Citation Nr: 1201016 Decision Date: 01/11/12 Archive Date: 01/20/12 DOCKET NO. 07-20 887A ) DATE ) ) On appeal from the Department of Veterans Affairs Regional Office in Buffalo, New York THE ISSUE Entitlement to compensation pursuant to 38 U.S.C.A. § 1151, for residuals of priapism as a result of Department of Veterans Affairs medical treatment. REPRESENTATION Appellant represented by: The American Legion ATTORNEY FOR THE BOARD D. Rogers, Associate Counsel INTRODUCTION This matter comes before the Board of Veterans' Appeals (Board) on appeal from a December 2005 rating decision of the Department of Veterans Affairs (VA) Regional Office (RO) in Buffalo, New York, which denied the benefit sought on appeal. The Veteran appeared and gave testimony at a personal hearing before a Decision Review Officer (DRO) at the RO in November 2007. A transcript of that hearing is of record. This case was previously before the Board in April 2011. On that occasion, the Board requested a medical expert advisory opinion from a Urologist on the medical questions at issue. The requested opinion was received in July 2011. Appellant's representative has offered additional argument. FINDINGS OF FACT 1. On October 22, 2003, the Veteran, a known cocaine user, was prescribed Trazodone for treatment of insomnia associated with a non-service connected psychiatric disorder by a VA physician at the Rochester, New York, VA Outpatient Clinic which resulted in the Veteran's development of priapism on November 27, 2003, which went unreported or treated for over 36 hours and ultimately resulted in permanent erectile impairment. 2. The Veteran had reported trouble taking Trazodone in the past, was prescribed a higher dose by the VA and had the resulting rare side effect of a priapism that resulted in erectile impairment; this is not a common foreseeable side effect of the medicine. CONCLUSION OF LAW With application of the doctrine of reasonable doubt, compensation pursuant to 38 U.S.C.A. § 1151 for residuals of priapism as a result of Department of Veterans Affairs medical treatment on October 22, 2003 have been met. 38 U.S.C.A. §§ 1151, 5103, 5107 (West 2002); 38 C.F.R. §§ 3.102, 3.361 (2011). REASONS AND BASES FOR FINDINGS AND CONCLUSION Veterans Claims Assistance Act of 2000 The Veterans Claims Assistance Act of 2000 (VCAA), is codified at 38 U.S.C.A. §§ 5100, 5102, 5103, 5103A, 5106, 5107, and 5126 (West 2002 & Supp. 2011) redefined VA's duty to assist a claimant 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) (2011). Given the Board's favorable disposition to grant the Veteran's claim for compensation pursuant to 38 U.S.C.A. § 1151 for residuals of priapism as a result of Department of Veterans Affairs medical treatment on October 22, 2003, the Board finds that no discussion of VCAA compliance is necessary at this time. Analysis The Veteran asserts that compensation under the provisions of 38 U.S.C.A. § 1151 (West 2002) is warranted for residuals of priapism as the Trazodone prescribed to him during the course of his VA medical treatment on October 22, 2003 was done without his informed consent as the VA physician neglected to inform him of the potentially adverse side effect of priapism that could and did resulted from his use of Trazodone. The Veteran further asserts that the VA physician prescribed a larger dose of Trazodone than has been prescribed to him in the past and that a review of his treatment records would suggest that he had difficulty in the past using this medication so it should not have been prescribed. The Veteran's claim for compensation under the provisions of 38 U.S.C.A. § 1151 was received by the VA after October 1, 1997. VA regulations provide that 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 (West 2002); 38 C.F.R. § 3.361 (2011). 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) (2011). 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) (2011). 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) (2010). 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 provider 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) (2011). 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) (2011). General requirements for informed consent: Informed consent is the freely given consent that follows a careful explanation by the practitioner to the patient or the patient's surrogate of the proposed diagnostic or therapeutic procedure or course of treatment. The practitioner, who has primary responsibility for the patient or who will perform the particular procedure or provide the treatment, must explain in language understandable to the patient or surrogate the nature of a proposed procedure or treatment; the expected benefits; reasonably foreseeable associated risks, complications or side effects; reasonable and available alternatives; and anticipated results if nothing is done. The patient or surrogate must be given the opportunity to ask questions, to indicate comprehension of the information provided, and to grant permission freely without coercion. The practitioner must advise the patient or surrogate if the proposed treatment is novel or unorthodox. The patient or surrogate may withhold or revoke his or her consent at any time. 38 C.F.R. § 17.32(c). Documentation of informed consent. (1) The informed consent process must be appropriately documented in the health record. In addition, signature consent is required for all diagnostic and therapeutic treatments or procedures that: (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. (2) A patient or surrogate will sign with an "X" when the patient or surrogate has a debilitating illness or disability, i.e., significant physical impairment and/or difficulty in executing a signature due to an underlying health condition(s), or is unable to read and write. When the patient's or surrogate's signature is indicated by an "X," two adults must witness the act of signing. By signing, the witnesses are attesting only to the fact that they saw the patient or surrogate and the practitioner sign the form. The signed form must be filed in the patient's health record. A properly executed VA-authorized consent form is valid for a period of 60 calendar days. If, however, the treatment plan involves multiple treatments or procedures, it will not be necessary to repeat the informed consent discussion and documentation so long as the course of treatment proceeds as planned, even if treatment extends beyond the 60-day period. If there is a change in the patient's condition that might alter the diagnostic or therapeutic decision, the consent is automatically rescinded. 38 C.F.R. § 17.32(d). Under the benefit-of-the-doubt rule embodied in 38 U.S.C.A. § 5107(b), in order for a claimant to prevail, there need not be a preponderance of the evidence in the veteran's favor, but only an approximate balance of the positive and negative evidence. In other words, the preponderance of the evidence must be against the claim for the benefit to be denied. Gilbert v. Derwinski, 1 Vet. App. 49, 54 (1994). Turning to the evidence, the record reveals that in December 2002, the Veteran received private in-patient psychiatric treatment for depressive disorder not otherwise specified. A history of cocaine use was noted with the last use a few days prior to this admission. Past psychotropic medications included Zoloft, and most recently, Paxil. During this impatient treatment, the Veteran's medication therapy included being started on Depakote and he was restarted on 20 mg. of Paxil once daily. Three days after this admission, the Veteran was discharged to E.B. Mental Health Center for mentally ill chemical abuse (MICA) treatment. Despite no mention of use of Trazodone during this 3 day inpatient stay, the Veterans December 2002 discharge medication list included Trazodone 50 mg. nightly, as needed, for sleep. In January 2003, private outpatient dual mental health and chemical dependence treatment records from U. Health System reveal that the Veteran was admitted to that facility on January 13, 2003 with presenting problems of mental illness, alcohol and drug abuse, depression/mood disorder, and suicidal ideation. The Veteran reported experiencing a stressful year with alternating depressive and manic-like symptoms all year. Regarding the Veteran's physiology, it was noted that sleep with Trazodone still was not good and he was not sleeping as well. The Veteran's medical history was negative for any serious illness or surgery with the exception of a past injury to the right arm. Cocaine use was reported once a week with alcohol use. The Veteran denied any concerns regarding his sexual functioning/difficulties/behaviors. Upon examination, physiological symptoms were significant for poor sleep and variable energy. The Veteran's medications included, among others, Trazodone 50 mg. nightly. Diagnoses included current mixed bipolar disorder unspecified with instruction to rule out recurrent major depression/mood disorder, and cocaine dependence in partial remission. On January 17, 2003, a medication consultation noted complaints of insomnia, significantly however, the Veteran complained that Trazodone caused him to feel hung-over and dizzy in the past. Accordingly, a medication treatment recommendation included a prescription for Ambien to treat the Veteran's complaints of insomnia. It was noted that the Veteran was informed about the effects and adverse effects of the medications prescribed. Continuing private treatment notes from U. Health Center for mental health and chemical dependence reveal that in February 2003, the Veteran was no longer taking Ambien because he was sleeping better. In April 2003, following a relapse of cocaine abuse, it was noted that the Veteran discontinued taking his medications, however, Paxil and Depakote were restored. In May 2003, the Veteran complained of insomnia and stated that Ambien did not help. The Veteran stated that he did not wish to be treated with any addictive medications for vocational rehabilitation purposes. In July 2003, it was noted that the Veteran was transferring care for his mental health and chemical dependence to the VA because, if accepted, his medications would be paid for. It was also noted that the Veteran reported sleeping well and that he was given samples of Depakote and Paxil. In October 2007, it was noted that the Veteran was put into chemical dependency treatment at VA and that he planned to transition his mental health treatment out VA outpatient treatment. Significantly, a September 23, 2003 VA behavioral health outpatient intake note indicated that the Veteran was taking Paxil and Depakote medications prescribed at the E.B. Mental Health Clinic. There was no indication that the Veteran was currently taking Trazodone upon this VA intake evaluation. Reportedly on intake in October 2003, it was noted that upon undergoing an intake evaluation, the Veteran admitted to cocaine use since 1990. His past mental health history and treatment history was noted. It was also noted that cocaine and alcohol dependence was in early remission with the most recent relapse approximately 1 month earlier. It was noted that the Veteran's current medications received from E.B. Mental Health Care included Paxil and Divalproex. The Veteran reported satisfaction with the aforementioned medications. Regard medication changes, it was noted that VA did not carry Paxil, so Paroxentine was prescribed instead. The VA psychiatrist further stated that he would enter prescriptions for Divalproex and for Trazodone 100 mg. as needed. The psychiatrist incorrectly stated, as demonstrated by the evidence outlined above, that such were the medications and doses that the Veteran was currently taking. Indeed, the record does not show that the Veteran had used Trazodone since approximately 9 months earlier whereby he complained of the way Trazodone made him feel. Significantly, regarding the Veteran's education, this treatment note merely stated that the Veteran was provided with medication and substance abuse treatment. However, it does not indicate that the Veteran was fully informed of the potential risks and side effects of the medications prescribed on this occasion. A November 14, 2003 VA treatment note indicates that upon the Veteran's discharge from private impatient treatment in December 2002, the Veteran's medications included Trazodone 50 mg. as needed for sleep. However, the VA psychiatrist did not note the subsequent private and VA treatment records indicating that the Veteran had complained about the way Trazodone made in feel, and he neglected to note that Trazodone was note listed as a current medication upon the Veteran's intake evaluation for VA treatment for mental health and chemical dependence. On November 28, 2003, VA treatment notes reveal that the Veteran called the VA Rochester Outpatient Clinic due to a questionable adverse reaction to Trazodone. The Veteran reported having had an erection for over 24 hours. Upon being instructed by the VA nurse to report to his local emergency room as soon as possible, the Veteran was reluctant. However, the nurse ultimately convinced the Veteran to report to his local emergency room and he stated that he was leaving for the emergency room at that time. Thereafter, on November 28, 2003, private emergency room treatment notes show that the Veteran was transferred from another private hospital with a diagnosis of priapism secondary to Trazodone use with a 36 hour history of having an erection/priapism. The Veteran reported that the condition developed after taking Trazodone in combination with cocaine use. The Veteran was initially treated with irrigation with normal saline and phenylephrine without resolution. Thereafter, he was scheduled for an emergent blue-sheet shunting procedure in attempts to detumesce is priapism. A Winter's shunt and corporal irrigation was performed, however, postoperatively, the penis was not fully detumesced. On postoperative day 2, November 30, 2003, the penis became more rigid and the Veteran was again taken to the operating room where he underwent a modified Winter's shunt to detumesce the penis. Thereafter, the penis was still somewhat firm, but the shunt was patent. The Veteran was discharged home and Trazodone was discontinued. The Veteran was instructed to see the physician who prescribed his psychiatric medicines to review his current regimen in light of the aforementioned complications with priapism and Trazodone. On December 8, 2003, a VA behavioral health outpatient progress note reveals that the Veteran stopped to see his VA psychiatrist to fill him in on recent events. On that occasion, the Veteran allegedly reported that he had been taking Trazodone 100 mg. as needed without experiencing any side effects. However, upon being prescribed the same dosage of the same medication by the VA psychiatrist, after taking the first pill from the new prescription, the Veteran experienced continued sexual arousal following intercourse. The Veteran reported that priapism persisted for about 36 hours prior to the Veteran calling the VA Rochester Outpatient Clinic on November 28, 2003 to advise them of the situation. The two emergency surgical procedures were noted. The VA psychiatrist reported that the Veteran was puzzled at how he took one month's worth of Trazodone 100 mg. without experiencing priapism on prior occasion and the Veteran wondered if his prescription for Trazodone may have been refilled with a larger sized tablet by mistake. In any event, the VA psychiatrist prescribed Vicodin for the Veteran's post-surgical pain and it was explicitly noted that the Veteran was warned that the medication should be used sparingly as it was potentially addicting. On December 23, 2003, the Veteran was seen for psychiatric care for the first time at an upstate New York VA Health Care Center. Interestingly, the VA psychiatrist confirmed that upon review of the VA treatment records, he too, was unable to find notation that the Veteran suffers from priapism due to Trazodone use. In any event, on December 31, 2003, the VA psychiatrist from the VA Rochester Outpatient Clinic recorded that the Veteran was receiving inpatient treatment at the Buffalo, New York VAMC, however, the Veteran stopped by to say hello and he reported doing quite well. The VA psychiatrist noted that last time he and the Veteran met, the Veteran reported that he had not experienced any sexual arousal when taking the first container of Trazodone, but once starting the refill on that container, he allegedly experienced prolonged sexual arousal on two occasions, the second of which resulted in the need for two urologic procedures. On this occasion, however, the Veteran allegedly reported that he actually experienced prolonged sexual arousal on many occasions while taking his first container of Trazodone. Regarding the Veteran's prior noted suspicions on the dosage of Trazodone, on this occasion, the Veteran reported that no mistake had been made and the pills in the first container were the same as the pills in the second container. Finally, it was noted that the Veteran confirmed being sexually potent after the surgical procedures to treat priapism. The psychiatrist advised the Veteran that perhaps 1/3 of men become impotent as a result, however, the Veteran made clear that he was not impotent. In August 2004, a VA Urology treatment note reveals that the following the November 2003 episode of priapism, the Veteran reported having a continuous semi-rigid erection that progressed to a full erection with sexual and non-sexual stimulation. The Veteran denied pain but reported feeling uncomfortable and constantly conscious and embarrassed due to his constant erection. Some sexual difficulties were also reported. The diagnostic assessment included priapism for 9 months after 36 hour emergent priapism, diminished sexual pleasure, and possible fibrosis. The VA urologist recommended cavernoglandular shunt and a penile implant and the Veteran was educated on the consequences of not foregoing the recommended surgery and about receiving the recommended shunt and penile implant. In November 2005, the Veteran was afforded a VA Genitourinary examination. A semi-erect penis was noted upon examination and there was minor scarring over the head of the penis. The examiner diagnosed priapism and opined that such condition was more likely than not secondary to Trazodone which the examiner stated does have a side effect of priapism. The examiner stated that while priapism is rare, it did occur. In April 2011, the Board requested an advisory expert medical opinion from a Urologist in this matter. Following a review of the claims folder, the reviewer stated that due to the Veteran's documented history of cocaine use/abuse, which is known to cause priapism by itself, he was unable to conclude that Veteran's priapism was caused by Trazodone use. In addition, the reviewer stated that priapism is not a foreseeable side effect of Trazodone as Trazodone induced priapism is rare, occurring in less than 0.1 percent of patients. As a Urologist, the reviewer stated that he was unable to comment as to the appropriateness of the medical indication of prescribing Trazodone because it was outside the scope of the urology specialty. From a urology standpoint, the reviewer stated that there were no contraindications for risk of priapism so long as the Veteran was instructed on the potential side effect of priapism, especially in light of his documented history of cocaine use/abuse, which is known to potentially increase the risk of priapism if combined with Trazodone. Regarding the Veteran's knowledge of the potential risks of Trazodone, the reviewer stated that although the record suggests that the Veteran was provided with education concerning Trazodone, there is no documentation in the record that the risk of priapism was specifically discussed. In this regard, the reviewer cited to medical literature which suggested that although rare, priapism is a serious medical emergency that requires immediate medical intervention. In addition, because most patients would not attribute a prolonged erection to Trazodone, patient counseling about the possibility of priapism is necessary for all men beginning therapy with the drug, and all men should be advised to report a prolonged or painful erection to their physician immediately. Accordingly, this reviewer opined that instruction on the side effect of priapism would be especially important in a clinical setting of a patient with a history of cocaine abuse given that the concurrent use of Trazodone and cocaine has a potential for an increased risk of priapism. Finally, the reviewer stated that if the Veteran was provided with information regarding the potential side effects of Trazodone, then prescribing that drug to the Veteran would not be considered an indication of negligence, carelessness, lack of proper skill, or other instance of indicated fault on VA medical personnel for prescribing Trazodone. Following a review of the evidence outlined above, the Board notes that the Veteran is competent to report what he was told. He has provided competent evidence that he was not told of the risk of priapism following Trazodone use. Specifically, in a statement received in February 2006, the Veteran asserted that if he were properly informed of the risks and side effects associated with Trazodone use, not only would be not have taken the drug to begin with, but he also would not have waited so long to seek treatment following the onset of priapism. The Veteran stated that his ignorance and lack of any knowledge about the potential adverse side effect of priapism, in addition to the potential seriousness of that condition, is further evidenced by the VA medical record documenting his phone contact with the nurse and his need to be convinced to seek emergency medical treatment for priapism in November 2003. As noted by the July 2011 VA reviewer, and confirmed by the Board's review of the claims folder, while the evidence of record indicates that while the Veteran may have been counseled concerning the potential risks and side effects of Trazodone use, the potential risk of priapism is not specifically mentioned anywhere in the VA treatment record, nor is there any mention of instruction on what to do in the event that priapism were to occur. In addition, the Veteran has submitted multiple statements indicating that he was not advised of the risk or potential for priapism to occur at any time prior to his development of that condition in November 2003, nor does the record show that such a risk was ever discussed. There is some argument to be made that the risk of the medication should be set out given the potential increase of priapism as a side effect in a cocaine user. It appears, however, that such notice may not have been highlighted in view of the relatively insignificant risk overall. The medical opinion received responded, in the question as to whether a priapism would be considered an "unforeseeable consequence" of the medication was to the effect that a Trazodone induced priapism is rare, occurring in less than 0.1% of patients. "As such it would not be considered as a common foreseeable side effect of this medication." Under the statute and regulations, this seems to render this an unforeseeable consequence of the treatment, given the rarity of the event. With consideration of the doctrine of reasonable doubt, this unforeseeable consequence, given the other facts of this case provides a basis for granting the claim for benefits pursuant to the provisions of 38 U.S.C.A. § 1151. ORDER Compensation under the provisions of 38 U.S.C.A. § 1151 for residuals of priapism following VA medical treatment with Trazodone on October 22, 2003, is granted. ____________________________________________ MICHAEL D. LYON Veterans Law Judge, Board of Veterans' Appeals Department of Veterans Affairs