Citation Nr: 21070268
Decision Date: 11/23/21	Archive Date: 11/23/21

DOCKET NO. 05-16 510
DATE: November 23, 2021

ORDER

Entitlement to VA benefits under 38 U.S.C. § 1151 for bilateral foot disabilities, status post bilateral bunionectomies, is denied.

FINDING OF FACT

The preponderance of the evidence demonstrates that the Veteran gave informed consent to the surgeries performed by VA, that the risks of surgery discussed with him included permanent and chronic disabilities including pain and numbness and the reoccurrence of the condition, that the neuropathic pain which the Veteran developed was a reasonably foreseeable outcome that a reasonable provider would have disclosed to him, and that there was no material deviation from the signed consent form which would negate its effect. 

CONCLUSION OF LAW

The criteria for entitlement to VA benefits under 38 U.S.C. § 1151for bilateral foot disabilities, status post bilateral bunionectomies, have not been met. 38 U.S.C. § 1151; 38 C.F.R. §§ 3.361, 17.32.

REASONS AND BASES FOR FINDING AND CONCLUSION

The Veteran had active-duty military service from August 1974 to October 1975.

This case has a long and complicated procedural history prior to the decision rendered herein. The present claim was filed in February 2006 as part of an attempt to reopen a previously denied claim. (See Statement in Support, 02/03/2006.) The appeal for reopening was denied in August 2006 and the Veteran perfected an appeal of this denial to the Board. (See Rating Decision, 08/29/2006.) In a Board decision issued in November 2010, the Board likewise denied the bid to reopen the claim. (See BVA Decision, 11/29/2010.) The Veteran appealed this determination to the Court of Appeals for Veterans Claims (Court) which, in July 2011, issued a Joint Motion for Remand (JMR), finding that the Board had failed to properly consider all evidence and all theories of entitlement when denying reopening. (See Court Documents, [incorrectly labelled] 11/29/2010.) The matter was returned to the Board for further development.

In a Board decision issued in January 2012, the Board found that new and material evidence had been received and reopened the claim for benefits under 38 U.S.C. § 1151 and remanded the matter to the Agency of Original Jurisdiction (AOJ) for further development to determine if additional disability as a result of VA surgical treatment was shown and for an opinion regarding the matter of informed consent. (See BVA Decision, 01/27/2012.) After a VA examination in January 2013, the matter was again before the Board in June 2015 and the Board denied the claim, finding that the elements of 38 U.S.C. § 1151 were not met. (See BVA Decision, 06/12/2015.) The Veteran again appealed to the Court, which issued a Memorandum Decision in September 2016. (See CAVC Decision, 09/19/2016.) The Court's decision found that the medical opinion on which the Board's decision was based was inadequate because it was too conclusory. The matter was again returned to the Board for further development.

In August 2017, the Board remanded the matter to the AOJ with instructions to obtain a new medical opinion to address the inadequacies highlighted by the Court. (See BVA Decision, 08/10/2017.) After the medical opinion was obtained in October 2017, the matter was returned to the Board. In July 2018, the Board issued a decision which again denied entitlement to VA compensation under 38 U.S.C. § 1151, finding that the Veteran's additional disability was not result of an event not reasonably foreseeable and was not the result of carelessness or similar fault on the part of VA. (See BVA Decision, 07/24/2018.) The Veteran again appealed the denial to the Court which, in August 2019, issued a JMR finding that the Board had failed to consider material evidence regarding whether the Veteran was properly informed of the potential for long-term consequences of the surgery. (See CAVC Decision, 08/09/2019.) The matter was again returned to the Board for further development. 

In January 2020, the Board again remanded the matter to the AOJ for additional development, to include obtaining an opinion regarding the type of information provided to the Veteran prior to surgery and whether informed consent was obtained. (See BVA Decision, 01/09/2020.) Such an opinion was obtained in March 2020 and in October 2020 the matter again came before the Board. The Board decision issued in October 2020 again found that the elements of 38 U.S.C. § 1151 had not been met and denied the claim. (See BVA Decision, 10/07/2020.) Again, the Veteran appealed the denial to the Court. In July 2021, the Court issued another JMR finding that the Board had erred in issuing a decision without considering a request by the Veteran's attorney for an extension of time in which to obtain a copy of the most recent examination and opinion. (See CAVC Decision, 06/28/2021.) The case has now been returned to the Board for further consideration. 

The Board notes that the Veteran's attorney was provided with a copy of the requested January 2020 examination and opinion on compact disc (CD) in September 2020. (See Correspondence, 09/19/2020.) The Veteran's attorney submitted additional argument on the matter in October 2021 and the Board will address that filing below.

Entitlement to VA benefits under 38 U.S.C. § 1151 for bilateral foot disabilities, status post bilateral bunionectomies

In December 1996, the Veteran underwent a surgical procedure at a VA facility to address bunions on both of his feet. Subsequent to that surgery, he has been found to have, and has been treated for, painful neuropathic symptoms in both feet which has been established to be the result of the surgeries in December 1996. It has been determined through the course of the appeals in this case that the Veteran has an additional disability that was directly caused by the surgery performed by VA.

A veteran who suffers disability resulting from hospital care or medical or surgical treatment provided by a VA employee or in a VA facility is entitled to compensation for the additional disability "in the same manner as if such additional disability... were service-connected" if the additional disability was not the result of willful misconduct and was proximately caused by "carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of [VA] in furnishing" that treatment or "an event not reasonably foreseeable." 38 U.S.C. § 1151 (a)(1)(A), (B); 38 C.F.R. § 3.361 (a)-(d); Viegas v. Shinseki, 705 F.3d 1374, 1377-78 (Fed. Cir. 2013). The purpose of the statute is to award benefits to those veterans who were disabled as a result of VA treatment. 38 U.S.C. § 1151 (a).

First, there must be evidence of additional disability, as shown by comparing the veteran's condition before and after the VA medical care in question. 38 C.F.R. § 3.361 (b). This element of the claim has been met as determined during previous adjudications in the course of this appeal. 

Second, the additional disability must be caused by hospital care, medical or surgical treatment, examination, or other services furnished the veteran by VA. 38 C.F.R. § 3.361 (c). This element of the claim has also been determined to have been met during previous adjudications in the course of this appeal.

Third, the proximate cause of the disability, as opposed to a remote contributing cause, must be (1) 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 (2) an event that was not reasonably foreseeable. 38 U.S.C. §1151 (a)(1); 38 C.F.R. § 3.361 (d).

Thus, 38 U.S.C. § 1151 contains two causation elements - an additional disability must not only be "caused by" the hospital care or medical treatment received from VA, but also must be "proximate[ly] cause[d]" by the VA's "fault" or an unforeseen "event." 38 U.S.C. § 1151 (a)(1). Such "similar instance of fault" can include a failure to obtain properly informed consent from the Veteran prior to any procedure being performed. 38 C.F.R. § 3.361 (d).

In the present case, the primary assertions offered by the Veteran and his attorney have concerned the question of informed consent and whether the additional disability resulted from an event not reasonably foreseeable. Those aspects of the claim will be addressed in detail below.

With regard to the question of whether the Veteran's additional disability resulted from carelessness, negligence, lack of proper skill, or error in judgment on the part of VA, the adjudication of this claim has included obtaining expert medical opinions. In September 2017, an expert medical opinion was obtained from a VA physician specializing in podiatry, or disabilities of the feet. (See C&P Exam, 09/21/2017.) After a review of the evidence in this claim, the medical expert offered the opinion that the Veteran's neuropathic pain in his feet following the December 1996 surgery is not attributable to any carelessness, negligence, lack of proper skill, error in judgment, or similar fault on the part of the VA providers.  The medical expert observed that the type of neurological pain experienced by the Veteran is a "well-documented possible complication of bunion surgery due to scar tissue." This was consistent with the discussion of informed consent in the record regarding pain and numbness after surgery. A medical opinion obtained in February 2020 re-examined all of the evidence and opinions of record and came to the same conclusion, that the additional disability was not due to carelessness, negligence, lack of proper skill, error in judgment, or similar fault on the part of VA. (See C&P Exam, 03/02/2020.) Given that the opinions were based on the Veteran's medical history as shown by the record and supported by clear rationale, the Board finds them persuasive as to the lack of carelessness or negligence, or similar error by VA as the cause of the Veteran's additional disability. See Nieves-Rodriguez v. Peake, 22 Vet. App. 295 (2008.) The Board notes that the Veteran and his attorney have not submitted argument asserting such error or negligence as the basis for the claim.

As noted, the assertions by the Veteran and his attorney in this matter have been focused on the question of whether the Veteran gave informed consent to the procedure and whether the additional disability is the result of an event not reasonably foreseeable. The reasonably foreseeable aspect of the case involves whether the risk was such that a reasonable medical provider would have disclosed it to the patient as part of the informed consent procedure.

The Court has provided guidance on the concept of informed consent in cases such as McNair v. Shinseki, 25 Vet. App. 98 (2011). In McNair, the Veteran had undergone breast reduction surgery at VA and experienced nerve damage and pain as a direct result. The Veteran had signed a consent form prior to undergoing surgery and asserted that the presumption of regularity applied to demonstrate that she was aware of the risks of surgery. The Veteran provided sworn testimony that she had not been advised of the specific possibility of continuing pain after surgery. The Court found that the presumption of regularity did not apply to the issue of informed consent for treatment because of the unique circumstances for each patient and each procedure which prevented a consistent practice for eliciting informed consent. The Court also ruled that failure to provide information to a patient about a potential adverse effect of treatment would not defeat a finding of informed consent if a reasonable person would have proceeded with the treatment under similar circumstances. See 25 Vet. App. 98 (2011).

In addition, informed consent is specifically addressed with respect to VA cases by regulation in 38 C.F.R. § 17.32. VA regulation outlines what is needed for informed consent, beginning with decision-making capacity on the part of the Veteran. 38 C.F.R. § 17.32 (b)(1). The Board notes and acknowledges that the Veteran is currently rated as 100 percent disabled due to an acquired psychiatric disability, diagnosed as paranoid schizophrenia, and has been so rated since 2006. However, the Board also notes that this disability was determined to be permanently disabling nearly 10 years after the surgery at issue here. Further, a rating decision issued in April 2011 considered the question of the Veteran's competency and found that he is considered competent to administer his own VA benefits. (See Rating Decision, 04/06/2011.) Neither the Veteran nor his attorney have ever asserted that he lacked the decision-making capacity to consent to the surgery on his feet. For these reasons, the Board finds that no further discussion regarding capacity is needed.

VA regulations governing informed consent also specifiy that the provider must disclose and discuss with the patient the appropriate information to enable the patient to decide whether to undergo the procedure at issue. 38 C.F.R. § 17.32 (c). Appropriate information is the information which a reasonable person in the same circumstances would expect to receive in order to make a fully informed choice about the treatment or procedure. This disclosure and discussion should be conducted in person, if possible, and in language which enables the patient to understand (a) the nature of the procure, (b) the expected benefits, (c) reasonably foreseeable risks or complications, (d) reasonable and available alternatives to the procedure, and (e) the anticipated results if no treatment or procedure takes place. 38 C.F.R. § 17.32 (c)(1), (2). Documentation of informed consent in writing should be obtained and should be retained in the patient's file. 38 C.F.R. § 17.32 (d).

In this instance, the record contains both a copy of the written consent form prior to the December 1996 surgery and a treatment note which describes the discussion of informed consent with the Veteran. The written consent form included a narrative description of the procedure to be performed, the name of the surgeon, the need for anesthesia, and a handwritten list of the risks of surgery which had been discussed with the Veteran. (See Medical Treatment Records, 08/10/2017, p. 41.) The risks of surgery as written by the provider were listed as "(1) pain, (2) numbness, (3) excessive bleeding, (4) reoccurrence, (5) infection, (6) swelling, and (7) loss of toe, toes, foot, legs, limbs, life."

The treatment note of December 13, 1996 indicated that written consent had been obtained on December 9, 1996 and was in the file. (See CAPRI, 12/13/1996, p. 20.) The consent process had included a discussion, in layman's terms, regarding the procedure, including the procedure to be performed (bilateral silver bunionectomy and bilateral 2nd toe arthroplasty and elevating osteotomy), the reason for the procedure (painful bunions and hammertoes bilaterally), the risks of the procedure ("loss of toe, toes, foot, feet, limb(s), life"), and the expected benefits (reduced pain and foot discomfort). Alternatives to the procedure were also discussed (conservative treatment, i.e., padding and palliation). The provider then noted that the Veteran "understands above procedure, indications, risks [and] benefits, alternatives, [and] agrees freely to have the procedure without duress or coercion. No guarantees were given as the outcome" of the surgery. (See CAPRI, 12/13/1996, p. 14 [with note "continued from other side"]).

Based on the documentation in the record, the Board concludes that the proper written informed consent document was obtained and associated with the Veteran's medical file. In addition, the requirements of 38 C.F.R. § 17.32 (c) appear on their face to have been met, in that the Veteran's provider discussed with him in person and in layman's terms, the elements set forth in 38 C.F.R. § 17.32 (c)(2). 

However, it is the Veteran's contention that the informed consent process did not address the possibility of developing the type of neuropathic pain he has experienced since the surgery. In a sworn affidavit in April 2017, the Veteran asserted that he had not been warned of the possibility of long-term persistent pain as a result of the surgery. (See Correspondence, 05/08/2017.) He further asserted that if he had known that bunion surgery could cause long-term pain, he would not have undergone the procedure because it would have been pointless to risk long-term pain to relieve his discomfort. The Board notes that prior to undergoing surgery in December 1996, the Veteran reported experiencing increasing pain in both feet for some 21 years. (See CAPRI, 12/13/1996.) The Veteran reported at the time that the only relief he had from his foot pain was through self-palliation of the plantar hyperkeratotic lesions. This information is not persuasive one way or the other with respect to whether the surgery would have seemed to be a reasonable solution to the Veteran, even with a risk of long-term pain.

The Board acknowledges the concerns raised by the Memorandum Decision with respect to whether the Veteran's consent with respect to the risk of "pain, numbness" encompassed immediate effects of the surgery or a chronic and persistent type of neuropathic pain that would last more than 20 years. (See CAVC Decision, 09/19/2016).  The Board notes the specific risks discussed in the informed consent document include loss of one or more toes, loss of limb, and death, as well as reoccurrence of the Veteran's symptoms, in addition to the pain and numbness mentioned. The Veteran stated in his affidavit that he did not interpret the warning regarding pain and numbness as denoting possible chronic pain rather than the immediate pain in the aftermath of surgery. The Board notes that the notion of chronic and persistent impairment is inherent in the risk of losing one or more toes or one or both feet, as well as in losing his life. Such adverse outcomes of the surgery would be irreversible. The fact that consent to the procedure was given despite these risks, as well as the risk of reoccurrence of the pain and discomfort prompting the surgery and the disclosed risk of pain and numbness is indicative of an understanding that both immediate and chronic consequences of the procedure were possible. 

In the argument submitted in October 2021, the Veteran's attorney argued that the Veteran was not actually informed of the potential consequence of neuropathic pain at the time of the informed consent being signed. (See Third Party Correspondence, 10/05/2021.) Therefore, she argues, there was no informed consent to the procedure. In reviewing the Veteran's sworn affidavit, his statement was that he does not recall being given the information of the possibility of neuropathic pain, which does not establish conclusively that the information was not given. Rather, the possibility remains that the information was given but not understood and/or remembered by the Veteran. The purpose of examining the wording of the informed consent document and of obtaining input from medical experts is to ascertain if a reasonable person would have been able to understand the risk from that information that would have been provided. The language on the informed consent makes it clear that long-term and irreversible consequences of the procedure are a possibility, and that numbness and pain are among the possible consequences. 

In February 2020, the Board obtained a medical opinion from a podiatrist regarding whether a reasonable health provider would have disclosed the risk of long-term neuropathic pain to the Veteran prior to surgery. (See C&P Exam, 03/02/2020.) The expert medical opinion stated that the expectations on providers with regard to the disclosures associated with informed consent are to include risks of long-term consequences, including worsening of the condition. As a result, the medical expert offered the opinion that it is at least as likely as not that the risks of the additional disability which the Veteran has experienced would have been included in the information provided at the time of the informed consent. Further, in a separate document of the same date, the medical expert notes that this type of disability, residual numbness and pain or neuritis, is a well-documented consequence of bunion surgery. (See C&P Exam, 03/02/2020.) As such, it is logical that such a well-known consequence would have been included in the informed consent obtained.

The Board notes the contentions of the Veteran's attorney with respect to whether the Veteran's signed consent form is not controlling under 38 C.F.R. § 17.32 because of a material change or deviation in the procedure. (See Third Party Correspondence, 11/20/2017.) Specifically, the form lists arthroplasty and osteotomy of the third digit in three places, although the procedure performed was of the second digit. In two of the three places where the word "third" appears, it has been crossed out and the word "second" written in, with circled initials next to the change. The Veteran's attorney asserted that this is evidence that the written consent form was irregular on its face and that it cannot therefore be deemed acceptable and there can be no presumption of regularity with respect to informed consent. The Board notes that the Court, in McNair, held that the presumption of regularity does not apply to informed consent procedures. In addition, the Court in McNair also considered the question of a minor deviation on the effectiveness of informed consent, as provided in 38 C.F.R. § 3.361 (d)(1)(ii). See 25 Vet. App. 98 (2011). The Court ruled that a deviation is minor if a reasonable person in similar circumstances would have proceeded with the treatment despite the risk. The Board finds that the erroneous listing of third as opposed to second digit as the subject of the operation  an error which was corrected and initialed two out of three times it appeared  constitutes a minor deviation, particularly in light of all of the other medical records in the claims file referencing the second digit and the fact that the nature of the procedure involved did not change.

Finally, the Board must address the question of whether the Veteran's current disability of bilateral neuropathic pain was an outcome that was reasonably foreseeable. An expert medical opinion obtained from a podiatrist in February 2020 stated that residual pain and numbness or neuritis causing additional disability is a well-known possible complication of bunion surgery due to scar tissue formation as is permanent loss of cutaneous sensation due to the nerves being located so close to the affected joints being operated on. (See C&P Exam, 03/02/2020.) That is, the specific type of additional disability experienced by the Veteran would be considered to be an ordinary risk of this type of surgery by any reasonable provider. The Board notes that numbness and pain are included in the list of possible complications on the informed consent documentation. In addition, the Veteran's attorney printed out an online article from the National Library of Medicine which discussed the particulars of bunion surgery. (See Web/HTML Documents, 10/09/2014.) The article includes a list of risks associated with the surgery, among which are "numbness in the big toe . . . nerve damage . . . persistent pain . . ." This article supports the statement by the medical expert in February 2020 that this type of complication is one which is reasonably foreseeable for this type of procedure.  

In conclusion, the Board notes that it is not possible, without the benefit of time travel, to determine exactly what was discussed and disclosed at the time of the informed consent being signed in December 1996. Moreover, it is impossible without interrogating the Veteran in December 1996 to know what he understood of the discussion, to include whether he truly could understand and envision the long-term neuropathic pain which was the actual outcome of the surgery. Because of these impossibilities, the legal standard that applies relies on a determination of whether a reasonable provider would have disclosed the risk of this well-known possible complication of the surgery and whether a reasonable person would have consented to the surgery in light of the disclosed complication. For the reasons set forth above, the Board finds that a reasonable provider would have so disclosed the risk and a reasonable person  understanding that the complications disclosed included loss of one or more toes, one or both feet, numbness, pain, reoccurrence of the original complaint, and even death  would have proceeded despite the risk. The claim for benefits under 38 U.S.C. § 1151 is denied. 

 

Eric S. Leboff

Veterans Law Judge

Board of Veterans' Appeals

Attorney for the Board	Cheryl E. Handy

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.