Comments On: United States Federal Court Decision May Impact the Bariatric Community

| August 1, 2015

Comments On:United States Federal Court Decision May Impact the Bariatric Community
Eligibility Standard of Care, Preoperative Diets Among Debate

Access referenced article here: http://bariatrictimes.com/united-states-federal-court-decision-may-impact-the-bariatric-community/

by DANIEL B. JONES, MD, MS, FACS

Dr. Jones is Professor of Surgery, Harvard Medical School, Vice Chair, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Disclosures: Dr. Jones was retained as a medical expert by the US Department of Justice.

Bariatric Times. 2015;12(8):9.

This case[1,2] is an issue of informed consent. There is no allegation that an operation was performed incorrectly or there was a mistake in the postoperative care. The plaintiff instead argued successfully to the court that the operation should have never been offered. Since the operation was offered and performed, any complications are secondary to malpractice.

The plaintiff’s expert witness claimed that the National Institutes of Health (NIH) criteria for surgery[3] are based on the risk-benefit of an operation for a patient at a given weight. When the body mass index (BMI) was above 40kg/m2, the patient qualified for surgery, but as soon as BMI dropped below 40kg/m2 (with no comorbid conditions), an operation should no longer be offered. The surgeon should tell the patient that the risks now exceed the benefits. The judge thought that the surgeon should be able to track weights up to the day of surgery or at least two weeks before hand and cancel the operation.

The plaintiff’s expert also claimed that the patient must have multiple medically supervised failed weight loss attempts prior to joining a bariatric surgery program. Prior to presenting to the bariatric program, this patient had struggled with weight gain, but only after joining the bariatric program did she have a five-month supervised program with a dietitian, personal trainer, and psychologist working with her on a weekly basis. In preparation for surgery, the expert argued she was successful at losing 34 pounds despite still having a BMI greater than 36kg/m2. Further, the court thought that as part of informed consent it should not be mentioned that weight regain after dieting is very likely.

As the expert for the defense, I took strong opposition to the plaintiff expert’s opinions. The standard practice for bariatric programs is to record the initial BMI when a patient joins a Bariatric Program. If the BMI is greater than 40, this would meet the eligibility guidelines in a patient without other comorbid illnesses. While patients need to document previous weight loss attempts before joining a Bariatric Program, if they have not, the patient can surely enroll in a supervised diet while undergoing their multidisciplinary assessment for weight loss surgery. The guideline is that a patient should have a serious weight loss attempt. It really should not matter whether this occurs before or after enrolling in a bariatric surgery program. The patient who is eating healthier, exercising, and loses 34 pounds in preparation for an operation should not be denied a gastric bypass operation with a BMI of 36. The patient is correct to consider the risk of weight regain in her decision to continue dieting or proceeding with surgery. I explained to the Court that canceling operations the day of surgery or even two weeks before an operation would create chaos in the hospitals. Moreover, patients would be reluctant to lose weight preoperatively for fear of being denied an operation.

So, as it stands today, it’s up to the bariatric surgical community to clarify what is the standard of care. We want our patients with BMI of 40 and 41kg/m2 to exercise, eat healthier, and drop a few pounds to make their operation safer. We want them to get their head in the process prior to an operation. However, this new ruling sends the message that patients should be careful not to lose weight prior to their operation or they will be canceled. Legally, the operative team needs to be ready to cancel the operation on the day of surgery if the patient drops below 40kg/m2 if no other weight-related cormorbid conditions. What craziness and chaos!
Furthermore, “failed medical supervised diets” is poorly defined. What defines success and failure? What types of diets count? Does it really matter if the diet is before or after joining a bariatric program? While the newer American Society for Metabolic and Bariatric Surgery (ASMBS) guidelines4 say that the patient should have had serious weight loss attempts prior to joining a bariatric surgery program, many of the bariatric programs refer to the NIH guidelines in their information session and web sites. In this patient’s case, a five-month supervised diet program occurred after joining the bariatric program and it seems to have met the requirement of getting the patient to rethink her relationship with food and understand what she can or cannot achieve without weight loss surgery.

The operations we do today (laparoscopic adjustable gastric banding [LAGB], laparoscopic Roux-en-Y gastric bypass [RYGB], and laparoscopic sleeve gastrectomy [LSG]) are different than when the NIH established its consensus conference. We now have fellowship training and work within accredited centers. Operations are safer. We know more about the role of dieting in patients with morbid obesity.

This case should challenge us to clarify our guidelines to be clear about the timing of the initial BMI, eligibility if BMI drops below initial BMI guideline, role and timing of diets, and whether patients should be told about weight regain as part of informed consent. As evident from this case, we can leave no ambiguity to the court as to the science and standard of care in 2015. Left to the judge, the court can get it very wrong.

References
1.    Mettias v. United States. Civ. No. 12-00527 ACK-KSC (D. Haw. Jan 15, 2015).
2.    Saba AM. United States Federal Court Decision May Impact the Bariatric Community: Eligibility Standard of Care, Preoperative Diets among Debate. Bariatric Times. 2015;12(6):8–9.
3.    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
4.    ASMBS: Bariatric Surgery Guidelines and Recommendations. Published June 2012. https://asmbs.org/resources/bariatric-surgery-guidelines-and-recommendations

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