Citation Nr: 21013810 Decision Date: 03/10/21 Archive Date: 03/10/21 DOCKET NO. 14-20 104 DATE: March 10, 2021 REMANDED Entitlement to compensation under 38 U.S.C. § 1151 for the additional disability of diabetes mellitus as a result of cholecystectomy surgery performed at Durham VA Medical Center in December 1982 is remanded. Entitlement to compensation under 38 U.S.C. § 1151 for the additional disability of osteomyelitis as a result of the Durham VA Medical Center prescribed medication Methotrexate is remanded. REASONS FOR REMAND The Veteran served on active duty in the United States Army from April 1980 until her honorable discharge in October 1981. These matters are before the Board of Veterans’ Appeals (Board) on appeal from a March 2014 rating decision issued by a Department of Veterans Affairs (VA) Regional Office (RO). In December 2018 the Board remanded the case to the Agency of Original Jurisdiction (AOJ) to obtain a VA examination and medical opinions. The case has been returned to the Board for further consideration. Although further delay is regrettable, the Board finds a remand is necessary to ensure due process is followed and there is a complete record upon which to decide the Veteran’s claim so that she is afforded every possible consideration. 38 U.S.C. § 5103A; 38 C.F.R. § 3.159. A remand by the Board confers upon the Veteran, as a matter of law, the right to compliance with the remand instructions and imposes upon VA a concomitant duty to ensure compliance with the terms of the remand. See Stegall v. West, 11 Vet. App. 268, 271 (1998). Under the relevant law and regulations, when a Veteran suffers from an additional disability or death as a result of training, hospital care, medical or surgical treatment, or an examination furnished by the VA, disability compensation shall be awarded in the same manner as if such disability or death was service-connected. 38 U.S.C. § 1151; 38 C.F.R. § 3.361. The evidence must show that the proximate cause of the additional disability is due to carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA in furnishing the hospital care or was an event not reasonably foreseeable. 38 U.S.C. § 1151. The United States Court of Appeals for Veterans Claims (Court) has clarified that the standard is not actual foreseeability or possible foreseeability, but that the test is driven wholly by how a “reasonable health care provider” would behave if asked to perform a certain procedure on a Veteran with the same characteristics as the Veteran in a given case. See Schertz v. Shinseki, 26 Vet. App. 362 (2013). In determining whether a Veteran has an additional disability, VA compares the Veteran’s condition immediately before the beginning of the hospital care, medical or surgical treatment, examination, training and rehabilitation services, or compensated work therapy program upon which the claim is based to the Veteran’s condition after such care, treatment, examination, services, or program has stopped. 38 C.F.R. § 3.361(b). A claim based on additional disability due to medical treatment must meet the causation requirement. 38 C.F.R. § 3.361(c). To establish causation, the evidence must show that the hospital care, medical or surgical treatment, or examination resulted in the Veteran’s additional disability. Merely showing that a Veteran received care, treatment, or examination and that the Veteran has an additional disability does not establish cause. 38 C.F.R. § 3.361(c)(1). In addition to causation, it must also be shown that (1) VA failed to exercise the degree of care that would be expected of a reasonable health care provider; or (2) VA furnished the hospital care, medical or surgical treatment, or examination without the Veteran’s, or in appropriate cases, the Veteran’s representative’s informed consent. 38 C.F.R. § 3.361(d)(1). Determinations of whether there was informed consent involve consideration of whether the health care provider substantially complied with the requirements of 38 C.F.R. § 17.32. Minor deviations from the requirements of 38 C.F.R. § 17.32 that are immaterial under the circumstances of the case will not defeat a finding of informed consent. 38 C.F.R. § 3.361(d)(1). 1. Entitlement to compensation under 38 U.S.C. § 1151 for the additional disability of diabetes mellitus as the result of cholecystectomy surgery performed at Durham VA Medical Center (VAMC) is remanded. The Veteran is seeking compensation under 38 U.S.C. § 1151. She contends that because her December 1982 cholecystectomy surgery was not performed correctly, she developed recurrent infections and boils at the penrose drainage site; as a result of these boils and infections, she developed diabetes mellitus. See August 2013 VA Form 21-526EZ, August 2013 Correspondence, March 2015 Notice of Disagreement with attached statement from Veteran, and May 2016 VA Form 9 with attached statement from Veteran. For background purposes, the Veteran was seen in the Durham VA emergency room on December 10, 1982, with reports of pain and tenderness in the right upper quadrant. An ultrasound of the gallbladder demonstrated cholelithiasis with some prominence in size of the common bile duct distally. The Veteran was admitted for cholecystectomy surgery at the Durham VAMC on December 13, 1982. Durham VAMC records indicate the Veteran was advised on the purpose and potential risks of the surgery; the surgical pre-op sheet notes “permit signed: yes.” According to the Durham VA hospital summary, “on December 14, 1982, the patient was taken to the operative room at which time Dr. S. performed a cholecystectomy and interoperative cholangiogram. The patient tolerated the procedure well. Penrose [drain] was advanced on postoperative day three and removed on postoperative day 5. Patient had a smooth postoperative course and was discharged on postoperative day 6 [December 21, 1982].” On January 14, 1983, the Veteran presented to the Durham VAMC for post-operative checkup status post cholecystectomy and interoperative cholangiogram. The VA physician’s assessment was “stable post-op, discharge from clinic, return prn.” On October 21, 1983, the Veteran presented to the Durham VAMC with complaints of persistent crampy epigastric and right upper quadrant pain, ongoing two to three months. The VA physician diagnosed “abdominal pain with questionable etiology.” On November 18, 1983, the Veteran underwent an ultrasound of her liver because of ongoing right upper quadrant pain. The VA physician’s “impression was probable gastritis – resolved.” A February 25, 1997, Durham VAMC record notes the Veteran sought treatment for a boil that developed at the 1982 cholecystectomy drainage site. The VA physician noted “the 1982 cholecystectomy had abdominal drains post op; she had an abscess develop there two years ago and it has now reaccumulated.” On March 11, 1997, the Veteran was reevaluated at Durham VAMC for right sided “boil.” The VA physician noted a history of retained drain in old cholecystectomy wound; removed by general surgery. On May 1, 2007, the Veteran presented to the Durham VAMC for her diabetes mellitus. During the examination she complained of “boil” on the right upper quadrant at the December 1982 cholecystectomy drainage site. On August 2, 2007, the Veteran presented to the Durham VAMC with complaints of a non-healing “boil” on her right side that she connected to an old drainage site from an open cholecystectomy in 1982. The VA physician noted ten years ago, the Veteran presented to the emergency room with malodorous purulent discharge from this same site and had a retained drain removed. Since then, she experiences flare-ups of this site every 4-5 years with hard nodules that form and subsequently burst open releasing a similar paste-like discharge. In August 2015, the Veteran presented to the Durham VAMC for evaluation of diabetes mellitus. During the examination she reported a lengthy history of diarrhea and boils on her right flank since the early 1990s. In February 2016, a Durham VAMC attending physician noted the Veteran’s history of cholecystectomy in December 1982. The Veteran reported several abscesses at the site of the penrose drain. The VA physician note, “February 25, 1997 handwritten emergency department note with GSU consult for abscess at the site on February 25, 1997. GSU note indicates an I & D was performed.” The Board notes here, it is unclear from the record whether the Veteran has a diagnosis of Type I diabetes mellitus or Type II diabetes mellitus. However, a diagnosis of diabetes mellitus is conceded. An April 21, 1995, Durham VAMC record notes the Veteran was diagnosed with diabetes mellitus in February 1995 (Greensboro). A May 25, 1995, Durham VAMC record notes a history of adult onset diabetes mellitus, insulin dependent. A November 3, 1995, Durham VAMC record notes a past medical history of diabetes mellitus – 1993. In February 2016, the Veteran’s VA physician noted a past medical history of diabetes – unclear type. In its most recent December 2018 remand, the Board directed the AOJ obtain an examination and medical opinion from an appropriate medical professional for the 38 U.S.C. § 1151 claim following VA surgical treatment. In offering a medical opinion the examiner was directed to state whether the Veteran has diabetes mellitus as a result of the December 1982 cholecystectomy surgery. In accordance with the December 2018 remand, a medical opinion was provided in October 2020. The examiner offered a negative opinion. The examiner stated a review of VA diagnosis and treatment was appropriate and timely, accepted protocols were followed, and the standard of care was met in this case. The examiner opined it is less likely as not the claimed condition was caused by or became worse as a result of the VA treatment, additional disability from carelessness, negligence, lack of skill, or similar incidence of fault on the part of the attending VA personnel or additional disability resulted from an event that could not have reasonably been foreseen by a reasonable healthcare provider, and/or failure on the part of VA to timely diagnose and/or properly treat the claimed disease or disability allowed the disease or disability to continue to progress. In support of this negative opinion, the examiner’s rationale, as documented, appears to be incomplete. The examiner stated, “osteomyelitis had the risk of dm plus many other factors… as causal of osteo… BUT diabetes is not linked to cholecystectomoy [sic].” Furthermore, the examiner’s rationale is contradictory. Although the examiner stated that “there is no medical plausible link of a cholecystectomy causing the development of DM, he concluded, “in the specifics of this case the onset is imprecise and even the type of dm is unclear.” The examiner stated, “the cholecystectomy surgery in 12/82 is not a cause of diabetes in any fashion or impact.” The Board cannot make a fully informed decision on the issue of entitlement to 38 U.S.C. § 1151 compensation for the additional disability of diabetes mellitus because the medical opinion is inadequate. See Reonal v. Brown, 5 Vet. App. 458, 461 (1993). The issue of entitlement to compensation under the provisions of 38 U.S.C. § 1151 requires a multifactor and complex analysis in its adjudication, as detailed above. Thus, the Board finds the opinion does not address all necessary information required to decide the claim, and an additional medical opinion addressing the multiple prongs of the 38 U.S.C. § 1151 claim is required. See 38 C.F.R. § 3.159(c)(4) (holding a medical examination or opinion is necessary if the information and evidence of record does not contain sufficient medical evidence to decide the claim). 2. Entitlement to compensation under 38 U.S.C. § 1151 for the additional disability of osteomyelitis, due to Durham VAMC prescribed medication Methotrexate (MTX) is remanded. The Veteran is seeking compensation under 38 U.S.C. § 1151. She contends that as a result of taking the Durham VAMC prescribed medication Methotrexate, she developed osteomyelitis. See August 2013 VA Form 21-526EZ; August 2013 Correspondence, March 2015 Notice of Disagreement with attached statement from Veteran, and May 2016 VA Form 9 with attached statement from Veteran. Durham VAMC treatment records show, starting December 7, 2007, and continuing to January 30, 2008, the Veteran was prescribed Methotrexate for the treatment of rheumatoid arthritis. A December 7, 2007, Durham VA Rheumatology note, shows the Veteran sought follow-up care of her erosive arthritis. The VA physician noted, “the plan was to start the Veteran on Methotrexate at 15 mg/week for two weeks, and then increase to 20 mg/week. Patient was explained the risk and benefits of Methotrexate. She was advised to take Folic acid along with Methotrexate and use contraception while on Methotrexate. We implored the necessity of monitoring toxicity labs closely.” On January 26, 2008, the Veteran was admitted to the Durham VAMC for osteomyelitis. The VA physician documented the Veteran’s history of seronegative rheumatoid arthritis on Methotrexate, diabetes mellitus with neuropathy and chronic lower extremity ulcers, who presents from dermatology clinic with a new ulcer on her right foot base. The VA physician noted (1) diabetic foot ulcer consistent with osteomyelitis, (2) rheumatoid arthritis: will continue her Methotrexate, and (3) anemia, chronic: may in part be due to recent start of Methotrexate. Dr. C.W. stopped Methotrexate in light of active infection. On July 15, 2009, the Veteran was admitted to the Durham VA medical clinic for intravenous antibiotics for diabetic foot/recurrent osteomyelitis. The VA physician’s impression was seronegative rheumatoid arthritis. The physician noted the Veteran was previously on Methotrexate, which was discontinued once the patient developed osteomyelitis. A March 29, 2010, Durham VAMC rheumatology record notes the Veteran had been on Methotrexate before, and the “patient had this held due to chronic foot infection.” A VA medical opinion was obtained in March 2014. The examiner stated that the Veteran had evidence of foot ulcers prior to starting Methotrexate. The examiner concluded Methotrexate was not the proximate cause of the foot ulcers in the Veteran. The examiner explained that there was no evidence Methotrexate ever caused significant leukopenia that would have been a contributing factor to wound healing had it occurred. The examiner opined, it is more likely than not that the foot ulcer was a consequence of her difficulty to control diabetes and diabetic neuropathy, than any toxicity attributable to Methotrexate. The Board cannot make a fully informed decision on the issue of entitlement to 38 U.S.C. § 1151 compensation because the medical opinion is inadequate. See Reonal, 5 Vet. App. at 461. The opinion did not address all necessary information required to decide the claim. In its most recent December 2018 remand, the Board directed the AOJ to obtain a medical opinion as to whether it is at least as likely as not that the Veteran’s osteomyelitis is due to the Veteran’s diabetes mellitus. However, the Board finds a medical opinion is necessary to determine entitlement to compensation under 38 U.S.C. § 1151 for the additional disability of osteomyelitis as a result of the Durham VAMC prescribed medication Methotrexate. The matters are REMANDED for the following actions: 1. Associate with the claims folder updated VA treatment records. 2. Obtain an opinion addressing the issue of entitlement to compensation under 38 U.S.C. § 1151 for the “additional disability of diabetes mellitus” as a result of cholecystectomy surgery performed at Durham VA Medical Center in December 1982. Refer the Veteran’s claims file to a qualified medical professional, preferably a specialist in endocrinology. A copy of this remand should be provided to the examiner. The examiner’s attention is drawn to the brief background history above. After review of the evidence of record, including the medical records and the Veteran’s lay statements, the examiner is asked to address each of the following: (a.) Is it at least as likely as not (probability of at least 50 percent) based upon the evidence of record and sound medical principles that the Veteran suffered an additional disability, including diabetes mellitus, following the cholecystectomy surgery in December 1982? In responding to this question, the medical examiner is requested to identify, to the extent possible, the nature and etiology of the Veteran’s diabetes mellitus. (b.) If the response to (a) is yes, is it at least as likely as not (probability of at least 50 percent) based upon the evidence of record and sound medical principles that an additional disability was proximately caused by either (A) carelessness, negligence, lack of proper skill, error in judgement, or similar instance of fault on the part of VA in furnishing the hospital care, medical or surgical treatment, or examination, or (B) an event not reasonably foreseeable? Proximate cause is shown if the additional disability is the result of VA’s failure to exercise the degree of care that would be expected by a reasonable health care provider. However, proximate cause is not shown if the additional disability is due to an event not reasonably foreseeable, i.e., an event that a reasonable health care provider would not have seen. Such event need not be unforeseeable or unimaginable but must be one that a reasonable health care provider would not have considered to be an ordinary risk of the cholecystectomy surgery. (c.) If the response to (a) is yes, is it at least as likely as not (probability of at least 50 percent) that the additional disability was a risk that a reasonable health care provider would have disclosed in connection with the informed consent procedures? If so, the medical expert should discuss whether the file indicates this risk was discussed with the Veteran prior to the December 15, 1982, procedure, with reference to the procedure consent form found in the medical file. 3. Obtain an opinion addressing the issue of entitlement to compensation under 38 U.S.C. § 1151 for the additional disability of osteomyelitis as a result of VA prescribed Methotrexate. Refer the Veteran’s claims file to a qualified medical professional, preferably a rheumatologist. A copy of this remand should be provided to the examiner. The examiner’s attention is drawn to the brief background history above. After review of the evidence of record, including the medical records and the Veteran’s lay statements, the examiner is asked to address each of the following: (a.) Whether it is at least as likely as not (a 50 percent probability or greater) that the Veteran’s osteomyelitis is proximately due to the use of Methotrexate as directed by a VA physician. (b.) If the examiner determines the Veteran’s osteomyelitis is due to Methotrexate usage, the examiner should state whether it is at least as likely as not (50 percent probability or greater) that the osteomyelitis is due to carelessness, negligence, lack of proper skill, error in judgement, or similar instance of fault on VA’s part in providing medical treatment. (c.) Whether the Veteran’s osteomyelitis was a reasonably foreseeable result of the prescription of Methotrexate. When considering whether the identified additional disability was caused by an event not reasonably foreseeable, the examiner should address whether a “reasonable health care provider” would have considered the Veteran’s claimed side-effects from Methotrexate to be an ordinary risk of the treatment provided and would have disclosed such risk in connection with such treatment, regardless of what risks the treatment provider actually anticipated and disclosed. The examiner should explain his or her answers by citing to supporting clinical data and/or medical literature, as deemed appropriate. A full rationale must be provided for all medical opinions given. If the examiner is unable to provide an opinion without resorting to mere speculation, he or she should explain why this is so. The examiner shall then explain whether the inability to provide a more definitive opinion is the result of a need for more information and indicate what additional evidence is necessary, or whether he or she has exhausted the limits of current medical knowledge in providing an answer to that particular question(s). 4. To help avoid future remand, the AOJ must ensure that all requested actions have been accomplished in compliance with this REMAND. If any action is not undertaken, or is taken to a deficient manner, appropriate corrective action should be undertaken prior to returning the case to the Board. S. Merrick Acting Veterans Law Judge Board of Veterans’ Appeals Attorney for the Board Grace Johnk, Associate 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.