Vaccine Liability Laws and COVID-19

By Sophie Lovering 

Sophie Lovering is a junior in the College of Arts and Sciences at the University of Pennsylvania majoring in Philosophy, Politics, and Economics (PPE) and minoring in American Sign Language and Deaf Studies.

Since Pfizer and Moderna introduced their COVID-19 vaccines, Americans have asked each other the question: “will you be getting vaccinated?” For many, the answer seems obvious. Vaccines are one of the greatest success stories of modern medicine; according to the CDC, vaccines have functionally eradicated smallpox and polio, and keep the levels of diseases such as measles, diphtheria, and whooping cough at an all-time low today [1]. 

Since Pfizer and Moderna introduced their COVID-19 vaccines, Americans have asked each other the question: “will you be getting vaccinated?” For many, the answer seems obvious. Vaccines are one of the greatest success stories of modern medicine; according to the CDC, vaccines have functionally eradicated smallpox and polio, and keep the levels of diseases such as measles, diphtheria, and whooping cough at an all-time low today [1]. 

However, some Americans fear the consequences of the COVID-19 vaccine; others are hesitant when it comes to vaccines in general. The benefits of vaccines overwhelmingly outweigh the potential risks, however it is true that no vaccine is completely safe. In theory, patients could experience allergic reactions and health issues such as paralysis [2]. Some people even hold the disproven belief that vaccines cause Autism. Accordingly, many people who experience these negative consequences may wish to sue their vaccine providers. 

A heightened concern for vaccines spiked in the mid-1970s when society turned its focus toward an increased personal health [1]. As people filed lawsuits against vaccine manufacturers and healthcare providers for adverse consequences of vaccinations, liability and prices soared [1]. As a result, many vaccine manufacturers had to halt production [1]. These lawsuits and the reaction by pharmaceutical companies threatened to create damaging vaccine shortages and reduce vaccination rates, so Congress enacted the National Childhood Vaccine Injury Act of 1986 (VICP) [3]. VICP is administered by the Division of Injury Compensation Programs, Healthcare Systems Bureau, Health Resources and Services Administration, U.S. Department of Health and Human Services [3]. Its goals include ensuring an adequate supply of vaccines, stabilizing vaccine costs, and maintaining an accessible forum for individuals who have been injured by certain vaccines [3]. VICP is a no-fault alternative to the traditional tort system that allows individuals to petition the government for compensation for injury by vaccine [3]. 

In 2011, the Supreme Court of the United States upheld VICP in Bruesewitz et al. v. Wyeth LLC [4]. The majority opinion, authored by Justice Antonin Scalia, explains that VICP preempts all design-defect claims against vaccine manufacturers [4]. Justice Scalia’s opinion explains that it remains a sensible choice to leave epidemiological judgements about vaccine design to the FDA and the National Vaccine Program, as opposed to juries [4]. Pfizer argued that, had the Supreme Court ruled in favor of the plaintiff, their company would have faced countless lawsuits, including some focused on the baseless claim that vaccines cause Autism [4]. This decision prompted much outside support from physicians and other healthcare workers. Notably, the American Academy of Pediatrics applauded the Supreme Court’s decision, writing that this decision protects children by strengthening America’s immunization system [4].

It is critical to consider vaccine liability in the time of this pandemic. Though not covered by VICP, COVID-19 vaccine manufacturers enjoy protection under the Public Readiness and Emergency Preparedness Act of 2005 (PREP), invoked by Health and Human Services Secretary Alex Azar in February of 2020 [5]. PREP provides legal protection to companies producing essential vaccines, barring “willful misconduct” [5]. 

In light of vaccine skepticism and increased vaccine availability to Americans, many may ask: If I were to face injuries resulting from the COVID-19 vaccine, could I “sue the government?” No, not really. But this holds with all other vaccinations, covered by either VCIP or PREP. Should you face any negative consequences, you are liable for compensation. It is important to keep in mind that facing injuries resulting from vaccinations is very unlikely. Throughout modern medicine, vaccines have minimized preventable diseases and eradicated fatal viruses. Existing laws balance the priority of eradicating deadly diseases while compensating victims of their rare negative consequences. If you are presented with the chance to receive the COVID-19 vaccine, I urge you to seize the opportunity. 

The opinions and views expressed in this publication are the opinions of the designated authors and do not reflect the opinions or views of the Penn Undergraduate Law Journal, our staff, or our clients.

References
[1] “U.S. Vaccine Safety.” Centers for Disease Control and Prevention. September 9, 2020. https://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html.
[2] Bauman, Valerie and Susan Decker. “Drugmakers Shielded from COVID Vaccine Liability But Funds for Injury Claims in Doubt.” Insurance Journal. August 14, 2020. https://www.insurancejournal.com/news/national/2020/08/14/579150.htm.
[3] “About the National Vaccine Injury Compensation Program.” Health Resources and Services Administration. December 2020. https://www.hrsa.gov/vaccine-compensation/about/index.html#:~:text=The%20National%20Childhood%20Vaccine%20Injury,be%20injured%20by%20certain%20vaccines.
[4] Sullivan, Thomas. “Supreme Court Rules in Favor of Protecting Vaccine Makers from State Lawsuits.” Policy and Medicine. May 5, 2018. https://www.policymed.com/2011/03/supreme-court-rules-in-favor-of-protecting-vaccine-makers-from-state-lawsuits.html.
[5] Sigalos, MacKenzie. “You can’t sue Pfizer or Moderna if you have severe Covid vaccine side effects. The government likely won’t compensate you for damages either.” CNBC. December 23, 2020. https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html.