Citation Nr: 1305265 Decision Date: 02/13/13 Archive Date: 02/21/13 DOCKET NO. 03-20 515 ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in St. Petersburg, Florida THE ISSUE Entitlement to compensation benefits under the provisions of 38 U.S.C.A. § 1151 (West 2002) for post-surgical complications of a radical retropubic prostatectomy, with lymph node dissection, to include incontinence, pelvic hematoma (claimed as swelling and blood clot in the scrotum), antibiotic diarrhea, impotence, open wound, and pain and numbness in the thighs. REPRESENTATION Appellant represented by: Daniel G. Krasnegor, Attorney ATTORNEY FOR THE BOARD James R. Siegel, Counsel INTRODUCTION The Veteran served on active duty from June 1965 to October 1971. This matter comes to the Board of Veterans' Appeals (Board) on appeal from a May 2002 rating decision of the Department of Veterans Affairs (VA) Regional Office (RO) that denied the Veteran's claim for compensation benefits pursuant to the provisions of 38 U.S.C.A. § 1151 for post-surgical complications of a radical retropubic prostatectomy, with lymph node dissection, to include incontinence, pelvic hematoma (claimed as swelling and blood clot in the scrotum), antibiotic diarrhea, impotence, open wound, and pain and numbness in the thighs. This case was previously before the Board in March 2005 and September 2006, and was remanded on each occasion for additional development of the record. By decision dated May 2009, the Board denied the claim. The Veteran filed a timely appeal to the United States Court of Appeals for Veterans Claims (Court) which, by Order dated April 2010 granted a joint motion for remand. The Board subsequently obtained medical opinions from the Veterans Health Administration and from an independent medical expert. The Board notes that in accordance with the provisions of 38 C.F.R. § 20.903 (2012), copies of the opinions from the independent medical expert were sent to the Veteran and his attorney. FINDINGS OF FACT 1. The Veteran underwent a radical retropubic prostatectomy at a VA hospital in November 2001. 2. Subsequently, the Veteran developed incontinence, impotence, pelvic hematoma, open wound, diarrhea and pain in the thighs. 3. These disabilities were not due to carelessness, negligence, lack of proper skill, or error in judgment. 4. A pelvic hematoma, open wound, diarrhea and pain in the thighs were not reasonably foreseeable complications of the Veteran's November 2001 prostatectomy. 5. Incontinence and impotence are reasonably foreseeable complications of the Veteran's November 2001 prostatectomy. CONCLUSIONS OF LAW 1. The criteria for entitlement to compensation benefits under the provisions of 38 U.S.C.A. § 1151 for pelvic hematoma, open wound, diarrhea and pain in the thighs due to treatment at a VA hospital in November 2001 have been met. 38 U.S.C.A. §§ 1151, 5107 (West 2002); 38 C.F.R. § 3.361 (2012). 2. The criteria for entitlement to compensation benefits under the provisions of 38 U.S.C.A. § 1151 for incontinence and impotence due to treatment at a VA hospital in November 2001 have not been met. 38 U.S.C.A. §§ 1151, 5107 (West 2002); 38 C.F.R. § 3.361 (2012). REASONS AND BASES FOR FINDINGS AND CONCLUSIONS Veterans Claims Assistance Act The Veterans Claims Assistance Act (VCAA) redefined VA's duty to assist the appellant in the development of a claim. VA regulations for the implementation of the VCAA were codified as amended at 38 C.F.R. §§ 3.102, 3.156(a), 3.159, and 3.326(a) (2012). Duty to Notify The notice requirements of the VCAA require VA to notify a veteran of what information or evidence is necessary to substantiate the claim; what subset of the necessary information or evidence, if any, the claimant is to provide; and what subset of the necessary information or evidence, if any, VA will attempt to obtain. 38 C.F.R. § 3.159(b) (2012). The requirements apply to all five elements of a service connection claim: veteran status, existence of a disability, a connection between a veteran's service and the disability, degree of disability, and effective date of the disability. Dingess/Hartman v. Nicholson, 19 Vet. App. 473 (2006). VCAA notice must be provided to a claimant before the initial unfavorable decision on a claim for VA benefits by the agency of original jurisdiction (in this case, the RO). Id; see also Pelegrini v. Principi, 18 Vet. App. 112 (2004). However, insufficiency in the timing or content of VCAA notice is harmless if the errors are not prejudicial to the claimant. Conway v. Principi, 353 F.3d 1369, 1374 (Fed. Cir. 2004) (VCAA notice errors are reviewed under a prejudicial error rule). In letters dated February 2002, April 2003, May 2005, September 2006 and February 2008, the RO provided notice to the Veteran regarding what information and evidence are needed to substantiate a claim for compensation benefits under the provisions of 38 U.S.C.A. § 1151. A letter dated September 2006 advised the Veteran of how the VA assigns a disability rating and an effective date, and the type of evidence which impacts such. Duty to Assist The record also reflects that VA has made reasonable efforts to obtain relevant records adequately identified by the appellant. Specifically, the information and evidence that have been associated with the claims file include private and VA medical records, VA examination reports, a VHA opinion, and the opinion of an independent medical expert. The Veteran was afforded a VA medical examination, and the VA obtained additional opinions regarding the effects of his November 2001 surgery at a VA hospital. The opinions were rendered by medical professionals following either a thorough examination and interview of the appellant, and/or a review of the pertinent medical records. The examiners laid a factual foundation for the conclusions that were reached. Therefore, the Board finds that the opinions of record are adequate. See Nieves-Rodriguez, 22 Vet. App. at 304. As discussed above, the appellant was notified and aware of the evidence needed to substantiate his claims, the avenues through which he might obtain such evidence, and the allocation of responsibilities between himself and VA in obtaining such evidence. The Veteran was an active participant in the claims process by responding to notices, submitting evidence, and providing argument. Thus, he was provided with a meaningful opportunity to participate in the claims process and has done so. Any error in the sequence of events or content of the notice is not shown to have affected the essential fairness of the adjudication or to cause injury to the claimant. Therefore, any such error is harmless and does not prohibit consideration of these matters on the merits. See Conway, supra; Dingess, supra; see also ATD Corp. v. Lydall, Inc., 159 F.3d 534, 549 (Fed. Cir. 1998). Analysis The Board has reviewed all the evidence in the appellant's claims file. Although the Board has an obligation to provide adequate reasons and bases supporting this decision, there is no requirement that the evidence submitted by the appellant or obtained on his behalf be discussed in detail. Rather, the Board's analysis below will focus specifically on what evidence is needed to substantiate the claims and what the evidence in the claims file shows, or fails to show, with respect to each claim. See Gonzales v. West, 218 F.3d 1378, 1380-81 (Fed. Cir. 2000) and Timberlake v. Gober, 14 Vet. App. 122, 128-30 (2000). In pertinent part, 38 U.S.C.A. § 1151 provides: (a) Compensation under this chapter and dependency and indemnity compensation under chapter 13 of this title shall be awarded for a qualifying additional disability or a qualifying death of a veteran in the same manner as if such additional disability or death were service-connected. For purposes of this section, a disability or death is a qualifying additional disability or qualifying death if the disability or death was not the result of the veteran's willful misconduct and-- (1) the disability or death was caused by hospital care, medical or surgical treatment, or examination furnished the veteran under any law administered by the Secretary, either by a Department employee or in a Department facility as defined in section 1701(3)(A) of this title, and the proximate cause of the disability or death was- (A) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the Department in furnishing the hospital care, medical or surgical treatment, or examination; or (B) an event not reasonably foreseeable. 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. See 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 a 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. See 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. See 38 C.F.R. § 3.361(c)(2). 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 (2008). 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. See 38 C.F.R. § 3.361(d)(1). Whether the proximate cause of a veteran's additional disability or death was an event not reasonably foreseeable is in each claim to be 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. See 38 C.F.R. § 3.361(d)(2). Pursuant to the language of the aforementioned law and regulation, section 1151 claims for additional disability are treated similarly to claims for service connection. See Jones v. West, 12 Vet. App. 383 (1999); Boggs v. West, 11 Vet. App. 334 (1998). Hence, to establish entitlement, there must be (1) medical evidence of a current disability; (2) medical evidence, or in certain circumstances, lay evidence of incurrence or aggravation of an injury as the result of hospitalization, medical or surgical treatment, or the pursuit of a course of vocational rehabilitation under Chapter 31 of title 38, United States Code; and (3) medical evidence of a nexus between that asserted injury or disease and the current disability. The Veteran was hospitalized by the VA in November 2001. It was noted he had adenocarcinoma of the prostate, and that he was at a very high risk for early death from aggressive prostate cancer, and that cancer cure was extremely unlikely with any form of treatment. A radical retropubic prostatectomy was recommended. The Veteran consented to the procedure, and was aware of the risks, which included erectile dysfunction, urinary incontinence, rectal injury, possibly requiring a colostomy, bleeding requiring a transfusion, infection, myocardial infarction, cerebrovascular accident and death. The operation report stated that informed consent was obtained. All risks and benefits were explained. The hospital discharge summary shows the Veteran tolerated the surgery well, without complications. His hematocrit dropped in the intensive care unit, and he received a transfusion. He had significant pain over the right lower abdomen. A CT of the abdomen and pelvis revealed a rectus sheath hematoma. Since his pain improved, it was decided to manage his pain conservatively. The Veteran reported severe scrotal swelling five days after the operation. There was no evidence of infection. He had significant scrotal edema and some hemorrhage, most likely from retracting of the rectus sheath hematoma. He was placed on medications with scrotal support. The diagnoses on discharge were prostate cancer and rectus sheath hematoma. VA outpatient treatment records disclose the Veteran was seen in March 2002 for pain in his thigh and groin since the surgery. It was indicated he had incontinence and that his diarrhea was better. In May 2002, it was noted his postoperative complications consisted of pelvic hematoma, wound separation and pseudomembranous enterocolitis. A private physician related in June 2003 that the Veteran had completed radiation therapy. He experienced some urinary frequency and dysuria during the treatment. The Veteran was afforded a genitourinary examination by the VA in June 2005. The diagnoses included status post prostate cancer; status post radical retropubic prostatectomy with lymphadenectomy; status postoperative abdominal wall and retroperitoneal hematoma with massive scrotal swelling; postoperative abdominal wall scar and tenderness; postoperative total incontinence; postoperative chronic diarrhea; and postoperative peripheral neuropathy. The examiner commented the postoperative complications of the radical retropubic prostatectomy with lymphadenectomy caused hematoma, incontinence, scrotal swelling, chronic diarrhea; impotence and peripheral neuropathy. He commented that these complications were not due to carelessness, negligence, lack of proper skill or error in judgment. In April 2008, the Veteran's claims folder was reviewed by a VA medical provider for an opinion as to whether the postoperative complications were reasonably foreseeable. He summarized his conclusions, and noted regarding impotency, that the neurovascular damage that occurred in the immediate postoperative period was not preventable; there was bladder sphincter damage that inadvertently occurred during the original surgery; scrotal swelling, which later resolved, resulted from the large degree of retroperitoneal bleeding that was unavoidable during the original surgery; the lateral femoral cutaneous nerve injury was as likely as not related to the operative period and positioning required to do the surgery; and that there was no one cause of diarrhea. He opined he saw nothing in the medical record to suggest carelessness or failure to foresee expected difficulties that occurred from the surgeries related to the Veteran's prostate cancer. At the direction of the Board, the Veteran's claims folder was reviewed by a VA medical oncologist. He noted the Veteran had an advanced cancer that required treatment with prostatectomy or radiation therapy, and he was treated with both modalities. The oncologist stated the Veteran experienced additional disability due to VA surgical care and postoperative treatment. This was evidenced by wound dehiscence, enterocolitis, pelvic hernia, and numbness in the anterior thighs. His incontinence and impotence were attributed to radiation therapy and surgery. The physician concluded there was no evidence of carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault on the part of the VA in furnishing hospital care, or medical or surgical treatment. He commented these complications are known complications of the surgical and radiation therapy procedures. He added impotence is also to be anticipated with goserelin therapy. There was no indication that a reasonable health care provider would have foreseen a risk for these additional disabilities. They should be considered as an ordinary risk of the surgical treatment provided in November 2001. The oncologist also stated a reasonable health care provider would disclose, in connection with the informed consent procedures for the surgical procedure performed in November 2001, the possibility of postoperative infection (including wound infection, dehiscence, nosocomial infection such as C. difficile enterocolitis causing diarrhea), hematoma, incontinence, impotence and hernia. He further noted numbness of the thighs related to the use of stirrups is uncommon and might not be routinely mentioned as a possible postoperative complication. Migration of the implanted penile prosthesis and a requirement for revision of the artifical urethral sphincter are also known complications of these procedures, which a reasonable health care provider would disclose in connection with the informed consent procedures for the surgical procedure. In April 2011, the medical oncologist furnished an addendum to his opinion. He commented that the complications are the complications of the surgical and radiation therapy procedures that can occur but cannot be foreseen. There is no indication that a reasonable health care provider could have prevented these additional disabilities. The complications should be considered as an ordinary risk of the surgical treatment provided in 2001. The complications that occurred are ones that a reasonable health care provider could not have foreseen. Finally, the Board referred the Veteran's claims folder to a urologic oncologist for an additional opinion. He stated in his August 2011 opinion that the Veteran suffered an injury resulting in additional disabilities by reason of the radical prostatectomy performed by the VA in November 2001. He said he did not believe that the proximate cause was carelessness, negligence, lack of proper skill, or error in judgment. He also asserted the specific event of bleeding after surgery was reasonably foreseeable and it seems to have been included in the informed consent. He noted the Veteran developed internal bleeding postoperatively. After this type of surgery, one would immediately expect deep pelvic bleeding (retropubic bleeding) from the prostate surgical bed. Instead, physical examination and CT findings indicated a rectus sheath hematoma. This type of bleeding is unusual. The physician stated the clinicians suspected the bleeding was due to an inadvertent injury of an epigastric vessel during wound closure. He opined this particular anatomic site of bleeding was a rare event that was not reasonably foreseeable (rectus sheath hematoma from wound closure); however, the possibility of bleeding, in general, after a radical prostatectomy, is definitely foreseeable and appears to be included in the informed consent. At the request of the Board, the independent medical expert provided an addendum to his opinion in March 2012. He again noted that immediately after the Veteran's radical prostatectomy, the Veteran developed a major rectus sheath hematoma, and ultimately developed an open wound that was left to heal by secondary intention. The Veteran had pseudomembranous colitis around that time, and this was characterized by diarrhea. He also had numbness and pain in his thighs after the surgery. The urologic oncologist opined that the open wound was probably secondary to the rectus sheath hematoma and, therefore, related to the surgery. He added that the pseudomembranous colitis and diarrhea were probably due to wound complications and antibiotic administration around the time of the surgery. The Veteran subsequently received radiation therapy to the prostate bed because of a rising PSA. Thus, chronic long-term diarrhea is more likely related to the radiation than anything else and is due to the natural disease course that required radiation. The chronic long-term diarrhea is likely not related to the surgery. The physician also noted the Veteran developed pain in his thighs after surgery. This could in some way be related to the rectus sheath hematoma or positioning during surgery. It is more likely than not related to the surgery. He concluded that the complications listed above were not reasonably foreseeable. Those events are not unimaginable, but they would not be considered an ordinary risk of a radical prostatectomy. These types of events would not ordinarily be disclosed in the context of an informed consent discussion preoperatively. He said he, and other experienced urologists would not ordinarily discuss open wounds, chronic long-term diarrhea and thigh pain during the informed consent procedures for a radical prostatectomy. It appears there is no question that any additional disabilities are not due to carelessness, negligence, lack of proper skill, or error in judgment. Thus, the issue in this case is whether the proximate cause of any additional disability was an event that was not reasonably foreseeable. The record reflects numerous opinions have been obtained. The Board notes that the opinion of the VA medical oncologist contains conflicting statements. In his April 2011 opinion, he stated the complications should be considered as an ordinary risk of the surgical treatment provided, but then added the complications were ones that a reasonable health care provider could not have foreseen. The Board notes that it appears that the physician misunderstood the question, and was essentially addressing whether a physician could know for certain whether a particular complication would occur, as opposed to addressing whether a complication was a foreseeable ordinary risk. In light of contradiction noted above (which rendered the opinion of little use in resolving the issues on appeal), the Board referred the Veteran's claims folder to an independent medical expert. He noted the Veteran had received reasonable informed consent regarding impotence, incontinence, bleeding, and death. He further noted the Veteran had unusual bleeding following the surgery that was not reasonably foreseeable (although bleeding in general was a foreseeable risk). Ultimately, he concluded the open wound, diarrhea and thigh pain were not reasonably foreseeable. Thus, resolving reasonable doubt in the Veteran's favor, the Board concludes compensation benefits under the provisions of 38 U.S.C.A. § 1151 are warranted for the pelvic hematoma (due to an unusual type of bleeding), open wound, diarrhea and thigh pain. There is no evidence in the record suggesting that incontinence and impotence are not reasonably foreseeable as complications of a radical prostatectomy. ORDER Compensation benefits under the provisions of 38 U.S.C.A. § 1151 for pelvic hematoma, open wound, diarrhea and thigh pain are granted. Compensation benefits under the provisions of 38 U.S.C.A. § 1151 for impotence and incontinence are denied. ____________________________________________ MICHAEL MARTIN Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs