Citation Nr: 0604759 Decision Date: 02/17/06 Archive Date: 02/28/06 DOCKET NO. 02-17 682 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Sioux Falls, South Dakota THE ISSUE Entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 for rhabdomyolysis caused by VA medical treatment during the period prior to June 1, 2001. REPRESENTATION Appellant represented by: The American Legion ATTORNEY FOR THE BOARD K.A. Kennerly, Associate Counsel INTRODUCTION The veteran served on active duty from April 1976 to April 1980 in the United States Navy. This matter comes before the Board of Veterans' Appeals (Board) on appeal from an August 2002 rating decision of the Sioux Falls, South Dakota Regional Office (RO) of the Department of Veterans Affairs (VA), which denied the veteran's claim to entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 (West Supp. 2005) for rhabdomyolysis caused by VA medical treatment during the period prior to June 1, 2001. The veteran filed a timely notice of disagreement (NOD) with the rating decision and was thereafter provided with a statement of the case (SOC) in October 2002. In October 2002, the veteran submitted a Substantive Appeal (VA Form 9), in which he indicated that he was only appealing the issue of entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 (West Supp. 2005) for rhabdomyolysis incurred during treatment at a VA medical facility. Subsequent documentation and argument submitted by the veteran's representative has been limited to that issue. The Board limits its consideration herein to the single issue stated on the title page of this decision. The Board remanded this claim in November 2003 and in July 2005 for further adjudication. FINDINGS OF FACT 1. On June 1, 2001, the veteran was admitted to the VA Medical Center with complaints of severe body aches and pain in the legs. 2. During this admission, the veteran was diagnosed with rhabdomyolysis, a result of combining Simvastatin and Gemfibrozil. 3. The veteran's rhabdomyolysis was not the result of any carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA. CONCLUSION OF LAW The criteria for entitlement to compensation benefits under the provisions of 38 U.S.C.A. § 1151 for rhabdomyolysis, claimed to be the result of VA treatment prior to June 1, 2001, have not been met. 38 U.S.C.A. §§ 1151, 5107 (West Supp. 2005); 38 C.F.R. § 3.102, 3.361 (2005). REASONS AND BASES FOR FINDINGS AND CONCLUSION I. Compliance with the Veterans Claims Assistance Act of 2000 (VCAA) The Veterans Claims Assistance Act of 2000 (VCAA), enacted on November 9, 2000, emphasized VA's obligation to notify claimants what information or evidence is needed in order to substantiate a claim, and it affirmed VA's duty to assist claimants by making reasonable efforts to get the evidence needed. See 38 U.S.C.A. §§ 5100, 5102, 5103, 5103A and 5107 (West Supp. 2005); see Quartuccio v. Principi, 16 Vet. App. 183, 187 (2002). In August 2001, VA issued regulations to implement the VCAA. See 38 C.F.R. §§ 3.102, 3.156(a), 3.159, 3.326(a) (2005). A VCAA notice, as required by 38 U.S.C. § 5103(a), must be provided to a claimant before the initial unfavorable agency of original jurisdiction (AOJ) decision on a claim for VA benefits. See Pelegrini v. Principi, 18 Vet. App. 112, 120 (2004). In this case, the RO did provide the veteran with notice of the VCAA in April 2002, prior to the initial decision on the claim in August 2002. Therefore, the timing requirement of the notice as set forth in Pelegrini has been met and to decide the appeal would not be prejudicial to the claimant. Moreover, the requirements with respect to the content of the VCAA notice were met in this case. VCAA notice consistent with 38 U.S.C. § 5103(a) and 38 C.F.R. § 3.159(b) must (1) inform the claimant about the information and evidence not of record that is necessary to substantiate the claim; (2) inform the claimant about the information and evidence that VA will seek to provide; (3) inform the claimant about the information and evidence the claimant is expected to provide; and (4) request or tell the claimant to provide any evidence in the claimant's possession that pertains to the claim. This "fourth element" of the notice requirement comes from the language of 38 C.F.R. § 3.159(b)(1). In this case, the RO informed the veteran in the April 2002 VCAA letter about the information and evidence that was necessary to substantiate his claim for compensation under 38 U.S.C.A. § 1151 for rhabdomyolysis. Specifically, the letter stated that for the veteran to establish benefits based on faulty or negligent VA treatment, the evidence must meet three requirements: (1) medical evidence of a current disability; this is best shown by medical records or a doctor's statement which contains a diagnosis of the disability; (2) medical (or in some circumstances, lay) evidence of injury or disability incurred or aggravated as a result of VA hospitalization, surgery or treatment; (3) medical evidence, preferably a doctor's statement, showing a reasonable possibility that the disability the veteran has was caused by the faulty or negligent VA treatment. A personal statement that the veteran's disability was caused by VA medical treatment is not sufficient. If the veteran claimed a new condition was caused by VA medical treatment, the veteran must submit medical evidence, preferably a doctor's statement, showing a reasonable possibility that the new disability was caused by VA medical treatment. In addition, the RO informed the veteran in the October 2002 SOC, the December 2004 SSOC and the December 2005 SSOC about the information and evidence that VA would seek to provide including obtaining any evidence of records held by a Federal agency or department. These statements also informed the veteran that VA would make reasonable efforts to assist him in obtaining such things as medical records, employment records or records from other Federal agencies. The RO also informed the veteran about the information and evidence he was expected to provide in the April 2002 letter. Specifically, the RO requested the veteran provide copies of any medical treatment records he had in his possession. The veteran was requested to contact his physician, medical clinic or hospital for reports of treatment for his claimed disability to be sent to VA. The veteran was asked to complete authorization forms for each of his physicians, specifically, he was requested to present medical evidence of injury or disability incurred or aggravated as a result of VA hospitalization, surgery or other treatment. Although the VCAA notice letter(s) that were provided to the veteran did not specifically contain the "fourth element," the Board finds that the veteran was otherwise fully notified of the need to give to VA any evidence pertaining to his claim. In this regard, the RO has informed the veteran in the rating decision, SOC and SSOCs of the reasons for the denial of his claim and, in so doing, informed him of the evidence that was needed to substantiate his claim. All the VCAA requires is that the duty to notify is satisfied and that claimants are given the opportunity to submit information and evidence in support of their claims. Once this has been accomplished, all due process concerns have been satisfied. See Bernard v. Brown, 4 Vet. App. 384 (1993); Sutton v. Brown, 9 Vet. App. 553 (1996); see also 38 C.F.R. § 20.1102 (harmless error). As noted above, because each of the four content requirements of a VCAA notice have been fully satisfied in this case, any error in not providing a single notice to the appellant covering all content requirements is harmless error. In addition, the duty to assist the veteran also has been satisfied in this case. All available VA medical records pertinent to the veteran's claim were reviewed by both the RO and the Board in connection with the veteran's claim. VA has also assisted the veteran and his representative throughout the course of this appeal by providing them with a SOC and SSOCs that informed them of the laws and regulations relevant to the veteran's claim. For these reasons, the Board concludes that VA has fulfilled the duty to assist the appellant in this case. II. Pertinent Law and Regulations Title 38, United States Code, Section 1151 provides that where a veteran suffers an injury or aggravation of an injury resulting in additional disability by reason of VA medical or surgical treatment, compensation shall be awarded in the same manner as if such disability were service connected. See Anderson v. Principi, 18 Vet. App. 371, 376 (2004); see also Kilpatrick v. Principi, 16 Vet. App. 1, 3 (2002). Amendments to 38 U.S.C.A. § 1151 made by Pub. L. 104-204 require a showing that the VA treatment in question not only resulted in additional disability but that the proximal cause of such disability was carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the VA's part in furnishing such treatment, or that the proximate cause of the additional disability was an event that was not reasonably foreseeable. The amendments apply to claims for compensation under 38 U.S.C.A. § 1151, which were filed on or after October 1, 1997. See VAOPGCPREC 40-97. The veteran filed his claim under 38 U.S.C.A. § 1151 in February 2002; therefore, the cited amendments to 38 U.S.C.A. § 1151 apply in this case. See 38 C.F.R. § 3.361 (effective September 2, 2004). 38 C.F.R. § 3.361 benefits under 38 U.S.C. 1151(a) for additional disability or death due to hospital care, medical or surgical treatment, examination, training and rehabilitation services, or compensated work therapy program, address the following: (a) Claims subject to this section-(1) General. Except as provided in paragraph (2), this section applies to claims received by VA on or after October 1, 1997. This includes original claims and claims to reopen or otherwise re- adjudicate a previous claim for benefits under 38 U.S.C. 1151 or its predecessors. The effective date of benefits is subject to the provisions of § 3.400(i). For claims received by VA before October 1, 1997, see 38 C.F.R. § 3.358... (b) Determining whether a veteran has an additional disability. To determine whether a veteran has an additional disability, VA compares the veteran's condition immediately before the beginning of the hospital care, medical or surgical treatment, examination, training and rehabilitation services, or CWT (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. VA considers each involved body part or system separately. (c) Establishing the cause of additional disability or death. Claims based on additional disability or death due to hospital care, medical or surgical treatment, or examination must meet the causation requirements of this paragraph and paragraph (d)(1) or (d)(2) of this section. Claims based on additional disability or death due to training and rehabilitation services or CWT program must meet the causation requirements of paragraph (d)(3) of this section. (1) Actual causation required. 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 the veteran has an additional disability or died does not establish cause. (2) Continuance or natural progress of a disease or injury. 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 diagnose and properly treat the disease or injury proximately caused the continuance or natural progress. The provision of training and rehabilitation services or CWT program cannot cause the continuance or natural progress of a disease or injury for which the services were provided. (3) Veteran's failure to follow medical instructions. 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. (d) Establishing the proximate cause of additional disability or death. The proximate cause of disability or death is the action or event that directly caused the disability or death, as distinguished from a remote contributing cause. (1) Care, treatment, or examination. 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 the hospital care, medical or surgical treatment, or examination caused the veteran's additional disability or death (as explained in paragraph (c) of this section); 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 or, in appropriate cases, the veteran's representative's informed consent. To determine whether there was informed consent, VA will consider whether the health care providers substantially complied with the requirements of 38 C.F.R. § 17.32 of this chapter. Minor deviations from the requirements of § 17.32 of this chapter that are immaterial under the circumstances of a case will not defeat a finding of informed consent. Consent may be express (i.e., given orally or in writing) or implied under the circumstances specified in § 17.32(b) of this chapter, as in emergency situations. (2) Events not reasonably foreseeable. Whether the proximate cause of a veteran's additional disability or death was an event not reasonably foreseeable is in each claim 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 § 17.32 of this chapter... See 38 C.F.R. § 3.361 (effective September 2, 2004). In rendering a decision on appeal, the Board must analyze the credibility and probative value of the evidence, account for the evidence which it finds to be persuasive or unpersuasive, and provide the reasons for its rejection of any material evidence favorable to the claimant. See Gabrielson v. Brown, 7 Vet. App. 36, 39-40 (1994); Gilbert v. Derwinski, 1 Vet. App. 49, 57 (1990). When there is an approximate balance of positive and negative evidence regarding any issue material to the determination of a matter, the benefit of the doubt shall be given to the claimant. See 38 U.S.C.A. § 5107(b). When a reasonable doubt arises regarding service origin, such doubt will be resolved in the favor of the claimant. Reasonable doubt is doubt which exists because of an approximate balance of positive and negative evidence which does not satisfactorily prove or disprove the claim. See 38 C.F.R. § 3.102. The question is whether the evidence supports the claim or is in relative equipoise, with the claimant prevailing in either event, or whether a fair preponderance of the evidence is against the claim, in which event the claim must be denied. See Gilbert, 1 Vet. App. at 54. III. Reasons and Bases The veteran seeks disability compensation for rhabdomyolysis, which he contends was the result of VA treatment prior to June 1, 2001. On that date, the veteran was admitted to the VAMC with complaints of extreme body aches, fatigability and dark brown urine. Prior to that date, the veteran was prescribed Gemfibrozil for elevated triglycerides and Simvastatin for cholesterol. The veteran contends that he currently suffers from chronic pain in his legs as a result of the combination of Simvastatin and Gemfibrozil. The veteran was admitted to the VAMC on June 1, 2001, with complaints of body aches and limited activity. A VA pain assessment form, also dated June 1, 2001, noted that the veteran indicated on a scale of zero to 10, his pain was approximately at eight. Effects of the pain included decreased function. Notes from the Hot Springs VAMC dated June 1, 2001, indicated that Simvastatin and Gemfibrozil were discontinued as part of the veteran's treatment. On June 4, 2001, the veteran received a note outlining how to address his adverse drug reaction, and was subsequently discharged. In May 2002, the veteran participated in a VA neurological disorders examination. The record reflected that the veteran was on Simvastatin (80mg daily) for some time. He had elevated triglycerides and in February 2001 was started on Gemfibrozil (600mg twice per day.) Approximately two weeks prior to the veteran's admission in June 2001, he developed a gradual onset of muscle aching. Following discharge, the veteran complained of chronic leg pain. Regarding the element of causation, under 38 U.S.C.A. § 1151, the May 2002 VA examiner commented that the veteran suffered from an episode of rhabdomyolysis in 2001. This had been reported in individuals on cholesterol lowering agents, particularly the combination of HMG-CoA reductase inhibitors such as Simvastatin and Gemfibrozil. It was noted to be more than likely that the veteran's rhabdomyolysis was caused by the medication combination. It can also be assumed that the interaction of the two inhibitors was the proximate cause of the veteran's rhabdomyolysis. See 38 U.S.C.A. § 1151 (West Supp. 2005); 38 C.F.R. § 3.361 (2005). The veteran described myalgias of the lower extremities as being present since the rhabdomyolysis in June 2001. The exact cause of the persistent myalgias had not been determined, but given the timing and the nature of the symptoms, it was the May 2002 VA examiner's opinion that it was at least as likely as not that the persistent myalgias were a residual of the rhabdomyolysis. The Board notes that the veteran has met the criteria for a current disability. The examiner noted that Gemfibrozil can cause myalgias, but looking at the veteran's medication profile, it appeared that the veteran was off of the Gemfibrozil for a significant amount of time during the time he did have the leg pains. Regarding the veteran's care and treatment, the VA staff pharmacist, J.S., who reviewed the veteran's pharmacy records, noted that the veteran was counseled as to drug's side effects when he was started on the Simvastatin. This counseling would have included discussion about myalgias. However, there was no record that the veteran received counseling when the Gemfibrozil was added. The medication was mailed to him, and apparently the veteran did not stop by the pharmacy at that time for counseling. To rebut the VA pharmacist's statement, the veteran submitted a December 2004 internal memorandum from M.L.D., M.D., chief of staff of the Black Hills Health Care System, to the medical staff. In pertinent part, the letter stated that it was discovered that many patients did not have indications for mediations written on their prescription labels. The pharmacy was instructed to issue no further prescriptions without these indications. The veteran contends that his medication was improperly labeled and he was not given the appropriate warnings regarding drug interaction. With regard to the degree of care exercised by VA, the May 2002 VA examiner commented that she had discussed the veteran's case with the Associate Chief of Staff for Primary Care for the Black Hills Health Care System. Since the combination of Simvastatin and Gemfibrozil was used in clinical practice when the benefits outweighed the risks, and since rhabdomyolysis was a known but infrequent complication of this combination, the Associate Chief of Staff did not feel that the use of these medications represented carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault on the VA's part. The occurrence of this complication did not indicate that the VA failed to exercise the degree of care that would be expected of a reasonable health care provider. In July 2005, the Board remanded this claim to obtain additional information regarding the December 2004 memorandum submitted by the veteran. Specifically, the veteran's claims folder referred to the Chief of Staff of the Black Hills Health Care System for comment on whether the pharmacy procedures referred to in the memorandum affected the veteran's incurrence of rhabdomyolysis. The remand also stated that the claims folder was to be forwarded to the same examiner who conducted the May 2002 VA examination, if possible. The examiner was to comment on whether the use of the medications administered to the veteran involved carelessness, negligence, lack of proper skill, error in judgment, or similar fault on VA's part. In response to the Board's remand, a statement from M.L.D., M.D., chief of staff of the Black Hills Health Care System, was received in September 2005. The physician stated that the memorandum referred to in the remand was in response to a Joint Commission Survey finding that many prescriptions given to patients did not have the indication for the medication included on the label. The physician cited the following example: A prescription reviewed by the Joint Commission might have said, "Gemfibrozil, take one tablet by mouth twice a day." The best practice the Joint Commission Standards recommend is to include the reason for the prescription. So, a best practice might be "Gemfibrozil, one by mouth twice a day for cholesterol." See Chief of Staff letter, dated in September 2005. Despite the veteran's claim that his medications were not appropriately labeled, the physician noted that he had gone back and reviewed some of the old prescriptions, one dated February 2001 from a Nurse Practitioner, where the instructions stated the reason for the prescription. The physician concluded that nothing was done wrong. Not only were the pharmacy procedures correct, but the practitioner involved had also met the Joint Commission Standard referred to in his memorandum by including the reason of each medication on the prescription label. Thus, the Board finds that the procedures followed by the pharmacy in informing the veteran of the purpose of his medication, were reasonable and were consistent with the appropriate degree of care required. See 38 U.S.C.A. § 1151 (West Supp. 2005); 38 C.F.R. § 3.361 (2005). In response to the Board's remand, a statement from J.R.S., M.D. was received in October 2005. The physician stated that he had reviewed the chart and clinic data and found that nothing was done wrong. The veteran developed rhabdomyolysis as a result of an interaction between Simvastatin and Gemfibrozil. This complication was noted to be well known with these two drugs, and although it does occur rarely, it does occur and is a significant clinical finding. There was no delay in treatment in the diagnosis of the illness, nor was there anything wrong with the way it was handled. The physician stated that as far as the veteran's prescriptions were concerned, the Gemfibrozil was labeled for elevated triglycerides; the Simvastatin was labeled for cholesterol. Pharmacy procedures, clinical diagnosis, management and diagnosis were all considered correct. The veteran continued to have pain in his legs after the rhabdomyolysis was diagnosed. There was no reason to suspect this was secondary to his myopathy. Rheumatology reports stated that the veteran had different areas of tendonitis in the hip and knees, pes planus of his feet and possible diabetic neuropathy. The physician concluded that he could find no evidence of carelessness, negligence, lack of skill, error in judgment or any such problem involved in this case. Indications for the medications given were well known. Medications were prescribed appropriately with follow-up and treatment appropriately also. The physician concluded that everything was handled as to the standard of care and no evidence was found of any wrongdoing. See 38 U.S.C.A. § 1151 (West Supp. 2005); 38 C.F.R. § 3.361 (2005). The veteran himself maintains that his current leg pain is the continuing result of VA treatment. However, where a determinative issue involves medical causation or a medical diagnosis, competent medical evidence is required. There is no indication in the record that the appellant is a physician. Therefore, as a layperson he is not competent to provide evidence that requires medical knowledge because he lacks the requisite professional medical training, certification and expertise to present opinions regarding diagnosis and etiology. See Espiritu v.Derwinski, 2 Vet. App. 492 (1992). The Board finds that the veteran has failed to meet the requirements set forth under 38 U.S.C.A. § 1151 and 38 C.F.R. § 3.361 to substantiate his claim. Although the treatment he received at the VAMC was the cause of his rhabdomyolysis, the VAMC acted in compliance with the appropriate standard of care. Physicians cited above also found that while the interaction of Simvastatin and Gemfibrozil was not unheard of, it was very rare. The VA acknowledged the risk in treating the veteran's variety of conditions with these medications, and felt the benefit outweighed the risk. The veteran was informed of these possible interactions, and the resulting rhabdomyolysis was reasonably foreseeable. See 38 U.S.C.A. § 1151 (West Supp. 2005); 38 C.F.R. § 3.361 (2005). The Board also notes that, regarding the veteran's current disability, the May 2002 VA examiner stated that Gemfibrozil can cause myalgias, but looking at the veteran's medication profile, it appeared that the veteran was off of the Gemfibrozil for a significant amount of time during the time he did have the leg pains. This evidence further demonstrates that treatment at the VAMC was not responsible for the veteran's current disability. See 38 U.S.C.A. § 1151 (West Supp. 2005); 38 C.F.R. § 3.361 (2005). As the preponderance of the evidence is against the veteran's claim, the benefit-of-the-doubt rule does not apply, and the veteran's claim of entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 for rhabdomyolysis caused by VA medical treatment during the period prior to June 1, 2001, must be denied. See 38 U.S.C.A §5107 (West Supp. 2005). ORDER Entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 for rhabdomyolysis caused by VA medical treatment during the period prior to June 1, 2001 is denied. ____________________________________________ KATHLEEN K. GALLAGHER Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs