VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00660 Package ID: USCOURTS-cofc-1_20-vv-00660 Petitioner: W.K. Filed: 2019-05-29 Decided: 2022-08-23 Vaccine: rotavirus Vaccination date: 2019-09-16 Condition: intussusception Outcome: dismissed Award amount USD: AI-assisted case summary: Patricia Koapke, as the parent and natural guardian of her minor son W.K., filed a petition on May 29, 2019, alleging that the rotavirus vaccine administered on September 16, 2019, caused W.K. to develop intussusception. Initially, the claim was pursued as a Table claim under the National Vaccine Injury Compensation Program. However, this claim was dismissed by Special Master Brian H. Corcoran on September 15, 2021, because W.K.'s symptoms began 26-28 days after vaccination, which falls outside the 1-21 day onset timeframe specified for intussusception on the Vaccine Injury Table. The Special Master granted Petitioner an opportunity to show cause why the case should proceed as a non-Table, causation-in-fact claim, requiring her to provide a medical or scientific basis for a longer onset period. Petitioner filed an amended petition on September 29, 2021, alleging causation-in-fact. However, Petitioner failed to provide any evidence, such as expert reports or medical literature, to support the contention that intussusception could medically be acceptable as a vaccine injury with an onset beyond the Table's timeframe. Respondent, represented by Sarah Christina Duncan of the U.S. Department of Justice, argued that symptoms typically occur within seven days and pointed to alternative causes for W.K.'s condition, such as his prolapsed appendix and a nodular lesion in his bowel. Special Master Corcoran found that due to the unique nature of intussusception and the scientific evidence supporting only a short onset window, a longer onset timeframe was not medically reasonable. The Special Master noted that while the Table claim allows for a 21-day window, the scientific evidence best supported an increased risk only one to seven days following vaccination. The public decision does not describe the specific symptoms W.K. experienced, any diagnostic tests performed, or treatments received. The Special Master concluded that Petitioner had not demonstrated any basis for a longer onset period and that expert input was unlikely to be fruitful. Consequently, the Special Master dismissed the causation-in-fact claim on August 23, 2022, and the case was dismissed. Petitioner was represented by Maximillian J. Muller of Muller Brazil, LLP. Theory of causation field: Petitioner Patricia Koapke alleged that the rotavirus vaccine administered to minor W.K. on September 16, 2019, caused intussusception. The initial Table claim was dismissed because W.K.'s symptoms began 26-28 days post-vaccination, exceeding the 1-21 day Table timeframe for intussusception. Petitioner sought to proceed on a causation-in-fact theory, but failed to provide any medical or scientific evidence, such as expert reports or literature, to support a medically acceptable longer onset period for intussusception following the rotavirus vaccine. Respondent argued for dismissal, citing scientific evidence that intussusception onset typically occurs within seven days and pointing to alternative causes for W.K.'s condition. Chief Special Master Brian H. Corcoran dismissed the causation-in-fact claim on August 23, 2022, finding that the unique nature of intussusception and the supporting science indicate a short onset window, making a 26-28 day onset medically unreasonable. The public decision does not name specific experts or detail the mechanism of injury beyond the general understanding of intussusception. The case was dismissed without award. Petitioner's counsel was Maximillian J. Muller; Respondent's counsel was Sarah Christina Duncan. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_20-vv-00660-0 Date issued/filed: 2021-10-15 Pages: 7 Docket text: PUBLIC DECISION (Originally filed: 09/15/2021) regarding 18 Findings of Fact & Conclusions of Law,, Order to Show Cause, Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00660-UNJ Document 21 Filed 10/15/21 Page 1 of 7 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-660V UNPUBLISHED PATRICIA KOAPKE, as parent and Chief Special Master Corcoran natural guardian of W.K., a minor, Filed: September 15, 2021 Petitioner, v. Special Processing Unit (SPU); Findings of Fact; Onset; Rotavirus SECRETARY OF HEALTH AND Vaccine; Intussusception HUMAN SERVICES, Respondent. Amy A. Senerth, Muller Brazil, LLP, Dresher, PA, for Petitioner. Adriana Ruth Teitel, U.S. Department of Justice, Washington, DC, for respondent. ORDER (I) GRANTING IN PART MOTION TO DISMISS, AND (II) REQUIRING PETITIONER TO SHOW CAUSE1 On May 29, 2019, Patricia Koapke filed a petition for compensation on behalf of her minor child, W.K., under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”). Petitioner alleges that W.K. developed intussusception, a Table injury, as a result of a rotavirus vaccine administered on September 16, 2019. Petition at 1. 1 Although I have not formally designated this Decision for publication, I am required to post it on the United States Court of Federal Claims' website because it contains a reasoned explanation for the action in this case, 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 Decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, 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-00660-UNJ Document 21 Filed 10/15/21 Page 2 of 7 On October 2, 2020, Respondent filed a Rule 4(c) Report arguing that compensation is not appropriate in this case. Specifically, Respondent argues that W.K.’s injury occurred outside the timeframe set forth in the Table, and also meets one or more of the exclusionary criteria set forth in the Qualifications and Aids to Interpretation (“QAI”) that govern Table claims. ECF No. 12, Respondent’s Rule 4(c) Report (“Report”) at 5-6.3 Respondent concurrently filed a Motion to Dismiss for the reasons set forth in his Rule 4(c) Report. ECF No. 13, Motion to Dismiss, dated October 2, 2020 (“Mot.”) at 1. Petitioner opposes the motion, arguing that she has established a prima facie case for causation and Respondent’s motion is premature. ECF No. 15, Petitioner’s Response to Respondent’s Motion to Dismiss (“Opp.”) at 1-3. Now, having considered both parties’ briefs as well as the medical records, I find that there is not preponderant evidence that Petitioner suffered a Table injury. Petitioner may be able to succeed on a causation-in-fact theory – although she will need to substantiate the contours of such a claim. I. Factual Background W.K. presented to his pediatrician for his two-month well check on September 16, 2019. Ex. 1 at 25. At that time, he received the pneumococcal and rotavirus vaccines. Id. at 26. Less than a month later, on October 14, 2019, W.K. was seen at the emergency room for rectal bleeding and bloody vomit. Ex. 1 at 56. Petitioner and her husband reported that his symptoms began that day. Ex. 3 at 13.4 W.K. had a fever at that time, fullness in the left lower quadrant, but did not appear tender on deep palpitation of his abdomen. Id. at 15. An abdominal x-ray indicated a possible obstruction of the left lower quadrant, and an ultrasound showed a colonic intussusception with marked edematous changes in the colonic wall. Id. at 40, 41. A barium enema was unsuccessful. Id. at 16. W.K. was thereafter admitted to Sanford Bismark Medical Center under the care of Drs. Kimber Boyko and Tod Twogood on October 14, 2019. Ex. 4 at 12-15, 23. Upon admission, Petitioner reported that W.K. had vomited several times over the previous two days. Id. at 23. Further, that morning Petitioner noticed blood in W.K.’s diaper and coming out of his anus. Id. 3 Respondent also argues that Petitioner has not established causation-in-fact. Report at 6-8. 4 The petitioner states that W.K. presented with two days of vomiting and blood in his stool. Petition at 1. However, the medical records are not consistent with this. Case 1:20-vv-00660-UNJ Document 21 Filed 10/15/21 Page 3 of 7 W.K. did not have a fever upon admittance, and received IV fluids prior to emergency surgery on October 14, 2019. He had a large segment of ileum intussuscepted into the ascending and part of the transverse colon that was not able to be manually reduced and was nonviable. Ex. 4 at 12, 48-49. He also had a section of necrotic bowel due to intussusception, including 20 cm of small intestine and ascending colon, and a separate 5 cm segment of transverse colon. Id. at 48-49. Dr. Boyko removed the necrotic bowel and connected the ileum to the transverse colon (an ileocolic anastomosis). Ex. 4 at 48-49. Pathology results revealed intussusception of the terminal ileum into the right colon, a prolapsed appendix, ischemic bowel and necrosis, severe acute inflammation and congestion, and an aggregate of five benign hypertrophic lymph nodes with severe congestion. Id. at 54-55. The pathologist noted in particular that “[d]irectly adjacent to the dusky portion of the bowel, there is a 1.7 x 1.2 x 1. cm dusky purple nodular lesion.” Id. Following surgery, W.K. had signs of shock with fever that was thought to be a response to his bowel injury and surgery. Ex. 4 at 13. He remained in the hospital for the following 15 days due to various complications, including abdominal distension, anemia, sepsis, and blood loss. Id. at 14-26. W.K. was discharged on October 29, 2019 without a fever, and a soft, non-tender and nondistended abdomen. Id. at 29. On October 31, 2019, W.K. had a follow-up visit with his pediatrician and was noted as doing well. Ex. 1 at 23. W.K. was seen again on November 20, 2019, for a well visit and was reported as normal. Id. at 20. That same day, W.K. was seen for a follow-up by Dr. Boyko, who also noted he was doing well. Ex. 4 at 97. II. Procedural History The Petition was filed on May 29, 2020 and alleges a table injury of intussusception resulting from a rotavirus vaccine. ECF No. 1. The Petition also states that the intussusception injury “was caused by the rotavirus vaccine,” indicating that a causation- in-fact non-Table claim is also alleged. Id. at 3. Respondent filed a Rule 4(c) Report on October 2, 2020, arguing that W.K. did not suffer a Table injury because his intussusception occurred outside of the timeframe set forth in the Table. Report at 5. Respondent also argues that W.K. had a preexisting condition, identified as the lead point for intussusception and/or bowel abnormalities, which is an exclusion criterion under the Table. Id. at 6. Respondent concurrently filed a motion to dismiss for the reasons set forth in his report. Mot. at 1. Petitioner opposed the Case 1:20-vv-00660-UNJ Document 21 Filed 10/15/21 Page 4 of 7 motion, arguing that she has established a prima facie case for causation, and also maintaining that Respondent’s motion is premature. Opp. at 1-3. III. Analysis of Substantive Issues Raised by Respondent's Motion A. Requirements of a Table Intussusception Claim A petitioner may prevail on a claim if he has “sustained, or endured the significant aggravation of any illness, disability, injury, or condition” set forth in the Vaccine Injury Table (the Table). Section 11(c)(1)(C)(i). The most recent version of the Table, which can be found at Section 100.3, 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); 42 C.F.R. § 100.3. Finding a petitioner is entitled to compensation cannot be “based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.” Section 13(a)(1). Indeed, contemporaneous medical records are deemed trustworthy proof of petitioner’s medical issues. Cucuras v. Sec’y of Health & Hum. Servs., 993, F.2d 1525, 1528 (Fed. Cir. 1993). Testimony offered after the events in question, by contrast, is considered less reliable, given the need for accurate explanation of symptoms at the time of treatment. Reusser v. Sec’y of Health & Hum. Servs., 28 Fed. Cl. 516, 523 (1993). “It must [also] be recognized that the absence of a reference to a condition or circumstance is much less significant than a reference which negates the existence of the condition or circumstance. Since medical records typically record only a fraction of all that occurs, the fact that reference to an event is omitted from the medical records may not be very significant.” Murphy v. Sec’y of Health & Hum. Servs., 23 Cl. Ct. 726, 733 (Fed. Cl. 1991), aff’d, 968 F.2d 1226 (Fed. Cir. 1992); see also Kirby v. Sec'y of Health & Hum. Servs., 997 F.3d 1378, 1383 (Fed. Cir. 2021) (rejecting as incorrect the presumption that medical records are always accurate and complete as to all of the patient’s physical conditions). However, in balancing these considerations, special masters in this Program have in most cases declined to credit later testimony over contemporaneous records. See, e.g., Stevens v. Sec’y of Health & Hum. Servs., No. 90–221V, 1990 WL 608693, at *3 (Cl. Ct. Spec. Mstr. Dec. 21, 1990); Vergara v. Sec’y of Health & Hum. Servs., No. 08–882V, 2014 WL 2795491, at *4 (Fed. Cl. Spec. Mstr. July 17, 2014) (“Special Masters frequently accord more weight to contemporaneously-recorded medical symptoms than those recounted in later medical histories, affidavits, or trial testimony.”); see also Cucuras, 993 Case 1:20-vv-00660-UNJ Document 21 Filed 10/15/21 Page 5 of 7 F.2d at 1528 (noting that “the Supreme Court counsels that oral testimony in conflict with contemporaneous documentary evidence deserves little weight”). If a petitioner establishes that he has suffered a “Table Injury,” causation is presumed. A Table injury following a rotavirus vaccine requires that intussusception occurs between 1 and 21 days after the vaccination. 42 C.F.R. § 100.3(a)(XI). The QAI provides additional guidance regarding intussusception, and in particular sets forth exclusionary criteria wherein an injury is not considered a Table intussusception. 42 C.F.R. § 100.3(c)(4)(ii). These include when an individual has a preexisting condition identified as the lead point for intussusception, such as intestinal masses and cystic structures, and when an individual has abnormalities of the bowel, including congenital anatomic abnormalities, anatomic changes after abdominal surgery, and other anatomic bowel abnormalities caused by mucosal hemorrhage, trauma, or abnormal intestinal blood vessels. 42 C.F.R. § 100.3(c)(4)(ii)(C), (D). B. Adequacy of Petitioner’s Table Claim Petitioner alleges that W.K.’s symptoms first occurred, consisting of vomiting, on October 12, 2019. Petition at 1-2. However, the medical records indicate that W.K.’s symptoms first manifested either on October 12 or October 14. Ex. 1 at 56 (noting W.K.’s symptoms began on October 14, 2019); Ex. 4 at 23 (reporting on October 14, 2019 that W.K. had vomited several times over the previous two days). But neither date saves the Table claim – for in either case, W.K.’s first symptoms began either 28 or 26 days after his rotavirus vaccine, and thus outside the 21-day timeframe set forth in the Table. 42 C.F.R. § 100.3(a)(XI). There are few cases that discuss the outside range of when intussusception can be attributed to a rotavirus vaccine. However, at least one case involving intussusception where the injury occurred outside twenty-one days resulted in dismissal of the Table claim. Carda v. Sec'y of Health & Hum. Servs., No. 14-191V, 2016 WL 3571539, at *1 (Fed. Cl. Spec. Mstr. May 24, 2016) (motion to dismiss table claim granted in case where intussusception occurred fifty-seven days after the second rotavirus vaccine dose). Further, in Carda there was no medically acceptable timeframe suggesting an intussusception following a rotavirus vaccination would occur more than twenty-one days post-vaccination – casting doubt on any form of non-Table claim. Carda v. Sec'y of Health & Hum. Servs., No. 14-191V, 2017 WL 6887368, at *21 (Fed. Cl. Nov. 16, 2017). Petitioner’s inability to establish onset in the proper timeframe is thus by itself sufficient basis for the Table claim’s dismissal.5 5 With regard to the exclusionary criteria cited by Respondent, there is simply not enough evidence to establish that the prolapsed appendix or “dusky purple nodular lesion” in the bowl qualify as either a Case 1:20-vv-00660-UNJ Document 21 Filed 10/15/21 Page 6 of 7 C. Resolution of Non-Table Claim Petitioner’s failure to establish a Table claim still leaves the possibility that the matter could advance as a causation-in-fact non-Table claim. To establish entitlement for a Non–Table claim, a petitioner must satisfy all three of the elements set forth in by the Federal Circuit in Althen: “(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 v. Sec'y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Here, Petitioner may be able to show that a longer onset was still medically acceptable, under a causation-in-fact theory. But the admittedly-limited prior case law bearing on that kind of intussusception claim supports a short temporal connection between a rotavirus vaccine and acute intussusception. In Carda, for example, petitioners unsuccessfully attempted to establish an intussusception that occurred seven or eight weeks after receipt of a rotavirus vaccine was causally related to that vaccine. Carda, 2017 WL 6887368 at 23. In that case, I noted that there was no medically acceptable evidence to support the conclusion that intussusception would occur more than 21 days after a rotavirus vaccination (the timeframe allowed for in a Table claim). Id. at 21. A non-Table version of an intussusception claim is of course not bound by the same 21-day timeframe (although Program petitioners cannot rely on how “close” they are to meeting it). Rowan v. Sec'y of Health & Hum. Servs., No. 17-760V, 2020 WL 2954954, at *15 (Fed. Cl. Apr. 28, 2020) (“controlling and persuasive Program precedent does not permit claimants to rely on the Table requirements, or even the mere existence of a Table version of a claim, in proving a non-Table claim”). It is not certain to me based on the present record whether a non-Table claim could be persuasively advanced. I will, however, provide Petitioner the opportunity to file an amended claim, and then show cause why such a claim should be permitted to proceed, setting forth the evidence (and if possible, the science) that would support the claim. I will thereafter transfer the claim out of SPU for adjudication of the non-Table claim if it is evident that such a claim might be tenable. preexisting condition that was identified as a lead point for the injury, or an abnormality of the bowel. But the insufficiency of evidence supporting a Table onset is ample grounds for that claim’s dismissal. Case 1:20-vv-00660-UNJ Document 21 Filed 10/15/21 Page 7 of 7 IV. Conclusion Petitioner has failed to file preponderant evidence to establish W.K. suffered a Table claim. Accordingly, • Petitioner’s Table Claim for intussusception is dismissed; • Petitioner may file an amended petition alleging a causation-in-fact claim by no later than September 29, 2021; and • Petitioner shall show cause by October 14, 2021, why she should be permitted to advance this matter as a non-Table claim. Respondent may oppose on or before October 29, 2021. IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_20-vv-00660-1 Date issued/filed: 2022-08-23 Pages: 5 Docket text: PUBLIC DECISION (Originally filed: 07/07/2022) regarding 26 DECISION of Special Master, Signed by Chief Special Master Brian H. Corcoran. (kp) Service on parties made. -------------------------------------------------------------------------------- Case 1:20-vv-00660-UNJ Document 28 Filed 08/23/22 Page 1 of 5 CORRECTED In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-660V (not to be published) PATRICIA KOAPKE, as parent and Chief Special Master Corcoran natural guardian of W.K., a minor, Petitioner, Filed: July 7, 2022 v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. Maximillian J. Muller, Muller Brazil, LLP, Dresher, PA, for Petitioner. Sarah Christina Duncan, U.S. Department of Justice, Washington, DC, for Respondent. DECISION1 On May 29, 2019, Patricia Koapke filed a petition for compensation on behalf of her minor son, W.K., under the National Vaccine Injury Compensation Program. 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”). Petitioner alleged a Table claim involving the injury of intussusception caused by the rotavirus vaccine. ECF No. 1, Petition (“Pet.”) at 1. The matter was assigned to the Special Processing Unit. In September 2021, I dismissed the Table intussusception claim based on my finding that W.K.’s symptoms began outside the onset timeframe specified for such a claim. Ruling and Order, dated September 15, 2021 (ECF No. 18) (the “Show Cause Order”). I did not dismiss the case entirely, however, noting that a non-Table version of 1 Because this unpublished decision contains a reasoned explanation for the action in this case, the undersigned intends to post it on the United States Court of Federal Claims' website, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012)(Federal Management and Promotion of Electronic Government Services). In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits within this definition, the undersigned will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:20-vv-00660-UNJ Document 28 Filed 08/23/22 Page 2 of 5 the claim might be tenable – although Petitioner would need to substantiate how such a claim could succeed, given the existence of some relevant prior decisions suggesting a too-long onset was not medically acceptable. Show Cause Order at 6-7. Both sides have now filed briefs on the topic. Petitioner’s Brief, dated November 15, 2021 (ECF No. 22) (“Br.”); Respondent’s Opposition, dated December 6, 2021 (ECF No. 24) (“Opp.”). Having reviewed the parties’ submissions, I hereby dismiss the non- Table version of the claim, for the reasons set forth below. ANALYSIS A full summary of the facts is set forth in my prior decision dismissing the Table claim. See generally Show Cause Order at 2–3. In short, W.K. received the rotavirus vaccine on September 16, 2019. He was later diagnosed with intussusception,3 but did not become symptomatic until 26-28 days after receiving the vaccine, which is outside the 1-21 day timeframe set forth for a Table intussusception claim. Pet. at 1; Show Cause Order at 5. Accordingly, the Table claim could not tenably advance. Id at 7. I noted, however, that Petitioner might be able to show a longer onset was medically acceptable, although she would need to provide some scientific or medical basis for allowing this to occur. Id. Therefore, I ordered her to show cause as to why this matter should be advanced as a non-Table claim, and to file an amended petition if she was asserting a causation-in-fact claim. Id. Petitioner filed an amended petition on September 29, 2021, revising her claim to allege W.K.’s intussusception was caused in fact by the rotavirus vaccine. ECF No. 22, Petitioner’s Response to Order (“Resp.”) at 7. Petitioner’s response to my Show Cause Order was subsequently filed on November 15, 2021, emphasizing that the case can move forward as a non-Table claim. Resp. at 7. Petitioner argued that the lack of on-point case law at least established that the contention about onset had never been explicitly rejected. See Id. at 6. Therefore, she should be given the opportunity to support this argument with an expert report and other persuasive evidence. Id. at 7. Petitioner did not, however, provide any evidence (whether a tentative report or item of medical/scientific literature) that in any way might support the conclusion that a post-vaccination intussusception onset of a week or more beyond the Table period might be medically acceptable. 3 The Table defines intussusception as “the invagination of a segment of intestine into the next segment of intestine, resulting in bowel obstruction, diminished arterial blood supply, and blockage of the venous blood flow” which typically causes sudden abdominal pain. 42 C.F.R. § 100.3(c)(4)(i). 2 Case 1:20-vv-00660-UNJ Document 28 Filed 08/23/22 Page 3 of 5 Respondent reacted to Petitioner’s filing on December 6, 2021, requesting the case be dismissed for reasons set forth in their Rule 4(c) Report. ECF No. 24, Respondent’s Reply to Petitioner’s Response (“Reply”) at 5. Specifically, Respondent reiterated the contention that a longer onset of intussusception following the rotavirus vaccine was not medically acceptable. Id. This contention was supported by scientific evidence indicating symptoms onset would typically occur within seven days of vaccination, making the 21-day timeframe set forth in the table intentionally generous. Id. Respondent also noted that Petitioner had not been formally prevented from filing an expert report, and has had ample time to do so. Id. at 4. Moreover, Respondent emphasized that none of W.K.’s treating physicians believed the rotavirus vaccine caused his intussusception, and pointed to W.K.’s prolapsed appendix and the dusky purple nodular lesion in his bowel as alternative causes to his post-vaccination intussusception. Id. at 4–5. Thus, Respondent argued that Petitioner could not substantiate a causation- in-fact claim. Id. at 5. I find that the sui generis nature of an intussusception injury claim weighs against allowing this petition to proceed. Intussusception is a unique injury in the Vaccine Program. Medical science supports an association with the rotavirus vaccine, albeit in a very short/acute timeframe. See National Vaccine Injury Compensation Program: Addition of Intussusception as Injury for Rotavirus Vaccines to the Vaccine Injury Table, 80 Fed. Reg. 35848 (June 23, 2015). But because intussusception can easily be treated quickly (via an invasive surgical procedure), the injury cannot satisfy the Act’s severity requirement, since full recovery can occur well within six months of vaccination. 42 U.S.C. §300aa-11(c)(1)(D) (1998). To get around this statutory contradiction, in 2000 the Vaccine Act was amended in response to the persuasive evidence linking the rotavirus vaccine and intussusception. See Children’s Health Act, Pub. L. No. 106-310, § 1701, 114 Stat. 1101, 1151 (2000) (codified as amended at 42 U.S.C. §300aa-11(c)(1)(D)). The amendment added the Table claim, and an exception to the six-month severity requirement was also created for injuries requiring “surgical intervention.” 42 U.S.C. §300aa- 11(a)(XI)(A); 42 U.S.C. §300aa-11(c)(1)(D). Although the Table intussusception claim allows any intussusception occurring within 21 days of vaccination to be actionable, this timeframe is understood to be overbroad. HHS emphasized in enacting the claim that the evidence best supported an increased risk of intussusception only one to seven days following vaccination (with peaks in the fourth and fifth days). 80 Fed. Reg. 35838. Thus, the 21-day timeframe set forth by the Table is more reflective of the Program’s policy goals of generosity than what the science supports – and this in turn suggests that onset timeframes that exceed the Table 3 Case 1:20-vv-00660-UNJ Document 28 Filed 08/23/22 Page 4 of 5 period are not likely to be medically reasonable, absent new research or discoveries showing that post-vaccination intussusception onset can occur in a longer timeframe than previously thought. The above reasoning has been implicitly embraced in some causation-in-fact cases in which a timeframe onset well outside the Table period was alleged. See, e.g., Carda v. Sec’y of Health & Hum. Servs., No. 14-191V, 2016 WL 3571539, at *2 (Fed. Cl. Spec. Mstr. Nov. 16, 2017). In Carda, (which I decided), the petitioners failed to prove that the rotavirus vaccine could cause transient intussusceptions that led to an acute episode requiring surgical intervention eight weeks after a second dose. While the facts of that case are not precisely on point, the result in Carda shows that an onset exceeding the Table period is not likely to be medically or scientifically reliable. I have provided Petitioner herein the opportunity to identify some evidence suggesting that expert input would be worthwhile on this question of onset exceeding the Table timeframe (short of simply filing a report). But Petitioner has failed to offer any scientific/medical support for a longer onset. Nor has she pointed to any previous cases where the rotavirus vaccine was shown (in the context of a non-Table claim) to cause intussusception in a longer timeframe than what is established by the Table. Response at 8. The fact that no cases specifically reject the concept is not the same as a conclusion that evidence supports it. Petitioner nevertheless asks for the opportunity to identify an expert who “might” be able to support the claim with an opinion. Response at 8. But special masters are tasked with determining what evidence is relevant or required to resolve a given case. Vaccine Rules 3(b)(1), 7(a), 8(a). They may therefore deny requests to offer evidence when the effort is likely to be futile. And here, Petitioner has not demonstrated any more than a hope that a longer onset could be defended – despite a fair opportunity, she has not offered any evidence at all that would suggest a 26 to 28 day post-vaccination onset could be medically acceptable for an injury otherwise understood to occur close-in-time to vaccination. Therefore, given the unique nature of an intussusception injury, and the science supporting only a fraction of the Table’s onset timeframe, I do not find that expert input on this matter is likely to be fruitful or result in an efficient and expeditious determination. There is no doubt that a petitioner’s inability to meet all the Table elements of a given claim does not always mean the entire petition should be dismissed. Rather, for some kinds of injuries, fairness dictates that the petitioner be allowed the opportunity to prove a causation-in-fact version of their claim. For example, a flu-GBS Table claim is not viable, even if onset occurs in the defined timeframe, when the injury turns out to be CIDP 4 Case 1:20-vv-00660-UNJ Document 28 Filed 08/23/22 Page 5 of 5 – yet such a claim provides reasonable grounds for a causation-in-fact claim. See, e.g., Nieves v. Sec’y of Health & Hum. Servs., No. 18-1602V, 2021 WL 841488 (Fed. Cl. Spec. Mstr. Jan. 11, 2021) (dismissing Table flu-GBS claim where CIDP was established injury, but allowing non-Table claim to proceed based on same set of facts). And I have tried cases in which a claimant could not meet a Table claim’s onset timeframe, but it appeared that some science existed to support the contention that a longer timeframe might be medically acceptable. See, e.g., Greene v. Sec’y of Health & Hum. Servs., No. 11-631V, 2019 WL 4072110 (Fed. Cl. Spec. Mstr. Aug. 2, 2019) (dismissing non-Table claim of brachial neuritis after Tdap vaccine; petitioner offered reasonable evidence that longer onset was medically acceptable, even though he was ultimately unsuccessful), mot. for review den’d, 146 Fed. Cl. 655, 669 (2020), aff’d, 841 F. App’x. 195, 205 (Fed. Cir. 2020). But the idiosyncratic nature of intussusception as a vaccine injury calls for a different outcome entirely. An onset of 26 to 28 days post-vaccination is simply not likely to be medically acceptable, given what is known about intussusception. For these reasons, Petitioner’s causation-in-fact claim for compensation is DISMISSED. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court SHALL ENTER JUDGMENT in accordance with the terms of this Decision.4 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 4 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment if (jointly or separately) they file notices renouncing their right to seek review. 5