting vaccine law part two for Quimbee. This course covers the last two major areas of vaccine law, vaccination mandates and vaccine injury compensation.

A vaccination mandate may generally be defined as a requirement that individuals receive one or more specified vaccines or experience some consequence of not receiving them. Most commonly, this consequence will be the denial of access to locations such as schools or hospitals, or activities such as employment or education more broadly. Vaccination mandates are nearly as old as vaccines themselves, but the authority for their application is much older. Prior to the existence of vaccines, governments used quarantines and isolation to counter infectious diseases. These practices also remain in use today with the United States Centers for Disease Control stating that isolation and quarantine help protect the public by preventing exposure to people who have or may have a contagious disease. Technically isolation is specifically the separation of people who have an infection or a contagious disease from people who are not infected, while quarantine separates and restricts the movement of people who are exposed to a contagious disease, but not known to have that disease yet to see whether they have in fact been infected.

As far back as the 1902 case of Compagnie Francaise de Navigation a Vapeur versus Board of Health, the state of Louisiana, the United States Supreme Court upheld laws requiring involuntary quarantine of a vessel during a yellow fever outbreak, finding that this was a reasonable exercise of state police power. Most early vaccination mandate cases involve smallpox vaccination. Smallpox vaccine was invented in 1796 and became widespread around the world within a few years. Many countries mandated vaccination of smallpox before the United States did. And in the United States, many states and municipalities adopted vaccination mandates to prevent epidemics of the disease, primarily in the latter half of the 1800s.

In the late 1800s, various State Court cases arose challenging these mandates, often on procedural grounds regarding their implementation by state agencies, with questions arising as to whether those agencies had properly been delegated the authority to mandate vaccines. The first vaccination mandate case to reach the United States Supreme Court was Jacobson V. Massachusetts in 1905. The state of Massachusetts had enacted laws enabling municipalities within that state to mandate vaccination of all people living in that municipality and to impose a penalty, a $5 fine on any person who refused to be vaccinated. A suit against the law was brought by Henning Jacobson, a pastor of Norwegian origin, who had lived through previous smallpox epidemics in his home country and who argued that the vaccination requirement violated his bodily autonomy. The State Courts upheld the law, the Supreme Court reviewing the matter found in this matter of first impression that it is within the police powers of the state to mandate smallpox vaccination to protect the public health generally. The court noted that Jacobson might have a valid objection if he could provide evidence that vaccination would endanger his life. But in this case, he had only articulated speculative concerns to the effect that there was a danger to him based on poor reactions to the vaccine by family members and by the general knowledge that some recipients of the smallpox vaccine had bad reactions. This was a seven to two opinion with the two dissenting justices not writing a dissent.

The only other case in which the Supreme Court directly examined vaccination in the 20th century was Zucht V. King in 1922. In that case, the San Antonio School District enacted an ordinance requiring all students attending public or private schools in the district be vaccinated for smallpox as a prerequisite to attending school. The Supreme Court applied the reasoning of Jacobson to the case and unanimously and quickly found that if the state can mandate vaccination, it can certainly engage in the less intrusive conduct of conditioning access to the schools on vaccination and therefore it can prohibit unvaccinated students from attending school. Between 1922 and 2021, no further cases directly addressing vaccination mandates were brought before the United States Supreme Court. There were many such cases, however, brought before various state and federal courts, which generally upheld such mandates while teasing out issues such as the availability and breadth of religious and medical exemptions to vaccination and which entities within the state specifically were entitled to establish and enforce such mandates. The Supreme Court itself, however, continued to cite Jacobson V. Massachusetts and vaccination, generally, as an example of an absolute baseline police power.

For example, in each of the following cases, the authority of the state to mandate vaccination was raised as a basis to allow the state to engage in some other activity. In Buck V. Bell, vaccination was held up as a precedent supporting a law, requiring the sterilization of persons deemed to be mentally retarded. In Prince V. Massachusetts, vaccination was upheld as an example of a law requiring parents to carry out certain activities with respect to their children, even where the parents claimed that this activity was against their religious belief. In Prince V. Massachusetts, the state law prohibited parents from making their children work, even where parents claimed that this work was compelled by religious beliefs and the court very pointedly stated that even parents who are opposed to vaccination on religious grounds must have their children vaccinated and that demonstrates the power of the state to police the relationship between parent and child. In Cruzan versus Director, Missouri Department of Health in 1990, the court used vaccination as a basis for upholding a requirement that a feeding tube be kept in a vegetative person against their family's wishes. In Vernonia School District 47J versus Acton, the court pointed to vaccination as a kind of invasion of privacy that is comparable to a law permitting random drug testing of students, thereby supporting the constitutionality of the drug testing law.

One condition of vaccination mandates that does arise from the Constitution is that they must not discriminate on the basis of race, ethnicity, religion, or other protected status. For example, in 1901, following a rumor that the plague was abounding in the city of San Francisco, the city government enacted an ordinance requiring that all Chinese people in the city receive an experimental plague vaccine. The order was premised on the belief that the plague was being spread by Chinese people, a clearly racist belief. The United States District Court with authority over the area, found this to be an equal protection violation. The identified group could not be singled out for different treatment than other residents of the city. The city government then issued a new ordinance, which they claimed it was race neutral. It didn't mention race at all, but specified vaccination or quarantine conditions for specific neighborhoods outlined in the ordinance, which it turns out were known to be the Chinese neighborhoods. The District Court, again, found this to be an equal protection violation because the intent remained to impose separate conditions on a group based on race in the application of the ordinance.

In modern times, some jurisdictions mandate human papillomavirus vaccination, or HPV vaccination, only for female students on the ground that the vaccine prevents a form of cancer prevalent in women. The sole legal challenge to this practice was brought in Washington DC in the 2010s and was dismissed for lack of standing because the person bringing the claim did not have a child enrolled in the schools where this mandate was in force. It is likely however that such a rule would withstand scrutiny of the courts because there is a scientific basis for the distinction made in his case. In modern society there are many different kinds of vaccination mandates in force. Mandates have generally existed at various times and in the current time for children entering school for the first time, which is generally the largest category of vaccination mandates and children entering secondary school. For college and university students, particularly students in the health and nursing professions. For healthcare workers, including students receiving in hospital training, even if their student programs don't require vaccination. For military personnel, immigrants to the United States and persons traveling to foreign countries to the extent that the countries to which they are traveling require vaccination. For students and healthcare workers, it is within the power of individual states to decide which vaccines are mandated and on what schedule.

States tend to follow recommendations made by the Advisory Committee on Immunization Practices or ACIP. A committee of experts selected by the secretary of Health and Human Services, working under the supervision of the Centers for Disease Control. Another body, the American Academy of Pediatrics, or AAP, also makes influential recommendations. It is not uncommon to see state statutes specifically referencing ACIP recommendations and stating that their vaccine schedule will be in accordance with ACIP recommendations, or AAP recommendations. There is some amount of federal funding for state vaccination programs that is routinely tied to states reaching specific goals in terms of vaccination statistics. In this way, the federal government can be influential in guiding states with respect to what kinds of vaccination mandates they should have in place. Although the states do deviate widely from each other and there are many different combinations of requirements.

The most widely mandated vaccines are vaccines for children and among these, the measles, mumps and rubella vaccine, or MMR and diptheria, tetanus, and pertussis vaccine, or DTP, along with the polio vaccine, commonly known as the IPV for intradermal polio vaccine to distinguish it from the oral polio vaccine or OPV, which is no longer used in the United States. These six vaccines combined into three doses are required in just about every jurisdiction in the United States. The only exception to any of these is that the state of Iowa does not mandate mumps vaccination, although it is not generally possible to get vaccine for measles and rubella, which does not contain the mumps component and since measles and rubella vaccination are mandated in Iowa, all three vaccines end up being administered. Other vaccines that are mandated for children to receive in smaller sets of jurisdictions include hepatitis A and hepatitis B vaccines, influenza vaccines, hemophilia influenza type B, rotavirus, varicella, meningococcal meningitis, although this is more commonly required for college students, pneumococcal pneumonia and HPV or human papillomavirus. Notably the HPV vaccine is considered highly controversial because it is intended to prevent a sexually transmitted disease and therefore it is only required in five jurisdictions in the United States. As of 2021, some states began preparing efforts to mandate COVID-19 vaccination for school children, although legal challenges were anticipated to come from such a program.

Every vaccination mandate has some exemptions, all jurisdictions mandating vaccination provide an exemption for persons with medical objections to vaccination. The specifics vary from jurisdiction to jurisdiction, but this is usually applicable where the person seeking the exemption can demonstrate that they have a contraindication to the vaccine. That is a condition determined by the manufacturer of the vaccine during clinical trials or reported to the manufacturer later based on use of the vaccine, which makes the vaccine incompatible with the vaccination of someone with a particular condition. The existence of a contrary indication typically must be determined by a licensed medical professional. Usually it is a physician, sometimes the statute requires a physician within that state, but in some jurisdictions a nurse, or a pharmacist, or a public health official, or other professional may also be permitted to determine that a medical exemption from vaccination is necessary. A substantial number of jurisdictions also provide an exemption for persons claiming a religious objection to vaccination.
As with medical objections, the conditions for obtaining these vary widely from state to state and jurisdiction to jurisdiction. But typically they entail a statement being made by the person seeking the exemption, articulating their religious basis for opposing vaccination. A small number of states provide no religious exemption at all and challenges to either the absence of a religious exemption, or the repeal of an existing religious exemption, have been upheld by the courts which have found that there is no constitutional right to a vaccine exemption on religious grounds. Cases have also held that the availability of religious exemption cannot be conditioned on a characteristic that only certain religions have, this constitutes an equal protection violation. These might include a requirement that the applicant belong to a congregational faith and have a religious leader that is able to attest to the existence of your religious objection to vaccination or having some other kind of religious structure that is not found uniformly. A small number of states allow objections based on personal beliefs that are not religious. And in these states it is generally sufficient for a person objecting to vaccination to say that they don't believe in vaccination. With both personal belief, exemptions and religious exemptions, states have tended towards removing or reducing these exemptions in the 21st century.

A somewhat similar set of concerns arises within the context of employment. Historically, employers have had the right to mandate vaccination of employees as they see fit. This is subject to certain state and federal limitations. A small number of states have placed limitations on the ability of employers to mandate specific vaccines. Lately this has been, particularly, with respect to the COVID-19 vaccines in response to a substantial increase in employer mandates. Under federal law employers who do mandate vaccination of employees are generally required to provide accommodations for employees who cannot be vaccinated for certain reasons. Employers are required to provide medical accommodations pursuant to the Americans with Disabilities Act and religious accommodations under title seven of the Civil Rights Act of 1964. In both cases the employer must provide an accommodation unless providing such an accommodation would constitute a burden on the employer above and beyond a certain statutory threshold. The burden is slightly higher with respect to medical accommodations than it is with religious accommodations. With medical accommodations and employer must provide an accommodation unless doing so would impose an undue burden on the employer. With respect to religious accommodations, the employer must provide one, unless providing an accommodation. When responding to requests for an accommodation, the employer has to take care with how they treat that request. An employer cannot request private medical information from an employee, pursuant to the ADA. The reason for this is that we don't want employers to be finding out things about an employee's medical condition that would lend to an employer's desire to discriminate against the employee on the basis of that condition. Therefore the employer can only ask the employee for proof of a medical disability that prevents them from being vaccinated, generally in the form of a note from a doctor. Unlike medical exemptions that are commonly provided under state laws, the Americans with Disabilities Act may require accommodation of an employee for reasons other than a contraindication. For example, a case has held that an employee who had severe anxiety about being vaccinated due to a history of allergies could be exempt from vaccination, even if there was no proof that they were specifically allergic to the vaccination itself. When providing religious accommodations, the employer may ask the employee questions designed to confirm that the employee has a sincerely held religious belief, as opposed to a generalized non-religious objection to vaccination. However, as with religious exemptions in the public sphere, the employer cannot require the employee to show that they belong to a particular religious denomination, nor can the employer require them to provide a note from a congregational leader, doing so would discriminate against employees who belong to religions that do not have a congregational structure or a congregational leader.

Common accommodations provided to non-vaccinating employees include allowing them to work remotely, working in locations, shifts, or duties that do not require physical proximity to others, or do not put the employee in physical proximity to particularly vulnerable patients or customers particularly in a medical setting, wearing of protective equipment such as masks around others, being required to be tested for disease under certain circumstances. For example, at regular intervals, when symptoms are present, or after exposure to those who are sick. Accommodations need not be those most convenient to the employee. The employer can choose whatever accommodations are least burdensome for that employer, providing that the accommodations chosen do not appear to be intended to punish the employee for seeking an accommodation. If the employer offers a reasonable accommodation and the employer refuses to accept it, the employer may terminate that employee. Once an accommodation is agreed to between employer and employee, it becomes part of the employee's job responsibilities. That's an employee who is required by an accommodation to be tested for diseases at regular intervals, or to wear a mask on the job and who fails to do so can be terminated for non-performance just as an employee whose job requires them to file a report at a particular interval, who fails to file that report can be fired for non-performance. One of the major concerns that people who are opposed to vaccination tend to raise is the prospect of forced vaccination, that is the idea that, where the government has imposed the vaccination mandate, ultimately this will result in people who are unvaccinated being physically restrained and forced to receive the vaccine against their will.

At the turn of the 20th century, forced vaccination was actually commonly practiced in the United States, very frequently against immigrant and minority communities. For example, in an 1899 meeting of the American Medical Association, a doctor who was in charge of a smallpox vaccination clinic bragged that the health department forcibly vaccinated the whole male Negro population of the city and as many women as could be captured. In 1901 New York Times article, similarly documented a raid on New York's little Italy neighborhood, in which hundreds of immigrants were rounded up and forcibly vaccinated. However, in the 1903 case of Commonwealth V. Pear in Massachusetts, the state Supreme Court noted that if a person deems it important that they not be vaccinated and the authorities think otherwise, it is not within their power to vaccinate them by force. And the worst that could happen to that person under the statute, would be that they would be required to pay the $5 fine that was in place at that time.

Modernly, if a person is forcibly vaccinated without their consent or where a child is vaccinated without parental consent, the typical remedy is that the person may sue for battery, even if the vaccine was intended for their benefit.

With respect to federal vaccination mandates, there has been a longstanding question of what power the United States federal government has to mandate vaccination of US citizens. The federal government has well-established power to mandate vaccination of persons specifically under its authority through constitutional grants of authority. For example, the federal government has long required vaccination of military personnel, certain federal contractors, primarily federal contractors who are in fact military contractors and who are deployed in forward positions alongside military service members and other federal employees. The federal government also has the authority to mandate that persons immigrating to the United States be vaccinated. And in some circumstances has mandated vaccination of federal prisoners. The full extent of the power of the federal government to mandate vaccination and other circumstances remains unknown. Scholars have speculated whether there is any circumstance under which the federal government would have the power to enact a general vaccination requirement for the population. Some have suggested that the Interstate Commerce Clause of the Constitution would provide this authority with respect to a pandemic, having a sufficient effect on Interstate Commerce. Others have suggested that the federal government could coerce states to require vaccination mandates by conditioning access to federal funds on such a policy.

In 2022, the United States Supreme Court examined applications for stays of two federal mandates that had been imposed in response to the COVID-19 pandemic and held that it was unlikely that the occupational safety and health administration had the authority to broadly mandate vaccination for employees of companies with over 100 employees during this pandemic. Although the court's opinion did suggest that OSHA may have the power to mandate vaccination in more targeted settings. The same court ruled that the Centers for Medicare and Medicaid Services likely could condition payment of funds under their authority on recipient hospitals and other medical providers, imposing vaccination mandates on their employees. These mandates occurred under an emergency setting and there are a number of statutory provisions that address emergencies in the United States.

When a national emergency is declared, this allows the Department of Health and Human Services to invoke the Public Readiness and Emergency Preparedness or PREP Act. The PREP Act statute immunizes the manufacturers of designated countermeasures, drugs and devices identified as being useful to counter the emergency, specifically including vaccines. These manufacturers are immunized from liability for harm caused by these countermeasures, unless there is willful misconduct. This immunity extends to those who are distributing and administering these countermeasures. For example, in the 2012 case of Parker V. St. Lawrence County Public Health Department, a school official administrative vaccine to a kindergarten child without parental consent during such a declared emergency. The court held that under the PREP Act that official was immune from liability.

Sovereign immunity also generally applies where government actors are involved. For example, in the 1898 case of Wyatt V. City of Rome, the Georgia Supreme Court held that sovereign immunity prevented a municipality from being held liable for an injury to a person vaccinated for smallpox by a municipal officer who errantly used impure vaccine matter. More recently in the 2012 case of BAB versus Board of Education of St. Louis, a student given an H1N1 vaccination by a school nurse who allegedly chose to ignore the parents denial of consent, was found to be immune from suit because the nurse was acting in her official capacity as a municipal employee and therefore was entitled to sovereign immunity. Note that PREP Act immunity and sovereign immunity are two different doctrines. PREP Act immunity would apply to any person administering a vaccine that has been declared a covered countermeasure for an emergency. Whereas sovereign immunity would only apply to a government employee carrying out a function of their job.

It has been argued that vaccines authorized for use under an emergency use authorization are experimental and therefore that mandates for such vaccines violate various statutes, regulations or international agreements. Over the course of the COVID-19 pandemic, however, several courts ruled on this question, the first being the court in Bridges V. Houston Methodist Hospital, which was the southern district of Texas, which found that an employer mandating a vaccine under an emergency use authorization was permissible. And that language in the emergency use authorization requiring recipients to be informed of their right to refuse the vaccine, did not prohibit an employer from terminating employees who refuse to be vaccinated. The court found that the vaccine was not experimental because those mandated to receive it were not part of a clinical trial. Later that year in the case of Klaassen V. Indiana University, decided by the Northern District of Indiana, the court expanded on the rationale of Bridges and found that the EUA status was no basis for disallowing a vaccination mandate and that the FDA had required substantially more evidence of safety and effectiveness for the vaccine in question to be allowed to be mandated than was required by the statute. This determination was then upheld by a panel of the United States Court of Appeals for the Seventh Circuit. The United States Supreme Court declined to intervene.

Vaccination mandates sometimes come up as an issue with respect to parental rights. Parents by default control vaccination decisions made for their minor children. However, courts have taken parental views on vaccination into account in family law proceedings. For example when deciding which parent will have custody of the children, or which parent will be given the authority to make medical decisions for the child. In these cases, the courts often, though not always, tend to favor the vaccination supporting parent. The most serious imposition of the law against parental rights occurs when a court severs those rights. And this is usually only invoked where parents are abusive or dangerously negligent. Once parental rights are severed, the parent has no further say and whoever has been deemed the legal guardian of the child for that purpose, in some cases a state agency, makes decisions as to whether the child will be vaccinated in according with vaccination mandates. There are some cases where parents who have lost parental rights have still sought to have exemptions applied to their children. And for the most part, those cases have resulted in decisions by the courts that the guardians appointed to the children still make those decisions. The rare exceptions to that have occurred in cases where severance has been deemed temporary by the courts, but even in those cases, the most common practices for the guardian of the state to have the power to vaccinate children.

In some states, minors have the ability to make certain medical decisions without parental consent. There are a number of different regimes that allow this, some of them are statutory and some of them are court made. Predominantly, this is known as the mature minor doctrine and very often under that doctrine, courts have recognized that a minor who is mature enough to understand the consequences of their actions can be allowed to make medical decisions affecting their lives. Generally, the person responsible for determining whether a person seeking to make those decisions as a minor has the capacity to make them, will be the physician or medical professional providing that treatment. The ability of a mature minor to indicate a preference for vaccination is heightened where parental rights have been diminished in some sense. We now move on to the next of vaccine law which is vaccine injuries and vaccine injury compensation. It is generally understood that a necessary corollary to vaccination mandates is a system of compensation for vaccine related injuries. Where a system has been put in place that requires people to participate in a particular activity, there are going to be a much larger number of people participating in that activity than if participation was entirely voluntary. And that means that if there are potential hazards rising from that activity, those will be multiplied as well. It is important to note at the outset that vaccine injuries are exceedingly rare with a few 1,000 occurring out of billions of doses of vaccines administered every year and most of those being relatively minor reactions. In the 2011 United States Supreme Court case of Bruesewitz V. Wyeth, majority justice Antonin Scalia wrote that, quote, in the 1970s and 1980s "Vaccines became", one might say, "victims of their own success."They had been so effective in preventing infectious diseases that the public became much less alarmed at the threat of those diseases and much more concerned with the risk of injury from the vaccines themselves, end quote.

Let's start by asking how vaccine injuries occur. There are four basic kinds of issues which lead to a vaccine injury.

First is a recipient allergy or other contrary indication. Now this is something that occurs when the vaccine is properly manufactured and properly administered and is generally safe, but there's something about the person receiving the vaccine that causes them to have a bad reaction to the vaccine.

The second concern is a manufacturer error, something that occurs when the pharmaceutical company manufacturing the vaccine allows a contaminant to get into the vaccine, or there is some problem with the machinery that causes an incorrect ratio of ingredients in the vaccine. It's also possible that a vaccine is developed that in and of itself has ingredients which are likely to lead to injury on the part of the person receiving the vaccine. However, when vaccines are developed, they are required to go through strenuous clinical trials which are likely to reveal any issues of this sort, which would prevent the vaccine from being licensed or otherwise authorized for use on the market.

A third possible area through which vaccine injury can arise is through improper storage or handling of the vaccine. Many vaccines are required to be kept below a certain, very cold temperature for their period of storage, or can only be stored for a certain period of time under certain conditions. And if the vaccine is mishandled during its storage, then even if it was properly manufactured and even if it was properly administered to a person who normally would not have a reaction to the vaccine, there may be some problem introduced by that improper handling.

Fourth, there is the category of administration errors of vaccines. The person administering the vaccine has to know how to inject a material into the body. And someone who uses the wrong injection technique can cause an injury. There's a specific kind of injury, in fact, called shoulder injury resulting from vaccine administration or SIRVA, which occurs specifically when the vaccine is injected incorrectly at the wrong angle, at the wrong depth into a person's arm and this causes an injury to the arm. There are also instances where the person administering the vaccine has injected too much of the vaccine into a person's body. For example, there was an instance early on in the administration of COVID vaccines, which were distributed in vials containing seven doses of the vaccine in each vial, wherein an administrator accidentally drew the entire seven doses into a syringe and injected them into a child. The child had a very uncomfortable reaction, but in the longterm did not suffer any injury.

Another thing that can lead to a vaccine injury that is technically an administration error, is where the person administering the vaccine fails to check the medication status of the person receiving it. And that person is taking a medication that is contra-indicated for receipt of that vaccine.

Due to high vaccination rates with well over 90% of the population routinely receiving at least the childhood vaccines, there is a correlation causation problem in determining whether vaccines are responsible for injuries that happen to manifest in children at the ages when vaccines are normally being administered. In practice, however, most vaccine injuries are redness and swelling at the site of administration, which resolves by itself within a few days, these injuries are generally not compensable.

There are three categories of vaccines for compensation purposes.

First, there are vaccines that are covered by the National Vaccine Injury Compensation Program, or NVICP. The NVICP covers most vaccines that are administered in the United States, including all of the vaccines that are licensed and routinely mandated for children by recommendation of the advisory committee on immunization practices, as well as triValent influenza vaccines.

Next, there are vaccines that are covered by the Countermeasures Injury Compensation Program, or CICP. This program covers vaccines that are used in response to a declared emergency under the PREP Act. This has included the COVID-19 vaccine, the H1N1 flu vaccine that was authorized for use in 2012 and the anthrax vaccine that was authorized for use in the early 2000s.
Finally, there are some vaccines that are less commonly used and are simply not covered by either program. For example, the vaccines for shingles, rabies, tuberculosis, or yellow fever, certain vaccines that are rarely administered in the United States outside of the military, such as the adeno virus vaccine, the anthrax vaccine, or the Japanese encephalitis vaccine. And certain vaccines that are only administered to people who are traveling to unusual locations or participating in unusual activities. For example if you're going to engage in sheep shearing in Australia, you need to receive the Q fever vaccine. These vaccines not being covered by any injury compensation program are subject to the same standards as other pharmaceutical products for which a defect is discovered, or from which an injury occurs.

Now, let's talk about the National Vaccine Injury Compensation Program, or NVICP. In the 1970s, the United States Congress became aware of the fact that a number of vaccine manufacturers were considering pulling out of the market due to the threat of liability from lawsuits over injuries caused by mandated vaccines. Congress therefore established this program first to protect the industries from such liability so that they would remain in the business of making vaccines which are considered to be vital and necessary to the health of the nation. And secondly, to ensure that people who did assert a valid claim of an injury caused by a vaccination would be able to be compensated for that injury quickly and without complication. Under 42 USC, section 300aa-11A2B, vaccine manufacturers and administrators are immune from suit. If a claim is filed against such an entity or individual, it should be dismissed as preempted by the statute. For counsel who represent a manufacturer or administrator of a vaccine, they should quickly seek dismissal under the statute of any claim brought against their client. For counsel who represents a vaccine injured person, they should not seek to initiate a lawsuit regarding the asserted injury, in a normal state or federal court that will be a waste of time.

There has been a split of authority over whether companies that manufacturer products used as components of vaccines are also immune under the suit. For example, in the 2004 case of Mohs V. Merkin Company, a court held that the manufacturer of the Marisol, an ingredient that has been used as a preservative in some vaccines was not immune from suit because even though if the Marisol was a vaccine ingredient, it was not itself a vaccine. For persons who seek compensation through the NVICP, that compensation is paid for out of an injury compensation fund administered by the United States Court of Federal Claims. It's funded by a 75 cent per dose tax on vaccines and it is carried out by special masters under the authority of the Court of Federal Claims. In order to see compensation through that program, a petition must be filed with the United States Court of Federal Claims, with the usual fee for filing a claim with that court. A copy must be properly served on the secretary of the United States Department of Health and Human Services. For an injury not resulting in death, the petitioner must file within 36 months of the first symptom.

It is important to note that there is no tolling for lack of association between a symptom and an illness or injury ultimately diagnosed, or between the vaccine and the injury. For example, in the case of Chlor V. secretary of Health and Human Services, a recipient of a hepatitis B vaccine had a Lhermitte signal, that is an electrical sensation shortly after vaccination. Later that person developed multiple sclerosis. At the time there was no indication that there was any connection between the hepatitis B vaccination and multiple sclerosis. However, four years later, an Italian researcher published a paper asserting that there was a connection between that vaccine in that condition. The court determined that the first symptom of these disease was the Lhermitte sign and even though there was no way anyone could have anticipated that there a connection to be found between that vaccine and that condition, it was held that the statute of limitations was not told and had expired prior to filing of the suit. Before filing the condition itself must either persist for six months or must require hospitalization or surgery. For an injury resulting in death, the petition must be filed within two years of the death and no more than 48 months from the first symptom.

Additionally, there can be no previous settlement for the injury. For example, in the case of Massing versus Secretary of HHS, parents of an allegedly vaccine injured child, first sued the doctor who had administered the vaccine. The doctor settled for $25,000, probably unaware that there was an NVICP that protected them from liability. The parents then tried to see the manufacturer who invoked their immunity under the NVICP. The parents filed a claim with a Court of Federal Claims, which dismissed the case as already having been settled because the parents had entered into a settlement with the doctor. The vaccine court has its own set of rules of procedure, the vaccine rules, which are available on the website of the Court of Federal Claims.

The court also provides guidelines on its website, which are very helpful to people seeking to press claims before that body. Special masters will review the claim and may issue compensation without a hearing, or they may require a hearing. Hearings when required are intended to be relatively informal, but are still full evidentiary proceedings, usually involving expert testimony. Various timetables are provided by which case milestones are expected to be met, but in practice parties often seek and receive extensions of time, which can result in cases being prolonged for years. In order to speed the process along somewhat under vaccine rule 4A, the respondent, that is the government, must review any petition and documentation provided along with it within 30 days of filing and identify any deficiencies specifically found they're in. Under rule 4-C1, the respondent must file a report stating its position as to whether an award should or should not be granted. The proceedings must be fundamentally fair, the special master can permit a limited amount of discovery. And again, no evidentiary hearing is required, but frequently one is conducted. The special master is technically required to make a decision within 240 days of filing, after which the petitioner can voluntarily leave the program and go to Civil Court, but this almost never happens. Instead, there are often lengthy extensions and suspensions to proceedings adding up to years of litigation. Decisions are required to go into detailed findings of fact and law and therefore are often very lengthy and often go into great detail about medical records, the cause of the injury, the credibility of the experts to testify and similar matters. Notably the NVICP is a no fault program. Petitioners do not need to prove fault on the part of the vaccine manufacturer or administrator. They merely need to make showings provided by the statute.

There are two basic kinds of injuries addressed by the NVICP, these are table injuries and non-table injuries.

For a table injury, the claimant needs to show that they received a vaccine listed on the vaccine injury table. The table lists specific vaccines, specific kinds of injuries and a specific timeframe within that injury has happened. And if all of those aspects are shown to exist, then compensation is fairly automatic. The vaccine injury table has three columns, one for the vaccine, one for the illness, disability, injury, or condition covered, one for the time period for the first symptom or manifestation of onset, or of significant aggravation after vaccine administration. Vaccines and specific vaccine injuries can be added to the VIT by the secretary of Health and Human Services, with the notice and comment proceeding. Typically, changes to the table follow either the introduction of a new vaccine to the table or the development of new evidence regarding the connection between an injury and a vaccine. In some instances, interested parties will petition the secretary of HHS to make changes to the table, which may or may not happen. The most recent change made to the table was the removal of SIRVA and vasovagal syncope as compensated entries, both were removed in January, 2021, but its removal was then undone in April, 2022. As noted, table injuries receive fairly automatic compensation.

Non-table injuries, however, require additional proof for compensation to be awarded. The criteria for proving a non-table injury were set forth in the case of V. Secretary of Health and Human Services, decided by the United States Court of Appeals for the Federal Circuit in 2005. For a non-table injury, the claimant must prove, first that a vaccine on the table was received. Second, that an injury followed the receive of the vaccination. Third, that a rational medical theory exists that connects the vaccination with the injury. Fourth, that the events occurred in a reasonable time period per this theory. And fifth, that the events occurred in illogical sequence per this theory. Non-table injuries must have expert testimony to substantiate the claimed connection between the vaccine and the injury alleged to have resulted from the vaccination. Once a petitioner presents their expert testimony, the respondent, that is the United States Department of Justice will have the opportunity to dispute it, presenting experts of their own to assert vaccine related causation and to prevent evidence that factors unrelated to vaccination caused the injury. This will then be in the hands of the special master to decide the case and determine whether compensation is to be awarded in such a case.
Attorney's fees are available in NVICP vaccine injury compensation cases. In fact, they can be applied for and paid in part midway through the case. They are available to prevailing parties and also to losing parties if the claim was not frivolous. For example, in the case of V. Secretary of HHS in 2020, an attorney filed a claim for an injury alleged to have derived from administration of a monovalent H1N1 flu vaccine. However, the VIT only covers triValent influenza vaccines. It does not cover monovalent influenza vaccines at all and the court found that this was a frivolous claim. The attorney had they done a modicum of investigation would have discovered that this was not a claim that could be compensated. Therefore the attorney was not entitled to attorney's fees. By contrast, in Chlor, the previously mentioned case in which the connection between hepatitis B vaccination and multiple sclerosis had not yet been considered, plaintiff's counsel was able to receive attorney's fees because they made a non-frivolous claim for the possible tolling of the statute, a question that had not been decided prior to that claim. If a special master determines that the petitioner is entitled to compensation, they can make an award of compensation. This also is within the authority of the special master to determine. Compensation typically includes past and future expenses incurred as a result of the injury, medical bills, medication, home care, special equipment and education costs in particular, potential lost earnings of the injured person, up to $250,000 for pain and suffering and up to $250,000 for an untimely death.

If the petitioner is unsatisfied with the outcome of the case, they can appeal to the Court of Federal Claims, which considers claim de novo. Decisions of the Court of Federal Claims can then be appealed to the United States Court of Appeals for the Federal Circuit. Ultimately some cases reach the United States Supreme Court, but it is very rare. In theory, an unsatisfied plaintiff can reject the decision of the Court of Federal Claims and then file a lawsuit in Civil Court. However, in 2011, the Supreme Court in the aforementioned case of Bruesewitz V. Wyeth, held that the intent of Congress was that no design defect claim can be brought against manufacturers so long as the vaccines were properly labeled. Therefore if the vaccine is deemed to be properly labeled and it has appropriate warnings on its labeling, then no claim can be brought asserting that the injury was caused by a defect in the vaccine itself. There is no comparable protection preventing a lawsuit being filed against the administering physician, following the rejection of a decision by the Court of Federal Claims. And in theory, such a physician would then be sued under the usual standards for medical malpractice. However, it will frequently be very difficult for a petitioner to show that a doctor administering a routinely recommended and routinely administered vaccine was not following the applicable standards of care. That would be a case that would generally require some showing that the doctor had reasons to know that the recipient of the vaccine was contraindicated, or should not receive this vaccine and administered the vaccine anyway.

A major concern that arose in the mid 2000s was a purported connection between vaccination and autism. Cases asserting such a connection were filed with the vaccine court and because a very large number of cases were filed in a short period of time, the court decided to hold an omnibus proceeding in which a panel of special masters would examine the three best cases that petitioners could put forward asserting such causation. The special masters examined all of the evidence available and found no causation in these cases, therefore making it very unlikely that a claim asserting that a vaccine has caused autism will result in compensation in future cases.

Now, what about the COVID-19 vaccine and other vaccines that are authorized for use in response to an emergency? The vaccine injury table will be inapplicable to the COVID-19 vaccine in particular, unless it is amended, which is a possible thing in the future. However, in February, 2020, the secretary of Health and Human Services issued a notice of declaration under the Public Readiness and Emergency Preparedness Act, the PREP Act, for medical countermeasures against COVID-19, even though no vaccine had yet been developed, this declaration covered vaccines and it remains in effect through October, 2024. This invokes the Countermeasures Injury Compensation Program. The CICP immunizes manufacturers, distributors, and administrators of covered countermeasures from liability for injuries caused by those countermeasures, absent willful misconduct.

Now, there are some important differences between the NVICP and the CICP. The CICP has a one-year filing deadline from the date of the administration of the vaccine. It doesn't matter when symptoms start, the only date that matters is when was the vaccine administered. Compensation is only provided for a, quote, serious physical injury, unquote. And that is something that is not defined in the statute. The CICP also covers incidentally injuries caused by medications used to treat a countermeasure injury. So if someone receives a COVID-19 vaccine and they have a bad reaction, they have an allergic reaction and they are administered epinephrin and the administration of the epinephrin causes them some additional injury, then that also is covered by the CICP. Unlike the NVICP, there are no judges or special masters, a person filing a claim under the CICP basically fills out a form and submits it to a bureaucratic functionary in the Department of Health and Human Services, that functionary who reviews the claim and makes a decision as to whether compensation will be provided or not. There is a process for appealing an adverse decision from that functionary, but that decision is basically asking the functionary supervisor to review the claim. There is no provision for judicial review beyond that and there is very little place for attorneys to be of assistance in the process.

There are a couple other routes through which vaccine injuries can be compensated.

First of all, workers' compensation is generally available, if a vaccine injury occurs in the course of an individual's employment and if the vaccine was either mandated by the employer, or it was voluntary, but was urged by the employer for the employers benefit or paid for by the employer, performed by an agent of the employer or offered on the employer's premises. Some jurisdictions excuse employers from liability for a vaccine injury incurring under one of these circumstances. If the vaccination was mandated by a government agency for some purpose or mandated by the state in which the employer was located for some purpose. However, jurisdictions are split on that. In some jurisdictions, for example, Florida, and the district of Columbia, liability is imposed even for government mandated vaccinations if this is deemed to be for the benefit of the employer.

For vaccines that are not covered by the NVICP and not covered countermeasures under the PREP Act, no immunity applies for the manufacturers and everyone in the chain of distribution of the vaccine, from the manufacturer to the distributor, to the administrator can be sued. The manufacturer can be sued under product liability theories. Administrators of the vaccine can be sued under medical malpractice theories. Note also that even for vaccines that are on the vaccine injury table, a foreign national receiving a US made vaccine in another country does not fall under the jurisdiction of the NVICP and they may sue the manufacturer of that vaccine in the US courts.

Additionally, military personnel have their own injury compensation system, the veteran's claim system. Nothing in the law prohibits a veteran from seeking compensation for a vaccine injury alleged to have been incurred during their military service from the veterans claim system. Injuries caused by counterfeit vaccines can result in criminal liability for the counterfeiters, which can include financial restitution to those harm, as well as civil liability. Bear in mind also that the NVICP and the CICP are both payers of last resort. If an individual receives some compensation through a Workers' Compensation Program, for example, and then files a claim in the NVICP or the CICP for that vaccine injury, any amount that is awarded to them will be reduced by the amount that they have already been paid through that other source of compensation.

Finally, a note on vaccines for animals, it's not something we commonly think about, but there are numerous statutory and regulatory requirements mandating that livestock and pets be vaccinated for various diseases, with the safety of vaccines for this purpose being regulated by the United States Department of Agriculture. These mandates generally serve one of two purposes, either to protect the commercial value of animals raised for food, we don't want diseases to be running through herds of livestock destroying them and diminishing the value of those investments and to protect humans from diseases potentially transmitted by animals. Now, of course, people do love their pets, they do wanna protect their pets from harm, but the general idea of laws requiring vaccination of animals is either commercial or the protection of humans. Federal law preempts lawsuits against manufacturers of USDA licensed animal vaccines if the manufacturing processes follow the conditions of the license. So if animal vaccines are administered to an animal and allegedly the animal is injured by the vaccines, as long as the manufacturer manufactures the vaccines according to the specifications that they told the USDA that they would, that manufacturer is generally considered to be immune from suit because the courts cannot step in and provide rights against the manufacturers that the government didn't provide in regulating those vaccines. There are typically several 1,000 instances per year in which a human is accidentally injected with or exposed to an animal vaccine and liability of the manufacturer for such an injury will generally hinge on whether the manufacturer provided appropriate warnings for persons engaged in activities posing a danger of such an accident.

This concludes vaccine law, class two. Thank you for your participation.

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