United States Federal Court Decision May Impact the Bariatric Community

| June 1, 2015

Eligibility Standard of Care, Preoperative Diets among Debate

by Angela M. Saba, Managing Editor, Bariatric Times.

Bariatric Times. 2015;12(6):8.


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One critical United States court case[1] that called into question eligibility standard of care and preoperative diet programs for weight loss surgery patients could have major implications for the bariatric surgery community.

After a 13-day bench trial, the United States Federal Court ruled in favor of a patient who claimed “personal injury” in connection with a Roux-en-Y gastric bypass surgery (RYGB) that she underwent at a United States hospital in September 2010. The hospital was ordered to pay the patient a 4.25-million-dollar reward.
Details of the patient’s weight loss surgery were reviewed in court.

One major inquiry during the case was body mass index (BMI) criterion for surgery. After reviewing the National Institutes of Health (NIH) Consensus Statement on Gastrointestinal Surgery for Severe Obesity,[2] the Court concluded that the standard of care was that a patient must have a BMI of 40kg/m2 or more with no comorbidities, or 35kg/m2 or more with comorbidities, in order to be eligible and an appropriate candidate for bariatric surgery. The Court also found that, in addition to the BMI criterion, the standard of care for bariatric surgery required that a patient have “failed in a formal weight loss program” of some kind prior to being enrolled in a Bariatric Surgery Program.

According to court documents, the patient’s height was 5 feet, 1.5 inches and her BMI was above 41kg/m2 when she was referred for bariatric surgery and attended an information session at the hospital. She did not have obesity-related comorbidities. In between her initial consultation and preoperative meeting to schedule surgery, she completed the facility’s comprehensive weight loss program, a mandatory step before surgery in which patients are required to lose at least five percent of their body weight at completion. Additionally, the patient was prescribed orlistat and it appeared she took it for some time in June and July 2010. The patient lost 34 pounds during this time, thus decreasing her BMI to around 36kg/m2. Her BMI was also 36kg/m2 on the day of her RYGB procedure.

The Court found that, as a part of the informed consent process, none of the patient’s providers discussed with her the fact that her BMI had fallen below 40kg/m2 with no comorbidities, and that this indicated that the “risks of the surgery outweighed the potential benefits.”

This case is important to the bariatric community because it could potentially call into question and perhaps even change the standard of care in determining patients’ eligibility for weight loss surgery. It indicates that the BMI measurement for eligibity should be evaluated not only at the time of enrollment, but also during the preoperative meeting or later. This could mean that bariatric surgeons and bariatric surgery programs that do not interpret BMI 40kg/m2 without comorbidities as a strict cut off to deny surgery up to the day of a patient’s surgery may be in danger of breaching what could become standard of care for bariatric surgery. It could also generate a wave of medical negligence claims from patients whose bariatric surgeries resulted in complications.

In the present case, the patient’s postoperative course included multiple complications that spanned over one year. However, the plaintiff expert did not claim any negligence during or after the operation. The case all hinged on informed consent and eligibility interpretation. When the BMI dropped below 40kg/m2, the plaintiff expert opined that the weight loss surgery operation should not have been offered.
This case also has the bariatric community talking about what constitutes a “failed attempt” at weight loss efforts before presenting for a surgery consultation and while undergoing preoperative weight loss programs once on the track to surgery. Many programs use preoperative dieting as a strategy to make bariatric surgery safer by reducing the liver volume in a patient that is already believed to be a surgical candidate. If diets are not previously documented, many bariatric programs start medically supervised diet as part of the bariatric program.

This case brings up debate over “informed consent,” as the Court found that the patient was not provided with sufficient, accurate information about the gastric bypass surgery’s risks and benefits in her situation, despite listing all the common complications on the consent form.

Although the decision has been made, The United States Attorney’s Office is reviewing the ruling to see if there are any grounds for appeal. As of the date of this article’s publication, no appeal has been initiated.

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References
1.    Mettias v. United States. Civ. No. 12-00527 ACK-KSC (D. Haw. Jan 15, 2015).
2.    Gastrointestinal Surgery for Severe Obesity. NIH Consensus Statement Online 1991 Mar 25-27;9(1):1-20. http://consensus.nih.gov/1991/1991gisurgeryobesity084html.htm. Accessed May 15, 2015

Additional resource
•    ASMBS: Bariatric Surgery Guidelines and Recommendations. Published June 2012. https://asmbs.org/resources/bariatric-surgery-guidelines-and-recommendations

Category: Brief Report, Past Articles

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