Citation Nr: 1541165 Decision Date: 09/24/15 Archive Date: 10/02/15 DOCKET NO. 10-04 602 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in St. Louis, Missouri THE ISSUE Entitlement to compensation pursuant to 38 U.S.C.A. § 1151 for diabetes mellitus due to VA medical treatment, including by prescribing the drug Zyprexa (Olanzapine). REPRESENTATION Appellant represented by: The American Legion WITNESSES AT HEARING ON APPEAL The Veteran, his girlfriend (G.C.), and his son ATTORNEY FOR THE BOARD P. Wirth, Associate Counsel INTRODUCTION The Veteran served on active duty from February to October 1969. This appeal to the Board of Veterans' Appeals (Board) is from a March 2009 rating decision of the Department of Veterans Affairs (VA) Regional Office (RO) in Chicago, Illinois. Jurisdiction over this claim was subsequently transferred to the RO in St. Louis, Missouri. In December 2009, the Veteran filed a timely Substantive Appeal (VA Form 9). The Veteran, his girlfriend (G.C.), and his son testified at a hearing at the RO in May 2012 before the undersigned Veterans Law Judge (VLJ). A transcript of the hearing is associated with the claims file. The Board remanded this claim in August 2012 to obtain VA treatment records, Social Security Administration (SSA) disability records, the disposition of the Veteran's Federal Tort Claims Act (FTCA) litigation, and a VA medical opinion. As the foregoing development has been completed, the Board finds compliance with its August 2012 remand instructions and that no further action is necessary prior to adjudication of this claim. See Stegall v. West, 11 Vet. App. 268, 271 (1998) (where the remand orders of the Board are not complied with, the Board errs as a matter of law when it fails to ensure compliance). In September 2013, after the September 2013 Supplemental Statement of the Case was issued, the Veteran's representative submitted additional argument and evidence that was not accompanied by a waiver of the Veteran's right to have this evidence initially considered by the RO. However, in October 2013, the Veteran resubmitted that evidence, along with additional private treatment records, which was accompanied by a waiver of the Veteran's right to have this evidence initially considered by the RO. Accordingly, the Board may consider this evidence in the first instance. See 38 C.F.R. § 20.1304(c) (2015). The Board notes that, in addition to the paper claims file, the Veteran also has electronic Virtual VA and Veteran Benefits Management System (VBMS) paperless claims files. Any future consideration of this Veteran's case should take into consideration the existence of this electronic record. FINDINGS OF FACT 1. The Veteran has an additional disability, diabetes mellitus. 2. The Veteran's additional disability was caused by VA medical treatment, including by prescribing the drug Zyprexa (Olanzapine). 3. The Veteran's additional disability was due to an event that was not reasonably foreseeable. CONCLUSION OF LAW Resolving all reasonable doubt in the Veteran's favor, the criteria for entitlement to compensation pursuant to 38 U.S.C.A. § 1151 for diabetes mellitus due to VA medical treatment, including by prescribing the drug Zyprexa (Olanzapine), have been met. 38 U.S.C.A. §§ 1151, 5107 (West 2014); 38 C.F.R. §§ 3.102, 3.361 (2015). REASONS AND BASES FOR FINDINGS AND CONCLUSION As the Board's determination below constitutes a full grant of the benefits sought on appeal, no further action is required to comply with the Veterans Claims Assistance Act of 2000 (VCAA) and implementing regulations. 38 U.S.C.A. §§ 5100, 5102, 5103, 5103A, 5107 (West 2014); 38 C.F.R. §§ 3.102, 3.156(a), 3.159, 3.326(a) (2015). Legal Criteria The issue before the Board is entitlement to compensation pursuant to 38 U.S.C.A. § 1151 for diabetes due to VA medical treatment, namely by prescribing the drug Zyprexa to treat the Veteran's psychosis. Specifically, the Veteran contends that he did not have diabetes prior to the time he began to take Zyprexa in April 1998, and that the Zyprexa caused him to develop diabetes. See May 2012 Transcript of Hearing at 3-4; see also October 2013 Statement. He maintains that, although there were no warnings when the Veteran was first prescribed Zyprexa that it could cause diabetes, VA should have known not to prescribe it for him. See May 2012 Transcript at 6 and 8. A veteran who suffers disability resulting from hospital care or medical or surgical treatment provided by a VA employee or in a VA facility is entitled to compensation for the additional disability in the same manner as if such additional disability were service-connected, if the additional disability was not the result of willful misconduct and was proximately caused by "carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of [VA] in furnishing" that treatment or "an event not reasonably foreseeable." 38 U.S.C.A. § 1151(a)(1)(A), (B) (West 2014); see 38 C.F.R. § 3.361(a)-(d) (2015); Viegas v. Shinseki, 705 F.3d 1374, 1377-78 (Fed. Cir. 2013). The purpose of the statute is to award benefits to those veterans who incurred additional disabled as a result of VA treatment or vocational rehabilitation. 38 U.S.C.A. § 1151 (West 2014). First, there must be evidence of additional disability, as shown by comparing the veteran's condition before and after the VA medical care in question. 38 C.F.R. § 3.361(b) (2015). To determine whether a veteran has an additional disability, VA compares the veteran's condition immediately before the beginning of the hospital care, medical or surgical treatment, examination, training and rehabilitation services, or compensated work therapy (CWT) program upon which the claim is based, to the veteran's condition after such care, treatment, examination, services, or program has stopped. VA considers each body part or system separately. Id. The additional disability must not be the result of the veteran's willful misconduct. 38 U.S.C.A. § 1151(a) (West 2014); 38 C.F.R. § 3.301(c)(3) (2015). Second, the additional disability must be caused by hospital care, medical or surgical treatment, examination, training and rehabilitation services, or a CWT program furnished the veteran by VA. 38 C.F.R. § 3.361(c) (2015). Merely showing that a veteran received care, treatment, or examination and that the veteran has an additional disability does not establish cause. 38 C.F.R. § 3.361(c)(1) (2015). In order for additional disability to be compensable under 38 U.S.C.A. § 1151, the additional disability must have been actually caused by, and not merely coincidental to, hospital care, medical or surgical treatment, or medical examination furnished by a VA employee or in a VA facility. 38 C.F.R. § 3.361(c)(1) (2015); Loving v. Nicholson, 19 Vet. App. 96, 99-100 (2005); Sweitzer v. Brown, 5 Vet. App. 503, 505-06 (1993). That is, the additional disability must have been the result of injury that was part of the natural sequence of cause and effect flowing directly from the actual provision of hospital care, medical or surgical treatment, or examination furnished by VA and that such additional disability was directly caused by that VA activity. Loving, 19 Vet. App. at 101. Third, the proximate cause of the disability, as opposed to a remote contributing cause, must be (1) 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 (2) an event that was not reasonably foreseeable. 38 U.S.C.A. § 1151(a)(1) (West 2014); 38 C.F.R. § 3.361(d)(1), (2) (2015). Thus, section 1151 contains two causation elements. A veteran's additional disability must not only be actually caused by the hospital care or medical treatment he or she received from VA, but also must be proximately caused by VA's fault or an unforeseen event. 38 U.S.C.A. § 1151(a)(1) (West 2014). The proximate cause of additional disability is the action or event that directly caused the disability, as distinguished from a remote contributing cause. 38 C.F.R. § 3.361(d) (2015). 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, it must be shown that the hospital care, medical or surgical treatment, or examination caused the veteran's additional disability (see 38 C.F.R. § 3.361(c)), and (i) that VA failed to exercise the degree of care that would be expected of a reasonable health care provider, or (ii) that VA furnished the hospital care, medical or surgical treatment, or examination without the veteran's or, in appropriate cases, the veteran's representative's informed consent. 38 C.F.R. § 3.361(d)(1) (2015). Finally, the determination of whether the proximate cause of a veteran's additional disability was an event not reasonably foreseeable is to be based on what a reasonable health care provider would have foreseen. The event does not have to 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. 38 C.F.R. § 3.361(d)(2) (2015). 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) (2015). In determining whether compensation is warranted for a disability, VA is responsible for determining whether the evidence supports the claim or is in relative equipoise, with the veteran prevailing in either event, or whether a preponderance of the evidence is against the claim, in which case the claim is denied. 38 U.S.C.A. § 5107(b) (West 2014); 38 C.F.R. § 3.102 (2015); Gilbert v. Derwinski, 1 Vet. App. 49 (1990). Background In April 1991, the Veteran filed for SSA disability benefits alleging he was unable to work due to mental depression, high blood pressure, arthritis, back problems, and headaches. It was determined that the Veteran was not disabled for SSA purposes. May 1989 to December 1993 private and VA treatment records obtained by SSA are negative for complaints, diagnosis, or treatment of diabetes and for elevated glucose levels. Private treatment records from S.M.H. for October 1990 are also negative for complaints, diagnosis, or treatment of diabetes and for elevated glucose levels. The Veteran was afforded a VA examination in February 2009. After a thorough review of the Veteran's claims file and examination of the Veteran, the examiner noted that the Veteran was begun on Zyprexa in April 1998, but medication to treat diabetes was not begun until December 1998. The examiner opined that the Veteran had, at the very least, impaired glucose tolerance in May 1998, as evidenced by an HbA1c of 6.21 (normal 4-6). In July 1996, the Veteran's blood glucose was recorded at 185 (normal 72-99). The examiner noted that the makers of Zyprexa caution that prescribers should monitor blood glucose levels in patients while taking that medication; however, he noted further that the cautionary statement may not have been present in 1998. It was the examiner's opinion that the Zyprexa did not cause the Veteran's diabetes. He added, however, that Zyprexa has the potential to cause diabetes to become progressively worse, and it was his opinion that the Zyprexa aggravated the Veteran's diabetes, causing the diabetes to worsen beyond its normal progression. The examiner also opined that the additional disability did not result from carelessness, negligence, lack of proper skill, or error in judgement. The examiner's rationale was that the Veteran's diabetes was monitored closely and his mental illness showed some improvement while on Zyprexa. As discussed above, the Board requested an additional medical opinion that was obtained in September 2013. After conducting a thorough review of the Veteran's claims file, the physician opined that, although the date of onset of the Veteran's diabetes cannot be determined precisely, it is clear his diabetes was diagnosed by at least 1998. The physician noted that the first evidence of possible diabetes is VA compensation claims the Veteran filed for "sugar in blood" in September 1991 and January 1992. The Veteran had a VA examination in April 1993, but the examiner did not address diabetes or include laboratory test results in his report. The physician noted an elevated HbA1c of 6.21 in May 1998 and an elevated blood glucose level of 185 in July 1998 (the Board notes this date should be July 1996). He stated that one note mentions the Veteran was on oral diabetic medications by December 1998. The physician opined that it is not possible to know if the Zyprexa prescribed by VA precipitated or aggravated diabetes in this veteran without resort to speculation. The physician noted that a statistical association between Zyprexa and diabetes is established; however, the mechanism by which this transpires is not established and, thereby, causation cannot be attributed. The physician stated that, at the time the Veteran was first prescribed Zyprexa, the association of Zyprexa and diabetes was not known. Japan was the first to issue a revised warning label concerning the increased risk of diabetes associated with Zyprexa usage in April 2002. The United States Food and Drug Administration (FDA) issued a similar revision in late 2003, with an official release date of January 2004. The manufacturer of Zyprexa, Eli Lilly, issued a March 2004 letter to prescribing physicians advising them of the Zyprexa-diabetes association. The physician opined that it is reasonable to assume that most physicians knew of this association in 2004. The physician opined that the VA physicians who prescribed Zyprexa to the Veteran did not exercise carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault. The physician's rationale was that, when Zyprexa was first prescribed to the Veteran on April 16, 1984, the FDA warning of the Zyprexa-diabetes association had not been issued and the association of Zyprexa with diabetes was virtually unknown. Despite this, the treating physicians were monitoring the Veteran's blood glucose and HbA1c. When the Veteran's diabetes manifested, the treating physicians rendered appropriate treatment. The Veteran's diabetes was monitored at the appropriate intervals and his treatment adjusted accordingly over time. The physician also determined that VA did not fail to exercise a degree of care that would be expected of reasonable health care providers. Finally, since at the time the Veteran was first prescribed Zyprexa the association of Zyprexa causing diabetes was not known, the physician opined that it was not reasonably foreseeable that prescribing Zyprexa would cause diabetes. The Veteran filed FTCA litigation in June 2007 concerning the same treatment and allegations that are in question in the current claim. In particular, he made a claim for $10 million because VA gave him Zyprexa, which caused diabetes after years of taking the medication. He noted that he was diagnosed as having diabetes in 2003. See June 2007 Claim for Damage, Injury or Death (Form 95). A July 2008 letter informed the Veteran that VA had exhaustively reviewed the treatment and services provided to him by VA. The "investigation revealed no evidence to demonstrate that [his] VA medical care and medication treatment was negligently undertaken." Accordingly, his claim under the FTCA was denied. The Veteran has submitted several documents showing that he received an award from a "Zyprexa Settlement" with Eli Lilly. The settlement associates the use of Zyprexa with New-Onset Insulin Dependent Diabetes Mellitus. Analysis After careful consideration of the lay and medical evidence of record and resolving all reasonable doubt in the Veteran's favor, the Board finds that compensation pursuant to 38 U.S.C.A. § 1151 is warranted for the Veteran in the present case. The record substantiates that VA prescribed Zyprexa for the Veteran in April 1998 and that he was diagnosed with diabetes in December 1998. The Board notes that there is evidence of record that suggests the Veteran had elevated blood glucose levels prior to starting Zyprexa, such as his VA compensation claims for "sugar in blood" in September 1991 and January 1992, elevated blood glucose levels of 185 and 201 in July 1996, and an elevated HbA1c of 6.21 in May 1998 just after beginning Zyprexa. However, the record does include evidence showing that, in general, Zyprexa use can causes diabetes. Thus, giving the Veteran the benefit of the doubt, the Board finds that he has suffered additional disability as the result of VA prescribing Zyprexa for him, and that the Zyprexa actually caused his diabetes. As the actual causation prong of the regulations has been satisfied, the inquiry now becomes whether the proximate cause of the Veteran's diabetes was carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part, or an event not reasonably foreseeable. 38 C.F.R. § 3.361(d)(1) (2015). The Board finds that the proximate cause of the Veteran's diabetes was not carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part in prescribing Zyprexa for the Veteran. The Board finds the September 2013 VA medical opinion to be highly probative to the matter at hand. In concluding that the VA physicians who prescribed Zyprexa to the Veteran did not act with carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault, the physician explained that, when Zyprexa was first prescribed to the Veteran in April 1984, the FDA warning of the Zyprexa-diabetes association had not been issued and the association of Zyprexa with diabetes was virtually unknown. Thus, VA did not fail to exercise a degree of care that would be expected of reasonable health care providers, including by continuing to prescribe Zyprexa for the Veteran after it was known that it can cause diabetes. Moreover, given that developing diabetes was not a foreseeable risk of taking Zyprexa, VA physicians could not have advised the Veteran of the risk. The Veteran's entire claim, therefore, rests on whether his additional disability was proximately caused by an "event not reasonably foreseeable." 38 U.S.C. § 1151(a)(1)(B) ; 38 C.F.R. § 3.361(d)(2) (2015). With regard to reasonable foreseeability, 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. 38 C.F.R. § 3.361(d)(2) (2015). In the present case, the issue is whether a reasonable health care provider would have disclosed the possibility to the Veteran that developing diabetes is a reasonably foreseeable risk of taking Zyprexa. As noted above, the September 2013 VA medical opinion makes clear that physicians were not aware that Zyprexa might cause diabetes at the time it was prescribed to the Veteran. Therefore, the physician opined that it was not reasonably foreseeable that prescribing Zyprexa could cause diabetes. As such, the Board finds that a "reasonable health care provider" would not have considered the Veteran's diabetes to be an ordinary risk of the treatment provided and would not have disclosed such risk in connection with such treatment. 38 C.F.R. § 3.361(d)(2) (2015). Therefore, in light of these conclusions, it follows that the proximate cause of the Veteran's diabetes was an event not reasonably foreseeable. Resolving doubt in the Veteran's favor, the evidence supports entitlement to compensation under the provisions of 38 U.S.C.A. § 1151 in the present case. 38 U.S.C.A. § 5107(b) (West 2014); 38 C.F.R. § 3.102). The claim is granted. ORDER Entitlement to compensation pursuant to 38 U.S.C.A. § 1151 for diabetes mellitus due to VA medical treatment, including by prescribing the drug Zyprexa (Olanzapine), is granted. ____________________________________________ K. OSBORNE Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs