Citation Nr: 0905556 Decision Date: 02/17/09 Archive Date: 02/24/09 DOCKET NO. 06-08 553 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Sioux Falls, South Dakota THE ISSUE Entitlement to compensation under 38 U.S.C.A. § 1151 for sciatic nerve neuropathy of the right lower extremity. REPRESENTATION Appellant represented by: Disabled American Veterans ATTORNEY FOR THE BOARD W. Yates, Counsel INTRODUCTION The Veteran served on active duty from June 1968 to March 1970. This matter comes before the Board of Veterans' Appeals (Board) on appeal from a January 2005 rating decision by the Department of Veterans Affairs (VA) Regional Office (RO) in Sioux Falls, South Dakota. FINDINGS OF FACT 1. The Veteran incurred additional disability of sciatic nerve neuropathy of the right lower extremity, as a result of his December 12, 2003 VA bone marrow biopsy. 2. It is not established that the Veteran provided informed consent for the December 12, 2003 bone marrow biopsy or that VA substantially complied with procedures for obtaining the Veteran's informed consent. CONCLUSION OF LAW The criteria for compensation under 38 U.S.C.A. § 1151 for sciatic nerve neuropathy of the right lower extremity have been met. 38 U.S.C.A. §§ 1151, 5107 (West 2002); 38 C.F.R. §§ 3.358, 17.32 (2008). REASONS AND BASES FOR FINDINGS AND CONCLUSION As provided for by the Veterans Claims Assistance Act of 2000 (VCAA), VA has a duty to notify and assist claimants in substantiating a claim for VA benefits. 38 U.S.C.A. §§ 5100, 5102, 5103, 5103A, 5107, 5126 (West 2002 & Supp. 2007); 38 C.F.R. §§ 3.102, 3.156(a), 3.159 and 3.326(a) (2008). In this case, the Board is granting in full the benefit sought on appeal. Accordingly, assuming, without deciding, that any error was committed with respect to either the duty to notify or the duty to assist, such error was harmless and need not be further considered. The Veteran asserts that he developed sciatic nerve neuropathy of the right lower extremity as a result of a December 12, 2003 VA bone marrow biopsy. Historically, the records reflect that on December 3, 2003, the Veteran was admitted to the VA Medical Center in Sioux Falls, South Dakota, with complaints of a 48-hour history of right lateral and mid abdominal pain. He was diagnosed with a right lower quadrant abscess for which he underwent CT guided drainage on December 5, 2003. A subsequent fistulogram, performed on December 8, 2003, showed a fistulous communication of the abscess cavity to an adjacent bowel loop. Continued abscess drainage was then recommended. A treatment report, dated December 11, 2003, noted that the Veteran had recently required three units of blood with no evidence of bleeding. A bone marrow biopsy and aspirate was then ordered to further assess the Veteran's anemia. An informed consent form, dated December 12, 2003, noted that the Veteran had been diagnosed with anemia, and that he was to undergo a bone marrow biopsy and aspirate. Where the consent form lists risks and possible complications of this procedure, it stated, "bleeding and infection." Where it lists options and alternatives discussed, it stated, "[n]one." A treatment report, dated December 12, 2003, noted that the Veteran underwent a bone marrow procedure that morning, and that he was now complaining of leg pain and numbness. The report further stated that these "[s]ymptoms are not common adverse effects of procedure" and that two VA physicians were contacted to evaluate his condition. A treatment report, dated December 13, 2003, noted the Veteran's complaints of pain along the right buttock and down the right leg. A treatment report, dated December 17, 2003, noted his complaints of right hip pain, radiating down into the right leg. The report also noted that the Veteran was crying out at times with complaints of pain. A treatment report, dated December 19, 2003, noted that a CT scan had revealed a hematoma, and that this was the likely source of the Veteran's pain. A surgical report, dated December 22, 2003, noted that ten days earlier, the Veteran underwent a bone marrow biopsy which was "technically difficult and was done with the patient on Heparin." The report noted that there was a problem with pain at the biopsy site, and that a CT scan had revealed a hematoma in that area. Physical examination revealed a very large, firm, tender area around his right buttock at and just below the bone marrow biopsy site. The report stated that they were "[e]ssentially treating a problem which is that of delayed hemorrhage after a bone marrow biopsy of the right iliac area with impending foot drop." A CT scan on that day showed enlargement of the gluteal hematoma from the prior week. Subsequent discharge diagnoses included right gluteal hematoma with radiculopathy. A VA treatment report, dated December 23, 2003, noted that following his bone marrow biopsy, the Veteran developed a large right buttock hematoma, significant blood loss, and right foot drop from compression of the sciatic nerve. The report noted that the Veteran was getting better, but was still unable to bear weight on his right leg. The VA physician further stated that "this unfortunate incident was procedure related." In September 2004, a VA examination for peripheral nerves was conducted. The VA examiner noted that the Veteran's claims folder had been reviewed in detail. A physical examination of the Veteran was not performed. The examination report noted the Veteran's history of morbid obesity, status post gastric bypass surgery with colon and small bowel resection; short bowel syndrome after bypass gastric surgery; and intra- abdominal abscess after the surgery. It also noted that the Veteran has valvular heart disease, and a history of renal insufficiency and hypercholesterolemia. The report noted that the Veteran was on Coumadin during his bone marrow aspiration, and that this could not have been reversed completely because of his aortic valve replacement and the need to be anticoagulated at all times. The VA physician further noted that he presumes that the evacuation of the hematoma was not done for possible excessive bleeding and progression of his anemia. Since then, the report noted that the Veteran has continued to have muscle weakness, tingling and numbing sensation of the right lower extremity. Nerve conduction studies, conducted in July 2004, revealed evidence of sensory motor peripheral neuropathy, the etiology of which was possible vitamin B12 deficiency, hypothyroidism and the hematoma caused by the injury to the sciatic nerve. According to the neurologist's evaluation, the strength in the Veteran's upper and left lower extremities was 5/5, but the strength in the right lower extremity was 4/5. Sensation to light touch and pinprick were reduced over anterior lateral surface of the right leg as well as both dorsal and plantar surfaces of the right foot. The report also noted that the Veteran walked with a slight limp on the left due to weakness and some numbness in the right lower extremity. Based upon a review of the records, the VA examiner concluded the examination report with a diagnosis of sciatica nerve neuropathy, secondary to hematoma, vitamin B12 deficiency and hypothyroidism. The VA examiner then opined that the hematoma which developed after the bone marrow aspiration was a foreseeable complication since the Veteran was on Coumadin, a blood thinner given for blood clot prevention. The VA examiner further noted that the "veteran was informed about complications prior to this procedure as this is standard protocol at the VAH." It appears the Veteran's signed consent form was not added to the file until after the VA examination had been conducted so this was not available for review. In June 2006 argument, the Veteran's representative asked the Board to consider whether adequate informed consent was provided by the Veteran prior to his December 10, 2003 procedure, noting that failure to provide such consent would in and of itself, constitute fault on the part of VA in conjunction with this procedure. In general, when a claimant experiences additional disability as the result of hospital care, medical or surgical treatment, or examination furnished 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. The provisions of 38 U.S.C.A. § 1151 provide that when there is no willful misconduct by a Veteran, disability resulting from VA hospital care furnished the Veteran will be compensated in the same manner as if service-connected, if the disability was caused by (A) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing hospital care or (B) an event which is not reasonably foreseeable. See also 38 C.F.R. § 3.358. From the plain language of the statute, it is clear that to establish entitlement to Section 1151 benefits, all three of the following factors must be shown: (1) disability/additional disability, (2) that VA hospitalization, treatment, surgery, examination, or training was the cause of such disability, and (3) that there was an element of fault on the part of VA in providing the treatment, hospitalization, surgery, etc., or that the disability resulted from an unforeseen event. Effective September 2, 2004, 38 C.F.R. § 3.361 relating to section 1151 claims was promulgated for claims filed on or after October 1, 1997, such as this appellant's claim (received in July 2004). See 69 Fed. Reg. 46,426 (Aug. 3, 2004) (codified as amended at 38 C.F.R. § 3.361 (2008)). In determining whether a veteran 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). 38 C.F.R. § 3.361(d) states that 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. 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) 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. 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). 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. 38 C.F.R. § 17.32(c). The informed consent process must be appropriately documented in the health 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 (HIV). 38 C.F.R. § 17.32(d). It is the policy of VA to administer the law under a broad interpretation, consistent with the facts in each case with all reasonable doubt to be resolved in favor of the claimant; however, the reasonable doubt rule is not a means for reconciling actual conflict or a contradiction in the evidence. 38 C.F.R. § 3.102. When there is an approximate balance of positive and negative 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(b). When all of the evidence is assembled, VA is responsible for determining whether the evidence supports the claim or is in relative equipoise, with the veteran prevailing in either event, or whether a fair preponderance of the evidence is against the claim, in which case the claim is denied. Gilbert v. Derwinski, 1 Vet. App. 49, 55 (1990). In order for the Veteran to prevail in the instant claim, it must be shown that the Veteran incurred additional disability; that the December 12, 2003 VA bone marrow biopsy was the "proximate cause" of such disability; and that there was some element of fault on the part of VA in providing the procedure. The evidence of record clearly shows that the Veteran incurred additional disability as a result of the December 12, 2003 VA bone marrow biopsy. As noted in his treatment reports, and the VA examination in September 2004, the Veteran developed a hematoma, with resulting nerve neuropathy of the right lower extremity, as a result of his December 12, 2003 VA bone marrow biopsy. Thus, additional disability has been established. Further, it is reasonably established that this additional disability was a result of the December 12, 2003 bone marrow procedure performed by VA. As noted in the December 23, 2003 VA treatment report, "this unfortunate incident was procedure related." Moreover, the VA examiner in September 2004 clearly opined that the Veteran developed a hematoma as a result of this procedure, and that this hematoma, at least in part, caused his subsequent sciatic nerve neuropathy of the right lower extremity. Thus, the Board finds that it is reasonably established that the December 12, 2003 VA bone marrow biopsy caused the Veteran additional disability in the form of sciatic nerve neuropathy of the right lower extremity. The Board also finds that there was fault on the part of VA in conjunction with the bone marrow biopsy as the record does not show that VA obtained informed consent from the Veteran regarding this procedure. In making this determination, the Board looks to the Veteran's signed consent form relating to this procedure, which is dated December 12, 2003. As noted above, the informed consent process must be appropriately document in the health record. See 38 C.F.R. § 17.32(d). The Veteran's consent form listed the risks and possible complications from the VA December 12, 2003 bone marrow procedure as "[b]leeding and infection." While the form, in paragraph 10, contained a catchall provision indicating that all risks and benefits were discussed, one has to question the breadth of any additional discussion provided to the Veteran in light of the specifically noted risks recorded on the form. Moreover, the Veteran, and his representative, have argued that he was never informed of the possibility of developing sciatic neuropathy of the right lower extremity. Standing in contrast to the limited disclosure of risks involved by VA, is the VA examiner's opinion which indicates that the Veteran's hematoma and resulting nerve sciatica to the lower extremity were foreseeable consequences of this procedure, "since the Veteran was on Coumadin: a blood thinner, given for blood clot prevention." Under these circumstances, the Board concludes that the Veteran was not fully advised of reasonably foreseeable associated risks with this procedure or treatment, as well as its complications or side effects. In addition, the Veteran's consent form specifically indicates that no other options or alternatives were discussed, and it is unclear if any discussion with the Veteran was had as to the anticipated result if this procedure had not been done. See 38 C.F.R. § 17.32(c). Under these circumstances, the Board finds that the VA failed to substantially comply with pertinent informed consent procedures, and the VA's efforts do not amount to "substantial compliance." Given that the record reasonably shows that the Veteran incurred additional disability in the form of sciatic nerve neuropathy of the right lower extremity, and given that it is not shown that the Veteran's informed consent for the procedure was obtained beforehand, or that there was substantial compliance in obtaining the Veteran's informed consent, the preponderance of the evidence is in the Veteran's favor and compensation under 38 U.S.C.A. § 1151 for sciatic nerve neuropathy of the right lower extremity is warranted. ORDER Compensation under 38 U.S.C.A. § 1151 for sciatic nerve neuropathy of the right lower extremity is granted. ____________________________________________ MILO H. HAWLEY Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs