H1N1 (Swine Flu): Pandemic Vaccines and Legal Concerns
The recent NEJM has an excellent article on the trials and tribulations of vaccines and vaccination law and how those both feature prominently in pandemic preparedness plans. Our recent H1N1 pandemic provides a good opportunity to assess the complex and perhaps bizarre effects of vaccine laws during a pandemic.
The vaccine market is fragile, prone to shortages of both supply and demand. There are many reasons for these shortages:
- · High costs and low profits of vaccine production,
- · Public’s failure to appreciate the importance of vaccination (as a result of the vaccines’ success in reducing the prevalence of once-common diseases)
- · Fears about vaccine safety
- · Tort liability.
Ever since the 1976 National Swine Flu Vaccination Program fiasco, 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.
Individuals 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.
When Congress focused on pandemics in 2005, it again combined tort immunity with no-fault compensation. Under the Public Readiness and Emergency Preparedness (PREP) Act, manufacturers, distributors, and health care providers administering vaccines and other pandemic countermeasures are granted total immunity (except in cases of willful misconduct) when the secretary of health and human services invokes such immunity while declaring a public health emergency. The PREP Act also authorizes limited no-fault compensation for persons harmed by covered countermeasures, but unlike NCVIA, it does not allow for judicial review or civil litigation. In June 2009, Secretary of Health and Human Services Kathleen Sebelius issued an emergency declaration for H1N1 influenza. The declaration has since been updated and reissued several times.
Ideally, the PREP Act’s immunity provisions — in conjunction with Section 564 of the Food, Drug, and Cosmetic Act, which allows the Food and Drug Administration to issue emergency-use authorizations — remove legal obstacles to the rapid production and dissemination of pandemic vaccines. The effect of these laws on the public’s willingness to be vaccinated, however, is uncertain. For example, during the 2003 smallpox-vaccination program for health care providers, doubts about the availability and adequacy of compensation for vaccine-related injuries were blamed for discouraging many providers from being inoculated. NCVIA’s effect on public confidence in vaccinations is also unclear. By requiring that vaccine cases first go before the Vaccine Court, NCVIA ensures that claims will be scrutinized by special masters who are well equipped to review the scientific evidence. Still, the act’s relatively broad immunity provisions and the barriers it creates for patients seeking jury trials have provided rich fodder for people who distrust vaccines. After special masters recently ruled in three cases that thimerosal, a mercury-based preservative used in some vaccines, does not cause autism, Rebecca Estepp, a member of a coalition that believes that vaccines cause autism, responded by claiming that the Vaccine Court was “stacked against families.”
Several states therefore limit the use of mercury-containing vaccines in young children and pregnant women. For example, Washington State prohibits the use of influenza vaccines with more than 1.0 µg of mercury per 0.05-ml dose in pregnant women or children under 3 years of age. The state’s secretary of health can suspend the prohibition during an outbreak of a vaccine-preventable disease or a shortage of mercury-free vaccine, but clinicians must inform pregnant patients and parents of children under 18 that the vaccines being used contain more mercury than is otherwise permitted. Last October, citing the shortage of mercury-free H1N1 vaccine, Washington State’s health department suspended the act’s prohibition, invoking the warning requirement. A local health official reported that this move may have discouraged health care providers and patients from getting vaccinated.
Public wariness regarding vaccination has led some public health and elected officials to consider vaccine mandates. All states require schoolchildren to be vaccinated, but 48 states provide religious exemptions, and 21 allow philosophical exemptions. Such laws regularize vaccination without penalizing families who most ardently oppose the practice.
Several states take a similar approach to promoting the vaccination of health care workers against influenza. For example, California and Massachusetts require hospital workers either to be vaccinated annually against influenza or to sign a written declination. These laws also regularize vaccination without actually compelling all hospital employees to comply.
Some officials have sought more coercive measures. In 2001, the Model State Emergency Health Powers Act proposed granting states authority to isolate people who refused vaccination during a public health emergency. Although many states have adopted this provision, none implemented it during the H1N1 pandemic. Indeed, during the peak of the outbreak, vaccine was either nonexistent or in short supply, and many people who wanted to be vaccinated could not be. Under such circumstances, which are likely to exist during any pandemic, mandates are bound to be ineffective.
Nevertheless, in August 2009, New York State’s health department issued an emergency regulation requiring health care workers who had contact with patients in hospitals and other specified settings to be vaccinated against H1N1 and seasonal influenza, unless they had medical contraindications. Several workers responded by filing lawsuits claiming that the department had exceeded its authority and violated their constitutional rights. On October 16, 2009, a trial court issued temporary restraining orders in two cases, blocking the implementation of the regulation. The department then rescinded the regulation, citing the shortage of H1N1 vaccine.
Despite the shortage, many hospitals required workers either to be vaccinated or to wear a protective mask. Predictably, such requirements led to a spate of lawsuits charging the hospitals with violating collective bargaining agreements as well as federal labor laws. Although the hospitals usually prevailed, a federal court in Nevada issued a temporary restraining order prohibiting the implementation of a mandate for vaccination against seasonal influenza, pending arbitration.
The H1N1-vaccine litigation shows that mandates not only may be ineffective when vaccine shortages exist but also may backfire. Although states can penalize people who refuse vaccination during an epidemic, the law also provides multiple ways to challenge vaccine mandates. These lawsuits can generate heated publicity that raises further doubts in people’s minds about vaccine safety. Certainly, media reports about health care workers going to court to avoid vaccination are not apt to inspire the public’s faith in vaccines.