Pandemic-related liability shields are saving lives - Washington Examiner

Little noticed among the plethora of writings about the COVID-19 pandemic, vaccines, and other actual or potential drug therapies is the topic of liability prevention. When pharmaceutical makers are compelled to produce vaccines or other treatments to combat pandemics, they understandably may be reluctant to do so if it could result in billions of dollars of liability exposure. The law should provide clear protections for these innovating manufacturers now so we are better prepared for future pandemics and other health crises.

It may seem to some like ancient history, but it was only 70 years ago that polio was at its peak ravaging the United States. Pioneering medical researchers such as Dr. Jonas Salk and Albert Sabin respectively developed a polio vaccine and oral vaccine pill, which together have effectively eradicated polio worldwide.

Unfortunately, a very small percentage of people who took the vaccine pill, which incorporated a weakened polio virus, allegedly contracted polio or experienced some other injury. Lawsuits against vaccine-makers followed, creating tremendous uncertainty that threatened the continued manufacture and use of these extraordinary medicines.

Learning from this history, Congress enacted the Public Readiness and Emergency Preparedness, or PREP Act, in 2005. The PREP Act establishes a mechanism for vaccine-makers and others to obtain liability protection in which the secretary of health and human services declares a public health emergency. In 2020, when COVID-19 burst on to the scene, HHS activated the PREP Act's protections. The agency has since amended its declarations regarding liability protections for covered persons and entities more than a half-dozen times.

Pursuant to the PREP Act, liability can only be imposed against a pharmaceutical manufacturer that engages in willful misconduct, such as an intentional disregard of others' safety. The act also wisely establishes a government fund to compensate persons who are seriously injured by a vaccine or other approved "countermeasure." This fund furthers the government's interest in promoting overall public health through mass vaccination or other treatments and providing adequate incentives for the continued development of such treatments.

Nevertheless, the PREP Act's liability protections may not always provide pharmaceutical manufacturers with a clear-cut immunity. As discussed, the liability protection is subject to HHS declarations, which could change or end in short order, including with a new administration's HHS secretary. This lack of certainty may prompt pharmaceutical manufacturers to think twice before investing potentially billions of research and development dollars in the pursuit of a safe and effective vaccine.

In this regard, the adage that "it is not a matter of 'if' there will be another pandemic, but 'when'" is a critical one.

Congress should learn from this pandemic and take the opportunity to shore up the PREP Act by making its liability protections more straightforward, consistent, and permanent. Although it may not feel like it with the COVID-19 death toll approaching 900,000 Americans, the U.S. was very fortunate in having innovative manufacturers develop three safe and effective vaccines in record time.

The next time, we might not be as fortunate in our ability to engineer a vaccine rapidly, particularly if liability issues loom large when this pandemic has run its course.

Victor Schwartz is a former law professor and law school dean, and current co-chairman of the Public Policy Group of the law firm Shook, Hardy & Bacon, LLP. He is co-author of Prosser, Wade & Schwartz's Torts: Cases and Materials (14th ed. 2020) .