Citation Nr: 1617930 Decision Date: 05/04/16 Archive Date: 05/13/16 DOCKET NO. 14-01 485 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Buffalo, New York THE ISSUE Entitlement to dependency indemnity and compensation (DIC) benefits on the basis of service connection for the cause of the Veteran's death. REPRESENTATION Appellant represented by: Katrina J. Engle, Attorney ATTORNEY FOR THE BOARD C. Fields, Counsel INTRODUCTION The Veteran had honorable active duty service from September 1963 to July 1967, including in the Republic of Vietnam, with awards and decorations including a Purple Heart Medal. The Veteran died in February 2012, and the Appellant is his surviving spouse. This matter comes before the Board of Veterans' Appeals (Board) on appeal from a February 2013 rating decision by the Department of Veterans Affairs (VA) Regional Office (RO) Buffalo, New York. The RO denied DIC benefits based on service connection for the cause of death, along with DIC benefits under 38 U.S.C.A. § 1318, accrued benefits, and nonservice-connected death pension benefits, as explained in the February 2013 notice letter. The Appellant appealed from the denial of service connection for the cause of the Veteran's death. FINDINGS OF FACT 1. The Veteran died in February 2012; the certificate of death listed the immediate cause of death as pancreatic cancer and no other significant contributing conditions. 2. The multiple disabilities that were service-connected at the time of the Veteran's death did not cause or contribute to cause his death. 3. The Veteran is presumed to have been exposed to herbicides (including Agent Orange) during his service in Vietnam. 4. Although the Veteran's immediate cause of death of pancreatic cancer is not subject to presumptive service connection based on herbicide exposure, there is evidence suggesting a direct link between this cancer and such herbicide exposure. 5. The Veteran's diagnosed type II diabetes mellitus is presumed to have been incurred as a result of herbicide exposure during his Vietnam service; and the evidence establishes that his diabetes materially contributed to cause his death. CONCLUSION OF LAW The criteria to establish service connection for the cause of the Veteran's death have been met. 38 U.S.C.A. §§ 1101, 1110, 1112, 1116, 1310, 5107(b) (West 2014); 38 C.F.R. §§ 3.303, 3.307, 3.309, 3.312 (2015). REASONS AND BASES FOR FINDINGS AND CONCLUSION A surviving spouse of a qualifying Veteran who died as a result of a service-connected disability is entitled to receive dependency and indemnity compensation (DIC). To warrant service connection for the cause of the Veteran's death, the evidence must show that a service-connected disability was either a principal or a contributory cause of death. 38 U.S.C.A. § 1310; 38 C.F.R. § 3.312. A disability will be considered the principal (primary) cause of death when such disability, singly or jointly with some other condition, was the immediate or underlying cause of death or was etiologically related thereto. 38 C.F.R. § 3.312(b). A disability will be considered a contributory cause of death when it contributed substantially or materially to death, combined to cause death, or aided or lent assistance to the production of death. 38 C.F.R. § 3.312(c)(1). Service connection for the cause of death is determined in accordance with the statutes referable to establishing service connection for compensation purposes under Chapter 11 of 38 U.S.C.A. (§ 1101 et. seq.). 38 U.S.C.A. § 1310(a). Service connection will be granted for a disability resulting from disease or injury that was incurred or aggravated in the line of duty during active service. 38 U.S.C.A. § 1110; 38 C.F.R. § 3.303(a). Where a disease is first diagnosed after service, direct service connection will be granted when all of the evidence, including that pertinent to service, establishes that the disease was incurred in service. 38 C.F.R. § 3.303(d). Presumptive service connection may be granted under certain circumstances, which are discussed below as pertinent to this case. When there is an approximate balance of positive and negative evidence regarding any issue material to the determination of a matter, all reasonable doubt will be resolved in favor of the claimant. 38 U.S.C.A. § 5107; 38 C.F.R. § 3.102. The Veteran died in February 2012. The evidence establishes that the Appellant is his surviving spouse, and she filed a timely claim for benefits in March 2012. The Veteran's death certificate listed the immediate cause of death as pancreatic cancer, with an onset of months prior to death. No other significant conditions were listed as contributing to the Veteran's death. At the time of his death, the Veteran had been granted service connection for several physical and mental health disabilities. There is no argument or indication that such disabilities caused or contributed to cause the Veteran's death. Instead, the Appellant contends that the Veteran's pancreatic cancer was due to his exposure to herbicides while serving in the Republic of Vietnam, to include as a result of type II diabetes mellitus as a contributing cause of fatal pancreatic cancer. If a veteran served in the Republic of Vietnam during the period from January 9, 1962, to May 7, 1975, he or she will be presumed to have been exposed to herbicides, including Agent Orange, during such service. 38 C.F.R. §§ 3.307(a)(6). In this case, the Veteran's service was during the relevant period, and he served in Vietnam. Thus, he is presumed to have been exposed to herbicides during service. Certain listed diseases, including type II diabetes mellitus and certain types of cancers, will be presumed service-connected due to herbicide exposure during service if they manifested to a compensable degree at any time. 38 C.F.R. §§ 3.307(a)(6), 3.309(e). VA's Secretary has repeatedly determined, based on reports of the National Academy of Sciences (NAS), that there is inadequate or insufficient evidence to determine whether an association exists between herbicide exposure and pancreatic cancer. See, e.g., 79 Fed. Reg. 20308, 20312 (April 11, 2014). Service connection may not be granted on a presumptive basis as due to herbicide exposure for any condition for which VA's Secretary has not specifically determined that a presumption of service connection is warranted. See, e.g., 68 Fed. Reg. 27630 (May 20, 2003); see also 38 U.S.C.A. § 1116(b),(c). As such, presumptive service connection is not authorized for the Veteran's fatal pancreatic cancer based on herbicide exposure. However, presumptive service connection is proper for the Veteran's diabetes on such basis, although the Veteran had not claimed service connection for this disability during his lifetime. A determination that presumptive service connection is not warranted for a disease does not preclude VA from granting service connection if there is evidence of a direct causal link to service. Combee v. Brown, 34 F.3d 1039 (Fed. Cir. 1994). In this case, the Appellant is not competent to offer an opinion as to the cause of the Veteran's pancreatic cancer or whether other conditions contributed to cause his death because she has no medical expertise. There is conflicting medical evidence. The Veteran's final VA treatment records and death certificate reflect that he was diagnosed with pancreatic cancer in February 2012. He was admitted for hospice care in February 2012 for advanced pancreatic cancer, metastatic cancer, and hepatobiliary obstruction. The previous medical history included diabetes mellitus Type II with neurological manifestations, morbid obesity, tobacco use disorder, hypertension, right-sided congestive heart failure, and other conditions. Upon admission in February 2012, the Veteran was found to have extensive metastatic disease of the liver with an ill-defined mass at the head of the pancreas. Pertinent imaging studies included a March 2010 pathology report for the urinary bladder showing a low-grade non-invasive papillary carcinoma. A February 2012 CT scan of the abdomen and pelvis showed hepatomegaly and multiple lesions in the liver, which were noted to be indicative of metastasis with progression in size and number since a prior CT scan in November 2008, which is not of record. An April 2010 VA treatment record after the March 2010 showing of a urinary bladder tumor noted that there was no evidence of regional lymph noted or distant metastasis. There has been no medical finding that the Veteran's pancreatic cancer was not a primary site of cancer. VA treatment records in December 2010 noted that the Veteran's diabetes was diet-controlled, and he was not taking oral medications or insulin. In October 2011, he had uncontrolled diabetes and Metformin was added as a medication; and active medications shortly before the Veteran's death in February 2012 included Metformin and insulin. A January 2011 record noted that the Veteran had a smoking history of one pack per day for 40 years until quitting in June 2010. Evidence in favor of the Appellant's claim includes opinion letters in January 2013 and April 2014 from Dr. B, a private physician who indicated that he is Board-certified in internal medicine, endocrinology, and metabolism. He also stated that he is an experienced academic physician and had spent his career teaching medical students, residents in internal medicine, and fellowship trainees in endocrinology. In his January 2013 letter, Dr. B discussed the types of symptoms that can be caused by exposure to herbicides with dioxin such as Agent Orange, and stated that the Veteran manifested many of those symptoms. He opined that the Veteran's medical records and problems were "in full accord with recent lines of emerging clinical and scientific evidence that establish a firm link" between the Veteran's Agent Orange exposure and his development of metabolic syndrome and three different cancers. Therefore, Dr. B opined that it was more likely than not that there was a "causal relationship" between the Veteran's in-service exposure to herbicides containing dioxin and his subsequently development of pancreatic cancer. Dr. B also noted in January 2013 that the risk of pancreatic cancer is increased in individuals who are obese, and that the Veteran was noted to be morbidly obese as early as 2004, before his presentation with pancreatic cancer in 2012, and to have hypertension, dyslipidemia, and Type 2 diabetes mellitus. Dr. B stated that this combination of conditions is now recognized to constitute metabolic syndrome, which has been shown to increase the risk of pancreatic cancer even in the absence of Agent Orange exposure, citing to a 2011 medical study in support of this proposition. Dr. B further stated that insulin resistance is a key feature of metabolic syndrome, and that this is believed to be a factor that promotes the development of cancer, citing to a 2012 medical study in support of this proposition. Dr. B noted that this disturbance in cell metabolism was first reported by investigators at a VA Medical Center to occur in healthy subjects with prior Agent Orange exposure. Dr. B opined in January 2013 that it was more likely than not that the Veteran had dioxin-acquired (i.e., related to herbicide exposure in service) insulin resistance and that this was etiologically related to his elevated blood pressure, obesity, dyslipidemia, and Type 2 diabetes. Dr. B noted that the Veteran's diabetes had been present since 2004, and that there is a presumption of service connection for this condition based on Agent Orange exposure. Dr. B provided a detailed discussion of medical literature, including relevant citations, concerning dioxins and metabolic syndrome and the development of various types of cancer. Dr. B opined that dioxin-related insulin resistance resulted in the Veteran's hyperplastic colonic polyps in 2005, bladder cancer in 2010, and pancreatic cancer in 2012. The RO obtained an opinion from a VA examiner in June 2013. This examiner noted Dr. B's 2013 opinion letter and indicated that he had provided accurate information as to the biochemical mechanisms for Agent Orange-induced cellular abnormalities. Nevertheless, the examiner discounted Dr. B's opinion, stating that the question was not whether the physiological abnormalities are similar to those in cancers that VA has already identified as related to Agent Orange, but rather whether the pancreatic cancer that caused the Veteran's death has been associated with Agent Orange. The examiner was unaware of any evidence that had been accepted by VA to show a likelihood of an increase of pancreatic cancer in individuals exposed to Agent Orange. Thus, this opinion essentially relied on a lack of presumptive service connection for pancreatic cancer to reject evidence regarding a direct link between pancreatic cancer and herbicide exposure, which is an improper for a negative etiology opinion on direct service connection between herbicide exposure and a disease. The VA examiner also pointed out that Dr. B's private opinion did not consider the Veteran's tobacco use disorder, and stated that it is well known that smokers are at risk of developing bladder cancer and pancreatic cancer. The examiner then opined that, "given the current state of medical knowledge, it is impossible to determine whether this veteran's exposure to Agent Orange in and of its self [sic] would have been sufficient to cause this veteran to develop pancreatic cancer in the absence of cigarette smoking." The examiner also stated that there is "no consensus medical opinion that individuals with diabetes are at high risk of the development of pancreatic cancer to the best of my medical knowledge." He noted, "There are obviously tens of thousands of individuals who have had pancreatic cancer who did not have pre-existing type II diabetes mellitus prior to development of their pancreatic cancer." Thus, the VA examiner stated that further scientific explanation is needed for a "full understanding of the development of pancreatic cancers." The VA examiner's rationale is inadequate because the fact that the Veteran had other conditions that may have resulted in his pancreatic cancer does not preclude a finding that his herbicide exposure or diabetes caused or contributed to cause his death from pancreatic cancer. Further, the VA examiner appeared to apply a higher standard of proof than "at least as likely as not," or at least a 50 percent probability, as required for VA claims under the benefit of the doubt doctrine. It is not necessary to have a full understanding of the etiology of a condition to warrant service connection, as reasonable doubt will be resolved in the appellant's favor. Dr. B submitted a response to this VA examination report in April 2014, in which he reiterated his prior opinion that the Veteran's development of pancreatic cancer was more likely than not related to his Agent Orange exposure during service. Dr. B acknowledged that pancreatic cancer is not a disease that VA presumes is related to Agent Orange exposure, and that the Institute of Medicine (IOM) had concluded several times that there was inadequate or insufficient evidence of an association between Agent Orange and pancreatic cancer, as noted above. However, Dr. B stated that the IOM did acknowledge in its 2006 report that there were significant increases in the rates of pancreatic cancer occurring in three different military groups that served in Vietnam and had presumed Agent Orange exposure. Dr. B further noted that the 2012 report from the IOM listed studies that showed increasing numbers of cases of pancreatic cancer among workers involved with herbicides containing dioxin. He stated that studies published prior to recent IOM meetings provided increasing evidence of biological plausibility to support a causal relationship between Agent Orange exposure and pancreatic cancer. In April 2014, Dr. B also acknowledged the Veteran's smoking history, but he indicated that VA had previously determined that five cancers that are generally deemed to be smoking-related were presumed to be associated with Agent Orange exposure, citing to cancers listed in the applicable VA regulation. Thus, Dr. B opined that the Veteran's history of tobacco use should not prevent his pancreatic cancer as being found to be related to his presumed Agent Orange exposure. The Board obtained opinions from two specialists with the Veterans Health Administration (VHA), pursuant to 38 C.F.R. § 20.901. The first specialist is an oncologist and provided opinions and clarification in September and December 2015; however, he stated in the clarification report that he had very limited expertise in cases involving pancreatic cancers, and suggested that an opinion from gastroenterology oncologist be obtained. As such, the Board requested an opinion from a gastroenterology oncologist, who provided opinions in March 2016. Each of these VHA specialists provided negative opinions regarding a link between the Veteran's pancreatic cancer and herbicide exposure, as well as between his pancreatic cancer and diabetes or hypertension. As discussed below, these opinions are less probative than the opinions provided by Dr. B, particularly when considered together with additional medical literature supplied by the VHA oncologist. In a September 2015 response, the VHA oncologist opined that it was less than 50 percent likely that the Veteran's pancreatic cancer was caused by exposure to herbicides. He had noted earlier in his report that the Veteran was diagnosed with pancreatic cancer more than 25 years after service, and pancreatic cancer is a rapidly growing cancer with a short expected survival. He stated that the cancer, therefore, could not have started shortly after Agent Orange exposure. This opinion is inadequate because it did not consider other evidence of record concerning possible delayed onset of pancreatic cancer as a result of herbicide exposure. In a December 2015 clarifying response, this VHA oncologist stated that he had reviewed the IOM article regarding Agent Orange exposure referenced by Dr. B, but that he did not see "any clear causal relationship between exposure to herbicides and pancreatic cancer." This rationale appears to have applied too high of a standard of proof "clear causal relationship"), requiring more than 50 percent probability, and is inadequate for VA purposes. In a March 2016 response, the VHA gastroenterology oncologist opined that there was not a greater than 50 percent probability that the Veteran developed pancreatic cancer as a result of exposure to herbicides for two main reasons. First, the specialist did not believe that "sufficient evidence of causality" had been established between in-service herbicide exposure and the development of pancreatic cancer. Second, the specialist stated that the Veteran's obesity and smoking history were established risk factors for developing pancreatic cancer, and that the relationship between smoking and pancreatic cancer was particularly strong, with estimates linking pancreatic cancer to smoking in 20-30 percent of cases. Thus, this specialist stated that it was "not possible to conclude with any reasonable degree of certainty" that herbicide exposure caused pancreatic cancer. These explanations are inadequate for similar reasons as the VA examiner's report. With regard to a relationship between the Veteran's diabetes and/or hypertension and his pancreatic cancer, the VHA oncologist stated in September 2015 that diabetes and hypertension are "very, very common diseases whereas pancreatic cancer is a relatively rare disorder." Thus, he opined that it was less than 50 percent likely that the Veteran's pancreatic cancer was caused by diabetes or hypertension. This rationale regarding frequency of the disorders is irrelevant, as the Veteran's type II diabetes is presumptively service-connected based on herbicide exposure. This VHA oncologist also referred to medical literature enclosed with his report, which is discussed below. Earlier in the report, he provided rationale that large studies showed that there was a concurrence of diabetes and pancreatic cancer, but they highlighted a more significant correlation in thin or rapidly worsening diabetics within two years preceding a history of cancer of the pancreas. This oncologist also stated that numerous studies had shown the relative risk of pancreatic cancer in a smoker to be at least 1.5, and that large studies showed that the risk of pancreatic cancer fell by 48 percent in two years after quitting smoking. In a December 2015 clarifying response, this VHA oncologist again stated that diabetes "is an extremely common metabolic disorder in the general public." He reiterated his reasoning that there was "no conclusive 'causal' relationship" between diabetes and pancreatic cancer "except in 'thin' new diabetics where diabetes is believed to be a paraneoplastic process rather than a cause." This specialist attached several medical articles that are discussed below in support of this conclusion. He also attached a list of the diseases that VA presumes to be associated with herbicide exposure, as summarized on VA's website, and stated that there was a "glaring absence of pancreatic carcinoma" in this list. Again, the specialist's requirement of a "conclusive" relationship is too high of a standard for VA claims, and his reliance on the list of presumptive diseases is inadequate because it ignores the possibility of a direct link to herbicide exposure. In a March 2016 response, the VHA gastroenterology oncologist opined that the Veteran's diabetes and hypertension "were not significant factors for developing or propagating" his pancreatic cancer. The specialist noted that diabetes is considered to be one of the risk factors for pancreatic cancer, but he stated that "the association is not considered strongly-related (unlike smoking)." The VHA gastroenterology oncologist further stated in March 2016 that the essence of the question of whether the Veteran's diabetes contributed to the Veteran's fatal pancreatic cancer had to do with what caused the Veteran's diabetes in this patient. Similar to the other VHA oncologist, this specialist also noted that diabetes is a common disorder and stated that the Veteran was at risk of developing diabetes due to being obese. This rationale is inadequate because VA presumes that the Veteran's diabetes was incurred as a result of his in-service herbicide exposure. In addition to the numerous medical articles cited by Dr. B in his two opinion letters, the VHA oncologist provided copies of multiple medical articles. An Up-to-Date article printed in September 2015 noted that there are many risk factors for pancreatic cancer, including cigarette smoking, obesity, and physical activity, as well as diabetes and other factors. This article stated that there was data to "support the view that abnormal glucose metabolism and insulin resistance are etiologic [i.e., causal] factors rather than the result of a subclinical cancer." In a study involving more than 29,000 participants, "[a]fter adjustment for age, years of smoking, and BMI [i.e., weight], higher pre-diagnosis serum concentrations of glucose and insulin, as well as insulin resistance were significantly correlated with the risk of pancreatic cancer." The reason for this association was unclear, but "at least some data suggest that [there is an] increased risk of pancreatic cancer in patients with metabolic disease such as diabetes mellitus and other states of insulin resistance as well as obesity." The article referenced new onset of diabetes in thin older adults as possibly warranting consideration of screening for early pancreatic cancer, but that currently the factors to distinguish "pancreatic cancer-associated diabetes from other cases with new-onset diabetes" had not yet been determined. The VHA oncologist also provided several Up-to-Date Medline abstracts for reference in December 2015. An abstract from 2005 noted that medical literature from 1996 to 2005, with information concerning over 9,000 individuals with pancreatic cancer indicated that patients who had been diagnosed with diabetes less than four years earlier had a 50 percent higher risk of pancreatic cancer those who had diabetes for five years or longer. The abstract concluded that this supported "a modest causal association between type-II diabetes and pancreatic cancer." An abstract of a 2013 study of 500 cancer patients and 100 patients without cancer reflected a conclusion that "the prevalence of [diabetes] in [pancreatic cancer] is very high." The abstract stated, "In particular, new-onset [diabetes] is a phenomenon that is unique to [pancreatic cancer]." The study had noted that patients with pancreatic cancer had a significantly higher prevalence of diabetes mellitus (68 percent) compared to similar aged patients with other types of cancers and non-cancer controls; and among the patients with pancreatic cancer, 40 percent developed diabetes in the 36 months preceding the diagnosis of pancreatic cancer. An abstract of a study of 88 patients in 2014 stated that the results demonstrated "a strong association" between pancreatic cancer and "recently diagnosed" diabetes, but that diabetes was also a "modest risk factor" for such cancer in the long-term. The above articles appear to support the VHA oncologist's statements in 2015 that studies highlighted a more significant correlation between diabetes and pancreatic cancer where the diabetes diagnosed close in time to cancer and in a thin individual. However, an abstract from 1998 for a study of over 1 million individuals in the United States showed that a "history of diabetes was significantly related to pancreatic cancer mortality" and that "[t]he death rate from pancreatic cancer was twice as high in diabetics as in non-diabetics during the second and third years of follow-up ... [and] about 40 percent higher in years nine to 12." The conclusion was that the "persistent increased risk of death from pancreatic cancer, seen even with the diagnosis of diabetes preceded death by many years, supports the hypothesis that diabetes may be a true, albeit modest, risk for pancreatic cancer." Similarly, an abstract of a 2014 study of more than 22,000 individuals, including over 8,000 cases of pancreatic cancer, stated that risk estimates were consistent even when considering variables such as body mass index and tobacco smoking. The study concluded that there was "an excess risk of pancreatic cancer among diabetics," and that "a 30 [percent] excess risk persists for more than two decades after diabetes diagnosis, thus supporting a causal role of diabetes in pancreatic cancer." Furthermore, "[o]ral antidiabetics may decrease the risk of pancreatic cancer, whereas insulin showed an inconsistent duration-risk relationship." An abstract from 2006 stated that, in a study of over 6,000 newly diagnosed cancer cases, the hazard ratio was "especially high" for those with pancreatic cancer. An abstract from 1998 stated, "Diabetes has been associated with an increased risk of several cancers, notably cancers of the pancreas..." A study of over 100,000 diabetic patients showed "a high ratio of 2.1 for pancreatic cancer" after 1-4 years, which declined to 1.3 after 5-9 years. The study concluded that patients hospitalized with diabetes appeared to have a higher risk for pancreatic cancer. An abstract of a 2005 study of over 1 million Korean individuals reflected that "[s]ignificant associations" were found between diabetes and pancreatic cancer and other cancers. Conclusions were that "elevated fasting serum glucose levels and a diagnosis of diabetes are independent risk factors for several major cancers, and the risk tends to increase with an increased level of fasting serum glucose." As noted above, the VA examiner and VHA specialists' opinions are inadequate for several reasons. Further, although some of the medical articles indicate that there is a more significant risk of pancreatic cancer when diabetes is of recent onset, there are several articles including studies of very large groups of individuals that reflect that there was still a significant risk factor for pancreatic cancer even when diabetes was diagnosed as many as 20 years earlier than the cancer. The articles also noted that diabetes could result in a higher risk of pancreatic cancer even when controlling for the effects of a smoking history and obesity. The private opinion letters from Dr. B applied medical expertise and pertinent medical literature, which appears consistent with the articles of record, and used the proper standards of proof Thus, considering all of the medical evidence of record, the Board finds that the evidence is in relative equipoise as to whether the Veteran's pancreatic cancer was caused by his herbicide exposure during Vietnam or was contributed to by his diabetes, which is presumed to be service-connected due to herbicide exposure. Resolving reasonable doubt in the appellant's favor, the criteria for service connection for the cause of the Veteran's death have been met. 38 C.F.R. § 3.102. ORDER Entitlement to service connection for the cause of the Veteran's death is granted. ____________________________________________ M. HYLAND Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs