As of 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 life-saving vaccine begin to shrink, the doctors, nurses, pharmacists, medical technicians and other healthcare professionals who have worked tirelessly to deliver all those injections into the arm are getting ready. to a new threat: liability lawsuits. Most of the risk of medical malpractice litigation related to COVID-19 vaccines stems from the possibility that staff have not followed their own best practices, and that risk can be significantly reduced by careful adherence to procedures.
Here are some things a doctor’s office should know and prepare for as the public health campaign to quickly administer COVID-19 vaccines sparks a wave of litigation.
Who is covered by the PREP Law
The Public Preparedness and Emergency Preparedness Act (PREP) grants immunity from legal liability to covered persons who work in the development, testing, manufacture and distribution of the vaccine (for example, wholesalers , retailers, repackagers and common and contract carriers), plus those authorized to administer or dispense the vaccine.
As part of public health efforts to get more people vaccinated quickly, several changes to the PREP law have expanded the list of professionals qualified to administer the vaccine. In addition to doctors, medical assistants, nurses and emergency medical technicians, the list now includes dentists, chiropodists, veterinarians, midwives, healthcare students trained in vaccine injections, professionals. recently retired and others.
Testing the immunity of the PREP law
There is a lot of confusion and uncertainty over whether normal medical malpractice insurance covers COVID-19 vaccine litigation.
If a professional is licensed to administer vaccines, it would be a “qualified person” under PREP immunity, so this may be a moot point; However, if a lawsuit is brought against a vaccine administrator, he will still need a defense attorney to file the necessary dismissal motions while invoking the PREP Act. It costs money. These types of lawsuits are expected to fall under medical malpractice or ordinary negligence, depending on the wording of the complaint. In any case, a practitioner should have this discussion with their insurer to ensure that coverage exists in the event that a lawsuit is brought against them.
Despite the wide immunity coverage of the PREP Act, plaintiffs’ lawyers have already filed complaints in many jurisdictions to test the waters for possible wins that could set a precedent in other places. Litigation can be probable around the 1 exception to the PREP law in which the immunity from liability is suspended: death or serious bodily injury caused by “willful misconduct”.
To overcome the obstacle of intentional misconduct, a complainant must demonstrate that the vaccine administrator acted intentionally to achieve an unlawful objective, knowingly without legal or factual justification, and without regard to a known or obvious risk that is. so great that it is highly likely that the harm will outweigh the benefit, resulting in serious bodily injury or death. Serious injuries include those that are life threatening, permanently impair bodily function, permanently damage bodily structure, or require medical intervention to avoid such permanence. Although there are isolated cases in which a serious injury or death may be directly and conclusively linked to the administration of a COVID-19 vaccine, these individuals may be eligible for compensation under the program. compensation for victims of countermeasures.
Follow the CDC’s vaccine toolkit
Doctors’ offices 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. These guidelines were developed in collaboration with vaccine manufacturers, scientific studies and public health officials and are reviewed or updated periodically.
Each practice should write and adopt standard operating procedures for the storage and handling of vaccines and document the staff training dates for each person who will be involved in their immunization program.
Stay on top of the evolving CDC guidelines
It is also important to research and adopt updated CDC guidelines when they are released.
Early toolkits did not address the importance of temperature maintenance and validation checks for vaccine storage units, for example, but this 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 fridge / freezer units are specifically prohibited. Practices should only use specially designed or pharmaceutical grade units.
As always, the best defense is a good offense. Encourage all staff to have meticulous record keeping practices and proactively seek opportunities for spot checks or double checks of important data or documents. Something as simple as sloppy writing could be problematic in front of a jury. A carelessly scribbled 9 may look like a 7 at first glance, for example. If in doubt, take a break, recheck and check.
In the event of a patient complaint or threat of lawsuit or litigation, ensure all staff follow protocols for keeping patient records, registration and discharge logs, handwritten notes, notes on verbal conversations, voicemail messages, emails and other recordings that will be detectable. Never modify a record and never perform an unscheduled record purge.
Hire legal counsel early
Each medical office should proactively work with an attorney experienced in defending medical malpractice and liability litigation to plan and prepare for a possible COVID-19 vaccine litigation. This preparation should include a comprehensive review of current policies, procedures, staff training, documentation practices, and other potential exposure areas. Having a solid plan in place improves the defendability of any claims that may arise and allows healthcare professionals to face potential disputes with more confidence.