Court Opinion

ID: 5118986
Source: CourtListenerOpinion
Date Created: 2021-10-18 13:03:51.747592+00
Date Added: 2024-06-11T08:22:10.592257
License: Public Domain

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                                        UNPUBLISHED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 CAUSE 1
       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).
        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.
       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
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
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
        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.
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