Citation Nr: 23014282 Decision Date: 03/09/23 Archive Date: 03/09/23 DOCKET NO. 18-54 346 DATE: March 9, 2023 ORDER Entitlement to compensation benefits pursuant to the provisions of 38 U.S.C. § 1151 for pancreatitis, claimed as due to treatment provided by the Department of Veterans Affairs is granted. REMANDED Entitlement to compensation benefits pursuant to the provisions of 38 U.S.C. § 1151 for a gall bladder condition, claimed as due to treatment provided by the Department of Veterans Affairs is remanded. FINDING OF FACT The evidence is in equipoise as to whether the Veteran's pancreatitis was not a reasonably foreseeable consequence following an endoscopic retrograde cholangiopancreatography (ERCP) and sphincterectomy. CONCLUSION OF LAW The criteria for establishing entitlement to compensation under 38 U.S.C. § 1151 for pancreatitis, as due to treatment provided by the Department of Veterans Affairs have been met. 38 U.S.C. §§ 1151, 5107; 38 C.F.R. §§ 3.102, 3.159, 3.361. REASONS AND BASES FOR FINDINGS AND CONCLUSIONS The Veteran served on active duty from June 29 to August 10, 1978. This matter comes before the Board of Veterans' Appeals (Board) on appeal from an April 2017 rating decision of the Department of Veterans Affairs (VA) Regional Office (RO). In March 2021, the Veteran testified at a Board hearing before the undersigned Veterans Law Judge. A transcript of the hearing has been associated with the claims file. In March 2022, the Board remanded the issues on appeal for further development, and the case has since been returned to the Board. The Board finds that the agency of original jurisdiction (AOJ) has not substantially complied with prior remand directives with respect to the issue on appeal of entitlement to compensation benefits pursuant to the provisions of 38 U.S.C. § 1151 for a gall bladder condition, claimed as due to treatment provided by the Department of Veterans Affairs. See Stegall v. West, 11 Vet. App. 268, 271 (1998) 1151 Eligibility Under 38 U.S.C. § 1151, compensation is awarded for a "qualifying additional disability" in the same manner as if such additional disability or death were service connected. The purpose of the statute is to award benefits to those veterans who were disabled as a result of VA treatment or vocational rehabilitation. 38 U.S.C. § 1151 (a). To be considered a "qualifying additional disability," a disability must meet two criteria. First, it must not be the result of the Veteran's willful misconduct. Second, the disability must have been either: (a) caused by hospital care, medical or surgical treatment, or examination furnished to the Veteran under any law administered by the Secretary, either by a Department employee or in a Department facility, and the proximate cause of the disability was either (i) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the Department in furnishing the hospital care, medical or surgical treatment, or examination; or (ii) an event not reasonably foreseeable; or (b) proximately caused by the provision of training and rehabilitation services by the Secretary as part of an approved rehabilitation program. Id. To determine whether the Veteran has an additional disability, VA compares the condition immediately before the beginning of the medical or surgical treatment upon which the claim is based to the condition AND after such treatment has stopped. 38 C.F.R. § 3.361 (b). The United States Court of Appeals for the Federal Circuit (Federal Circuit) also recognized that a claimant may succeed under a referral theory pursuant to 38 U.S.C. § 1151 if VA doctors were the proximate cause of the performance of a certain medical procedure. Ollis v. Shulkin, 857 F.3d 1338 (Fed. Cir. 2017). In Ollis, the Federal Circuit addressed the application of § 1151 to referral situations when the disability-causing event occurs during a medical procedure not performed by a VA doctor or in a VA facility. The Federal Circuit determined that even where benefits could not be granted under 38 U.S.C. § 1151 (a)(1)(A) on a negligence theory, because the medical services rendered were performed by a non-VA provider at a non-VA facility, benefits could be granted under a referral theory pursuant to § 1151(a)(1)(B) as an event not reasonably foreseeable. The Federal Circuit held that when recovery is predicated on a referral theory involving an unforeseeable event under § 1151(a)(1)(B), § 1151(a)(1) requires that the VA medical care proximately cause the medical treatment or care during which the unforeseeable event occurred. The Federal Circuit further held that § 1151(a)(1)(B) requires that the unforeseeable event proximately cause the additional disability. "As such, the chain of causation has two components (neither of which requires fault)-i.e., proximate cause between VA medical care and the treatment, and proximate cause between the unforeseeable event and the disability." Ollis, 857 F.3d at 1346. Entitlement to compensation benefits pursuant to the provisions of 38 U.S.C. § 1151 for pancreatitis, claimed as due to treatment provided by the Department of Veterans Affairs The Veteran seeks compensation benefits under 38 U.S.C. § 1151 for pancreatitis that he contends occurred as the result of negligence following an endoscopic retrograde cholangiopancreatography (ERCP) and sphincterectomy by a VA-employed physician at a non-VA facility, New York Upstate Medical Center (UMC), in November 2014. Specifically, the Veteran contends that the VA-employed physician scheduled him for an ERCP at a VA medical center, but then rescheduled it at UMC because the VA medical center did not have the correct equipment to perform the procedure. The Veteran contends that the VA-employed physician negligently chose to perform a sphincterectomy before getting the necessary pressure readings or other required diagnostic testing. The Veteran also contends that he was initially informed he would require 48 hours of care in the hospital after his surgery but was then negligently discharged the same day. The Veteran experienced severe abdominal distress and required emergency department care following his discharge from UMC, which has manifested as pancreatitis. To that end, in a December 2021 Board remand, the AOJ was directed, in pertinent part, to provide the Veteran with an opinion addressing whether the pancreatitis condition that occurred subsequent to the ERCP procedure and sphincterectomy was a known risk of the procedure or was it an accident that was not reasonably foreseeable. In a March 2022 VA opinion, the examiner opined that it is less likely than not that the Veteran has an additional disability after the November 2014 ERCP procedure and sphincterotomy that he did not have prior to such treatment. The rationale provided was: ... Based on the above and available document, the veteran had recurrent abdominal pain/ acute pancreatitis/ pancreatic cyst after the ERCP. The abdominal CT with contrast in 2017 showed unremarkable CT of the abdomen and pelvis. No other direct diagnosis of chronic pancreatitis. Computed tomography (CT) or MRI for the first-line diagnosis of CP. Either test should be the first choice for the diagnosis of CP. Endoscopic ultrasonography (EUS), because of its invasiveness and lack of specificity, should be used only if the diagnosis is in question after cross-sectional imaging is performed. The veteran's had recurrent abdominal pain/ acute pancreatitis/ pancreatic cyst, which are acute episodes without residuals as showed on the normal CT in 2017. The etiology of later recurrent acute pancreatitis was unknown. Further, the examiner opined that it was less likely that the veteran had the result of negligence following an ERCP and sphincterectomy or the pancreatis condition that Veteran sustained following the November 2014 ERCP and sphincterectomy was an event not reasonably foreseeable with a rationale stating: The veteran had suspected SOD and recurrent abdominal pain as the indication for the manometry, which could not be performed, and ERCP and sphincterectomy was done. The ERCP and sphincterectomy was indicated with negative workup and SOD. In April 2022, the Veteran's representative provided a private opinion from Dr. M.R. who opined, after a review of the Veteran's claims file, that: Based on my training, experience, and professional qualifications and under penalty of perjury, it is more likely than not that the proximate (immediate or direct) cause of the disabilities (including chronic pancreatitis, chronic abdominal pain, and complications of chronic pancreatitis) from [the Veteran] ERCP was a not reasonably foreseeable complication (under 38 U.S.C. 1151) of the ERCP diagnosis and treatment of his chronic abdominal pain. This treatment led to chronic pancreatitis, chronic abdominal pain, weight loss, and chronic diarrhea and led to [the Veteran] being disabled due to these symptoms and conditions related to chronic pancreatitis. [the Veteran]'s chronic pancreatitis resulted in his having to endure multiple ED visits, complications, moderate to severe pain, and diarrhea The VA medical opinion provided by Dr. Yi Jia asserted that [the Veteran]'s 2014 ERCP less likely than not resulted in a chronic disability from chronic pancreatitis. Dr Jia acknowledges that the Veteran had an initial acute episode of abdominal pain due to acute pancreatitis and soon afterwards developed a pancreatic pseudo cyst (Dr. Jia doesn't mention the second episode of acute pancreatitis in January of 2015). Dr Jia argues that this acute episode was without residuals because [the Veteran] had a normal CT in 2017. Dr. Jia goes onto state that the etiology of later recurrent acute and chronic pancreatitis was unknown. Dr. Jia's opinion is NOT supported by the peer-reviewed medical literature. In fact, per Uptodate.com, a subscription peer reviewed medical literature website, acute pancreatitis and chronic pancreatitis area spectrum of the same disease and acute pancreatitis is one of the strongest risk factors for development of chronic pancreatitis, as occurred with [the Veteran]... Furthermore, the fact that the CT scans showed that the pseudocyst had resolved, does NOT mean that the pancreatitis had resolved. In fact, [the Veteran] is prescribed Creon 36,000 units 3 times a day with meals (pancreatic enzymes that replace the needed digestive enzymes that have ceased being produced by the body due to damage to the pancreas from recurrent pancreatitis, Promethazine HCL 25 mg as needed for nausea (nausea is a common symptom of chronic pancreatitis), and Hydrocodone 5-325 (narcotic pain medication) one or two pills as needed for abdominal pain from pancreatitis attacks. These medicines are all necessary and prescribed to treat an ongoing disability and provide irrefutable evidence of [the Veteran]'s chronic disability related to his post ERCP pancreatitis. Additionally, the CT scan the VA did on 12/6/2018 shows lesions on the pancreas, which were not visible in prior CT scans, destruction of the pancreas between the 2017 CT scan and the 2018 CT scan. Dr. Jia's opinion that there are no current residuals of the ERCP is directly and repeatedly contradicted by the medical record and the peer-reviewed medical literature. Given the relatively rare nature of this complication of chronic relapsing pancreatitis especially in the setting of [the Veteran]'s relatively low risk for ERCP and there search documenting the relationship between pre-existing risk factors including anatomic problems that make the procedure more technically difficult and an increased risk of complications following ERCP, it is reasonable to expect that [the Veteran] was not informed of this risk. There is no written documentation of discussion of the risk of post-ERCP acute pancreatitis in the medical records I reviewed. Because at the time of the procedure, [the Veteran] did not have any known risk factors which would have made him at high risk of developing pancreatitis, a reasonable physician would likely not disclose chronic pancreatitis as part of the informed consent for an ERCP. In other words, given [the Veteran]'s low risk medical history, a reasonable health care provider primarily responsible for performing an ERCP, would not have foreseen the risk of developing chronic pancreatitis or determined this risk to be subject to disclosure in [the Veteran]'s case. It bears repeating that the risk of a severe outcome such as occurred with [the Veteran], who had post-ERCP acute pancreatitis requiring a 2-week hospitalization followed by pseudocyst formation and chronic pancreatitis, is extremely rare. As a result of this not reasonably foreseeable outcome of the ERCP with sphincterotomy procedure (under 38 U.S.C.1151) namely post-ERCP acute pancreatitis, it is my professional opinion and that of any reasonable healthcare professional, that [the Veteran] suffered multiple disabilities under the care of the VA Medical Center in NY. This rare complication caused significant disabilities from the time of his diagnosis in November of 2014 that continue to the present time. He has frequently been disabled due to his post-ERCP chronic pancreatitis that has resulted in chronic recurrent abdominal pain and has had necessitated multiple ED visits. [the Veteran] has endured multiple surgeries and medical procedures, suffered significant pain, weight loss, diarrhea, and disability due to ERCP induced chronic pancreatitis. Per VA Diagnostic code 7347, he should be rated at 60%. In a July 2022 VA addendum opinion, the examiner stated: Literature states that; The most frequent complications of endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic biliary sphincterotomy are pancreatitis, cholangitis, hemorrhage, and duodenal perforation. (https://www.uptodate.com/contents/uncommon-complications-of-endoscopic-retrograde-cholangiopancreatography-ercp#)Although asymptomatic elevation of serum amylase is a common occurrence after ERCP, the incidence of clinically significant PEP (pOST ENDOSCOPIC PANCREATITIS) ranges from 1-15.7%.12,33,55-58 PEP is defined as new-onset or worsening abdominal pain with the elevation of serum amylase of 3 or more times the upper limit of normal at 24 hours postprocedure and the need for more than 2 days of pancreatitis-related hospitalization.55 Several studies and reviews have identified several risk factors. High PEP rates have been reported after interventional ERCP, especially those involving extensive biliary or pancreatic manipulation, after which PEP rates can approach 30%.5-.The mechanisms that cause pancreatitis are poorly understood, but numerous theories have been proposed. The common endpoint is the activation of inflammatory pathways. Mechanical obstruction of the papilla or pancreatic sphincter by instrumentation, hydrostatic injury from the injection of contrast, water, and chemical or allergic injury from contrast injection are possible mechanisms that may occur during ERCP. Injury, edema, or perforation of the pancreatic sphincter, bile duct, or ampulla by instrumentation or from thermal injury produced by electrocautery, may also obstruct the flow of pancreatic secretions. These same mechanisms may produce intraluminal activation of proteolytic enzymes and resultant injury. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4324870/#:~:text=Post-ERCP%20pancreatitis%2). CT abdomen with contrast 28 Nov 2014 provider reported pancreatitis status post ERCP 11/19/14. Based on the literature it is commonly known that ERCP may result to acute onset of pancreatitis. Because of the complexity of the anatomy of the operative site trauma to the sphincter of the pancreas during manipulation may happen resulting in acute pancreatitis. Therefore, it is at least as likely as not that what the Veteran sustained following the November 2014 ERCP and sphincterectomy, was an event not reasonably foreseeable (i.e., the type of risk that a reasonable health care provider would not have disclosed in informed consent procedures. Consequently, the Board now concludes that the evidence of record is in relative equipoise for the Veteran's 38 U.S.C. § 1151 entitlement claim for pancreatitis. The Board notes that entitlement may be granted for any injury diagnosed after discharge when the weight of the pervasive evidence establishes that the injury was incurred during VA treatment. 38 C.F.R. § 3.303 (d). VA is responsible for determining whether the weight of the persuasive evidence supports the claim or is in relative equipoise (with the Veteran prevailing in either event) or whether a weight of the persuasuve evidence is against the claim (in which case the claim is denied). At this time, the Board concludes that VA and private examination reports are in relative equipoise; consequently, the Veteran's claim for entitlement to compensation, under 38 U.S.C. § 1151 for pancreatitis, must be granted. REASONS FOR REMAND Entitlement to compensation benefits pursuant to the provisions of 38 U.S.C. § 1151 for a gall bladder condition, claimed as due to treatment provided by the Department of Veterans Affairs is remanded. The Veteran seeks compensation benefits under 38 U.S.C. § 1151 for a gall bladder condition that he contends occurred as the result of negligence following an endoscopic retrograde cholangiopancreatography (ERCP) and sphincterectomy by a VA-employed physician at a non-VA facility, New York Upstate Medical Center (UMC), in November 2014. Specifically, the Veteran contends that the VA-employed physician scheduled him for an ERCP at a VA medical center, but then rescheduled it at UMC because the VA medical center did not have the correct equipment to perform the procedure. The Veteran contends that the VA-employed physician negligently chose to perform a sphincterectomy before getting the necessary pressure readings or other required diagnostic testing. The Veteran also contends that he was initially informed he would require 48 hours of care in the hospital after his surgery but was then negligently discharged the same day. The Veteran experienced severe abdominal distress and required emergency department care following his discharge from UMC, which has manifested as pancreatitis. To that end, in a December 2021 Board remand, the AOJ was directed, in pertinent part, to provide the Veteran with an opinion addressing whether the Veteran suffered from a gall bladder condition, and whether that condition occurred subsequent to the ERCP procedure and sphincterectomy was a known risk of the procedure or was it an accident that was not reasonably foreseeable In February 2021, the issue on appeal was remanded by the Board for additional development. In pertinent part, the AOJ was directed to obtain a medical opinion addressing whether the gall bladder condition that occurred subsequent to the ERCP procedure and sphincterectomy was a known risk of the procedure or was it an accident that was not reasonably foreseeable. In response, a VA examiner in March and July 2022 collectively opined that there was no additional gall bladder disability, following the Veteran's ERCP procedure, as it was resolved by surgery. However, the Board finds these opinions insufficient because the examiner failed to address whether the gall bladder removal surgery itself was a known risk of the ERCP procedure and sphincterectomy or was it an accident that was not reasonably foreseeable. The matter is REMANDED for the following action: The RO must refer the claims folder to an appropriate VA examiner to answer the following questions (whether another physical examination of the Veteran is required is left to the discretion of the examiner): a) Was the Veteran's gall bladder removal at least as likely as not that such additional disability was the result of the ERCP procedure and/or early discharge from the hospital? b) Was the Veteran's gall bladder removal sustained following the November 2014 ERCP and sphincterectomy an event not reasonably foreseeable (i.e., the type of risk that a reasonable health care provider would not have disclosed in informed consent procedures), or was it an ordinary known risk of the surgery performed? L. M. BARNARD Veterans Law Judge Board of Veterans' Appeals Attorney for the Board R. A. Elliott II, Counsel The Board's decision in this case is binding only with respect to the instant matter decided. This decision is not precedential and does not establish VA policies or interpretations of general applicability. 38 C.F.R. § 20.1303.