Citation Nr: 21068291 Decision Date: 11/09/21 Archive Date: 11/09/21 DOCKET NO. 14-20 104 DATE: November 9, 2021 ORDER Entitlement to compensation under 38 U.S.C. § 1151 for additional disability of bilateral-foot osteomyelitis, as due to prescription of methotrexate, is denied. FINDING OF FACT The objective evidence of record does not show additional disability was caused by carelessness, negligence, lack of proper skill, or error in judgment by VA, by an event not reasonably foreseeable or the Veteran not having been fully informed of the effects of prescribed methotrexate. CONCLUSION OF LAW The criteria for an award of 38 U.S.C. § 1151 compensation for additional disability of bilateral-foot osteomyelitis, as due to prescription of methotrexate, have not been met. 38 U.S.C. §§ 1151, 5107 (2012); 38 C.F.R. § 3.361 (2020). REASONS AND BASES FOR FINDING AND CONCLUSION The Veteran served on active duty in the United States Army from April 1980 to October 1981. Compensation Under 38 U.S.C. § 1151 The Board will first note the Veteran submitted her § 1151 claim no earlier than an August 2013 VA Form 21-526EZ and a series of August 2013 statements and that all relevant treatment occurred in and after December 2007. Therefore, the claim must be adjudicated under only the current version of 38 U.S.C. § 1151, which requires a showing of fault on the part of VA. See 69 Fed. Reg. 46,426 (Aug. 3, 2004) (including the codification of 38 C.F.R. § 3.361, which applies to such claims filed on or after October 1, 1997 and revising 38 C.F.R. § 3.358 to state that the section only applied to claims filed before October 1, 1997). Under VA laws and regulations, when a Veteran suffers additional disability or death as a result of training, hospital care, medical or surgical treatment, or an examination furnished by the VA, compensation under 38 U.S.C. § 1151 shall be awarded for a qualifying additional disability or qualifying death of a Veteran in the same manner as if that additional disability or death were service connected. A qualifying disability is one which is not the result of a Veteran's willful misconduct and which was caused by hospital care, medical or surgical treatment or examination furnished under any law administered by VA and the proximate cause of the disability was (A) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA in furnishing the hospital care, medical or surgical treatment or examination; or (B) an event not reasonably foreseeable. 38 U.S.C. § 1151 (a). The issue in this case is whether VA care, to include prescribing methotrexate, proximately caused bilateral-foot osteomyelitis. To determine whether a veteran has an additional disability, VA compares the condition immediately before the beginning of the hospital care, medical or surgical treatment or examination upon which the claim is based to the condition after such care, treatment or examination. VA considers each involved body part separately. 38 C.F.R. § 3.361 (b). To establish causation, the evidence must show that the hospital care, medical or surgical treatment or examination resulted in the additional disability. Merely showing the Veteran received care, treatment or examination and the Veteran has an additional disability does not establish cause. 38 C.F.R. § 3.361 (c)(1). Hospital care, medical or surgical treatment or examination cannot cause the continuance or natural progress of a disease or injury for which the care, treatment or examination was furnished unless VA's failure to diagnose and properly treat in a timely manner the disease or injury proximately caused the continuance or natural progress. 38 C.F.R. § 3.361 (c)(2). Additional disability caused by a veteran's failure to follow properly given medical instructions is not caused by hospital care, medical or surgical treatment or examination. 38 C.F.R. § 3.361 (c)(3). As such, the proximate cause of disability is the action or event which directly caused the disability, as distinguished from a remote contributing cause. 38 C.F.R. § 3.361 (d). As noted above, a claimant may establish that the qualifying disability was directly caused in either of two ways: 1) by carelessness, etc., or 2) by an event not reasonably foreseeable. 38 U.S.C. § 1151 (a). The Board notes that such disability or death need not be "directly" caused by the "actual" medical care provided by VA personnel; however, section 1151 does not extend to the "remote consequences" of VA medical treatment. See Viegas v. Shinseki, 705 F.3d 1374, 1377-78 (Fed. Cir. 2013). 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 additional disability or death. 38 C.F.R. § 3.361 (c). It must also be shown that VA (i) failed to exercise the degree of care that would be expected of a reasonable health care provider; or (ii) furnished the hospital care, medical or surgical treatment or examination without the Veteran's or, in appropriate cases, a representative's informed consent. 38 C.F.R. § 3.361(d)(1). 3.361 (d)(1). At issue in this case is whether VA failed to exercise the degree of care which would be expected of a reasonable health care provider. Id. Entitlement to compensation under 38 U.S.C. § 1151 for additional disability of bilateral-foot osteomyelitis, as due to prescription of methotrexate. The Veteran contends she has suffered additional disability, specifically, in developing bilateral-foot osteomyelitis, as a result of the prescription of methotrexate for the treatment of rheumatoid arthritis. The Board notes at the outset the Veteran does not assert, nor does the evidence suggest, any allegations of a lack of consent by her to the prescribed medication. The record indicates the Veteran was prescribed methotrexate for the treatment of rheumatoid arthritis on December 7, 2007, continuing through January 18, 2008. A December 2007 VA rheumatology note shows the Veteran sought follow-up care of her erosive arthritis. The treatment provider noted "the plan was to start the Veteran on Methotrexate at 15 mg/week for two weeks, and then increase to 20 mg/week. Patient was explained [sic] the risk and benefits of methotrexate. She was advised to take Folic acid along with Methotrexate and use contraception while on Methotrexate. We implored the necessity of monitoring toxicity labs closely." In January 2008, the Veteran was admitted VA for osteomyelitis. The treatment provider documented the Veteran's history of seronegative rheumatoid arthritis on methotrexate, diabetes mellitus with neuropathy and chronic lower-extremity ulcers, the Veteran now presenting from the dermatology clinic with a new ulcer on her right-foot base. The treatment provider further noted, "(1) diabetic foot ulcer consistent with osteomyelitis, (2) rheumatoid arthritis: will continue her Methotrexate, and (3) anemia, chronic: may in part be due to recent start of Methotrexate." The treatment provider stopped methotrexate in light of active infection. In her several visits during January 2008, it was clear to treatment providers that the Veteran's foot ulcers were worsening, the right more so than the left. Clinicians broached the subject of amputation with the Veteran. They further informed the Veteran that she would require a minimum another 6 weeks of antibiotics and even then, relapse was a possibility. By March 2008, the Veteran's presentation to VA indicated ever-worsening foot ulcers, "look[ing] much worse than when I saw her in January, and I certainly don't remember such a foul smell or drainage. Though I do think that her bone changes were c/w [consistent with] her underlying inflammatory condition in January, I'd have to imagine that its progression is indeed osteo[myelitis]." The Veteran reported no further significant changes and only slow progression of foot erosion was noted for the rest of 2008 and into 2009. In July 2009, the Veteran was admitted to VA for intravenous antibiotics for diabetic foot/recurrent osteomyelitis. The treatment provider's impression was seronegative rheumatoid arthritis. He noted the Veteran was previously on methotrexate, which was discontinued once she developed osteomyelitis. An October 2009 VA treatment provider characterized the Veteran' disorder as chronic osteomyelitis and non-healing diabetic foot ulcers of her right foot, noting that her current presentation was her third admission for antibiotic therapy for osteomyelitis flare, having previous episodes in May 2008 and July 2009. A VA rheumatology note in March 2010 notes the Veteran had been on methotrexate, but the "patient had this held due to chronic foot infection." Diagnoses included recurrent osteomyelitis, as well as diabetic foot ulcer, "? gout" and chronic venous insufficiency. In March 2014, the Chief of Medicine at Durham VA medical center reviewed the relevant records to this claim, summarized the course of treatment and opined it is more likely than not that the foot ulcer was a consequence of the Veteran's difficulty to control diabetes and diabetic neuropathy, than any toxicity attributable to methotrexate. He explained that the Veteran had evidence of foot ulcers prior to starting methotrexate, there was no evidence methotrexate ever caused significant leukopenia that would have been a contributing factor to wound-healing had it occurred and part of her "disease progression was related to both nonadherence to treatment recommendations for the foot ulcer and to difficulty with her controlling her diabetes." He concluded methotrexate was not the proximate cause of the Veteran's foot ulcers. In its March 2021 Remand, the Board noted that the previous December 2018 Board Remand directed the Agency of Original Jurisdiction (AOJ) to obtain a medical opinion as to whether it is at least as likely as not that the Veteran's osteomyelitis is due to the Veteran's diabetes mellitus. However, the Board now found a new medical opinion is necessary to determine entitlement to compensation under 38 U.S.C. § 1151 for the additional disability of osteomyelitis as a result of the Durham VAMC prescribed medication, methotrexate. Accordingly, a VA examiner later in March 2021 opined it is less as likely than not the claimed condition was caused by or became worse as a result of the VA treatment, additional disability from carelessness, negligence, lack of skill, or similar incidence of fault on the part of the attending VA personnel or additional disability resulted from an event that could not have reasonably been foreseen by a reasonable healthcare provider, and/or failure on the part of VA to timely diagnose and/or properly treat the claimed disease or disability allowed the disease or disability to continue to progress. He explained that VA diagnosis and treatment was appropriate and timely, accepted appropriate protocols were followed, and the standard of care was met in this case. Methotrexate was used for seronegative rheumatoid arthritis and "osteomyelitis of the foot was due to diabetes and its neuropathy only... there is no time course to suggest otherwise in the specifics of her record.... The vast majority of these osteomyelitis cases such as hers is shown to be diabetic and neuropathy related... and there is no note of concern in c file for such a claim." However, the Board in its May 2021 Remand noted that the record reflects numerous VA treatment notes suggesting the Veteran's use of methotrexate may have resulted in anemia, which in turn may have contributed to osteomyelitis. Furthermore, treatment records show providers advised the Veteran to discontinue use of methotrexate shortly after the medication was started due to adverse effects, including anemia. The Board concluded the March 2021 VA examiner who conducted the records review did not address adequately this evidence, opining only that osteomyelitis "was due to diabetes and its neuropathy only," without reconciling that finding with the aforementioned evidence. Therefore, once again, the Board remanded for opinions addressing whether an additional disability, to include osteomyelitis, was incurred as a result of prescribed methotrexate and whether this was due to fault on the part of VA and to an event not reasonably foreseeable, but also requested the examiner comment on a diagnosis of anemia following the use of methotrexate, the cessation of methotrexate soon after and any etiological link between anemia and osteomyelitis in this case. The July 2021 examiner first opined it is less likely than not that the Veteran incurred additional disability, to include osteomyelitis, as a result of VA prescribed methotrexate. He explained in his rationale that the Veteran was started with methotrexate in December 2007, at which time she was already noted to have an ulcer on her right-foot base. She was then seen on January 16, 2008, at which time she was given Augmentin, an indication that infection had been going on even before methotrexate was ever started. Methotrexate was started on December 7, 2007 and was stopped on January 18, 2008, a timeline of more than 5 weeks, "which in my opinion is not enough to cause suppression of the bone marrow and reduce production of WBC [the white-blood-cell count] or have caused anemia." He added that, based on the records, the Veteran is also diagnosed with diabetes mellitus with poorly controlled blood sugar, "which is the more plausible cause of osteomyelitis resulting from direct extension of infection from the foot ulcer." He noted the June 10, 2009 WBC was 2.9 L, which is a little lower than normal. "In my opinion, [this] is not any[]more related to methotrexate, as bone marrow suppression returns to normal within one week to six weeks after the drug is stopped. As to the contention VA treatment notes suggesting the Veteran's use of methotrexate may have resulted in anemia, record of rheumatology-clinic-follow-up/Durham VAMC dated 07 December 2007 showed that anemia has been present before the start of methotrexate. The Veteran was only given methotrexate for 40 days and red blood cells have a life span of 120 days. Therefore, it will take 120 days before anemia will occur due to methotrexate." The examiner next opined that an additional disability is less likely than not the result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA. He explained that the Veteran was informed of the risk, she was given folic acid supplementation prior to start of methotrexate and an antibiotic was prescribed for infection. "However[,] due to poor wound healing infection of the foot [it] progressed to osteomyelitis, due to poor wound healing as a result of poorly controlled diabetes mellitus." He further opined it is less likely than not that additional disability was due to an event not reasonably foreseeable. He explained, "Methotrexate [is] known to cause anemia and low wbc and precaution was given [sic] to the patient during follow up examination before the start of the medication." The Board has carefully considered the Veteran's August 2013 correspondence statement, a March 2015 Statement in Support of Claim and her statement accompanying the May 2016 Veterans Appeals Form 9, as well as her reports to VA examiners and treatment providers, as they appear throughout the record. The Board is well aware lay persons are competent to report on matters observed or within their personal knowledge. See Layno v. Brown, 6 Vet. App. 465, 470 (1994). Therefore, the Veteran is competent to provide statements of symptoms which are observable to her senses and there is no reason to doubt her credibility. However, the Veteran's lay evidence must in turn be weighed against other evidence, as all relevant evidence of varying kinds must be considered. The Veteran's essential contention in the above statements and reports is that methotrexate caused a right-foot ulcer directly upon its prescribed use in December 2007; when it was prescribed, she had only a left-foot ulcer. As her VA treatment providers in January and February 2008 directed her to stop this medication, this indicated to her that methotrexate in fact must be the cause of her osteomyelitis, now manifesting in her right foot. She adds that since then, she has been hospitalized 7 times because the infection has returned. However, nothing in the record establishes that, during VA treatment, examination and hospital care, treatment providers exhibited carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault, nor did any negative effects result from an event not reasonably foreseeable. In fact, in her March 2015 statement the Veteran notes that the VA rheumatologist, when he prescribed methotrexate in December 2007, told her that she should "not get an infection." Although the Veteran states she was offended by both the substance and tone of this admonition, her rheumatologist in fact gave her useful advice of the risk of the medications, as the record indicates, as shown above, January 2008 that VA treatment provider, Dr. C.W., stopped methotrexate, "in light of active infection." A VA rheumatology note in March 2010 notes the Veteran had been on methotrexate, but the "patient had this held due to chronic foot infection." Overall, the Board assigns more probative weight to the opinions of the July 2021 VA examiner as well as the March 2021 examiner. The examiner is a medical professional. The examiner thoroughly reviewed the Veteran's medical history and the July 2021 opinions are based on clinical evidence and therefore are adequate for VA adjudication purposes. See generally Nieves-Rodriguez v. Peake, 22 Vet. App. 295, 302-04 (2008) (noting that the central issue in assessing the adequacy of an opinion is whether the examiner was informed of the relevant facts in rendering a medical opinion). Based on the medical evidence of record, there is no discernible error made by VA in any of the procedures in the period of the prescription of methotrexate between December 7, 2007 and January 18, 2008, nor has the Veteran identified a specific instance of clinical error or a questionable medical procedure. As the Veteran's ulceration worsened throughout January 2008, indicating persistent and greater infection, her in-hospital treatment providers stopped methotrexate and her rheumatologist in a call to her home on February 3rd contacted the Veteran to make certain it was stopped. The cessation of the drug by the Veteran's treatment providers does not show the drug caused osteomyelitis, as the Veteran has reasoned in her statements, she already had a left-foot ulcer indicating infection was well on its way and all providers recognized in quick succession the drug would lessen the power of the immune system to fight further infection. Moreover, in his detailed summary of the record, the July 2021 VA examiner tracked the relevant segments of the record of treatment and accordingly rendered a series of opinions as to whether VA's procedures and the conclusions drawn from them by its medical professionals were sufficient and correct, as well as providing a clinically-based explanation of the greater likelihood of uncontrolled diabetes causing further ulcerations and, most significantly, that any adverse effects of methotrexate in bringing down the white-blood-cell count in the Veteran's system would only take effect over a period of about 3 times longer (about 120 days) than the approximately 40 days' duration of her prescribed use of methotrexate. For these reasons and based on the evidence of record, the preponderance of the evidence is against a finding of entitlement to compensation under 38 U.S.C. § 1151. The Board has considered the benefit-of-the-doubt doctrine; however, the Board does not perceive an approximate balance of positive and negative evidence. As the preponderance of the evidence is against the claim, the doctrine is not applicable and the claim must be denied. 38 U.S.C. § 5107 (b); 38 C.F.R. § 4.3. EMILY TAMLYN Veterans Law Judge Board of Veterans' Appeals Attorney for the Board P. Franke, Associate Counsel 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.