Citation Nr: 1300755 Decision Date: 01/09/13 Archive Date: 01/16/13 DOCKET NO. 08-04 585 ) DATE ) ) On appeal from the Department of Veterans Affairs (VA) Regional Office in Houston, Texas THE ISSUE Entitlement to VA compensation under the provisions of 38 U.S.C.A. § 1151 for additional left hip disability following resurfacing of the left femoral head by VA in October 2005 for treatment of avascular necrosis. REPRESENTATION Appellant represented by: Texas Veterans Commission WITNESS AT HEARINGS ON APPEAL Appellant ATTORNEY FOR THE BOARD Brian J. Milmoe, Counsel INTRODUCTION The Veteran served on active duty from May 1986 to May 1990 and from February 2002 to March 2002. This matter comes before the Board of Veterans' Appeals (Board) on appeal from a rating decision entered in September 2006 by the Department of Veterans Affairs (VA) Regional Office (RO) in Houston, Texas. The Veteran was afforded a hearing before the RO's decision review officer in October 2011 and before the Board, sitting at the RO, in May 2012, transcripts of which are of record. Following the Board hearing, the Veteran submitted additional documentary evidence along with a written waiver for its initial consideration by the RO. Under its authority set out in 38 U.S.C.A. § 7109 (West 2002); 38 C.F.R. § 20.901, the Board in July 2012 sought an expert medical opinion as to questions raised by this appeal through the VA's Veterans Health Administration (VHA). That opinion was received by the Board in September 2012, and in October 2012, the Veteran was furnished a copy of the opinion and offered an opportunity to provide any additional evidence or argument relating thereto within a 60-day period. No response was received within the allotted time frame and, thus, the Board proceeds to adjudicate herein the merits of the claim presented. At his May 2012 hearing, the Veteran raised the issue of the issue of his entitlement to VA compensation under 38 U.S.C.A. § 1151 for prescription drug dependency following October 2005 surgery for the treatment of avascular necrosis of the left hip. That issue has not been adjudicated by the Agency of Original Jurisdiction (AOJ). Therefore, the Board does not have jurisdiction over it and it is referred to the AOJ for appropriate action. FINDING OF FACT The Veteran sustained additional disability involving an increased level of severity of his avascular necrosis of the left hip as a direct result of an October 2005 operative procedure undertaken by VA for resurfacing of the left femoral head, without first obtaining his full and informed consent. CONCLUSION OF LAW The criteria for entitlement to VA compensation under 38 U.S.C.A. § 1151 for an increased level of avascular necrosis of the left hip have been met. 38 U.S.C.A. §§ 1151, 5107 (West 2002); 38 C.F.R. §§ 3.102, 3.358, 3.361, 17.32 (2012). REASONS AND BASES FOR FINDING AND CONCLUSION As the disposition herein reached is favorable to the appellant, the need to discuss the VA's efforts to comply with the Veterans Claims Assistance Act of 2000, Pub. L. No. 106-475, 114 Stat. 2096 (Nov. 9, 2000), as codified in the United States Code, its implementing regulations, or the body of law interpretive thereof, is obviated. Where a veteran has an additional disability resulting from a disease or injury or an aggravation of an existing disease or injury suffered as a result of training, hospital care, medical or surgical treatment, or an examination by 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. For claims filed on or after October 1, 1997, as in this case where the § 1151 claim was received by VA in May 2006, the claimant must show that VA examination or treatment resulted in additional disability or death and that the proximate cause of the disability was carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the VA's part in furnishing the medical or surgical treatment, or that the proximate cause of additional disability was an event which was not reasonably foreseeable. 38 U.S.C.A. § 1151; see VAOPGCPREC 40-97, 63 Fed. Reg. 31263 (1998). By changes effectuated as of September 2, 2004, 38 C.F.R. § 3.358 was rendered applicable only to claims received by VA prior to October 1, 1997. See 69 Fed. Reg. 46433 (2004). The provisions of 38 C.F.R. § 3.361 were promulgated for review of claims received on and after October 1, 1997. Id. Compensation is not payable for the necessary consequences of medical or surgical treatment properly administered with the express or implied consent of the veteran, or in appropriate cases, the veteran's representative. 38 C.F.R. § 3.358(c)(3). "Necessary consequences" are those which are certain to result from, or were intended to result from, the medical or surgical treatment administered. Id. Claims based on additional disability due to hospital care, medical or surgical treatment, or examination must meet the causation requirements of 38 C.F.R. § 3.361(c), (d). 38 C.F.R. § 3.361(c). The proximate cause of disability 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, it must be shown that the hospital care, medical or surgical treatment, or examination caused the veteran's additional disability (as explained in § 3.361(c)), 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, 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). To determine whether there was informed consent, VA will consider whether the health care providers substantially complied with the requirements of 38 C.F.R. § 17.32. Id. Minor deviations from the requirements of 38 C.F.R. § 17.32 of this chapter that are immaterial under the circumstances of a case will not defeat a finding of informed consent. Id. Consent may be express (i.e., given orally or in writing) or implied under the circumstances specified in 38 C.F.R. § 17.32(b) of this chapter, as in emergency situations. Id. Whether the proximate cause of a veteran's additional disability was an event not reasonably foreseeable is in each claim to be determined based on what a reasonable health care provider would have foreseen. 38 C.F.R. § 3.361(d)(2). 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. Id. Under 38 C.F.R. § 17.32, except as otherwise provided in that regulation, all patient care furnished under title 38 U.S.C. shall be carried out only with the full and informed consent of the patient or, in appropriate cases, a representative thereof. In order to give informed consent, the patient must have decision-making capacity and be able to communicate decisions concerning health care. If the patient lacks decision-making capacity or has been declared incompetent, consent must be obtained from the patient's surrogate. Practitioners may provide necessary medical care in emergency situations without the patient's or surrogate's express consent when immediate medical care is necessary to preserve life or prevent serious impairment of the health of the patient or others and the patient is unable to consent and the practitioner determines that the patient has no surrogate or that waiting to obtain consent from the patient's surrogate would increase the hazard to the life or health of the patient or others. In such circumstances consent is implied. 38 C.F.R. § 17.32(b). Under 38 C.F.R. § 17.32(c), an informed consent is the freely given consent that follows a careful explanation by the practitioner to the patient or the patient's surrogate of the proposed diagnostic or therapeutic procedure or course of treatment. The practitioner, who has primary responsibility for the patient or who will perform the particular procedure or provide the treatment, must explain in language understandable to the patient or surrogate the nature of a proposed procedure or treatment; the expected benefits; reasonably foreseeable associated risks, complications or side effects; reasonable and available alternatives; and anticipated results if nothing is done. The patient or surrogate must be given the opportunity to ask questions, to indicate comprehension of the information provided, and to grant permission freely without coercion. The practitioner must advise the patient or surrogate if the proposed treatment is novel or unorthodox. The patient or surrogate may withhold or revoke his or her consent at any time. Under 38 C.F.R. § 17.32(d), an informed consent must be appropriately documented in the medical record. In addition, signature consent is required for all diagnostic and therapeutic treatments or procedures that: (i) Require the use of sedation; (ii) require anesthesia or narcotic analgesia; (iii) are considered to produce significant discomfort to the patient; (iv) have a significant risk of complication or morbidity; (v) require injections of any substance into a joint space or body cavity; or (vi) involve testing for human immunodeficiency virus. In his written statements of record and hearing testimony, it is alleged by and on behalf of the Veteran that he is entitled to VA compensation under 38 U.S.C.A. § 1151 for additional disability involving a change in leg length of his left lower extremity and other manifestations and symptoms of an increased level of avascular necrosis of the left hip directly resulting from the VA's operative procedure of October 2005 for resurfacting of his left femoral head. He acknowledges that the resurfacing procedure was presented to him as a stop-gap measure to avoid a total hip replacement, but that it was presented to him as a means to obtain relief of his left hip symptoms for a period of up to seven years, with a reduction in manifestations as to permit him to return to gainful employment. He asserts that the October 2005 procedure was undertaken by an intern, that the surgery was performed negligently, and that the private surgeon who afforded subsequent corrective surgery indicated to him that the VA's surgery was a failure. An increased level of pain to a severe degree, spasm, limited motion, and very restricted ambulation and other activities, leading to increased usage of prescribed narcotics, are described following the October 2005 surgery. Due to the deteriorating state of his left hip, a total left hip replacement was required in 2007 by a private surgeon, who according to the Veteran described the VA's 2005 surgery as "definitely very poor work." The record reflects that, following a course of medical evaluation beginning in or about September 2004 for increasing complaints of left hip pain and dysfunction, the Veteran was approved by attending VA medical professionals to undergo surgery for resurfacing of his left femoral head in lieu of a total left hip replacement. Prior to the surgery, the Veteran executed a Request for Administration of Anesthesia and for Performance of Operations and Other Procedures, on October 19, 2005, for left femoral head resurfacting and possible total hip arthroplasty and all indicated procedures. Only the identified risks of bleeding, infection, and injury to the blood vessels and/or nerves were specified. The accompanying VA Form 11-77, Informed Consent, with the practitioner's signature indicated that a discussion of the relevant aspects of the planned treatment had been made with the Veteran and that its indications, benefits, risks, and potential complications had also been discussed, but none were specifically set forth in the space provided on that form. Resurfacing of the left femoral head was accomplished by VA on October 19, 2005, under general endotracheal anesthesia. The operative report indicated that the Veteran had a long history of left hip pain and that a preoperative workup had confirmed the existence of a left hip avascular necrosis, which had been followed by a long trial of nonoperative treatment that was unsuccessful. It was also noted that all treatment options, including cord decompression, femoral head resection, and total hip arthroplasty, had been reviewed, with indications, benefits, risks, and alternatives being identified and all questions of the Veteran being answered. No intraoperative complication was encountered, and following immediate postoperative care, the Veteran was transferred to another service for rehabilitative care, including physical therapy, which continued until late October 2005. During that period, the Veteran experienced mobility difficulties and complained of significant pain and weakness of the left leg, with an intermittent loss of sensation. Following his discharge from rehabilitative care, the Veteran experienced continued pain and swelling of the left leg, and, during the course of follow-up care, complained of a leg length discrepancy measured on physical examination by a medical professional on November 21, 2005, to be two inches. Various other medical professionals during the course of outpatient treatment variously recorded a leg length discrepancy ranging between two centimeters and two inches. The Veteran thereafter sought medical input from a private physician as to the status of his left hip. That physician noted that X-rays revealed that the surface replacement was well-fixed to the femur, but the metallic ball had eroded through the acetabular cartilage and was beginning to erode into the pelvis. There were noted to be significant pain and disablement due to the wearing away of cartilage and bone, with shortening of the leg and significant pelvic tilt. The conversion of the surface replacement to a total hip arthroplasty followed in June 2007. The RO in developing the Veteran's claim sought an examination and professional medical opinion from a VA physician's assistant (PA). This occurred in February 2012. The PA's review of the record was reported to show only one occasion on which a "true measurement" of leg lengths was undertaken following the October 2005 surgery. The PA found that such measurement had occurred on December 28, 2005, and showed each leg to measure 92 centimeters, leading him to conclude that there was no postsurgical leg length discrepancy. He further found that there was no evidence of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of indicated fault on the part of VA in the surgical care afforded the Veteran and his left hip in October 2005. He also determined that the failure of the 2005 procedure and the prosthesis utilized were reasonably foreseeable events. Received by VA in March 2012 was a written statement from the Veteran's former spouse. Therein, she indicated that the Veteran's legs were of unequal lengths as soon as he could walk following the VA resurfacing in October 2005, which was attributed to swelling. To offset the Veteran's severe pain, increased use of pain killers was prescribed and, due to continued unequal leg lengths, orthopedic shoes and a lift were prescribed, without any significant reduction in pertinent symptoms. The private physician who performed the total hip arthroplasty was noted to describe "the mess" that he found inside the left hip joint, with enormous scar tissue and protrusion of a metal part above the ball of the joint. According to her, the private physician could not label what he found as malpractice in the absence of any intentional mistakes, but described the prior surgery as "definitely very poor work." In July 2012, the Board referred this case for a VHA opinion from a VA medical expert. This opinion was received in September 2012 and indicated that hip resurfacing was known to be a temporary treatment, with risks of worsening avascular necrosis and continued pain. No reference was found in the record by the expert as to the condition of the bone prior to the resurfacing, with notation that a contraindication of that procedure was excessive bone loss or deformity. The Veteran was noted to have had a poor outcome of the resurfacing surgery, with complaints of pain and leg inequality. Notes within the chart were found to identify the left leg being two inches longer than the right to being one inch shorter and the expert noted that it would be almost impossible to lengthen the left leg two inches from resurfacing. It was more likely, in the opinion of the expert, that the left leg would be shorter, based on the findings of the private physician that did the total hip replacement that the head and neck of the femoral head had collapsed. According to the expert, the only way to document absolute leg length would be to do a scanogram and that was not accomplished in this case. The VHA expert noted generally that only limited treatment options were available to younger patients with avascular necrosis and that total hip replacement was not a good option because of the early failure rate in younger patients. Core decompression and resurfacing procedures were developed in order to bridge some additional years before hip replacement. In the opinion of the expert, the Veteran was offered acceptable options and it was foreseeable that the resurfacing procedure would eventually fail requiring conversion to total hip replacement. As such, the Veteran's disability was directly related to his preexisting avascular necrosis, not the subsequent two surgeries, and he further opined that the leg length discrepancy would be expected. The only caveat was that, if the bone stock at the time of resurfacting was deficient, a better option would have been to do the total hip replacement. The Board has fully considered all of the evidence of record, including competent, credible, and probative testimony and statements of the Veteran and his former spouse, excepting that pertaining to the conduct of the October 2005 surgery by an intern. There is of record evidence for and against entitlement, but the record as a whole supports the existence of additional disability resulting from the October 2005 resurfacing of the Veteran's left femoral head by VA, manifested largely by constant, severe pain and a left leg shortening. A preponderance of the evidence is against a showing of any lengthening of the left leg, which the Veteran asserts as basis of his entitlement to section 1151 compensation. The record, however, supports a finding that left leg shortening occurred as a direct result of the October 2005 surgical intervention. The VA's culpability in carrying out the surgery at issue, the reasonable foreseeability of additional disability of the left hip, and whether there was a failure by VA to obtain informed consent under 38 C.F.R. § 17.32 for that surgery are all questions posed by this appeal; however, it is now clear that this case turns on whether informed consent was properly obtained for the October 2005 resurfacing of the left femoral head and the Board finds that it was not. The Board points out to the Veteran that VA is not a guarantor of the success of any surgical procedure undertaken by its employees. That notwithstanding, it is clear from a review of the entirety of the Veteran's claims folder that VA failed to obtain informed consent from the Veteran under the requisites of 38 C.F.R. § 17.32 for the VA October 2005 surgery. There is evidence on file indicating that treatment options, as well as the relative risks and benefits of October 2005 procedure, were discussed with the Veteran prior to the surgery in question, but the only risks he specifically assumed were those listed on the informed consent document as to bleeding, infection, and blood vessel and/or nerve injury. Neither the statement contained in the operative report as to the surgeon's explanation of the potential risks, nor the informed consent document signed by the Veteran in October 2005, satisfies the nondiscretionary criteria of 38 C.F.R. § 17.32. Also, the surgery itself was not emergent and it is not demonstrated by the record that the Veteran was unfit or incapable of speaking, writing, or engaging in a conversation with attending medical professionals as to the risks and benefits of the proposed October 2005 surgery, such that obtaining a writing or signature was not feasible. As well, the question of informed consent was not specifically addressed by the VA examiner in 2011 or fully so by the VHA expert in terms of the risks and benefits of the surgery to which the Veteran actually consented or acknowledged. Thus, it reasonably follows that the surgery was undertaken without informed consent under 38 C.F.R. § 17.32, thereby rendering the Veteran entitled to VA compensation under 38 U.S.C.A. § 1151 for additional disability resulting from that surgery; namely, an increased level of left hip disability manifested by severe and constant pain, left leg shortening, and resultant effects thereof. See 38 C.F.R. § 3.361(a)-(d). In sum, the evidence supporting entitlement to VA compensation under 38 U.S.C.A. § 1151 for an increased level of severity of avascular necrosis of the left hip outweighs evidence to the contrary. To that extent, the benefit sought on appeal is allowed. 38 U.S.C.A. § 5107(b); see also, generally Gilbert v. Derwinski, 1 Vet. App. 49 (1990). ORDER VA compensation under 38 U.S.C.A. § 1151 for additional left hip disablement is granted. ____________________________________________ MILO H. HAWLEY Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs