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Controversial New "Sepsis-3" Guidelines May Make Claims Harder When Patients Are Not Timely Diagnosed and Treated

By Tyler Goldberg-Hoss

Introduction

Earlier this year, boxing legend, social activist, and American icon, Muhammad Ali, died of sepsis/septic shock. Ali’s death shined new light, at least temporarily, on a disease that is now thought to be the leading cause of mortality and critical illness worldwide.1

Still, our medical community’s understanding of this disease is evolving, including how it is defined. This author published an article in Trial News in January 2015 about sepsis,2 and how its management may give rise to medical negligence claims. It was based in part on definitions of sepsis and septic shock that were originally developed in 1991 (and updated in 2001).

Since that time, the Sepsis Definitions Task Force has come out with new definitions that will likely change how plaintiff attorneys evaluate and prosecute such claims. This article will describe what changes have been proposed, identify some potential problems with these changes, and discuss how these changes affect attorneys who are investigating such claims.

The changes

The reported incidence of sepsis is increasing, and it remains the primary cause of death from infection, especially if not recognized and treated properly. In 2014-15, the European Society of Intensive Care Medicine and the Society of Critical Care Medicine convened a task force of 19 critical care, infectious disease, surgical and pulmonary specialists to evaluate and, as needed, update definitions for sepsis and septic shock.

One purpose of this evaluation is to contrast sepsis from otherwise uncomplicated infection, and to update definitions to be consistent with improved understanding of how the disease works. The result of this task force is The Third International Consensus Definitions for Sepsis and Septic Shock (a.k.a. Sepsis-3), which was published in the Journal of the American Medical Association (JAMA) in February of 2016.

The Old Definitions

Sepsis was originally defined as the presence of infection along with two of the four SIRS (Systemic Inflammatory Response Syndrome) criteria:

Severe sepsis was defined as sepsis with organ dysfunction, which could then progress to septic shock, defined as “sepsis-induced hypotension persisting despite adequate fluid resuscitation.”

The New Definitions (“Sepsis-3”)

Because considerable advances have been made into the pathobiology and management of sepsis, this most recent task force was convened to evaluate the old definitions for sepsis, severe sepsis, and septic shock. It eventually concluded that these previous definitions could be improved, and proposed new definitions for sepsis and septic shock to replace the previous definitions of sepsis, severe sepsis, and septic shock.

The 2014-15 task force offered a number of reasons for this. SIRS criteria can be useful in the general diagnosis of infection, but can simply reflect an appropriate host response to infection, rather than an implication that the patient may be faced with something more life threatening. For example, one of the SIRS criteria is an abnormal white blood cell count. Oftentimes, such lab results indicate the presence of an infection and also that the patient’s body is appropriately responding to an infection. So, some patients who met the SIRS criteria for sepsis may in fact be at very low risk for progressing to a life threatening condition (including organ failure).

The 2014-15 task force, then, focused on organ dysfunction, which is the threshold factor that differentiates an uncomplicated infection from sepsis. As such, they proposed a new definition of sepsis: a “life-threatening organ dysfunction caused by a dysregulated host response to infection.” This new definition emphasizes the patient’s inadequate response to infection, and the resulting potential mortality from that inadequate response. Essentially, the new “sepsis” is the old “severe sepsis.” In lay terms, sepsis is “a life-threatening condition that arises when the body’s response to an infection injures its own tissues and organs.”

The task force recommended use of the Sequential [Sepsis-Related] Organ Failure Assessment (SOFA) scoring system in defining organ dysfunction and therefore sepsis. The SOFA is a tool that has been widely used in the critical care community, and “a well-validated relationship to mortality risk.”

SOFA is meant for ICU patients, and its factors include tests for breathing, coagulation, mental status, and heart, liver, and kidney function. Within each category, a patient can be given a SOFA score between 0-4. “Organ dysfunction” is identified as “an acute change in total SOFA score ≥ 2 points consequent to the infection.” For a full table of the SOFA factors and scoring system, visit the National Institutes of Health webpage on the subject: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2703722/.

For non-ICU settings, the task force recommended a new measure for screening patients suspected of having sepsis. “qSOFA” (a.k.a. “quickSOFA”) is meant to be used simply at the bedside by providers to identify adult patients with suspected infection who are likely to go on to have a poor outcome. The qSOFA criteria are:

The qSOFA is considered positive if the patient has two or more of these criteria. While not as “robust” as the SOFA, it doesn’t require any lab tests and can be assessed quickly and repeatedly.Septic shock has been redefined as well. It is now: “a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone.” The task force notes that septic shock can be clinically identified with two criteria: persisting hypotension requiring vasopressors to maintain a mean arterial pressure of 65 mm Hg or greater, and serum lactate level greater than 2 mmol/L despite adequate volume resuscitation.3

The data cited by the task force indicated that the mortality rate for patients who meet these two criteria is 40%, or 4 times higher than patients with sepsis alone.4

Potential Problems

Soon after these “Consensus Definitions” were published, a number of groups came out in opposition to them, including (perhaps most importantly for plaintiff attorneys) emergency medicine physicians, who often are the doctors diagnosing sepsis.5

Dr. Justin Morgenstern published an article in May 2016 titled “New Sepsis Guidelines: Don’t Fix What Isn’t Broken.”6 In it, he makes the case for why the guidelines should not be adopted. His main criticisms are twofold.

First, the old criteria (SIRS) works just fine in conjunction with sound clinical judgment. He questions whether the new criteria, especially the qSOFA, adds anything to clinical judgment. After all, writes Dr. Morgenstern, “How often are you missing sepsis in hypotensive patients with altered mental status?”7

Second, Dr. Morgenstern echoes a concern shared by other organizations, namely that there have been no prospective studies validating the new SOFA (or qSOFA) scoring system as being better than the previous SIRS-based system.8 Until we actually know if SOFA/qSOFA works better, why use it?

In addition to these concerns, others have been raised:

Evaluating and Prosecuting Medical Negligence Cases After the New Definitions

Attorneys who handle medical negligence cases know that cases involving sepsis may be viable given the catastrophic nature of the harm that can be done, including death, loss of limb, and organ failure. This author’s previous article outlined potential medical legal issues relating to such cases.13 With these new guidelines bring new potential issues for attorneys to consider when evaluating such a claim.

In most potential sepsis cases, the focus is not on any particular health care provider causing the infection leading to sepsis. Rather, it is on whether the health care provider or providers met the standard of care in appropriately diagnosing and treating the sepsis. During this period of conflicting criteria, it may be difficult to point to a particular one as defining the standard of care, and it is possible that a potential client fit into one particular set of criteria but not another.

For example, you may have a patient with a known infection with vitals that include a blood pressure of 132/88, a heart rate of 92/min, and a respiratory rate of 23/min. This patient fits the old definition of sepsis (fitting two SIRS criteria) but not the new qSOFA screening criteria. Without labs, it is impossible to tell whether the patient fits the new SOFA criteria. Additionally, often the plaintiff attorney will find when reviewing the records that ordered labs do not include some of the tests that comprise the SOFA scoring system.

If a potential client fits into both old and new sets of criteria, then the attorney can argue that there were multiple accepted guidelines available to the provider, and he or she chose to not use either of them. Additionally, it would likely be helpful if the institution where the negligence occurs had adopted one of the sets that applied to the doctor in question. Similarly, an attorney might choose to focus on the criteria approved by the target defendant’s professional organization, if it applied.

With respect to the SOFA and qSOFA, the criteria are mostly black and white, with lab values and pulmonary function tests using clear thresholds for defining a patient’s score. However, at least one criterion, the Glascow Coma Scale, can be subjective. This will allow a defendant health care provider to cite to his or her clinical judgment in making the determination, and this is often a losing battle for a patient’s attorney.

Case Examples

We previously reported on three different sepsis cases. Below are two more examples of possibly meritorious cases.

A young man had symptoms of pneumonia that were missed in an urgent care clinic visit, but the next day was admitted to a hospital with beginning signs of sepsis and organ failure. Despite strenuous efforts to treat, he died a few days later, leaving a spouse and two children. An issue in the case is whether diagnosis of the pneumonia at the time of the urgent care visit would have allowed earlier antibiotic treatment and avoided the sepsis that led to his death.

A gentleman in his 60’s was admitted to a hospital with symptoms consistent with a bowel obstruction. After a week of treatment, it became apparent that he had a bowel perforation and a surgeon performed emergent surgery. That night he developed signs of peritonitis and sepsis that were not treated appropriately by the night hospitalist, and his blood pressure dropped precipitously in the early morning. By the time an intensivist was called and the right treatment started, including fluids and pressors, he suffered loss of oxygen to his brain and optic nerves. He is now totally blind and has mild brain damage with memory loss.

Conclusion

With these changes in definition and medical analysis, the key for a lawyer handling a sepsis case remains the same: focus on the early signs and symptoms and any delay in treatment. In sepsis cases, sometimes a few hours can make a huge difference in changing the outcome. A phrase commonly used by doctors is “source control,” i.e., identify the source of the underlying infection and aggressively treat that before it develops into sepsis or septic shock. In the example mentioned of the young man with pneumonia, the focus would be on diagnosis at the urgent care center, by simply ordering a chest x-ray, and then admitting him to the hospital for aggressive antibiotic treatment. In other cases, the infection may be treatable surgically, such as a blocked kidney stone causing urosepsis.

The new “Sepsis-3” definitions have the potential to add confusion to what the standard of care is for providers in diagnosing patients with sepsis (and septic shock). Unfortunately for patients/claimants and their attorneys, doctors, and other potentially negligent actors may use this confusion to instead rely on clinical judgment.

1 Singer, Mervyn, et al., The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3), JAMA. 2016; 315(8):801-810, 802. The facts contained within this article may be credited to this publication unless otherwise indicated.

2 Goldberg-Hoss, Tyler et. al., Sepsis – A Serious and Growing Threat to Patient Safety, Trial News January 2015.

3 This article is focused more on the changes with respect to sepsis, not septic shock. For more information about septic shock, please read the full article cited as footnote 1.

4 Society of Critical Care Medicine website, http://jama.jamanetwork.com/article.aspx?articleid=2492881.

5 In addition to the emergency medicine societies, the American College of Chest Physicians, the Infectious Disease Society of America, and hospitalist societies have either not endorsed or formally opposed Sepsis-3.

6 Morgenstern, Justin, News: New Sepsis Guidelines: Don’t Fix What Isn’t Broken, Emergency Medicine News (May 2016).

7 Id.

8 Id.

9 Seymour, Christopher, et. al., Assess­ment of the Clinical Criteria for Sepsis for the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3), JAMA 2016; 315(8):762-774

10 Farkas, Josh, PulmCrit – Top ten problems with the new sepsis definition. http://emcrit.org/pulmcrit/problems-sepsis-3-definition/

11 Simpson, Steven Q., New Sepsis Criteria – A Change We Should Not Make. Chest 2016, 149(5):1117-1118.

12 Morgenstern, supra.

13 Goldberg-Hoss, supra.

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