Sticking Points—Part 1: A Survey of Remedies for Vaccination Injuries, 1021 COBJ, Vol. 50, No. 9 Pg. 26

• Author: BY GREGORY B. CAIRNS, MARK SALIMAN, KENNETH PLATT, AND DAVID SESERMAN.
• Position: Vol. 50, 9 [Page 26]

50 Colo.Law. 26

Sticking Points—Part 1: A Survey of Remedies for Vaccination Injuries

No. Vol. 50, No. 9 [Page 26]

Colorado Lawyer

October, 2021

TORT AND INSURANCE LAW

BY GREGORY B. CAIRNS, MARK SALIMAN, KENNETH PLATT, AND DAVID SESERMAN.

This two-part article provides an overview of federal and state remedies available for vaccine injuries, including C0VID-19 vaccinations. It offers practical guidance to triage injury claims. This part 1 focuses on two federal programs currently providing remedies for injuries caused by certain vaccinations.

Vaccines are subject to well-designed clinical trials and, ultimately, US Food and Drug Administration (FDA) approval. Despite this rigor, some vaccinations bring injury and even death to their recipients.¹ While injuries are rare, some people experience idiosyncratic reactions to serum, some encounter "bad batches" of the injected drug, and a few endure negative medication interactions, including with other recently obtained vaccinations. Significant numbers of Americans also suffer shoulder injuries from the intramuscular injection of vaccines, often because the wrong-sized needle was used or the needle was inserted in correctly (SIRVA² injuries). Whether due to the serum or to its administration, the discomfort some recipients experience from the vaccination is temporary (e.g., anaphylaxis, fever, or soreness at the injection site), but for others the pain and functional deficit are long-lasting and devastating (e.g., chronic inflammation of affected tissue, paralysis, autoimmune disorder, or neurological condition).³

This two-part article acquaints practitioners with the panoply of remedies available for recipients of a vaccination that went awry. This part 1 addresses two significant federal programs: (1) the National Vaccination Injury Compensation Program (VICP) mandated under the National Childhood Vaccine Injury Act of 1986 (Vaccine Act),⁴ for those injured in the course of receiving specified childhood vaccinations, or routinely administered vaccinations such as seasonal flu; and (2) the Countermeasures Injury Compensation Program (CICP), for those who may be injured from the administration of designated public health emergency vaccinations, including a COVID-19 vaccination.⁵

Part 2 will outline residual state tort law remedies for injuries from vaccinations not covered by the VICP or CICP, or available following an authorized opt-out of the VICP. It also surveys other available remedies, including workers' compensation, non-workers' compensation funds, and general employment remedies.

The sidebar offers a decision tree for evaluating whether a potential claim is covered by the VICP or CICP.

History of Federal Vaccination Injury Programs

Since the mid-20th century, the approval and use of vaccines has been federally regulated by the same Food, Drug and Cosmetic Act (FDC A) and Public Health Service Act (PHSA) process that is applicable to other prescription medications.⁶ Historically, personal injury claims arising from adverse health reactions from a vaccine, or injuries from the vaccination administration, were creatures of state law (absent some rare preemption issues under the Swine Flu Act of 1976⁷ or the FDCA). By the 1970s and 1980s, vaccine use had become so commonplace and successful in preventing outbreaks of infectious disease that the public began to be more concerned about the risks and injuries from the vaccines than from the infectious diseases they mitigated.⁸ According to medical-legal commentators, that concern led to a vast increase in the incidence of state law product liability claims against vaccine manufacturers by the mid-1980s, with a corresponding threat that such lawsuits would cause manufacturers to abandon the market and thus destabilize vaccine supplies.⁹ At the same time, claimants were faced with enormous hurdles in successfully pursuing even the most legitimate personal injury actions due in large part to the difficulty and expense of proving the vaccine manufacturer's identity, the manufacturer's fault, and causation between the vaccine and the injuries.¹⁰

The VICP

In response to the problems inherent in pursuing traditional tort remedies, Congress passed the Vaccine Act, which created both the National Vaccine Program to study vaccines and prevention of adverse reactions and the VICP, a no-fault federal judicial "scheme of recovery designed to work faster and with greater ease than the civil tort system."¹¹ The VICP does not provide an exclusive personal injury remedy in most cases where it applies.

Instead, it provides a compensation program that a claimant must exhaust before pursuing a state law tort remedy. The compensation funds paid to claimants under the VICP are collected from an excise tax on doses sold by covered vaccine manufacturers.¹² While not applicable to all vaccine injury claims, the Vaccine Act and VICP evidence another foray (after the immunity of the Swine Flu Act) into re-routing vaccine injury claims from state tort law systems into a federal adjudication and compensation program.¹³

VICP-Covered Vaccines and the Vaccine Injury Table

As a general rule, vaccines covered by the VICP are listed on a VICP vaccine injury table (VICP Table) promulgated and amended by the Department of Health and Human Services (HHS). The VICP Table currently in effect lists the following vaccines:¹⁴

■ vaccines containing tetanus toxoid (e.g., DTaP, DTP, DT, Td, or TT);

■ vaccines containing whole cell pertussis bacteria, extracted or partial cell pertussis bacteria, or specific pertussis antigen(s) (e.g., DTP, DTaP, P, DTP-Hib);

■ vaccines containing measles, mumps, and rubella virus or any of its components (e.g., MMR, MM, MMRV);

■ vaccines containing rubella virus (e.g., MMR, MMRV);

■ vaccines containing measles virus (e.g., MMR, MM, MMRV);

■ vaccines containing polio live virus(OPV);

■ vaccines containing polio inactivated virus (e.g., IPV);

■ hepatitis B vaccines;

■ haemophilus influenzae type b (Hib) vaccines;

■ varicella vaccines;

■ rotavirus vaccines;

■ pneumococcal conjugate vaccines;

■ hepatitis A vaccines;

■ seasonal influenza vaccines;

■ meningococcal vaccines;

■ human papillomavirus (HPV) vaccines; and

■ any new vaccine recommended by the Centers for Disease Control and Prevention (CDC) for routine administration to children, after publication by the CDC Secretary of a notice of coverage.

The VICP Table identifies the vaccines covered by the program¹⁵and lists specific injuries ("On Table injuries") for each vaccine. While causation of On-Table injuries is rebuttably presumed, claimants suffering other types of injuries following the administration of a vaccine specified on the VICP Table may still recover compensation by proving that the administration of the vaccine caused their injury or aggravated a prior condition.¹⁶

Practitioners must keep current with any proposed and actual VICP Table changes that can significantly expand, or contract, the scope of VICP relief. For example, in July 2020 the HHS secretary issued a notice of a proposed rulemaking to revise the VICP Table to delete not only the final category of vaccines but also SIRVA injuries and vasovagal syncope (fainting) injuries, in an effort to reduce VICP liability to individuals injured from vaccine administration rather than reactions to vaccine serum components.¹⁷ In one of his final official acts, the HHS secretary adopted the revised VICP Table as a final rule with an effective date of February 22, 2021.¹⁸The new administration, through its acting HHS secretary, postponed the rule's effective date until April 23, 2021, to review the revised VICP Table.¹⁹ HHS has now rescinded entirely the revised VICP Table based on both procedural concerns over its last-minute adoption and policy concerns that deleting SIRVA and syncope would have a negative impact on vaccine administrators. The revised VICP Table would be at odds with the federal government's efforts to increase confidence in vaccinations, "particularly in light of efforts to respond to the [COVID-19] pandemic."^[20] This recent episode illustrates the need to stay abreast of ongoing political and administrative changes and to review the most current VICP (and CICP) related regulations when advising a vaccine-injured client.

The VICP Process and Compensation

A detailed "how to" procedural guide for litigating a VICP case is beyond the scope of this article and is available elsewhere.²¹ In a nutshell, a VICP claim is commenced by filing a petition and submitting medical and damages proof in the US Court of Federal Claims (vaccine court) alleging that the injured party received a covered vaccine and developed either an On-Table injury within the VICP Table's specified time period, or another injury caused by the vaccine, and suffered damages.^[22] The claim is filed against HHS, which is represented in vaccine court by the US Department of Justice (DOJ). The claim is initially handled by a special master with broad procedural discretion to review the claim and response, resolve motions in opposition to the claim, permit discovery, and either resolve on the filings or through hearings the critical issues in the VICP case: whether the claimant established eligibility and, if so, the compensable damages.²³

The Vaccine Act specifies the compensation that can be awarded to an eligible claimant as actual and future non-reimbursable costs for medical and custodial care, rehabilitation, and related expenses; actual and future lost earnings; up to $250,000 for actual and future pain and suffering; and, if applicable, death benefits up to S250,000.^[24] The VICP also allows reasonable attorney fees and costs for...