AstraZeneca, one of several pharmaceutical companies engaged in the race to create a COVID-19 vaccine, has been granted immunity from product liability claims related to its future immunization. According to a company executive, these protections have been extended in several countries.
The Product Liability Protection Agreement
AstraZeneca is currently one of 25 companies developing a vaccine for the novel coronavirus. For many pharmaceutical companies, questions of liability related to the vaccine have been a focal point of supply agreements. While AstraZeneca leadership claims the company has reached agreements in several countries that protect it from liability, to date they have not named the countries offering legal immunity.
AstraZeneca continues to pursue its plans to create and distribute a working COVID-19 vaccine and already has made arrangements with a Chinese company, Shenzhen Kangtai Biological Products, to manufacture its COVID-19 vaccine in China. The two companies have also expressed interest in working together to distribute the vaccine in other markets. AstraZeneca has also pledged to supply two billion doses of a COVID-19 vaccine at cost to several countries, including the United States, Britain, and countries of the European Union.
Seeking Immunity for Vaccine Manufacturers
A working COVID-19 vaccine will save lives, but it will also come with unusually high risks for the company or companies that manufacture and distribute it. Since a COVID-19 vaccine is likely to be distributed to billions of people worldwide, the risk of product liability claims is highly significant.
As a result, pharmaceutical companies are turning to national governments to seek immunity from product liability claims related to any proposed vaccine. Product liability immunity has been an ongoing debate between the European Union and companies such as Pfizer, Sanofi, and Johnson & Johnson. Meanwhile in the United States, the 2005 Public Readiness and Emergency Preparedness Act (PREP Act) offers immunity from tort claims for product liability when the product in question helps control a public health crisis—baked-in legislative protection for such emergency instances.
COVID-19 Vaccine Protections in the U.S.
In March 2020, the Department of Health and Human Services (HHS) released a declaration clarifying how the PREP Act applies to medical countermeasures designed to combat or treat COVID-19. The declaration applies to entities that manufacture, test, develop, administer and use a number of items in the prevention, diagnosis, or treatment of COVID-19. The list includes vaccines against the virus and guidelines for distribution.
To be covered under the PREP act, a countermeasure must fall into one of three categories: qualified pandemic/epidemic products, security countermeasures, or products authorized for emergency use. A vaccine, falling in the first category, must also receive the proper approval, clearance, exemption or authorization from the Food and Drug Administration (FDA).
The entities that manufacture, develop, and distribute a covered vaccine may also be eligible for immunity under the PREP Act and theHHS declaration. Such immunity would extend to “any claim for loss that has a causal relationship with the administration or use by an individual of a covered countermeasure.” Whether immunity applies in a particular case is a rebuttable presumption.
How a Potential Vaccine Claim May Move Forward
However, not all possible uses of a vaccine are immune from product liability claims under the PREP Act. For example, a claim may still be made on the basis of “willful misconduct” and a plaintiff may prevail if they can show by clear and convincing evidence that the vaccine’s creator, manufacturer, or distributor engaged in misconduct more egregious than mere negligence or recklessness. In addition, the declaration does not expressly mention immunity from lawsuits when a medication—including a vaccine—is used off-label.
Lawsuits that deal with the side effects of a COVID-19 vaccine are also likely to appear, even in the presence of the PREP Act and HHS guidelines. These claims, however, may be required to focus on proving more than mere negligence by a preponderance of the evidence.
The participation of expert witnesses well-versed in the process of creating, testing, manufacturing, and distributing vaccines will likely be required for any plaintiff to meet their burden of proof. Experts who can clarify the causal relationship between alleged willful misconduct and harm to vaccine recipients will also play a key role in these claims.