With 422 million doses of the COVID-19 vaccine administered in the U.S. alone, many Americans who believe they have experienced adverse symptoms after receiving the vaccine are left wondering what legal remedies are available to them. Unfortunately, there is no clear-cut answer, and the route to retribution with respect to long-lasting symptoms is remarkably limited. As Americans continue to settle into a new normal—global pandemic style—and COVID-19 vaccines and boosters become part of our routine, preventive medical care, lawsuits pertaining to COVID-19 could allege, among other things, that the COVID-19 vaccine has been defectively designed, defectively manufactured, and marketed with inadequate warnings.
The ensuing post will attempt to navigate defective drug law liability with respect to pharmaceutical manufacturers and the U.S. government, and explore the admittedly limited legal recourse that can be taken to compensate individuals for the adverse symptoms they experienced upon receiving the COVID-19 vaccine.
Understanding the Basics of Defective Drugs Law
To understand liability with respect to defective vaccines, it is necessary to discuss “defective drugs law” and potential defects that drug manufacturers are liable for. Defective drugs law lies within an umbrella category known as products liability Law, often overlapping with pharmaceutical law and medical malpractice law. Within the narrow scope of product liability, defective drug claims are classified into three categories: (1) manufacturing defects; (2) design defects (defects resulting in dangerous or hazardous side effects); and (3) defective marketing (also known as “failure to warn” claims).
A manufacturing defect is exactly what you’d think it’d be—the improper manufacturing of a drug. However, a manufacturing defect also encompasses pharmaceuticals that have been contaminated during the manufacturing process, resulting in harm to the user. A design defect, or dangerous side effect claim, originates when the drug is manufactured properly, but the side-effects associated with the administration of the drug result in harm to the user. Finally, with respect to defective marketing, or failure to warn claims, liability exists when there is a failure to provide accurate instructions, warnings and recommendations concerning the use of the drug. Defective drug law liability is far-reaching, and several entities and individuals can be held liable when defective drug claims arise, including, but not limited to, manufacturers, pharmaceutical sales representatives, prescribing physicians, hospitals, and pharmacists.
Notwithstanding the causes of action, a special “blanket” of protection exists with respect to pharmaceutical companies as both state and federal governments attempt to address COVID-19—a global pandemic—while balancing individual liberties.
Who is Liable for defects and adverse symptoms with respect to the COVID-19 vaccine?
Manufacturers
While pharmaceutical companies like Moderna and Pfizer are usually provided limited protection under law and would typically be liable for manufacturing defects, design defects, and defective marketing with respect to their product, the U.S. Government has granted pharmaceutical producers of the vaccine with a sort of “blanket immunity” under The Public Readiness and Emergency Preparedness Act, also known as “the PREP Act.” The PREP Act provides that the Secretary of the Department of Human Health and Services (DHHS) can authorize a “PREP Act declaration”—an Act which supplies pharmaceutical companies with immunity from liability (other than “willful misconduct”): (1) with respect to claims for “loss caused” from the administration—or relating to the administration—of “countermeasures used to eliminate diseases, threats, and conditions;” (2) with respect to claims that “constitute a present and credible risk of a future public health emergency;” and (3) “claims against entities and individuals involved in the development, manufacture, testing, distribution, and use of such countermeasures.”
Here, the sweeping provisions of the PREP Act essentially eliminate all avenues of relief for any individual that experienced a “loss”—or adverse symptom—after receiving the COVID-19 vaccine. These provisions are not only applicable to the pharmaceutical companies manufacturing and administering the vaccine and pharmacists administering the vaccine, but also to the U.S. government.
The U.S. Government
If pharmaceutical companies are relieved of liability, what about the U.S. government? After all, the Food and Drug Administration (FDA)—a U.S. government agency—must approve a vaccine for administration, right? While it is true that the FDA approved the vaccine for administration, the FDA, as a government entity, is also relieved of liability under the doctrine of “sovereign immunity,” which provides that the government can’t be sued without its consent. That’s right—even if the government is partially responsible for the adverse symptoms you experienced because of a vaccine they approved, you can’t bring a lawsuit against the U.S. government without them giving you the “OK” to do so. You can rest assured that the U.S. government would decline to provide its consent, as doing so would ostensibly “open the flood gates” of litigation to potentially millions of complainants.
Special Note: Employers and Their Liability with Respect to Vaccine Mandates
What about an employer who requires you to receive the COVID-19 vaccine before returning to work, and what if you comply and experience adverse symptoms? Is there any recourse? Notwithstanding the mounting legal issues surrounding an employer’s right to mandate vaccines and the narrow exceptions that permit an employee to remain unvaccinated (i.e., collective bargaining agreements of unionized companies, medical exemptions under the Americans with Disabilities Act of 1990 (the ADA) and the “sincerely held religious belief” under the Civil Rights Act of 1964 (the CRA)), an employee who has already received the vaccine, although unable to “sue” per se, could potentially obtain relief under their company’s worker’s compensation program. However, the process for obtaining worker’s compensation can often be a tenuous one that results in little benefit, as damages under worker’s compensation are often capped.
So, no one is “liable,” and I can’t sue for the adverse symptoms I’ve experienced, what can I do?
Along with the PREP Act, discussed above, the Countermeasures Injury Compensation Program (CICP) was instituted (over ten years ago) to compensate individuals who experience serious harm from the administration of certain vaccines. Assuredly, you have likely never heard of CICP because it has previously only been applicable with respect to uncommon vaccines, such as the H1NI1 vaccine. Like worker’s compensation benefits, also discussed above, the benefits associated with CICP are also capped—specifically, at $50,000. The $50,000 can be applied to reimburse you for lost wages and out-of-pocket medical expenses that you incurred. However, be warned that obtaining CICP is no easy feat and is accompanied with significant disadvantages. For instance, the burden of proof with respect to the harm sustained is exceedingly high, and if any portion of your medical expenses associated with treating the adverse symptoms was covered by insurance, you are not a candidate for CICP. In addition, the $50,000 cannot be applied to any legal fees associated with retaining an attorney to assist you in obtaining CICP or the attorney fees used to obtain any other legal remedies associated with adverse symptoms from the vaccine.
There is good news, however—many of the protections that vaccine manufacturers enjoy are temporary, as the PREP Act is designed to address wide-scale, semi-short-term emergencies. As COVID-19 becomes less prominent and vaccines become more routine, the American public will have more options when it comes to holding vaccine manufacturers liable. However, if you’re feeling pigeonholed by the mounting regulations surrounding COVID-19 vaccinations, you’re not alone. Although exceptionally rare, symptoms and illnesses associated with the administration of the COVID-19 vaccine include anaphylaxis, thrombosis, Guillain-Barre Syndrome, myocarditis, pericarditis, and death. If you have experienced any adverse symptoms after receiving the COVID-19 vaccine, consider contacting an attorney to discuss your options and potential legal recourse that can address medical expenses and other damages you’ve incurred because of receiving the vaccine.
