Citation Nr: 21007022 Decision Date: 02/08/21 Archive Date: 02/08/21 DOCKET NO. 15-27 476A DATE: February 8, 2021 ORDER Entitlement to compensation pursuant to 38 U.S.C. § 1151 for an eye condition (to include cataracts) as a result of VA prescribed steroid (prednisone) therapy is denied. FINDING OF FACT The evidence of record does not support a finding that the Veteran sustained any additional disability resulting from carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the VA in treating an eye condition (to include cataracts) as a result of VA prescribed steroid (prednisone) therapy or resulting from an event not reasonably foreseeable. CONCLUSION OF LAW The criteria for entitlement to compensation pursuant to 38 U.S.C. § 1151 for an eye condition (to include cataracts) as a result of VA prescribed steroid (prednisone) therapy have not been met. 38 U.S.C. §§ 1151, 5107 (2012); 38 C.F.R. §§ 3.361, 3.1000 (2019). REASONS AND BASES FOR FINDING AND CONCLUSION The Veteran had active duty service from January 1971 to April 1972 and from February 1973 to February 1976. In February 2019, the Veteran testified at a videoconference hearing before the undersigned Veterans Law Judge. A transcript of that hearing is of record. In July 2019, the Board remanded the Veteran’s appeal for evidentiary development. It has since been returned to the Board for further consideration. Entitlement to compensation pursuant to 38 U.S.C. § 1151 for an eye condition (to include cataracts) as a result of VA prescribed steroid (prednisone) therapy The Veteran contends that he developed premature cataracts as a result of using VA prescribed steroid (prednisone) therapy. Under 38 U.S.C. § 1151, VA compensation shall be awarded for a qualifying additional disability or a qualifying death of a Veteran in the same manner as if such additional disability were service-connected. A disability or death is a qualifying additional disability or qualifying death if the disability or death was not the result of the Veteran’s willful misconduct and either: 1) the disability or death was caused by hospital care, medical or surgical treatment, or examination furnished the Veteran under any law administered by the Secretary, either by a Department employee or in a Department facility, and the proximate cause of the disability or death was either A) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the Department in furnishing the hospital care, medical or surgical treatment, or examination; or B) an event not reasonably foreseeable; or 2) the disability or death was proximately caused by the provision of training and rehabilitation services by the Secretary as part of an approved rehabilitation program. 38 U.S.C. § 1151; 38 C.F.R. § 3.361. To determine whether there was informed consent, VA will consider whether the health care providers substantially complied with the requirements of 38 C.F.R. § 17.32. Informed consent may be express (i.e., given orally or in writing) or implied under the circumstances specified in 38 C.F.R. § 17.32 (b), such as in emergency situations. 38 C.F.R. § 3.361(d)(1). Minor deviations from the requirements of 38 C.F.R. § 17.32 that are immaterial under the circumstances of a case will not defeat a finding of informed consent. Failure to advise a patient of a foreseeable risk can be considered a minor, immaterial deviation under the regulation if a reasonable person in similar circumstances would have proceeded with the medical treatment even if informed of the foreseeable risk. See McNair v. Shinseki, 25 Vet. App. 98 (2011). VA regulations provide that informed consent is the freely given consent that follows a careful explanation by the practitioner to the patient or the patient’s surrogate 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 or surrogate the nature of a proposed procedure or treatment; the expected benefits; reasonably foreseeable associated risks, complications or side effects; reasonable and available alternatives; and, anticipated results if nothing is done. The patient or surrogate must be given the opportunity to ask questions, to indicate comprehension of the information provided, and to grant permission freely without coercion. The practitioner must advise the patient or surrogate if the proposed treatment is novel or unorthodox. The patient or surrogate may withhold or revoke his or her consent at any time. 38 C.F.R. § 17.32(c). The Board acknowledges that the Veteran has received both VA and private treatment for several conditions. The records reveal that the Veteran was prescribed prednisone for the sudden onset of right ear hearing loss, hearing a loud roaring sound, and parotid swelling. The records also show that a decision was made to treat him for possible Meniere’s disease with a tapering course of oral prednisone lasting ten days. He was seen by the VA Eye Clinic on May 4, 2010, but no cataracts were detected. By then, he had completed one course of oral steroids. Further records note that he was seen by ENT service on June 28, 2010, where he received a prescription for a Medrol dose pack for his ear condition. The usual duration of this course of steroid treatment is approximately one week. An Eye Clinic note of January 5, 2011 documented the presence of a left eye cataract. An Eye Clinic note of June 8, 2011 documented the presence of bilateral cataracts. Additional treatment records through 2018 reveal that he has received several additional doses of prednisone therapy since 2010. The Veteran has also submitted a report from his private provider, Dr. Ostrovsky, dated April 2012. Dr. Ostrovsky stated that the Veteran developed visually significant cataracts by late 2010 and opined that their progression was due to systemic steroid therapy by VA that lasted for several months. A VA opinion was obtained in June 2015. The examiner noted that there are six common risk factors for developing cataracts: cigarette smoking, long term high dose steroid use, eye injuries, sunlight and ionizing radiation, diabetes, and obesity. The examiner opined that the Veteran’s cataracts are less likely as not due to VA prescribed steroid therapy. He reasoned that the Veteran’s steroid treatment lasted less than three weeks. He conceded that Dr. Ostrovsky is correct about the potential long-term effect of steroid use in the development of cataracts but noted that the VA clinical records do not support her assertion that the Veteran’s steroid therapy lasted for several months. The examiner found no instance of carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault by VA in furnishing care. Nor did he find that the proximate cause of the Veteran’s claimed disability was an event not reasonably foreseeable. Pursuant to the Board’s July 2019 remand, the Veteran received another VA eye examination in January 2020, wherein he was diagnosed with exophthalmos, keratoconus, and corneal transplant. Ultimately, the examiner determined that the Veteran’s cataracts were less likely aggravated beyond natural progression by steroid usage. The examiner provided the following remarks: I have reviewed the notes from the VA and have discovered that cataracts were observed in the veterans eyes as far back as 2004 at the Memphis VA. Throughout the notes there is mention of steroid (prednisone) drops used to treat swelling and pain from Fuchs’ cornea dystrophy as mentioned in the Bay Pines VA eye note on 6/13/2018. Steroids given in any form including eye drops and by mouth will produce cataracts or aggravate existing cataracts. Reference #1: Journal of Pharmacology and therapeutics. The etiology of steroid cataract. 2007, Oct. 23(5), pp 403-420. James, ER. Steroids result in glucocorticoid reception activation and subsequent change to the transcription of specific genes within the lens epithelial cells resulting in cataract formation in the lens of an eye. Cataract formation from steroids will have a classical appearance of a posterior subcapsular cataract. Reference #2: Survey of Ophthalmology Vol 31, Issue 2, Sept-Oct 1986 pp 102 - 110. Corticosteroid induced cataracts. Urban, RD and Cutlier, E. “The association linking corticosteroid therapy with the development of posterior subcapsular cataracts has been well documented.” The report from Dr. Ostrovsky in 2012 does mention the presence of posterior subcapsular cataracts in both eyes which is consistent with the usage of steroids in this patient. The finding of posterior subcapsular cataracts in both eyes was confirmed by the eye exam performed on July 20, 2017 at the Bay Pines VA Medical center clearly states that this patient has bilateral posterior subcapsular cataracts which is confirmed on my eye exam today and is consistent with the usage of steroids by this patient. I have reviewed the notes from the June 2015 VA opinion. Unfortunately, while they do review the note from Dr. Ostrovsky there is no mention of the presence of posterior subcapsular cataracts as noted by Dr. Ostrovsky in her note on 2012 which are directly associated with steroid usage. a) Is at least as likely as not (50 percent or greater probability) that the Veteran through continued steroid use has aggravated cataracts beyond their natural progression through the presence of posterior subcapsular cataracts consistent with steroid usage. See Reference #1. b) [If so, then is it at least as likely as not (50 percent or greater probability) that such additional disability was a result of treatment that was not reasonably foreseeable?] No. The usage of steroid eye drops to treat pain and swelling from Fuchs’ corneal endothelial dystrophy is considered standard therapy. Reference: Tauber Eye Center, Kansas City, MO. The progression of cataracts from steroid eye drops may occur but was not reasonably foreseeable. c) It is less likely than not that there was carelessness, negligence, lack of proper skill, error in judgment or similar instances of fault in prescribing steroid (prednisone) therapy for Fuchs’ corneal endothelial dystrophy as steroid (Prednisone) eye drops are considered standard treatment for pain and swelling from Fuchs’ corneal endothelial dystrophy. Reference: Tauber Eye Center, Kansas City, MO. I could not find any mention of informed consent regarding the prescribing of steroids. d) It is less likely than not that VA failed to exercise the degree of care that would be expected of a reasonable health care provider in prescribing steroid (prednisone) therapy without the veterans informed consent as steroid (prednisone) therapy is used for the treatment of pain and swelling from Fuchs’ corneal endothelial therapy. The Board notes that additional private treatment records from Dr. Mackie were later added to the record, dated September 2019. As a result of these records, an addendum opinion from the previous VA examiner was obtained in September 2020. The examiner provided the following remarks: I have reviewed the report by Dr. Mackie on 9/4/2019 and agree with her findings of age related cataract, right eye and age related nuclear cataract, left eye. I also observed an early posterior subcapsular cataract in both eyes on my examination which was confirmed by an eye examination done on 2/9/2017 at the Bradenton VA clinic which showed early posterior subcapsular cataract centrally in both eyes. Posterior subcapsular cataracts are seen in steroid usage. Ref: Clin Exp Optom 2002 Mar; 85(2): 61-75. What causes steroid cataracts? A review of steroid induced posterior subcapsular cataracts. Andrew I Jobling and Robert C. Augusteyn. My medical opinion from January 17, 2020 has not changed after reviewing Dr. Mackie’s examination on 9/4/2019. Per VA policy, an event is considered “not reasonably foreseeable” if it is not the type of risk that would be disclosed as part of the informed consent procedures shown in 38 C.F.R. § 17.32 (2019). Notably, the VA examiners and private provider have all essentially determined that steroid therapy (including prednisone) is standard treatment for pain and swelling stemming from Fuchs’ corneal endothelial dystrophy and that cataract formation is a known risk. The Board affords the VA examiner opinions substantial probative value. After reviewing the Veteran’s electronic claims file and VA treatment, the examiners found no evidence of carelessness, negligence, lack of proper skill, or error in judgement by the VA for the Veteran’s claimed eye condition (to include cataracts) as a result of VA prescribed steroid (prednisone) therapy. Here, the VA examiners determined that the Veteran’s cataracts were less likely aggravated beyond natural progression by steroid usage. They also found no instance of carelessness, negligence, lack of proper skill, error in judgment or similar instance of fault by VA in furnishing care. Nor did the examiners find that the proximate cause of the Veteran’s claimed disability was an event not reasonably foreseeable. In essence, they explained that prednisone is standard treatment for treating the Veteran’s condition and cataract formation is a well-known risk of long-term steroid use. Meanwhile, the Board affords little probative value to the 2012 report from Dr. Ostrovsky as there is no indication she had reviewed the entirety of the Veteran’s electronic claims file and provided limited rationale. Her report was also reconciled by the August 2020 VA examiner. The Board observes the Veteran’s assertions that he has experienced an eye condition such as cataracts stemming from prednisone therapy, which he claims to have caused additional disability. While he is competent to report certain symptoms such as vision problems, he is not competent to independently render a medical diagnosis or opine as to any potential carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of VA. Accordingly, the preponderance of the evidence of record, to include the examination reports and treatment described above, is against a finding that carelessness, negligence, lack of proper skill, or error in judgment on the part of VA caused additional disability. In addition, the preponderance of the evidence of record is against a finding that an event not reasonably foreseeable caused   additional disability. Therefore, the claim for entitlement to compensation pursuant to 38 U.S.C. § 1151 for an eye condition (to include cataracts) as a result of VA prescribed steroid (prednisone) therapy must be denied and the benefit of the doubt rule enunciated in 38 U.S.C. § 5107(b) is not for application. MICHAEL D. LYON Veterans Law Judge Board of Veterans’ Appeals Attorney for the Board M. Miller, 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.