Citation Nr: 1307461 Decision Date: 03/05/13 Archive Date: 03/11/13 DOCKET NO. 04-34 902 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Boston, Massachusetts THE ISSUES 1. Entitlement to service connection for bladder cancer, to include as due to herbicide (Agent Orange (AO)) exposure. 2. Entitlement to a total disability evaluation based upon individual unemployability due to service-connected disabilities (TDIU). REPRESENTATION Appellant represented by: Michael Wishnie, Attorney-at-Law ATTORNEY FOR THE BOARD T. S. Kelly, Counsel INTRODUCTION The Veteran, who is also the appellant, served on active duty from December 1968 to November 1970. As to claim of service connection for bladder cancer, this matter originally came before the Board of Veterans' Appeals (Board) on appeal from a July 2004 rating determination of the Regional Office (RO) of the Department of Veterans Affairs (VA) located in Boston, Massachusetts, which denied service connection for cancer of the bladder, including as due to herbicide exposure. In an April 2009 decision, the Board denied the appeal for service connection for bladder cancer, including as due to herbicide exposure. The Veteran appealed the Board's denial to the United States Court of Appeals for Veterans Claims (Court), and the Board's decision was vacated pursuant to a September 2010 Joint Motion for Remand (JMR). The parties requested that the Court vacate the Board's April 2009 decision regarding the denial of service connection for bladder cancer and remand the matter so the Board could discuss apparent inconsistencies in a March 2009 opinion from a physician of the Veterans Health Administration (VHA). The Court granted the joint motion and remanded the case to the Board. In April 2011, the Board referred the matter for an independent medical expert opinion. The requested opinion was provided in May 2011. Thereafter, the Board, in an August 2011 decision, again denied service connection for cancer of the bladder, to include as due to AO exposure. The Veteran again appealed the Board's denial to the Court, and the Board's decision was vacated pursuant to an April 2012 JMR. The parties requested that the Court vacate the Board's August 2011 decision regarding the denial of service connection for bladder cancer and remand the matter so the Board could provide an adequate statement of reasons and bases that discussed whether the March 2009 VHA report was adequate to deny service connection and so that the Board could provide a statement of reasons and bases in which it specifically addressed the probative weight or value it assigned to the April 2008 opinion from the Veteran's private physician, A. O., M.D., and whether the benefit of the doubt rule was for application in the Veteran's case. In April 2012, the Court granted the joint motion and remanded the matter to the Board for actions consistent with the terms of the joint motion. As to the issue of a TDIU, the RO denied the Veteran's claim for a TDIU in February 2010. The Veteran filed a notice of disagreement with the TDIU denial in March 2010. To date, a statement of the case has not been issued with regard to this claim. As it relates to the claim for a TDIU, the Board notes that the Veteran was initially represented by The American Legion on this claim. In September 2012, Michael Wishnie, Esq., on behalf of the Veterans Legal Services Clinic at Yale Law School, filed a VA Form 21-22a, Appointment of Individual as Claimant Representative Form, to represent the Veteran. As the form did not limit representation to any specific issue or claim, Attorney Wishnie/Veterans Legal Services at Yale Law School is now the Veteran's representative with regard to all claims, to include the issue of entitlement to a TDIU. The issue of entitlement to a TDIU is remanded to the RO. FINDING OF FACT The Veteran's bladder cancer had its origin in service. CONCLUSION OF LAW Resolving reasonable doubt in favor of the Veteran, bladder cancer was incurred in service. 38 U.S.C.A. §§ 1110, 1112, 1113 (West 2002); 38 C.F.R. §§ 3.102, 3.159, 3.303, 3.307, 3.309 (2012). REASONS AND BASES FOR FINDING AND CONCLUSION Duties to Assist and Notify The Veterans Claims Assistance Act of 2000 (VCAA) and implementing regulations impose obligations on VA to provide claimants with notice and assistance. 38 U.S.C.A. §§ 5102, 5103, 5103A, 5107, 5126 (West 2002 & Supp. 2011); 38 C.F.R §§ 3.102, 3.156(a), 3.159, 3.326(a) (2012). Proper VCAA notice must inform the claimant of any information and evidence not of record (1) that is necessary to substantiate the claim; (2) that VA will seek to provide; (3) and that the claimant is expected to provide. 38 U.S.C.A. § 5103(a); 38 C.F.R. § 3.159(b)(1). For claims pending before VA on or after May 30, 2008, 38 C.F.R. § 3.159 has been amended to eliminate the requirement that VA request that a claimant submit any evidence in his or her possession that might substantiate the claim. 73 Fed. Reg. 23,353 (Apr. 30, 2008). As the Board is granting the full benefit sought on appeal as it relates to the claim of service connection for bladder cancer, the claim is substantiated, and there are no further VCAA duties. Wensch v. Principi, 15 Vet App 362, 367-368 (2001); see also 38 U.S.C.A. § 5103A(a)(2) (VA Secretary not required to provide assistance "if no reasonable possibility exists that such assistance would aid in substantiating the claim"); VAOPGCPREC 5-2004 (the notice and duty to assist provisions of the VCAA do not apply to claims that could not be substantiated through such notice and assistance). Service Connection for Bladder Cancer Service connection may be granted for disability resulting from disease or injury incurred in or aggravated by active service. 38 U.S.C.A. § 1110; 38 C.F.R. § 3.303(a) (2012). In addition, service connection may be granted for any disease diagnosed after discharge, 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). In order to establish service connection for a claimed disorder on a direct basis, generally, there must be: (1) medical evidence of a current disability; (2) medical, or in certain circumstances, lay evidence of the in-service incurrence or aggravation of a disease or injury; and (3) medical evidence of a nexus between the claimed in-service disease or injury and the current disability. See Hickson v. West, 12 Vet. App. 247, 253 (1999). The determination as to whether the requirements for service connection are met is based on an analysis of all of the evidence of record and the evaluation of its credibility and probative value. 38 U.S.C.A. § 7104(a) (West 2002); 38 C.F.R. § 3.303(a) (2012). See Baldwin v. West, 13 Vet. App. 1 (1999). When there is an approximate balance of positive and negative evidence regarding a material issue, the benefit of the doubt in resolving each such issue shall be given to the claimant. 38 U.S.C.A. § 5107(b) (West 2002); 38 C.F.R. § 3.102. See Ortiz v. Principi, 274 F.3d 1361, 1364 (Fed. Cir. 2001). If the Board determines that the preponderance of the evidence is against the claim, then it has necessarily found that the evidence is not in approximate balance, and the benefit of the doubt rule will not be applicable. Ortiz, 274 F.3d at 1365 VA regulations provide that a veteran who had active military, naval, or air service in the Republic of Vietnam during the Vietnam Era shall be presumed to have been exposed during such service to an herbicide agent, unless there is affirmative evidence to establish that the veteran was not exposed to any such agent during that service. 38 C.F.R. § 3.307(a)(6)(iii). The following diseases are deemed associated with herbicide exposure, under current VA law: chloracne or other acneform diseases consistent with chloracne, Type 2 diabetes, Hodgkin's disease, multiple myeloma, non-Hodgkin's lymphoma, acute and subacute peripheral neuropathy, porphyria cutanea tarda, prostate cancer, respiratory cancers (cancer of the lung, bronchus, larynx, or trachea), and soft-tissue sarcomas (other than osteosarcoma, chondrosarcoma, Kaposi's sarcoma, or mesothelioma). The foregoing diseases shall be service connected if a veteran was exposed to an herbicide agent during active military, naval, or air service, if the requirements of 38 U.S.C.A. § 1116, 38 C.F.R. § 3.307(a)(6)(iii) are met, even though there is no record of such disease during service, provided further that the rebuttable presumption provisions of 38 U.S.C.A. § 1113 and 38 C.F.R. § 3.307(d) are also satisfied. 38 U.S.C.A. §§ 501(a), 1116 (West 2002); 38 C.F.R. § 3.309(e). The diseases listed at § 3.309(e) shall have become manifest to a degree of 10 percent or more at any time after service, except that chloracne or other acneform disease consistent with chloracne, porphyria cutanea tarda, and acute and subacute peripheral neuropathy shall have become manifest to a degree of 10 percent or more within a year after the last date on which the veteran was exposed to an herbicide agent during active military, naval, or air service. 38 C.F.R. § 3.307(a)(6)(ii). VA regulations specify that the last date on which a veteran shall be presumed to have been exposed to an herbicide agent shall be the last date on which he or she served in the Republic of Vietnam during the period beginning on January 9, 1962 and ending on May 7, 1975. 38 C.F.R. § 3.307(a)(6)(iii). The Board here observes that bladder cancer is not listed among those disorders for which service connection may be presumptively warranted based upon exposure to certain herbicide agents. The Secretary, under the authority of the Agent Orange Act of 1991 and based on the studies by the NAS, has determined that there is no positive association between exposure to herbicides and any condition for which the Secretary has not specifically determined that a presumption of service connection is warranted. See Notice, 59 Fed. Reg. 341-346 (1994); see also Notice, 61 Fed. Reg. 41,442-449, and 61 Fed. Reg. 57,586-589 (1996); Notice, 64 Fed. Reg. 59,232 -243 (Nov. 2, 1999); Notice, 67 Fed. Reg. 42,600-08 (June 24, 2002); Notice, 72 Fed. Reg. 32,395 -407 (June 12, 2007); Final Rule, 74 Fed. Reg. 21,258 -260 (May 7, 2009); Final Rule, 75 Fed. Reg. 53,202-16 (Aug. 31, 2010). Notwithstanding the foregoing, a veteran may still establish service connection with proof of actual direct causation. See Combee v. Brown, 34 F.3d 1039, 1043-44 (Fed. Cir. 1994); see also McCartt v. West, 12 Vet. App. 164, 167 (1999). "Of particular relevance to an analysis of medical evidence supporting such a nexus are factors such as whether a medical professional finds studies persuasive, whether there are other risk factors that might be the cause of the condition for which benefits are sought, and whether the condition has manifested itself in an unusual manner." Polovick v. Shinseki, 23 Vet. App. 48, 53 (2009). A statistical correlation between AO and a disease not on the presumptive list may not be the only basis for a positive nexus opinion, it may be part of the analysis, but the entirety of the analysis provided by the medical professional must be weighed and considered. Polovick, 23 Vet. App. at 53-54. The Board has reviewed all the evidence in the Veteran's claims file, with an emphasis on the evidence relevant to this appeal. Although the Board has an obligation to provide reasons and bases supporting its decision, there is no need to discuss, in detail, every piece of evidence of record. Gonzales v. West, 218 F.3d 1378, 1380-81 (Fed. Cir. 2000). Hence, the Board will summarize the relevant evidence where appropriate and the analysis below will focus specifically on what the evidence shows, or fails to show, as to the claim. The Veteran contends that he is entitled to service connection for bladder cancer. He contends that bladder cancer is a direct result of his exposure to dioxin (AO) in Vietnam. In statements presented throughout the duration of the appeal, the Veteran has maintained that his current bladder cancer is directly related to herbicide exposure during his active military service. The record shows that the Veteran served in the Republic of Vietnam from June 1969 to December 1969. As the evidence of record reflects that the Veteran served in the Republic of Vietnam, exposure to herbicides is presumed. Service treatment records note that the Veteran reported a history of frequent urination in the course of his pre-induction examination conducted in October 1968. The remainder of the service treatment records are negative for complaints or findings concerning genitourinary problems. A private hospital treatment record dated in October 2003 notes a history of bladder cancer. A cystoscopy was performed. It was noted that the site of the previous tumor was free of any obvious tumor. The postoperative diagnosis was likely suspicious area seen. In a May 2004 letter, the Veteran's private physician, N. H., M.D., indicated that he had treated the Veteran for transitional cell carcinoma of the bladder. He opined that it was as least as likely as not that the Veteran's transitional cell carcinoma of the bladder was the result of his exposure to dioxin in Vietnam. He did not provide any reasons for this opinion. In December 2007, the Board sought an advisory medical opinion from the Veterans Health Administration (VHA) (to be rendered by a urological oncologist) in the matter of entitlement to service connection for bladder cancer, to include as due to exposure to AO. The reviewing VA specialist was asked to provide an opinion concerning whether it was at least as likely as not that the Veteran's cancer of the bladder tumors was related to service, to include exposure to AO. In a January 2008 report, the urologist observed that the Veterans Education and Expansion Act of 2001, Public Law 107-103, Section 201 (D) had determined that a presumption of service connection was not warranted based on exposure to herbicides used in the Republic of Vietnam during the Vietnam Era for health outcomes including bladder cancer. He noted that the findings regarding bladder cancer in AO remained unchanged in the 2004 update, issued March 4, 2005 and again in 72 Fed. Reg. 32395. He added that the Veteran's exposure to known risk factors such as smoking or certain other chemicals were not included in the provided records. The urologist noted the March 2004 letter from the Veteran's private physician, which provided an opinion that the Veteran's transitional cell carcinoma of the bladder "is at least as likely as not" the result of dioxin exposure. The VA staff urologist commented that as "there is no new evidence that I am aware of regarding the possibility of Agent Orange causing bladder cancer, I would conclude that the cause of this patient's bladder cancer is unknown." In response to the January 2008 VHA opinion, the Veteran, in June 2008, submitted two private medical opinions. The first opinion from D. K., M.D., dated in February 2008, noted that the Veteran was under his care for transitional cell carcinoma of the bladder. He opined that "it is at least as likely as not that this condition is the result of his exposure to dioxin during his military service" in Vietnam. There was no reason given to support his opinion. The second opinion is dated in April 2008, from the Veteran's private physician, A. O., M.D. He indicated that he also was treating the Veteran for bladder and prostate cancer. It was opined that "[i]t is at least as likely as not that [the Veteran's bladder cancer] is the result of exposure to dioxin during his military service" in Vietnam. The physician submitted two studies to substantiate this opinion. The first study, from the National Institute of Public Health, Bilthoven, Netherlands, Department of Chronic Diseases and the American Journal of Epidemiology, was noted to have been published in 1998, by the American Journal of Epidemiology. A second study, from the Mario Negri Institute for Pharmacological Research, in Milan, Italy, was noted to have been published in the International Journal of Epidemiology in 1990. In November 2008, a second advisory medical opinion from the VHA (to be rendered by a urological oncologist) in the matter of entitlement to service connection for bladder cancer, to include as due to exposure to Agent Orange was requested. The opinion request letter notified the reviewing physician of the above discussed two private medical opinions, which both found that it was as least as likely as not that the Veteran's bladder cancer resulted from his exposure to dioxin in Vietnam. The medical research studies cited by the Veteran's private physician were noted and it was requested that a discussion of those studies be included in the opinion. The letter also noted, as did the December 2007 VHA request letter, that the Secretary of VA had determined, based on a National Academy of Science report issued in March 2005, that there was no positive association between exposure to herbicides and any other condition for which the Secretary has not specifically determined that a presumption of service connection is warranted. See Notice, 72 Fed. Reg. 32395-32407 (June 12, 2007). That report further identified an absence of a causal association between herbicide exposure and urinary bladder cancer. It was added, however, that, as noted above, the VA Secretary's decision not to establish presumptive service connection for urinary bladder cancer did not prohibit service connection for such a disorder on other bases. The reviewing VA specialist was asked to provide an opinion as to whether it was at least as likely as not that the Veteran's cancer of the bladder tumors was related to service, to include exposure to AO therein. In a March 2009 VHA medical opinion, the VA oncologist indicated that it was "more unlikely" that the Veteran's bladder cancer had resulted from exposure to dioxin while in Vietnam. While noting that the Veteran was exposed to AO between June and September 1969, and acknowledging his review of the above cited private medical opinions as well as the two private studies supplied by the Veteran, the VA oncologist noted that there appeared to be insufficient epidemiologic data to suggest a cause and effect relationship between exposure in Vietnam and the development of bladder cancer. He added that, while the two small case controlled studies cited (from Milan and the Netherlands) suggested that there may be a relative risk of the development of bladder cancer in workers exposed to herbicides/other chemicals over a prolonged period of time (defined in one study as at least more than one year), there appeared to be no large epidemiologic study or data to support this. In April 2011, the Board requested that the Veteran's claims file be reviewed by an Independent Medical Examiner (IME). The request noted all of the prior medical opinions and studies of record and asked that an opinion be rendered regarding whether it is at least as likely as not that the Veteran's cancer of the bladder is related to his exposure to the dioxin AO during service. In May 2011, the IME response was received. He noted that he had been asked to render an opinion as to whether exposure to AO was responsible for the bladder cancer; i.e., was this malignancy service-related. He stated that the first place to look to establish this relationship was the epidemiologic study performed at the Institute of Medicine ((IOM) of the National Academy of Science (NAS) in 1991. This study failed to show a relationship between AO and exposure to bladder cancer. The IME then noted the April 2008 letter from Dr. O. and the two publications to which Dr. O. cited to support his opinion that the Veteran's bladder cancer was a result of his exposure to AO. The IME also observed that the January 2008 VHA opinion did not support the relationship between AO and bladder cancer. The IME also noted the March 2004 letter/opinion from Dr. H., which was not supported by any scientific data. The IME further reported that in a chapter entitled "Epidemiology of bladder cancer" by Yves Fradet, M.D., found in the textbook Comprehensive Textbook of Genitourinary Oncology by Vogelsang, Scardino, Shipley, and Coffey, the author stated "urinary bladder cancer is historically the neoplastic disease most strongly linked to occupational and environmental exposure to chemicals." It also stated that, however, that cigarette smoking is strongly associated with the development of cancer with a RR of 2-20. The IME indicated that the case had arguments for and against associating the bladder cancer with AO exposure. Integrating all this information, he concluded that despite a brief (3 month) exposure and the epidemiologic publications cited by Dr. O., the preponderance of the evidence was against the relationship. He indicated that virtually all the patients he had seen in his over 40 year career in radiation oncology with bladder cancer had been smokers. He also noted that the fact that bladder cancer had not figured in the IOM/NAS study was also strong evidence that the relationship was just not there. After reviewing the epidemiologic studies, medical opinions, and medical literature, the IME concluded that the preponderance of the evidence was against a relationship between the Veteran's bladder cancer and his exposure to dioxin in Vietnam. In summary, the IME noted that the Veteran had a three month exposure to AO in service in 1969, had a 30 pack/years history of cigarette smoking after service, and 38 years after service the Veteran developed muscle-invasive bladder cancer requiring radical surgery. In the IME's opinion, there was less than a fifty percent likelihood that the tumor was caused by the AO and that there was a greater than fifty percent likelihood that it was caused by heavy cigarette smoking. Subsequent to the April 2012 JMR, the Veteran, through his attorney, submitted additional evidence, in the form of argument, statements from the Veteran and members of his family, and additional letters/opinions from Drs. K. and O, along with the appropriate waiver. In a December 2012 statement, the Veteran indicated that he stopped smoking in January 1973. He stated that he had not smoked a single cigarette since January 1, 1973. The Veteran's wife, in a December 2012 statement, indicated that she had met the Veteran in 1974 and that during their 38 years of courtship and marriage, she never saw the Veteran smoke a single cigarette, cigar, or pipe. The Veteran's brother, in a December 2012 statement, also indicated that the Veteran had stopped smoking in early 1973. In an April 2012 letter, Dr. K. again indicated that he had treated the Veteran for transitional cell carcinoma of the bladder while at Massachusetts General Hospital. He again stated that in his opinion it was at least as likely as not that this condition was the result of exposure to AO while in military service in the USMC in Vietnam. He indicated that the reason behind his opinion was that AO was a known potent carcinogen, with a convincing causative association with prostate cancer, another genitourinary cancer. He stated that as far as other carcinogens implicated in bladder cancer, the Veteran reported no others, except for cigarette usage. He observed that the Veteran had stopped smoking 30 years before the diagnosis of cancer was established. The Veteran's attorneys forwarded the curriculum vitae of the Dr. K., which the Board notes demonstrates extensive experience, in the form of treating, teaching, and writings/publications, relating to bladder cancer. An additional letter was also received from Dr. O., dated in April 2012, again indicating that it was his opinion that it was at least as likely as not that the Veteran's transitional cell carcinoma was induced and initiated by the Veteran's exposure to AO. He again referenced the two studies that he had provided in conjunction with his April 2008 opinion. He noted that the Veteran's exposure to AO, coupled with the fact that he quit smoking more than 30 years prior to his cancer diagnosis, made it plausible that it was at least as likely as not that the Veteran's bladder cancer was caused by his exposure to AO. The Veteran served in Vietnam, thus, exposure to AO is recognized. While the Board observes that bladder cancer is not one the presumptive diseases listed in VA regulations, this does not prevent the Veteran from presenting evidence which would allow for service connection on a direct basis. In this regard, the Board notes that there have been numerous opinions rendered as to whether the Veteran's bladder cancer is related to his presumed AO exposure in service. In support of his claim the Veteran has submitted statements from three individuals who have treated the Veteran for his bladder cancer. These physicians have indicated that it is at least as likely as not that the Veteran's bladder cancer was caused by his exposure to AO. Dr. O. has provided two specific studies linking bladder cancer to dioxins. Dr. K., who also treated the Veteran and has indicated that it is at least as likely as not that the his bladder cancer is related to AO, is one of the foremost authorities on the issue of bladder cancer. In contrast, there are two VHA opinions and one IME opinion of record which find it less likely as not that the Veteran's bladder cancer is related to his AO exposure. As to the January 2008 VHA urologist's opinion, the Board notes that while he indicated that there was no new evidence that he knew of regarding the possibility of AO causing bladder cancer, he ultimately concluded that the cause of the Veteran's bladder cancer was unknown. As to the March 2009 VHA opinion, the Board notes that the examiner, while indicating that it was unlikely that the Veteran's bladder cancer had resulted form the exposure to dioxin while in Vietnam, indicated that that he was unaware of the Veteran's smoking history. Moreover, while making reference to the studies provided by Dr. O., and indicating that there were no large epidemiologic studies or data to support those findings, the VHA examiner did not supply any studies to refute the evidence which had been presented by Dr. O. Finally, the May 2011 IME while indicating that that there was less than a 50 percent likelihood that the Veteran's bladder cancer was caused by AO, also made reference to medical literature which found that urinary bladder cancer was historically the neoplastic disease most strongly linked to occupational and environmental exposure to chemicals. He further observed that this case had arguments for and against associating bladder cancer with exposure to AO. While the IME found that the Veteran's smoking was more likely the cause of his bladder cancer, based upon a 30 pack/years history of cigarette smoking, there appears to be some discrepancy as to the quantity and duration of the Veteran's cigarette smoking based upon both the treatment records available and the statements from the Veteran and his family. In sum, the medical evidence of record is at least in equipoise as to whether the Veteran's bladder cancer is a result of his exposure to AO while in Vietnam; therefore, resolving reasonable doubt in favor of the Veteran, service connection is warranted for bladder cancer. 38 U.S.C.A. § 5107; 38 C.F.R. §§ 3.102. As the full benefit sought on appeal is being granted, any previous noncompliance with the prior JMRs is rendered moot. ORDER Service connection for bladder cancer is granted. REMAND As it relates to the issue of entitlement to a TDIU, the Boston RO denied this claim in February 2010. In a March 2010 statement in support of claim, the Veteran indicated that he disagreed with the decision made by the RO in the February 2010 rating determination. To date, a statement of the case has not been promulgated as it relates to this issue. The Board is required to remand the case for issuance of the statement of the case. Manlincon v. West, 12 Vet. App. 238 (1999). Accordingly, the issue of TDIU is REMANDED for the following action: Issue a statement of the case on the issue of entitlement to a TDIU that was decided in the February 2010 rating determination. The issue should be certified to the Board only if a timely substantive appeal is received. The Veteran has the right to submit additional evidence and argument on the matter the Board has remanded. Kutscherousky v. West, 12 Vet. App. 369 (1999). This claim must be afforded expeditious treatment. The law requires that all claims that are remanded by the Board of Veterans' Appeals or by the United States Court of Appeals for Veterans Claims for additional development or other appropriate action must be handled in an expeditious manner. See 38 U.S.C.A. §§ 5109B, 7112 (West Supp. 2011). ______________________________________________ J. Parker Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs