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N Engl J Med. Pandemic Vaccines — The Legal Landscape

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  • N Engl J Med. Pandemic Vaccines — The Legal Landscape

    Pandemic Vaccines -- The Legal Landscape (N Engl J Med., extract, edited)

    [Source:, extract, edited, <cite cite="">NEJM -- Pandemic Vaccines -- The Legal Landscape</cite>.]

    Volume 362:1949-1952 May 27, 2010
    Number 21

    Pandemic Vaccines — The Legal Landscape

    Wendy E. Parmet, J.D.

    Vaccines and vaccination law feature prominently in pandemic preparedness plans. The recent H1N1 influenza vaccine program provides an important opportunity to assess the complex and perhaps paradoxical effects of vaccine laws during a pandemic.

    The vaccine market is fragile, prone to shortages of both supply and demand. These shortages have been attributed to such factors as the high costs and low profits of vaccine production, the public's failure to appreciate the importance of vaccination (due, ironically, to vaccines' success in reducing the prevalence of once-common diseases), fears about vaccine safety, and tort liability. In order to protect public health, law must address each of these concerns. Resolving one without exacerbating another is always challenging; during a pandemic, it can be especially difficult.Ever since the 1976 National Swine Flu Vaccination Program, Congress has addressed these problems by coupling liability protection for vaccine makers with alternative compensation programs for injured patients. For example, the National Childhood Vaccine Injury Act (NCVIA, see National Childhood Vaccine Injury Act) provides relatively swift, but limited, compensation for persons with well-recognized listed injuries from covered vaccines. NCVIA also allows other claimants to go before a tribunal of Special Masters of the U.S. Court of Federal Claims, known as the Vaccine Court, to show that a vaccine caused their injury. This court's rulings can be reviewed by the U.S. Court of Appeals for the Federal Circuit. Parties who are dissatisfied with a Vaccine Court ruling also retain a limited right to sue in state court. Recently, the U.S. Supreme Court agreed to review a case, Bruesewitz v. Wyeth, in which the U.S. Court of Appeals for the Third Circuit held that NCVIA bars a state-law design-defect claim brought by a minor after the Vaccine Court found that the whole-cell diphtheria–pertussis–tetanus vaccine did not cause her neurologic injuries. The Supreme Court's decision in Bruesewitz should help to clarify which state-law claims survive NCVIA.