Citation Nr: 1324772 Decision Date: 08/05/13 Archive Date: 08/13/13 DOCKET NO. 10-23 649 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Louisville, Kentucky THE ISSUE Entitlement to compensation under 38 U.S.C. § 1151 for additional disability as a result of a January 2001 VA surgery to remove a left thigh mass. REPRESENTATION Appellant represented by: Kentucky Department of Veterans Affairs WITNESSES AT HEARING ON APPEAL Appellant and spouse ATTORNEY FOR THE BOARD A. Fagan, Associate Counsel INTRODUCTION The Veteran served on active duty from June 1990 to July 1992. This matter came before the Board of Veterans' Appeals (Board) on appeal from an August 2009 decision by the Department of Veterans Affairs (VA) Regional Office (RO) in Louisville, Kentucky. In March 2011, the Veteran and his spouse testified in a Travel Board hearing before the undersigned Veterans Law Judge. A transcript of that hearing has been associated with the claims file. In July 2013, additional lay evidence and argument was received by the Board in support of the Veteran's claim. That evidence was accompanied by a waiver of RO consideration. FINDINGS OF FACT 1. The Veteran gave written informed consent in January 2001 for excisional biopsy of a left thigh mass and additional procedures found to be necessary in the judgment of the professional staff. 2. VA exercised the degree of skill and care that would be expected of a reasonable health care provider in the treatment and care provided to the Veteran. 3. The Veteran's additional disability, to include pain, weakness, and loss of muscle in the left lower extremity, did not result from carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA, or an event that was not reasonably foreseeable. CONCLUSION OF LAW The criteria for compensation under the provisions of 38 U.S.C.A. § 1151 for have not been met. 38 U.S.C.A. § 1151 (West 2002); 38 C.F.R. § 3.361 (2012). REASONS AND BASES FOR FINDINGS AND CONCLUSION Duties to Notify and Assist Under applicable criteria, VA has certain notice and assistance obligations to claimants. See 38 U.S.C.A. §§ 5102, 5103, 5103A, 5107; 38 C.F.R. §§ 3.102, 3.156(a), 3.159, 3.326(a). Upon receipt of a complete or substantially complete application for benefits, VA is required to notify the claimant and his or her representative of any information, and any medical or lay evidence, that is necessary to substantiate the claim. 38 U.S.C.A. § 5103(a); 38 C.F.R. § 3.159(b). Proper notice must inform the claimant of any information and evidence not of record (1) that is necessary to substantiate the claim; (2) that VA will seek to provide; and (3) that the claimant is expected to provide in accordance with 38 C.F.R. § 3.159(b)(1). Pelegrini v. Principi, 18 Vet. App. 112, 120-121 (2004). This notice should be provided prior to an initial unfavorable decision on a claim by the agency of original jurisdiction (AOJ). Mayfield v. Nicholson, 444 F.3d 1328 (Fed. Cir. 2006); Pelegrini v. Principi, 18 Vet. App. 112 (2004). VA's notice requirements were satisfied by a letter issued in May 2009, prior to the initial adjudication of the Veteran's claim, which advised the Veteran of the criteria for establishing entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 . The AOJ most recently readjudicated the claim in June 2010. Next, VA has a duty to assist the Veteran in the development of his claim. This duty includes assisting him in the procurement of pertinent medical records and providing an examination when necessary. 38 U.S.C.A. § 5103A; 38 C.F.R. § 3.159. In this case, the RO has obtained and associated with the claims file the Veteran's available records of his post-service VA and private treatment. The Veteran has not identified any relevant outstanding records pertinent to his claim. The Veteran was also afforded a VA examination in July 2009, and the Board obtained an additional VHA opinion in April 2013. The opinions are adequate as they considered the Veteran's medical history, were based on a review of the record, and were accompanied by rationale. The Veteran has been afforded a hearing before a VLJ at which he presented oral argument in support of his claim. In Bryant v. Shinseki, 23 Vet. App. 488 (2010), the United States Court of Appeals for Veterans Claims (Court) held that 38 C.F.R. § 3.103(c)(2) (2010) requires that the VLJ who chairs a hearing fulfill two duties to comply with the above the regulation. These duties consist of (1) the duty to fully explain the issues and (2) the duty to suggest the submission of evidence that may have been overlooked. Here, during the hearing, the Veteran's testimony reflected his full understanding of the issue and the criteria to be met for the award of benefits sought, and the VLJ clarified whether all available relevant records had been obtained. Accordingly, the Veteran is not shown to be prejudiced on the basis of the conduct of the hearing. For the foregoing reasons, the Board concludes that VA made all reasonable efforts to obtain evidence necessary to substantiate the Veteran's claim. Therefore, no further assistance to the Veteran with the development of evidence is required. Analysis Pursuant to 38 U.S.C. § 1151, a Veteran may be compensated for a "qualifying additional disability" that was not the result of the Veteran's willful misconduct and that is actually and proximately caused by VA hospital care, medical or surgical treatment, or examination furnished by VA. 38 U.S.C. § 1151(a); 38 C.F.R § 3.361. "To determine whether a Veteran has an additional disability, VA compares the Veteran's condition immediately before the beginning of the....medical or surgical treatment...upon which the claim is based to the Veteran's condition after such...treatment." 38 C.F.R § 3.361(b). A "qualifying additional disability" is actually caused by VA care, treatment, or examination when the VA care, treatment or examination "resulted" in the additional disability. 38 C.F.R § 3.361(c)(1). When an additional disability is caused by a Veteran's failure to properly follow medical instructions, such a disability will not be considered to have been caused by VA hospital care or medical treatment. 38 C.F.R § 3.361(c)(3). A "qualifying additional disability" is proximately caused by VA medical care, treatment, or examination when the disability results either from the carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing the medical treatment; or from "an event" that is "not reasonably foreseeable." 38 U.S.C. § 1151(a); 38 C.F.R § 3.361(d)(1). To establish that the proximate cause of a disability was the result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA, the claimant must show that either (1) VA failed to exercise the degree of care that would be expected of a reasonable health care provider; or (2) VA furnished the care, treatment, or examination without the Veteran's informed consent. 38 C.F.R § 3.361(d)(1). Alternatively, to establish that the proximate cause of a disability was an event that was not reasonably foreseeable, the evidence must demonstrate that a reasonable health care provider could not have foreseen the disability. The event does not have to be "completely unforeseeable or unimaginable," but it 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)(1). 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). The Veteran essentially contends that during surgery to remove a "small cyst" from his left thigh, muscle tissue was removed without his consent. He reports that prior to the surgery, he was advised that the mass was likely not malignant because it had not increased in size. However, post surgery, he was informed that the mass might be cancerous and as a result, muscle tissue was removed. He further asserts that "irregularities during the surgery contributed to the amount of muscle that was removed." In this regard, the Veteran has asserted that due to VA error, the surgery was longer than necessary, which resulted in the loss of additional muscle tissue. The Veteran's wife has also provided testimony that during the Veteran's procedure, a physician informed her that they were having trouble finding the area of the cyst and were going to have to take out more than they had originally thought. However, she reports that her consent was neither requested nor given. Most recently, the Veteran's mother has submitted a July 2013 written statement indicating that she accompanied her son to the surgery and was never informed of the possibility of any cancer. However, she was informed during the surgery that it was taking longer than expected and that a larger piece of muscle had to be cut out. Initially, the Board observes that the Veteran was diagnosed with and treated for muscle problems due to hypokalemic periodic paralysis prior to his January 2001 left thigh mass excision. By way of history, the Board notes that in June 1999, the Veteran underwent an MRI for myalgia affecting his left lower thigh to his knee. He was found to have a mass in the vastus medialis muscle at the mid-thigh level, and thereafter, was monitored for changes. Following a June 2000 MRI, which revealed no changes compared to prior examination, it was noted that the mass most likely represented a vascular formation, possibly a hemangioma. Per the Veteran's testimony, he then elected to undergo surgery to remove the mass. The record reflects that, in January 2001, the Veteran underwent elective surgery to remove a mass located in his left thigh. Prior to the procedure, the Veteran consented to an excisional biopsy of a left thigh mass with identified risks of "bleeding, infection, vascular, nerve injury." The consent form signed by the Veteran also indicates a request of "additional operations or procedures as are found to be necessary or desirable, in the judgment of the professional staff...during the course of the above-named operation or procedure." The January 2001 operative report indicates that initially, the left thigh mass shown on MRI was not palpable. However, with the use of intraoperative ultrasound, the mass was located and excised by electrocautery. The report indicates that several branches of the artery and veins supplying the muscle tissue were ligated for hemostasis and that, following excision of the mass, "the remaining muscle tissues that had discolored during the excision was excised." The operative report indicates that tissue from the left vastus medialis was sent to pathology for permanent section. It was further noted that the Veteran tolerated the procedure well, but was to be on 23-hour observation for pain management due to the extent of the dissection and excision. The Veteran was discharged, but readmitted for post-operative wound infection. He received intravenous antibiotic treatment for several days and was discharged in stable condition with antibiotics. The January 2001 VA surgical pathology report notes that the Veteran underwent excision of vastus medialis muscle of the left upper leg and reflects diagnoses of intramuscular lipoma and focal foreign body reaction, hemosiderin deposition and scar, consistent with reparative process. In July 2009, the Veteran underwent a VA examination. Following a review of the Veteran's record and physical examination, the examiner found that the Veteran had additional disability in the form of deficit in muscle and skin that was caused by the surgery to remove the lipoma from the left thigh, though he found little if any functional deficit based on physical examination results. The examiner opined that the Veteran's residual disabilities were less likely than not caused by carelessness on the part of the physician. In support of that conclusion, the examiner noted that there was discolored muscle around the lipoma which was felt to be abnormal and requiring excision by the surgeon. He continued that, even though the lipoma was smaller than the muscle excision, "the muscle around the lipoma had been affected and required removal." Finally, the examiner opined that the residual disabilities were as likely as not to have been reasonably foreseeable. However, in his supporting rationale, the examiner stated that the "extensive residual defect might not have been reasonably foreseeable since this was a small lipoma," but that it was known that some of the reactive tissue around the tumor would require resection. Because the July 2009 medical opinion was somewhat unclear, the Board requested a medical opinion from an expert with the Veterans Health Administration (VHA). In April 2013, a VHA general surgeon opined that the 2001 surgery performed on the Veteran was appropriate and standard of care. He noted that the mass was treated as if it was a sarcoma and the technique used was to prevent any spilling of cancer cells or recurrence of the tumor, which could lead to more serious consequences. He found no evidence of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA surgeon. The surgeon noted that discolored muscle noted on the operative report can be attributed to vascular supply, which is not always the same. He further noted that muscle that becomes discolored during surgery should be resected and not left behind because dead tissue within a wound can have severe consequences. Furthermore, he noted that muscle loss and weakness would be an obvious consequence of the surgery, though the amount of muscle requiring resection could not be exactly predicted. Finally, the examiner noted the consent to be valid and generic for mass removal. After careful review of the evidence of record, the Board finds that entitlement to compensation for additional disability, including pain, weakness, and loss of muscle in the left lower extremity, pursuant to 38 U.S.C.A. §1151, is not warranted. In reaching this decision, the Board finds that the competent and probative evidence fails to support the Veteran's contention that his additional disability is the result of negligent care, lack of proper skill or any error in judgment on the part of VA, or an event not reasonably foreseeable. The competent medical opinions of record contradict, rather than support, the Veteran's assertion that his additional disability is the result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA, or an event that was not reasonably foreseeable. Most persuasive is the April 2013 VHA opinion that the Veteran's treatment was standard of care, and that opinion is supported by the July 2009 VA examiner's conclusion that the 2001 VA surgeon was not careless. Moreover, both the July 2009 and April 2013 examiners opined that the Veteran's residual symptoms were reasonably foreseeable or even an "obvious consequence" of the surgery. While both examiners noted that the amount or extent of muscle requiring resection could not be foreseen or predicted, they both concurred that the loss of muscle tissue was a foreseeable consequence. In finding April 2013 specialist's medical opinion to be competent, highly persuasive, and thus is determinative in this matter, the Board notes that the specialist carefully reviewed the claims file and documented medical history of the Veteran. His opinion was supported with a well-reasoned rationale that referenced specific clinical findings. Furthermore, his opinion is wholly consistent with the October 2009 VA examiner's opinion, which was also based on a review of the claims file and a physical examination of the Veteran. Thus, those opinions are adequate, persuasive, and determinative in this matter. See Nieves-Rodriguez v. Peake, 22 Vet. App. 295, 304 (2008); see also Prejean v. West, 13 Vet. App. 444, 448-9 (2000) (Factors for assessing the probative value of a medical opinion include the thoroughness and detail of the opinion). Significantly, there are no contrary opinions of record. The Board also finds that the Veteran gave informed written consent prior to his January 2001 surgery. Of record is a signed January 2001 consent form in which the Veteran consented to excisional biopsy of "left thigh mass" and "such additional operations or procedures as are found to be necessary or desirable, in the judgment of the professional staff...during the course of the...operation or procedure." The VA treatment records identify the mass as being located in the Veteran's left vastus medialis muscle and show that initial evaluation revealed the mass to be "deep inside the muscle tissue very close to the bone." While the Veteran contends that he did not specifically consent to the removal of muscle tissue, he has not contended that he was unaware of the location of the mass (deep inside muscle tissue of left thigh) for which he consented to undergo excisional biopsy. Regarding potential risks, the signed consent form specifically lists "bleeding, infection, vascular, nerve injury." The April 2013 VHA opinion supports both that the removal of discolored muscle tissue in January 2001 was the result of vascular injury, notably an identified risk on the signed informed consent form. It further supports that removal of muscle tissue was necessary in the judgment of the VA surgeon during the course of the excisional biopsy of the left thigh, as both a consequence of the mass excision and because leaving dead tissue in a wound could lead to severe consequences. Furthermore, the April 2013 VHA specialist noted the consent form to be valid and generic for mass removal. Thus, the Board concludes that the Veteran gave informed consent. In addition, the Board finds that the opinions of the Veteran, his wife, and his mother, regarding the cause of additional disability is entitled to no probative weight because that issue is complex. See Woehlaert v. Nicholson, 21 Vet. App. 456, 462 (2007) (certain conditions are not capable of lay diagnosis); see also Kahana v. Shinseki, 24 Vet. App. 428 (2011) (when considering whether lay evidence is competent the Board must determine, on a case by case basis, whether the Veteran's particular disability is the type of disability for which lay evidence may be competent). In this case, because a determination of medical fault, carelessness, or negligence is not subject to lay observation and requires complex medical knowledge, the Board finds that the lay opinions as to the cause of the Veteran's additional disability are not competent for VA purposes. Finally, to the extent that the Veteran and his wife and mother have asserted that they were never informed of the possibility of cancer, inasmuch as it relates to the type of procedure performed in January 2001, the Board is not persuaded. In this regard, an August 1999 echogram of the left thigh noted that the possibility of malignancy was not excluded, and in January 2001, the record shows that, "regarding the possibility of cancer," the excisional biopsy was required to help diagnose the mass. Indeed, the purpose of a biopsy is to diagnose, and the Veteran consented to a biopsy, supporting that there was some question as to whether the mass was malignant. Regardless, the Board finds that there is no competent and credible medical evidence of record suggesting that VA failed to exercise standard of care or was otherwise negligent or careless in performing the excisional biopsy of the left thigh mass, or that the surgery was performed without the Veteran's informed consent. Based on the foregoing, the Board finds that entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 for additional disability is not warranted because the record is devoid of any competent evidence reflecting that additional disability was proximately caused either by the VA's carelessness, negligence, lack of proper skill, error in judgment, or an event not reasonably foreseeable. There also is no competent evidence that VA failed to exercise the degree of care that would be expected of a reasonable health care provider in the course of treatment for the Veteran's left thigh mass. As such, the Board concludes that a preponderance of the evidence is against awarding compensation under the provisions of 38 U.S.C.A. § 1151. In reaching this decision, the Board has considered the doctrine of reasonable doubt; however, as the preponderance of the evidence is against the Veteran's claim, it is not for application. ORDER Compensation under 38 U.S.C.A. § 1151 for additional disability including pain, weakness, and loss of muscle in the left lower extremity, is denied. ____________________________________________ MICHAEL E. KILCOYNE Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs