VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_16-vv-01664 Package ID: USCOURTS-cofc-1_16-vv-01664 Petitioner: Kelli Tenneson Filed: 2016-12-20 Decided: 2019-03-18 Vaccine: influenza Vaccination date: 2015-10-06 Condition: shoulder injury related to vaccine administration (SIRVA) Outcome: compensated Award amount USD: 88017 AI-assisted case summary: On December 20, 2016, Kelli Tenneson filed a petition for compensation under the National Vaccine Injury Compensation Program, alleging that an influenza vaccination she received on October 6, 2015, caused a shoulder injury related to vaccine administration (SIRVA). Ms. Tenneson, who was 58 years old at the time, stated that the day after her vaccination, she experienced severe pain in her left shoulder, which radiated down her arm. She attributed her delay in seeking medical treatment for several months to her reluctance to see doctors and her unfamiliarity with vaccine-related shoulder injuries. She eventually sought treatment in March 2016, where she was diagnosed with adhesive capsulitis. The Secretary of Health and Human Services (respondent) argued that the claim should be denied because her symptoms did not manifest within the medically accepted timeframe of 48 hours. The Chief Special Master, Nora Beth Dorsey, issued a ruling on entitlement on March 30, 2018, finding that Ms. Tenneson's testimony, supported by her medical records from subsequent treatment, established that her pain began within 48 hours of the vaccination. The Chief Special Master noted that the delay in seeking treatment did not negate the credibility of her account and that her medical records corroborated her reported timeline. The case proceeded as an off-Table claim, requiring proof of causation-in-fact. The Chief Special Master applied the Althen test, finding that a medical theory connected the vaccine to the injury, a logical sequence of cause and effect was established, and a proximate temporal relationship existed. The respondent filed a motion for review, challenging the Chief Special Master's factual finding regarding the onset date as arbitrary and capricious. On March 18, 2019, Judge Elaine D. Kaplan of the U.S. Court of Federal Claims denied the motion for review, upholding the Chief Special Master's decision. Judge Kaplan found that the Chief Special Master's determination was based on evidence in the record and reasonable inferences, and that the delay in seeking treatment did not render the petitioner's account not credible. On November 19, 2018, following the entitlement ruling, Chief Special Master Dorsey issued a decision awarding Ms. Tenneson $88,017.82 in compensation. This amount was comprised of $85,000.00 for past and future pain and suffering and $3,017.82 for unreimbursable expenses, paid as a lump sum. Theory of causation field: Kelli Tenneson, a 58-year-old female, received an influenza vaccination on October 6, 2015. She alleged that this vaccination caused a Shoulder Injury Related to Vaccine Administration (SIRVA). The public decision does not detail the specific medical theory or expert testimony presented to establish the mechanism of injury, but notes that SIRVA is thought to occur as a result of unintended injection of vaccine antigen or trauma into and around the shoulder's bursa, leading to inflammation. The Chief Special Master found that Ms. Tenneson's shoulder pain began within 48 hours of the vaccination, satisfying the proximate temporal relationship prong of the Althen test. The injury was diagnosed as adhesive capsulitis. The case was an off-Table claim, requiring proof of causation-in-fact. The Chief Special Master found that the petitioner established a logical sequence of cause and effect and that there was no evidence of unrelated factors causing the injury. The respondent argued against entitlement based on the delay in seeking treatment and alleged inconsistency with contemporaneous records, but this was rejected by both the Special Master and the Court of Federal Claims. Ms. Tenneson was awarded $88,017.82, consisting of $85,000.00 for pain and suffering and $3,017.82 for unreimbursable expenses, as a lump sum payment. Attorneys for petitioner were Ronald Craig Homer and Meredith Daniels (Conway Homer, P.C.), and for respondent was Daniel Anthony Principato (U.S. Department of Justice). The decision on entitlement was issued by Chief Special Master Nora Beth Dorsey on March 30, 2018, and the damages decision by Chief Special Master Dorsey on November 19, 2018. The Court of Federal Claims, Judge Elaine D. Kaplan, upheld the entitlement decision on March 18, 2019. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_16-vv-01664-0 Date issued/filed: 2018-06-19 Pages: 12 Docket text: PUBLIC ORDER/RULING (Originally filed: 3/30/2018) regarding 31 Ruling on Entitlement. Signed by Chief Special Master Nora Beth Dorsey. (rp) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-01664-EDK Document 35 Filed 06/19/18 Page 1 of 12 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-1664V Filed: March 30, 2018 UNPUBLISHED KELLI TENNESON, Special Processing Unit (SPU); Petitioner, Ruling on Entitlement; Causation-In- v. Fact; Influenza (Flu) Vaccine; Shoulder Injury Related to Vaccine SECRETARY OF HEALTH AND Administration (SIRVA) HUMAN SERVICES, Respondent. Ronald Craig Homer, Conway, Homer, P.C., Boston, MA, for petitioner. Daniel Anthony Principato, U.S. Department of Justice, Washington, DC, for respondent. RULING ON ENTITLEMENT1 Dorsey, Chief Special Master: On December 20, 2016, petitioner filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.,2 (the “Vaccine Act”). Petitioner alleges that she suffered a shoulder injury related to vaccine administration (“SIRVA”) as a result of her October 6, 2015 influenza (“flu”) vaccination. Petition at 1. The case was assigned to the Special Processing Unit of the Office of Special Masters. Petitioner now moves for a decision on the written record finding she is entitled to compensation. (See ECF No. 28.) Respondent conversely moves for a ruling on the record denying compensation to petitioner. (See ECF No. 27.) For the 1 Because this unpublished ruling contains a reasoned explanation for the action in this case, the undersigned intends to post it on the United States Court of Federal Claims' website, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits within this definition, the undersigned will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:16-vv-01664-EDK Document 35 Filed 06/19/18 Page 2 of 12 reasons described below, the undersigned finds that petitioner is entitled to compensation. I. Procedural History Between December 23, 2016 and April 13, 2017, petitioner filed medical records and affidavits from six individuals, including herself, in support of her claim. (ECF Nos. 7-8, 10-11, 16.) On June 19, 2017 respondent filed his Rule 4(c) Report arguing that petitioner failed to establish the onset of her left shoulder symptoms within a medically appropriate time period, 48 hours, and thus failed to establish by preponderant evidence that she developed SIRVA as a result of her October 6, 2015 flu vaccination. (ECF No. 18 at 5- 6) Thereafter, on July 18, 2017 a status conference was convened by the OSM staff attorney managing this claim on behalf of the undersigned to share the undersigned’s impressions of the claim having reviewed petitioner’s medical records and affidavits, as well as respondent’s Rule 4(c) Report. The undersigned issued a follow-up Order indicating as follows: [T]his claim generally meets the requirements for SIRVA. As an initial matter, petitioner’s affidavit together with the records evidence onset within 48 hours of petitioner’s vaccination. Accordingly, a fact hearing should not be necessary. Specifically, both petitioner and her husband aver in their affidavits that petitioner suffered pain the day after her October 6, 2015 flu shot. Exs. 6 and 8. Further, at petitioner’s March 30, 2016 medical appointment she indicated she had “left arm pain since the flu shot.” Ex. 2 at 89. Additionally, the undersigned notes that petitioner’s clinical course is consistent with SIRVA and that petitioner’s delay in reporting her injury speaks to the severity and value of her injury. The undersigned does not believe this is a claim that should go to hearing, but rather should be resolved for a reasonable amount. Accordingly, the undersigned encourages petitioner to make a reasonable demand upon respondent. Order filed July 26, 2017. (ECF No. 19) To address concerns raised by respondent in his Rule 4(c) Report and at the July 18, 2017 status conference petitioner agreed to file a supplemental affidavit. (Id.) On August 22, 2017 petitioner filed supplemental affidavits from three witnesses including herself. (ECF No. 21) Respondent filed a status report on October 2, 2017 indicating that he was not willing to engage in settlement discussions and intended to defend this case. (ECF No. 25) Subsequently, the parties agreed the undersigned should issue a ruling on the written record in lieu of a fact hearing and a briefing schedule was set. Additionally, the undersigned filed the following two medical journal articles as evidence in regard to Case 1:16-vv-01664-EDK Document 35 Filed 06/19/18 Page 3 of 12 SIRVA: B. Atanasoff et al., Shoulder injury related to vaccine administration (SIRVA), 28 Vaccine 8049 (2010), filed as Court Exhibit I, and M. Bodor and E Montalvo, Vaccination-related shoulder dysfunction, 25 Vaccine 585 (2007), filed as Court Exhibit II. (ECF No. 26) Petitioner and respondent each filed a motion for a ruling on the record on November 20, 2017. (ECF Nos. 27-28) Petitioner filed response to respondent’s motion on December 4, 2017 and respondent filed a reply to petitioner’s response on December 5, 2017. (ECF Nos. 29-30) Thus, this matter is ripe for a ruling on petitioner’s entitlement to compensation. II. Factual History3 On October 6, 2015, petitioner received an intramuscular flu vaccination from Kaiser Permanente – Colorado, her primary care provider, which was administered in her left deltoid. (Ex. 1 at 1) At the time of her vaccination, petitioner was 58 years old. (Ex. 1 at 1.) Her prior medical history was significant for low back pain, osteoporosis, and irritable bowel syndrome. (Ex. 2 at 46-48) Petitioner, a recently retired director of a preschool, provided testimony in her affidavits that the vaccine was administered “very high up on my left arm.” (Ex. 6 at 1; Ex. 14 at 1.) Petitioner explained that the “next day, I woke up with extreme pain in my shoulder. The pain started in the exact area where the shot was given and by the end of the evening I was having sharp pains all the way down my left arm. I thought the pain would go away eventually, so I tried to wait it out.” (Ex. 6 at 1-2; Ex. 14 at 1.) Petitioner further testified that she is not someone “who easily goes to the doctor, so despite my ongoing pain as time progressed, I did not immediately seek care for my symptoms.” (Ex. 14 at 1; Ex. 6 at 2). Petitioner further explained that she was busy watching her granddaughter and “had never heard of the flu vaccine causing this type of sustained pain, so I continued to tough it out.” (Ex. 6 at 2; Ex. 14 at 1). Petitioner’s husband, Michael Tenneson, likewise testified by affidavit that the day after she received her flu vaccine petitioner told him that “where she received the flu shot, really hurt. She also told me that she could not lift her left arm above her shoulder without being in pain.” (Ex. 8 at 1) Mr. Tenneson testified that he told petitioner it was “probably normal to feel pain the day after receiving a flu shot.” (Id.) On December 17, 2015, primary care records indicate that petitioner called her primary care provider requesting “a form faxed to her employer, please asap” indicating that “she has been seen in the last year and is in good health.” (Ex. 2 at 78) Petitioner averred in her affidavit that this phone call related to a form that was required by the State of Colorado in order for her to serve as a Substitute Director at the preschool from where she recently retired. (Ex. 14 at 2) Petitioner testified that the form was a one 3 While the undersigned has reviewed and considered all of the filed evidence in this claim, this factual history is condensed for brevity. Case 1:16-vv-01664-EDK Document 35 Filed 06/19/18 Page 4 of 12 page document indicating she had no communicable diseases that her doctor had seen her within the year, and that she was able to work with children. (Id.) Petitioner stated the form was based on a physical examination which took place prior to her October 6, 2015 flu vaccination. Petitioner did not undergo a physical examination on December 17, 2015. Petitioner explained that at that time she requested the form be completed “my shoulder was painful, but because I did not know that the flu vaccine could cause such a sustained injury, I continued to have the mindset it would get better with time.” (Ex. 14 at 2) As the pain continued, petitioner testified in her affidavit that she made an appointment in January of 2016 to see her primary care provider. (Id. at 3) The appointment was scheduled for March 30, 2016.4 (Id.) On January 22, 2016, petitioner’s medical records reflect that she placed a phone call to Kaiser, her primary care provider, regarding a possible UTI. (Ex. 2 at 80) That same day petitioner presented to the emergency room (“ER”), at which time the following symptoms were recorded: right flank/abdominal pain, low back pain, blood in urine, discomfort with urination, pain and vomiting. (Ex. 3 at 1) The level of petitioner’s symptoms were documented by the ER as “severe.” (Id.) The physical exam section of petitioner’s ER record includes an “extremities” section with the following descriptions checked: “non-tender,” “nml ROM,” and “no pedal edema.” (Id. at 2) Ultimately, petitioner was found to be suffering an acute urinary tract infection and kidney stones. (Id. at 3-8) Petitioner explained in her affidavit that she was enroute to a trip to the mountains with her family on January 22, 2016 when she started to experience “excruciating back pain” and that by the time they reached their destination she was “in horrible pain, and could not stop urinating and vomiting.” (Ex. 14 at 3) Petitioner indicated due to her severe symptoms her husband and son took her to the ER where she spent several hours, but was only seen by a doctor for two to three minutes. (Id. at 3-4) Petitioner testified that no examination of her upper extremities was conducted while she was at the ER, to include that no examination of her left shoulder for tenderness or range of motion. (Id. at 4)5 Petitioner testified that only her back and abdomen were touched. (Id.) Petitioner explained subsequent to her visit she spoke to the billing department in regard to her visit and after describing her experience at the ER they reduced the cost billed to her and apologized for the care she received. (Id.) The affidavits of petitioner’s son and husband, both who stayed with her in the ER examination room, are consistent with petitioner’s recollection of January 22, 2016. (Exs. 15-16) Thereafter, the medical records reflect that petitioner placed phone calls to Kaiser on January 25 and 26, 2016 in follow-up to her ER visit due to concerns about 4 The undersigned notes petitioner’s affidavit contains a typographical error indicating that the appointment was scheduled for March 31, 2016. 5 However, petitioner did aver that she noted to the CT scan technician at the ER that she could not raise both of her arms overhead because she had very minimal range of motion as a result of her flu vaccine in October. (Ex. 14 at 5) He indicated she should let a doctor know what occurred and she told him she had a physical scheduled for March. (Id.) Case 1:16-vv-01664-EDK Document 35 Filed 06/19/18 Page 5 of 12 leaving town in a few weeks. (Ex. 2 at 84-85) Petitioner described her kidney stone, and “[d]enied pain, blood in her urine and fever.” (Id. at 84) Deja Vandeloo, MD, noted that pain medication was “not really need(ed) right now unless absolutely has to” and that petitioner indicated she was feeling better. (Id. at 85) Dr. Vandeloo stated urology indicated the stone should pass and to follow-up in two weeks if it does not. (Id.) Subsequently, petitioner first received medical treatment for her shoulder pain on March 30, 2016. (Ex. 2 at 89) Petitioner testified in her affidavit this was the first time she had seen her primary care doctor, Dr. Vandeloo, since prior to her flu shot. (Ex. 14 at 6) According to Dr. Vandeloo’s record, petitioner reported she experienced left arm pain since flu shot 10/15, pain all the way down arm. Can barely move arm now. Just hasn't gotten better. Wakes her up at night. Does watch her grand-baby and can lift her but hard time getting seat belt, etc. No other trauma. No prior shoulder problems. Wondering if they hit a nerve or something as they gave the flu shot kind of high up she thinks. (Ex. 2 at 89) Dr. Vandeloo’s muscoskeletal examination of petitioner found “limited ROM left shoulder—can only abduct/extend to approx 80-90 degrees and can only get a few more degrees passively.” (Id. at 90 ) Dr. Vandeloo diagnosed petitioner with adhesive capsulitis of the left shoulder. (Id.at 91) Dr. Vandeloo followed up with the “shot line who said [petitioner’s shoulder injury] was not due to vaccine by they can’t comment on administration.” (Id.) An orthopedist was also consulted who “also felt unlikely this is all related to flu shot.” (Id.) However, the orthopedist did note that petitioner “certainly could have developed a frozen shoulder if she hasn’t moved it [for] 5 mo[nths] [since the flu vaccination].” (Id. at 97) Dr. Vandeloo ordered a left shoulder xray and referred petitioner to physical therapy and an orthopedist. (Id. at 91) Petitioner’s orthopedist referral notes as follows: Kelli Tenneson is a 58 year old female. Please see this patient and send me a copy of your note including your opinion and recommendations for the following left shoulder problem: frozen shoulder--pt has had pain ever since flu shot 10/15 w/ no injury. Worsening ROM over last 5 months. No trauma. (Id. at 89) Petitioner followed up with physical therapist, Robert Webers, on April 13, 2016. (Id. at 99) Mr. Webers recorded the following history: “Pt got a flu shot in Oct. 2015, and since then she has had pain as above [right lateral humerus pain].” (Id.) Mr. Webers performed an exam and found petitioner’s range of motion to be limited. (Id.) Mr. Webers found that petitioner presented with signs and symptoms consistent with adhesive capsulitis and recommended treatment every 10 days for four weeks with a goal to increase petitioner’s range of motion. (Id.) Case 1:16-vv-01664-EDK Document 35 Filed 06/19/18 Page 6 of 12 Subsequently, petitioner was evaluated by orthopedist, Tracy Frombach, DO, on April 27, 2016. Dr. Frombach recorded the following history, patient is a 58-year-old female who in October received her flu shot. The patient states that the day following her flu shot she had significant pain in the left shoulder and had limited range of motion. The patient states that she is unable to lift her arms above her head, but her strength close to the body and lower than the shoulder is adequate. (Id. at 109) Dr. Frombach’s exam found petitioner suffered limited range of motion and mild tenderness through petitioner’s mid deltoid. (Id. at 110) Dr. Frombach assessed petitioner’s injury as follows: “1. Adhesive capsulitis of the left shoulder following a flu injection in October 2015. 2. Left rotator cuff syndrome.” (Id.) Dr. Frombach administered a left subacromial injection to treat petitioner’s left shoulder and recommended petitioner strictly adhere to her home exercise program through physical therapy. (Id. at 110-111) Thereafter, petitioner continued to follow-up with Dr. Frombach through October 2016 at which time Dr. Frombach noted in her history that “[t]his started in October of 2015 and is resolving” and found specifically that petitioner’s “[l]eft adhesive capsulitis [was] almost completely resolved.” (Ex. 4 at 44-45) Petitioner continued to pursue physical therapy through at least March of 2017. (Ex. 13 at 33) III. Party Contentions In sum,6 petitioner argues she has satisfied the criteria, as detailed by Vaccine Injury Table’s Qualifications and Aids to Interpretation (“QAI”), to establish a Table claim for SIRVA. (ECF No. 28 at 16-20) Alternatively, petitioner argues that she has met the burden for establishing entitlement to compensation in an “Off-Table” claim by demonstrating the Althen v. HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005) criteria to establish petitioner more likely than not suffered a SIRVA. (Id. at 24-26) Respondent argues that petitioner’s contemporaneous records do not establish that her injury manifested within a medically appropriate time frame. (ECF No. 27 at 6.) Respondent argues that petitioner’s contemporaneous records indicate that petitioner’s shoulder pain began approximately three to six months subsequent to her October 6, 2015 vaccination. (Id. at 7) Respondent asserts that the literature submitted by the court establishes that most SIRVA injuries begin within two days, and all occur within four days of vaccination. (Id. at 6) Accordingly, respondent argues petitioner’s claim should be denied. (Id. at 7-10) IV. Finding of Fact The first issue to be addressed is when the onset of petitioner’s shoulder injury occurred. Petitioner has the burden of demonstrating the facts necessary for entitlement to an award by a “preponderance of the evidence.” § 300aa-12(a)(1)(A). Under that standard, the existence of a fact must be shown to be “more probable than 6 The undersigned has fully reviewed and considered the parties’ briefing in this matter, however for the purpose of brevity does not summarize and/or address each argument put forward. Case 1:16-vv-01664-EDK Document 35 Filed 06/19/18 Page 7 of 12 its nonexistence.” In re Winship, 397 U.S. 358, 371 (1970) (Harlan, J., concurring). In light of all of the above record evidence and for the reasons described below, the undersigned finds that there is preponderant evidence that the onset of petitioner’s alleged shoulder pain occurred within 48 hours of petitioner’s October 6, 2015 flu vaccination. As described above, petitioner’s medical records demonstrate that petitioner repeatedly and consistently placed the onset of her condition within 48 hours of her vaccination. Respondent argues that there is no corroborating evidence that petitioner experienced the onset of symptoms during the six months after the vaccination and before seeking treatment for her injury. (ECF No. 27 at 9) However, respondent unreasonably dismisses petitioner’s contemporaneous treatment records since the records were not created contemporaneously with the onset of petitioner’s shoulder pain. (ECF No. 30 at 1-2) The fact that petitioner delayed seeking treatment for her shoulder symptoms does not negate the value of her treatment records or render this evidence not credible, although it may speak to the severity of her injury.7 The undersigned does not find petitioner’s delay in treatment of nearly six months to be dispositive regarding the question given the facts and circumstances of this case. Three different health care providers documented consistently as to onset. The first time petitioner sought medical treatment for her injury from her primary care provider, Dr. Vandeloo on March 30, 2016, she placed the onset of her pain as since her October 2015 flu shot. (Ex. 2 at 89) Her subsequent physical therapy evaluation by physical therapist, Robert Webers on April 13, 2016 noted that “[patient] got a flu shot in Oct. 2015, and since then she has had pain.” (Id. at 99) Petitioner again linked her shoulder pain to her October 6, 2015 flu vaccination at her April 27, 2016 evaluation by orthopedist, Dr. Frombach. Dr. Frombach noted “patient is a 58-year-old female who in October received her flu shot. The patient states that the day following her flu shot she had significant pain in the left shoulder and had limited range of motion.” (Id. at 109) Additionally, the undersigned finds petitioner’s affidavits explaining her pattern of treatment and reports to her physicians as reasonable and credible. See, e.g. Stevens v. HHS, 90-221V, 1990 WL 608693, *3 (Cl. Ct. Spec. Mstr. 1990)(noting that clear cogent, and consistent testimony can overcome missing or contradictory medical records). Petitioner’s account is detailed, cogent and corroborates the statements she made to her health care providers. Moreover, in the undersigned’s experience, petitioner’s affidavits and medical records together reflect a pattern of treatment consistent with and similar to many other SIRVA claims.8 Likewise, petitioner’s affidavits are consistent with the affidavits filed from petitioner’s family members. 7 The undersigned further rejects respondent’s argument that her finding of onset in these circumstances opens up the Vaccine Program to fraud and abuse. (ECF No. 27 at fn 6; ECF No. 30 at 1-2) The undersigned has carefully reviewed all evidence filed in this matter and finds no evidence of fraud. 8 The undersigned disagrees with respondent’s characterization of petitioner’s affidavit as internally inconsistent. (ECF No. 27 at 9-10) The undersigned finds that petitioner’s lack of awareness that a flu Case 1:16-vv-01664-EDK Document 35 Filed 06/19/18 Page 8 of 12 Respondent argues petitioner’s earlier visit to the ER on January 22, 2016, and follow-up phone calls to Kaiser, establish that petitioner’s shoulder pain approximately began three to six months subsequent to her October 6, 2015 flu vaccination. (ECF No. 27 at 7-9) In particular, respondent relies upon checkmarks next to “non-tender,” “nml ROM,” and “no pedal edema” under the “extremities” portion of the physical exam section of petitioner’s ER record (Ex. 3 at 2) as evidence that the onset of petitioner’s injury did not commence until three to six months after the flu vaccine. (Id.) Given the context of these records the undersigned disagrees with respondent’s assertion. The undersigned notes that petitioner was seen at the ER on January 22, 2016 for a UTI and kidney stones which are extremely painful conditions for which petitioner was seeking urgent medical attention. Additionally, in the undersigned’s experience thorough physical examinations are not conducted in the ER setting for issues beyond or unrelated to the reason for the visit. The undersigned notes this is in contrast to a general or physical examination conducted by a primary care physician or orthopedist. The undersigned finds that petitioner’s subsequent phone calls to Kaiser on January 25 and 26, 2016 are clearly in follow-up to petitioner’s emergency room visit for her UTI and kidney stones, and the description of lack of pain relates accordingly to those issues, as opposed to a lack of pain in her left shoulder. Additionally, petitioner, her husband, and son in their testimony by affidavit offer consistent, cogent, and reasonable descriptions of the events leading to petitioner’s ER visit and the ER visit itself. (See Ex. 14-16) The undersigned finds that the affidavits submitted by and on behalf of petitioner and the medical records work in tandem to provide preponderant evidence that petitioner’s shoulder pain began within 48 hours of her October 6, 2015 flu vaccination. V. Ruling on Entitlement In light of the above finding of fact, the undersigned further finds that this case is ripe for adjudication on the question of petitioner’s entitlement to compensation for her alleged SIRVA. For the reasons described below, the undersigned finds that petitioner is entitled to compensation. a. Legal Standard In this case, because petitioner’s claim predates the inclusion of SIRVA on the Vaccine Injury Table,9 petitioner must prove her claim by showing that her injury was “caused-in-fact” by the vaccination in question. § 300aa-13(a)(1)(B); § 300aa- 11(c)(1)(C)(ii). In such a situation, of course, the presumptions available under the Vaccine Injury Table are inoperative. The burden is on the petitioner to introduce vaccination can cause a sustained injury is not inconsistent with petitioner still believing or attributing her left shoulder pain to her flu shot in the left shoulder. 9 Effective for petitions filed beginning on March 21, 2017, SIRVA is an injury listed on the Vaccine Injury Table (“Table”). See National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, Final Rule, 82 Fed. Reg. 6294, Jan. 19, 2017 (codified at 42 CFR Part 100.3(c)); National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, Delay of Effective Date, 82 Fed. Reg. 11321, Feb. 22, 2017 (delaying the effective date of the final rule until March 21, 2017). Case 1:16-vv-01664-EDK Document 35 Filed 06/19/18 Page 9 of 12 evidence demonstrating that the vaccination actually caused the injury in question. Althen v. HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. HHS, 940 F.2d 1518, 1525 (Fed. Cir. 1991). The showing of “causation-in-fact” must satisfy the “preponderance of the evidence” standard, the same standard ordinarily used in tort litigation. § 300aa-13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that standard, the petitioner must show that it is “more probable than not” that the vaccination was the cause of the injury. Althen, 418 F.3d at 1279. The petitioner need not show that the vaccination was the sole cause or even the predominant cause of the injury or condition, but must demonstrate that the vaccination was at least a “substantial factor” in causing the condition, and was a “but for” cause. Shyface v. HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999). Under the leading Althen test, petitioner must satisfy three elements. The Althen court explained this “causation-in-fact” standard, as follows: Concisely stated, Althen’s burden is to show by preponderant evidence that the vaccination brought about her injury by providing: (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of proximate temporal relationship between vaccination and injury. If Althen satisfies this burden, she is “entitled to recover unless the [government] shows, also by a preponderance of the evidence, that the injury was in fact caused by factors unrelated to the vaccine.” Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner need not necessarily supply evidence from medical literature supporting petitioner’s causation contention, so long as the petitioner supplies the medical opinion of an expert. Id. at 1279-80. The court also indicated that, in finding causation, a Program fact-finder may rely upon “circumstantial evidence,” which the court found to be consistent with the “system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants.” Id. at 1280. b. Analysis The undersigned finds that petitioner satisfies the three prongs of Althen as follows: i. Althen Prong 1 Under Althen Prong One, there must be preponderant evidence of a medical theory causally connecting petitioner’s vaccination to her injury. In satisfaction of Althen Prong One, the undersigned takes judicial notice of the fact that respondent has added SIRVA to the Vaccine Injury Table for the influenza vaccine. See National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 80 Fed. Reg. 45132, Notice of Proposed Rulemaking, July 29, 2015 (citing Atanasoff S, Ryan T, Lightfoot R, and Johann-Liang R, 2010, Shoulder injury related to vaccine Case 1:16-vv-01664-EDK Document 35 Filed 06/19/18 Page 10 of 12 administration (SIRVA), Vaccine 28(51):8049-8052)10; see also Doe 21 v. HHS, 88 Fed. Cl. 178 (July 30, 2009), rev’d on other grounds, 527 Fed. Appx. 875 (Fed. Cir. 2013)(holding that recognition of a link between vaccine and injury on the Vaccine Injury Table supports petitioner’s burden under Althen Prong One.) In any event, although it is petitioner’s burden to establish all Althen prongs by preponderant evidence, respondent has not disputed that the flu vaccine can cause SIRVA. In that regard, it is worth noting that there is a well-established track record of awards of compensation for SIRVA being made on a cause-in-fact basis in this program. See, e.g. Loeding v. HHS, No. 15-740V, 2015 WL 7253760 (Fed. Cl. Spec. Mstr. Oct. 15, 2015)(noting that “respondent ‘has concluded that petitioner’s injury is consistent with SIRVA; that a preponderance of evidence establishes that her SIRVA was caused in fact by the flu vaccination she received on October 14, 2014; and that no other causes for petitioner’s SIRVA were identified.”); see also Johnson v. HHS, No. 16- 165V, 2016 WL 3092002 (Fed. Cl. Spec. Mstr. April 13, 2016)(awarding compensation for a SIRVA caused-in-fact by the influenza vaccine); Koenig v. HHS, No. 16-1496V, 2017 WL6206391 (Fed. Cl. Spec. Mstr. April 13, 2017)(same). Moreover, respondent has conceded causation in many prior Hep A-caused SIRVA cases in particular. See, e.g. Telonidis v. HHS, No. 15-450V, 2015 WL 5724746 (Fed. Cl. Spec. Mstr. Sept. 2, 2015); Salas v. HHS, No. 16-739V, 2016 WL 8459834 (Fed. Cl. Spec. Mstr. Nov. 7, 2016). ii. Althen Prong 2 Under Althen Prong Two, petitioner must demonstrate a logical sequence of cause and effect showing that the vaccination was the reason for the injury. Although petitioner’s claim does not constitute a Table Injury, the undersigned finds the QAI criteria for SIRVA to be persuasive regarding the factors necessary to demonstrate a logical sequence of cause and effect. The criteria under the QAI are as follows: Shoulder Injury Related to Vaccine Administration (SIRVA). SIRVA manifests as shoulder pain and limited range of motion occurring after the administration of a vaccine intended for intramuscular administration in the upper arm. These symptoms are thought to occur as a result of unintended injection of vaccine antigen or trauma from the needle into and around the underlying bursa of the shoulder resulting in an inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal structures of the shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological injury and abnormalities on neurological examination or nerve conduction studies (NCS) and/or electromyographic (EMG) studies would not support SIRVA as a diagnosis (even if the condition causing the neurological abnormality is not known). A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following: 10 Codified at 42 CFR Part 100.3(c). Case 1:16-vv-01664-EDK Document 35 Filed 06/19/18 Page 11 of 12 (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). 42 CFR Part 100.3(c)(10) (Qualifications and Aids to Interpretation for SIRVA). In light of the factual history described above, the undersigned finds that all four of the criteria listed in the QAI for SIRVA are satisfied by preponderant evidence. Based on petitioner’s medical records and affidavit, prior to petitioner’s flu vaccination October 6, 2015 she had no history of pain, or other signs or symptoms in her left shoulder consistent with SIRVA. The undersigned further notes that respondent has not alleged that petitioner had any symptoms of SIRVA prior to her October 6, 2015 flu vaccine. Additionally, petitioner’s post-vaccination medical records reveal no other proffered explanation for her injury and her diagnostic evaluations are significant for findings consistent with a SIRVA injury, including limited range of motion (Id. at 90-91, 99, 110) and a diagnosis of adhesive capsulitis (Id. at 90-91, 99, 110). As discussed above, based upon petitioner’s medical records and affidavits, the undersigned finds petitioner’s onset of her shoulder injury is within the specified time frame of < 48 hours. The undersigned finds petitioner offers a reasonable and persuasive explanation in her affidavits for her delay in reporting her shoulder injury, and finds persuasive petitioner’s reports to both Drs. Vandeloo and Frombach, as well as physical therapist, Mr. Webers regarding the onset of her shoulder pain. The undersigned further finds that petitioner offers a reasonable and cogent explanation of the limited nature of her examination at the ER on January 22, 2016 and the nature of her follow-up phone calls with Kaiser. For all these reasons, the undersigned finds that petitioner has presented preponderant evidence pursuant to Althen Prong Two of a logical sequence of cause and effect showing that her injury was vaccine-caused. iii. Althen Prong 3 Case 1:16-vv-01664-EDK Document 35 Filed 06/19/18 Page 12 of 12 Under Althen Prong Three, there must be a proximate temporal relationship between vaccination and injury. Respondent asserts that the relevant, medically accepted, timeframe for onset of a SIRVA injury based upon the literature submitted by the undersigned is within 4 days of vaccination. (ECF No. 27 at 6) Thus, in light of the above finding of fact that petitioner’s shoulder pain began within 48 hours of her October 6, 2015 flu vaccination, petitioner has satisfied Althen Prong Three. iv. Factors Unrelated to Vaccination Respondent has not asserted, nor has the undersigned identified any factor unrelated to petitioner’s vaccination which would meet respondent’s burden of establishing an alternative cause for petitioner’s injury unrelated to vaccination. VI. Conclusion Thus, for all the foregoing reasons, the undersigned finds petitioner’s has established by preponderant evidence that her October 6, 2015 flu vaccination was the cause-in-fact of her SIRVA. Accordingly, the undersigned DENIES respondent’s request for a ruling denying compensation (ECF No. 27 at 10) and GRANTS petitioner’s motion for a finding that petitioner is entitled to compensation for SIRVA (ECF No. 28 at 26). IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Chief Special Master ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_16-vv-01664-1 Date issued/filed: 2019-01-09 Pages: 4 Docket text: PUBLIC DECISION (Originally filed: 11/19/2018) regarding 51 DECISION Stipulation/Proffer ( Signed by Chief Special Master Nora Beth Dorsey. )(mpj) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-01664-EDK Document 54 Filed 01/09/19 Page 1 of 4 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-1664V Filed: November 19, 2018 UNPUBLISHED KELLI TENNESON, Petitioner, Special Processing Unit (SPU); v. Damages Decision Based on Proffer; Influenza (Flu) Vaccine; Shoulder SECRETARY OF HEALTH AND Injury Related to Vaccine HUMAN SERVICES, Administration (SIRVA) Respondent. Ronald Craig Homer, Conway, Homer, P.C., Boston, MA, for petitioner. Daniel Anthony Principato, U.S. Department of Justice, Washington, DC, for respondent. DECISION AWARDING DAMAGES1 Dorsey, Chief Special Master: On December 20, 2016, petitioner filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.,2 (the “Vaccine Act”). Petitioner alleges that she suffered a Shoulder Injury Related to Vaccine Administration (“SIRVA”) as a result of her October 6, 2015 influenza (“flu”) vaccination. Petition at 1. The case was assigned to the Special Processing Unit of the Office of Special Masters. On March 30, 2018, a ruling on entitlement was issued, finding petitioner entitled to compensation for SIRVA. On November 16, 2018, respondent filed a proffer on 1 The undersigned intends to post this decision on the United States Court of Federal Claims' website. This means the decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits within this definition, the undersigned will redact such material from public access. Because this unpublished decision contains a reasoned explanation for the action in this case, undersigned is required to post it on the United States Court of Federal Claims' website in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:16-vv-01664-EDK Document 54 Filed 01/09/19 Page 2 of 4 award of compensation (“Proffer”) indicating petitioner should be awarded $$88,017.82 (comprised of $85,000.00 in past and future pain and suffering and $3,017.82 in unreimbursable expenses). Proffer at 1. In the Proffer, respondent represented that petitioner agrees with the proffered award. Based on the record as a whole, the undersigned finds that petitioner is entitled to an award as stated in the Proffer. Id. Pursuant to the terms stated in the attached Proffer, the undersigned awards petitioner a lump sum payment of $$88,017.82 (comprised of $85,000.00 in past and future pain and suffering and $3,017.82 in unreimbursable expenses) in the form of a check payable to petitioner, Kelli Tenneson. This amount represents compensation for all damages that would be available under § 15(a). The clerk of the court is directed to enter judgment in accordance with this decision.3 IT IS SO ORDERED. s/Nora Beth Dorsey Nora Beth Dorsey Chief Special Master 3 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice renouncing the right to seek review. 2 Case 1:16-vv-01664-EDK Document 54 Filed 01/09/19 Page 3 of 4 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS KELLI TENNESON, ) ) Petitioner, ) No. 16-1664V ) Chief Special Master Dorsey v. ) ECF ) SECRETARY OF HEALTH ) AND HUMAN SERVICES, ) ) Respondent. ) ) PROFFER ON AWARD OF COMPENSATION I. Compensation for Vaccine Injury-Related Items On March 30, 2018, the Chief Special Master issued a Ruling on Entitlement, concluding that petitioner is entitled to compensation under the National Childhood Vaccine Injury Act of 1986, as amended, 42 U.S.C. §§ 300aa-1 to -34. Respondent proffers that, based on the Chief Special Master’s entitlement decision and the evidence of record, petitioner should be awarded $88,017.82 (comprised of $85,000.00 in past and future pain and suffering and $3,017.82 in unreimbursable expenses).1 This amount represents all elements of compensation to which petitioner would be entitled under 42 U.S.C. § 300aa-15(a). Petitioner agrees. 1 The parties have no objection to the amount of the proffered award of damages. Assuming the Chief Special Master issues a damages decision in conformity with this proffer, the parties waive their right to seek review of such damages decision. However, respondent reserves his right, pursuant to 42 U.S.C. § 300aa-12(e), to seek review of the Special Master’s March 30, 2018, entitlement decision. Case 1:16-vv-01664-EDK Document 54 Filed 01/09/19 Page 4 of 4 II. Form of the Award The parties recommend that the compensation provided to petitioner should be made as a lump sum payment of $88,017.82, in the form of a check payable to petitioner.2 This amount accounts for all elements of compensation under 42 U.S.C. § 300aa-15(a) to which petitioner would be entitled. Respectfully submitted, JOSEPH H. HUNT Assistant Attorney General C. SALVATORE D’ALESSIO Acting Director Torts Branch, Civil Division CATHARINE E. REEVES Deputy Director Torts Branch, Civil Division ALEXIS B. BABCOCK Assistant Director Torts Branch, Civil Division /s/ Daniel A. Principato DANIEL A. PRINCIPATO Trial Attorney Torts Branch, Civil Division U.S. Department of Justice P.O. Box 146 Benjamin Franklin Station Washington, D.C. 20044-0146 Phone: (202) 616-3662 Fax: (202) 353-2988 Dated: November 16, 2018 2 Should petitioner die prior to entry of judgment, the parties reserve the right to move the Court for appropriate relief. In particular, respondent would oppose any award for future medical expenses, future pain and suffering, and future lost wages. 2 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_16-vv-01664-2 Date issued/filed: 2019-03-18 Pages: 13 Docket text: PUBLIC DECISION of 58 Opinion and Order on Motion for Review (originally filed under seal on 2/28/2019). Signed by Judge Elaine D. Kaplan. (feb) Service on parties made. -------------------------------------------------------------------------------- Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 1 of 13 In the United States Court of Federal Claims No. 16-1664V (Filed Under Seal: February 28, 2019 | Reissued: March 18, 2019)∗ ) KELLI TENNESON, ) Keywords: Motion for Review; Vaccine ) Act; Contemporaneous Medical Records; Petitioner, ) Shoulder Injury Related to Vaccine ) Administration (SIRVA) v. ) ) SECRETARY OF HEALTH AND HUMAN ) SERVICES, ) ) Respondent. ) ) Ronald C. Homer and Meredith Daniels, Conway Homer, P.C., Boston, MA, for Petitioner. Daniel A. Principato, Trial Attorney, Torts Branch, Civil Division, U.S. Department of Justice, Washington, DC, with whom were Alexis B. Babcock, Assistant Director, Catharine E. Reeves, Deputy Director, C. Salvatore D’Alessio, Acting Director, and Joseph H. Hunt, Assistant Attorney General, for Respondent. OPINION AND ORDER KAPLAN, Judge. The Secretary of Health and Human Services (“the HHS Secretary” or “the Secretary”) seeks review of the ruling of Chief Special Master Nora B. Dorsey finding Petitioner Kelli Tenneson entitled to compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 et seq. (“the Vaccine Act”). Specifically, the Secretary challenges as arbitrary, capricious, and contrary to law the Chief Special Master’s factual finding that Ms. Tenneson suffered a shoulder injury within forty-eight hours of receiving a flu vaccination. For the reasons that follow, the Court finds the Secretary’s arguments unpersuasive. The Secretary’s motion for review is therefore DENIED. ∗ This opinion was previously issued under seal on February 28, 2019. The parties were given the opportunity to propose redactions on or before March 14, 2019. Because the parties have not filed proposed redactions, the Court reissues its decision in its entirety. Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 2 of 13 BACKGROUND I. The Evidence Before the Chief Special Master On October 6, 2015, Kelli Tenneson, who was then fifty-eight years old, received an intramuscular flu vaccination from her primary care provider, Kaiser Permanente-Colorado. Pet’r’s Ex. 1, at 1, ECF No. 7-2. According to an affidavit she executed in connection with this litigation, the vaccination was administered “very high up on [her] left arm, almost at [her] shoulder.” Pet’r’s Ex. 6, ¶ 2, ECF No. 8-1. Ms. Tenneson asserts that the day after she received the vaccination, she woke up with extreme pain in her shoulder, which “started in the exact area where the shot was given.” Id. ¶ 3. By the end of that evening, she states, she experienced “sharp pains all the way down [her] left arm.” Id. Although she alleges that she continued to experience shoulder pain in the months that followed, Ms. Tenneson did not seek medical care for her shoulder until January 2016 and did not actually see a physician for the injury until the end of March 2016. Id. ¶¶ 4–6. The central issue raised by the Secretary’s request for review is whether, in light of that delay, it was arbitrary, capricious, and contrary to law for the Chief Special Master to credit Ms. Tenneson’s testimony that her shoulder injury manifested itself within forty-eight hours of her October 6, 2015 vaccination. Ms. Tenneson explained in her affidavit that she decided to “wait it out” rather than seeking medical care immediately because she is “not one who easily goes to the doctor” and because she “had never heard of a flu vaccine causing this type of sustained pain.” Id. ¶¶ 3–4. Ms. Tenneson’s husband, Michael Tenneson, as well as her son, Josh, provided supporting affidavits concerning the effects of the vaccination. Pet’r’s Ex. 8, 9, ECF Nos. 8-3, 8-4. Michael Tenneson stated that his wife had complained of severe pain the day after she received her flu shot and that she “could not lift her left arm above her shoulder without being in pain.” Pet’r’s Ex. 8, ¶ 1. According to Mr. Tenneson, in the days and months that followed, “the pain in her left upper arm still remained without any mobility above the shoulder.” Id. ¶ 2. He stated that “on numerous occasions while lying in bed at night, I heard her moan while she moved around in bed, trying to find a comfortable position to somewhat alleviate her pain.” Id. “On several occasions,” according to Mr. Tenneson, Ms. Tenneson’s pain kept them both awake. Id. Similarly, Josh Tenneson testified by affidavit that, beginning in late October 2015, he noticed that his mother, who babysat his infant daughter four days a week, was for the first time having difficulties lifting things above her head and lifting the baby. Pet’r’s Ex. 9, ¶¶ 1–2. He further testified that when he asked his mother if something was wrong, “she mentioned that she had been unable to lift her arm above her head since the vaccination” but that “[n]either of us thought much of it at the time and assumed the symptoms would dissipate.” Id. On December 17, 2015, Ms. Tenneson called Kaiser to request a letter of good health. Pet’r’s Ex. 14, ¶ 2, ECF No. 21-1. The letter, which state law requires all employees of preschools to submit to their employer, is a one-page document affirming that the employee had been examined within the past year, that she had no communicable diseases, and that she was 2 Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 3 of 13 able to work with children. Id. ¶¶ 2–3; see also Pet’r’s Ex. 2, at 78, ECF No. 7-3 (call record reflecting a request by Ms. Tenneson for a “letter stating she has been seen within the last year and is in good health”). According to Ms. Tenneson, her primary care physician signed the form based on the prior year’s physical exam, which had taken place several months before she received the influenza vaccination. Pet’r’s Ex. 14, ¶ 4. Ms. Tenneson’s sister-in-law testified by affidavit that as the family gathered for Christmas in 2015 she was “very surprised to see that not only was [Ms. Tenneson’s] arm not any better, but it actually seemed to be worse.” Pet’r’s Ex. 11, ¶ 4, ECF No. 10-2. Ms. Tenneson nonetheless “continued to tough it out” until January 2016, when she scheduled a March 30 appointment to see her primary care doctor about the shoulder pain. Pet’r’s Ex. 14, ¶ 5; see also Ruling on Entitlement (“CSM Dec.”) at 4, ECF No. 31. In the meantime, on the morning of January 22, 2016, Ms. Tenneson called Kaiser complaining of blood in her urine and pressure “in [her] lower extremities,” which she had been experiencing for the preceding two days. Pet’r’s Ex. 14, ¶ 6; Pet’r’s Ex. 2, at 80. The nurse who took her call listed her “chief complaint” as a “UTI” (urinary tract infection). Pet’r’s Ex. 2, at 80. Later that day, Ms. Tenneson and her family left for a trip to the mountains. While traveling, Ms. Tenneson asserts, she experienced “excruciating low back pain.” Pet’r’s Ex. 14, ¶ 6. After the family arrived at their destination, Ms. Tenneson reported to an emergency room at Middle Park Medical Center, which she characterizes as a “small mountain hospital” in a “small ski town in Colorado.” Id. ¶ 7. Hospital records indicate that she complained of severe right flank/abdominal pain, low back pain, blood in her urine, discomfort with urination, nausea, and vomiting. Pet’r’s Ex. 3, at 1, ECF No. 7-4. The physical exam section of the emergency room report includes a heading entitled “extremities.” The following terms were checked off: “non-tender,” “nrml ROM [range of motion],” and “no pedal edema.” Id. at 2. Ms. Tenneson asserts that she remained at the emergency room for several hours but “only saw the doctor for approximately 2–3 minutes.” Pet’r’s Ex. 14, ¶ 7. She also states that although her shoulder was painful during the visit, her abdominal pain was worse. Id. ¶ 8. Ms. Tenneson was diagnosed with a kidney stone. Id. Despite the notations in the extremities section of the emergency room report, Ms. Tenneson testifies that she “was never given an exam of [her] upper extremities, and specifically, [her] left shoulder was never tested for tenderness or range of motion.” Id. ¶ 9. Furthermore, she states that when she was preparing to undergo a CT scan, she informed the technician that she had been unable to raise her hands above her head after having received a flu shot several months prior. Id. ¶ 10. This alleged comment is not reflected in the accompanying records. Ms. Tenneson’s husband and son, who were with her during her visit to the emergency room, submitted supplemental affidavits that are generally consistent with Ms. Tenneson’s recollection. See generally Pet’r’s Ex. 15, 16, ECF Nos. 21-2, 21-3. After she was released from the emergency room, Ms. Tenneson had two follow-up phone calls with Kaiser. The first was with a nurse on January 25, and the second was with her 3 Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 4 of 13 primary care physician, Dr. Deja Vandeloo, on January 26. Pet’r’s Ex. 2, at 84–85. In a summary of these calls, Dr. Vandeloo noted that pain medication was not then-needed because Ms. Tenneson was feeling better and that the kidney stone should pass within two weeks. Id. at 85. There is no mention of shoulder pain complaints in the call summaries. On March 30, 2016, Ms. Tenneson kept the appointment that she had made in January to address her shoulder pain. Id. at 86. Medical records documenting the visit contain the notation “left arm pain since flu shot 10/15, pain all the way down arm. Can barely move arm now. Just hasn’t gotten better. Wake her up at night. Does watch her grand-baby and can lift her but hard time getting seatbelt, etc.” Id. at 89. Dr. Vandeloo conducted a musculoskeletal evaluation which confirmed Ms. Tenneson’s complaints. She found “limited ROM left shoulder—can only abduct/extend to approx 80-90 degrees and can only get a few more degrees passively.” Id. at 90. Dr. Vandeloo diagnosed Ms. Tenneson with adhesive capsulitis of the left shoulder. Id. at 91. She advised Ms. Tenneson to take over-the-counter pain medications and perform a series of stretching exercises. Id. Ms. Tenneson was also given a referral for physical therapy and an orthopedist. Id. Dr. Vandeloo’s referral to the orthopedist noted “left shoulder problem: frozen shoulder—[patient] has had pain ever since flu shot 10/15 [with] no injury. Worsening ROM over last 5 months.” Id. at 89. Records summarizing the March visit indicate that Dr. Vandeloo discussed Ms. Tenneson’s injury with “shot line,” which the Court understands to be a telephone service that provides advice to health care workers about vaccines and their administration. Id. at 91; see also Pamela K. Strohfus, Sharon R. Brown & Paige Potratz, Effective and Sustainable Advice Line Promotes Safe Vaccine Practices, 14 Int’l J. of Evidence-Based Healthcare 130 (2016), https://scholarworks.boisestate.edu/nursing_facpubs/174/. According to Dr. Vandeloo’s notes, she was advised by “shot line” that the injury was “not due to [the] vaccine but they can’t comment on administration.” Pet’r’s Ex. 2, at 91. Dr. Vandeloo also apparently consulted with an orthopedist who “felt [it] unlikely [that] this is all related to flu shot” but who acknowledged that Ms. Tenneson “certainly could have developed a frozen shoulder if she hasn’t moved it x 5 mo” since the flu vaccination. Id. at 91, 97. Ms. Tenneson met with Robert L. Webers, a physical therapist, on April 13, 2016. Id. at 99. Mr. Webers noted that Ms. Tenneson “got flu shot in [] Oct 2015, [and] since then she has had pain.” Id. During the appointment, Ms. Tenneson advised Mr. Webers that her sleep was “disturbed” and that her pain level was “6/10.” Id. Mr. Webers opined that her symptoms were “consist[e]nt with Adhesive capsulitis.” Id. at 100. He recommended that Ms. Tenneson continue treatment every ten days for four weeks to increase her range of motion. Id. A few weeks later, on April 27, 2016, Ms. Tenneson was examined by Dr. Tracy Frombach, an orthopedist. Id. at 105. Dr. Frombach noted “5 months left shoulder pain since flu shot 10/15 . . . [v]ery limited [range of motion]” and “[m]ild degenerative changes [in her] left shoulder.” Id. at 107–08. Dr. Frombach described Ms. Tenneson’s conditions as “Adhesive capsulitis of the left shoulder shortly following a flu injection in October 2015” and “[l]eft rotator cuff syndrome.” Id. at 110. During the visit, Ms. Tenneson received a left subacromial injection after which her “range of motion was pain free” but still limited. Id. Dr. Frombach 4 Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 5 of 13 advised Ms. Tenneson to continue with physical therapy and to follow up in six weeks. Id. at 111. According to Dr. Frombach, Ms. Tenneson’s adhesive capsulitis was “almost completely resolved” by October 2016. Pet’r’s Ex. 4, at 45, ECF No. 7-5. Ms. Tenneson continued physical therapy through at least March 2017. See Pet’r’s Ex. 13, at 33, ECF No. 16-2. II. The Vaccine Claim On December 20, 2016, Ms. Tenneson filed a petition for compensation under the Vaccine Act. She alleged that the flu vaccination she had received on October 6, 2015 had caused a shoulder injury. Pet. for Vaccine Compensation at 1, ECF No. 1. Her case was assigned to the Chief Special Master the next day for evaluation by the Special Processing Unit. See ECF Nos. 4, 5. On June 19, 2017, the HHS Secretary filed a Rule 4(c) report opposing Ms. Tenneson’s claim. See generally Resp’t’s Rule 4(c) Report, ECF No. 18. The Secretary argued that Ms. Tenneson had not established that the onset of her symptoms occurred within forty-eight hours of her vaccination, which is the time period that the relevant medical literature establishes for most vaccine-related shoulder injuries. Id. at 5. To the contrary, according to the Secretary, the contemporaneous medical records indicated that her shoulder pain began some three to six months after the vaccination. Id. In a July 26, 2017 scheduling order, the Chief Special Master observed that based on the record before her, it appeared that Ms. Tenneson’s claim “generally meets the requirements for SIRVA [(shoulder injury related to vaccine administration)].” Scheduling Order at 1, ECF No. 19. She further noted that “petitioner’s affidavit together with the records evidence onset within 48 hours of petitioner’s vaccination.” Id. The Chief Special Master further stated that she did not “believe this [was] a claim that should to go to hearing,” but that it rather “should be resolved for a reasonable amount.” Id. She further “encourage[d] [Ms. Tenneson] to make a reasonable demand upon [the Secretary].” Id. In a status report filed on October 2, 2017 the Secretary stated his intent to oppose Ms. Tenneson’s claim and conveyed his unwillingness to engage in settlement discussions. Status Report at 1, ECF No. 25. At a status conference held on October 18, 2017, the Chief Special Master gave Ms. Tenneson the option of requesting a fact hearing or a ruling on the record; Ms. Tenneson elected the latter. See Scheduling Order at 1, ECF No. 26. Counsel for the government did not object to having the case decided on the record, stating instead that “he would defer to petitioner on how to proceed” and indicating that he was “amenable” to disposition on the record without a hearing. Id. The Chief Special Master gave the parties thirty days to file additional evidence. Id. at 2. In addition, the parties were advised that the record would include two medical journal articles that concern shoulder injuries caused by vaccinations. Id. at 1; see also S. Atanasoff, Shoulder injury related to vaccine administration (SIRVA), 28 Vaccine 8049 (2010) (entered into the record as Court Ex. I, ECF No. 26-1); Marko Bodor & Enoch Montalvo, Vaccination-related 5 Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 6 of 13 shoulder dysfunction, 25 Vaccine 585 (2007) (entered into the record as Court Ex. II, ECF No. 26-2). III. The Chief Special Master’s Decision On March 30, 2018, the Chief Special Master issued a decision holding that Ms. Tenneson was entitled to compensation under the Vaccine Act. CSM Dec. at 12. She found that “the affidavits submitted by and on behalf of petitioner and the medical records work in tandem to provide preponderant evidence that petitioner’s shoulder pain began within 48 hours of her October 6, 2015 flu vaccination.” Id. at 8. The Chief Special Master declined the government’s invitation to infer that Ms. Tenneson’s account of the onset of her injury was unreliable because she waited several months to seek medical treatment. Id. at 7. The Chief Special Master concluded that the delay in seeking treatment was more relevant to the severity of the shoulder injury than to the date it began. Id. She reasoned that “[p]etitioner’s account is detailed, cogent and corroborates the statements she made to her health care providers.” Id. “Moreover,” the Chief Special Master observed, in her experience, “petitioner’s affidavits and medical records together reflect a pattern of treatment consistent with and similar to many other SIRVA claims.” Id. The Chief Special Master applied, and found satisfied, the three-prong test for establishing causation set forth in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). The Chief Special Master took judicial notice of the fact that HHS added SIRVA to the Vaccine Injury Table for the influenza vaccine effective March 21, 2017, after Ms. Tenneson filed her claim. CSM Dec. at 9. Based on that designation, the Chief Special Master found that prong one of the Althen test—which requires preponderant evidence of a medical theory causally connecting the flu vaccine to SIRVA—was met. Id. at 9–10; see also Althen, 418 F.3d at 1278. The Chief Special Master further concluded that there was a logical sequence of cause and effect between the vaccination and Ms. Tenneson’s shoulder injury (prong two of the Althen test) based on an application of the Qualifications and Aids to Interpretation (“QAI”) for SIRVA codified at 42 U.S.C. § 100.3(c)(10). CSM Dec. at 10–11.1 Finally, the Chief Special 1 That provision states in pertinent part that: A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following: (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time-frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and 6 Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 7 of 13 Master found that the third prong of the Althen test—requiring a proximate temporal relationship between the vaccine and injury—was satisfied based on her factual finding that the onset of Ms. Tenneson’s SIRVA pain (the morning after she was vaccinated) fell within the two-day period that HHS recognizes as the relevant medically accepted timeframe for such onset. Id. at 12; see also Althen, 418 F.3d at 1278. Having found Ms. Tenneson entitled to compensation, the Chief Special Master instructed the parties to confer to discuss damages. Damages Order at 1, ECF No. 32. After several months of discussion, the Secretary filed a proffer of award on November 16, 2018, recommending a lump-sum payment of $88,017.82. Proffer on Award of Compensation at 1, ECF No. 50. The Chief Special Master accepted the recommendation and issued an order awarding damages in that amount to Ms. Tenneson on November 19, 2018. See Dec. Awarding Damages at 2, ECF No. 51. IV. The Government’s Motion for Review On December 18, 2018, the Secretary filed the present motion for review which requests that the Court reverse the Chief Special Master’s ruling on entitlement. See generally Resp’t’s Mot. for Review (“Resp’t’s Mot.”), ECF No. 52. The Secretary advances two interrelated arguments in support of his motion. First, he argues that the Chief Special Master’s ruling contravenes 42 U.S.C. § 300aa-13(a)(1), which prohibits a special master from finding a petitioner entitled to compensation “based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.” Second, he argues, the Chief Special Master’s factual finding as to the onset date of Ms. Tenneson’s shoulder injuries was arbitrary and capricious because the Chief Special Master credited Ms. Tenneson’s testimony, notwithstanding its alleged inconsistency with certain contemporaneous medical records (i.e., the notes concerning Ms. Tenneson’s calls to her primary care physician in December 2015 and January 2016, and the record of her emergency room visit in January 2016). For the reasons set forth below, the Court concludes that the Secretary’s arguments lack merit. Accordingly, the motion for review is DENIED and the Chief Special Master’s ruling on entitlement is SUSTAINED.2 DISCUSSION I. Jurisdiction Congress established the National Vaccine Injury Compensation Program in 1986 to provide a no-fault compensation system for vaccine-related injuries and deaths. Figueroa v. (iv) No other condition or abnormality is present that would explain the patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). 2 The Court has determined that oral argument is unnecessary in this case. Accordingly, its decision is based on the record, the Chief Special Master’s ruling on entitlement, and the parties’ briefs. 7 Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 8 of 13 Sec’y of Health & Human Servs., 715 F.3d 1314, 1316–17 (Fed. Cir. 2013). The Vaccine Act is remedial legislation that should be construed in a manner effectuating its underlying spirit and purpose. Id. at 1317. To secure compensation under the Vaccine Act, a petitioner must prove by a preponderance of the evidence that the injury at issue was caused by a vaccine. See 42 U.S.C. §§ 300aa-11(c)(1), -13(a)(1)(A). Where a petitioner sustains an injury in association with a vaccine listed in the Vaccine Injury Table, causation is presumed. Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1341–42 (Fed. Cir. 2010) (citing 42 U.S.C. § 300aa- 11(c)(1)(C)(i); Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1374 (Fed. Cir. 2009)). Where, as in this case, the injury is not listed in the Table, the petitioner must prove causation-in-fact. Broekelschen, 618 F.3d at 1342 (citing Moberly ex rel. Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010)). To discharge that burden, “a petitioner must show that the vaccine was ‘not only a but-for cause of the injury but also a substantial factor in bringing about the injury.’” Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373, 1379 (Fed. Cir. 2012) (quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352–53 (Fed. Cir. 1999)). “Once the petitioner has demonstrated causation, she is entitled to compensation unless the government can show by a preponderance of the evidence that the injury is due to factors unrelated to the vaccine.” Broekelschen, 618 F.3d at 1342 (citing Doe v. Sec’y of Health & Human Servs., 601 F.3d 1349, 1351 (Fed. Cir. 2010); 42 U.S.C. § 300aa- 13(a)(1)(B)). A petition seeking compensation under the Vaccine Act is filed in the Court of Federal Claims, after which the Clerk of Court forwards it to the Chief Special Master for assignment to a special master. 42 U.S.C. § 300aa-11(a)(1). The special master to whom the petition is assigned “issue[s] a decision on such petition with respect to whether compensation is to be provided under the [Vaccine Act] Program and the amount of such compensation.” Id. § 300aa- 12(d)(3)(A). That decision is subject to review in the Court of Federal Claims and in the Court of Appeals for the Federal Circuit. Mahaffey v. Sec’y of Health & Human Servs., 368 F.3d 1378, 1383 (Fed. Cir. 2004) (citing 42 U.S.C. § 300aa-12(d)(3)(A)). II. Standard of Review The Vaccine Act grants the Court of Federal Claims jurisdiction to review the record of the proceedings before a special master, and authority, upon such review, to: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s decision, (B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or (C) remand the petition to the special master for further action in accordance with the court’s direction. Id. § 300aa-12(e)(2); see also Vaccine Rule 27. 8 Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 9 of 13 On review of the special master’s decision, the Court applies the arbitrary and capricious standard to factual findings and the “not in accordance with law” standard to legal rulings. Moberly, 592 F.3d at 1321. “The arbitrary and capricious standard of review is difficult for an appellant to satisfy with respect to any issue, but particularly with respect to an issue that turns on the weighing of evidence by the trier of fact.” Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000). The Court “do[es] not reweigh the factual evidence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence or the credibility of the witnesses,” because those “are all matters within the purview of the fact finder.” Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1249 (Fed. Cir. 2011) (citing Broekelschen, 618 F.3d at 1349). “[A]s long as a special master’s finding of fact is ‘based on evidence in the record that [is] not wholly implausible,’” the Court must uphold it. Id. (quoting Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010) (alteration in original)). “[T]he standard of review is uniquely deferential” to special masters’ decisions. Milik v. Sec’y of Health & Human Servs., 822 F.3d 1367, 1376 (Fed. Cir. 2016) (quoting Hodges v. Sec’y of Health & Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993)). “If the special master ‘has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision,’ then reversible error is ‘extremely difficult to demonstrate.’” Id. (quoting Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)). III. The Secretary’s Arguments As noted above, the Secretary challenges the Chief Special Master’s decision on two interrelated grounds. First, he argues that the Chief Special Master found that Ms. Tenneson’s shoulder injury manifested itself within forty-eight hours of her vaccination based solely on her testimony and that of her family, and “unsubstantiated by medical records or medical opinions.” Resp’t’s Mot. at 1–2 (citing 42 U.S.C. § 300aa-13(a)). This finding, according to the Secretary, contravened “the express terms of the Vaccine Act,” specifically 42 U.S.C. § 300aa-13(b)(2). Id. at 8–9. Second, he argues that, in any event, the Chief Special Master’s onset determination was arbitrary and capricious because: 1) she gave undue weight to Ms. Tenneson’s affidavits, which he alleges were inconsistent with the contemporaneous medical records; and 2) she improperly relied upon her own personal experience (rather than record evidence) in determining the weight to be given to the records of Ms. Tenneson’s emergency room visit. Id. at 14–17. For the reasons set forth below, the Secretary’s legal argument lacks merit. Further, the Secretary has failed to persuade the Court to second guess the Chief Special Master’s factual finding regarding the onset date of Ms. Tenneson’s shoulder injury. That finding must be upheld because it is based on reasonable inferences that the Chief Special Master drew from all of the evidence in the record, informed by her significant experience adjudicating similar cases under the Vaccine Program. A. The Secretary’s Argument That the Chief Special Master’s Decision Violates 42 U.S.C. § 300aa-13(a)(1) The Secretary’s first argument, as noted above, is that the Chief Special Master’s decision contravenes 42 U.S.C. § 300aa-13(a)(1). That provision states that a petitioner is entitled to compensation where the special master finds that she has demonstrated by 9 Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 10 of 13 preponderant evidence “the matters required in the petition by section 300aa–11(c)(1) of [Title 42]” and “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition.” 42 U.S.C. § 300aa-13(a)(1)(A)–(B). The provision further states that “[t]he special master or court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa- 13(a)(1). According to the Secretary, it is this prohibition that the Chief Special Master violated by allegedly relying entirely upon Ms. Tenneson’s testimony (and that of her family members) to establish the onset date of her shoulder injury. The Secretary’s argument is flawed because it relies on a faulty premise—i.e., that the Chief Special Master’s finding as to the onset date of Ms. Tenneson’s shoulder injury was based entirely on affidavits that were “unsubstantiated by medical records or by medical opinion.” In fact, the Chief Special Master did not rely exclusively on the affidavits to determine the onset date. She also cited the records of Ms. Tenneson’s visit with Dr. Vandeloo on March 30, 2016, during which she reported that her shoulder pain had begun immediately after the October 2015 flu shot. CSM Dec. at 7. In addition, the Chief Special Master cited the records of Ms. Tenneson’s physical therapy evaluation on April 13, 2016, which recount that “[patient] got a flu shot in Oct. 2015, and since then she has had pain.” Id. Finally, the Chief Special Master relied upon the records of Ms. Tenneson’s visit with the orthopedist on April 27, 2016, which stated that “the day following her flu shot she had significant pain in the left shoulder and had limited range of motion.” Id. To be sure, these medical records were not prepared contemporaneously with the event in question (i.e., the onset of Ms. Tenneson’s shoulder injury). But Ms. Tenneson’s delay in seeking treatment for her shoulder injury does not deprive the records of probative value as to the date Ms. Tenneson began experiencing shoulder pain and disability. Thus, the records are probative because they “contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions” and “[w]ith proper treatment hanging in the balance, accuracy has an extra premium.” Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Given this presumption that an individual seeking treatment is likely to supply accurate information to their health care provider, the Court is unpersuaded by the Secretary’s argument, which seems to assume—with no supporting evidence, direct or circumstantial—that Ms. Tenneson intentionally deceived her doctors regarding the onset date of her shoulder pain. Finally, and in any event, it is not readily apparent that 42 U.S.C. § 300aa-13(a)(1) precludes a special master or court from finding an onset date supported by preponderant evidence based on lay testimony, as the Secretary contends. That provision’s language states that an adjudicator cannot find that a petitioner has demonstrated by preponderant evidence “the matters required in the petition by section 300aa–11(c)(1) of [Title 42]” without substantiation by medical evidence or medical opinion. But 42 U.S.C. § 300aa-13(a)(1) does not speak to the circumstances under which particular subsidiary facts relevant to causation (such as, for example, the fact of a vaccination or the onset date of an injury) may be established by preponderant evidence on the basis of lay testimony, so long as the overall finding of causation is sustained by medical records or medical opinion. Centmehaiey v. Sec’y of Dep’t of Health & Human Servs., 32 Fed. Cl. 612, 621, aff’d sub nom. Centmehaiey v. Sec’y of Health & Human 10 Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 11 of 13 Servs., 73 F.3d 381 (Fed. Cir. 1995) (noting that 42 U.S.C. § 300aa–13(a)(1) does not bar recovery where there is no contemporaneous, documentary proof of a vaccination) (citing Brown v. Sec’y of Dep’t of Health & Human Servs., 18 Cl. Ct. 834, 839 (1989), rev’d on other grounds, 920 F.2d 918 (1990)). As the Court sees it, the prohibition in 42 U.S.C. § 300aa-13(a)(1) is against finding a cause-and-effect relationship between a vaccine and an injury without any substantiation by medical evidence or opinion. See Johnston v. Sec’y of Dep’t of Health & Human Servs., 22 Cl. Ct. 75, 78 (1990) (“Section 300aa–13(a)(1) is a general admonition. It is an effort to weed out claims which have no medical basis to support the injury.”); Camery v. Sec’y of Health & Human Servs., 42 Fed. Cl. 381, 389 (1998) (same). In any event, the Court has found that the onset date for Ms. Tenneson’s shoulder injury was supported by medical records. It therefore need not decide whether it is always impermissible to rely on lay testimony to establish an onset date. In short, there is no merit to the Secretary’s argument that the Chief Special Master committed a legal error when she found that the onset date of Ms. Tenneson’s shoulder injury was within forty-eight hours of her vaccination. The Court turns, therefore, to the Secretary’s argument that the onset date finding—if not legally erroneous—was nonetheless arbitrary and capricious. B. The Secretary’s Argument That the Chief Special Master’s Factual Determination Regarding the Date of Onset Was Arbitrary and Capricious The Secretary’s second argument is that the Chief Special Master’s onset determination was arbitrary and capricious because she found Ms. Tenneson’s testimony regarding the onset date of her symptoms credible, notwithstanding what the Secretary asserts was its inconsistency with contemporaneous medical records. Specifically, the Secretary takes the Chief Special Master to task for not giving greater weight to Ms. Tenneson’s failure to seek treatment more promptly or to mention her shoulder condition when she called her physician’s office in December 2015 and January 2016. He contends that these actions (or failures to act), undermine the credibility of Ms. Tenneson’s testimony as to the onset date of her injury. Moreover, the Secretary argues, contemporaneous medical records (the records of Ms. Tenneson’s January emergency room visit) affirmatively indicated a lack of tenderness in her extremities and a normal range of motion, results which are inconsistent with Ms. Tenneson’s contention that she had been suffering significant shoulder pain since the preceding October. As the Court explained above, however, its function on review of the decision of a special master is not to “reweigh the factual evidence, assess whether the special master correctly evaluated the evidence, or examine the probative value of the evidence or the credibility of the witnesses.” Porter, 663 F.3d at 1249. In fact, the Court is required to uphold factual findings that are “based on evidence in the record that [is] not wholly implausible.” Cedillo, 617 F.3d at 1338. Here, the Chief Special Master provided an entirely reasonable explanation for crediting Ms. Tenneson’s testimony (and that of her family) regarding the onset date of her shoulder injury, notwithstanding her delay in seeking treatment. She observed that Ms. Tenneson’s medical records “repeatedly and consistently placed the onset of her condition within 48 hours of 11 Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 12 of 13 her vaccination.” CSM Dec. at 7. She found that “the fact that [Ms. Tenneson] delayed seeking treatment for her shoulder symptoms does not negate the value of her treatment records or render this evidence not credible, although it may speak to the severity of her injury.” Id. She further found “reasonable and credible” Ms. Tenneson’s affidavits explaining her “pattern of treatment and reports to her physicians” (which were consistent with those of her family members), and observed that in her (considerable) experience, “petitioner’s affidavits and medical records together reflect a pattern of treatment consistent with and similar to many other SIRVA claims.” Id. Further, the Chief Special Master provided an adequate explanation for her decision not to give greater weight to the emergency room treatment records which reflected that checkmarks had been placed next to boxes for “non-tender,” “nrml ROM,” and “no pedal edema” under the “extremities” portion of the physical exam section. As the Chief Special Master explained, Ms. Tenneson “was seen at the ER on January 22, 2016 for a [urinary tract infection] and kidney stones which are extremely painful conditions for which petitioner was seeking urgent medical attention.” Id. at 8. Ms. Tenneson’s testimony was that her shoulders were not examined and that the doctor spent no more than two or three minutes with her. Id. at 4. And the Chief Special Master noted that, in her experience, “thorough physical examinations are not conducted in the ER setting for issues beyond or unrelated to the reason for that visit . . . in contrast to a general or physical examination conducted by a primary care physician or orthopedist.” Id. at 8. Similarly, the Chief Special Master found that the calls on January 25 and 26 were “clearly in follow-up to petitioner’s emergency room visit for her UTI and kidney stones, and the description of lack of pain relates accordingly to those issues.” Id. The Secretary contends that the Chief Special Master “erred by relying upon her own undisclosed (and effectively unrebuttable) opinion about the standard of care in emergency rooms based on her personal experience.” Resp’t’s Mot. at 17. According to the Secretary, “the Chief Special Master’s determination that no extremities exam was performed here . . . was purely speculative.” Id. The Court finds this argument unpersuasive. The Chief Special Master did not speculate; she found credible Ms. Tenneson’s testimony that—notwithstanding the checked boxes—her left shoulder was not examined during her visit. The Chief Special Master reasonably noted that a more thorough examination is often not conducted for issues beyond those for which the patient presents at an emergency room. After all, the purpose of an emergency room visit is to receive emergency treatment, not a comprehensive health check-up. That the Chief Special Master is “not herself a medical doctor” and “has no direct knowledge of the particular medical facility in question” does not mean she cannot rely on her experience and common sense to evaluate evidence. See id. Indeed, a special master may rely upon her “accumulated expertise” gained adjudicating Vaccine Act claims. Hodges, 9 F.3d at 961. That includes her accumulated expertise reviewing a variety of medical reports and considering numerous medical procedures, including those produced and undertaken in the emergency room setting. It was equally sensible for the Chief Special Master not to draw conclusions about the onset of Ms. Tenneson’s shoulder injury from her contacts with one of the medical assistants at Kaiser in December, when she was seeking a “letter of good health” to enable her to work at a 12 Case 1:16-vv-01664-EDK Document 60 Filed 03/18/19 Page 13 of 13 preschool. The impetus for those contacts was limited to securing the required certification for employment purposes. Finally, the Court gives no credence to the Secretary’s claim that the Chief Special Master’s decision resolved “a question of extraordinary importance to the Vaccine Injury Compensation Program” and that “if allowed to stand, the decision . . . would set a troubling precedent that petitioner can establish entitlement to compensation simply by averring an appropriate onset in an affidavit even where the contemporaneous medical records do not support these claims, and in fact affirmatively show a lack of symptoms.” See Resp’t’s Mot. at 12. For one thing, to the extent that the Secretary wished to challenge the credibility of Ms. Tenneson’s affidavit regarding the onset date (or the affidavits of her family members), he could have requested the opportunity to cross-examine her at a hearing. Instead, he agreed that the case could be decided on the record. Second, it is not true that Ms. Tenneson’s claims as to onset have no support in the medical documentation. As described above, Ms. Tenneson’s allegations in her affidavit regarding the onset date are consistent with what she told her physicians and medical professionals when she sought treatment for her injury. And finally, the Chief Special Master explained why, in the context of the facts of this case, she did not give weight to the perfunctory notations regarding Ms. Tenneson’s “extremities” that were contained in the emergency room records. In short, the Chief Special Master’s decision was based on all of the evidence before her. She provided an adequate and reasonable explanation for her finding that Ms. Tenneson’s shoulder injury manifested within forty-eight hours of the vaccination. The inferences she drew and the conclusions she reached were not unreasonable. The Court, accordingly, sustains her decision. CONCLUSION On the basis of the foregoing, the Respondent’s motion for review is DENIED and the Chief Special Master’s ruling on entitlement is SUSTAINED. The Clerk is directed to enter judgment accordingly. IT IS SO ORDERED. s/ Elaine D. Kaplan ELAINE D. KAPLAN Judge 13