Moriarty v. Sec'y of Health & Human Servs.
| Decision Date | 23 August 2016 |
| Docket Number | No. 03-2876V,03-2876V |
| Parties | EILISE MORIARTY, a minor, by her parents and natural guardians, MARIE LOUISE and STEPHEN MORIARTY, Petitioners, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. |
| Court | U.S. Claims Court |
Entitlement; measles, mumps, rubella ("MMR") vaccine; autoimmune epileptic encephalopathy; decision on remand.
Clifford J. Shoemaker, Shoemaker, Gentry & Knickelbein, Vienna, VA, for petitioners;
Alexis B. Babcock, United States Dep't of Justice, Washington, D.C., for respondent.
Marie Louise and Stephen Moriarty allege that the measles, mumps, rubella ("MMR") vaccine caused their daughter, Eilise, to develop seizures, encephalopathy, and a decline in cognitive and motor functions. Am. Pet. at 2. The Moriartys seek compensation pursuant to the National Childhood Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 through 34 (2012). Theirclaim was denied, first by the undersigned special master, 2014 WL 4387582 (Aug. 15, 2014), and then by a judge of the Court of Federal Claims, 120 Fed. Cl. 102 (2015). However, the Federal Circuit vacated the August 15, 2014 decision, ordering reconsideration of the evidence. No. 2015-5072, 2016 WL 1358616, at *10 (Fed. Cir. Apr. 6, 2016).
In accord with the Federal Circuit's order, the undersigned has re-reviewed all the evidence after remand. This re-evaluation changes one aspect of the August 15, 2014 decision. While that decision had found that the Moriartys had not established that the MMR vaccine can cause an epileptic encephalopathy, this decision changes course. The Weibel article supports this finding.
However, a re-review of the record has not identified any persuasive basis for altering the outcome for another element of the Moriartys' case. Federal Circuit precedent indicates that even after the Moriartys present a persuasive case for the first Althen prong, to prevail on the second Althen prong, the Moriartys must establish, by a preponderance of the evidence, that Eilise's epilepsy was autoimmune in origin. They have not made that showing. Therefore, the Moriartys are not entitled to compensation.
For approximately eight years, it appeared that the Moriartys were alleging that vaccines caused Eilise to suffer autism. By the end of this time, the case had been assigned to Special Master Vowell. Special Master Vowell oversaw the case's development, including the submission of medical records, affidavits, and expert reports. The Moriartys submitted a report from Yuval Shafrir, M.D. Exhibit 35. In response, the Secretary filed a report from John MacDonald, M.D. Exhibit B.
Special Master Vowell scheduled a hearing on May 6, 2013. Order, issued March 1, 2013. She also set a deadline of April 5, 2013, for the submission of anymedical literature and a deadline of April 22, 2013, for the submission of various other documents such as briefs. On March 26, 2013, the case was reassigned to Special Master Zane.
In accord with the March 1, 2013 order, the Moriartys filed another report from Dr. Shafrir. Exhibit 37. The Secretary responded by filing a second report from Dr. MacDonald, exhibit C, on April 22, 2013. On April 22, 2013, both parties also filed briefs.
Special Master Zane presided at the hearing held on May 6, 2013. Dr. Shafrir and Dr. MacDonald testified. Three other witnesses testified about Eilise's medical history: Harris Moriarty (her brother), Marie Louise Moriarty (her mother), and Stephen Moriarty (her father). After the hearing, Special Master Zane set a schedule for submitting briefs. Order, issued July 17, 2013.
Special Master Zane's tenure as a special master ended before she decided this case. Thus, the case was re-assigned to the undersigned. Order, issued Sept. 23, 2013. Both parties declined an opportunity for a second hearing. Pet'rs' Status Rep., filed Oct. 8, 2013; Resp't's Status Rep., filed Oct. 25, 2013. Both parties filed briefs.
The undersigned issued a decision on August 15, 2014. Initially, the undersigned made a finding about when Eilise first started experiencing symptoms of a neurologic disorder. Although the undersigned had not observed Harris Moriarty testify, the undersigned credited his testimony that Eilise made abnormal movements on January 7, 2001, which was five days after her vaccination. 2014 WL 4387582, at *4. This finding, in turn, was the predicate for a determination that the Moriartys established an appropriate temporal relationship, the third of the three prongs from Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005). Id. at *16-17.
However, the undersigned also found that the Moriartys had not established the first or second Althen prong. The first prong requires the petitioners to present "a medical theory causally connecting the vaccination and the injury." Althen, 418 F.3d at 1278. The undersigned found that the Moriartys were claiming that Eilise suffered from an autoimmune epilepsy. Thus, to prevail, the Moriartys must haveestablished a theory that connected the MMR vaccine to autoimmune epilepsy. The undersigned found that Dr. Shafrir presented little evidence about autoimmune epilepsy.3 In this context, the undersigned discussed two articles in particular, one by Pampiglione and the other by Gibbs, because Dr. Shafrir appeared to discuss only those two articles in his testimony. Citing Moberly v. Sec'y of Health & Human Servs., 85 Fed. Cl. 571, 598 (2009), aff'd, 592 F.3d 1315 (Fed. Cir. 2010), the undersigned stated: "When an expert does not explain the relevance of any article, a special master is not required to interpret the study without the benefit of an expert's guidance." 2014 WL 4387582, at *11. The undersigned's analysis of Althen prong one concluded with an examination of whether Dr. MacDonald's testimony that "it's possible" that the measles vaccine can cause epilepsy satisfied the petitioners' burden. The undersigned concluded that the testimony about a possibility was not the same as testimony about a probability. Thus, the undersigned found that the Moriartys did not meet prong one.
For the second prong of Althen, the undersigned found that the Moriartys' evidence was "spotty." "Dr. Shafrir identified few, if any, solid bases for his conclusion that Eilise suffered from an epileptic encephalopathy that was autoimmune in origin." 2014 WL 4387582, at *14. The undersigned found that this lack of persuasiveness was a basis for finding that the Moriartys did not carry their burden as established in Hibbard v. Sec'y of Health & Human Servs., 698 F.3d 1355, 1364 (Fed. Cir. 2012) and Broekelschen v. Sec'y of Health & Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010).
Separately, the undersigned also noted that Dr. MacDonald had raised the possibility that Eilise's epilepsy was metabolic in origin because she improved when on the ketogenic diet.4 The undersigned did not resolve this issue, however, because it was superfluous and because the parties did not brief the issue. 2014 WL 4387582, at *17.
The Moriartys filed a motion for review of the August 15, 2014 decision, challenging the outcome with respect to the first and second Althen prongs.5 For Althen prong one, the Moriartys made several intertwined arguments. They argued that an acknowledgement that the MMR vaccine has been found to cause ADEM was a sufficient basis for finding that the MMR vaccine can cause autoimmune epilepsy. Pet'rs' Mot. for Review, filed Sept. 15, 2014, at 12. They argued that the special master wrongly focused on a limited part of Dr. Shafrir's testimony and erred in the assessment of the Pampiglione and Gibbs articles. Id. at 13-16. They also argued that the special master wrongly required them to establish the probability of their theory and erroneously did not credit Dr. MacDonald's testimony regarding possibility. Id. at 17-18.6
For Althen prong two, the Moriartys argued that they are not required to provide "direct proof of the autoimmune basis for [Eilise's] encephalopathy." Because the special master had looked for evidence that Eilise's epilepsy was autoimmune in origin, the special master employed "an impermissible level of proof." Id. at 20.
The Secretary filed a response to the motion for review. With respect to prong one, the Secretary appears to have taken slightly inconsistent positions. At one point, the Secretary argued that the first prong of Althen "requires a plausible medical theory linking the MMR vaccination with the specific injury alleged." Resp't's Resp. to Pet'rs' Mot. for Rev., filed Oct. 17, 2014, at 11. But, at another place, the Secretary contended that "Petitioners' medical theory needed to be 'persuasive.'" Id. at 14, quoting Moberly v. Sec'y of Health & Human Servs., 592 F.3d at 1322. In any event, the Secretary maintained that the special master's decision reflected a "thorough consideration of Dr. Shafrir's testimony in itsentirety, as well as his consideration of the literature cited as supportive of it." Id. at 12. The Secretary also addressed Dr. MacDonald's testimony about "possible." Id. at 13.
For prong two, the Secretary argued that the special master was not arbitrary in finding that the petitioners had not established that Eilise suffered an autoimmune encephalopathy. Id. at 15, 17-19. As to the potential alternative cause, the Secretary, like the Moriartys, mentioned the ketogenic diet only as part of Eilise's medical history.
The Court denied the motion for review. For prong one, the "Special Master reasonably determined that Petitioners failed to offer a reliable theory as to how the MMR vaccine can cause autoimmune epileptic encephalopathy, and thus he did not act contrary to law in concluding that Petitioners failed to prove the first prong." 120 Fed. Cl. at 107. For prong two, the special master's "finding that Petitioners did not...
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