Citation Nr: 1323585 Decision Date: 07/24/13 Archive Date: 08/01/13 DOCKET NO. 09-46 754A ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Chicago, Illinois THE ISSUE Entitlement to compensation pursuant to 38 U.S.C.A. § 1151 for renal failure as a result of treatment at a Department of Veterans Affairs medical facility between July 2001 and August 2001. ATTORNEY FOR THE BOARD R. Giannecchini, Counsel INTRODUCTION The Veteran had active military service from June 1966 to March 1968. This matter comes to the Board of Veterans' Appeals (Board) on appeal from a December 2005 rating decision of the Department of Veterans Affairs (VA) Regional Office (RO) in Chicago, Illinois. In June 2011, the Board remanded the Veteran's claim to the agency of original jurisdiction (AOJ) for a VA medical examination. Following that examination the AOJ issued a supplemental statement of the case (SSOC) in August 2012 continuing the denial of the Veteran's claim. Following return of the Veteran's appeal to the Board, a VHA medical opinion was obtained. The Board provided the Veteran with a copy of the January 2013 VHA opinion and gave him an opportunity to submit additional argument or evidence. In March 2013, the Board received notification from the Veteran that he had no additional argument or evidence to submit. FINDINGS OF FACT 1. The Veteran underwent right shoulder surgery at Hines (Chicago) VA Medical Center (VAMC) on June 15, 2001; he later developed a wound infection that was treated by VA personnel at the Hines VAMC with the antibiotics Amikacin and Gentamicin. 2. The Veteran was diagnosed with Amikacin-induced acute renal failure and/or acute/chronic renal insufficiency secondary to Amikacin. 3. There is reasonable doubt as to whether the Veteran's medical treatment with Amikacin resulted in renal failure and whether VA failed to exercise the degree of care that would be expected of a reasonable health care provider in its treatment of the Veteran with Amikacin. CONCLUSION OF LAW The criteria for compensation benefits under 38 U.S.C.A. § 1151 for renal failure have been met. 38 U.S.C.A. §§ 1151, 5107 (West 2002 & Supp. 2012); 38 C.F.R. §§ 3.102, 3.361 (2012). REASONS AND BASES FOR FINDINGS AND CONCLUSION The Veteran asserts that he is entitled to compensation pursuant to 38 U.S.C.A. § 1151 for renal failure incurred as a result of treatment at Hines VAMC between July 2001 and August 2001. He specifically contends that the medications (Amikacin and Gentamicin) that he was given to treat a post-operative right shoulder infection resulted in his developing acute renal failure which led to chronic renal failure. The Veteran's claim for benefits under 38 U.S.C.A. § 1151 was received after October 1, 1997. With respect to claims filed on or after October 1, 1997 (see VAOPGCPREC 40-97), 38 U.S.C.A. § 1151 provides in pertinent part that compensation shall be awarded for a qualifying additional disability or death in the same manner as if such additional disability or death was service connected. For purposes of this section, a disability or death is a qualifying additional disability if the disability or death was not the result of the veteran's willful misconduct and (1) the disability or death was caused by hospital care, medical or surgical treatment, or examination furnished the veteran under any law administered by the Secretary, and the proximate cause of the disability or death was (A) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing the hospital care, medical or surgical treatment, or examination; or (B) an event not reasonably foreseeable. 38 U.S.C.A. § 1151(a). To determine whether additional disability exists within the meaning of § 1151, the veteran's condition immediately before the beginning of the hospital care, medical or surgical treatment, examination, training and rehabilitation services, or compensated work therapy program upon which the claim is based is compared to his or her condition after such care, treatment, examination, services, or program has been completed. Each body part or system involved is considered separately. 38 C.F.R. § 3.361(b). To establish causation, 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 does not establish cause. 38 C.F.R. § 3.361(c)(1). 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. 38 C.F.R. § 3.361(c)(2). 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. 38 C.F.R. § 3.361(c)(3). 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. 38 C.F.R. § 3.361(d). 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 and (i) that VA failed to exercise the degree of care that would be expected of a reasonable health care provider or (ii) that 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. 38 C.F.R. § 3.361(d)(1). See also 38 C.F.R. § 17.32 (2012) (Protection of Patient Rights-provisions of informed consent). The causation element noted above is satisfied not only when an injury is directly caused by the actions of VA employees, but also when that injury occurs in a VA facility as a result of the VA's negligence. See Viegas v. Shinseki, 705 F.3d 1374, 1378 (2013). Congress intended the statute to encompass not simply the actual care provided by VA medical personnel, but also treatment-related incidents that occur in the physical premises controlled and maintained by VA. Id. Finally, the determination of whether the proximate cause of a veteran's additional disability was an event not reasonably foreseeable is to be based on what a reasonable health care provider would have foreseen. The event does not have to 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. 38 C.F.R. § 3.361(d)(2). The regulation further provides that, 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. See 38 C.F.R. § 3.361(d)(2). The evidence regarding the Veteran's right shoulder infection and his treatment with the antibiotics Amikacin and Gentamicin is not in dispute. Likewise, there is no disputing that the Veteran developed aminoglycoside (Amikacin)-induced acute renal failure and that his renal function progressively worsened after his treatment with Amikacin. In this regard, the Veteran developed chronic renal failure and underwent kidney dialysis treatment and a later successful kidney transplant. The question for the Board in the present case is whether the Veteran's Amikacin toxicity resulting from VA prescribed treatment resulted in any additional disability, and if so, whether the additional disability was caused by VA's carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault, or was from an event not reasonably foreseeable. The medical evidence reviewed does reflect assessments by VA clinicians that the Veteran's worsening renal function was the result of diabetic nephropathy and hypertension. In particular, a November 2002 VA treatment record reflects the clinician's assessment that the Veteran's chronic renal insufficiency was secondary to diabetes and hypertension. A January 2003 VA treatment record documents the clinician's comment that the Veteran's worsening renal function was most likely the natural progression of diabetic nephropathy because the Veteran's blood pressure and glucose had been poorly controlled in the past. At the same time, a VA general surgery admission note (associated with the Veteran's kidney transplant at the VAMC Iowa City), dated in November 2010, identified that the Veteran had been diagnosed with renal failure in 2001, that he had been taking Amikacin for treatment at the time and that his renal function had continued to deteriorate after he stopped Amikacin and that the deteriorating renal function had progressed to end-stage renal disease (ESRD) by 2006. Otherwise, in a report of June 2005 VA examination, a VA clinician provided an opinion that the Veteran's acute renal failure was not caused or made worse by VA medical treatment/ IV (intravenous) Amikacin because the Veteran had a increased risk for kidney failure given his length of diabetes mellitus (15 years), his beginning stages of nephropathy, and his long standing history of hypertension. In a subsequent report of December 2005 VA examination, a different clinician commented that he agreed with the opinion given by the June 2005 clinician. However, the clinician failed to provide any supporting discussion of the evidence. In a report of October 2009 VA examination, another VA clinician provided a medical opinion but failed to provide any clinical rationale for his conclusion. In the present case, in considering the totality of the evidence before it, the Board finds the most probative and persuasive evidence of record to be a report of July 2011 VA examination/opinion as well as the above noted January 2013 VHA opinion. Both opinions were provided by physicians with backgrounds in nephrology (a specialty of medicine that concerns itself with the study of kidney function and problems), the physician reviewed the Veteran's claims folders, and each opinion reflects discussion of the clinical evidence of record along with explanations for the conclusions reached by the physicians. In the report of July 2011 VA examination, the examiner commented, in particular, as follows, Chronic renal failure was the result of acute renal failure from [G]entamicin and [A]mikacin. There is no evidence that the renal failure was either due or aggravated by the natural progression of diabetic nephropathy or hypertension. For diabetic nephropathy, there was not sufficient protein in the urine to incriminate the natural progression of diabetes mellitus. For hypertension, the hypertension was well controlled at all times and did not contribute to renal failure. The VA examiner also opined, The approximate cause of the [V]eteran's renal failure was not due to carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault on the part of the VA or an event not reasonably foreseeable. The rationale is that [G]entamicin and [A]mikacin was indicated for treatment of infection of the right shoulder, and they are also known to cause renal impairment. Every effort was made to try and minimize the damage. In the January 2013 VHA opinion, following his review and discussion of the evidence, the VA physician concluded as follows, 1. The [Veteran] almost certainly suffered an episode of acute kidney injury as the result of aminoglycoside toxicity in August, 2001. This does NOT however, indicate that the [Veteran's] subsequent end-stage renal failure was on this basis, since the [Veteran] recovered renal function in the subsequent weeks following aminoglycoside withdrawal. 2. The [Veteran's] aminoglycoside toxicity resulted from a deviation from standard practice of monitoring aminoglycoside levels with sufficient frequency, monitoring renal function with adequately, and making appropriate, timely adjustments of aminoglycoside dose and/or dosing interval. 3. Alternative(s) to aminoglycoside therapy for the Veteran's infection should have been sought when renal function had begun to decline. 4. The VA was at fault for the aforementioned errors in aminoglycoside monitoring, dose adjustment, and delay in cessation of aminoglycoside therapy. The Board finds that the opinions from the July 2011 VA examiner and the physician who provided the January 2013 VHA opinion contradict each other. Nonetheless, both opinions are probative and persuasive based on the expertise of the physicians and the rationales for the opinions provided by both doctors. When there is an approximate balance of evidence regarding the merits of an issue material to the determination of the matter, the benefit of the doubt in resolving each such issue shall be given to the claimant. 38 U.S.C.A. § 5107; 38 C.F.R. § 3.102. In a claim for VA benefits, the Veteran need only demonstrate that there is an approximate balance of positive and negative evidence in order to prevail. Entitlement need not be established beyond a reasonable doubt, by clear and convincing evidence, or by a fair preponderance of the evidence. Under the benefit of the doubt doctrine, when the evidence is in "relative equipoise," the law dictates that the Veteran prevails. See e.g., Gilbert v. Derwinski, 1 Vet. App. 49, 53 (1990). Here, the Board finds there is reasonable doubt as to whether additional disability resulted from Amikacin-induced acute renal failure. Notwithstanding the January 2013 unfavorable VHA opinion on this issue, the July 2011 VA examiner identified that acute renal failure did lead to chronic renal failure and his opinion included discussion of the affects of diabetic nephropathy and hypertension on the Veteran's condition. The Board also finds that there is reasonable doubt as to whether VA failed to exercise the degree of care that would be expected of a reasonable health care provider in administering Amikacin to the Veteran. Notwithstanding the July 2011 unfavorable VA examiner opinion on this issue, the January 2013 VHA opinion of the VA physician clearly and thoroughly discusses VA's errors in administering Amikacin treatment for the Veteran's right shoulder infection which resulted in acute renal failure. Thus, the Board finds a basis in the record to support that the Veteran suffered an additional disability secondary to VA treatment with Amikacin, and that the additional disability was caused by VA's failure to exercise the degree of care that would be expected of a reasonable health care provider in administering Amikacin to the Veteran. In so finding, the Board is mindful that Amikacin toxicity is a foreseeable consequence when using the antibiotic drug. Notwithstanding that fact, the January 2013 opinion of the VA physician clearly points to errors made by VA in administering the drug that led to acute kidney injury. Therefore, when reasonable doubt is resolved in the Veteran's favor, the Board finds that it is as likely as not that additional disability was incurred by the Veteran secondary to errors made by VA in administering Amikacin; thus, the additional disability was caused by VA's failure to exercise the degree of care that would be expected of a reasonable health care provider in administering aminoglycoside. See 38 U.S.C.A. § 5107(b); 38 C.F.R. § 3.102. Given this finding, the Board concludes that the criteria for compensation benefits under 38 U.S.C.A. § 1151 for renal failure have been met. ORDER Entitlement to compensation benefits under the provisions of 38 U.S.C.A. § 1151 for renal failure due to VA medical treatment is granted, subject to the laws and regulations governing the payment of monetary awards. ____________________________________________ KATHLEEN K. GALLAGHER Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs