Citation Nr: 21005094 Decision Date: 01/29/21 Archive Date: 01/29/21 DOCKET NO. 13-09 545A DATE: January 29, 2021 ORDER Entitlement to service connection for heart disease is denied. Entitlement to service connection for liver disease is denied. Entitlement to compensation under 38 U.S.C. § 1151 for liver disease is denied. FINDINGS OF FACT 1. The heart disease was not present until years after service and is not etiologically related to service. 2. The liver disease was not an additional disability of VA treatment. 3. The liver disease was not incurred in service and is not etiologically related to service. CONCLUSIONS OF LAW 1. The criteria for service connection for heart disease have not been met. 38 U.S.C. §§ 1110, 1112; 38 C.F.R. §§ 3.303, 3.307, 3.309. 2. The criteria for compensation under 38 U.S.C. § 1151 for liver disease have not been met. 38 U.S.C. § 1151; 38 C.F.R. § 3.361. 3. The criteria for service connection for liver disease have not been met. 38 U.S.C. §§ 1110, 1112; 38 C.F.R. §§ 3.303, 3.307, 3.309. REASONS AND BASES FOR FINDINGS AND CONCLUSIONS The Veteran served on active duty from August 1972 to August 1974. The Veteran died in June 2013. The appellant is the Veteran’s surviving spouse who has been recognized as a valid substitute. Service connection may be established for disability resulting from disease or injury incurred in or aggravated by active military, naval, or air service. 38 U.S.C. § 1110; 38 C.F.R. § 3.303. Service connection may be granted for any disease initially diagnosed after discharge, when all the evidence, including that pertinent to service, establishes the disease was incurred in service. 38 C.F.R. § 3.303(d). Where a veteran served for at least 90 days during a period of war or after December 31, 1946, and manifests cardiovascular-renal disease to a degree of 10 percent within one year from the date of termination of such service, such disease shall be presumed to have been incurred or aggravated in service, even though there is no evidence of such disease during the period of service. 38 U.S.C. §§ 1101, 1112, 1137; 38 C.F.R. §§ 3.307, 3.309. For the showing of chronic disease in service, there is required a combination of manifestations sufficient to identify the disease entity, and sufficient observation to establish chronicity at the time, as opposed to merely isolated findings or a diagnosis including the word “chronic.” When the fact of chronicity in service (or during any applicable presumptive period) is not adequately supported, then a showing of continuity after discharge is required to support the claim. 38 C.F.R. § 3.303(b). The term “chronic disease” refers to those diseases listed under section 1101(3) of the statute and section 3.309(a) of VA regulations. 38 U.S.C. § 1101(3); 38 C.F.R. § 3.309(a); Walker v. Shinseki, 708 F.3d 1331 (Fed. Cir. 2013). The Veteran’s personnel records indicate that he was stationed at Camp Lejeune. VA has acknowledged that persons residing or working at the U.S. Marine Corps Base Camp Lejeune between August 1953 and December 1987 were potentially exposed to drinking water contaminated with volatile organic compounds (VOCs). Effective March 14, 2017, VA amended its adjudication regulations regarding presumptive service connection, adding certain diseases associated with contaminants present in the base water supply at U.S. Marine Corps Base Camp Lejeune, North Carolina from August 1, 1953, to December 31, 1987. The final rule establishes that Veterans who served at Camp Lejeune for no less than 30 days during this period, and who have been diagnosed with any of eight associated diseases (adult leukemia, aplastic anemia and other myelodysplastic syndromes, bladder cancer, liver cancer, multiple myeloma, Non-Hodgkin’s lymphoma, and Parkinson’s disease) are presumed to have incurred or aggravated the disease in service for purposes of entitlement to VA benefits. See 38 C.F.R. § 3.309(f). To obtain compensation under 38 U.S.C. § 1151, a claimant must show a “qualifying additional disability” resulting from VA treatment or hospitalization. The proximate or direct cause of the “additional disability” must be (1) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing medical or surgical treatment or (2) an event which was not reasonably foreseeable. 38 U.S.C. § 1151; 38 C.F.R. § 3.361. To determine whether additional disability exists, the veteran’s condition immediately prior to 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 is compared to his or her condition after such care, treatment, examination, services, or program has been completed. Each body part or system involved is considered separately. 3 8 C.F.R. § 3.361(b). 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 causation. 38 C.F.R. § 3.361(c)(1). The proximate cause of a disability is the action or event that directly caused the disability, as distinguished from a remote contributing cause. 38 C.F.R. § 3.361(d). 1. Heart Disease August 1991 private treatment record indicate that the Veteran presented for treatment with intermittent exertional chest pain over a week that became persistent and unrelenting prior to visiting the Emergency Room. The diagnosis was arteriosclerotic coronary artery disease with acute inferior wall myocardial infarction, for which the Veteran underwent single-vessel aortocoronary bypass. Inpatient records reveal that the Veteran had a heavy cigarette smoking history. An August 1992 VA examination record reveals the Veteran’s history of smoking three packages of cigarettes daily for two years and his history of two silent myocardial infarctions and acute myocardial infarction in August 1991. He reported family history of heart disease. The diagnosis was arterioslerotic heart disease with angina pectoris, status post coronary artery bypass graft. An October 2010 VA examination record reveals the examiner’s determination that it was less likely than not that the heart disease was related to service, including at Camp LeJeune, because the Veteran had multiple risk factors for atherosclerosis including hypercholesterolemia, tobacco dependence, and family history. A December 2019 VA medical opinion reveals the finding that it was less likely than not that the Veteran’s heart disease was incurred in or caused by service, including Camp LeJeune service. The physician reported that there was no objective medical evidence of reputable medical literature to indicate a link between exposure to contaminated water and the heart disease. The physician added that there was no evidence of heart disease in service and that the heart was noted normal at separation. The physician added that the Veteran had multiple risk factors including age, gender, tobacco use disorder, obesity, dyslipidemia, and diabetes mellitus type 2. A July 2020 VA medical opinion notes all previous relevant findings and opinions. The physician determined it was less likely than not that the heart disease was incurred in or caused by service. The physician noted that the heart disease was diagnosed in 1991 and that the Veteran had four risk factors, notably being a smoker, histories of diabetes mellitus and dyslipidemia, and family history of heart disease. The physician reported that there was no evidence of a link between exposure to contaminated water at Camp Lejeune and the development of heart disease and that the expected clinical time frame between the exposure to the development of disease is usually measured in days to weeks and not 17 years. Service connection is not warranted for heart disease: the heart disease was not present until years after the Veteran’s discharge from service and was not related to service including the reported in-service exposure to contaminated water. Service treatment and examination records reveal no notation indicative of a heart disorder, the initial diagnosis dates many years after discharge from service, and the record is absent a history that the Veteran manifested symptoms attributed to heart disease during and since service. Additionally, VA physician provided probative opinions that the heart disease was not incurred in and is not related to the Veteran’s service, including Camp LeJeune service, and there is no probative evidence of such a relationship. Notably, heart disease is not a disease for which an association to in-service exposure to contaminated water has been suggested, and there is no medical evidence that the Veteran’s heart disease is related to service. The Board notes that the Veteran submitted a copy of an April 2020 Board decision which granted service connection for heart disease based on Camp LeJeune service. That grant was based in part on private nexus opinions specific to that Veteran and that Veteran’s medical history, however, and the Board finds it is not probative evidence based on which service connection can be granted. Accordingly, the claim must be denied. In reaching this decision, the Board has considered the doctrine of reasonable doubt but has determined that it is not applicable because the preponderance of the evidence is against the claim. 2. Liver Disease October 2009 VA treatment records indicate that the Veteran was admitted for workup of hepatic disease due to uncontrolled pruritus, dark urine, and jaundiced eyes. A complete metabolic panel suggested possibility of primary biliary cirrhosis and a computerized tomography (CT) of the abdomen showed infiltering lesions in the right lobe liver suspicious of infiltrating carcinoma. The record reveals the Veteran’s history of smoking two packs per day for 40 years, prior to quitting nine months earlier. After biopsy, the diagnosis was changed to cryptogenic liver cirrhosis. A July 2010 VA medical opinion notes that a minor elevation in the AST enzyme was noted in March 2008, that the Veteran was using Zocor, a statin medication, when he developed myalgia and an elevated CPK so Zocor was stopped, and that the Veteran was placed on Gemfibrozil and Niacin SR in early 2007. The physician added that enzyme studies in 2007 showed minor elevation. The physician reported that the clinicians were very concerned about the Veteran’s hyperlipidemia and the fact that he had diabetes mellitus and coronary atherosclerosis at that time. The physician further noted that Gemfibrozil is hepatotoxic, that Niacin sustained release was indicated with severe hepatotoxicity, that the Veteran was taking relatively high doses of both, and that he was stopped when he was admitted in October 2009. The physician reported that after review of the record, the physician determined the medical personnel were correctly monitoring the Veteran’s liver function studies and noted that the liver function tests were not severely abnormal. However, the physician also determined that because the tests showed abnormal tendencies and both medications were hepatotoxic, the physician believed continued use of the medications was at least as likely as not the cause of the hepatic disease. However, the physician believed the medical personnel were not careless or negligent in the monitoring of the medications though there was error in not using available information to manage the Veteran’s cholesterol-lowering treatment. The physician believed a reasonable healthcare provider could have foreseen the possible liver toxicity with the laboratory information available. The physician provided an addendum after further review and tabulation of the dates and amounts of the liver enzyme values. The physician reported that the VA medical personnel were correctly following the Veteran’s liver function studies once a year as recommended and that liver function tests were normal in April 2007 and only minor elevation in February 2008. The physician noted that the average physician would be concerned enough to repeat the studies based on the minor elevation and that this was done in June 2008, at which time AST was normal and ALT was moderately above normal. The physician reported that a clinician facing these values would have properly concluded that the cholesterol lowering medications were still safe to use. The physician reported that the Veteran again had slight elevation of ALT in March 2009 but noted that AST, alkaline phosphatase, and serum bilirubin were all normal. The physician reported that the values would not have alerted a clinician to change the medication. The physician added that in reviewing the impression of the Veteran’s liver condition, there was uncertainty over the reason for the hepatoxicity. The physician reported that the Gemfibrozil and Niacin SR were stopped and over time liver function studies improved which would tend to indicate that there was a causative relationship between these medications and the liver problems. In sum, the physician reported that it was not at least as likely as not that the VA clinicians were negligent or careless in handling the cholesterol medications and that a reasonable healthcare provider could not have foreseen the possibility of liver toxicity. In July 2010, medical articles were associated with the record about drug-induced hepatotoxicity. The articles stated that statins rarely caused clinically significant liver injury, even in patients with underlying liver disease but that all lipid-lowering agents have been associated with some degree of hepatotoxicity, that niacin is contraindicated with patients with hepatic dysfunction, active liver disease, or unexplained transaminase elevations and that there were cases of severe hepatoxicity when immediate release niacin products were substituted with sustained-release at equivalent doses, and that Gemfibrozil should not be used in patients with hepatic impairment. An October 2010 VA examination record notes that the Veteran’s current diagnosis appeared to be cryptogenic cirrhosis. The record notes that an April 2002 progress note mentioned abnormal liver function study but that the Veteran’s liver troubles otherwise began in October 2009. The record reports the Veteran’s history that his liver issues may be due to Camp LeJeune service or the use of statins. The examiner reported that review of liver function tests obtained minimum twice yearly from 1992 to present showed the first episode of elevated liver function in February 2008 with continued elevation in March 2008 but normal by March 2009. The examiner added that the first record of statin use was in October 1997, when the Veteran was prescribed Simvastatin which was continued until April 2005, at which time liver enzymes were normal. The examiner reported that the Veteran was on Niacin from July 2005 past March 2009. The examiner reported that the exact nature of the Veteran’s liver problems was unclear because the Veteran was in the middle of a private work-up to rule out adult-onset Wilson disease and cancer. The examiner reported that the Veteran had at least one major risk factor for liver disease from the August 1991 blood transfusion which was done prior to screening for viral hepatitides. The examiner stated that although current tests for anti-HCV were negative nad the test was sensitive, a small percentage of people with hepatitis C test negative and that it was less likely that the hepatitis was related to Camp Lejeune than this transfusion. A November 2010 addendum opinion reveals that additional information showed the Veteran underwent EUS and that he was thought to have possible occult carcinoma of the pancreas, liver, or lung versus primary biliary cirrhosis versus other liver condition. A December 2012 VA examination record reveals diagnosis of cirrhosis. The record reveals duplicative histories and notations as the October 2010 VA examination record, except for an addendum reportedly dated January 10, 2010, in which it reports that additional information showed that the Veteran was thought to have possible occult carcinoma of pancreas, liver or lung versus primary biliary cirrhosis versus other liver condition. The physician reported that chronic hepatic failure is not due to exposure to contaminated water and the cryptogenic cirrhosis was from possible occult malignancy. A February 2019 VA medical opinion reports a detailed diagnostic history of the liver disease. The physician reported that the Veteran’s AST and ALT remained in the normal range and did not significantly change from August 1997 to April 2005. The physician added that the record supported the diagnosis of non-alcoholic fatty liver disease. A March 2019 VA medical opinion from the same physician reports the determination that it was less likely than not that the liver disease was incurred in or caused by service. The physician reported that liver disease is a rare complication of statin medication use and occurs early in the course of use of such medications. The physician noted that the Veteran had normal liver enzymes for 30 years after exposure to Fort LeJeune water which argued against the water being causative. The physician added that it had not been established that the Veteran had chemical driven liver damage and that exposure to a potential pathogen does not equate injury or damage from that pathogen. The physician noted that the etiology of the liver damage had not been clearly established at the time of the Veteran’s death and that the Veteran’s private medical records had not been available. The physician reported that the Veteran had had cholelithiasis which can cause liver damage and that although the Veteran was closely followed for suspected carcinoma, there was no clear cancer diagnosis. The physician provided an addendum in July 2019 after review of private medical records and the death certificate. The physician noted that a March 2, 2011, VA treatment record showed conditions including “severe acute cholestatic liver injury which was never etiologically identified,” and an impression that the acute cholestatic injury was due to cholelithiasis and that a March 8, 2011, treatment record reported assessment of “cryptogenic cirrhosis with suspicion for NASH, pancreatic mass, large liver nodules without diagnosis of cancer, and likely new onset DM.” The physician determined the etiology of the cirrhosis appeared to have been due to a combination of NASH and obstructive cholelithiasis. A December 2019 VA medical opinion reports that the cirrhosis was less likely than not incurred in or caused by service. The physician determined it was likely caused by a combination of NASH and obstructive cholelithiasis. The physician stated that there was no nexus between the Veteran's service, to include exposure to contaminated water at Camp Lejeune, and his cirrhosis of the liver. There was no objective medical record or reputable medical literature evidence to indicate otherwise and there was no evidence of cirrhosis during service. The physician noted that examination was normal at separation. The physician further found no evidence of negligence of malpractice on the part of VA or its employees by prescribing statin therapy. A July 2020 VA medical opinion reveals the determination that it was less likely that the Veteran incurred an additional liver disability as a result of statin-prescription. The physician explained that there was no objective medical evidence to indicate such a relationship. Another July 2020 VA medical opinion notes all previous relevant findings and opinions. The physician determined it was less likely than not that the liver disease was incurred in or related to service. The physician reported that the liver disease was most likely due to nonalcoholic fatty liver disease (NAFLD) caused by obesity and dyslipidemia and obstructive cholelithiasis. The physician explained that NAFLD is the most common cause of abnormal liver tests results in the United States and that most patients with NAFLD have insulin-resistance-associated obesity, hypertriglyceridemia, and/or type 2 diabetes mellitus. The physician noted that the Veteran was considered obese since at least 2002, 7 years prior to diagnosis of NAFLD and that this risk factor was the most likely and proximal known risk factor for the Veteran’s NAFLD. The physician noted that occupational/ environmental exposure can lead to hepatic steatosis and that the Veteran was exposure to contaminated water in service. However, the examiner determined the clinical timeline following exposure to hepatotoxin in the development of disease was usually measured in days to weeks following exposure and not 35 years later. 38 U.S.C. § 1151 After consideration of the record, the Board finds the record does not support the finding that the Veteran has an “additional disability” as defined by VA as a result of VA prescription of statins. Although the record includes opinions provided in July 2010 suggesting that it was the result of medications prescribed by VA, the Board finds the opinions are less probative than the contradictory opinions, particularly those provided in 2019 and 2020, that the liver disease was not medication-related but was due to different etiology. The opinions, and the medical articles associated with the record in 2010, indicate that liver disease from statin use is rare and that the mediations were particularly hepatotoxic to people with preexisting liver impairment, which the record does not show. Notably, the record does not suggest chronic liver impairment prior to October 2009 though the Veteran was using statins: although there is evidence of abnormal findings in 2002 and 2008, subsequent tests reveal normal clinical findings. The opinions further explain that if the medications caused the liver disease, it would be expected that the liver disease would have manifested prior to October 2009 since the medications had been used long-term. The Board finds the opinions provided in 2019 and 2020 are particularly probative because they are supported by more detailed rationale that are consistent with the medical work-ups surrounding the Veteran’s liver disease and overall health which show multiple potential etiologies for the liver disease other than medication. Accordingly, the Board must conclude that compensation under the provisions of 38 U.S.C. § 1151 is not warranted. In reaching this conclusion, the Board has considered the benefit-of-the-doubt doctrine. However, as the preponderance of the evidence is against the Veteran’s claim, that doctrine is not applicable. Service Connection Service connection is not warranted for liver disease: the liver disease was not present until years after the Veteran’s discharge from service and was not related to service including the reported in-service exposure to contaminated water. Service treatment and examination records reveal no notation indicative of a liver disorder, the initial diagnosis dates many years after discharge from service, and the record is absent a history that the Veteran manifested symptoms attributed to liver disease during and since service. Additionally, VA physician provided probative opinions that the liver disease was not incurred in and is not related to the Veteran’s service, including Camp LeJeune service. Notably, cirrhosis is not a disease for which an association to in-service exposure to contaminated water has been suggested. The Board acknowledges that hepatic steatosis is such a disease. The July 2020 VA physician provided a probative opinion that the Veteran’s environmental exposure to the contaminated water did not result in the Veteran’s fatty liver disease based on the clinical timeline. There is no medical evidence tailored to the Veteran’s circumstances that link his liver disease to service, and the Board finds the July 2020 VA opinion, which is based on the Veteran’s specific facts, is more probative than the generic evidence that exposure can lead to hepatic steatosis. Accordingly, the claim must be denied. In reaching this decision, the Board has considered the doctrine of reasonable doubt but has determined that it is not applicable because the preponderance of the evidence is against the claim. G. Jackson Acting Veterans Law Judge Board of Veterans’ Appeals Attorney for the Board N. Snyder, 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.