Citation Nr: 0126262 Decision Date: 11/13/01 Archive Date: 11/20/01 DOCKET NO. 99-04 161 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in St. Petersburg, Florida THE ISSUE Entitlement to a disability compensation pursuant to 38 U.S.C.A. § 1151 for pancreatitis secondary to the drug Depakote prescribed for a nonservice-connected psychiatric condition. REPRESENTATION Appellant represented by: Veterans of Foreign Wars of the United States ATTORNEY FOR THE BOARD Patrick J. Costello, Counsel INTRODUCTION The veteran had active military service from July 1963 to July 1965. This matter comes before the Board of Veterans' Appeals (Board) on appeal from a September 1998 rating decision of the Department of Veterans Affairs (VA) Regional Office (RO), in St. Petersburg, Florida. FINDINGS OF FACT 1. Sufficient evidence for an equitable disposition of the veteran's appeal has been obtained by the agency of original jurisdiction. 2. In 1996, the veteran was prescribed, by a VA doctor, Depakote for depression. 3. The veteran submitted a Patient Information Pamphlet, which listed, in part, the various side effects, including pancreatitis, caused by Depakote. 4. Shortly after taking Depakote, the veteran developed pancreatitis. CONCLUSIONS OF LAW 1. VA has satisfied its duty to assist the veteran in developing facts pertinent to this claim. Veterans Claims Assistance Act of 2000, Pub. L. No. 106-475, § 4, 114 Stat. 2096, 2097-98 (2000) (to be codified as amended at 38 U.S.C. § 5103A); 38 C.F.R. § 3.103 (2001). 2. The veteran is not entitled to compensation benefits pursuant to the provisions of 38 U.S.C.A. § 1151 for pancreatitis secondary to the drug Depakote prescribed for a nonservice-connected psychiatric condition. 38 U.S.C.A. § 1151 (West Supp. 2000); 38 C.F.R. § 3.358 (2001). REASONS AND BASES FOR FINDINGS AND CONCLUSIONS In August 1996, the veteran obtained treatment at his local VA medical facility for depression. He was initially prescribed Prozac. A September 1996 VA hospital summary shows that the veteran was admitted complaining of feelings of depression mixed with episodes of anger and anxiety. It was noted that he had a history of reflux esophagitis. It was indicated that he was prescribed Depakote. It was noted that he was very good at giving feedback regarding the use of Depakote and whether or not it was giving him any side effects. It was also noted that he complained of epigastric pain and was prescribed Prilosec. Subsequent September 1996 hospital records shows that the veteran was admitted with complaints of epigastric pain, nausea and vomiting. The diagnoses included pancreatitis and history of esophagitis. In connection with his March 1998 claim for compensation, the veteran submitted an original patient information leaflet. The paper insert was provided by Abbott Laboratories, the maker of Depakote. Said insert described the medication and also gave additional information such as adverse reactions, precautions, dosage and administration, etcetera. The Patient Information Leaflet reads, in part: Please read this leaflet carefully before you take Depakote(r) (divalproex sodium) tablets. . . . If you have any questions or concerns, or want more information about Depakote(r), contact your doctor or pharmacist. Per the insert, under the category "Adverse Reactions", the veteran was given notice that: The following additional adverse events were reported by greater than 1% but less than 5% of the 358 patients treated with DEPAKOTE in the controlled trials of complex partial seizures: . . . Digestive System: Increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess. The veteran underwent a VA internal medicine examination in September 1998. He was diagnosed as having chronic pancreatitis and the doctor stated, "It is as likely as not that the utilization of Depakote for this patient's depression is the etiological factor of his pancreatitis." The results were returned to the RO, which, after reviewing the evidence, concluded that benefits pursuant to 38 U.S.C.A. § 1151 (West Supp. 2000) were not warranted. The veteran was notified of this decision and he has appealed to the Board for review. When a veteran submits a compensation claim to VA, VA has a duty to assist him with that claim. Veterans Claims Assistance Act of 2000, Pub. L. No. 106-475, § 3(a), 114 Stat. 2096, 2097-98 (2000) (to be codified at 38 U.S.C. § 5103A); 38 C.F.R. § 3.103 (2001). Over the course of this appeal, VA has obtained his private and VA treatment records and provided an internal medicine examination. The veteran has also provided written statements before the VA. Additional private or other government records that would assist in the processing of this claim have not been identified by the veteran. The veteran has been provided appropriate notice of the pertinent laws and regulations, and he has been given the opportunity to provide additional information in support of his claim. It is the conclusion of the Board that the VA has satisfied its duty to assist the veteran. The Board notes that the statutory criteria applicable to claims for benefits under the provisions of 38 U.S.C.A. § 1151, underwent a significant revision effective October 1, 1997, for claims filed on or after that date. Here, the veteran's request for benefits under § 1151 was filed in April 1998; thus, his claim must decided under the current, post-October 1, 1997, version of 38 U.S.C.A. § 1151. The provisions of 38 U.S.C.A. § 1151 (West Supp. 2000) provide, in pertinent part, that: (a) Compensation under this chapter and dependency and indemnity compensation under chapter 13 of this title shall be awarded for a qualifying additional disability or a qualifying death of a veteran in the same manner as if such additional disability or death were service-connected. For purposes of this section, a disability or death is a qualifying additional disability or qualifying death if the disability or death was not the result of the veteran's willful misconduct and - (1) the disability or death was caused by hospital care, medical or surgical treatment, or examination furnished the veteran under any law administered by the Secretary, either by a Department employee or in a Department facility as defined in section 1701(3)(A) of this title, and the proximate cause of the disability or death 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 (West Supp. 2000). Thus, under the new law, a claim for benefits under the provisions of 38 U.S.C.A. § 1151 must be supported by medical evidence of additional disability from VA hospitalization, or medical or surgical treatment, the results of which were not reasonably foreseeable. See Boeck v. Brown, 6 Vet. App. 14, 16-17 (1993), Ross v. Derwinski, 3 Vet. App. 141, 144 (1992). In the alternative, it must be shown that there is additional disability due to VA treatment that was careless, negligent, or otherwise administered in some degree of error as set forth above. The Board acknowledges that the veteran now has an additional disability, pancreatitis, that he did not have previously. Moreover, the Board recognizes the VA doctor's opinion that states that the veteran's pancreatitis was probably caused by the ingestion and use of the VA-prescribed drug, Depakote. However, evidence has not been presented which fulfills the second portion of 38 U.S.C.A. § 1151 (West Supp. 2000), that the veteran's disability not be reasonably unforeseeable. In fact, evidence has been presented by the veteran to the contrary. The pharmaceutical maker of Depakote provided the veteran with a Patient Information Leaflet describing the hazards, side effects, and adverse reactions a patient may have when using this drug. The veteran, through his proffering of the original Patient Information Leaflet, acknowledged that he had been given notice of the side effects. Thus, it may be reasonably concluded that the veteran's incurrence of pancreatitis was a reasonably foreseen consequence of taking Depakote. Furthermore, this claim must be evaluated to determine whether there was any carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault on the part of the VA before compensation under 38 U.S.C.A. § 1151 (West Supp. 2000) may be granted. In this case, the veteran has not contended and there is no medical opinion or medical evidence which reflect any carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault, on the part of VA in providing treatment. The Board notes that the veteran is competent to report that on which he has personal knowledge, that is what comes to him through his senses. Layno v. Brown, 6 Vet. App. 465, 470 (1994). However, as a layperson, the veteran is not competent to provide the required nexus evidence. See Espiritu v. Derwinski, 2 Vet. App. 492 (1992) and Grottveit v. Brown, 5 Vet. App. 91 (1993). Since in this case, the veteran has not submitted medical, or otherwise competent evidence showing that that the pancreatitis was an event not reasonably foreseeable or that it was the result of carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault on the part of the VA in furnishing his, treatment, the Board finds that the preponderance of the evidence is against the veteran's claim for benefits under 38 U.S.C.A. § 1151 and the appeal is denied. ORDER Entitlement to a disability compensation pursuant to 38 U.S.C.A. § 1151 for pancreatitis secondary to the drug Depakote prescribed for a nonservice-connected psychiatric condition is denied. K. J. ALIBRANDO Acting Member, Board of Veterans' Appeals