Citation Nr: 0910604 Decision Date: 03/20/09 Archive Date: 03/26/09 DOCKET NO. 05-39 823 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Huntington, West Virginia THE ISSUE Entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 (West 2002) for myopathy due to VA treatment on January 15, 2003. REPRESENTATION Appellant represented by: Veterans of Foreign Wars of the United States WITNESSES AT HEARING ON APPEAL Appellant, his wife and daughter. ATTORNEY FOR THE BOARD M. Riley, Associate Counsel INTRODUCTION The Veteran served on active duty from August 1972 to August 1975. This case comes before the Board of Veterans' Appeals (Board) on appeal from a September 2004 rating decision issued by the Department of Veterans Affairs (VA) Regional Office (RO) in Huntington, West Virginia, which, in pertinent part, denied entitlement to compensation for myopathy under the provisions of 38 U.S.C.A. § 1151 (West 2002). The Veteran's appeal was previously before the Board in June 2007 when the Board remanded the case for further action by the originating agency. The case has been returned to the Board for further appellate action. In its June 2007 remand, the Board referred the issue of entitlement to compensation for fibromyalgia under the provisions of 38 U.S.C.A. § 1151 (West 2002) to the RO. This issue has not yet been adjudicated, and is once again referred to the RO for the appropriate action. FINDING OF FACT Myopathy resulted from Gemfibrozil, prescribed at the Clarksburg VA Medical Center (VAMC) on January 15, 2003, but was not the proximate result of a lack of skill, carelessness, negligence, error in judgment, or an unforeseen event. CONCLUSION OF LAW The criteria for entitlement to compensation under 38 U.S.C. § 1151 for myopathy have not been met. 38 U.S.C.A. § 1151 (West 2002); 38 C.F.R. §§ 3.358, 3.800, 17.32 (2008). REASONS AND BASES FOR FINDING AND CONCLUSION The Veterans Claims Assistance Act of 2000 (VCAA), Pub. L. No. 106-475, 114 Stat. 2096 (Nov. 9, 2000) (codified at 38 U.S.C.A. §§ 5100, 5102, 5103, 5103A, 5106, 5107, 5126 (West 2002 & Supp. 2008) redefined VA's duty to assist a Veteran in the development of a claim. VA regulations for the implementation of the VCAA were codified as amended at 38 C.F.R. §§ 3.102, 3.156(a), 3.159, 3.326(a) (2008). Under the VCAA, VA must inform the claimant of any information and evidence not of record (1) that is necessary to substantiate the claim; (2) that VA will seek to provide; (3) that the claimant is expected to provide; and (4) must request that the claimant provide any evidence in his possession that pertains to the claim. Pelegrini v. Principi (Pelegrini II), 18 Vet. App. 112, 120-21 (2004), see 38 U.S.C.A. § 5103(a); 38 C.F.R. § 3.159(b). The United States Court of Appeals for Veterans Claims (Court) has also held that the VCAA notice requirements of 38 U.S.C.A. § 5103(a) and 38 C.F.R. § 3.159(b) apply to all five elements of a service connection claim. Those five elements include: 1) Veteran status; 2) existence of a disability; 3) a connection between the Veteran's service and the disability; 4) degree of disability; and 5) effective date of the disability. Dingess/Hartman v. Nicholson, 19 Vet. App. 473 (2006). In a letter issued in July 2007, subsequent to the initial adjudication of the claim, the RO notified the Veteran of the evidence needed to substantiate his claim for entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 (West 2002). The letter also satisfied the second and third elements of the duty to notify by informing the Veteran that VA would try to obtain medical records, employment records, or records held by other Federal agencies, but that he was nevertheless responsible for providing any necessary releases and enough information about the records to enable VA to request them from the person or agency that had them. For claims pending before VA on or after May 30, 2008, 38 C.F.R. 3.159 has been amended to eliminate the requirement that VA request that a claimant submit any evidence in his or her possession that might substantiate the claim. 73 Fed. Reg. 23,353 (Apr. 30, 2008). The Veteran has substantiated his status as a Veteran. He was notified of all elements of the Dingess notice, including the disability-rating and effective-date elements of the claims, by the July 2007 letter. In Pelegrini II, the Court also held that VCAA notice should be given before an initial AOJ decision is issued on a claim. Pelegrini II, 18 Vet. App. at 119-120. While complete VCAA notice was provided after the initial adjudication of the claim, this timing deficiency was cured by the issuance of VCAA notice followed by readjudication of the claim in a November 2008 SSOC. Mayfield v. Nicholson, 499 F.3d 1399 (Fed. Cir. 2007). The Duty to Assist The VCAA also requires VA to make reasonable efforts to help a claimant obtain evidence necessary to substantiate his claim. 38 U.S.C.A. § 5103A; 38 C.F.R. § 3.159(c), (d). This "duty to assist" contemplates that VA will help a claimant obtain records relevant to his claim, whether or not the records are in Federal custody, and that VA will provide a medical examination or obtain an opinion when necessary to make a decision on the claim. 38 C.F.R. § 3.159(c)(4). VA has obtained records of treatment reported by the Veteran, including service treatment records, records from various federal agencies, and private medical records. Additionally, the Veteran was provided VA examinations in October 2003 and October 2008 in response to his claim. The Veteran's representative argued in the February 2009 informal brief that an additional remand was necessary to allow for a third VA examination to clear a conflict of medical opinions. As discussed below, while the preponderance of the medical evidence establishes that the Veteran's myopathy resulted from his prescription and taking of the medication Gemfibrozil, the evidence weighs against a finding that the prescribing of this medication was the proximate result of a lack of skill, carelessness, negligence or error judgments, or an unforeseen event in VA treatment. There is no medical opinion to the contrary. Therefore, the medical evidence is not in conflict, and remanding for an additional VA examination would only further delay the claim. For the reasons set forth above, the Board finds that VA has complied with the VCAA's notification and assistance requirements. The appeal is thus ready to be considered on the merits. Legal Criteria When a Veteran suffers additional disability or death as the result of training, hospital care, medical or surgical treatment, compensated work therapy, or an examination furnished by the VA, disability compensation shall be awarded in the same manner as if such additional disability or death were service-connected. 38 U.S.C.A. § 1151; 38 C.F.R. § 3.361. Under 38 U.S.C.A. § 1151, it is necessary to show that disability or death was the result of carelessness, negligence, lack of proper skill, error in judgment, similar instance of fault, or an event not reasonably foreseeable. Merely showing that a Veteran received care, treatment, or examination and that the Veteran has an additional disability or died does not establish cause. 38 C.F.R. § 3.361(c)(1). 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 38 C.F.R. § 17.32. 38 C.F.R. § 3.361(d)(2). In addition to a showing of additional disability or death, there must be evidence showing either that VA failed to exercise the degree of care that would be expected of a reasonable health care provider, or that VA furnished treatment without the informed consent of the Veteran and his representative, in compliance with 38 C.F.R. § 17.32. Minor deviations from the 38 C.F.R. § 17.32 requirements that are immaterial under the circumstances of a case will not defeat a finding of informed consent. Consent may be express or implied as specified under 38 C.F.R. § 17.32(b), as in emergency situations. 38 C.F.R. § 3.361(d)(1). Analysis The Veteran contends that he incurred myopathy as a result of taking Gemfibrozil prescribed at the Clarksburg VAMC on January 15, 2003. The Veteran also contends that he did not give informed consent prior to being prescribed Gemfibrozil, and that VA should have taken him off the medication when he initially complained of muscle pain in January 2003. Treatment records from the Clarksburg VAMC establish that the Veteran was seen on January 15, 2003, with symptoms consistent with diabetes mellitus. He was diagnosed as having new onset diabetes mellitus and hypertriglyceridemia. Gemfibrozil was prescribed to treat the Veteran's hypertriglyceridemia. On January 21 and January 27, 2003, the Veteran was seen again at the VAMC for laboratory work and blood pressure checks. He reported feeling symptoms of low blood glucose levels due to diabetes mediation, and his dosages were adjusted. On April 17, 2003, the Veteran reported a three month history of muscle pain and weakness to his physician. His symptoms were constant and were noted to have started soon after he began Gemfibrozil therapy. He was admitted to the VAMC overnight and was diagnosed with drug-induced myopathy. Gemfibrozil was discontinued and an adverse drug reaction was reported to the pharmacy. The Veteran changed his primary care physician in July 2003 and was noted to have experienced Gemfibrozil-induced myopathy from which he had recovered. The physician noted that there was a question as to whether the Veteran's myopathy was caused by Gemfibrozil alone, or was a result of a combination of the medication and the Veteran's drinking. Upon VA examination in October 2003, the Veteran reported that his muscle pain had been slightly improving. The examiner noted that myopathy was a "normal and well-known side-effect" of Gemfibrozil and the Veteran's myopathy was more likely than not caused by Gemfibrozil, as it was prescribed to treat his elevated triglycerides and cholesterol. Another VA examination was conducted in October 2008. The Veteran acknowledged receipt of relevant clinical information about Gemfibrozil at the time it was prescribed. The examiner noted that Gemfibrozil was appropriately initiated as monotherapy in January 2003. Upon physical examination, there was no evidence of myopathy. The examiner concluded that that the Veteran's VA provider exercised a degree of care that would be expected of a reasonable provider in rendering treatment. The examiner also noted that the Veteran provided informed consent prior to beginning the treatment. Thus, there was no indication of any carelessness, negligence, lack of proper skill, error in judgment, or fault on the part of VA in prescribing the medication. While the Veteran argues that he did not give informed consent before taking Gemfibrozil, the Board notes that during his October 2008 VA examination he reported that he received relevant clinical information about Gemfibrozil at the time it was prescribed. In addition, during his July 2006 hearing, the Veteran's spouse testified that the Veteran received a copy of the medication instructions for Gemfibrozil at the time he filled the prescription, but that it was difficult to read. The Board finds that the Veteran provided informed consent prior to his taking of the medication Gemfibrozil. He was given, and has acknowledged receipt of, a list of instructions for Gemfibrozil. A copy of these instructions is in the claims folder and shows that they included a complete listing of potential side-effects and cautions, including the development of severe muscle pain. In addition, the instructions advise that if there were any questions about the use of the product, they should be directed to a medical professional. The Veteran has not provided the copy of instructions that he received, but the instructions in the claims folder are legible. There is no evidence that the Veteran was coerced into taking Gemfibrozil, nor is there evidence that his consent was revoked. The Veteran also argues that compensation is warranted for myopathy as it was caused by the VA-prescribed Gemfibrozil. While the medical evidence of record does establish that the Veteran's incurred an additional disability, i.e. myopathy, as a result of Gemfibrozil, it does not establish that the prescription of Gemfibrozil was the proximate result of a lack of skill, carelessness, negligence or error judgments, or an unforeseen event in VA treatment. In fact, the October 2003 VA examiner noted that myopathy was a normal and well-known side-effect of Gemfibrozil. In addition, the October 2008 VA examiner found that Gemfibrozil was appropriately prescribed in January 2003, and that VA exercised reasonable care in treating the Veteran for his elevated triglycerides and cholesterol. The examiner also specifically noted that there was no indication of any carelessness, negligence, lack of proper skill, error in judgment, or fault on the part of VA in prescribing the medication. Finally, the Veteran argues that VA failed to timely diagnose and properly treat his myopathy. He contends that his muscle pain symptoms began one week after he started taking Gemfibrozil and VA should have discontinued his use of Gemfibrozil when he was treated at the VAMC in January 2003. Records of treatment from the Clarksburg VAMC document that the Veteran complained of dizziness and light-headedness on January 21 and 27, 2003, and his diabetes medications were adjusted accordingly. The records do not document that the Veteran reported symptoms of muscle pain until April 17, 2003, when he was admitted to the clinic for drug-induced myopathy and Gemfibrozil was promptly discontinued. While the Veteran reported a three month history of muscle pain at the time of his April 17, 2003 treatment, there is no indication that he previously reported these symptoms to VA, or that VA did not properly treat or diagnose the Veteran's myopathy. The clinical evidence that the myopathy has resolved also weighs against a finding that the condition was not properly treated or that there was additional disability as the result of faulty treatment. As the weight of the competent evidence is against the claim, the doctrine of reasonable doubt is not applicable in the instant appeal. 38 U.S.C.A. § 5107(b); 38 C.F.R. § 3.102; Gilbert v. Derwinski, 1 Vet. App. 49, 53-56 (1990). Therefore, the claim for entitlement to compensation for myopathy under the provisions of 38 U.S.C.A. § 1151 is denied. ORDER Entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 for myopathy due to VA treatment on January 15, 2003, is denied. ____________________________________________ Mark D. Hindin Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs