Citation Nr: 18144131 Decision Date: 10/25/18 Archive Date: 10/23/18 DOCKET NO. 15-04 202 DATE: October 25, 2018 ORDER Entitlement to compensation benefits under the provisions of 38 U.S.C. § 1151 (2012) for residuals of an adverse reaction to Caverject for impotence with scarring of the penis, also described as Peyronie’s disease (penis deformity), is denied. FINDINGS OF FACT 1. The Veteran developed an additional disability to his penis, including corpral fibrosis, after undergoing medical treatment at a VA facility, during which he was prescribed Caverject injections. 2. The preponderance of the evidence is against a finding that the Veteran sustained an additional disability to his penis as a result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA health care providers who provided treatment, or that there is any additional disability resulting from that treatment constituting an event that was not reasonably foreseeable. CONCLUSION OF LAW The criteria for entitlement to compensation benefits under the provisions of 38 U.S.C. § 1151 for a penis deformity have not been met. 38 U.S.C. §§ 1151, 5107 (2012); 38 C.F.R. §§ 3.154, 3.361 (2017). REASONS AND BASES FOR FINDINGS AND CONCLUSION The Veteran had active duty service from January 1970 to December 1972. The Veteran testified before the undersigned Veterans Law Judge (VLJ) via videoconference during an April 2018 Board hearing. A transcript of the hearing is included in the claims file. VA’s duty to assist includes making reasonable efforts to assist the Veteran in obtaining evidence necessary to substantiate a claim for the benefit sought, unless no reasonable possibility exists that such assistance would aid in substantiating a claim. See Golz v. Shinseki, 590 F.3d 1317, 1320-21 (2010). The record shows that certain records from the Veteran’s treatment at the Portland, Oregon VA Medical Center (VAMC) from 1994 to 1997 are unavailable. Specifically, the Regional Office (RO) and the Veteran have attempted to ascertain these records on several occasions. As indicated by the July 2013 reply from the Portland VAMC, as well as the Veteran’s April 2018 Board hearing testimony, these records are unavailable and future attempts to ascertain them would be futile. The issue of entitlement to service connection for erectile dysfunction as secondary to service-connected major depressive disorder (MDD) has been raised by the record in an April 2018 fully developed claim form (VA Form 21-526EZ), but has not been adjudicated by the Agency of Original Jurisdiction (AOJ). Therefore, the Board does not have jurisdiction over this matter, and it is referred to the AOJ for appropriate action. 38 C.F.R. § 19.9(b) (2017). The Veteran contends that his current penis deformity was caused by Caverject injections that were prescribed by a VA physician, “Dr. SR,” in the mid- or late-1990s, and that this additional disability resulted from carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of Dr. SR when he prescribed this injection medication. Under the provisions of 38 U.S.C. § 1151, if VA hospitalization or medical or surgical treatment causes additional disability, which is not the result of a veteran’s own willful misconduct or failure to follow instructions, disability compensation may be awarded for a “qualifying additional disability” in the same manner as if the additional disability was service connected. See 38 C.F.R. § 3.361. If additional disability is present, two principal criteria apply in determining whether it is compensable within the ambit of 38 U.S.C. § 1151. First, the additional disability may qualify for compensation if the disability is not the result of a veteran’s willful misconduct and the disability was caused by hospital care, medical or surgical treatment, or examination provided under the laws administered by VA. Second, in order to constitute a qualifying additional disability, the proximate cause of the additional disability must have been (1) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the facility furnishing the care, treatment, or examination, or (2) an event not reasonably foreseeable. These provisions of law apply to claims received by VA on or after October 1, 1997. 38 U.S.C. § 1151; 38 C.F.R. § 3.361(a). To determine whether an additional disability was caused by medical treatment, VA compares a veteran’s condition immediately before the beginning of such treatment to his condition thereafter. To establish causation, the evidence must show that the treatment resulted in the veteran’s additional disability. Merely showing that a veteran received care, treatment, or examination, and that a veteran has an additional disability does not establish cause. Disability that is due to the continuance or natural progress of the disease is not due to VA treatment 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(b), (c). To establish that carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on VA’s part in furnishing medical treatment proximately caused a veteran’s additional disability, it must be shown that the medical treatment caused the additional disability, and that VA failed to exercise the degree of care that would be expected of a reasonable health care provider; or that VA furnished the medical treatment without the veteran’s informed consent. To determine whether there was informed consent, VA will consider whether the health care provider substantially complied with the requirements of 38 C.F.R. § 17.32 (2017). “Informed consent is the freely given consent that follows a careful explanation by the practitioner to the patient...of the proposed diagnostic or therapeutic procedure or course of treatment.” 38 C.F.R. § 17.32(c). The practitioner must explain to the patient, in a language understandable to the patient: the nature of the proposed treatment; the expected benefits; reasonably foreseeable associated risks, complications or side effects; reasonable and available alternatives; and anticipated results if nothing is done. Id. 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. 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. 38 C.F.R. § 3.361(d). 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. Id. Regulations further provide that compensation is not payable for the necessary consequences of VA treatment properly administered with the express or implied consent of a veteran or, in appropriate cases, a veteran’s representative. “Necessary consequences” are those which are certain or intended to result from the treatment provided. Consequences otherwise certain or intended to result from treatment will not be considered uncertain or unintended solely because it had not been determined, at the time consent was given, whether that treatment would, in fact, be administered. 38 C.F.R. § 3.361. Initially, the Board finds that the Veteran developed an additional disability to his penis, including corpral fibrosis, after undergoing medical treatment at a VA facility, during which he was prescribed Caverject injections. Specifically, the claims file includes many statements from the Veteran, as well as medical evidence, including a July 2014 VA examination report, which shows that he was diagnosed with a penile deformity, including corpral fibrosis, as a result of injections to his penis. This deformity began after the Veteran performed numerous injections on himself, both at a VA medical facility and at home, after he was prescribed the Caverject medication by a VA physician. However, the preponderance of the evidence is against a finding that the Veteran sustained an additional disability to his penis as a result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA health care providers who provided treatment, or that there is any additional disability resulting from that treatment constituting an event that was not reasonably foreseeable. First, the Board looks to see whether VA failed to exercise the degree of care that would be expected of a reasonable health care provider when the Veteran was prescribed the Caverject medication in the 1990s. In this regard, the claims file includes the statements from a September 1997 VA physician, the opinion of the July 2014 VA examiner, and the Veteran’s statements from November 2010. In a September 1997 physician’s note, a VA doctor noted that the Veteran reported that the Caverject medication resulted in scarring of the penis and that it did not work for impotence any longer. The doctor noted that the Veteran was upset about this and that the medical professionals who prescribed the medication should have known that scarring would occur. This doctor stated that the Veteran was clearly advised that such intervention, i.e., injections into his penis, always carried the possibility of complications. Similarly, after reviewing the Veteran’s pertinent records, a VA examiner opined in July 2014 that the Veteran’s corpral fibrosis was a well-known potential side effect on injection therapy, and there is no evidence per se of any malpractice as long as there was an informed consent. Likewise, in a November 2010 statement, the Veteran asserted that he was damaged in treatment at the VA Hospital in Portland. However, he stated that he doubted that there was any malice, incompetence, or negligence involved on the part of VA medical staff. Rather, the Veteran asserted at the time that a small fraction of men, including himself, do not react well to the Caverject or Alprostadil medication, which required him to mix up the powdered chemicals and inject himself in the penis with a syringe or needle. He also described the resulting penile deformity, including scar tissue and curvature of the penis. This evidence shows that VA did not fail to exercise the degree of care that would be expected of a reasonable health care provided when the Veteran was prescribed the Caverject medication in the 1990s. Specifically, the July 2014 VA examiner determined that there was no per se malpractice on the part of Dr. SR in prescribing the medication. Furthermore, the Veteran, himself, also stated in the November 2010 statement that he doubted there was any malice, incompetence, or negligence involved on the part of VA in prescribing and providing the Caverject medication. Nonetheless, the Veteran asserted in numerous statements, including on December 2014 and January 2018 Substantive Appeal to the Board forms (VA Forms 9) and at the April 2018 Board hearing testimony, that Dr. SR failed to inform him of the complications. In the VA Forms 9, the Veteran contended that Dr. SR told him that the downside risk of this treatment was, at worst, that he would develop a bump on the outside of the penis at the injection site. However, the preponderance of the evidence shows that VA did not furnish the medical treatment without the veteran’s informed consent. Specifically, as indicated by the September 1997 VA physician’s note, the Veteran was clearly advised that injections into his penis always carried the possibility of complications. Additionally, the Board notes that the July 2014 VA examiner determined that the Veteran’s corpral fibrosis was a well-known potential side effect on injection therapy. Moreover, the claims file includes a December 2011 Internet article showing the common and other side effects of Caverject injection therapy, which includes small bumps and hard tissue in the penis, penile angulation, cavernosal fibrosis, and Peyronie’s disease. Given this evidence, the Board finds that the Veteran did not sustain an additional disability resulting from VA treatment constituting an event that was not reasonably foreseeable. In summary, the evidence of record does not reflect that the Veteran sustained an additional disability to his penis as a result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA health care providers who provided treatment, or that there is any additional disability resulting from that treatment constituting an event that was not reasonably foreseeable. For those reasons, the preponderance of the evidence is against his claim for benefits under 38 U.S.C. § 1151. Accordingly, the benefit of the doubt doctrine is inapplicable, and the claim must be denied. See 38 C.F.R. § 5107(b); Gilbert v. Derwinski, 1 Vet. App. 49 (1990). A. P. SIMPSON Veterans Law Judge Board of Veterans’ Appeals ATTORNEY FOR THE BOARD A. Hodzic, Counsel