Given the mounting frustration over the slow pace of vaccinations, yesterday’s HHS announcement broadening the distribution and prioritization for Covid vaccines came as little surprise. Unfortunately, more rapid deployment of vaccines might not stem the risk of litigation from those looking to assert blame for delays and other glitches in treatment. At a stage that could mark an endgame for the Covid-19 pandemic, it’s more important than ever to clarify legal protections so health providers devote their time and attention to patients instead of fending off lawsuits.
The unprecedented rollout of Covid-19 vaccines is logistically challenging. It may even lead to criminal acts — consider the Wisconsin hospital pharmacist arrested over the holidays for purposely leaving 500 doses of Moderna’s vaccine unrefrigerated, knowing that could render them unusable. Such rogues deserve full prosecution.
To reach herd immunity as fast as possible, everyone else in the chain of vaccine distribution should be shielded from the threat of civil actions.
Until now, a little-known federal statute helped achieve that important goal. Early in the pandemic, Secretary of Health and Human Services Alex Azar issued a declaration under the Public Readiness and Emergency Preparedness Act, which was originally signed into law in 2005. Azar’s action, followed by subsequent amendments, gave broad liability protection to a diverse group of individuals and organizations working to provide “countermeasures” against the coronavirus.
The statute erases nebulous concepts of negligence in order to free health professionals from the distraction of second-guessing in times of exceptional need. It also excludes from protection those who engage in “willful misconduct,” so truly bad actors like the Wisconsin pharmacist still face potential civil liability in addition to criminal prosecution.
Shielding the Covid-19 response chain from civil liability makes sense. Whatever struggles and shortages the U.S. health care system endured throughout 2020, we can at least be thankful that the people fighting to save lives weren’t simultaneously fighting lawsuits.
But these protections might not be guaranteed in the coming months.
Azar’s Dec. 3 declaration contains curious language about vaccination decisions and highlights a worrisome gap in the PREP Act’s liability shield. The declaration clarifies HHS’s position that not administering a countermeasure (such as not providing a vaccine) to a patient in a “less vulnerable population” in order to provide it to a “more vulnerable” patient legally constitutes a covered countermeasure that shields the provider from lawsuits.
Why bother publishing that in the Federal Register? Because prior court decisions have allowed patients who did not receive a vaccine to sue their providers. Those courts interpreted the PREP Act to apply only if a patient receives the vaccine.
In one case, the widow of a man who died of swine flu sued his health care provider for failing to administer the H1N1 vaccine, which at the time was in short supply. Although the physician followed guidelines from the Centers for Disease Control and Prevention to determine that the patient did not fall into any health priority categories, the New York court allowed the lawsuit to proceed, ruling that the PREP Act’s shield “only applies to the actual use of the vaccine.” In a recent advisory opinion, the HHS’s General Counsel offered an extraordinary rebuke of that decision, saying “the court was wrong.” Unfortunately for HHS, judges get the final word on interpreting federal statues, and it will be up to Congress to clarify any remaining ambiguity.
This matters. For the next few months at least, vaccine supplies will be limited and Americans will be rightly impatient to be vaccinated. States and the federal government are busy developing distribution plans for different vaccines with competing storage requirements to different tiers of recipients. New York state and Florida are investigating potential Covid-19 vaccine fraud and allegations of people paying to jump the line for vaccines. Criminal behavior will be punished.
But decisions about vaccine delivery and administration should be not be influenced by civil litigation. The CDC’s Stage 1 recommendations seem clear enough in favoring two vulnerable groups: health care providers and the elderly in long-term care facilities. No one knows how this week’s revised guidance will alter the next stage of distribution. This may hasten debate about the definition of “less-vulnerable populations” and a temptation to litigate those decisions in vaccine dispersions.
Do we really want clinics and pharmacies prioritizing limited vaccine supplies not for those most in need but for those perceived as most likely to sue?
Lest we assume 100% perfection from the human beings tasked with delivering, storing, and handling Covid-19 vaccines, there’s an even more worrisome concern. If judges continue to interpret the PREP Act as shielding only the physical administration of the vaccine, and allowing liability for the decision not to vaccinate, perverse incentives abound. When a person in the distribution chain raises a good-faith concern about a particular batch of vaccines — for refrigeration issues or otherwise — we would hope that experts thoroughly analyze the situation and make the best-informed decision for the safety of patients. What we don’t want is for someone in that discussion to say, “If we just go ahead and administer those doses, maybe we won’t get sued.”
Azar’s PREP Act declarations are good policy, but Congress can and should patch the hole in the act. Secretary-designate Xavier Becerra can do his part by publicly endorsing the existing PREP Act declarations. He and President-elect Biden should support the U.S. vaccine-delivery systems by vowing to continue the federal government’s effort to keep health care decisions free from the fear of lawsuits.
The new administration has already taken an important first step by announcing faster distribution of the Covid vaccine. Along with endorsing PREP Act protections, an important second step is to ensure consistency between the recommendations and guidance from federal authorities. Consistency can aid in enforcing PREP Act liability protections. Unfortunately, without rock-solid liability protection under the PREP Act or state equivalents, those in the vaccine supply chain could still face threats of lawsuits from groups of people unable to get vaccinated before getting infected.
We’re too close to beating the pandemic to let partisanship, politics, or litigation sidetrack us.
Samuel Tarry and Davis Walsh are partners at McGuireWoods LLP and editors of “Infectious Disease Litigation: Science, Law and Procedure” (American Bar Association, February 2021).