Since the declaration of an H1N1 influenza pandemic in June 2009, virtually all countries are now reporting cases. Speaking at a press conference in Geneva Switzerland in November, Dr. Keiji Fukuda, Special Adviser to the Director of the World Health Organization (WHO) on Pandemic Influenza, told reporters “the pandemic virus has become the dominant influenza virus in all countries.” Dr. Fukuda went on to say that WHO anticipates continued or increased activity during the winter period in the northern hemisphere, and continued reports of serious cases and deaths.
Dr. Fukuda made it clear, however, that although most people who become infected develop a self-limiting illness and recover without any interventions, we are not dealing with seasonal influenza. Despite the fact that most patients recover from the swine flu without complication, WHO is still seeing complications in people who have chronic underlying medical conditions and pregnant women. However, complications can also occur in people who are healthy.
The response by the medical system in the United States has been mixed with various states declaring public health emergencies. New York State, in particular, is involved in a lawsuit filed by two nurses over mandatory vaccination of healthcare workers for seasonal and H1N1 influenza ordered by the state’s Commissioner of Health despite the fact that the Center for Disease Control (CDC) has recognized the need to protect hospital patients and long-term care facility residents by recommending influenza vaccinations for healthcare workers since 1981.
Resistance to vaccination is seen by many in the healthcare industry as inexplicable and puzzling considering that in November 2003, twenty four health organizations including the Society for Hospital Epidemiology of America, the American Medical Association, the American Academy of Family Practitioners, the American Academy of Pediatrics, and the American Nurses Association endorsed vaccination for healthcare workers.
In February 2006, the Healthcare Infection Control Practices Advisory Committee (HICPAC) and the Advisory Committee on Immunization Practices (ACIP) jointly recommended that all healthcare workers be vaccinated annually against influenza. Also, in January 2007, the Infectious Disease Society of America called for a mandatory requirement for all healthcare personnel to receive influenza vaccination yearly.
The constitutionality of mandatory vaccination programs has yet to be tested but a decision is forthcoming. On October 16, 2009 a Supreme Court judge in Albany County, NY issued a temporary restraining order on the emergency mandatory vaccination program implemented by the state’s Commissioner of Health. Shortly thereafter, NY Gov. David Patterson issued an executive order declaring a state of emergency while the issue of requiring healthcare workers to be vaccinated was still working its way through the courts. A few days later, the governor halted the program altogether. The issues have been placed on the back burner for now due to a shortage of the vaccine.
There is little dispute that vaccination leads the list in the armamentarium of preventive measures in the war on H1N1. WHO and virtually all state public health authorities believe that vaccines are useful against pandemic infection and support their use. H1N1 vaccination programs have started in more than 20 countries and have been administered to millions of people according to WHO. The levels of local side-effects such as painful vaccination site, sore arm and redness are reported to be similar to what is seen with seasonal influenza vaccines. There have been no reported unusual or unexpected side-effects of the vaccines, and WHO and the United States Department of Health and Human Services continue to promote vaccination as the best way to prevent infection with what is now recognized as a new pandemic influenza. The CDC and the Advisory Committee on Immunization Practices (ACIP) have made recommendations for who should receive the H1N1 vaccine while state and local health departments determine how to implement these recommendations.
Physician Liability and PREP
Still, there are skeptics, even in the medical community, who resist vaccination and claim that it is irresponsible to administer an as yet unproven and relatively untested vaccine. The public perception and, in some cases, outright distrust of government advocated vaccination programs have left many physicians fearful of their liability in the event that a patient who receives the vaccine suffers an unexpected severe side effect such as what occurred in 1976 when Guillain-Barré syndrome was reportedly linked to the flu vaccine. Against this backdrop, physicians find themselves in the middle of a controversy that understandably causes anxiety over professional liability.
The good news is that under a federal law known as the Public Readiness and Emergency
Preparedness Act (PREP) passed in 2005, physicians who administer H1N1 vaccine need not fear lawsuits for injuries related to the administration of the vaccine provided they make a vaccine adverse event report within seven days of discovery of a suspected injury. PREP was originally part of the “Department of Defense, Emergency Supplemental Appropriations to
Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act of 2006” (PL 109-148).
The law gives broad liability protections to covered persons such as physicians who administer the vaccine, and compensates individuals injured by the vaccine.
PREP was enacted specifically to address the pandemic influenza threat by affording liability protections to manufacturers and persons administering the vaccine after a declaration by the Secretary of Health and Human Services of covered countermeasures. H1N1 vaccine has now been declared to be a covered countermeasure, as defined in section 319F-3(i)(1) of the Public Health Service Act (42 U.S.C. 247d-6d). The liability protections under PREP cover the manufacture, testing, development, distribution, or use of the H1N1 vaccine. As far as the seven day reporting period is concerned, adverse event reports should be filed from the day the physician discovers a suspected adverse event as opposed to seven days from the day the vaccine was administered.
In addition to protecting persons who administer H1N1 vaccine, the PREP Act also gives the Administrator of the Health Resources and Services Administration the authority to compensate eligible individuals under the Countermeasure Injury Compensation Program (CICP). The CICP is the exclusive remedy for compensation and grants complete immunity to the vaccine manufacturer and physician or person administering the vaccine from being sued in state or federal court, except in situations where willful conduct is established. What this means for physicians is that they cannot be sued by a patient who claims to have suffered a serious injury or death from the H1N1 vaccine provided they file a Vaccine Adverse Event Report (VAER) within seven days of discovery of a suspected vaccine related injury.
Even though physicians can safely recommend and administer H1N1 without fear of being sued, they should be familiar with the recommendations of the Advisory Committee on Immunization Practices (ACIP). ACIP states that patients with a history of Guillain-Barre syndrome (sudden weakness/paralysis of the extremities) from previous flu vaccination (estimated at 1-2 cases per 1 million vaccinated patients) are under a precaution for receipt of the contraindication.
ACIP defines a precaution as a condition that might increase the risk for a serious adverse reaction or that might compromise the ability of the vaccine to produce immunity. In such, a patient injury may result, or the patient might experience a more severe reaction to the vaccine than would have otherwise been expected. ACIP advises that under normal circumstances, vaccinations should be deferred when a precaution is present. However, ACIP is not a substitute for sound medical judgment. There will obviously be cases where a vaccination will be indicated in the presence of a precaution because the benefit of protection from the vaccine outweighs the risk for an adverse reaction. In addition, physicians are encouraged to familiarize themselves with the most recent 2009 Vaccine Information Statement posted at http://www.immunize.org/vis.
It must be emphasized that PREP does not apply to seasonal flu vaccine since the Secretary of HHS has not declared a seasonal influenza pandemic emergency. Persons who claim to have been injured by seasonal flu vaccine can be compensated under a different federal program known as the National Vaccine Injury Compensation Program (VICP), which was created under the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660). The VICP is a no-fault alternative to the tort system that gives individuals injured by a covered vaccine a special legal forum to obtain compensation. The CICP pays claims through the Vaccine Injury Compensation Trust Fund for proven vaccine-related injury or death resulting from the covered vaccine.
The VICP does not give the same protection to physicians and manufacturers as the PREP Act does, so it is important to know the difference. Under the VICP the U. S. Court of Federal Claims has exclusive jurisdiction over vaccine-related injury claims, but private lawsuits are permitted if the claim is found to be non-compensable or dismissed; or if the claimant chooses to reject the award. Unlike the CICP, which only bars lawsuits against physicians for administering H1N1 vaccine unless engaged in willful conduct, the VICP, which covers seasonal flu vaccine, – does not bar lawsuits against physicians.
Finally, it is important to remember that under the CICP, although most lawsuits are brought against manufacturers, private lawsuits can still be filed against a physician if the injured plaintiff believes that administration of the vaccine was contraindicated or the vaccine was otherwise negligently administered.
Charles E. Kutner is the senior member and lead trial attorney for the medical malpractice group of New York City based Charles E. Kutner, LLP specializing in insurance defense litigation, professional liability defense and general liability defense.