CHRISTIAN J. MORAN, Special Master.
Marie Louise and Stephen Moriarty alleged that 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 (2006). In support of their petition, the Moriartys rely upon the testimony of Yuval Shafrir, a board-certified pediatric neurologist.
Dr. Shafrir's opinion was opposed by respondent's expert, John MacDonald, who is also a pediatric neurologist. On May 6, 2013, a hearing was held in which the Moriartys, Eilise's brother (Harris), Dr. Shafrir, and Dr. MacDonald testified.
Because the Moriartys did not prove that the MMR vaccine administered on January 2, 2001 could cause Eilise's injury and did not provide a logical sequence of cause and effect linking Eilise's vaccination to the onset of her injuries, the Moriartys did not meet their statutory burden. Thus, they are not entitled to compensation.
Because the parties relied upon Dr. Shafrir and Dr. MacDonald to explain the significance of the events in Eilise's life, their qualifications are discussed below in section A. Their comments on Eilise's history are presented in Section B, below.
Dr. Shafrir attended medical school in Israel and graduated in 1982. Exhibit 38 at 3. After graduation, he spent two and a half years in pediatric residency. He moved to the United States and continued to study pediatrics at North Shore University Hospital in New York from February 1986 through June 1988. Next, Dr. Shafrir went to Washington University in St. Louis to complete a pediatric neurology fellowship, which he finished in June 1991. He continued to Miami Children's Hospital to complete an epilepsy fellowship.
Dr. Shafrir is board-certified in psychiatry and neurology with a special competence in child neurology and in clinical neurophysiology. Exhibit 38 at 4. Currently, Dr. Shafrir works in private practice as a pediatric neurologist in Baltimore, MD.
Dr. MacDonald studied medicine at the University of Michigan. Exhibit A at 1. He stayed in Ann Arbor after graduation in 1970 to study pediatrics.
Dr. MacDonald is board-certified in psychiatry and neurology with a special competence in child neurology. Exhibit A at 2. He has worked in academia for the past 10 years, and currently holds an appointment in the Department of Neurology at the University of Minnesota. Tr. 220; exhibit A at 1. Dr. MacDonald teaches pediatric neurology to pediatric residents, fellows, and neurology residents and supervises clinical rotations. Exhibit A at 10.
The parties generally agree that the medical records created contemporaneously with the events they describe set forth Eilise's history accurately. Thus, there is relatively little dispute about the facts. The most prominent point of contention on factual matters concerns whether Eilise suffered a seizure on January 7, 2001. This issue is addressed and is resolved in section 2.a below.
Eilise was born in 1996. Exhibit 4 at 1; Tr. 19. Ms. Moriarty described Eilise as a "very energetic, motivated child," but Eilise also had trouble walking and talking from a young age. Tr. 19-20. The first record of Eilise's developmental delay was in June 1997, when Eilise was ten months old.
On August 26, 1999, when Eilise was three, Dr. Susan Berman evaluated Eilise. Exhibit 8 at 112-14. Dr. Berman described Eilise as a "slow walker" because she did not start walking until the age of 21 months.
Ms. Moriarty expressed her concern about Eilise's language development to Dr. Berman. Exhibit 8 at 113. Eilise's vocabulary consisted of only approximately ten words, and most of her speech was unintelligible.
After the evaluation, Dr. Berman diagnosed Eilise with hypotonia and developmental delay. Exhibit 8 at 113. According to Dr. Shafrir, a child with developmental delay is the same as a child with static encephalopathy. Tr. 185 ("when you see a child with developmental delay[,] you say that they have static encephalopathy"). Dr. Berman also noted that the department of physical medicine and rehabilitation at Children's had followed Eilise's older sister, Mairin, who was diagnosed with cerebral hypotonia and learning disabilities.
Dr. Berman recommended a hearing test to determine whether Eilise's language delay was not "secondary to hearing impairment." Exhibit 8 at 113. She also recommended that Eilise begin occupational therapy once a week for at least twelve weeks to address "the same visual motor issues that her sister had."
On November 15, 1999, Eilise was found to have normal hearing. Exhibit 8 at 118. After a subsequent speech and language evaluation on November 24, 1999,
Eilise was diagnosed as having a moderate receptive language disorder and a severe expressive language disorder, and her speech skills were said to be "severely impaired."
In addition to numerous evaluations, Eilise had several surgeries as a young child. In April 1999, she had surgery to correct exotropia in her left eye, with similar surgery to correct the same defect in her right eye the next year. Exhibit 8 at 110, 112. In March 2000, Eilise's tonsils and adenoids were removed. Exhibit 49 at 1. Eilise's sister, Mairin, also had a tonsillectomy when she was around Eilise's age. Before surgery, Mairin was developmentally delayed, but after surgery, Mairin improved dramatically. Tr. 118-19, 121-22, 298. Ms. Moriarty testified that after the surgery, Eilise had never "[spoken] so clearly or engage[d] and [paid] such close attention to anything." Tr. 21. She added that Eilise's "whole demeanor was more confident" after her surgery. Tr. 81.
On May 1 and May 24, 2000, Eilise went to the Devonshire Center to be evaluated for a special education preschool program. Exhibit 27 at 9. To assess her cognitive functioning, Eilise took the Bayley Scales of Infant Development Second Edition. Exhibit 27 at 12. Eilise's performance resulted in an overall cognitive age equivalent of 20 months.
To assess her speech and language skills, Eilise took several tests. On the Peabody Picture Vocabulary Test — Revised (Form L), she earned a score matching that of a two year old, a "very significant delay." Exhibit 27 at 16. The Preschool Language Scale — 3 revealed a "severe receptive and expressive language delay."
After reviewing Eilise's assessments, the Fairfax County school system approved Eilise for special education services. Exhibit 27 at 38-44. On June 30, 2000, Eilise underwent an IEP. Tr. 60; exhibit 27 at 198-201. The IEP report described Eilise as having a "normal activity level" but also as "having difficulty fully participating in the preschool environment." Exhibit 27 at 37. The team recommended that Eilise receive "adult guidance and modeling" for developing fine motor skills, interacting and playing with peers, and for communicating more effectively.
Eilise started a preschool program in fall 2000. Tr. 23. She continued to improve in her development and was "very chatty," according to Ms. Moriarty.
The school required Eilise to have certain vaccinations before returning to school in January 2001. Exhibit 51 at 2. Thus, on January 2, 2001, at Dr. Russo's office, Eilise received the second dose of the MMR vaccine. Exhibit 8 at 77, 134; Tr. 135. Although Dr. Russo also gave Eilise a dose of the DTaP and IPV vaccines on the same occasion, the Moriartys' claim and Dr. Shafrir's opinion are based upon the MMR vaccine.
The Moriartys allege that Eilise suffered a seizure on January 7, 2001. Pet'rs' Posthr'g Br., filed Sept. 25, 2013, at 2. The basis is a report from Harris, Eilise's older brother, who provided an affidavit (exhibit 47) and testified. The Secretary has some questions about Harris's account because a medical record was not created contemporaneously.
According to Harris, on Sunday, January 7, 2001, Eilise and he stayed at home alone while the rest of the family attended Catholic Mass. Tr. 25-26. While watching television, he witnessed Eilise as her back "arched into the couch," her head "thrust back," her eyes "rolled back," and her left side jerked "very strangely, almost in a rhythmic pattern" for about 45 seconds. Tr. 6. Eilise was disoriented and dazed after the episode, so Harris put Eilise to bed and then called their parents. Tr. 6-7, 10-11. Although Harris did not know it on that day, he now believes, after witnessing many other seizures, that what he witnessed was Eilise having a seizure. Tr. 7. According to Mr. and Ms. Moriarty, Eilise was feverish and lethargic the night of January 7, 2001. Tr. 27, 121;
Harris's testimony raises two questions. First, did anything happen to Eilise, and, second, if something unusual did occur, was it a seizure? Dr. Shafrir believes that this episode was a seizure, constituting the onset of Eilise's epileptic encephalopathy. Exhibit 37 at 2; Tr. 148. Dr. MacDonald stated that he agreed "there was probably an event" on January 7, 2001, but that he "would not characterize it as unequivocally a seizure." Tr. 229;
Here, strong evidence supports a finding that Eilise behaved unusually during the evening of January 7, 2001. Less than three weeks later, when Eilise was in Inova Fairfax Hospital following an unquestioned seizure, Harris told one of Eilise's doctors about what he saw. Exhibit 7 at 162. Harris's report to Dr. Elgin was made to facilitate his sister's treatment and was not made in the context of litigation. Consequently, Harris's account has sufficient indicia of reliability to be accepted.
The ensuing question is: was this behavior was a seizure? The evidence preponderates in favor of finding it was. First, in the years between this episode and his appearance in court, Harris has learned how Eilise acts during a seizure. Second, Dr. Shafrir, someone with medical training, accepted Harris's description of Eilise's behavior and characterized her as suffering a seizure. Third, the contrary position taken by Dr. MacDonald seems to be a consequence of an overly demanding burden of proof Under the simpler more-likely-than-not evidentiary standard, the Moriartys have established that on January 7, 2001, Eilise suffered a seizure.
On the next day, January 8, 2001, Eilise went to school, but returned home early. Later that afternoon, Eilise was running a fever. Tr. 28. The following day, Ms. Moriarty took Eilise to see Dr. R. A. Comunale.
Over the next two weeks, Eilise continued to attend school, but she was "glassy and tired and lethargic and put herself to bed." Tr. 28. Ms. Moriarty described Eilise as "under the weather and not sure how or why." Tr. 69. Eilise did not go to the doctor during this period.
On January 23, 2001, Eilise had a seizure at school and was taken in an ambulance to Columbia Reston Hospital ("Reston"). Exhibit 17 at 2-3. The Emergency Department record indicated that Eilise "had a grand mal seizure at school consisting of arching back of head [and] rolling back of eyes and tonic clonic movement of extremities." Exhibit 24 at 3. Her seizure lasted several minutes.
On January 24, 2001, Ms. Moriarty and a nurse witnessed Eilise having a left-sided focal seizure lasting approximately 40 seconds. Exhibit 24 at 45; Tr. 30. Eilise was transferred to Inova Fairfax Hospital ("Fairfax") later that day. Exhibit 24 at 46.
A pediatric neurologist, Virginia Elgin, saw Eilise while she was at Fairfax. Exhibit 7 at 169-71. Dr. Elgin noted that Eilise had another focal seizure lasting approximately two minutes involving left side jerking.
On January 25, 2001, Eilise had a seizure that lasted for approximately 75 seconds, consisting of left-sided focal activity. Exhibit 7 at 161. Eilise initially was given Cerebyz, Ativan, and Dilantin.
Eilise had images of her brain taken while she was at Fairfax. Exhibit 7 at 185-89. The images from her brain MRI only showed "a moderate degree of inflammatory change in the paranasal sinuses."
Eilise also had an EEG. The test administrator indicated that Eilise was in "the drowsy, light sleep state" when the EEG was taken. Exhibit 7 at 188. The EEG had a single burst of spike and high voltage slow activity symmetrically.
Eilise continued to have seizures for the next two days and her medications were adjusted accordingly.
Eilise was discharged on January 28, 2001, after her seizures had been controlled. Exhibit 21 at 55-56; Tr. 33. Upon discharge, Dr. Elgin noted that Eilise had a "new onset of seizure disorder," exhibit 21 at 56, and "there seem to be no precipitating factors causing the seizures," including that Eilise had no illnesses recently. Exhibit 7 at 160.
On January 30, 2001, Eilise went to Johns Hopkins Medical Center and saw Dr. Eileen Vining. Exhibit 4 at 18-20. In her report, Dr. Vining commented that Eilise had recently recovered from an upper respiratory infection.
On March 18, 2001, Eilise was readmitted to Fairfax after exacerbation of her seizures. Exhibit 7 at 130; exhibit 8 at 98. Ms. Moriarty reported that Eilise's seizure activity was focused on the right side. The doctor noted that Eilise had a history of partial and partial complex seizures. Exhibit 8 at 98. Dr. Elgin attributed the increased seizure activity due to auto-induction of liver enzymes and "increased leptic clearance." Exhibit 7 at 132. Because Eilise had not been responding to changing doses of Tegretol, Dr. Elgin started Eilise on Carbatrol, a slow-release anticonvulsant. Exhibit 7 at 69. Eilise did not have seizures overnight, and was discharged.
In response to "drop attacks," on March 23, 2001, Eilise went back to Fairfax and saw Dr. Elgin. Exhibit 8 at 96; exhibit 21 at 40. Although Eilise appeared to show improvement in the partial seizures, Ms. Moriarty reported that during Eilise's recent episodes, she had a tendency to drop her head suddenly and sometimes to collapse altogether. Exhibit 8 at 96. Overall, Dr. Elgin believed that Eilise was improving, but she noted concern "regarding the possibility of additional seizure types which had not manifest[ed] previously."
Eilise continued to have seizures. On March 26, 2001, Eilise again was admitted to Fairfax. Exhibit 7 at 66, 69. Ms. Moriarty reported that Eilise had experienced more than 20 episodes of acute onset seizures since discharge three days prior. During these seizures, Eilise would fall to the floor.
Ms. Moriarty also reported that Eilise was experiencing expressive language regression. Exhibit 7 at 66. Dr. MacDonald believed that when Eilise began having daily seizures, she was recovering from both the seizures and Todd's paralysis.
Eilise had more images taken. She had an EEG on March 27, 2001, which was consistent with clinical seizure disorder. Exhibit 7 at 85. The EEG was abnormal because of the prominent bilateral spike, poly spike, and slow wave activity. Exhibit 7 at 85; see Tr. 200. It also indicated an evolving disorder. Tr. 280. Eilise was discharged on March 28, 2001. Exhibit 7 at 80.
Dr. Elgin also ordered an MRI scan, which yielded normal results, including "mild to moderate membrane thickening involving a few paranasal sinuses." Exhibit 21 at 59, 62. Dr. Shafrir added that this condition would not contribute to encephalopathy. Tr. 206-07 ("Take every child on the street with a cold and nasal discharge, and they will have the same thing on the MRI.")
Mr. and Ms. Moriarty decided to take Eilise to Johns Hopkins Hospital to enroll her in the ketogenic diet program. Exhibit 51 at 5. However, there was a wait list and she was not able to see the doctors until June 2001.
In the meantime, on April 19, 2001, the school system administered a psychological assessment to determine Eilise's continuing eligibility for special education services. Exhibit 27 at 94. She was four years and seven months old at the time of assessment.
One month later, on May 10 and May 23, a speech clinician evaluated Eilise's speech and language to determine her continued eligibility for special education services. Exhibit 27 at 117-18. Testing indicated that Eilise had severe delays in receptive and expressive language, and her quality of speech was slurred.
In her June 2001 preschool progress report, Eilise's teacher, Ms. Dulong, commented on Eilise's communication and cognition. Exhibit 27 at 126. Ms. Dulong indicated that Eilise was capable of speaking in sentences, but on most occasions, she did not.
On June 6, 2001, Eilise was admitted to Johns Hopkins Hospital for intractable seizures and to begin a ketogenic diet. Exhibit 8 at 89.
Eilise returned to Johns Hopkins for a follow-up examination on September 25, 2001. Exhibit 4 at 14. She was reportedly seizure-free after beginning the diet "except for [three] incidents."
On January 15, 2002, Eilise went to Johns Hopkins for a six-month follow up visit. She saw Dr. James Rubenstein for her appointment. Exhibit 4 at 12. By this time, Eilise was no longer taking any seizure medications.
Eilise was a "super-responder" to the ketogenic diet with respect to her seizure disorder. Exhibit 4 at 9 (report of Dr. Eric Kossof). After one year on the diet, Eilise began developing kidney stones, but had been seizure free for eight months.
Dr. Shafrir proposed that the ketogenic diet was an effective anti-epileptic medication or treatment for Eilise because the diet stopped the seizures, and the stopped seizures helped with her epileptic encephalopathy, but did not reverse the injury. Tr. 189. He commented that doctors do not have a theory for why some seizure patients, like Eilise, respond well to a ketogenic diet. Tr. 188. Dr. MacDonald attributed Eilise's success to the ketogenic diet's effect on Eilise's metabolism, suggesting that Eilise's problem was actually a metabolic disorder. Tr. 284.
On July 21 and July 29, 2004, Eilise went to Dr. Rachna Varia for a psychoeducational evaluation. Exhibit 18 at 74-83. Her test results showed deficits in language, attention, memory, sensorimotor, and visual-spatial skills.
On August 31, 2004, Eilise underwent an audiological and occupational therapy evaluation. Exhibit 18 at 57. The examiners noted that Eilise had made progress in auditory processing and sensory integration functions in "the past two years," but recommended that Eilise continue at least two hours a week of speech and occupational therapy.
On February 22, 2005, Eilise had another occupational therapy evaluation at Georgetown University Hospital. Exhibit 18 at 42. The examiner found that Eilise was at risk for further developmental delay if she did not receive direct occupational therapy services.
During Eilise's developmental speech and language evaluation on April 28, 2005, the clinician indicated that Eilise presented an "expressive/receptive language delay as a result of seizure activity prompted by an adverse reaction to an MMR vaccine in January 2001." Exhibit 18 at 62. She also stated that the seizures "caused regression of development and loss of all language ability."
At the time of the hearing, Eilise was 17 years old and would have normally been a junior in high school. Tr. 46. However, she was reading at an "easy fifth grade level."
Acting through their attorney, the Moriartys filed a petition on December 31, 2003. In this original petition, they alleged that vaccines caused Eilise to suffer autism. Their designation led to this case being grouped and stayed with other cases involving autism.
After special masters issued decisions in the lead cases of the autism omnibus proceeding, the special master to whom this case was assigned ordered the Moriartys to file an amended petition. The amended petition no longer referred to autism. Eilise does not have autism. Tr. 244. Instead, the Moriartys claimed that she suffered a "seizure disorder and encephalopathy." Am. Pet., filed July 14, 2011, ¶ 12.
Nearly eight years after the original petition was filed, the Moriartys filed the initial set of medical records on August 15, 2011. Another set was submitted on October 14, 2011.
The Secretary reviewed this material and concluded that the evidence did not support an award of compensation. To the Secretary, the notations of treating doctors associating Eilise's MMR vaccination with her subsequent neurological problems were not persuasive. The Secretary also noted that the Moriartys had not presented the report of an expert discussing causation. Resp't's Rep't, filed Jan. 13, 2012, at 16-17.
After the Moriartys filed two more sets of records, the parties obtained reports from experts. The petitioners submitted a report from Yuval Shafrir, M.D. and his curriculum vitae. Exhibits 35-36. The respondent countered with a report from John MacDonald, M.D., his curriculum vitae, and articles. Exhibits A-B.
By a March 1, 2013 order, the special master set the case for hearing on May 6, 2013. She also set a deadline of April 5, 2013, for the submission of any medical 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 another special master.
The parties complied with the March 1, 2013 order. The Moriartys filed a second report from Dr. Shafrir, exhibit 37, on April 3, 2013, and additional medical records a few days later. 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.
The hearing was held on May 6, 2013. Five witnesses testified. Three witnesses testified about Eilise's medical history: Harris Moriarty (her brother), Marie Louise Moriarty (her mother), and Stephen Moriarty (her father). The other two witnesses were Dr. Shafrir and Dr. MacDonald.
The then-assigned special master set a schedule for submitting briefs. Order, filed July 17, 2013. In the midst of this process, the term of service for this special master ended and the case was re-assigned to the undersigned. The undersigned issued an order directing both parties to state whether they wanted a second hearing. The Moriartys stated that they do "not believe that conducting another hearing, rather than the Special Master simply relying on the evidence as submitted, is necessary and therefore respectfully decline[] to request a new hearing." Pet'rs' Status Rep't, filed Oct. 8, 2013. The Secretary also declined an opportunity for another hearing. Resp't's Status Rep't, filed Oct. 25, 2013.
Consequently, the parties submitted their briefs. With the submission of the Moriartys' reply brief, the case is ready for adjudication.
The elements of the Moriartys' case are set forth in the often cited passage from the Federal Circuit's decision in
The first element of petitioners' case has been described as a "can it?" question which asks whether the vaccine could cause the alleged injury.
In Dr. Shafrir's opinion, the measles vaccine can cause various adverse reactions. Manifestations of an adverse reaction include acute disseminated encephalomyelitis ("ADEM") and cerebral ataxia. Tr. 159, 180. Another type of manifestation along this spectrum, according to Dr. Shafrir, is an epileptic encephalopathy. Tr. 159.
Dr. Shafrir has a sound basis for saying vaccines can cause ADEM. Many cases have made that finding.
Petitioners elicited very little testimony about the basis for Dr. Shafrir's opinion that the measles vaccine can cause an epileptic encephalopathy. Their direct examination on this topic was covered in approximately three transcript pages. Tr. 158-60;
Although Dr. Shafrir had cited various articles in support of his opinion in his second report, exhibit 37, petitioners did not elicit testimony from Dr. Shafrir about these articles as part of the direct examination.
The lack of direct testimony from Dr. Shafrir was ameliorated to some extent because the Secretary and the presiding special master inquired about a few of the articles that Dr. Shafrir cited. Tr. 174-83, 202. During cross-examination, the Secretary questioned Dr. Shafrir about the Pampiglione article, exhibit 42 (G. Pampiglione et al.,
In the Pampiglione study, eight children received an injection of live attenuated measles vaccine, Beckenham 31 strain, and were observed with a control group of three children for a total of three weeks after vaccination. Exhibit 42 at 2.
When asked about the relevance of the Pampiglione study, Dr. Shafrir explained that he "just wanted to show that there was a very viable, well-supported possibility that the measles vaccination will cause EEG changes" and sometimes will lead to epileptic encephalopathy. Tr. 179.
Dr. MacDonald discussed the outdated eight-channel EEG method used in the Pampiglione article. Tr. 248. Dr. MacDonald explained that this method limits the reader's "ability to interpret the EEG, but given who was reading them they did the best they [could]."
The Secretary's counsel also asked Dr. Shafrir about the Gibbs article. Tr. 182-84;
Six of the children with histories of metabolic or neurologic disease had abnormal initial EEGs with unchanged readings 9-13 days later.
Dr. MacDonald made the same remarks about the eight-channel EEG method, which was also used in the Gibbs study. Tr. 248. Respondent argues that the medical literature cited by petitioners does not support their case. Resp't's Posthr'g Br. at 14-15.
The Gibbs article does not support Dr. Shafrir's previous point from the Pampiglione article discussion. The one child in the Gibbs study did not have cerebellar ataxia or other preexisting neurologic disease. Tr. 183. Additionally, when Dr. Shafrir was asked if "the abnormal, slow activity would quickly subside and the EEG [would] revert back to normal," he answered, "Yes."
These two articles do not establish the reliability of Dr. Shafrir's theory. The Pampiglione study did not support Dr. Shafrir's reasoning because the children did not develop epileptic encephalopathy and the children's EEG changes disappeared after 14 days. The Gibbs article did not appear relevant to Dr. Shafrir's opinion of Eilise's condition because the study indicated that the EEG changes were due to intercurrent illness rather than vaccination.
After the Secretary challenged Dr. Shafrir, the Moriartys did relatively little to rehabilitate his opinion by demonstrating its reliability. Rather, in their reply, the Moriartys appear to be relying upon testimony from the Secretary's expert, Dr. MacDonald. Pet'rs' Posthr'g Reply Br., filed Feb. 3, 2014, at 5. While the Moriartys argue that Dr. MacDonald "conceded the plausibility of Dr. Shafrir's theories," Pet'rs' Reply at 5, the Moriartys exaggerated the consequence of Dr. MacDonald's "concession." Dr. MacDonald did not say that Dr. Shafrir's theories were "plausible." When asked whether the measles vaccine can cause an encephalopathy resulting in epilepsy, Dr. MacDonald testified "it's possible." Tr. 272. There's a difference between "possibility" and "plausibility." Additionally, even if Dr. MacDonald had said Dr. Shafrir's theory was "plausible," this testimony would not get the petitioners very far. The petitioners' burden is to demonstrate the probability, not just the plausibility, of the theory.
Rather than relying on the Secretary's expert, petitioners would have been more persuasive if they had developed Dr. Shafrir's medical theory. But, Dr. Shafrir was unpersuasive. Consequently, petitioners failed to demonstrate that the MMR vaccine can cause an autoimmune epileptic encephalopathy, and failed to meet
The second element is to establish by preponderant evidence "a logical sequence of cause and effect" showing that the MMR vaccine did in fact cause Eilise's autoimmune epileptic encephalopathy.
The Moriartys' presentation on this point was spotty. In their direct examination of Dr. Shafrir, they asked relatively few questions about why he believed that the MMR vaccine specifically caused Eilise's epileptic encephalopathy.
This reasoning is not adequate. As Dr. MacDonald noted, it would be illogical to find that because the cause of Eilise's problems has not been identified, the cause must be the vaccine. Tr. 244;
The gaps in the Moriartys' evidence are also reflected in their brief Most of their argument regarding
The Moriartys' problem stems, in part, from the vagueness in Dr. Shafrir's theory for how the MMR vaccine can cause an epileptic encephalopathy. As described in the preceding section, the Moriartys maintain that Eilise epileptic encephalopathy was "immune-mediated." Pet'rs' Posthr'g Br. at 6. As also discussed in the preceding section, the Moriartys presented thin support for the theory that the MMR vaccine can cause an autoimmune epileptic encephalopathy. Hence, the Moriartys failed to meet their burden of proof on the first
Even if there were persuasive evidence that a vaccine can cause an autoimmune epileptic encephalopathy, petitioners are required to establish that Eilise suffered an autoimmune epileptic encephalopathy.
Dr. MacDonald, by contrast, testified that Eilise's presentation did not resemble an autoimmune epileptic encephalopathy. Tr. 293. These patients most commonly present with "lethargy, behavioral issues, confusion, speech loss, aphasia, a whole host of cognitive problems, balance problems, hemiparesis." Tr. 290. Additionally, objective evidence of an autoimmune encephalopathy may include brain swelling on an MRI scan, lateral and focal neurological damage, elevated white cells, and changes in gammaglobulin levels. Tr. 291. An autoimmune process that affects the brain is likely to be visible on an MRI. The MRI would be grossly abnormal and the EEG would show "total disorganization." Tr. 290. Seizures stemming from an autoimmune process would not be sporadic. Tr. 287.
As to whether Eilise suffered from an autoimmune epileptic encephalopathy, Dr. MacDonald was more persuasive than Dr. Shafrir. First, although Dr. Shafrir relied on his clinical experience, he admitted he was referring to only a few patients. Tr. 193-96. Second, it is unusual for a disease not to have any typical clinical symptoms as Dr. Shafrir asserted. Dr. MacDonald was more credible when he provided a list of clinical signs and diagnostic assessments. Dr. MacDonald's persuasiveness on this topic was enhanced by the lack of contradiction from Dr. Shafrir. With respect to Eilise's clinical presentation, Dr. MacDonald stated he did not "know of any clinical scenario that [he] could accept where [there is] an ongoing autoimmune process that's damaging the brain" where there is a history of "a day and a half of fever and then two weeks with nothing." Tr. 260. Dr. MacDonald disagreed with the assertion that Eilise had autoimmune epileptic encephalopathy because in his experience, patients are "desperately sick" if they have immune-mediated encephalopathies that result in seizures. Tr. 276. Additionally, Dr. MacDonald's suggestion that an autoimmune process is likely to cause changes on neuroimaging studies rings true.
Moreover, Eilise's treating doctors did not identify her problem as autoimmune in origin. If they thought she was having an autoimmune reaction, then the proper course, according to Dr. Shafrir, would have been to prescribe intravenous immunoglobulin or steroids. But, the doctors did not, as Dr. Shafrir conceded. Tr. 215-16, 219. Dr. MacDonald's assessment of how Eilise's doctors would have responded was similar. In his view, Eilise's treating doctors did not think that her condition was autoimmune related because, at a minimum, they would have done a spinal tap. Tr. 272. The treatment ordered by Eilise's doctors, although not dispositive, tends to support Dr. MacDonald's opinion that Eilise did not suffer an autoimmune disorder.
Finally, how the treating doctors viewed Eilise when they were treating her in 2001 makes relying upon later occasional statements linking the MMR vaccination to the onset of Eilise's seizure disorder problematic. Examples include Dr. Varia's report from 2004, exhibit 18 at 74 (stating Eilise had a "medically acknowledged MMR reaction, Lennox [Gastaut]), an occupational therapist's report from 2005, exhibit 18 at 42 (stating Eilise's "medical team attributed her seizures to a reaction to her MMR injection), and a speech pathologist's report from 2005, exhibit 18 at 62 (indicating that Eilise presented with an "expressive/receptive language delay as a result of seizure activity prompted by an adverse reaction to an MMR vaccine in January 2001"). These passages occur in the parts of the reports giving Eilise's remote history. Presumably, the source of information for this material was Ms. Moriarty. While Ms. Moriarty may genuinely believe that the doctors attributed Eilise's seizure disorder to an adverse reaction to the MMR vaccine, she has not identified any record from a doctor directly. Regardless of the sincerity of Ms. Moriarty's belief, her views about causation are not persuasive because she is not a medical doctor.
In short, although Dr. Shafrir claimed Eilise suffered an epileptic encephalopathy that was immune-mediated, he did not explain the basis for his opinion. Dr. Shafrir, for example, failed to list any clinical symptoms for an immune-mediated epileptic encephalopathy. In contrast, Dr. MacDonald provided an unrebutted list of symptoms and diagnostic signs most of which Eilise did not start experiencing in January 2001, when the alleged autoimmune epileptic encephalopathy began. Consequently, the Moriartys failed to demonstrate an autoimmune basis for Eilise's epileptic encephalopathy. Since Dr. Shafrir's theory proposes the MMR vaccine would cause an autoimmune reaction leading to epileptic encephalopathy, the petitioners' case is not logical. Eilise's presentation does not match Dr. Shafrir's theory. Therefore, they necessarily failed to establish
In addition to presenting a reliable medical theory explaining how the MMR vaccine can cause an autoimmune epileptic encephalopathy and a logical sequence of cause and effect between Eilise's MMR vaccination and her autoimmune epileptic encephalopathy, the Moriartys must also show that Eilise's first manifestation of autoimmune epileptic encephalopathy occurred in a medically appropriate timeframe to infer causation.
For the first aspect of the third prong of
For the second aspect of the third prong of
The Secretary's primary argument on prong 3 is to question whether Eilise started having neurologic problems on January 7, 2001. Resp't's Posthr'g Br. at 16-18. As explained in the Facts, Dr. Shafrir and Dr. MacDonald dispute whether Eilise's episode on January 7, 2001 was a seizure.
Whether petitioners met their burden of demonstrating a proximate temporal relationship between the date of vaccination and onset of symptoms is a close question. However, close calls are to be construed in the petitioners' favor.
For the reasons explained in the preceding sections, the Moriartys have not established
In addition to Dr. MacDonald's report, the Secretary submitted medical articles demonstrating that children with GLUT 1 may suffer from developmental delay and seizures. The medical articles also stated people with this problem may benefit from the ketogenic diet because the brain substitutes ketones for glucose as an alternative energy source. Exhibit B, tab 7 (Jörg Klepper,
Dr. Shafrir did not challenge the basic premise that GLUT 1 may cause developmental delays.
Dr. MacDonald relied upon Eilise's medical history to support the possibility that Emily suffers from GLUT 1. In his view, Eilise's developmental problems before and after the vaccination reflect one continual process that was apparent at a very early age. Tr. 242-46. In addition, Eilise improved dramatically after starting the ketogenic diet. This rapid improvement suggests that the underlying cause of Eilise's problems may have been metabolic. Tr. 236-37, 283.
Dr. Shafrir disagreed. He pointed out that after Eilise stopped the ketogenic diet, she did not deteriorate. In Dr. Shafrir's opinion, if the introduction of ketones stopped seizures, then the removal of ketones should lead to seizures. Tr. 188. Without referencing any specific articles, Dr. MacDonald maintained that some recent studies have presented examples of children who improved on the ketogenic diet and remained improved after leaving the diet years later. Tr. 237.
Ultimately, this debate is largely academic. The best evidence about whether Eilise suffers from GLUT 1 is genetic and metabolic testing that was not performed in this case.
Before her MMR vaccine, Eilise had developmental delay that was improving with therapy. On January 2, 2001, Eilise received her MMR vaccine. She developed seizures that started five to six days after the vaccine, and her seizures continued sporadically, until she started the ketogenic diet in June 2001.
Eilise's parents alleged that MMR vaccine can cause epileptic encephalopathy through an autoimmune process. However, the Moriartys' proof was not persuasive on this point, and they did not establish Eilise suffered an autoimmune disorder. Thus, the Moriartys are not entitled to compensation.
The Clerk's Office is instructed to issue judgment in accord with this decision.
In his second report, exhibit 37, Dr. Shafrir discusses a connection between measles vaccination and encephalopathy. He chiefly relies upon the National Childhood Encephalopathy Study (NCES) and also discusses other articles. Although he mentioned the diphtheria-tetanuspertussis vaccine briefly, his opinion is that "Eilise's epileptic encephalopathy sits within the spectrum of
The Moriartys did not present any basis for lengthening the longer interval found in the NCES, which was 15 days. Dr. Shafrir actually acknowledged that if Eilise did not have a seizure on January 7, 2001, then it would be difficult to establish a connection between the MMR vaccination and her epileptic encephalopathy. Tr. 187.
