Sepsis: The Medicine, Claims and Defenses

Sepsis has reached epidemic levels, and even with appropriate interventions, sepsis has associated adverse outcomes, and medical malpractice litigation often will follow.

Sepsis is a serious illness, the hallmarks of which are an overwhelming systemic inflammatory response by the body and widespread tissue injury. It occurs secondary to severe infection and constitutes a medical emergency (as emergent as a heart attack or stroke), because it causes an interruption of oxygen and nutrients to the tissues (i.e., hypoperfusion), including vital organs such as the brain, intestines, liver, kidneys, and lungs. Early identification and restoration of adequate perfusion are critical in preventing irreversible organ dysfunction and death. Management includes recognition and implementation of aggressive interventions aimed at source control and reversal of sepsis-induced tissue hypoperfusion.

The incidence of sepsis is at epidemic levels. From 2000 to 2008, the number of hospitalizations with septicemia or sepsis listed as the first, principal, or secondary diagnoses jumped from 621,000 to 1,141,000. See Hall et al., Inpatient Care for Septicemia or Sepsis: A Challenge for Patients and Hospitals, NCHS Data Brief No. 62, Nat’l Ctr. for Health Statistics (June 2011). While it occurs in just 10 percent of all hospital patients in the United States, it contributes to 33–50 percent of all hospital deaths. Liu et al., Hospital Deaths in Patients with Sepsis from 2 Independent Cohorts, JAMA, Vol. 312, No. 1 (July 2, 2014), available at http://jama.jamanetwork. com/article.aspx?articleid=1873131 (last visited Feb. 9, 2016). Sepsis globally is more common than heart attack and claims more lives than any cancer. World Sepsis Day Org., Sepsis Facts, http://www.world-sepsisday. org/?MET=SEPSISSTART&vPRIMNAVISEL ECT=3 (last visited Feb. 9, 2016).

In 2011, the United States spent more than 20 billion dollars on the diagnosis and treatment of sepsis, making it the most expensive condition treated in hospitals. See Celeste M. Torio & Roxanne M. Andrews, National Inpatient Hospital Costs: The Most Expensive Conditions by Payer, HSUP Statistical Brief No. 160, Agency for Healthcare Research and Quality, Aug. 2013, at http://www.hcup-us.ahrq.gov/ reports/statbriefs/sb160.pdf. The Agency for Healthcare Research and Quality found that from 1997 through 2008, the inflation-adjusted aggregate costs for treating hospital patients with sepsis increased annually at a rate of 11.9 percent. See Hall et al., supra. Using that percentage, sepsis can be expected to cost over 30 billion dollars in 2016.

Sepsis and its related conditions—systemic inflammatory response syndrome (SIRS), severe sepsis, and septic shock— can be associated with adverse outcomes, including chronic deficits and death— even with appropriate interventions. As a consequence, claims of medical professional liability often follow. It is important for defense practitioners to understand these medical conditions and their treatments, common plaintiffs’ theories, and potential defense themes. This article will address these serious medical conditions and provide practical pointers for consideration, focusing on the diagnosis and treatment issues for individual health-care providers in medical malpractice litigation rather than environmental (nosocomial) claims against hospitals and other healthcare facilities.

Important International Sepsis- Related Clinical Goals

In August 1991, the American College of Chest Physicians and the Society of Critical Care Medicine held a consensus conference with the goal of agreeing on a set of definitions for application to patients with sepsis and its sequelae. Bone et al., ACCP/SCCM Consensus Conference, Definitions for Sepsis and Organ Failure and Guidelines for the Use of Innovative Therapies in Sepsis, Chest 101:1644–55 (1992). In 2001, a second sepsis conference resulted in modification of the 1992 criteria definitions to reflect the thencurrent understanding of the pathophysiology of sepsis. Levy et al., 2001 SCCM/SCCP/ ATS/SIS International Sepsis Definitions Conference, Crit. Care Med., 31(4):1250–56 (2003). Five conclusions resulted:

• Conclusion 1: Current concepts of sepsis, severe sepsis, and septic shock remain useful to clinicians and researchers.

• Conclusion 2: These definitions do not allow precise staging or prognostication of the host response to infection.

• Conclusion 3: While SIRS remains a useful concept, the diagnostic criteria for SIRS published in 1992 are overly sensitive and nonspecific.

• Conclusion 4: An expanded list of signs and symptoms of sepsis may better reflect the clinical response to infection.

• Conclusion 5: PIRO, a hypothetical model for staging sepsis, may better characterize the syndrome on the basis of predisposing factors and premorbid conditions, the nature of the underlying infection, the characteristics of the host response, and the extent of the resultant organ dysfunction.

In 2002, relative to the increased awareness of sepsis, the Surviving Sepsis Campaign was formed as a joint collaboration of the Society of Critical Care Medicine, the European Society of Intensive Care Medicine, and the International Sepsis Forum. Its goal was to achieve a 25 percent reduction in mortality from sepsis by 2009 through such things as increasing sepsis awareness, educating health-care professionals, and developing guidelines of care. In March and April 2004, Critical Care Medicine and Intensive Care Medicine published the first guidelines for the management of severe sepsis and septic shock.

In 2008, the second edition of the “Surviving Sepsis Campaign Guidelines for Management of Severe Sepsis and Septic Shock” was published. In 2012, the Guidelines again were updated and revised treatment bundles were incorporated. Surviving Sepsis Campaign, International Guidelines for Management of Severe Sepsis and Septic Shock: 2012, http://www.sccm.org/Documents/ SSC-Guidelines.pdf. The guidelines provided recommendations for clinicians caring for patients with severe sepsis or septic shock. It is critical for defense litigators to understand and emphasize that while “these recommendations are intended to be best practice… [they were] not created to represent standard of care” as that phrase is understood in the legal field. Id. As the document notes: “Recommendations from these guidelines cannot replace the clinician’s decision-making capability when he or she is presented with a patient’s unique set of clinical variables.” Id.

The guidelines identify a number of risk factors for sepsis: children younger than one year of age and adults over 65; patients with bacteremia (bacteria in the blood); ICU patients; patients who are immunosuppressed; patients with chronic illness, cancer, diabetes, or renal dysfunction; patients who undergo surgery and other invasive procedures; and patients with cardiac disease, community-acquired pneumonia, malnutrition, poor mobility, trauma, burns, prolonged antibiotic use, and presence of invasive devices. Genetic defects also have been identified as potentially increasing susceptibility to specific classes of microorganisms.

Additionally, the guidelines delineate the following poor prognostic factors for patients with sepsis: hypothermia with the inability to spike a fever; leukopenia (low white cell count); persons older than 40 years of age; comorbidities such as AIDS; hepatic failure; cirrhosis; cancer; alcohol dependence and immunosuppression; a non-urinary source of infection; a nosocomial source of infection (acquired in a hospital or other health-care facility); inappropriate antibiotic coverage; and failure to restore perfusion aggressively and early (failure to initiate early goal directed therapy). In the context of sepsis-related litigation, plaintiffs tend to focus their claims on the last three poor prognostic factors.

U.S. Government Mandates

On August 4, 2014, the Centers for Medicare and Medicaid Services (CMS) announced its intent to institute new federal reporting requirements and guidelines for how clinicians should treat patients with severe sepsis and septic shock, as well as new definitions for each of these conditions. See Ctrs. for Medicare and Medicaid Servs., CMS to Improve Quality of Care During Hospital Inpatient Stays, Fact Sheet (Aug. 4, 2014), https://www.cms.gov/Newsroom/ MediaReleaseDatabase/Fact-sheets/2014-Factsheets- items/2014-08-04-2.html (last visited Feb. 9, 2016). Various providers and healthcare groups expressed concern over these anticipated mandates because of the broad definitions included in them and the potential that this measure overall may result in over treatment. See, e.g., The Advisory Bd. Co., CMS’s New Sepsis Measure Makes Some Providers Worried. Here’s Why (Aug. 24, 2015), https://www.advisory.com/daily-briefing/ 2015/08/24/new-cms-sepsis-measures (last visited Feb. 9, 2016). The CMS mandate became effective on October 1, 2015. See Nat’l Quality Forum (NQF), NFQ #0500 Severe Sepsis and Septic Shock: Management Bundle, http:// emcrit.org/wp-content/uploads/2015/06/0500.pdf (last updated Jan. 5, 2015).

The concerns identified by various individuals and groups in response to the CMS mandates offer cross-examination material beneficial to defense litigators. For example, “Dr. Smith, isn’t it true that the Infectious Diseases Society of America is concerned about overtreatment as a result of this mandate?” Additionally, attempts by plaintiffs to use the CMS mandates during litigation can be countered by the disclaimer at the end of the measure, expressly designed to preempt and negate any legal effect: “These performance measures are not clinical guidelines and do not establish a standard of medical care, and have not been tested for all potential applications.” See id.

Sepsis-Related Conditions

Sepsis always begins with an infection from some source. There are four sepsis related conditions every litigator should be familiar with: SIRS, sepsis, severe sepsis, and septic shock. SIRS is often presented in litigation as the precursor to sepsis and is defined as a systemic response to an insult. While a bodily insult can be bacterial in origin, it also can be fungal, viral, or parasitic. It is a truism that SIRS and early sepsis often cannot be easily distinguished, and a common refrain from plaintiffs is that a source of sepsis should be sought whenever SIRS is suspected, along the same lines as the reptilian “worst first” mantra. For a patient to be considered as meeting SIRS criteria, two of the following must be present: (1) a fever of greater than 38.3° C (101° F) (hyperthermia), or a temperature of less than 36° C (96.8° F) (hypothermia); (2) an elevated heart rate of greater than 90 beats per minute (tachycardia); (3) an elevated respiratory rate of greater than 20 breaths per minute (tachypnea); and (4) a white blood cell count high of greater than 12,000 (leukocytosis) or a white blood cell count low of less than 4,000 (leukopenia), or greater than 10 percent bands (bandemia). Bone et al., supra.

Sepsis is defined by the CDC as “the body’s overwhelming and life-threatening response to infection, which can lead to tissue damage, organ failure and death.” Ctrs. for Disease Control and Prevention, Sepsis, http://www.cdc.gov/sepsis/ (last visited Feb. 9, 2016). Sepsis is the presence—probable or documented—of infection together with systemic manifestations of infection; in other words, it is a confirmed or suspected infection plus the existence of two or more of the SIRS criteria. Surviving Sepsis Campaign, International Guidelines 2012, supra. Other potential manifestations of infection that plaintiffs may raise include the following: altered mental status (confusion, anxiety, agitation); significant edema (swelling); high blood glucose of greater than 140 mg/dL without diabetes; plasma C-reactive protein (CRP) of greater than 2 SD (standard deviation) above the normal value; plasma procalcitonin of greater than 2 SD above the normal value; systolic blood pressure (SBP) of less than 90 mmHg or SBP decrease of greater than 40 mmHg in adults below their baseline; arterial hypoxemia (PaO2/ FiO2 <300); acute oliguria (urine output of less than 0.5 mg/kg per hour for at least 2 hours despite adequate fluid resuscitation); creatinine increase of greater than 0.5 mg/ dL; coagulation abnormalities (INR >1.5 or aPTT >60 seconds); ileus (absent bowel sounds); thrombocytopenia (platelet count <100,000); hyperbilirubinemia (plasma total bilirubin >4 mg/dL); hyperlactemia (>1 mmol/L); decreased capillary refill (>3 seconds); and mottling. Id.

Severe sepsis is defined as sepsis plus sepsis-induced tissue hypoperfusion or organ dysfunction thought to be due to the infection. Id. (It is important to note that the recent CMS mandates removed the “thought to be due to infection” phrase from its definition of severe sepsis.) Sepsis-induced tissue hypoperfusion or organ dysfunction is defined as sepsis-induced hypotension, elevated lactate, or oliguria (low urine output  0.5 mL/kg/hr for more than two hours despite adequate fluid resuscitation). Sepsis-induced hypotension is defined as a systolic blood pressure (SBP) of less than 90-mmHg, or mean arterial pressure (MAP) of less than 70 mmHg, or a SBP decrease of greater than 40 mmHg below baseline without other causes of hypotension. Neviere et al., Sepsis and the Systemic Inflammatory Response Syndrome: Definitions, Epidemiology and Prognosis, http://www.uptodate.com/ (last searched Feb. 9, 2016) (search “sepsis”).

Signs and symptoms of organ dysfunction in cases of severe sepsis include the potential manifestations of infection identified previously, as well as Glasgow coma scale abnormalities, acute lung injury with low oxygen saturations of less than 90 percent in the absence or presence of pneumonia as the infection source or acute respiratory distress syndrome (ARDS), elevated liver enzymes (AST, ALT, Alkaline Phosphatase), jaundice, decreased albumin, disseminated intravascular coagulation (DIC), abnormal EKG, left ventricular dysfunction, anuria, and blood in nasogastric aspirate. Al-Khafaji et al., Multiple Organ Dysfunction Syndrome in Sepsis (Mar. 20, 2015), http://www.medscape.com/ (last searched Feb. 9, 2016) (search title).

Septic shock is defined as severe sepsis plus sepsis-induced hypotension that does not respond to standard treatment (fluid resuscitation); lactate levels greater than or equal to 4 mmol/L; perfusion abnormalities resulting in cellular hypoxia; and imbalance between oxygen supply and demand. Surviving Sepsis Campaign, International Guidelines 2012, supra.

State-Mandated Sepsis Protocols and Screening Tools

Concerns exist about state regulatory mandates for sepsis care due to the fact that there is still much to learn regarding the best way to organize sepsis care, and reliable tools do not exist to measure sepsis incidence. See Rhee et al., Regulatory Mandates for Sepsis Care—Reasons for Caution, New Engl. J. Med. 370:1673–76 (2014). However, that has not stopped states and individual facilities from implementing sepsis protocols and screening tools for evaluating patients for severe sepsis in emergency departments, on the medical and surgical floors, or in ICUs, and then instituting template treatments.

For example, effective May 1, 2013, New York became the first state to mandate that all hospitals in the state adopt a sepsis protocol because of the sad case of Rory Staunton. Rory was a 12-year-old from Queens, New York, who had cut his arm while diving for a basketball in the school gym. He vomited after midnight later that evening. He was taken to the family physician later the next day with a fever, severe leg pain, and delayed capillary refill. His family physician suspected a stomach bug and sent him to the emergency department for fluids. The emergency medicine physician thought that Rory had improved after Rory received IV fluids and the physician discharged him with some Zofran for nausea. Rory died three days later from septic shock; group A streptococci had entered his bloodstream through the cut on his arm.

Known as “Rory’s Regulations,” Sections 405.2 and 405.4 of Title 10 (Health) of the official New York Codes, Rules and Regulations were amended. Of particular note, the amendments included the addition of subparagraph (8) of Section 405.2, which states that “hospitals shall have in place evidence-based protocols for the early recognition and treatment of patients with severe sepsis/septic shock that are based on generally accepted standards of care as required by subdivision (s) of section 405.4 of this Part.” Subparagraph 4 of Section 405.4 specifies processes for sepsis screening and treatment protocols, as well as guidelines for hemodynamic support and fluid resuscitation in children. The state required hospitals to submit protocols by July 1, 2013, for review, in accordance with subparagraph 6. Subparagraph 5 mandated sufficient training of medical staff with respect to the implementation of sepsis protocols. Subparagraph 7 addressed the collection, use, and reporting of quality measures related to the recognition and the treatment of sepsis, and subparagraph 8 provided definitions for sepsis, severe sepsis, and septic shock that mirrored those set forth in the Surviving Sepsis Campaign guidelines.

The New Jersey Hospital Association Institute for Quality & Patient Safety developed the New Jersey 2015 Sepsis Learning-Action Collaborative with one of the stated goals being for all hospitals in the state to implement early recognition sepsis-screening and treatment protocols by December 2015. See N.J. Hospital Ass’n Inst. for Quality & Patient Safety, Charter, 2015 Sepsis Learning-Action Collaborative, http://www.njha.com/media/315870/Charter- NJHA-Quality-Institute-New-Jersey-2015-Sepsis- Learning-Action-Collaborative.pdf (last visited Feb. 9, 2016). On June 29, 2015, various assemblymen and assemblywomen introduced a bill to supplement Chapter 2H of Title 26 of the New Jersey Revised Statutes to require hospitals to establish sepsis recognition and treatment protocols. See Assemb. B. 4678, 216th Leg. (N.J. June 29, 2015), available at http://www.njleg.state. nj.us/2014/Bills/A5000/4678_I1.HTM (last visited Feb. 9, 2016).

On February 20, 2015, Illinois introduced Senate Bill 1862 for the purpose of amending 20 Ill. Comp. Stat. 2310/2310-314 and 210 Ill. Comp. Stat. 85/6.23a. This bill will require hospitals to adopt evidence-based protocols for the early recognition and treatment of patients with sepsis, severe sepsis, or septic shock based on generally accepted standards of care. Senate Bill 1862 is substantially similar to “Rory’s Regulations.” See S.B. 1862, 99th Leg. (Ill. Feb. 20, 2015), available at http://www.ilga. gov/legislation/fulltext.asp?DocName=&SessionI d=88&GA=99&DocTypeId=SB&DocNum=1862& GAID=13&LegID=&SpecSess=&Session= (last visited Feb. 9, 2016).

To date, neither the New Jersey nor the Illinois legislation have been passed or signed into law, but it is expected that both will in the future in light of the push toward regulatory mandates for the management of sepsis patients. In addition, many individual hospitals, such as Charleston Area Medical Center in Charleston, West Virginia, Baylor University Medical Center in Dallas, Texas, and St. Joseph Mercy Ann Arbor in Ann Arbor, Michigan, have instituted sepsis-screening tools.

Each litigator should know whether or not his or her state or the applicable facility has developed such a sepsis-screening tool or protocol. In litigation, plaintiffs will advance these tools and protocols as mandating the guidelines for and the methodologies by which providers must investigate, diagnose, and treat sepsis-related conditions. Plaintiffs and their experts will argue that using a sepsis-screening tool to identify sepsis early is essential and that screening must be a multidisciplinary process that involves all providers, thus inferring a duty of care across multiple providers. Plaintiffs and their experts also will argue that a sepsis protocol reflects the accepted standard of care with respect to treatment and that any deviation from a sepsis protocol constitutes a breach of the duty of care.

Generalizations About Mandated Protocols

As for these protocols generally, a bedside nurse, as the health-care team member the most often with patients, is responsible for the initial screening. If a paper tool is used, a bedside nurse gathers the data required and documents it; if the screening tool is electronic, the nurse receives the alerts. In either case, the information is verified and it is expected that positive screening results be communicated to the medical team so they can make a decision about the appropriate intervention.

Most sepsis-screening tool checklists begin with making a determination whether infection is suspected. First, a screening provider must determine whether or not a patient’s history suggests a new infection, such as meningitis, endocarditis (infection of a heart valve), or a wound infection, such as if the patient recently underwent a surgical procedure. Then a provider must evaluate the signs and the symptoms of the patient to determine if there are any indicators of infection, such as altered mental status, tachycardia, hyperthermia, tachypnea, or leukocytosis. If at least two of these items are present and are new to the patient and the history suggests a new infection then a suspicion of infection, then a suspicion of infection is present and the provider should obtain lactic acid, blood cultures, CBC with differential, basic chemistry labs, and bilirubin. At the physician’s discretion, a urinalysis, chest X-ray, amylase, lipase, ABG, CRP, CT scan or combination of these may be obtained.

Next, a determination is made whether organ dysfunction criteria exist at a site remote from the site of infection. Signs of this include a systolic blood pressure of below 90 or a mean arterial pressure of lower than 65, creatinine of greater than 2.0 mg/dL or urine output of less than 0.5 mL/ kg/hour for two hours (indicating renal insufficiency), or a platelet count of less than 100,000 μL or an acute lung injury with a PaO2/FiO2 of less than 250 (absent pneumonia as infection source) or of less than 200 (in the presence of pneumonia as infection source). If an infection is suspected, and organ dysfunction is present, then a patient meets the criteria for severe sepsis (as defined above, sepsis plus sepsis-induced tissue hypoperfusion, or organ dysfunction thought to be due to the infection), and the patient should begin receiving the treatment specified by the severe sepsis protocol, as outlined in the treatment bundles described in the next section.

Treatment Bundles

Therapeutic priorities for patients with severe sepsis and septic shock include securing the airway, correcting hypoxemia (low oxygen), and administering IV fluids and antibiotics. Intubation and mechanical ventilation may be required in some patients. Treatment bundles have been developed to improve outcomes because early treatment is the most important factor in improving patient outcomes. Surviving Sepsis Campaign, International Guidelines 2012, supra. It has been reported that each hour of delay in antibiotic administration in patients with severe sepsis results in a corresponding 7.6 percent increase in mortality. Kumar et al., Duration of Hypotension Before Initiation of Effective Antimicrobial Therapy Is the Critical Determinant of Survival in Human Septic Shock, Crit. Care Med. 34:1589–96 (2006).

The Surviving Sepsis Campaign guidelines continue to use triage time as “time zero” in patients presenting to an emergency department, but the guidelines recognize that a percentage of patients may not meet criteria for severe sepsis or septic shock during triage in an emergency department. Remember that while the Surviving Sepsis Campaign guidelines discuss SIRS, sepsis, severe sepsis, and septic shock, the treatment bundles provided are for severe sepsis and septic shock.

The three-hour bundle is to be completed within three hours of presentation, that is, the time of triage in an emergency department, or if presenting from another care venue, from the earliest chart annotation consistent with all elements of severe sepsis or septic shock as ascertained through chart review. This bundle includes the following: (1) measuring the lactate level; (2) obtaining two sets of blood cultures before administering antibiotics; (3) administering broad spectrum antibiotics; and (4) administering 30 mL/ kg crystalloids for hypotension or a lactate level of greater than or equal to 4 mmol/L. Cultures of other sites (e.g., urine, cerebrospinal fluid, wound, respiratory secretion, body fluid) that may be the source or pathway of infection should be obtained before antibiotic therapy, as long as doing so does not cause significant delay in antibiotic therapy. It is recommended that IV antimicrobials be administered within the first hour of recognition of septic shock and severe sepsis without septic shock.

The six-hour bundle is to be completed within six hours of presentation. Vasopressors are to be applied for hypotension that does not respond to the initial fluid resuscitation, to maintain a mean arterial pressure of greater than or equal to 65. If hypotension persists after the initial fluid administration, or if the initial lactate level was greater than or equal to 4 mmol/L, volume status and tissue perfusion should be reassessed. The lactate should be measured again if the initial lactate was elevated. To reassess volume status and tissue perfusion, a focused exam of vital signs, cardiopulmonary signs, capillary refill, pulse, and skin findings should be repeated. Alternatively two of the following should be done: a patient’s central venous pressure should be measured, the patient’s central venous oxygen saturation should be measured, a bedside cardiovascular ultrasound should be performed, or a dynamic assessment of fluid responsiveness through passive leg raise or fluid challenge should occur.

What Does This Mean in Litigation?—Plaintiff Claims

Similar to most other medical malpractice cases, sepsis cases follow the traditional legal formula of duty, breach of the standard of care, proximate causation (or loss of a chance), and damages. Plaintiffs focus on alleged breach or breaches of the standard of care and proximate causation, since duty and damages usually are foregone conclusions. Most providers whose names are not somewhere on a chart are not named in the litigation, and most septic patients have had prolonged hospitalizations with significant attendant medical costs, and possibly long-term deficits. The common claim regarding sepsis is that (1) a provider or providers failed to diagnose sepsis or there was an improper delay in the diagnosis, and (2) as a consequence, necessary antibiotic, fluid resuscitation, and other treatments were delayed, leading to serious injury or death to a patient.

Many plaintiffs’ firms advertise specifically for sepsis cases. See, e.g., http:// www.protectingpatientrights.com/blog/sepsis- death-leads-to-medical-malpractice-lawsuit. cfm; https://www.medmalfirm.com/resources/ informative-materials/sepsis-or-septic-shock-lawyer/; http://www.beasleyfirm.com/medical-malpractice- lawyers/sepsis-infection/; and http:// www.indianamalpracticelawyer.com/Sepsis_and_ Septic_Shock_Due_To_Malpractice.htm (all last visited Feb. 9, 2016). This is not necessarily surprising. Septic patients often have adverse outcomes and therefore significant damages. The mortality rate is up to 30 percent for sepsis, up to 50 percent for severe sepsis and up to 80 percent for septic shock. Jawad et al., Assessing Information on the Burden of Sepsis: Global Estimates of Incidence, Prevalence and Mortality, J. of Global Health, Vol. 2, No. 1 (June 2012). Additionally, plaintiffs’ attorneys are cognizant of the lists of risk and poor prognostic factors, the nonspecific infection signs and symptoms, and the screening and treatment templates that can be used as informal standard of care checklists during depositions and during trials.

With that in mind, plaintiffs’ attorneys in sepsis cases tend to review a medical record to identify the first instance that a patient met two or more of the SIRS criteria. They review all temperature readings and pull out those that demonstrate a fever greater than 101 or less than 96.8 Fahrenheit. They focus on each heart rate reading greater than 90 beats per minute, and each respiratory rate greater than 20 breaths per minute. They examine all complete blood count results, with particular focus on a patient’s WBC count and percentage of bands. They pinpoint any other results or symptoms potentially indicative of infection, such as the following: confusion/ altered mental status; low platelet level (potentially indicative of bacteremia); and urinalysis with a positive leukocyte esterase (an enzyme in WBCs). They also review a patient’s medical and family history to identify all factors that may place the patient at increased susceptibility for infection. With this information in hand, and knowledge of the outcomes—unlike the providers involved in the litigation— plaintiffs’ attorneys generally will argue that a provider ignored or otherwise failed to recognize the hallmark signs of SIRS, the “precursor to sepsis.” Alternatively, if a probable infection source can be identified (e.g., recent surgery), or suggested (e.g., the patient visited his mother in a nursing home regularly or showered in gym locker rooms every day), plaintiffs’ attorneys generally will argue that a provider ignored or failed to diagnose sepsis.

Plaintiffs claim that the point when two or more of the SIRS criteria are fulfilled is when the treatment modalities, described above, should be initiated. They claim blood cultures should be done, broad spectrum antibiotics initiated and fluid resuscitation administered immediately without waiting for the results of the cultures.

The reasoning underlying immediate initiation of broad spectrum antibiotics is that depending on the facility or the lab, it can take a prolonged period of time for the results of blood cultures to become available. Given the concerns that accompany delaying treatment by as little as one hour, plaintiffs expect providers to “err on the side of caution” and begin treatment with medications that are considered “harmless” to a patient in comparison with the possible outcomes for a septic patient left untreated.

Other claims in sepsis cases can include the alleged failure to communicate and to coordinate with other health-care providers regarding a patient’s care; failure to evaluate and follow up on the results of diagnostic tests ordered to ensure timely and appropriate management of infection; failure to follow the sepsis protocol (if one exists at the particular facility); improper medication management, such as failure to order the appropriate type or dosage of antibiotic; failure to reevaluate and change the treatment plan if a patient’s condition does not improve; failure to perform surgery in a timely manner; failure to develop a differential diagnosis; failure to determine sensitivity of the infecting organism to the antibiotics ordered (once the culture results became available); post-operative negligence such as failing to recognize and treat complications arising from surgery organ perforation, peritonitis, or respiratory failure; failure to order the necessary consults (e.g., infectious disease); and failure to send a patient to a specialist if the current physician’s care is insufficient.

What Does This Mean in Litigation? Defense Themes and Practice Pointers

One common defense theme in sepsis cases is that a patient unfortunately would have succumbed inevitably to the overwhelming systemic inflammatory response to the infection and no intervention, regardless of how timely, would have changed the outcome, i.e., a classic “absence of proximate causation” theme. This theme often is appropriate in a sepsis case because patients may choose not to seek medical care for what they consider initially to be cold- or flu-like symptoms. It may not be until a patient demonstrates more serious indications of an infection, such as a rash of the torso or altered mental status, that a patient will seek treatment by and present serious symptoms to a health-care provider. By that time, a patient often will have fallen into a poor prognostic category and intervention may make no difference in the outcome. Key sources of information for such an analysis are any autopsy report, culture reports, and radiological reports that yield important information regarding the severity and the timing of the infection (e.g., seeding of bacteria), and the overall progression of the systemic inflammatory response. Infectious disease and pathology expert witnesses are important for developing this causation theme.

A standard of care theme is that a patient’s vital signs, physical exam, and laboratory findings all were consistent with a provider’s alternative impression of the patient’s condition. For example, hyperthermia can be caused by minor viral processes such as the common cold or the flu, medications, cancer, vaccines, and other conditions that cause inflammation. Tachycardia can be caused by exercise, sudden stress including fright, smoking, fever, drinking too much alcohol, caffeine, medications, hyperthyroidism, and cardiac issues. Tachypnea can be caused by exercise, asthma, chronic obstructive pulmonary disease (COPD) and other lung diseases, heart failure, anxiety, and pneumonia. Leukocytosis can be caused by stress, exercise, medications, cancer, and viral infections.

Also, specific to lab values, keep in mind that the “normal” ranges provided with each CBC, CMP, UA, or some other report vary from facility to facility. Additionally, patients’ baseline lab values also are not uniform. Thus, for example, a patient with a WBC value of 11,000 does not automatically indicate an abnormality or leukocytosis. It is important for a defense litigator to undertake a thorough analysis of each aspect of a patient’s presentation to a provider and to establish through the plaintiff’s and the defense experts each of the other medical conditions that can manifest with the same clinical picture.

Another defense theme is to establish that a patient has no suspected source of infection because the definition of sepsis mandates the existence of a suspected source of infection. If a patient discloses no recent surgical procedure, respiratory infection, urinary or GI infection, skin or soft tissue infection, or has no open wound to serve as a pathway for bacteria into the bloodstream, the lack of a suspected source of infection should be a strong defense. The factual information related to this defense theme should exist in the history, review of systems, and physical exam portions of a provider’s notes and warrants close scrutiny.

Yet one more defense theme involves attacking the SIRS criteria by demonstrating that they are not specific to sepsis alone. As the 2001 International Sepsis Definitions Conference proceedings noted, “The SIRS concept is valid to the extent that a systemic inflammatory response can be triggered by a variety of infectious and non-infectious conditions. Signs of systemic inflammation can and do occur in the absence of infection among patients with burns, pancreatitis, and other disease states.” Levy et al., supra. A 2015 article published in the New England Journal of Medicine addressed this issue, as well. The authors observed that not only do the SIRS criteria apply to patients without infection, but they also exclude patients who have infection and organ failure. Kaukonen et al., Systemic Inflammatory Response Syndrome Criteria in Defining Severe Sepsis, NEJM 372:1629–38 (Apr. 23, 2015). For example, a patient may be tachycardic and tachypneic if he or she just walked briskly into an emergency department after parking far away from the entrance. The body temperature also may be elevated. Even though such a patient has met the SIRS criteria, that would not be a sufficient predicate for initiating antibiotic and fluid resuscitation therapy, in particular if the patient’s tachycardia, tachypnea, and hyperthermia resolve in the emergency department. However, if such a patient did die from septic shock four days later, a plaintiff’s attorney certainly would key in on those vital sign measurements from that hospital visit.

Other items for investigation include the deficits that a patient was likely to develop, not just secondary to sepsis, but also stemming from the underlying infection, for example, neurological issues caused by meningitis, encephalitis, or a brain abscess. Audit trails should be scrutinized to prepare for and to explain timing issues or discrepancies in the medical record.

Finally, contributory or comparative negligence defenses also may be warranted if a patient introduced the source of the bacteria to him- or herself, such as through IV-drug use, or if a patient did not comply with discharge instructions from a previous health-care provider.

Conclusion

We hope that the information presented here provides you with some facts and suggestions useful in the defense of your clients who may be faced with failure to diagnose, delay in diagnosis, misdiagnosis or mismanagement of sepsis claims. The definitions for the sepsis-related conditions, the lists of risk and poor prognostic factors, and the recommended treatment bundles provide a roadmap of the topics and the details upon which your client will be cross-examined by a wellprepared plaintiff’s attorney. These materials will assist you to evaluate a provider’s care and potential exposure thoroughly, and they will arm you with the information that you need to develop appropriate themes to explain and to defend against the theories advanced by plaintiffs’ attorneys.

Susan Carleo, RN, CAPA, LNCC, is a board-certified legal nurse consultant in Syracuse, New York, with an independent practice focusing on medical malpractice. She has assisted plaintiff and defense attorneys analyzing multiple sepsis cases. Mrs. Carleo has clinical expertise in medicine, surgery, obstetrics, emergency department, and post-anesthesia care and is a legal documentation educator for nurses and medical providers. She is the incoming president of the American Association of Legal Nurse Consultants. Bernard S. Vallejos is a member of Farrell White & Legg PLLC in Huntington, West Virginia, and he practices law in West Virginia and Kentucky. He defends health care providers in medically complex professional liability actions, and he also defends corporate clients in product liability and toxic tort litigation.