Citation Nr: 9926482 Decision Date: 09/15/99 Archive Date: 09/28/99 DOCKET NO. 97-20 566A ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in White River Junction, Vermont THE ISSUE Entitlement to benefits under 38 U.S.C.A. § 1151 for residuals of ammonia poisoning, claimed to have resulted from treatment during hospitalization at a VA medical facility. REPRESENTATION Appellant represented by: Disabled American Veterans WITNESS AT HEARING ON APPEAL The veteran ATTORNEY FOR THE BOARD S. J. Janec, Associate Counsel INTRODUCTION The veteran had active military service from June 1968 to June 1971. This matter comes before the Board of Veterans' Appeals (Board) from an April 1997 rating decision of the White River Junction, Vermont, Regional Office (RO) of the Department of Veterans Affairs (VA) which denied benefits under 38 U.S.C.A. § 1151 for residuals of ammonia poisoning, claimed to have resulted from treatment during hospitalization at a VA facility. In his July 1997 substantive appeal, the veteran indicated that he wished to testify at a personal hearing before a Member of the Board at the RO. He also requested a personal hearing before a hearing officer at the local office. In February 1998, the veteran testified at a personal hearing before a hearing officer at the RO. In a September 1998 decision, the hearing officer confirmed the denial of the veteran's claim. In a March 1999 statement, the veteran reported that he no longer desired to have a personal hearing before a Member of the Board. The Board notes that, in a September 1998 rating decision, the RO found that the veteran had not presented new and material evidence sufficient to reopen a claim for service connection for schizophrenia. It does not appear that the veteran has appealed the decision as to that issue, and the matter has not been certified for appellate review. Therefore, it is not presently before the Board, and is not addressed in this decision. FINDINGS OF FACT 1. All relevant evidence necessary for an equitable disposition of the veteran's appeal has been obtained. 2. The veteran was hospitalized at a VA Medical Center in White River Junction, Vermont, from December 1996 to January 1997, for treatment of a psychiatric disorder. 3. During the hospitalization, the veteran was treated with valproic acid, which caused him to lapse into a coma; he was immediately resuscitated, and diagnostic tests revealed that the valproic acid caused hyperammonia in the veteran, secondary to a carnitine deficiency. 4. No chronic residual effects from the adverse reaction were noted at discharge from the VA Medical Center, or upon VA examination in April 1997. 5. The claim for benefits under the provisions of 38 U.S.C.A. § 1151 is not plausible under the law, as there is no evidence that the veteran has additional disability which is a result of the temporary hyperammonia condition he experienced during the VA hospitalization pertinent to this claim. CONCLUSION OF LAW The claim for benefits under the provisions of 38 U.S.C.A. § 1151, for residuals of ammonia poisoning as a result of treatment at a VA facility, is not well grounded. 38 U.S.C.A. §§ 1151, 5107(a) (West 1991); 38 C.F.R. § 3.358 (1998). REASONS AND BASES FOR FINDINGS AND CONCLUSION I. Factual Background A discharge summary from the White River Junction, Vermont, VA Medical Center (VAMC) indicates that the veteran was hospitalized from December 6, 1996, to January 17, 1997. He was admitted because he had been experiencing increased anger and depression, with thoughts of ending his life. He denied any acute medical problems. He reported that he had been on Valium in the past to help him reduce his anxiety and become more focused. He noted that, when he had lived in Europe, he had smoked marijuana on a daily basis for the same reasons. Upon admission to the VAMC, it was noted that the veteran appeared strained and irritable. His speech was clear and normal in volume, but it increased in rate with pressure and was difficult to interrupt. His mood was angry and depressed; and his affect was dysphoric, congruent with mood, and ranged from anger to sadness to grandiose, suspicious, and guarding. His thought processes were goal-directed, and fairly logical. He described a chronically varying sleep pattern. Physical and neurological examinations were within normal limits. The veteran was initially treated with various medications in an attempt to stabilize his symptoms. On December 10, 1996, he was found to be irritable and manic. He was then given valproic acid, which was gradually increased to 1250 mg by December 16, 1996. Shortly thereafter, he appeared more sedate; he also appeared disheveled, but voiced no subjective complaints. However, on December 19, 1996, he exhibited an acute change in mental status; he appeared obtunded and minimally responsive to stimuli, with an unclear etiology. An EEG, pulse oximeter, EKG with rhythm strip, and CT scan of the head with contrast were performed. Various laboratory and drug screens were also performed. It was discovered that the veteran had a significantly elevated ammonia level in his blood,which was measured at 143, well above the normal range. Immediate Neurology and Medicine consultations were obtained, and it was determined that the veteran's abrupt mental status change was due to a valproic-acid-induced carnitine deficiency which had been previously unrecognized in the veteran. The valproic acid was stopped immediately, and the veteran was given Lactulose and L-carnitine, with resolution of the acute changes in mental status. No further complications from the valproic acid were noted. He was discharged on January 17, 1997. The discharge diagnoses were: bipolar affective disorder; and chronic left leg and hip pain. At a VA examination in April 1997, the veteran reported that he had experienced an adverse reaction to valproic acid secondary to a carnitine deficiency in December 1996, and had slipped into a coma. He related that the valproic acid overdose had caused his ammonia level to reach 140. He stated that, as a result, he currently had difficulty concentrating, reading, and focusing his eyes. He also needed to nap three to four times a day, and suffered from hair loss and headaches. The examiner recounted the pertinent history upon review of the veteran's medical records. He noted that the veteran's liver function tests were normal before the reaction to the valproic acid, and that a carnitine deficiency was rare. The veteran had manifested three progressive days of lethargy, and was then found comatose. He had been resuscitated without incident. An EEG had revealed changes consistent with hyperammonia, and the valproic acid was then stopped. The following morning, the records indicated that the veteran had been up and around in the Day Room. Recent laboratory tests, completed in March 1997, revealed normal total bilirubin, alkaline phosphatase, amylase, SGOT, and SGPT. Therefore, the examiner concluded that there had been no residual effects on the veteran's liver as a result of the incident. Clinical evaluation revealed that the veteran had moderate alopecia of the upper crown of his head. Motor and neurological examinations were reported to be within normal limits. In further discussion of this case, the examiner reported that the half life of valproic acid is typically five to 20 hours, and could be up to 30 hours following an overdose. He also reported that manifestations of an overdose of valproic acid may produce somnolence or coma. In addition, possible side effects include: abnormal liver function tests, alopecia, sedation, and drowsiness. Diplopia and nystagmus had also been reported, although rarely. The examiner concluded that, in light of the time frame that had lapsed, it was unlikely that the veteran had any chronic residual effects from the hyperammonia. He attributed the veteran's complaints of difficulty focusing his eyes, and difficulty concentrating, to his psychiatric medications. The examiner further noted that the headaches had pre-dated the incident upon which this claim is based. The final diagnosis was status post hyperammonia secondary to carnitine deficiency and an adverse reaction to valproic acid, with no major residual effects other than alopecia, which should be transient. VA outpatient treatment reports, dated in 1997, reflect that the veteran was seen at the Mental Health Clinic. At a personal hearing before a hearing officer at the RO in February 1998, the veteran testified that he has been experiencing seizures on almost a daily basis since his hospitalization in December 1996. He also described experiencing migraine headaches, and complained of memory loss and confusion. He indicated that he still attended outpatient psychotherapy at the Mental Health Clinic. He submitted numerous copies of articles and abstracts from medical journals and treatises, which discussed the side effects of ammonia poisoning and valproic acid. II. Analysis The statutory criteria applicable to this case appear at 38 U.S.C.A. § 1151 (West 1991), which provides that, if a veteran suffers an injury or an aggravation of an injury as a result of VA hospitalization or medical or surgical treatment, not the result of the veteran's own willful misconduct, and the injury or aggravation results in additional disability or death, then compensation, including disability, death, or dependency and indemnity compensation, shall be awarded in the same manner as if the additional disability or death were service-connected. See 38 C.F.R. § 3.358(a), 38 C.F.R. § 3.800(a) (1998). The regulations provide that, in determining whether additional disability exists, the veteran's physical condition immediately prior to the disease or injury upon which the claim for compensation is based will be compared with the physical condition subsequent thereto. With regard to medical or surgical treatment, the veteran's physical condition prior to the disease or injury is the condition which the medical or surgical treatment was intended to alleviate. Compensation is not payable if the additional disability or death results from the continuance or natural progress of the disease or injury for which the training, treatment, or hospitalization was authorized. 38 C.F.R. § 3.358(b)(1), (2). In addition, the regulations specify that the additional disability or death must actually result from VA hospitalization or medical or surgical treatment, and not merely be coincidental therewith. In the absence of evidence satisfying this causation requirement, the mere fact that aggravation occurred will not suffice to make the additional disability or death compensable. 38 C.F.R. § 3.358(c)(1), (2). The regulations further provide that compensation is not payable for the necessary consequences of medical or surgical treatment properly administered with the express or implied consent of the veteran, or, in appropriate cases, the veteran's representative. "Necessary consequences" are those which are certain to result from, or were intended to result from, the medical or surgical treatment provided. Consequences otherwise certain or intended to result from a treatment will not be considered uncertain or unintended solely because it had not been determined, at the time consent was given, whether that treatment would in fact be administered. 38 C.F.R. § 3.358(c)(3). Finally, if the evidence establishes that the proximate cause of the injury suffered was the veteran's willful misconduct or failure to follow instructions, the additional disability or death will not be compensable, except in the case of a veteran who is incompetent. 38 C.F.R. § 3.358(c)(4). So as to avoid any misunderstanding as to the governing law, the Board notes that earlier interpretations of the statute, embodied in regulations, required evidence of negligence or other fault on the part of VA, or the occurrence of an accident or an otherwise unforeseen event, to establish entitlement to benefits under 38 U.S.C.A. § 1151. See 38 C.F.R. § 3.358(c)(3) (1994). Those provisions were invalidated by the United States Court of Appeals for Veterans Claims (formerly known as the United States Court of Veterans Appeals) in the case of Gardner v. Derwinski, 1 Vet.App. 584 (1991). That decision was affirmed by both the United States Court of Appeals for the Federal Circuit, in Gardner v. Brown, 5 F.3d 1456 (Fed. Cir. 1993), and the United States Supreme Court, in Brown v. Gardner, 513 U.S. 115 (1994). In March 1995, the Secretary of Veterans Affairs published an interim rule amending 38 C.F.R. § 3.358 to conform with the Supreme Court decision. The amendment was made effective November 25, 1991, the date the initial Gardner decision was issued by the Court of Appeals for Veterans Claims. 60 Fed. Reg. 14,222 (Mar. 16, 1995). The interim rule was later adopted as a final rule, 61 Fed. Reg. 25,787 (May 23, 1996), and codified at 38 C.F.R. § 3.358(c) (1998). Subsequently, Congress amended 38 U.S.C.A. § 1151, effective for claims filed on or after October 1, 1997, to preclude compensation in the absence of negligence or other fault on the part of VA, or an event not reasonably foreseeable. Pub. L. No. 104-204, § 422(a), 110 Stat. 2926 (Sept. 26, 1996), codified at 38 U.S.C.A. § 1151 (West Supp. 1997); see also VAOPGCPREC 40-97 (Dec. 31, 1997). The veteran's claim for benefits under section 1151 was filed in December 1996. Therefore, under the statute and the opinion of the General Counsel cited above, this claim has been adjudicated by the RO, and is being reviewed by the Board, under the version of 38 U.S.C.A. § 1151 extant before the enactment of the statutory amendment, as interpreted in the Gardner decisions, supra, and under the interim rule issued by the Secretary on March 16, 1995, and adopted as a final regulation on May 23, 1996. Thus, neither VA fault nor an event not reasonably foreseeable would be required for this claim to be granted. However, a claimant seeking benefits under any law administered by the Secretary of Veterans Affairs has the burden of submitting evidence sufficient to justify a belief by a fair and impartial individual that the claim is well grounded. If the claim is well grounded, the Secretary is obligated to assist a claimant in developing evidence pertaining to the claim. 38 U.S.C.A. § 5107(a). If the claim is not well grounded, there is no duty to assist. Epps v. Brown, 9 Vet.App. 341 (1996), aff'd sub nom. Epps v. Gober, 126 F.3d 1464 (Fed. Cir. 1997), cert. denied sub nom. Epps v. West, 118 S. Ct. 2348 (1998); Murphy v. Derwinski, 1 Vet.App. 78 (1990). Thus, the threshold question for any claim, including one filed under the provisions of 38 U.S.C.A. § 1151, is whether the claimant has presented a well-grounded claim. See Elkins v. West, 12 Vet.App. 209, 213 (1999) (en banc), citing Caluza v. Brown, 7 Vet.App. 498 (1995), aff'd per curiam, 78 F.3d 604 (Fed. Cir. 1996) (table), and Epps, supra. A well-grounded claim is one which is meritorious on its own or capable of substantiation. Such a claim need not be conclusive, but only plausible, to satisfy the initial burden of 38 U.S.C.A. § 5107(a). Murphy, supra. To present a well- grounded claim, the claimant must provide evidence; mere allegation is insufficient. Tirpak v. Derwinski, 2 Vet.App. 609 (1992). The evidence the claimant must provide must be sufficient to justify a belief by a fair and impartial individual that the claim is plausible. Lathan v. Brown, 7 Vet.App. 359 (1995). Where the determinative issue is factual in nature, competent lay evidence may suffice. Gregory v. Brown, 8 Vet.App. 563 (1996). Where the determinative issue involves medical etiology or diagnosis, medical evidence is required. Lathan, supra. The Court of Appeals for Veterans Claims has recently held that the requirements for a well-grounded claim under section 1151 are, paralleling those generally set forth for establishing other service connection claims, as follows: (1) medical evidence of a current disability; (2) medical evidence, or in certain circumstances lay evidence, of incurrence or aggravation of a disease or injury as the result of hospitalization, medical or surgical treatment, or the pursuit of a course of vocational rehabilitation under chapter 31 of title 38, United States Code; and (3) medical evidence of a nexus (i.e., a link or a connection) between the asserted injury or disease and the current disability. In addition, the Court has determined that an appellant's claim would also generally be well grounded, with respect to the continuity-of-symptomatology analysis under 38 C.F.R. § 3.303(b), if he or she submitted evidence of each of the following: (a) evidence that a condition was "noted" during his/her VA hospitalization or treatment; (b) evidence showing continuity of symptomatology following such hospitalization or treatment; and (c) medical or, in certain circumstances, lay evidence of a nexus between the present disability and the post- hospitalization/treatment symptomatology. See Jones v. West, ___Vet.App. ___, No. 98-664, slip op. at 5-6 (July 7, 1999). Thus, a claim for benefits under the provisions of 38 U.S.C.A. § 1151 must be supported by medical evidence of additional disability that resulted from hospitalization, or from medical or surgical treatment, provided by VA. A review of the evidence reflects that the veteran experienced an episode of acute change in mental status and briefly lapsed into a coma during his hospitalization at the White River Junction VAMC in December 1996. Diagnostic tests at that time revealed that the valproic acid with which the veteran was being treated had caused hyperammonia secondary to a carnitine deficiency that had not been previously detected. The valproic acid was stopped, and other medications were administered. No chronic residual effects were noted upon discharge from the hospital. Subsequently, upon VA examination in April 1997, the examiner, having reviewed the hospital records and clinically evaluated the veteran, concluded that, although the veteran did have an adverse reaction to the valproic acid, he did not exhibit any chronic residuals from the episode, and all laboratory findings, including liver function tests, were within normal limits. Furthermore, the veteran's complaints of difficulty concentrating and sleeping, as well as the blurred vision, were attributed to the medication he took for his psychiatric disability, and thus are etiologically unrelated to the temporary hyperammonia. The examiner did note that the veteran had alopecia as a result of the incident; however, this condition was considered transient, and would not be a ratable disability even if it were permanent. Thus, the Board is compelled, by the unequivocal medical evidence of record, to find that no additional disability has actually resulted from VA hospitalization or medical or surgical treatment. 38 C.F.R. § 3.358(c)(1), (2). While we do not doubt the sincerity of the veteran's contention that he has additional disability as a result of the adverse reaction to valproic acid, we note that he has not met his burden of presenting evidence of a well-grounded claim under section 1151 merely by presenting his own assertions, or those of his representative on his behalf, however strongly they may be felt because, as lay persons, they are not competent to offer medical opinions. See Bostain v. West, 11 Vet.App. 124, 127 (1998). See also Carbino v. Gober, 10 Vet.App. 507, 510 (1997), aff'd sub nom. Carbino v. West, 168 F.3d 32 (Fed. Cir. 1999); Routen v. Brown, 10 Vet.App. 183, 186 (1997) ("a layperson is generally not capable of opining on matters requiring medical knowledge"), aff'd sub nom. Routen v. West, 142 F.3d 1434 (Fed. Cir. 1998), cert. denied, 119 S. Ct. 404 (1998). In this regard, the Board notes that the medical journal and treatise evidence submitted by the veteran in support of his claim discussed hyperammonia and valproic acid in only a general way. That material did not provide evidence that the veteran himself had any chronic residuals as a result of his treatment with valproic acid, or the hyperammonia that resulted from it. Nor did the generic information contained therein purport to establish a relationship between the incident in the VAMC and any subsequent disability shown to be present in the veteran. Therefore, this evidence is not sufficiently specific to well ground his claim. See Wallin v. West, 11 Vet.App. 509 (1998); Sacks v. West, 11 Vet.App. 314 (1998). In view of the foregoing, the Board holds, based upon the evidence in this case, that the veteran does not have any additional disability as a result of the hyperammonia he experienced during hospitalization at the White River Junction VAMC in December 1996. Accordingly, the claim is not well grounded, and benefits under section 1151 may not be granted. ORDER Entitlement to benefits under 38 U.S.C.A. § 1151 for residuals of ammonia poisoning, claimed to have resulted from treatment during hospitalization at a VA medical facility, is denied. ANDREW J. MULLEN Member, Board of Veterans' Appeals