Reducing the Risk of
Legal Liability To Third-Parties When Treating Non-vaccinating
Patients
Budd N. Shenkin, MD,
FAAPa,
Dorit Rubinstein Reiss, PHDb,
David I. Levine, JDb
Affiliations: a
Bayside Medical Group, Berkeley, CA; and b
University of California, Hastings College of the Law, San Francisco,
CA
Abbreviations: American Academy
of Pediatrics (AAP), Vaccine Information Statements (VIS),
Non-Vaccinating Information Statements (NVIS)
Abstract
Deciding whether to
accept voluntary non-vaccinators into a practice has become
increasingly controversial. One important concern is the fear that a
practice accepting such patients might incur legal liability if
another susceptible patient should contract a vaccine-preventable
disease in the practice’s office.
This paper addresses the question of legal liability and
offers suggestions to minimize that risk.
Reducing the Risk of
Legal Liability To Third-Parties When Treating Non-vaccinating
Patients
As preventable
disease outbreaks due to voluntary non-vaccination spread, deciding
whether to accept these non-vaccinators into a practice has become
increasingly controversial. Some authorities argue that it is
ethically correct to care for children despite the risky decision of
the parents, and many pediatricians want the opportunity to convince
hesitant parents to vaccinate. Others, however, are vexed when
patients reject medical advice, don't want the increased burden of
treating non-vaccinated patients, believe that not accepting
non-vaccinators is more effective than persuasion at increasing
vaccination rates, and fear that they will be disserving other
patients who cannot be vaccinated because of their age, compromised
immunity, or other reasons.i
In addition, some fear the possibility of their own legal liability
if a susceptible patient should contract a vaccine-preventable
disease in the office from a contagious, unvaccinated individual.ii
This potential for liability has been noted by the Committee on
Infectious Diseases of the American Academy of Pediatrics (AAP).iii.
Our concern in this paper is to address the question of
legal liability and to offer suggestions to minimize that risk.
If Patient A were
to contract a disease in a practice from voluntarily non-immunized
Patient B, Patient A could sue the practice for negligence.iv
The suit might allege: “Practice X knowingly included
non-vaccinating patients who could potentially spread immunizable
diseases to their other patients, but the practice neither informed
all patients of that potential, nor took sufficient steps to reduce
it.” Physicians have a special legal duty of care to avoid
unreasonably harming others because of their professional knowledge
and patients' reliance on their recommendations. Patients can expect
that health facilities will be reasonably safe environments. In
fact, hospitals (another natural congregating point for infectious
disease vulnerable patients), have been sued over hospital-acquired
infection.v
Indeed, states seek to protect children against disease transmission
by requiring vaccination for school admission.
If a preponderance
of evidence proved that such a disease transmission took place in the
practice's office, the practice's liability for monetary damages
would hinge on whether the physician and the practice acted
reasonably or negligently in safeguarding the injured patient’s
health. The crucial issue would be, then, what actions are
“reasonable?”
Courts would be
unlikely to conclude that merely accepting such patients was legally
unreasonable. This policy is still widespread and expert opinion is
currently divided.vi
The next issue
would be vital: has the practice acted “reasonably” to protect
patients from contagion due to unimmunized individuals? A trial
court admits evidence of what informed opinion recommends in a field,
such as AAP’s committee statements, to determine whether the
defendant met the standard of care. Ultimately, a jury would have to
weigh the evidence (presented through physicians testifying as
experts) and determine what was reasonable under the circumstances.
Practically
speaking, the plaintiff’s experts would have the complex task of
proving that the disease was contracted at the practice’s premises
and that the practice acted unreasonably. The litigation would
involve lengthy investigation; early dismissal of the case would be
unlikely because both inquiries are fact-dependent. The stakes for
the practice could be high, if the insured’s liability limits were
exceeded because of a very serious injury or if several children were
injured in one outbreak. Even if the practice were not left
financially harmed, the process could be harrowing for the
defendants.
What Can A
Practice Do?
For a practice
accepting voluntarily non-vaccinating patients, it would be both
medically ethical and legally prudent to take steps to safeguard the
health of the other patients. These steps would help demonstrate that
the non-vaccinator-accepting practice had acted reasonably should a
legal claim arise. The safest way to avoid infecting other patients
would be to treat unvaccinated children only with home and telehealth
visits. Some practices might try this, but it would be impractical
on a large scale.
A minimal step to
would be to inform all patients that non-vaccinating patients are
accepted in the practice. A simple notice in the waiting room might
be insufficient to provide meaningful warning. We suggest instead
that, similar to the Vaccine Information Statements (VIS) that are
routinely used in offices, Non-Vaccinating Information Statements
(NVIS) could be given to patients to be read and signed, and then
kept on file. These would explain that the practice accepted
non-vaccinators, and would detail the specific dangers of each
disease, those most liable to contract the disease (babies,
immune-compromised patients), and what protective measures the
practice is taking. The weaknesses of any protection system should be
noted, especially that many diseases are most communicable before
there are signs of illness. Since a uniform NVIS does not currently
exist, practices would need to develop their own, probably utilizing
legal advice.
Another important
measure would be to exclude potentially infected non-vaccinating
patients from common spaces. The practice's computer system should
inform staff that the patient involved is unvaccinated, especially at
the stage of making the appointment, so that anticipatory protective
steps might be taken. Since these patients might be infectious in a
prodromal stage even when they are not known to be sick, the practice
should consider if all visits should be accomplished by entering the
office by a separate entrance, treating in an isolated room,
disinfecting the room, and not using it for some hours afterwards.
Certainly, these steps should be taken if the patient is symptomatic,
as pediatricians did with suspicious infectious cases prior to the
vaccines being available. Of course, if a case of infectious
disease develops in the patient who has visited the office, all
patients who might have been exposed must be contacted and
prophylaxis offered, according to the directives of the Red Book.vii
A practice might
also consider if state law permits requiring voluntarily
non-vaccinating families to sign an indemnity statement accepting
financial liability to the practice resulting from an outbreak
emanating from them. (This indemnification would be in addition to a
vaccine waiver, such as the one available through the AAP.)
Documentation that
policies were actually being followed in the practice would be
essential. As physicians have been told repeatedly, “if it is not
documented, it did not happen.”
In summary,
practices accepting voluntary non-vaccinators may be expected by law
to act reasonably to protect all of their vulnerable patients from
the foreseeable risk of disease transmission. Methods to avoid
liability may be cumbersome, but practices accepting voluntary
non-immunizing patients should consider adopting policies like those
recommended here, for the safety of their patients and their legal
protection.
References:
iDeem MJ, Navin, MC, Lantos, JD. Considering whether the dismissal of vaccine-refusing families is fair to other clinicians. JAMA Pediatr. 2018; 172(6): 515-516.
ii
Sugerman DE, Barskey
AE, Delea
MG,
et al. Measles outbreak in a highly vaccinated population,
San
Diego, 2008: Role of the intentionally undervaccinated. Pediatrics.
2010; 125:747-755.
iii
Rathore MH, Jackson MA. Committee on Infectious
Diseases. Infection prevention and control in
pediatric ambulatory settings. Pediatrics.
2017; 140(5):e20172857.
ivAmerican
Law Institute. Restatement of the law third, torts, liability for
physical and emotional harm. 2012.
vMiller
JM. Liability relating to contracting infectious diseases in
hospitals. J Leg Med. 2004; 25: 211-227.
viEdwards KM, Hackell JM, Committee on Infectious Diseases, Committee on Practice and Ambulatory Medicine. Countering vaccine hesitancy. Pediatrics. 2016; 138(3): e20162146.
viiCommittee
on Infectious Diseases, AAP, Red Book: 2018-2021 Report of the
Committee on Infectious Diseases. 2018; 31st
ed.
"... Since these patients might be infectious in a prodromal stage even when they are not known to be sick, the practice should consider if all visits should be accomplished by entering the office by a separate entrance, treating in an isolated room, disinfecting the room, and not using it for some hours afterwards." Budd, have you contemplated the practical impediments to this strategy? MK
ReplyDeleteYes. It seems to me that properly handling the non-vaxxers and protecting the other patients will be cumbersome and expensive. I think there is then a policy question - who should bear this expense, and how?
DeleteMy EMR flagged unvaccinated patient, so that when they called for an appt they were reminded to call from their cell phone in the parking lot so we could walk them in the back door straight to a room. As long as the flag was noticed by front office staff (and front office communicated what was happening to the physician) it worked well (but this was a 2.5 provider practice in a small 1-story building, so I will grant it was easier than being on a 2nd floor, etc). However, what made me give up on this system for electively unvaccinated patients is that some of them would come in the front unannounced and sick looking for a walk-in appt even though we were appt only (the practice was right next to a large grade school). After the elective non-vaccinating families were expelled we still used the flag system for children with medical conditions the prevented full vaccination or may have caused loss of vaccine-mediated immunity such as chemotherapy or organ transplant. And we always try to get newborns back into a room quickly.
DeleteI think, Budd, that the costs and logistics would be prohibitive and without data that such a cost is worthwhile. And, what about beyond the MDs offices? Would a store or restaurant be liable if a non-vaxxer infected other patrons? And as an aside, I rec'd no email notice of your reply and discovered it only by logging back to your blog from my blog site. I enjoyed your piece. MK
ReplyDeleteAddendum! My error! I now see the 'Notify me' box!
ReplyDeleteI know the costs will be high. I agree with those who say that the non-vaccinators should somehow bear the costs of their decisions. Among those costs are those incurred in the pediatric offices, as clinicians seek to protect their other patients, as they must. I think pediatricians need to press this case, although I don't now exactly how. Leadership is necessary. If that doesn't happen, more and more offices will decide that serving the non-vaxxers will decide that it isn't worth it.
ReplyDeleteThank you for this article for those practices that allow elective non-vaccinating families.
ReplyDeleteWhen I had my own practice in Tucson I finally expelled all electively non-vaccinating families after a 2012 pertussis outbreak where I repeatedly had unvaccinated older children with florid pertussis coming into my waiting room as "walk-in" (aka unannounced/unscheduled) patients, exposing newborns in my waiting room. Those newborns then had to be given 5 days of antibiotics and closely monitored to make sure they didn't contract pertussis which can have a 2-4% mortality rate for this group. I didn't care about my liability in this scenario--I was simply damn angry that selfishly non-vaccinators were putting my newborns at risk this way. Where I practiced at that time had some very high non-vaccinating areas and I was sick of dealing with that demographic and the risks they brought to my most fragile of patients. --Chris Hickie, MD
Thanks for this great comment. Protecting our patients is by far the most important thing.
DeleteThanks, Dr. Shenkin. I hope your article gets into a journal soon.
Delete