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)
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.
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? MKReplyDelete
Yes. 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?Delete
My 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.Delete
I 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. MKReplyDelete
Addendum! My error! I now see the 'Notify me' box!ReplyDelete
I 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.ReplyDelete
Thank you for this article for those practices that allow elective non-vaccinating families.ReplyDelete
When 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.Delete
Thanks, Dr. Shenkin. I hope your article gets into a journal soon.Delete