Citation Nr: 1640412 Decision Date: 10/12/16 Archive Date: 10/27/16 DOCKET NO. 12-25 757 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in New Orleans, Louisiana THE ISSUE Entitlement to compensation pursuant to 38 U.S.C.A. § 1151 (West 2014) for additional disability due to statin therapy. REPRESENTATION Appellant represented by: Paralyzed Veterans of America, Inc. ATTORNEY FOR THE BOARD D. Orfanoudis, Counsel INTRODUCTION The Veteran had active service from May 1954 to April 1957. This matter comes before the Board of Veterans' Appeals (Board) on appeal from a December 2011 rating decision of the Department of Veterans Affairs (VA), Regional Office (RO), in New Orleans, Louisiana. In a decision dated in February 2013, the Board denied compensation benefits pursuant to 38 U.S.C.A. § 1151 claim, and he appealed the decision to the United States Court of Appeals For Veterans Claims (Court). In a November 2014 Memorandum Decision, the Court vacated the February 2013 Board decision and remanded the case to the Board for further appellate review consistent with the decision. In March 2016, the Board referred the matter for an independent medical expert (IME) opinion concerning the Veteran's claim of entitlement to compensation pursuant to 38 U.S.C.A. § 1151 for additional disability due to statin therapy, to specifically include myopathy/rhabdomyolysis. In May 2016, the Veteran was provided with a copy of the IME opinion dated April 19, 2016, and afforded the opportunity to respond. In July 2016, the Veteran's representative submitted correspondence raised the issue of whether the Veteran experienced additional disability as a result of statin therapy, in the form of a psychiatric disorder manifested by extreme anxiety. As such, the issue has been amended as captioned above to broaden the scope of additional disability asserted by the Veteran. The Veteran's claims file has been converted into a paperless claims file via the Virtual VA and Veterans Benefits Management System (VBMS) paperless claims processing systems. All records in such files have been considered by the Board in adjudicating this matter. This appeal has been advanced on the Board's docket pursuant to 38 C.F.R. § 20.900(c) (2015). 38 U.S.C.A. § 7107(a)(2) (West 2014). The appeal is REMANDED to the Agency of Original Jurisdiction (AOJ). VA will notify the appellant if further action is required. REMAND As noted above, in correspondence dated in April 2016, the Veteran's representative raised the issue of whether the Veteran experienced additional disability as a result of statin therapy, in the form of a psychiatric disorder manifested by extreme anxiety. As such, the Board finds that an additional opinion as to the raised issue must be obtained. The Veteran asserts that due to VA's improper decision to prescribe statins in combination with other medications he has incurred additional disability in the form of statin-induced myopathy resulting in extreme anxiety and should be compensated under 38 U.S.C.A. § 1151. VA treatment records reflect that medical providers at the Shreveport, Louisiana VA Medical Center (VAMC) prescribed Gemfibrozil and Zocor (Simvastatin) to the Veteran for high cholesterol and heart conditions. A November 2010 VA cardiology outpatient treatment record reflects right hand muscle wasting and mild wasting in left hand. The Veteran was worried about muscle wasting in the right hand and indicated that he thought it was most likely due to statins. The treatment provider noted that the Veteran had stopped using statins in May 2010 and that he also took Lopid only for a month. The physician opined that it was unlikely to be due to statins. The physician explained that statins induced myalgias were reversible in two to three months once they were stopped. The Veteran had been on statins for more than 10 years. The examiner added that the Veteran had other medical problems, including B12 deficiency and peripheral neuropathy, that could have contributed to it. VA outpatient treatment records dated in 2011 reflect that the Veteran repeatedly reported a history of complications related to Gemfibrozil and high dose statins such as myopathy, neuropathy and optic stroke. A February 2011 VA Hematology/Oncology outpatient treatment record reflects the Veteran's report that he had drug induced myopathy that was getting worse. He reported a worsening of muscle pain that he attributed to a drug interaction that had occurred in April 2010. The examiner's assessment was polycythemia and history of drug induced myopathy. The examiner discussed with the Veteran the etiology of his myopathy. The Veteran contended that his myopathy was solely related to a drug interaction that was caused by addition of Lopid to his statin therapy. The examiner explained that the Lopid therapy had occurred 10 months earlier and that this would not be the cause of his current myopathy and neuropathy. The examiner referenced results of a recent MRI of the cervical spine which had shown neural foraminae narrowing from C-3 to C-7. The examiner also opined that Polycythemia could also be a factor in the myopathy. The examiner encouraged the Veteran to have a phlebotomy performed in hopes of decreasing some of his myopathic pain. A VA examination report dated in November 2011 shows that the examiner, who was a nurse practitioner, noted the Veteran's contention that rhabdomyolysis was due to treatment at a VAMC wherein he was prescribed Gemfibrozil for triglycerides. The Veteran contended that he had already been taking Zocor which he was prescribed through the VAMC for his heart condition. The Veteran asserted that these two medications should not be taken together. The examiner noted that Zocor had been prescribed and Gemfibrozil was started on April 8, 2010. Both of these prescriptions were stopped on July 20, 2010. Following examination, a diagnosis of probable statin induced myopathy was provided. The examiner found no evidence to support a claim of rhabdomyolysis or myopathy secondary to use of Simvastatin and Lopid concurrently. There were no extreme elevations of CPK or other lab values that would be consistent with a diagnosis of rhabdomyolysis. Acute renal failure did not occur. He had been treated for chronic kidney disease since 2003. He had also been on Simvastatin (80 milligrams) since 2003 without any side effects. On the day of the VA examination, kidney function was within normal limits. The examiner noted that the Veteran had complains of joint and body pain prior to his treatment with Lopid and Simvastatin combination. The medications were listed as active from April to July but the Veteran indicated he only took medications for less than a week. Per review of Uptodate, any symptoms associated with rhabdomyolysis abate quickly once medications are stopped. The Veteran had multiple medical conditions to include degenerative disc disease of the cervical spine with radiculopathy as well as neuropathy of his upper extremities all of which existed prior to his trial of Simvastatin and Lopid combinations. He had multiple conditions that could have accounted for many of his symptoms. A VA outpatient treatment record date in April 2012, includes an impression of statin induced myopathy. A VA examination report dated in August 2012 shows that the VA examiner reviewed the Veteran's claims file and noted that he had been prescribed Simvastatin since 1999 and had been on 80 milligrams of the drug in 2010. On April 8, 2010, Gemfibrozil (600 milligrams) was prescribed twice a day which was added in combination with Simvastatin. He took both medications for 10 days and noted muscle pain and generalized muscle weakness. He stopped both medications and called his primary care physician who agreed to do this. He has continued pain in muscle and he sought medical attention a few months later. The examiner added that the Veteran had seen his cardiologist and primary care physician in October 2010 where he complained of right hand muscle atrophy. In December 2010, he was found to have elevated aldolase and saw a neurologist due to pain in "whole body" and right hand numbness. He had atrophy of interossei muscle of right hand with weakness. He was noted to have been advised to undergo ulnar transposition due to entrapment but his other medical conditions-lung-made him unstable for surgery. He continued to report pain in muscle hand joints and tendons of feet and took Oxycodone for chronic pain in his back. He experienced no joint swelling but he had gout. His other medical conditions were Parkinson's disease and neuropathy. The examiner commented that the Veteran had pre-existent Parkinson's disease, degenerative disc disease (DDD), cervical spondylosis and peripheral neuropathy. He had been diagnosed as having Parkinson's disease since at least in 2008 and he was on pain medications for neuropathy and carbidopa and levodopa for Parkinson's disease. Per his statement, he had been on statin for a long time and he took the combination with Gemfibrozil for a few weeks in April 2010 and he stopped both medications after a short time due to muscle aching. He has been on pain medication previously for his lumbar spine condition for years. He was now on Oxycodone. On his cardiac evaluation, he complained of right hand muscle atrophy. He noted right hand intrinsic hand muscles atrophy and dropping things from his hand and he cannot do activities he was able to do before like buttoning his shirt, using a pen or a spoon. December 2010 testing had shown that he had a generalized acquired sensory motor polyneuropathy, which is both axonal and demyelinating. Superimposed, he has a right ulnar neuropathy from compression at the elbow with marked atrophy of the right hand intrinsic muscles that on the electromyogram portion showed marked signs of denervation. A January 2011 MRI of the cervical spine had shown that he has multilevel cervical spondylitic changes. Blood for CPK and Isoenzymes all were normal. The impression was cervical radiculopathy/right ulnar neuropathy from compression at the right elbow. He was to seek right ulnar nerve transposition private, under local anesthesia due to his heart condition. No diagnosis of statin myopathy was done. The examiner noted review of the prior VA examination report and VA treatment records. The examiner stated that the problem list does not contain a diagnosis of statin but does include statin induced myopathy in the listed impressions. Upon reviewing the medical records, the examiner stated that the Veteran had exposure to statin and subjective pain and aching. There were no available labs to confirm elevation of CK or liver enzymes. He took the combination only for 10 days. He complained of hand muscle atrophy in October (6 months later). The examiner added that the medical literature does not support late complications of statin myopathy. As per medical literature Uptodate, 93 percent had resolved symptoms. The examiner commented that the Veteran had confirmed ulnar neuropathy, which was related to development of the hand atrophy. In addition, patients with Parkinson's disease showed muscle atrophy as indicated in medical literature. The elevation of aldolase is non-specific in view of CK was normal. Elevated aldolase levels may be found with hepatitis, other liver diseases, myocardial infarction, hemorrhagic pancreatitis, gangrene, delirium tremens, and in some cases of neoplasis. In cases of acute viral hepatitis, increase in serum aldolase tends to parallel ALT (SGPT) levels and is usually up to 20 times the average of normal. Normal results are usually obtained in portal cirrhosis and obstructive jaundice. A small fraction of cases of measles in young adults have been reported to have significant elevations of serum CK and aldolase. The subjective complaints of shortness of breath, joint and aching and other might be related to the multiple problems of degenerative disc disease, gout, sleep apnea, diverticulosis, etc. The examiner opined that the Veteran had no active statin myopathy syndrome and the current neurologic problems were not related to any complication of statin myopathy. In formulating this opinion, the examiner cited to multiple medical studies. In January 2013, the Appeals Management Center obtained an additional independent medical opinion from a podiatrist as to the questions of additional disability as a result of delay in diagnosis and treatment by the VA medical facility. Following a review of the medical evidence of record, the podiatrist concluded that it was as least as likely as not that the Veteran's complicated cardiovascular and hematological history provided sufficient medically-based, clinical evidence to support diffuse muscle pain (myopathy), and that it was less likely than not that there was additional disability due to statin therapy, to include myopathy/rhabdomyolysis. The podiatrist explained that there was a lack of medically-based, clinical evidence and/or current medical literature that supported chronic (long-term) statin-induced myopathy from combination drug use of Gemfibrozil and Simvastatin, and clear and unmistakable medically-based, clinical evidence to support the Veteran's claimed right hand condition, to include muscle myopathy and atrophy, as related to, caused by and/or aggravated by ulnar nerve compression. It was also concluded that it was less likely than not that the Veteran's claimed rhabdomyolysis related to and/or caused by combination statin use because of the lack of medically-based, clinical evidence and/or laboratory chemistry results to support the breakdown of muscle tissue and life-threatening muscle hemorrhage. In December 2015, the Veteran's representative asserted that the opinion provided by the podiatrist was inadequate because the examiner focused on the fact that the Veteran was elderly and being treated for multiple conditions and suggested that it was therefore difficult to assign etiological relationships because of the cumulative complexity of his health profile. The representative continued that the same reasoning should have been a compelling factor in the initial evaluation of potential problems when introducing additional prescription medication to a patient with a complex health profile. In January 2016, the Board requested an opinion from an independent internist as to the likelihood that the Veteran had experienced additional disability, to include (i) myopathy and/or (ii) rhabdomyolysis resulting from any combination of medications prescribed to the Veteran by the VA medical facility. In April 2016, an independent internist concluded that it was less likely as not that the Veteran experienced additional disability, to include (i) myopathy and/or (ii) rhabdomyolysis resulting from any combination of medications prescribed to the Veteran by the VA medical facility. In correspondence dated in April 2016, the Veteran's representative raised the issue of whether the Veteran experienced additional disability as a result of statin therapy, in the form of a psychiatric disorder manifested by extreme anxiety. As the nature and extent of the Veteran's asserted psychiatric disorder is unclear, as is the etiology thereof, the Board finds that an additional opinion as to the raised issue must be obtained. Finally, as this matter is being remanded for the reasons set forth above, any additional VA treatment records of the Veteran for his asserted disability should also be obtained. See 38 U.S.C.A. § 5103A(b), (c); 38 C.F.R. § 3.159(b); see also Bell v. Derwinski, 2 Vet. App. 611 (1992) (VA medical records are in constructive possession of the agency, and must be obtained if the material could be determinative of the claim). Accordingly, the case is REMANDED for the following action: (Please note, this appeal has been advanced on the Board's docket pursuant to 38 C.F.R. § 20.900(c). Expedited handling is requested.) 1. The AOJ shall ask the Veteran to identify all locations of VA treatment or evaluation for his asserted disabilities and contact each VA medical facility identified by the Veteran to obtain ongoing medical treatment records pertaining thereto. All records obtained must be associated with the Veteran's claims file. 2. The AOJ shall schedule the Veteran for a VA examination by an appropriate psychiatrist so as to determine the nature and etiology of his asserted psychiatric disorder, manifested by extreme anxiety. The claims file must be sent to the examiner for review. All tests and studies deemed necessary by the examiner must be conducted. The examiner should answer all of the following questions as definitively as possible: (a) Does the Veteran at least as likely as not have additional disability, to include a psychiatric disorder manifested by extreme anxiety, resulting from any combination of medications prescribed to the Veteran by the VA medical facility? (b) If additional disability is shown, was such additional disability the result of, or caused by, a lack of proper care or negligent treatment on the part of VA caregivers? In other words, did any action or inaction by VA caregivers cause additional disability or constitute carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault? If so, did VA fail to exercise the degree of care that would be expected of a reasonable health care provider? (c) If additional disability is shown, was the cause of the additional disability an event not reasonably foreseeable? [Note: The event need not be 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 addressing the foregoing, the Veteran's competent reports as to the onset and continuity of symptomatology must be specifically acknowledged and considered. If the examiner is unable to provide an opinion without resort to speculation, he or she should explain why this is so and what if any additional evidence would be necessary before an opinion could be rendered. The examiner must provide a rationale for each opinion given. 3. The AOJ will then readjudicate the Veteran's claim. If the benefit sought on appeal remains denied, the Veteran and his representative shall be provided with a Supplemental Statement of the Case. An appropriate period of time must be allowed for response. Thereafter, if appropriate, the case is to be returned to the Board, following applicable appellate procedure. The Veteran need take no action until he is so informed. He has the right to submit additional evidence and argument on the matter or matters the Board has remanded. Kutscherousky v. West, 12 Vet. App. 369 (1999). The purposes of this remand are to obtain additional information and comply with all due process considerations. No inference should be drawn regarding the final disposition of this claim as a result of this action. This claim must be afforded expeditious treatment. The law requires that all claims remanded by the Board of Veterans' Appeals or by the United States Court of Appeals for Veterans Claims for additional development or other appropriate action must be handled in an expeditious manner. See 38 U.S.C.A. §§ 5109B, 7112 (West 2014). _________________________________________________ JAMES L. MARCH Veterans Law Judge, Board of Veterans' Appeals Under 38 U.S.C.A. § 7252 (West 2014), only a decision of the Board of Veterans' Appeals is appealable to the United States Court of Appeals for Veterans Claims. This remand is in the nature of a preliminary order and does not constitute a decision of the Board on the merits of your appeal. 38 C.F.R. § 20.1100(b) (2015).