Citation Nr: 1132829 Decision Date: 09/06/11 Archive Date: 09/12/11 DOCKET NO. 01-08 897 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Montgomery, Alabama THE ISSUE Entitlement to VA compensation under 38 U.S.C.A. § 1151 for rectourethral fistula, postoperative colostomy, due to surgery performed by VA for adenocarcinoma of the prostate. REPRESENTATION Appellant represented by: John F. Cameron, Attorney at Law ATTORNEY FOR THE BOARD B. R. Mullins, Associate Counsel INTRODUCTION The Veteran had active service from June 1953 to May 1955 and from June 1955 to May 1958. This matter comes before the Board of Veterans' Appeals (Board) on appeal from a July 2001 rating decision of the Department of Veterans Affairs Regional Office (RO) in Decatur, Georgia. In April 2006, the Board denied the Veteran's claim for entitlement to compensation under 38 U.S.C.A. § 1151. The Veteran appealed this denial to the United States Court of Appeals for Veterans Claims (Court). In an April 2009 decision, the Court vacated the Board's April 2006 decision and remanded the case back to the Board. The Veteran's claim was subsequently remanded by the Board in June 2010. Please note this appeal has been advanced on the Board's docket pursuant to 38 C.F.R. § 20.900(c) (2010). 38 U.S.C.A. § 7107(a)(2) (West 2002). FINDING OF FACT The Veteran's rectourethral fistula, postoperative colostomy, was not caused by carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA when it conducted the September 1997 radical prostatectomy and it was not due to an event that was not reasonably foreseeable. CONCLUSION OF LAW The requirements for compensation under 38 U.S.C.A. § 1151 have not been met. 38 U.S.C.A. § 1151 (West 2002); 38 C.F.R. §§ 3.102, 3.159, 3.361 (2010). REASONS AND BASES FOR FINDINGS AND CONCLUSION Duty to Notify VA has a duty to notify and assist veterans in substantiating a claim for VA benefits. 38 U.S.C.A. §§ 5100, 5102, 5103, 5103A, 5107, 5126 (West 2002 & Supp. 2010); 38 C.F.R. §§ 3.102, 3.156(a), 3.159 and 3.326(a) (2010). Proper notice from VA must inform the Veteran of any information and medical or lay evidence not of record (1) that is necessary to substantiate the claim; (2) that VA will seek to provide; and (3) that the Veteran is expected to provide in accordance with 38 C.F.R. § 3.159(b)(1). This notice must be provided prior to an initial unfavorable decision on a claim by the RO. Mayfield v. Nicholson, 444 F.3d 1328 (Fed. Cir. 2006); Pelegrini v. Principi, 18 Vet. App. 112 (2004). Previously, the United States Court of Appeals for the Federal Circuit (Federal Circuit) held that the failure to provide pre-adjudicative notice of any of the necessary duty to notify elements was presumed to create prejudicial error. Sanders v. Nicholson, 487 F.3d 881 (2007). VA was required to show that that the error did not affect the essential fairness of the adjudication, and that to make such a showing the VA had to demonstrate that the defect was cured by actual knowledge on the claimant's part or that a benefit could not have been awarded as a matter of law. Id. However, the United States Supreme Court (Supreme Court) recently held this framework to be inconsistent with the statutory requirement that the CAVC take "due account of the rule of prejudicial error" under 38 U.S.C.A. § 7261(b)(2). Shinseki v. Sanders, 129 S. Ct. 1696 (2009). In reversing the Federal Circuit's decision, the Supreme Court held that the burden is on the claimant to show that prejudice resulted from the error, rather than on VA to rebut a presumed prejudice. Id. In the present case, the Veteran was not provided with the necessary notice prior to the initial adjudication of his claim. However, the Veteran was subsequently provided with notice in April 2005 that informed him of how to establish his claim of entitlement to compensation under 38 U.S.C.A. § 1151. Even though the Veteran was not provided with this notice until after the initial adjudication of his claim, the claim was subsequently readjudicated, no prejudice has been alleged, and none is apparent from the record. See Prickett v. Nicholson, 20 Vet. App. 370, 376 (2006) (the issuance of a fully compliant notification followed by readjudication of the claim, such as a statement of the case or supplemental statement of the case, is sufficient to cure a timing defect). Under these circumstances, the Board finds that the notification requirements have been satisfied as to both timing and content. Adequate notice was provided to the Veteran prior to the transfer and certification of his case to the Board that complied with the requirements of 38 U.S.C. § 5103(a) and 38 C.F.R. § 3.159(b). Duty to Assist Next, VA has a duty to assist the Veteran in the development of the claim. This duty includes assisting him in the procurement of service medical records and pertinent treatment records and providing an examination when necessary. 38 U.S.C.A. § 5103A; 38 C.F.R. § 3.159. The Board finds that all necessary development has been accomplished, and therefore appellate review may proceed without prejudice to the appellant. See Bernard v. Brown, 4 Vet. App. 384 (1993). VA obtained the Veteran's service treatment records, VA treatment records and VA hospitalization records. Also, VA obtained a medical expert's opinion in May 2003 and a copy of a private medical opinion has also been incorporated into the claims file. Significantly, neither the Veteran nor his representative has identified any additional existing evidence that is necessary for fair adjudication of the claim that has not yet been obtained. Hence, no further notice or assistance to the Veteran is required to fulfill VA's duty to assist him in the development of the claim. Smith v. Gober, 14 Vet. App. 227 (2000), aff'd 281 F.3d 1384 (Fed. Cir. 2002); Dela Cruz v. Principi, 15 Vet. App. 143 (2001); see also Quartuccio v. Principi, 16 Vet. App. 183 (2002). (CONTINUED ON NEXT PAGE) Relevant Laws and Regulations When a Veteran suffers an injury or an aggravation of an injury resulting in additional disability or death as the result of VA training, hospitalization, medical or surgical treatment, or an examination furnished by the VA, disability compensation shall be awarded in the same manner as if such disability or death were service connected. 38 U.S.C.A. § 1151; 38 C.F.R. § 3.361. Amendments to 38 U.S.C.A. § 1151 made by Public Law 104-204 require a showing not only that the VA treatment in question resulted in additional disability but also that the proximate cause of the additional disability was carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part in furnishing the medical or surgical treatment, or that the proximate cause of additional disability was an event which was not reasonably foreseeable. Those amendments apply to claims for compensation under 38 U.S.C.A. § 1151 which were filed on or after October 1, 1997. VAOPGCPREC 40-97, 63 Fed. Reg. 31263 (1998). Therefore, as the Veteran's claim was received well after October 1997, this claim must be decided under the current, post- October 1, 1997 version of 38 U.S.C.A. § 1151, as enacted in Public Law No. 104-204. 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. 38 C.F.R. § 3.361(c)(1). Hospital care or medical or surgical treatment cannot cause the continuance or natural progress of a disease or injury for which the care or treatment 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) (2009). To establish that carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA's part in furnishing hospital care, medical or surgical treatment, or examination proximately caused a Veteran's additional disability or death, it must be shown that the hospital care or medical or surgical treatment caused the Veteran's additional disability or death; and (i) VA failed to exercise the degree of care that would be expected of a reasonable health care provider; or (ii) VA furnished the hospital care or medical or surgical treatment without the Veteran's informed consent. 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) (2009). Whether the proximate cause of a Veteran's additional disability or death was an event not reasonably foreseeable is determined based on what a reasonable health care provider would have foreseen. The event need not 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. 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). Where it is determined that there is a disability resulting from VA treatment, compensation will be payable in the same manner as if such disability were service-connected. 38 U.S.C.A. § 1151; 38 C.F.R. §§ 3.358, 3.800. Facts and Analysis The Veteran contends that he is entitled to compensation under 38 U.S.C.A. § 1151 for additional disability acquired as a result of VA treatment. Specifically, the Veteran is seeking compensation for the development of a rectourethral fistula following prostate cancer surgery in August 1997. However, as outlined below, the preponderance of the evidence of record demonstrates that VA personnel did not act with carelessness, negligence, lack of proper skill, error in judgment, or similar instance when performing the Veteran's radical prostatectomy, nor was his rectourethral fistula an event not reasonably foreseeable. As such, compensation under 38 U.S.C.A. § 1151 is not warranted. The record demonstrates that the Veteran signed an informed consent for surgery form on August 7, 1997. According to this form, risk factors included impotence, incontinence and rectal injury. In September 1997, the Veteran underwent a radical retropubic prostatectomy. An October 1997 surgical report notes that the Veteran was status post-radical prostatectomy two weeks earlier. The Veteran reported to the emergency room with feces coming from his penis. It was determined that the Veteran had a rectourethral fistula. Surgery was performed and a colostomy bag was prepared. A subsequent October 1997 VA treatment record notes that the Veteran had been home from the above procedure for six days and that he developed constipation. The Veteran reported inserting glycerine suppositories to relieve his constipation (the Veteran's wife has disputed this fact and this assertion will be discussed in greater detail in a later part of the decision). He then again noted fecal material in his urinary system several days later. Surgery was again performed and a loop colostomy was prepared. Subsequent medical records demonstrate that the colostomy was taken down in 1998. In May 2003, VA requested an independent medical opinion from a physician outside of the VA medical system. The physician noted that the Veteran underwent a radical retropubic prostatectomy and bilateral ileal node dissection in September 1997. The medical expert noted that the Veteran's treatment options, given his age, were either external beam radiation, I-125 radioactive seed placement, or radical prostatectomy. It was felt that, after consultation with physicians, the Veteran appropriately elected to have a radical prostatectomy. A rectal injury was noted during this surgery and the injury was closed in an appropriate manner. The Veteran subsequently developed a rectourethral fistula, and according to the physician, this was treated appropriately with a Foley catheter, suprapubic tube and a loop colostomy. The physician noted that the fistula healed and the Veteran's carcinoma was apparently cured. However, for reasons that were unclear, his fistula redeveloped in May 2001. The examining physician opined that the Veteran's surgery was appropriately recommended and performed and the known complications were appropriately and well-cared for. It was explained that upon discovery of the Veteran's prostate cancer, a radical prostatectomy was appropriately elected. While the Veteran did suffer complications during his procedure, the physician felt that the injury was appropriately treated during the surgical procedure. Despite the repair, the Veteran developed a known complication of rectourethral fistula that was also treated appropriately. This condition subsequently healed but the Veteran did have a recurrence. The physician explained that recurrence can happen due to a current tumor (for which there was no indication in this case), stricture distal to the tumor or even instrumentation by the patient. The etiology of the recurrence was not clear in this case. Therefore, the physician explained that the radical prostatectomy with the surgical complication was not a proximate cause of any disability that the Veteran now claims. In fact, from a review of the record, the physician noted that the Veteran appeared to be both cured of his cancer and was for a number of years continent of urine. As such, the Veteran was deemed to have been well-managed and well-taken care of. In contrast to the above, the record also contains a November 1999 opinion from a private physician with the initials J.G. According to Dr. G, the VA physicians and surgeons failed to exercise the degree of skill and care ordinarily exercised by the medical profession in general. Specifically, Dr. G opined that a radical prostatectomy should not have been performed as it was not warranted. In addition, tissue outside of the operative field was lacerated during the radical prostatectomy. Dr. G felt that the VA physicians should have performed no more than a simple prostatectomy. Therefore, Dr. G opined that the failure of the VA physicians to exercise the proper standard of care resulted in the Veteran's fistula between his colon and urinary tract. The May 2003 medical expert found the above November 1999 opinion to be inaccurate. It was noted that Dr. G was an internist and that he was neither a urologist nor a surgeon experienced in the matters of care of adenocarcinoma of the prostate. The physician also felt that Dr. G's opinion that only a simple prostatectomy should have been performed was disingenuous and incorrect. In August 2003, the Veteran sought private medical treatment. The examining physician noted that the Veteran had a rectourethral fistula following a radical prostatectomy in 1997. It was also noted that a colostomy was performed but that his colostomy had since been taken down. Examination revealed a probable urethrorectal fistula. A rectovesical fistula repair was performed in October 2003. The evidence also demonstrates that the Veteran filed a tort action against the United States regarding this issue. A May 1999 finding by the VA Department of Regional Counsel in Atlanta, Georgia revealed that the employees of the VAMC in Decatur, Georgia were not negligent in caring for the Veteran. Also, it was noted that the Veteran signed an informed consent which outlined the risks associated with his treatment. Accordingly, any liability on the part of the United States was denied. The preponderance of the above evidence demonstrates that the Veteran is not entitled to compensation under 38 U.S.C.A. § 1151 for rectourethral fistula, postoperative colostomy, due to surgery performed by VA for adenocarcinoma of the prostate. According to the May 2003 VA examiner, a radical prostatectomy was the appropriate course of action to treat the Veteran's prostate cancer at this time. It was also noted that a rectourethral fistula was a known possible complication of this surgical procedure. This conclusion is further supported by the informed consent form signed by the Veteran prior to his operation. Finally, the May 2003 medical expert concluded that while an injury to the rectum was incurred during surgery, this was appropriately treated during the surgical procedure. As such, the evidence demonstrates that a rectourethral fistula was an event reasonably foreseeable with a radical prostatectomy and that VA physicians did not act with carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault when performing the Veteran's radical prostatectomy. As such, compensation under 38 U.S.C. §1151 is not warranted. In reaching the above opinion, the Board also considered the November 1999 conflicting medical opinion of Dr. G. While Dr. G did opine in November 1999 that VA physicians and surgeons failed to exercise the degree of skill and care ordinarily exercised by the medical profession in general, the Board does not find this opinion to be as reliable as the one obtained by the May 2003 medical expert. Dr. G opined that a radical prostatectomy should not have been performed as it was not warranted. Dr. G gave no information or rationale for how he reached this conclusion, aside from saying that VA physicians should have performed a simple prostatectomy. The Court has held that the value of a physician's statement is dependent, in part, upon the extent to which it reflects "clinical data or other rationale to support his opinion." Bloom v. West, 12 Vet. App. 185, 187 (1999). While Dr. G did not offer any rationale in support of his opinion, the May 2003 medical expert discussed the Veteran's age and his alternative treatment options, and concluded that a radical prostatectomy was in fact the proper procedure based on these factors and a discussion with his physicians at the time of the operation. As such, the Board finds the May 2003 medical expert's opinion to be more persuasive. VA also received a statement from the Veteran's wife in December 2005. In this statement, she described the events that led to the Veteran's additional disability. According to this statement, the Veteran's wife felt that the Veteran should not have been released home after the initial repair in September 1997. Rather, she felt that a colostomy should have been performed after the Veteran's intestines were originally injured, preventing the need for the subsequent surgeries. However, while the Board has considered this statement, the record fails to demonstrate that the Veteran's wife is competent to offer a medical opinion as to the proper course of treatment for a rectourethral fistula. VA surgeons and physicians, who were present in the operating room and capable of examining the actual complications incurred by the Veteran, concluded that the proper course of treatment in the first instance was stitches. The May 2003 medical expert agreed with the course of action of the VA physicians, calling their treatment of this condition appropriate. Therefore, while the Board has considered the assertions of the Veteran's wife, it must find the competent opinions of VA surgeons and the May 2003 medical expert to be more probative. The Veteran's wife also described the suffering and quality of life impact experienced by the Veteran. However, the fact that the Veteran has suffered as a result of complications following his radical prostatectomy is not in question. The Board fully concedes this issue, but the fact remains that the record fails to indicate that VA acted with carelessness, neglect, or lack of other proper skill when performing the Veteran's surgery. Finally, the Veteran's wife indicated in her statement that the assertions by the VA Medical Center that the Veteran was constipated and that he used a laxative in October 1997 was false. The Board has considered this assertion, but this does not change the fact that there are significant medical records documenting that the Veteran was in fact constipated. Regardless, whether or not the Veteran was in fact constipated in October 1997 is of no relevance in the matter at hand. According to the May 2003 physician who reviewed the Veteran's claim, while a rectourethral fistula did develop, this was a known complication and it was subsequently treated by VA in a proper fashion. Whether the original treatment failed as a result of the insertion of rectal laxatives or merely due to the nature of the injury is of little significance. Either way, there is no evidence of carelessness or negligence on the part of VA and they were found to have treated the Veteran appropriately by the May 2003 physician. VA also received numerous articles on rectourethral fistulas from the Veteran in May 2010. According to one of the articles, rectourethral fistulas can develop after a radical retropubic prostatectomy. While the occurrence of a rectourethral fistula was a small percentage of overall surgeries, it was nonetheless clear that it was a real risk. Another article from the Journal of Urology again notes that rectourethral fistulae are rare but severe complications following a radical prostatectomy. Another article from "CA - A Cancer Journal for Clinicians" stresses that rectal, bowel and urinary injuries are rare but can occur. Having reviewed these articles, the Board does not find that they provide support for the Veteran's claim. According to these articles, rectourethral fistulas, while rare, are indeed a known risk factor of a radical prostatectomy. These articles do not suggest that VA exercised carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault when performing surgical treatment. The Board has also considered a statement provided to VA in November 2005. According to this statement, the Veteran was already sedated when he signed the consent form for his prostate cancer surgery so he was not fully aware of the risks involved. The Board does not find this assertion to be credible. The Veteran's informed consent form was signed in August 1997 - more than a month before he actually underwent his radical prostatectomy in September 1997. Therefore, the assertion that he was already sedated as of this time seems highly unlikely. In summary, while the Board is extremely sympathetic to the Veteran's situation, the preponderance of the evidence of record does not demonstrate that VA surgeons were negligent, careless, lacking proper skill, or erring in judgment when performing a radical prostatectomy. The May 2003 medical opinion stressed that this was the proper course of treatment in this case. In addition, based on the May 2003 medical opinion and the articles submitted by the Veteran, it is well-known that rectourethral fistulas are a possible, yet rare, complication. The evidence demonstrates that the Veteran was notified of this risk in August 1997 and that he gave his informed consent for the operation to proceed. Since the preponderance of the evidence is against the claim, the provisions of 38 U.S.C. § 5107(b) regarding reasonable doubt are not applicable. The Veteran's claim of entitlement to compensation under 38 U.S.C.A. § 1151 for rectourethral fistula, postoperative colostomy, due to surgery performed by VA for adenocarcinoma of the prostate must be denied. (CONTINUED ON NEXT PAGE) ORDER Compensation under 38 U.S.C.A. § 1151 for rectourethral fistula, postoperative colostomy, due to surgery performed by VA for adenocarcinoma of the prostate is denied. ____________________________________________ J. A. MARKEY Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs