By Aryeh S. Klonsky, Esq., and Michelle A. Frankel, Esq.
Tuesday, August 20, 2019
The decision about whether to be vaccinated is a patient’s choice. Vaccine manufacturers and medical providers are not commonly sued when patients become injured or sick or when they die after being vaccinated, as most cases are processed by the National Vaccine Injury Compensation Program.
However, vaccines, like every non-emergent medical intervention, must be preceded by a discussion between the patient and clinician concerning the risks, benefits and alternatives associated with receiving and refusing the intervention.
Well-known risks (low-grade fever and soreness at the injection site) and risks that are less common but more severe (development of brain inflammation and seizures) should be discussed. For many vaccines, medical providers are required by federal law to give printed Vaccine Information Statements (VIS) that include written instructions about the risks and benefits of the vaccine, how to identify reactions and when to seek medical intervention. Patients may be asked to sign documents that detail the risks, benefits and alternatives, further memorializing their understanding and choice to receive or not receive a vaccination. Documenting risk, benefit and alternative discussions can help patients appropriately decide whether to receive vaccines and can be useful to defend medical providers if negative outcomes arise.
Over the past century, vaccines reduced the incidence of serious and potentially fatal diseases including chickenpox, polio, tetanus, whooping cough and measles, which was essentially eradicated in 2000. Patients may be inclined to refuse vaccination because they are unfamiliar with the theories behind vaccinations. Recently, there have been drastic increases in vaccine-preventable diseases. In 2019, there have been 52 cases of measles in California and 588 cases in New York City alone. These cases primarily developed in patients who were not vaccinated by choice on the basis of religious or moral exemption. The increase in vaccine-preventable diseases forced many local governments to reconsider these exemptions that existed for decades.
In June, New York lawmakers voted to end religious exemptions for all required vaccines. Personal exemptions are no longer allowed in New York, and absent medical necessity, all children must receive vaccinations to attend school. Maine enacted a similar law, and Massachusetts has proposed one. California, where some of the strictest vaccination laws in the country were enacted in 2015 after a measles outbreak, is now considering a bill that would trigger review of a physician’s practice if he or she issues more than five medical exemptions per year. This law is being considered because physicians had granted exemptions for patients who did not need them but paid for them.
In other efforts to reduce opt-out rates, states enacted or are contemplating “mature minor” laws that give minors the right to make vaccine decisions without parental knowledge or consent. These laws permit consent from the minor patient, and therefore, medical providers should be prepared to discuss the vaccine’s risks, benefits and alternatives with the minor patient, rather than the patient’s guardian. Given the recent changes surrounding vaccine mandates, medical providers should familiarize themselves with federal, state and local laws to ensure compliance and prevent malpractice claims and other violations.