Citation Nr: 21015400 Decision Date: 03/17/21 Archive Date: 03/17/21 DOCKET NO. 17-02 194 DATE: March 17, 2021 ORDER Entitlement to compensation under 38 U.S.C. § 1151 for loss of bladder control is denied. FINDING OF FACT Additional disability manifested as loss of bladder control (urinary incontinence) was not the result of carelessness, negligence, lack of proper skill, error in judgment or other instance of fault on the part of VA, nor was it due to an event not reasonably foreseeable. Informed consent was properly obtained prior to the December 10, 1998 surgery at issue. CONCLUSION OF LAW The criteria for compensation pursuant to the provisions of 38 U.S.C. § 1151 for additional disability claimed as loss of bladder control due to care received by VA in December 1998 have not been met. 38 U.S.C. §§ 1151, 5103, 5103A, 5107; 38 C.F.R. §§ 3.102, 3.159, 3.361. REASONS AND BASES FOR FINDING AND CONCLUSION The Veteran served on active duty from June 1956 to May 1965. He testified before the undersigned Veterans Law Judge at a June 2018 videoconference hearing. This matter was denied by the Board in October 2018. The Veteran appealed that decision to the United States Court of Appeals for Veterans Claims, resulting in a July 2019 Joint Motion for Remand (JMR). Pursuant to the JMR, the Board remanded this matter in October 2019 for evidentiary development. 1. Entitlement to compensation under 38 U.S.C. § 1151 for loss of bladder control The Veteran requests compensation under 38 U.S.C. § 1151 for additional disability resulting from a December 10, 1998, radical retrograde prostatectomy with a bilateral pelvic lymph node dissection performed by VA. The Veteran has two primary assertions: (1) the operation was performed by a medical resident who lacked the necessary skill and expertise to perform the surgery; and (2) his informed consent was not properly obtained prior to the procedure, as his resulting urinary incontinence was not explained to be a risk factor. In pertinent part, section 1151 provides for compensation for a qualifying additional disability in the same manner as if such additional disability were service connected. 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 (2) 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. § 1151. In determining whether additional disability exists, the physical condition immediately prior to the disease or injury upon which the claim for compensation is based will be compared with the subsequent physical condition resulting from the disease or injury. Compensation will not be payable for the continuance or natural progress of diseases or injuries for which the hospitalization or treatment was authorized. 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 or died does not establish cause. 38 C.F.R. § 3.361 (c)(1). The proximate cause of disability or death is the action or event that directly caused the disability or death, as distinguished from a remote contributing cause. To establish that carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA’s part in furnishing hospital care, medical or surgical treatment, or examination proximately caused a veteran’s additional disability or death, it must be shown that the hospital care, medical or surgical treatment, or examination caused the Veteran’s additional disability or death (as explained in paragraph (c) of this section); and (i) VA failed to exercise the degree of care that would be expected of a reasonable health care provider; or (ii) VA furnished the hospital care, medical or surgical treatment, or examination without the Veteran’s or, in appropriate cases, the Veteran’s representative’s informed consent. 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. 38 C.F.R. § 3.361 (d). 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 section 17.32. The evidence is clear that the December 10, 1998, VA surgery resulted in additional disability in the form of urinary incontinence through no fault of the Veteran. An October 2013 VA examiner explained that “urinary incontinence post-operatively has been severe and his external sphincter implant helped, but some incontinence persists and is getting progressively worse.” As additional disability exists, the Board must examiner the proximate cause of the disability and whether such an event was reasonably foreseeable. 38 U.S.C. § 1151. The December 1998 operative report indicates that the procedure was performed to treat prostate cancer. The procedure took three times longer than usual, 6 hours, due to the Veteran’s deep and small pelvis. It was reported to be a difficult procedure, but notably there were no complications. He was discharged five days later and told to return in eight days for catheter and staple removal. He had post-prostatectomy urinary incontinence and in July 2000 underwent placement of artificial urinary sphincter without complications. However, some degree of incontinence has continued, and he must use absorbent pads. The October 2013 VA examiner opined that additional disability (urinary incontinence) was not caused by either (a) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing the surgical treatment, or (b) an event not reasonably foreseeable. The physician provided the following rationale. Examiner has reviewed the operative report and notes the following; surgery took approximately 3 x the average operating time for the procedure the surgeon, a urology resident, in his operative note describes a technically difficult procedure because of a deep, narrow pelvis. The resident was assisted by a seasoned urology staff surgeon throughout the procedure. While the surgeon was a resident, there is no indication in the operative report suggesting negligence or malpractice. The probative value of a medical opinion primarily comes from its reasoning; threshold considerations are whether a person opining is suitably qualified and sufficiently informed. See Nieves-Rodriguez v. Peake, 22 Vet. App. 295, 304 (2008). In this case, the Board accepts the October 2013 VA examiner’s opinion as highly probative medical evidence. The Board notes that the examiner rendered the opinion after thoroughly reviewing the claims file and relevant medical records. The examiner noted the Veteran’s pertinent history and provided a reasoned analysis of the case. See Hernandez-Toyens v. West, 11 Vet. App. 379, 383 (1998); Gabrielson v. Brown, 7 Vet. App. 36, 40 (1994). Here the evidence is clear that VA did not fail to exercise the degree of care that would be expected of a reasonable health care provider. The examiner that performed the operation was appropriately skilled and knowledgeable, the procedure was performed in accordance with proper procedure, and while it was reported to be “a technically difficult procedure,” that was due to the Veteran’s anatomical dimensions and not the fault of the surgeon. 38 U.S.C. § 1151; 38 C.F.R. § 3.361 (d)(1)(i). There is also no evidence that urinary incontinence was an event that was not reasonably foreseeable. 38 U.S.C. § 1151. A review of the July 2019 JMR makes clear that those findings are not at issue, as the parties focused on the informed consent requirement of 38 C.F.R. § 3.361 (d)(1)(ii). The JMR determined that the Board did not adequately address the Veteran’s assertion that informed consent had not been properly obtained. Pursuant to this section, “[t]o determine whether there was informed consent, VA will consider whether the health care providers substantially complied with the requirements of § 17.32 of this chapter. Minor deviations from the requirements of § 17.32 of this chapter that are immaterial under the circumstances of a case will not defeat a finding of informed consent. Consent may be express (i.e., given orally or in writing) or implied under the circumstances specified in § 17.32(b) of this chapter, as in emergency situations.” 38 C.F.R. § 3.361 (d)(1)(ii). As explained in the JMR, sections 17.32(b), (c), and (d) are critical to determine if informed consent was properly obtained. Section 17.32(b) provides that “[e]xcept as otherwise provided in this section, no medical treatment or procedure may be performed without the prior, voluntary informed consent of the patient.” A patient must have “decision-making” capacity to give informed consent. Notably, the Veteran does not assert that he lacks such capacity. Section 17.32 (c) delineates general requirements for informed consent: Informed consent is the process by which the practitioner discloses to and discusses appropriate information with a patient so that the patient may make a voluntary choice about whether to accept the proposed diagnostic or therapeutic procedure or course of treatment. Appropriate information is information that a reasonable person in the patient’s situation would expect to receive in order to make an informed choice about whether or not to undergo the treatment or procedure. (Appropriate information includes tests that yield information that is extremely sensitive or that may have a high risk of significant consequence (e.g., physical, social, psychological, legal, or economic) that a reasonable person would want to know and consider as part of his or her consent decision.) The specific information and level of detail required will vary depending on the nature of the treatment or procedure. 38 C.F.R. § 17.32 (c). There are six requirements that are relevant here, documented in subsections (1) – (6). Subsection (7) is not applicable as there is no evidence that the procedure was performed in an emergency situation. The informed consent discussion should be conducted in person with the patient whenever practical. If it is impractical to conduct the discussion in person, or the patient expresses a preference for communication through another modality, the discussion may be conducted by telephone, through video conference, or by other VA-approved electronic communication methods. 38 C.F.R. § 17.32 (c) (1). The practitioner must explain in language understandable to the patient each of the following, as appropriate to the treatment or procedure in question: The nature of the proposed procedure or treatment; expected benefits; reasonably foreseeable associated risks, complications or side effects; reasonable and available alternatives; and anticipated results if nothing is done. 38 C.F.R. § 17.32 (c) (2). The patient must be given the opportunity to ask questions, to indicate comprehension of the information provided, and to grant or withhold consent freely without coercion. 38 C.F.R. § 17.32 (c) (3). The practitioner must advise the patient if the proposed treatment is novel or unorthodox. 38 C.F.R. § 17.32 (c) (4). The patient may withhold or revoke consent at any time. 38 C.F.R. § 17.32 (c) (5). The practitioner may delegate to other trained personnel responsibility for providing the patient with clinical information needed for the patient to make a fully informed consent decision but must personally verify with the patient that the patient has been appropriately informed and voluntarily consents to the treatment or procedure. 38 C.F.R. § 17.32 (c) (6). Lastly, section 17.32 (d) delineates the requirements for documentation of informed consent: The informed consent process must be appropriately documented in the health record. For treatments and procedures that are low risk and within broadly accepted standards of medical practice, a progress note describing the clinical encounter and the treatment plan are sufficient to document that informed consent was obtained for such treatments or procedures. For tests that provide information that is extremely sensitive or that may have a high risk of significant consequences (e.g., physical, social, psychological, legal, or economic) that a patient might reasonably want to consider as part of the consent decision, the health record must specifically document that the patient or surrogate consented to the specific test. 38 C.F.R. § 17.32 (d) (1). The patient’s and practitioner’s signature on a form prescribed by VA for that purpose is required for all diagnostic and therapeutic treatments or procedures that meet any of the following criteria: (i) Require the use of sedation; (ii) Require anesthesia or narcotic analgesia; (iii) Are considered to produce significant discomfort to the patient; (iv) Have a significant risk of complication or morbidity; or (v) Require injections of any substance into a joint space or body cavity. 38 C.F.R. § 17.32 (d) (2). Consent for treatments and procedures that require signature consent must be documented in the health record on a form prescribed by VA for that purpose, or as otherwise specified in this paragraph (d). 38 C.F.R. § 17.32 (d) (3). The record contains a SF Form 522 Request for Administration of Anesthesia and for Performance of Operations and Other Procedures. The form indicates the procedure to be performed: “radical retrograde prostatectomy with a bilateral pelvic lymph node dissection.” The nature of the procedure is documented as “to remove prostate and lymphatic tissue.” It was noted that additional procedures, including “possible blood transfusion, possible mechanical ventilation, possible placement of central venous catheters for hemodynamic monitoring or parenteral nutrition, and possible arterial catheters for hemodynamic monitoring” may be performed dependent on the circumstances of the scheduled procedure. The Veteran signed this formed on December 7, 1998. This is well within the 60-day period of validity for authorized consent under 38 C.F.R. § 17.32 (d) (3) (ii). The file also contains a Progress Note for Informed Consent Discussion dated December 7, 1998. This discussion took place 15 minutes prior to the Veteran’s signature on the SF Form 522. The patient was reported to have decision-making capacity. The form notes that the following items were discussed with the patient: (1) treatment(s) and/or procedure(s); (2) indications, risks, benefits, options, potential complications & alternative treatment options; and (3) indications, risks, benefits, options, potential complications for medications, blood transfusions. The Veteran was reported to have freely consented to the procedure without fraud, duress, deceit or coercion. The form was signed by the counseling physician, Dr. C.B., who performed the surgery. A December 10, 1998, (date of the operation) Nurse Intraoperative Report also documents valid consent. A review of the record indicates that informed consent was properly obtained prior to the December 10, 1998 operation, in accordance with 38 C.F.R. § 17.32. Notably, there is no evidence or argument that the Veteran lacked decision-making capacity. Relevant forms document that the practitioner completed a proper in-person informed consent discussion that met the requirements of 38 C.F.R. § 17.32 (c). Informed consent was properly documented in accordance with 38 C.F.R. § 17.32 (d). The Board notes the February 2021 statement by the Veteran’s representative asserting that informed consent was not properly obtained because urinary incontinence was not specifically listed on the SF Form 522. The representative notes that the VA surgeon specifically noted the possible requirement for blood transfusion, mechanical ventilation, and the other procedures listed above. Importantly, these procedures do not represent potential risks of the scheduled radical retrograde prostatectomy with a bilateral pelvic lymph node dissection. Rather, they represent medical procedures that may have been medically necessary during the scheduled procedure. While the representative is correct that the SF Form 522 does not specifically list urinary incontinence as a risk factor, there is no requirement under section 17.32 that each specific risk factor for a procedure is documented on the signed informed consent form. Rather, section 17.32 requires that an informed consent discussion take place and that the occurrence of such discussion is documented. 38 C.F.R. § 17.32 (c) (d). Here, those requirements have been met. In conclusion, while the evidence is clear that additional disability in the form of urinary incontinence manifested as a result of the December 10, 1998, VA operation, the preponderance of the evidence shows that the proximate cause of such additional disability was not the carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing the surgical treatment, or (b) an event not reasonably foreseeable. In determining that the additional disability was not due to the fault of VA in furnishing surgical treatment, the evidence is clear that informed consent was properly obtained prior to the operation in accordance with relevant VA regulation. 38 C.F.R. §§ 3.361 (d)(1)(ii), 17.32. H. N. SCHWARTZ Veterans Law Judge Board of Veterans’ Appeals Attorney for the Board W. R. Stephens The Board’s decision in this case is binding only with respect to the instant matter decided. This decision is not precedential and does not establish VA policies or interpretations of general applicability. 38 C.F.R. § 20.1303.