Citation Nr: 1328559 Decision Date: 09/06/13 Archive Date: 09/16/13 DOCKET NO. 99-19 010 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Oakland, California THE ISSUE Entitlement to compensation pursuant to 38 U.S.C.A. § 1151 for additional left arm disability due to VA medical treatment in October 1998. REPRESENTATION Veteran represented by: Disabled American Veterans ATTORNEY FOR THE BOARD M. G. Mazzucchelli, Counsel INTRODUCTION The Veteran, who is the appellant, served on active duty from August 1966 to August 1968. This matter is before the Board of Veterans' Appeals (Board) on appeal of a rating decision in May 1999 of a Department of Veterans Affairs (VA) Regional Office (RO). In October 2003 and in February 2005, the Board remanded the claim for additional development. In a decision in April 2006, the Board denied the claim. The Veteran appealed the Board's decision to the United States Court of Appeals for Veterans Claims (Court). In an order in December 2007, the Court granted the parties' Joint Motion to Remand, and remanded the case to the Board for action consistent with the Joint Motion. In August 2009, the Board remanded the case for additional development consistent with the parties' Joint Motion. After the additional development was completed, the Board denied the claim in May 2011. The Veteran appealed the Board's decision to the Court. In a Memorandum Decision in July 2012, the Court vacated the Board's decision, and remanded it for action consistent with the Memorandum Decision. In March 2013, the Board remanded the case for additional development consistent with the Court's Memorandum Decision. FINDINGS OF FACT 1. The Veteran received an influenza vaccination at the VA Medical Center (VAMC) in San Francisco, California in October 1998. 2. Left brachial neuritis is likely the result of the influenza vaccination given by VA in October 1998. 3. Left brachial neuritis as a result of the influenza vaccination given by VA in October 1998 was not a reasonably foreseeable event. CONCLUSION OF LAW The criteria for disability compensation under 38 U.S.C.A. § 1151 for additional left arm disability, brachial neuritis, due to VA medical treatment in October 1998, are met. 38 U.S.C.A. § 1151, 5107(b) (West 2002); 38 C.F.R. §§ 3.361, 17.32 (2012). Veterans Claims Assistance Act of 2000 (VCAA) The VCAA amended VA's duties to notify and to assist a claimant in developing information and evidence necessary to substantiate a claim. 38 U.S.C.A. §§ 5103(a), 5103A; 38 C.F.R. § 3.159. As the claim is resolved in the Veteran's favor, the Board need not further address VCAA compliance. REASONS AND BASES FOR FINDINGS AND CONCLUSION Legal Criteria As the Veteran's claim under 38 U.S.C.A. § 1151 was received after October 1, 1997, the following statutory and regulatory provisions apply. Compensation is awarded for a qualifying additional disability of a veteran in the same manner as if such additional disability were service-connected. A disability is a qualifying additional disability if the disability was caused by VA surgical treatment, and the proximate cause of the disability was carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing the medical treatment; or the additional disability was not reasonably foreseeable. Under 38 C.F.R. § 3.361(c), a claim based on additional disability due to VA medical treatment requires actual causation. To establish causation, the evidence must show that the VA medical treatment resulted in the veteran's additional disability. Whether the proximate cause of an additional disability was an event not reasonably foreseeable 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 of 38 C.F.R. § 17.32. 38 C.F.R. § 3.361(d)(2). Evidentiary Standards VA must give due consideration to all pertinent medical and lay evidence in a case where a veteran is seeking service connection. 38 U.S.C.A. § 1154(a). Competent medical evidence means evidence provided by a person who is qualified through education, training, or experience to offer a medical diagnosis, statement, or opinion. 38 C.F.R. § 3.159. The Board, as fact finder, must determine the probative value or weight of the admissible evidence. Washington v. Nicholson, 19 Vet. App. 362, 369 (2005) (citing Elkins v. Gober, 229 F.3d 1369, 1377 (Fed.Cir.2000) ("Fact-finding in veterans cases is to be done by the Board)). When there is an approximate balance of positive and negative admissible evidence regarding any issue material to the determination of a matter, the Secretary shall give the benefit of the doubt to the veteran. 38 U.S.C.A. § 5107(b). Facts VA records disclose that in October 1998 the Veteran was given an intramuscular influenza vaccine at the left deltoid. At the time, he was asked if he was allergic to eggs protein or egg by-products and the Veteran denied having allergies to egg protein or egg by-products. About a month later in November 1998, the Veteran complained of left shoulder pain of two days' duration. There was no history of trauma. An EMG revealed acute denervation in the left deltoid. The assessment was idiopathic brachial neuritis versus C-5 nerve root lesion. When he was seen in December 1998, the impression was brachial neuritis. In January 1999, the Veteran requested information about the contents of the flu vaccine and the viruses he was vaccinated against. In January 1999, a VA physician filed a report with the appropriate Federal agency about the Veteran's adverse reaction to the flu vaccine, which was identified as left brachial neuritis. In May 1999, an EMG of the left upper extremity was normal. In various statements, including the notice of disagreement in July 1999, the Veteran contended that prior to the flu shot he had pain and stiffness in his left shoulder and the flu shot aggravated his left shoulder. In October 1999 the Veteran was evaluated for left shoulder pain by an orthopedic surgeon. The Veteran stated that he developed left shoulder pain several weeks after having had a flu shot in October 1998. The impression was a history of left shoulder pain, rule out subacromial bursitis versus resolved neuritis. On VA examination in July 2004, the assessment was left upper extremity weakness and numbness with onset about one month after a flu vaccine, which was more likely than not left brachial neuritis related to the flu vaccine in October 1998. On VA examination in July 2005, the diagnosis was probable acute brachial plexus neuritis (upper trunk) exacerbated by flu vaccination with associated cervical radiculopathy. After a review of the record, the examiner expressed the opinion that there was nothing in the record to indicate negligence, technical error, or erroneous type of treatment performed by VA with regard to the flu vaccine administered to the Veteran in October 1998. Also, the examiner stated that there had been studies looking into the neurological complications of immunization with a cause and effect relationship between immunization and brachial neuritis being suggested, but never clearly proved. The examiner noted that it was reasonable to assume that the Veteran had some underlying cervical degenerative disease that was producing radicular symptoms and that influenza vaccination resulted either in a direct brachial neuritis or into an exacerbation of prior symptoms. The examiner concluded that there was no negligence, technical error, or erroneous type of treatment in performing the immunization as prior studies have shown that it was commonly known that there was possibly a 1 per 100,000 patient complication rate with these types of vaccinations, although the numbers were not proven. The examiner then expressed the opinion that to withhold a vaccination based on those numbers was far outweighed by the possible risk of a acquiring the influenza virus. The examiner noted that while the Veteran had underlying cervical radiculopathy, his symptoms were more so than not brought about by the vaccination. He appeared to have acute brachial plexus neuritis based on the EMG results and the medical history, which began acutely and resolved a number of months later. In September 2009, an opinion was obtained from the San Francisco VA Medical Center Chief of Staff. As to the question of whether in October 1998 the protocol for administering the influenza vaccine intramuscularly required a signed informed consent, she replied that as the vaccine was given intramuscularly in the left deltoid muscle, which is not a joint space or body cavity, the protocol for administering the influenza vaccine intramuscularly did not require written informed consent under 38 C.F.R. § 17.32(d). As to whether the protocol for administering the influenza vaccine required oral consent, the doctor explained that there was oral consent given the Veteran's negative reply to the nurse's questions about allergy to egg protein or egg by products documented in conjunction with the influenza immunization discussion in October 1998. She noted that the influenza vaccine administration is currently covered under Appendix D of Informed Consent Medical Center Memorandum (MCM) #11-37 dated in 2009 (noting that the 1998 MCM is not available). The physician concluded that since immunization was a low risk routine procedure and since allergy to egg products was the most significant risk associated with the vaccine, documentation in the record was appropriate. In June 2013, a VA physician, after review of the Veteran's file and the relevant medical literature, stated that the development of brachial neuritis following influenza vaccination was not reasonably foreseeable as brachial neuritis was not among the expected complications of such a vaccination as noted by the Vaccine Healthcare Centers Network. The VA physician stated that brachial neuritis was not a risk that a reasonable health care provider would consider to be an ordinary risk of the treatment provided. Analysis On the question of informed consent raised by the Court, the Chief of Staff at the San Francisco VA Medical Center stated that the protocol for administering the influenza vaccine intramuscularly did not require written informed consent under 38 C.F.R. § 17.32(d). And that oral consent was implied as the Veteran answered the nurse's questions about any allergy to egg protein or egg by products in conjunction with the influenza immunization. The Chief of Staff noted that the influenza vaccine administration was currently covered under Appendix D of Informed Consent Medical Center Memorandum and (MCM) #11-37, dated in 2009, and did not require written consent, noting that the 1998 MCM was not available. In this case, no written informed consent was required, which distinguishes the case on the facts from McNair v. Shinseki, 25 Vet. App. 98 (2011) (failure to advise a patient of a foreseeable risk can be considered minor, immaterial deviation under Section 17.32 for obtaining informed consent). The record shows that in October 1998 the Veteran was given an intramuscular influenza vaccine at the left deltoid by VA. On the question of whether the Veteran has any additional disability as a consequence of VA medical treatment, the medical evidence shows the Veteran developed left brachial neuritis after the flu vaccination administered by VA in October 1998. Whether the Veteran has an additional disability resulting from VA treatment is not in dispute. As for whether brachial neuritis was caused by carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA, there is no such evidence. The remaining question is whether the left brachial neuritis was not reasonably foreseeable. Under 38 C.F.R. § 3.361(d), whether the proximate cause of an additional disability was an event not reasonably foreseeable 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. The VA examiner in 2005 stated that there had been studies looking into the neurological complications of immunization with a cause and effect relationship between immunization and brachial neuritis being suggested, but never clearly proved. The examiner noted that prior studies have shown that it was commonly known that there was possibly a 1 per 100,000 patient complication rate with these types of vaccinations, although the numbers were not proven. In June 2013, a VA physician, who had reviewed the Veteran's file, expressed the opinion that brachial neuritis following influenza vaccination was not reasonably foreseeable as it was not a risk that a reasonable health care provider would consider to be an ordinary risk of the treatment provided. The competent medical evidence of record supports a finding that left brachial neuritis is likely the result of the influenza vaccination given by VA in October 1998, and that left brachial neuritis as a result of the influenza vaccination given by VA in October 1998 was not a reasonably foreseeable event and the Veteran prevails. ORDER Disability compensation pursuant to 38 U.S.C.A. § 1151 for additional left arm disability, brachial neuritis, due to VA medical treatment in October 1998, is granted. ____________________________________________ George E. Guido Jr. Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs