Citation Nr: 1337822 Decision Date: 11/19/13 Archive Date: 12/06/13 DOCKET NO. 09-12 544 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Louisville, Kentucky THE ISSUE Entitlement to compensation under 38 U.S.C.A. § 1151 for additional disability due to treatment by the Department of Veterans Affairs from September 2005 to January 2006. REPRESENTATION Appellant represented by: Disabled American Veterans WITNESSES AT HEARING ON APPEAL The Veteran and M. I. ATTORNEY FOR THE BOARD J. Castillo, Associate Counsel INTRODUCTION The Veteran, who is the appellant, served on active duty from July 1980 to July 1983. This matter is before the Board of Veterans' Appeals (Board) on appeal of an April 2008 rating decision issued by the Department of Veterans Affairs (VA) Regional Office (RO) in Huntington, West Virginia. In April 2010, the Veteran appeared at a hearing before the undersigned Veterans' Law Judge. A transcript of the hearing is in the Veteran's file. In January 2011, in accordance with 38 U.S.C.A. § 7109 and 38 C.F.R. § 20.901, the Board obtained a medical expert opinion from the Veterans Health Administration. The Veteran and his representative were provided a copy of the opinion and afforded the opportunity to submit additional evidence and argument. In May 2011, the Board remanded the case for further development, which has been completed. Stegall v. West, 11 Vet. App. 268, 271 (1998). The issue has been recharacterized to comport with the evidence of record. FINDING OF FACT After the Veteran underwent cardiac stenting at the Lexington VA Medical Center in September 2005, he suffered a myocardial infarction in January 2006, which was not due to carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA, and which was a reasonably foreseeable event of the cardiac stenting. CONCLUSION OF LAW The criteria for disability compensation under 38 U.S.C. § 1151 for additional disability due to treatment by the Department of Veterans Affairs from September 2005 to January 2006 have not been met. 38 U.S.C.A. §§ 1151, 5107(b) (West 2002); 38 C.F.R. § 3.361 (2013). The Veterans Claims Assistance Act of 2000 (VCAA) The VCAA, codified in part at 38 U.S.C.A. §§ 5103, 5103A, and implemented in part at 38 C.F.R § 3.159, amended VA's duties to notify and to assist a claimant in developing information and evidence necessary to substantiate a claim. Duty to Notify When VA receives a complete or substantially complete application for benefits, it will notify the claimant of the following: (1) any information and medical or lay evidence that is necessary to substantiate the claim, (2) what portion of the information and evidence VA will obtain, and (3) what portion of the information and evidence the claimant is to provide. Also, the VCAA notice requirements apply to all five elements of a service connection claim. The five elements are: 1) veteran status; 2) existence of a disability; 3) a connection between the Veteran's service and the disability; 4) degree of disability; and 5) effective date of the disability. Dingess v. Nicholson, 19 Vet. App. 473, 484-86 (2006). The VCAA notice, as required by 38 U.S.C.A. § 5103(a), must be provided to a claimant before the initial unfavorable adjudication by the RO. Pelegrini v. Principi, 18 Vet. App. 112, 119 (2004). The RO provided pre-adjudication VCAA notice by letter, dated in December 2007. The notice included the type of evidence needed to substantiate the claim under 38 U.S.C.A. § 1151, namely, evidence of additional disability, evidence of VA treatment, evidence of fault on the part of VA in providing the treatment, resulting in additional disability; or the additional disability was not a reasonably foreseeable event of VA treatment. As for the content and the timing of the VCAA notice, the documents complied with the specificity requirements of Quartuccio v. Principi, 16 Vet. App. 183, 186-87 (2002) (identifying evidence to substantiate a claim and the relative duties of VA and the claimant to obtain evidence); of Charles v. Principi, 16 Vet. App. 370, 374 (2002) (identifying the document that satisfies VCAA notice); of Pelegrini v. Principi, 18 Vet. App. 112, 119-120 (2004) (pre-adjudication VCAA notice); of Dingess v. Nicholson, 19 Vet. App. 473, 484-86 (2006) (notice of the elements of the claim). Duty to Assist Under 38 U.S.C.A. § 5103A, VA must make reasonable efforts to assist the claimant in obtaining evidence necessary to substantiate a claim. The RO has obtained service treatment records, VA records, and private medical records. In January 2011, in accordance with 38 U.S.C.A. § 7109 and 38 C.F.R. § 20.901, the Board obtained a medical expert opinion from the Veterans Health Administration (VHA). The opinion contains the Veteran's medical history, describes the disability in sufficient detail, and provides a rationale to support the conclusion reached in the opinion. The Board finds that the VHA opinion adequate. See Stefl v. Nicholson, 21 Vet. App. 120, 123 (2007) (a medical opinion must be based on consideration of the veteran's prior medical history and examinations and also describe the disability, if any, in sufficient detail so that the Board's evaluation of the claimed disability will be a fully informed one). As there is no indication of the existence of additional evidence to substantiate the claim, the Board concludes that no further assistance to the Veteran in developing the facts pertinent to the claim is required to comply with the duty to assist. REASONS AND BASES FOR FINDINGS AND CONCLUSION Legal Principles As the Veteran's claim under 38 U.S.C.A. § 1151 was received after October 1, 1997, the following statutory and regulatory provisions apply. When a veteran suffers additional disability as the result of surgical or medical treatment by VA, disability compensation shall be awarded for a qualifying additional disability of a veteran in the same manner as if such additional disability were service connected. A disability is a qualifying additional disability if the disability was caused by VA treatment, and the proximate cause of the disability was carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing the surgical or medical treatment; or the additional disability was not reasonably foreseeable. 38 U.S.C.A. § 1151 (a). A claim based on additional disability due to surgical treatment must meet the causation requirements. To establish causation, the evidence must show that VA's surgical treatment resulted in additional disability. Merely showing that a Veteran received treatment and that the Veteran has an additional disability does not establish cause. The proximate cause of disability is the action or event that directly caused the disability, as distinguished from a remote contributing cause. Evidence In September 2005, the Veteran began experiencing exertional chest pains, which had been mild for one month, but became severe while trying to load lumber. On September 20, 2005, he underwent a heart catheterization at Lexington VA Medical Center which revealed significant stenosis in the left anterior descending (LAD) artery and the diagonal branch artery. Drug-eluting stents were placed in each artery. VA records show no intraoperative complications. The Veteran was given medications and instructions on a cardiac diet, smoking cessation, and activity and lifting restrictions. Medical records in December 2005 show complaints of chest pain with substernal heaviness brought on by heavy exertion beginning in mid-November. The Veteran stated that he had been unable to quit smoking. In January 2006, the Veteran suffered a myocardial infarction and had instent restenosis that was treated by angioplasty. Medical records show that noncompliance with medications likely contributed to the myocardial infarction. Notes indicate that aggressive risk modification was needed, including smoking cessation. On follow-up evaluation in February 2006, the Veteran reported that he had stopped smoking and was compliant with medications; only mild chest pain was reported, which occurred with heavy exertion. Pre-operative authorization for an invasive procedure was signed and reviewed prior to surgery on September 20, 2009. The authorization shows that the plans, risks, and options had been discussed with the Veteran and he consented to the surgery. On the form, the Veteran and his VA surgeon provided their signatures, documenting that an informed consent discussion had taken place regarding the surgery to address the Veteran's heart problems. The Veteran indicated his understanding of the nature of the proposed procedure, the attendant risks, and expected results. He agreed that the following had been fully explained to him, namely, the nature and purpose of the operation; possible alternative methods of treatment available; and the attendant risks, including excessive bleeding, infection, damage to blood vessels/valves, arrhythmias, loss of limb, emergent surgery, kidney damage, cerebrovascular accident, myocardial infarction, and death. He acknowledged that no guarantees had been made to him concerning the results of the procedure. In November 2010, the Board requested a medical expert opinion from VHA regarding standard of VA care. The following are Board's questions and the medical expert's responses: a). Given the Veteran's clinical presentation in September 2005, did VA exercise the degree of care that would be expected of a reasonable health care provider in proceeding with the placement of cardiac stents? Response: The care provided by the VA was according to the guidelines for chest pain/myocardial infarction. [The Veteran] was quickly taken to the cath lab upon presentation and the stents were appropriately placed. The cardiologists who took care of him are nationally and internationally known for their excellence. b). Did VA exercise the degree of care that would be expected of a reasonable health care provider in the follow-up care from April 2006 to September 2006? Response: Appropriate medications and patient education were accomplished by the VA. The patient understood the significance and importance of ending his 60 pack year smoking history and of taking a statin for his hypercholesterolemia. c) Were the findings on the stress test in July 2006, which resulted in bypass surgery, reasonably foreseeable, that is, were the findings what a reasonable health-care provider would have considered to be the ordinary risk of the care undertaken to treat the Veteran's heart disease? Response: As an expert on stress testing, I can say that it was appropriate and its findings most helpful in deciding that bypass surgery was indicated. d) Did VA fail to timely diagnose and properly treat the Veteran's heart disease from September 2005 and up to the time of the bypass surgery in October 2006 that caused the continuance or natural progress of heart disease? Response: The records that I reviewed reflect excellent care provided by the VA and all steps were taken to slow or avoid the natural progression of disease. All efforts were made to motivate the patient to stop smoking and drinking and to take his medications. Testing and interventions were appropriate according to the guidelines. The care provided was similar in quality and technical skill as our facility. Analysis Informed Consent A claim under 38 U.S.C.A. § 1151 may be established by showing carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part in furnishing surgical treatment and the surgical treatment caused an additional disability and VA furnished the surgical treatment without the Veteran's informed consent. 38 C.F.R. § 3.361(d)(1)(ii). To determine whether there is informed consent, substantial compliance with the requirements of 38 C.F.R. § 17.32 is to be considered. Under 38 C.F.R. § 17.32, informed consent is the freely given consent that follows a careful explanation by the practitioner to the patient 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 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 must be given the opportunity to ask questions and to indicate comprehension of the information provided, and to grant permission freely without coercion. The practitioner must advise the patient if the proposed treatment is novel or unorthodox. The patient may withhold or revoke her consent at any time. The informed consent process must be appropriately documented in the health record. On the question of informed consent, the Veteran has questioned the adequacy of the informed consent prior to the September 20, 2005, surgery. He concedes that he had signed a consent form, but argues that he did not give consent to have bare metal stents, which is patently demonstrated to not be of record on the purported informed consent form." See Appellant's Post-Remand Brief, 2 (Oct. 2013). Surgical notes, however, dated September 20, 2005, show that drug-eluting stents, not bare metal stents, were deployed. Nonetheless, in signing the consent form, the Veteran indicated his understanding of the nature of the proposed procedure, the attendant risks, and expected results. He agreed that the following had been fully explained to him, namely, the nature and purpose of the operation; possible alternative methods of treatment available; and the attendant risks, namely damage to blood vessels/valves and myocardial infarction. He acknowledged that no guarantees had been made to him concerning the results of the procedure. Even if the VA physician failed to provide information to the Veteran about the potential adverse effects of the heart surgery, such would not defeat a finding of informed consent if a reasonable person faced with similar circumstances would have proceeded with the treatment. See McNair v. Shinseki, 25 Vet. Ap. 98 (2011); 38 C.F.R. § 3.361(d)(1)(ii) (2012). Based on the nature and severity of the Veteran's heart condition, the Board concludes that a reasonable person faced with similar circumstances would have proceeded with the surgery to reduce natural progression of the condition. On the basis of the evidence of record, the Board finds substantial compliance with the requirements of 38 C.F.R. § 17.32 as to the content of the consent form signed by the Veteran and the Board concludes that the Veteran's consent was informed consent. Additional Disability A claim under 38 U.S.C.A. § 1151 may also be established by showing carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part in furnishing surgical treatment and the surgical treatment caused an additional disability and VA failed to exercise the degree of care that would be expected of a reasonable health care provider. In September 2005, after obtaining informed consent, the VA performed heart surgery, which including heart catheterization and deployment of drug-eluting stents. On the question of whether the Veteran had any additional disability as a consequence of the surgery, the Veteran asserts that he suffered a major myocardial infarction in January 2006 as a result of the stents deployed during the September 2005 surgery, which is evidence of additional disability. Fault With evidence of additional disability due to surgery by VA, the next questions are whether the additional disability was due to carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part in furnishing surgical treatment and whether VA failed to exercise the degree of care that would be expected of a reasonable health care provider. On the question of fault, a VHA medical expert expressed the following opinion: The records that I reviewed reflect excellent care provided by the VA and all steps were taken to slow or avoid the natural progression of disease. All efforts were made to motivate the patient to stop smoking and drinking and to take his medications. Testing and interventions were appropriate according to the guidelines. The care provided was similar in quality and technical skill as our facility. As to the placement of the stents, the medical expert stated that "[t]he care provided by the VA was according to the guidelines for chest pain/myocardial infarction . . . . stents were appropriately placed." In the VHA advisory opinion dated in January 2011, the medical expert did not find negligence or error on the part of the VA surgeon. He, instead, found that the level of care was appropriate and properly delivered. The Board finds this medical opinion to be highly probative, which opposes, rather than supports, the claim. See Nieves-Rodriquez v. Peake, 22 Vet. App. 295 (2008) (the probative value of a medical opinion comes from when it is the factually accurate, fully articulated, and sound reasoning for the conclusion, not the mere fact that the claims file was reviewed). There is no medical opinion in the record to indicate that the VA surgeon failed to exercise that degree of care that would be expected of a reasonable health care provider during the September 2005 surgery. There is no evidence of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA. From this the Board concludes that the myocardial infarction in January 2006 was not the result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part and it is not shown that VA failed to exercise the degree of care that would be expected of a reasonable health care provider. An Event Not Reasonably Foreseeable Apart from fault and additional disability and informed consent, or fault and additional disability and the degree of care that would be expected of a reasonable health care provider, a claim under 38 U.S.C.A. § 1151 may also be established by showing that the additional disability was an event not reasonably foreseeable, which is 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 informed consent. 38 C.F.R. § 3.361(d)(2). As the pre-operative authorization for invasive procedure, which the Veteran and VA physician signed prior to the heart surgery on September 20, 2005, clearly stated that myocardial infarction was a risk involved in the surgery, myocardial infarction was reasonably foreseeable risk. The Veteran's Lay Statements and Opinions VA must give due consideration to all pertinent lay and medical evidence. 38 U.S.C.A. § 1154(a). In statements and testimony, the Veteran maintains that disability compensation is warranted under 38 U.S.C.A. § 1151 on the basis error in judgment on VA's part during a surgical procedure he underwent on September 20, 2005. The Veteran asserts that his heart condition was made worse by the decision to deploy stents in September 2005, alleging that if a bypass was performed, the January 2006 myocardial infarction could have been avoided. Specifically, he contends that VA improperly used a "bare metal stents" instead of drug-eluting stents; b) that the stents were defective; and c) that that in 2006, a VA cardiologist stated that the VA cardiologist who performed the September 2005 surgery should have conducted a bypass surgery instead of deploying stents. The Veteran as lay person is competent to offer an opinion on a simple medical condition. Davidson v. Shinseki, 581 F.3d 1313, 1316 (Fed. Cir. 2009). Competent lay evidence means any evidence not requiring that the proponent have specialized education, training, or experience. Lay evidence is competent if it is provided by a person who has knowledge of facts or circumstances and conveys matters that can be observed and described by a lay person. 38 C.F.R. § 3.159; Layno v. Brown, 6 Vet. App. 465, 469 (1994) (a witness must have personal knowledge in order to be competent to testify to a matter; personal knowledge is that which comes to the witness through the use of the senses). Competency is a legal concept in determining whether lay or medical evidence may be considered, in other words, whether the evidence is admissible as distinguished from weight and credibility, a factual determination going to the probative value of the evidence, that is, does the evidence tend to prove a fact, once the evidence has been admitted. Rucker v. Brown, 10 Vet. App. 67, 74 (1997). Competency is a question of fact, which is to be addressed by the Board. Jandreau, v. Nicholson, 492 F.3d 1372, 1377 (2007). To the extent the Veteran's statements are offered as a lay opinion on the question of additional disability by reason of fault on the part of VA in deciding to deploy stents instead of conducting a bypass in September 2005 or on the question of additional disability not reasonably foreseeable, resulting from the surgery, the Veteran as lay person is competent to offer an opinion on a simple medical condition. As a lay person, the Veteran's statements or opinions are limited to inferences that are rationally based on the Veteran's perception and do not require specialized education, training, or experience. While the Veteran is competent to describe his symptoms and the events surrounding the surgery, the question of fault on the part of VA or on the question of additional disability not reasonable foreseeable are not simple medical conditions that can be determined by the Veteran based on inferences gained by his own personal knowledge, that is, perceived through the use of his senses without specialized knowledge, education, or experience. And it is not argued or shown that the Veteran is otherwise qualified through specialized education, training, or experience to offer an opinion on the questions of fault on the part of VA or on an event not reasonably foreseeable. As to the contention that VA improperly used a "bare metal stents" instead of drug-eluting stents, VA medical records show that drug-eluting stents were used for the surgery in September 2005. The Veteran has submitted no evidence to suggest that the VA records are inaccurate. The Veteran has stated on several occasions that drug-eluting stents were used. And the Veteran's argument is without merit. As to the contention that the stents were defective, the Veteran is not competent to provide a medical opinion as to this effect. The question of whether a defect in the stents caused a myocardial infarction is a complex medical question. The Veteran has provided no medical evidence suggesting the stents were defective or that they resulted in a myocardial infarction in January 2006. And the Veteran's argument is without merit and is not favorable evidence in support of the claim. The Veteran also contends that in late 2006, a VA cardiologist stated that the VA cardiologists who performed the September 2005 surgery should have conducted a bypass surgery instead of deploying stents. The Veteran's sister corroborated the veracity of the statement. The connection between what a physician said and the layman's account of what he purportedly said, filtered as it was through a layman's sensibilities, is simply too attenuated and inherently unreliable to constitute 'medical' evidence." Robinette v. Brown, 8 Vet. App. 69, 77 (1995). While the Board considers this statement, it is not viewed as medical evidence and is afforded little probative value. In short, there is no competent, independent medical evidence to support the Veteran's assertions regarding questions of fault on the part of VA. As there is no favorable competent evidence to support the claim as articulated above, the preponderance of the evidence is against the claim for VA disability compensation under 38 U.S.C.A. § 1151 for additional disability as the result of VA treatment from September 2005 to January 2006, and the benefit-of-the-doubt standard of proof does not apply. 38 U.S.C.A. § 5107(b). (The Order follows on the next page.). ORDER VA disability compensation under 38 U.S.C.A. § 1151 for additional disability due to treatment by the Department of Veterans Affairs from September 2005 to January 2006 is denied. ____________________________________________ George E. Guido, Jr. Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs