Citation Nr: 1508068 Decision Date: 02/24/15 Archive Date: 02/26/15 DOCKET NO. 07-34 823 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Waco, Texas THE ISSUES 1. Entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 for diabetes mellitus, type II. 2. Entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 for hypertension. REPRESENTATION Appellant represented by: American Red Cross ATTORNEY FOR THE BOARD C. Boyd, Associate Counsel INTRODUCTION The Veteran served on active duty from September 1975 to July 1977. This case comes before the Board of Veterans' Appeals (Board) on appeal from a June 2007 rating decision issued by the Department of Veterans Affairs (VA) Regional Office (RO) in Waco, Texas. The appellant had requested a hearing before the Board; however, in October 2009, the appellant withdrew that request in writing and the request is deemed withdrawn. In May 2010, the Board remanded the claims to provide the Veteran proper notice of what information and evidence must be submitted to substantiate a claim for compensation under 38 U.S.C.A. § 1151. In addition, the Board sought treatment records and a medical opinion. The RO sent a notice letter to the Veteran in September 2010; additional medical records were obtained and medical opinions were provided in October 2010, May 2011, June 2011 and February 2014. In September 2014, the Board sought an expert medical opinion from a specialist in endocrinology which was provided in November 2014. The Board finds that the RO satisfied the remand directives and that remanding the claim again is not necessary pursuant to the holding in Stegall v. West, 11 Vet. App. 268 (1998). FINDINGS OF FACT 1. It is at least as likely as not that Zyprexa (under the generic name Olanzapine) that was prescribed by VA to treat the Veteran's schizophrenia contributed to the development of an additional disability, specifically diabetes mellitus type II (hereinafter diabetes). 2. The proximate cause of diabetes was not due to any fault on the part of VA in providing care or treatment for the Veteran's schizophrenia and the incurrence of diabetes as a result of taking Olanzapine was a reasonably foreseeable event. 3. The evidence demonstrates that Olanzapine has been the best medication to control the Veteran's psychiatric symptoms since 1998; although VA did not provide literature pertaining to Olanzapine at the time the medication was prescribed, a failure to provide information about a potential adverse side effect does not defeat a finding of informed consent if a reasonable person faced with similar circumstances would have proceeded with the treatment. 4. Written informed consent was not required for the prescription of Olanzapine. 5. The Veteran did not incur an additional disability of hypertension as a result of VA treatment, to include the prescription of Olanzapine. CONCLUSIONS OF LAW 1. The criteria are not met under the provisions of 38 U.S.C.A. § 1151 for diabetes mellitus, type II. 38 U.S.C.A. § 1151 (West 2002); 38 C.F.R. §§ 3.102, 3.159, 3.361, 17.32 (2014). 2. The criteria are not met under the provisions of 38 U.S.C.A. § 1151 for hypertension. 38 U.S.C.A. § 1151 (West 2002); 38 C.F.R. §§ 3.102, 3.159, 3.361, 17.32 (2014). REASONS AND BASES FOR FINDINGS AND CONCLUSIONS I. VA's Duty to Notify and Assist 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); 38 C.F.R. §§ 3.102, 3.156(a), 3.159 and 3.326(a) (2014). Proper notice from VA must inform the claimant and his representative, prior to the initial unfavorable decision on a claim by the agency of original jurisdiction (AOJ) of any information and any medical or lay 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. 38 U.S.C.A. § 5103(a); 38 C.F.R. § 3.159(b); Mayfield v. Nicholson, 444 F.3d 1328 (Fed. Cir. 2006); Pelegrini v. Principi, 18 Vet. App. 112 (2004); Quartuccio v. Principi, 16 Vet. App. 183 (2002). VA's duty to notify under 38 C.F.R. § 3.159(b)(1) was met by letters from the RO dated in January 2004, March 2007 and September 2010. Initially, the RO interpreted the Veteran's correspondence as claims for service connection which were denied in March 2005. Thereafter, the Veteran sought to reopen the claims. The RO denied the petition in May 2007; he appealed. In a May 2010 decision, the Board reopened the claims and remanded them for further development regarding the Veteran's entitlement to compensation pursuant to 38 U.S.C.A. § 1151. In September 2010, as directed by the Board, the RO sent the Veteran a letter providing notice of what information and evidence must be submitted to substantiate his claims. The Board finds that the RO satisfied the duty to notify the Veteran and that he is aware of the criteria necessary to establish entitlement to compensation under 38 U.S.C.A. § 1151. The duty to assist was also met in this case. All pertinent VA and private treatment records have been obtained and associated with the file and the Veteran has not alleged that there are outstanding records. In addition, five medical opinions have been obtained in the course of developing these claims. Initially an opinion was provided in October 2010 following review of the claims file. Addendum opinions were rendered in May 2011, June 2011 and February 2014. All these opinions were provided by doctors who had reviewed the claims file and specifically addressed the criteria necessary to establish entitlement to compensation. In September 2014, the Board sought a medical expert opinion from an endocrinology specialist pursuant to VHA Directive 1602-01 (February 4, 2013). In November 2014, a physician specializing in endocrinology reviewed the claims file and provided responses to the Board's questions. Upon review of the opinion, the Board finds it to be adequate and that obtaining another medical opinion is not necessary to decide the claims. See Barr v. Nicholson, 21 Vet. App. 303, 311 (2007) (affirming that a medical opinion is adequate if it provides sufficient detail so that the Board can perform a fully informed evaluation of the claim). The Board recognizes the Veteran's November 2014 statement in support of claim alleging that the opinion is inadequate and was not based on sound medical judgment. As discussed further below, the Board disagrees with this argument. Overall, the Board finds that when considering the five opinions of record along with the entirety of the claims file, to include private and VA medical records along with the Veteran's numerous statements in support of claim, all evidence necessary to determine whether the criteria for entitlement to compensation have been met is currently present in the claims file and seeking an additional opinion in this case would be redundant and unnecessary. See Sabonis v. Brown, 6 Vet. App. 426, 430 (1994) (remands which would only result in unnecessary delay with no benefit flowing to the veteran are to be avoided). Notably, the record contains many statements in support of claim and numerous pages of lay testimony. The Board has thoroughly reviewed all the evidence in the Veteran's claims file. Although the Board has an obligation to provide reasons and bases supporting this decision, there is no need to discuss, in detail, all the evidence submitted by the Veteran or on his behalf. See Gonzales v. West, 218 F.3d 1378, 1380-81(Fed. Cir. 2000) (the Board must review the entire record, but does not have to discuss each piece of evidence). The analysis below focuses on the most salient and relevant evidence and on what this evidence shows, or fails to show, in regard to the claims. The Veteran must not assume that the Board has overlooked pieces of evidence that are not explicitly discussed herein. See Timberlake v. Gober, 14 Vet. App. 122 (2000) (the law requires only that the Board address its reasons for rejecting evidence favorable to the Veteran). The Veteran was provided the opportunity to meaningfully participate in the development of his claims and he has actively participated throughout the process. Washington v. Nicholson, 21 Vet. App. 191 (2007). The Board concludes that no further assistance to the Veteran with the development of the evidence is required. II. Entitlement to Compensation The Veteran contends that disability compensation is warranted under 38 U.S.C.A. § 1151 because he developed diabetes and subsequently hypertension as a direct result of taking the prescription drug Olanzapine which was prescribed by VA to treat schizophrenia. In addition, he argues that because he was not told of the risk of hyperglycemia at the time Olanzapine was prescribed that VA was at fault for prescribing the medication without his informed consent. The Veteran has been taking Olanzapine since 1998 when he was admitted to a VA hospital with severe psychiatric symptoms. He has taken Olanzapine since that time and it has proven helpful in alleviating his symptoms. In April 2003, the Veteran was diagnosed with diabetes; thereafter, he was diagnosed with hypertension in September 2003. For purposes of VA compensation under 38 U.S.C.A. § 1151, the Veteran must establish that he sustained additional disability caused by hospital care, medical or surgical treatment, or examination furnished by VA, 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 part of VA in furnishing the hospital care, medical or surgical treatment, or examination; or that the proximate cause of the disability was an event not reasonably foreseeable. The Board will address each of these factors in turn as it applies to the specific facts in this case. First, the Veteran must establish that taking Olanzapine, as prescribed by VA, directly caused diabetes and/or hypertension. To establish causation, the evidence must show that care provided by VA, i.e. the prescribing of Olanzapine, actually resulted in the Veteran's additional disability, here diabetes and/or hypertension. Merely showing that the Veteran received care and that he has an additional disability does not establish cause. The proximate cause of disability is defined for these purposes as the action or event that directly caused the disability, as distinguished from a contributing cause. 38 C.F.R. § 3.361(d). The Veteran has submitted evidence showing that Olanzapine is associated with, and increases the risk of, diabetes. Specifically, he has submitted evidence showing that, in August 2006, a settlement was reached with Eli Lilly, the drug manufacturer, after claimants, to include the Veteran, alleged that the drug label did not adequately warn about the possible side effects, namely the risk of high blood sugar and diabetes. Notably, there is no such evidence related to hypertension. In this specific case, none of the medical professionals who provided an opinion as to the relationship between Olanzapine and the Veteran's diagnosis of diabetes could say it was at least as likely as not that Olanzapine directly caused the Veteran to become diabetic. The VA examiner in October 2010 acknowledged that Olanzapine is well-known for exacerbating hyperglycemia; however, he found through a review of the available medical literature that Olanzapine was not shown to cause diabetes with 100 percent certainty. In June 2011, the examiner reiterated that a review of medical literature showed that Olanzapine had not been found to cause diabetes "even though there is an association and it [is] known to exacerbate elevated blood sugar . . ." The examiner in February 2014 indicated he could not determine whether Olanzapine caused the Veteran's diabetes without resorting to speculation and that the Veteran could have developed diabetes without ever having taken Olanzapine. He noted that as far as he knew all atypical antipsychotics, such as Olanzapine, had been associated with diabetes. In September 2014, the Board sought further detail through a medical expert opinion from an endocrinologist. In November 2014, the specialist stated that it "is possibly as likely as not" that Olanzapine was the proximate cause of the Veteran's diabetes. The endocrinologist indicated that an association between second generation antipsychotics, such as Olanzapine, and diabetes has been reported since the medications became available in 1996. The specialist indicated there are a wide variety of studies with Olanzapine and other antipsychotics that have not yet definitively established the reason for the increased risk, although an associated weight gain is considered important. In reference to the cause of the Veteran's diabetes, she indicated that at the time he was diagnosed in 2003, he already had a high risk based on his age, being African American, and having a high body mass index. She stated it was not possible "to assign cause to the medication olanzapine" because the Veteran may or may not have developed diabetes at that specific time without having been treated with the drug. The specialist stated that current medical knowledge would not allow for "assigning causality of 50 percent probability or greater to the olanzapine." However, she was willing to say that it is at least as likely as not that Olanzapine contributed to the development of diabetes in the Veteran. Notably, the term "at least as likely as not" does not mean within the realm of medical possibility, but rather that the medical evidence both for and against a conclusion is so evenly divided that it is as medically sound to find in favor of a certain conclusion as it is to find against it. It is within the "realm of medical possibility" that Olanzapine was the direct cause of the Veteran's diabetes; however, none of the examiners who provided an opinion in this case could conclude that it was "at least as likely as not" that Olanzapine was the direct cause. It appears clear that at this time, even were the Board to seek yet another medical opinion, it would not be possible for a medical professional to opine with even 50 percent confidence that Olanzapine caused the Veteran's diabetes. The evidence, however, does show a high likelihood that Olanzapine contributed to the development of diabetes in the Veteran. See January 2004 Treatment Record (noting the Veteran had become hyperglycemic "after gaining weight on Olanzapine"). Thus, the Board finds it appropriate to continue the analysis if only to demonstrate that even if it could be said that Olanzapine definitely caused the Veteran to become diabetic that there was no fault on the part of VA or an event not reasonably foreseeable that would establish entitlement to compensation under 38 U.S.C.A. § 1151. As for hypertension, each examiner indicated there was no known association between Olanzapine and hypertension and no indication that Olanzapine causes hypertension. Because the Veteran has not established that hypertension was an additional disability caused by VA treatment, specifically prescribing Olanzapine, his claim for compensation must be denied and no further analysis of the criteria for entitlement to compensation under Section 1151 is necessary. Assuming it could be said that it was, in fact, at least as likely as not that the prescription of Olanzapine was the cause of the Veteran's diabetes, the Veteran would also have to establish that diabetes was proximately caused by carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part by demonstrating that either (i) VA failed to exercise the degree of care that would be expected of a reasonable health care provider when prescribing Olanzapine; or (ii) VA furnished the treatment without adequate 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. See 38 C.F.R. § 3.361(d)(1). Minor deviations from those requirements that are immaterial under the circumstances of a case will not defeat a finding of informed consent. Id. Here, the lay and medical evidence of record supports the conclusion that Olanzapine helped alleviate the Veteran's psychiatric symptoms better than any other medication. The Veteran has consistently stated his belief that Olanzapine has improved his psychiatric condition. See, e.g., January 2003 Progress Note (noting the Veteran reported again that Olanzapine had been the "only beneficial medication he has tried"); October 2011 Progress Note (stating the Veteran attributed improvement in his condition and his ability to stay sober to initiation of Olanzapine); January 2012 Progress Note (indicating "significant improvement in quality of life since starting on olanzapine in 199[8] and benefit has been maintained"). The Board finds that the Veteran has not successfully shown that VA failed to exercise the degree of care expected of a reasonable health care provider when choosing to prescribe Olanzapine for his schizophrenia. Indeed, none of the medical opinions rendered in this case supports a finding that a reasonable health care provider would not have provided care in the manner administered by VA when prescribing Olanzapine to treat the Veteran's psychiatric disability. In fact, the evidence clearly shows the decision to prescribe Olanzapine was, in fact, an excellent treatment choice. The next question, therefore, is whether VA improperly provided treatment without adequate informed consent. Informed consent is defined as "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." 38 C.F.R. § 17.32(c). This information should include the expected benefits, the reasonably foreseeable associated risks, the complications or side effects, the reasonable and available alternatives and the anticipated results if nothing is done. Id. Informed consent is required for diagnostic or therapeutic procedures in the following cases: where the use of sedation is required; where the use of anesthesia or a narcotic is required; where the procedure may produce significant discomfort for the patient; where there is a significant risk of complication or morbidity; or where an injection of a substance into a joint space or body cavity is required. See 28 CFR 17.32(d). In general, low risk procedures, such as the administration of most drugs, routine x-ray procedures, etc., only require oral informed consent. VHA Handbook 1004.01 (Aug. 14, 2009). The necessity of explicit informed consent for the prescription of medication does not appear as a requirement in VA regulations. The Board has reviewed the records surrounding the initial prescription of Olanzapine. Treatment records show the Veteran's wife brought him to the hospital in March 1998 because he was having visual and auditory hallucinations. He was prescribed Olanzapine and it was noted within a few days he became "very cooperative, pleasant, polite, and was acting acceptably." See March 4, 1998 Treatment Note. He was discharged on March 6, 1998. Along with the records of the Veteran's admission were information pages regarding his medications. The handouts were to be for Fluphenazine, Benztropine, Diazepam and Olanzapine. However, literature regarding Olanzapine was not provided. Instead, information for Olasaline, which is prescribed for the maintenance of remission of ulcerative colitis, was included in the medication papers. This was clearly an error on VA's part; however, as explained below, the Board finds that such mistake does not automatically entitle the Veteran to compensation for diabetes pursuant to 38 C.F.R. § 1151. It is likely the Veteran was, in fact, not aware of the risk of hyperglycemia or elevated blood sugar when he began taking Olanzapine. The United Staes Court of Appeals for Veterans Claims (Court) dealt with the issue of failure to provide information regarding a potential adverse effect of treatment in McNair v. Shinseki, 25 Vet. App. 98 (2011). In that case, a veteran filed for Section 1151 benefits based on continual nerve pain experienced after surgery. Prior to surgery she had signed an authorization form; however, the form was general and did not state that the specific risks were discussed prior to surgery. The veteran argued that the specific risk of nerve pain was not disclosed to her and that therefore she had not given informed consent. The Court addressed whether the presumption of regularity should apply in Section 1151 cases with respect to the informed consent requirement. The presumption of regularity generally provides that public officers perform their duties correctly, fairly, in good faith, and in accordance with law and governing regulations. The Court concluded that "the diversity of patients, procedures, and circumstances . . . counsels against recognizing a presumption that a doctor has fully informed a particular patient about a particular consequence of a particular medical procedure simply because a generic consent form has been filled out properly." Id. at 105-07. However, the Court further held that "a failure to provide information to a patient about a potential adverse effect does not defeat a finding of informed consent if a reasonable person faced with similar circumstances would have proceeded with the treatment." Id. Here, the record clearly demonstrates that Olanzapine worked to alleviate the Veteran's psychiatric symptoms, and it is reasonable to conclude that someone faced with the same need to alleviate symptoms would have proceeded with treatment because that treatment undeniably worked better than any other. The Board finds that even though VA gave the Veteran an information sheet for the incorrect medication, such action does not automatically lead to the conclusion that that the Veteran took the medication without having been given adequate informed consent. See Halcomb v. Shinseki, 23 Vet. App. 234, 241 (2009) (finding that given that "the Secretary's regulations and handbook do not require a detailed recitation of all of the information conveyed in securing informed consent, it cannot be presumed that the appellant's complications were not discussed simply because they were not recorded.") Indeed, the medical practitioners who provided opinions in this case all indicated that there is not a standard of care to require informed consent for most prescription drugs, to include Olanzapine. See February 2014 Medical Opinion (concluding that it is not normal practice to get informed consent, in terms of a signed document, for medications that are routinely prescribed for specific illnesses); November 2014 Specialist Statement (stating that there is "not a standard of care or a requirement for informed consent for most prescription drugs even when there is a known causal effect which is not the case for olanzapine"). The Board concludes that the mistake made by VA in giving the Veteran the wrong piece of paper at the time he was prescribed Olanzapine was a minor deviation from the requirement that a patient should be informed prior to being administered treatment. As explained, there is not a generalized expectation that proof of informed consent be shown when prescribing medications. Based on the foregoing, the Board concludes that a finding of informed consent has not been defeated in this case. Finally, the Veteran could demonstrate entitlement to compensation by showing that getting diabetes was an event not reasonably foreseeable by a reasonable health care provider when prescribing Olanzapine. In determining whether an event was reasonably foreseeable, VA considers 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. See 38 C.F.R. § 3.361(d)(2). The fact that Olanzapine can exacerbate blood sugars and increases the risk of diabetes is one which is disclosed by pharmacy information, and therefore, such events could not be beyond that which is reasonably foreseeable. The Board understands the ongoing frustration the Veteran feels and his steadfast belief that Olanzapine directly caused his disabilities and that, therefore, because VA prescribed the medication, he is entitled to compensation. However, the record does not contain conclusive evidence of causation and even if it did, there is no evidence of fault on the part of VA in prescribing Olanzapine to treat schizophrenia. In addition, the evidence does not support a finding that adequate informed consent pursuant to VA regulations was not obtained or that the development of diabetes was an event not reasonably foreseeable following the prescription of Olanzapine. Because the preponderance of the evidence is against the claims, the benefit-of-the-doubt doctrine does not apply, and the claims for compensation under 38 C.F.R. § 1151 must be denied. 38 U.S.C.A. § 5107(b); Gilbert v. Derwinski, 1 Vet. App. 49 (1990); Ortiz v. Principi, 274 F. 3d 1361 (Fed. Cir. 2001). ORDER Entitlement to compensation benefits under the provisions of 38 U.S.C.A. § 1151 for diabetes mellitus is denied. Entitlement to compensation benefits under the provisions of 38 U.S.C.A. § 1151 for hypertension is denied. ____________________________________________ KATHLEEN K. GALLAGHER Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs