Citation Nr: 21012244 Decision Date: 03/03/21 Archive Date: 03/03/21 DOCKET NO. 12-21 064 DATE: March 3, 2021 REMANDED Entitlement to compensation under 38 U.S.C. § 1151 for residuals of a cerebrovascular accident, to include depression, as a result of VA treatment in February 2007, is remanded. REASONS FOR REMAND The Veteran had active service in the United States Navy from August 1964 to August 1967. In September 2012, the Veteran, his wife and his daughter testified at a Travel Board hearing before the undersigned Veterans Law Judge. A transcript of that hearing is of record. Entitlement to compensation under 38 U.S.C. § 1151 for residuals of a cerebrovascular accident, to include depression, as a result of VA treatment in February 2007. On February 9, 2007, the Veteran was prepared at West Los Angeles Medical Center to undergo a percutaneous coronary intervention (PCI). A number of medications were administered, including one experimental medication, cangrelor, following which the Veteran experienced blurry and/or double vision. The procedure was immediately terminated, with it being eventually determined that the Veteran had suffered a cerebrovascular accident (stroke). In pertinent part, it is argued that, while the Veteran and (by inference) his wife had provided informed consent for the PCI procedure, they had not provided informed consent for the administration of an experimental drug. A VA research enrollment note, dated on February 8, 2007 states informed consent was in fact obtained for the use of the experimental drug and the informed consent form was to be filed in the “research study folder.” A VA cardiology pre-catheterization assessment, dated February 7, 2007, states the risks, benefits and alternatives of the PCI procedure and sedation/analgesia had been explained to and discussed with the Veteran, who consented to the procedure and the plan for sedation. However, the actual informed consent form has never been associated with the claims file. This document was directed to be obtained by the Board’s January 2015, May 2017, May 2018, and March 2020 Remands and no explanation has been submitted as to why that clinical record is unavailable until the July 2020 Memorandum of Dr. R.E., submitted in response to the Board’s March 2020 Remand, which states, “In accordance with NARA regulations regarding research documents, all files, including the research consent, pertaining to this study (0019) have been destroyed.” VA treatment records in the period from February 6 through February 9, 2007 reveal a series of discrepancies and inconsistencies concerning the times stated when the Veteran was informed regarding the procedure, his participation in a research study and the use of the test drug, cangrelor. Additionally, the Veteran and members of his family testified at the September 2012 Board hearing that the Veteran was in fact given a form to sign the evening before the day of the procedure by the research coordinator, T.K., who stated it was for the next day’s “routine procedure,” with no further explanation provided and no questions elicited from the Veteran. The Veteran signed. He and his family members assert they did not know about the test drug, cangrelor, until the day after of the aborted procedure, during which complications developed. The Veteran’s family members contacted Dr. R.E. by letter at a later date requesting him to inform them whether the Veteran had in fact been administered the test drug. The Veteran’s wife testified Dr. R.E. refused to comply with that request. It now appears from the record that it was never determined whether the Veteran was given the experimental drug or the placebo. The administration stopped once the Veteran began to complain. It appears, although needs medical clarification, that any stroke was not the result of new bleeding, but may have been from an embolus from an arrhythmia. This needs to be clarified further. As evidence not yet considered by a VA examiner has been submitted in response to the Board’s March 2020 Remand directives, such as the July 2020 Memorandum of Dr. S.E. K., the Acting Associate Chief of Staff, Research, Los Angeles VA and the July 2020 Memorandum by Dr. R.E. to Dr. S.E.K., addressing the events of February 6 through February 9, 2007, as well as the Veteran’s new arguments appearing in the February 2021 Appellate Brief, remand is necessary for review of the record and opinions addressing specific questions, as set forth in the directives. The matters are REMANDED for the following action: 1. Arrange for a VA examiner(s) with specialties in coronary artery disease surgery and cerebrovascular accidents (strokes) to review the claims file. The examiner(s) chosen should NOT include Dr. Ramin Ebrahimi, Dr. Jeffrey R. Spina, Chief, Administrative Medicine and Medical Review Officer, or Dr. Scott E. Krahl, Acting Associate Chief of Staff, Research, each of the VA Greater Los Angeles Healthcare System, or, if practicable, any physician practicing in the VA Greater Los Angeles Healthcare System. If the examiner(s) deems a new examination(s) is necessary, arrange for that examination(s). The complete electronic claims file must be made available to the examiner in conjunction with the examination. The examiner should detail all findings. The examiner(s) is requested to review the entire claims file. However, the Board first directs the examiner(s)’s attention to the following documents for particularly thorough and careful review and consideration: The March 2020 Board Remand, found in the file at March 6, 2020. The Appellate Brief of the Veteran’s representative, found in the file at February 8, 2021. The Memorandum of the Acting Associate Chief of Staff, Research, VA Greater Los Angeles Healthcare System, Dr. S.E. K., found in the file at July 29, 2020. The Memorandum by Dr. R.E. to Dr. S.E.K., found in the file at July 29, 2020. All treatment notes of record, found in the file in the period from February 6 through February 9, 2007. The VA opinion of Dr. J. R. S., found in the file at November 2, 2017. The VA opinion of Dr. J. R. S., found in the file at December 28, 2015. The transcript of the September 2012 Travel Board hearing, found in the file at September 12, 2012. The lay statements of the Veteran, his wife and his daughter, found in the file at October 5, 2009, November 18, 2009, August 30, 2010, March 10, 2011 (correspondence), March 28, 2011, May 23, 2011, August 3, 2012 (accompanying the Veteran’s Appeals Form 9), April 11, 2016, and June 27, 2018. The examiners(s) is requested to render opinions addressing the following: (a) In considering the discrepancies of the times stated when the Veteran’s “consent” to being in a research study, to include the use of the experimental test drug, cangrelor, was obtained, as shown in VA treatment notes from February 7 through February 9, 2007 and set forth in the February 8, 2021 Appellate Brief at pages 1 – 2, as well as discussed in the September 12, 2012 Board hearing and all lay statements identified above, whether it is at least as likely as not (a 50 percent or greater probability) or less likely than not (less than a 50 percent probability) that VA furnished the Veteran with medical treatment on February 9, 2007, to include administering cangrelor, without the Veteran’s informed consent or that of members of his family to being in a research study and to taking cangrelor. (b) In considering the July 29, 2020 Memorandum of Dr. R.E. describing the use of the experimental test drug, cangrelor, as an antiplatelet or “blood-thinning” agent and the treatment notes appearing in the CAPRI records uploaded to the claims file on September 6, 2017 at page 62, as well as the argument of the February 8, 2021 Brief on pages 1 – 2, whether it is at least as likely as not (a 50 percent or greater probability) or less likely than not (less than a 50 percent probability) that it was reasonably foreseeable that a cerebrovascular accident could occur due to excessive anticoagulation caused by the potency of cangrelor used in conjunction with the primary antiplatelet agent, aspirin. In this response, please indicate whether the Veteran’s stroke was more likely due to bleeding or a hemorrhage, or whether it was more likely to do an embolus or other development from an arrythmia unrelated to blood thinners. (c) In considering the documented medical condition of the Veteran, to include having diabetes mellitus, type II, and on the information provided in the February 8, 2021 Appellate Brief at pages 2 – 3, as well as the Brief’s argument on the those pages regarding the efficacy of coronary artery bypass graft surgery (CABG) as opposed to percutaneous coronary intervention (PCI) for improved survival rates and a reduced risk of myocardial infarction and repeat revascularization, whether VA, in recommending and implementing a PCI, exhibited primarily an error in judgment, as well as carelessness, negligence, lack of proper skill, or similar instance of fault in furnishing surgical treatment on February 9, 2007. The opinions rendered by the examiner(s) must be accompanied by a rationale, by which conclusions are supported by references to and discussion of findings on examination (if one is deemed necessary), to clinical findings in the medical evidence of record and/or to accepted medical literature. The examiner(s) is further requested to comment on all other relevant opinions in the record, as they pertain to the Veteran’s February 9, 2007 surgery and stroke. The examiner is requested to address, consider and evaluate the September 2012 Board hearing testimony of the Veteran, his wife and his daughter and their lay statements set forth above between October 2009 and June 2018, as well as the Veteran’s reports to treatment providers as they appear throughout the record. The examiner(s) is urged to take note that opinions rendered without addressing the hearing testimony, lay evidence and reports to treatment providers by the Veteran, his wife and his daughter, as a matter of law, are insufficient for VA adjudication purposes. MICHAEL D. LYON Veterans Law Judge Board of Veterans’ Appeals Attorney for the Board P. Franke, Associate Counsel 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.