TORT AND INSURANCE LAW
BY GURNEY F. PEARSALL III
This article provides the history and an overview of the National Vaccine Injury Compensation Program. It offers practical guidance for practitioners to evaluate and litigate vaccine injury claims.
Vaccines are a hallmark of modern medicine. The smallpox virus, which once plagued humanity with centuries of outbreaks and a 30% fatality rate, has perished because of the smallpox vaccine.1 The novel coronavirus may be the next virus to meet its end at the hands of a vaccine. But notwithstanding their utility, vaccines can injure, and sometimes catastrophically.
After a wave of vaccine injury lawsuits nearly chased vaccine manufacturers out of the US vaccine market in the 1980s, Congress established the Vaccine Injury Compensation Program (VICP), a non-adversarial, no-fault alternative to common law tort. This article offers an overview of the VICP and guidance on how to evaluate and litigate vaccine injury claims.
How Vaccines Work
We live in a microbial world. Our immune system is locked in a constant struggle with the microbes all around us, but viruses and bacteria are as interested as we are in surviving.2 Anyone who has had a cold knows that the immune system is not always successful in this struggle. At times, it mistakes a harmless microbe as a threat—hence, seasonal allergies. At times, it mistakes a harmful microbe as no threat, leading to viral and bacterial infections.
are effective at killing bacteria, until they develop
antibiotic resistance.3 But because viruses are much tinier
and harder to target than bacteria, the best defense against
them is a strong immune system.4To that end, vaccines
train the immune system to recognize a viral invasion as a
threat.5 Typically, vaccines accomplish this by
introducing a weakened version of the pathogen into an immune
system. As more people develop immunity to that pathogen, it
runs out of eligible hosts and perishes.6 This "herd
immunity" helps protect immunocompromised people, whose
immune systems would be overwhelmed even by the weakened
vaccine version of the pathogen.
All medical intervention comes with risk, whether one is ingesting aspirin or injecting a vaccine.8 Vaccine injuries typically result from either the vaccination or from the vaccine itself. Vaccination injuries result from poorly administering an otherwise perfectly good vaccine, while vaccine injuries result when, even after the injection is correctly performed, die body responds poorly to the vaccine.
the main vaccine on the market, the influenza (flu) vaccine.
It should be injected in the midpoint of the non dominant
arm's deltoid muscle, at a 90-degree angle. If the
vaccinator misses that injection site or injects at a poor
angle, the injection may result in inflammation that damages
musculoskeletal structures, causing chronic pain and limited
range of motion due to adhesive capsulitis, shoulder bursitis
(frozen shoulder), or rotator cuff tear.10 Paralysis or
neuropathy can also result if the injection hits a
Even if the vaccinator correctly administers die flu shot, adverse effects might occur. Typically, these effects are merely a brief inconvenience such as a fever, or a mild allergic reaction or soreness at the injection site. These reactions are a natural result of the immune system responding to, fighting off, and remembering the injected pathogen. If a more severe adverse reaction takes place, it often occurs as a severe allergic reaction, inflammation, or autoimmune disorder.
A severe allergic reaction to vaccine ingredients, such as egg or gelatin, can result in anaphylaxis, which often presents as itchy hives or swelling of the throat.Vaccine-induced transverse myelitis may occur when die injection of the vaccine leads to spinal cord inflammation and nerve damage, which can present as blurred vision, weakness, paralysis, and bladder or bowel dysfunction.13 Encephalitis occurs when the immune system response to the vaccine causes brain inflammation, resulting in headaches, fatigue, and/or brain damage.14
Autoimmune disorders involve the immune system attacking itself. The autoimmune disorders that most often appear in vaccine injury cases are Guillain-Barre syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIPD), and chronic arthritis.15 GBS results from die immune system attacking its own nerve cells, leading to muscle weakness and paralysis.16CIPD is a form of GBS that results from the immune system attacking its own myelin, leading to impaired sensory function and loss of motor coordination.17 Chronic arthritis can result if the immune system response causes joint pain and swelling.18
As severe as these disorders may be, their symptoms are amorphous and often take weeks or months to develop, making it difficult to diagnose the disorder as a vaccine-induced injury with a high degree of medical certainty. Starting with die first vaccine injury lawsuits, causation was and continues to be die most challenging aspect of vaccine injury litigation.
Common Law Vaccine Injury Liability
Courts first addressed vaccine injury liability in Gottsdanker v. Cutter Laboratories.20 In 1955, lonas Salk released a polio vaccine.21 Sadly, poor manufacturing standards led to "The Cutter Incident," in which 40,000 children who received this vaccine contracted polio and infected their families and communities.22 The resulting polio epidemic marks one of die worst pharmaceutical disasters in American history.23
Gottsdanker distinguished between vaccine efficacy and vaccine safety, noting that die case did not involve a vaccine efficacy claim that die vaccine failed to protect the vaccinee against polio.24 Such a claim would have failed.25 Instead, the petitioners presented a vaccine safety claim, alleging that die vaccine itself caused polio.26 With that distinction, Gottsdanker set t he framework for manufacturer liability in vaccine injury claims.27
In 1976, an outbreak of swine flu resulted in a government swine flu program that immunized vaccine manufacturers from vaccine injury liability, created a federal vaccine injury claims process, and facilitated the quick vaccination of one-third of the adult US population.28 To boost public confidence in the shot's safety, President Gerald Ford televised his immunization.29 By 1985, over 4,000 vaccine injury claims had been filed, alleging injuries such as Guillain-Barre syndrome.30 Even though most cases were dismissed for failure to prove a causal connection between the injury and the vaccination, the claims cost the government nearly as much as the program itself.31
The 1980s saw a wave of diphtheria/tetanus/pertussis (DTP) vaccine lawsuits based on negligence theories, public outrage over vaccine injuries, and congressional hearings on vaccine safety.32 By the mid-80s, DTP lawsuits against Lederle alleged damages exceeding 200 times the manufacturer's total sales,33 and Connaught Laboratories found itself defending against lawsuits demanding a combined billion dollars in damages.34 In 1985, Kearl v. Lederle Laboratories expanded vaccine injury liability to new heights as the first case to permit product liability claims over vaccine injuries.35
Faced with ever-increasing liability, both in quantity and quality, vaccine manufacturers began spiking vaccine prices or leaving the market altogether.36 The very real possibility of vaccine shortages loomed on the horizon, along with the loss of herd immunity and the return of routine epidemic outbreaks.37
Congress stepped in to avert the crisis with the National Childhood Vaccine Injury Act of 1986,38 which established an extensive federal role in vaccine safety, development, and monitoring, and created the VICP.39 The VICP preempts virtually all vaccine injury claims in the United States, requiring that vaccine injury petitioners bring their claims to the US Court of Federal Claims (CFC).40 These claims proceed under a simplified, informal system that does not involve a jury, formal discovery process, or rules of evidence; imposes a statutory 240-day deadline for the court to issue its final ruling; and extends the promise of compensating "vaccine-injured persons quickly, easily, and with certainty and generosity."41
A chief special master and seven associate special masters preside over these cases, with a Department of Justice (DOI) staff attorney representing the respondent, the Department of Health and Human Services (HHS). A 75-cent excise tax on each vaccine dose administered in the US funds the program.42While the CFC sits in Washington, D. C., nearly everything is filed electronically and handled telephonically. As a result, a vaccine attorney in Colorado can offer full representation to petitioners worldwide.43
Evaluating a Prospective Vaccine Injury Case
The vaccine claims process may be simplified, but strict adherence to the process is required. Disregarding the vaccine court rules and formalities can result in the dismissal of an otherwise viable case. Given the extent of the injuries often involved, a dismissal may expose practitioners to significant malpractice liability.
For this reason, practitioners should carefully review the vaccine court's rules and guidelines (including sample forms),44 and evaluate a prospective vaccine injury claim by evaluating (1) whether the claim is timely, (2) what the medical records show, (3) whether HHS will contest entitlement, and (4) the nature and extent of damages.
Is the Claim Timely?
If a prospective vaccine-injured client walks into your...