Legal Considerations in Gastroenterology: Key Concerns

Judge gavel and stethoscope , close-up view
In gastroenterology, legal concerns encompass procedural skill and use of non-technical strengths such as communication and decision making.

As medicine evolves, medicolegal considerations become increasingly complex. This clinical reality is particularly germane to gastroenterology, which is consistently ranked in the top 10 most commonly litigated medical specialties.1 In gastroenterology, procedures commonly used to diagnose gastrointestinal (GI) cancers such as endoscopy and colonoscopy can increase the risk for malpractice claims due to the frequency with which these procedures are performed and the potential for human error, despite technician skill.

In 2017, approximately 135,000 new cases of colorectal cancer (CRC) were diagnosed in the United States. Over the past few decades, CRC incidence and mortality have declined while 5-year survival rates have increased, thanks to increased use of colonoscopy in the screening, detection, and prevention of CRC.2 Major GI societies have emphasized the importance of guideline-supported CRC screening, in accordance with goals to screen at least 80% of average-risk patients in the US. Although there are multiple modalities that can be used to screen for CRC, colonoscopy is considered the gold standard in gastroenterology and is routinely offered to eligible patients.  

Legal Concerns for Colonoscopy

Even with the most skilled and experienced technicians, complications during colonoscopy can be inevitable. For this reason, it is critical that health care providers discuss possible complications, such as bleeding, infection, and perforation, with patients prior to the procedure.

In recent years, several GI societies such as the American Society for Gastrointestinal Endoscopy (ASGE) have published guidance on the complications that gastroenterologists should be aware of pre-procedure, due to their potential to be used in litigation. In 2015, the ASGE published quality indicators for colonoscopy that specifically addressed perforation.3 The risk for perforation is important to note because perforation is the diagnosis most commonly associated with endoscopy-related malpractice claims.4  

The ASGE guidance stated that the incidence of perforation in all colonoscopies should be less than 1:500; in screening colonoscopies, the incidence of perforation should not exceed 1:1000. Rates that surpass these benchmarks can be cause for evaluation of a clinician’s technical capability.3 In 2019, Kothari et al conducted a systematic review and meta-analysis evaluating the adverse events associated with colonoscopy.5 This ASGE review found pooled rates of perforation of 5.8 per 10,000 colonoscopies (95% CI, 5.7-6.0) and a pooled death rate of 0.003% (or 3) in 100,000 colonoscopies.

To better understand what information is specifically involved in gastroenterology malpractice claims, a group led by Panuganti et al reviewed CRC litigation cases that proceeded between 1988 and 2018. Findings from the analysis were published in the American Journal of Gastroenterology in 2018. The evaluation included 240 CRC malpractice cases procured from the VerdictSearch legal database. Most patients were men (67%); the average plaintiff age at the beginning of each case was 55.6 years.2 

The majority of the verdicts were either found in favor of the defense (42.1%) or ended in a settlement (40%). Only 15.4% of cases favored the plaintiff. Interestingly, 22.9% of all defendants were gastroenterologists. 

The plaintiffs were found to have significantly higher allegations regarding errors in diagnosis (80%) compared with procedural errors (17%; P <0.01). The 3 most common allegations identified in the malpractice suits were failure to perform diagnostic colonoscopy for symptomatic patients (27.9%), failure to perform screening colonoscopy according to screening guidelines (19.2%), and failure to detect CRC with colonoscopy (18.8%).

The most prevalent plaintiff-reported patient health outcomes included cancer metastasis (56.3%) and development of new cancer (21.7%). Fifty-nine percent of the cases included a patient death; however death was not necessarily a direct result of the colonoscopy.

The largest settlement or plaintiff verdict payments were awarded in scenarios where plaintiffs alleged failure to perform colonoscopy when indicated by screening guidelines. In these cases, settlement or plaintiff verdict payments ranged from $135,000 to $7.1 million. The next largest payments were in the plaintiff group alleging failure to perform colonoscopy according to a patient’s presenting symptoms, with payments hitting a maximum of $5.36 million.  

Unfortunately, this study was not able to identify which guidelines were cited in specific cases. Guideline adherence will continue to be an important consideration for both gastroenterologists and lawyers, particularly as there has been a recent trend towards screening patients for CRC at younger ages, regardless of family history. However, this trend is not unanimous, and professional societies such as the ASGE, American Cancer Society, and United States Preventive Services Task Force have yet to arrive at a consensus.

Beyond guideline concordance, insurance coverage is another critical component of CRC screening. Many insurance plans may not cover colonoscopy for younger patients considered average-risk, which could delay a diagnosis of CRC and further complicate the legal landscape.

Findings from Panuganti et al’s study underscore why some gastroenterologists may practice “defensive medicine,” which could lead providers to recommend tests like colonoscopy to avoid potential malpractice suits. Depending on the patient, “defensive medicine” and its manifestations could lead to increased costs to the health care system at large. 

The Role of Non-Technical Skills

Although obtaining the initial guideline-supported colonoscopy is the first step in screening for CRC, there are many subsequent steps that could prompt malpractice claims, such as coordinating colonoscopy recalls. Although many gastroenterologists might be concerned about the procedural components of a malpractice case that concerns colonoscopy, as Panuganti et al’s study demonstrated, alleged diagnostic errors can be more substantial in a court of law.

Evaluating a provider’s technical skill can be challenging and often includes a review of their procedure volume, complication rates, and prior training and experience.6 Procedural complications can occur when even the most technically skilled physicians carry out the procedure; therefore, providers’ use of their diagnostic and communication skills is critical. 

However, non-technical skills (NTS) such as communication and decision making can also play a role in malpractice claims. Although providers are expected to exercise these skills when managing complications, they may underutilize these capacities, placing more of an emphasis on medical treatments or interventions.  However, there is increasing research to support the notion that NTS are a key component of patient outcomes when complications occur. NTS have become increasingly incorporated in both residency and fellowship training as well as continuing medical education (CME) courses.

Importantly, NTS can be cited in malpractice claims, with 1 study finding that 33% of claims indicated a deficiency in these skills. To further investigate how NTS impact legal outcomes in GI procedures, Hernandez et al recently reviewed 175 claims involving perforations. Their findings were published in the American Journal of Gastroenterology.6 

All claims included in the analysis involved allegations of improper performance of an endoscopic procedure. The most common procedure was colonoscopy (106/175, 60.6%) with 95% of patients requiring surgery. Forty-one percent of all patients had a prolonged or complicated post-surgical hospitalization course. A total of 26 cases (14.8%) resulted in patient death.  

With respect to NTS, the claims were broken into communication (71, 41%) and clinical judgement (60, 34%), with some overlap between the 2 categories in some instances. Inadequate consent was the most common communicative factor cited in the cases; 24 cases (14% of all cases) citing inadequate consent. After inadequate consent, lack of communication with the patient and/or family (10%), poor communication with other providers (5%), and alteration or lack of documentation (5%) were the most frequently reported communicative issues. 

Premature discharge (11%) was the most prevalent clinical judgement factor, followed by failure to appreciate signs and symptoms of perforation (10%), failure or delay in ordering diagnostic tests (9%), and failure to establish differential diagnosis (5%).  

When these NTS factors were analyzed using a multivariable model, both communication issues (odds ratio [OR] 3.31; 95% CI, 1.46-7.48, P =0.003) and clinical judgement issues (OR 3.18; 95% CI, 1.44-7.01; P=0.003) were found to have more than 3-times the odds of an indemnity payment. There was no evidence of a statistically significant association between age, type of procedure, trainee involvement, clinical severity, need for surgery, or procedure-related death. Cases with an allegation of poor technical skill but no accusation of NTS deficiency correlated with a lower risk for indemnity payment (OR 0.43; 95% CI, 0.15-0.80; P =0.011).  

The study authors concluded that inadequate NTS were associated with indemnity payments: “inadequate communication and clinical judgment seem to trend toward worse legal outcomes independent of the severity of clinical outcomes,” they said. Therefore, the likelihood of a procedure-related complication that leads to a paid malpractice claim may depend more on what happens before and after the procedure rather than what transpires during the procedure.6 Hernandez et al also indicated that although perforation is typically covered in all patient consent forms, this does not guarantee a provider’s immunity from a malpractice claim. 

The medicolegal environment is complex and will continue to be challenging to navigate amid changes in healthcare policy and professional guidelines. In addition to highlighting the importance of procedural skill, these studies emphasize that NTS are commensurately crucial to managing procedural complications.

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1.      Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to physician specialty. N Engl J Med. 2011;365(7):629-636.  doi: 10.1056/NEJMsa1012370

2.      Panuganti PL, Hartnett DA, Eltorai AEM, Eltorai MI, Daniels AH. Colorectal cancer litigation: 1988-2018. Am J Gastroenterol. 2020;115(9):1525-1531. doi: 10.14309/ajg.0000000000000705

3.      Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53. doi: 10.1016/j.gie.2014.07.058

4.      Hitchins CR, Metzner M, Edworthy J, Ward C. Non-technical skills and gastrointestinal endoscopy: a review of the literature. Frontline Gastroenterol. 2018; 9(2):129–134. doi: 10.1136/flgastro-2016-100800

5.      Kothari ST, Huang RJ, Shaukat A, et al. ASGE review of adverse events in colonoscopy. Gastrointest Endosc. 2019;90(6):863-876.e33. doi: 10.1016/j.gie.2019.07.033

6.      Hernandez LV, Klyve D, Feld L, Nalini G, Feld A. Do nontechnical skills affect legal outcomes after endoscopic perforations? Am J Gastroenterol. 2020;115(9):1460-1465. doi: 10.14309/ajg.0000000000000671