COVID-19 clinical trial participants injured by vaccine side effects only eligible for limited financial compensation
Individuals who agree to participate in COVID-19 vaccine clinical trials essentially do so for altruistic purposes, and should be aware that if they suffer serious and potentially permanent side effects as a result of a trial vaccine, they will have limited financial recourse. Personal injury and civil rights attorney A. Vince Colella of Southfield, Mich.-based Moss & Colella explains how traditional medical malpractice or personal injury cases differ from clinical trials like the ones for COVID-19.
“The purpose of personal injury law is to provide compensation to those who have been purposely or mistakenly harmed by another’s actions, and that’s not the situation with COVID-19,” Colella said.
It has been reported that side effects for those participating in COVID-19 are common and frequent and may include fever, chills, headache, shoulder pain, and exhaustion. Colella clarifies that this is different from harm stemming from traditional personal injury or medical malpractice claims.
“Individuals who agree to participate in these trials receive thorough health screenings and are fully aware of the risks – and provide informed consent attesting to that,” Colella said. “Unlike victims of personal injury who suffer an injury unexpectedly without an opportunity to avoid the harmful consequences of another’s conduct, individuals who volunteer in vaccine trials are ultimately doing it for the common good, even when limited compensation is offered. Society is grateful for their contribution.”
Potential for liability (and damages) may arise from clinical trials where the volunteers are subjected to a substantial risk of harm where safety measures are completely ignored or concealed due to the fact that pharmaceutical companies may not disclaim grossly negligent trials. Colella says that is extremely unlikely, though.
“With the leading players in the global pharmaceutical industry currently involved in the development of a vaccine under stringent regulatory guidelines, it is highly doubtful that a COVID-19 trial would be conducted in a reckless manner,” Colella said.
So what compensation is available for those who may be injured by a COVID-19 vaccine clinical trial? While there is a compensation fund for select established vaccines, the funds for COVID-19 injuries fall under the Countermeasures Injury Compensation Program (CICP), which was established in 2010 to cover certain flu pandemics, Ebola and anthrax attacks. The CICP “provides compensation to certain individuals who suffer serious adverse events from covered diagnostic devices, medications or therapies used to identify, prevent, or treat certain conditions.” Covered expenses include out of pocket medical expenses, lost employment income and survivor death benefits. Average individual claims paid out from CICP have been $207,000, per a recent article in the Wall Street Journal.Law school presents ‘Congressional Oversight of the Digital Marketplace’ webinar.
This article was first published in the Detroit Legal News on October 26, 2020