Citation Nr: 22012298 Decision Date: 03/03/22 Archive Date: 03/03/22 DOCKET NO. 18-17 420 DATE: March 3, 2022 ORDER Entitlement to compensation under 38 U.S.C. § 1151 for residuals of prescription medication Simvastatin is denied. FINDING OF FACT The persuasive evidence shows that a VA prescription of Simvastatin did not cause an additional disability because of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA or was due to an event not reasonably foreseeable. CONCLUSION OF LAW The criteria for benefits under 38 U.S.C. § 1151 for residuals of prescription medication Simvastatin have not been met. 38 U.S.C. §§ 1151, 1732, 5107; 38 C.F.R. §§ 3.361, 17.32. REASONS AND BASES FOR FINDING AND CONCLUSION The Veteran served on active duty from March 1963 and December 1963. This matter comes before the Board of Veterans' Appeals (BVA or Board) on appeal from a May 2014 rating decision of the Department of Veterans Affairs (VA) Regional Office (RO). The Veteran testified at a hearing before the undersigned Veterans Law Judge in February 2020. The transcript is of record. In August 2020, May 2021, and September 2021, the Board remanded this matter to the Agency of Original Jurisdiction (AOJ) for additional development. The appeal has since returned to the Board. 1. Entitlement to compensation under 38 U.S.C. § 1151 for residuals of prescription medication Simvastatin is denied. The Veteran asserts that due to VA prescription of Simvastatin prescribed for his cholesterol, he has muscle pain, fatigue, shortness of breath, and memory loss, and is therefore entitled to VA compensation benefits under 38 U.S.C. § 1151. Under 38 U.S.C. § 1151, in order to warrant compensation the claimant must demonstrate that the VA hospital care, medical or surgical treatment, or examination in question resulted in an additional disability and that the proximate cause of the additional disability was carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part in furnishing such care, treatment, or examination, or that the proximate cause of the additional disability was an event that was not reasonably foreseeable. See also VAOPGCPREC 40-97, 63 Fed. Reg. 31,263 (1998). In determining whether a claimant has an additional disability, VA compares the veteran's condition immediately before the beginning of the hospital care or medical or surgical treatment upon which the claim is based to the veteran's condition after such care or treatment. 38 C.F.R. § 3.361 (b). To establish causation, the evidence must show that the hospital care or medical or surgical treatment resulted in the veteran's additional disability. Merely showing that a veteran received care or treatment and that the veteran has an additional disability does not establish cause. 38 C.F.R. § 3.361 (c)(1). Hospital care or medical or surgical treatment cannot cause the continuance or natural progress of a disease or injury for which the care or treatment was furnished unless VA's failure to timely diagnose and properly treat the disease or injury proximately caused the continuance or natural progress. 38 C.F.R. § 3.361 (c)(2). 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 or medical or surgical treatment caused the veteran's additional disability or death; 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 without the veteran's informed consent. In this regard, determinations of whether there was informed consent involve consideration of whether the health care providers substantially complied with the requirements of 38 C.F.R. § 17.32. Minor deviations from the requirements of 38 C.F.R. § 17.32 that are immaterial under the circumstances of a case will not defeat a finding of informed consent. 38 C.F.R. § 3.361 (d)(1). Whether the proximate cause of a veteran's additional disability or death was an event not reasonably foreseeable is 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 As to the question of whether the Veteran has an additional disability, the Veteran testified at the February 2020 hearing that his symptoms of muscle pain, fatigue, memory loss, and shortness of breath began after taking Simvastatin for five years. Moreover, at the February 2020 hearing, the Veteran testified that these symptoms caused functional impairment, in that, he could not perform yard work, be as physically active as he once was, and had episodes where he forgets things, A review of the record confirms that the Veteran did not have these symptoms prior to taking Simvastatin. Additionally, these symptoms are known side effects of Simvastatin, as established by internet-based searches provided by the Veteran and medical opinion evidence from the November 2021 VA examiner. Although, there is negative medical evidence against finding that the Veteran has an additional disability caused by Simvastatin, the Board resolves all doubt in favor of the Veteran and finds that the Veteran has additional disabilities caused by Simvastatin. Accordingly, the claim turns on the question of whether these disabilities were, in substance, due to VA's negligence and/or a not reasonably foreseeable event. In this regard, the record reveals that Simvastatin was prescribed when the Veteran submitted to a diabetes mellitus study with the VA in December 2001. When the Veteran's VA provider was informed that the Veteran was having side effects from Simvastatin, this medication was immediately discontinued and listed as an allergy in the Veteran's medical file. Here, medical evidence of record is in agreement that the Veteran's additional disabilities were less likely than not the result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's behalf. The November 2011 examiner rationalized that statins are some of the best-selling prescription drugs in the world. They lower the incidence of cardiovascular disease and stroke morbidity and mortality. Providers often prescribe statins for people with high cholesterol to lower their total cholesterol and reduce their risks. Thus, the Board finds that the prescribing of Simvastatin did not rise to the level of fault. Additionally, the November 2021 VA examiner further opined that VA's prompt discontinuance of Simvastatin was a reasonable action for management of its side effects. The Board finds the November 2011 VA examiner's opinions expressed above highly probative evidence of record because it was provided after a review of the record on appeal, it considered his VA treatment records, and included a detailed medical explanation for the opinions expressed. No contrary opinion has been submitted. The Board additionally concludes that the most probative evidence supports that the Veteran's additional disabilities were the type of risks that a reasonable health care provider would have disclosed with the informed consent procedure of 38 C.F.R. § 17.32 and for which the Veteran gave implied informed consent. In so finding, the Board notes that a prescription for Simvastatin, whether mailed or retrieved in person, would have contained information in regard to potential side effects of the drug. Furthermore, VA treatment notes in May 2005 document that the Veteran had received patient education comprised of instructions, benefits, and side effects of his medications on his medication list, including Simvastatin. While the November 2021 VA examiner noted that the Veteran's symptom of shortness of breath was not a listed side effect of statin drugs, and therefore an unforeseen risk, this opinion is not persuasive, as the record contains several internet-based articles that list trouble of breathing or shortness of breath as a known side effect. Furthermore, the Board finds that the Veteran is not competent to provide opinions as to negligence and a not reasonably foreseeable event because he does not have the required medical expertise to provide answers to these complex medical questions. See Jandreau v. Nicholson, 492 F.3d 1372 (Fed. Cir. 2007). Accordingly, the Board finds that the persuasive evidence is against the Veteran's claims for compensation under 38 U.S.C. § 1151, even though the prescription of Simvastatin caused additional disabilities, because the most probative evidence of record shows that the additional disabilities were neither due to VA's negligence nor a not reasonably foreseeable event. See 38 U.S.C. § 1151; 38 C.F.R. §§ 3.361, 17.32; VAOPGCPREC 40-97. In reaching such decision, the Board has considered the applicability of the benefit of the doubt doctrine. However, as the weight of the evidence is persuasively against the Veteran's claim, that doctrine is not applicable in the instant appeal, and the claim must be denied. 38 U.S.C. § 5107; 38 C.F.R. § 3.102. Bethany L. Buck Veterans Law Judge Board of Veterans' Appeals Attorney for the Board N.B. Mmeje, Associate Counsel The Board's decision in this case is binding only with respect to the instant matter decided. This decision is not precedential and does not establish VA policies or interpretations of general applicability. 38 C.F.R. § 20.1303.