Citation Nr: 21062982 Decision Date: 10/12/21 Archive Date: 10/12/21 DOCKET NO. 13-02 358 DATE: October 12, 2021 ORDER Entitlement to compensation pursuant to 38 U.S.C. § 1151 for additional disability, to include a seizure disorder and an acquired psychiatric disorder, due to VA's administration of Tramadol for pain, is denied. FINDING OF FACT The preponderance of the evidence demonstrates that the Veteran did not undergo an additional disability as a result of the VA prescribed Tramadol for pain, that was proximately due to VA's 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. CONCLUSION OF LAW The criteria for compensation under the provisions of 38 U.S.C. § 1151 for a seizure disorder are not met. 38 U.S.C. §§ 1151, 5107; 38 C.F.R. §§ 3.102, 3.361. REASONS AND BASES FOR FINDING AND CONCLUSION The Veteran served on active duty from November 1974 to March 1975 and from July 1975 to May 1977. In September 2013, the Veteran was afforded a hearing before a Veterans Law Judge (VLJ) other than the undersigned. In February 2021, the Veteran was informed that the VLJ who had conducted his September 2013 Board hearing was no longer employed by the Board, and that he had a right to an additional hearing before a different VLJ. Because the Veteran did not respond to the letter within 30 days, the Board has assumed that the Veteran does not wish to attend another Board hearing. The transcript of the Veteran's September 2013 Board hearing is of record and has been reviewed by the undersigned. This case was previously before the Board in February 2015, March 2019, September 2020, and April 2021 when it was remanded for further development, including clarifying medical opinions. It has now returned to the Board for further appellate action. Compensation Pursuant to 38 U.S.C. § 1151 Compensation under 38 U.S.C. § 1151 is awarded for a qualifying additional disability caused by improper VA treatment. A disability is a qualifying additional disability if the disability was not the result of the Veteran's willful misconduct and the disability was caused by hospital care, medical or surgical treatment, or examination furnished the Veteran under any law administered by the Secretary of the VA, either by a Department employee or in a Department facility and the proximate cause of the disability was 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 an event not reasonably foreseeable. 38 U.S.C. § 1151; 38 C.F.R. § 3.361. In Viegas v. Shinseki, the United States Court of Appeals for the Federal Circuit (Federal Circuit) noted that section 1151 delineates three prerequisites for obtaining disability compensation. First, a putative claimant must incur a "qualifying additional disability" that was not the result of his own "willful misconduct." 38 U.S.C. § 1151 (a). Second, that disability must have been "caused by hospital care, medical or surgical treatment, or examination furnished the Veteran" by VA or in a VA facility. Finally, the "proximate cause" of the Veteran's disability must be "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." See Viegas v. Shinseki, 705 F.3d 1374 (Fed. Cir. 2013); 38 U.S.C. § 1151(a)(1)(A), (a)(1)(B). Thus, section 1151 contains two causation elementsa Veteran's disability must not only be caused by the hospital care or medical treatment he received from VA, but also must be proximately caused by the VA's fault or an unforeseen event. 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 care or treatment is rendered. 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 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 causation. 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 of 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). To establish that carelessness, negligence, lack of proper skill, error in judgment, or similar instance on VA's part in furnishing hospital care, medical or surgical treatment, or examination proximately caused a Veteran's additional disability, it must be shown that the hospital care or medical or surgical treatment caused the veteran's additional disability; 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. 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). Whether the proximate cause of a veteran's additional disability 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. 38 C.F.R. § 3.361(d)(2). The Board must weigh any competent lay evidence and to make a credibility determination. See Barr v. Nicholson, 21 Vet. App. 303 (2007); see also Layno, supra. The credibility of lay evidence may not be refuted solely by the absence of corroborating contemporaneous medical evidence, but it is a factor. Davidson v. Shinseki, 581 F.3d at 1313, 1316 (Fed. Cir. 2009). Other credibility factors are the lapse of time in recollecting events attested to, prior conflicting statements as opposed to consistency with other statements and evidence, internal consistency, facial plausibility, bias, interest, the length of time between alleged incurrence of disability and the earliest or first corroborating medical or lay evidence thereof, and statements given during treatment (which are usually given greater probative weight, particularly if close in time to the onset thereof). Caluza v. Brown, 7 Vet. App. 498, 506 (1995), aff'd, 78 F.3d 604 (Fed. Cir. 1996) [(table)]. When there is an approximate balance of positive and negative evidence regarding any issue material to the determination of a matter, the Secretary shall give the benefit of the doubt to the claimant. 38 U.S.C. § 5107; 38 C.F.R. § 3.102; Gilbert v. Derwinski, 1 Vet. App. 49, 53 (1990). Background In the April 2021 Remand, the Board summarized the medical history of the Veteran's claimed condition as follows: The claims file documents consistent mental health problems beginning in August 1990, when the Veteran was hospitalized at a private psychiatric facility for an adjustment disorder, major depression, and polysubstance abuse. However, the Veteran's reported history during this and subsequent inpatient treatment dates the onset of his psychiatric symptoms to more than 10 years earlier. The Veteran has reported on several occasions that he began to abuse alcohol in 1978, when he joined the Merchant Marines. In 1981, he struggled with binge drinking and had problems at work. He was fired from his job and "moved around." In 1985, while living in Michigan, he began to use crack cocaine at this time, the Veteran also began to experience some psychotic symptoms, including auditory hallucinations. This led to his first suicide attempt and psychiatric hospitalization. In 1986, after his discharge from the hospital, the Veteran's apartment was burglarized, and he was struck in the head with a baseball bat. Although medical records from this incident are not included in the claims file, the Veteran has consistently reported that he incurred a serious head injury, lost consciousness and was in a coma for approximately three weeks and experienced a grand mal seizure upon reawakening. Following this head injury, which has been described by VA physicians as a closed head traumatic brain injury (TBI) and "major TBI," the Veteran experienced additional psychotic symptoms and was diagnosed with schizophrenia, posttraumatic stress disorder (PTSD), and an adjustment disorder as secondary to the closed head injury. During the 1990s and early 2000s, the Veteran was hospitalized on several occasions for substance abuse and psychiatric symptoms. His treating physicians related his schizophrenia, PTSD, and other mental health diagnoses to the 1986 closed head injury. Providers in January 1991, June 1998, March 2001, and October 2004 also noted the Veteran's previous history of seizures related to the 1986 TBI. In a June 2003 letter, a VA Medical Center (VAMC) doctor found that the Veteran had severe mental and psychiatric disabilities that were complicated by "severe brain damage from a previous head injury." Similarly, subsequent treatment records have consistently shown a complicated relationship between the Veteran's head injury, substance abuse, and mental health conditions. In October 2005, the Veteran applied to participate in the Little Rock VAMC Residential Rehabilitation Treatment Program (RRTP) for PTSD. He was examined at the VAMC in October and November 2005 for entry into the program. The examining providers noted his current medications included tramadol and reviewed the Veteran's history of mental illness, including the 1986 head injury. In November 2005, the examiner noted that the onset of the Veteran's psychotic symptoms appeared in close proximity to his first use of cocaine. This occurred before the 1986 head injury, suggesting that the Veteran may have had an underlying psychotic disorder that was emerging prior to the head injury, or that his hallucinations were due to cocaine use. In any event, the examiner recommended a more thorough assessment to determine if the Veteran's psychotic processes were present before his cocaine use and head injury or if they were instead exacerbated by the drug use and TBI. In closing, the examiner noted that the Veteran's history of "cocaine and alcohol use greatly complicates the diagnostic picture." Several possible diagnoses were identified including schizophrenia or a psychotic disorder, both due to a closed head injury, or substance-induced psychotic disorder PTSD. A November 2005 VAMC discharge summary also noted that the Veteran had a history of seizure in 1986 associated with a head injury and TBI with loss of consciousness. The Veteran was first prescribed tramadol at the VAMC to treat "severe pain" in August 2005. VAMC treatment records do not document the exact cause for the prescription, but it appears the medication was necessary for various joint pains. Tramadol was discontinued as an active medication in December 2005 when the Veteran reported experiencing some side effects, including increased depression. There is no indication he experienced a seizure or other side effects from the use of tramadol over this four-month period. On July 2, 2007, the Veteran was seen at the VAMC with complaints of chronic left knee pain. He reported that Tylenol was no longer effective, and tramadol was listed as a "pending outpatient medication." Two weeks later, on July 16, 2007, tramadol was included on the Veteran's active medication list during an orthopedic examination at the VAMC. The VA orthopedist also noted that the Veteran was taking oxycodone for pain associated with a recent diagnosis of throat and mouth cancer. The Veteran continued to take both tramadol and oxycodone through August 2007; his only reported side effect was straining during urination which he associated with both medications during two urology appointments at the VAMC in July 2007. During the period from August 2007 to April 2008, it is unclear whether the Veteran was consistently taking his prescribed tramadol. On August 20, 2007, approximately six weeks after the medication was prescribed, the Veteran presented at the VAMC emergency department with suicidal and homicidal ideation. He reported that he had been manipulated by his friends into taking drugs and alcohol and had not taken his psychiatric medications for approximately one month. He was admitted for inpatient psychiatric treatment and was given his medications, though he refused to take tramadol. Similarly, during another VA emergency department visit in December 2007, the Veteran stated that he did not want to take tramadol due to the side effects, though he did not specify what side effects he was referencing. In February 2008, the Veteran called the VAMC and requested to "restart [t]ramadol" for knee pain, but then stated during an April 2008 orthopedic evaluation that he preferred not to take tramadol. Later in April 2008, the Veteran again contacted the VAMC asking for pain medication, and he was advised that tramadol was ordered for his knee pain. On April 24, 2007, the Veteran was seen by his VA primary care physician who noted "fair results" from tramadol with no changes to the Veteran's judgment, insight, or memory. The Veteran's past medical history was noted to include a head injury, an unspecified1986 coma, a closed head TBI, and possible seizure disorder. The Veteran appears to have started reported new seizure-like symptoms in May 2008. On May 17, 2008, he called the VAMC and reported symptoms of syncope during a recent bible study class, when a friend observed he had period of black outs and jerking in his seat every few minutes. The Veteran also reported experiencing vertigo and weakness and stated that he was not driving because he did not believe he was correctly taking his medication. The next day, the Veteran was seen at the VA emergency department for general complaints related to what he stated was a medication reaction, though the examining nurse noted that he was not on any new medications and was not able to identify which medications might be causing the problem. The Veteran reported having symptoms over the last month and stated that he thought he was "making mistakes on medication doses." The Veteran was admitted overnight for treatment of schizophrenia, TBI, and multiple complaints including increased auditory and visual hallucinations and paranoia. The examining physician noted that the Veteran's increased paranoid may be due to medication compliance issues. On May 28, 2008, the Veteran was seen again at the VAMC emergency department, having been transferred from a private hospital. Treatment records show that the Veteran began to behave erratically two nights before while staying at a local hotel and presented to a private hospital the evening of May 28, 2008 looking for pain medication. He exhibited psychotic behavior and was transferred to the VAMC. He was admitted for psychosis, likely substance-related, and reported having had a seizure at the hotel with bleeding from the mouth and incoherent speech. On May 29, 2008, the Veteran was admitted to the VAMC for inpatient mental health treatment and was noted to carry a diagnosis of schizophrenia "but had never been psychotic without drugs being involved." In response to the Veteran's reports of a seizure, he was provided a head CT on May 20, 2008 that was normal. Two days later, on June 1, 2008, the Veteran stated that he had a seizure about 96 hours ago and had previously not had a seizure since more than 20 years earlier following a closed head injury. On June 2, 2008, the Veteran again reported experiencing several seizures in the last 96 hours and was recently given tramadol by his primary care doctor which caused him much harm. The Veteran was discharged from the VAMC back to a private hospital on June 3, 2008 and again reported that the prescription of tramadol by his primary doctor had caused great harm. The Veteran also requested an anti-seizure medication. Thereafter, he did not report for a scheduled EEG on June 10, 2008 and tramadol was discontinued from his medication list on July 2, 2008. Following the discontinuance of tramadol on July 2, 2008, the Veteran has received consistent treatment for a seizure disorder. His medication allergy list includes tramadol since August 2008, and he has taken anti-seizure medication since February 2009. The Veteran's VAMC current problem list also includes a diagnosis of epilepsy and VA examiners in June 2015 and April 2020 diagnosed a current seizure disorder. He also continues to receive inpatient and outpatient treatment for various psychiatric disorders, including schizophrenia, PTSD, and polysubstance abuse. In August 2013, in support of his claim, the Veteran submitted a fact sheet from Drugs.com providing information on tramadol. According to the fact sheet, taking the medication is not advised if someone is allergic to tramadol, has ever been addicted to drugs or alcohol, or has attempted suicide. A person should also not take tramadol if they are taking alcohol or street drugs, narcotic pain medication, or medicine for depression, anxiety, or mental illness. Additionally, the fact sheet notes that seizures (convulsions) can occur in some people who take tramadol and may be "more likely to cause a seizure" in a person with a history of seizures or head injury or someone who is taking certain medications, such as antidepressants. Possible side effects of tramadol are listed as: seizure, agitation/hallucinations, dizziness, or feeling nervous or anxious. The Veteran contends that VA's prescribing tramadol for treatment of knee pain in July 2007 resulted in the seizures he experienced in May 2008 and the aggravation of his previous seizure disorder and psychiatric disorders (including schizophrenia, PTSD, and depression). He also contends that the prescribing of tramadol in July 2007 was the result of carelessness, negligence, lack of proper skill, error in judgment, similar instance of fault, or an event not reasonably foreseeable. He points to the information contained in the Drugs.com fact sheet in support of his claim, and notes that his VA physician was aware of his past history of polysubstance abuse, suicide attempts, head injury and history of seizure, and use of narcotics associated with his June 2007 diagnosis of mouth and throat cancer. The Veteran and his mother also testified in September 2013 that his psychiatric symptoms, such as hallucinations and memory loss, drastically worsened following his use of tramadol in July 2007. On VA examination in June 2010, the examiner attributed the Veteran's seizure disorder to his TBI. In an August 2010 opinion, the examiner stated that there was no direct evidence that the Veteran's mental condition is related to the administration of Tramadol to a veteran with a TBI. Further, the examiner was unable to identify definitively any negligence, carelessness, lack of proper skill, error in judgment or similar incidence of fault on the department in causing these conditions; nor was the event described by the Veteran foreseeable by his physician treating him. Upon VA examination in June 2015, the examiner noted that the Veteran was prescribed Gabapentin and Tegretol for seizures. The examiner opined that there was no evidence of misconduct by VA staff and that the Veteran's results could not be foreseen. In a requested expert review opinion, a VA neurologist examiner opined that VA staff did not fail to exercise the degree of care that would be expected of a reasonable health care provider in prescribing tramadol. The history of the severe head injury in 1986 is not a contraindication to prescribing tramadol. The examiner also noted that the Veteran's diagnosis of a seizure disorder was not an established fact and remained speculativeand that the presumptive diagnosis of epilepsy was made when the Veteran reported to medical staff that he had suffered one or two seizures before he was admitted to hospital for acute psychosis on May 29, 2008. When he informed the medical staff on June 1, 2008, he said the seizure(s) had occurred sometime within the previous 96 hours. No seizures were noted by the medical staff during his stay between May 29 and June 2. The Veteran's tongue was lacerated, which was cited as possible evidence that a seizure had indeed occurred. It should be noted that tongue laceration is a sign that facial trauma has occurred, but in and of itself it is insufficient to diagnose seizure. Acting on the presumptive diagnosis on June 1, 2010, an EEG was ordered, but there is no record that the Veteran has undergone that test. In October 2017, the Board requested an expert review and opinion, clarifying that the examiners must accept as true that the Veteran has a valid diagnosis of seizures for the purposes of providing an opinion. In the June 2018 VA addendum expert opinion, the reviewing neurologist stated that warnings about possible side effects and interactions with other medications are meant to be taken into consideration by the treating physician but do not forbit use. Therefore, even if the post-traumatic seizure event had been acknowledged to VA healthcare providers, it would not have constituted an absolute contraindication to prescribing or continuing to prescribe tramadol. The VA neurologist opined that to a reasonable degree of certainty that there is no evidence that VA staff failed to exercise the degree of care that would be expected of a reasonable healthcare provider in prescribing tramadol. The examiner further explained that there is no evidence that informed consent was obtained before tramadol was prescribed. However, informed consent for medications is not required by current standards of medical practice. In April 2020, a VA examiner reviewed the Veteran's medical record under the assumption that he had a diagnosed and witnessed seizure condition. In the accompanying opinion, the examiner was instructed to presume that the Veteran does have a seizure disorder related to Tramadol use. Concerning whether VA staff failed to exercise the degree of care that would be expected of a reasonable healthcare provider in prescribing and providing Tramadol in 2007 and continuing treating until 2008, the examiner explained that while Tramadol does increase threshold for seizures, in 2007 and 2008, it was considered a safer drug for controlling severe pain than the alternatives such as opioid medicines. Even though Tramadol may increase the threshold for seizure, it rarely causes an increase in seizures in general. The risks and benefits ratio for Tramadol in this particular patient would make it a reasonable pain killer to prescribe to him. The risk of Tramadol exacerbating the Veteran's seizures was low, and in fact, his seizures were relatively controlled, even when he was taking Tramadol. The examiner opined that it was less likely than not that his seizures were aggravated beyond natural progression by his use of Tramadol from July 2007 to May 2008 as there was no documentation of increased seizure activities during that time period. In an October 2020 medical opinion, the reviewing examiner stated that it was less likely that VA failed to exercise reasonable care in the prescribing of tramadol starting in 2007. VA prescribed Tramadol in an appropriate dosage, for an appropriate indication, informed the Veteran of potential side effects, and monitored the administration appropriately. The examiner explained that seizures were foreseeable. The Veteran was at high risk for seizure as he had a history of TBI, and was already taking multiple medications with potential side effect of seizure, even if used properly. Tramadol is one of those medicines that may lower seizure threshold and provoke seizures and is a known, predictable side effect. The October 2020 examiner further explained that the records reflect that the Veteran was educated on the risks of the medications he was prescribed, including Tramadol. Thus, it is less likely than not that the VA had the Veteran take Tramadol without informing him of the risks associated with taking the medication, including those specifically related to his personal medical history, under the standards for a reasonable healthcare provider. As directed in the April 2021 Board Remand, medical opinions concerning conflicting medical evidence were obtained from a qualified neurologist. In an April 2021 medical opinion, the examiner addressed the conflicting medical evidence of record concerning whether the Veteran was informed of the potential side effects of his prescribed tramadol. In doing so, the examiner explained that the Veteran did have other reasons to have seizures, including alcohol and cocaine abuse and a severe TBI in addition to a prescription for tramadol. As noted in the package insert for tramadol and the 2013 drugs.com document, there are contraindications to use of tramadol. for example, physicians would consider a prior allergic reaction like urticaria or anaphylaxis an absolute contraindication. The drugs.com document notes that a person with history of addiction or seizures should talk with their doctor about the risks. There is evidence in the records that the Veteran was informed of side effects and potential side effects of tramadol. VA's treating physicians were aware of the Veteran's history when the tramadol was prescribed. This Veteran was specifically advised of potential side effects of tramadol multiple times, including falls and serotonin syndrome. Also, this Veteran attended many pharmacy educational groups in 2006 and 2007. The examiner opined that it was therefore less likely than not that the VA had the Veteran take tramadol without notifying him of side effects. An additional April 2021 opinion addressed whether it was foreseeable that seizures might occur after taking tramadol. The examiner opined that, as tramadol is known to increase risk of seizure in individuals at risk for seizure with prior seizure history, with reasonable medical probability, it was at least as likely as not foreseeable that seizures after taking tramadol might occur. The Veteran did have other reasons to have seizures, including alcohol and cocaine abuse and a severe TBI in addition to tramadol. In support of this opinion, the examiner cited the package insert for tramadol and the 2013 drugs.com document, which provides for contraindications to use of tramadol. The drugs.com document notes that a person with history of addiction or seizures should talk with their doctor about the risks. The examiner also cited a JAMA article, which concluded that clinicians are advised to be mindful of these potential adverse sequalae when prescribing antidepressants to patients on tramadol, particularly in the elderly and/or those who might be at a heightened risk. If coadministration is undertaken, careful monitoring for these two particular hazards is advised. Tramadol is a remarkable drug, but like all drugs, effective use entails balancing the benefits versus the risks. In an April 2021 opinion considering the reasonableness of the treating VA physicians, the examiner opined that a reasonable physician would consider prior history of alcohol or drug abuse, history of TBI, history of seizures, risk of seizures or use of antidepressants relative contraindications. Tramadol would be used with caution in these individuals and seizures, if they occur, would be expected to occur shortly after the medication was initiated. The physicians prescribing tramadol to the Veteran would be expected to use caution while treating him with tramadol. "It is my opinion that it is at least as likely as not that the treating physicians did use appropriate caution and that their treatment did exhibit reasonable care in prescribing tramadol from July 2007 to July 2008." It was less likely than not that the VA failed to exercise the degree of care that would be expected of a reasonable health care provider in prescribing tramadol at that time. Analysis Based on the evidence above, the Board finds that the Veteran's seizure and acquired psychiatric condition, or worsening thereof, was not the result of negligence or carelessness on the part of VA in prescribing Tramadol. Standard of Care Each opinion of record indicates there is no evidence of negligence, lack of proper skill, error in judgment, or similar instance on VA's part in furnishing hospital care, medical or surgical treatment. Additionally, under the applicable law cited above, it must be shown that the hospital care or medical or surgical treatment caused the Veteran's additional disability; 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. Despite the Veteran's lay testimony that his condition worsened after taking Tramadol, the medical opinions indicate there is no evidence that either his seizures or acquired psychiatric condition worsened after taking Tramadol. There is no medical evidence of record for the Board to consider showing or even suggesting that the Veteran's seizure or acquired psychiatric condition worsened after being prescribed Tramadol by VA, or that VA staff exhibited negligence, lack of proper skill, error in judgment, or failed to exercise the degree of care that would be expected of a reasonable health care provider. Additionally, the opinions also explained that, while the use of Tramadol can lead to an increased risk of seizures, it was reasonable to prescribe the drug to the Veteran under the circumstances. To the extent the Veteran contends otherwise, he does not possess the requisite medical expertise to assess negligence in relation to dosages of medication. Accordingly, the claim for compensation pursuant to 38 U.S.C. § 1151 must be denied. Informed Consent The medical opinions of record are well-reasoned and clear that, while the use of Tramadol can lead to an increased risk of seizure in TBI patients, not only is there a lack of evidence that the Veteran's seizure disorder worsened during the time he was prescribed Tramadol, but the Veteran was informed of possible side effects, and prescribing Tramadol was reasonable under the circumstances. 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). Here, it was noted several times in the medical record that the Veteran was educated concerning his medications, including potential side effects. For these reasons, the Board finds the preponderance of the evidence demonstrates that the Veteran did not undergo an additional disability as a result of the VA prescribed Tramadol for pain, that was proximately due to VA's 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. (CONTINUED ON NEXT PAGE) Entitlement to compensation pursuant to 38 U.S.C. § 1151 for additional disability, to include a seizure disorder and an acquired psychiatric disorder, due to VA's administration of Tramadol for pain a seizure disorder, is denied. THERESA M. CATINO Veterans Law Judge Board of Veterans' Appeals Attorney for the Board M.E. Lee 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.