VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00482 Package ID: USCOURTS-cofc-1_20-vv-00482 Petitioner: Chris McMullen Filed: 2020-04-21 Decided: 2023-08-03 Vaccine: Tdap Vaccination date: 2018-11-07 Condition: shoulder injury related to vaccine administration (SIRVA) Outcome: denied Award amount USD: AI-assisted case summary: Chris McMullen filed a petition alleging that a Tdap vaccine administered on November 7, 2018, caused a shoulder injury related to vaccine administration (SIRVA). The initial special master found that Mr. McMullen's shoulder pain began in late November 2018, which was outside the 48-hour window required for an on-Table SIRVA claim. This finding meant he did not qualify for automatic compensation under the Vaccine Injury Table. The case was reassigned, and Mr. McMullen sought compensation by arguing for an off-Table, causation-in-fact claim. He submitted medical articles and argued that his injury met the Althen prongs for causation. However, his argument for the temporal proximity prong relied on an assertion of immediate onset, which contradicted the prior finding of onset in late November. The court found that Mr. McMullen failed to establish the necessary temporal relationship for an off-Table claim, as his alleged onset was too distant from the vaccination date. Consequently, the court denied his petition for compensation, and no award was granted. The decision was issued on August 3, 2023, following the petition filed on April 21, 2020. Theory of causation field: Off-Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_20-vv-00482-0 Date issued/filed: 2023-05-12 Pages: 9 Docket text: PUBLIC ORDER/RULING (Originally filed: 07/08/2022) regarding 32 Findings of Fact & Conclusions of Law, ( Signed by Chief Special Master Brian H. Corcoran. )(mpj) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00482-UNJ Document 46 Filed 05/12/23 Page 1 of 9 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-0482V UNPUBLISHED CHRIS MCMULLEN, Chief Special Master Corcoran Petitioner, v. Filed: July 8, 2022 SECRETARY OF HEALTH AND Special Processing Unit (SPU); HUMAN SERVICES, Table Injury Dismissal; Tetanus, Diphtheria, acellular Pertussis (Tdap) Respondent. Vaccine; Shoulder Injury Related to Vaccine Administration (SIRVA); Onset of Shoulder Pain Maximillian J. Muller, Muller Brazil, LLP, Dresher, PA, for Petitioner. Mallori Browne Openchowski, U.S. Department of Justice, Washington, DC, for Respondent. FINDINGS OF FACT AND CONCLUSIONS OF LAW DISMISSING TABLE CLAIM1 On April 21, 2020, Chris McMullen 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 alleged that he suffered a left shoulder injury related to vaccine administration (“SIRVA”), a defined Table Injury, after receiving a tetanus-diphtheria- acellular pertussis (“Tdap”) vaccine on November 7, 2018. Petition at 1, ¶ 3. He further 1 Because this unpublished Fact 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). This means the Fact 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 1:20-vv-00482-UNJ Document 46 Filed 05/12/23 Page 2 of 9 alleged that his “symptoms began within forty-eight (48) hours of vaccination and lasted for more than six (6) months.” Id. at 1; accord. Id. at ¶ 14. For the reasons discussed below, a preponderance of the evidence supports the conclusion that the onset of Petitioner’s left shoulder pain occurred later than 48 hours post-vaccination – meaning he cannot establish the onset required for his Table SIRVA claim, and therefore the Table claim must be dismissed (although a causation-in-fact version of the claim could succeed). I. Relevant Procedural History Along with the Petition, Mr. McMullen filed a vaccine record showing he received a Tdap vaccine intramuscularly on November 7, 2018, and an affidavit addressing the basic requirements for compensation under the Act. Exhibits 1-2, ECF Nos. 1-4 through 1-5. Approximately two weeks later, he filed the medical records required under the Vaccine Act. Notice of Filing for Exhibit 3, filed by CD on May 4, 2020, ECF No. 5; see Section 11(c). These medical records contained a more comprehensive vaccine record, indicating the Tdap vaccine was administered in Petitioner’s left deltoid as alleged. Exhibit 3 at 2. After the certification for these records was filed on July 30, 2020 (Exhibit 4, ECF No. 11), the case was activated and assigned to SPU. ECF No. 13. On December 9, 2020, Petitioner forwarded a demand and supporting documentation to Respondent as instructed. Status Report, filed Feb. 19, 2021, ECF No. 19. On August 19, 2021, Respondent agreed to engage in settlement discussions. ECF No. 21. However, after three months, the parties informed me they had reached an impasse. ECF No. 26. Approximately one month later, on December 21, 2021, Respondent filed his Rule 4(c) Report, opposing compensation in this case. ECF No. 27. Specifically, Respondent argued that “[P]etitioner has not demonstrated that his pain began within 48 hours of vaccination” as required for a Table SIRVA injury. Id. at 5. In reaction, on January 18, 2022, I issued an order to show cause, allowing Petitioner a final chance to obtain and to file the evidence needed to support his allegations regarding the onset of his alleged SIRVA injury. ECF No. 28. I also “instruct[ed] the parties to make one last attempt to engage in settlement discussions.” Id. at 7. On February 22, 2022, the parties filed a joint status report indicating they “[we]re unlikely to reach a settlement agreement, . . . [and] Petitioner intends to submit additional evidence and a response to the Order to Show Cause.” ECF No. 29. Petitioner provided 2 Case 1:20-vv-00482-UNJ Document 46 Filed 05/12/23 Page 3 of 9 his response on April 20, 2022. Petitioner’s Brief in Response to Order to Show Cause (“Pet. Response”), ECF No. 31. II. Issue At issue is whether Petitioner’s first symptom or manifestation of onset after vaccine administration (specifically pain) occurred within 48 hours as set forth in the Vaccine Injury Table and Qualifications and Aids to Interpretation (“QAI”) for a Table SIRVA. 42 C.F.R. § 100.3(a) I.C & II.C. (2017) (Tdap vaccination); 42 C.F.R. § 100.3(c)(10)(ii) (required onset for pain listed in the QAI). III. Authority Pursuant to Vaccine Act Section 13(a)(1)(A), a petitioner must prove, by a preponderance of the evidence, the matters required in the petition by Vaccine Act Section 11(c)(1). A special master must consider, but is not bound by, any diagnosis, conclusion, judgment, test result, report, or summary concerning the nature, causation, and aggravation of petitioner’s injury or illness that is contained in a medical record. Section 13(b)(1). “Medical records, in general, warrant consideration as trustworthy evidence. The records contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in the balance, accuracy has an extra premium. These records are also generally contemporaneous to the medical events.” Cucuras v. Sec’y of Health & Hum. Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). Accordingly, where medical records are clear, consistent, and complete, they should be afforded substantial weight. Lowrie v. Sec’y of Health & Hum. Servs., No. 03- 1585V, 2005 WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). However, this rule does not always apply. “Written records which are, themselves, inconsistent, should be accorded less deference than those which are internally consistent.” Murphy v. Sec’y of Health & Hum. Servs., No. 90-882V, 1991 WL 74931, *4 (Fed. Cl. Spec. Mstr. April 25, 1991), quoted with approval in decision denying review, 23 Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed.Cir.1992)). And the Federal Circuit recently “reject[ed] as incorrect the presumption that medical records are accurate and complete as to all the patient’s physical conditions.” Kirby v. Sec’y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021). The United States Court of Federal Claims has outlined four possible explanations for inconsistencies between contemporaneously created medical records and later testimony: (1) a person’s failure to recount to the medical professional everything that 3 Case 1:20-vv-00482-UNJ Document 46 Filed 05/12/23 Page 4 of 9 happened during the relevant time period; (2) the medical professional’s failure to document everything reported to her or him; (3) a person’s faulty recollection of the events when presenting testimony; or (4) a person’s purposeful recounting of symptoms that did not exist. La Londe v. Sec’y of Health & Hum. Servs., 110 Fed. Cl. 184, 203-04 (2013), aff’d, 746 F.3d 1335 (Fed. Cir. 2014). The Court has also said that medical records may be outweighed by testimony that is given later in time that is “consistent, clear, cogent, and compelling.” Camery v. Sec’y of Health & Hum. Servs., 42 Fed. Cl. 381, 391 (1998) (citing Blutstein v. Sec’y of Health & Hum. Servs., No. 90-2808, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998). The credibility of the individual offering such fact testimony must also be determined. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367, 1379 (Fed. Cir. 2009); Bradley v. Sec’y of Health & Hum. Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993). A special master may find that the first symptom or manifestation of onset of an injury occurred “within the time period described in the Vaccine Injury Table even though the occurrence of such symptom or manifestation was not recorded or was incorrectly recorded as having occurred outside such period.” Section 13(b)(2). “Such a finding may be made only upon demonstration by a preponderance of the evidence that the onset [of the injury] . . . did in fact occur within the time period described in the Vaccine Injury Table.” Id. The special master is obligated to fully consider and compare the medical records, testimony, and all other “relevant and reliable evidence contained in the record.” La Londe, 110 Fed. Cl. at 204 (citing Section 12(d)(3); Vaccine Rule 8); see also Burns v. Sec’y of Health & Hum. Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that it is within the special master’s discretion to determine whether to afford greater weight to medical records or to other evidence, such as oral testimony surrounding the events in question that was given at a later date, provided that such determination is rational). IV. Relevant Factual Evidence A review of the medical records and other evidence filed in this case shows Petitioner suffered a right shoulder SLAP3 tear in 2010 which continued to cause him pain as late as 2016 (Exhibit 3 at 29-45) and complaints of neck and upper back pain less than six months prior to vaccination in May and August 2018 (id. at 100-11, 126-40).4 There is 3 SLAP stands for Superior Labrum Anterior Posterior. MEDICAL ABBREVIATIONS at 552 (16th ed. 2020). 4 Prior to vaccination, Petitioner also suffered from depression (Exhibit 3 at 3-45, 112-25), neck pain in 2015 (Id. 418-45), and right hand and wrist pain in late 2016 and early 2017 (id. at 46-99). 4 Case 1:20-vv-00482-UNJ Document 46 Filed 05/12/23 Page 5 of 9 no evidence that he suffered any prior left shoulder pain, however. As noted, he received the Tdap vaccine on November 7, 2018. Petitioner first sought treatment for left shoulder pain from his primary care provider (“PCP”) more than two months post-vaccination on January 14, 2019. Exhibit 3 at 141- 44. At that initial visit, he complained of “moderately severe left shoulder pain,” “present for 1.5 months ‘s/p[5] flu[6] shot.’” Id. at 141. He reported that the pain was “aggravated by abduction and rotation.” Id. Upon examination, the PCP observed no swelling, redness, or tenderness but “[l]imited abduction and internal rotation.” Id. at 142. He prescribed Tylenol with codeine and provided referrals for physical therapy (“PT”) and to a pain management clinic. Id. at 143. The same description of Petitioner’s left shoulder pain is found in the medical record from his January 26th visit to the pain management clinic. Exhibit 3 at 158. Under consultation, “progressive L shoulder pain and weakness s/p flu shot” is listed. Id. Referencing Petitioner’s earlier right shoulder SLAP tear diagnosis, the treating physician noted that Petitioner now ha[d] symptoms on the left side and is worried about having a rotator cuff tear of slap lesion.” Id. at 161. The treating physician ordered an MRI, agreed Petitioner should begin PT, and administered a cortisone injection. Id. at 160-62. The MRI, performed on February 9th, showed mild tendinopathy without tearing, slight arthrosis, and mild degeneration of the biceps anchor, but “no significant bursal fluid and/or inflammation.” Id. at 164. At his first PT session on February 1, 2019, Petitioner reported “developing L shld pain since TDAP shot in November.” Exhibit 3 at 177. After three sessions, Petitioner was discharged from PT on March 1st, for a failure to return for treatment. Id. at 212. It was noted that Petitioner’s PCP had authorized PT through April 1, 2019. Id. Following two of the three PT sessions he attended and two days prior to his discharge from PT, Petitioner visited an orthopedist, complaining of “left shoulder pain since November.” Exhibit 3 at 199. At this February 28th visit, he described “[m]inimal pain at rest” in his lateral shoulder which radiated down his arm and was worse with abduction. Id. After reviewing Petitioner’s February 9th MRI, the orthopedist diagnosed him with a “ligament injury possibl[y] a bucket handle tear.” Id. at 198. Mentioning his “prior history 5 S/P stands for status post. MEDICAL ABBREVIATIONS at 552. 6 In his affidavit, Petitioner insists that he was misquoted, maintaining that he indicated the Tdap, rather than the flu, vaccine. Exhibit 6 at ¶ 4. The medical records show that Petitioner also received an influenza (“flu”) vaccine on September 4, 2018, two months prior to receiving the Tdap vaccine alleged as causal. Exhibit 3 at 1. It also was administered in his left deltoid. Id. 5 Case 1:20-vv-00482-UNJ Document 46 Filed 05/12/23 Page 6 of 9 of right shoulder having a slap lesion,” he recommended Petitioner undergo an arthrogram. Id. Approximately one month later, on April 3, 2019, Petitioner was seen at the urgent care clinic, complaining of back pain for two days after recent heavy lifting. Exhibit 3 at 220. It was noted that he had a “[p]rior history of back problems: recurrent self-limited episodes of low back pain in the past.” Id. He was diagnosed with lumbar muscle strain and instructed to apply heat and to take muscle relaxers. Id. at 221. He was seen by his PCP for his lower back pain two times in May 2019. Id. at 230, 245. Petitioner returned to the orthopedist on May 30, 2019. Exhibit 3 at 257. At that visit, he again described moderate left shoulder pain since November 2018. However, next to “[m]echanism of injury,” it is noted that Petitioner had “no hx of trauma.” Id. Petitioner reported that the January cortisone injection “helped [for] about 2.5 months and his shoulder is now about the same as it was before the injection.” Id. After reviewing the earlier MRI, performed on February 9, 2019, the orthopedist amended his earlier opinion, now stating that he believed a “[d]isplaced bucket-handle tear is thought to be less likely,” but reiterated his belief that an MRI arthrogram would be helpful. Id. at 260. The orthopedist administered a second cortisone injection and recommended that Petitioner continue his home exercise program. Id. A few weeks later, Petitioner was seen at the pain management clinic for his lower back pain. Exhibit 3 at 270. It appears that he received multiple trigger point injections. Id. at 274. At his next orthopedic visit on August 30, 2019, Petitioner reported that he obtained two months of relief from the second cortisone injection. Exhibit 3 at 285-86. Although interested in surgery, he indicated that it currently was not a good time due to his work. Id. at 286. Petitioner eventually underwent surgery in late November 2019. Exhibit at 328-37. He attended follow-up orthopedic appointments and PT during December 2019 through mid-January 2020. Id. at 339-415. In addition to the information contained in his medical records, Petitioner has provided a second affidavit and a one-page screen shot of written communications with his finance during the morning of January 3, 2019, approximately two months post- vaccination. Exhibits 5-6. In the affidavit, executed on September 28, 2021, Petitioner described receiving the Tdap vaccine on November 7, 2018, indicating it was administered “high up on [his] left deltoid” while seated and reporting that he “immediately felt pain in [his] upper deltoid.” Exhibit 6 at ¶ 1. In the January 9th message to his finance, Petitioner wrote the following: 6 Case 1:20-vv-00482-UNJ Document 46 Filed 05/12/23 Page 7 of 9 Yeah, just tired. I’ve been looking up my shoulder pain and I’m pretty sure it was caused by my last immunization. I got a Tdap shot in November and it has hurt ever since. I’m finding several things online about vaccine related shoulder injuries. Going to see my doctor in a few weeks. Exhibit 5 at 1. In this one-page screen shot, containing only a portion of the entire conversation, the word Tdap is highlighted. Id. V. Parties’ Arguments When asserting that Petitioner has failed to establish the onset required for a Table SIRVA injury, Respondent emphasizes the following: 1. the two-month delay between vaccination and the date he first complained of left shoulder pain; 2. the January 2019 entries describing his left shoulder pain as present for one and a half months and occurring after the flu, rather than Tdap, vaccine; and 3. the lack of specific language in the medical records identifying exactly when onset occurred. Rule 4(c) Report at 5. He stresses that “Petitioner did not advise a medical provider that his pain began after a Tdap vaccination until he presented to PT on February 1, 2019.” Id. (emphasis added). Regarding the screenshot of the Facebook Message communication between Petitioner and his finance, Respondent observes that it was produced with a date stamp, but no accompanying metadata to confirm its date of creation. Id. at 5 n.7. Countering Respondent’s arguments, Petitioner insists that “[t]he record, as a whole, supports immediate onset.” Pet. Response at 9. He contends that “the only record that suggests a non-immediate onset of symptoms” is the entry regarding onset contained in the medical record from the January 14, 2019 visit to his PCP. Id. at 10. Mentioning several entries describing left shoulder pain since vaccination (id. at 10-11), Petitioner maintains the record from January 14th “is ambiguous at best, and wholly inconsistent with the other descriptions of onset in the record.” Id. at 11. 7 Case 1:20-vv-00482-UNJ Document 46 Filed 05/12/23 Page 8 of 9 VI. Findings of Fact and Dismissal of Table Claim As I stated in my previous order, a two-month delay in treatment is, by itself, unremarkable. In vaccine injury cases, it is common for individuals who have experienced a vaccine-caused SIRVA to delay treatment, thinking his/her injury will resolve on its own. However, when treatment is sought, these individuals usually provide detailed descriptions of the onset of their pain, and display a conviction that their pain was linked to the vaccination they received. In this case, Petitioner showed some hesitancy regarding the cause of his pain – indicating in early January, for example, that he was “pretty sure” it was caused by the Tdap vaccine after performing research on the internet. Exhibit 5 at 1. It is illogical to believe he would have not reached that conclusion earlier if he had experienced the immediate pain he described in his later affidavit. Exhibit 6 at ¶ 1. More significantly, when he first sought treatment on January 14, 2019 – approximately ten days later and two months post-vaccination - Petitioner reported that the pain had been present for only 1.5 months, placing onset at the end of November 2018. Exhibit 3 at 141, 158. Petitioner argues that this initial report is an outlier, inconsistent with the remainder of the evidence, but that characterization is incorrect. Although the medical records contain some entries referring to pain since or post status vaccination – including the record in question - none provide a more detailed or earlier depiction of pain onset. And there are multiple entries showing that the onset of Petitioner’s pain was gradual. Thus, it was described as “progressing” in late January 2019, and then “developing” at his first PT session on January 1, 2019. Id. at 158, 177. Petitioner’s January 14th report of pain which began in late November 2018 aligns with these later medical records. The record in this case supports a finding that the onset of Petitioner’s pain developed gradually, beginning in late November 2018. It does not support Petitioner’s assertion of an immediate pain onset close-in-time to his receipt of the Tdap vaccine. Petitioner has thus failed to provide evidence to establish onset within 48 hours of vaccination as required for a Table SIRVA injury. VII. Potential for Off-Table Claim A petitioner’s failure to establish a Table injury does not necessarily constitute the end of a case under all circumstances, because he or she might well be able to establish a non-Table claim for either causation-in-fact or significant aggravation. See Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005); W.C. v. Sec’y of Health 8 Case 1:20-vv-00482-UNJ Document 46 Filed 05/12/23 Page 9 of 9 & Human Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013) (citing Loving v. Sec’y of Health & Human Servs., 86 Fed. Cl. 135, 144 (2009)). Here, it is conceivable that Petitioner may be able to prove that the Tdap vaccine caused his left shoulder pain injury, despite the delayed and gradual onset described in the medical records. However, he must establish a causal link and appropriate time frame between the Tdap vaccine he received and his left shoulder pain. Formal resolution of this issue will likely require further review and most likely the retention of experts, which I am not inclined to authorize in the SPU. Moreover, this case has already been pending in the SPU for almost two years – meaning it is inadvisable to allow it to stay in SPU any longer. Thus, the claim may go forward as a causation-in-fact claim – but it may no longer remain in SPU. VIII. Conclusion Petitioner has not established the onset of his left shoulder pain occurred within 48 hours of his receipt of the Tdap vaccine on November 7, 2018. Accordingly, his Table SIRVA claim is dismissed. Pursuant to Vaccine Rule 3(d), I will issue a separate order reassigning this case randomly to a Special Master. IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 9 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_20-vv-00482-1 Date issued/filed: 2023-08-03 Pages: 6 Docket text: PUBLIC DECISION (Originally filed: 07/11/2023) regarding 47 DECISION of Special Master Signed by Special Master Christian J. Moran. (ceo) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00482-UNJ Document 48 Filed 08/03/23 Page 1 of 6 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS * * * * * * * * * * * * * * * * * * * * * * * * * CHRIS MCMULLEN, * * No. 20-482v Petitioner, * Special Master Christian J. Moran * v. * * Filed: July 11, 2023 SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * Maximilian Mueller, Muller Brazil, Dresher, PA, for petitioner; Mallori B. Openchowski, United States Dep’t of Justice, Washington, DC, for respondent. DECISION DENYING COMPENSATION1 Chris McMullen alleges that a tetanus-diphtheria-acellular pertussis (“Tdap”) vaccine injured his left shoulder. Pet., filed Apr. 21, 2020. The chief special master found that Mr. McMullen had not persuasively established he suffered a shoulder injury related to vaccine administration (“SIRVA”) and then reassigned the case. After reassignment, Mr. McMullen submitted medical articles and sought a ruling that he was entitled to compensation. Mr. McMullen remains not entitled to compensation as the evidence shows that his shoulder injury started too long after the vaccination. 1 Because this Decision contains a reasoned explanation for the action taken in this case, it must be made publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), the parties have 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. Any changes will appear in the document posted in the website. Case 1:20-vv-00482-UNJ Document 48 Filed 08/03/23 Page 2 of 6 I. Procedural History Mr. McMullen filed his petition on April 21, 2020, and medical records by July 30, 2020, and the case was assigned to the chief special master. After reviewing this material, the Secretary recommended that compensation be denied because Mr. McMullen had not established that his shoulder pain began within 48 hours of the vaccination as required by the implementing regulations. Resp’t’s Rep., filed Dec. 21, 2021, at 5. The parties submitted the question of onset to the chief special master. The chief special master found that Mr. McMullen’s shoulder pain started in late November 2018. Findings of Fact and Conclusions of Law Dismissing Table Claim, 2023 WL 3409215 (posted May 12, 2023) (originally filed July 8, 2022). Because Mr. McMullen received the Tdap vaccine on November 7, 2018, he did not qualify for SIRVA. See 42 C.F.R. § 100.3(c)(10) (requiring that shoulder pain start within 48 hours). Thus, the chief special master dismissed Mr. McMullen’s claim that he suffered an on-Table injury. Findings of Fact at *5-6. However, the chief special master noted that Mr. McMullen might succeed on a causation-in-fact claim with the assistance of an expert. The case was then transferred to the undersigned. To guide the parties’ experts, the undersigned issued a set of instructions. Order, issued July 18, 2022. In an August 11, 2022 status conference, Mr. McMullen expressed dissatisfaction with the Findings of Fact. Mr. McMullen expressed an intention to file a motion for a ruling on the record. Order, issued Aug. 11, 2022. Mr. McMullen submitted two types of material on October 13, 2022. One set of material was a collection of medical articles addressing how a vaccination can cause a shoulder injury. Exhibits 7-16. The other submission was a motion for a ruling on the record. Mr. McMullen argued that he fulfilled the first prong of Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274 (Fed. Cir. 2005) because the Vaccine Table associates Tdap vaccines with a shoulder injury and because he submitted articles. Pet’r’s Mot. at 9. Mr. McMullen next argued that he met the second prong of Althen due to the “absence of any shoulder injury prior to the vaccination, onset of post-vaccination symptoms and Petitioner’s physical examinations and diagnoses.” Id. at 10. Finally, for the third Althen prong, Mr. McMullen maintained that his shoulder pain started immediately following the Tdap vaccine. Id. at 12. In doing so, Mr. McMullen indicated that he “is contemplating filing a Motion for Review” of the chief special master’s fact ruling. Id. at 12 n.2. The Secretary opposed Mr. McMullen’s motion. Resp’t’s Resp., filed Nov. 14, 2022. The Secretary argued that Mr. McMullen cannot qualify for an on-Table SIRVA due to the finding of the chief special master. Id. at 6-7. The Secretary also contended that Mr. McMullen did not establish that he satisfied the elements of a causation-in-fact claim. Id. at 7-10. Mr. McMullen declined to file a reply. Pet’r’s Status Rep., filed Jan. 3, 2023. The case is ready for adjudication. 2 Case 1:20-vv-00482-UNJ Document 48 Filed 08/03/23 Page 3 of 6 II. Relevant Facts The chief special master’s Findings of Fact summarize the evidence, including Mr. McMullen’s medical records and other evidence reflecting the onset of his shoulder pain. For purposes of the present decision two facts are dispositive. First, Mr. McMullen received the Tdap vaccine on November 7, 2018. Second, Mr. McMullen began experiencing shoulder pain “in late November 2018.” Findings of Fact at *6. III. Standards for Adjudication The Vaccine Act authorizes two means of recovery. The simpler way is for petitioners to demonstrate that they received a vaccine and suffered an injury within the time listed on the Vaccine Injury Table. 42 U.S.C. § 300aa–11(c)(1)(C)(i). Alternatively, petitioners may establish that a covered vaccine was the cause-in-fact of an injury. 42 U.S.C. § 300aa– 11(c)(1)(C)(ii). For causation-in-fact claims (also known as off-Table cases), the Federal Circuit has defined petitioners’ burden. Petitioners bear a burden “to show by preponderant evidence that the vaccination brought about [the vaccinee’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 was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278. A petitioner is required to establish his case by a preponderance of the evidence. 42 U.S.C. § 300aa–13(1)(a). The preponderance of the evidence standard requires a “trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the judge of the fact's existence.” Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315, 1322 n.2 (Fed. Cir. 2010) (citations omitted). Proof of medical certainty is not required. Bunting v. Sec'y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). Petitioners may not receive compensation “based upon the claims of a petitioner alone, unsubstantiated by medical records or by medical opinions.” 42 U.S.C. § 300aa–13(a)(1). IV. Analysis The pending motion raises at least two issues. First, what is the permanence of the chief special master’s finding that Mr. McMullen’s shoulder pain started in late November? Second, how does that finding affect the remainder of the case? A. What is the Value of An Earlier Finding by a Special Master? On the topic of whether the chief special master’s finding of onset is binding on the undersigned, the parties’ briefs could have been better. Mr. McMullen directly argues that the “finding that onset likely began gradually in late November of 2018 is not supported by the evidence.” Pet’r’s Mot. at 12. However, Mr. McMullen does not cite any cases regarding the effect of the earlier finding. See id. On the other hand, the Secretary maintains that “under the 3 Case 1:20-vv-00482-UNJ Document 48 Filed 08/03/23 Page 4 of 6 law of the case doctrine, the Chief Special Master’s findings control.” Resp’t’s Resp. at 7, citing Gould, Inc. v. United States, 67 F.3d 925, 927-28 (Fed. Cir. 1995) and Suel v. Sec’y of Health & Hum. Servs., 192 F.3d 981 (Fed. Cir. 1999). The Secretary appears to overlook the role appellate courts play in the law of the case doctrine. The law of the case is a judicially created doctrine, the purposes of which are to prevent the relitigation of issues that have been decided and to ensure that trial courts follow the decisions of appellate courts. The doctrine requires a court to follow the decision on a question made previously during the case.... When a judgment of a trial court has been appealed, the decision of the appellate court determines the law of the case, and the trial court cannot depart from it on remand. Exxon Corp. v. United States, 931 F.2d 874, 877 (Fed. Cir. 1991), quoting Jamesbury Corp. v. Litton Indus. Prod., Inc., 839 F.2d 1544, 1550 (Fed. Cir. 1988). Consequently, the law of the case doctrine “has long been held not to require the trial court to adhere to its own previous rulings if they have not been adopted, explicitly or implicitly, by the appellate court's judgment.” Exxon Corp., 931 F.3d at 877. Exxon Corp. presents an example in which one judicial officer could reconsider a finding made by another judicial officer. Initially, Judge Alex Kozinski found that a company (Essosa) became insolvent on a particular date, although the date of insolvency was not necessary to resolve the case. 931 F.3d at 876. The case was appealed, and the Federal Circuit reversed the outcome without addressing the date of insolvency. Id. Eventually, the successor to Judge Kozinski, Judge Loren Smith, found a different date of insolvency. Id. On this appeal, the Federal Circuit ruled that because its earlier rulings did not consider the date of insolvency, Judge Smith “remained free to amend its earlier finding of fact relating to the date of [the] insolvency.” Id. at 878. The Federal Circuit also addressed the relationship between Judge Kozinski (the original judge) and Judge Smith (the successor judge): “A successor judge steps into the shoes of his or her predecessor, and is thus bound by the same rulings and given the same freedom, as the first judge. To the extent that a trial judge can alter a previous ruling, so too can a successor judge." Id. “At least to the extent it was not dependent upon weighing conflicting testimony and evaluation of witness credibility, Chief Judge Smith had authority to amend his predecessor’s finding as to the date of insolvency as he deemed appropriate.” Id. The two cases the Secretary cites discuss the law of the case doctrine in the context of appellate remands. In Gould, the Federal Circuit held that an intervening Supreme Court opinion did not allow the Court of Federal Claims to depart from the Federal Circuit’s earlier ruling that the Court of Federal Claims possessed jurisdiction. 67 F.3d at 931. In Suel, the Federal Circuit 4 Case 1:20-vv-00482-UNJ Document 48 Filed 08/03/23 Page 5 of 6 ruled that a special master could not reopen entitlement after a judge from the Court of Federal Claims found that the petitioners were entitled to compensation. 192 F.3d at 984. The present case contrasts with Exxon Corp., Gould, and Suel in that an appellate tribunal has not considered any aspect of the chief special master’s finding. Without this appellate review, the chief special master’s finding is subject to reconsideration just as any other finding is subject to reconsideration. Thus, if the Secretary, in arguing that the chief special master’s findings “control”, were contending that the finding is binding, then the Secretary’s argument is not in accord with precedent. A special master to whom a case has been reassigned without any appellate review possesses the ability to reconsider an earlier factual ruling. While, as a matter of law, special masters possess authority to reconsider previous rulings, this exercise of discretion is appropriately limited to narrow circumstances. See Vaccine Rule 10(e); Leming v. Sec’y of Health & Hum. Servs., 161 Fed. Cl. 744, 757 (2022) (indicating that a special master may decline to entertain a motion for reconsideration when the evidence is not new), appeal filed, No. 23-1032 (Fed. Cir. Oct. 12, 2022). These circumstances are even more limited in a case, which is not Mr. McMullen’s case, in which the findings were made after a hearing in which a special master observed a witness’s demeanor. Although Mr. McMullen has not stylized his October 13, 2022 motion as requesting reconsideration of the chief special master’s finding, the motion does argue in favor of finding an immediate onset of Mr. McMullen’s shoulder pain. However, this argument resembles the argument Mr. McMullen presented to the chief special master and the evidence is same. Thus, Mr. McMullen has not demonstrated that the “interest of justice” requires a different outcome. In short, the chief special master’s finding of an onset in late November is reasonable and supported by substantial evidence. B. How the Chief Special Master’s Finding Affects Mr. McMullen’s Off-Table Claim Mr. McMullen has argued that he has met his burden regarding a causation-in-fact claim. Pet’r’s Mot. at 9-13. His argument regarding the appropriate temporal interval is based upon an (erroneous) argument that his shoulder pain started within 48 hours of the vaccination. Id. at 12- 13. Mr. McMullen has not presented any argument that the appropriate time of onset for a shoulder injury following a vaccination might extend more than two weeks. Accordingly, Mr. McMullen has failed to establish the third prong of Althen. This finding means that Mr. McMullen is not entitled to compensation. Thus, an examination of the other Althen prongs is not necessary.2 2 For the first Althen prong, Mr. McMullen argued that the Secretary’s recognition that the administration of some vaccines can cause shoulder injuries and various articles from medical journals support a finding that he presented a theory. Pet’r’s Mot. at 9. However, the Secretary did not answer this argument. See Resp’t’s Resp. at 8-9. 5 Case 1:20-vv-00482-UNJ Document 48 Filed 08/03/23 Page 6 of 6 V. Conclusion Mr. McMullen has not established that he is entitled to compensation via either an on-Table or off-Table claim. Therefore, the Clerk’s Office is instructed to issue a judgment in accord with the decision unless a motion for review is filed. Information about a motion for review, including the deadline, is found in the Vaccine Rules, which are available on the website for the Court of Federal Claims. IT IS SO ORDERED. S/Christian J. Moran Christian J. Moran Special Master 6