     In the United States Court of Federal Claims
                                     OFFICE OF SPECIAL MASTERS
                                           Filed: May 10, 2017

* * * * * * * * * * * * * * * * * * *
                                    *
RETA ERXLEBEN,                      *
                                    *                                      No. 14-385V
                  Petitioner,       *
v.                                  *                                      Special Master Gowen
                                    *
SECRETARY OF HEALTH                 *                                      Influenza (“Flu”) Vaccine;
AND HUMAN SERVICES,                 *                                      Dysphagia; Vocal Cord Dysfunction;
                                    *                                      Failure to Obtain Expert Report;
                  Respondent.       *                                      Dismissal for Insufficient Proof.
                                    *
* * * * * * * * * * * * * * * * * * *

Edward M. Kraus, Law Offices of Chicago Kent, Chicago, IL, for petitioner.
Sarah C. Duncan, U.S. Dept. of Justice, Washington, DC, for respondent.

                                                    DECISION1

       On May 4, 2014, Reta Erxleben (“petitioner”) filed a petition pursuant to the National
Vaccine Injury Compensation Program.2 Petition, ECF No. 1. Petitioner alleged that she
suffered from dysphagia, vocal cord dysfunction, and laryngeal dystonia caused-in-fact by an
influenza (“flu”) vaccine administered on September 14, 2011. Petition at Preamble. As
discussed below, petitioner has not been able to obtain a medical opinion supporting her claim.
Therefore, this case is dismissed for insufficient proof.

       I.     Background

        On May 4, 2014, petitioner filed her claim in the Vaccine Program. During the initial
status conference on June 9, 2014, the undersigned directed petitioner to file outstanding medical

1
  Because this decision contains a reasoned explanation for the undersigned’s action in this case, the undersigned
intends to post this ruling on the website of the United States Court of Federal Claims, in accordance with the E-
Government Act of 2002, 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). As provided by Vaccine Rule 18(b), each party has 14 days within which to request
redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in
substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which
would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b).

2
 The Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-10 et seq.
(hereinafter “Vaccine Act” or “the Act”). Hereafter, individual section references will be to 42 U.S.C. § 300aa of the
Act.


                                                            1
records and to subsequently file an expert report opining that the flu vaccine was the cause in
fact of petitioner’s condition, under Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274,
1278 (Fed. Cir. 2008). Order, filed June 13, 2014 (ECF No. 5). Petitioner secured an expert and
filed her two reports. Petitioner’s Exhibit 56, filed January 14, 2015 (ECF No. 17); Petitioner’s
Exhibit 58, filed July 9, 2015 (ECF No. 25). Respondent filed a Rule 4(c) report recommending
against compensation, as well as two responsive expert reports. Rule 4(c) report, filed April 15,
2015; Respondent’s Exhibit A, filed April 15, 2015 (ECF No. 22); Respondent’s Exhibit C, filed
December 7, 2015 (ECF No. 34).

       During a status conference on January 6, 2016, the undersigned ordered petitioner to have
her expert review the additional medical records and to file another report no later than March 7,
2016. Order, filed January 6, 2016 (ECF No. 36). The undersigned scheduled an entitlement
hearing to take place on March 9, 2017 and March 10, 2017. Hearing Order, filed February 9,
2016 (ECF No. 38).

        At petitioner’s request, the undersigned held a status conference on November 22, 2016.
Order, filed November 22, 2016 (ECF No. 44). Petitioner reported that her expert was no longer
available to support the claim. Id. Accordingly, the undersigned cancelled the hearing
scheduled for March 2017. Id. Petitioner’s counsel advised that he had already contacted
another expert about possibly supporting petitioner’s claim. Id. The undersigned directed
petitioner to file a status report on this expert’s decision no later than December 15, 2016. Id.
Petitioner subsequently advised that the second expert was unable to offer an opinion in this
case. Status Report, filed December 15, 2016 (ECF No. 45).

       During a status conference on January 19, 2017, petitioner’s counsel stated that he was
continuing to seek another expert. Order, filed January 23, 2017 (ECF No. 47). On February 9,
2017, petitioner’s counsel indicated that he had not been successful and requested another status
conference to discuss how to proceed in light of these circumstances. Status Report, filed
February 9, 2017 (ECF No. 48).

        Petitioner then filed a report from Dr. Marcel Kinsbourne. Petitioner’s Exhibit 75, filed
March 28, 2017 (ECF No. 49). In his report, Dr. Kinsbourne offered a diagnosis of paradoxical
vocal cord motion disorder (“PVCM”). Id. at 1. He opined that the mechanism of PVCM is
uncertain. Id. at 2. However, his “extensive search” of the literature on this disorder “failed to
reveal any indication that a vaccination could provoke its onset, or any mechanism by which it
might do so. Specifically, there is no suggestion that PVCM might be immune-mediated.” Id.

        On March 30, 2017, the undersigned held a status conference with petitioner, petitioner’s
counsel, and respondent’s counsel. Order to Show Cause, filed March 31, 2017 (ECF No. 50).
The undersigned stated that he did not believe that petitioner will be able to demonstrate that her
condition was caused by the flu vaccine. While petitioner’s condition developed in close
temporal proximity to the vaccine, timing alone is not sufficient to show entitlement. To prevail,
petitioner would need to submit a medical opinion or medical literature supporting that the
vaccine actually caused her condition. The undersigned that in 2015, petitioner filed two reports
from an expert who then withdrew from the case. Petitioner’s counsel diligently attempted to
secure a supportive opinion from another expert. Petitioner’s counsel was only able to secure an


                                                 2
opinion from Dr. Kinsbourne, who wrote there was no evidence that PVCM can be caused by a
vaccine or is immune-mediated. Petitioner’s counsel had also indicated that he would seek leave
to withdraw from the case. Following this discussion, petitioner expressed a desire to attempt to
seek an expert on her own. The undersigned granted petitioner an additional thirty days, until
May 1, 2017, to attempt to locate an expert and supportive medical literature. The undersigned
advised petitioner that if an expert is not located in that time, her case would be dismissed for
insufficient proof.

        On April 24, 2017, petitioner filed additional records of treatment by an otolaryngologist
and a primary care physician. ECF No. 51. On April 26, 2017, petitioner filed a response, which
she wrote herself, to the Order to Show Cause. ECF No. 52. The response addressed one aspect
of respondent’s Rule 4(c) report. It also detailed petitioner’s health before the flu vaccine, her
allergies, her research on the flu vaccine she received, and her theories of how the flu vaccine
might have caused her condition, and her current condition. To date, petitioner has not filed an
expert report or any medical literature in support of her claim, or indicate that she has made any
progress towards doing so.

     II.   Analysis

        To receive compensation under the Vaccine Act, a petitioner must prove either that (1) she
suffered a “Table injury” – i.e., she suffered a specified injury within a specified period of time
following the administration of a specified vaccine listed on the Vaccine Injury Table or (2) that
her injuries were actually caused by a vaccine listed on the Table. §§ 300aa-13(a)(1)(A); §§ 300aa-
11(c)(1). The records do not suggest, and petitioner does not contend, that she suffered a Table
injury. Thus, she is necessarily pursuing a causation-in-fact claim. She has the burden of
presenting (1) a medical theory; (2) a logical sequence of cause and effect; and (3) a medically
acceptable temporal relationship between the vaccination and the injury. Althen, 418 F.3d at 1278
(Fed. Cir. 2008).

        Under the Vaccine Act, a petitioner may not be found eligible to receive compensation
based solely on her own claims. § 300aa-13(a)(1). Rather, the petition must be supported by
either medical records or by medical opinion. § 300aa-13(a)(1).

         In this case, because the medical records do not support petitioner’s claim, she must file a
medical opinion – either in the form of an expert report or medical literature. Petitioner was first
informed of this burden during the initial status conference on June 9, 2014. Petitioner’s injury
is not often, if ever, seen in the Program. Petitioner did initially obtain an expert, who withdraw
from the case in November 2016. For the next four months, petitioner’s counsel - who has
significant experience in the Vaccine Program – diligently attempted to find another expert.
Counsel managed to obtain an opinion from Dr. Kinsbourne, an expert neurologist who has
testified in support of other petitioners’ claims in the Vaccine Program and is aware of its
requirements. However, Dr. Kinsbourne ultimately could not offer an opinion in support of
petitioner’s claim. After fully reviewing the record and holding a status conference with
petitioner, I granted her an additional thirty days to pursue a supportive expert opinion and
medical literature. To date, petitioner has not filed an expert report or given any indication that
she will be able to do so. Instead of filing the required medical opinion, petitioner filed her own


                                                  3
theory of the case. I sympathize with petitioner and appreciate the detailed history she has
provided. However, it is not sufficient to establish causation. It is not from a medical expert,
which in the case of this very unusual injury, would be particularly necessary. In fact, the most
recent expert report that petitioner’s counsel was able to obtain found no evidence of a causal
relationship between the vaccine and petitioner’s condition. Petitioner’s self-written response
details the chronology, but does not and could not address the first two Althen prongs, i.e., a
medically and scientific theory as to how the vaccine could cause the injury, and a logical
explanation of how it did. Petitioner’s self-written response only presents a temporal association
between the vaccine and the onset of her symptoms. However, timing cannot stand on its own
without a theory. In summary, there is insufficient evidence to support petitioner’s claim. 3

    III.     Conclusion

    Petitioner’s claim is DISMISSED for insufficient proof. The Clerk SHALL ENTER
JUDGMENT accordingly.

         IT IS SO ORDERED.

                                                                         s/Thomas L. Gowen
                                                                         Thomas L. Gowen
                                                                         Special Master




3
  Counsel also seems to recognize the difficulties with petitioner’s claim. Her current counsel filed petitioner’s
claim in May 2014. After working diligently on her behalf for almost three years, in March 2017, he stated his
intention to withdraw from the case. However, petitioner has not managed to obtain substitute counsel.

                                                           4
