Citation Nr: 1320339 Decision Date: 06/24/13 Archive Date: 07/02/13 DOCKET NO. 11-19 314 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Detroit, Michigan THE ISSUE 1. Entitlement to compensation under 38 U.S.C.A. § 1151 for prostate cancer, status post radiation therapy, including residuals of bladder and bowel impairment, caused by testosterone therapy provided by the Department of Veterans Affairs (VA). 2. Entitlement to compensation under 38 U.S.C.A. § 1151 for bladder and bowel impairment caused by radiation treatment provided by VA. REPRESENTATION Appellant represented by: The American Legion WITNESS AT HEARING ON APPEAL Appellant ATTORNEY FOR THE BOARD S.K.C. Boyce, Associate Counsel INTRODUCTION The Veteran served on active duty from July 1957 to July 1959. This matter comes before the Board of Veterans' Appeals (Board) on appeal from an August 2010 rating decision of the Department of Veterans Affairs (VA) Regional Office (RO) in Detroit, Michigan, which denied entitlement to compensation under 38 U.S.C.A. § 1151 (West 2002 & Supp. 2012) for prostate cancer. The Veteran testified at a March 2012 hearing before the undersigned Veterans Law Judge (VLJ). He also testified at an April 2011 hearing before a Decision Review Officer (DRO). Transcripts of both hearings have been associated with the claims file. In June 2012, the Board remanded the matter to the AMC for further evidentiary development. This matter was previously characterized as one issue, entitlement to compensation under 38 U.S.C.A. § 1151 for cancer of the prostate, claimed as a result of testosterone therapy, in the Board's June 2012 remand order. It has become clear over the course of the development of this claim that the Veteran is actually alleging two claims under 38 U.S.C.A. § 1151: (1) that he was negligently provided with testosterone therapy that caused or aggravated his prostate cancer, and (2) that he was provided with improper radiation therapy for prostate cancer that resulted in unnecessary bladder and bowel impairment. Accordingly, this appeal has been separated into two claims for differently characterized disabilities, i.e., all residuals of prostate cancer versus residuals of radiation therapy only, that arise from two different instances of VA treatment, i.e., testosterone therapy versus radiation treatment for prostate cancer. See Boggs v. Peake, 520 F.3d 1330, 1336-37 (Fed. Cir. 2008); cf. Hillyard v. Shinseki, 24 Vet. App. 343, 355 (2011) (explaining that different theories remain part of the same claim when they pertain to the same benefit for the same disability). The Board retains proper jurisdiction over both claims even though the August 2010 rating decision and May 2011 statement of the case (SOC) do not expressly state the allegation of bladder and bowel impairment due to improper radiation treatment as a separate issue. These claims were filed at the same time and are facts related to each claim are repeatedly alleged together by the Veteran and his representative throughout the record, the issue is expressly discussed in the August 2010 rating decision and May 2011 SOC, the Veteran has been represented throughout the adjudication of his claim, and, while separate, it cannot be said that the claims are "in no way related" as they concern, essentially, two halves of the same factual narrative. See Munro v. Shinseki, 616 F.3d 1293, 1296-1300 (Fed. Cir. 2010); Adams v. Shinseki, 568 F.3d 956, 961-65 (Fed. Cir. 2009); Cogburn v. Shinseki, 24 Vet. App. 205, 212-13 (2010). Accordingly, a reasonable claimant would be aware from timing and content of adjudication that benefits were not awarded for bladder and bowel impairment caused by radiation therapy. Munro, 616 F.3d 1299; Adams, 568 F.3d 963-65. In this decision and remand order, the Board permissibly adjudicates one claim under 38 U.S.C.A. § 1151 and remands the other for further development as these claims do not concern the same theory of entitlement or turn on the same evidentiary issues. The decision below denying entitlement to benefits for prostate cancer does not have an impact on the remanded claim for benefits for bladder and bowel impairment due to radiation therapy and any eventual decision on the remanded claim for bladder and bowel impairment due to radiation therapy would not have had a significant impact on the decision on the claim for benefits for prostate cancer; therefore, these claims are not inextricably intertwined. See Smith v. Gober, 236 F.3d 1370, 1373 (Fed. Cir. 2001); Harris v. Derwinski, 1 Vet. App. 180, 183 (1991); see also Tyrues v. Shinseki, 23 Vet. App. 166, 186 (2009) (en banc), aff'd, 631 F.3d 1380 (Fed. Cir. 2011), vacated and remanded, 132 S. Ct. 75 (2011). The issue of entitlement to compensation under 38 U.S.C.A. § 1151 for bladder and bowel impairment caused by improper radiation treatment is addressed in the REMAND portion of the decision below and is REMANDED to the RO via the Appeals Management Center (AMC) in Washington, DC. Please note this appeal has been advanced on the Board's docket pursuant to 38 C.F.R. § 20.900(c) (2012). 38 U.S.C.A. § 7107(a)(2). FINDING OF FACT Testosterone replacement therapy prescribed by VA was not the actual cause of any additional disability from prostate cancer, status post radiation therapy, including residuals of bowel and bladder impairment. CONCLUSION OF LAW Compensation under the provisions of 38 U.S.C. § 1151 for prostate cancer, status post radiation therapy, including residuals of bladder and bowel impairment, is not warranted. 38 U.S.C.A. § 1151 (West 2002 & Supp. 2012); 38 C.F.R. § 3.361 (2012). REASONS AND BASES FOR FINDING AND CONCLUSION I. Duty to Notify and Assist VA has duties to notify and assist claimants in substantiating a claim for VA benefits. 38 U.S.C.A. §§ 5100, 5102, 5103, 5103A, 5107, 5126 (West 2002 & Supp. 2012); 38 C.F.R. §§ 3.102, 3.156(a), 3.159, 3.326(a) (2012). A letter dated November 2009 notified the Veteran of the information and evidence necessary to substantiate the claim, the portion of the information and evidence VA would obtain on his behalf, and the portion of the information and evidence the Veteran was asked to provide. See Quartuccio v. Principi, 16 Vet. App. 183, 186 (2002). Therefore, the Veteran has received all essential notice and has not been prejudiced by any technical notice deficiency. See Conway v. Principi, 353 F.3d 1369 (Fed. Cir. 2004). The Veteran's relevant VA treatment records from the VA Medical Center (VAMC) in Detroit, Michigan, including his records from the Community Based Outpatient Clinic (CBOC) in Pontiac, Michigan, and the VA Medical Center in Ann Arbor, Michigan have been obtained and associated with the claims file, including his complete laboratory test results from November 10, 2008, requested in the Board's June 2012 remand order. These records did not include PSA level data from November 10, 2008, because, as determined by the AMC, and the VA examiner upon review of the November 10, 2008, laboratory test data, PSA levels were not requested and do not exist for this date. The RO obtained a VA medical opinion in July 2010 and supplemental opinion in February 2013 that adequately addresses the medical questions raised in the § 1151 claim adjudicated in this decision. In the opinion, the examiner addressed the pertinent questions in this appeal, namely the issue of whether the Veteran suffered additional disability due to prostate cancer caused by testosterone therapy as a result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA in furnishing medical treatment, as alleged by the Veteran. The issue of whether the additional disability alleged was due to an event not reasonably foreseeable was not raised by the Veteran or the evidence of record and, furthermore, is not relevant to the determination of this claim. Issues concerning proximate causation are not reached where, as here, the preponderance of the evidence is against finding actual causation, as discussed further in the decision below. Therefore, no medical determination on that issue is necessary to ensure the adequacy of the July 2010 and February 2013 medical opinions. See Roberson v. Shinseki, 22 Vet. App. 358, 366 (2009) (holding that an opinion is adequate where it is sufficiently detailed to allow for a fully informed Board decision), aff'd 607 F.3d 809 (Fed. Cir. 2010). Similarly, the July 2010 and February 2013 opinions are adequate even though the examiner was not able to review the Fact Sheet from the National Cancer Institute submitted by the Veteran in April 2011 regarding DNA markers of inheritable cancer risk in July 2010 and did not directly address the Fact Sheet in the February 2013 medical opinion, but explained that testosterone therapy, and, consequently, any issue related to the provision of testosterone therapy, did not have an effect on the outcome of the Veteran's prostate cancer. Id. (explaining that a medical examiner need not discuss all evidence favorable to the claim when rendering an opinion); Nieves-Rodriguez v. Peake, 22 Vet. App. 295, 302-03 (2008) (explaining that in assessing "whether the examiner is aware of sufficient facts and data, the relevant inquiry is whether the medical expert is informed of sufficient facts upon which to base an opinion relevant to the problem at hand") (emphasis added). As the examiner expressed uncertainty resulting from the absence of any laboratory testing data from November 2008 when the existence of this information was mentioned in the testosterone therapy treatment records, the Board's June 2012 remand order, as previously discussed, directed the AMC to undertake all necessary efforts to procure those records and to return the claims file to the examiner for a supplemental medical opinion if the records were located. Consequently, as the November 2008 laboratory testing data was obtained on remand, a supplemental medical opinion was obtained in February 2013. The examiner determined that the November 2008 laboratory testing data did not include PSA levels and that no such data was ordered by the Veteran's medical care providers at that time. The examiner further recognized an error in the facts relied upon in the July 2010 medical opinion, corrected the error, and provided an updated medical opinion premised on the correct facts. The July 2010 opinion and February 2013 supplemental opinion are thorough and include detailed findings that are adequate for adjudication of the claim for § 1151 for prostate cancer due to testosterone therapy. Roberson, 22 Vet. App. at 366; Stefl v. Nicholson, 21 Vet. App. 120, 123 (2007). Any factual inaccuracies in the reasoning provided in the July 2010 opinion were corrected by the February 2013 supplemental opinion, and the examiner provided a sufficiently detailed reasoned medical explanation for the opinions provided. See Nieves-Rodriguez, 22 Vet. App. at 301. Therefore, the Board finds that the medical evidence of record is sufficient to resolve this appeal, and the VA has no further duty to provide an examination or opinion. 38 U.S.C.A. § 5103A(d); 38 C.F.R. § 3.159(c)(4). Furthermore, as the AMC undertook all necessary and legally required steps to obtain the Veteran's November 2008 laboratory testing data, to include any data on his PSA levels; the claims file was returned to the VA examiner for a supplemental medical opinion; the VA examiner determined that there is no existent November 2008 PSA level data and provided a supplemental medical opinion; the Veteran's outstanding recent VA treatment records were obtained; and, finally, the appeal was readjudicated in a February 2013 supplemental statement of the case, there has been substantial compliance with the Board's June 2012 remand order. Dyment v. West, 13 Vet. App. 141, 146-47 (1999); see also Stegall v. West, 11 Vet. App. 268, 271 (1998). Lastly, in Bryant v. Shinseki, 23 Vet. App. 488, 496-97 (2010), the United States Court of Appeals for Veterans Claims (Court) held that a hearing officer must fulfill two duties to comply with 38 C.F.R. § 3.103(c)(2): (1) the duty to fully explain the issues and (2) the duty to suggest the submission of evidence that may have been overlooked. Here, review of the transcripts show that the DRO and VLJ continuously sought to clarify and explain the issues on appeal at the April 2011 and March 2012 hearing, repeatedly sought information from the Veteran and his representative when necessary to facilitate understanding of his specific contentions, and sought to identify any outstanding records relevant to the Veteran's claims. Neither the Veteran nor his representative have asserted that VA failed to comply with 38 C.F.R. § 3.103(c)(2), nor have they identified any prejudice in the conduct of the April 2011 or March 2012 hearings. As such, the Board finds that the DRO and VLJ complied with the duties set forth in 38 C.F.R. § 3.103(c)(2). See Bryant, 23 Vet. App. at 496-97. Based on the foregoing, the Board finds that the VA fulfilled its duties to notify and to assist the Veteran in the evidentiary development of the § 1151 claim decided herein. No additional assistance or notification is required. The Veteran has suffered no prejudice that would warrant a remand on the issue adjudicated in this decision, and his procedural rights have not been abridged. Vazquez-Flores v. Shinseki, 24 Vet. App. 94, 107 (2010); Bernard v. Brown, 4 Vet. App. 384 (1993); see also Shinseki v. Sanders, 556 U.S. 396, 410 (2009). The Board will therefore proceed with the adjudication of this appeal. II. Evidentiary Standards The Board has reviewed all of the evidence in the Veteran's claims file and in Virtual VA (i.e., VA's electronic data storage system), with an emphasis on the evidence relevant to this appeal. Although the Board has an obligation to provide reasons and bases supporting this decision, there is no need to discuss, in detail, the evidence submitted by the appellant or on his behalf. See Gonzales v. West, 218 F.3d 1378, 1380-81 (Fed. Cir. 2000) (holding that the Board must review the entire record, but does not have to discuss each piece of evidence); see also 38 U.S.C.A. § 7104(d)(1). The analysis below focuses on the most salient and relevant evidence and on what this evidence shows, or fails to show, on the claim. The appellant must not assume that the Board has overlooked pieces of evidence that are not explicitly discussed herein. See Timberlake v. Gober, 14 Vet. App. 122 (2000) (explaining that the law requires only that the Board address its reasons for rejecting evidence favorable to the claimant). The Board must analyze the credibility and probative value of the evidence, account for the evidence that it finds persuasive or unpersuasive, and provide the reasons for its rejection of any material evidence favorable to the Veteran. Kahana v. Shinseki, 24 Vet. App. 428, 433 (2011). In doing so, equal weight is not accorded to each piece of evidence in the record as every item of evidence does not have the same probative value. Gilbert v. Derwinski, 1 Vet. App. 49, 57 (1990). When all the evidence is assembled, VA is responsible for determining whether the evidence supports the claim or is in relative equipoise, with the Veteran prevailing in either event, or whether a preponderance of the evidence is against a claim, in which case, the claim is denied. See Gilbert, 1 Vet. App. at 53; see also 38 U.S.C.A. § 5107; 38 C.F.R. § 3.102. III. 38 U.S.C.A. § 1151 For all claims filed on or after October 1, 1997, disability compensation under 38 U.S.C.A. § 1151 may be awarded where: (1) the Veteran incurred a qualifying additional disability that was not the result of his own willful misconduct, (2) the additional disability was caused by hospital care, medical or surgical treatment, or examination provided by VA or in a VA facility, and (3) the proximate cause of the disability was (a) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA or (b) an event not reasonably foreseeable. 38 U.S.C.A. § 1151(a)(1); Viegas v. Shinseki, 705 F.3d 1374, 1377 (Fed. Cir. 2013). Disability benefits under 38 U.S.C.A. § 1151 are awarded "in the same manner as if such additional disability or death were service-connected." 38 U.S.C.A. § 1151(a); see generally Trafter v. Shinseki, No. 10-3605, 2013 WL 1789774 (Vet. App. April 29, 2013). In determining whether a Veteran has incurred a "qualifying additional disability," the VA compares the Veteran's physical condition immediately prior to the beginning of the hospital care or medical treatment in which the claimed injury was sustained with his condition at the conclusion of such care or treatment. See 38 C.F.R. § 3.361(b). The remaining elements in the current version of 38 U.S.C.A. § 1151 constitute two different causation elements. See Viegas, 705 F.3d 1377-78. The additional disability must be both (1) actually caused by the hospital care or medical treatment received from VA and (2) proximately caused by VA's fault or an unforeseen event. See id.; see also 38 U.S.C.A. § 1151(a); 38 C.F.R. § 3.361(c)(1), (d). In determining whether the Veteran's disability was actually caused by VA hospital care or medical treatment, only a causal connection, and not direct causation, is required. Viegas, 705 F.3d at 1380; see also Brown v. Gardner, 513 U.S. 115, 119 (1994). However, a mere showing of additional disability following the receipt of VA care, treatment, or examination will not establish cause; the evidence must show that the hospital care, medical or surgical treatment, or examination resulted in the Veteran's additional disability. 38 C.F.R. § 3.361(c)(1). Proximate cause due to carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part in furnishing hospital care, medical or surgical treatment, or examination may be established by showing that VA failed to exercise the degree of care that would be expected of a reasonable healthcare provider, including failure to timely diagnose or properly treat a disease or injury, or that VA failed to obtain informed consent for the hospital care, medical or surgical treatment, or examination. 38 C.F.R. § 3.361(c)(2), (d)(1). Proximate cause due to an unforeseen event is determined based on what a reasonable healthcare provider would have foreseen. 38 C.F.R. § 3.361(d)(2). The event need not be completely unforeseeable or unimaginable, but must be one that a reasonable healthcare provider would not have considered to be an ordinary risk of the treatment provided. Id. IV. Discussion Here, the Board finds that the preponderance of the evidence is against the Veteran's claim of entitlement to compensation under 38 U.S.C.A. § 1151 for additional disability due to prostate cancer, status post radiation therapy, including residuals of bladder and bowel impairment, caused by testosterone therapy, as the evidence does not show that testosterone therapy is an actual cause of any additional disability due to prostate cancer. See Viegas, 705 F.3d 1380; 38 C.F.R. § 3.361(c)(1); see also 38 U.S.C.A. § 1151(a). The Veteran contends that the VA is at fault for the testosterone replacement therapy he received from the Pontiac Osteopathic Hospital, a contract partner with VA, resulting in additional disability of prostate cancer and the residuals of radiation therapy for prostate cancer, including incontinence of the bladder and bowel. He has alleged several theories in support of this contention. First, the Veteran asserts that he did not freely choose to use the testosterone patches, but was ordered to use them by a nursing assistant who shook him by both shoulders and told him he had to do testosterone therapy or "we will cease your service, it is an order." See February 2011 Veteran's statement; see also March 2012 hearing testimony, July 2011 formal appeal, April 2011 hearing testimony, March 2011 Veteran's statement, February 2010 Veteran's statement, February 2010 spouse's statement, December 2009 representative's statement, October 2009 report of general information. He also alleges that he was not competent to give informed consent to testosterone replacement therapy because of progressive dementia. See April 2011 hearing testimony. Secondly, he asserts that a doctor would not have approved the treatment if his medical history had been reviewed. See May 2010 representative's statement. Specifically, he alleges that VA should have known of his prostate cancer risk from his gastrointestinal irregularities; his history of heart disease, high blood pressure, high cholesterol, stroke; and family history of heart disease, all of which preclude radiation therapy treatment. See March 2012 hearing testimony, July 2011 formal appeal, March 2011 Veteran's statement; February 2011 Veteran's statement; March 2010 Veteran's letter to Dr. Kvale; October 2009 report of general information. He also alleges that VA should have been aware of his DNA marker for inherited cancer risk. See March 2012 hearing testimony, April 2011 hearing testimony. Further, he alleges that he should have been given a rectal examination and that a baseline PSA level should have been taken before starting testosterone therapy. See March 2012 hearing testimony, July 2011 formal appeal, April 2011 hearing testimony, March 2011 Veteran's statement; February 2011 Veteran's statement. He also asserts that he was not warned of the associated high risk of prostate cancer when using testosterone treatment, and that he was not appropriately monitored for rising PSA levels while using the testosterone patches, which prevented his rising PSA levels from being noticed early enough to take corrective action. See April 2011 hearing testimony, September 2010 representative's statement; May 2010 representative's statement; February 2010 spouse's statement; December 2009 representative's statement. In support of these contentions, he has submitted excerpts from several independent sources of medical information. An abstract of a study on PSA changes and prostate cancer in hypogonadal men treated with testosterone therapy explains that the potential increased risk of prostate cancer from using testosterone therapy to treat late-onset hypogonadism is a primary concern, but that testosterone therapy is effective in normalizing serum testosterone levels, provides a beneficial cardiovascular effect, and improves sexual function and overall quality of life. The abstract also states that PSA levels remain stable after normalization of testosterone for five or more years, prostate cancer can be effectively diagnosed and treated in men taking testosterone therapy, and the incidence of prostate cancer among men with late-onset hypogonadism on testosterone therapy is no greater than in general population. Information from the Cleveland Clinic warns men with prostate cancer against taking testosterone replacement therapy as it may "stimulate the cancer's growth." Drug information for androderm, a testosterone patch, cautions that it is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. In the book Cancer and Nutrition, the author, Dr. Charles B. Simone, suggests that receiving testosterone injections to restore or rejuvenate potency in older men who have become impotent due to low hormone levels may be dangerous, because testosterone could activate a dormant prostatic cancer. VA treatment records show that the Veteran began testosterone therapy in November 2008. The November 2008 VA treatment record notes the following: "He was noted for a low testosterone level and was started on testosterone patches. He felt the patches were for erectile dysfunction only and threw them out. He now has been reading about this with his wife and he would like to restart the patches to see if they help his strength and mentation." The note, signed by both a physician's assistant and a reviewing physician, shows that the Veteran was restarted on testosterone 25 mg daily. The Veteran was advised that he would need to come in every three to four months for PSA level testing. The note also says that follow up blood work was ordered. It should be noted that this treatment record also notes that the Veteran continued to have problems with "weight loss, generalized debility, and intermittent rectal bleeding" and "was seen by gastroenterology" and "has an upcoming colonoscopy." The Veteran's rectal bleeding is discussed in greater detail at a gastroenterology consultation in September 2008. His previous lab data was reviewed and his previous colonoscopies were found to be incomplete. He was scheduled for a colonoscopy and underwent the procedure in mid-November 2008. The pre-procedural assessment notes, dated from about one week before the colonoscopy and one week after the appointment where testosterone therapy was discussed, show that the Veteran required blood work for this procedure, and, furthermore, that he refused a rectal examination. Cancer of the prostate was diagnosed in May 2009, several months after initiation of testosterone therapy, based on pathological studies of a biopsy of the prostate. The biopsy was performed when blood tests in March 2009 showed an elevated prostate specific androgen (PSA) level of 6.05 ng/mL. The normal reference range for PSA levels is 0 to 4 ng/mL, according to the laboratory report. The urologist who ordered the biopsy noted in a May 2009 VA treatment record that the current literature regarding testosterone (T) therapy in patients with occult prostate cancer (CaP) is mixed. He explained that "certainly T therapy doesn't cause CaP, but it's role in increasing aggressiveness or activating previously indolent cancer is not currently elucidated." The urologist decided that biopsy was the best course of action because of the Veteran's hypogonadism, which put him at increased risk for a higher grade cancer of the prostate, with the plan to restart testosterone therapy if the biopsy results were normal. Prostate cancer was confirmed by biopsy in July 2009 and the Veteran chose to undergo radiation treatment. According to the Veteran's wife, the biopsy results indicated advanced prostate cancer with an expected one to two years to live; the Veteran told her that he was told he could not be operated on and that surgery and "doing nothing" were his only options. See February 2010 spouse's statement see also January 2011 Veteran's statement (describing his prostate cancer as "terminal"). The Veteran has also repeatedly asserted that his condition is terminal, or that he has only "three years to live." See, e.g., February 2010 Veteran's statement. However, a statement from his representative notes that his medical records from July 2009 show a diagnosis of stage II prostate cancer, intermediate risk group. Furthermore, VA treatment records show that radiation therapy was completed in November 2009, and lab results from November 2010 show that his PSA level was 0.69 ng/mL. The Veteran reports physical damage to his bladder and bowel as a result of radiation therapy for prostate cancer and his treatment records dating from October 2010 to the present establish urinary and fecal incontinence due to radiation therapy. Furthermore, in June 2011 he was seen in the emergency room for recurrent rectal bleeding related to his radiation therapy. Therefore, the evidence establishes an additional disability of prostate cancer, status post radiation, including bowel and bladder impairment. In July 2010, a VA medical opinion was obtained. The VA physician noted that she conducted an extensive review of the claims folder and the relevant medical literature. The VA physician explained that recent studies have not found a link between testosterone therapy and the aggravation of prostate cancer. She cited to a March 2009 study published in the British Journal Urology International (BJUI) stating that the incidence of prostate cancer among men with late-onset hypogonadism who had been placed on testosterone replacement therapy was no greater than in the general population. The opinion also includes this quote from UpToDate, an evidence-based clinical decision support resource: "There is no reason to think that men who rely on medication to maintain a normal serum testosterone concentration are more likely to develop [prostate cancer] than men who produce their own testosterone." The examiner acknowledged that UpToDate did recommend monitoring men over age 50 started on this medication, as well as a digital rectal examination and serum PSA prior to starting therapy. In the February 2013 supplemental opinion, the examiner reviewed the laboratory testing data from November 2008, which did not include PSA levels, and realized that she had previously misread the March 2008 PSA levels of record, which showed that the latest value prior to starting testosterone therapy was started was below 4 ng/mL. Nevertheless, the examiner explained that it is possible that testosterone therapy would not have been initiated if PSA levels had been obtained in February 2008 and were over 4 ng/mL. However, ultimately, the examiner found that the initiation of testosterone therapy did not have any effect on the outcome concerning the Veteran's prostate cancer. She explained that, as prostate cancer grows slowly, it is likely that the Veteran already had prostate cancer when the Veteran started testosterone therapy as he had a positive biopsy only four months later. The examiner also noted the decreased likelihood of any effect of testosterone therapy on the Veteran's prostate cancer given the very brief four month period of testosterone therapy administered. Lastly, the examiner's review of the current medical research did not support a relationship between testosterone therapy and prostate cancer, with regard to either causation or aggravation. The examiner concluded that, "[i]n summary, testosterone therapy did not cause or aggravate this Veteran's prostate cancer" because he would have developed cancer regardless of any such therapy. The examiner also discussed the May 2009 VA urology treatment record, and found that the urologist's statements do not indicate that testosterone therapy causes prostate cancer. Rather, in the opinion of the examiner, the urologist said that testosterone does not cause prostate cancer and it was unknown whether testosterone could activate indolent cancer. Further, the examiner explained that the statement regarding hypogonadism and associated risk for higher grade cancer does not assert that hypogonadism is associated with an increased risk for the diagnosis of prostate cancer. The opinion also addresses the book "Cancer and Nutrition" and the excerpt regarding a link between prostate cancer and testosterone therapy submitted by the Veteran. The examiner found that it was not persuasive as medical evidence as it was two decades old and inconsistent with the current research on testosterone therapy and prostate cancer. In addition to the question of actual causation, the examiner also addressed the issue of any fault on the part of VA. The examiner did not find that VA's actions concerning the provision of testosterone therapy were improper. The medical records did not support the Veteran's contention that he was shaken and ordered to use the testosterone patches against his will. Instead, as also reflected in the review of the Veteran's VA treatment records above, he was prescribed this medication on November 4, 2008, upon his request, as he had apparently been given this medication in the past and stopped it since he thought it was only for erectile dysfunction. The examiner noted that the Veteran had previously been diagnosed with hypogonadism. Furthermore, the records show that testosterone was discontinued in March 2009 when laboratory test data showed elevated PSA levels, four months after starting testosterone therapy. When he first saw the urologist in May 2009, the notes show that the Veteran liked the patches as they improved his energy and erectile dysfunction. The notes also show that a complete rectal examination could not be performed due to the Veteran's inability to tolerate the procedure. After testosterone therapy was started, the Veteran was monitored closely, as a PSA level was obtained four months after starting treatment. As his PSA levels were elevated, testosterone was discontinued and a referral to urology was scheduled. The examiner also determined that there was no reason to think that testosterone would not have been prescribed if the VA physicians had been adequately aware of his medical history. Colon polyps and even colon cancer are not related to prostate cancer and are not relevant to or a contraindication for testosterone therapy. Heart disease, high blood pressure, high cholesterol, a family history of heart disease, and stroke history are often thought to be related to breast cancer and estrogen therapy, but are completely unrelated to prostate cancer and testosterone therapy. In response to the medical literature submitted by the Veteran, the examiner explained that the Veteran did not have known or suspected carcinoma of the breast or prostate when testosterone therapy was prescribed. The examiner noted that the Veteran's VA urologist did not think there was any contraindication to the Veteran taking testosterone if biopsy showed that he did not have prostate cancer, and that, in the examiner's opinion, there was no reason to think that the Veteran did have prostate cancer prior to his PSA level of 6.05 in March 2009. The records show that the Veteran requested testosterone supplementation and had a positive response to it with an improvement of his quality of life. Furthermore, the Veteran had no medical conditions which would have been contraindications to testosterone supplementation or which should have suggested to his provider that he was at increased risk for prostate cancer. Therefore, the opinion concludes, the Veteran's prostate cancer was not a result of carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault on the part of the VA in furnishing medical treatment. Lastly, the examiner explained that "[w]ith regard to his current status, the medical records support that his radiation was definitive treatment and his PSA has been continuing to decrease, most recently on 4/23/10 being .69. There is nothing to support that his condition is terminal or metastatic." In April 2011, the Veteran submitted a Fact Sheet from the National Cancer Institute that explained that men with harmful BRCA1 mutations have an increased risk of breast cancer and, possibly, of pancreatic cancer, testicular cancer, and early-onset prostate cancer, though male breast cancer, pancreatic cancer, and prostate cancer appear to more strongly associated with BRCA-2 gene mutations. Laboratory data from August 2007 serum testing shows the result of "DNA: canc." In weighing the medical information submitted by the Veteran in support of his claim, the treatment notes recorded by the Veteran's VA urologist, and the findings of the VA examiner as recorded in the July 2010 medical opinion and February 2013 medical opinion, the Board finds that the probative value of the VA medical opinions outweighs the other evidence of record. The examiner thoroughly reviewed the Veteran's relevant medical records and the relevant medical literature and provided a detailed and exhaustive rationale that accounted for the arguments raised by the Veteran or on his behalf. The examiner directly addressed the notes of the VA urologist and accounted for the medical information submitted in support of the Veteran's claim. The urologist's opinion is speculative and it does not definitively state an opinion on the relationship between testosterone replacement therapy and the activation of indolent cancer in the May 2009 VA treatment record. See Hogan v. Peake, 544 F.3d 1295, 1298 (Fed. Cir. 2008) (the Board may discount the value of competent medical evidence based on factors including the lack of a definitive statement as to etiology). Consequently, it is outweighed by the VA examiner's opinion, as it was based on the most recent medical research, states a definitive conclusion, and contains a thorough rationale for the opinion provided. Nieves-Rodriguez, 22 Vet. App. at 303. The examiner's opinion also outweighs the medical information submitted by the Veteran in support of his claim. When the examiner applied the general information presented in these documents to the specific facts of the Veteran's case, much of the information was shown to have been misinterpreted by the Veteran and inapplicable to the relevant facts in this case. See Wallin v. West, 11 Vet. App. 509, 514 (1998). The source directly alleging a link between testosterone replacement therapy and prostate cancer was outdated given the trends in the recent research data against the existence of a causal link. Nieves-Rodriguez, 22 Vet. App. at 303 (explaining that knowledge of the pertinent medical literature may be considered in assessing the probative value of the medical evidence). First, the Board finds that the Veteran, his spouse, and his former representative, are not competent to provide an opinion on the relationship between testosterone therapy and prostate cancer. The VA urologist noted that the role testosterone therapy plays in increasing aggressiveness or activating previously indolent cancer is not current elucidated in the medical community, and the VA examiner found that a review of the most recent relevant medical data and literature was necessary to adequately address the existence of a relationship between prostate cancer and testosterone therapy. Consequently, any determination on this issue involves complex medical research data requiring relevant medical expertise. The Veteran, his spouse, and his former representative are not shown to have acquired such expertise or knowledge, and, consequently, those statements do not constitute competent evidence. See Jandreau v. Nicholson, 492 F.3d 1372, 1377 & n. 4 (Fed.Cir.2007) (explaining that whether lay evidence is competent to establish etiology depends on the simplicity of the disease). Lastly, though the examiner did not directly address the evidence showing the existence of an increased risk of prostate cancer where certain DNA markers are present, the examiner accounted for any evidence indicating that VA may have had a duty to exercise greater caution in prescribing testosterone patches to the Veteran in light of his medical history or without additional screening and testing, as the examiner's ultimate opinion is that testosterone therapy did not cause or aggravate the Veteran's prostate cancer. There is no per se requirement that a medical examiner address any particular evidence in his report for that report to be assigned weight by the Board. See Acevedo v. Shinseki, 25 Vet. App. 286, 293 (2012) (noting that the law imposes no reasons-or-bases requirement on examiners). Here, the examiner determined that similar objections were irrelevant as the evidence does not support the existence of a link between testosterone replacement therapy and prostate cancer, with regard to either causation, aggravation, or activation of indolent cancer. Therefore, as the July 2010 and February 2013 medical opinions are found to be more probative on the question of causation than the other competent evidence of record, the preponderance of the evidence is against finding a causal link between testosterone replacement therapy and any additional disability related to prostate cancer. As actual causation is not established, the issues raised concerning informed consent, including competency to give informed consent to testosterone therapy and adequacy of warning of the risks of testosterone therapy; review of the Veteran's medical history, including any knowledge regarding any DNA markers he may have; prescreening for prostate cancer before starting testosterone therapy; and monitoring for prostate cancer during testosterone therapy, are immaterial to the resolution of this claim. 38 U.S.C.A. § 1151(a); 38 C.F.R. § 3.361(c)(1). In reaching this conclusion, the Board has considered the applicability of the benefit-of-the-doubt doctrine. See 38 U.S.C.A. § 5107(b); 38 C.F.R. § 3.102; Gilbert, 1 Vet. App. 53-56. As the preponderance of the evidence shows that testosterone therapy does not cause or aggravate prostate cancer, that doctrine is not applicable. Id. Therefore, claim for entitlement to compensation under 38 U.S.C.A. § 1151 for additional disability due to prostate cancer, status post radiation therapy, including residuals of bladder and bowel impairment, caused by testosterone therapy, must be denied. ORDER Entitlement to compensation under 38 U.S.C.A. § 1151 for prostate cancer, status post radiation therapy, including bladder and bowel impairment, caused or aggravated by testosterone therapy is denied. REMAND The Veteran also contends that his urinary and bowel incontinence is the result of negligent VA radiation treatment of his prostate cancer, specifically "inadequate radiation treatment on old obsolete equipment" at the John Dingell VA Hospital in Detroit, Michigan. See March 2012 hearing testimony, March 2010 statement. The Veteran had a urology consultation at the Detroit VAMC following his prostate cancer diagnosis by biopsy in July 2009. The note says that options for treatment were discussed in detail including active surveillance, surgery, and radiation, and that the Veteran wished to pursue radiation. The urologist noted that this was a reasonable plan because the Veteran was (1) "emphatic about having something done" and (2) he was not a good surgical candidate considering his age and comorbidities. VA treatment records from later in August 2009 show that the Veteran was "adamant that he would like a second opinion" and wanted to reconsider surgery. The record shows that an opinion request was submitted to the Ann Arbor VAMC. In a February 2010 statement, the Veteran's wife asserted that he told her that his choices were limited to "doing nothing or radiation therapy," and he chose radiation therapy instead of "wait[ing] to expire." In April 2011, he testified that he chose radiation because the VA was not equipped to perform surgery, but that VA has a "terrible history of radiation treatment" and used the wrong dosage. An August 2009 informed consent form for radiation therapy for prostate cancer is of record and shows that the Veteran verbalized understanding. A corresponding radiation oncology nursing assessment dated August 2009 shows that the Veteran was able to give consent and exhibited a good ability to learn with no barriers to learning. However, VA treatment records show that the Veteran has a history of dementia, and review of his recent VA treatment records obtained on remand raises questions regarding the level of severity of his dementia in August 2009. A February 2008 neuropsychology consultation report from the Detroit VAMC shows an assessment of dementia of unclear etiology, possibly of vascular origin given his cardiovascular history, but also broadly consistent with Alzheimer's type or frontotemporal dementia, with profound deficits in judgment and decision making, as well as an "unclear" history of alcohol abuse. Later treatment records noted a history of alcoholism. The Veteran and his wife were advised to consult with social work about the possibility of guardianship and to follow up with neurology to obtain a more specific differential diagnosis. Neurology found memory loss, cognitive decline/dementia syndrome, and a possible movement disorder in November 2008, but noted significant improved in January 2009, potentially due to the effects of a successful medication regime and/or the cessation of alcohol use. The neurologist found that no further evaluation and management was needed and a March 2009 preventative medicine note shows that neurology found no sign of dementia in January 2009. However, when the Veteran established care at the Ann Arbor VAMC in October 2010, he was found to have gradually worsening dementia. These notes also indicate that the Veteran was extremely hostile to the idea of guardianship and consistently refused to undergo neuropsychological or psychiatric testing. Geriatrics was able to conduct cognitive testing in August 2011 and identified significant memory, attention, and executive functioning difficulties. Questions regarding the severity and history of the Veteran's dementia are raised in his treatment records from the Ann Arbor VAMC and the February 2008 neuropsychiatric testing report showing an assessment of dementia syndrome of unknown etiology, possible vascular, Alzheimer's type, or Frontotemporal, is explicitly mentioned. Despite his lack of acquiescence, the Veteran's wife ultimately requested and received guardianship letters in March 2012, though the records do not indicate that any action has since been taken. The Veteran's VA treatment records show that he has ongoing bowel and bladder impairment that is attributed to radiation therapy and his records raise the issue of whether he had capacity to give informed consent to radiation therapy for prostate cancer in August 2009. Consequently, this claim must be remanded in order to obtain an opinion on the Veteran's capacity to give informed consent to radiation treatment for prostate cancer in August 2009. Trafter, at *11 (holding that "the Board must analyze the evidence of record to determine whether it indicates that the disability or symptoms may be associated with the hospital care, medical or surgical treatment, or examination" provided by VA); see also Robinson v. Peake, 21 Vet. App. 545, 552 (2008) (Board must address issues raised by claimant or reasonably raised by record), aff'd sub nom. Robinson v. Shinseki, 557 F.3d 1355 (Fed. Cir. 2009). Additionally, an opinion must be obtained from an appropriate VA medical professional as to whether a reasonable person in the Veteran's situation, in consideration of his age, comorbidities, and relevant cancer staging data, such as PSA level and biopsy results, when presented with the options of active surveillance, surgery, and radiation therapy, would have proceeded with radiation treatment even if advised of the risk that he could suffer from gastrointestinal and genitourinary damage as a result of that treatment. See McNair v. Shinseki, 25 Vet. App. 98, 107 (2011); 38 C.F.R. § 3.361(d)(1)(ii). Lastly, appropriate efforts should be made to obtain any outstanding relevant VA treatment records and associate them with the claims folder or electronic records file, including the opinion request submitted to the Ann Arbor VAMC by the Pontiac CBOC in August 2009, as discussed in the August 2009 preventative medicine progress note. 38 U.S.C.A. § 5103A(b)(3), (c)(2); 38 C.F.R. § 3.159(c)(2), (3). Accordingly, the case is REMANDED for the following action: (Please note, this appeal has been advanced on the Board's docket pursuant to 38 C.F.R. § 20.900(c). Expedited handling is requested.) 1. Obtain all of the Veteran's outstanding relevant VA treatment records, including the opinion request submitted to the Ann Arbor VAMC by the Pontiac CBOC in August 2009. All information which is not duplicative of evidence already received should be associated with the claims file or the Veteran's electronic claims folder. Efforts to obtain these records must continue until it is determined that they do not exist or that further attempts to obtain them would be futile. The non-existence or unavailability of the records must be verified by each Federal department or agency from whom they are sought and documented in the record 2. Then, forward the Veteran's file to a VA psychologist or psychiatrist for a medical opinion on the issue of informed consent. The claims file and a copy of this remand must be reviewed by the VA psychologist or psychiatrist. The examiner is asked to review all of the relevant evidence, including the Veteran's VA neuropsychology, neurology, and preventative medicine records from the Detroit VAMC dated from February 2008 to March 2009; the August 2009 VA radiation oncology nursing care plan and consent progress note for radiation therapy; and the VA primary care, geriatric, geropsychiatry, and pharmacy records from the Ann Arbor VAMC from October 2010 to June 2012, as well any additional relevant treatment notes added to the record on remand. In consideration of the available evidence and the relevant psychiatric or psychological principles, determine whether it is at least as likely as not that the Veteran was competent to give informed consent to radiation treatment for prostate cancer in August 2009. Specifically, is it at least as likely as not that the Veteran possessed: (a) the decision-making capacity, defined as the ability to understand and appreciate the nature and consequences of health care treatment decisions, and (b) the ability to communicate decisions concerning health care. The examiner must provide a comprehensive report, including a complete rationale for all opinions that clearly states the conclusions, identifies the facts and/or principles supporting each conclusion, and provides a reasoned explanation linking those facts and principles to that conclusion. If any requested information cannot be provided without resort to speculation, indicate whether the inability to provide a definitive opinion is due to a need for further information, because the limits of medical knowledge have been exhausted, or for some other reason. 3. Obtain a medical opinion from an appropriate VA medical professional as to whether a it is more likely than not that a reasonable person in the Veteran's situation, in consideration of his age, comorbidities, and relevant cancer staging data, such as PSA level and biopsy results, when presented with the options of (a) active surveillance, (b) surgery, and (c) radiation therapy, would have proceeded with radiation treatment for his prostate cancer even if advised of the risk that he could suffer from gastrointestinal and genitourinary damage as a result of that treatment. The examiner must provide a comprehensive report including a complete rationale for all opinions and conclusions reached that clearly states the conclusions, identifies the supporting data for each conclusion, and provides a reasoned medical explanation connecting the supporting data to each conclusion. If any requested information cannot be provided without resort to speculation, indicate whether the inability to provide a definitive opinion is due to a need for further information, because the limits of medical knowledge have been exhausted, or for some other reason. 4. Review the medical examination reports obtained to ensure that the remand directives have been accomplished, and return the case to the examiners if all questions posed are not answered. 5. Finally, readjudicate the claim for entitlement to compensation under 38 U.S.C.A. § 1151 for bladder and bowel impairment caused by radiation treatment provided by VA. If the claim remains denied, provide the Veteran and his representative with a supplemental statement of the case that clearly and thoroughly summarizes the relevant evidence, identifies the applicable law, and explains the reasons for decision, as all past adjudication of the remaining claim on appeal has been implicit only. Allow an appropriate time for response. The appellant 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. 2012). ______________________________________________ S. L. Kennedy Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs