Citation Nr: 0720844 Decision Date: 07/12/07 Archive Date: 07/25/07 DOCKET NO. 00-09 991 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Milwaukee, Wisconsin THE ISSUE Entitlement to compensation for the veteran's death under the provisions of 38 U.S.C.A. § 1151 based on VA hospital care and medical treatment rendered between February 1998 and September 1998. REPRESENTATION Appellant represented by: Wisconsin Department of Veterans Affairs ATTORNEY FOR THE BOARD R. Giannecchini, Counsel INTRODUCTION The veteran had active military service from December 1945 to May 1947, and from November 1950 to May 1956. The veteran died in September 1998. The appellant is the widow of the veteran. This matter comes before the Board of Veterans' Appeals (Board) on appeal of a July 1999 rating decision by the Department of Veterans Affairs (VA) Regional Office (RO) in Milwaukee, Wisconsin. This case was remanded by the Board in December 2001. Thereafter, the Board denied the claim for compensation pursuant to 38 U.S.C.A. § 1151 by a decision dated September 23, 2002. The appellant appealed the Board's denial to the United States Court of Appeals for Veterans Claims (Court). In an order dated in May 2003, the Court granted a joint motion for remand filed by the parties, vacated the Board's September 23, 2002, decision, and remanded the case to the Board. In order to comply with the Court's remand, the Board remanded the case to the originating agency in January 2004. The Board again remanded the appellant's case in December 2005. The requested development has since been completed and the case is once again before the Board. FINDINGS OF FACT 1. While hospitalized at a VA medical facility in September 1998, the veteran died from sepsis due to pseudomembranous pancolitis. 2. The veteran's fatal pseudomembranous pancolitis developed as a result of recurrent Clostridium difficile infections contracted either during earlier VA hospitalizations, or from antimicrobial therapy prescribed by VA physicians starting in February 1998. 3. The veteran's Clostridium difficile infections were timely recognized and the veteran was afforded appropriate treatment for the infections. 4. The development of Clostridium difficile infections in the veteran as a result of VA hospitalization or prescribed antimicrobial therapy was not 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 veteran's hospital care and medical treatment. 5. The development of recurrent Clostridium difficile infections in the veteran as a result of antimicrobial therapy was an event that was reasonably foreseeable. 6. The proximate cause of the veteran's death was not carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing the veteran's hospital care and medical treatment; nor was the veteran's death the proximate result of an event not reasonably foreseeable. CONCLUSION OF LAW The criteria for compensation benefits under 38 U.S.C.A. § 1151 for the cause of the veteran's death based on VA hospital care and medical treatment rendered between February 1998 and September 1998 have not been met. 38 U.S.C.A. § 1151 (West 2002 & Supp. 2007); 38 C.F.R. § 3.361 (2006). REASONS AND BASES FOR FINDINGS AND CONCLUSION I. Duties to Notify & Assist At the outset, the Board notes the enactment of the Veterans Claims Assistance Act of 2000 (VCAA), Pub. L. No. 106-475, 114 Stat. 2096 (2000), in November 2000. See 38 U.S.C.A. §§ 5100, 5102, 5103, 5103A, and 5107 (West 2002 & Supp. 2007). To implement the provisions of the law, VA promulgated regulations codified at 38 C.F.R. §§ 3.102, 3.156(a), 3.159, 3.326(a) (2006). The VCAA and its implementing regulations include, upon the submission of a substantially complete application for benefits, an enhanced duty on the part of VA to notify a claimant of the information and evidence needed to substantiate a claim, as well as the duty to notify the claimant of what evidence will be obtained by whom. 38 U.S.C.A. § 5103(a); 38 C.F.R. § 3.159(b). In addition, they define the obligation of VA with respect to its duty to assist a claimant in obtaining evidence. 38 U.S.C.A. § 5103A; 38 C.F.R. § 3.159(c). Here, the Board finds that all notification and development action needed to render a decision on the claim on appeal has been accomplished. In this respect, through August 2004 and December 2005 notice letters, the RO notified the appellant of the legal criteria governing her claim and the evidence that had been considered in connection with her claim. Thereafter, the appellant was afforded the opportunity to respond. Hence, the Board finds that the appellant has received notice of the information and evidence needed to substantiate her claim, and has been afforded ample opportunity to submit such information and evidence. The Board also finds that the August 2004 and December 2005 notice letters satisfy the statutory and regulatory requirement that VA notify a claimant what evidence, if any, will be obtained by the claimant and which evidence, if any, will be retrieved by VA. See Quartuccio v. Principi, 16 Vet. App. 183, 187 (2002) (addressing the duties imposed by 38 U.S.C. § 5103(a) and 38 C.F.R. § 3.159(b)). In those letters, the RO notified the appellant that VA was required to make reasonable efforts to obtain medical records, employment records, or records from other Federal agencies. It requested that the appellant identify any medical providers from whom she wanted the RO to obtain and consider evidence. The RO also encouraged the appellant to submit evidence in her possession in support of her claim. Also as regards to VA's notice requirements, the Board notes that, in the decision of Pelegrini v. Principi, 18 Vet. App. 112 (2004), the United States Court of Appeals for Veterans Claims (Court) held that proper VCAA notice should notify the claimant of: (1) the evidence that is needed to substantiate the claim, (2) the evidence, if any, to be obtained by VA, and (3) the evidence, if any, to be provided by the claimant; and (4) VA must make a request that the claimant provide any evidence in the claimant's possession that pertains to the claim. As indicated above, the four content-of-notice requirements have been met in this case. Although the complete notice required by the VCAA was not provided until after the RO initially adjudicated the appellant's claim, the appellant was provided the content- complying notice to which she was entitled. Pelegrini, 18 Vet. App. at 122. Consequently, the Board does not find that any late notice in this case under the VCAA requires remand to the RO. Nothing about the evidence or any response to VA's notification suggests that the case must be re- adjudicated ab initio to satisfy the requirements of the VCAA. Here, following the notice letters to the appellant in August 2004 and December 2005, the appellant's claim was readjudicated in August 2005 and October 2006. See Medrano v. Nicholson, ___ Vet. App. ___ 2007 WL 1201524, citing Mayfield v. Nicholson, 444 F. 3d 1328 (Fed. Cir. 2006) (In order to cure a VCAA notice timing defect, a compliant notice must be issued followed by the readjudication of the claim.). The Board also notes that although notice regarding an award of an effective date has not been provided, see Dingess/Hartman v. Nicholson, 19 Vet. App. 473 (2006), aff'd, Hartman v. Nicholson, 483 F.3d 1311 (Fed. Cir. 2007), the Board does not now have such an issue before it. Consequently, a remand for additional notification on this question is not necessary. The Board also points out that there is no indication whatsoever that any additional action is needed to comply with the duty to assist in connection with the claim on appeal. The appellant has submitted evidence in support of her claim, and medical records identified by the appellant have been obtained and associated with the claims file. The record also reflects that medical opinions addressing the appellant's claim have been obtained. Otherwise, neither the appellant nor her representative has alleged that there are any outstanding medical records probative of the appellant's claim that need to be obtained. Under these circumstances, the Board finds that VA has complied with all duties to notify and assist required under 38 U.S.C.A. § 5103A and 38 C.F.R. § 3.159. II. Factual Background The veteran died in September 1998 while hospitalized at the VA Medical Center (VAMC) in Milwaukee, Wisconsin. His certificate of death lists the cause of death as sepsis secondary to pseudomembranous pancolitis. The veteran had a long history of multiple medical problems to include chronic renal insufficiency as well as acute renal failure requiring hemodialysis, chronic obstructive pulmonary disease, arteriosclerotic heart disease, hypertension, congestive heart failure, and hepatitis C infection. He had an automatic implantable cardioverter/defibrillator (AICD) placed in 1991. From February to March 1998, the veteran was hospitalized at the Milwaukee VAMC for a congestive heart failure exacerbation and for lung problems. An associated hospital summary notes that upon admission, the veteran denied experiencing any fevers, chills, diarrhea or abdominal pain. During the course of hospitalization, he was started on empiric intravenous antibiotic therapy with Clindamycin and Ceftizoxime for suspected pneumonia. The veteran's condition improved, and the antibiotic therapy was discontinued by the time of his discharge. The veteran was again hospitalized at the Milwaukee VAMC from March to April 1998 for problems with his AICD firing. He reported on admission that he had been experiencing diarrhea for three days. The veteran was empirically started on Flagyl for suspected Clostridium difficile infection, but since he was showing slow clinical improvement on that medication, with persistent fevers and diarrhea, he was changed to oral Vancomycin. The veteran eventually tested negative for Clostridium difficile and was placed back on Flagyl. Although he continued to experience some diarrhea, his treating physicians felt it was unrelated to the Clostridium difficile pathogen. From April to May 1998, the veteran was readmitted to the Milwaukee VAMC for complaints of AICD firing and complaints of diarrhea of recent onset. During the course of hospitalization, he was determined to have a Clostridium difficile infection. He was started on intravenous Flagyl, which was then changed to oral Vancomycin until the diarrhea resolved. At that time he was again placed on Flagyl. A flexible sigmoidoscopy showed evidence of colitis, and the veteran was consequently prescribed Flagyl for use after discharge. The veteran was next hospitalized at the Milwaukee VAMC from May to June 1998 for complaints of AICD firing. He was noted to have recently started using Flagyl. During the course of hospitalization, the veteran became hypotensive and developed increased body temperature. His treating physicians believed those symptoms might be due to sepsis. The veteran's loose stools resolved on Flagyl by the time of his discharge, and his discharge medications included Metronidazole. While the veteran was discharged to a nursing ward, he was soon transferred back to the intensive care unit and remained hospitalized from June to August 1998. During hospitalization he was found to be Clostridium difficile positive and he was prescribed Flagyl when discharged. An August 1998 treatment note following his discharge reflects that the veteran's wife reported that the veteran had not experienced any diarrhea since he arrived home. A final Milwaukee VAMC hospital summary notes that the veteran was admitted to the facility in September 1998 for problems with his AICD firing. He denied experiencing any fever or chills, but he reported passing loose watery stools for the six days prior to admission. The veteran was brought to the intensive care unit, and by afternoon on the day of admission was running high fevers. He was placed on Vancomycin and Gentamicin for possible coverage of Clostridium difficile, but by the second day of admission, his condition had deteriorated. His stool samples were positive for Clostridium difficile, and he was placed on Flagyl, but after consultation with the infectious diseases unit, the veteran was placed on oral and intravenous Vancomycin; it was thought that the veteran was not completely free of his last Clostridium difficile infection. The veteran remained septic and was started on Aztreonam. He also remained severely acidotic, hypokalemic and hypoxic, and was thought to be in septic shock. Although intravenous Flagyl was added to his regimen of medications, his condition continued to deteriorate until he died within days of his admission. The veteran was autopsied later in September 1998. The autopsy report indicates that the veteran died of "sepsis (days) secondary to pseudomembranous pancolitis (weeks/months)". Other conditions noted as present included atherosclerotic and ischemic cardiac disease, pulmonary emphysema, and arterionephrosclerosis. The report reflects that the veteran's entire colonic mucosa was studded with pseudomembranes, consistent with a Clostridium difficile infection, and that the Clostridium difficile colitis was presumed to be the source of the sepsis from which the veteran died. Furthermore, the autopsy report reflects that with the veteran's cardiac compromise and frequent hospitalizations, he was at increased risk for acquiring the frequent nosocomial pathogen, and had diminished capacity to combat it. III. Analysis The appellant filed her claim for compensation benefits under 38 U.S.C.A. § 1151 in February 1999. With respect to claims filed on or after October 1, 1997 (see VAOPGCPREC 40-97 (Dec. 31, 1997)), 38 U.S.C.A. § 1151 provides in pertinent part that compensation shall be awarded for a qualifying additional disability or death in the same manner as if such additional disability or death was service connected. For purposes of this section, a disability or death is a qualifying additional disability if the disability or death was not the result of the veteran's willful misconduct and (1) the disability or death was caused by hospital care, medical or surgical treatment, or examination furnished the veteran under any law administered by the Secretary, and the proximate cause of the disability or death was (A) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the Department in furnishing the hospital care, medical or surgical treatment, or examination; or (B) an event not reasonably foreseeable. 38 U.S.C.A. § 1151. The Board notes that regulations to implement the current version of 38 U.S.C.A. § 1151 were promulgated in August 2004. See 38 C.F.R. § 3.361 (2006). The effective date of the change was September 2, 2004. (See 38 C.F.R. § 3.358 pertaining to claims for compensation for disability or death from hospitalization, or medical/surgical treatment filed prior to October 1, 1997). A review of 38 C.F.R. § 3.361 reflects that in pertinent part, the regulation is a restatement of the criteria of 38 U.S.C.A. § 1151. In this case, the appellant has been provided the regulatory provisions for 38 C.F.R. § 3.361. As such, the Board finds the appellant has been properly notified of the regulatory provisions pertaining to her claim. With respect to 38 C.F.R. § 3.361, to determine whether additional disability exists within the meaning of § 1151, the veteran's condition immediately prior to 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 his or her condition after such care, treatment, examination, services, or program has been completed. Each body part or system involved is considered separately. 38 C.F.R. § 3.361(b). To establish causation, evidence must show that the hospital care, medical or surgical treatment, or examination resulted in the veteran's additional disability or death. Merely showing that a veteran received care, treatment, or examination and that the veteran has an additional disability does not establish cause. 38 C.F.R. § 3.361(c)(1). 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. 38 C.F.R. § 3.361(c)(2). 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)(3). 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. 38 C.F.R. § 3.361(d). 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 (see 38 C.F.R. § 3.361(c); and (i) that VA failed to exercise the degree of care that would be expected of a reasonable health care provider or (ii) that VA furnished the hospital care, medical or surgical treatment, or examination without the veteran's or, in appropriate cases, the veteran's representative's informed consent). 38 C.F.R. § 3.361(d)(1). Finally, the determination of whether the proximate cause of a veteran's additional disability was an event not reasonably foreseeable is to be based on what a reasonable health care provider would have foreseen. The event does not have to be completely unforeseeable or unimaginable but must be one that a reasonable health care provider would not have considered to be an ordinary risk of the treatment provided. 38 C.F.R. § 3.361(d)(2). The regulation further provides that, in determining whether an event was reasonably foreseeable, VA will consider whether the risk of that event was the type of risk that a reasonable health care provider would have disclosed in connection with the informed consent procedures of 38 C.F.R. § § 17.32. 38 C.F.R. § 3.361(d)(2). In this case, the facts are not in dispute. The record reflects that the veteran died of sepsis caused by pseudomembranous pancolitis, in turn the result of recurrent Clostridium difficile infections. However, the only competent medical evidence of record with respect to the veteran's death and its relationship to his VA treatment weighs against the appellant's claim. The Board notes that, in a July 1999 medical opinion from the Chief of the section of Infectious Diseases at the Milwaukee VAMC, it was concluded that there was no evidence suggesting any carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault on the part of the Milwaukee VAMC in furnishing hospital care or medical treatment to the veteran. The physician also concluded that there were no accidental events (i.e., events not reasonably foreseeable) involved in the veteran's death. In this regard, the physician explained that the Clostridium difficile organism was most likely acquired by the veteran during one of his previous hospitalizations, since the organism was usually a hospital-acquired one, made worse or precipitated by broad-spectrum antibiotic therapy. The physician noted that in most cases, Clostridium difficile colitis would respond either to cessation of the causative antibiotics, or to treatment with different antibiotics that are effective against that particular infection-usually oral Metronidazole or Vancomycin. The physician also noted that the veteran did not respond to appropriate therapy for reasons which were unclear, and that it was possible that his age or underlying medical conditions compromised host defenses against that particular pathogen, leaving him open to serious complications. The physician added that there were a small number of patients who would not respond to the therapy. In June 2001, an independent medical opinion was received from J.F.F., M.D., an Associate Professor of Medicine and Infectious Diseases. In his opinion, Dr. F. noted that the veteran died from sepsis in association with the colonic injury caused by antibiotic-associated Clostridium difficile colitis. He also noted that other serious medical conditions contributed to the veteran's demise. Dr. F. pointed out that the fact that the veteran was septic in appearance by the second hospital day in September 1998 suggested that severe antibiotic colitis was already present on admission. He noted that the ordinary pace of antibiotic colitis from onset to severe colitis was much slower, and that diarrhea or some type of abdominal symptoms or signs should have been present on admission in a patient with such extensive disease. However, he concluded that it was not likely that any failure of VA hospital personnel to maintain proper hygiene was the proximate cause of the veteran's sepsis. Dr. F. also reported that it was possible that the veteran became colonized with Clostridium difficile during a previous admission, although he indicated that there was insufficient information to determine the appropriateness of infection control procedures during previous hospitalizations. He indicated that it was, in any event, extremely difficult to say how the veteran acquired the organism. With respect to whether any negligence, carelessness, error in judgment or lack of proper skill by VA medical personnel was the proximate cause of the veteran's death, Dr. F. noted that Clostridium difficile was easily diagnosed and treated, in general. In severe cases, however, oral Metronidazole was indicated, although relapses were noted to occur in up to 20 percent of cases. He indicated that the veteran was administered appropriate initial therapy with oral Metronidazole, as well as oral Vancomycin when the veteran did not respond to the initial therapy. Dr. F. explained that the intravenous Gentamicin, Aztreonam and Vancomycin, along with the Metronidazole, should have been sufficient to cover sepsis from bowel flora, provided the oral Metronidazole was absorbed. Dr. F. concluded that it was unlikely that any negligence, carelessness, error in judgment or lack of proper skill by VA medical personnel was the proximate cause of the veteran's death. He cited to medical literature in support of his opinion. In February 2002, the veteran's claims file was reviewed by the Chief of Infectious Diseases at the VAMC in Madison, Wisconsin. The physician recounted the veteran's medical history, the events leading up to his death, and the autopsy results. He indicated that the possibility of pseudomembranous colitis developing, as a consequence of Clostridium difficile toxin production in the setting of exposure to anti-microbial therapy, was a well recognized potential consequence of such therapy. The physician also indicated that the most commonly implicated antibiotics for diarrhea due to Clostridium difficile infection include Clindamycin, Cephalosporins and Penicillins, but that virtually any antibiotic could be implicated. The physician noted that the manufacturer package inserts for both Clindamycin and Ceftizoxime list pseudomembranous colitis as a possible adverse event of therapy. Thus, the possibility of the veteran acquiring pseudomembranous colitis due to Clostridium difficile through the use of Clindamycin and Ceftizoxime in February 1998 was a foreseeable risk of his antimicrobial therapy. The physician cited to medical literature in support of his opinion. Here, the above medical opinions were proffered by physicians who are involved in the field of infectious diseases, and are each based on a review of the veteran's claims files and medical records collectively. The opinion evidence establishes that the possibility of the veteran acquiring pseudomembranous colitis due to Clostridium difficile infection through the use of Clindamycin and Ceftizoxime in February 1998 was a foreseeable risk of his antimicrobial therapy. As such, acquiring pseudomembranous colitis due to Clostridium difficile was an event reasonably foreseeable. As noted above, the determination of whether the proximate cause of a veteran's additional disability was an event not reasonably foreseeable is to be based on what a reasonable health care provider would have foreseen. The event must be one that a reasonable health care provider would not have considered to be an ordinary risk of the treatment provided. 38 C.F.R. § 3.361(d)(2). The Board notes that it is bound by the laws and regulations governing the veteran's claim. Otherwise, collectively, the opinions indicate that the development of the veteran's infection was not the result of any carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA; and that the treatment for the veteran's infection was appropriate under the circumstances. Thus, the Board finds the weight of the competent medical evidence reflects that the proximate cause of the veteran's death due to sepsis caused by pseudomembranous pancolitis, in turn the result of recurrent Clostridium difficile infections, was not due to carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing medical care. Neither the appellant nor her representative has alluded to or identified competent medical evidence that would support the appellant's claim or otherwise contradict the medical opinion evidence of record. While the Board does not doubt the sincerity of the appellant's beliefs regarding her claim on appeal, as a lay person without the appropriate medical training or expertise, she simply is not competent to provide a probative opinion on a medical matter. See Bostain v. West, 11 Vet. App. 124, 127 (1998), citing Espiritu v. Derwinski, 2 Vet. App. 492 (1992). See also Routen v. Brown, 10 Vet. App. 183, 186 (1997) ("a layperson is generally not capable of opining on matters requiring medical knowledge"). As such, the appellant's assertions, alone, while considered by the Board, cannot provide a basis for a grant of compensation under the provisions of 38 U.S.C.A. § 1151. Thus, under these circumstances, the claim for compensation under the provisions of 38 U.S.C.A. § 1151 must be denied. In reaching this conclusion, the Board has considered the applicability of the benefit-of-the-doubt doctrine. However, as the preponderance of the evidence weighs against the claim, that doctrine is not applicable in the instant appeal. See 38 U.S.C.A. § 5107(b); 38 C.F.R. § 3.102; Gilbert v. Derwinski, 1 Vet. App. 49, 53-56 (1990). ORDER Entitlement to compensation for the veteran's death under the provisions of 38 U.S.C.A. § 1151 based on VA hospital care and medical treatment rendered between February 1998 and September 1998 is denied. ________________________________ MARK F. HALSEY Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs