DENISE K. VOWELL, Chief Special Master.
On March 7, 2011, Ramanathan Padmanabhan and Krithika Srinivas ["Mr. Padmanabhan," "Ms. Srinivas," or "petitioners"], acting pro se, timely filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.
In the four years since the petition was filed, petitioners have repeatedly refused to file complete medical records as required by § 11(c)(2) and Vaccine Rule 2(c). Petitioners insist that the records they have provided establish entitlement to compensation. These incomplete medical records reflect that I.R.I. has an autism spectrum disorder ["ASD"] diagnosis.
For the reasons set forth below, I dismiss their petition for failure to comply with court orders and failure to prosecute. Alternatively, I treat their assertions that they have established a prima facie case for entitlement to compensation (see Petitioners' Motion, filed Aug. 16, 2013, at 2; see also Petitioners' Post-Argument Filing at 4) as either a motion for summary judgment or a request that I rule on the record as it stands. Based on any of their theories, the record does not contain preponderant evidence establishing their entitlement to compensation.
This case has a somewhat unusual procedural history. Shortly after the petition was filed, the former Chief Special Master transferred the case to me.
The matter was assigned to Judge Mary Ellen Coster Williams, who concluded that the Court of Federal Claims lacked jurisdiction to review matters unrelated to "compensation for injuries or attorneys' fees under the Vaccine Act." Memorandum Opinion and Order Dismissing Motion for Review, filed Sept. 15, 2011, at 3. I then began what has proved to be a futile effort to obtain a complete record of I.R.I.'s medical treatment. See, e.g., Order, issued Oct. 11, 2011. Although petitioners filed some medical records with their petition on March 7, 2011, and some additional records on June 13, 2011, December 8, 2011, and August 16, 2013, the medical records remain incomplete.
In the four years since filing this petition on their son's behalf, petitioners have refused to comply with numerous orders. They have refused to follow the Vaccine Rules regarding the filing of motions. They have repeatedly requested that proceedings in their case be suspended and have twice demanded that I recuse myself because of my opinions in the Omnibus Autism Proceeding cases.
In the spring of 2012, petitioners first requested that proceedings in their case be suspended. Pursuant to § 12(d)(3)(C), I suspended proceedings for 30 days. After they filed a request explaining why a longer suspension was necessary, I suspended the proceedings for an additional 150 days. See Order, issued Mar. 22, 2012; Pet. Motion for Extension of Time, filed May 24, 2012; Order, issued May 25, 2012; Pet. Motion to Suspend Proceedings, filed Jul. 2, 2012; Order, issued Jul. 11, 2012. This 180-day suspension is the maximum period authorized by the Vaccine Act. § 12(d)(3)(C).
Following this suspension of proceedings, respondent filed a status report listing important medical records that had not been filed. Specifically, respondent requested (1) I.R.I.'s prenatal and birth records; (2) results of the muscle biopsy, brain MRI, and other mitochondrial and metabolic testing recommended by Dr. Richard Haas at I.R.I.'s October 19, 2010 appointment; and (3) I.R.I.'s relevant treatment records from 2012 to the present.
After failing to comply with this order and two additional orders filed Feb. 7, 2013, and Feb. 28, 2013, petitioners filed a status report indicating that they did not "have possession of the records asked as those tests have not been performed on the advise [sic] of treating physicians." Petitioners asserted that their son has been diagnosed with mitochondrial and metabolic disorders and that "those records are already on file." Petitioners also indicated that birth and prenatal records had been filed. Pet. Status Report, filed Mar. 7, 2013, at 3.
Shortly thereafter, I issued a detailed order explaining the deficiencies in the medical records and petitioners' obligation to file all recent medical and treatment records. Order, issued Mar. 12, 2013. I instructed petitioners to file by May 13, 2013: (1) I.R.I.'s prenatal and birth records and (2) medical treatment records of I.R.I. from October 2011 forward. Order, issued Mar. 12, 2013, at 4.
Once more, petitioners failed to comply with my order. After an Order to Show Cause was issued on May 13, 2013, petitioners filed I.R.I.'s complete prenatal and birth records, but not his recent treatment records. Petitioners also moved to suspend proceedings, to be given more time to file updated records, and for recusal. Motion, filed Aug. 16, 2013. I denied petitioners' motions and again ordered petitioners to file medical records from all providers who had seen or treated I.R.I. since October 2011. Order, issued Sept. 26, 2013. I also addressed petitioners' concerns that their son's treatment could be jeopardized by asking his physicians to opine on I.R.I.'s case, noting that petitioners had only been ordered to file records pertaining to medical treatment, not opinions on causation. Id. at 4.
Petitioners again failed to comply with my order. On November 15, 2013, I issued an order in which I noted that dismissal for failure to prosecute appeared warranted, but I would give petitioners "one last chance to comply with my orders and establish they are entitled to compensation because the interests of a minor child are involved." Order, issued Nov. 15, 2013 at 2. I carefully explained petitioners' burden of proof under Althen and its progeny and reminded petitioners that a finding of entitlement to compensation must be supported by medical records or the opinion of a medical expert. Id. at 3. I ordered petitioners to file "any additional documentation they believe will establish their entitlement to compensation, or otherwise show cause why this case should not be dismissed for their failure to prosecute and failure to establish vaccine causation" by January 17, 2014. Id. at 4.
On November 21, 2013, petitioners contacted my law clerk and informally requested that proceedings in this case be suspended for six months. In response, I issued an order in which I explained that I would not act on an informal request and reiterated that any motion must be filed with the clerk of court. Order, issued Nov. 25, 2013. I explained the difference between a law clerk and a court clerk and why petitioners must file documents and requests formally with the Clerk of Court, not informally with my chambers staff. I ordered petitioners to comply with my prior orders by January 17, 2014. Id. I also informed petitioners that I had instructed my law clerk to disregard any email from them that did not pertain to administrative questions.
A few weeks later, on December 4, 2013, petitioners emailed my law clerk and again requested a suspension of proceedings. My law clerk reminded petitioners that they must bring all substantive matters to my attention in formal filings and directed them to my previous orders.
On January 2, 2013, petitioners again emailed my law clerk. My law clerk directed petitioners to my November 25, 2013 order and reiterated that all motions must be officially filed with the Court. Petitioners responded with other informal communications.
In one more effort to explain why petitioners were required to file documents in accordance with the Vaccine Rules, an ability they had demonstrated, I restated and summarized the guidance given in my previous orders. See Order, issued Jan. 8, 2014. I gave detailed instructions about filing requirements and explained the role of status conferences. I reminded petitioners that they had not provided any evidence that producing the records required would actually affect the doctor-patient relationship or their son's treatment. I noted that if such evidence existed, I could conduct an in camera review of any material they deemed sensitive. Id. at 5.
I also explained to petitioners once again that the medical records on file were not sufficient to prove causation. I informed them that they had not advanced a medical theory explaining how vaccines can significantly aggravate mitochondrial disorders, nor had they filed any medical records indicating their son has been diagnosed with a mitochondrial disorder or a SCAD deficiency. I again urged petitioners to retain counsel and directed them once more to a list of attorneys with experience representing petitioners in the Vaccine Program.
On January 17, 2014, petitioners filed another motion to suspend proceedings, requested a status conference, and made a discovery request. Despite my numerous warnings about the consequences of their failure to comply with my orders, petitioners again failed to file any medical records with their motion. On March 28, 2014, I denied petitioners' motions and made "one final attempt to explain to petitioners the devastating effect that their refusal to comply with court orders is about to have on their son's vaccine injury claim." Order, issued Mar. 28, 2014.
I also noted that petitioners' January 17, 2014 filing appeared to allege that I.R.I. suffered a Table
This March 28, 2014 order also addressed petitioners' concerns about potential intimidation of I.R.I.'s medical care providers. I noted that Mr. Padmanabhan's assertions regarding efforts to coerce or intimidate doctors treating his son had not been accompanied by any evidence. I once again provided petitioners with the opportunity to send any evidence of impropriety directly to the court for my in camera review. Order, issued Mar. 28, 2014, at 6. I explained that the filing of medical records is routine in vaccine injury cases. I provided information about how to request their son's records via the websites of several facilities where I.R.I. received treatment. Id.
Because petitioners alleged that I had not reviewed "the entire record and relevant research," I pointed out that petitioners had not filed any relevant research
Regarding petitioners' request for a status conference, I explained that periodic status conferences are designed to "expedite the processing of the case." Vaccine Rule 6(a). I noted that a status conference would serve no useful purpose in this case until petitioners clarified their theory of causation and filed updated medical records.
Finally, I laid out options for petitioners. I noted that they could ask me to rule on the record as it now stands or request summary judgment, although I urged them to seek an attorney before doing so. I provided petitioners with a list of attorneys who had indicated a willingness to review cases filed by pro se petitioners. I ordered petitioners to file either an amended petition or a causation statement setting forth their theory or theories of vaccine causation by April 28, 2014. I also ordered petitioners to file by May 27, 2014, updated medical records, including all doctor appointments and testing performed since October 2011. Order, issued Mar. 28, 2014, at 8.
Petitioners filed nothing in response to my order. Nevertheless, prior to taking any further action, I afforded them the opportunity to point out in a telephonic conference any matters in the record that support their claim of vaccine causation of I.R.I.'s condition. Order, issued Jun. 4, 2014. I held this telephonic conference on July 23, 2014. Following the conference, petitioners requested the opportunity to address in writing the cases cited by respondent during the conference once the transcript of the proceedings was available. See Orders filed Jul. 25, 2014, and Aug. 18, 2014. On October 1, 2014, petitioners filed their response, which included one more motion to suspend proceedings. Respondent filed her reply on October 16, 2014.
The evidentiary record remains incomplete due to petitioners' refusal to file records pertaining to I.R.I.'s diagnoses and treatment. Nevertheless, it is the record upon which I now must decide this case.
Petitioners' latest motion to suspend the proceedings is denied for the reasons set forth in Section II. Further, petitioners have repeatedly refused to comply with my orders and their intractability on this issue leaves me no reason to expect that they will ever complete the record. Failure to follow court orders, as well as failure to file medical records or an expert medical opinion, is ground for dismissal. Their case is thus dismissed for failure to prosecute for the reasons set forth in Section III.
Alternatively, treating petitioners' assertions that the record establishes entitlement to compensation as either a motion for summary judgment or a motion for a ruling on the record, their case is likewise dismissed for the reasons set forth in Section IV.
In March 2012, petitioners first requested that I suspend further proceedings in this case. I granted their request, giving them first a 30-day suspension and, once a justification for additional time was filed, granting a further 150-day suspension period. Since that time, petitioners have made five requests, formal and informal, for additional suspensions. I denied each of the formal requests, pointing out that the Vaccine Act authorizes the special master to grant a suspension of proceedings for only 180 days.
On September 30, 2014, petitioners moved once again to suspend proceedings, arguing that a pending Congressional investigation could "impact the outcome of [their] petition." Pet. Mot. to Suspend Proceeding [hereinafter "Pet. Mot. Sept. 30"], at 1. They alleged "substantial harm if [their] petition is decided by Office of Special masters [sic] without waiting for complete evidence that has come to light." Pet. Mot. Sept. 30 at 1. Their motion included a statement that a "senior researcher" at the Centers for Disease Control and Prevention ("CDC") admitted to tampering with data that showed a positive link between the MMR vaccine and autism in male, African-American children. Pet. Mot. Sept. 30 at 1-2. Arguing that the CDC is an "operating arm" of the respondent, petitioners contended that a denial of their motion to suspend proceedings would unjustly prejudice petitioners because of an intentionally dishonest action by the respondent herself. See Pet. Mot. Sept. 30 at 1, 3. Petitioners asserted that this unidentified
In her reply, respondent claimed she was unaware of any Congressional investigation, and furthermore, stated that petitioners "have not offered any evidence of a pending Congressional investigation that impacts their case in any way." Reply to Petitioners' Post-Argument Filing [hereinafter "Res. Reply Oct. 16"] at 5. Respondent further incorporated her past responses to petitioners' motions to suspend proceedings. Res. Reply Oct. 16 at 4; see also Respondent's Response to Petitioners' Response to Order to Show Cause (Jan. 29, 2014); Response to Petitioners' Motion (Sept. 3, 2013); Respondent's Response to Petitioners' Motion to Suspend Proceedings, July 10, 2012; Respondent's Response to Petitioners' Motion to Correct the Record (Dec. 20, 2011). She argued that, under Vaccine Rule 9, petitioners are entitled to one automatic suspension for 30 days if requested, and then a maximum suspension of 150 additional days. Resp. Reply Oct. 16 at 4-5. Respondent observed that I had already granted the maximum amount of time allowed by the Vaccine Rules of the United States Court of Federal Claims. Id.
In my 278-page OAP test case decision, Snyder v. Sec'y, HHS, No. 01-162V, 2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), about five pages were devoted to a summary and analysis of various epidemiological studies of a relationship between the MMR vaccine and autism. Id. at *142-46. The journal article in question, filed as Cedillo Respondent's Exhibit P, Tab 38, is referenced in one paragraph of n.397 of my decision, and was otherwise cited at n.228 for the fact that the MMR vaccination was usually administered in the U.S. at 12-15 months of age. This small portion of the decision in Snyder summarized many epidemiological studies conducted in the United States, Great Britain, the Netherlands, and Japan, and noted that none of them found any connection between the MMR vaccine and autism. Even accepting petitioners' claims at face value, the other epidemiological studies provided ample evidence of no epidemiological association between MMR vaccination and autism. And, contrary to petitioners' assertions, epidemiological evidence played only a limited role in the rationale for my decision finding insufficient evidence of vaccine causation in Snyder.
This is petitioners' fifth formal request to suspend proceedings.
Vaccine Rule 9, which addresses requests for a suspension of proceedings, tracks the statutory language in § 12(d)(3)(C) of the Vaccine Act. Under Rule 9(b)(1), a special master must grant an initial motion for suspension for 30 days. Accordingly, I granted petitioners' initial request for a suspension of proceedings. Order, issued May 25, 2012. A special master has the discretion to grant additional motions for suspension up to 150 days, but may not grant additional suspensions. Vaccine Rule 9(b)(2). I granted petitioners' motion to suspend proceedings for 150 days in my July 11, 2012 Order. Thus, I cannot grant any further suspensions of proceedings under the Vaccine Rules or the Vaccine Act.
Even were I to interpret petitioners' request as one for a delay rather than a suspension of proceedings, they have not identified a date certain when they will be ready, willing, and able to file the missing evidence. An indefinite stay, delay, or suspension is not warranted; in effect, their case has been delayed since their last substantive filing of medical records on August 16, 2013. No further delays will be granted.
Petitioners have repeatedly failed to comply with court orders to file the medical records required by § 11(c)(2)of the Vaccine Act and Vaccine Rule 2. These records are essential to establish I.R.I.'s diagnosis and current condition, thus forming the basis for any opinion on causation. As their claim is based on the presence of a mitochondrial disorder, petitioners have the burden to demonstrate that their son has such a disorder. See Broekelschen v. Sec'y, HHS, 618 F.3d 1339, 1346 (Fed. Cir. 2010). Moreover, they have asserted that treating physicians agree with them that vaccines are responsible for I.R.I.'s condition, but they have refused to file any records containing such opinions. In effect, they ask me to rule in their favor because they believe vaccines are responsible.
As I have reminded petitioners on several occasions, they cannot simply file a claim, demand compensation, and expect to receive it. The Vaccine Act prohibits a special master from finding entitlement to compensation based on a petitioner's unsubstantiated claims. § 13(a)(1). Petitioners must show preponderant evidence of vaccine causation to obtain compensation. § 13(a). The orders to file medical records and other evidence of vaccine causation have been issued to obtain the evidence necessary for a full and fair adjudication of their claim on behalf of I.R.I. Without the missing records, "they cannot establish the factual underpinning necessary to [their] causation theory." See, e.g., Order, issued Mar. 28, 2014. I have emphasized that their refusal to comply with such orders will result in the dismissal of their claim. See, e.g., Orders filed Feb. 7, 2013, Feb. 28, 2013, and May 13, 2013. During the final conference call, respondent also explained why the evidence of record is insufficient, factually and legally, to meet petitioners' burden to produce preponderant evidence of vaccine causation. Transcript ["Tr."] at 37-49.
Petitioners have had ample opportunity in the last three years to cure the defects in their case. It is not so much that they have failed to do so; it is that they have refused to do so.
Under Vaccine Rule 21(b), a claim may be dismissed "for failure of the petitioner to prosecute or comply with [the Vaccine Rules] or any order of the special master or the court." Vaccine Rule 21(b)(1). See also Tsekouras v. Sec'y, HHS, 26 Cl. Ct. 439 (1992), aff'd per curiam, 991 F.2d 810 (Fed. Cir. 1993); Sapharas v. Sec'y, HHS, 35 Fed. Cl. 503 (1996). For more than 18 months, petitioners have repeatedly refused to comply with orders to file the matters required by the Vaccine Act and Vaccine Rule 2.
The evidence discussed below is based primarily on the filed medical records. I have, however, considered the assertions of petitioners in their petition, status reports, motions, and other filings, but I have placed more weight on the contemporaneously-recorded medical symptoms than those recounted in later medical histories or in petitioners' various filings or arguments. "It has generally been held that oral testimony which is in conflict with contemporaneous documents is entitled to little evidentiary weight." Murphy v. Sec'y, HHS, 23 Cl. Ct. 726, 733 (1991) (citation omitted); see also Cucuras v. Sec'y, HHS, 993 F.2d 1525, 1528 (Fed. Cir. 1993) (medical records are generally trustworthy evidence). Memories are generally better the closer in time to the occurrence reported and when the motivation for accurate explication of symptoms is more immediate. Reusser v. Sec'y, HHS, 28 Fed. Cl. 516, 523 (1993). "[W]ritten documentation recorded by a disinterested person at or soon after the event at issue is generally more reliable than the recollection of a party to a lawsuit many years later." Id. The following medical history and the conclusions drawn therefrom are presented with these legal principles in mind.
The medical records are not complete
I.R.I. was born at 41 weeks gestation after an uncomplicated pregnancy via a vacuum assisted vaginal delivery in November 2006. Pet. Exs. 1, p. 2; 6, p. 250. The vacuum assistance was necessary due to fetal heart rate decelerations. Pet. Ex. 6, p. 250. His Apgar scores were 9 and 9, reflective of a healthy newborn.
I.R.I. was born into a family with a history of mild developmental delays. His father was delayed in language acquisition, although he developed language without receiving any treatment. Pet. Ex. 10, p. 341. I.R.I.'s maternal cousin was diagnosed with Pervasive Developmental Disorder, Not Otherwise Specified ["PDD-NOS"], a disorder on the autism spectrum. Pet. Ex. 6, p. 251.
His primary medical care was provided by pediatricians at the John Muir Medical Group ["John Muir"], where he usually saw Drs. Andrew Nash, Gregory Hahn, or Lynne Whyte. He had well baby visits a few days after birth and at regular intervals thereafter. At all of these visits through one year of age, he appeared to be developing normally, and his parents expressed no concern about any developmental problems.
During his first two years, I.R.I. received the recommended childhood vaccines at well child visits.
There were several sick child visits as well. I.R.I. was seen on January 10, 2007 (about six weeks after birth and the administration of his initial hepatitis B vaccination) and on August 18, 2007 (three months after his most recent vaccination) for minor childhood illnesses. Pet. Ex. 1, pp. 20, 24.
At his well child visit on May 24, 2007, shortly before six months of age, I.R.I. exhibited normal development for his age. He cooed, smiled, reached for a toy, babbled, rolled, and sat with support. Pet. Ex. 1, p. 23. At his nine month well child visit on August 24, 2007, I.R.I.'s parents did not express any concerns about his development. Pet. Ex. 1, p. 25.
At his one year well child visit in December 2007, I.R.I. was walking and saying "mama" and "dada," although not specifically in reference to his parents. They expressed no concerns about his development, and his pediatrician assessed him as "doing great." Pet. Ex. 1, p. 26. He received an influenza vaccination, his initial hepatitis A vaccination, and his fourth Prevnar vaccination at this visit. Id., p. 13. According to a history provided to Dr. Haas in October 2010, petitioners had no concerns about I.R.I.'s health or development during his first year of life. Pet. Ex. 7, p. 305.
Later in December 2007, I.R.I. developed a cough and cold with a fever. Pet. Ex. 1, p. 27. His pediatrician diagnosed croup. Id. On January 10, 2008, I.R.I.'s parents returned to the pediatrician, reporting that their son had experienced a fever that had since resolved. I.R.I. had a runny nose and cough, and was diagnosed with right otitis media. His parents were told to follow up in 10 to 14 days. Pet. Ex. 1, p. 28. I.R.I.'s symptoms presumably resolved on their own, as petitioners did not return to the pediatrician for several months.
The allegedly causal vaccinations were administered on March 13, 2008, when I.R.I. was 15 months old. At that point, I.R.I. was walking well, had three words (other than "mama" and "dada"), and was imitating housework. Pet. Ex. 1, p. 29. At this visit, he received his fourth DTaP, third Hib, and initial MMR and varicella vaccinations. Id., p. 13. There are no medical records reflecting any reaction to these vaccinations.
On April 7, 2008, more than three weeks after the 15 month immunizations, I.R.I. had a cold, cough, rash on his face, a slight fever, and vomiting. He was diagnosed with a viral syndrome. Pet. Ex. 1, p. 30. On April 30, 2008, I.R.I. and his parents returned to the pediatrician. I.R.I. had run a fever the previous day, and was experiencing a decreased appetite and seemed fussy. He also had a rash on his upper trunk, back, and cheeks. I.R.I.'s doctor described him as alert and in no apparent distress. The doctor concluded that I.R.I. had a viral illness with associated exanthema and possible mild gastroenteritis. Id., p. 31.
He was next seen at his 18 month well child visit on June 13, 2008. He was reported as bilingual and speaking more than ten words (a gain of language since the 15 month visit) and using eating utensils. He was assessed as a well child and was, according to the pediatrician, "doing great." Pet. Ex. 1, p. 32. No vaccinations were administered at this visit. Id., p. 13.
I.R.I.'s sister was born when he was approximately 18 months old. In a history provided in late April 2009, petitioners recounted some regression in I.R.I.'s development at around the time of his sister's birth. Pet. Ex. 10, p. 339; see also Pet. Ex. 7, p. 305.
On July 31, 2008, I.R.I. again experienced fever and vomiting. His tonsils were enlarged without exudate and Dr. Nash believed he had viral pharyngitis with mild gastroenteritis. Pet. Ex. 1, p. 33.
At his two year well child visit on December 2, 2008, I.R.I. was using two-word phrases and had a vocabulary of 40-50 words. However, a concern about "licking" was noted. His pediatrician assessed him as a well child, but this assessment was followed by a note reflecting "slower" social communication development. Although the remainder of the note is difficult to read, it appears to indicate that this would be followed up at another appointment, and that petitioners should involve I.R.I. in a play group or gymnastics. He received hepatitis A and Flumist (influenza) vaccinations at this visit. Pet. Ex. 1, pp.13, 34-35 (duplicate pages). This consultation note appears to reflect the first report of concerns about I.R.I.'s speech development and behavior.
I.R.I. had diaper rash shortly after the two year well child visit. Pet. Ex. 1, p. 36. Over the period between his second and third birthdays, I.R.I. was also seen for bronchitis in January 2009, a viral illness with cough and congestion in June 2009, and influenza in August 2009.
Although petitioners correctly asserted that I.R.I. had more illnesses after his 15 month vaccinations than before them
At a pediatric visit on January 20, 2009, when I.R.I. was a little over two years old, his parents expressed concern about his development to Dr. Nash. Pet. Ex. 1, p. 37. Petitioners were concerned primarily with his lack of social development. Although he was in a play group, he was not engaging with other children; rather, he preferred to stand back and observe. They thought I.R.I. had a lot of words and was trilingual, but he did not put two or three words together very often. Petitioners also stated that their son had begun licking objects, both at home and at the playground. I.R.I.'s treating physician, Dr. Nash, assessed social delays and possible language delays and referred him to the Regional Center of the East Bay ["RCEB"] for a developmental evaluation. He indicated that I.R.I. would likely need occupational and speech therapy.
On February 2, 2009, I.R.I. was evaluated for speech and language services offered through the RCEB. Pet. Ex. 9, p. 335. During the evaluation, he responded to his name on only one occasion. He made only fleeting eye contact. I.R.I. exhibited maladaptive behaviors, including sensitivity to touch and stimuli and licking non-food objects such as balls and books. Id. I.R.I.'s receptive language age equivalent was seven months, while his expressive language age equivalent was 12 months. Pet. Ex. 9, p. 336. According to the evaluation, these delays were not attributable to the multiple languages spoken in the home. Id.
In late April and early May 2009, Dr. Rene Wachtel, a developmental pediatrician, and Dr. (Ph.D.) Lori Wensly, a clinical psychologist, conducted a comprehensive evaluation of I.R.I. which included direct observation of I.R.I., a detailed parental history, and the administration of tests measuring cognitive development, communication, adaptive behavior, and behaviors relevant to a diagnosis of autism. Pet. Ex. 10, pp. 343-44. His intellectual performance was within normal limits for his age. Id., pp. 344-45. His fine motor skills were likewise in the normal range, although his gross motor skills were slightly delayed. Id., p. 345. However, he had significant delays in both receptive and expressive language, results that were also reflected on the adaptive skills testing. I.R.I. had "significant impairment" in socialization skills; he interacted and played at the level of a seven month old child. Id., pp. 345-46.
Administration of the Childhood Autism Rating Scale ["CARS"],
Shortly after his diagnosis in the spring of 2009, his parents began pursuing less conventional therapies for treatment. On June 16, 2009, Mr. Padmanabhan and Ms. Srinivas returned to John Muir for a consultation regarding medication and speech delay. They indicated that I.R.I. had been evaluated by the RCEB and diagnosed with speech delay and social anxiety, but "not autism."
Nevertheless, it appears that petitioners at least suspected an autism diagnosis, as the record for this visit also indicates that they planned to visit a DAN!
Blood testing was performed on June 19, 2009. Only two of the three pages were filed, but most of the results reported were within the reference ranges. A handwritten note at the bottom of the second page reflects"? fighting virus. will repeat LFTs in 2-4 weeks. Sooner prn [as necessary]." Pet. Ex. 1, pp. 88-89. The signature following these notes appears to be the same as that of the physician who met with petitioners on June 16.
Beginning in July 2009, I.R.I. was subjected to a battery of laboratory tests for gastrointestinal pathogens, food allergies, celiac disease, immunoglobulins, vitamin D, blood toxic metals, urinary porphyrins and toxic metals, various viral antibodies, stool parasites, thyroid function, and antinuclear antibodies. See, e.g., Pet. Exs. 1, pp. 61, 63, 64-65, 75-78, 110-14; 2, pp. 127-31, 141; 3, pp. 147-51; 4, pp. 157-83; 5, pp. 208-16. With very few exceptions (mostly involving Dr. Goldberg, whose treatment is discussed, infra), the results were within reference ranges or not interpreted as significant by any physician.
At his two and a half year well child appointment on July 8, 2009, I.R.I. was reported to be receiving occupational and speech therapy. Pet. Ex. 1, p. 41. The pediatrician also noted Dr. Wachtel's diagnosis of mild to moderate autism and recorded that I.R.I. was receiving 25-40 hours of ABA therapy per week.
On August 10, 2009, Mr. Padmanabhan visited his son's pediatrician to go over the laboratory test results, although it is unclear how I.R.I.'s doctor interpreted the results (or even which tests were discussed).
At a John Muir pediatrics visit in early September 2009, petitioners reported that I.R.I. was beginning a gluten- and casein-free diet on a diet plan developed by Dr. Abrin.
On September 23, 2009, I.R.I. visited Dr. Haddad, a pediatric gastroenterologist, the result of a referral from one of I.R.I.'s pediatricians. Pet. Ex. 1, pp. 124-26. Doctor Haddad identified tests results he found significant as "a positive gliadin IgG, several food allergen positivities on the ELISA IgG, elevated vitamin B12 level, low ferritin, history of elevated transaminases [AST and ALT] in June 2009 with improvement of ALT (now normal), but mild elevation of the AST." Id., p. 125. He provided five differential diagnoses: celiac disease (although he noted that the gliadin IgA was normal, making this disease less likely); allergic enteropathy (commenting that the ELISA IgG tests were "difficult to interpret clinically"); inflammatory bowel disease (also less likely); lactose intolerance; and small bowel bacterial overgrowth. He recommended further testing. Id. Although Dr. Haddad wanted to see I.R.I. again in a month, no further records from his office were filed.
However, the results from the tests Dr. Haddad ordered were filed. Serological testing for anti-gliadin antibodies was negative; genetic testing for susceptibility to celiac disease showed I.R.I. was at low risk; AST and ALT were within reference ranges; his vitamin B12 level remained high;
At I.R.I.'s three year well child visit,
Doctor Whyte also noted a "long discussion about vaccines" with his parents, but the substance of the discussion is not set forth in the records. She provided names of immunologists and metabolic doctors in the area to petitioners in case "they want to see someone based on information they get from their DAN[!] Doctor" or "to discuss metabolic/mitochondrial concerns further." Id., p. 46.
In summary, by the time I.R.I was a little over three years of age, he had a diagnosis of an autism spectrum disorder, for which he was receiving ABA, speech, and occupational therapy. While some of I.R.I.'s health care providers speculated that he might have some other developmental disorder, ASD remains I.R.I.'s only developmental diagnosis.
By the fall of 2010, petitioners began seeking explanations other than autism for I.R.I.'s condition. Petitioners explored immune system dysfunction and possible metabolic or mitochondrial disorders with several practitioners in 2010-11.
One explanation advanced by a treating physician, Dr. Goldberg, was that I.R.I. has an immune system dysfunction.
On September 2, 2010, at I.R.I.'s initial consultation with Dr. Goldberg, petitioners told him their son developed normally until he was 18 months old and that he had no reactions to his MMR vaccine received March 13, 2008. Pet. Ex. 5, p. 185. This is in marked contrast to the assertions in the petition for compensation filed approximately six months later. Doctor Goldberg felt I.R.I. had a neurocognitive dysfunction and was on the "Autistic Spectrum/NIDS."
Although Dr. Goldberg made a diagnosis of immune dysfunction on several occasions,
Doctor Goldberg's records reflect the testing he ordered throughout 2010-11, but do not reflect the significance of any of the results, except for noting that an EEG was normal
Other records of immune system testing by the Mayo Clinic in 2011 were filed as Pet. Ex. 18, pp.389-96. The ordering official is simply identified as a "staff physician." Id. Although the results were not interpreted by a physician, the only result outside the reference range was an elevated "IgM+% of CD19+B cells." Pet. Ex. 18, p. 390. These mostly normal results "did not necessarily rule out CVID."
In July 2011, another physician, Dr. Kendal Stewart,
Although Dr. Goldberg diagnosed I.R.I. with an immune system disorder, he never specified the precise type of the disorder. He never specifically opined that I.R.I.'s autism symptoms were caused by a dysfunctional immune system. Moreover, the immune system testing performed by several different physicians involved in I.R.I.'s care did not show objective evidence that I.R.I.'s immune system was dysfunctional. He had adequate immunoglobulin levels overall and had memory cells (as reflected by IgG levels) to several common viruses, indicating that he had previous viral infections and recovered.
Mitochondria are small organelles (structures inside cells) that turn food and oxygen into the body's supply of chemical energy. In addition to energy production, mitochondria are also responsible for maintaining proper functioning of various organs. When mitochondria do not function as they should, many organ systems likewise fail to work properly. See Bast v. Sec'y, HHS, No. 01-565V, 2012 WL 6858040 at *24 (Fed. Cl. Spec. Mstr. Dec. 20, 2012), mot. for review denied sub nom. [M.S.B.] by Bast v. Sec'y, HHS, 117 Fed.Cl. 104 (2014); appeal dismissed sub nom. M.S.B. ex rel. Bast v. Sec'y, HHS, 579 Fed.Appx. 1001 (2014).
"Mitochondrial disease is not a single entity but, rather, a heterogeneous group of disorders characterized by impaired energy production due to genetically based oxidative phosphorylation dysfunction." Court Exhibit I, R. Haas, et al., Mitochondrial Disease: A Practical Approach for Primary Care Physicians, PEDIATRICS, 120(6) 1326-33, (2007) at 1326 [hereinafter "Haas, Court Ex. I"]. Physicians have difficulty definitively diagnosing a mitochondrial disease as patients often present with a wide array of symptoms. Id. There is no "definitive biomarker that characterizes mitochondrial disease in all patients." Id. at 1331. "Mitochondrial diseases are usually progressive and multisystemic," typically affecting organs with "a high energy demand, including skeletal and cardiac muscle, endocrine organs, kidney, nonmucosal components of the intestinal tract, retina, and the central nervous system." Id. at 1327.
A SCAD disorder is a fatty acid oxidation disorder (an inborn error of metabolism (metabolic disorder)) (see NELSON'S at 456, 460) that may affect mitochondrial function, but it is not a primary mitochondrial disorder or disease. Haas, Court Exhibit I, at 1330 (discussing secondary mitochondrial dysfunction caused by a defect in fatty acid and other metabolic disorders); N. Wolf and J. Smeitink, Mitochondrial disorders: A proposal for consensus diagnostic criteria in infants and children, NEUROLOGY 59: 1402-06 (2002) at 1404-05, filed as Court Ex. II [hereinafter "Wolf and Smeitink, Court Ex. II"] (discussing secondary respiratory chain involvement of fatty acid oxidation disorders).
The issue of whether I.R.I. might have a metabolic or mitochondrial disorder was first raised by I.R.I.'s parents at his three year well child visit with Dr. Whyte. Pet. Ex. 1, p. 46. She offered to refer them to a metabolic specialist to discuss their concerns. Id.
In February 2010, I.R.I. was evaluated for "in toeing" by Dr. Scott Hoffinger, the Director of Children's Orthopaedic Associates, a part of the Children's Hospital and Research Center in Oakland. In a letter to I.R.I.'s pediatrician, Dr. Hoffinger noted that I.R.I.'s parents told him that their son had "some type of metabolic disorder" being treated by a doctor in Texas. Pet. Ex. 1, p. 115. He referred them to a rehabilitation doctor, Elaine Pico, who was "generally quite receptive to looking at kids with slightly different diagnoses and trying to put together a treatment plan." Id., pp. 115-16.
A possible mitochondrial disorder was mentioned in March 2010, when I.R.I. saw Dr. Pico. Petitioners told her that I.R.I. was "on the spectrum" with "mitochondrial dysfunction." Pet. Ex. 1, p. 117. Petitioners also reported that I.R.I. had been recently diagnosed with "heavy metals"
In a history provided to Dr. Goldberg at the initial visit on September 2, 2010, Mr. Padmanabhan indicated that Dr. Abrin did testing that showed mitochondrial dysfunction, but the records do not reflect which test results were involved. Pet. Ex. 5, p. 187. Doctor Goldberg apparently did not find the results significant, as he recommended waiting before conducting any further mitochondrial testing. Pet. Ex. 5, p. 190.
In September and October 2010, I.R.I. saw several new specialists. The first was Dr. Jonathan Bernstein, a geneticist at Lucile Packard Children's Hospital, who first saw I.R.I. in September. The second was a specialist in mitochondrial and metabolic disorders, Dr. Haas, at Rady Children's Hospital, who first saw I.R.I. in October.
I.R.I.'s parents were referred by Dr. Jepson to Dr. Bernstein to discuss "the diagnosis, management and counseling for the findings of autism." Pet. Ex. 6, p. 250. At the initial visit on September 13, 2010, Dr. Bernstein discussed a possible genetic link to autism but informed petitioners that I.R.I.'s "history and physical exam are not strongly suggestive of a specific genetic etiology for his autism at this time." Pet. Ex. 6, p. 252. He noted that only 5% to 20% of autism cases have a single identified genetic cause. Id.
However, the language history provided by petitioners to Dr. Bernstein was significantly different from the reports in the contemporaneous records. Petitioners reported to Dr. Bernstein that I.R.I. "experienced a setback in his language skills such that he was speaking only a few words at age 2." Pet. Ex. 6, p. 250. I.R.I.'s pediatric records reflect that at one year of age, he was saying "mama" and "dada," albeit not with specificity. Pet. Ex. 1, p. 26. At the 15 month well child visit (when the allegedly causal vaccinations were administered), he had three words, in addition to "mama" and "dada." Id., p. 29. He had more than 10 words by the time of his 18 month well child visit. Id., p. 32. At his two year well child visit on December 2, 2008, I.R.I. was using two-word phrases and had a vocabulary of 40-50 words. Id., pp. 34-35 (duplicate pages). Either petitioners conflated events in I.R.I.'s language development or deliberately misinformed the geneticist. Petitioners also reported many respiratory illnesses in the second year of I.R.I.'s life, with the contemporaneous medical records reflecting only four upper respiratory illnesses that year.
To pursue a potential genetic cause for I.R.I.'s condition, Dr. Bernstein recommended array-based comparative hybridization and DNA testing for Fragile X Syndrome.
The results from the metabolic testing were abnormal. An undated addendum to Dr. Bernstein's report indicated that the urine organic acid test results from a sample collected on October 7, 2010, showed increased levels of ethylmalonic and methylsuccinic acids. Plasma amino acids were normal. I.R.I.'s plasma lactate was reported as quite high on one test and slightly high on the other. His ammonia level was very slightly elevated. The urine organic acid test was repeated on October 14, with similar results. Additionally, an acylcarnitine profile from October 14 showed an elevation of C4 acylcarnitine, but free carnitine and total carnitine were within reference ranges. Pet. Ex. 6, pp. 253 (addendum), 259-66, 274, 286 (test results). According to Dr. Bernstein and the laboratory report, these results suggested that I.R.I. might have a SCAD deficiency. Id., pp. 253, 264.
While a SCAD deficiency diagnosis was not made at that (or any other) time,
On October 19, 2010, Mr. Padmanabhan took his son for an initial visit with Dr. Haas to discuss I.R.I.'s ASD and a possible metabolic disorder. Pet. Ex. 7, p. 305. He reported no concerns about I.R.I. in his first year of life, and some regression in I.R.I.'s development at about 18 months of age when his sister was born. He also reported a loss of all words, but did not specify when such loss occurred.
According to petitioners, they declined to pursue some of the recommended tests. Pet. Status Report, filed Mar. 7, 2013, at 3. Tests ordered by Dr. Haas and performed on the date of the visit included a plasma acylcarnitine profile, a comprehensive metabolic panel, plasma ammonia, lactic acid, pyruvic acid, and a carbohydrate deficient transferrin test. Pet. Ex. 7, pp. 306, 312-18, 322.
His metabolic panel also indicated elevated levels of blood urea nitrogen, total protein, and albumin, with low levels of total bilirubin and ammonia. Id., pp. 298-99. In additional testing performed on samples collected on November 1, 2010, I.R.I.'s excretion of ethylmalonic acid ["EMA"] was markedly elevated, suggesting a possible SCAD deficiency or mitochondrial respiratory chain defect. Id., p. 303. The report indicated that a SCAD deficiency presenting in early childhood was usually a "milder form with hypotonia and developmental delay" and that an "EMA aciduria might be the only biochemical feature of ACAD deficiency." Id., p. 304. Repeat testing showing elevations of EMA and C4-carnitine was conducted in January 2011, with the laboratory noting that the combination of the two elevations was "consistent with SCAD deficiency, a disorder of fatty acid oxidation." Id., pp. 326-27.
On October 21, 2010, Dr. Goldberg's records reflect that an unidentified "Stanford doctor" believed I.R.I. might have a mitochondrial disorder and wanted him to start taking Levocarnitine. Doctor Goldberg refused to prescribe the medication without proof of some mitochondrial disorder. He offered to re-test I.R.I. but said that it would not change his current treatment plan. Pet. Ex. 5, p. 200.
The Mayo Clinic tested I.R.I. for a SCAD mutation in January 2011. The laboratory identified one known mutation, one known variant, and two variants of unknown significance. Pet. Ex. 6, p. 289.
It does not appear that any additional testing for a mitochondrial disease was performed. The diagnosis of a mitochondrial disease is difficult to make, even with additional testing. The Haas article, Court Ex. I, states that a "definitive diagnosis of mitochondrial disease cannot be based on biochemical findings alone." Id. at 1330. In fact, some patients with suspected mitochondrial disease have, upon further testing, been given definitive diagnoses involving copper-metabolism disorders, lysomal disorders, and others. Id. at 1331.
On July 27, 2011, I.R.I. underwent another EEG. Dr. Olson, who performed the procedure, determined that the results were abnormal and noted a "mild, diffuse, encephalopathy." Pet. Ex. 20, p. 416. Notably, Dr. Olson did not convey any opinion as to when I.R.I.'s encephalopathy developed. Dr. Olson also found that I.R.I. had an increased risk of seizures, but that there was "no evidence of an epileptic encephalopathy."
An October 28, 2011 brain pattern test (a qualitative EEG) was not interpreted by any physician. Pet. Ex. 21. It was the most recent medical record filed. Petitioners have not provided any information about any medical care or treatment their son has received for the past three and a half years.
There is nothing in the record indicating whether I.R.I. ever received a definitive diagnosis of a SCAD deficiency. Had any reputable physician opined that I.R.I. has a SCAD deficiency, I would have no difficulty in finding preponderant evidence that he does. In the absence of evidence of such a diagnosis, I cannot make this finding.
Evidence that I.R.I. has a primary mitochondrial disorder, the course of which could be significantly aggravated by a physiologic stressor such as illness, infection, or surgery, is utterly lacking. At best, I.R.I. has some test results suggesting a possible mitochondrial dysfunction, but petitioners have opted against the more definitive testing suggested by Dr. Haas.
Even assuming I.R.I. has a fatty acid oxidation disorder, such conditions are "inborn," not acquired. An inborn error of metabolism may induce some secondary mitochondrial dysfunction, but it does not constitute the type of primary mitochondrial disorder that may lead to sudden regression or decompensation. The distinction between dysfunction secondary to primary mitochondrial disorders and dysfunction secondary to metabolic diseases is made very clearly by Dr. Haas in Court Ex. I at 1330.
The record is devoid of proof that a SCAD deficiency can be significantly aggravated by a vaccine. The only evidence regarding SCAD that petitioners filed discusses the misfolding of proteins in SCAD. Pederson, Pet. Ex. 15. The authors identified several variations of the ACADS
The next step in analyzing petitioners' causation claims examines the possible bases for a finding of entitlement to compensation in light of the evidentiary record.
Although there are ample grounds to dismiss this case for failure to prosecute, I elect to rule in the alternative. In so doing, I treat petitioners' assertions that the record as it now stands establishes entitlement to compensation as the functional equivalent of either a motion for summary judgment or a request that I rule on the record.
Petitioners' repeated assertions that they have established their entitlement to compensation could be construed as a motion for summary judgment. Summary judgment is permitted under the Vaccine Act. See § 12((d)(2)(C)) (requiring the Vaccine Rules to "include the opportunity for summary judgment"). A special master may "decide a case on the basis of written submissions without conducting an evidentiary hearing. Submissions may include a motion for summary judgment, in which event the procedures set forth in [Rule 56 of the Rules for Court of Federal Claims ("RCFC")] will apply." Vaccine Rule 8(d). Summary judgment standards in vaccine cases are the same as those in any other case. Jay v. Sec'y, HHS, 998 F.2d 979, 983 (Fed.Cir. 1993).
Under RCFC 56, summary judgment is appropriate when "there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." A material fact is one "that would affect the outcome of the litigation." Lowrie v. Sec'y, HHS, No. 03-1585V, 2007 WL 2734999, at *5 (Fed. Cl. Spec. Mstr. Aug. 31, 2007) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)). There is a genuine issue if "the evidence would permit a reasonable trier of fact to find in favor of the nonmoving party." Lowrie, 2007 WL 2734999 at *5.
Proof that the vaccinee suffers from the injury claimed is a matter that has a substantial impact on the outcome of a vaccine case. See Broekelschen, 618 F.3d at 1346; Lombardi v. Sec'y, HHS, 656 F.3d 1343, 1352 (Fed. Cir. 2011) ("under Broekelschen, identification of a petitioner's injury is a prerequisite to an Althen analysis of causation."). Thus, a diagnosis of a metabolic or mitochondrial disorder, or lack thereof, may be considered a "material fact."
No findings of fact can be made in deciding a motion for summary judgment; if fact finding is necessary, logically there must be some factual dispute. See Jay, 998 F.2d at 983. In summary judgment, the court must draw "all justifiable factual inferences . . . in favor of the non-movant." Shell Oil Co. v. U.S., 751 F.3d 1282, 1290 (Fed. Cir. 2014) (quoting Ford Motor Co. v. U.S., 378 F.3d 1314, 1316 (Fed. Cir. 2004)); see also Anderson, 477 U.S. at 255.
Petitioners cannot establish that there are no genuine issues as to material fact. Such threshold issues as whether I.R.I. has any of the diagnoses they claim for him remain in dispute. Diagnoses aside, their theory of how vaccines may have caused the symptoms listed in their petition remains unclear.
The failure to establish entitlement to summary judgment does not result in a dismissal of petitioners' claim. However, in view of their refusal to file additional evidence, I will treat their assertion that they have established entitlement to compensation as a request to rule on the record.
The Vaccine Act requires that the Vaccine Rules provide "the opportunity for parties to submit arguments and evidence on the record without requiring routine use of oral presentations cross examinations, or hearings." § 12(d)(2)(D). Thus, a special master "may decide a case on the basis of written submissions without conducting an evidentiary hearing." Vaccine Rule 8(d). Treating petitioners' assertion that the record establishes their entitlement to compensation as a request that I rule on the record as it now stands, I find that petitioners have failed to muster preponderant evidence of vaccine causation.
In ruling on the record, a special master may decide controverted questions of fact and make conclusions of law. See Vaccine Rule 8(d). Congress has instructed special masters to "be vigorous and diligent in investigating factual elements necessary to determine the validity of the petitioner's claim." H.R. REP. No. 99-908, at 17 (1986), reprinted in 1986 U.S.C.A.N. 6344, 6358.
There are two ways to establish entitlement to compensation under the Vaccine Act's no-fault system. First, petitioners may demonstrate that I.R.I. suffered a vaccine-specific injury listed on the Vaccine Injury Table within the requisite time period set forth in the Table (a "Table injury"). To prove a Table injury, petitioners must show that the first symptom or manifestation of the onset...of any such illness, disability, injury, or condition...occurred within the time period after vaccine administration set forth in the Vaccine Injury Table." Shalala v. Whitecotton, 514 U.S. 268, 270 (1995) (quoting 42 U.S.C. § 11(c)(1)(C)(i)). In such cases, causation is presumed. See 42 C.F.R. § 100.3.
Second, petitioners may demonstrate by preponderant and reliable evidence that an injury was caused in fact or significantly aggravated by a vaccine listed on the Table ("actual causation" or "causation-in-fact" or "significant aggravation"). See § 11(c)(1)(C); see also Moberly v. Sec'y, HHS, 592 F.3d 1315, 1321 (Fed. Cir. 2010) (causation in fact claims); W.C. v. Sec'y, HHS, 704 F.3d 1352, 1357 (Fed. Cir. 2013); Loving v. Sec'y, HHS, 86 Fed. Cl. 135, 144 (2009); Hennessey, 2009 WL 1709053 at *40.
To prove actual causation, petitioners must demonstrate 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, HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005); see also Grant v. Sec'y, HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992); Hines v. Sec'y, HHS, 940 F.2d 1518, 1525 (Fed. Cir. 1991); de Bazan v. Sec'y, HHS, 539 F.3d 1347, 1351-52 (Fed. Cir. 2008); Caves v. Sec'y, HHS, 100 Fed. Cl. 119, 132 (2011), aff'd per curiam, 463 Fed. Appx. 932, 2012 WL 858402 (Fed. Cir. 2012) (holding that each Althen factor must be established by preponderant evidence). The applicable level of proof is the "traditional tort standard of `preponderant evidence.'" Moberly, 592 F.3d at 1322 (citing de Bazan, 539 F.3d at 1351; Pafford v. Sec'y, HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006); Capizzano v. Sec'y, HHS, 440 F.3d 1317, 1320 (Fed. Cir. 2006); Althen, 418 F.3d at 1278).
To prove significant aggravation, petitioners must establish the three Althen factors, plus demonstrate by preponderant evidence: (1) the vaccinee's condition prior to the vaccination; (2) the condition after the vaccination; and (3) that a comparison of the two conditions constitutes a significant change for the worse after vaccination. W.C., 704 F.3d at 1357 (adopting the six-factor test established in Loving); see also Hennessey, 2009 WL 1709053, at *40. A significant aggravation is "any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness accompanied by a serious deterioration in health." § 300aa-33(4).
The Vaccine Injury Table includes "encephalopathy" as an associated injury (Table injury) for both the DTaP and MMR vaccines. Onset of the first symptom of the encephalopathy must occur within 72 hours following a DTaP vaccination and within 5-15 days of an MMR vaccination. 42 CFR §§ 100.3(a)(II)(B) (DTaP); 100.3(a)(III)(B) (MMR). The other two vaccines received by I.R.I. at the 15 month well child visit (Hib and varicella) do not have any associated Table injuries. 42 C.F.R. § 100.3(a)(IX) (Hib); § 100.3(a)(X) (varicella).
To prove a Table encephalopathy, petitioners have the burden to show that I.R.I. suffered an encephalopathy "and the first symptom or manifestation of the onset...of any such illness, disability, injury, or condition...occurred within the time period after vaccine administration set forth in the Vaccine Injury Table." Shalala, 514 U.S. at 270 (quoting § 300aa-11(c)(1)(C)(i)).
However, none of the medical records suggest that I.R.I. experienced any difficulty within either time frame after vaccination. Although petitioners assert that they telephonically reported a fever with hardness and swelling at the injection site after the 15 month vaccinations, there is no evidence that they did so. More significantly, fever and hardness, and swelling at an injection site are not symptoms of a Table encephalopathy.
A Table encephalopathy occurs when an acute encephalopathy is followed by a chronic encephalopathy which lasts for "more than 6 months beyond the date of vaccination." 42 C.F.R. § 100.3(b)(2). An acute encephalopathy is one that is "sufficiently severe so as to require hospitalization (whether or not hospitalization occurred)" and "is indicated by a `significantly decreased level of consciousness' lasting for at least 24 hours." 42 C.F.R. § 100.3(b)(2)(i). A "significantly decreased level of consciousness" occurs when at least one of the following symptoms arises for a period of at least 24 hours:
42 C.F.R. § 100.3(b)(2)(i)(D).
Petitioners have made several claims that I.R.I. suffered an encephalopathy. See, e.g., Petitioners' Filing, January 17, 2014, at 5. Although there is laboratory evidence that I.R.I. has a mild diffuse encephalopathy, there is no evidence that this encephalopathy meets the requirements for a "Table" encephalopathy, much less that it began during the time frames for onset set forth in the Table. Most significantly, I.R.I. was seen by one of his regular pediatricians three weeks after the allegedly causal vaccinations. At this visit, there were no reports of any symptoms consistent with an acute encephalopathy and no indication by the physician that I.R.I. was displaying symptoms consistent with a chronic encephalopathy. On April 30, 2008, I.R.I.'s pediatrician described him as alert and in no apparent distress, descriptions utterly incompatible with a chronic Table encephalopathy.
In short, petitioners have failed to demonstrate that I.R.I. suffered a Table encephalopathy after the allegedly causal vaccinations. Because their Table injury argument is unpersuasive, petitioners can prevail only by demonstrating that a vaccine or vaccines actually caused or significantly aggravated I.R.I.'s condition. I next turn to their causation in fact claim.
To establish causation in an off-Table case, petitioners must demonstrate by preponderant evidence that the vaccine caused the injury by "providing: (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 proximate temporal relationship between vaccination and injury." Althen 418 F.3d at 1278. The preponderance standard "requires the trier of fact to believe that the existence of a fact is more probable than its nonexistence." In re Winship, 397 U.S. 358, 371 (1970) (Harlan, J., concurring) (internal quotation and citation omitted).
A petitioner is not required to establish identification and proof of specific biological mechanisms, as "the purpose of the Vaccine Act's preponderance standard is to allow the finding of causation in a field bereft of complete and direct proof of how vaccines affect the human body." Althen, 418 F.3d at 1280. The petitioner does not have to show that the vaccination was the sole cause, or even the predominant cause, of the injury or condition; showing that the vaccination was a "substantial factor"
Although a petitioner cannot be required to show "epidemiologic studies, rechallenge, the presence of pathological markers or genetic disposition, or general acceptance in the scientific or medical communities to establish a logical sequence of cause and effect,"
Causation is determined on a case by case basis, with "no hard and fast per se scientific or medical rules." Knudsen v. Sec'y, HHS, 35 F.3d 543, 548 (Fed. Cir. 1994). Close calls regarding causation must be resolved in favor of the petitioner. Althen, 418 F.3d at 1280; but see Knudsen, 35 F.3d at 550 (when evidence is in equipoise, the party with the burden of proof fails to meet that burden).
Althen requires that a petitioner in an off-Table causation case present a reliable medical theory by which a vaccine can cause the injury in question. Althen, 418 F.3d at 1278. This first prong of Althen's three-part causation test has also been characterized as the equivalent of the "Can it cause?" inquiry used in toxic tort litigation. See Pafford v. Sec'y, HHS, No. 01-165V, 2004 WL 1717359, at *4 (Fed. Cl. Spec. Mstr. July 16, 2004), aff'd, 64 Fed. Cl. 19 (2005), aff'd, 451 F.3d 1352 (Fed. Cir. 2006). The medical theory must be a reputable one, although it need only be "legally probable, not medically or scientifically certain." Knudsen, 35 F.3d at 548-49. Theories of causation must be reliable as well. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 590 (1993); Moberly, 592 F.3d at 1324.
Althen's second prong requires a logical sequence of cause and effect between the vaccine and the injury. It has been characterized as addressing the "Did it cause?" or specific causation query. See Pafford, 2004 WL 1717359, at *4. Circumstantial evidence and medical opinions may be sufficient to satisfy this requirement. Capizzano, 440 F.3d at 1325-26. Opinions of treating physicians may also provide the logical connection. See Andreu v. Sec'y, HHS, 569 F.3d 1367, 1376 (Fed. Cir. 2009); see also Moberly, 592 F.3d at 1323; Capizzano, 440 F.3d at 1326.
The third Althen factor requires a proximate temporal relationship between the allegedly causal vaccine and the injury suffered. The requirement of temporal connection necessitates a showing that the injury occurred in a medically or scientifically reasonable period after the vaccination, not too soon (see de Bazan, 539 F.3d at 1352) and not too late (see Pafford, 451 F.3d at 1358). Merely showing a temporal connection between a vaccination and an injury is insufficient, standing alone, to establish causation. Grant, 956 F.2d at 1148. A temporal relationship, even when coupled with the absence of any other identified cause for the injury, is not enough to demonstrate probable cause under the Vaccine Act's preponderance standard. Moberly, 592 F.3d at 1323 (citing Althen, 418 F.3d at 1278).
Petitioners never articulated a coherent theory about how vaccines caused their son's condition. After reviewing all of the records filed, the transcript, and recorded status conferences, I deduce that petitioners believe that I.R.I.'s DTaP vaccination interacted with an underlying mitochondrial disorder, causing an immune reaction. Tr. at 18-19. This immune reaction then detrimentally interacted with I.R.I.'s MMR vaccine, which in turn caused hypoxia of the brain. Tr. at 19, 33. This hypoxia then caused an encephalopathy, resulting in I.R.I.'s developmental disorders. Tr. at 13, 33. In Mr. Padmanabhan's words, the rash that I.R.I. experienced four weeks after the vaccines in question "is obviously his immune system being haywire, trying to fight the live viruses that were injected to him. And because of his SCAD ailment and possibly his metabolic or mitochondrial dysfunction at this time, he was not able to, and he had either rubella that was—he was fighting from the vaccine and it was causing all the other clinical symptoms like fever, cough and congestions, and—and that was getting worse." Id. at 31. Devoid of any supporting scientific evidence, petitioners' theory appears to be that since I.R.I.'s medical condition worsened after his March 2008 vaccines, they must be related to his ailments. This theory confuses timing with causation.
There is simply no evidence—no opinion by a treating physician, no opinion by an expert, and no medical literature—supporting a theory that the DTaP vaccine can interact with an underlying mitochondrial disorder to cause an immune reaction. The record is devoid of evidence that an immune reaction, coupled with an MMR vaccination, can induce hypoxia, or that hypoxia leads to encephalopathy, and in particular to the mild, diffuse encephalopathy I.R.I.'s MRI showed.
Absent "clear, definitive medical records" establishing vaccine causation of the injury in question, an expert medical opinion is necessary to establish a reputable causation theory. Keith v. Sec'y, HHS, 55 Fed. Cl. 791, 797 (Fed. Cl. 2003) (citing Dickerson v. Sec'y, HHS, 35 Fed. Cl. 593, 599-600 (Fed. Cl. 1996)). In Keith, 55 Fed. Cl. at 797, the court affirmed a special master's dismissal of a claim of causation without a medical expert's opinion; Dickerson, 35 Fed. Cl. at 599 (citing Thornton v. Sec'y, HHS, 35 Fed. Cl. 432, 440-42 (1996) (stating "the firm requirement that medical opinion evidence is still necessary" even in on-Table claims of causation)).
In summary, without an expert opinion, petitioners cannot demonstrate that I.R.I.'s condition, whatever it may be, is vaccine caused. See Althen, 418 F.3d at 1278 ("A persuasive medical theory is demonstrated by `proof of a logical sequence of cause and effect'...supported by `reputable medical or scientific explanation [,]' i.e., `evidence in the form of scientific studies or expert medical testimony.'") (quoting Grant, 956 F.2d at 1148). The records that have been filed do not present a definitive diagnosis of a mitochondrial disorder, nor is there any evidence linking this alleged disorder and I.R.I.'s childhood vaccines to his ASD. By failing to submit complete medical records and an expert medical opinion, petitioners are unable to meet the first prong of Althen.
While some petitioners in the Vaccine Program have argued, with limited success, that Althen's prong one analysis only requires petitioners to provide a "biologically plausible medical theory," see Doe 93 v. Sec'y, HHS, 98 Fed. Cl. 553, 566-67 (2011), the Federal Circuit has required petitioners to prove all three prongs "by a preponderance of the evidence." Koehn v. Sec'y, HHS, 773 F.3d 1239, 1241-42 (Fed. Cir. 2014). In doing so, the court endorsed the preponderance standard articulated in Caves v. Sec'y, HHS, 100 Fed. Cl. 119, 144 (2011); aff'd without opinion, 463 Fed. Appx. 932 (Fed. Cir. 2012). In this case, petitioners have fallen far short of establishing prong one by preponderant evidence. Indeed, given the absence of a coherent medical theory, petitioners are unable to meet their burden under any standard.
Althen's second prong requires petitioners to establish "specific causation." But because I.R.I.'s parents have been unable to establish that their son's vaccines are logically capable of causing his condition, they cannot possibly demonstrate that the allegedly causal vaccines did in fact cause their son's condition. A claim cannot succeed after it has failed Althen's first prong. See Verzyer v. Sec'y, HHS, 100 Fed.Cl. 344, 353 (Fed.Cl. 2011), aff'd without opinion, 475 Fed. Appx. 765 (Fed. Cir. 2012); see also Caves, 100 Fed. Cl. 144; aff'd without opinion, 463 Fed. Appx. 932.
The second Althen prong addresses the evidence showing a logical connection between the theory and the injury. Assuming arguendo that stringing vaccines, mitochondrial dysfunction, immune reaction, hypoxia, and encephalopathy together constitutes a reliable theory explaining how vaccines can cause the autistic-like symptoms and autism diagnosis clearly established in this record, petitioners have failed to show the predicate facts that would place their son's clinical picture within the ambit of this theory.
I.R.I. received both of the vaccines in question. However, demonstrating that I.R.I. experienced a rash three weeks after the vaccinations does not show that his immune system was compromised by them. His pediatrician called the rash and illness a "viral syndrome" and possible gastroenteritis. He recovered from the illness and actually gained language and other skills between the 15 month vaccinations and his 18 month well child visit.
There is no evidence in this record that I.R.I. suffered hypoxia or that hypoxia is somehow responsible for the diffuse, mild encephalopathy found on the 2011 MRI. Moreover, there is no evidence that the encephalopathy occurred at any particular time.
None of his pediatricians noted anything unusual in the type or number of infections he experienced after the allegedly causal vaccinations. Although it appears to me to be quite unlikely that I.R.I. actually has a dysfunctional immune system, accepting Dr. Goldberg's diagnosis at face value, I find no evidence of any connection between immune dysfunction and the symptoms I.R.I. displayed.
Even if I.R.I. actually has SCAD, there is no evidence that vaccines can cause or trigger its onset, and there is some evidence that SCAD alone could account for I.R.I.'s clinical symptoms. I note that SCAD is an inborn error of metabolism. In other words, if I.R.I. has a SCAD deficiency, he was born with it, even if the dysfunction it caused did not begin for many months after his birth.
The evidence that I.R.I. actually has a primary mitochondrial disorder is very scant. Although fatty acid oxidation disorders like SCAD may produce some impairment in mitochondrial function, this dysfunction is classified as a secondary disorder. The Haas article (Court Ex. I) indicates that regression and loss of skills may occur in a primary mitochondrial disorder, but there is no contemporaneous evidence that I.R.I. experienced any regression or loss of skills within six months of the allegedly causal vaccinations.
Having failed to establish Althen's first two prongs, petitioners cannot satisfy the third. Petitioners are unable to show a "proximate temporal relationship between the vaccination and the injury." Althen, 418 F.3d at 1278. Petitioners have shown neither a logical nor a specific link between I.R.I.'s vaccines and his condition. Given the evidence presented, it is impossible to establish a proximate and medically appropriate temporal connection between the DTaP, MMR, and Hib vaccines I.R.I. received in March 2008 and onset of his autism symptoms.
To summarize, petitioners deny that I.R.I. has ASD, in spite of the diagnosis by specialists in the field and observations by other physicians that he appears to be "on the spectrum." Instead they assert that he has a mitochondrial or metabolic disorder, but have failed to file any records reflecting either diagnosis. Their causation theory is confused, relies on facts not in evidence, and is unsupported by the opinion of any expert or even by a treating physician. I cannot accept petitioners' second hand assertions that one or more of I.R.I.'s physicians supports their causation theory as reliable evidence. Thus, petitioners have not satisfied any of Althen's requirements, and have failed to establish their off-Table causation claim.
A significant aggravation is defined as "any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness accompanied by a serious deterioration in health." 42 U.S.C. § 300aa-33(4). To prevail under a significant aggravation theory, petitioners must establish, in addition to the Althen factors, preponderant evidence of: (1) the vaccinee's condition prior to administration of the vaccine; (2) the vaccinee's current condition or condition following the vaccine; and (3) whether the comparison of the two conditions constitutes a significant aggravation of the person's condition. Loving, 86 Fed. Cl. at 144. Because petitioners have failed to establish any of the Althen factors by preponderant evidence, they have failed to meet three of the prongs of the Loving six-factor test. Nevertheless, I briefly discuss the significant aggravation aspect of their claim because it illustrates the impact of their refusal to file updated medical records.
Petitioners' significant aggravation theory is also entirely unsubstantiated by the record. In their petition, I.R.I.'s parents claim that the vaccines he received significantly aggravated an underlying mitochondrial disorder. Since petitioners have not established that their son suffers from the condition alleged in the petition, I cannot find it was significantly aggravated by a vaccination.
Petitioners have filed sufficient evidence to determine I.R.I.'s condition before the vaccine, but they have repeatedly refused to file any medical records from the last three years, thus precluding me from determining his current condition or adequately comparing his current and past conditions. Comparing I.R.I.'s condition in the six months before and after the vaccination, I cannot conclude that I.R.I was significantly worse. Determining if he is significantly worse today is impossible.
Significantly, petitioners did not report any concerns about I.R.I.'s development until his two year well child visit, eight months after the allegedly causal vaccinations. They reported "licking" and slower social communication development, but did not indicate when these symptoms were first observed. They later reported some concerns about I.R.I.'s development at around the time of his sister's birth, when I.R.I. was about 18 months old. They specifically denied any symptoms following his 15 month vaccinations as late as six months before the petition was filed in this case.
I have no doubt of petitioners' love for I.R.I. Nor do I doubt that they have pursued treatments that they believe are in his best interest. Their belief that I.R.I. has a mitochondrial disorder, a SCAD deficiency, and immune dysfunction was apparent in their filings and in the oral argument. Their belief that I.R.I.'s condition is vaccine caused is, no doubt, also sincere, but the facts do not support a Table injury, a causation in fact, or a significant aggravation claim. They have firm, fixed beliefs that the Vaccine Program was designed to compensate them based on the evidence they have been willing to produce. However, their beliefs constitute neither the evidence necessary to prevail nor the law that I must apply.
For the reasons stated above, I dismiss this case for failure to prosecute. Alternatively, I find that petitioners have not established preponderant evidence of a Table encephalopathy. Petitioners have also not demonstrated by preponderant evidence that vaccines caused or significantly aggravated their son's condition. Having failed to demonstrate that the vaccines I.R.I received on March 13, 2008 are in any way responsible for his condition, petitioners are not entitled to compensation.
The petition for compensation is therefore DENIED. The clerk is directed to enter judgment accordingly.
