Citation Nr: 0813147 Decision Date: 04/21/08 Archive Date: 05/01/08 DOCKET NO. 03-26 103 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Jackson, Mississippi THE ISSUE Entitlement to compensable benefits under the provisions of 38 U.S.C. § 1151 for pulmonary thromboembolism secondary to knee surgery performed by VA in October 2002. REPRESENTATION Appellant represented by: Paralyzed Veterans of America, Inc. ATTORNEY FOR THE BOARD Kelli A. Kordich, Counsel INTRODUCTION The veteran served on active duty from October 1967 to November 1970. This matter comes before the Board of Veterans' Appeals (Board) on appeal from a May 2003 rating decision by the Department of Veterans Affairs (VA) Regional Office (RO) in Jackson, Mississippi, which denied the benefit sought on appeal. In April 2005 the Board remanded the appeal for further development. FINDINGS OF FACT 1. The veteran did not incur additional disability as the result of carelessness, negligence, lack of proper skill or error in judgment on the part of VA health care providers. 2. The veteran was properly informed by the surgical team performing the procedure of the nature of the proposed procedure, the expected benefits, reasonably foreseeable associated risks, complications or side effects; reasonable and available alternatives, and anticipated results if nothing was done. The veteran signed his consent to the procedure on a VA-authorized consent form, which was witnessed. There is no evidence that the veteran was not properly informed of the procedure or did not give informed consent. CONCLUSION OF LAW The requirements for compensation pursuant to 38 U.S.C.A. § 1151 for pulmonary thromboembolism secondary to knee surgery performed by VA in October 2002, have not been met. 38 U.S.C.A. §§ 1151, 5103, 5103A (West 2002 & Supp. 2007); 38 C.F.R. §§ 3.159, 3.358, 3.361 (2007). REASONS AND BASES FOR FINDINGS AND CONCLUSION Applicable law provides that compensation shall be awarded for a qualifying additional disability in the same manner as if such additional disability or death were service- connected. For purposes of this section, a disability is a qualifying additional disability if the disability or death was not the result of the veteran's willful misconduct and (1) the disability 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 was (A) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the Department in furnishing the hospital care, medical or surgical treatment, or examination, or (B) an event not reasonably foreseeable. 38 U.S.C.A. § 1151. Compensation is not payable for the necessary consequences of medical or surgical treatment properly administered with the expressed or implied consent of the veteran or the veteran's representative. "Necessary consequences" are those which are certain or intended to result from the VA hospitalization or medical or surgical treatment. Consequences otherwise certain or intended to result from treatment will not be considered uncertain or unintended solely because it had not been determined at the time consent was given whether that treatment would in fact be administered. 38 C.F.R. § 3.358 (c)(3). Effective September 2, 2004, the regulations pertaining to claims for compensation pursuant to 38 U.S.C.A. § 1151 filed on or after October 1, 1997 were amended. See 69 Fed. Reg. 46,426 (Aug. 3, 2004). Those regulations largely implemented the provisions of 38 U.S.C.A. § 1151. 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). Hospital care or medical or surgical treatment cannot cause the continuance or natural progress of a disease or injury for which the care or treatment 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). 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 or medical or surgical treatment 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 or medical or surgical treatment without the veteran'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). 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. 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; 38 C.F.R. § 3.361(d)(2). 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) (2007). Informed consent is discussed at 38 C.F.R. § 17.32. Paragraph (b), concerning VA policy, provides that, except as otherwise provided, all patient care furnished by VA 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. Paragraph (c) provides that 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. Paragraph (d) provides that the informed consent process must be appropriately documented in the medical record. The patient's or surrogate's signature on a VA-authorized consent form must be witnessed. The witness' signature only attests to the fact that he or she saw the patient or surrogate and the practitioner sign the form. The signed form must be filed in the patient's medical record. A properly executed OF 522 or other VA-authorized consent form is valid for a period of 30 calendar days. If, however, the treatment plan involves multiple treatments or procedures, it will not be necessary to repeat the informed consent discussion and documentation so long as the course of treatment proceeds as planned, even if treatment extends beyond the 30-day period. If there is a change in the patient's condition that might alter the diagnostic or therapeutic decision, the consent is automatically rescinded. 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. 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. 38 C.F.R. § 3.361(d)(2) (2007). VA Medical Center treatment records from Jackson, Mississippi showed that the veteran signed a consent form in September 2002 acknowledging that he was advised of and understood the potential complications which could result from the procedure. In discussing the consent given, the veteran's representative argues in January 2006 that if no transfusion was given, then there was no associated risk of blood clotting problems disclosed to the veteran. The January 2007 addendum to the July 2006 VA examination states that blood bank files were reviewed and show that the veteran had two units of blood typed and matched, but did not receive any blood transfusions. The Board acknowledges that the informed consent form signed by the veteran on September 20, 2002, specifically included blood clotting problems among the risks of blood/blood product transfusion. But the form also indicates that the risks of treatment had been explained. This does not necessarily exclude clots, as the representative argues. The form did not list the specific risks of treatment discussed with the patient. In October 2002, the veteran underwent surgery for a left knee flexion contracture, status post total knee replacement with heterotopic ossification. The knee surgery itself was completed with complication. Treatment records note postoperatively that the veteran had a complication of a pulmonary embolus for which he was admitted to the hospital and treated with IV heparin. At the time of discharge he was placed on therapeutic Coumadin and managed by General Medicine for his medications. In September 2003 a VA physician rendered an opinion in response to an RO request. The physician was asked whether the veteran's pulmonary embolus subsequent to the knee surgery in October 2002 was the result of negligence, lack of proper care or an unforeseen event. The physician noted that the claims file was reviewed and indicated that the veteran did indeed have a pulmonary embolus subsequent to his surgery. The physician indicated that this unfortunately was a complication of knee surgery and was not reflective of negligence, lack of proper care, error or an unforeseen event. At a July 2006 VA examination, the examiner noted that the veteran underwent an orthopedic procedure on his right knee in October 2002. Approximately one week postoperatively the veteran experienced onset of shortness of breath and stated that he had mild hemoptysis. He also experienced a pleuritic type chest pain in the anterior chest area and was re- evaluated at the VA hospital. The veteran was found to have a pulmonary embolus and was treated with anticoagulant therapy. He remained on anticoagulants for approximately six months, according to the veteran. The veteran reported that since the pulmonary embolus, he had experienced some difficulty with shortness of breath. He stated he could walk approximately a half city block on his own pace prior to developing shortness of breath. The veteran stated he occasionally wheezes. He had an intermittent cough characterized by production of whitish sputa. He reported coughing up approximately one cup of sputa twice weekly. Some days this sputum is very minimal. It was noted that the veteran smoked approximately three to seven cigarettes per week. He had been smoking since age 38, but stated that he had only averaged three to seven cigarettes a week during this entire time. The examiner noted that the veteran took no regular medication for his breathing difficulty. There was no history of asthma, pneumonia, or tuberculosis. The veteran had a prior history of hypertension, but there was no history of heart disease. The veteran did not experience any significant swelling about the ankles, and there was no history of orthopnea or paroxysmal nocturnal dyspnea. The examination showed the veteran's chest to be symmetrical with good expansion on inspiration. The lungs were clear to percussion and auscultation. The precordium was normal in appearance. The PMI was non-palpable. No heaves, thrills, or shocks were noted. No murmurs, gallops, clicks, or rubs were audible. There was no jugular venous distension at 30 degrees. There was no peripheral edema. Forced expiratory volume in one second (FEV1) was noted as 87 percent. The examiner noted that the veteran was retired and had not worked since the late 1990s. He was able to engage in activities of daily living. The veteran was not on anticoagulant therapy. The examiner noted the claims file was reviewed. The blood bank reports showed that two units of red blood cells were requested during the October 2002 admission. The echocardiogram was normal without evidence of pulmonary hypertension. In the January 2007 addendum to the July 2006 VA examination the examiner indicated that he was unable to identify any residual problems related to the veteran's pulmonary embolism. Minor changes in pulmonary function studies as well as chest x-ray were noted, but both of these abnormalities were felt related to the veteran's smoking history. No evidence of pulmonary hypertension resultant from pulmonary embolism was found by the examiner. The examiner noted that the veteran was treated appropriately with anticoagulant therapy with resolution of the pulmonary embolus without sequelae. Upon careful consideration of the evidence of record, it is apparent that the preponderance of the evidence is against the veteran's claim for benefits under the provisions of 38 U.S.C.A. § 1151 and 38 C.F.R. § 3.361. The appellant has submitted no competent evidence which tends to substantiate his contentions that he suffered additional disability due to carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part in furnishing the medical or surgical treatment, or that the proximate cause of any additional disability was the surgery performed in October 2002 or any follow-up care provided. Furthermore, there is no competent evidence that the result was not reasonably foreseeable. The veteran knew the risk and accepted the risk. While unfortunate, it does not rise to the level of actionable negligence. In addition, the VA physicians in September 2003 and January 2007 opined that unfortunately pulmonary embolus was a complication of knee surgery and was not reflective of negligence, lack of proper care, error or an unforeseen event; and there were no residual problems related to the veteran's pulmonary embolism. The January 2007 physician noted that the veteran was treated appropriately with anticoagulant therapy with resolution of the pulmonary embolus without sequelae. For the veteran to now say that he did not consent to the procedure and its associated risks, he must bear the burden of proving that he was actually misinformed or misled by the VA health care providers. After reviewing the evidence the Board finds that the veteran failed to meet that burden. Hence, his consent to the surgery is persuasive and is conclusive in law, and the Board may rely upon it to conclude that the appellant knowingly consented to the procedure notwithstanding the risks involved. It bears recalling that in Brown v. Gardner, 115 S. Ct. 552 (1994), a seminal case in adjudicating claims under 38 U.S.C.A. § 1151, the United States Supreme Court specifically stated that it did not intend to exclude application of the doctrine volenti non fit injuria. That is, if one, knowing and comprehending the danger, voluntarily exposes himself to it, though not negligent in so doing, he is deemed to have assumed the risk and precluded from a recovery for a resulting injury. Id. at 556. In the absence of competent evidence which demonstrates additional disability as a result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part in furnishing the medical or surgical treatment, the Board concludes that compensation under 38 U.S.C.A. § 1151 for additional disability following surgery in October 2002 is not warranted. Accordingly, the claim is denied. In reaching this decision the Board considered the doctrine of reasonable doubt, however, as the preponderance of the evidence is against the appellant's claim, the doctrine is not for application. Gilbert v. Derwinski, 1 Vet. App. 49 (1990). Duties to notify and assist VA's duties to notify and assist claimants in substantiating a claim for VA benefits are found at 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, 3.326(a) (2007). Upon receipt of a complete or substantially complete application for benefits, VA is required to notify the claimant and his or her representative, if any, of any information, and any medical evidence or lay evidence that is necessary to substantiate the claim. 38 U.S.C.A. § 5103(a); 38 C.F.R. § 3.159(b); Quartuccio v. Principi, 16 Vet. App. 183 (2002). In accordance with 38 C.F.R. § 3.159(b)(1), 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. Proper notice must also ask the claimant to provide any evidence in his or her possession that pertains to the claim. Notice should be provided to a claimant before the initial unfavorable decision on a claim. Pelegrini v. Principi, 18 Vet. App. 112 (2004). In this case, there is no issue as to providing an appropriate application form or completeness of the application. Written notice provided in April 2005 correspondence fulfills the provisions of 38 U.S.C.A. § 5103(a). The Board acknowledges that under 38 U.S.C.A. § 5103(a) notice must be provided to a claimant before the initial unfavorable agency of original jurisdiction (AOJ) decision on a claim for VA benefits. In this case, the notice provided in February 2003, shortly after the claim was filed in January 2003, discussed the elements of a claim for service connection, rather than a claim for benefits pursuant to section 1151, although it did otherwise informed the veteran correctly of the actions that VA would take and the actions that the claimant should take. Correct notice was given in the April 2005 letter, and the veteran has since had an opportunity to provide information, evidence, and argument to support his claim. The veteran has been afforded a meaningful opportunity to participate in the adjudication of his claim, to include the opportunity to present pertinent evidence. Thus any error in the timing was harmless; the appellant was not prejudiced. Simply put, there is no evidence any VA error in notifying the appellant that reasonably affects the fairness of this adjudication. ATD Corp. v. Lydall, Inc., 159 F.3d 534, 549 (Fed. Cir. 1998). The Board acknowledges that the veteran was not provided the specific notice required by Dingess v. Nicholson, 19 Vet. App. 473 (2006) (as the degree of disability and effective date of the disability are part of a claim for service connection, VA has a duty to notify claimants of the evidence needed to prove those parts of the claim). The failure to provide the specific notice required by Dingess is harmless in this instance because the veteran's claim for benefits under the provisions of 38 U.S.C. § 1151 is denied. Any questions as to the disability rating or the effective date to be assigned are moot. In addition, VA has fulfilled its duty to assist the claimant in obtaining identified and available evidence needed to substantiate a claim. The veteran's VA medical records and VA examinations have been associated with the claims folder. In sum, there is no evidence of any VA error in notifying or assisting the appellant that reasonably affects the fairness of this adjudication. ORDER Entitlement to compensation under 38 U.S.C.A. § 1151 for additional disability as a result of October 2002 VA medical care is denied. ____________________________________________ MARY GALLAGHER Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs