Citation Nr: 25001098 Decision Date: 01/28/25 Archive Date: 01/28/25 DOCKET NO. 13-09 545A DATE: January 28, 2025 REMANDED The issue of entitlement to compensation under 38 U.S.C. § 1151 for liver disease is remanded. The issue of entitlement to service connection for liver disease is remanded. REASONS FOR REMAND The Veteran had active service from August 1972 to August 1974. The Veteran died in June 2013. The Board is thankful to the Veteran's family for his service to our country. The appellant is the Veteran's surviving spouse who has been recognized as a valid substitute. In January 2021, the Board denied the appeal. In March 2022, by Memorandum Decision, the Court of Appeals for Veterans' Claims (Court) vacated the January 2021 decision, and the appeal was remanded to the Board. In December 2022, the Board again denied the appeal. The Veteran appealed the December 2022 Board decision to the Court. In a December 2023 Court Order granting a December 2023 Joint Motion for Remand (Joint Motion), the Court vacated the Board's December 2022 decision. The Court remanded the matters from the vacated December 2022 Board decision back to the Board to take action pursuant to the parties' agreement in the Joint Motion. In July 2024, the Board remanded this appeal for actions to ensure compliance with the directives of the Joint Motion. The case has now returned to the Board for further appellate review. The Board recognizes the time that the appellant has devoted to this appeal process and appreciates her patience. As explained below, the Board finds that remand is necessary to adequately complete the prior remand directives, to resolve the concerns presented by the Joint Motion, and to afford complete consideration to the appellant's claim. 1. The issue of entitlement to compensation under 38 U.S.C. § 1151 for liver disease is remanded. 2. The issue of entitlement to service connection for liver disease is remanded. Unfortunately, the Board finds that another remand is necessary in this case because the actions directed in the Board's prior remand have not been substantially completed and remain necessary to enable informed appellate review of the issue and compliance with the directives of the Court-endorsed Joint Motion. See Stegall v. West, 11 Vet. App. 268, 271 (1998) (A remand by the Board confers on the claimant, as a matter of law, the right to compliance with the remand orders.). There are multiple reasons that a new remand of this case is necessary. First, the July 2024 remand directed the AOJ to "obtain an advisory medical opinion from an independent (non-VA) medical expert, pursuant to the authority of 38 U.S.C. § 5109. If feasible, the opinion should be obtained from a physician with specialized experience in liver (hepatology) disorders." Under 38 U.S.C. § 5109(a), VA may obtain an advisory medical opinion from an independent medical expert from outside the Department based upon the medical complexity or controversy of a particular case. In this case, as explained in the July 2024 remand, the Board has determined that such an opinion is warranted. However, the resulting November 2024 medical opinion was authored by a VA Staff Physician. There is also no indication that the author has specialized experience in liver (hepatology) disorders. While the Board appreciates the effort the VA examiner made in preparing the medical opinion in this case, the Board is unable to conclude that the report complies with the Board's remand directives in this case. No explanation is presented in the record for the absence of the requested advisory medical opinion from an independent medical expert from outside the Department, preferably with specialized experience in liver (hepatology) disorders. The Board observes that the author of the November 2024 VA medical opinion states that she "previously opined on the veteran's liver condition on my 07 Dec 2012 C&P Medical Opinion." The Board has reviewed the record to ensure that the referenced prior evidence is in the claims-file. Upon review, the Board does not find a December 2012 VA medical opinion from the same author; there is a December 2012 VA medical opinion from a different date and a different author concerning the Veteran's liver health. Nevertheless, the Board has identified a July 2019 "C&P Examination .... Medical Opinion" regarding the Veteran's liver health from the same author as that of the November 2024 VA medical opinion. The Board finds that it is reasonable to conclude that the July 2019 medical opinion is the prior opinion referenced in the November 2024 discussion, and there is no need to direct development to add any outstanding past medical opinions to the claims-file. Second, the Board's directives included the instruction for the medical opinion to: "please explain the significance of a July 2011 medical record indicating an assessment of 'Nonalcoholic Hepatic Nodular Cirrhosis w/o clinical insufficiency[,] hx possible Niacin reaction contributing to above' in considering question (a)." However, the resulting November 2024 VA medical opinion does not offer the requested explanation, nor does it otherwise address the July 2011 medical record. Third, the Board's directives included the instruction for the medical opinion to: "please explain the significance of an article in the record titled: 'Niacin' from 'LiverTox: Clinical and Research Information on Drug-Induced Liver Injury'[] which stated, 'Niacin can cause mild-to-moderate serum aminotransferase elevations[,] and high doses and certain formulations of niacin have been linked to clinically apparent, acute liver injury which can be severe as well as fatal.'" However, the resulting November 2024 VA medical opinion does not offer the requested explanation, nor does it otherwise address the referenced article in the record, nor its quoted content. Fourth, the Board's directives included the instruction for the medical opinion to: "please explain the significance of the article, Statins in Patients with Cirrhosis: A Note of Caution in the Middle of Hope, Digestive Medicine Research Journal, Volume 3 (December 2020), which indicated that in a recent study....]" The Board's directive then summarized a number of significant indications from the article's discussion of the study that require attention in the requested medical opinion. However, the resulting November 2024 VA medical opinion does not offer the requested explanation, nor does it otherwise address the referenced article in the record, nor its quoted content. Fifth, the Board's directives included the instruction for the medical opinion to: "please explain whether the medical evidence supports the reports of the Veteran and the appellant that he was on statins and Niacin for multiple years and was diagnosed with severely elevated liver enzymes in 2009; that he was told at that time that 'over half the Liver was damaged and [he] definitely had chemically induced Cirrhosis and not alcohol induced because [he is] not and never have drank alcohol'; that the VA doctors who treated him told him that they could not believe that he 'had not been taken off the Statins or Niacin at the first sign of Liver elevation'; that he reported his doctor, 'Dr. Pandya was 90% sure that [the Veteran's] liver damage[] was chemically induced and caused by continuous use of statin medications to include [g]emfibrozil and niacin;' that the Veteran had been prescribed 2000mg of Niacin and that 'Dr. Pandya told them that the maximum dose for Niacin should be 600mg/day; and that later that month, the Veteran said that 'MT VERNON VA CBOC had him on [more] Statins than is recommended in addition to three times the recommended amount of Niacin; and that the side effect of the Niacin is the sorosis (sic) of the liver.'" However, the resulting November 2024 VA medical opinion does not clearly offer all of the requested explanation, nor does it otherwise address all of the referenced key contentions. Sixth, the Board's directives included the instruction that, in addressing the question of the alleged etiological link to service, "the clinician must address and take as fact that for VA purposes hepatic steatosis is in the category of limited/suggestive evidence of an association with exposure to contaminated water at Camp Lejeune." However, the resulting November 2024 VA medical opinion does not mention hepatic steatosis nor otherwise clearly address this fact. As discussed in the July 2024 Board remand, the Board's remand directives were necessary "[t]o ensure compliance with the Joint Motion, and to enable informed appellate review of the claims with attention to the concerns highlighted by the Joint Motion." The Board explained the need "for a new medical opinion that more adequately addresses the arguments and information presented in the July 2022 brief." As the resulting November 2024 VA medical opinion does not comply with the Board's remand directives, and as there is no explanation in the record to indicate that requested development is unachievable, the Board must again remand this case to develop the previously requested medical opinion. The Board makes no credibility findings at this time. Finally, the Board notes that it has slightly revised the remand directives presented below, as compared to the July 2024 Board remand, simply for improved clarity. The substance of the remand directives remains substantially unchanged. The matters are REMANDED for the following action: 1. Please obtain an advisory medical opinion from an independent (non-VA) medical expert, pursuant to the authority of 38 U.S.C. § 5109. (If for any reason this cannot be accomplished, an explanation must be associated with the claims file.) If feasible, the opinion should be obtained from a physician with specialized experience in liver (hepatology) disorders. The medical expert should review the record and offer opinions with regard to the claims for service connection and for entitlement to compensation under 38 U.S.C. § 1151 for liver disability due to VA treatment consisting of the prescription of statins and Niacin as to each of the following questions: (a.) As to each liver disability found in the Veteran's case, is it at least as likely as not (meaning that the likelihood is at least approximately balanced or nearly equal, if not higher) that the Veteran suffered from a liver disability that was etiologically linked to active service in light of the Veteran's exposure to contaminated water at Camp Lejeune. (i.) In the response to question (a), the clinician must address and take as fact that for VA purposes hepatic steatosis is in the category of limited/suggestive evidence of an association with exposure to contaminated water at Camp Lejeune. (b.) Please identify any additional disability, in terms of the Veteran's liver disease, resulting from VA treatment consisting of statins and Niacin (comparing his liver condition before and after the use of statins and Niacin prescribed by VA). i. In your response to question (b), please explain whether the Veteran's liver disease is related to alcohol use, in light of the contentions that: "his conditions were non-alcohol liver conditions." "Medical records from 2001, 2003, and 2005 noted the Veteran reported no alcohol use within the past year." "The Veteran's April 2007, April 2008, and December 2009 alcohol screenings were negative, as the Veteran answered 'Never' when asked how often he had had a drink containing alcohol in the past year." "Furthermore, during an October 2010 C&P examination, the Veteran denied a history of alcohol use since 1974." ii. In your response to question (b), please explain the significance of a July 2011 medical record indicating an assessment of "Nonalcoholic Hepatic Nodular Cirrhosis w/o clinical insufficiency[,] hx possible Niacin reaction contributing to above." iii. In your response to question (b), please explain the significance of an article in the record titled: "Niacin" from "LiverTox: Clinical and Research Information on Drug-Induced Liver Injury," which stated, "Niacin can cause mild-to-moderate serum aminotransferase elevations[,] and high doses and certain formulations of niacin have been linked to clinically apparent, acute liver injury which can be severe as well as fatal." iv. In your response to question (b), please explain the significance of the article, "Statins in Patients with Cirrhosis: A Note of Caution in the Middle of Hope," Digestive Medicine Research Journal, Volume 3 (December 2020), which indicated that in a recent study, patients in the group who received 40 mg Simvastatin plus Rifaximin had "more pronounced elevations in ALT and AST." Also, "3 patients (19%) in the higher simvastatin dose group met the diagnostic criteria of DILI [drug-induced liver injury], while none of the patients in the other groups did." The article also indicated muscle toxicity was "common in the high simvastatin dose group. Elevations of CK were more prominent in these patients, with a median increase above 800%, and 3 patients developed rhabdomyolysis." The article concluded that "liver and/or muscle toxicity in cirrhotic patients receiving simvastatin at 40 mg/day is common and may be particularly high in those classified as Child-Pugh C. These findings indicate that simvastatin at a dose of 20 mg/day be adopted in decompensated cirrhosis in future clinical studies and also in clinical practice, with strict clinical and laboratory monitoring for side effects." The article also stated that it remained to be seen if the smaller dose would be safe in the long-term and still attain the clinical benefits demonstrated in previous studies using 40 mg/day. The article indicated that "[u]ntil more data is available, statins should be used with extreme caution in decompensated cirrhosis." v. In your response to question (b), please explain whether the medical evidence supports the reports of the Veteran and the appellant: that he was on statins and Niacin for multiple years and was diagnosed with severely elevated liver enzymes in 2009; that he was told at that time that "over half the Liver was damaged and [he] definitely had chemically induced Cirrhosis and not alcohol induced because [he is] not and never have drank alcohol"; that the VA doctors who treated him told him that they could not believe that he "had not been taken off the Statins or Niacin at the first sign of Liver elevation"; that the Veteran's doctor, "Dr. Pandya was 90% sure that [the Veteran's] liver damage[] was chemically induced and caused by continuous use of statin medications to include [g]emfibrozil and niacin"; that the Veteran had been prescribed 2000mg of Niacin and that Dr. Pandya told them that the maximum dose for Niacin should be 600mg/day; and that "MT VERNON VA CBOC had him on [more] Statins than is recommended in addition to three times the recommended amount of Niacin; and that the side effect of the Niacin is the sorosis (sic) of the liver." If the clinician determines the medications prescribed by VA caused additional disability, please provide opinions as to the following: (c.) Whether it is at least as likely as not (likelihood is at least approximately balanced or nearly equal, if not higher) that the proximate cause of the additional disability identified was carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing care or treatment. Please explain. (d.) Whether it is at least as likely as not (likelihood is at least approximately balanced or nearly equal, if not higher) that any additional disability identified was proximately caused by an event not reasonably foreseeable. A result is not reasonably foreseeable if a reasonable health care provider would not have considered the result as an ordinary risk of the treatment provided. Please explain. 2. Thereafter, after undertaking any other development deemed appropriate, readjudicate the issues on appeal. If any benefit sought is not granted, furnish the appellant and her representative with a supplemental statement of the case (SSOC), and afford them an opportunity to respond before the record is returned to the Board for further review. M. C. GRAHAM Veterans Law Judge Board of Veterans' Appeals Attorney for the Board Barone, Alexander 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.