Citation Nr: 18141455 Decision Date: 10/10/18 Archive Date: 10/10/18 DOCKET NO. 13-29 093 DATE: October 10, 2018 ORDER Entitlement to compensation benefits under the provision of 38 U.S.C. § 1151 for the additional disability of gynecomastia is denied. FINDING OF FACT The evidence of record indicates that the Veteran’s use of spironolactone constituted a single period of treatment for the period between 2001 and 2007 requiring only one instance of informed consent, which the Veteran gave in 2001. CONCLUSION OF LAW The criteria for compensation under the provisions of 38 U.S.C. § 1151 for any additional disability as a result of VA medical treatment have not been met. 38 U.S.C. §§ 1151, 5103A, 5107; 38 C.F.R. §§ 3.358, 3.361, 17.32. REASONS AND BASES FOR FINDING AND CONCLUSION The Veteran served on active duty from November 1968 to February 1971. This matter comes to the Board of Veterans’ Appeals (Board) on appeal from a September 2011 rating decision of the Department of Veterans Affairs (VA) Regional Office (RO). In a May 2016 decision, the Board denied the Veteran’s 38 U.S.C. § 1151 claim. The Veteran appealed to the United States Court of Appeals for Veterans Claims (CAVC). In a January 2018 Memorandum Decision, CAVC vacated the May 2016 Board decision as to the denial of compensation pursuant to 38 U.S.C. § 1151, and remanded the matter back to the Board for readjudication. Duty to Notify and Assist The Veteran’s attorney included language in an August 2018 correspondence to the effect that “the prior Court Decision did not address…the Vas (sic) duty to notify and assist.” The Board finds that such language has identified no specific deficiencies in the duties to assist in this case. See Daye v. Nicholson, 20 Vet. App. 512, 517 (2006) (observing that “boilerplate” language is ineffective unless used with precision); see also Massie v. Shinseki, 25 Vet. App. 123, 135 (2011) (“[A]ttorneys who represent veterans before VA should be oil for the gears of the system, not sand in the works.”). As neither the Veteran nor his attorney has raised any specific issues with the duty to notify or duty to assist in this case, no further action or discussion is necessary. See Scott v. McDonald, 789 F.3d 1375, 1381 (Fed. Cir. 2015) (holding that “the Board’s obligation to read filings in a liberal manner does not require the Board…to search the record and address procedural arguments when the veteran fails to raise them before the Board.”); Dickens v. McDonald, 814 F.3d 1359, 1361 (Fed. Cir. 2016) (applying Scott to a duty to assist argument). 38 U.S.C. § 1151 Claim Under VA laws and regulations, when a veteran incurs additional disability or death as a result of training, hospital care, medical or surgical treatment, or an examination furnished by the VA, disability compensation shall be awarded in the same manner as if such disability or death was service-connected. 38 U.S.C. § 1151; 38 C.F.R. §§ 3.358, 3.361. In determining that an additional disability exists, VA compares the Veteran’s condition immediately before the beginning of the hospital care, medical or surgical treatment, examination, training and rehabilitation services, or compensated work therapy program upon which the claim is based to the Veteran’s condition after such care, treatment, examination, services, or program has stopped. 38 C.F.R. § 3.361(b). To establish causation, the evidence must show that the hospital care, medical or surgical treatment, or examination resulted in the Veteran’s additional disability or death. Merely showing that a Veteran received care, treatment, or examination and that that the Veteran has an additional disability or died does not establish cause. 38 C.F.R. § 3.361(c)(1). Hospital care, medical or surgical treatment, or examination cannot cause the continuance or natural progress of a disease or injury for which the care, treatment, or examination was furnished unless VA’s failure to timely diagnoses and properly treat the disease or injury proximately caused the continuance or natural progress. 38 C.F.R. § 3.361(c)(2). Additional disability or death caused by a Veteran’s failure to follow properly given medical instructions is not caused by hospital care, medical or surgical treatment, or examination. 38 C.F.R. § 3.361(c)(3). To establish that 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 proximately caused a Veteran’s additional disability or death, it must be shown that VA failed to exercise the degree of care that would be expected of a reasonable health care provider; or, that VA furnished the hospital care, medical or surgical treatment, or examination without the Veteran’s informed consent. The second prong of proximate causation requires that the Veteran’s additional disability or death be an event that was not reasonably foreseeable. This fact is to be determined based on what a reasonable health care provider would have foreseen. The event need not be completely unforeseeable or unimaginable but must be one that a reasonable health care provider would not have considered to be an ordinary risk of the treatment provided. In determining whether an event was reasonably foreseeable, VA will consider whether the risk of that event was the type of risk that a reasonable health care provider would have disclosed in connection with the informed consent procedures. 38 C.F.R. §§ 3.361(d)(2), 17.32. The Veteran asserts that he developed gynecomastia after taking spironolactone, a medication first prescribed by a VA treatment provider in December 2001. He contends that he was not informed of the side effects, specifically gynecomastia, prior to taking spironolactone and that he was not properly monitored for side effects after the medication was prescribed. In December 2001, the Veteran was prescribed spironolactone, for which he received an educational handout and counseling, including potential side effects. He stopped taking the medication in June 2002. In July 2005, the Veteran was re-prescribed spironolactone in July 2005 by his primary nurse practitioner. VA treatment records note the Veteran’s continued use of spironolactone without any mention of gynecomastia, until August 2006, when gynecomastia was diagnosed and the Veteran was continued on spironolactone after discussing the benefits and potential side effects of prescribed medications and agreeing with the plan of care. His spironolactone was subsequently continued in October 2006 and January 2007, after the Veteran voiced no complaints despite his gynecomastia being observed. In June 2007, the Veteran called to request a refill of spironolactone and reported that he was doing well. A July 2007 telephone contact included the Veteran’s request for refills on his medications. Side effects of prescribed medications were discussed again. In September 2007, the Veteran once again called to request a refill on spironolactone. In December 2007, the Veteran was instructed to stop taking spironolactone and to schedule a follow up appointment. A June 2008 letter from VA’s Acting Director of Primary Care Service noted that the Veteran requested a new primary care physician, which had been granted. In written correspondence dated December 2011, the Veteran reported that he had told his primary nurse practitioner that his breasts were enlarging “shortly after beginning [spironolactone]” in 2005, and that he “would then mention [his] concern about the continued enlargement of [his] breasts” prior to each prescription renewal. During a September 2011 VA examination, the Veteran reported that he did not know why, but there were periods of time where spironolactone was not prescribed but that he took it intermittently for several years. The Veteran stated that he was told that the gynecomastia would resolve within a matter of a few months after stopping the medication but it had not resolved or improved. He reported that there had been no significant change in the condition since 2006. A physical examination revealed bilateral gynecomastia, without palpable or visible abnormalities associated with the condition. The examiner opined that gynecomastia was less likely than not the result of carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault on the part of VA. The examiner opined that the Veteran was appropriately prescribed spironolactone in December 2001, as he had three of the most common indications for that treatment. The examiner stated that the evidence of record demonstrated that there was no question that the Veteran had indications for treatment with spironolactone and that there were “not a lot of other good options, if any, available to his providers at the time.” The examiner noted the Veteran’s reports that he was never informed of the possible side effects of spironolactone but stated that records demonstrated that a pharmacy consultation was requested and completed in December 2001, in which the pharmacist noted that the Veteran was counseled on spironolactone and was ready and motivated to learned. Side effects were noted as discussed. It was also noted twice that the Veteran was provided an educational handout. The examiner also opined that gynecomastia was less likely than not the result of an event which was not reasonably foreseeable. The examiner explained that gynecomastia was a well-established known adverse effect of spironolactone. The examiner noted that this risk was known at the time of prescription and that it was not a rare or even uncommon side effect which would not be foreseeable. In an April 2015 addendum to the September 2011 VA examination, the examiner who conducted the September 2011 VA examination determined that the Veteran’s gynecomastia was less likely as not the result of carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault on the part of VA. The examiner noted the Veteran was re-prescribed spironolactone in July 2005. It was noted that although the prescription was entered by the primary care nurse practitioner this was done so on the day following a note from the VA endocrinologist, upon the endocrinologist’s recommendation. It was indicated that the nurse practitioner noted on July 29, 2005, that she called the Veteran to communicate her discussion with the endocrinologist about resuming spironolactone. The examiner noted that the Veteran had regular follow-up appointments with two primary care nurse practitioners of the prescription until it was discontinued in 2007. The examiner cited frequent documentation of current history taken from the Veteran, along with a review of systems and thorough physical examinations during this time period. Lab work is also found to have been performed on a regular basis. The examiner stated that the first indication of gynecomastia was shown on August 2006, at which time it was noted that physical examination noted large well-developed breasts. A diagnosis of gynecomastia was provided and that labs were indicated. The examiner additionally noted that the medical provider documented the benefits and potential side effects of prescribed medications were discussed and the Veteran was in agreement with the plan of care. The examiner stated that in a follow-up appointment in January 2007, the Veteran reported that he had no complaints and felt great and that gynecomastia was reported as unchanged. The examiner further cited the Veteran’s September 2007 request for a refill of that prescription. The examiner stated that there was no indication that gynecomastia was progressing or severe or that the Veteran wished to alter the treatment plan during that time, noting again that treatment records documented that the plan was discussed, including benefits and risks of treatment including prescription medications. In fact, the examiner elaborated, the Veteran called for refills of the medication, at which time counseling was again appropriately documented by his nurse practitioner. The examiner stated that when the condition worsened in late 2007, the nurse practitioner appropriately asked the veteran to stop the spironolactone at that time. The examiner concluded that gynecomastia was not proximately caused by carelessness, negligence, lack of proper skill, error in judgment, or a similar instance of fault on the part of the VA, in treating the Veteran from 2001 to 2007, including the actions of VA in monitoring the use of and prescribing renewals of spironolactone over the phone in 2007. Based on the aforementioned, the Board, in a May 2016 decision, denied the claim, finding that the side effects of the spironolactone were discussed when they were first prescribed in December 2001; that the Veteran’s requests for renewals in 2007 indicate that he was aware of the side effects and had accepted them as a result of his treatment; and that the use of spironolactone was both reasonable and properly monitored. In the January 2018 memorandum decision, CAVC found that the Board characterized the Veteran’s use of spironolactone as comprising a single period of use that began in 2001 and ended in 2007, but that the Board did not address the significance of the interruption in use between June 2002 and July 2005. CAVC found that the Board neither explained why the Veteran’s use of spironolactone constituted a single period of treatment, requiring only one instance of informed consent, nor explained how, if there were two separate periods of treatment (i.e., between 2001 and 2002 and between 2005 and 2007), the informed consent requirement was met in 2005. Accordingly, CAVC remanded this matter for the Board to clarify and adequately support its findings as to whether there are single or multiple periods of treatment with spironolactone. The Board finds that the Veteran’s use of spironolactone constituted a single period of treatment beginning in 2001 and ending 2007 requiring only one instance of informed consent. In December 2001, the Veteran underwent a pharmacy consultation on the potential side effects of spironolactone and received an educational handout. Despite the Veteran’s contentions that he was never warned about the possible side effects of spironolactone, the Board places more probative weight on the objective medical evidence at the time (which indicates the Veteran was counseled on spironolactone and was provided an educational handout), as it is documented by a medical provider based on the current information at the time. Although he continued the medication in 2005, the Veteran admitted in his December 2011 written correspondence, that he reported that his breasts were enlarging as a result of restarting spironolactone in 2005. Despite the lapse in taking the medication from 2002 to 2005, this communication indicates that the Veteran knew that gynecomastia was a side effect of spironolactone. This is further evidenced by the Veteran’s statement that he mentioned his concerns about gynecomastia prior to renewing his prescriptions in 2007. The Board also notes that the Veteran admitted to the September 2011 VA examiner that there were periods of time that spironolactone was not prescribed and that he took it intermittently for several years. Although the Veteran did not specify the time frames of use and nonuse of spironolactone, this statement suggests the Veteran continued to take the medication from 2002 to 2005, as there is no other lapse of use of the medication in the medical record. Thus, based on the Veteran’s own admissions and the objective medical evidence, the Board finds that the evidence of record indicates that the Veteran’s use of spironolactone for the period between 2001 and 2007 constitutes a single episode of use and that the Veteran gave informed consent in 2001. In August 2018, the Veteran’s representative advanced two new theories of entitlement under 38 U.S.C. § 1151: first, he questions the propriety of the prescriptions given. Second, he argues that VA did not provide the proper standard of care when it provided refills issued to the Veteran. With regard to the propriety of the prescriptions given, the September 2011 examiner stated that the evidence of record demonstrated that there was no question that the Veteran had indications for treatment with spironolactone and that there were “not a lot of other good options, if any, available to his providers at the time.” The examiner explained that gynecomastia was a well-established known adverse effect of the medication spironolactone and the risk was known at the time of prescription. Gynecomastia, according to the examiner, was not a rare or even uncommon side effect which would not be foreseeable. Furthermore, with regard to the standard of care regarding refills, the September 2011 examiner noted that the Veteran had regular follow-up appointments of the prescription until 2007. The examiner stated that in a follow-up appointment in January 2007, the Veteran reported that he had no complaints and felt great and that gynecomastia was reported as unchanged. The examiner further cited the Veteran’s September 2007 request for a refill of that prescription. The examiner stated that there was no indication that gynecomastia was progressing or severe or that the Veteran wished to alter the treatment plan during that time, noting again that treatment records documented that the plan was discussed, including benefits and risks of treatment including prescription medications. In fact, the examiner elaborated, the Veteran called for refills of the medication, at which time counseling was again appropriately documented by his nurse practitioner. The examiner stated that when the condition worsened in late 2007, the nurse practitioner appropriately asked the Veteran to stop the spironolactone at that time. The September 2011 examiner concluded that gynecomastia was not proximately caused by carelessness, negligence, lack of proper skill, error in judgment, or a similar instance of fault on the part of the VA, in treating the Veteran from 2001 to 2007, including the actions of VA in monitoring the use of and prescribing renewals of spironolactone over the phone in 2007. In light of these findings, the Board finds that the arguments questioning the propriety of the prescriptions given and the standard of care regarding refills are unfounded. The Board has reviewed the evidence submitted by the Veteran and his representative of a purported “transcript,” based entirely on the Veteran’s recollections, of an encounter between the Veteran and his pharmacist in September 2012. The Board notes outright that the transcript supposedly relates events that supposedly occurred approximately five years after the Veteran stopped using spironolactone. Hence, it has no bearing on determining whether or not the Veteran’s use of spironolactone constituted a single period of use. Furthermore, in as much as this evidence lends credibility to the assertions made by the Veteran’s representative regarding standard of care and propriety of prescription refills, the Board finds the September 2011 transcript to be of little probative weight, as it amounts to the Veteran’s remote recollections regarding events which occurred more than six years earlier, especially when considered that these recollections were made in the context of a claim for monetary benefits. See Mense v. Derwinski, 1 Vet. App. 354, 356 (1991). Having found that the Veteran’s use of spironolactone from 2001 to 2007 constitutes a single period of use, the Board also finds that the evidence of record fails to demonstrate that the Veteran failed to give informed consent in 2001. As such, the Veteran’s claim is denied. As the preponderance of the evidence is against the claim of entitlement to compensation under 38 U.S.C. § 1151 for additional disability, the benefit-of-the-doubt doctrine is not applicable. 38 U.S.C. § 5107(b); Gilbert v. Derwinski, 1 Vet. App. 49, 53-56 (1990). M. H. HAWLEY Veterans Law Judge Board of Veterans’ Appeals ATTORNEY FOR THE BOARD A. Norwood, Associate Counsel