Citation Nr: 18149360 Decision Date: 11/09/18 Archive Date: 11/09/18 DOCKET NO. 15-06 679 DATE: November 9, 2018 ORDER Entitlement to compensation under 38 U.S.C. § 1151 for Guillain-Barré syndrome (GBS) is denied. FINDINGS OF FACT 1. The weight of the most probative and credible evidence does not show that VA administered an influenza vaccination to the Veteran at any time on or about January 2006. 2. The Veteran’s current GBS was not proximately caused by a lack of skill, carelessness, negligence, error in judgment, or a similar instance of fault on VA’s part in administering an October 2004 influenza vaccination; there is no competent evidence suggesting that VA failed to exercise the degree of care that would be expected of a reasonable healthcare provider in administering the October 2004 influenza vaccination; and the weight of the most probative and credible evidence does not show that VA administered the October 2004 influenza vaccination without informed consent. CONCLUSION OF LAW The criteria for entitlement to compensation under 38 U.S.C. § 1151 for GBS have not been met. 38 U.S.C. § 1151; 38 C.F.R. §§ 3.358, 3.361, 3.800, 17.32. REASONS AND BASES FOR FINDINGS AND CONCLUSION The Veteran served on active duty from April 1967 to October 1971. He testified before the undersigned Veterans Law Judge during a July 2017 Travel Board hearing and transcript of that proceeding is of record. The record contains evidence that the Agency of Original Jurisdiction (AOJ) has not considered. In November 2018 correspondence, the Veteran’s representative stated that the Veteran wished to waive initial AOJ review of this evidence. The Board has thoroughly reviewed all the evidence in the Veteran’s VA files. In every decision, the Board must provide a statement of the reasons or bases for its determination, adequate to enable an appellant to understand the precise basis for the Board’s decision, as well as to facilitate review by the Court. 38 U.S.C. § 7104(d)(1); see Allday v. Brown, 7 Vet. App. 517, 527 (1995). Although the entire record must be reviewed by the Board, the Court has repeatedly found that the Board is not required to discuss, in detail, every piece of evidence. See Gonzales v. West, 218 F.3d 1378, 1380-81 (Fed. Cir. 2000); Dela Cruz v. Principi, 15 Vet. App. 143, 149 (2001) (rejecting the notion that the Veterans Claims Assistance Act mandates that the Board discuss all evidence). Rather, the law requires only that the Board address its reasons for rejecting evidence favorable to the appellant. See Timberlake v. Gober, 14 Vet. App. 122 (2000). 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 id. Pertinent regulations for consideration were provided to the Veteran in the December 2014 Statement of the Case (SOC) and will not be repeated here in full. Neither the Veteran nor his representative has raised any duty to notify or duty to assist issues. 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). Moreover, neither the Veteran nor his representative has asserted that VA failed to comply with 38 C.F.R.§ 3.103(c)(2), and neither has identified any prejudice in the conduct of the Board hearing. As the issue has not been raised, there is no need for the Board to discuss compliance with Bryant v. Shinseki, 23 Vet. App. 488 (2010). See Dickens, supra. The Veteran seeks entitlement to compensation under 38 U.S.C. § 1151 for GBS. He contends that his GBS arose from an influenza vaccination that VA allegedly administered a few days before his January 2006 VA hospital admission for neurological symptoms, which ultimately were diagnosed as manifestations of GBS. He primarily contends that the VA provider who administered the flu vaccine failed to obtain informed consent by providing him with a Center for Disease Control (CDC) document warning him that GBS was one potential risk of the vaccine. Under 38 U.S.C. § 1151, compensation may be paid for a qualifying additional disability from VA treatment as if the additional disability were service connected. Here, the Veteran filed his § 1151 claim and all relevant treatment occurred well after October 1997. Thus, the claim must be adjudicated under the current version of 38 U.S.C. § 1151, which requires a showing of fault on the part of VA. See 69 Fed. Reg. 46,426 (Aug. 3, 2004) (codifying 38 C.F.R. § 3.361, which applies to such claims filed on or after October 1, 1997, and revising 38 C.F.R. § 3.358 to state that the section only applied to claims filed before October 1, 1997). The proximate cause of disability is the action or event that directly caused the disability, as distinguished from a remote contributing cause. 38 C.F.R. § 3.361(d). To establish that carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part in furnishing medical treatment proximately caused a veteran's additional disability, it must be shown that the medical treatment caused the veteran's additional disability, and: (i) VA failed to exercise the degree of care that would be expected of a reasonable health care provider; or (ii) VA furnished the hospital care, medical or surgical treatment, or examination without the veteran's informed consent. Id. § 3.361(d)(1)(i)-(ii). In sum, 38 U.S.C. § 1151 contains two causation elements; the disability must have been both caused by the VA medical treatment, and proximately caused by fault on VA’s part. See Viegas v. Shinseki, 705 F.3d 1374, 1377-78 (2013). To determine whether there was informed consent, VA will consider whether the health care providers substantially complied with the requirements of 17.32. Minor deviations from the requirements of § 17.32 that are immaterial under the circumstances of a case will not defeat a finding of informed consent. See 38 C.F.R. § 3.361(d)(1)(ii). Section 17.32(c) defines informed consent as freely given consent that follows a careful explanation by the practitioner to the patient of the proposed diagnostic or therapeutic procedure or course of treatment. The practitioner, who has primary responsibility for the patient or who will perform the particular procedure or provide the treatment, must explain in language understandable to the patient or surrogate the nature of a proposed procedure or treatment; the expected benefits; reasonably foreseeable associated risks, complications or side effects; reasonable and available alternatives; and anticipated results if nothing is done. The patient or surrogate must be given the opportunity to ask questions, to indicate comprehension of the information provided, and to grant permission freely without coercion. The practitioner must advise the patient or surrogate if the proposed treatment is novel or unorthodox. The absence of a specific list of risks is not evidence that VA failed to obtain informed consent, and it may not be presumed that complications were not discussed because they were not recorded. See Halcomb v. Shinseki, 23 Vet. App. 234, 241 (2009) (holding veteran did not establish lack of informed consent before eye surgery as the basis for entitlement to compensation benefits for loss of vision of the eye under 38 U.S.C. § 1151 based solely on failure of consent documents to list specific disclosed risks). After a full review of the record, the claim is denied. The evidence of record does not show that the Veteran’s GBS was proximately caused by a lack of skill, carelessness, negligence, error in judgment, or an unforeseen event, or that VA failed to exercise the degree of care that would be expected of a reasonable healthcare provider. Nor does the most probative and credible evidence show that VA furnished medical treatment without informed consent. Initially, it is undisputed that beginning in late January 2006, the Veteran was treated for neurological symptoms that ultimately were diagnosed as manifestations of GBS. See generally VA treatment records. However, the weight of the most probative evidence does not support his contention that VA administered the flu vaccine to him at any time on or about January 2006, a few days before the onset of his GBS symptoms. To the contrary, VA treatment records show that before January 2006, the only documented VA flu vaccines were administered in October 2002 and October 2004. In addition, his VA treatment records from early-to-mid-2006 regarding his initial hospitalization, diagnosis, and treatment for GBS notably omit any reference to him receiving an influenza vaccination at any point on or about January 2006, even when they expressly noted his immunization history. See May 2006 VA NHCU admission history (detailing Veteran’s vaccination history including October 2004 influenza vaccination and 2002 vaccinations against other illnesses; notably this note makes no reference to any influenza vaccination on or about January 2006). It is reasonable to assume that if the Veteran had received a flu vaccine in 2006, especially if it was contemporaneous with the onset of his symptoms, then this fact would have been included in his vaccination history obtained when he was treated for those symptoms. The fact that there is absolutely no reference to a 2006 flu vaccine in the history he provided when hospitalized in 2006, along with the absence of any notation of such a vaccine in 2006 in his VA treatment records, conclusively prove he did not receive a flu vaccine from VA on or about January 2006. The Board considered the Veteran’s contention that VA willfully altered his medical records to omit references to the alleged January 2006 flu vaccination to avoid awarding VA compensation claim. This allegation completely lacks merit. Under the "presumption of regularity," the Board presumes that government officials properly discharged their official duties, including creating and maintaining VA medical records in the ordinary course of business. Clear evidence to the contrary is required to rebut the presumption of regularity. See Ashley v. Derwinski, 2 Vet. App. 307 (1992); Mindenhall v. Brown, 7 Vet. App. 271 (1994). There is no clear evidence that the Veteran’s VA treatment records were altered after-the-fact. His bald, unsubstantiated allegation is insufficient to rebut the presumption of regularity, and the Board does not find such contentions raised while seeking VA compensation benefits to be credible. This is especially so because the private hospitalization records also fail to record any statement from him or any history that he had, in fact, received a flu shot from VA in 2006. Therefore, it is not just the fact that the VA records fail to document a 2006 flu shot that the Board finds persuasive, but also the fact that independent private medical records do not corroborate the Veteran’s allegations. As such, the Board affords no probative weight to any allegations of altered VA medical records. Even assuming the Veteran is claiming entitlement to compensation under 38 U.S.C. § 1151 for GBS based on the documented, October 2004 VA flu vaccination, the claim still must be denied. As noted above, the Board concedes that his GBS symptoms began in late January 2006. In addition, the evidence is at least in equipoise that the October 2004 VA flu immunization caused his subsequent development of GBS. See November 2014 VA medical opinion (summarizing conflicting medical research on this point); see also December 2014 VA addendum medical opinion (competently concluding that it was at least as likely as not that the Veteran’s GBS was a result of the October 2004 VA flu vaccine because: at least some medical literature supports a connection between GBS and the flu vaccine; the Veteran received the October 2004 flu vaccine in close proximity to the onset of GBS; and the lack of another causative factor). However, the weight of the most probative evidence does not show that his GBS was proximately caused by any instance of fault on VA’s part in administering the October 2004 flu vaccine. It is not enough to show current disability to prevail on a section 1151 claim; there must be a showing of fault on the part of VA. The Board affords great probative value to the December 2014 VA addendum medical opinion. See Nieves-Rodriguez v. Peake, 22 Vet. App. 295 (2008) (holding that the probative value of a medical opinion comes from when it is the factually accurate, fully articulated, and sound reasoning for the conclusion). The VA examiner considered the contention that the VA provider who administered the October 2004 flu vaccine did not give him a CDC handout informing him of the possible side effects. However, the VA examiner competently found that there was no documentation of negligence by VA in the administration of the October 2004 flu vaccination. Moreover, the Veteran acknowledged during the Board hearing that no medical providers ever indicated that there was any negligence involved in how the flu vaccine was administered. Furthermore, the Board rejects as factually inaccurate the theory that the VA provider who administered the flu vaccine failed to provide him with CDC information regarding the vaccine’s risks. The October 2004 VA immunization note expressly states, “CDC Flu Vaccine information sheet given to patient.” This VA medical record, which an objective medical provider contemporaneously created to document clinical treatment, is much more probative than his subjective recollection that he did not receive CDC flu vaccine information, which he first raised years later in support of a VA compensation claim. In summary, the Board does not find this contention credible. The Board recognizes that the October 2004 VA immunization note does not include the contents of the referenced CDC information sheet that the VA provider gave to the Veteran at that time. However, this is an insufficient basis to presume that the October 2004 VA provider did not advise the Veteran of such risks. Halcomb, 23 Vet. App. at 241. Moreover, the Board takes judicial notice of the fact that as early as May 2004, the CDC was aware of medical research addressing whether and to what extent GBS was a possible risk of the influenza vaccination. See Harper, Scott A., M.D. et al., “Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP),” https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5306a1.htm (page last reviewed May 18, 2004) (discussing research showing that 1976 swine flu vaccination was associated with increased frequency of GBS; however, also noting that “…investigations to date indicate no substantial increase in GBS associated with influenza vaccines [other than the swine influenza vaccine in 1976], and that, if influenza vaccine does pose a risk, it is probably slightly more than one additional case/1 million persons vaccinated;” concluding, “The potential benefits of influenza vaccination in preventing serious illness, hospitalization, and death substantially outweigh the possible risks for experiencing vaccine-associated GBS.”). It is not known whether the October 2004 CDC information sheet that the VA provider gave to the Veteran referenced the CDC’s contemporaneous, officially promulgated finding that the benefits of the flu vaccine outweighed the remote risk of GBS based on currently available research. In any event, the claim would still be denied. If the 2004 CDC information sheet did warn GBS was a possible risk of receiving the flu vaccine, then the Veteran was constructively aware of the risk as the VA records document he was provided this form. If the 2004 CDC information sheet did not warn about the potential of developing GBS, then there was certainly no failure on VA’s part to warn the Veteran of the risk. If CDC had not yet concluded research substantiated the risk enough to include it on the information sheet, there is no reason any medical professional would be expected to discuss GBS. Thus, despite the facts that the Veteran unfortunately developed GBS symptoms beginning in January 2006, and that the evidence is at least in equipoise that his October 2004 VA flu vaccine caused his GBS, the Board finds that his GBS was not proximately caused by VA’s fault in failing to warn him of possible risks of the vaccine – either the risk was included on CDC’s information sheet or it was not because the state of medical research at that time did not support giving such a warning. Under either scenario, there is no fault on the part of VA. In summary, there is no competent medical evidence suggesting that there was any carelessness, negligence, lack of proper skill, error in judgment, or fault on the part of VA in administering the October 2004 influenza vaccine. In addition, there is no competent medical evidence suggesting that VA failed to exercise the degree of care that would be expected of a reasonable health care provider in administering the October 2004 influenza vaccine. Finally, the weight of the most probative and credible evidence does not show that VA furnished this treatment without the Veteran’s informed consent. In conclusion, entitlement to compensation for GBS under 38 U.S.C. § 1151 is denied. As the weight of the evidence is against the claim, the benefit of the doubt doctrine does not apply. MICHELLE L. KANE Veterans Law Judge Board of Veterans’ Appeals ATTORNEY FOR THE BOARD R. Janofsky, Associate Counsel