Citation Nr: 9913138 Decision Date: 05/13/99 Archive Date: 05/21/99 DOCKET NO. 95-38 831 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Roanoke, Virginia THE ISSUE Entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 (formerly § 351) for additional disability, claimed as herpes simplex keratitis of the left eye due to Prednisone therapy resulting in functional blindness. REPRESENTATION Appellant represented by: Veterans of Foreign Wars of the United States WITNESS AT HEARING ON APPEAL Appellant ATTORNEY FOR THE BOARD L.A. Howell, Associate Counsel INTRODUCTION The veteran served on active duty from April 1944 to December 1945. This matter comes before the Board of Veterans' Appeals (Board) on appeal from a rating decision of the Department of Veterans Affairs (VA) Regional Office (RO) in Roanoke, Virginia, which denied entitlement to benefits pursuant to 38 U.S.C.A. § 1151 for herpes simplex keratitis in the left eye. Procedurally, the Board notes that the veteran filed a claim for benefits under 38 U.S.C.A. § 1151 (then § 351) in April 1985 for an eye condition as a result of Prednisone therapy, which was denied by rating decision dated in July 1985. He was notified and there was no timely disagreement therewith. In October 1986, he filed a claim in the United States District Court for the Western District of Virginia (Federal District Court) under the Federal Tort Claims Act (FTCA) asserting that VA was negligent in prescribing Prednisone and failed to monitor it properly and instruct him on its use. He argued that, as a result, he suffered an outbreak of herpes simplex virus leaving him functionally blind in his left eye. Although the Federal District Court found VA negligence, the case was dismissed because the veteran failed to establish a proximate cause between the VA's negligence and his left eye disorder. That decision was upheld by the United States Court of Appeals for the Fourth Circuit (Federal Court of Appeals). In March 1992, the veteran again filed a claim for § 1151 benefits. However, the claim was stayed pending resolution of another case involving the legal standard for benefits under § 1151. See Gardner v. Derwinski, 1 Vet. App. 584 (1991), aff'd, Gardner v. Brown, 5 F.3d 1456 (Fed. Cir. 1993), aff'd, 513 U.S. 115 (1994). On January 26, 1995, the Chairman of the Board announced the lifting of the Board's stay on the adjudication of cases affected by Gardner involving claims for benefits. In a June 1995 rating decision, the RO denied the veteran's claim for additional disability for a left eye disorder under 38 U.S.C.A. § 1151. On appeal, the Board remanded the issue to the RO for further development in October 1997. The requested developments were accomplished and the case was returned to the Board for appellate review. Finally, a hearing was held before a Member of the Board sitting in Washington, D.C., in March 1999. The undersigned Member was designated by the Chairman of the Board to conduct such a hearing. A transcript of the hearing testimony has been associated with the claims file. FINDINGS OF FACT 1. The RO has developed all evidence necessary for an equitable disposition of the veteran's claim. 2. The veteran received treated at a VA medical facility since February 1971 for urticaria. He also had private treatment for urticaria. Prednisone therapy was prescribed for urticaria by both VA physicians and his private treating physician. 3. In August 1984, the veteran experienced decreased visual acuity and was subsequently diagnosed with herpes simplex keratitis (HSK). Outpatient treatment records show on-going examinations and treatment for left eye HSK. 4. The evidence of record does not establish that the veteran's left eye disorder was caused by or related to the Prednisone treatment he received at VA facilities. 5. There is no competent evidence that there is clearly additional disability as the result of VA hospitalization, medical or surgical treatment. CONCLUSION OF LAW Entitlement to benefits pursuant to 38 U.S.C.A. § 1151 for additional disability, claimed as herpes simplex keratitis in the left eye due to Prednisone therapy resulting in functional blindness, is denied. 38 U.S.C.A. §§ 1151, 5107(a) (West 1991 & Supp. 1998); 38 C.F.R. § 3.358 (1998); Gardner v. Brown, 5 F.3d 1456 (Fed. Cir. 1993), aff'd, 513 U.S. 115 (1994). REASONS AND BASES FOR FINDINGS AND CONCLUSION Initially, the Board finds that the veteran's claim is "well grounded" within the meaning of 38 U.S.C.A. § 5107(a) (West 1991 & Supp. 1998); that is, he has presented a claim that is plausible. Specifically, the Board finds that the report of the expert testimony offered in support of the veteran's claim at the trial before the Federal District Court is sufficient to well ground his claim. Further, he has not alleged nor does the evidence show that any records of probative value, which could be associated with the claims folder and that have not already been sought, are available. The Board accordingly finds that the duty to assist the veteran, as mandated by § 5107(a), has been satisfied. The veteran contends, in essence, that Prednisone therapy for hives caused suppression of his immune system, which resulted in an opportunistic herpes simplex keratitis infection of his left eye, leaving him functionally blind. Controlling Regulatory Framework A veteran is entitled to additional compensation if he or she was injured as a consequence of hospitalization or treatment, and such injury or aggravation resulted in additional disability. 38 U.S.C.A. § 1151 (West 1991). Specifically, in pertinent part, 38 U.S.C.A. § 1151 provided that: Where any veteran shall have suffered an injury, or an aggravation of an injury, as the result of hospitalization, medical or surgical treatment, . . . and not the result of such veteran's own willful misconduct, and such injury or aggravation results in additional disability . . . , disability or death compensation . . . shall be awarded in the same manner as if such disability, aggravation, or death were service- connected. 38 U.S.C.A. § 1151 (West 1991). The regulation implementing that statute, provided, in pertinent part: (c) Cause. In determining whether such additional disability resulted from a disease or injury or an aggravation of an existing disease or injury suffered as a result of . . . hospitalization, medical or surgical treatment . . . , the following considerations will govern: (1) It will be necessary to show that the additional disability is actually the result of such disease or injury or an aggravation of an existing disease or injury and not merely coincidental therewith. (2) The mere fact that aggravation occurred will not suffice to make the additional disability compensable in the absence of proof that it resulted from disease or injury or an aggravation of an existing disease or injury suffered as the result of . . . hospitalization, medical or surgical treatment, . . . . (3) Compensation is not payable for the necessary consequences of medical or surgical treatment . . . properly administered with the express or implied consent of the veteran . . . "Necessary consequences" are those which are certain to result from, or were intended to result from, the . . . treatment administered. 38 C.F.R. § 3.358 (1998). The Board notes that in 1994, the Supreme Court affirmed decisions of the lower United States Court of Appeals for Veterans Claims (formerly the United States Court of Veterans Appeals) (Court) and the Federal Court of Appeals, which had essentially found that the statutory language of 38 U.S.C.A. § 1151 simply required a causal connection and that the elements of fault or negligence were not a valid part of the implementing regulation. See Brown v. Gardner, 513 U.S. 115 (1994). In light of the Supreme Court's decision, the VA amended 38 C.F.R. § 3.358(c), the regulation implementing 38 U.S.C.A. § 1151, to eliminate the requirement of fault. Thus, where a causal connection existed and no willful misconduct was shown, and the additional disability did not fall into one of the listed exceptions, the additional disability would be compensated as if service connected. Id. Parenthetically, in response to Gardner, the statutory authority for the regulation was subsequently once more amended effective in October 1997 to again require fault on the part of the VA. Nonetheless, due to the effective date of the statute, the veteran's case is not affected by that amendment. See 38 U.S.C.A. § 1151 (West 1991 & Supp. 1998). The provisions of 38 C.F.R. § 3.358 set forth above are the revised provisions and are the regulatory criteria that apply to this case. Accordingly, the ultimate issue before the Board is whether the use of Prednisone caused the veteran's herpes simplex keratitis and resultant functional blindness of the left eye. It is not sufficient nor determinative to the outcome to find Prednisone was negligently given as argued by the veteran (as there was no requirement that negligence be found under the controlling regulation); rather, it must be proved that the Prednisone caused the additional disability. Medical Evidence Turning first to the medical evidence, records from the VA Medical Center (VAMC) in Martinsburg, West Virginia, show that the veteran was admitted in February 1971 for recurrence of hives, and a ten to twelve year history of the same. A trial of exogenous steroids for relief had been attempted. He was hospitalized in December 1971 for abdominal pain. A history of urticaria, etiology unknown, was reported and he was on anti-histamines for hives. He was hospitalized in April 1974 for an acute flare-up of chronic urticaria. It was noted that he was first treated in February 1971 for a 23 year history of urticaria. Since 1971, he had had at least six additional admissions. During his hospital course, he was given an injection of Decadron and placed on Prednisone and discharged approximately one week later. He was admitted in April 1975 for an unrelated problem but was noted to be on Prednisone 5 mg. daily and 20 mgs. every two hours as needed in case of urticaria or sudden edema. Records dated in 1976 show that he was still receiving Prednisone and was hospitalized for chronic urticaria. A 1978 note shows Prednisone therapy. In December 1983, the veteran complained of a several day history of itching and swelling. Apparently, the dermatologist recommended "restarting" the Prednisone at 10 mg. daily. In a February 1984 progress note, he was reportedly taking Prednisone 5 mg. daily; however, by July 1984, he was noted to be taking Prednisone in a tapering dose. In late August 1984, he reported a ten day history of decreased visual acuity. The clinical impression was herpes simplex keratitis. Several days later, he received follow-up care and the clinical impression was improving HSK (herpes simplex keratitis). Treatment notes reveal on-going subjective complaints of pain and notations that the HSK was improving. However, in October 1984, the clinical impression was possible relapse of HSK and eye medications were increased. By November 1984, he was again improved and the diagnosis was disciform keratitis. By December 1984, he was feeling slightly less pain and the clinical impression was less inflammation. In a "follow-up" note for HSK dated in February 1985, the examiner remarked that the veteran complained of pain and burning. The clinical impression was chronic herpes. In a March 1985 progress note, the veteran complained of burning in his stomach and mouth. The examiner related a history of herpes simplex in the left eye with mouth blisters and pycosis. The clinical assessment was herpes, left eye. In a May 1985 note regarding another medical problem, he had reportedly been on Prednisone for "quite some time" for a skin condition but had been discontinued from the same. Additional treatment records show on-going treatment for a myriad of other medical disorders. Initial Regional Office and Federal Tort Claims Act Adjudication In April 1985, the veteran filed a claim for § 1151 benefits on the basis that Prednisone had weakened his immune system and caused herpes simplex, which had caused near blindness in his left eye, and the right eye had also been affected. The RO denied the claim by rating decision dated in July 1985 on the basis that no medical records indicated any connection between Prednisone and the herpes, and that development of keratitis and the use of steroids was totally coincidental. Finally, the RO concluded that there was no evidence that there was any indication of fault on the part of the VA or that the eye condition was the result of some accident stemming from treatment. The veteran was notified, and no timely disagreement with the determination is of record. In October 1986, the veteran filed a claim in the Federal District Court under the Federal Tort Claims Act (FTCA). According to court documents associated with the file, he asserted that the VA was negligent in prescribing Prednisone and failed to monitor it properly and instruct him on its use. He argued that, as a result of this alleged negligence, he suffered an outbreak of herpes simplex virus in this left eye which lead to functional blindness in that eye. In a Memorandum Opinion dated in May 1991 (which is associated with the claims file), Judge James H. Michael, Jr. concluded that the veteran had not proved his medical malpractice claim against the VA and dismissed the case. See Griffith v. United States, No. 86-0117-H (W.D. Va. May 6, 1991) (mem. opinion). Specifically, Judge Michael found, as a matter of law, that the veteran failed to prove proximate cause between the VA's negligence and the veteran's injury. As discussed below, the Board similarly concludes that the veteran has failed to satisfy the causation element for entitlement to § 1151 benefits. (It is noted that the Judge concluded that the VA had been negligent in not monitoring more closely the appellant's use of Prednisone.) As the entire trial transcript is not associated with the claims file and the veteran has made no challenge to the Federal District Court's findings of fact with respect to the expert testimony, the Board will consider the expert medical evidence as adopted by the Federal District Court. In support of his FTCA claim, the veteran offered expert testimony from Dr. Ruddy at trial to the effect that Prednisone suppressed the immune system and that immunosuppressed patients frequently developed herpes simplex infections. See Griffith, No. 86-0117-H, Memorandum Op. at 13. Dr. Ruddy opined that the large dose of Prednisone that the veteran took in August 1984 lowered his immune system and made him less able to defend himself again reactivation of the virus. Id. A second expert, Dr. Fox, agreed that Prednisone proximately caused the veteran's herpes infection. Id. Dr. Fox observed that it was generally well known in the ophthalmologic community that cortisone steroids would reactivate or trigger the herpes virus. Judge Michael, however, found this evidence not dispositive. Dr. Fischmann, a government expert, indicated that 20-40 mgs. of Prednisone per day for weeks or months was required to depress the immune system sufficiently to cause problems with infections and that daily high doses of the drug over two or three weeks would not result in sufficient immunosuppressant to create infection with complications. Id. at 14-15. Dr. Fischmann reasoned that exposure to sunlight was a more likely cause of the HSK infection than was Prednisone. Id. at 15. Another government expert, Dr. Stevens, remarked that given the numerous possible causes of HSK, no one could say with a reasonable degree of medical certainty what specifically caused the virus to manifest itself. Dr. Stevens further concluded that Prednisone therapy was not the primary cause or a substantial cause of the veteran's HSK infection. Id. All the experts testified that they had seen many patients who took Prednisone for longer periods in larger doses and had never developed an HSK infection. Id. at 13-14. Dr. Ruddy admitted that less than 10 percent of the Prednisone- treated patients had developed herpes infections and most had developed herpes zoster, not herpes simplex. Id. at 14. The court also indicated that Dr. Ruddy reported that it was "unusual" for a patient on Prednisone to develop a herpes infection. According to the court, the record showed that herpes simplex virus could occur spontaneously for no reason. Judge Michael's also found relevant that the veteran offered no evidence that he was immunosuppressed in August 1984. He concluded that these failures were critical in light of the fact that Prednisone was widely used and a herpes infection of the eye was uncommon. In light of conflicting expert testimony, and because of the veteran's lack of proof that Prednisone therapy actually suppressed his immune system, and that immunosuppression actually caused the HSK infection, the Federal District Court concluded that the VA's negligence was not a proximate cause of the veteran's injury. Id. at 15. In dicta, the Federal District Court also raised the possibility that the Prednisone the veteran took in August 1984 was, in fact, not prescribed by the VA. Apparently, the veteran's private treating physician had also prescribed Prednisone therapy and long-acting Decadron injections, which, as the veteran's expert reflected, could have impaired the veteran's immune system. Id. at 15-16. The Board notes that the Court of Appeals affirmed the decision of the Federal District Court. See Griffith v. United States, No. 91-1607 (4th Cir. May 13, 1992). As noted, as the issue of negligence is not before the Board at this time, the question of whether a VA or a private treating physician prescribed Prednisone in August 1984 will not be addressed in this decision. Similarly, in a Substantive Appeal dated in September 1995, a Statement of Accredited Representation in Appeal Cases dated in January 1997, and in correspondence dated in June 1997, the veteran asserted that Dr. Ancheta, his private treating physician, was an employee of the VA because the VA paid him for treating the veteran. Therefore, the veteran asserts, the VA is liable for Dr. Ancheta's treatment in August 1984. However, the Board finds that this argument is not germane to the current § 1151 claim because the threshold issue is one of causation, not negligence. The Board has also considered evidence not specifically noted by the Federal District Court in the May 6, 1991, Memorandum Opinion. Specifically, the Board notes the assertions presented in a written brief before the court at trial that the veteran and his wife were told by an ophthalmology resident that the Prednisone caused the herpes infection to "come out" in the veteran's eye. See Plaintiff's Proposed Findings of Fact and Conclusions of Law at 19, Griffith v. United States, No. 86-0117-H (W.D. Va. May 6, 1991) (mem. opinion) (citing to deposition testimony). However, the resident did not recall making those statements to the veteran, but neither did he recall any details of the examination. Id. In addition, the veteran asserted that the resident later told him that the Prednisone triggered the herpes infection but not to tell anyone he said so. Id. at 20. Finally, the Board notes that Dr. Fischmann admitted in deposition testimony that there was no consensus for the opinion that 20-40 mg. of Prednisone was needed on a constant basis for weeks or months to suppress a person's immune system and very little literature on the point. Id. at 34. Current § 1151 Claim The veteran filed the current § 1151 claim in March 1992. Because of modifications to the regulations from the time of the prior denial, the RO apparently considered it a new claim and the Board will do likewise. At the time Gardner was on appeal, all § 1151 claims, including the veteran's claim, were stayed pending resolution of that case. Subsequently, the RO denied the veteran's claim in June 1995. In his Notice of Disagreement dated in July 1995, the veteran maintained that the Federal District Court's and the Court of Appeal's findings that the VA was negligent were sufficient to create an overwhelming degree of doubt and that service- connection was warranted. In October 1997, the Board remanded the claim for additional development, including a complete copy of the trial court record. In the meantime, the veteran requested a hearing before the Board, which was undertaken in March 1999. At his hearing before the Board, the veteran testified that because a finding of negligence was made with respect to the use of Prednisone at the trial, that he was entitled to benefits. He acknowledged that he sent letters Senators John Warner and Charles Robb (listed as Roth) for help. He related that four experts testified at his trial in Federal District Court and that the experts on his behalf indicated that Prednisone lowered his immune system and made him less likely to defend against the reactivation of the herpes infection. He challenged various findings of the Federal District Court, including whether his immune system was suppressed in August 1984 and whether exposure to sunlight was the more likely cause. He reiterated that a doctor told him that Prednisone had put a herpes infection in his eye. He read excerpts from Dr. Rudy's and Dr. Stevens' (noted as "Stevenson") testimony at the trial, and Dr. Fischmann's cross-examination. The veteran also read into the record a letter dated in 1975 from Dr. Hume (noted as "Huhms"), which was already associated with the claims file, regarding the onset of urticaria and a more recent letter from Dr. Hume dated in 1996 to the effect that the Penicillin the veteran received in service resulted in a severe cough and hives, which continued to the present time. He observed that he had to quit his job because of his health. He stressed that he believed Prednisone had caused his health problems. Upon further questioning, he related the chronology of receiving Penicillin in service and developed urticaria, which he had continued to have. He started receiving Prednisone in 1971 for hives and continued into the 1980s. Apparently, Dr. Hume told him take an increased dose of Prednisone when he had a flare-up of hives and to taper it. He reported that Dr. Hume told him that the Prednisone caused him to go blind because of the weakened immune system. The first he knew of a herpes virus was when it developed in his eyes in the 1980s. He was currently using over-the-counter antihistamines for a skin condition. Legal Analysis It is readily apparent to the Board that this issue revolves around conflicting expert medical testimony proffered at trial in Federal District Court in 1990 regarding the causation issue. As an initial matter, the Board will consider the standard for causation under § 1151. As noted above, the controlling regulation provides that the additional disability claimed was necessarily "actually the result" of hospitalization or medical treatment. This language suggests a more stringent standard than "proximate cause" required under the FTCA and applied by the Federal District Court. However, the Supreme Court's decision in Gardner appeared to recognize, without discussion, a proximate cause standard under § 1151. See Gardner, 513 U.S. at 119. Accordingly, the Board will review this issue under a proximate cause standard. See also Memorandum from Department of Justice, Office of Legal Counsel, to Secretary of Veterans Affairs (Jan. 20, 1995) (Court appeared to presume, without deciding, proximate causation standard applied in Gardner). In this case, the Board finds that the bulk of the evidence does not show that Prednisone therapy proximately caused suppression of his immune system, which resulted in a herpes simplex keratitis infection of his left eye, and functional blindness. Primarily, the veteran has offered expert testimony from Drs. Ruddy and Fox that the large dose of Prednisone which the veteran took in August 1984 lowered his immune system and made him less able to defend against a herpes simplex virus. First, the Board observes that the medical testimony is not necessarily dispositive of the Board's inquiry. See Harder v. Brown, 5 Vet. App. 183, 188 (1993); Guerrieri v. Brown, 4 Vet. App. 467, 473 (1993). In addition, the Board notes that Dr. Ruddy admitted that it was unusual for Prednisone patients to develop herpes infection, with less than 10 percent of Prednisone patients acquiring herpes infections, and that most developed herpes zoster, not herpes simplex. The Board is also compelled to find testimony of the veteran's experts less persuasive because the medical records created concurrently with the veteran's August 1984 visual disturbances did not make reference to a connection between herpes simplex keratitis and the veteran's Prednisone treatments. The medical evidence suggests that he was tapering his dose in July 1984. Further, in the initial denial of the veteran's claim, the RO found that the onset of herpes simplex keratitis and Prednisone therapy was totally coincidental and the Board can find nothing in the contemporaneous records that suggests otherwise. Moreover, the veteran had been treated for nearly 13 years at VA and apparently an additional 10-12 years prior to that with Prednisone without any reported history of herpes simplex infections. The Board specifically accords more probative weight to the two government experts, whose findings were adopted by the Federal District Court and affirmed by the Court of Appeals, which found that the veteran's left eye disorder was not related to Prednisone therapy. The Board makes this finding, in part, upon the bases that the medical evidence indicated that a herpes simplex virus was unusual in Prednisone-treated patients, that herpes simplex viruses could occur spontaneously for no reason, that herpes simplex keratitis had numerous possible causes, and that all the experts agreed that they had seen many patients with higher doses of Prednisone over longer periods of time who had never develop herpes simplex keratitis. This is consistent with Dr. Fischmann's testimony that higher doses of Prednisone over weeks or months was required to depress the immune system sufficiently to cause problems with opportunistic infections, although the Board notes that she conceded that very little medical literature existed on the subject. It is concluded therefore, that the Government's expert witness opinions are more conclusively supported by the contemporaneous records of the event in question. The Board is also persuaded by the Federal District Court's finding that the veteran failed to prove that he was immunosuppressed in August 1984. A fair reading of the outpatient treatment records did not suggest that he was experiencing other opportunistic infections at the time. Nor did he complain of slow healing wounds, redness, swelling, or other indications that his system was immunosuppressed. Therefore, the Board finds the evidence more suggestive that there was no connection between Prednisone therapy, and immunosuppression leading to the veteran's left eye disorder. Finally, the Board has considered the veteran's own statements and sworn testimony that his left eye disorder is the result of Prednisone therapy. Although the veteran's statements and sworn testimony are probative of symptomatology, they are not competent or credible evidence of a diagnosis, date of onset, or medical causation of a disability. See Grottveit v. Brown, 5 Vet. App. 91, 93 (1993); Espiritu v. Derwinski, 2 Vet. App. 492, 494-95 (1992); Miller v. Derwinski, 2 Vet. App. 578, 580 (1992). The veteran's assertions alone are not deemed to be credible in light of the preponderance of evidence showing no relationship between his left eye disorder and Prednisone therapy. The veteran lacks the medical expertise to offer an opinion as to the existence of a current left eye disorder, as well as to medical causation of any current disability. Id. In the absence of competent, credible evidence of a causal relationship, entitlement to § 1151 benefits are not warranted. Therefore, the Board must conclude that the preponderance of the evidence is against the veteran's claim and the claim is denied. ORDER Entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 (formerly § 351) for additional disability, claimed as herpes simplex keratitis of the left eye due to Prednisone therapy resulting in functional blindness, is denied. MICHAEL D. LYON Member, Board of Veterans' Appeal