VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-01255 Package ID: USCOURTS-cofc-1_17-vv-01255 Petitioner: Breana Porcello Filed: 2017-09-14 Decided: 2021-02-26 Vaccine: influenza Vaccination date: 2016-11-22 Condition: shoulder injury related to vaccine administration (SIRVA) Outcome: dismissed Award amount USD: AI-assisted case summary: Breana Porcello, a 20-year-old college student and field hockey player, filed a petition for compensation under the National Vaccine Injury Compensation Program on September 14, 2017. She alleged that she suffered a shoulder injury related to vaccine administration (SIRVA) as a result of an influenza vaccine she received on November 22, 2016. Ms. Porcello claimed that the pain began immediately after the vaccination. However, contemporaneous medical records did not document her shoulder pain until March 17, 2017, over three months later. She presented to various medical providers, including an athletic trainer, her primary care physician Dr. Laura L. Carman, and orthopedist Dr. Marie Walcott. Medical records from these visits noted pain and weakness in her left shoulder, and an MRI revealed bone marrow edema. Dr. Walcott consulted with a colleague who suggested SIRVA, and Dr. Walcott reviewed literature and found similar MRI findings. Ms. Porcello's expert, Dr. Jeffrey A. Dlabach, opined that she sustained a SIRVA due to the vaccination, citing the MRI findings of edema. The respondent argued that Ms. Porcello failed to establish a proximate temporal relationship between the vaccination and her injury, noting the significant delay in seeking treatment and the lack of contemporaneous documentation. Chief Special Master Brian H. Corcoran issued a decision on June 22, 2020, finding that Ms. Porcello failed to establish the third prong of the Althen test for off-Table claims: a proximate temporal relationship between vaccination and injury. The Special Master noted that the evidence of onset was vague and contradicted by some records, and the medical records did not confirm onset within a medically acceptable timeframe, particularly given the nearly four-month gap between vaccination and the first documented complaint. The Special Master denied Ms. Porcello's motion for summary judgment and dismissed the petition for insufficient proof. Ms. Porcello moved for review of this decision. On February 26, 2021, Senior Judge Loren A. Smith of the U.S. Court of Federal Claims affirmed the Special Master's decision, finding it was not arbitrary, capricious, or contrary to law. The court agreed that the evidence of onset was vague and that Ms. Porcello had not established a medically acceptable timeframe for a non-Table SIRVA injury. The petition was dismissed. Theory of causation field: Petitioner Breana Porcello, age 20, received an influenza vaccine on November 22, 2016, and alleged a shoulder injury related to vaccine administration (SIRVA). The petition was filed on September 14, 2017. Ms. Porcello claimed immediate onset of pain, but medical records did not document shoulder pain until March 17, 2017, over three months later. Her expert, Dr. Jeffrey A. Dlabach, opined that the vaccination caused a SIRVA, citing MRI findings of edema. The Special Master, Brian H. Corcoran, found that Ms. Porcello failed to establish the third Althen prong (proximate temporal relationship) due to vague and contradictory evidence of onset and the lack of a medically acceptable timeframe, leading to dismissal. The U.S. Court of Federal Claims, per Senior Judge Loren A. Smith, affirmed the dismissal, finding the Special Master's decision regarding the lack of proximate temporal relationship was not arbitrary or capricious. Petitioner was represented by Michael G. McLaren, and Respondent by Ryan Daniel Pyles. The decision was issued on June 22, 2020, and affirmed on February 26, 2021. The case was dismissed for insufficient proof. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_17-vv-01255-0 Date issued/filed: 2020-08-13 Pages: 14 Docket text: PUBLIC DECISION (Originally filed: 06/22/2020) regarding 62 DECISION of Special Master Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 1 of 14 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 17-1255V UNPUBLISHED BREANA PORCELLO, Chief Special Master Corcoran Petitioner, Filed: June 22, 2020 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Findings of Fact; Onset; Influenza HUMAN SERVICES, (Flu) Vaccine; Shoulder Injury Related to Vaccine Administration Respondent. (SIRVA) Michael G. McLaren, Black McLaren, et al., P.C., Memphis, TN, for Petitioner. Ryan Daniel Pyles, U.S. Department of Justice, Washington, DC, for Respondent. DECISION (A) DENYING MOTION FOR SUMMARY JUDGEMENT, AND (B) GRANTING DISMISSAL OF CLAIM1 On September 14, 2017, Breana Porcello 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 an influenza (“flu”) vaccination administered on November 22, 2016. Petition at 1. The case was assigned to the Special Processing Unit of the Office of Special Masters. 1 Because this unpublished ruling contains a reasoned explanation for the action in this case, I am 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). I intend to post this ruling on the United States Court of Federal Claims' website. This means the ruling 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, I agree that the identified material fits within this definition, I 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 section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 2 of 14 Ms. Porcello moved for summary judgement on May 22, 2019. Motion for Summary Judgement, ECF No. 47. On January 6, 2020, Respondent filed his Response to Summary Judgment, and cross-moved for dismissal of Petitioner’s case. ECF No. 60. For the reasons stated below, Petitioner’s motion for summary judgement is denied. Further, I conclude that Petitioner has failed to offer preponderant evidence sufficient to satisfy all of the three Althen prongs. Therefore, the petition is dismissed for insufficient proof. I. Factual History Ms. Porcello received a flu vaccination on November 22, 2016, in her left shoulder. Ex. 2 at 11. At the time of vaccination, Ms. Porcello was a twenty-year old college sophomore and field hockey player. Id. at 10; Ex. 1 at 2. In her affidavit, Ms. Porcello stated that while she suffered no pain or injury to her left shoulder prior to her vaccination, after its administration she experienced immediate pain. Ex. 1 at 1-2. Ms. Porcello also stated that, because she was away at college, she initially sought treatment from her athletic trainer through her campus’s health services department. Id. at 2. This statement is corroborated in Hilary Ann Turner’s affidavit. Ex. 13. In it, Ms. Turner stated that she served as a Certified Athletic Trainer at Ms. Porcello’s college and remembered speaking with her in January 2017 about her shoulder pain. Id. at 2. Specifically, she recalled that Ms. Porcello “had begun to have left shoulder pain in late 2016.” Id. Further, in a March 22, 2017 note, Ms. Turner documented that “after winter break,” Ms. Porcello “asked about some left upper arm pain she had been experiencing” that was most noticeable when lifting or doing pushups. Ex. 9 at 1. On January 18, 2017, Ms. Porcello presented to Lawrence Memorial Healthcare Center with complaints of cough, fever, and chills. Ex. 3 at 4. The medical note documenting this visit does not give any indication that Ms. Porcello mentioned suffering from shoulder pain. Id. at 3-5. Moreover, under musculoskeletal findings it is noted: “[r]ange of motion grossly normal. No pain with range of motion.” Id. at 4. Despite this reported finding, Ms. Porcello stated that her range of motion was not examined during this appointment. Ex. 12 at 1 (Petitioner’s third affidavit). Ms. Porcello further stated that she informed the treating physician that her shoulder pain had been bothersome since she received the flu shot “a few months back.” Id. at 1-2. Almost two months later, on March 17, 2017, Ms. Porcello presented to Dr. Laura L. Carman, her primary care physician, with complaints of left arm pain. Ex. 2 at 6. The medical note indicates that Ms. Porcello “had flu shot in November – has had pain in arm since then.” Id. It is also noted that Ms. Porcello was seen by her trainer and “heath services doctor” who recommended that she undergo an evaluation by a primary care provider. Id. Dr. Carman assessed Ms. Porcello with left shoulder pain and referred her to an orthopedist. Id. at 9. On March 20, 2017, Ms. Porcello presented to Dr. Marie Walcott at Agility Orthopedics with a complaint of left shoulder pain. Ex. 4 at 16-17. The medical note documenting this visit indicates that Ms. Porcello “developed left shoulder pain in 2 Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 3 of 14 November after getting a flu shot” and that she’d seen her field hockey team’s physician, trainer, and primary care physician about her injury. Id. at 16. Ms. Porcello reported “developing weakness in her left shoulder and difficulty doing her training for field hockey.” Id. On examination, Dr. Walcott found that Ms. Porcello had full supple range of motion of her left shoulder. Id. at 17. It was also found that “[Ms. Porcello] has pain but intact strength with supraspinatus testing in the empty can position. She has pain and weakness with resisted external rotation.” Id. Dr. Walcott remarked “[i]t is unusual to have these symptoms after a flu shot and to last so long.” Id. Ms. Porcello was advised to get an MRI. Id. Ms. Porcello underwent an MRI on her left shoulder on April 7, 2017. Ex. 4 at 18. It revealed “bone marrow edema in the superficial distal posterior aspect of the left humeral greater tuberosity with associated soft tissue and periosteal edema worrisome for chronic osteomyelitis.” Id. Ms. Porcello returned to discuss her MRI results with Dr. Walcott on April 13, 2017. Ex. 4 at 20-22. Dr. Walcott observed that Ms. Porcello “continues to have significant pain when reaching to the side and reaching overhead.” Id. at 20. She also noted that Ms. Porcello had full supple range of motion in her left shoulder, pain and weakness with supraspinatus testing and external rotation, and was tender to greater palpation over greater tuberosity. Id. at 21. Referencing Ms. Porcello’s MRI, Dr. Walcott indicated “[t]he bright on T2, dark on T1 is likely either a contusion or a chronic osteomyelitis.” Id. Dr. Walcott explained that the MRI was reviewed with both a radiologist and tumor specialist who agreed with her assessment. Id. It was noted that a tagged white blood cell scan or a biopsy would be needed to rule out infection. Id. In a medical note dated April 26, 2017, Dr. Walcott indicated that after reviewing Ms. Porcello’s MRI and lab results with “Dr. Olans from infectious disease,” this individual concluded that Ms. Porcello did not have osteomyelitis. Ex. 4 at 21. Dr. Walcott also stated that she reviewed the MRI and lab results with an unnamed “colleague in Boston” who believed that Ms. Porcello had a SIRVA. Id. Dr. Walcott concluded by indicating that she “reviewed the literature relating to this diagnosis and the MRI findings are similar to [Ms. Porcello’s].” Id. at 21-22. On April 24, April 28, and May 1, 2017, Ms. Porcello presented to her college’s health services department concerning sinusitis. Ex. 8 at 1-6. Her shoulder was not mentioned during these visits. Id. On April 27, 2017, Ms. Porcello’s mother, Cheri Porcello, sent an email to Sam Tarabelsi. Ex. 15. Although the recipient’s title is not given, it appears that he is associated with Dr. Carman’s medical practice. Ms. Cheri Porcello wrote that “from the day [my daughter] received the injection she has been complaining of arm/shoulder pain and weakness.” Id. She further wrote that her daughter was recently diagnosed with SIRVA. Id. 3 Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 4 of 14 On May 9, 2017, Ms. Porcello returned to Dr. Carman for a follow-up visit. Ex. 2 at 1-5. In the medical note documenting this appointment it is noted that Ms. Porcello “developed left shoulder pain after flu vaccine last fall,” and that Dr. Walcott’s colleague, Dr. Lee, “suggested dx [diagnosis] is SIRVA (shoulder injury related to vaccine administration).” Id. at 1. It was further noted that Ms. Porcello has had left shoulder pain since November. Id. at 3. Additionally, Dr. Carman found that Petitioner “has had weakness [in her] left arm” and decreased strength in her left shoulder. Id. at 1, 3. While Dr. Carman offered to refer Ms. Porcello to Dr. Lee, who was noted to be familiar with SIRVA, she declined. Id. at 4. Ms. Porcello presented to Dr. Walcott on June 5, 2017 “for follow-up of her left shoulder SIRVA.” Ex. 4 at 23. Ms. Porcello reported that her pain was improving, rating it as “5/10.” Id. Further, while she noted having discomfort when reaching overhead or lifting anything heavy, she was able to play field hockey. Id. Upon examination, Dr. Walcott found that Ms. Porcello had “[f]ull supple and symmetric range of motion.” Id. Dr. Walcott recommended that Ms. Porcello begin a short course of physical therapy with the ultimate goal of “regain[ing] fitness prior to starting field hockey this fall.” Id. at 24. Among the goals charted on the referral to physical therapy are “passive range of motion” and “active- assisted range of motion.” Ex. 18 at 4. Ms. Porcello participated in physical therapy for her left shoulder from July 31 to August 16, 2017, completing six sessions. Ex. 18. On the intake form, Ms. Porcello indicated that the date of onset of her injury was November 11, 2017 – 11 days prior to vaccination. Id. at 15. However, when prompted to describe the cause of injury, Ms. Porcello wrote “I got the flu shot, months later told I had SIRVA, from the way the shot got injected.” Id. On September 28, 2017, Ms. Porcello again presented to Dr. Walcott regarding her left shoulder. Ex. 10 at 1-2. It was noted that while Ms. Porcello’s strength was improving, she continued to have pain in her shoulder. Id. at 1. Dr. Walcott recommended that Ms. Porcello undergo a second MRI. Id. at 2. Ms. Porcello returned to Dr. Walcott’s office to discuss the results of her MRI on October 5, 2017. Ex. 10 at 3. Dr. Walcott found that the MRI had “normalized.” Id. She also noted: “We discussed the findings of small partial-thickness infraspinatus tear. We discussed treatment for her shoulder pain, which may be coming from the partial tear versus the residual SIRVA.” Id. Ms. Porcello opted to forego having a cortisone injection but agreed “to work with physical therapy and do exercise program at home.” Id. II. Affidavit Testimony Regarding Onset Although Ms. Porcello was vaccinated on November 22, 2016, there are no contemporaneous medical records that document her complaint of left shoulder pain until March 17, 2017 (almost four months later). Ex. 2 at 6. However, Ms. Porcello stated in her affidavit that “the pain began immediately after receiving the vaccination in my shoulder.” Ex. 1 at 1-2. 4 Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 5 of 14 A witness affidavit submitted by a third party, Leah Marie Sullivan, states that she recalled Ms. Porcello having issues with her shoulder in the fall of 2016. Ex. 16 at 1. She noted “[w]e were both field hockey teammates so I noticed that Breana was unable to fully participate in practices and games.” Id. at 1-2. Ms. Sullivan also remarked on Ms. Porcello’s initial attempts to “determine what caused the injury”, stating “[t]his was a frustrating process that really required a lot of patience on [Ms. Porcello’s] part because of all the unanswered questions initially about the cause of the injury.” Id. at 2. A witness affidavit was also submitted by Mackenzie Anne Foley, Ms. Porcello’s teammate and roommate. Ex. 17. In it she recalled that Ms. Porcello suffered from a shoulder injury “late 2016 through 2017.” Id. at 1. Like Ms. Sullivan, Ms. Foley also acknowledged the difficulty in establishing the cause of Ms. Porcello’s injury. She explained that “when [Ms. Porcello] told me she was having pain I tried to help her recall what she could have done to hurt herself. She cold [sic] recall nothing substantial that would cause the pain.” Id. at 1-2. As previously noted, Ms. Porcello also submitted an affidavit from Hilary Ann Turner, her college’s certified athletic trainer. Ex. 13. In addition to recalling Ms. Porcello’s complaint of left shoulder pain in January 2017, Ms. Turner also noted her attempt to figure out the source of Ms. Porcello’s injury. Id. at 2. She explained that Ms. Porcello “did not have a specific mechanism of injury related to sports. When I pressed further into what she did over the winter break that might have caused the pain she mentioned that she had received a flu shot.” Id. at 2. III. Petitioner’s Expert Report In addition to medical records and affidavits, Ms. Porcello submitted an expert report authored by Dr. Jeffrey A. Dlabach. Ex. 14 (“Dlabach Rep.”). Dr. Dlabach did not set forth his areas of expertise or attach his curriculum vitae, however. Id. In his report, Dr. Dlabach noted that his review of Ms. Porcello’s pre-vaccination records had not revealed any pre-existing injury, diagnosis or complaint related to her left shoulder. Dlabach Rep. at 2. He also noted that Ms. Porcello’s left shoulder MRI showed edema in the greater tuberosity and in the surrounding soft tissues and stated that these traits are consistently seen in SIRVA cases. Id. According to Dr. Dlabach, the edema in the greater tuberosity “was a result of the flu vaccine administration in the nonideal location resulting in bone contusion. As a result of the chronic inflammation a partial thickness tear of the infraspinatus tendon developed.” Id. Dr. Dlabach concluded that, in his medical opinion, to a reasonable degree of medical certainty, “Ms. Porcello sustained a SIRVA as a result of her November 22, 2016 flu shot.” Dlabach Rep. at 2. 5 Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 6 of 14 IV. Relevant Procedural History Ms. Porcello filed her petition without medical records on September 14, 2017 3. ECF No. 1. The parties subsequently spent several months in settlement negotiations, but reached an impasse in the fall of 2018. ECF No. 38. Thus, on November 20, 2018, Respondent filed his Rule 4(c) report (“Report”) asserting that this case was not appropriate for compensation under the terms of the Vaccine Act. Report at 1, ECF No. 40. In it, Respondent noted Petitioner’s almost four-month delay in seeking treatment. Report at 5. Respondent further argued that, “in order to sustain a Table claim for SIRVA, the condition must manifest as ‘shoulder pain and [a] limited range of motion,’” but Ms. Porcello’s orthopedist “always documented [her] as having a full range of motion.” Id. Lastly, Respondent argued that Ms. Porcello had not proven actual causation. Id. at 5-6. Petitioner filed some additional records in an attempt to address Respondent’s concerns, but Respondent adhered to his objections. ECF No. 45. Thereafter, on May 22, 2019, Ms. Porcello filed a Motion for Summary Judgement (“Motion”), Memorandum of Law in Support of Motion for Summary Judgement (“Memorandum”) and Statement of Undisputed Material Fact (“Statement”) arguing that she had met her burden of proving that she is entitled to compensation under the Vaccine Act. ECF No. 47. Later that summer and into the fall, she filed Dr. Dlabach’s expert report as well as additional evidence regarding the onset of her injury. ECF Nos. 50-51; 53-54.4 On January 6, 2020, Respondent filed his response to Petitioner’s Motion (“Response”) asserting that Ms. Porcello’s Motion should be denied and her claim dismissed for failure to demonstrate entitlement to compensation. Response at 10, ECF No. 60. The matter is now ripe for resolution. V. Ruling on the Record vs Summary Judgement Pursuant to Vaccine Rule 3(b)(2), special masters are responsible for “mak[ing] the proceedings expeditious, flexible, and less adversarial, while at the same time affording each party a full and fair opportunity to present its case and creating a record sufficient to allow review of the special master’s decision.” Under Vaccine Rule 8(d), a special master “may decide a case on the basis of written submissions without conducting an evidentiary hearing. Submissions may include a motion for summary judgement, in which event the procedures set forth in RCFC 56 will apply.” As I have previously observed (relying on controlling Federal Circuit precedent), “a special master’s ability to decide a case based upon written submissions without a hearing is not limited to a motion for summary judgement.” Smallwood v. Sec’y of Health 3 On December 6, 2017, Petitioner filed an amended petition to clarify that she was the recipient of a collegiate academic scholarship. ECF No. 14. 4 On May 29, 2020, Petitioner filed a duplicate copy of her physical therapy records. ECF No. 61. These records were originally filed on September 12, 2019. ECF No. 56. 6 Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 7 of 14 & Human Servs., No. 18-0291V, 2020 WL 2954958, at *7 (Fed. Cl. Spec. Mstr. Apr. 29, 2020) (emphasis added), citing Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020). Instead, “Rule 8(d) contemplates that special masters can decide cases on written submissions other than motions for summary judgement.” Kreizenbeck, 945 F.3d at 1366. (emphasis in original). Citing Vaccine Rule 3(b)(2), the Kreizenbeck court explained that special masters may rule on the record after affording the parties “a full and fair opportunity to present its case.” As noted in Smallwood, such a ruling makes evidentiary determinations based on the parties’ submissions, and in so doing may weigh competing arguments about what conclusions are preponderantly supported by the evidence. A ruling on the record is thus distinguishable from a summary judgement determination, that presumes facts in the non-movant’s favor and only involves determining questions of law. Smallwood, 2020 WL 2954958, at *7. By contrast, a summary judgment motion is more appropriate when a party “believe[s] at an early stage of the proceedings that no material facts are in dispute and they will prevail as a matter of law.” Kreizenbeck, 945 F. 3d at 1366. Although Petitioner styles her present motion as one for summary judgment, I find at this stage in the proceedings (and given the extensive factual materials filed) that it is best treated as requesting a ruling on the record. The record in this case is fully developed, and the parties have been afforded a full and fair opportunity to present their evidence and arguments. In order to resolve the motion and determine if in fact Petitioner should receive a damages award, I must weigh the evidence – a task I am empowered to perform without hearing, but which goes beyond the more limited judicial determinations implicit to the summary judgment process. Accordingly, I treat Petitioner’s motion as one requesting a ruling on the record (and to the extent it is not, I DENY the motion for summary judgment, so that I may instead evaluate the evidence overall). VI. Actual Causation A petitioner may prevail on her claim if she has “sustained, or had significantly aggravated, any illness, disability, injury, or condition” set forth in the Vaccine Injury Table (“Table”). Section 11(c)(1)(C)(i). The most recent version of the Table, which can be found at 42 C.F.R. § 100.3(c)(10), identifies the vaccines covered under the Program, the corresponding injuries, and the time period in which the particular injuries must occur after vaccination. Section 14(a). If a petitioner establishes she has suffered a “Table injury,” causation is presumed. However, when a petitioner has suffered an injury that either is not listed in the Table or did not occur within the prescribed timeframe, she must prove that the administered vaccine caused injury in order to receive Program compensation. Section 11(c)(1)(C)(ii) and (iii). Effective for petitions filed beginning on March 21, 2017, a SIRVA is an injury listed on the Vaccine Injury Table. See Vaccine Injury Table: Qualifications and Aids to interpretation (“QAI”). 42 C.F.R. § 100.3(c)(10). 7 Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 8 of 14 While Ms. Porcello asserted a Table claim for SIRVA in her amended petition, she took a different stance in her Motion and, without explanation, has conceded that she did not suffer a Table injury.5 Memorandum of Law at 5, ECF No. 47-1. Therefore, Ms. Porcello must prove her claim by showing that her injury was “caused-in-fact” by the vaccine in question. Sections 13(a)(1)(B) and 11(c)(1)(C)(ii). In such a situation, the presumptions available under the Table are inoperative, and the burden is on Ms. Porcello to introduce evidence demonstrating that the vaccination actually caused her shoulder injury. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. Sec’y of Health & Human Servs., 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. Section 13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that standard, a 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. A 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. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352 (Fed. Cir. 1999). Based upon the above, Ms. Porcello must show by preponderant evidence that her November 22, 2016 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 her injury; and (3) a showing of proximate temporal relationship between vaccination and injury. Althen, 418 at 1278 (citations omitted). All three prongs of Althen must be satisfied. Id. a. Analysis While I find that while Ms. Porcello is able to satisfy the first and second Althen prongs, she has failed to satisfy all three – as she must do to prevail. i. Althen Prong One Under Althen prong one, there must be preponderant evidence of a medical theory causally connecting Ms. Porcello’s vaccination to her injury. To satisfy this prong, Petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.” Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory must only be “legally probable, not medically or scientifically certain.” Id. at 548-49. Petitioner may satisfy the first Althen prong without resort to medical literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted medical theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 5 As discussed in VI(a)(iii), below, Ms. Porcello would not have been able to sustain a Table claim for SIRVA in any event, because she failed to present preponderant evidence that she experienced onset of left shoulder pain within 48 hours of her November 22, 2016 vaccination. 8 Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 9 of 14 1367, 1378–79 (Fed. Cir. 2009) (citing Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1325–26 (Fed. Cir. 2006)). In his expert report, Dr. Dlabach asserts that Ms. Porcello’s left shoulder MRI “revealed edema in the greater tuberosity, as well as surrounding soft tissues” and that this is a “consistent and diagnostic finding that is consistently seen in shoulder injury related to vaccine administration (SIRVA).” Ex. 14 at 2. Although Dr. Dlabach does not provide any additional explanation as to the mechanism of injury, I do find that Ms. Porcello has provided a “reputable medical theory.” Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355-56 (Fed. Cir. 2006)(citations omitted). Furthermore, while it is Ms. Porcello’s burden to establish all Althen prongs by preponderant evidence, Respondent has not disputed that the flu vaccine can cause SIRVA. It is also worth noting that there is a well-established track record of SIRVA compensation awards in non-Table cases (although settled cases are not particularly strong evidence). See, e.g. Loeding v. Sec’y of Health & Human Servs., No. 15-740V, 2015 WL 7253760 at *1 (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. Sec’y of Health & Human Servs., 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. Sec’y of Health & Human Servs., No. 16-1496V, 2017 WL 6206391 (Fed. Cl. Spec. Mstr. April 13, 2017)(same). Accordingly, Ms. Porcello has preponderantly satisfied Althen prong one. ii. Althen Prong 2 The second Althen prong requires proof of a logical sequence of cause and effect, usually supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu, 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” an injury, the opinions and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a ‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’ ”) (quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly trustworthy evidence, since they are created contemporaneously with the treatment of the patient. Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). However, medical records and/or statements of a treating physician’s views do not per se bind the special master to adopt the conclusions of such an individual, even if they must be considered and carefully evaluated. See § 13(b)(1) (providing that “[a]ny such diagnosis, conclusion, 9 Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 10 of 14 judgment, test result, report, or summary shall not be binding on the special master or court.”) The medical record for this case does not contain statements from Petitioner’s primary care provider concluding directly that Petitioner’s injury was caused by the flu shot, but instead relied on Dr. Walcott’s findings. See Ex. 2 at 1 (noting that Petitioner “had evaluation by Dr. Walcott – April 2017 – showed bone bruise.”). These findings in turn were largely based on a suggestion put forth by Dr. Walcott’s colleague. While her initial plan for treating Ms. Porcello included obtaining a tagged white blood cell scan to rule out infection, Dr. Walcott later noted that she had reviewed Ms. Porcello’s MRI and lab results with “a colleague in Boston who thought it was SIRVA.” Ex. 4. at 21-22. Dr. Walcott then reviewed literature related to this condition and found “the MRI findings are similar.” Id. at 22. However, without any additional explanation, Dr. Walcott’s medical notes indicate that her colleague’s opinion was, in fact, adopted: in documenting Ms. Porcello’s next appointment, Dr. Walcott stated that Petitioner returned to the clinic “for follow-up of her left shoulder SIRVA.” Id. at 23. It thus appears that Dr. Walcott’s diagnosis was the result of her consultation with an individual who had neither physically examined Petitioner nor reviewed Petitioner’s medical history. There is no indication that Dr. Walcott meaningfully assessed the cause of Ms. Porcello’s reported shoulder pain. Dr. Dlabach also concluded that Ms. Porcello sustained a SIRVA as a result of her November 22, 2016 flu shot. Ex. 14 at 2. However, aside from noting that Petitioner’s “MRI revealed edema in the greater tuberosity, as well as surrounding soft tissues,” and stating that “[f]ollow up MRI revealed the resolution of the edema in the greater tuberosity that was a result of the flu vaccine administration in the nonideal location resulting in bone contusion,” Dr. Dlabach does not address causation in any detail. “A special master is not required to rely on a speculative opinion that ‘is connected to existing data only by the ipse dixit of the expert.’” Isaac v. Sec’y of Health & Human Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012); quoting Synder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 743 (2009). Accordingly, while his opinion is helpful to Petitioner, it does not stand as particularly robust support for her claim. The next question is whether the medical records support Petitioner’s contention that she experienced a SIRVA injury. In prior cases where a SIRVA has been addressed as a cause-in-fact-claim, the QAIs governing the Table Injury of SIRVA have nevertheless been found to be persuasive guidance in establishing whether there is a logical sequence of cause and effect leading to a SIRVA. See, e.g., Portee v. Sec’y of Health & Human Servs., No. 16-1552V, 2018 WL 5284599, at *10 (Fed. Cl. Spec. Mstr. Sept. 14, 2018); Capasso v. Sec’y of Health & Human Servs., No. 17-0014, 2018 WL 5077781, at *5 (Fed. Cl. Spec. Mstr. August 3, 2019). The criteria under the QAI are as follows: 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 10 Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 11 of 14 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). 82 Fed. Reg. 6303 (Qualifications and Aids to Interpretation for SIRVA). Nothing in Ms. Porcello’s prior medical history suggests any relevant history of pain, inflammation or dysfunction of her left shoulder. Moreover, I find no evidence that her pain and reduced range of motion extended beyond her left shoulder. Respondent has not suggested, nor do I find, that any other condition is present that could explain Ms. Porcello’s reported injury. Accordingly, and although the evidence is not particularly robust on this point, I find that Petitioner has established that she did likely experience a SIRVA injury, and that it is preponderantly associated with her vaccination. iii. Althen Prong 3 The question of when Petitioner’s shoulder pain first manifested, and whether that time frame is medically acceptable, is the primary basis for Respondent’s recommendation against compensation in this case. Report at 5. Under Althen Prong three, there must be a proximate temporal relationship between vaccination and injury. This “requires preponderant proof that the onset of symptoms occurred within a timeframe for which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation-in-fact.” de Bazan v. Sec’y of Health & Human Servs., 539. F.3d 1347, 1352 (Fed. Cir. 2008). Ms. Porcello must therefore show that her injury did not occur too soon or too long after vaccination. Id. The Table version of a SIRVA claim requires establishing onset of symptoms within 48 hours or less of vaccination. 42 C.F.R. § 100.3(c)(10). Although this is admittedly a causation-in-fact claim, the medical science supporting this onset period has been deemed persuasive even in cases alleging a non-Table claim. See Almanzar v. Sec’y of Health & Human Servs., No. 16-0340V, 2018 WL 4042365, at *7 (Fed. Cl. Spec. Mstr. April 20, 2018) (employing SIRVA Table criteria to find that the onset of symptoms within 48 hours of vaccination is a medically accepted timeframe for which to infer causation). It is therefore reasonable to keep that timeframe in mind even in a non-Table case. A petitioner as here asserting a non-Table SIRVA claim may not need to meet this fact issue to prevail, but will need to demonstrate a medically acceptable onset – and in so doing will need to pay some heed to the prevailing scientific view of when SIRVA claims are most likely to manifest. As a result, timeframes for a non-Table SIRVA onset that is too long or short, relying on the Table timeframe as a general “yardstick,” have failed. See, e.g., Mack v. 11 Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 12 of 14 Sec’y of Health & Human Servs., No. 15-0149V, 2016 WL 5746367, at *11 (Fed. Cl. Spec. Mstr. July 14, 2016) (onset of six months is not evidence of a proximate temporal relationship for non-Table SIRVA claim). By contrast, in Jewell v. Sec’y of Health & Human Servs., 2017 WL 7259139, at *3 (Fed. Cl. Spec. Mstr. Aug. 4, 2017), former Chief Special Master Dorsey explained that while she was unable to find that the petitioner had experienced the onset of her shoulder injury within 48 hours “as required by the current Table,” the onset of her injury within 72 hours was nevertheless “a medically appropriate temporal relationship.” Id. In Ms. Porcello’s case, based on the earliest date of record proof, the time between vaccination and onset appears to be more than three months. Ms. Porcello avers, however, that the onset of her left shoulder pain occurred immediately after receiving the flu vaccination in the same shoulder. Ex. 1 at 1-2. This is echoed in her mother’s April 27, 2017 email, in which it is noted that Ms. Porcello “has been complaining of arm/shoulder pain and weakness” from the day she received the flu shot. Ex. 15. In reaction, Respondent observes that Ms. Porcello did not seek treatment for her left shoulder “until likely sometime in March 2017, at a minimum three months and one week after vaccination.” Report at 5. There is also no contemporaneous record documentation of injury in the immediate days following Ms. Porcello’s vaccination. Indeed, while Hillary Ann Turner submitted an affidavit stating that she remembered Ms. Porcello complaining of left shoulder pain that had begun “in late 2016”, the only evidence from this period is a January 18, 2017 doctor’s note that does not mention this ailment. Exs. 13 at 2; 3 at 4-5. Not until March 17, 2017 is Ms. Porcello’s injury documented “in real time.” Ex. 2 at 6. The lack of reliable and persuasive record proof confirming an onset reasonably close in time to vaccination is compounded by Petitioner’s vague descriptions of the onset of her pain, and her initial inability to identify her vaccination as its source. Thus, some records only indicate that Petitioner’s shoulder pain began “in November” or some unspecified amount of time subsequent to vaccination. For instance, when Ms. Porcello first presented to Dr. Carman in March 2017, she reported having had arm pain “since she got the flu shot in November.” Ex 2 at 6, 7. See also Ex. 4 at 16 (noting that Ms. Porcello “developed left shoulder pain in November after getting a flu shot”); Ex. 2 at 1 (stating “patient developed left shoulder pain after flu shot last fall . . .”). But the only precise date that Ms. Porcello mentions is November 11, 2016 – 11 days prior to vaccination. See Ex. 18 at 15 (reporting the date of onset on her July 31, 2017 physical therapy intake form). Petitioner has attempted to bolster her claim that her shoulder pain began immediately after vaccination by obtaining affidavits from Leah Marie Sullivan and Mackenzie Anne Foley, who were her former field hockey teammates. Exs. 16, 17. However, although both recall that Ms. Porcello experienced issues with her shoulder “in fall 2016,” associating her symptoms with an entire season, spanning several months, lacks the precision needed to determine whether the onset of Petitioner’s injury occurred 12 Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 13 of 14 within a medically acceptable time frame. Further, their statements indicate that at least some time had passed between vaccination and the onset of Petitioner’s pain, as they both recall their attempts to help Ms. Porcello identify a triggering event.6 Additionally, Dr. Dlabach’s expert report does not shed any light on the issue of onset. Ex. 14. Instead, it is merely noted that “[r]ecords indicate development of left shoulder pain.” Id. at 2. I acknowledge that the standard applied to SIRVA claims on the onset issue is fairly liberal (at least in the Table context), and will often permit a determination that onset began within the 48-hour timeframe set by the Table, based on records prepared a few months after vaccination, and/or corroborated by sworn witness statements intended to amplify otherwise-vague records. There are many situations in which compelling testimony may be more persuasive than written records, such as where records are deemed to be incomplete or inaccurate. Campbell v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006)(“like any norm based upon common sense and experience, this rule should not be treated as an absolute and must yield where the factual predicates for its application are weak or lacking). However, not every SIRVA claim can be so preponderantly established, and certainly not where witness affidavits contradict, or inadequately support, a petitioner’s assertions of immediate onset. This case presents such circumstances. The evidence of when Petitioner’s SIRVA began is vague, and in some cases contradicted by evidence suggesting a pre-vaccination start. In addition, Petitioner has not at all established what a reasonable timeframe for a non-Table SIRVA injury would be, as Dr. Dlabach’s report is silent on this important question. As a result of these twin deficiencies, I cannot find that the timeframe for Petitioner’s SIRVA was medically acceptable, and therefore the claim cannot succeed. VII. Conclusion Having reviewed the medical records, expert report, and arguments put forth by the parties, I find that Petitioner has failed to offer preponderant evidence sufficient to satisfy the third Althen prong. Therefore, the petition is dismissed for insufficient proof. The clerk is directed to enter judgement in accordance with this decision.7 6 Referring to Ms. Porcello’s college’s calendar of sports events from the fall of 2019, Respondent argues that Petitioner’s vaccination was presumably administered after the end of the 2016 field hockey season, impacting the credibility of Ms. Sullivan’s statement that Petitioner was unable to participate in practices and games. However, Respondent has not presented evidence of the field hockey schedule in place in 2016. See Response at 6. 7 Pursuant to Vaccine Rule 11(a), entry of judgement can be expedited by each party filing a notice renouncing the right to seek review. 13 Case 1:17-vv-01255-LAS Document 72 Filed 08/13/20 Page 14 of 14 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 14 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_17-vv-01255-1 Date issued/filed: 2021-02-26 Pages: 8 Docket text: JUDGE VACCINE REPORTED OPINION re: 74 Order on Motion for Review. Signed by Senior Judge Loren A. Smith. (cew) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-01255-LAS Document 81 Filed 02/26/21 Page 1 of 8 In the United States Court of Federal Claims No. 17-1255 Filed: November 25, 2020 Reissued: February 26, 20211 ) BREANA PORCELLO, ) ) Petitioner, ) Vaccine Case; Motion for Review; ) Influenza Vaccine; Althen; Motion for v. ) Summary Judgment; Dismissal; Arbitrary ) and Capricious Standard; Ruling on the SECRETARY OF HEALTH AND ) Record HUMAN SERVICES, ) ) Respondent. ) ) OPINION Michael G. McLaren, Black McLaren, et al., Memphis, TN, for petitioner. Ryan Daniel Pyles, Vaccine/Torts Branch, Civil Division, United States Department of Justice, Washington, DC, for respondent. SMITH, Senior Judge: Petitioner, Breana Porcello, seeks review of a decision issued by Chief Special Master Brian H. Corcoran denying her petition for vaccine injury compensation. Petitioner brought this action pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 et seq. (the “Vaccine Act”), alleging that she suffered a shoulder injury related to vaccine administration (“SIRVA”) as a result of an influenza (“flu”) vaccine administered on November 22, 2016. The Chief Special Master dismissed the petition for insufficient proof, finding that petitioner failed to offer preponderant evidence sufficient to satisfy all three of the Althen prongs. Porcello v. Sec’y of Health & Human Servs., No. 17-1255, 2020 WL 4725507 (Fed. Cl. Spec. Mstr. June 22, 2020) (“Porcello”). Petitioner now moves for review of that decision. For the reasons that follow, the Court DENIES her motion. I. BACKGROUND 1 An unredacted version of this opinion was issued under seal on November 25, 2020. The parties were given an opportunity to propose redactions, but no such proposals were made. Case 1:17-vv-01255-LAS Document 81 Filed 02/26/21 Page 2 of 8 A brief recitation of the facts provides necessary context.2 A. Factual History Ms. Porcello received the flu vaccination in her left shoulder on November 22, 2016. When Ms. Porcello received her vaccination, she was a twenty-year-old college student and field hockey player. She stated that her shoulder pain began immediately following vaccine administration, and, because she was away at college, she sought treatment from an athletic trainer with her campus’s health services department. That athletic trainer, Hilary Ann Turner, stated in an affidavit that she spoke with Ms. Porcello regarding her shoulder pain in January 2017 and again in March 2017, and she noted that Ms. Porcello “asked about some left upper arm pain she had been experiencing” when lifting or doing pushups “after winter break.” On January 18, 2017, Ms. Porcello presented to Lawrence Memorial Healthcare Center with a cough, fever, and chills, at which time the medical note documented a “[r]ange of motion grossly normal. No pain with range of motion.” Regardless, Ms. Porcello alleged that her range of motion was not examined during this appointment, and she further asserted that she informed her treating physician that she suffered from bothersome shoulder pain since she received her flu shot “a few months back.” On March 17, 2017, Ms. Porcello visited her primary care physician, Dr. Laura L. Carman, complaining of left arm pain since receiving her flu shot in November. Dr. Carman referred her to an orthopedist. On March 20, 2017, petitioner met with Dr. Marie Walcott at Agility Orthopedics, reporting that she developed “weakness in her left shoulder and difficulty doing her training for field hockey.” Dr. Walcott found that Ms. Porcello had full supple range of motion of her left shoulder, as well as noting that she “had pain but intact strength with supraspinatus testing in the empty can position. She has pain and weakness with resisted external rotation.” Dr. Walcott further remarked that “[i]t is unusual to have these symptoms after a flu shot and to last so long.” She then recommended that petitioner get an MRI.3 2 As the basic facts here have not changed significantly, the Court’s recitation of the background facts here draws from the Chief Special Master’s earlier opinion in Porcello. Porcello v. Sec’y of Health & Human Servs., No. 17-1255, 2020 WL 4725507 (Fed. Cl. Spec. Mstr. June 22, 2020) (“Porcello”). 3 MRI is defined as “magnetic resonance imaging.” Dorland’s Illustrated Medical Dictionary 1167 (33rd ed. 2020) (“Dorland’s”). - 2 - Case 1:17-vv-01255-LAS Document 81 Filed 02/26/21 Page 3 of 8 Ms. Porcello underwent an MRI on her left shoulder on April 7, 2017, which revealed “bone marrow edema4 in the superficial5 distal6 posterior aspect7 of the left humeral greater tuberosity8 with associated soft tissue and periosteal9 edema worrisome for chronic osteomyelitis.”10 She returned to discuss her MRI results with Dr. Walcott on April 13, 2017, at which point Dr. Walcott observed that she “continues to have significant pain when reaching to the side and reaching overhead.” She also noted that Ms. Porcello had full supple range of motion in her left shoulder, pain and weakness with supraspinatus testing and external rotation, and was tender to greater palpation11 over greater tuberosity. Dr. Walcott concluded that Ms. Porcello likely suffered from “either a contusion or a chronic osteomyelitis,” an assessment supported by the contemporaneous review of both a radiologist and a tumor specialist, and Dr. Walcott determined that a tagged white blood cell scan or a biopsy12 would be needed to rule out infection. On April 26, 2017, Dr. Walcott indicated that she reviewed Ms. Porcello’s MRI results with “Dr. Olans from infection disease,” who concluded that Ms. Porcello did not have osteomyelitis. Dr. Walcott also stated that she reviewed the results with an unnamed “colleague in Boston” who concluded that Ms. Porcello had SIRVA. At a follow-up appointment on May 9, 2017, Dr. Carman offered to refer Ms. Porcello to Dr. Lee, who was noted to be familiar with SIRVA, but Ms. Porcello declined the referral. Ms. Porcello completed six sessions of physical therapy for her left shoulder between July 31 and August 16, 2017. On her intake form, Ms. Porcello listed the date of onset of her shoulder injury as November 11, 2017—eleven days before she received the flu vaccination. 4 Edema is defined as “the presence of abnormally large amounts of fluid in the intercellular tissue spaces of the body, usually referring to subcutaneous tissues.” Dorland’s 587. 5 Superficial is defined as “pertaining to or situated near or nearer the surface.” Dorland’s 1774. 6 Distal is defined as “remote; farther from any point of reference; opposed to proximal.” Dorland’s 549. 7 Posterior aspect is defined as “the surface of a body viewed from the back.” Dorland’s 162. 8 Also known as tuberbulum majus humeri and defined as “a large flattened prominence at the proximal end of the lateral surface of the humerus, just lateral to the highest part of the anatomic neck, giving attachment to the supraspinatus, the infraspinatus, and the teres minor muscles.” Dorland’s 1951. 9 Periosteal is defined as “pertaining to the periosteum.” Dorland’s 1396. 10 Osteomyelitis is defined as “inflammation of bone caused by infection, usually by a pyogenic organism, although any infectious agent may be involved.” Dorland’s1328 11 Palpation is defined as “the act of feeling with the hand; the application of the fingers with light pressure to the surface of the body for the purpose of determining the consistency of the parts beneath in physical diagnosis.” Dorland’s 1345. 12 A biopsy is defined as “the removal and examination, usually microscopic, of tissue from the living body, performed to establish precise diagnosis.” Dorland’s 214. - 3 - Case 1:17-vv-01255-LAS Document 81 Filed 02/26/21 Page 4 of 8 At a visit with Dr. Walcott on September 28, 2017, Ms. Porcello was noted as having improved strength but residual pain in her shoulder. She underwent a second MRI and returned to Dr. Walcott’s office on October 5, 2017 to discuss those results. At that time, Dr. Walcott noted that the MRI had “normalized,” but that they “discussed the findings of a small partial-thickness infraspinatus tear” and “discussed treatment for her shoulder pain, which may be coming from the partial tear verses the residual SIRVA.” Ms. Porcello forwent a cortisone13 injection but agreed “to work with physical therapy and do [an] exercise program at home.” B. Procedural History Petitioner filed her petition, without medical records, with the Office of Special Masters on September 14, 2017. See generally Petition. On July 22, 2019, petitioner filed the expert report of Dr. Jeffrey A. Dlabach. The parties attempted settlement but were unsuccessful. On November 20, 2018, respondent filed a Rule 4(c) report, asserting that this case was not appropriate for compensation under the Vaccine Act. On May 22, 2019, petitioner filed a motion for summary judgment, arguing that she met her burden of proving she is entitled to compensation under the Vaccine Act. On January 6, 2020, respondent filed its response to petitioner’s Motion, arguing that her Motion should be denied, and her claim dismissed for failure to demonstrate entitlement to compensation. Under Vaccine Rule 8(d), a special master “may decide a case on the basis of written submissions without conducting an evidentiary hearing. Submissions may include a motion for summary judgment, in which event the procedures set forth in [Rule] 56 [of the Rules of the Court of Federal Claims] will apply.” On June 22, 2020, without first holding an entitlement hearing, Chief Special Master Corcoran issued a decision denying petitioner’s Motion for Summary Judgment and dismissing the claim for compensation. Decision (A) Denying Motion for Summary Judgment, and (B) Granting Dismissal of Claim [hereinafter Dec.]. In that decision, the Chief Special Master found that “[p]etitioner has failed to offer preponderant evidence sufficient to satisfy the third Althen prong.” Porcello, 2020 WL 4725507, at *10. Petitioner filed her Motion for Review on July 22, 2020. See generally Petitioner’s Motion for Review, ECF No. 67. In addition to her Motion for Review, petitioner filed three identical copies of her supporting Memorandum of Objections. See Petitioner’s Memorandum of Objections, ECF No. 66; Petitioner’s Memorandum of Objections, ECF No. 68; Petitioner’s Memorandum of Objections, ECF No. 69 [hereinafter MFR]. That same day, petitioner filed a motion to strike the first two copies of her Memorandum of Objections, as she filed the first copy out of order and linked the second copy to the wrong document. Motion to Strike, ECF No 70. Respondent filed its Response to petitioner’s Motion for Review on August 21, 2020. See generally Response to Motion for Review [hereinafter Resp. to MFR]. Petitioner’s Motion is now fully briefed and ripe for review. 13 Cortisone is defined as “a natural glucocorticoid that is metabolically convertible to cortisol.” Dorland’s 417. - 4 - Case 1:17-vv-01255-LAS Document 81 Filed 02/26/21 Page 5 of 8 II. STANDARD OF REVIEW Under the Vaccine Act, this Court may review a special master’s decision upon the timely request of either party. See 42 U.S.C. § 300aa-12(e)(1)–(2). In that instance, the Court may do the following: (A) uphold the findings of fact and conclusions of law . . . , (B) set aside any findings of fact or conclusion of law . . . found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law . . . , or, (C) remand the petition to the Special Master for further action in accordance with the court’s direction. Id. at § 300aa-12(e)(2)(A)–(C). Findings of fact and discretionary rulings are reviewed under an “arbitrary and capricious” standard, while legal conclusions are reviewed de novo. Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). This Court cannot “substitute its judgment for that of the special master merely because it might have reached a different conclusion.” Snyder ex rel. Snyder v. Sec’y of Dep’t of Health & Human Servs., 88 Fed. Cl. 706, 718 (2009). “Reversal is appropriate only when the special master’s decision is arbitrary, capricious, an abuse of discretion, or not in accordance with the law.” Id. Under this standard, a special master’s decision “must articulate a rational connection between the facts found and the choice made.” Cucuras v. Sec’y of Dep’t of Health & Human Servs., 26 Cl. Ct. 537, 541–42 (1992), aff’d, 993 F.2d 1525 (Fed. Cir. 1993) (citing Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168 (1962)). This standard is “highly deferential.” Hines v. Sec’y of Dep’t of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991). “If the special master has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision, reversible error will be extremely difficult to demonstrate.” Id. III. DISCUSSION Althen v. Secretary of Health & Human Services provides the evidentiary burden for petitioners attempting to succeed in a vaccine petition based on causation. See generally Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). There are two means of proving causation under the Vaccine Act: (1) showing that the injury falls under the Vaccine Injury Table, which provides a presumption of causation; and (2) proving causation-in-fact for an injury not listed on the Vaccine Injury Table. See id. at 1278 (citing 42 U.S.C. §§ 300aa-14(a), -13(a)(1), -11(c)1(C)(ii)(I)). The latter applies to this case; thus, in order to prove causation-in-fact, a petitioner must show by preponderant evidence that the vaccination brought about [petitioner’s] 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 - 5 - Case 1:17-vv-01255-LAS Document 81 Filed 02/26/21 Page 6 of 8 was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury. Id. at 1278. For a petitioner to meet the preponderance standard and succeed on the claim, petitioners must provide a “reputable medical or scientific explanation” for their claim. See id. Within this framework, petitioner makes two numbered objections to the Chief Special Master’s June 22, 2020 decision. See MFR at 1. First, petitioner asserts that “[t]he [Chief] Special Master erred in sua sponte converting [p]etitioner’s Motion for Summary Judgment into one for a Ruling on the Record and weighing the evidence without providing [p]etitioner an opportunity to present evidence related to specific factual discrepancies relied upon by the [Chief Special Master] to ultimately dismiss [p]etitioner’s claim.” Id. at 4. Second, petitioner argues that “[t]he [Chief] Special Master erred in determining [p]etitioner had not met her burden for showing causation and entitlement.” Id. at 6. A. Ruling on the Record In her Motion for Review, petitioner alleges that “dismissal of her claim in the face of no procedurally correct motion from Respondent seeking such relief is arbitrary and capricious and not in accordance with the law.” MFR at 4–5. In making this assertion, petitioner argues that she “did not have a full and fair opportunity to develop and present her evidence and arguments on the issue of timing of onset in relation to the issues that the Special Master found probative in his ruling.” Id. at 5. Additionally, petitioner argues that “a ruling on the record was never contemplated amongst the parties before it was unilaterally made.” Id. In response, respondent argues that there is no requirement that a party file a “procedurally correct motion” under the Vaccine Act. Resp. to MFR at 10. Rather, respondent argues, “a special master is only required to ‘afford[] each party a full and fair opportunity to present its case and creat[e] a record sufficient to allow review of the special master’s decision,’” and by extension, determine that the record is “‘comprehensive and fully developed before ruling on the record.” Id. at 10–11 (quoting Kreizenbeck v. Sec’y of Health & Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020) (quoting Vaccine Rule 3(b)(2))). Petitioner does not argue that, as a result of the manner in which the Chief Special Master procedurally managed this case, that she would have presented additional evidence that was never considered in the Chief Special Master’s decision. Rather, the petitioner argues that she “merely seeks the opportunity with notice to present material evidence . . . that the [Chief Special Master] was going to and did eventually consider.” MFR at 5. Alternatively, respondent argues at length that petitioner was afforded the opportunity to fully develop the record, as evidenced by the numerous evidentiary filings and record supplementations. Resp. to MFR at 11. Moreover, respondent alleges that petitioner “submits no specific proffer of evidence that would have materially changed the record if the Chief Special Master had explicitly filed notice that he intended to rule on entitlement on the record.” Id. at 13. Finally, respondent contends that “Kreizenbeck makes clear that parties have no right to compel the special masters to hold hearings.” Id. (citing Kreizenbeck, 945 F.3d at 1365–66). - 6 - Case 1:17-vv-01255-LAS Document 81 Filed 02/26/21 Page 7 of 8 While the Court acknowledges that the procedural path of this case does not fit the usual arc of a case emerging from the Office of Special Masters, the Court does not believe that the petitioner was in any way prejudiced by the manner in which the Chief Special Master reached its ultimate disposition. As the record makes clear, petitioner had multiple opportunities to provide evidentiary and affidavit support for her claim, all of which she took advantage. The Court cannot see how, if given the opportunity to present her case in a different way, petitioner’s already-admitted evidence would change the ultimate decision of the Chief Special Master. As such, the Court declines to find that the Chief Special Master abused his discretion by issuing a ruling on the record. In fact, this procedure saved time and legal resources. B. Burden of Proof Petitioner’s second numbered objection alleges that the Chief Special Master erred in determining that petitioner had not met her burden for showing causation and entitlement. MFR at 6. In making this assertion, petitioner argues that “[t]he [Chief] Special Master erroneously failed to consider the totality of the records, basing his decision on improper weighing of evidence in support of positions not advanced by either party.” Id. (emphasis in original). Specifically, petitioner objects to the Chief Special Master’s determination regarding onset. Id. at 7. In response, respondent argues that “the record demonstrates that petitioner did not establish the onset of a shoulder injury in a time period proximate to vaccination, as contemplated under the Table, or during a timeframe that would establish the third prong of Althen.” Resp. to MFR at 15. Furthermore, respondent contends that the Chief Special Master reasonably concluded “that evidence of the onset of petitioner’s shoulder injury was vague, and ‘in some cases contradicted by evidence suggesting a pre-vaccination start.’” Id. at 16 (quoting Dec. at 12–13). Upon careful review, the Court does not believe that the Chief Special Master erred in determining that petitioner has not met the requisite burden of establishing a reasonable timeframe for a non-Table SIRVA injury. In order to prevail under Althen¸ petitioner must establish by a preponderance of the evidence a proximate temporal relationship between vaccination and injury. Althen, 418 F.3d at 1278. Finding such a proximate temporal relationship “requires preponderant proof that the onset of symptoms occurred within a timeframe for which, given the medical understanding of the disorder’s etiology, it is medically acceptable to infer causation-in-fact.” De Bazan v. Sec’y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). In a causation-in-fact SIRVA claim, medical science has deemed persuasive the onset period of the Table version of such a claim, which requires the onset of symptoms within 48 hours or less of vaccination. See Almanzar v. Sec’y of Health & Human Servs., No. 16-340V, 2018 WL 4042365, at *7 (Fed. Cl. Spec. Mstr. April 20, 2018) (employing SIRVA Table criteria to find that the onset of symptoms within 48 hours of vaccination is a medically acceptable timeframe for which to infer causation); see also 42 C.F.R. § 100.3(c)(10). Moreover, as the Chief Special Master correctly pointed out, “timeframes for a non-Table SIRVA onset that are too long or too short, relying on the Table timeframe as a general ‘yardstick,’ have failed.” Dec. at 11 (citing Mack v. Sec’y of Health & Human Servs., No. 15-149V, 2016 WL 5746367, at *11 (Fed. Cl. Spec. Mstr. July 14, 2016) - 7 - Case 1:17-vv-01255-LAS Document 81 Filed 02/26/21 Page 8 of 8 (finding an onset of six months is not evidence of a proximate temporal relationship for a non-Table SIRVA claim)). The evidence and affidavits provided by petitioner paint, at best, a murky picture with regard to the onset date of petitioner’s symptoms. Ms. Porcello alleges that the onset of her left shoulder pain occurred immediately after receiving the flu vaccination. Dec. at 12. However, a physical therapy intake form directly contradicts that statement, as Ms. Porcello self-reported on that form that the injury began on November 11, 2016, eleven days prior to her vaccination. Id. Moreover, petitioner did not begin to seek treatment for her left shoulder until March 2017, over three months after she received the vaccination. Id. In determining whether a special master’s finding of fact is arbitrary and capricious, this Court must look to plausibility, not to whether it is supported by a preponderance of the evidence. As long as the finding of fact is “based on evidence in the record that [is] not wholly implausible, [this Court is] compelled to uphold the finding as not being arbitrary or capricious.” Porter v. Sec’y of Health & Human Servs., 663F.3d 1242, 1249 (Fed. Cir. 2012) (quoting Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010)). Upon careful review of the record, the Court finds that the finding of the Chief Special Master—that, based on the lack of reasonable timeframe and vague and inadequate evidence of petitioner’s SIRVA onset date, he “cannot find that the timeframe for Petitioner’s SIRVA was medically acceptable” to infer causation-in-fact—is neither arbitrary, capricious, nor contrary to law. IV. CONCLUSION The Court finds that petitioner has not met her burden of proof in alleging that her November 2016 influenza vaccine resulted in her SIRVA. For the foregoing reasons, the Court DENIES petitioner’s Motion for Review. Additionally, petitioner’s MOTION to Strike Document Number 66 and 68 is hereby GRANTED. IT IS SO ORDERED. Loren A. Smith s/ Loren A. Smith, Senior Judge - 8 -