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New treatment approaches may be good options for a particular ED patient, but a bad outcome can trigger malpractice litigation alleging the standard of care was violated. The ED defense team must:
An emergency physician (EP) is aware of a new treatment approach in the literature and believes it’s a reasonable option for a particular patient — possibly even better than the traditional approach. What are the legal risks in this situation?
“If it’s the best thing for the patient, you should do it. But it doesn’t necessarily change the standard of care,” says Kevin Klauer, DO, EJD, FACEP, chief medical officer of Knoxville, TN-based TeamHealth’s emergency medicine division. Klauer also is chief risk officer at TeamHealth.
If there’s any question whether a new approach is the patient’s best option, or if it’s more of an alternative to the traditionally accepted approach, the EP shouldn’t offer it without a thorough informed discussion, Klauer advises. If the EP uses a new approach and a bad outcome occurs, the plaintiff’s attorney is likely to build a case around the fact that the new approach was not the standard of care.
“If you decide to take a certain pathway — traditional or alternative — with a high-risk presentation, always document your rationale for doing so,” Klauer says.
Documentation of the EP’s reasoning, and of existing evidence to support the new approach, helps to defend the claim.
“It’s really important for every emergency physician to recognize what reasonable standards are — and that there are circumstances where it’s reasonable to deviate from the more traditional approach,” Klauer says.
Acceptance of new ED clinical practices begins with a small number of “innovators” who propose new ideas supported by science.
“If those ideas are compelling, a larger number of early adopters take the idea and run with it,” says William Sullivan, DO, JD, FACEP, an EP at the University of Illinois in Chicago and a practicing attorney in Frankfort, IL. Practices then may gain wider acceptance in the emergency medicine community.
Not all EPs change their practice, and not all hospitals change their policies, even after a “new” practice becomes mainstream. Some will adopt it sooner, while others take longer.
“At the end of the bell curve are the ‘laggards’ who just don’t like adopting new innovations,” Sullivan offers.
Practicing “reasonably” amounts to working within the middle of the bell curve, Sullivan says.
“Being a laggard and not keeping up with technological advances is difficult to defend if there is a proven innovation that has been generally adopted,” he says.
Case in point: A Philadelphia jury returned a $78 million verdict in 2012, partly stemming from the hospital’s use of outdated equipment that caused a doctor to misinterpret the images.1 On the other hand, “early adopter” EDs face legal exposure, too.
“Innovations are great when they improve patient outcomes, but if an innovative treatment causes a bad outcome, it is likely that the early adopters will be labeled as reckless,” Sullivan cautions.
A recent example involved a surgeon who used a stent, and then a suturing device, to attempt to repair a leak in a child’s esophagus, which the plaintiff alleged were unproven and inappropriate practices. The case resulted in a $30 million settlement.2
Another possibility is that plaintiffs will allege that new and potentially unproven innovations studied at tertiary care centers are “standard practice.” Such an approach, says Sullivan, “turns the standard of care on its head by holding all physicians to the high-level, cutting-edge treatments practiced at specialized tertiary care centers.”
Since the standard of care is defined as what a reasonable physician would do in the same or similar circumstances, alleging that all EPs should be performing at the level of the specialized centers, Sullivan says, is “similar to saying that an average person is negligent if they can’t cook like a master chef or handle a car like a stunt driver.”
In some cases, expert testimony as to the standard of care ends up inadmissible because it doesn’t meet a “general acceptance” standard. Generally, court determinations as to whether an expert’s testimony is admissible are based on two Supreme Court cases: Daubert v. Merrell Dow Pharmaceuticals, Inc. and Frye v. United States. The Daubert standard is used by federal courts and by most state courts.
“It basically states that evidence is admissible if the judge determines that it is relevant, reliable, and derived from sound scientific methodology,” Sullivan explains.
In contrast, the Frye standard says it’s admissible if the judge determines it has gained “general acceptance” within the field. “While both standards seem similar, there are some subtle differences,” Sullivan notes.
Novel treatment or research that’s admissible under the Daubert standard (because it’s undergone reliable scientific testing and is relevant to the issues in the case) may be excluded under the Frye standard because it has not reached “general acceptance” in the medical community. An expert’s opinion was thrown out in a 2015 malpractice case for this reason.3 The case involved a patient who alleged that two prescription medications had caused cardiac arrhythmia resulting in placement of a permanent pacemaker. Case studies and articles were submitted, but none linked the drugs to the patient’s atrioventricular block. The court found that the expert’s opinion was not accepted in the medical community.
“The case was dismissed because the ‘general acceptance’ standard was not met,” Sullivan adds.
Since malpractice litigation often occurs months or even years after the ED visit, the standard of care may well have changed during that time. Klauer has seen plaintiff attorneys inappropriately attempt to hold the EP to that new standard of care.
“When the EP is defending a claim, both sides need to consider what the standard of care was at the time the care was delivered, not at the time the claim is being defended,” Klauer says.
The ED defense team also needs to push back against assertions that certain guidelines constitute the standard of care.
“The jumping off point for the allegation that the plaintiff is going to make will oftentimes be based on what a guideline says,” Klauer says. A typical deposition question is: “Do you consider guidelines from this society to be authoritative?” By answering affirmatively, the EP defendant has just acknowledged that the guidelines are the standard of care.
“What you have done is agreed that everything in that guideline should be followed and that you should be familiar with its recommendations in detail,” Klauer cautions.
A better response is that no guidelines are authoritative, because every patient presentation is different.
“Every responsible specialty society should make it very clear that it’s not appropriate to apply guidelines in a black and white manner,” Klauer adds. The EP’s clinical judgment is needed on a case-by-case basis, regardless of what any guidelines say.
Klauer suggests EPs exercise caution before mentioning a specific guideline in their documentation if they did not follow it.
“You have to be careful. If you reference a guideline, make certain you used it correctly,” Klauer says.
Specificity can help if a guideline influenced the EP’s decision-making. For instance, the EP could document that the HEART Pathway for Early Discharge in Acute Chest Pain was used to determine that admission wasn’t required, or that he or she clinically cleared the cervical spine based on the National Emergency X-Radiography Utilization Study (NEXUS) criteria. Generally speaking, says Klauer, “If you use evidence in the literature to inform your decisions, you should refer to that, and that will help to defend you.”
If the EP defendant points to research supporting an alternative treatment approach, the plaintiff attorney’s expert can challenge the validity of the study.
“The expert might say, ‘this journal article was based on just 25 patients and it’s really not statistically significant — and even though it worked on those patients, it hasn’t been tried and tested, so therefore it’s not really the standard of care,’” says Mark Kadzielski, JD, a partner at BakerHostetler in Los Angeles. There may be a good reason why the traditional approach is just not appropriate for a particular patient.
A well-documented rationale can help the defense, says Kadzielski, “but that doesn’t mean you are going to be right in the second guessing of a jury.”
1. Upsey v. Pottstown Memorial Medical Center, et al., 2012 November Term 2009, Number 4525.
3. Pullman v. Silverman, 125 AD3d 562 (1st Dept. 2015).
Financial Disclosure: The following individuals disclose that they have no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study: Arthur R. Derse, MD, JD, FACEP (Physician Editor), Kay Ball, PhD, RN, CNOR, FAAN (Nurse Planner), Stacey Kusterbeck (Author), Gregory Moore, MD (Author), John Bass, MD (Author), Kyle Couperus, MD (Author), Jonathan Springston (Editor), Jesse Saffron (Editor), and Terrey L. Hatcher (Editorial Group Manager).