Follow the CDC’s Vaccine Toolkit and stay current on evolving CDC guidelines
As of early May 2021, about 152 million Americans had received at least 1 dose of a COVID-19 vaccine and about 115 million people were fully vaccinated, according to the Centers for Disease Control and Prevention (CDC).
As the long lines of patients seeking a lifesaving vaccine begin to shorten, the physicians, nurses, pharmacists, medical technicians, and other health care professionals who have been working tirelessly to administer all those shots in the arm are bracing for a new threat: liability lawsuits. Most of the risk of medical malpractice litigation related to COVID-19 vaccines comes from the possibility that staff did not follow their own best practices, and this risk can be greatly reduced by meticulous adherence to procedures.
Here are a few things a medical practice needs to know and prepare for as the public health campaign to quickly administer COVID-19 vaccines spurs a wave of litigation.
Who is covered by the PREP Act
The Public Readiness and Emergency Preparedness (PREP) Act provides immunity from legal liability for covered persons who work on the development, testing, manufacturing, and distribution of the vaccine (eg, wholesalers, retailers, repackers, and common and contract carriers), plus those who are authorized to administer or dispense the vaccine.
As part of the public health push to get more people vaccinated quickly, several amendments to the PREP Act have expanded the list of professionals qualified to administer the vaccine. In addition to physicians, physicians’ assistants, nurses, and emergency medical technicians, the list now includes dentists, podiatrists, veterinarians, midwives, health care students trained on vaccine injections, recently retired professionals, and others.
Testing the PREP Act’s immunity
There is much confusion and uncertainty about whether normal medical malpractice insurance covers litigation related to the COVID-19 vaccines.
If a professional is authorized to administer vaccines, they would be a “qualified person” under the PREP Act’s immunity, so it may be a moot point; however, if a lawsuit is filed against a vaccine administrator, they would still need a defense attorney to file the necessary motions to dismiss while invoking the PREP Act. This costs money. It is anticipated that these types of lawsuits would fall under medical malpractice or ordinary negligence, depending on the wording of the complaint. In any event, a practitioner should have this discussion with their insurance carrier to ensure coverage exists in the event that a lawsuit is filed against them.
Despite the PREP Act’s broad immunity coverage, plaintiffs’ attorneys have already been filing complaints in many jurisdictions to test the waters for possible wins that could set precedent in other venues. Litigation may be likely around the 1 exception to the PREP Act in which liability immunity gets suspended: death or serious physical injury caused by “willful misconduct.”
To overcome the willful misconduct hurdle, a plaintiff must show that the vaccine administrator acted intentionally to achieve a wrongful purpose, knowingly without legal or factual justification, and in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit—all of which results in serious physical injury or death. Serious injuries include those that are life-threatening, permanently impair a body function, permanently damage a body structure, or require medical intervention to avoid such permanency. Even if isolated cases exist in which serious injury or death can be conclusively tied directly to the administration of a COVID-19 vaccine, those individuals may be eligible to receive compensation through the Countermeasures Injury Compensation Program.
Follow the CDC’s Vaccine Toolkit
Medical practices must be able to demonstrate that they have fully trained their staff and adopted protocols to carefully follow the CDC’s COVID-19 Vaccine Storage and Handling Toolkit. Those guidelines were developed in collaboration with vaccine manufacturers, scientific studies, and public health officials and are revised or updated periodically.
Each practice should write and adopt standard operating procedures for vaccine storage and handling and document the dates of staff training for each person who will be involved in their vaccine program.
Stay current on evolving CDC guidelines
It is also important to look for and adopt updated guidelines from the CDC when they are issued.
The early toolkits didn’t address the importance of maintenance and temperature validation checks to vaccine storage units, for example, but that concern is addressed in the 65-page toolkit released in March 2021.
A faulty seal on the door of a cold storage unit could compromise the potency of the vaccine, and dormitory-style combination refrigerator/freezer units are specifically banned. Practices must use only purpose-built or pharmaceutical-grade units.
As always, the best defense is a good offense. Encourage all staff to have meticulous record-keeping practices and proactively look for opportunities to spot-check or conduct double verification of important data or documents. Something as simple as sloppy handwriting could be problematic in front of a jury. A carelessly scribbled 9 might look like a 7 on first glance, for example. If there is any doubt, pause, double-check, and verify.
Should a patient complaint or threat of a lawsuit or litigation occur, ensure that all staff follow protocols for preserving patient charts, check-in and release logs, handwritten notes, notes about verbal conversations, voicemails, emails, and other records that will be discoverable. Never alter a record or perform an unscheduled records purge.
Engage legal counsel early
Every physician practice should be working proactively with an attorney who is experienced in medical malpractice and liability litigation defense to plan and prepare for possible COVID-19 vaccine litigation. That preparation should include a comprehensive review of current policies, procedures, staff training, documentation practices, and other areas of potential exposure. Putting a solid plan in place improves the defensibility of any claim that could arise and allows health care professionals to deal with possible litigation in a more confident way.