Citation Nr: 18161044 Decision Date: 12/28/18 Archive Date: 12/28/18 DOCKET NO. 15-28 585 DATE: December 28, 2018 ORDER Entitlement to compensation under 38 U.S.C. § 1151 for disability resulting from chemotherapy and radiation treatment performed at a VA fee-contracted facility in July 2010 is denied. FINDING OF FACT The Veteran’s anal incontinence did not result from an event not reasonably foreseeable or any carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA. CONCLUSION OF LAW The criteria for entitlement to compensation under 38 U.S.C. § 1151 for anal incontinence are not met. 38 U.S.C. § 1151 (2012); 38 C.F.R. § 3.361 (2018). REASONS AND BASES FOR FINDING AND CONCLUSION Duty to Notify and Assist The Veterans Claims Assistance Act of 2000 (VCAA), codified in pertinent part at 38 U.S.C. §§ 5103, 5103A (2012), and the pertinent implementing regulation, codified at 38 C.F.R. § 3.159 (2018), provide that VA will assist a claimant in obtaining evidence necessary to substantiate a claim but is not required to provide assistance to a claimant if there is no reasonable possibility that such assistance would aid in substantiating the claim. The record reflects that all pertinent available service treatment records (STRs) and all available post-service medical evidence identified by the Veteran have been obtained. In addition, the Veteran was provided a VA examination in February 2016, and the Board also obtained a comprehensive independent medical opinion from a VA physician at the Detroit VAMC in July 2018. Further, in September 2015, the Veteran was afforded a hearing before a Decision Review Officer at the Oakland VA Regional Office, and in June 2016 he was afforded a videoconference hearing before the undersigned Veterans Law Judge. Transcripts of those hearings are of record. Neither the Veteran nor his representative has identified any outstanding evidence that could be obtained to substantiate the claim; the Board is also unaware of any such evidence. Accordingly, the Board will address the merits of the Veteran’s claim. Analysis of the Claim The Veteran has contended compensation benefits are warranted for anal incontinence caused by treatment for his anal cancer that was performed in July and August of 2010 at Stanford University Medical Center, a VA fee-contracted facility. When a Veteran suffers additional disability or death as the result of training, hospital care, medical or surgical treatment, or an examination by VA, disability compensation shall be awarded in the same manner as if such additional disability or death were service connected. See 38 U.S.C. § 1151 (2012); 38 C.F.R. § 3.358(a) (2018). The Board notes that Congress intended to encompass not simply the actual care provided by VA medical personnel, but also treatment-related incidents that occur in the physical premises controlled and maintained by the VA, which includes treatment at a VA contracted private facility such as occurred in this case. For claims, as here, filed on or after October 1, 1997, the Veteran must show that the VA treatment in question resulted in additional disability, and further, 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 the disability was an event which was not reasonably foreseeable. 38 U.S.C. § 1151 (2012); see also VAOPGCPREC 40-97 (Dec. 31, 1997). In determining whether additional disability exists, the Veteran’s physical condition immediately prior to the beginning of the hospital care, medical or surgical treatment, or other incident in which the claimed disease or injury was sustained (i.e., medical examination, training and rehabilitation services, or work therapy), is compared to his condition after such treatment, examination or program has stopped. See 38 C.F.R. § 3.361 (b) (2018). Provided that additional disability is shown to exist, the next consideration is whether the causation requirements for a valid claim have been met. In order to establish actual causation, the evidence must show that the medical or surgical treatment rendered resulted in the Veteran’s additional disability. See 38 C.F.R. § 3.361 (c)(1) (2018). Furthermore, the proximate cause of the disability claimed must be the event that directly caused it, as distinguished from a remote contributing cause. To establish that carelessness, negligence, lack of proper skill, error in judgment or other instance of fault proximately caused the additional disability, it must be shown either that VA failed to exercise the degree of care expected by a reasonable treatment provider, or furnished the medical treatment at issue without the Veteran’s informed consent. See 38 C.F.R. § 3.361 (d)(1) (2018). Proximate cause may also be established where the Veteran’s additional disability was an event not reasonably foreseeable—to be determined based on what a reasonable health care provider would have foreseen. See Schertz v. Shinseki, 26 Vet. App. 362 (2013). 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 the type of risk that a reasonable health care provider would have disclosed as part of the procedures for informed consent (in accordance with 38 C.F.R. § 17.32). See 38 C.F.R. § 3.361(d)(2) (2018). Determinations as to 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 (2018). 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) (2018). Failure to advise a patient of a foreseeable risk can be considered a minor, immaterial deviation under the regulation if a reasonable person in similar circumstances would have proceeded with the medical treatment even if informed of the foreseeable risk. See McNair v. Shinseki, 25 Vet. App. 98 (2014). The Veteran was diagnosed with squamous cell carcinoma of the anal canal in May 2010. Thereafter, he was authorized by VA to obtain fee-contracted treatment at the Stanford University Medical Center. The record indicates that on June 11, 2010 the Veteran and his son met with Drs. D.C. and J.B. to discuss treatment options. Following this meeting, the Veteran began receiving chemotherapy and radiation in July 2010. During his 5-week treatment cycle, the Veteran developed anal incontinence. The Veteran asserts his incontinence was either not an event reasonably foreseeable; or alternatively, that his incontinence developed as a result of negligence on the part of his treating physician, because he reports he was never informed of this treatment risk. Alternatively, the Veteran also asserts negligence occurred because he was not informed of alternative treatment options. In sum, for the Veteran to prevail in this matter, he must demonstrate the following: a) a “qualifying additional disability” that was not the result of his own “willful misconduct;” b) that his disability was directly “caused by hospital care, medical or surgical treatment, or examination furnished the veteran” by VA or in a VA facility; and c) that the “proximate cause” of his disability was the “carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part” of VA, or “an event not reasonably foreseeable.” The evidence indicates the Veteran does indeed have an additional disability following his chemoradiation therapy. Further, a June 2014 statement from his treating Oncologist indicates the Veteran’s fecal incontinence is attributable to his radiation therapy. Therefore, the first two elements noted above are satisfied, because the Veteran has a qualifying additional disability, which was directly caused by the medical care he received. As such, the central issue that must be determined by the examiner in this case is whether the Veteran’s incontinence was at least as likely as not (a 50 percent probability or greater) proximately caused by: a) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA contracted facility; or b) an event that could not have reasonably been foreseen by a reasonable healthcare provider administering the Veteran’s chemoradiation therapy. The Board finds the greatest probative evidence indicates the Veteran’s anal incontinence was both a risk that was reasonably foreseeable, and a complication of standard treatment that did not result from carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA contracted facility. In this respect, the Board notes the Veteran has on numerous occasions acknowledged that no carelessness or negligence occurred by way of actual administration of his chemoradiation treatment. That is to say, the Veteran has conceded the Stanford University Medical Center did not carelessly, negligently, or otherwise unreasonably administer treatment to him that resulted in his claimed disability. Rather, the Veteran has recognized that even though his chemoradiation was properly administered, his anal incontinence was a known side-effect of the treatment. The Veteran principally asserts that negligence occurred because he was not properly informed of either alternative treatment options or the risk of anal incontinence prior to the administration of the elected treatment option. In support of his contention, the Veteran has provided several letters detailing his experiences. In addition, the Veteran has provided a statement from his son, which indicates he was present with his father during the meetings with his treating physicians, and also did not recall a discussion of bowel irregularities or anal incontinence during those meetings. However, a review of all evidence of record indicates the Veteran was informed of alternative treatment options, as well as anal incontinence being a risk factor associated with the elected treatment option. In particular, the June 11, 2010 treatment note provided a complete chronology of the detailed discussion the Veteran had with Drs. D.C. and J.B. This chronology indicates the Veteran was provided a detailed description of the proposed treatment option and alternative treatment options. The note also indicates numerous long-term risk factors associated with chemoradiation treatment were discussed. These risk factors included “damage to the pelvic bones leading to increased risk of fracture, risk of damage to the external anal sphincter causing incontinence, risk of damage to the bowel including small bowel obstruction and perforations that may require surgery to fix, damage to the bladder that may require surgery to fix, damage to nerves which could potentially lead to impotence, rare risk of lymphedema, and a rare risk of a secondary cancer.” (emphasis added). Additionally, the Veteran was provided a list of treatment instructions. This letter also informed the Veteran that chemoradiation treatment could result in diarrhea. Further, by way of a June 2015 letter, the Veteran acknowledged that he was provided a list of long-term side effects that included anal incontinence in a list of “small print items.” Following the February 2016 VA examination, the examiner acknowledged anal incontinence was a known risk factor associated with the Veteran’s chemoradiation treatment, but noted that the alternative surgical treatment option would have likely resulted in a permanent colostomy. Likewise, the July 2018 independent medical examiner—a radiation oncology specialist—also acknowledged anal incontinence was an entirely foreseeable risk factor associated with the chosen treatment option. The examiner further indicated the information provided to the Veteran was within the reasonable standards of care under the circumstances. Specifically, the examiner indicated the Veteran signed a radiation treatment general consent form, which discussed in detail that anal incontinence could be a potential adverse effect of treatment. The Board notes this form was provided to the Veteran well in advance of his actual treatment commencement in July 2010, which allowed ample time for him to follow-up with any additional questions he may have had with respect to any of the listed risks associated with the treatment. Though the Veteran may sincerely believe he did not receive a sufficiently comprehensive report of this risk factor from his treating physicians, the Board finds he did receive reasonable notice. The Veteran has acknowledged, his primary concern at that time was to “get the recommended treatment started.” The Board is sympathetic that under such circumstances the Veteran may not have been primarily focused on the treatment side effects, as he has indicated his principal concern was eradicating his cancer. However, the Board finds the greatest weight of the evidence indicates the Veteran was provided both written and oral counseling by his treating physicians prior to the administration of his chemoradiation treatment. Whether this specific risk factor was or was not discussed is immaterial. In this case the Veteran has clearly evidenced the ability to read and articulate himself at a very high level. He has acknowledged that he was provided a complete written report, which detailed the long-term risk factors associated with the chosen treatment options, as well as the alternative treatment options available. The Veteran was provided the opportunity to discuss any of the noted risk factors with his treating physicians, and thereafter, elected to move forward with chemoradiation treatment. It is clear that anal incontinence was an entirely foreseeable side-effect associated with chemoradiation treatment. Further, it cannot be said the Veteran was not reasonably informed of this side-effect, as he was provided two separate letters indicating this consequence could result. The Board appreciates the difficulties the Veteran has faced as a result of his anal incontinence; however, the Board finds his anal incontinence was both a risk that was reasonably foreseeable—as evidenced by its inclusion as a risk factor in the June 2010 written informed consent—and also a complication of standard treatment that did not result from carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA contracted facility. Therefore, the Veteran’s claim for entitlement to compensation under 38 U.S.C. § 1151 must be denied. T. REYNOLDS Veterans Law Judge Board of Veterans’ Appeals ATTORNEY FOR THE BOARD G. Fraser, Counsel