Veterans’ claims: HH v. Shinseki 11-1612

           

United States Court of Appeals for Veterans Claims

_________________________

Vet. App. No. 11-1612

______________________

H.H

Appellant,

v.

ERIC K. SHINSEKI,

Secretary of Veterans Affairs,

Appellee.

_______________________________________________________________

BRIEF FOR APPELLANT

_________________________________________________________________

David Anaise, MD, JD

Benham & Anaise, LLC

177 N Church Ave Ste 883

Tucson AZ 85701

(520) 882-3622

TABLE OF CONTENTS

TABLE OF CONTENTS

TABLE OF CASES, STATUTES, AND OTHER AUTHORITIES

STATEMENT OF THE ISSUES

STATEMENT OF THE CASE

SUMMARY OF THE ARGUMENT

ARGUMENT

1. THE BOARD FAILED TO OBTAIN THE ENTIRE MEDICAL RECORD, FAILED TO ORDER A MEDICAL EXPERT EVALUATION OF THE ISSUES PRESENTED AT THE 9/30/2004 EVENT, AND FAILED TO DELIBERATE AND RENDER A DECISION REGARDING WHETHER THE ALLEGED NEGLIGENCE BY THE VA MET 38 USC §1151.

2. THE BOARD INAPPROPRIATELY LIMITED ITS INQUIRY TO THE CARE VETERAN RECEIVED PRIOR TO HIS DEMISE IN APRIL 2005 RATHER THAN TO 9/30/2004 WHEN THE ALLEGED NEGLIGENCE OCCURRED.

3. THE BOARD MINIMIZED THE TOXIC EFFECTS OF DILANTIN.

4. THE VA STAFF’S DECISION TO ADMINISTER DILANTIN RATHER THAN OTHER ANTISEIZURE MEDICATION WAS NEGLIGENT.

5. THE DECISION TO DISCHARGE THE VETERAN WITHIN A FEW HOURS FROM HIS ADMISSION ON SEPTEMBER 30, 2004, WAS NEGLIGENT.

6. THE ADMINISTRATION OF DILANTIN BY THE APPELLANT WITH NO INSTRUCTION OR SUPERVISION BY MEDICAL STAFF WAS NEGLIGENT UNDER THE CIRCUMSTANCES.

7. AS A RESULT OF ERRORS BY THE EMPLOYEES OF THE VA ON SEPTEMBER 30, 2004, THE VETERAN SUFFERED IRREVERSIBLE DAMAGE TO HIS HEALTH THAT LED TO HIS DEMISE.

8. THE BOARD FAILED TO ASSIST APPELLANT (VETERAN’S WIDOW).

9. THE BOARD ERRED IN NOT APPLYING THE BENEFIT-OF-THE-DOUBT DOCTRINE.

   CONCLUSION

TABLE OF CASES, STATUTES, AND OTHER AUTHORITIES

Addington v. Texas , 441 U.S. 418, 99 S.Ct. 1804, 60 L.Ed.2d 323 (1979)	21, 25
Brown v. Bd. of Educ. , 347 U.S. 483, 495 n.11 (1954)	21-22
Cohen v. Brown , No. 94-661 10 (U.S. Vet.App. March 7, 1997)	21
Dep’t of Labor v. Greenwich Collieries , 512 U.S. 267, 281, 129 L. Ed. 2d 221, 114 S. Ct. 2251	26
Gardner v. Brown , 5 F.3d 1456 (Fed.Cir. 1993)	13
Gilbert v. Derwinski , 1 Vet. App. 49, 53-56 (1990)	25, 27
Murphy v. Derwinski , U.S. Vet. App. No. 90-107	17
Ortiz v. Principi , 274 F.3d 1361 (Fed. Cir. 2001)	26
Paralyzed Veterans of Am. v. McPherson , 2008 Sept. Dist. Sept 69542	22
Patton v. West , 12 Vet.App. 272, 280 (1999)	17
Ragin v. Harry Macklowe Real Estate Co. , 6 F.3d 898, 907-08 (2d Cir. 1993) (quoting Maurer v. United States, 668 F.2d 98, 100 (2d Cir. 1981) (per curiam), and citing Restatement (Second) of Torts 435, at 454 (1965) and W. Page Keeton et al., Prosser and Keeton on the Law of Torts 43, at 292 (5th ed. 1984)); see Maurer, 668 F.2d at 99-100	21
Roberson v. Shinseki , 607 F.3d 809 (2010)	14

Statutes

38 USC §1151	5, 7, 8, 10, 11, 14, 15, 25, 28
38 USC §1151, 5107 (West 2002 & Supp. 2010)		8
38 USC §3007(b)		25, 27
38 USCA §4004(d)(1)		27
38 USC §4061(a)(1), (3), (4)		27
38 USC §5107		26
38 USCA §5107 (West 2002)		14
38 USC §5107(a)		17
38 USC §5107(b) (West Supp. 2001)		26

Regulations and Other Authorities

38 CFR §3.102	26
38 CFR §3.103(c)	17
38 CFR §3.358	6, 10, 12
38 CFR §3.358 (1992)	13
38 CFR §3.358(b)(1), (2) (2008)	14
38 CFR §3.358(c)(1)	13
38 CFR §3.358(c)(3)	13
38 CFR §3.361 (2010)	8
Federal Rule of Evidence 201	21
Federal Rule of Evidence 201(b)	21, 22
Federal Rule of Evidence 201(d)	21
American Association of Poison Control, 2004 Annual Report	9, 18
Mattson in New England Journal of Medicine 1985, 31.3, 145 and Smith D.B., Results of nationwide Veteran Administration Cooperative Study, comparing the efficacy and toxicity of carbamazepine, phenobarbital, Dilantin published in Epilepsia in 1987, 28 supplement 3, page 550.	23
Veterans’ Claims Assistance Act of 2000 (VCAA)	15-16
West’s Encyclopedia of American Law, Edition 2, Copyright 2008 The Gale Group, Inc.	13

Record before the Agency

R. 2203	20
R. 2487	5
R. 2491	5, 6, 16
R. 2498	6, 18
R. 2505	6, 12, 16
R. 2529	20

Appendices

1	Potentially Inappropriate Antiepileptic Drugs for Elderly Patients with Epilepsy.  Mary Joe Pugh, PhD, et al; JAGS Volume 52:417-422, 2004.	23
2	Seizure Disorders in the Elderly. Lourdes Velez, M.D., and Linda M. Selva, M.D. Am Fam Physician 2003; 67:325-32. Copyright © 2003 American Academy of Family Physicians.	22, 24
3	Phenytoin (Dilantin] – drug information from the US National Library of Medicine, National Institutes of Health (http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682022.html)	—
4	Toxic Neuropathies Associated with Pharmaceutic and Industrial Agents.  Neurologic Clinics – Volume 25, Issue 1 (Feb.2007) Copyright © 2007 W. B. Saunders Co.	—
5 & 6	Veteran’s (Mr. CWH) hospital records from September 30, 2004, Houston VAMC.  36 pages (submitted in two parts)	15

STATEMENT OF THE ISSUES

1. Whether the Board’s decision to deny Appellant (Veteran’s widow) DIB pursuant to 38 USC §1151 is clearly erroneous and therefore must be reversed?

2. Whether the Board’s finding that no nexus is found between Veteran’s injury by the VA on 9/30/2004 and his ultimate demise in 4/2005 is clearly erroneous and therefore must be reversed?

3. In the alternative whether the Board failed to assist Appellant (Veteran’s widow) in adequately investigating Appellant’s complaint?

4. In the alternative whether the Board erred in not applying the benefit-of-the-doubt doctrine?

   STATEMENT OF CASE

               Richard H (“Veteran”) served on active duty from July 1946 to January 1948 and passed away in April 2005. Appellant is Veteran’s surviving spouse (“Appellant”). The case was before the Board of Veterans’ Appeals. After a July 2005 rating decision which had denied benefits, Appellant sought an appeal (R. 2487). A hearing before a BVA board member was held in August 2006 (R. 2491). The widow testified at a hearing (R. 2491) that prior to Veteran’s hospitalization on September 30, 2004, Veteran had been functional at home and had never been admitted to a nursing home or any extended care facility for any extended period of time. Appellant testified that on September 30, 2004, she called 911, because Veteran was diabetic, and she suspected diabetic problems. At the hospital, physicians told Appellant that they suspected that Veteran had had a seizure. Veteran was promptly discharged and taken home that night. The hospital personnel gave Veteran two pills of Dilantin and told Appellant to give him two pills every day and three pills every night. (R. 2491). She was instructed to make an appointment in two weeks.

               On October 14, 2004, Appellant called for an ambulance to bring Veteran back to the hospital. Dilantin toxicity was diagnosed. Dilantin level was twice the upper limit of the therapeutic level. (R. 2498). Due to Veteran’s marked medical deterioration as a result of the Dilantin toxicity, Veteran was admitted first to the hospital and then to a nursing facility. He never returned home. Veteran was admitted to the hospital in April 2005 in a severely debilitative state and succumbed shortly to sepsis.

               Mr. Knox, who was Veteran’s representative, stated (R. 2505) that prior to Veteran’s exposure to Dilantin, Veteran was fully functional at home, had not been in any medical facilities, and had not been under any hospital care. He was actually helping to take care of his wife. Veteran actually was well enough to be sent home after only a brief stay at the ER on September 30, 2004. After the Dilantin episode, Veteran remained under hospital and nursing care until his demise. Mr. Knox argued, with no objection from the hearing judge, that Dilantin toxicity was an aggravated cause of injury, which led directly to Veteran’s death with no intervening causes.

               Pursuant to 38 CFR 3.358,^[1] the representative argued that the Board must compare the physical condition of Veteran immediately prior to the disease or injury to the physical condition of Veteran after the disease or injury. Veteran was admitted on October 14, 2004, because of Dilantin toxicity, and Veteran never returned home to his full strength or intellectual capacity after that episode.

               The BVA judge remanded the case to the RO. Specifically this judge did not limit the inquiry to April 2005. Rather, the Judge held that the file would be forwarded for review to a qualified physician who had not previously treated or evaluated Veteran, and the expert would answer the question whether Veteran’s death was caused or in any way contributed to by carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA in furnishing the relevant treatment, including views on Dilantin, or due to an event not reasonably foreseen. The opinion would address the principal of “it is as likely as not to at least a 50-50 degree of probability.” The case would then be reviewed and a supplemental statement of the case would be issued and then returned to the Board.

               The BVA heard Veteran’s case on February 28, 2011, on appeal from the Department of Veterans’ Affairs, Regional Office in Houston, Texas. Appellant requested Entitlement to Dependency and Indemnity Compensation (Ole) benefits under 38 USC §1151.

               The BVA noted that Veteran died on April 10, 2005. The immediate cause of death was reported as gram negative sepsis due to or as a likely consequence of pneumonia, due to or as a likely consequence of acute myocardial infarction. No other significant condition contributing to death was reported on the death certificate.

   The Board determined that:

   “The competent evidence of record does not demonstrate that Veteran’s death was actually caused by VA hospitalization or medical or surgical treatment, or was proximately caused by carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA in furnishing the hospital care, medical or surgical treatment, or that it was proximately caused by an event not reasonably foreseeable.      The criteria for entitlement to compensation under 38 USC §1151, for the cause of Veteran’s death have not been met. 38 USC §§1151,5107 (West 2002 & Supp. 2010); 38 CFR §3.361 (2010).”

               In an October 2004 VA hospital entry, it was noted that Veteran had been admitted and was treated for Dilantin toxicity. In a statement from Veteran’s attending physician dated prior to his death in April 2005, it was noted that his primary diagnoses were severe dementia; a moderate seizure disorder; and diabetes. In a July 2005 VA medical opinion, the clinician noted that he was asked to determine if Veteran’s death was the result of an overmedication with Dilantin. He noted that the record revealed Veteran died from gram negative sepsis, pneumonia, and acute myocardial infarction.

               A May 2005 letter from Appellant alleged that Veteran had been overmedicated with Dilantin which eventually caused an infection in his blood stream leading to his death. The clinician noted that Veteran had previously been treated with Dilantin but had been taken off of Dilantin due to toxicity. After a review of the medical records and claims file, the clinician offered the following opinion:

   “16 [The Veteran] was admitted to the hospital with cachexia and numerous chronic health problems. He died of causes listed on his death certificate signed by Dr. Gorin, compounded with his age. It is my firm belief that none of his diseases was caused or aggravated by his treatment with Dilantin, or history of seizure disorder, or by discontinuing of Dilantin.”

               In a May 2010 VA medical opinion, it was opined that the death of Veteran was less likely as not caused by, contributed to, or as the result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing the relevant treatment including use of Dilantin and/or due to an event not reasonably foreseeable. The rationale given was that the 2004 Annual Report of the American Association of Poison Control Center’s Toxic Exposure Surveillance System reviewed 4,059 toxic Dilantin exposures in 2003 that resulted in only seven deaths, six of which included combined exposures to Dilantin and other drugs. Although rarely used today for cardiac arrhythmias, the FDA only noted 10 deaths from cardiac events between 1997 and 2002 due to the infusion of fosDilantin. It was noted that adverse cardiac events from Dilantin toxicity are [relatively very] rare compared to the frequency of toxic and/or therapeutic exposure to this drug. Adverse cardiac events were frequently associated with additional predisposing factors beyond just Dilantin.

               The clinician further noted that the date of death was April 10, 2005, and that the hospital discharge summary noting the resolved Dilantin toxicity was dated November 2, 2004 (date of admission October 14, 2004).

               The discharge summary gave no indication of any residual toxic effects or conditions related to the Dilantin. In summary, the clinician opined: “I find no probable basis for attributing this Veteran’ death to his having received Dilantin or at this point to inadequate VA care in general.”

   SUMMARY OF THE ARGUMENT

               Mr. Knox, who was Veteran’s representative, argued that pursuant to 38 CFR 3.358, the Board must compare the physical condition of Veteran immediately prior to the disease or injury to the physical condition of Veteran after the disease or injury. Veteran was admitted on October 14, 2004, because of Dilantin toxicity, and Veteran never returned home to his full strength or intellectual capacity after that episode.

               The BVA judge remanded the case to the RO. Specifically this judge did not limit the inquiry to April 2005. Rather, the Judge held that the file would be forwarded for review to a qualified physician who had not previously treated or evaluated Veteran, and the expert would answer the question whether Veteran’s death was caused or in any way contributed to by carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA in furnishing the relevant treatment.

               The BVA heard Veteran’s case on February 28, 2011. The BVA limited its review to Veteran’s admission to the hospital on April 10, 2005. They noted that the immediate cause of death was reported as gram negative sepsis due to or as a likely consequence of pneumonia, due to or as a likely consequence of acute myocardial infarction. No other significant condition contributing to death was reported on the death certificate. With that fact alone, the BVA concluded that the Veteran was not eligible for disability based on 38 USC §1151.

               We argue:

1. The Board failed to obtain the entire medical record, failed to order a medical expert evaluation of the issues presented at the 9/30/2004 event, and failed to deliberate and render a decision regarding whether the alleged negligence by the VA met 38 USC §1151.

2. The Board inappropriately limited its inquiry to the care Veteran received prior to his demise in April 2005 rather than to 9/30/2004 when the alleged negligence occurred.

3. The Board minimized the toxic effects of Dilantin.

4. The VA staff’s decision to administer Dilantin rather than other antiseizure medication was negligent.

5. The decision to discharge Veteran within a few hours from his admission on September 30, 2004, was negligent.

6. The administration of Dilantin by the Appellant with no instruction or supervision by medical staff was negligent under the circumstances.

7. As a result of errors by the employees of the VA on September 30, 2004, the Veteran suffered irreversible damage to his health that led directly to his final demise on April 10, 2005, with no further intervening cause.

8. The Board failed to assist Appellant (Veteran’s widow).

9. The Board erred in not applying the benefit-of-the-doubt doctrine.

   ARGUMENT

   The BVA erred by limiting the inquiry to the events of April 2005.

               The Board limited its inquiry to the care Veteran received prior to his demise in April 2005. It concluded:

• No error in care was shown during that hospitalization.

• The death certificate did not indicate that the cause of death was Dilantin toxicity.

• Direct death from cardiac toxicity caused by Dilantin is rare.

              The Board ignored Appellant’s direct request during the 2006 hearing to have the Board investigate the events that led to Veteran’s death in April 2005 which emanated from proven Dilantin toxicity in October 2004. At the BVA hearing in 2006^[2], Veteran’s Representative argued, with no objection from the hearing judge, that Dilantin toxicity was an aggravated cause of injury, which led directly to Veteran’s death with no intervening causes. Pursuant to 38 CFR 3.358, the Representative argued that the Board must compare the physical condition of Veteran immediately prior to the disease or injury, to the physical condition of Veteran after the disease or injury. Veteran was admitted by VA records because of Dilantin toxicity, and Veteran never returned home to his full strength or intellect after that episode.

              The record shows that Veteran was admitted in April 2005 suffering from “cachexia” defined as “a profound and marked state of constitutional disorder; general ill health and malnutrition; state of health with physical atrophy and weakness often found in the last stages of terminal illness.” There is also no doubt that on October 14, 2004, the Veteran was found to suffer from Dilantin toxicity caused by what we argue was negligent administration of the drug by the staff of the VA hospital. It is also established fact that Veteran never regained his health after that insult and was brought in a moribund state to the hospital in April 2005 only to die shortly thereafter. The Court in Gardner v. Brown, 5 F.3d 1456, defined the way 38 USC §1151, should be applied:

  “38 USC §1151 provides for compensation to veterans who are disabled by VA medical treatment or examination or vocational training. It states in pertinent part: Where any veteran shall have suffered an injury, or an aggravation of an injury, as the result of hospitalization, medical or surgical treatment, … and such injury or aggravation results in additional disability to or the death of such veteran, disability or death compensation under this chapter … shall be awarded in the same manner as if such disability, aggravation, or death were service-connected.”

              The interpretation of the statute asserted by the VA appears at 38 CFR §3.358 (1992). The regulation provides that a veteran must prove he suffered a disability, disease, or injury, or aggravation thereof, as the result of a specified VA service, and not merely coincidental with it. 38 CFR §3.358(c)(1). Compensation is payable in the event of the occurrence of an “accident” (an unforeseen, untoward event), causing additional disability or death proximately resulting from Department of Veterans’ Affairs hospitalization or medical or surgical care. 38 CFR §3.358(c)(3).

              The operative words are “additional disability or death proximately resulting from Department of Veterans’ Affairs hospitalization or medical or surgical care.” Proximate cause is defined as^[3]: An act from which an injury results as a natural, direct, uninterrupted consequence and without which the injury would not have occurred. Proximate cause is the primary cause of an injury. It is not necessarily the closest cause in time or space or the first event that sets in motion a sequence of events leading to an injury. Proximate cause produces particular, foreseeable consequences without the intervention of any independent or unforeseeable cause. It is also known as legal cause. The regulation further states:

  “In determining whether additional disability exists, the Veteran’s physical condition immediately prior to the disease or injury upon which the claim for compensation is based will be compared with her physical condition subsequent thereto. With regard to medical or surgical treatment, the Veteran’s physical condition prior to the disease or injury is the condition which the medical or surgical treatment was intended to alleviate. 38 CFR §3.358(b)(1), (2) (2008). As with any claim, when there is an approximate balance of positive and negative evidence regarding any matter material to the claim, the claimant shall be given the benefit of the doubt. 38 USCA §5107 (West 2002).”

              In Roberson v. Shinseki, 607 F.3d 809, a leading case for the evaluation of 38 USC §1151, (a case that has ended in the United States Supreme Court), Appellant Catherine Roberson appealed the decision of the Court of Appeals for Veterans’ Claims (Veterans’ Court) affirming the Board of Veterans’ Appeals (Board) decision denying Mrs. Roberson’s claim for death and indemnity compensation (DIC) pursuant to former 38 USC §1151 for her husband’s death from non-service-connected cancer. It was determined that onset of the cancer occurred four to six months before the August 1995 diagnosis. Mrs. Roberson appealed the Board’s decision to the Veterans’ Court asserting that VA treatment, that is, the failure to diagnose her husband’s cancer, had the effect of hastening his death. Thus the Board correctly evaluated the events that led to the veteran’s death 6 months earlier and not simply the final days of his death from cancer.

  The BVA failed to assist appellant.

              In the present case, after reviewing the entire medical record composed of more than 2600 pages certified by the board as evidence, we are still puzzled as to exactly what happened on September 30, 2004. Attached are additional records from the VA hospital regarding the 9/30/2004 admission to the ER. These documents were forwarded to the VA attorney and the central staff prior to the conference but were clearly not reviewed by the Board. The few pages of medical records from 9/30/2004 do not shed sufficient light as to exactly what was found, what instructions were given, and exactly what the personnel did regarding Veteran’s care. It is obvious from Appellant’s testimony and from the medical records of the visit on October 14, 2004, that the September admission resulted in the dramatic deterioration in Veteran’s health and led to his ultimate demise.

              Following the conference, it appears to us that the VA attorney does not contest that the inquiry should be limited to 4/2005, but rather he wishes to defend the decisions made by the VA based in part on the records we have obtained that were not made part of the record before you until now. We argue that the sole remedy for the failure of the BVA to review Veteran’s claim fully is a remand. The Board failed to obtain the entire medical record, failed to order a medical expert evaluation of the issues presented on 9/30/2004, and failed to deliberate and render a decision regarding whether the alleged negligence by the VA met 38 USC §1151.

              On November 9, 2000, the Veterans’ Claims Assistance Act of 2000 (VCAA) was signed into law. This law redefines the obligations of the Department of Veterans’

Affairs (VA), and includes the Board of Veterans’ Appeals (BVA). The law specifies the VA’s duty to assist the appellant in obtaining evidence necessary to substantiate a claim and includes an enhanced duty to notify the appellant as to the information and evidence necessary to substantiate a claim for VA benefits. The VA must make reasonable efforts to obtain relevant evidence, such as private medical records, employment records, or records from state or local government agencies.

            It is clear from the record that Appellant, through her representative, specifically asked the BVA judge at the 2006 hearing to investigate the events beginning in 9/30/2004, and not only the 4/2005 admission.

“In the Statement of the Case the question the doctor was asked was, was the veteran’s cause of death the result of overmedication with Dilantin. We feel like this question is not actually the appropriate question to be asked in this situation. The CFR 38 3.358 states that all we have to show is that it was an aggravated cause of the veteran’s death, did it cause disability, meaning did it deprive the veteran of physical and, which is basically the definition of disability, physical, mental or intellectual strength. I think by the story we heard definitely denied the veteran of his physical and his mental strength. The veteran was hospitalized up until that point and never returned home after that until his demise.” (R. 2505).

            The BVA judge remanded the case to the RO. (R. 2491). Specifically, this judge did not limit the inquiry to April 2005. Rather, the Judge held that the file would be forwarded for review to a qualified physician who had not previously treated or evaluated Veteran, and the expert would answer the question whether Veteran’s death was caused or in any way contributed to by carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA in furnishing the relevant treatment, including views on Dilantin, or due to an event not reasonably foreseen. The opinion would address the principal of “it is as likely as not to at least a 50-50 degree of probability.” The case would then be reviewed and a supplemental statement of the case would be issued and then returned to the Board. Regrettably the original judge did not participate in the 2011 proceedings, and it is obvious that his intent for a full review was not carried out. This is a legal error, and the only remedy is a remand.

            Once the claimant has met his burden of submitting evidence sufficient to justify a belief by a fair and impartial individual that the claim is well grounded under §5107(a), the burden then shifts to the Secretary to “assist such a claimant in developing the facts pertinent to the claim.” 38 USC §5107(a).

“Within the non-adversarial process of VA claims adjudication, the word ‘pertinent’ takes on an even stronger meaning; the Secretary’s duty applies to all relevant facts, not just those for or against the claim.” Murphy v. Derwinski, U.S. Vet. App. No. 90-107

            In Patton, the CAVC held that during personal hearings conducted by VA adjudicators, pursuant to 38 CFR §3.103(c), the VA has the responsibility to “suggest the submission of evidence which the claimant may have overlooked and which would be of advantage to the claimant’s position.” Accordingly, if the claimant or the records in the claims file put the VA on notice of the existence of evidence that may help substantiate the claim, the VA is required to obtain the evidence itself or advise the claimant to submit the evidence.

The Board minimized the toxic effects of Dilantin

            It is indisputable that Veteran suffered from Dilantin toxicity. The Dilantin level measured at his admission to the hospital was twice the therapeutic dose (R. 2498). The Board recognized in its decision that Veteran arrived at the hospital a few days before his death in April 2005 in an extreme state of malnutrition and debility. The physician who reviewed the case for the Board stated that Veteran was admitted to the hospital with cachexia^[4] and numerous chronic health problems. The only question is whether there is a nexus between the Dilantin toxicity (October 2004) and Veteran’s ultimate demise (April 2005). The Board cited a report by the American Association of Poison Control noting that only 10 cardiac deaths were caused by Dilantin.

“The rationale given was that the 2004 Annual Report of the American Association of Poison Control Center’s Toxic Exposure Surveillance System reviewed 4059 toxic Dilantin exposures in 2003 that resulted in only seven deaths, six of which included combined exposures to Dilantin and other drugs. Although rarely used today for cardiac arrhythmias, FDA only noted 10 deaths from cardiac events between 1997 and 2002 due to the infusion of fosDilantin. It was noted that adverse cardiac events from Dilantin toxicity are [relatively very] rare compared to the frequency of toxic and/or therapeutic exposure to this drug. Adverse cardiac events were frequently associated with additional predisposing factors beyond just Dilantin.”

            The number of cases where an infusion by Dilantin or similar agents caused immediate death is irrelevant to the question of whether or not the negligent administration of Dilantin on September 30, 2004, caused marked debility, atrophy, and weakness in a veteran who had previously been functional at home. Dilantin is a potent and toxic drug, and VA studies strongly recommend not prescribing this drug to elderly veterans (see infra). The 2007 Annual Report of the American Association of Poison Control Center’s National Poison Data (the same organization relied on by the Board) reported that of the 2,395 reported toxic exposures in 2007, 1,710 were treated in a health care facility. Of this subset of patients, 528 had moderate morbidity, 45 had major morbidity, and 4 resulted in fatality. Cardiac toxicity is not the only toxicity caused by Dilantin and not the only explanation to Veteran’s morbid state on arrival in April 2005. It is well known that Dilantin kinetics are nonlinear and saturable, resulting in highly variable concentrations even with minor dosage changes. A small increase in dose may lead to a large increase in drug concentration as elimination becomes saturated. Dilantin may accumulate in the
cerebral cortex over long periods of time, as well as causing atrophy of the cerebellum when administered at chronically high levels. At therapeutic doses, Dilantin produces horizontal gaze nystagmus^[5]. At toxic doses, patients experience sedation, cerebellar ataxia,^[6] and ophthalmoparesis,^[7] as well as seizures. Idiosyncratic side-effects of Dilantin, as with other anticonvulsants, include rash and severe allergic reactions. Dilantin causes a reduction in folic acid levels, predisposing patients to megaloblastic anemia. Folic acid is presented in foods as polyglutamate, which is then converted into monoglutamates by intestinal conjugase. Dilantin acts by inhibiting this enzyme, thereby causing folate deficiency. Other side effects may include: agranulocytosis, aplastic anemia, leukopenia [thrombocytopenia]. The FDA has also warned of an increased suicide risk for any patients treated with certain anti-seizure drugs. The study of 44,000 patients found that patients whose epilepsy is treated with drugs face about twice the risk of suicidal thoughts compared to placebo-takers. The VA’s own study concluded that Dilantin is highly toxic and should not be prescribed to the elderly. (See infra).

VA personnel were negligent in administering Dilantin

            Appellant stated (on R. 2203 and 2529), that her claim does not allege any wrong doing on the part of VA staff during Veteran’s admission on April 10, 2005. Rather she argued that Veteran incurred injuries due to maltreatment at the hands of the VA employees on September 30, 2004, and as a result of that injury, Veteran had a marked deterioration of his health that led to his ultimate demise in 2005. Specifically, Appellant stated (R. 2203) that Veteran had no history of seizures. There is no clear documentation of seizure disorder at the September 30th hospitalization when Dilantin was started; therefore Ms. H claims that Dilantin was not necessary. We further argue that:

1. The VA staff’s decision to administer Dilantin rather than other antiseizure medication was negligent.

2. The decision to discharge the Veteran within a few hours from his admission on September 30, 2004, was negligent.

3. The administration of Dilantin by the Appellant with no instruction or supervision by medical staff was negligent under the circumstances.

4. As a result of errors by the employees of the VA on September 30, 2004, the Veteran suffered irreversible damage to his health that led directly with no further intervening cause to his final demise on April 10, 2005.

               We agree that Veteran had multiple medical problems, including diabetes, heart disease, and dementia. These conditions actually made Veteran more vulnerable to the toxic effects of a medication which might not have had such devastating effects on a young and healthy individual. In Cohen v. Brown, No. 94-661 10, Vet.App, the Court addressed the issue of the “eggshell skull rule.” The Cohen Court held:

   “VA does not deny a service-connection award to a veteran whose lack of good balance causes him to fall and be injured during service even though a serviceperson with better balance would not have been injured at all. This is analogous to the well-established principle of tort law that a tortfeasor “takes the plaintiff as he finds him.” Ragin v. Harry Macklowe Real Estate Co., 6 F.3d 898, 907-08 (2d Cir. 1993) (quoting Maurer v. United States, 668 F.2d 98, 100 (2d Cir. 1981) (per curiam), and citing Restatement (Second) of Torts 435, at 454 (1965) and W. Page Keeton et al., Prosser and Keeton on the Law of Torts 43, at 292 (5th ed. 1984)); see Maurer, 668 F.2d at 99-100 (“It is a settled principle of tort law that when a defendant’s wrongful act causes injury, he is fully liable for the resulting damage even though the injured plaintiff had a preexisting condition that made the consequences of the wrongful act more severe than they would have been for a normal victim.”

               As the BVA has failed to adequately investigate the case, and as the VA attorney has indicated his intentions to litigate the merit of the allegation, we must rely on our own investigation and supplement the record with treatises supporting our position. Federal Rule of Evidence 201 allows the court to take judicial notice, at any stage of the proceeding, of facts that are “capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 201(b). Judicial notice is mandatory where a party requests it and supplies the Court with the necessary information. Fed. R. Evid. 201(d). Scientific studies are a proper subject of judicial notice. See Brown v. Bd. of Educ., 347 U.S. 483, 495 n.11 (1954) (taking judicial notice of scientific studies). See also Paralyzed Veterans of Am. v. McPherson, 2008 Sept. Dist. Sept 69542. Medical treatises published in peer-reviewed publications clearly meet the definition of the rule “sources whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 201(b)

   Anti-seizure medication was not indicated

               The record of September 30, 2004, does not adequately describe a seizure event. The record of 9/30/2004 obtained by us and provided to the VA counsel shows that the EEG performed on 9/30/2004 did not find seizure activity. Clearly the VA staff failed to investigate the cause of the Veteran’s seizure and discharged the Veteran immediately.

               The Standard of Care requires a new seizure event to be well-recorded and investigated. The Veteran should have been admitted, and no anti seizure medication should have been provided, until it was found to be necessary. The American Academy of Family Physicians instructs:

   “If the diagnosis is uncertain, inpatient monitoring may be indicated. A recent retrospective review of 15 of 18 older adults who were admitted to an epilepsy-monitoring unit at a university hospital found that three patients who were receiving antiepileptic drug therapy did not, in fact, have seizures. Five of the 18 patients had seizures, and the remaining 10 patients (eight of whom had previously been treated with antiepileptic drugs) had diagnoses other than epilepsy.”^[8]
   
   
   
   
   (See copy of article attached.)

Dilantin should not be administered to elderly patients

            In an article titled “Potentially Inappropriate Antiepileptic Drugs for Elderly Patients with Epilepsy,” published in JAGS Volume 52, #3, March 2004, Mary Joe Pugh, PhD, et al, reviewed the records of patients hospitalized at the Department of Veterans’ Affairs and who were 65 years and older. (See copy of article attached.) They referenced two landmark studies from the Department of Veterans’ Affairs which assessed the use of Dilantin and phenobarbital and compared these drugs to the newer anti seizure drugs.^[9] The nationwide Veteran Administration Cooperative Study identified a higher burden of adverse effects with significantly more adverse cognitive effects noted in patients receiving Dilantin as compared to new antiepileptic drugs. Lamotrigine emerged as the drug of choice for the elderly combining high efficiency with low incidence of adverse effects. The authors of the VA study recommended that Dilantin not to be used as a first line in the management of seizures. The authors further cautioned that Dilantin should not be administered to patients with newly diagnosed seizures (as in the case at bar). They concluded: “The recommendation for Dilantin is a departure from the traditional treatment of epilepsy.”

Administration of Dilantin should have been done under medical supervision

            The Appellant testified that on September 30, 2004, she called 911, because the Veteran was diabetic, and she suspected diabetic problems. At the hospital, Appellant was told that they suspected a seizure, and they gave Veteran Dilantin. Thus, the first time that Veteran was ever given Dilantin was in that hospitalization of September 30, 2004. The Veteran was promptly discharged and was taken home that night. The hospital personnel gave Veteran two pills of Dilantin and told Appellant to give him two more pills every day and three more pills every night. She was instructed to make an appointment in two weeks. At some later point, the Appellant called for an ambulance to bring Veteran back to the hospital.

            In view of the toxicity associated with a high blood level of Dilantin, slow titration of the drug under close medical supervision was necessary. It is well known that Dilantin kinetics are nonlinear and saturable, resulting in highly variable concentrations even with minor dosage changes. A small increase in dose may lead to a large increase in drug concentration. As elimination becomes saturated, Dilantin may accumulate in the
cerebral cortex over long periods of time, as well as causing atrophy of the cerebellumwhen administered at chronically high levels. Appellant was never advised about Dilantin toxicity. No blood levels were ordered, and the delicate titration of the drug was left in the hands of a disabled lay person.

            A publication of the American Academy of Family Physicians advises^[10]:

“The goal of antiepileptic drug therapy is to control seizures but preserve quality of life. If possible, seizure control should be achieved with one agent given in the lowest effective dosage. Clinical response, rather than drug levels, should guide dosage changes. All antiepileptic drugs can cause dose dependent sedation and cognitive impairment. In general, it is advisable to “start low and go slow” with one agent. Results from the Veterans Affairs Cooperative Study on the effects of age on epilepsy and its treatment indicate that compared with younger adults, older adults appear to be more responsive to antiepileptic drug therapy. However, they are also more likely to experience side effects at lower serum antiepileptic drug concentrations. Consequently, older adults usually require lower dosages and longer dosing intervals. With any antiepileptic drug therapy, patients should be monitored closely for adverse effects, drug interactions, poor seizure control, and toxicity. Determination of the unbound drug concentration may be helpful when the clinical response appears inappropriate or side effects are prominent”

The Board erred in not applying the Benefit-of-the-Doubt Doctrine.

            To prove her case under 38 US 1151, Appellant only needed to prove that the Dilantin toxicity was as likely as not a major contributory cause to Veteran’s demise, not necessarily the only cause. In Gilbert v. Derwinski, 1 Vet. App. 49, 53- 56 (1990), the Court held that, in order to deny benefits, the negative evidence cannot be phrased as “not as likely,” but rather the preponderance of the evidence must be against the claim, i.e., that there is no reasonable possibility that Veteran is correct.

            The Supreme Court noted that the Benefit-of-the-Doubt Doctrine is a unique standard of proof doctrine reserved only for decisions on claims for veterans’ benefits. Unlike other claimants and litigants, pursuant to 38 USC §3007(b), a veteran is entitled to the “benefit of the doubt” when there is an “approximate balance of positive and negative evidence.” In Addington v. Texas, 441 U.S. 418, 99 S.Ct. 1804, 60 L.Ed.2d 323 (1979), the Supreme Court reasoned:

“Addington teaches that, in any given proceeding, the minimum standard of proof tolerated by the due process requirement reflects not only the weight of the private and public interests affected, but also a societal judgment about how the risk of error should be distributed between the litigants.”

            The benefit-of-the-doubt rule is codified at 38 USC §5107, which provides that:

“The Secretary shall consider all information and lay and medical evidence of record in a case before the Secretary with respect to benefits under laws administered by the Secretary. When there is an approximate balance of positive and negative evidence regarding any issue material to the determination of a matter, the Secretary shall give the benefit of the doubt to the claimant.” 38 USC §5107(b) (West Supp. 2001)

            The implementing regulation, 38 CFR §3.102, restates that provision in terms of reasonable doubt:

“When, after careful consideration of all procurable and assembled data, a reasonable doubt arises regarding service origin, the degree of disability, or any other point, such doubt will be resolved in favor of the claimant. By reasonable doubt is meant one which exists because of an approximate balance of positive and negative evidence which does not satisfactorily prove or disprove the claim.”

            The Court in Ortiz v. Principi, 274 F.3d 1361 (Fed. Cir. 2001) explained:

“Whether the positive and negative evidence renders a decision “too close to call” can perhaps be best understood by analogizing to sandlot baseball’s “tie goes to the runner” rule.”

            Alternatively, the Ortiz court noted the benefit-of-the-doubt rule may be viewed as shifting the “risk of non-persuasion” onto the VA to prove that the veteran is not entitled to benefits, citing the Supreme Court decision in Dep’t of Labor v. Greenwich Collieries, 512 U.S. 267, 281, 129 L. Ed. 2d 221, 114 S. Ct. 2251. According to the Ortiz ruling, to deny benefits, the preponderance of the evidence must be against granting benefits in the veteran’s claim. It is only when the evidence is clearly negative that the VA has overcome its risk of non-persuasion.

            The Gilbert Court held that, in order to deny benefits, the negative evidence cannot be phrased as “not as likely,” but rather the preponderance of the evidence must be against the claim, i.e., that there is no reasonable possibility that Veteran is correct:

“A veteran need only demonstrate that there is an “approximate balance of positive and negative evidence” in order to prevail; entitlement need not be established “beyond a reasonable doubt,” by “clear and convincing evidence,” or by a “fair preponderance of evidence.” … This unique standard of proof is in keeping with the high esteem in which our nation holds those who have served in the Armed Services. It is in recognition of our debt to our veterans that society has through legislation taken upon itself the risk of error when, in determining whether a veteran is entitled to benefits, there is an “approximate balance of positive and negative evidence.” By tradition and by statute, the benefit of the doubt belongs to the veteran. … The reasonable doubt doctrine is also applicable even in the absence of official records, particularly if the basic incident allegedly arose under combat, or similarly strenuous conditions, and is consistent with the probable results of such known hardships.” (Gilbert, 1Vet.App. 49)

            The benefit-of-the-doubt doctrine imposes an additional duty on the court. When 38 USCA §4004(d)(1) has been complied with, and when this Court is reviewing Board decisions which do not apply the “benefit-of-the-doubt” standard, then the Court is engaged in two separate analyses. Pursuant to 38 USC §4061(a)(4), the Court must first determine if the Board’s findings of material fact made in reaching its decision were clearly erroneous. Second, after making these determinations, this Court must use them and apply 38 USC §4061(a)(1), (3) to decide whether the Board’s decision not to apply the “benefit of the doubt” standard was in accordance with 38 USC §3007(b). Though these two analyses are interrelated, they are still made independently of one another and under different scopes of review.

CONCLUSION

            We argue that as a result of errors by the employees of the VA on September 30, 2004, Veteran suffered irreversible damage to his health that led directly with no further intervening cause to his final demise on April 10, 2005 The Board failed to obtain the entire medical record, failed order a medical expert evaluation of the issues presented on 9/30/2004, and failed to deliberate and render a decision regarding whether the alleged negligence by the VA met 38 USC §1151. The Board inappropriately limited its inquiry to the care Veteran received prior to his demise in April 2005, rather than to 9/30/2004, when the alleged negligence occurred. Remand is necessary, therefore, to allow adequate review of the medical records and expert testimony regarding the events of 9/30/2004.

Date:  March _____, 2012                                                      Respectfully Submitted,

/s/ David Anaise, MD, JD

David Anaise, MD, JD

Benham & Anaise, LLC

177 N Church Ave Ste 883

Tucson AZ 85701

(520) 882-3622

Counsel for Appellant