Hatfield: Informed consent, 38 U.S.C. § 1151

Hatfield v. McDonough, docket no. 19-7165 (Mar. 8, 2021)

HELD: In McNair v. Shinseki, 25 Vet.App. 98, 100 (2011), the Court held that “deviations from the informed consent requirements of 38 C.F.R. § 17.32 are minor and immaterial if a reasonable person in similar circumstances would have proceeded with the medical treatment even if informed of the foreseeable risk.” The issue addressed by the Court here was whether this exception to the informed-consent requirement applies where VA obtains no consent. The Court held that “McNair applies only when VA has attempted to obtain informed consent but obtains consent that contains some defect.” It does not apply where VA does not obtain any consent at all. The Court reversed the Board’s decision and granted benefits.

SUMMARY: Veteran was treated for Hodgkin’s disease with radiation therapy at VA facility. There was no evidence of informed consent in his medical records. The radiation eliminated the Hodgkin’s disease, but caused severe pulmonary complications that resulted in his death. His wife applied for DIC and death pension benefits under 38 U.S.C. § 1151 and was repeatedly denied. The present appeal arises from a 2010 request to reopen. After eight Board decisions and two appeals to the Court, the Court finally ended her “long march through the VA system.”

The Court explained the requirements for establishing service connection under § 1151 (additional, qualifying disability; actual causation; proximate causation – carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault, or event not reasonably foreseeable.” In this case, there was no dispute that there was an additional, qualifying disability (pulmonary complications) that were actually caused by VA treatment (radiation). The only disputed element was regarding proximate cause.

To establish proximate cause (carelessness, etc.), claimant must show either (1) VA failed to exercise the degree of care expected of a reasonable health care provider OR (2) VA provided the treatment without obtaining informed consent. 38 C.F.R. § 3.361(d)(1). Informed consent must meet the requirements of 38 C.F.R. § 17.32 – but “minor deviations” that are “immaterial under the circumstances of the case” will not defeat a finding of informed consent.” 38 C.F.R. § 3.361(d)(1)(ii).

In this case, the Board determined that informed consent can be established EITHER (1) through evidence of a document signed by the patient or representative showing that the practitioner explained the procedure, its benefits, and risks OR (2) by showing that a reasonable person would have proceeding with the treatment even if informed of the risks. This is a misstatement of the McNair rule – and is contrary to the plain language of § 3.361 and 17.32, which do not contemplate the “reasonable person” alternative exception to establishing informed consent where there is no evidence of any consent at all.

McNair’s “reasonable person” alternative provides an exception to defective consent – when the defect is a “minor deviation” from 17.32’s requirements. It does not provide an alternative to a finding of informed consent. In McNair, there was evidence of an attempt to obtain informed consent – but it was defective in that it did not provide information of a specific potential risk. The McNair Court held 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.” Here, the Court held that “McNair does not apply when there is no attempt to obtain consent (as opposed to where defective consent has been obtained).”

Here, the Board made a factual finding that there was no evidence of informed consent in the record – yet attempted to use the McNair rule to excuse the wholesale lack of consent as a “minor deviation.” The Court found that this “would effectively make a finding of a lack of informed consent meaningless because the reasonable person standard from McNair could excuse any failure to document informed consent in almost every situation.” Because the Board made the necessary factual findings – including that there was no attempt to obtain consent – and because it erred in applying the McNair rule to this case – the Court reversed the Board’s decision and remanded for the Board to assign the correct effective date for the award of benefits.