Hatfield: Section 1151 Claims and Informed Consent

Hatfield v. Shinseki, Opinion Number 19-7165, was decided March 8, 2021 and a Section 1151 claim (VA’s own medical malpractice) and specifically informed consent.

The veteran developed Stage 2B Hodgkin’s disease which manifested as a large mass in the chest wall of his lungs.  His VA physician recommended radiation therapy to reduce the size of the tumor, which occurred from September to November 1978.  The veteran’s medical records contained no evidence of any informed consent for the radiation therapy.

The radiation therapy eliminated the veterans’s Hodgkins’s disease, but produced adverse effects including severe pulmonary complications.  He died in 1979 due to those pulmonary complications.

The veteran’s widow filed a DIC claim and a VA medical opinion stated the VA had provided an appropriate care plan and standard of care.  The opinion also noted radiation pneumonitis is a predictable  result of radiation therapy, but also that the rate at which patients can experience it can vary as much as 50%.  The VA denied which led to a multi-decade procedural history replete with Board and Court remands.

The widow argued:

First, she argues that the Board erred in determining that informed consent was obtained because it misapplied both 38 C.F.R. §§ 17.32 and 3.361 as well as our decision in McNair. 38 Appellant asserts that VA obtained no informed consent and as a matter of law such a lack of consent satisfies the proximate causation requirement of § 3.361(d)(1)(ii).39 She contends the Board erred when it used McNair to establish consent instead of curing consent that was otherwise defective. Appellant seeks reversal on this basis.40 Second, appellant argues that the Board erred in finding no pending issues remaining from the time of the 1980 Board decision.41 Specifically, she contends that the October 1980 Board decision denying her claim did not address whether the quickness of the veteran's death was an unforeseeable event.

Id. at *4-5.

The Court centered its Section 1151 analysis on proximate causation and then turns to the implementing regulation, 38 C.F.R. 3.361.  In part, Section 3.361 “provides that proximate causation can be established with a showing of "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 caused for the additional disability or death.”  Id. at *9.  Informed consent fits into Section 3.361(d)(1) because

[t]o establish that the proximate cause of a disability was . . . 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.

 

***

The plain language of subparagraphs 3.361(d)(1)(i) and (ii) further show that proximate causation is established when VA fails to exercise the expected standard of care of a reasonable health care provider or, as relevant here, when VA fails to obtain the veteran's informed consent based on the requirements of 38 C.F.R. § 17.32.

Id. at *9-10.

In this case, the Board noted informed consent was established by substantially complying with Section 17.32 or “by evidence that a reasonable person in similar circumstances would have proceeded with the medical treatment even if informed of the foreseeable risk.” See McNair v. Shinseki.”  Id. at *11.

The Court noted that in McNair v. Shinseki, informed consent was given with a signed informed consent form, but the consent was defective.  However, McNair stood for the proposition that: “VA's failure to inform a patient about a potential adverse effect did not defeat a finding of informed consent if a reasonable person faced with similar circumstances would have proceeded with the treatment.”  Id. at *12.

In the case at hand, the Court determined:

the facts before us are different from those in McNair, because here there was no documentation of the veteran's informed consent at all. We conclude that McNair does not apply when there is no attempt to obtain consent (as opposed to where defective consent has been obtained). Therefore, the Board legally erred by applying the McNair minor-deviation standard to appellant's case.

Id. at *12.

In sum, the Court holds that that the minor-deviation exception provided in § 3.361(d)(1)(ii) applies only when there has been a predicate finding of informed consent (as directed by the first sentence in that subparagraph) that is in substantial compliance with § 17.32's requirements (as contemplated under the second sentence). Furthermore, we hold that the McNair rule does not apply to situations where no informed consent was obtained or attempted. Thus, the Board legally erred in applying the third sentence of § 3.361(d)(1)(ii) and the reasonable person standard from McNair when it made no finding of an attempt to provide informed consent in substantial compliance with § 17.32. Simply put, the minor-deviation exception does not allow the Board to conjure informed consent when no attempt at obtaining consent can be demonstrated and, especially, when the Board itself makes a finding that there was no informed consent.

Id. at *14.

The Court then considered the remedy in this case.  The Court noted that under Section 1151 the three elements are

(1) The veteran must have experienced a qualifying additional disability or death that was not the result of the veteran's willful misconduct; (2) the additional disability or death must be caused by VA medical treatment, care, or examination (i.e., actual causation); and (3) the proximate cause of the veteran's additional disability or death was "carelessness, negligence, lack of proper skill, error in judgment, or similar instances of fault on the part" of VA or "an event not reasonably foreseeable" (i.e., proximate causation).

Id. at *14.  The Court then noted the Board itself determined the first two factors were met.  It also noted normally remand would be appropriate, but noted the Board determined there was no attempt to obtain informed consent.  Id. at *15.  “The fact of the matter is that there is little room to read the Board decision as doing anything other than making a factual finding that there was no proper procurement of informed consent because VA did not document the informed consent process according to § 17.32. The Board thought that was not dispositive because of its erroneous view of the law.”  Id. at *16.

This case is remarkable in limiting McNair to cases where there is a showing of an attempt at informed consent (i.e., the minor deviation exception can't save a situation where their was no evidence of informed consent) and that the Court actually reversed and granted DIC.  A reversal and grant is very rare, but likely made in this case due to the fact the case had gone on for so long—sympathy is still a factor.  The facts in this case might make the ruling limited, but it is still a nice victory for a veteran.

Decision by Judge Allen and joined in by Chief Judge Bartley and Judge Greenberg.

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