Citation Nr: 0828663 Decision Date: 08/22/08 Archive Date: 09/02/08 DOCKET NO. 03-02 928 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Oakland, California THE ISSUE Entitlement to dependency and indemnity compensation (DIC) under the provisions of 38 U.S.C.A. § 1151 for the cause of the veteran's death. REPRESENTATION Appellant represented by: California Department of Veterans Affairs WITNESS AT HEARING ON APPEAL Appellant ATTORNEY FOR THE BOARD Dan Brook, Associate Counsel INTRODUCTION The veteran served on active duty from September 1954 to October 1957. He died in October 2002; the appellant is his surviving spouse. This matter comes to the Board of Veterans' Appeals (Board) from a February 2001 rating decision of the Department of Veterans Affairs (VA) Regional Office (RO) in Oakland, California, which denied service connection for the cause of the veteran's death. A Decision Review Officer Hearing was held at the RO in October 2003; a transcript of the hearing is of record. In August 2004, the Board issued a decision denying appellant's general claim for service connection for cause of death but remanding her claim for dependency and indemnity compensation pursuant to 38 U.S.C.A. § 1151 for further development. Consequently, the Board's decision is limited to responding to appellant's claim under section 1151 that VA health care caused, or contributed to, the veteran's death. FINDINGS OF FACT 1. According to the certificate of death, the appellant's spouse died in October 2000 from a cerebral edema due to a subdural hematoma, with severe coronary artery disease as a significant condition contributing to his death. 2. It is not shown that the veteran's taking of any medication including cisparide, Coumadin, Aldactone and Lasix resulted in additional disability or death. CONCLUSION OF LAW The criteria for entitlement to dependency and indemnity compensation pursuant to 38 U.S.C.A. § 1151 are not met. 38 U.S.C.A. §§ 1151, 1310 (West 2002); 38 C.F.R. §§ 3.303, 3.309, 3.312 (2003). REASONS AND BASES FOR FINDINGS AND CONCLUSION I. VCAA The Veterans Claims Assistance Act of 2000 (VCAA) describes VA's 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 & Supp. 2007); 38 C.F.R. §§ 3.102, 3.156(a), 3.159 and 3.326(a) (2007). Upon receipt of a complete or substantially complete application for benefits, VA is required to notify the claimant and his or her representative, if any, of any information, and any medical or lay evidence, that is necessary to substantiate the claim. 38 U.S.C.A. § 5103(a) (West 2002); 38 C.F.R. § 3.159(b) (2007); Quartuccio v. Principi, 16 Vet. App. 183 (2002). Proper VCAA notice must inform the claimant of any information and evidence not of record (1) that is necessary to substantiate the claim; (2) that VA will seek to provide; (3) that the claimant is expected to provide; and (4) must ask the claimant to provide any evidence in her or his possession that pertains to the claim in accordance with 38 C.F.R. § 3.159(b)(1). VCAA notice should be provided to a claimant before the initial unfavorable agency of original jurisdiction (AOJ) decision on a claim. Pelegrini v. Principi, 18 Vet. App. 112 (2004). The appellant has been advised of VA's duties to notify and assist in the development of her claim. A September 2004 letter from the RO explained what the evidence needed to show to substantiate a claim for dependency and indemnity compensation. It also explained that VA was responsible for obtaining relevant records from any federal agency, and that VA would make reasonable efforts to obtain records not held by a federal agency, but that it was the appellant's responsibility to make sure that VA received all requested records not in the possession of a federal department or agency. This letter also advised the appellant to submit any evidence in her possession pertaining to her claim. Although the appellant was not provided notice regarding criteria for rating the disabilities at issue and effective dates of awards (See Dingess/Hartman v. Nicholson, 19 Vet. App. 473 (2006)) such notice would only be relevant if the benefits sought were being granted. The Board notes that the appellant did not receive notice in a VA notice letter of the specific criteria applicable to a claim under 38 U.S.C.A. § 1151. The Board finds, however, that she was not prejudiced by this omission as her submissions establish that she understands that in order for her section 1151 allegations relating to VA's prescribing of certain medications to be substantiated, it must be established that the medications caused or contributed to cause the veteran's death and that VA was in some way at fault for prescribing them. Thus, with this understanding the appellant had ample opportunity to voice her contentions regarding VA fault leading to the veteran's death, and in fact, has presented a number of such contentions. Further, in November 2007, the appellant indicated that she had no further evidence to submit. Consequently, the Board finds that given the appellant's general knowledge of what was needed to be established to substantiate her claim as evidenced by her specific contentions that VA fault through the prescribing of certain medications led to the veteran's death; given that the appellant has had ample opportunity to present such contentions; and given that the appellant has affirmatively indicated that she has no further evidence to submit, the Board finds that the appellant was not prejudiced by the lack of specific section 1151 notice, as it did not affect the essential fairness of the adjudication. Sanders v. Nicholson, 487 F.3d 881 (Fed. Cir. 2007). Further, although VCAA notice was not given prior to the rating on appeal, the appellant had ample opportunity to respond to the notice letter, along with subsequent supplemental statements of the case (SSOCs) after notice was given. These SSOCs also readjudicated the claim after the notice was provided. The appellant is not prejudiced by any technical notice deficiency that may have occurred along the way, and no further notice is required. See Conway v. Principi, 353 F.3d 1369 (Fed. Cir. 2004). Regarding VA's duty to assist, the RO has obtained the available medical evidence. Additionally, a VA medical opinion was provided in October 2004. The appellant has not identified any additional evidence pertinent to this claim. VA's assistance obligations are met. The veteran is not prejudiced by the Board's proceeding with appellate review. II. Factual Background A March 1999 VA examination report noted that one of the medications the veteran was taking was propulsid. VA medical records show that the veteran was taking cisparide (i.e. propulsid) during the time frame between March 2000 and July 2000. A June 2000 letter from the VA pharmacy service noted that pharmacy records indicated that the veteran had received a prescription for a drug called cisparide (Propulsid) during the last year. The letter then indicated that the company that made cisparide had informed the pharmacy service that some serious heart problems had been reported in patients taking Cisparide. In most of the cases the problems occurred when cisparide was used with patients with known risk factors. These risk factors included drug interactions, certain heart rhythm problems, and low calcium, potassium or magnesium levels. Because of these problems, the manufacturer was removing cisparide from the market as of July 2000. The veteran was advised that if he was still taking cisparide and his provider had not already contacted him, that he should contact the provider soon to discuss other treatments. A June 2000 progress note shows that a treating physician of the veteran was informed by the pharmacy that cisparide had been discontinued from the market due to associated cardiac toxicity. The physician called the veteran's home and left a message for the veteran to stop taking the cisparide and to inform the veteran that he was sending him a Reglan prescription in the mail to replace the cisparide. An August 18, 2000 VA progress note showed that the veteran was taking the following medications, simvastatin, atenolol, diphenydramine, metoclopramide, fosinopril, warfarin (coumadin), spironolactone (i.e. aldactone), lansoprazole, furosemide, allopurinol, colchidine PRN, digoxin, K-Dur, Nitroglycerin and ferrous sulfate. A September 29, 2000 VA medical record shows that the vetean's anticoagulation medication was deemed to be therapeutic. It was noted that his new medications might increase anticoagulation so he needed to be monitored due to the medication change. He was supposed to return to the clinic for a recheck in 4 weeks. A September 29, 2000 VA progress note shows that the veteran was seen by treating physician Dr. B. Dr. B noted that there was better ventricular rhythm control but not ideal and that the veteran was somewhat hypervolemic. She also noted that the veteran staunchly refused a multigated angiogram or a persantine thallium stress test. A separate September 29, 2000 progress note signed by a pharmacist shows that the veteran reported chronic chest pain relieved by nitroglycerin and that he needed a nitroglycerin dose almost everyday. Cardiology was noted to be aware of the situation. The veteran also experienced shortness of breath, which was relieved by rest. It was further noted that the veteran had been put on digoxin and spironolactone that day. An October 2000 ambulance report shows that the veteran fell at Wal Mart. When the ambulance arrived at the scene, county personnel were trying to restrain the veteran who was supine with blood coming from the back of his head and right ear. The veteran was very combative and confused. Bystanders stated that the veteran had been standing in line at a register, looking confused. He started to shake, then his eyes rolled back and he fell. The veteran was placed on a backboard, loaded into an ambulance and taken to the hospital. An October 4, 2000 emergency room note shows that the veteran presented with complaints of suffering a syncopal episode, by witness statements at Wal Mart, hitting the ground and becoming combative. He was brought in to the emergency room and was noted to be bleeding from the right ear. A subsequent October 4, 2000 history and physical noted that the veteran's past history was significant for cardiomyopathy and that he had had episodes of syncope in the past with documented intermittent atrial flutter, right bundle branch block and left vesticular block. A current EKG showed a similar pattern. A subsequent October 4, 2000 operative report shows that the veteran received a craniotomy for evacuation of the subdural hematoma along with placement of a subdural pressure monitor for intracranial pressure measurement. The report noted that the veteran had had a syncopal episode, falling down and striking his head. An October 2000 hospital discharge summary noted that the veteran had originally been brought to the emergency room after collapsing and hitting his head while shopping. After arriving at the ER it was apparent that he had a basilar skull fracture and intracranial bleeding. His left sided subdural hematoma was eventually evacuated and he was then monitored in the intensive care unit (ICU). In the ICU the veteran did poorly, with ongoing problems with brain edema. Efforts to control the edema with mannitol and hyperventilation were not fruitful. The veteran had continued difficulties with cardiac rhythm, at least one episode requiring resuscitation. The veteran later became unresponsive and it was apparent that brain death had occurred. After discussion with the family it was elected to withdraw further life support. An October 2000 autopsy report concluded that the diagnosis and cause of death of the veteran was cerebral edema due to subdural hematoma with necrosis of a large area of the left temporal parietal cerebrum. The veteran's October 2000 death certificate shows that the immediate cause of death was cerebral edema due to subdural hematoma. Old myocardial infarction and severe coronary arteriosclerosis native and graph were listed as other significant conditions contributing to death but not related to the immediate cause. An October 2000 record, submitted by the appellant in March 2001 and apparently written by Officer P of the Yuba County Sheriff's Office indicated that the officer had spoken with the appellant and that the appellant had indicated that on the day of his collapse, the veteran had left home to do some errands. He was at Wal Mart in Yuba City when he collapsed and was taken to Rideout Emergency Center by ambulance. The appellant was notified and when she got to the hospital she learned he needed surgery in his head because of the fall. Before the surgery the veteran was coherent and wanted to leave the hospital and after it he did not fully regain consciousness. The appellant noted that the veteran had been treated by a Dr. B at Mather VA since April 2000 and that Dr. B last saw the veteran on September 29, 2000. She also indicated that on September 29, 2000 she and the veteran told Dr. B that the veteran's dizzy spells were getting worse every day and that he would almost pass out. Dr. B informed them not to worry as it was a common symptom for patients such as the veteran. She then increased the veteran's aldactone and added lasix (160 mg per day) and digoxin. An October 2001 memorandum from the director of the VA Northern California Health Care System responded to a number of allegations by the appellant. The appellant had alleged that VA physicians had known that the veteran had a bleeding problem but was given Coumadin, Aldactone and Lasix anyway. Also, when previously on the Aldactone medication the veteran had passed out twice and the physicians knew this, but still prescribed it. While on the medications the veteran passed out again in a store causing him to fall and hit his head. This in turn caused brain damage and the veteran died as a result. The appellant also indicated that because the veteran had had congestive heart failure and artery disease, he should not have been taking coumadin as the veteran had told his assigned VA physician that he had had made him feel faint and dizzy. The veteran had seen the doctor on September 29, 2000 and then passed out and hit his head on October 4, 2000, approximately four days after seeing the physician. The memorandum found that all of the above allegations were unfounded. It noted that the veteran was first seen at the Sacramento VA Medical Center cardiology clinic by a Dr. M on June 15, 1999, after a referral by his primary care physician, Dr. C. During his first visit to primary care, it was noted that no medical records from Dr. C were available for the VA physicians to review. The veteran had had a long history of multiple medical problems including congestive heart failure and coronary artery disease. His status was closely monitored during three more visits to the VA's cardiac clinic in 1999. In 2000, the veteran was evaluated in the cardiology clinic every one to two months. It was often necessary for physicians to try various medications to arrive at one which works best for a particular patient. All patients did not react in the same way to the same medications. A medication, which worked well for one patient may cause unwanted side effects in another patient. Because the veteran had multiple chronic medical conditions he was evaluated frequently at his clinic visits with laboratory tests to ensure that his prescribed medications were effective and safe. Also, the veteran's cardiac care was peer reviewed in October 2000 and it was found that the standard of care was met. In November 2000 the Sacramento VA Medical Center's physician review committee reviewed the case and agreed with these findings. Medical records obtained from the veteran's October 2000 hospitalization after his fall and prior to his death noted multiple medical problems and made no reference to an adverse drug event or improper care at the Sacramento VA Medical Center contributing to the veteran's injury on October 4, 2000. Dr. B, the cardiologist, personally notified the Quality Improvement staff about the complaint received from the appellant shortly after the veteran's death so appropriate follow-up could occur. In a December 2001 statement the appellant indicated that the veteran was given cisparide for a year and that it made his heart condition worse. She noted that cisparide was taken off the market in July 2000 because it was known not to be safe. She found out about the safety issues in April 2000 and stopped giving it to the veteran. The appellant also attached to this statement an information sheet pertaining to Coumadin. On the information sheet she once again noted that she and the veteran had told Dr. B that the veteran felt like he was going to pass out all the time but Dr. B told them not to worry as this was a common symptom. At her April 2003 Decision Review Officer (DRO) hearing at the RO, the appellant indicated that she believed that the veteran fell at the Wal Mart in October 2000 at least in part because of medication he was taking, which would make him faint. The appellant also testified that VA had the appellant on Propulsid for almost two years from 1999 to April 2000 and then in June 2000 they told him not to take the medication because it was bad for his heart. When he started taking Propulsid, his health started getting worse. She felt that the medication must have damaged the veteran's heart as it was capable of causing damage to a person who did not have pre-existing heart trouble. In an October 2004 VA medical opinion, Dr. G, after reviewing the claims file noted that in September 2000 the veteran was a 63 year old male with a history of atrial fibrillation, coronary artery bypass graft, peripheral vascular disease, status post carotid endarectomy, congestive heart failure, hypertension, chronic renal insufficiency and gout. The medicines that he was taking were Coumadin, Simvastatin, Atenolol, Diphenydramine, Metoclopramide, Fosinopril, Warfarin, Spironolactone, Lansoprazole, Lasix, Allopurinol, Colchicine, Nitroglycerin, K-Dur and Digoxin. The veteran had not been taking Cisparide after July 2000 and he was not having any symptoms related to the Cisparide that could be determined from the claims file. With regard to the question as to whether Cisparide adversely affected the veteran's cardiac status, Dr. G noted that the veteran had had coronary artery disease long before he starting Cisparide and that he had EKGs performed while he was taking Cisparide and these showed no evidence of QT prolongation or torsade de pointes. Also, the veteran was taken off cisparide not due to any cardiac toxicity but for non-medical reasons (i.e. the medication was being taken off the market). Consequently, Dr. G found that there was no specific evidence in the claims file that the veteran had cardiac adverse effects due specifically to the use of Cisparide. In June 2006 a VA cardiologist indicated that he concurred with Dr. G's assessment. In January 2005 the appellant submitted an undated newspaper article indicating that Spironolactone (i.e. Aldactone) helped the kidneys get rid of excess water and salt but could cause potassium to build up in the blood. At high blood levels (i.e. hyperkalemia) potassium could cause irregular heart rates or sudden death. The article also cited a study that showed that adding Spironolactone to standard treatments of heart failure cut the death rate by 30 percent in people with serious heart failure. III. Law and Regulations 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 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 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. From the plain language of the statute, it is clear that to establish entitlement to Section 1151 benefits, all three of the following factors must be shown: (1) disability/additional disability, (2) that VA hospitalization, treatment, surgery, examination, or training was the cause of such disability, and (3) that there was an element of fault on the part of VA in providing the treatment, hospitalization, surgery, etc., or that the disability resulted from an unforeseen event. Effective September 2, 2004, 38 C.F.R. § 3.361 relating to section 1151 claims was promulgated for claims filed on or after October 1, 1997, such as this appellant's claim (received in August 2000). See 69 Fed. Reg. 46,426 (Aug. 3, 2004) (codified as amended at 38 C.F.R. § 3.361 (2007)). In determining whether a veteran has an additional disability, VA compares the veteran's condition immediately before the beginning of the hospital care or medical or surgical treatment upon which the claim is based to the veteran's condition after such care or treatment. 38 C.F.R. § 3.361(b). To establish causation, the evidence must show that the hospital care or medical or surgical treatment resulted in the veteran's additional disability. Merely showing that a veteran received care or treatment and that the veteran has an additional disability does not establish cause. Hospital care, medical or surgical treatment, or examination cannot cause the continuance or natural progress of a disease or injury for which the care, treatment, or examination was furnished unless VA's failure to timely diagnose and properly treat the disease or injury proximately caused the continuance or natural progress. Additional disability or death caused by a veteran's failure to follow properly given medical instructions is not caused by hospital care, medical or surgical treatment, or examination. 38 C.F.R. § 3.361(c)(1). 38 C.F.R. § 3.361(d) states that the proximate cause of disability or death is the action or event that directly caused the disability or death, as distinguished from a remote contributing cause. 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, medical or surgical treatment, or examination caused the veteran's additional disability or death (as explained in paragraph (c) of this section); 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, medical or surgical treatment, or examination without the veteran's or, in appropriate cases, the veteran's representative's 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. Minor deviations from the requirements of 38 C.F.R. § 17.32 that are immaterial under the circumstances of a case will not defeat a finding of informed consent. 38 C.F.R. § 3.361(d)(1). It is the policy of VA to administer the law under a broad interpretation, consistent with the facts in each case with all reasonable doubt to be resolved in favor of the claimant; however, the reasonable doubt rule is not a means for reconciling actual conflict or a contradiction in the evidence. 38 C.F.R. § 3.102. When there is an approximate balance of positive and negative evidence regarding the merits of an issue material to the determination of the matter, the benefit of the doubt in resolving each such issue shall be given to the claimant. 38 U.S.C.A. § 5107(b). When all of the evidence is assembled, 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 fair preponderance of the evidence is against the claim, in which case the claim is denied. Gilbert v. Derwinski, 1 Vet. App. 49, 55 (1990). IV. Analysis The appellant essentially alleges that VA health care in the form of the prescribing of certain medications caused or contributed to cause the veterans death. More specifically she alleges that cisparide caused or contributed to cause the veteran's death by damaging his heart; that coumadin and/or aldactone and perhaps also lasix and digoxin caused the veteran to fall at Wal-Mart, resulting in his subdural hematoma; and that side effects from aldactone (i.e. hyperkalemia) caused or contributed to cause the veteran's death. The Board will examine these allegations in turn. There is no competent evidence of record that the veteran's taking of cisparide had any adverse impact on his health, let alone that it contributed to his death. To the contrary, the October 2004 VA medical opinion specifically indicated that the veteran that EKG's performed while the veteran was taking Cisparide showed no evidence of QT prolongation or torsade de pointes and that the veteran was taken off cisparide not due to any cardiac toxicity but for non-medical reasons. Thus, the opinion concluded that there was no specific evidence in the claim file that the veteran had any cardiac adverse effects due specifically to the cisparide. Although the appellant alleges that the veteran's heart was damaged by cisparide, her allegations are not competent evidence of a medical nexus. See Espiritu v. Derwinski, 2 Vet. App. 492, 494 (1992). Thus, in the absence of any evidence that cisparide harmed the veteran's heart or otherwise harmed him in any way, and with the specific VA physician's opinion indicating that the veteran did not experience any cardiac adverse effects from the cisparide, the weight of the evidence is clearly against a finding that the veteran's taking of the prescribed cisparide caused or contributed to his death. Similarly, there is no evidence of record indicating that any of the veteran's medications, including Coumadin, Aldactone, Lasix or digoxin, caused the veteran's fall at Wal-Mart, which in turn caused his death causing subdural hematoma. The medical records from the veteran's hospitalization after his fall show that, according to witness descriptions, the veteran's fall was apparently caused by an episode of syncope. Syncope is defined as loss of consciousness and postural tone caused by diminished cerebral blood flow (See Stedmans Medical Dictionary, 27th edition, 2000) and the veteran was noted to have a history of this symptomatology. There is no competent medical evidence of record showing that the medications the veteran was taking, including Coumadin, Aldactone, digoxin or Lasix caused the apparent syncope that led to the veteran's fall or any other episode of syncope. Also, the October 2001 VA memorandum specifically looked into the appellant's allegations that these medications caused the veteran to fall and after reviewing the record and noting that the veteran's cardiac care had been peer reviewed and reviewed by the Sacramento VA medical center's peer review committee, the memorandum concluded that the appellant's allegations had no merit. Once again, although the appellant alleges that the medications caused, or contributed to cause, the veteran's death by causing his fall, as a layperson, her allegations are not competent evidence of a medical diagnosis or nexus. See Espiritu, 2 Vet. App. at 494. Thus, in the absence of any competent evidence that the medications caused the veteran's fall or otherwise caused or contributed to cause the veteran's death, and with specific competent evidence showing that the appellant's allegations in this regard were without merit, the weight of the evidence is against a finding that the veteran's death causing fall was related to the medications taken by the veteran and prescribed by VA. Further, there is no competent evidence of record that side effects from aldactone caused or contributed to cause the veteran's death. Notably, the record contains no evidence that the major side effect cited by the appellant in conjunction with taking aldactone, hyperkalemia, caused or contributed to cause the veteran's death. Nor is there any evidence that any other effects from aldactone caused or contributed to cause the veteran's death. Also, as discussed above, the appellant is not competent to provide an opinion on the medical question of whether taking aldactone caused or contributed to cause the veteran's death. Id. In summary, given that there is no competent evidence that medications prescribed by VA caused or contributed to cause the veteran's death and specific competent evidence weighing against VA prescribed medications causing, or contributing to cause, the veteran's death, there is no basis in the record for substantiating appellants 38 U.S.C.A. § 1151 dependency and indemnity compensation claim. 38 U.S.C.A. § 1151; 38 C.F.R. § 3.361(c)(1). The preponderance of the evidence is against this claim and it must be denied. ORDER Entitlement to dependency and indemnity compensation (DIC) under the provisions of 38 U.S.C.A. § 1151 for the cause of the veteran's death is denied. ____________________________________________ James L. March Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs