Court Opinion

ID: 2680460
Source: CourtListenerOpinion
Date Created: 2014-06-25 16:01:01.900634+00
Date Added: 2024-06-11T13:14:55.545476
License: Public Domain

In the United States Court of Federal Claims
                              OFFICE OF SPECIAL MASTERS
                                      No. 13-668V
                                     March 13, 2014
                                    Not to be Published

*****************************
GERALD LEONARDI, III,                              *
                                                   *
                               Petitioner,         *
                                                   *
        v.                                         *         Tdap vaccine; eight-week
                                                   *         onset to seizure; petitioner
                                                   *         moves for dismissal; petitioner’s
SECRETARY OF HEALTH                                *         expert Dr. Blitshteyn prefers not
AND HUMAN SERVICES,                                *         to offer an opinion
                                                   *
                               Respondent.         *
                                                   *
*****************************
Jeffrey S. Pop, Beverly Hills, CA, for petitioner.
Ryan D. Pyles, Washington, DC, for respondent.

MILLMAN, Special Master
                                           DECISION1

       Petitioner filed a petition on September 11, 2013, under the National Childhood Vaccine
Injury Act, 42 U.S.C. § 300aa-10-34 (2012). Petitioner alleges that his Tdap vaccination on
October 14, 2010, caused a seizure one week later. All the medical histories petitioner gave to

1
  Because this decision contains a reasoned explanation for the special master’s action in this
case, the special master intends to post this decision on the United States Court of Federal
Claims’s website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116
Stat. 2899, 2913 (Dec. 17, 2002). Vaccine Rule 18(b) states that all decisions of the special
masters will be made available to the public unless they contain trade secrets or commercial or
financial information that is privileged and confidential, or medical or similar information whose
disclosure would constitute a clearly unwarranted invasion of privacy. When such a decision is
filed, petitioner has 14 days to identify and move to redact such information prior to the
document’s disclosure. If the special master, upon review, agrees that the identified material fits
within the categories listed above, the special master shall redact such material from public
access.
treating doctors show an eight-week onset. Petitioner submitted an expert report from Dr.
Svetlana Blitshteyn, a neurologist, saying that Tdap vaccine caused petitioner’s seizures. Ex. 9,
at 4. Dr. Blitshteyn relied on petitioner’s and his wife’s affidavits that the onset was one week,
and remarked that “the first medically documented episode of loss of consciousness after
dizziness” occurred about eight weeks after vaccination. Id. at 1, 3.

       On January 8, 2014, the undersigned held a telephonic status conference with petitioner
and respondent, explaining that Dr. Blitshteyn’s report does not answer the question whether she
would support causation if she assumed the onset of seizures was eight weeks as medically
documented, and not one week as petitioner and his wife wrote in their affidavits. Petitioner’s
counsel did not know if Dr. Blitshteyn would support causation if she accepted an eight-week
onset. In an Order dated January 8, 2014, the undersigned ordered petitioner to file a
supplemental expert report from Dr. Blitshteyn answering that question.

        On March 14, 2014, petitioner filed the supplemental report of Dr. Blitshteyn, in which
she states that if she were to rely on the medical records alone, which consistently note onset was
eight weeks after vaccination, that timeline would be “less compatible with vaccination-related
seizure disorder. . . .” Ex. 19, at 1. Dr. Blitshteyn concludes: “Given the uncertainty about the
timeline, I would prefer not to offer an opinion connecting Petitioner’s seizures to the Tdap
vaccination administered on October 14, 2010.” Id.

        On March 13, 2014, the undersigned held another telephonic status conference with
petitioner and respondent and asked petitioner’s counsel if petitioner is dismissing in light of Dr.
Blitshteyn’s refusal to support causation in this case. Petitioner’s counsel orally moved to
dismiss.

       The undersigned grants petitioner’s motion and dismisses his case.

                                              FACTS

       Petitioner was born on November 19, 1985.

       On October 14, 2010, he received flu vaccine and Tdap vaccine. Med. recs. Ex. 2, at 1,
3. (Petitioner does not allege that he had a reaction to flu vaccine.)

        On December 8, 2010, petitioner saw his personal care physician, Dr. Allan Wohl, and
stated that he had fainted at work on December 7, 2010, but refused to go to the hospital. Med.
recs. Ex. 2, at 2.

        On December 8, 2010, on referral from Dr. Wohl, petitioner saw Dr. Craig Frankil, a
cardiologist, for a cardiovascular consultation. Id. at 4. Petitioner gave Dr. Frankil a history
that he had no real significant past medical history. Id. At work earlier that week, he had a
documented syncopal event. Id. He was unconscious for five minutes. Id. He did not have
chest pain, pressure, burning, or lightheadedness, but he did have dizziness. Id. Petitioner

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denied that he had any prior syncopal event in the past. Id. Dr. Frankil diagnosed petitioner with
syncopal event, smoking disorder, and obesity. Id. at 5.

        On December 22, 2010, petitioner was taken to Aria Health Emergency Department by
ambulance, where he told Dr. Bakhshish S. Sandhu that he had been at McDonald’s when he felt
lightheaded and woke in an ambulance. Id. at 15. Petitioner said he had a shaking episode,
which lasted about five minutes. Id. Afterward, he felt confused. Id. Petitioner told Dr. Sandhu
that he had a similar episode about two weeks ago but refused to be evaluated at that time,
although he did follow up with his family doctor who sent him to a cardiologist for an
evaluation. Id. Dr. Sandhu diagnosed petitioner with seizure vs. syncope and prescribed
Topamax. Id.

        Also on December 22, 2010, petitioner saw Dr. Robert Quinby, who wrote a history.
Med. recs. Ex. 5, at 64. Petitioner had an apparent seizure that morning at McDonald’s when he
became lightheaded and then woke up in an ambulance. Id. He was told he had a shaking
episode that lasted about five minutes. Id. Afterward, he felt confused and noted mild
discomfort in the back of his head. Id. He had a similar episode about two weeks ago, but
refused medical evaluation at that time. Id. He did follow up with his PCP, who sent him to a
cardiologist for evaluation. Id. Petitioner’s symptoms began as noted and he did not have a
prior history of a similar problem. Id.

        On December 23, 2010, petitioner saw Dr. Jay Klazmer, a neurologist. Med. recs. Ex. 2,
at 19. Petitioner told Dr. Klazmer that his initial episode began two weeks earlier, associated
with a transient mental fogginess and sphincter incontinence. Id. On December 22, 2010, while
at McDonald’s, petitioner suddenly became lightheaded and fell to the ground. Id. He woke in
an ambulance and was taken to Virtua Hospital Mt. Holly, where he refused to be treated. Id.
He walked back to his car several blocks away. Id. His mother-in-law brought him to Atria ED,
and he was admitted. Id. He recalled feeling foggy mentally after the episode, which gradually
remitted. Id. An EEG showed generalized theta slowing without focal or epileptiform features.
Id. at 20. Dr. Klazmer diagnosed petitioner with either convulsive syncope or recurrent seizures.
Id.

                                         DISCUSSION

       To satisfy his burden of proving causation in fact, petitioner must prove by preponderant
evidence: “(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 HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). In Althen, the Federal Circuit quoted its opinion
in Grant v. Secretary of Health and Human Services, 956 F.2d 1144, 1148 (Fed. Cir. 1992):

               A persuasive medical theory is demonstrated by “proof of a logical
               sequence of cause and effect showing that the vaccination was the
               reason for the injury[,]” the logical sequence being supported by

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               “reputable medical or scientific explanation[,]” i.e., “evidence in
               the form of scientific studies or expert medical testimony[.]”

Althen, 418 F.3d at 1278.

       Without more, “evidence showing an absence of other causes does not meet petitioner’s
affirmative duty to show actual or legal causation.” Grant, 956 F.2d at 1149. Mere temporal
association is not sufficient to prove causation in fact. Id. at 1148.

        The Vaccine Act does not permit the undersigned to rule for petitioner based on his
claims alone, “unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa-
13(a)(1) (2012). His affidavit and that of his wife are not sufficient legally to support his
allegation of causation from Tdap vaccine.

       The medical records do not support his allegation that Tdap vaccine caused his seizure
disorder. Petitioner told five different doctors that the onset of his dizzy spells was December 7,
2010, or two weeks before December 22, 2010, which is about eight weeks after vaccination on
October 14, 2010. When asked by various doctors if he had any syncopal episodes before early
December, petitioner answered in the negative.

        Petitioner’s expert Dr. Svetlana Blitshteyn initially supported petitioner’s allegation
because she assumed a one-week onset after Tdap vaccine, based solely on petitioner’s and his
wife’s affidavits, while she recognized in her expert report that the first medical documentation
of a seizure was in December 2010, eight weeks after vaccination. When asked if she would
support an eight-week onset as causative from the vaccine, Dr. Blitshteyn demurred in her
supplemental report and said that was less compatible for causation. In the last sentence of her
supplemental report, she stated she preferred not to offer an opinion on causation in this case.

       Without either medical record or expert support that Tdap vaccine can cause seizure
disorder eight weeks later, petitioner has failed to satisfy prong one of Althen.

       Because petitioner has failed to prove that Tdap vaccine can cause seizure disorder eight
weeks later, he has also failed to prove that Tdap vaccine did cause his seizure disorder eight
weeks later. Petitioner has failed to satisfy prong two of Althen.

        In addition, petitioner has failed to prove that eight weeks is an appropriate time interval
to support a holding of causation of seizure disorder from Tdap vaccine. Thus, he has failed to
satisfy prong three of Althen.

       Petitioner has failed to make a prima facie case. The undersigned GRANTS his oral
motion for dismissal. This petition is hereby DISMISSED.

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                                       CONCLUSION

     This petition is DISMISSED. In the absence of a motion for review filed pursuant to
RCFC Appendix B, the clerk of the court is directed to enter judgment herewith.2

IT IS SO ORDERED.

Dated: March 13, 2014                                        s/Laura D. Millman
                                                               Laura D. Millman
                                                                Special Master

       2
         Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party,
either separately or jointly, filing a notice renouncing the right to seek review.
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