Citation Nr: 0926388 Decision Date: 07/15/09 Archive Date: 07/22/09 DOCKET NO. 99-04 161 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in St. Petersburg, Florida THE ISSUE Entitlement to compensation pursuant to 38 U.S.C.A. § 1151 for chronic pancreatitis claimed as secondary to Depakote prescribed for a nonservice-connected psychiatric disorder. REPRESENTATION Appellant represented by: Sandra E. Booth, Attorney-at- Law ATTORNEY FOR THE BOARD S. M. Kreitlow, Counsel INTRODUCTION The Veteran served on active duty from July 1963 to July 1965. This appeal comes before the Board of Veterans' Appeals (Board) on appeal from a September 1998 rating decision by the Department of Veterans Affairs (VA) Regional Office (RO) in St. Petersburg, Florida. FINDINGS OF FACT 1. The Veteran developed pancreatitis after the VA psychiatric hospitalization from September 5, 1996, to September 13, 1996, during which he was started on Depakote. 2. The Veteran's chronic pancreatitis is at least as likely as not the result of Depakote use. 3. Pancreatitis was a reasonably foreseeable result of the use of Depakote. 4. The evidence of record fails to establish that the Veteran gave informed consent prior to the administration of Depakote during the September 1996 VA psychiatric hospitalization. CONCLUSION OF LAW Compensation under 38 U.S.C.A. § 1151 for chronic pancreatitis is warranted. 38 U.S.C.A. § 1151 (West 2002 & Supp. 2008); 38 C.F.R. § 17.32 (1996); 38 C.F.R. § 3.361 (2008). REASONS AND BASES FOR FINDINGS AND CONCLUSION In this decision, the Board grants the Veteran's § 1151 claim, which represents a complete grant of the benefit sought on appeal. Thus, no discussion of VA's duty to notify and assist is necessary. I. Background The Veteran's claim arises out of a September 1996 VA psychiatric hospitalization and the administration of the medication, Depakote. Specifically the Veteran alleges that, as a result of the use of Depakote prescribed by VA, he developed chronic pancreatitis. He has alternately argued that such an outcome was not a reasonably foreseeable event or that he was not given informed consent prior to the administration of Depakote that pancreatitis could arise from the use of this medication. The Veteran's claim was initially before the Board in November 2001 and was denied. The Veteran appealed to United States Court of Appeals for Veterans Claims (hereinafter, "Court"). In November 2002, pursuant to a Joint Motion for Remand, the Court vacated the Board's November 2001 decision and remanded the Veteran's appeal to the Board. In the Joint Motion for Remand, the parties agreed that the Board failed to provide adequate reasons and bases for its denial for the following reasons: (1) the Board failed to explain its reliance upon a patient information leaflet from the pharmaceutical manufacturer in concluding that pancreatitis was a reasonably foreseen consequence of taking Depakote; (2) the Board failed to explain whether the failure to obtain a medical opinion as to whether there was carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault on the part of VA under § 1151 was a breach of VA's duty to assist; and (3) the Board failed to discuss application of 38 C.F.R. § 3.385, including whether the Veteran's incurrence of pancreatitis was a necessary consequence of the VAMC medical treatment, whether Depakote was properly administered, and whether the Veteran gave his express or implied consent. The Joint Motion for Remand specifically set forth in detail what findings the Board must make if it were to again deny the Veteran's claim. In June 2003, the Board remanded the Veteran's claim for compliance with VA's duties to notify and assist the Veteran. In April 2005, the Board again denied the Veteran's claim. The Veteran appealed that denial to the Court which, by memorandum decision issued in October 2007, vacated the Board's April 2005 decision and remanded the Veteran's appeal. In its decision, the Court agreed with the Veteran that the Board's reliance on a May 2004 VA medical opinion was misplaced because the opinion was inadequate. Specifically, the VA medical examiner's opinion was found to be internally inconsistent because the examiner twice acknowledged that the Veteran suffered from pancreatitis as a reaction to Depakote, but then concludes that there is "no way" that Depakote is responsible for the Veteran's chronic pancreatitis. In addition, the VA medical examiner's opinion was found to be inadequate because he failed to follow his instructions and state what he believed to be the etiology of the Veteran's chronic pancreatitis (except to state it was not due to Depakote), and, although the examiner suggests that the Veteran's chronic pancreatitis may have preexisted his use of Depakote, the examiner offers no clear opinion as to whether Depakote use aggravated his pancreatitis. Finally, the Veteran argued, and the Secretary conceded, that the Board did not comply with the April 2003 Joint Motion for Remand in rendering its decision, meaning the Board failed to make the specific findings set forth in the Joint Motion for Remand. In response to the Court's decision, the Board sought a VHA medical opinion pursuant to VHA Directive 2006-019, 38 U.S.C.A. §§ 5103A and 7109, and 38 C.F.R. § 20.901. That opinion was provided in July 2008 from a VA gastroenterologist from the Birmingham, Alabama, VA Medical Center, and was forwarded to the Veteran and his representative for response. In May 2009, the Board received a response from the Veteran's representative with a report from an R.N. (i.e., registered nurse). The Veteran's claim is now before the Board for final adjudication. The evidence of record consist of VA and non-VA medical records for both inpatient and outpatient treatment, reports of VA examinations from September 1998 and May 2004, a VHA medical opinion from July 2008, and private medical opinion from an R.N. dated in April 2009. The Board has reviewed all the evidence of record. Although the Board has an obligation to provide adequate reasons and bases supporting this decision, it is not required to discuss each and every piece of evidence in the case. The Board will summarize the relevant evidence where appropriate. The record shows the Veteran has a long history of epigastric complaints, which he has reported date back to the 1970s. Relevant private treatment records show that that Veteran was hospitalized in November 1994 for three days for severe epigastric pain. It was initially thought to possibly be due to either peptic ulcer disease or pancreatitis; but the discharge diagnosis was abdominal pain of undetermined etiology. The Veteran continued to have complaints of epigastric problems and to seek treatment. In May 1995, he was given a diagnosis of reflux esophagitis. The Board notes that none of these treatment records show a diagnosis of pancreatitis as the cause of the Veteran's epigastric complaints. The Veteran was admitted to the Gainesville VA Medical Center on September 5, 1996, for treatment relating to his psychiatric disorder. At the time of admission, the Veteran gave a history of having reflux esophagitis. He had some light tenderness of the gastrium, but physical examination was otherwise normal. Lab tests taken upon admission revealed the Veteran's glucose, BUN, alkaline phosphatase, ALT and amylase were all high. During the course of the Veteran's hospitalization, he was started on Depakote, 250 mg by mouth, twice a day, in light of his long history of mood instability, angry outbursts, and lack of impulse control. He did very well throughout the entire admission, including giving feedback regarding any side effects from the Depakote. He continued, however, to complain of epigastric pain. He was sent for a gastrointestinal consult on September 10, 1996. An esophagogastroduodenoscopy (EGD) showed moderately severe esophagitis and nonspecific inflammation of the bulb and duodenum. He was started on 20 mg of Prilosec. On discharge, the Veteran was in no acute distress. It was noted that he had tolerated well all the additional medications he was given and was discharged on Depakote 250 mg three times a day, Paxil 20 mg once a day, and Prilosec 20 mg once a day. He was advised to avoid foods that irritate his stomach, and to take the Depakote with food secondary to it causing nausea when taken on an empty stomach. He was seen at VA for mental health follow up on September 18, 1996. At that time, he reported no great improvement in his esophagitis with the treatment received during his hospitalization. He was also still depressed. His Depakote levels were within normal limits. His prescriptions for Depakote and Paxil were refilled. On September 27, 1996, the Veteran was seen in the emergency room of a private hospital with complaints of epigastric pain, nausea and vomiting. The Veteran complained of significant abdominal discomfort lasting for the last few months described as epigastric in nature with significant heartburn and belching, associated with spastic pain in the upper abdominal area. Upon arrival in the emergency room, evaluation revealed epigastric tenderness, nausea and vomiting. It was noted that the Veteran was on Depakote for unknown reasons, and the impression was pancreatitis, rule out etiology; question gallstones versus hypertriglyceridemia-induced pancreatitis or other etiologies. He underwent a gastroenterology consult on September 28th. The assessment was that the Veteran presented with acute onset of abdominal pains associated with hyperamylasemia and episodes of emesis as well as intermittent episodes of diarrhea. The question of pancreatitis was raised. He was also noted to have significant leukocytosis with shift to the left from an unclear etiology. Work up included an abdominal ultrasound that showed no evidence of abdominal abnormality except increased fat deposition in the liver; a barium swallow that was unremarkable except for a short sliding hiatal hernia; and a CT scan of the abdomen that showed no evidence for peripancreatic inflammation, pseudocyst formation or free fluid within the abdomen. During the course of hospitalization, the Veteran's amylase and lipase levels gradually returned to normal. He was discharged home on October 1, 1996, and continued on his medications, which included Depakote. The discharge diagnoses were active pancreatitis, esophagitis and hiatal hernia. A VA mental health treatment note from November 13, 1996, indicates that the Veteran reported having acute pancreatitis imputed to Depakote by his private medical doctor, and he had been severely ill and hospitalized for four days. Depakote was discontinued and he was advised to follow up with medical for the acute pancreatitis. Subsequently the Veteran was seen at VA on January 6, 1997, with continued complaints of considerable abdominal distress. On January 14, 1997, he was seen at the private hospital's emergency room and admitted for acute pancreatitis. He was hospitalized for four days. Discharge diagnosis was recurrent pancreatitis. On January 21, 1997, he was seen at a private emergency room with epigastric pain, and the assessment was suspect chronic pancreatitis. He was seen at VA on January 22, 1997, and diagnosed with gastroesophageal reflux disease (GERD) and chronic pancreatitis. It was questioned whether the chronic pancreatitis was secondary to previous alcohol use (Veteran reported no alcohol use for six years but heavy beer use prior to then). VA follow up treatment note of February 4, 1997, indicates diagnoses of GERD and pancreatitis (noted to be questionably secondary to Depakote). On March 13, 1997, the Veteran underwent a pancreatogram at VA that revealed changes of chronic pancreatitis present, including mild ectasia of the secondary pancreatic ducts. The impression was grade I/minimal chronic pancreatitis. The Veteran has continued to carry the diagnosis of chronic pancreatitis. (see VA treatment records from October 20, 1999 and August 16, 2000). In addition to the above treatment records, the Veteran has undergone two VA examinations. The first examination was conducted in September 1998, resulting in a diagnosis of chronic pancreatitis. The examiner opined that "It is as likely as not that the utilization of Depakote for this patient's depression is the etiologic factor of his pancreatitis." The second VA examination was conducted in May 2004. Although this examiner's nexus opinion was found to be inadequate by the Court in its recent October 2007 decision, the examination findings are still instructive so long as the deficiencies found are taking into consideration. The examiner's assessment was history of recurrent pancreatitis, some mild pancreatitis seen in 1993 (should be 1994) hospitalization and then apparently a more severe bout in 1996 after bad reaction to Depakote; and chronic pancreatic insufficiency, diabetes mellitus type 2, as well as, dumping syndrome and probably pancreatic enzyme insufficiency. Based on the history provided by the Veteran, the examiner found that his gastroesophageal symptomatology began in the early 1970s with gastroesophageal reflux symptoms and peptic ulcer disease. Ethanolism and substance abuse further irritated the gastric lining and pancreas and contributed to hypertriglyceridemia, which the examiner indicated is a known risk factor for pancreatitis. The examiner went on to note the Veteran also has posttraumatic stress disorder, was being treated at that time (presumably September 1996) for depression, and subsequently had a worsening of the pancreatitis due to nobody's fault other than idiosyncratic drug reaction. The examiner stated there was no evidence of any failure or negligence of the medical staff in any way, and that in no way was the Depakote responsible for the Veteran's chronic pancreatitis, it having existed prior to that drug usage. In July 2008, the Board obtained a medical opinion from a VA gastroenterologist. This person indicated that he was unable to confirm the presence of chronic pancreatitis without review of the "grade I/minimal chronic pancreatitis" pancreaticogram and laboratory evaluation of exocrine function. Furthermore, he was unable to determine the onset of possible chronic pancreatitis, although he noted the Veteran's symptoms of epigastric pain, nausea and vomiting present in 1994, which preceded the use of Depakote. However, he acknowledged that the Veteran had never been diagnosed with pancreatitis in the past. This person also questioned the diagnosis of acute pancreatitis made in September 1996 given the lack of objective data, and indicated there was insufficient evidence to support Depakote "increasing the possible chronic pancreatitis." Finally, this person cited from the Depakote package insert: "In clinical trials, there were 2 cases of pancreatitis without alternative etiology in 2416 patients, representing 1044 patient-years experience," but noted that on July 31, 2000, a black-box warning was added to the labeling for Depakote about pancreatitis, well after the prescribing of the medication to the patient. He stated that he did not see any evidence of negligence or carelessness in the drug prescribing in this case. In response to the VHA medical opinion, the Veteran submitted a private medical opinion from an R.N. dated in April 2009. After setting forth in detail the Veteran's medical history, the R.N. opined that it is at least as likely as not that the Veteran's pancreatitis was caused by Depakote use. She acknowledged that pancreatitis is a reasonably foreseeable risk of Depakote administration (citing authority that it was first recognized in 1979), and that the Veteran had risk factors for pancreatitis other than Depakote use, such as hypertriglycerides, history of alcohol usage, and history of smoking. Thus, she stated it is impossible to determine conclusively which factor was the primary cause of the Veteran's pancreatitis; however, because Depakote is a known risk factor, and because the Veteran did not have clinical findings to support a diagnosis prior to ingesting Depakote, she opined that the initial clinical presentation after Depakote treatment supports that pancreatitis was most likely due to Depakote use. In addition, this R.N. stated that, after reviewing the complete claims file, she did not find documentation which indicates that the Veteran was informed, in writing, of the risk of pancreatitis prior to his September 1996 ingestion of Depakote. She stated that it is not likely that medical treatment providers would have given him the medication's package insert prior to giving him Depakote because of how drugs are dispensed within a hospital setting. Also, she advised that under generally applicable medical standards in 1996, the medical provider's provision of a prescription drug package insert to the patient is not adequate disclosure of the risks as a lay person is without the specialized scientific expertise necessary to evaluate the technical information contained in the insert, and is without the medical expertise to understand how the circumstances of the patient's particular medical condition may be impacted by that particular drug, whether there are available treatment alternatives with less risk to the patient's safety, and whether the benefits of the particular prescription drug treatment outweigh the risks. II. Analysis Under 38 U.S.C.A. § 1151, compensation shall be awarded for a qualifying additional disability or a qualifying death of a Veteran in the same manner as if such additional disability were service connected. 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 either (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, and the proximate cause of the disability or death was either (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; or (2) the disability or death was proximately caused by the provision of training and rehabilitation services by the Secretary as part of an approved rehabilitation program. 38 U.S.C.A. § 1151. 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. 38 C.F.R. § 3.361(d)(1). In considering the Veteran's claim, the Board must first determine whether there is an additional disability. In determining whether the Veteran has an additional disability, 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 is compared to the Veteran's condition after such care, treatment, examination, service, or program has stopped. 38 C.F.R. § 3.361(b). It is not sufficient, however, to merely show that a Veteran received care, treatment or examination and that the Veteran has an additional disability or died therefrom. 38 C.F.R. § 3.361(c)(1). The evidence must also establish that the proximate cause of the Veteran's additional disability was either 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 that it was an event not reasonably foreseeable. 38 C.F.R. § 3.361(d). The Board finds that the evidence is at least in equipoise as to whether the Veteran has an additional disability due to VA medical treatment. The Veteran claims that he has chronic pancreatitis due to Depakote use for his psychiatric disorder, which the VA prescribed and began administering to him during inpatient psychiatric treatment from September 1996 and continued use until November 1996. The record is unclear as to whether the Veteran had pancreatitis prior to this September 1996 VA psychiatric hospitalization. The May 2004 VA examiner and the July 2008 VA medical expert both seem to indicate that the Veteran's symptoms at the time of the November 1994 hospitalization point to the possibility of pancreatitis being present then. On the other hand, the September 1998 VA examiner clearly expressed his opinion that Depakote use was the etiology of the Veteran's chronic pancreatitis - an indication that he did not find that pancreatitis preexisted the September 1996 VA hospitalization. Finally, the April 2009 R.N.'s opinion clearly expresses her belief that the Veteran's symptoms in November 1994 were related to his then diagnosed gastritis and that pancreatitis was ruled out at that time. Thus she opined that the first episode of acute pancreatitis was at the end of September 1996 with recurring bouts of pancreatitis thereafter resulting in chronic pancreatitis and, since the Veteran's Depakote use predated the first episode of pancreatitis, it is the most likely etiology of the Veteran's chronic pancreatitis. The contemporaneous medical evidence fails to indicate a diagnosis of pancreatitis prior to September 1996. Furthermore, two out of four medical experts believe the Veteran's pancreatitis did not predate September 1996. Finally, even if the Veteran may have had an acute episode of pancreatitis in November 1994, the onset of chronic pancreatitis does not appear to be until after September 1996 and the administration of Depakote. The Board notes the July 2008 VA medical expert did not even concede that the Veteran has chronic pancreatitis presently or that he had an acute episode of pancreatitis at the end of September 1996. However, given the medical evidence of record indicating a diagnosis of chronic pancreatitis supported by diagnostic testing and subsequent treatment with pancreatic enzyme replacement, as well as, the two VA examinations that confirmed a diagnosis of chronic pancreatitis, the Board does not find the VA medical expert's questioning of the presence of a current disability to be controlling. Thus, the Board concludes that a reasonable doubt is raised by the evidence that the Veteran has an additional disability, i.e., chronic pancreatitis, after treatment with Depakote by VA from September 1996 to November 1996. The Veteran has contended that his developing chronic pancreatitis as a result of the use of Depakote was not a reasonably foreseeable event. However, the patient prescription leaflet in the claims file shows that pancreatitis is a known side affect of Depakote use. Moreover, the Veteran's own expert acknowledged that it was reasonably foreseeable and noted that the medical profession knew of the link between Depakote use and pancreatitis as early as 1979. Thus, it would appear that developing pancreatitis was a reasonably foreseeable event, and this cannot be a basis for granting the Veteran's claim. This, however, does not end the inquiry as the Veteran has also alleged that VA failed to advise him of the risk of developing pancreatitis because of the use of Depakote, and thus he did not give informed consent. Per VA regulation in effect in 1996, "informed consent" meant the freely given consent that follows a carful explanation by a practitioner to the patient or the patient's representative of the proposed diagnostic or therapeutic procedure or course of treatment. 38 C.F.R. § 17.32 (a)(1) (1996). Such informed consent should consist of information regarding the nature of the proposed procedure or treatment, as well as the expected benefits; reasonably foreseeable associated risks, complications or side effects; reasonable and available alternatives; and anticipated results if nothing is done. The patient should be given the opportunity to ask questions, to indicate comprehension of the information provided, and to grant permission freely and without coercion, as well as the opportunity to withhold or revoke such permission at any time without prejudice. 38 C.F.R. § 17.32 (b) (1996). The fact that the patient (or a representative) has been provided appropriate information and counseling and has consented to a proposed procedure or course of treatment shall be documented in the patient's medical record. 38 C.F.R. § 17.32 (c) (1996). The Veteran's medical expert states in her report that she has reviewed the complete claims file and she could find no documentation which indicates that the Veteran was informed, in writing, of the risk between Depakote use and pancreatitis. Although the Board does not believe that 38 C.F.R. § 17.32 required that informed consent be it writing in 1996, it does state that the obtaining of informed consent must be documented in the patient's medical record. After reviewing the available VA medical records relating to the September 1996 VA psychiatric hospitalization, the Board cannot find any documentation that the Veteran was advised of the purposes for using Depakote to treat his psychiatric disorder, the benefits and risks involved in such use, and whether there was alternative forms of treatment, and that he thereafter gave informed consent for the administration of Depakote. As the VA medical records do not establish that informed consent was obtained to treat the Veteran with Depakote in September 1996 and since it has been concluded that such treatment resulted in the Veteran developing chronic pancreatitis, the criteria for establishing entitlement to benefits under 38 U.S.C.A. § 1151 and 38 C.F.R. § 3.361 for chronic pancreatitis have been met. Therefore, the Board grants the Veteran's claim. ORDER Entitlement to compensation pursuant to 38 U.S.C.A. § 1151 for chronic pancreatitis claimed as secondary to Depakote prescribed for a nonservice-connected psychiatric disorder is granted. ____________________________________________ MICHAEL E. KILCOYNE Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs