          UNITED STATES COURT OF APPEALS FOR VETERANS CLAIMS


                                           NO . 07-1081

                                JAMES A. HALCOMB, APPELLANT ,

                                                 v.

                                      ERIC K. SHINSEKI,
                          SECRETARY OF VETERANS AFFAIRS, APPELLEE.

                          On Appeal from the Board of Veterans' Appeals



(Argued April 15, 2009                                              Decided October 20, 2009)



        Zachary M. Stolz, with whom Landon E. Overby (non-attorney practitioner), was on the brief,
both of Washington, D.C., for the appellant.

         Mark M. McNabb, with whom Paul J. Hutter, General Counsel; R. Randall Campbell,
Assistant General Counsel; and Joan E. Moriarty, Deputy Assistant General Counsel, were on the
brief, all of Washington, D.C., for the appellee.

       Before GREENE, Chief Judge, and LANCE and DAVIS, Judges.

       DAVIS, Judge: U.S. Army veteran James A. Halcomb appeals through counsel from a
December 19, 2006, Board of Veterans' Appeals (Board) decision that denied entitlement to
compensation benefits under 38 U.S.C. § 1151 for loss of vision in the left eye. The issue before the
Court is whether the appellant has established that VA's care and treatment proximately caused an
additional qualifying disability under 38 U.S.C. § 1151(a) and 38 C.F.R. § 3.361 where the only
evidence concerning whether VA obtained informed consent prior to the appellant's surgery is a
standard form signed by the appellant that does not identify any specific risks that were discussed
with him. This Court has jurisdiction to review the Board's decision pursuant to 38 U.S.C.
§§ 7252(a) and 7266(a). See Frankel v. Derwinski, 1 Vet.App. 23, 25-26 (1990). For the following
reasons, the Court will affirm the Board's December 2006 decision.
                                              I. BACKGROUND
         On April 10, 2002, the appellant underwent "same day" surgery at the Marion, Illinois, VA
Medical Center for removal of a left-eye cataract and lens replacement. After the surgery, he
developed endophthalmitis.1 Later, at St. Louis University Hospital, he underwent a vitreal antibiotic
injection of the left eye and a second surgery, known as a "trans para plana victrectomy," to address
retinal detachment that was discovered in the course of his treatment. Since these procedures, the
veteran has suffered left-eye blindness.
         Prior to undergoing his cataract surgery at the VA facility, the appellant signed two
documents relating to his permission for the procedures. The first was a form stating that "[t]he
nature and purpose of the operation or procedure, possible alternative methods of treatment, the risks
involved and the possibility of complications have been fully explained to me." Record (R.) at 426.
The other document was a statement typewritten on a VA progress note sheet that read, in relevant
part, as follows:
         The relevant aspects of the above stated procedure/treatment, the indications, risks,
         benefits, and alternatives have been discussed with the patient in understandable
         language. The patient was given opportunity to ask questions concerning the
         procedure/treatment. Comprehension of the discussion was indicated, and the patient
         freely consented to the procedure/treatment without duress or coercion.

R. at 427. Both documents were co-signed by a physician and witnessed by a nurse. Neither
document contained any itemization, notations, or further description of what risks or alternatives
may have been discussed.
         Because his left-eye blindness resulted after the cataracts surgery and subsequent procedures
at St. Louis University Hospital, the appellant sought compensation from VA under 38 U.S.C.
§ 1151(a). In January 2005, a VA regional office (RO) denied that claim. He appealed and in June
2006, the Board remanded the matter for the RO to obtain an opinion as to whether any of appellant's
vision loss was due to carelessness, negligence, lack of proper skill, error in judgment, or similar
fault of VA in furnishing care during the April 2002 eye surgery. R. at 598. A VA examiner opined


         1
            "Endophthalmitis" is defined as "inflammation involving the ocular cavities and their adjacent structures."
D O RLAN D 'S I LLU STRATED M ED ICAL D ICTIO N ARY 627 (31st ed. 2007).



                                                          2
that there was no carelessness, negligence, lack of proper skill, error in judgment, or similar fault of
VA in furnishing care, and the RO again denied the appellant's claim for compensation under 38
U.S.C. § 1151(a). The appellant again appealed to the Board.
       In the decision here on appeal, the Board denied entitlement to benefits under 38 U.S.C.
§ 1151(a). Preliminarily, the Board found that both the endophtalmitis and the retinal tears were
reasonably foreseeable consequences of the appellant's medical procedures. The Board based its
finding on a VA medical examination report that stated that endophthalmitis "is a rare, but not
unheard of complication," and that "retinal tears are always a possible complication" in such
procedures. R. at 618.     The Board further found that "the medical evidence reflects informed
consent on the veteran's behalf under 38 C.F.R § 17.32." R. at 10. Relying on the text and content
of the consent form, the Board stated that there was no indication that the veteran's consent was not
an informed one. This appeal followed.


                            II. CONTENTIONS OF THE PARTIES
                                          A. The Appellant
       The appellant asserts that a generic written consent form fails to comply with the VA
regulations on informed consent and establishes negligence per se. He argues that the Board's
finding that endophthalmitis and retinal tears were reasonably foreseeable events means that under
38 C.F.R.§ 17.32(c), VA had a duty to specifically inform him of these possible outcomes. The
appellant asserts that his VA health care providers failed to tell him of these known risks, that such
failure constitutes negligent care under 38 U.S.C. § 1151 and 38 C.F.R. § 3.361(d)(1)(ii), and that
this negligence entitles him to VA benefits. Cf. Ashley v. Derwinski, 2 Vet.App. 62, 66 (1992)
(providing that "the presumption [of official regularity] operates in reverse. If [the action] appears
irregular, it is irregular, and the burden shifts to the proponent to show the contrary" (quoting United
States v. Roses Inc., 706 F.2d 1563, 1567 (Fed. Cir. 1983))). The alleged failure to inform is based
on the fact that these risks were not explicitly mentioned on the face of the consent form, and the
consent form is the only evidence on which the Board relied to find informed consent. The appellant
maintains that the vague statement on the consent form that the "relevant aspects of the
procedure/treatment, the indications, risks, benefits, and alternatives have been discussed," which


                                                   3
does not explicitly list the specific risks of endophthalmitis and retinal tears, does not satisfy the
regulation's requirement.
         The appellant, however, has pointed to no evidence in the record that he ever alleged that the
informed consent discussion was defective in any way. Rather, he states that "in his brief before the
Board, he addressed the issues of negligence and reasonable forseeability, both of which are
intertwined with the issue of informed consent." Appellant's Supplemental Brief (Supp. Br.) at 1.
He further points out that the Board discussed the adequacy of informed consent under 38 C.F.R.
§ 17.32. Id.
                                                  B. The Secretary
         The Secretary asserts that the appellant's signed consent form is the only evidence in the
record bearing on the question. He contends that the governing regulation and statute do not require
complete documentation of the informed consent process. Rather, the Secretary insists that
38 C.F.R. § 17.32 requires only that the consent process be "appropriately documented." He proffers
that an established interpretation of appropriate documentation is found in the VHA Handbook
1004.1, Paragraph 6, which requires, among other things, "[a] statement that relevant aspects of the
treatment or procedure including indications, risks, benefits, and alternative options have been
discussed with the patient in language the patient understood." Id. ¶6(b)(6). Therefore, the Secretary
concludes that the informed consent document in this case constitutes appropriate documentation
of the informed consent process under 38 C.F.R. § 17.32, deviations from regulatory requirements
notwithstanding.2           The Secretary also contends that the sufficiency of the informed consent
process documented in the generic consent form is governed by the presumption of administrative




         2
           As the Secretary acknowledges, the informed consent progress note (R. at 427), on which the Board relied as
evidence of informed consent, does not conform to the requirements of VHA Handbook 1004.1 in several respects. There
is no indication of the date or time. There is no indication of the patient's mental status at the time the informed consent
information was provided, and the practitioner did not indicate whether the patient had decisionmaking capability.

          Moreover, the regulation itself requires the consent discussion to be conducted by "[t]he practitioner who has
primary responsibility for the patient or who will perform the particular procedure." 38 C.F.R. § 17.32(c) (2009). The
form provides no evidence that this requirement was fulfilled. The signature of the practitioner writing the note is
illegible. The form also provides no evidence that there was any discussion of "anticipated results if nothing is done."
Id. Thus, even if the Secretary were correct that comporting with manual requirements achieves informed consent, this
form might have been challenged on several bases.

                                                             4
regularity. He argues that applying this presumption, the adequacy of an appropriately documented
informed consent process can be overcome only by submission of clear evidence to the contrary.


                                     III. APPLICABLE LAW
       A veteran who believes that he has sustained an additional disability resulting from treatment
in a VA facility can seek compensation in two ways. The veteran can submit a claim for benefits
under 38 U.S.C. § 1151(a). He may also seek compensation by filing a claim against the
government, based on the purported negligence of its employees, including lack of informed consent
before surgery, under the Federal Tort Claims Act (FTCA). See 38 U.S.C. § 1151(b).
       Under 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" if the
disability was
       (a) . . . not the result of the veteran's willful misconduct and –

                 (1) . . . was caused by hospital care, medical or surgical treatment, or
                 examination furnished the veteran under any law administered by the
                 Secretary . . . 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 [VA] in furnishing the hospital care,
                 medical or surgical treatment, or examination; or

                 (B) an event not reasonably foreseeable.
38 U.S.C. § 1151; see Pub. L. No. 104-204, § 422(b)(1), (c), 110 Stat. 2926-27 (1996) (amending
section 1151 to incorporate fault requirement and providing that those amendments were made
applicable to claims filed on or after October 1, 1997). Thus, to obtain benefits under 38 U.S.C. §
1151(a), a claimant must show: (1) A "qualifying additional disability," (2) actually caused by the
treatment furnished by VA, and (3) a proximate or direct cause that is either a fault on the part of VA
or an event not reasonably foreseeable. Id; 38 C.F.R. § 3.361(c)(1), (d)(1) (2009).
       A "qualifying additional disability" is proximately caused by VA medical care, treatment, or
examination when the disability results from either the carelessness, negligence, lack of proper skill,
error in judgment, or similar instance of fault on the part of the Department in furnishing the medical
treatment; or the disability results from "an event" that is "not reasonably foreseeable." 38 U.S.C.

                                                   5
§ 1151(a); 38 C.F.R. § 3.361(d)(1). To establish that the proximate cause of a disability was the
result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault
on the part of VA, the claimant must show either (1) VA failed to exercise the degree of care that
would be expected of a reasonable health care provider; or (2) VA furnished the care, treatment, or
examination without the veteran's informed consent. 38 C.F.R. § 3.361(d)(1).
        Section 3.361, the VA regulation implementing 38 U.S.C. § 1151(a), advances definitions
pertaining to informed consent and reasonably foreseeable events and reads, in relevant part, as
follows:
                (1) Care, treatment, or examination. 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 veteran's additional
                disability or death (as explained in paragraph (c) of this section); 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, 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 § 17.32 of this chapter. 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. Consent
                may be express (i.e., given orally or in writing) or implied under the circumstances
                specified in § 17.32(b) of this chapter, as in emergency situations.

                (2) Events not reasonably foreseeable. Whether the proximate cause of a veteran's
                additional disability or death was an event not reasonably foreseeable is in each claim
                to be determined based on what a reasonable health care provider would have
                foreseen. 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 § 17.32 of this chapter.




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38 C.F.R. § 3.361(d); see also 69 Fed. Reg. 46,433 (2004). Because VA cited 38 U.S.C. § 1151
as authority for 38 C.F.R. § 3.361, it is apparent the Agency regarded lack of informed consent to
be a "similar instance of fault" under that statute.
        There is another statute that bears upon the regulatory structure pertaining to informed
consent. Subchapter III of title 38, entitled "Protection of Patient Rights," provides that
        [t]he Secretary . . . shall prescribe regulations establishing procedures to ensure that
        . . . to the maximum extent practicable, all patient care furnished under this title shall
        be carried out only with the full and informed consent of the patient . . . .

38 U.S.C. § 7331 (emphasis added). Pertinent regulations require that "[e]xcept as otherwise
provided in this section, all patient care furnished under title 38 U.S.C. shall be carried out only with
the full and informed consent of the patient or, in appropriate cases, a representative thereof."
38 C.F.R. § 17.32(b).
        Concerning the definition of and requirements for informed consent, at the time of the
appellant's procedure, 38 C.F.R. § 17.32 provided:
                (c) General requirements for informed consent. Informed consent is the freely given
        consent that follows a careful explanation by the practitioner to the patient . . . of the
        proposed diagnostic or therapeutic procedure or course of treatment. 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 . . . [1] the
        nature of a proposed procedure or treatment; [2] the expected benefits; [3] reasonably
        foreseeable associated risks, complications or side effects; [4] reasonable and available
        alternatives; and [5] anticipated results if nothing is done. The patient . . . must be given the
        opportunity to ask questions, to indicate comprehension of the information provided, and to
        grant permission freely without coercion.

                 (d) Documentation of informed consent. (1) The informed consent process must be
        appropriately documented in the medical record. In addition, signature consent is required
        for all [surgical procedures].
38 C.F.R. § 17.32(c), (d) (2001). That regulation was promulgated to implement 38 U.S.C. §§ 7331
through 7333. The regulation further defined "signature consent" as "[t]he patient's . . . signature on
a VA-authorized consent form, e.g., a published numbered VA form (OF 522) or comparable form
approved by the local VA facility." 38 C.F.R. § 17.32(a) (2001).




                                                    7
                                          IV. ANALYSIS
       The Court is not persuaded by the appellant's argument that he is entitled to VA benefits
under 38 U.S.C. § 1151 on the basis that the content of a generic consent form contained in the
record establishes that VA was negligent per se. As discussed below, the standard VA consent form
does not constitute affirmative evidence of negligence per se. Accordingly, the Court need not
resolve the Secretary's arguments concerning the potential evidentiary value of such a form in a case
where the adequacy of the consent is in dispute.
                                   A. The Evidence in This Case
       Generally, a claimant seeking VA benefits has the burden of presenting evidence supporting
his or her claim, albeit with the statutorily mandated assistance of VA. See 38 U.S.C. § 5107(a);
Skoczen v. Shinseki, 564 F.3d 1319 (2009). In this case, it is undisputed that the appellant introduced
no evidence below—not even his own lay statements—that the informed consent discussion was
defective in any way. Rather, he relies on the absence of a listing of specific disclosed risks on the
informed consent form as evidence that VA did not obtain informed consent. He argues that the
Board's finding that endophthalmitis and retinal tears were reasonably foreseeable events required
their specific disclosure when VA obtained his consent. He contends that the fact that the consent
form does not refer to these specific risks raises a presumption that these reasonably foreseeable
complications were not discussed, thus contravening the regulatory requirements for informed
consent. See 38 C.F.R. § 17.32(c) (2009).
       We observe that when dealing with similar consent issues, some U.S. district courts, applying
state law, have relied heavily on the lack of written documentation of a material risk in the informed
consent document to find that informed consent was not obtained. See Parkins v. United States, 834
F. Supp. 569, 574 (D. Conn. 1993) (finding most significant evidence showing lack of informed
consent to be absence of text in informed consent document discussing paralysis as possible
consequence of procedure ); Powers v. United States, 589 F. Supp. 1084, 1098 (D. Conn. 1984)
(finding that consent form, which did not list paralysis as risk of operation "argues powerfully and
convincingly for the proposition that the plaintiff was never advised of the material risks inherent
in the [procedure].").




                                                   8
                             B. The Consent Form in the Regulatory Scheme
         There are several difficulties, however, that counsel against such an approach in the context
of the veterans benefits system. Significantly, to do so would ignore the statutory role of the
Secretary in prescribing regulations to carry out statutory directives. "If Congress has explicitly left
a gap for the agency to fill, there is an express delegation of authority to the agency to elucidate a
specific provision of the statute by regulation." Chevron U.S.A., Inc. v. Natural Resources Defense
Counsel, Inc., 467 U.S. 837, 843 (1984). In this instance, Congress instructed the Secretary to
"prescribe regulations establishing procedures to ensure that . . . all patient care furnished under this
title shall be carried out only with the full and informed consent of the patient." 38 U.S.C. § 7331.
The Secretary responded by implementing a regulation requiring that "the informed consent process
must be appropriately documented in the health record." 38 C.F.R. § 17.32(d)(1) (2008).
         Moreover, the Secretary's interpretation of his own regulation is entitled to deference where
it "reflect[s] the agency's fair and considered judgment on the matter in question." Auer v. Robbins,
519 U.S. 452, 462 (1997). The VHA handbook addressing the consent requirements demonstrates
that the Department has long regarded the use and completion of consent forms such as VA Form
OF-522 as appropriate documentation of the consent process. That view predates the creation of the
implementing statute.3



         3
          During the Senate hearings on 38 U.S.C. § 7331, a VA official testified as to the implementation of informed
consent referred to in the statute:

         Before a patient has a surgical operation it has long been customary to obtain his signature on some type of
         document indicating his permission to undergo the outlined procedure. This is not a legal document and does
         little more than protect the operating team from being charged with assault. In recent years (1973) [VA] has
         changed this operation permit so that it is now a "Request for Administration of Anesthesia and for Performance
         of Operations and Other Procedures." In this document, the counseling physician signs his or her name to the
         statement that he has "counseled this patient as to the nature of the proposed procedures, attendant risks
         involved and expected results, as described above." It is obviously both impractical and impossible to detail
         every potential risk involved, and indeed if this were done many patients might well become so frightened that
         they would decline to accept needed and indicated treatment. Nevertheless, this document has seemed to
         function well and to my knowledge there have been few if any problems associated with its use over many
         thousands of operative procedures carried out in the system each year.

Veterans Omnibus Health Care Act of 1976: Hearings Before the Subcomm. on Health and Hospitals of the S. Comm.
on Veterans' Affairs, 94th Cong. 596-97 (1976), at 597 (testimony of George A. Higgins, M.D., Chief of the Surgical
Service of the Veterans' Administration Hospital, W ashington, D.C.). The title of the document referred to in the
testimony is that of Optional Form 522.



                                                           9
       Thus, both the manual and the legislative history confirm that it is the Agency's considered
judgment that the generic, standard form is the best overall approach to accomplishing
documentation of the consent process. Although the Court does not entirely follow the Secretary's
position with respect to the legal effect of the generic consent form, it will not disturb his judgment
that such forms are best suited to the overall needs of VA medical facilities where such surgical
procedures are performed. Given that the Secretary's regulations and handbook do not require a
detailed recitation of all of the information conveyed in securing informed consent, it cannot be
presumed that the appellant's complications were not discussed simply because they were not
recorded. Accordingly, the Court is not persuaded by the appellant's reliance upon a negative
evidentiary presumption.
       In the absence of any evidence in support of the appellant's section 1151–based claim on a
theory of negligence per se, his argument fails. The appellant may seek to reopen his claim with new
and material evidence that raises specific questions as to the adequacy of the informed consent
process, which would have to include his lay assertions that he indeed was not informed of the
potential, reasonably foreseeable complications that occurred in his case.
       Based on this holding, the Court need not resolve the question of what evidentiary value a
generic consent form might have in a case where the claimant introduced other evidence that VA did
not obtain informed consent. In this regard, the Court notes that any potential error in the Board's
finding that "the medical evidence reflects informed consent on the veteran's behalf under
38 C.F.R § 17.32" (R. at 10) would not have been prejudicial in this case. Should the appellant
introduce evidence disputing the issue of consent, the Secretary will need to make a de novo
determination on that factual issue when the claim is reopened. The evidentiary significance of the
consent form can be fully addressed at that time.


                                        IV. CONCLUSION
       Based on the foregoing reasoning, the Court AFFIRMS the Board's December 19, 2006,
decision.




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