Citation Nr: 18141780 Decision Date: 10/11/18 Archive Date: 10/11/18 DOCKET NO. 13-09 261A DATE: October 11, 2018 REMANDED Entitlement to benefits under 38 U.S.C. § 1151 for liver damage, is remanded. Entitlement to benefits under 38 U.S.C. § 1151 for kidney damage, is remanded. Entitlement to benefits under 38 U.S.C. § 1151 for rhabdomyolysis, is remanded. Entitlement to service connection for the cause of Veteran’s death resulting from liver damage, kidney damage, and rhabdomyolysis stemming from a violation of 38 U.S.C. § 1151, is remanded.   REASONS FOR REMAND The Veteran served on active duty from March 1969 to February 1971. He died in February 2011. The appellant in this case, the Veteran’s widow (Appellant), has been substituted in the Veteran’s appeal under 38 U.S.C. § 1151 as a claim accrued benefits. Additionally, the Appellant is seeking Department of Veteran Affairs (VA) death benefits as the Veteran’s surviving spouse. This case arises from the Veteran’s March 2010 claim for benefits under 38 U.S.C. § 1151 claiming that his liver damage, liver damage, and rhabdomyolysis were caused by his VA prescribed Simvastatin. After the Veteran’s death, the Appellant, in April 2011, filed a claim for service connection for cause of Veteran’s death. The Appellant appeals an August 2010 and 2011, and June 2013 rating decisions from the Department of Veteran Affairs Regional Offices (RO) in Roanoke, Virginia and Philadelphia, Pennsylvania, respectively. The Appellant was afforded a Board video hearing in June 2014. In August 2018, the Appellant waived the opportunity for a second hearing after receiving notice that the Veterans Law Judge for her March 2014 hearing was no longer with the Board. Instead the Veteran’s representative submitted an appellate brief in June 2018. 1. Entitlement to benefits under 38 U.S.C. § 1151 for liver damage is remanded. 2. Entitlement to benefits under 38 U.S.C. § 1151 for kidney damage is remanded. 3. Entitlement to benefits under 38 U.S.C. § 1151 for rhabdomyolysis is remanded. The issues of entitlement to benefits under 38 U.S.C. § 1151 for liver and kidney damage, and rhabdomyolysis are remanded for further development. First, VA examinations from April 2013 or June 2016 are not entirely adequate to resolve the appeal. The Appellant, in her June 2014 hearing, asserted that the VA was negligent in failing to monitor the Veteran’s medication. Because the VA failed to monitor the Veteran’s medication, the Appellant contends, the Veteran was inflicted with liver and kidney damage, and rhabdomyolysis. The Appellant further asserts that these side effects caused or contributed to the Veteran’s death. The April 2013 and June 2016 VA examinations did not consider all the medical evidence of record. A July 2009 VA medical note reported that the Veteran had a medical history of alcoholism. According to Simvastatin drug information submitted by the Appellant, individuals with a history of alcohol abuse should not take Simvastatin as it could increase the risk of serious liver injury. See https://www.healthline.com/health/simvastatin/oral-tablet. The Appellant asserts that the Veteran was first prescribed Simvastatin in 2006. In a July 2009 VA medical note, the Veteran was prescribed 80 mg of Simvastatin (which he took 40 mg before bed), and 10 mg of Amlodipine. The Veteran was on this regimen of Simvastatin and Amlodipine until his November 2009 allergic reaction to Simvastatin, which led him to be hospitalized. According to the Simvastatin’s drug interaction information, Amlodipine may increase the serum concentration of Simvastatin. Concurrent use of Amlodipine with Simvastatin should be avoided when possible. If the two drugs are used concurrently, a daily dose of Simvastatin should not be greater than 20 mg. A private doctor in August 2012 opined that the Veteran had chronic renal failure after developing acute renal failure secondary to Zocor. He did not have any kidney disease prior to that episode, and “in my opinion, it is more likely than not that the patient had chronic renal failure secondary to rhabdomyolysis that was induced by Zocor. Patient continued to have residual renal disease because of the insult to his kidney’s.” This doctor’s opinion did not address proximate cause (negligence, foreseeability, or informed consent). The Appellant points to medical study findings in the British Medical Journal (BMJ) in March 19, 2013. See June 2018 Appellant Brief. The reported study found that those taking higher dosages of statins (i.e. Simvastatin) may be more likely to develop kidney problems, and 34 percent were more likely to be hospitalized for acute kidney injury during the first 120 days of treatment. Id. Finally, the April 2013 VA examiner opined that the Veteran had a kidney (chronic renal disease), and liver (gall stones) condition pre-existing his allergic reaction to Simvastatin. However, the VA examiner did not consider whether the Veteran’s kidney and liver damage were aggravated by the Veteran’s reaction to Simvastatin, or his Simvastatin regimen. Based on the above, a remand for new VA examinations is warranted. 4. Entitlement to service connection for the cause of Veteran’s death resulting from liver damage, kidney damage, and rhabdomyolysis stemming from a violation of 38 U.S.C. § 1151 is remanded. Considering the above remand, the issue of VA benefits for the cause of Veteran’s death is remanded for further development. The matters are REMANDED for the following action: 1. Obtain and associate with the record all VA treatment records for the Veteran. 2. Then, provide the Veteran’s claims folder to a qualified clinician (not associated with the Hampton VA Medical Center) to provide an opinion on the questions below. After reviewing the claims file, the clinician is asked to provide responses to the following: (a.) Regarding the issues of liver and kidney damage: a. Is it at least likely as not (a probability of 50 percent or greater) that the Veteran’s pre-existing liver and kidney disabilities were aggravated by the VA’s failure to monitor the Veteran’s drug regimen of Simvastatin and Amlodipine, or the Veteran’s allergic reaction to Simvastatin? That is, were the Veteran’s gall stones, and/or chronic renal disease aggravated by the Veteran’s allergic reaction to Simvastatin, or the Veteran’s drug regimen of 80 mg of Simvastatin and 10 mg of Amlodipine? b. Only if the Veteran’s gall stones and chronic renal disease were aggravated: was the aggravation at least likely as not (a probability of 50 percent or greater) caused by carelessness, negligence, lack of proper skill, error in judgement, or similar instance of fault on part of the VA? c. Only if the Veteran’s gall stones and chronic renal disease were aggravated: Did the aggravation at least likely as not (a probability of 50 percent or greater) result from an event that was not reasonably foreseeable? That is, would a VA physician exercising the degree of skill and care ordinarily required of the medical profession have reasonably foreseen that the Veteran’s gall stones, and/or chronic renal disease would have been aggravated by an allergic reaction to Simvastatin, or the Veteran’s drug regimen of 80 mg of Simvastatin and 10 mg of Amlodipine? d. In considering these questions, the clinician must take note of the following: i. A July 2009 VA medical note reported that the Veteran had a medical history of alcoholism. According to Simvastatin drug information submitted by the Appellant, individuals with a history of alcohol abuse should not take Simvastatin as it could increase the risk of serious liver injury. See https://www.healthline.com/health/simvastatin/oral-tablet. ii. The March 2013 study reported in the BMJ that found that those taking higher dosages of statins (i.e. Simvastatin) may be more likely to develop kidney problems, and 34 percent were more likely to be hospitalized for acute kidney injury during the first 120 days of treatment. (b.) Regarding the issue of rhabdomyolysis: a. Is at least likely as not (a probability of 50 percent or greater) that the Veteran’s rhabdomyolysis caused by carelessness, negligence, lack of proper skill, error in judgement, or similar instance of fault on part of the VA either being prescribed 80 mg of Simvastatin, or failing to monitor the Veteran’s drug regimen of 80 mg of Simvastatin and 10 mg of Amlodipine? b. Did the Veteran’s rhabdomyolysis at least likely as not (a probability of 50 percent or greater) result from an event that was not reasonably foreseeable? That is, would a VA physician exercising the degree of skill and care ordinarily required of the medical profession have reasonably foreseen that the Veteran would develop rhabdomyolysis because of either being prescribed 80 mg of Simvastatin, or failed to monitor the Veteran’s drug regimen of 80 mg of Simvastatin and 10 mg of Amlodipine? c. In answering both questions, the clinician must take note of the following: i. VA medical treatment notes from July to November 2009 indicating that the Veteran was prescribed 80 mg of Simvastatin (which he took 40 mg before bed), and 10 mg of Amlodipine. ii. According to the Simvastatin’s drug interaction information, Amlodipine may increase the serum concentration of Simvastatin. Concurrent use of Amlodipine with Simvastatin should be avoided when possible. If the two drugs are used concurrently, a daily dose of Simvastatin should not be greater than 20 mg. iii. A July 2009 VA medical note reported that the Veteran had a medical history of alcoholism. According to Simvastatin drug information submitted by the Appellant, individuals with a history of alcohol abuse should not take Simvastatin as it could increase the risk of serious liver injury. See https://www.healthline.com/health/simvastatin/oral-tablet. d. The FDA in 2011 labeled the drug with warning for increased risk of rhabdomyolysis at the 80mg dose which the veteran admitted taking less than 6 months prior to the reaction. See April 2013 VA exam. e. The April 2013 VA examiner’s statement that rhabdomyolysis occurred in this case and is more likely than not associated with the use of the Simvastatin. (c.) Regarding the issue of Veteran’s cause of death: Based on the opinion’s issued above, is it at least likely as not (a probability of 50 percent or greater), that either the Veteran’s liver, kidney damage, or rhabdomyolysis was a principal cause of death which, singly or jointly with some other condition, was the immediate or underlying cause of death or was etiologically related to his death. 1. In answering the above question, the clinician must consider: (Continued on the next page)   a. The Veteran’s death certificate indicating that chronic renal failure was a significant contributor to the Veteran’s death. C. BOSELY Acting Veterans Law Judge Board of Veterans’ Appeals ATTORNEY FOR THE BOARD Timothy A. Campbell, Associate Counsel