The Federal Circuit Court of Appeals affirmed the denial of a vaccine injury compensation claim filed by Sally Herms, who alleged that a diphtheria tetanus toxoid acellular pertussis vaccination caused sensorineural hearing loss and tinnitus in her left ear.
In a nonprecedential decision issued Jan. 15, Herms appealed after both a special master and the U.S. Court of Federal Claims rejected her petition under the National Vaccine Injury Compensation Program. The three-judge panel, consisting of Circuit Judges Lourie, Taranto, and Chen, unanimously upheld the lower court rulings.
Herms received the DTaP vaccine on June 18, 2017. Two days later, she experienced fever, muscle aches, and other symptoms. She subsequently filed her petition in the Court of Federal Claims seeking compensation under the federal vaccine injury program, which provides a no-fault alternative to traditional tort litigation for individuals who suffer injuries allegedly caused by covered vaccines.
The National Vaccine Injury Compensation Program, established under 42 U.S.C. sections 330aa-10 to 330aa-34, was created by Congress in 1986 to provide compensation for vaccine-related injuries while protecting vaccine manufacturers from most lawsuits. The program covers specific vaccines and injuries listed in the Vaccine Injury Table, and petitioners must demonstrate either that their injury appears on the table or prove causation through medical evidence.
The case proceeded through the specialized vaccine court system, where special masters with expertise in vaccine injury claims review petitions. Special Master Charles F. Lettow initially denied Herms' claim in a March 4, 2024 decision. The Court of Federal Claims subsequently affirmed that denial, finding insufficient evidence to establish that the DTaP vaccination caused Herms' alleged hearing problems.
Herms was represented by John Francis McHugh of New York throughout the proceedings. The Department of Justice defended the case on behalf of the Secretary of Health and Human Services, with attorney Alec Saxe from the Torts Branch leading the government's legal team. The DOJ representation also included Brian M. Boynton, C. Salvatore D'Alessio, Colleen Hartley, and Heather Lynn Pearlman.
The Federal Circuit's affirmance represents the final step in the administrative process for Herms' claim, though petitioners who are unsuccessful in the vaccine injury program retain the right to file traditional tort lawsuits against vaccine manufacturers under certain circumstances. However, such litigation faces significant legal hurdles given federal preemption doctrines and the requirement to first exhaust the administrative remedy.
Vaccine injury cases often involve complex medical and scientific evidence regarding causation. Petitioners must typically demonstrate that their injuries occurred within a specific timeframe after vaccination and that no other cause better explains their condition. The burden of proof varies depending on whether the alleged injury appears on the Vaccine Injury Table or requires off-table causation analysis.
The DTaP vaccine protects against three serious diseases: diphtheria, tetanus, and pertussis (whooping cough). It is routinely administered to children and adults as part of standard immunization schedules recommended by the Centers for Disease Control and Prevention. While serious adverse reactionsto vaccines are rare, the compensation program provides an avenue for individuals who experience qualifying injuries.
Sensorineural hearing loss and tinnitus, the conditions Herms attributed to her vaccination, involve damage to the inner ear or auditory nerve pathways. Establishing causation between these conditions and vaccinations requires medical evidence demonstrating a temporal relationship and ruling out other potential causes.
The Federal Circuit's decision was designated as nonprecedential, meaning it does not establish binding legal precedent for future cases. Such designations are common for routine appeals that do not involve novel legal questions or significant policy implications.
The case illustrates the challenges faced by vaccine injury petitioners in establishing causation, particularly for conditions that may have multiple potential causes. While the compensation program was designed to provide a more accessible alternative to traditional litigation, petitioners still must meet evidentiary standards to demonstrate that vaccines caused their alleged injuries.
The original petition was filed in 2019, highlighting the lengthy timeline often involved in vaccine injury cases as they proceed through the administrative process and potential appeals. The specialized nature of these cases requires extensive medical review and expert testimony to evaluate causation claims.
The affirmance closes this chapter of Herms' legal challenge, though the broader questions surrounding vaccine injury compensation continue to evolve as medical understanding advances and new vaccines enter the market. The program has compensated thousands of petitioners since its inception while maintaining public confidence in vaccination programs essential to public health.