Download Impact of Obesity in Medical Outcomes and Lawsuits

Impact of Obesity in Medical
Outcomes and Lawsuits
Dennis C. Smith, Jr., MD, FACS, FASMBS
WellStar Comprehensive Bariatric Services
55 Whitcher Street, Suite 410
Marietta, GA 30189
(770) 919-7050
[email protected]
Dr. Dennis C. Smith, Jr. is the Medical Director of the Bariatric Surgery Program
for the WellStar Health System at Kennestone Hospital in Marietta, Georgia. He
has been doing bariatric surgery since 1997 and laparoscopic bariatric surgery
since 1999. He regularly performs the Duodenal Switch, the Roux-en-Y Gastric
Bypass, the Sleeve Gastrectomy, and Adjustable Gastric Bands, as well as revisions
of those procedures. Dr. Smith is a long-time leader and innovator in laparoscopic
bariatric surgery, serving as faculty for many courses teaching laparoscopic bariatric
operations and techniques, and presenting techniques and results at national and
international meetings.
Impact of Obesity in Medical
Outcomes and Lawsuits
Table of Contents
I.Introduction..................................................................................................................................................63
II.Epidemiology................................................................................................................................................63
III. Etiology of Obesity........................................................................................................................................63
IV. Health Implications......................................................................................................................................63
V. Other Effects of Obesity................................................................................................................................64
VI. Weight Bias and Discrimination..................................................................................................................64
VII. Obesity in Medicine......................................................................................................................................65
VIII. Treatment of Obesity....................................................................................................................................66
IX. Surgical Treatment of Severe Obesity..........................................................................................................66
X. Medicolegal Aspects of Bariatric Surgery...................................................................................................67
XI. Avoidance of Malpractice Claims................................................................................................................69
XII. Patient Contracts...........................................................................................................................................70
XIII. Minimizing Risk in the Performance of Bariatric Surgery........................................................................70
XIV. Complications After Surgery........................................................................................................................71
XV. Expert Witnesses...........................................................................................................................................71
XVI.Summary.......................................................................................................................................................71
Impact of Obesity in Medical Outcomes and Lawsuits ■ Smith ■ 61
Impact of Obesity in Medical Outcomes and Lawsuits
I.Introduction
Obesity is a rapidly growing problem in the United States and around the globe. It is the fastest growing health care problem in the US. It is commonly referred to in recent years as the epidemic health issue of
our time. It affects virtually all aspects of a person’s life, and shortens lives significantly, as well as adding massive costs to health care for society overall. In addition, health care adds to the cost of doing business in the
form of added programs, structural modifications, and legal costs related to litigation and protection from litigation.
II.Epidemiology
Obesity is defined as a BMI of 30 or more, where BMI is defined as kg/m2. Obesity is now at about 30
percent of the adult population in the United States and is expected to increase steadily from there. By 2018
it is estimated that more than 40 percent of the adult population in the US will be obese or heavier, and in
that year it is estimated that some $340 billion dollars will be spent on health care related to obesity. Much of
those funds will be public/government funds [The Future Costs of Obesity: National and State Estimates of the
Impact of Obesity on Direct Health Care Expenses. Nov, 2009. Based on research by Kenneth E. Thorpe, Ph.D.,
Emory University].
III. Etiology of Obesity
Obesity has come to be considered a disease process rather than simply a disorder of willpower.
Causes of obesity in our culture are multifactorial, and include genetics, environmental effects such as portion
sizes and poor quality food. Also implicated are sedentary lifestyles, psychological factors, and medical conditions such as hypothyroidism and musculoskeletal issues. Generally the more processed and Westernized a
population’s diet, the more obesity is in that population.
IV. Health Implications
Severe obesity causes or contributes to a multitude of medical problems that significantly impair
health. Obesity-related illnesses include Diabetes, Hypertension, Sleep Apnea, Hypercholesterolemia, Hypertriglyceridemia and many other disease processes that involve nearly all major organ systems. Health costs
directly or indirectly attributable to obesity are increasing rapidly and driving up the overall cost of health
care in developed countries the world over, and especially in the United States.
These medical problems, referred to as “co-morbid” conditions, also contribute to the documented
shortened lifespan of morbidly obese individuals who remain in a morbidly obese condition, relative to the
lifespan of those who undergo bariatric surgery and are thus removed from the condition of morbid obesity.
These co-morbid conditions recede for the majority of patients who are able to lose a great deal of weight,
whether it is by surgical or non-surgical means.
The cost of health care per capita is increasing rapidly as a result of these co-morbid medical conditions. Studies now confirm that interventions such as bariatric surgery can pay for themselves over about two
years by reducing the costs of treating these co-morbid conditions. The justification for bariatric surgery is
largely the reduction of these medical problems and the associated cost and health benefits rather than cosmetic improvements.
Impact of Obesity in Medical Outcomes and Lawsuits ■ Smith ■ 63
V. Other Effects of Obesity
Bias against the obese is widely prevalent and deeply ingrained in our society. While many other
areas of prejudice have been greatly suppressed, especially in the media, disparaging portrayals and jokes
aimed at obesity remain very common. Entire movies are regularly produced that center around “fat jokes”. In
popular movies with a group of characters involved, there is often an overweight character who is considered
an easy target for jokes related to weight.
Bias exists in everyday life as well. Obese persons are commonly viewed by non-obese people as
being lazy, lacking in willpower, drive and intelligence, being malodorous, having less worth, being gluttonous, and being noncompliant. In the legal arena, there is evidence that overweight and obese persons may
be judged differently solely because of their weight [Schvey NA, Puhl RM, Levandoski KA, Brownell KD. The
influence of a defendant’s body weight on perceptions of guilt. International Journal of Obesity. 2013 Jan;1:1-7].
As a result, the obese person often feels social rejection, has poorer relationship quality, demonstrates
poorer academic performance, is more likely to avoid continuing education, and is more likely to avoid seeking healthcare. Effects on employment include inequitable hiring practices, lower wages, and poorer career
advancement.
Further, these tendencies end up resulting in a person with diminished self-esteem, social isolation
and poor social support systems. Health care is compromised, leading to elevated health risks, increased morbidity and mortality, and a shortened lifespan. Socioeconomic status is reduced as well. Overall, the person
with severe obesity has a tendency toward poor physical, mental, economic and social health.
VI. Weight Bias and Discrimination
In terms of social justice, there are few protections for the obese. Until the past few years, laws protecting against discrimination against the obese were very few and far between [Puhl RM, Moss-Racusin CA,
Schwartz MB, Brownell KD. Weight stigmatization and bias reduction: perspectives of overweight and obese
adults. Health Education Research. 2009 Sep;23(2):347-358].
The Equal Protection Clause of the U.S. Constitution does not consider health, education, housing or
employment to be fundamental rights.
The Americans with Disabilities Act [Americans with Disabilities Act, 42 U.S.C. §§12101-12213] protects well against those with actual disabilities, but this has not historically protected against common weightbased discrimination [Staman, J. (2007). Obesity discrimination and the Americans with Disabilities Act
(RS22609). Washington, DC: Congressional Research Service]. The ADA defines a disability as a physical or
mental impairment that substantially limits one or more major life activities. Protected status includes those
with a history or record of such an impairment, or a person perceived by others as having such an impairment. Protection has been conferred upon those with a disability related to diseases and conditions resulting
from excess weight, but not to those with the excess weight alone. Extending this Act to those with only excess
weight as a problem has been seen as tantamount to declaring those with excess weight as being “disabled”,
which has been considered a problematic stance.
Obesity is similarly poorly protected from discrimination under the Rehabilitation Act of 1973. Section 504 of the Rehabilitation Act states that “no otherwise qualified individual ... shall, solely by reason of her
or his disability, ... be subjected to discrimination under any program or activity receiving Federal financial
assistance.” [29 U.S.C. §794(a)], however this has not been extended well to obesity in the courts.
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Recently, as in a Montana Supreme Court ruling in 2012 [BNSF RY. CO. v. FEIT, 281 P.3d 225 (2012),
2012 MT 147], the ADA Amendments Act of 2008 has been more broadly interpreted to classify obesity alone as
an “impairment” that should be protected against discrimination. However, this has yet to gain wide acceptance.
Title II (Two) of the ADA calls for businesses and institutions to provide “…equal opportunity to
benefit from all of their programs, services and activities”. This has been interpreted in a more beneficial way
for the obese population. Under this section of the ADA, public education, employment, health care, social
services, the courts, voting venues, town meetings, etc. must be accessible to those with disabilities. This has
led to the development of the ADA Standards for Accessible Design (2010) [28 CFR part 35], a code detailing
requirements for architectural standards, policies, practices and procedures, and methods of communication
for those with sight, hearing and speech disabilities. This has required the removal of barriers to this access in
existing buildings and facilities, and also the inclusion of appropriate access in new construction.
There are other regulations that have extended to the obese, via more broad interpretation. The Fair
Housing Act, Sec. 800. [42 USC §3601 note] requires owners to make reasonable exceptions in their policies
and operations in order to afford equal opportunities. The Air Carrier Access Act [49 USC §41705] prohibits
discrimination against the physically or mentally disabled, and this extends to foreign carriers as well. There
are also regulations that protect against discrimination in the areas of education and incarceration.
The law is still imperfect at protecting those with excess weight against common discrimination. The
Yale Rudd Center, an influential clearinghouse and advocate for those with disabilities, has made recommendations that would serve to improve protection against discrimination [Weight Bias, A Social Justice Issue A
Policy Brief, 2012, RR Friedman, ScM, RM Puhl, PhD]. On the Federal, State and Local government level, they
call for including weight as a protected class under civil and human rights statutes, creation of new weightbased employment discrimination legislation mirrored off of the ADEA [29 U.S.C. §621], and the alignment
of state disability laws with the ADA Amendments Act to cover weight-based impairments and perceived
impairments.
The Rudd Report also calls for State and Local School Boards to adopt and enforce policies prohibiting harassment, intimidation, bullying and cyber-bullying on school property or by school peers, and to
include weight as a specific protected category. Rudd further calls for teachers and staff to be trained on how
to recognize and intercept prohibited behavior in order to effectively enforce these policies.
In the health care arena, the Rudd Report recommends inclusion of language on weight bias in
patients’ rights policies. Rudd also calls for coverage of obesity as a diagnosis that is a reimbursable expense.
VII. Obesity in Medicine
Apart from causing obese persons to be more reluctant to seek medical care, obesity results in overall
poorer healthcare in other ways as well. For a multitude of reasons, obesity can contribute to delays in diagnosis. Complaints made by obese patients are often not given as much credence. It is often the case that
complaints are assumed to be related to their obesity, and are not given the investigation or treatment they
warrant. Because of the extra weight, examination of these patients is more difficult, and it is more difficult
to appreciate findings when they are present. Diagnostic equipment can often not accommodate very heavy
patients. Following procedures such as surgery, recognition of complications can be very difficult as well for
all of the same reasons.
In addition to the more tangible issues involved with care of the obese patient, there are the additional problems that can be present that include layers of psychological issues, the generally poorer likelihood
of follow-up, and often poorer compliance with medications and other treatment.
Impact of Obesity in Medical Outcomes and Lawsuits ■ Smith ■ 65
Severely obese patients have higher risks of infections and hernias, and limited functional pulmonary and cardiac reserves. Their mobility and conditioning are generally poor, and in addition tend toward
deficient overall nutrition as a result of poor quality food intake. These aspects of health all contribute to a less
effective ability to cope with stresses of illness, and thus a higher rate of hospitalizations and complications.
VIII. Treatment of Obesity
Treatment of obesity, especially severe obesity, is notoriously difficult. Treatment modalities include
diet, exercise, psychological and behavioral modification, medical treatment, and bariatric surgery. Any one
of these alone is insufficient and doomed to failure. Especially in the case of severe obesity, it is not enough
to ask the patient to eat less and exercise more. Even in structured settings with close follow-up this is minimally successful, and long-term the patients almost universally gain the weight back. There are no medications in existence that project to be successful for significant or long-term weight loss. The ones that have been
used have significant side effects, lead to highly variable and mostly poor results, and are at best a temporary
advantage. The best chance for a person of severe obesity to lose a large amount of weight and keep it off longterm is to undergo bariatric surgery in the context of a comprehensive program, with attention to psychological and behavioral triggers, dietary counseling and long-term monitoring and follow-up.
IX. Surgical Treatment of Severe Obesity
“Bariatric” surgery means surgery for the treatment of “morbid” or “severe” obesity. Surgery is
proper for certain patients once they are at a certain level of obesity, where it is impacting on their overall
health in a significant way, and where it can be shown that the non-surgical methods of weight loss have been
unsuccessful. This surgery is not meant for cosmetics, but rather is a well-established treatment that can substantially improve your health, and minimize some of the co-morbidities that go along with severe obesity,
such as hypertension, diabetes, sleep apnea, degenerative joint disease, etc.
The use of surgery for the treatment of morbid obesity has gained favor over the past 20 years, largely
due to the recognition of the comprehensive “program” approach. There are several different types of operations, and there are rigid criteria as to who qualifies for surgery. The “program” refers to all of our weapons in
attacking the problem: surgery, nutrition, exercise, psychologists, medical specialists, etc.
The Consensus Conference of the National Institute of Health (NIH) in 1992 defined the patient
selection criteria as being greater than 100 pounds over the ideal body weight for a given height, or with
a Body Mass Index (BMI) greater than 40. A patient could also qualify with a BMI between 35 and 40 if a
patient has one of the major co-morbidities directly related to severe obesity present, such as hypertension,
diabetes, sleep apnea, or disabling arthritis, etc.
Bariatric Surgery is not appropriate for every patient, and extensive screening and preparation are
done with each prospective patient. In addition, a very small fraction of obese people who could qualify for
surgery are actually interested in it – we only currently are operating on about 1 percent of the population
who could qualify. The simpler operations lose less weight, and have fewer complications, while the more
complex operations lose more weight and are more prone to complications. Overall the observed weight loss
varies from about 50 percent of the excess body weight with Lap Banding, to about 85 percent of the excess
body weight with the Duodenal Switch. The overall mortality is about 0.1 percent [Buchwald H, Avidor Y,
Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and metaanalysis. JAMA. 2004 Oct 13;292(14):1724-37].
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The four major operations done most commonly in the US for the treatment of morbid obesity are:
the Biliopancreatic Diversion with Duodenal Switch, and the Roux-en-Y Gastric Bypass, the Sleeve Gastrectomy, and Adjustable Gastric Banding. All four are most commonly done laparoscopically. Each has its
strengths and weaknesses, and there are situations when a surgeon might feel that one or the other is better
for a particular patient. Each operation also has side effects and possible complications that are particular to
that operation.
The Duodenal Switch is a mixed malabsorptive and restrictive operation. It combines a Sleeve Gastrectomy with a longer small bowel bypass in order to effect restrictive as well as malabsorptive weight loss. It
is associated with the best long-term weight loss, but carries a higher risk of nutritional abnormalities.
The Roux-en-Y Gastric Bypass is still considered the “Gold Standard” operation. The operation
makes a small pouch at the top of the stomach, and then routes the food through a “Roux” limb of small
bowel, bypassing the major part of the stomach and a relatively short portion of small intestine. The RNY is
the second most powerful operation for weight loss, but does involve some malabsorptive effects, though to a
lesser degree than the Duodenal Switch.
The Sleeve Gastrectomy is a relatively new option for bariatric surgery patients. It can either be done
as a standalone procedure or as part of a staged approach to a Duodenal Switch or a RNY Gastric Bypass. The
weight lost is somewhat less than the RNY, but it is associated with fewer post-operative complications and
fewer nutritional concerns.
Adjustable Gastric Banding utilizes a silastic device that is placed around the upper part of the stomach to restrict the size of the stomach. It has the advantage of being a less invasive operation than the other
surgical alternatives, but it is generally considered to have more long-term complications related to it being
a foreign body. The weight loss seen is highly unpredictable, but is generally less than the other three operations.
Most bariatric surgeons feel strongly that the best results from bariatric surgery are obtained when
the surgery is done in the context of a comprehensive bariatric surgery “program”. The program consists of:
Bariatric Surgeon, Program Nurse Coordinator, specialized Nursing Staff on Floor and in OR, Internists and
other medical specialists, Psychologists, Dietary and Nutrition Services, Support Groups, and also extends to
having the appropriate equipment in the office and hospital to accommodate severely obese patients.
The patient is extensively educated before and after surgery on how to achieve and maintain success.
Follow-up is crucial both for achieving success and for avoiding nutritional and other complications.
Bariatric programs follow their patients very closely during the first year, with visits every 3 months
or so. Follow-up is then for the rest of the patient’s life, on a yearly basis. Most programs obtain a broad spectrum of labs at three months, six months, and one year post-op, and then yearly for the rest of the patient’s
life, to assess nutritional status.
Support groups are a very important part of a bariatric program. Bariatric surgery programs may
also have Internet message board areas that help with support and education of both pre-ops and post-ops.
X. Medicolegal Aspects of Bariatric Surgery
Litigation is a constant concern in the performance of bariatric surgery, despite every precaution.
Problems can arise with patient selection and preparation, surgeon qualification, hospital qualification, the
inherent risks of the operations, and the aftercare of the operations. Bariatric surgery has been a popular target of plaintiff attorneys, and there is a subculture of expert witnesses who participate in the process.
Impact of Obesity in Medical Outcomes and Lawsuits ■ Smith ■ 67
As is well known in the legal profession, there are certain conditions that must be present for malpractice to be considered to have occurred. There must be a duty to treat on the part of the treating health care provider, an occurrence of harm, a breach in the standard of care, and the concept of “causality” must be present.
There are few studies of malpractice litigation published in the literature. The top two areas of litigation in bariatric surgery [Kaufman AS, McNelis J, Slevin M, La Marca C. Bariatric surgery claims - a medicolegal perspective. Obes Surg. 2006 Dec;16(12):1555-8] are:
a) Faulty patient screening and education
b) Delay in recognition and treatment of complications
Technical errors are a less common issue, but do occur. Inadequate MD training, hospital or office
staffing, inappropriate credentialing and deficiencies of informed consent account for many other instances of
litigation.
Unfortunately there are few standards that are etched in stone regarding the proper administration
of bariatric surgery, but there are some generally accepted standards of care. These are in a constant state of
evolution as new information is gained in the field. One of the best sources for these is the AACE/TOS/ASMBS
Guidelines [Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical guidelines for clinical practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient.
Surg Obes Relat Dis. 2008;4(supplement 1):1–83]. It is doubtful that there will ever be an accepted standardization of techniques in bariatric surgery.
Factors that increase risk for mortality include male gender, age > 50-55, an open procedure vs. laparoscopic, congestive heart failure, peripheral vascular disease, and chronic renal failure [Nguyen NT, Masoomi
H, Laugenour K, Sanaiha Y, Reavis KM, Mills SD, Stamos MJ. Predictive factors of mortality in bariatric surgery: data from the Nationwide Inpatient Sample. Surgery. 2011 Aug; 150(2):347-51]. In some studies, presence of diabetes and Medicare status are also identified as risk factors.
In one of the only studies evaluating actual malpractice claims published, the most common adverse
events leading to litigation in bariatric surgery were leaks (53 percent), abscess (33 percent), and bowel
obstruction (18 percent) [Cottam D, Lord J, Dallal RM, Wolfe B, Higa K, McCauley K, Schauer P. Medicolegal
analysis of 100 malpractice claims against bariatric surgeons. Surg Obes Relat Dis. 2007 Jan-Feb;3(1):60-6; discussion 66-7]. The most common outcomes associated with litigation were death (53 percent), near full recovery (28 percent), minor disability (12 percent) followed by major disability (7 percent).
A published commentary from the legal field [Eagan MC. Bariatric surgery: malpractice risks and
risk management guidelines. Am Surg. 2005 May; 71(5):369-75] reviewed experience with bariatric malpractice claims versus non-bariatric claims, and found a higher severity of injury with bariatric claims with more
death claims (40 percent vs. 23 percent of all claims). Also noted was a higher average indemnity ($183K
compared to $173K for all claims) and more indemnity payments (43 percent compared to 31 percent for all
claims).
Obesity, especially severe obesity, increases risk of malpractice litigation in all types of medicine.
As an example, Cohen details incidence of medical negligence lawsuits relating to labor and delivery [Cohen
WR. Medical negligence lawsuits relating to labor and delivery. Clin Perinatol 2007 June; 34(2): 345-60, vii-viii].
Shoulder dystocia is a recognized occurrence during delivery, and obesity is clearly a risk factor for shoulder
dystocia. Factors cited in litigation included use of inappropriate maneuvers to remove the impacted shoulder,
failure to use appropriate maneuvers, and failure to have appropriately trained and experienced personnel at
the time of delivery.
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XI. Avoidance of Malpractice Claims
Attempts to avoid litigation are always present in the mind of an appropriately cautious health practitioner. Obviously it is important to have things go well, but it’s also very important to have taken the proper
steps along the way, so that if things don’t go well, there are fewer areas to target for the plaintiffs.
Careful preoperative screening, evaluation and medical clearance of patients is an extremely important starting concept. The NIH criteria must be met, but this is not as universally followed as one might think.
Some surgeons will operate outside the criteria if the patient is a self-pay and strongly desires surgery. In this
situation the surgeon obviously has little defense if things don’t go well. Screening of patients must include
comprehensive medical evaluation as well as psychological evaluation. Patients are evaluated for possible substance abuse, compliance issues, and their level of social support. Although it is difficult to justify ethically,
consideration should in some cases be given to a patient’s financial resources, since the follow-up care, lab
studies, vitamins and supplements that are necessary for success can be expensive for those without insurance
coverage.
A history of prior litigation would not render a patient a non-candidate, but it is a good thing to
know when entering into a doctor-patient relationship. This is usually elicited and reported via the psychological evaluation.
Proper preparation of patients and significant others for surgery also includes extensive education
about the risks and benefits of surgery, and about how to keep themselves healthy and out of trouble after surgery. In our program, we use live classes, reading materials, videos, support groups, and quizzes, with a great
deal of redundancy in the process. Education continues while in the hospital and post-operatively as patients
move through the various stages of recovery and dietary progression, and on into the long-term follow-up.
Another very important component of the preparation for surgery is the informed consent process
[Wee, C. C., Pratt, J. S., Fanelli, R., Samour, P. Q., Trainor, L. S. and Paasche-Orlow, M. K. (2009), Best Practice
Updates for Informed Consent and Patient Education in Weight Loss Surgery. Obesity, 17: 885–888]. The preoperative education process is all part of the informed consent process as well. Risks are discussed in the live sessions, in the videos, and in the discussion with the surgeon at the pre-operative visit. The consent form itself
is very long and detailed, and includes many places for the patient to initial or sign. The family and/or significant other are included in this process. The patient signs a contract that covers post-operative behaviors and
acknowledges their responsibility in maintaining their health. The patient also signs a video completion certification to acknowledge that they have watched the videos and have understood the material. The patient’s
significant other also signs a letter of support. The patient must have a Primary Care Physician (PCP), and that
PCP must agree to continue caring for that patient after they’ve had bariatric surgery. A letter of support is
obtained from the patient’s PCP. This sometimes (though less often the last several years) requires the patient
to change PCP’s.
The informed consent process should be an integral part of the overall operation, and should be utilized not only to educate the patient and family, but also to improve communication between the physician
and the patient and family Steven [Raper E, Sarwer DB. Informed consent issues in the conduct of bariatric surgery Review Article. Surg Obes Relat Dis., 2008 Jan-Feb; 4(1):60-68]. Done properly, it should help to improve
the doctor-patient relationship, improve outcomes, and improve patient safety.
Another important factor that deserves emphasis is to impart realistic expectation onto the patient
and family [Wee CC, Jones DB, Davis RB, Bourland AC, Hamel MB. Understanding patients’ value of weight
loss and expectations for bariatric surgery. Obes Surg. 2006 Apr; 16(4):496-500]. This really begins with the
program’s marketing materials and web presence, and extends throughout the evaluation and education proImpact of Obesity in Medical Outcomes and Lawsuits ■ Smith ■ 69
cess, and should be practiced by all those who come in contact with the patient on behalf of the program.
The patient should be made to have realistic expectations not only of the risks of surgery, but also of expected
weight loss, pain levels, nausea levels, what vitamins and supplements will be necessary and how much they’ll
cost, etc. Categorical predictions and goals should be avoided.
XII. Patient Contracts
One of the more common modalities in modern bariatric surgery is the concept of patient contracts.
These are documents that detail many of the behaviors that are expected of the patient after surgery, including following up appropriately, taking the proper vitamins and supplements, avoiding negative behaviors like
smoking and ingestion of caustic substances, etc. These are non-binding, but serve to emphasize the importance of these factors in the patient’s long-term well-being, and can be used to show in another way that the
patient understood these things heading into surgery. The patient can be shown to have been a true and willing partner in the decision-making process. The patient’s family or significant other is also included in this
process.
XIII. Minimizing Risk in the Performance of Bariatric Surgery
Risk management in the performance of bariatric surgery requires meticulous technique and the
observance of specialized safety measures. Well-trained and attentive surgeons as well as covering surgeons
are necessary. Timely and thorough documentation is always of paramount importance. A properly trained
and experienced team of health care providers helps eliminate errors and avoid stress and friction for the
patient as they go through the process. When problems do arise, prompt attention, evaluation and attention are critical to avoiding delays in diagnosis. Once the operative phase is over, it remains very important to
maintain close follow-up, good and prompt communication, and frequent patient re-education.
Bariatric operations seem to be best accomplished in centers that demonstrate a commitment to safe
and appropriate bariatric patient care [Nguyen NT, Nguyen B, Nguyen VQ, Ziogas A, Hohmann S, Stamos
MJ. Outcomes of bariatric surgery performed at accredited vs nonaccredited centers. J Am Coll Surg. 2012 Oct;
215(4):467-74]. Standards followed should include specialty trained personnel, proper equipment for the care
and evaluation bariatric patients, standardized clinical pathways, etc.
Surgery volumes performed at bariatric centers have been proposed as a measure of competence.
Volume does appear to improve outcomes as long as the volume attains a certain minimum level, but beyond
that doesn’t seem to continue to improve outcomes as volume rises [Gould JC, Kent KC, Wan Y, Rajamanickam V, Leverson G, Campos GM. Perioperative safety and volume: outcomes relationships in bariatric surgery: a study of 32,000 patients. J Am Coll Surg. 2011 Dec;213(6):771-7]. It is felt that too much volume might
impair the doctor/patient relationship, thereby increasing the likelihood of subsequent litigation, especially
if the operating surgeon is buffered from spending time with the patient. Interestingly, as the ASMBS moves
toward a joint certification process for Bariatric Surgery Centers of Excellence, volumes are no longer a hard
criterion for qualification.
In addition to meticulous technique, there are many factors in the OR that can make a difference in
outcomes, and these must be included in any program’s performance of bariatric surgery. A consistent team is
extremely important. IV access can be difficult in severely obese patients, and some provision should be made
to obtain safe and reliable access, whether it is by multiple large-bore IV sites, or a percutaneously placed
catheter in the arm or central vein.
70 ■ Medical Liability and Health Care Law ■ March 2013
As with any complications during or after surgery, timely recognition and correction is critical, and
it is best to do the proper intervention as completely and thoroughly as possible the first time, as often there is
but one chance to make things right. Conversion to an open operation should not be inappropriately delayed,
and help should be summoned if it proves necessary.
XIV. Complications After Surgery
Complications following bariatric surgery are unavoidable. Bleeds, marginal ulcers, internal hernias,
etc. will occur. Keys to more successful outcomes are having a high index of suspicion for complications, taking prompt steps toward evaluation and intervention, and maintaining good communication with the patient
and significant other(s) throughout the process. Delays in diagnosis can be catastrophic.
XV. Expert Witnesses
Having a knowledgeable and competent expert can make a critical difference in the defense of
malpractice claims. Ideally, there should be a great deal of input from the expert, and on an ongoing basis
throughout the process. The expert should be an active part of the defense team, and should take part in the
determination of standards and breaches, review of testimony, assistance with other experts and resources for
the defense, and in court testimony.
The ASMBS has produced guidelines for expert witnesses, and there are some key elements of these
guidelines that merit emphasis [R. M. Dallal, M.D.*, D. Cottam, N. Bertha, F. Bonanni, E S. Bour, R. E. Brolin,
K. Keith, A. Petrick, W. A. Sweet, R. P. Blackstone. Qualifications of expert witnesses in bariatric surgery medicolegal matters. 2011 Dec; ASMBS Patient Safety Committee, from http://asmbs.org/2012/06/qualifications-ofexpert-witnesses-in-bariatric-surgery-medicolegal-matters/]. Both sides should have at least one expert who
has expertise in bariatric surgery. The expert involved should have “significant direct experience” with the
operation about which he or she acts as an expert. The expert should show a dedication to the practice of bariatric surgery, with direct patient care experience. The expert should have > 24 hours of AMA PRA Category 1
CME every 3 years. All of these criteria should be met at the time of the alleged negligence.
In the performance of his or her duties, the expert should exercise confidentiality, maintain integrity
and avoid conflict of interest, and testimony should be prepared with accuracy and impartiality. The ASMBS
Code of Ethics [http://asmbs.org/2012/06/asmbs-code-of-ethics/] asserts that expert witnesses should serve
as experts for plaintiffs and defendants. Views that are alternative to or differing from prevailing views should
be referenced in testimony. Compensation should not be based on the content of the testimony or on the outcome of the case. Finally, testimony should be presented as that of the expert, and not that of the ASMBS.
XVI. Summary
Obesity is a problem of epidemic proportions in our society, affecting every aspect of the lives of
those afflicted. The costs associated with obesity are staggering, and are increasing exponentially. Costs relate
not only to health care, but to the accommodation for obese persons in society, and to the liability expenses
that come with obesity. As the etiology of obesity is multi-factorial, so will be any solution, and will require
fundamental changes in our society.
Impact of Obesity in Medical Outcomes and Lawsuits ■ Smith ■ 71