Medical Malpractice Claims and Risk Management in Gastroenterology and Gastrointestinal Endoscopy

Sections:

• Introduction
• What is Risk Management?
• How Does Patient Injury Relate to Malpractice Claims?
• What is Known About Patient Injury Resulting From Endoscopy?
• The PIAA Database
• What Does The PIAA Database Tell Us About Endoscopic Claims and Lawsuits?
• Summary
• References

Introduction 

Gastroenterologists have reason to be concerned about malpractice risk. Recent factors which have heightened concern about malpractice risk among gastroenterologists include:

1. The Institute of Medicine’s widely publicized report of medical error ¹
2. public anger over health care costs and over managed care ²
3. the political debate over ability to sue for medical injury, which may encourage patients to seek compensation for certain medical injuries
4. trends toward increasing values of jury awards for medical malpractice claims in recent years ³.
5. Concern over medical malpractice, and the felt crisis of malpractice, is not new ⁴.

However, despite the increasing complexity inherent in gastrointestinal endoscopy practice, gastroenterologists are sued less frequently than most other specialty groups.

Data specific to gastroenterology malpractice claims are difficult to find. Commercial insurance carriers have never been willing to share data on claim frequency and severity with outside parties. Institutions that self insure, such as most major academic medical centers and very large clinics (e.g., Mayo Clinic and Cleveland Clinic) have no mechanisms in place to share information on claims. Furthermore, most risk managers in these organizations are loathe to provide data to the public on the types, frequency and severity of claims made or settled for fear that this will result in adverse publicity or escalation of monetary demands from plaintiff's attorneys.

This review updates material on endoscopy-related claims presented by Gerstenberger and Plumeri a decade ago ^5,6. These earlier reports and the current study detail information obtained from medical malpractice claim data pooled from more than 20 member companies of the Physician Insurers Association of America (PIAA) ^5,7. The typical PIAA member company was established in the last 2 decades by its state's medical association; the association sought to provide physician-owned or managed sources of medical malpractice insurance for its members. The PIAA companies pool and share claims data to provide information for ongoing claims adjudication and risk management. It is important to realize, however, that data obtained regarding gastroenterology claims from PIAA generally represents the experience of private-practice gastroenterologists rather than gastroenterologists in academic settings, US military, or very large self-insured clinics or organizations.

The goal of the current PIAA report ⁷ was a better understanding of actual malpractice claims, an awareness of the type of injury leading to claims, and a resultant potential ability to reduce patient injury and lawsuit. Exposure data (claims per numbers of insured physicians per year) were not collected. Therefore, the relative frequency of the claims reported is not available. Furthermore, the report uses a set of generic categories to capture data, which prevents some more detailed queries endoscopists may wish were possible. However, this large database does give the only available recent snapshot of malpractice actions specific to gastrenterology and allows several valid conclusions to be drawn:

1. Gastroenterology ranks 23rd of 28 specialty groups in the number of claims reported.
2. Gastroenterology claims were only 1.3% of claims reported to the PIAA in 1999.
3. Only 25 paid gastroenterology claims were reported to the PIAA in 1999.
4. A diagnostic consultation was the “procedure” performed that resulted in the most claims against gastroenterologists (32% of claims).
5. The most prevalent procedure resulting in claims against gastroenterologists was a diagnostic procedure of the large intestine (14% of claims)
6. Other reasons for malpractice claims included failure to supervise or monitor a case, and medication errors. Less common allegations were failure to recognize a complication of treatment, performance when not indicated or contraindicated, improper supervision of residents/other staff, and failure/delay in referral or consultation
7. The most common patient conditions for which claims were filed against gastroenterologists were regional enteritis, colitis and “symptoms involving the abdomen and pelvis”.
8. Claims involving cancer of the colon and rectum resulted in the highest average payment ($225,311).

What is risk management? 

Risk management is a process that involves the collection and utilization of data to reduce the risk of a particular loss. Risk management for gastroenterology and gastrointestinal endoscopy has the following objectives:

1. To define instances that place the physician at risk.
2. To determine the frequency and significance of these instances.
3. To apply this awareness in the treatment of individual patients.
4. To develop remedial and preventive measures to prevent injury and/or losses.

Gastrointestinal endoscopic risk management specifically attempts to reduce preventable endoscopy related patient injuries that leads to liability claims, and to limit the frequency and cost of claims that may otherwise arise.

How does patient injury relate to malpractice claims? 

Several published studies ^8-12 have examined the frequency of patient injury encountered in general medical and surgical care. In one report, 36% of 815 consecutive admissions to a university medical service were associated with some iatrogenic illness. One fourth of these adverse events was life threatening or caused substantial disability. Another study reviewed 5,612 surgical admissions and identified 36 surgical mishaps (0.64 % of cases) resulting from provider error. The review of 20,864 medical and surgical hospital records found a 4.65% incidence of iatrogenic disabilities. The investigators determined that 17% of these iatrogenic injuries (0.8 % of all reviewed charts) would lead to a finding of provider liability if litigated to a court verdict. The remaining 83 % of adverse events were judged to have resulted from the normal risk of medical treatment. On the basis of the studies, iatrogenic injury resulting from provider care is a common occurrence in the hospital care of medical and surgical patients.

Less than 10 % of patients sustaining an injury during provider care ultimately file a malpractice claim. Of claims that are filed, 66.5% are closed without payment to the plaintiff. Thus, less than I in 25 patients injured by negligent medical care are compensated through the current tort system.

What is known about patient injury resulting from endoscopy? 

Numerous studies in the medical literature report complication rates of specific endoscopic procedures ¹³. These studies estimate the rate of direct patient injury resulting from specific procedures. Issues of operator error and negligent performance are not raised in these reports. Using the prior PIAA data set, Gerstenberger and Plumeri attempted to calculate relative risks of complications leading to medical malpractice actions in various endoscopic procedures ⁵. Published complication rates define the status quo for particular procedures and are helpful in the disclosure and consent process, credentialing, and quality assurance activities. However, these rates fail to provide enough data to construct risk management strategies to reduce preventable injuries.

The PIAA database 

The Physician Insurers Association of America (PIAA) is an association of approximately 30 physician owned or managed professional liability insurance companies in the United States. As such, it can capture data from the experience of large numbers of physicians in private or group practices. It does not, however, include information on academic medical center practice or data from large self-insured groups. Nevertheless, the PIAA database is probably the most recent, most detailed and largest currently available source of medical malpractice loss causation data in the United States.

The research department of PIAA develops reports on malpractice claims. The most recent report available tracks claims from January 1985 through December 1999 ⁷. The PIAA reports are unique in that they include all claims whose severity resulted in establishing an insurance reserve for potential payment of the claim. (Only 25% of these reserved claims, however, resulted in any indemnity payment to the claimant.)

The PIAA reports provide a larger cross section of claim experience than, for example, would data based on reports of settlements from legal and court records, or data from settlements reported to the individual state licensing bodies or to the National Practitioner Data Bank, even if such data were available for public scrutiny. Thus, the PIAA reports present a unique risk management tool to educate practitioners regarding nationwide risk trends in their specialty group.

The current PIAA report ⁷ is a compilation of 15 years of medical malpractice claim data from more than 20 member companies. More than 30 major medical and dental specialties are represented in the 173,166 claims. The reports are structured to provide strict confidentiality to the reporting companies and to the individuals they insure. Thus, certain interpretive data are lacking in these generic reports. For instance, there is no exposure data that allows one to calculate the percentage of encounters or procedures that result in a claim, or the numbers of claims per insured physician per year. The reports do not get to the level of detail of anecdotal interest to practitioners, such as: What main problems with the diagnostic interview that lead to claims? Which omissions led to suits for failure to diagnose colon cancer? Were suits related to failure to recall patients for follow-up exams? However, the unique data does provide useful information for risk management.

What does the PIAA database tell us about endoscopic claims and lawsuits?

1. Age, gender and Board Certification Data:
   Gastroenterologists with claims included in the PIAA Data Sharing System are younger in comparison to all physician specialties. Almost 50% of gastroenterologists were under 45 years old when the malpractice claim occurred. This compares to 45% for all physician specialties. Males represented 98.4% of the insured gastroenterologists with claims, suggesting that women gastroenterologists, with only 1.6% of claims, were less likely to be sued than men. (An estimated 6.6% of gastroenterologists were women according to American Medical Association statistics.) Eighty percent of gastroenterologists with claims were Board certified.
   
   
2. Comparison of Gastroenterology with other specialties:
   Of the 28 specialty groups included in the database, gastroenterology ranks 23rd in the number of claims reported. The ratio of paid claims to total closed claims was 21.5%, which was 10% less than that for all specialty groups.
   The total indemnity paid on behalf of gastroenterologists for the 15 years in which records were kept was $37 million, which ranked 24th of the 28 specialty groups in monies paid. The cumulative average indemnity for this specialty group was 13% less than the overall average paid ($142,602 vs. $163,743).
   
   
3. Recent trends in claim frequency and severity:
   Only 25 paid gastroenterology claims were reported to the PIAA in 1999. Total indemnity paid for these claims amounted to $6.7 million, with the average of these payments being $269,596 and a median payment of $150,000. The largest gastroenterology payment reported in 1999 was $950,000.
   
   Whereas in 1999 the average indemnity paid on behalf of gastroenterologists was $269,596, in 1994, the comparable average payment was only $126,416. Thus, in that five-year period the average gastroenterology indemnity more than doubled. When adjusted for inflation, the average payment between the two periods increased 90%. This trend for increasing severity of payments was somewhat worse than experiences reported for other PIAA specialties ⁷ but does mirror national trends generally observed by analysts of the insurance industry ³.
   
   The PIAA data did not analyze claim frequency and severity by geographic location of the insured. As of February, 2001, only 22 of the 50 states had caps on non-economic awards in medical malpractice liability cases (published information, American Medical News, American Medical Association, February 5, 2001). In those states with such caps, medical malpractice liability insurance premiums are markedly reduced as compared with similar premiums in states without limits on damages. This strongly suggests that frequency and/or severity of cases in states without liability award caps is very different than in states whose legislatures have passed such award limits.
   
   Gastroenterology claim frequency of approximately 6 claims per 100 insured physician years for the last decade are quoted by Greene (M.L. Greene, unpublished information). This number is based on more than 1000 gastroenterologist insured practice years from a PIAA company in a state with no legislative limits on non-economic damage awards for malpractice actions.
   
   Other comparative data suggest that gastroenterology claims may be more prevalent in recent years, although the data on which to base this statement is scanty. In 1999, gastroenterology claims were 1.3% of all PIAA claims and represented 1.2% of all indemnity dollars. Ten years ago, gastroenterology claims accounted for only 0.8% of claims and 0.4% of indemnity payments.
   
   Approximately 25% of gastroenterology claims closed in 1999 resulted in an indemnity payment to the plaintiff. This percentage has decreased only slightly from 26.5% a decade ago. For all specialties combined, 29% of claims closed in 1999 resulted in a payment.
   
   
4. Characterization of the claims--Cognitive vs. Procedural Misadventures
   Scrutiny of the data for the more than 1200 claims analyzed ⁷ suggests that not all reporting companies provided complete data for all questions. Nevertheless, useful information on problems leading to claims can be obtained from the report (Table 1).
   
   The data does not allow us to tell what percentage of all claims were specifically related to performing, or failing to perform, gastrointestinal endoscopy procedures, as reports were incomplete in their sub categorization of the groups listed in Table 1. Regarding overall claim experience, a larger percentage of claims against gastroenterologists are related to "cognitive misadventures" rather than to "procedural misadventures". (Table 2). This data is supported by other information from Greene ¹⁴ who found that only 59 of 144 (41%) of gastroenterology medical-legal cases he reviewed alleged endoscopic or procedural-related misadventures, the remainder (59%) being related to alleged cognitive errors.
   
   The most common patient conditions for which claims were filed against gastroenterologists were regional enteritis, colitis and symptoms involving the abdomen and pelvis. Claims involving cancer of the colon and rectum resulted in the highest average payment for this specialty group ($225,311).
   
   A diagnostic interview, evaluation or consultation was the interaction that resulted in the most claims against gastroenterologists both in 1999 and in the cumulative 15-year data (32% of total claims with more than $13 million paid out). The next most prevalent subcategory in claims against gastroenterologists was diagnostic procedures of the large intestine (14% of claims and $3.8 million paid out). The data did not allow us to calculate specific claim rates for upper endoscopy, colonoscopy, and ERCP-related misadventures (claims per 1000 procedures or claims per physician-year) because denominators to calculate these figures were not available.
   
   
5. Relation of severity of injury to claims
   Data from the Harvard Medical Practice Study (not specific to gastroenterology) found that 47 malpractice claims occurred among 30,195 patients after initial hospital visits; of 280 patients identified with adverse events caused by medical negligence (defined per study protocol), only eight filed claims (<2%) ¹¹. Further analysis of this landmark study database, found that severity of the patients disability, not the occurrence of an adverse event, nor an adverse event due to negligence, was predictive of payment to the plaintiff ¹².
   
   In reviewing gastroenterology claims by the severity of the injury, the patient expired in 36% of the claims. For this group of claims, a payment resulted in 22% of the closed cases. Almost 40% of the total indemnity paid on behalf of gastroenterologists were for claims where the patient died. The average payment when the alleged incident resulted in the patient’s death was $152,109, approximately 7% higher than the cumulative average for all paid claims for gastroenterology.
   
   Errors in diagnosis were the most common medical misadventure reported when the patient died (40%). A payment was made in 25% of the claims involving diagnostic error. The patient condition most commonly reported in death cases was regional enteritis and colitis.
   
   When the treatment by a gastroenterologist allegedly resulted in a condition of grave severity such as quadriplegia, brain damage or need for lifelong care (3.6% of closed claims), the average payment was $307,917. The two most common conditions reported to result in this serious outcome were cancer of the colon and rectum and cancer of the stomach. Claims related to misadventures of conscious sedation or monitoring were not separately broken out in this data but may have been involved in some of these cases of severe brain damage. We will urge the PIAA companies to add this subcategory of misadventure to future claims analyses.
   
   
6. Emotional trauma, informed consent and other issues in claims
   Claims that involve allegations of emotional trauma to the patient (and no physical injury) represent just 3.7% of closed claims against this specialty group. Only 6.7% of these claims resulted in an indemnity payment, with an average payment of $31,567. Not surprisingly, the most common medical misadventure reported was "no medical misadventure," a term which is commonly used in the absence of any evidence of medical negligence against the provider.
   
   Associated medical-legal issues in claims included informed consent issues, breach of contract or warranty. Over 15% of the closed claims that reported an associated issue included consent issues as a related factor in a case. Claims involving this issue resulted in an indemnity payment 35% of the time, and an average payment value of $99,430.

Summary 

Data specific to gastroenterology malpractice claims are difficult to find. This review details information from the Physician Insurers Association of America (PIAA) database ⁷, which analyzed 173, 166 medical malpractice claims over a 15 year period. Of these claims, 1286 (0.74%) involved gastroenterologists as the insured physician.

Trends in claims suggest that claims against gastroenterologists are increasing in frequency and severity. Claims against this specialty were 1.3% of all claims in 1999, and severity of paid claims has increased 90% in the last 5 years.

The majority of claims against gastroenterologists involve "cognitive" misadventures (61.2%) as compared with procedural-related maloccurrences (38.8%). Thus, the study supports the contention that gastroenterologists are more likely to be sued from problems arising out of cognitive practice issues than for problems related to endoscopic complications. Diagnostic errors during evaluation and consultation, issues in dealing with patients with inflammatory bowel disease and colon cancer, and colonoscopy procedures were issues most commonly mentioned in this analysis of malpractice claims.

TABLE 1

MEDICAL MISADVENTURE RESULTING IN GASTROENTEROLOGY CLAIMS CLOSED OR PAID, 1985-1999

TABLE 2
INTERACTION OR PROCEDURE LEADING TO PIAA GASTROENTEROLOGY CLAIMS, 1985-1999
BASIS FOR CLAIM PERCENTAGE OF CLAIMS (N=1007 claims)

• COGNITIVE MISADVENTURES (Diagnostic interviews, evaluations, consultations, medication prescription, injections, vaccinations) 61.2%
  
• PROCEDURAL MISADVENTURES (Procedures on large intestine, small intestine, esophagus, stomach, gallbladder or biliary tract including ERCP) 38.8%

References:

1. Institute of Medicine Report: To Err is Human: Building a Safer Health System 1999
2. Marriner WK: “What recourse?—liability for managed care decisions and the Employee Retirement Income Security Act. N Engl J Med 343(8):593-596 , 2000
3. Medical malpractice insurance. Ills diagnosed, cures elusive. 2000. Conning Insurance Research and Publications, Hartford CT 06103 (Summary report published, 2000).
4. Bovbjerg RR: Medical malpractice: folklore, facts, and the future. Ann Int Med 117(9):778-791, 1992
5. Gerstenberger PD, Plumeri PA: Malpractice claims in gastrointestinal endoscopy: Analysis of an insurance industry database. Gastrointest Endosc 39:132-8, 1993
6. Plumeri PD, Gerstenberger PA, Hughes RW, Miller WN, Smith LE, Taylor DM: Risk Management: An Information Resource Manual. Manchester, Massachusetts ASGE 1990
7. A risk management review of malpractice claims: Gastroenterology. Research Department, Physician Insurers Association of America, Rockville, MD 20850 (Summary report published 2000)
8. Brennan TA, Leape L, Laird N et al: Incidence of adverse events and negligence in hospitalized patients. N Engl J Med 324(6):370-376, 1991
9. Leape L, Brennan TA, Laird N et al The nature of adverse events in hospitalized patients: Results of the Harvard Malpractice Study II. N Engl J Med 324(6):377-384 1991
10. Kuszler P “Liability for Medical Negligence in an Era of Managed Care” in Wing Jacobs and Kuszler eds. The Law And American Healthcare , Aspen Law & Business NY NY 1998
11. Localio RA, Lawthers AG, Brennan TA: Relationship between malpractice claims and adverse events due to negligence. N Engl J Med 325(4):245-251, 1991
12. Brennan TA, Sox CM, Burstin HR: Relationship between negligent adverse events and the outcomes of medical malpractice. N Engl J Med. 335(26):1963-1967, 1996
13. Miskovitz P, Gibofsky A: Risk management in endoscopic practice. Gastrointest Endosc Clin N Am 5:391-401, 1995
14. Greene ML. Medical-legal consultation in gastroenterology. Gastrointest Endosc Clin N Am 5:403-419, 1995

IMPORTANT REMINDER:
The preceding information is intended only to provide general information and not as a definitive basis for diagnosis or treatment in any particular case. It is very important that you consult your doctor about your specific condition.