Veteranclaims’s Blog

November 13, 2013

Single Judge Application; Informed Consent; Section 17.32(d)(1)

Filed under: Uncategorized — Tags: — veteranclaims @ 8:29 pm

Excerpts from decision below:

“Section 17.32(d)(1) states that the “informed consent process must be
appropriately documented in the health record.” Because the Board apparently found that the record is only capable of suggesting that informed consent was properly obtained, it is not clear to the Court that the informed consent process was appropriately documented. The Board did not discuss § 17.32(d)(1), and remand is warranted for the Board to consider whether its conclusion is supportable in light of the regulatory requirement that informed consent be “appropriately documented.”2”
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Designated for electronic publication only
UNITED STATES COURT OF APPEALS FOR VETERANS CLAIMS
NO. 12-1080
JOHN T. LEHMAN, APPELLANT,
V.
ERIC K. SHINSEKI,
SECRETARY OF VETERANS AFFAIRS, APPELLEE.
Before PIETSCH, Judge.
MEMORANDUM DECISION
Note: Pursuant to U.S. Vet. App. R. 30(a),
this action may not be cited as precedent.
PIETSCH, Judge: The appellant, John T. Lehman, appeals through counsel a January 25,
2012, Board of Veterans’ Appeals (Board) decision in which the Board denied him entitlement to
compensation pursuant to 38 U.S.C. § 1151 for peripheral neuropathy of the lower extremities
resulting from treatment for human immunodeficiency virus (HIV) administered by a VA care
provider. Record (R.) at 3-17. This appeal is timely and the Court has jurisdiction over the matters
on appeal pursuant to 38 U.S.C. §§ 7252(a) and 7266. Single-judge disposition is appropriate when
the issue is of “relative simplicity” and “the outcome is not reasonably debatable.” Frankel v.
Derwinski, 1 Vet.App. 23, 25-26 (1990). For the reasons that follow, the Court will vacate the
Board’s decision and remand the matter for additional proceedings consistent with this decision.
I. BACKGROUND
The appellant served on active duty in the U.S. Air Force from August 1978 until December
1982. R. at 5, 205, 292. The record reveals that in September 2000, the appellant’s VA care
provider, Dr. Dannah W. Wray, prescribed him Stavudine and Didanosine to counteract an HIV
“[v]iral rebound.” R. at 58, 69. In a January 2001 treatment note, Dr. Wray wrote that the appellant
“says doing well on last med change with only report of mild stable neuropathy symptoms involving
soles of feet.” R. at 65. Dr. Wray then wrote:
Clinically doing well but [peripheral neuropathy] worries me on
[Stavudine/Didanosine] combo . . . I would expect this to progress. He is very loath
to change meds, however, since he feels these are working and would like to continue
and monitor. I suggested we see what his new labs on these meds look like and will
readdress the issue.
R. at 66.
According to a May 2001 note written by Dr. Wray, the appellant’s peripheral neuropathy
had worsened. R. at 60. Dr. Wray wrote:
He has been putting up with [his peripheral neuropathy] for a couple of months since
he says he feels the new regimen is really good for him and doesn’t want to
jeopardize it. I assured him this was intolerable and not surprising as we have him
on [Stavudine and Didanosine]. I told him we need to at least switch [Stavudine] and
follow.
Id.
The appellant stopped taking Stavudine but continued to take Didanosine. R. at 58, 61, 491-
92. The record reveals that Dr. Wray believed that the appellant’s peripheral neuropathy should
improve even though he was still taking Didanosine. R. at 491. According to an August 2001
treatment note written by a different physician, the appellant’s “peripheral neuropathy (pain in feet)
has perhaps improved slightly but still is persistent, keeping him up at night.” R. at 59. The
physician stated that his continued peripheral neuropathy symptoms “could be [Didanosine], residual
from [Stavudine], or HIV.” Id.
In February 2006, the appellant filed a claim for entitlement to compensation for peripheral
neuropathy. R. at 565-83. In various documents the appellant has submitted since his initial claim,
he has asserted that (1) Dr. Wray did not warn him that peripheral neuropathy may result from using
Stavudine and Didanosine; (2) Dr. Wray did not mention peripheral neuropathy at all until he
complained about his symptoms in May 2001; (3) Dr. Wray apologized to him in August 2001 for
not instructing him to stop taking Didanosine; (4) Dr. Wray mistakenly thought his neurological
symptoms were temporary; (5) Dr. Wray’s January 2001 statement that the appellant was “very
loathe” to discontinue use of Didanosine and Stavudine was inaccurate; (6) all treatment decisions
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he made were based on Dr. Wray’s suggestions, and it Dr. Wray’s decision, not his, to continue
treating his HIV with Stavudine and Didanosine in January 2001; (7) when Dr. Wray told him to
discontinue use of Stavudine, he failed to explain that continued use of Didanosine could cause his
peripheral neuropathy to worsen; and (8) Dr. Wray inaccurately told him that a change in his drug
regimen would cause his neurological symptoms “to reverse and eventually dissipate.” R. at 23, 66,
132-34, 176-81, 183-84, 186-87, 192, 197-98, 273-276, 318, 419-20, 440, 460, 573.
The appellant has asserted that he should receive compensation effective January 2001, “a
time when Dr. Wray could have taken relevant action and discontinued both [Stavudine] and
[Didanosine], thus giving me the best chance of avoiding permanent and snowballing neurological
damage.” R. at 135. The appellant also essentially argued that he should at least be compensated
for Dr. Wray’s failure to instruct him to stop taking Didanosine as well as Stavudine in May 2001.
See R. at 135, 186, 274.
In November 2008, the Board denied the appellant’s claim. R. at 295-307. In a March 30,
2010, memorandum decision, the Court vacated the Board’s decision and remanded the appellant’s
claim for additional development. R. at 205-08. In August 2010, the Board remanded the appellant’s
case. R. at 121-24. The Board ordered the Secretary to obtain an opinion from a VA medical
examiner addressing “whether the VA practitioner who treated the [appellant] between 1998 and
2001 exercised the proper standard of care in treating [him].” R. at 123.
On September 29, 2010, a VA medical examiner opined that “[a]lthough the medical
literature advises against using Didanosine in combination with [S]tavudine due to risk of
neurotoxicity, it is not an absolute contraindication as the beneficial effects on viral load suppression
and immune function recovery may outweigh their potential neurotoxicity.” R. at 89. The examiner
stated that, because Dr. Wray prescribed Didanosine and Stavudine in response to “the increased
viral load” and not as “a first line regimen,” “there is no evidence that Dr. Wray did not exercise the
proper standard of care in treating this veteran.” Id.
In a November 2011 Supplemental Statement of the Case, VA confirmed its decision to deny
the appellant’s claim. R. at 27-30. In December 2011, the appellant wrote that he was not arguing
that Dr. Wray’s decision to prescribe Stavudine and Didanosine in September 2000 was against the
accepted standard of care. R. at 22. Instead, he asserted, “[m]y claim encompasses Dr. Wray’s
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fail[ure] to remove me from these two new drugs after I complained of neuropathy symptoms in
January 2001.” Id. (emphasis removed). In its January 25, 2012, decision here on appeal, the Board
denied the appellant’s claim. R. at 3-17.
II. APPLICABLE LAW AND THE BOARD’S DECISION
Pursuant to 38 U.S.C. § 1151:
(a) Compensation . . . shall be awarded for a qualifying additional disability . . . in the
same manner as if such additional disability . . . were service-connected. For
purposes of this section, a disability . . . is a qualifying additional disability. . . if the
disability . . . was not the result of the veteran’s willful misconduct and —
(1) the disability. . . was caused by hospital care, medical or surgical treatment, or
examination furnished the veteran under any law administered by the Secretary,
either by a Department employee or in a Department facility . . . , and the proximate
cause of the disability or death was –
(A) 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
(B) an event not reasonably foreseeable[.]
The Board concluded that the appellant’s peripheral neuropathy was “at least in part” directly
caused by care provided to the appellant by a VA employee. R. at 7; 38 U.S.C. § 1151(a). The
appellant does not argue that his peripheral neuropathy resulted from an event not reasonably
foreseeable. 38 U.S.C. § 1151(a)(1)(B). The issue in this case, therefore, is whether the proximate
cause of the appellant’s peripheral neuropathy was “carelessness, negligence, lack of proper skill,
error in judgement, or [a] similar instance of fault” by his VA care provider. 38 U.S.C.
§1151(a)(1)(A).
VA regulations provide veterans two ways to meet the section 1151(a)(1)(A) proximate
causation requirement. First, the appellant may demonstrate that “VA failed to exercise the degree
of care that would be expected of a reasonable health care provider.” 38 C.F.R. § 3.361(d)(1)(i)
(2013). The Board, relying heavily on the September 2010 VA examiner’s opinion, determined that
Dr. Wray did not act inappropriately. R. at 8-10.
Next, the appellant may show proximate causation by demonstrating that
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VA furnished the hospital care, medical or surgical treatment, or examination without
the veteran’s . . . informed consent. To determine whether there was informed
consent, VA will consider whether the health care providers substantially complied
with the requirements of [38 C.F.R.] § 17.32. . . . Minor deviations from the
requirements of § 17.32 of this chapter 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)(ii).
Pursuant to 38 C.F.R. § 17.32(c),
[i]nformed 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. The practitioner . . . must explain in language understandable
to the patient . . . the nature of the 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 informed consent process must be appropriately documented in the health record.”
38 C.F.R. § 17.32(d)(1)(2013). A patient is required to sign an acknowledgment of consent for
certain kinds of treatment, including treatment that is “considered to produce significant discomfort
to the patient” or has “a significant risk of complication or morbidity.” 38 C.F.R. § 17.32(d)(1)(iii),
(iv). The Board determined that the appellant did not sign a consent form authorizing Dr. Wray to
administer the treatment he received. R. at 11. The Board concluded, however, that signed consent
was not required in this case. Id. Finally, the Board determined that the appellant orally consented
to the treatment suggested by Dr. Wray. R. at 11-15.
III. ANALYSIS
A. 38 C.F.R. § 3.361(d)(1)(i)
Relying on the September 2010 VA medical examiner’s opinion, the Board concluded that
Dr. Wray did not fail to exercise the appropriate degree of care while treating the appellant. R. at
8-10. The appellant questions the adequacy of the examiner’s opinion. Appellant’s Br. at 17-20;
Reply Br. at 12-15.
A medical opinion is adequate “where it is based on consideration of the veteran’s prior
medical history and examinations and also describes the disability, if any, in sufficient detail so that
the Board’s ‘evaluation of the claimed disability will be a fully informed one.'” Stefl v. Nicholson,
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21 Vet.App. 120, 123 (2007) (quoting Ardison v. Brown, 6 Vet.App. 405, 407 (1994)). The opinion
“must support its conclusion with an analysis that the Board can consider and weigh against contrary
opinions.” Id. at 124. It must “contain not only clear conclusions with supporting data, but also a
reasoned medical explanation connecting the two.” Nieves-Rodriguez v. Peake, 22 Vet.App. 295,
301 (2008). Whether a medical examination report is adequate is generally a finding of fact that the
Court reviews under the “clearly erroneous” standard of review. 38 U.S.C. § 7261(a)(4); Nolen v.
Gober, 14 Vet.App. 183, 184 (2000).
The September 2010 examiner stated:
Although the medical literature advises against using Didanosine in combination with
Stavudine due to risk of neurotoxicity, it is not an absolute contraindication as the
beneficial effects on viral load suppression and immune function recovery may
outweigh their potential neurotoxicity. In this case, Dr. Wray did not use the
combination as a first line regimen and only used the [co]mbination in response to
the increased viral load. Therefore, there is no evidence that Dr. Wray did not
exercise the proper standard of care in treating this veteran.
R. at 89.
The examiner’s opinion is deficient for a number of reasons. First, the examiner restricted
her opinion to Dr. Wray’s initial decision to prescribe the appellant a combination of Stavudine and
Didanosine. She was asked to analyze whether Dr. Wray treated the appellant appropriately
throughout the three-year period the appellant was under his care. R. at 86, 123. The examiner did
not do so and, as a consequence, the Board made its decision without any medical evidence
addressing whether Dr. Wray’s decisions to allow the appellant to continue taking Stavudine and
Didanosine in January 2001 and to allow the appellant to continue taking Didanosine in June 2011
were appropriate.
Second, the examiner addressed whether Dr. Wray followed the proper standard of care. R.
at 89. That is not quite the correct inquiry, or at least the examiner’s conclusion is not sufficiently
precise. The examiner should have discussed whether Dr. Wray “failed to exercise the degree of care
that would be expected of a reasonable health care provider.” 38 C.F.R. § 3.361(d)(1)(i). The
examiner conveyed that, in general, it may be acceptable to prescribe a combination of Stavudine
and Didanosine in certain circumstances. However, she did not fully state and explain whether an
objective reasonable health care provider faced with the facts of the appellant’s case would have
6
agreed that Dr. Wray made the correct decision by prescribing the Stavudine/Didanosine
combination. See Schertz v. Shinseki, ___ Vet.App. ___, 2013 LEXIS 1630 No. 11-2694 at *16-20
(Sept. 26, 2013).
Third, the Board has determined that Dr. Wray’s decision to prescribe Stavudine and
Didanosine in tandem caused the appellant to develop an additional disability. The examiner does
not explain why the appellant’s increased viral load was so concerning that it was best treated in the
manner Dr. Wray recommended. She did not fully explain if there were other options, why those
options were not better than a Stavudine/Didanosine combination, and why it was appropriate in this
case for Dr. Wray to initiate a drug regimen with a well-known potential to cause an additional
disability.1
Finally, the examiner attached to her opinion the medical evidence she relied upon. R. at 89-
93. The following unequivocal statement can be found in that evidence: “Didanosine should not be
used in combination with [S]tavudine due to overlapping mitochondrial toxicities such as peripheral
neuropathy and lipodystrophy.” R. at 93. The examiner downplayed the significance of this
unambiguous warning by citing to different medical evidence indicating that the “potential
neurotoxicity of antiretroviral drugs does not preclude their use, since the beneficial effects on viral
load suppression and immune function recovery appears to outweigh their potential neurotoxicity.”
R. at 89, 91. The examiner’s attempt to confound what appear to be two separate expert conclusions
is unconvincing. If the medical evidence is unclear or contradictory, the examiner should have said
so and explained how the lack of clarity on this matter affects her analysis of Dr. Wray’s actions. For
1 In the portion of its discussion concerning whether the appellant gave informed consent for Dr. Wray’s
treatment decisions, the Board stated:
While the [appellant] now disagrees with the medication decisions that were made, because they may
have caused his peripheral neuropathy to worsen, as they say, hindsight is 20/20. Knowing now the
course of the [appellant’s] disability, a different medication regimen might, or might not, have been
pursued, or may have made his medical condition much worse. The Board lacks the medical
knowledge to answer such a question.
R. at 14.
The Board is correct that it lacks expertise, but it was the Board’s responsibility to gather evidence that would
inform it on all key medical questions. This statement reveals that it did not do so.
7
these reasons, the Board’s determination that the September 2010 VA medical opinion is adequate
is clearly erroneous. See Stefl and Nieves-Rodriguez, both supra.
B. Informed Consent
1. Written Consent
Pursuant to the Secretary’s regulations, if any one of five outcomes may result from a medical
treatment, signed consent must be obtained before that treatment is provided. 38 C.F.R. § 17.32(d).
Two of those outcomes–”significant discomfort to the patient” and “a significant risk of complication
or morbidity”–appear to be potentially applicable in this case. Id. The Board acknowledged that
there is no evidence that the appellant signed a consent form authorizing the treatment he received.
R. at 11. The Board, however, determined that “a signed document is not required in this case, as
this is not one of the situations . . . in which signature consent is required.” Id. The parties agree that
the Board’s conclusion was perfunctory and unsupported, and the Secretary concedes that remand
is warranted for the Board to more thoroughly address this point. Appellant’s Br. at 10-12;
Secretary’s Br. at 9-12; Reply Br. at 3.
When making factual determinations, the Board is required to provide a written statement
of the reasons or bases for its findings and conclusions adequate to enable an appellant to understand the precise basis for the Board’s decision as well as to facilitate review in this Court. 38 U.S.C. § 7104(d)(1); Allday v. Brown, 7 Vet.App. 517, 527 (1995); Gilbert v. Derwinski, 1 Vet.App. 49, 56-57 (1990). To comply with this requirement, the Board must analyze the credibility and probative value of the evidence, account for the evidence that it finds persuasive or unpersuasive, and provide the reasons for its rejection of any material evidence favorable to the claimant. Caluza v. Brown, 7 Vet.App. 498, 506 (1995), aff’d per curiam, 78 F.3d 604 (Fed. Cir. 1996) (table); Gilbert, 1 Vet.App. at 57. The Court agrees with the parties that the Board did not support its conclusion that written consent was not required in this case with an adequate statement of reasons or bases. See 38 U.S.C. § 7104(d)(1); Allday, Caluza, and Gilbert, all supra.

2. Oral Consent
The Board chose to disbelieve the appellant’s account of his meetings with Dr. Wray and infer from Dr. Wray’s treatment notes (which the Board deemed to be “unusually clear”) that the appellant was entirely aware of the risks of his drug regimen. R. at 12-15. The Board stated that it
8

“is satisfied” that Dr. Wray thoroughly explained the treatment he was recommending, that his records “would suggest that a discussion of the risk of peripheral neuropathy” occurred, and that the record “clearly suggests the [appellant] was actively involved in his treatment.” R. at 14. Further, it stated that “nothing is present in the treatment records created contemporaneously with the prescribed medication to suggest that the [appellant] disagreed with the decision to take the path that was chosen, nor is there any suggestion that he was not aware of the risks.” R. at 14.
Finally, the Board stated that “[t]here is nothing to suggest that the [appellant] did not have an opportunity to ask questions or that he was not in full agreement with the medication decisions that were made. In fact, the record clearly suggests the [appellant] was actively involved in his treatment.” Id.
Section 17.32(d)(1) states that the “informed consent process must be appropriately documented in the health record.” Because the Board apparently found that the record is only capable of suggesting that informed consent was properly obtained, it is not clear to the Court that the informed consent process was appropriately documented. The Board did not discuss §17.32(d)(1), and remand is warranted for the Board to consider whether its conclusion is supportable in light of the regulatory requirement that informed consent be “appropriately documented.”2 The Board should state definitively whether Dr. Wray’s notes are appropriate documentation of informed consent or whether, pursuant to § 3.361(d)(1)(ii), Dr. Wray’s failure to fully document informed
consent procedures is legally insignificant in this case, and it should thoroughly explain the reasons and bases for its conclusion.

C. Other Matters
The Court will not at this time address any additional arguments raised by the appellant. See Best v. Principi, 15 Vet.App. 18, 20 (2001) (per curiam order) (holding that “[a] narrow decision

2 The appellant requested that the Court determine that his oral informed consent for Dr. Wray’s treatment was not documented, reverse the Board’s decision, and award him entitlement to the compensation he seeks. See Reply Br. at 15. This Court has held that “reversal is the appropriate remedy when the only permissible view of the evidence is contrary to the Board’s decision.” Gutierrez v. Principi, 19 Vet.App. 1, 10 (2004). Remand is appropriate “where the Board has incorrectly applied the law, failed to provide an adequate statement of reasons or bases for its determinations,
or where the record is otherwise inadequate.” Tucker v. West, 11 Vet.App. 369, 374 (1998). The Court is not convinced to the degree required by Gutierrez that the appellant’s consent was not appropriately documented and that this lack of
documentation was legally significant. See 38 C.F.R. §§ 17.32(d)(1), 3.361(d)(1)(ii). Moreover, because the Board has failed to make factual findings on this point, it is inappropriate for the Court to do so at this juncture. See Hensley v.
West, 212 F.3d 1255, 1263 (Fed. Cir. 2000) (stating that “appellate tribunals are not appropriate fora for initial fact finding”); see also 38 U.S.C. § 7261(c).
9

preserves for the appellant an opportunity to argue those claimed errors before the Board at the
readjudication, and, of course, before this Court in an appeal, should the Board rule against him”).
On remand, the appellant is free to submit additional evidence and argument on the remanded
matters, and the Board is required to consider any such relevant evidence and argument. See Kay
v. Principi, 16 Vet.App. 529, 534 (2002); Kutscherousky v. West, 12 Vet.App. 369, 372-73 (1999)
(per curiam order). The Court has held that “[a] remand is meant to entail a critical examination of
the justification for the decision.” Fletcher v. Derwinski, 1 Vet.App. 394, 397 (1991). The Board
must proceed expeditiously, in accordance with 38 U.S.C. § 7112 (requiring the Secretary to provide
“expeditious treatment” of claims remanded by the Court).

IV. CONCLUSION
After consideration of the appellant’s and the Secretary’s briefs and a review of the record, the Board’s January 25, 2012, decision is VACATED and the matter is REMANDED for additional proceedings consistent with this decision.
DATED: October 25, 2013
Copies to:
Nigel Barrella, Esq.
VA General Counsel (027)
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