Vaccine Breakthrough: Tort Immunity Under PREP Act Spurs Innovation


By: Kevin Kenneally

Recent news of possible imminent availability of groundbreaking COVID-19 vaccines has catapulted financial markets and infused optimism for recovery in global economies and the daily lives of people throughout the globe. These pharmacological and biotech advances were made possible in part by guarantees from the United States government that vaccine makers and distributors will not be liable in lawsuits to any vaccine recipient who suffers complications or illness from the immunization.

The pharma industry has often been targeted for class action and mass tort litigation based on state law causes of action for side effects of its new drugs. Most of the those pharmaceuticals go through a rigorous, structured testing and approval process by the U.S. Food and Drug Administration (FDA). In the face of a worldwide pandemic, however, regulators recognized the need to quickly develop an immunization and vaccine program to combat this life-threatening and easily-transmissible virus. The federal government conferred broad immunity to vaccine manufacturers from products liability suits and tort claims for rapidly-developed COVID-19 vaccines and therapeutics. Established principles of federal preemption in the field of pharma litigation will likely prevent injured victims from pursuing state law tort or products liability actions.  

On March 17, 2020, the government issued notice under authority of the longstanding “PREP Act” (the Public Readiness and Emergency Preparedness Act) to grant immunity from litigation for companies developing drugs or vaccines to battle COVID-19. The PREP Act is the existing federal law that governs the nation’s response to public health emergencies. An administrative declaration was issued in response to the COVID-19 pandemic that expanded PREP Act immunity to companies developing coronavirus therapeutics and vaccines. As a result, future claims arising from complications, adverse effects or death caused by a vaccine or a therapeutic manufactured, distributed or sold by a potential defendant will be barred, except in the case of “willful misconduct.”

Individuals who suffer adverse effects, however, will not be left without a monetary remedy as a result of this immunity granted to makers or suppliers of any drug causing harm. The federal program, known as “CIPC” (the Countermeasures Injury Compensation Program), which provides compensation to victims suffering side effects or complications from vaccines has been expanded to include claims arising from COVID-19 therapeutics and vaccines. CIPC permits recovery of death benefits, lost earnings, medical expenses and other damages suffered by the vaccine recipient or surviving family.

Such immunity from litigation exposure is not a new development in the vaccine manufacturing arena. Vaccine manufacturers and pharmacies have long been protected from tort law claims. The National Vaccine Injury Compensation Program (“VICP”) was created in the 1980s when widespread lawsuits against pharma companies and healthcare providers threatened to cause vaccine shortages and reduce vaccination rates as risk management concerns would lead few entities or health care providers to take part in the fight against preventable diseases. Claims under the VICP cannot be filed in local state or federal courts, but must be litigated in the U.S. Court of Federal Claims in Washington, D.C. and claims are administered by the Department of Justice.

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