GEORGE L. HASTINGS, Jr., Special Master.
This is an action in which the Petitioners, Harold Hardy and Tiffany Ann Hardy-Bell, seek an award under the National Vaccine Injury Compensation Program (hereinafter the "Program"
Under the National Vaccine Injury Compensation Program, compensation awards are made to individuals who have suffered injuries after receiving vaccines. In general, to gain an award, a petitioner must make a number of factual demonstrations, including showing that an individual received a vaccination covered by the statute; received it in the United States; suffered a serious, long-standing injury; and has received no previous award or settlement on account of the injury. Finally — and the key question in most cases under the Program — the petitioner must also establish a causal link between the vaccination and the injury. In some cases, the petitioner may simply demonstrate the occurrence of what has been called a "Table Injury." That is, it may be shown that the vaccine recipient suffered an injury of the type enumerated in the "Vaccine Injury Table," corresponding to the vaccination in question, within an applicable time period following the vaccination also specified in the Table. If so, the Table Injury is presumed to have been caused by the vaccination, and the petitioner is automatically entitled to compensation, unless it is affirmatively shown that the injury was caused by some factor other than the vaccination. § 300aa-13(a)(1)(A); § 300aa-11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).
In other cases, however, the vaccine recipient may have suffered an injury not of the type covered in the Vaccine Injury Table. In such instances, an alternative means exists to demonstrate entitlement to a Program award. That is, the petitioner may gain an award by showing that the recipient's injury was "caused-in-fact" by the vaccination in question. § 300aa-13(a)(1)(B); § 300aa-11(c)(1)(C)(ii). ("Causation-in-fact" is also known as "actual causation.") In such a situation, the presumptions available under the Vaccine Injury Table are inoperative. The burden is on the petitioner to introduce evidence demonstrating that the vaccination initially caused, or significantly aggravated, the injury in question. Althen v. HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005); Hines v. HHS, 940 F.2d 1518, 1525 (Fed. Cir. 1991). The showing of "causation-in-fact" must satisfy the "preponderance of the evidence" standard, the same standard ordinarily used in tort litigation. § 300aa-13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that standard, the petitioner must show that it is "more probable than not" that the vaccination initially caused or aggravated the injury. Althen, 418 F.3d at 1279. The petitioner need not show that the vaccination was the sole cause or even the predominant cause of the injury or aggravation, but must demonstrate that the vaccination was at least a "substantial factor" in causing or aggravating the condition, and was a "but for" cause. Shyface v. HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999). Thus, the petitioner must supply "proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury;" and the logical sequence must be supported by "reputable medical or scientific explanation, i.e., evidence in the form of scientific studies or expert medical testimony." Althen, 418 F.3d at 1278; Grant v. HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992).
The Althen court also provided additional discussion of the "causation-in-fact" standard, as follows:
Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner need not necessarily supply evidence from medical literature supporting petitioner's causation contention, so long as the petitioner supplies the medical opinion of an expert. (Id. at 1279-80.) The court also indicated that, in finding causation, a Program fact-finder may rely upon "circumstantial evidence," which the court found to be consistent with the "system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants." (Id. at 1280.)
Since Althen, the Federal Circuit has addressed the causation-in-fact standard in several additional rulings, which have affirmed the applicability of the Althen test, and afforded further instruction for resolving causation-in-fact issues. In Capizzano v. HHS, 440 F.3d 1317, 1326 (Fed. Cir. 2006), the court cautioned Program fact-finders against narrowly construing the second element of the Althen test, confirming that circumstantial evidence and medical opinion, sometimes in the form of notations of treating physicians in the vaccinee's medical records, may in a particular case be sufficient to satisfy that second element of the Althen test. Both Pafford v. HHS, 451 F.3d 1352, 1355 (Fed. Cir. 2006), and Walther v. HHS, 485 F.3d 1146, 1150 (Fed. Cir. 2007), discussed the issue of which party bears the burden of ruling out potential non-vaccine causes. DeBazan v. HHS, 539 F.3d 1347 (Fed. Cir. 2008), concerned an issue of what evidence the special master may consider in deciding the initial question of whether the petitioner has met her causation burden. The issue of the temporal relationship between vaccination and the onset of an alleged injury was further discussed in Locane v. HHS, 685 F.3d 1375 (Fed. Cir. 2012), and W.C. v. HHS, 704 F.3d 1352 (Fed. Cir. 2013). Moberly v. HHS, 592 F.3d 1315 (Fed. Cir. 2010), concluded that the "preponderance of the evidence" standard that applies to Vaccine Act cases is the same as the standard used in traditional tort cases, so that conclusive proof involving medical literature or epidemiology is not needed, but demonstration of causation must be more than "plausible" or "possible." Both Andreu v. HHS, 569 F.3d 1367 (Fed. Cir. 2009), and Porter v. HHS, 663 F.3d 1242 (Fed. Cir. 2011), considered when a determination concerning an expert's credibility may reasonably affect the outcome of a causation inquiry. Broekelschen v. HHS, 618 F.3d 1339 (Fed. Cir. 2010), found that it was appropriate for a special master to determine the reliability of a diagnosis before analyzing the likelihood of vaccine causation. Lombardi v. HHS, 656 F.3d 1343 (Fed. Cir. 2011), and Hibbard v. HHS, 698 F.3d 1355 (Fed. Cir. 2012), both again explored the importance of assessing the accuracy of the diagnosis that supports a claimant's theory of causation. Doe 11 v. HHS, 601 F.3d 1349 (Fed. Cir. 2010) and Deribeaux v. HHS, 717 F.3d 1363 (Fed. Cir. 2013), both discuss the burden of proof necessary to establish that a "factor unrelated" to a vaccine may have caused the alleged injury.
Another important aspect of the causation-in-fact case law under the Program concerns the factors that a special master should consider in evaluating the reliability of expert testimony and other scientific evidence relating to causation issues. In Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme Court listed certain factors that federal trial courts should utilize in evaluating proposed expert testimony concerning scientific issues. In Terran v. HHS, 195 F.3d 1302, 1316 (Fed. Cir. 1999), the Federal Circuit ruled that it is appropriate for special masters to utilize Daubert's factors as a framework for evaluating the reliability of causation-in-fact theories presented in Program cases.
The Petitioners in this case appear to allege at times that the vaccinations that HH received on August 26, 2005, initially caused her neurodevelopmental disorder. (Petition, ¶ 23: Amended Petition, ¶ 23.) Alternatively, at times the Petitioners have alleged that those vaccinations significantly aggravated a pre-existing condition, causing it to worsen. (E.g., Amended Petition, ¶ 21.) According to W.C. v. HHS, 704 F.3d 1352 (Fed. Cir. 2013), "the National Vaccine Injury Compensation Program *** allows certain petitioners to be compensated upon showing, among other things, that a person `sustained, or had significantly aggravated' a vaccine-related `illness, disability, injury, or condition.'" Id. at 1355-56, quoting 42 U.S.C. § 300aa-11(c)(1)(C)) (emphasis added.) In Whitecotton v. HHS, 81 F.3d 1099, 1103 (Fed. Cir. 1996), the U.S. Court of Appeals for the Federal Circuit stated that "the statutory requirements to make out a prima facie significant aggravation claim are analogous to those required to make out a prima facie initial onset claim." The Vaccine Act states that "[t]he term `significant aggravation' means any change for the worse in a preexisting condition which results in markedly greater disability, pain or illness accompanied by substantial deterioration of health." § 300aa-33(4).
The elements of an off-Table significant aggravation case are set forth in Loving v. HHS, 86 Fed. Cl. 135, 144 (2009). There, the court combined the test from Althen, above, which defines off-Table causation cases, with the test from Whitecotton v. HHS, 81 F.3d 1099, 1107 (Fed. Cir. 1996), which concerns on-Table significant aggravation cases. The resultant test has six components, which are:
Loving, 86 Fed. Cl. at 144; see also W.C. v. HHS, 704 F.3d 1352, 1357 (Fed. Cir. 2013) (holding that "the Loving case provides the correct framework for evaluating off-table significant aggravation claims").
This case is one of more than 5,400 cases filed under the Program in which petitioners alleged that conditions known as "autism" or "autism spectrum disorders" ("ASD")
A group called the Petitioners' Steering Committee ("PSC") was formed in 2002 by the many attorneys who represented Vaccine Act petitioners who raised autism-related claims. About 180 attorneys participated in the PSC. Their responsibility was to develop any available evidence indicating that vaccines could contribute to causing autism, and eventually present that evidence in a series of "test cases," exploring the issue of whether vaccines could cause autism, and, if so, in what circumstances. Ultimately, the PSC selected groups of attorneys to present evidence in two different sets of "test cases" during many weeks of trial in 2007 and 2008. In the six test cases, the PSC presented two separate theories concerning the causation of ASDs. The first theory alleged that the measles portion of the measles, mumps, rubella ("MMR") vaccine could cause ASDs. That theory was presented in three separate Program test cases during several weeks of trial in 2007. The second theory alleged that the mercury contained in thimerosal-containing vaccines could directly affect an infant's brain, thereby substantially contributing to the causation of ASD. That theory was presented in three additional test cases during several weeks of trial in 2008.
Decisions in each of the three test cases pertaining to the PSC's first theory rejected the petitioners' causation theories. Cedillo v. HHS, No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009) aff'd, 89 Fed. Cl. 158 (2009), aff'd, 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. HHS, No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff'd 88 Fed. Cl. 473 (2009), aff'd, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. HHS, No. 01-162V, 2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff'd, 88 Fed. Cl. 706 (2009).
The "test case" decisions were comprehensive, analyzing in detail all of the evidence presented on both sides. The three test case decisions concerning the PSC's first theory (concerning the MMR vaccine) totaled more than 600 pages of detailed analysis, and were solidly affirmed in many more pages of analysis in three different rulings by three different judges of the United States Court of Federal Claims, and in two rulings by two separate panels of the United States Court of Appeals for the Federal Circuit. The three special master decisions concerning the PSC's second theory (concerning vaccinations containing the preservative "thimerosal") were similarly comprehensive.
All told, the 11 lengthy written rulings by the special masters, the judges of the U.S. Court of Federal Claims, and the panels of the U.S. Court of Appeals for the Federal Circuit unanimously rejected the petitioners' claims, finding no persuasive evidence that either the MMR vaccine or thimerosal-containing vaccines could contribute in any way to the causation of autism.
Thus, the proceedings in the six "test cases" concluded in 2010. Thereafter, the Petitioners in this case, and the petitioners in other cases within the OAP, were instructed to decide how to proceed with their own claims. The vast majority of those autism petitioners elected either to withdraw their claims or, more commonly, to request that the special master presiding over their case decide their case on the written record, uniformly resulting in a decision rejecting the petitioner's claim for lack of support. However, a small minority of the autism petitioners have elected to continue to pursue their cases, seeking other causation theories and/or other expert witnesses. A few such cases have gone to trial before a special master, and in the cases of this type decided thus far, all have resulted in rejection of petitioners' claims that vaccines played a role in causing their child's autism. See, e.g., Blake v. HHS, No. 03-31V, 2014 WL 2769979 (Fed. Cl. Spec. Mstr. Vowell May 21, 2014) (autism not caused by MMR vaccination); Henderson v. HHS, No. 09-616V, 2012 WL 5194060 (Fed. Cl. Spec. Mstr. Vowell Sept. 28, 2012) (autism not caused by pneumococcal vaccination); Franklin v. HHS, No. 99-855V, 2013 WL 3755954 (Fed. Cl. Spec. Mstr. Hastings May 16, 2013) (MMR and other vaccines found not to contribute to autism); Coombs v. HHS, No. 08-818V, 2014 WL 1677584 (Fed. Cl. Spec. Mstr. Hastings Apr. 8, 2014) (autism not caused by MMR or Varivax vaccines); Long v. HHS, No. 08-792V, 2015 WL 1011740 (Fed. Cl. Spec. Mstr. Hastings Feb. 19, 2015) (autism not caused by influenza vaccine); Brook v. HHS, No. 04-405V, 2015 WL 3799646 (Fed. Cl. Spec. Mstr. Hastings May 14, 2015) (autism not caused by MMR or Varivax vaccines); Holt v. HHS, No. 05-136V, 2015 WL 4381588 (Fed. Cl. Spec. Mstr. Vowell June 24, 2015) (autism not caused by Hepatitis B vaccine); Lehner v. HHS, No. 08-554V, 2015 WL 5443461 (Fed. Cl. Spec. Mstr. Vowell July 22, 2015) (autism not caused by influenza vaccine); Miller v. HHS, No. 02-235V, 2015 WL 5456093 (Fed. Cl. Spec. Mstr. Vowell August 18, 2015) (ASD not caused by combination of vaccines); Allen v HHS, No. 02-1237V, 2015 WL 6160215 (Spec. Mstr. Vowell Sept. 26, 2015) (autism not caused by MMR vaccination); R.K. v. HHS, (not yet published) (Spec. Mstr. Vowell Sept. 28, 2015) (autism not caused by influenza vaccine).
In addition, some autism causation claims have been rejected without trial, at times over the petitioner's objection, in light of the failure of the petitioner to file plausible proof of vaccine-causation. See, e.g., Waddell v. HHS, No. 10-316V, 2012 WL 4829291 (Fed. Cl. Spec. Mstr. Campbell-Smith Sept. 19, 2012) (autism not caused by MMR vaccination); Bushnell v. HHS, No. 02-1648, 2015 WL 4099824 (Fed. Cl. Spec. Mstr. Hastings June 12, 2015) (autism not caused by multiple vaccines); Miller v. HHS, No. 06-753V (Fed. Cl. Spec. Mstr. Hastings Sept. 25, 2012) (autism not caused by DTaP or MMR vaccines); Fesanco v. HHS, No. 02-1770, 2010 WL 4955721 (Fed. Cl. Spec. Mstr. Hastings Nov. 9, 2010); Fresco v. HHS, No. 06-469V, 2013 WL 364723 (Fed. Cl. Spec. Mstr. Vowell Jan. 7, 2013); Pietrucha v. HHS, No. 00-269V, 2014 WL 4338058 (Fed. Cl. Spec. Mstr. Hastings Aug. 22, 2014). Judges of this court have affirmed the practice of dismissal without trial in such a case. E.g., Fesanco v. HHS, 99 Fed. Cl. 28 (Judge Braden affirming).
In none of the rulings since the test cases has a special master or judge found any merit in an allegation that any vaccine can contribute to causing autism.
HH was born on February 23, 2005. (Ex. 1, p. 8.)
Rachel Chatters, M.D., performed an evaluation on March 11, 2005, when HH was two weeks of age. (Ex. 2, p. 47.) At that time, Dr. Chatters noted that there had been "no problem since last visit," and that HH's developmental assessment was within normal limits. During the next assessment, on March 31, 2005, Dr. Chatters referred HH to a specialist for further evaluation of a heart murmur. (Ex. 2, p. 48.) At a follow-up visit on April 13, 2005, HH's mother reported that HH was experiencing choking episodes and a feeding problem. (Ex. 2, p. 49.) Dr. Chatters diagnosed HH with gastroesophageal reflux disease (GERD), and prescribed treatment with Zantac. (Id.)
On April 28, 2005, when HH was two months of age, Dr. Chatters reported that she was "doing well," and her developmental assessment was within normal limits. (Ex. 2, p. 50.) At this visit, HH received several vaccinations. (Ex. 2, pp. 21, 50.)
On June 6, 2005, HH's parents took her to the Children's Clinic of Southwest Louisiana, because they were concerned that HH was congested, had little appetite, and had trouble sleeping. (Ex. 2, p. 5.) Dr. Bryan Karriker diagnosed HH with a viral infection. (Id.) One month later, on June 23, 2005, HH had a "well visit" at the same clinic, where it was noted that she was developing normally, exhibiting "coos, kicks, smiles." (Ex. 2, p. 33.) On June 29, 2005, HH received several more vaccinations. (Ex. 2, pp. 21, 41.)
No irregularities were noted at HH's check-up at six months of age, on August 26, 2005. (Ex. 2, p. 6.) HH received DTaP (diphtheria, tetanus, acellular pertussis), Hepatitis B, IPV (inactivated polio vaccine), and Prevnar (pneumococcal) vaccinations. (Ex. 2, p. 21.)
On September 7, 2005, HH's mother brought her to the Children's Clinic again, and reported that HH had been suffering from congestion, runny nose, and fever, off and on for the previous 1½ weeks. (Ex. 2, p. 9.) It was also noted that HH had exhibited increased sleeping and decreased appetite. (Id.) The pediatrician diagnosed right otitis media (ear infection) and an upper respiratory infection. (Id.) At a follow-up visit one month later, on October 7, 2005, HH was diagnosed with acute sinusitis and prescribed an antibiotic treatment. (Ex. 2, p. 11.)
HH and her mother returned to the pediatrician's office on December 21, 2005, with a renewed complaint of "earache." (Ex. 2, p. 13.) HH was diagnosed with an upper respiratory infection and "otalgia." (Id.) However, during this visit, the pediatrician also indicated that HH's development should be monitored, because she was not "scooting" or "crawling." (Id.) It was also noted that HH was able to express a "few words." (Id.)
On January 10, 2006, the pediatrician performed a general check-up and noted HH's ongoing constipation. (Ex. 2, p 14.) He also noted significant "developmental concerns" about HH, such as "not sitting alone, only reaches for things occasionally, slow response if any to stimuli." (Id.) HH reportedly remained lethargic after napping, had a slow facial expression, and would not get on her hands and knees. (Id.) She also exhibited esotropia of the right eye. (Id.) The physician recorded his diagnoses as "developmental delay" and "esotropia." (Id.) He referred HH to an ophthalmologist, and ordered an MRI of the brain, a CMP (comprehensive metabolic panel) test, and other testing. (Id.) More notes of the visit indicated that HH's mother had already contacted "Early Steps," an early childhood disability program. (Ex. 2, p. 15.) The CMP and chromosomal test results for HH were normal. (Ex. 2, pp. 4, 24.) The MRI report indicated "negative" for any abnormalities. (Ex. 2, pp. 26-27.) On January 23, 2006, Dr. Karriker requested an EEG examination for HH, due to "developmental delay" and to rule out "absence" seizures. (Ex. 2, p. 35.)
HH was evaluated by Dr. Duane Superneau, a geneticist, on January 26, 2006. (Ex. 6, p. 1.) Dr. Superneau diagnosed HH with neurodevelopmental delay, but he could not identify any specific syndrome. (Id., pp. 1-2.) The parents reported to him that "by nine months of age" they had realized HH was behind in her development. (Ex. 6, p. 1.) Further, HH's parents were "worried about her losing skills." (Id.) At this time, Dr. Superneau noted that HH's "head circumference is at the lower limits of normal and outside the range of expected for family average." (Ex. 6, p. 2.) Dr. Superneau recorded the following assessment: "Neurodevelopmental delay; [Rule out] seizure disorder; Relative microcephaly." (Id.) He also recommended that HH receive an EEG test and be examined by a neurologist, to determine "whether the spells she seems to exhibit reflect a seizure disorder." (Id.) The EEG result was normal. (Ex. 14, p. 8.)
On January 27, 2006, HH was seen again by Dr. Karriker because she was "not crying, not eating." (Ex. 2, p. 16.) Dr. Karriker noted that HH's "eyes [were] dazing off," that she was "always tired," that she would not sit up by herself, would not crawl, would not grab things and that she was experiencing a decrease in appetite. (Id.)
On February 23, 2006, when HH was 12 months old, she was examined by Dr. Stephanie Cave. (Ex. 7, p. 53.) Based on her initial discussion with a parent, Dr. Cave recorded that HH had "stopped progressing" at six to seven months of age, then "regressed" at ten months of age. (Ex. 7, p. 60.) Dr. Cave diagnosed HH's condition as: 1) hypotonia, 2) cow milk intolerance, 3) constipation, and 4) developmental delay. (Ex. 7, p. 53.) Dr. Cave also made a series of recommendations concerning medicines, nutrition, liver detoxification, and laboratory testing. (Id., pp. 54-59.)
Dr. Robert P. Cruse, a pediatric neurologist, evaluated HH on June 22, 2006. (Ex. 14, pp. 7-9.) Dr. Cruse recorded the history of HH's condition, as provided by her parents, including their belief that HH suffered seizures ("spells of getting tense") shortly after her birth. (Id., p. 7.) The parents felt that HH was "normal" for the first six months of life. (Id.) At about that time, "she received a hepatitis immunization, and the mother reports that two hours after the shot she had a seizure which was described as staring and unresponsiveness. From that time on, she was felt to show regression
The neurological examination of HH by Dr. Cruse had an outcome characterized as "abnormal" in many ways. (Ex. 14, p. 9.) Dr. Cruse considered the possibility that HH had a combined central and peripheral nervous system disorder based on her symptom presentation. (Id.) He described HH's series of head circumference measurements, from birth until one year of age, which showed a gradually slowing rate of growth, and by one year of age resulted in a head size below the 2ndpercentile. (Id., pp. 8-9.) He summarized the following impressions:
(Ex. 14, p. 9, emphasis added.) Thus, Dr. Cruse indicated that soon after age 3 months HH had a declining head growth which indicated a neurologic disorder.
On July 19, 2006, HH received an electromyography (EMG) and a nerve conduction test, which revealed no evidence of peripheral neuropathy or a myopathy. (Ex. 14, p. 101.) On July 20, 2006, Petitioners wanted to discuss growth hormones for HH with Dr. Karriker. (Id., p. 40.)
On August 9, 2006, Mr. Hardy reported to Dr. Cave's staff that HH had been hospitalized for an esophageal perforation caused by swallowing broken glass. (Ex. 7, p. 65; Ex. 14, p. 23.) Dr. Karriker noted this recent history of "esophageal perforation" when he re-examined her on August 14, 2006. (Ex. 14, p. 198.) She had delayed motor development as well as hypotonic reflexes. (Id.) Dr. Karriker noted two chronic ailments, developmental delays and microcephaly. (Id.) On September 21, 2006, Dr. Karriker examined HH again, noted her developmental delays and the commencement of speech and physical therapy. (Ex. 14, p. 3.)
In a letter to Dr. Karriker dated March 19, 2007, Dr. Superneau stated that HH's symptoms did not suggest a diagnosis of Rett Syndrome. (Ex. 14, pp. 10-11.) A genomic microarray analysis was performed and the results were normal, so no specific genetic syndrome had been identified. (Id., p. 11.) He commented that the "microcephaly [abnormally small head size] in [HH] has been present from prior to the immunizations which have been implicated by the mother as potentially complicating [HH's] clinical course." (Id.) Dr. Superneau concluded that HH's "physical findings suggested the problems existed from birth, consistent with the majority of problems of this type." (Id.)
Six months later, on October 27, 2007, Dr. Superneau sent another letter to Dr. Karriker. (Ex. 14, pp. 12-13.) Dr. Superneau maintained that HH had not demonstrated actual regression, but he noted that HH's mother remained concerned that HH had regressed. (Id., p. 12.) He suggested that HH's family seek out a second opinion from another clinical geneticist. (Id.)
A multidisciplinary evaluation of HH's educational needs was completed on February 18, 2008, by the Calcasieu Parish School system. (Ex. 22, pp. 1-22.) As part of that process, a psychologist administered the Autism Diagnostic Observation Schedule (ADOS) to HH, and concluded that she fell within the category of "autism" (i.e., Autistic Spectrum Disorder.) (Id., pp. 1, 8, 21.)
The initial Petition in this case was filed on February 25, 2008. The petition was accompanied by some of HH's medical records and medical literature.
On April 3 and October 23, 2008, the special master then presiding over this case, Special Master Gary Golkiewicz, ordered Petitioners to file certain medical records and affidavits in support of their claim. These items were not filed, but instead on November 18, 2008, Petitioners filed a notification of their intent to remain in the Program and a proposal to transfer the case into the Omnibus Autism Proceeding ("OAP"). On December 16, 2008, the special master issued an order which directed Petitioners to show cause why the case should not be dismissed for failure to prosecute.
Petitioners filed various documents in March 2009.
After the conclusion of the autism "test cases," Special Master Golkiewicz issued an order directing the Petitioners in this case to file an Amended Petition that clearly explained their theory of vaccine causation and included all of the documents required by § 300aa-11(c). (Order, filed June 28, 2011.) On July 29, 2011, Petitioners filed an Amended Petition containing the same claims they had alleged in their initial Petition, with only one change. Based on the medical opinion of Dr. Cave, the Amended Petition added a new allegation that HH suffered from a "mitochondrial disorder." (Amended Petition, ¶ 22.)
Attached to the Amended Petition was an undated letter from Dr. Cave addressed "To Whom It May Concern." (Amended Petition, pp.7-8, hereinafter "Dr. Cave's First Letter").
(Dr. Cave's First Letter.) Dr. Cave described HH's various symptoms that appeared during the two years following August 2005, including "gross motor delay, fine motor delay, poor response to sensory stimulation, weak proximal and distal musculature, delayed self care and delayed balance." (Id.) She opined that HH's "[l]aboratory abnormalities showed mitochondrial dysfunction, which would explain the hypotonia and muscle weakness, and deficiencies in vitamin B12, B6 and glutathione." (Id.) She contended that children with mitochondrial dysfunction "are prone to patterns of regression if they have infections or immunizations." (Id.) Dr. Cave concluded that HH "more likely than not became encephalopathic as a result of the August 26, 2005 vaccinations." (Id.)
On August 12, 2011, this case was reassigned to the docket of Chief Special Master Patricia Campbell-Smith.
During a status conference held on October 5, 2011, Respondent's counsel indicated that a review of the records did not disclose any support for the allegation that HH had a mitochondrial disorder, or suffered any seizures. (Order, filed Oct. 6, 2011.) Following that discussion, Petitioners were ordered to supplement the record with any test results or other medical evidence that supported their allegations concerning mitochondrial disorder and seizures. (Id.) Further, Petitioners were specifically instructed that "any filed expert report would be expected to provide detailed, pinpoint record citations that speak directly to the factual record in this case." (Id.) Petitioners' counsel subsequently filed a statement acknowledging that "petitioners are unaware of any additional test results or other medical evidence of HH's mitochondrial disorder or HH's seizures other than the medical records that have previously been filed in this case." (Status Report, filed Nov. 3, 2011.)
On November 30, 2011, Petitioners filed an expert report
After reviewing the filed medical records and Dr. Cave's expert report, Special Master Campbell-Smith issued a lengthy Order explaining that both the factual record and Dr. Cave's expert report fell short of establishing that the vaccines that HH received on August 26, 2005, caused her alleged encephalopathy and developmental delay. (Order, filed on March 2, 2012, p. 10.) This Order explained that Petitioners' allegations concerning an "encephalopathy" were insufficient to establish a "Table Injury," and further, there was no evidence in the medical record that HH experienced an encephalopathy following her vaccinations. (Id., pp. 2-3.) Also, there was "no evidentiary support for petitioners' claim that [HH] has a mitochondrial disorder or suffers from seizures." (Id., p. 5.)
In that order, Special Master Campbell-Smith observed that Petitioners' expert witness, Dr. Cave, had not proposed a medical theory of vaccine-related causation, and that the doctor lacked specialized education and training in genetics, neurology, and/or immunology that would give probative weight to her opinions. (Order, filed on March 2, 2012, pp. 4-5.) The Order also discussed evidence in the medical record suggesting a pre-natal origin for HH's condition. (Id., pp. 7-8.) Based on these and other shortcomings in Petitioners' claim, the Order concluded that "the reasonableness of moving forward is in question." (Id., pp. 9-10.)
In light of these deficiencies in Petitioners' claim, they were ordered to file a response indicating how they intended to proceed. (See Order, filed March 2, 2012, p. 10; see also Show Cause Order, filed April 10, 2012.) In response, Petitioners filed a Status Report on May 10, 2012, suggesting that they would ask their expert to review the matter. Thereafter, another Order was issued, which again required Petitioners to show cause why the case should not be dismissed, since they "have not addressed the stated inadequacies with their supplemental expert report." (Show Cause Order, filed May 14, 2012.)
On June 27, 2012, Petitioners filed additional medical records and medical articles (Exs. 23-26), and another supplemental expert report (Ex. 10-b), with Dr. Cave's curriculum vitae attached. This lengthy "Second Supplemental Report" by Dr. Cave was intended to "address the issues raised by the court." (Ex. 10-b, p. 2) In that report, Dr. Cave discussed a theory of vaccine causation, and her opinions concerning mitochondrial dysfunction and alleged symptoms of encephalopathy. (Id., pp. 4-8.) Within the context of this discussion, Dr. Cave argued that "the case could be considered a Vaccine Table Case." (Id., p. 14.)
Petitioners filed a Status Report on June 28, 2012, indicating their desire to proceed to an evidentiary hearing. On July 6, 2012, Special Master Campbell-Smith issued an Order stating that while Petitioners' recent filings were responsive to the recent show cause order, the special master's concerns about various issues still persisted. Nonetheless, in preparation for a hearing, Respondent was ordered to file a "Rule 4 report" and an expert report. (Order, filed July 6, 2012.) On October 5, 2012, Respondent filed a "Rule 4 report," along with the expert opinion of Dr. Max Wiznitzer, M.D. (Exhibit A.)
On April 3, 2013, counsel for both parties participated in a status conference to discuss how this case would proceed. Special Master Campbell-Smith filed another lengthy Order reiterating that the factual allegations made by Dr. Cave concerning the existence of symptoms of a Table encephalopathy or seizures could not be confirmed by contemporaneous medical records. (Order, filed April 8, 2013, pp. 1-3.) That Order noted that only the retrospective accounts of the parents supported Dr. Cave's recorded history of HH's condition, and the Special Master declined to base her factual determinations on those unsubstantiated claims. (Id.) The Order noted that the parties' experts "disagreed entirely" with regard to evidence of mitochondrial dysfunction, and a factual determination could be made only if Petitioners provided a fuller explanation of their theory linking HH's injury to mitochondrial dysfunction and vaccines. (Id., p. 3-4.) The Order also noted that Dr. Cave possessed far less of the specialized training needed to offer "an opinion on the neurological aspects of this matter," compared to a pediatric neurologist, such as respondent's witness, Dr. Wiznitzer. (Id., p. 5.)
On April 9, 2013, this case was reassigned to my docket.
Petitioners filed a supplemental report from Dr. Cave, on May 29, 2013, acknowledging that Petitioners could not support a finding that HH suffered a Table encephalopathy, or that she had suffered post-vaccination seizures, without relying on the statements of HH's parents. (Ex. 27, p. 1.) Following these concessions, Dr. Cave's supplemental report asserted that HH suffered from a mitochondrial dysfunction, which allegedly made her vulnerable to injury due to the effects of aluminum, a vaccine adjuvant. (Id., pp. 4-5.)
Petitioners indicated that they wanted to move forward with an evidentiary hearing. (Status Report, filed June 26, 2013.) During a status conference on July 2, 2013, Petitioners reiterated their intention to proceed to a trial consisting of expert testimony, but stated that it would not be necessary to present their own personal testimony. (Order, filed July 8, 2013.)
Pursuant to instructions from the court, Respondent filed a Pre-Hearing Brief on January 10, 2014, and Petitioners filed a Pre-Hearing Brief on January 14, 2014. An evidentiary hearing featuring testimony only from the expert witnesses (Dr. Cave and Dr. Wiznitzer) occurred on February 7, 2014. The transcript of those proceedings became available on March 11, 2014. (See Transcript of Proceedings ("Tr.").) Petitioners filed their Post-Hearing Brief on September 8, 2014; and Respondent filed a Post-Hearing Brief on November 21, 2014. Petitioners had the opportunity to file a reply brief, but did not do so.
At this point, I will briefly summarize both the qualifications and the opinions of the expert witnesses.
Stephanie F. Cave, M.D., graduated from Louisiana State University ("L.S.U.") in 1966, with a B.S. degree in medical technology, then served as a medical technologist at the Ochsner Foundation Hospital. (Ex. 29, pp. 1-2.) From 1972 to 1979, Dr. Cave taught clinical chemistry, medical mycology, and hematology at the Department of Allied Health of L.S.U. (Id., p. 2.) She received a M.S. degree in clinical chemistry from L.S.U. in 1978. (Id.)
In 1983, Dr. Cave received her medical degree from the L.S.U. School of Medicine. (Ex. 29, p. 1.) Dr. Cave performed her medical internship and residency in family medicine, between 1983 and 1986, at the Earl K. Long Memorial Hospital, where she served as chief resident in 1986. (Id.) She served as a preceptor at the L.S.U. Department of Family Medicine from 1986 until 2003. (Id.) Dr. Cave was certified by the American Board of Family Practice in 1986, and re-certified repeatedly, most recently in 2011. (Id.)
In 1986, Dr. Cave commenced a private practice in "Family Medicine/Integrative Medicine," which she continues to the present. (Ex. 29, p. 2.) That practice specializes in children with developmental delays, and Dr. Cave states that over the past decade, she has participated in treating over 10,000 children with autism. (Id., p. 1; Tr. 8, 40.) She currently maintains hospital privileges at Our Lady of the Lake Hospital and Women's Hospital in Baton Rouge. (Tr. 44.)
As part of her specialized practice, Dr. Cave has delivered a multitude of professional presentations concerning autism and immunizations, throughout the United States and internationally. (Ex. 29, pp. 3-6.) She has written or co-authored four articles addressing that topic, and a book entitled What Your Doctor May Not Tell You About Children's Vaccinations.
Dr. Cave is the mother of Petitioners' counsel, Michael L. Cave. (Tr. 40.)
On November 30, 2011, Petitioners filed an expert report by Dr. Cave, which contended that "Children with mitochondrial dysfunction are prone to patterns of regression if they have infections or immunizations," and that "[HH] is such a child with mitochondrial dysfunction who experienced a seizure two hours after the vaccine series on August 26, 2005." (Ex. 10, p. 1.) Dr. Cave opined that HH "more likely than not became encephalopathic as a result of the August 26, 2005 vaccines and remains so today." (Id.)
Petitioners filed a second report of Dr. Cave on January 16, 2012. That report reasserted that HH was afflicted with a "mitochondrial dysfunction," but did not include any references to "seizures." (Ex. 10-a.) Rather, it asserted that, according to reports by her parents, HH suffered a "regression in development" following the vaccinations of August 26, 2005. (Ex. 10-a, p. 2.) Dr. Cave observed that "vaccines could offer environmental triggers that induce inflammation and immune dysfunction in the children with mitochondrial dysfunction." (Id.) Dr. Cave concluded that HH "more likely than not became encephalopathic and regressed developmentally" as a result of those vaccines. (Id.)
On June 27, 2012, Petitioners filed another, more extensive version of Dr. Cave's opinion, which contended that HH "suffered an acute encephalopathy following the vaccines given on August 26, 2005," and that her case "could be considered a Vaccine Table case." (Ex. 10-b, p. 13.) Dr. Cave contended that, based on parental recollections, HH suffered seizure-like symptoms soon after her vaccinations of August 26, 2005. (Id., p. 7.) Dr. Cave also argued that HH had a "mitochondrial dysfunction" that made her likely to suffer regression in response to immunizations. (Id., pp. 4-6, 14.) She supported her diagnosis of mitochondrial dysfunction by citing HH's laboratory test results that allegedly showed aberrant levels of various metabolites. (Id., pp. 5-6.) Dr. Cave argued that these test results, along with a re-analysis of HH's symptoms, fulfilled or exceeded all of the factors emphasized in a seminal study of mitochondrial disease, published by Morava, et al.
Thereafter, in response to an order from the court, Dr. Cave prepared a supplemental report, which was filed on May 29, 2014. (Ex. 27.) That report acknowledged that Petitioners could not support a finding that HH suffered from a "Table encephalopathy" based on the medical records, without relying exclusively on the recollections of her parents. (Id., p. 1.) Likewise, Dr. Cave conceded that Petitioners are unable to demonstrate that HH experienced seizures following the vaccinations of August 26, 2005, except by relying entirely on parental statements. (Id.)
Instead, Dr. Cave reviewed various laboratory test results and comments recorded in the medical records that allegedly support her contention that HH suffered from mitochondrial dysfunction. (Ex. 27, pp. 1-4.) She also stated that HH possessed two genetic mutations that allegedly decreased her ability to detoxify neurotoxic adjuvants contained in vaccines (such as aluminum), which allegedly increased "oxidative stress" on her central nervous system. (Id., p. 5.) Dr. Cave opined that "[t]he patterns of [HH's] developmental delay may have been determined by genetics or prenatally determined, but it is possible that the mitochondrial dysfunction did either exacerbate or increase the severity of the delay." (Id., p. 4, emphasis added.)
Finally, Dr. Cave concluded that her "explanation of vaccine contents, the effect of immunization on a child with mitochondrial dysfunction, the deleterious effects of malfunctioning mitochondria in the development of the brain of a child and the showing of a proximate temporal relationship between the vaccination and the injury satisfy the Althen criteria in this case." (Ex. 27, p. 7.) She concluded by asserting that the "DTaP vaccine" of August 26, 2005, "caused the injury" to HH. (Id.)
Dr. Cave's testimony during the evidentiary hearing on February 7, 2014, incorporated some but not all aspects of her four written reports. During the hearing, Dr. Cave relied chiefly upon her understanding that HH suffered a severe adverse event during the 24 hours after her August 2005 vaccinations, and that HH had a mitochondrial dysfunction that made her susceptible to injury by the vaccines.
Max Wiznitzer, M.D., received his B.S. degree in medical education in 1975, and a medical degree in 1977, both from Northwestern University. (Ex. B, p. 1; Tr. 66-67.) He completed his residency in pediatrics, in 1980, at the Children's Hospital Medical Center in Cincinnati, Ohio. (Id.) He completed a one-year fellowship at the Cincinnati Center for Developmental Disorders; a three-year fellowship in pediatric neurology at the Children's Hospital of Philadelphia; and a two-year fellowship at the Albert Einstein College of Medicine in New York, studying higher cortical functions. (Ex. B, pp. 1-2.)
Dr. Wiznitzer has received appointments to practice at several hospitals for various lengths of time, including at the Department of Neurology of Montefiore Medical Center in New York; at the Department of Neurology at Bronx Municipal Hospital Center; and at Rainbow Babies and Children's Hospital in Cleveland. (Ex. B, p. 2.) He has also served as a consultant in pediatrics and neurology at several other hospitals. Dr. Wiznitzer has also maintained a continuous practice as an associate pediatrician and associate neurologist at University Hospitals of Cleveland, since 1986. (Id.) He sees approximately 200 to 300 children per month, the vast majority of them exhibiting developmental disorders, and more than 25% of them diagnosed with autism. (Tr. 71.)
At Rainbow Babies and Children's Hospital, in Cleveland, Dr. Wiznitzer served as Co-Director of the Rainbow Autism Center in 1991; as Chief of the Division of Pediatric Neurology from 1992 to 1995; and, concurrently, as the Director of the Rainbow Autism Center, from 1992 through 2010. (Ex. B, p. 3.)
Dr. Wiznitzer is certified by the American Board of Pediatrics. (Ex. B, p. 5; Tr. 67.) He also received certification from the American Board of Psychiatry and Neurology, with a special qualification in Child Neurology. (Ex. B, p. 5.) In 2004, the American Board of Psychiatry and Neurology certified his competence in Neurodevelopmental Disabilities. (Id.) He maintains a license to practice medicine in Ohio, Pennsylvania and New York. (Id.)
Concurrent with his hospital practice, Dr. Wiznitzer has instructed medical students, residents and attending doctors since 1984, when he was an instructor at the Albert Einstein College of Medicine. (Tr. 67.) Most notably, he has taught pediatrics and neurology since 1986 at the Case Western Reserve University School of Medicine. (Tr. 65-66; Ex. B, pp. 9-11.)
Dr. Wiznitzer has performed medical research funded by grants from the National Institutes of Health, and various university medical programs. (Ex. B, p. 4.) He has been a reviewer of articles for many medical journals, most notably for Pediatric Neurology, Lancet Neurology, and the Journal of Child Neurology, where he also served on the editorial boards. (Id., p. 6.) He currently serves on a multitude of medical advisory groups at the local, state, and national levels. (Id., pp. 6-9.) Dr. Wiznitzer has published fifty-eight medical articles, eleven book chapters, and fifty-five abstracts. (Id., pp. 13-23.) He has also presented numerous lectures at the invitation of community organizations concerning childhood developmental disorders, primarily on the subject of autism. (Id., pp. 23-55.)
The opinion of Respondent's expert was first set forth in Exhibit A, filed on October 5, 2012. Dr. Wiznitzer opined that the first symptoms of HH's neurodevelopmental disorder occurred prior to her vaccinations of August 2005. (Ex. A, pp. 12-13.)
Dr. Wiznitzer rejected Petitioners' allegation that HH suffered a "Table Injury encephalopathy," because she did not exhibit symptoms of a "decreased level of consciousness" lasting for more than 24 hours, during the 72 hours following the vaccinations of August 26, 2005. (Ex. A, p. 10.) Further, he noted that HH's contemporaneous medical records make no mention of encephalopathic changes in her level of consciousness after her August vaccinations, but describe only the typical symptoms of upper respiratory infection and otitis media. (Id.)
Likewise, Dr. Wiznitzer considered and rejected Petitioners' claims that HH suffered seizures shortly after her August 2005 vaccinations, or in the months thereafter. (Ex. A, p. 13.) He noted that multiple physicians, including pediatric neurologists and a pediatric epileptologist (Dr. Wilfong) examined HH, but none of them diagnosed a seizure disorder or prescribed anticonvulsant medications. (Id.)
Dr. Wiznitzer contended that HH has not presented the symptoms of a mitochondrial disorder or dysfunction, based on the criteria set forth in the Morava article. (Ex. A, pp. 10-12, referring to the article filed as Ex. C.) He explained that Dr. Cave misinterpreted HH's medical history with regard to many of those criteria, and greatly exceeded the scoring allowed pursuant to the Morava criteria. (Id., p. 12.) While Dr. Cave's method of assigning points produced a score of "14," Dr. Wiznitzer's recalculation of those points produced a score of "1," which he interpreted as "mitochondrial disorder unlikely." (Id.)
Dr. Wiznitzer's testimony at the hearing on February 7, 2014, was consistent with, and further explained, the opinions set forth in his written expert report. Based on his own examination of HH's medical record, Dr. Wiznitzer concluded that "the August 26th, 2005, vaccination did not cause or significantly aggravate her present neurologic condition." (Tr. 71.)
Unfortunately, it is not completely clear exactly what Petitioners are arguing in this case. For example, as will be detailed below (see Section VII(B) of this Decision), Petitioners and Dr. Cave were not even clear as to what vaccinations they allege to have harmed HH. Further, some of the allegations set forth in Petitioners' Amended Petition appear to have been abandoned by the Petitioners. For example, Petitioners at one time alleged that HH's esotropia of the right eye and her otitis media (ear infection) were "caused-in-fact" by her DTaP and Prevnar vaccinations. (Amended Petition, p. 1.) Petitioners' expert, Dr. Cave, initially supported those allegations (Ex. 10), but did not substantiate those particular claims, or even mention them, in her several subsequent expert reports or her trial testimony. Further, the allegations stated by Petitioners in their Post-Hearing Memorandum do not always correspond to Dr. Cave's testimony.
This Decision, accordingly, will be organized according to the two general theories of vaccine causation which seem to have been advocated by Petitioners, at the evidentiary hearing and in their Post-Hearing Memorandum. Specifically, the two primary issues to be decided here are: 1) whether HH suffered a "Table Injury encephalopathy;" and 2) whether, as Petitioners alternatively argue, HH's vaccinations of August 26, 2005, played any role in "causing-in-fact" her neurodevelopmental disorder, either by "initially causing," or by "significantly aggravating," that disorder.
For all of the reasons set forth in this section and the sections of this Decision below, I conclude that Petitioners have failed to demonstrate that it is "more probable than not" either that HH suffered a "Table Injury encephalopathy," or that HH's vaccinations of August 26, 2005, played any role in initially causing, or aggravating, her neurodevelopmental disorder. And the first of the reasons for this conclusion is simply that I found Respondent's expert, Dr. Wiznitzer, to be far more persuasive than the expert upon whom Petitioners relied, Dr. Cave.
Dr. Wiznitzer regularly diagnoses and treats children with mitochondrial disorders as part of his everyday clinical practice, in conjunction with mitochondrial and metabolism experts. (Tr. 70.) He received training concerning mitochondrial disorders and neurotoxicology as part of his training for board certifications in both pediatric neurology and neurodevelopmental disorders. (Id.)
Dr. Wiznitzer's clinical practice and academic career are focused on children's neurodevelopmental disorders, particularly Autism Spectrum Disorders (ASDs). He devotes approximately 36 hours each week to evaluating and treating children with neurological illnesses such as ASD, seizure disorders, and developmental delay. (Tr. 68.) More than 25% of his regular caseload of 200 to 300 children per month are diagnosed with ASD. (Tr. 71.) Under the auspices of the National Institutes of Health, he has participated in major research projects concerning ASDs. (Ex. B, p. 4.) He has served on the editorial boards of medical journals dedicated to childhood neurological disorders, such as Pediatric Neurology, Lancet Neurology, and the Journal of Child Neurology, and published numerous articles about ASDs in these and other prominent medical journals. (Id., p. 6; see also Ex. B, pp. 13-17.) He is the author of several medical textbook chapters devoted to ASDs and related disorders. At the Rainbow Babies and Children's Hospital in Cleveland, Dr. Wiznitzer was Director of the Rainbow Autism Center, from 1992 to 2010. (Ex. B, p. 3.) For all these reasons, he is extremely well qualified to offer an opinion about the matters under consideration here.
In contrast with Dr. Wiznitzer's strong credentials, Dr. Cave lacks strong expert qualifications to opine about the complex issues presented in this case. Beginning with a status conference on October 5, 2011, Petitioners were advised by Special Master Campbell-Smith that Dr. Cave lacked the expertise to be appropriately responsive to Respondent's expert. (Order, filed Oct. 6, 2011.) Five months later, Petitioners were reminded that less evidentiary weight would be afforded to the opinion of an expert such as Dr. Cave, who did not have specialized training as a developmental-behavioral pediatrician, a geneticist, a neurologist, or an immunologist. (Order, filed Mar. 3, 2012, pp. 3-4.) On April 4, 2013, Special Master Campbell-Smith considered Dr. Cave's qualifications as a family practitioner, and commented that —
(Order, filed April 8, 2013, p. 5.) Special Master Campbell-Smith's comparison of the qualifications of the competing experts in this case proved to be quite accurate.
To be sure, Dr. Cave is a physician board-certified in the area of family practice, who, to her credit in this regard, has spent much of her lengthy medical career engaged in treating children with autism spectrum disorders. (E.g., Tr. 8, 40.) However, Dr. Wiznitzer has far superior academic credentials and specialized medical training qualifications in the area of ASDs and ASD diagnosis.
Thus, in terms of specialized medical training relevant to ASDs, Dr. Wiznitzer has the much superior resume.
In addition to the vast gap between Dr. Cave and Respondent's expert in qualifications, there was an even greater gap in the experts' ability to explain their opinions. The written reports and hearing testimony of Wiznitzer seemed to me to be coherent and logical. In contrast, the written reports of Dr. Cave were not well explained and contained significant factual errors, while her hearing testimony was often poorly explained, self-contradictory, and less than logical.
In this regard, I note that, as suggested above, both Dr. Cave and Petitioners' counsel never even made it completely clear exactly what they are arguing in this case. For example, they were inconsistent even in stating which vaccinations they believe to have harmed HH. In Dr. Cave's first, second, and third written expert reports, she seems to indicate only that the "vaccinations" of August 26, 2005, harmed HH, without specifying which of those vaccinations harmed HH. (Ex. 10, Ex. 10-a, Ex. 10-b.) Then, in her fourth written report she pointed only to the "DTaP vaccine" as the alleged agent of harm. (Ex. 27, p. 7.) But in her trial testimony, Dr. Cave merely referred to all of the vaccines received by HH on August 26, 2005, and seemed to imply, without ever clearly stating, that alleged unspecified toxins in those "vaccines" harmed HH. (E.g., Tr. 14-15.)
To add to the confusion, in both Petitioners' initial Petition (p. 1) and their Amended Petition (p. 1), Petitioners' counsel pointed only to the DTaP and Prevnar vaccinations as allegedly causing harm. And their Pre-Hearing Memorandum (filed on January 14, 2014) was confused, at one time pointing simply to the "August 26, 2005 vaccines" (p. 7, line 8), but later on the same page pointing only to the DTaP vaccination (p. 7, line 20). Their Post-Hearing Memorandum again was unclear, not specifying at all what vaccines allegedly caused injury to HH.
Further, Dr. Cave seemed at times to be very unsure of her "causation" conclusion. For example, in her expert report, Dr. Cave stated that "[t]he patterns of [HH's] developmental delay may have been determined by genetics or prenatally determined, but it is possible that mitochondrial dysfunction did either exacerbate or increase the severity of the delay." (Ex. 27, p. 4, emphasis added.) Thus, according to Dr. Cave herself, it is only possible that a mitochondrial dysfunction contributed to HH's condition. During the hearing Dr. Cave also testified that—
(Tr. 33-34, emphasis added.) Thus, Dr. Cave admitted that "it's not really clear" what caused HH's condition. These ambiguous statements do not constitute a persuasive expert opinion that HH, more likely than not, suffered an injury that was caused by one or more vaccinations. Rather, Dr. Cave's descriptions of her own theory of causation, in the quotations above, acknowledged her inability to make a clear attribution of causation, and this acknowledgment was then followed by her speculation about what might be possible.
Moreover, as will be detailed below (see section IX(D. this Decision), while Dr. Cave relied on her (erroneous) belief that HH suffered from a "mitochondrial dysfunction," Dr. Cave made no serious attempt to explain why such a circumstance would therefore tend to show that vaccinations either initially caused or aggravated HH's neurodevelopmental disorder. Dr. Cave did not present any explanation of her theory that the presence of "mitochondrial dysfunction" would make an infant more susceptible to the unspecified "toxins" in unspecified vaccines. She simply did not explain her theory in this regard in any detail. Dr. Cave merely seemed to assume that the presence of "mitochondrial dysfunction" would render an infant more susceptible to purported vaccine-related damage. But she presented no persuasive reason why I should adopt such an assumption.
Another very important difference between Dr. Cave and Dr. Wiznitzer was the huge gap in the two experts' ability to base their opinions on HH's medical records. The written report and hearing testimony of Dr. Wiznitzer was well grounded in HH's medical records, while Dr. Cave's opinion was contradicted by those medical records.
In this regard, I note that Dr. Cave's early reports in this case were not based on HH's medical records; rather, they were based on the parents' retrospective accounts of events and symptoms that were not reported in HH's medical records. As noted above, a prior presiding special master in this case, Special Master Campbell-Smith, ordered Petitioners to file supplementary expert reports with specific citations to the medical records, in order to substantiate Dr. Cave's allegations concerning alleged symptoms of seizures, encephalopathy, and/or "mitochondrial dysfunction," which HH may have experienced. (See Orders, filed on Oct. 6, 2011; Dec. 12, 2011; Mar. 2, 2012; Apr. 8, 2013.) Eventually, Dr. Cave acknowledged that she could not support the allegations that HH suffered a Table encephalopathy, or that she suffered post-vaccination seizures, without relying entirely on the statements of HH's parents. (Ex. 27, p. 1.)
The sequence of events described above is disturbing because Dr. Cave is not new to the Vaccine Program, and she had previously been advised that causation conclusions that are not based on medical records would be in grave danger of rejection for that reason. In Berge v. HHS, No. 08-223V, 2010 WL 3431601 (Fed. Cl. Spec. Mstr. Aug. 2, 2010), the presiding special master dismissed the case largely because, "[i]n light of Dr. Cave's report being premised upon information supplied by the parents, without discussing the medical records at all, that opinion is rejected as without factual predicate." Id. at *2 (citation omitted). Thus, in 2010 Dr. Cave was made aware of the necessity to substantiate her factual allegations in Vaccine Act cases by citing the medical records, but nevertheless, she failed in this regard in this case. In another case, the presiding special master observed that "[d]ue to `a lack of documentary support for the factual allegations' in Dr. Cave's report, the special master ordered petitioners to file a supplemental report, referencing the exhibit and page number of records supporting her factual assertions." Blake v. HHS, No. 03-031V, 2014 WL 2769979, at *3 (Fed. Cl. Spec. Mstr. May 21, 2014), describing an order issued in that case in 2011.
In the present case, despite the criticisms of Dr. Cave in other cases in 2010 and 2011, described in the paragraph above, Petitioners' counsel filed reports by Dr. Cave containing allegations that HH had suffered seizures, a "Table encephalopathy," and developmental regression, that are not supported by the medical records. (See Ex. 10-a, filed Jan. 16, 2012.) Special Master Campbell-Smith addressed those deficiencies in detail (see Orders filed Mar. 3, 2012 and April 8, 2013), but Dr. Cave persisted in relying upon some of the same unsubstantiated factual allegations.
Thus, Dr. Cave's pattern, of repeatedly offering testimony based upon factual allegations that appear contrary to the medical records, gives me another good reason to question her credibility, in general.
More importantly, specifically in this case, Dr. Cave based her opinion, both as to the "Table Injury encephalopathy" that HH allegedly suffered, and as to the allegation that HH's vaccinations of August 26, 2005, "caused-in-fact" or aggravated HH's neurodevelopmental disorder, in large part on the following assumption of fact: that HH experienced a "severe adverse event," including "seizures" and a dramatic alteration in her development ("slowness, not grabbing objects, not pushing up on her arms, no attempts to crawl, poor coordination, and [poor] eye contact" — Tr. 15) within a day after her vaccinations of August 26, 2005. (Ex. 10, p. 1; Tr. 15.)
However, HH's medical records contradict Dr. Cave's assumption that HH experienced seizures, a "severe adverse event," or a dramatic change in her development within the 24-hour period post-vaccinations. To the contrary, the records indicate that HH was not brought to any health provider until 12 days later, on September 7, 2005. And at that September 7 visit her mother did not report that HH had displayed any seizure-like behaviors, or experienced either a severe adverse event or a sudden behavioral change, either within 24 hours of the vaccinations on August 26, or at any time in the meantime. Instead, HH's mother reported on September 7 only that HH had been experiencing some congestion, a "runny nose," and fever "off and on," for the previous 1½ weeks. (Ex. 2, p. 9.)
I conclude that if HH had actually suffered seizures, a "severe adverse event," and/or a dramatic behavioral change in the day following the vaccinations, her parents (1) would have immediately sought medical assistance, and/or (2) would have reported those symptoms to HH's doctor during the visit of September 7, 2005. Therefore, in light of the medical record made on September 7, 2005, combined with the lack of any medical treatment between August 26 and September 7, I conclude that Dr. Cave is relying on a mistaken assumption as to HH's symptom history.
To be sure, HH's parents have supplied affidavits, stating that HH suffered "convulsions" two hours after a "Hepatitis B shot," apparently referring to one of the vaccinations of August 26, 2005. (Exs. 3 and 4.) The virtually identical affidavits of the two parents also state that HH "continued to have convulsions on about 7 to 8 occasions later" (although it was not made clear whether "later" meant later that day, or some other time). (Id.)
In this regard, I also note that my own finding is supported by the prior-stated analysis of then-Special Master Campbell-Smith, who noted that HH's medical records do not support the factual assumptions upon which Dr. Cave based her opinions. (See Orders filed Dec. 12, 2011, March 12, 2012, July 6, 2012.)
Petitioners argue that HH suffered a "Table Injury encephalopathy," and that, therefore, her case "benefits from a statutorily-prescribed, rebuttable presumption of causation." (See Pet. Post-Hearing Memorandum ("Pet. Brief"), filed Sept 8, 2014, p. 9.) However, the record as a whole, particularly the contemporaneous medical records, make it clear that HH did not suffer a "Table Injury encephalopathy" in temporal proximity to the vaccinations administered on August 26, 2005.
For Vaccine Act petitions, such as this one, filed after the modifications to the Vaccine Injury Table that went into effect on March 24, 1997, "encephalopathy" exists as a Table Injury for DTaP vaccinations. I will set forth the relevant Table Injury definition below.
42 C.F.R. § 100.3 (2015 edition of C.F.R.).
Thus, to establish their Table Encephalopathy claim, under the regulatory language set forth above, Petitioners must demonstrate that HH manifested an injury encompassed in the definition of an "acute encephalopathy" within 72 hours of her DTaP vaccination, and that a "chronic encephalopathy" was then present for more than 6 months after the acute encephalopathy. 42 C.F.R. § 100.3(b)(2).
For a child younger than 18 months, presenting without an associated seizure event, an acute encephalopathy is, as set forth above, indicated "by a significantly decreased level of consciousness . . . lasting for at least 24 hours." § 100.3(b)(2)(i)(A). A significantly decreased level of consciousness is demonstrated by the presence of one of three clinical signs for a period of at least 24 hours: "(1) Decreased or absent response to environment (responds, if at all, only to loud voice or painful stimuli); (2) Decreased or absent eye contact (does not fix gaze upon family members or other individuals); or (3) Inconsistent or absent responses to external stimuli (does not recognize familiar people or things)." § 100.3(b)(2)(i)(D). Sleepiness, irritability (fussiness), high-pitched and unusual screaming, persistent inconsolable crying, and bulging fontanelle are not, alone, or in combination, a demonstration of an acute encephalopathy. § 100.3(b)(2)(E). An acute encephalopathy is an event "that is sufficiently severe so as to require hospitalization (whether or not hospitalization occurred)." § 100.3(b)(2)(i).
A chronic encephalopathy is defined in the QAI as "a change in mental or neurologic status, first manifested during the applicable time period, [that] persists for a period of at least 6 months from the date of vaccination." § 100.3(b)(2)(ii).
The clinical signs and symptoms of an acute encephalopathy were incorporated into the QAI to "clearly distinguish infants and children with brain dysfunction from those with transient `lethargy.'" Revision of the Vaccine Injury Table, 60 Fed. Reg. at 7687. As noted in Waddell, by then-Chief Special Master Campbell-Smith,
Based on my own review of the contemporaneous medical records, it is absolutely clear that HH did not suffer an "acute encephalopathy" that would satisfy the above definition of a "Table encephalopathy." Such contemporaneous records have more evidentiary weight than retrospective accounts recorded months later.
As explained in detail above, HH's parents supplied affidavits indicating that HH suffered "convulsions" about two hours after her vaccination of August 26, 2005. (Exs. 3-4). But, as also explained above, based on the only contemporaneous medical record, the notation recorded on September 7, 2005, I cannot credit those affidavits in that regard. (See the discussion at Section VII(C) of this Decision above.)
Similarly, the medical records offer no support whatsoever to the Petitioners' claim that HH suffered an "acute encephalopathy" as described in the regulatory "Table encephalopathy" definition set forth at Section VIII(A) above. The record of September 7, 2005, gives no indication that HH suffered a seizure or a "significantly decreased level of consciousness."
In this regard, see also the testimony of Dr. Wiznitzer, who similarly concluded that there is nothing in HH's medical records indicating that she suffered an acute encephalopathy within the Table definition. (Tr. 86-87, 133-35.)
To be sure, in the medical record made on September 7, 2005, there is a notation of "sleep↑," indicating that sometime between August 26 and September 7, HH's sleep increased at least to some degree. (Ex. 2, p. 9.) But some increase in sleep certainly does not rise to the level of showing the type of "significantly decreased level of consciousness" required by the regulatory definition set forth above. Dr. Wiznitzer so interpreted that record. (Tr. 86-87.) Further, the regulatory definition itself states plainly that "sleepiness" does "not demonstrate an acute encephalopathy or a significantly change in * * * level of consciousness." 42 C.F.R. § 100(3)(E) (10-1-97 edition of C.F.R.) (emphasis added).
Therefore, I conclude that Petitioners have failed, by far, to demonstrate that HH suffered a "Table Injury encephalopathy" within the 72 hours after her DTaP vaccination of August 26, 2005.
Sadly, as noted above, HH has suffered from a severe neurodevelopmental disorder, which has been diagnosed as falling within the category of an Autistic Spectrum Disorder. (E.g., Ex. 22, pp. 1, 8, 21.) However, Petitioners have failed completely to demonstrate that HH's vaccinations of August 26, 2005, played any role in either initially causing, or aggravating, that neurodevelopmental disorder.
As explained in detail above, Dr. Cave based her opinion as to "actual causation," just like her opinion that HH suffered a "Table Injury encephalopathy, on the assumption that HH experienced a "severe adverse event," including "seizures" and a dramatic alteration in her development, within 24 hours of her vaccinations of August 26, 2005. But as explained above, I have rejected Dr. Cave's factual assumption in that regard as plainly wrong, so that her causation conclusions must be rejected for that reason alone. (See Section VII(C) above.)
On March 2, 2012, the then-presiding Special Master Campbell-Smith filed an order in this case stating that "the evidence suggests that [HH's] neurodevelopmental injury was already underway prior to the administration of the vaccines at issue here." (Order, filed Mar. 2, 2012, pp. 5-6.) This suggestion was based on a series of head circumference measurements performed during HH's infancy, which were later analyzed by a treating pediatric neurologist of HH, Dr. Robert Cruse. On June 26, 2006, Dr. Cruse recorded the following assessment of HH:
(Ex. 14, p. 9, emphasis added). Therefore, Dr. Cruse's opinion was that a significant brain abnormality in HH became evident soon after age three months, and thus likely before the vaccinations here in question. Similarly, on March 19, 2007, Dr. Duane Superneau, a treating geneticist of HH, opined that the "microcephaly [abnormally small head and brain size] in [HH] has been present from prior to the immunizations which have been implicated by the mother as potentially complicating [HH's] clinical course." (Ex. 14, p. 11.) Dr. Superneau concluded that HH's "physical findings suggested the problems existed from birth, consistent with the majority of problems of this type." (Id.)
Dr. Cave contended that both of these treating medical specialists, Drs. Superneau and Cruse, misinterpreted the available data concerning HH's head growth. (Ex. 10-b, p. 9.) During the trial, Dr. Cave testified that she had re-analyzed the various head measurements in the medical records, and concluded that HH's head size was roughly at the 5th percentile at birth, and her rate of head growth thereafter was about the 5th to the 7th percentile. (Tr. 11.) "She's small, and she has a small head." (Id.) Dr. Cave concluded that "the evidence does not suggest that [HH's] developmental injury was already underway prior to the administration of the vaccines at issue here." (Ex. 10-b, p. 10, emphasis in original.)
Respondent's expert Dr. Wiznitzer, however, testified that HH was microcephalic, meaning a significantly abnormally small head size, a sign of an abnormal brain development. (Tr. 85.) Moreover, he performed an analysis of HH's medical records and concluded that she had an abnormal head circumference prior to the vaccinations in question. (Ex. A, pp. 9, 12-13.)
Dr. Wiznitzer concluded that HH displayed "a slowing of head circumference growth [that] reflects a slowing of brain growth that predated the 8/26/05 vaccinations." (Ex. A, p. 12.) Dr. Wiznitzer reiterated this analysis at the trial. (Tr. 79-85).
In analyzing this issue, I have studied the contemporaneous medical notations, the experts' opinions, and the various growth charts submitted in evidence by both parties. I note that two different treating doctors of HH—one pediatric neurologist (Dr. Cruse) and one geneticist (Dr. Superneau)—have opined that onset of HH's microcephaly pre-dated her vaccinations of August 26, 2005, and probably contributed to her subsequent neurodevelopmental problems. (Ex. 14, pp. 9, 11.) Respondent's well-qualified medical expert, Dr. Wiznitzer, also a pediatric neurologist, reached the same conclusion. To be sure, Dr. Cave, a family practitioner, opined that all three of those specialists were not correct. However, I find that the persuasive weight of the opinions of those three highly qualified doctors is supported by multiple growth charts showing that HH's head size (and therefore brain size), in comparison to other infants, was abnormally small well before the vaccinations of August 26, 2005.
Dr. Cave argued that HH's head circumference measurements "started out in the 5th percentile at birth and two years later ended up at the 5th percentile." (Ex. 27, p. 5.) During the trial she re-stated this argument. (Tr. 11.) When I reviewed the medical records as Dr. Cave suggested, I found that HH had a head circumference notation of 12½ inches (31.75 cm) at birth (see Ex. 1, p. 8), which appears to register on the pediatric growth charts as the 5th percentile or less, as alleged by Dr. Cave. However, I also noted Dr. Wiznitzer's opinion that a head measurement taken immediately after birth is often distorted by compression of the infant's skull during the birthing process, and that measurements taken at two weeks of age are considered more accurate.
Apparently, Dr. Cave's assessment of the first few months of HH's life excluded all of the head measurements performed by HH's first pediatrician, Dr. Chatters, and emphasized only the measurement of 31.75 cm at birth. (See Ex. 1, p. 8; Tr. 84). This maneuver by Dr. Cave concealed the significant deceleration of HH's head growth rate during infancy, which was described by both the treating pediatric neurologist, Dr. Cruse (Ex. 14, p. 9), and Respondent's expert witness, Dr. Wiznitzer (Ex. A, p. 12). Both of these pediatric neurologists diagnosed "microcephaly" (abnormally small head size) with an onset that preceded HH's vaccinations of August 26, 2005. Dr. Cave's testimony did nothing to persuade me otherwise.
Dr. Wiznitzer also pointed out more evidence in HH's medical records, in addition to the head circumference data, indicating that HH was likely developmentally delayed prior to the vaccinations in question. (See Tr. 72-74, 75-77.)
Accordingly, in this case I find further reason to conclude that the vaccinations of August 26, 2005, did not initially cause HH's neurodevelopmental problems, because the evidence concerning HH's microcephaly shows that her "neurodevelopmental injury was already underway prior to the administration of the vaccines at issue here," (quoting the Order of Special Master Campbell-Smith, filed on Mar. 2, 2012). Further, Dr. Cave's misanalysis of HH's pre-existing microcephaly and other evidence of HH's pre-existing delay adds additional reason to doubt the credibility of Dr. Cave's overall causation theory in this case.
In this regard, I note that Dr. Cave's theory that HH's vaccines either "initially caused," or "significantly aggravated," HH's neurodevelopmental disorder rests on the argument that HH suffered from a "mitochondrial dysfunction" that allegedly made her more vulnerable to neurologic injury by toxins contained in vaccines, particularly aluminum. (Ex. 27, p. 4; Tr. 19; 46-47.) Consequently, there was extensive discussion in the parties' expert reports and hearing testimony concerning whether HH suffered from "mitochondrial disorder" and/or "mitochondrial dysfunction," based on certain criteria elaborated by Morava, et al.
To summarize, my analysis of this issue shows that Dr. Cave's analysis was fatally flawed in yet another respect, and was far inferior to that of Dr. Wiznitzer.
In analyzing this issue, I note first that the parties' experts both claim that they relied on the Morava article to assess HH's condition, yet they reached completely opposite conclusions. Second, I note that Petitioners' expert, Dr. Cave, declined to utilize the terminology employed by these articles (i.e., "mitochondrial disorder") in her reports and testimony, and chose instead to generally use the expression "mitochondrial dysfunction." (E.g., Ex. 10, p. 1; Ex. 10-a, p. 2; Ex. 10-b, p. 5; Ex. 27, pp. 1-3; Tr. 17-18, 38, 61.) In my analysis, I will generally employ the term used in the defining articles, that is, "mitochondrial disorder."
Dr. Cave contended that Respondent's expert, Dr. Wiznitzer, does not understand "how to interpret laboratory tests that are pertinent to the [Morava] criteria." (Ex. 27, p. 1.)
I found, however, that in her testimony, it was Dr. Cave who often demonstrated a lack of knowledge about that subject matter. For example, she explained that "I've done quite a bit of CME [continuing medical education] activity in the field of toxicology and heavy metal toxicology" (Tr. 9), and, when explaining that her theory of causation implicates aluminum as an injurious component of vaccines, she asserted that "aluminum itself is a heavy metal and it's destructive" (Tr. 19; see also Tr. 51). However, when Dr. Wiznitzer was asked whether aluminum was a heavy metal, he replied that it was not, "it's actually light." (Tr. 88.) In this matter, as in many others, I found Dr. Wiznitzer's opinion to be more informed. That is, "heavy metal" means "one with a high specific gravity, usually defined as being above 5.0." Dorland's Illustrated Medical Dictionary (31st ed. 2007), p. 1161. Aluminum has a specific gravity of 2.699 (id., p. 56), placing it outside, contrary to Dr. Cave's assumption, the category of "heavy metals."
Moreover, Dr. Cave also seemed to misunderstand the Morava article and the Morava criteria, as I will demonstrate in detail in the next section of this Decision.
It is important to examine the specific content of the Morava article as it pertains to the contrasting opinions of Drs. Cave and Wiznitzer. The Morava article sets forth a diagnostic scoring system to identify mitochondrial disorders. (Ex. C, see also the Wolf article, Ex. D.) According to the authors of the Morava article, the Morava criteria can and should be applied in clinical situations where mitochondrial disease is suspected but not yet confirmed by a muscle biopsy. (Ex. C, p. 1; Ex. D, p. 3.) No muscle biopsy was performed on HH, so the criteria appear to apply directly to this case.
The system set forth in these articles requires assessment in three major diagnostic Sections: I — clinical signs and symptoms; II — metabolic/imaging studies; and III — morphology/histopathology. (Ex. C, pp. 1-2; Ex. D, pp. 1-2; see also Tr. 91-92.) In devising this system, the authors allotted points for each symptom exhibited by a patient, but capped the total amount of scoring in each of these three Sections at four points, resulting in a maximum possible score of twelve (12) points when the three sections are combined. (Ex. D, p. 1.) This explicit limitation was meant to avoid giving unreasonable diagnostic weight to multiple symptoms that may present together within a particular section. (Ex. D, pp. 1-2.)
The first major Section (I—Clinical signs and symptoms) is further divided into three categories with specific point limitations: A — Muscular presentation (2 points); B — Central nervous system presentation (2 points); Multisystem disease (3 points). (Ex. C, pp. 1-2; Ex. F, pp. 2-5; see also Ex. 25, pp. 3-4; Tr. 91-92.) Thus, the points assigned to categories A, B, and C could reach a possible total of seven points, when considered separately, but when combined together in Section I, the authors deliberately restrict the total to only four points. (Ex. C, pp. 2-3.) Likewise, in Section II (Metabolic/imaging studies), there are various individual components that may be assigned one or two points, which would result in a potential total of 17 points if all of them were present; however, the authors will allow a total score of only four points, no matter how many of the individual laboratory test results are present. (Id.)
Dr. Cave discussed application of the Morava criteria in her supplemental expert reports. (See Ex. 10-a, p. 2; Ex. 10-b, pp. 4-6.) In the first supplemental report, she calculated that HH exceeded "the highest score on Morava's 2006 Criteria for Mitochondrial Disorder — above 12." (Ex. 10-a, p. 2.) In the second supplemental report, she calculated a total score of 14 points. (Ex. 10-b, p. 6.) During the hearing, Dr. Cave revised her calculations to reach a total of 9 or 10 points. (Tr. 31-32.) It is notable that for each of these estimates, points were not included for category III, because there were no muscle biopsy results. Thus, the points allowed for Sections I and II under the Morava criteria without a muscle biopsy, by the very definition set forth in the Morava article itself, could reach a maximum total of only 8 points. Yet all of Dr. Cave's various calculations, incongruously, exceeded the maximum allowed by the Morava criteria.
This is not surprising. Dr. Cave's diagnosis of a mitochondrial "dysfunction" is achieved by tabulating all the points available in the major Sections identified in the Morava and Wolf articles (regarding mitochondrial disorders), but without applying any of the limitations required by the articles. (See Tr. 90.) Respondent's witness, Dr. Wiznitzer, observed that Dr. Cave's total score of 14 was "impossible, because there's defined rules for how many points you can apply per section of the criteria ... [a]nd unfortunately, it appears that ... the specific instructions were not followed to achieve [Dr. Cave's] score of 14." (Id.) The same criticism can be applied to all of Dr. Cave's assessments totaling between 9 and 14 points, allegedly based on the Morava criteria. Dr. Cave has simply not adhered to the methods described in the Morava and Wolf articles.
The Morava article presents the consensus mitochondrial disease criteria, a methodology that imposes strict limitations on scoring relevant symptoms for the purpose of making a diagnosis. The authors wanted an analytical methodology that was not impeded by "the lack of agreement on optimal biochemical assays and cut-off values" related to diagnosing mitochondrial disorders. (Ex. C, p. 1.) This goal is stated explicitly in the first sentence of the article. Yet, in Dr. Cave's expert reports and in her trial testimony, there are many pages of discussion concerning optimal biochemical assays and cut-off values. This is precisely what the authors stated that they wished to avoid when making this type of diagnosis. Dr. Cave asserted that she relied on this article, but she refused to accept the underlying premises articulated by the authors.
Dr. Cave appears to have attempted to obscure her refusal to accept the Morava article's underlying premises, by her insistence that HH suffers from a mitochondrial "dysfunction," rather than a mitochondrial "disorder" (Ex. 10-b, p. 5),
In contrast to the vagueness, ambivalence, self-contradiction, and illogic of Dr. Cave's testimony, the testimony of Dr. Wiznitzer was coherent, consistent, and logical throughout. He reviewed the totality of the medical records, not just selected parts, and reached a diagnosis of microcephaly predating the vaccinations (Tr. 79-85), in concurrence with the treating pediatric neurologist, Dr. Cruse. Further, Dr. Wiznitzer considered each of Dr. Cave's allegations concerning application of the Morava criteria to the facts of this case, regarding: exercise intolerance, muscle weakness, eye problems, developmental regression, possible seizures, constipation, and multiple laboratory test results. (Ex. A, pp. 10-12.) He concluded that Dr. Cave had used unreliable information and/or misapplied the medical standards in all but one of her allegations about HH's symptoms, in relation to the Morava criteria. (Id.) That is, Dr. Wiznitzer agreed with Dr. Cave on one issue, that HH suffered from developmental delay, and that solitary positive criterion registered only one point on the consensus mitochondrial disease criteria advocated by the Morava and Wolf articles. Thus, Dr. Wiznitzer, in contrast to Dr. Cave, found that HH actually should be scored as a total of only "1" on the Morava criteria, which would put her in the "mitochondrial disorder unlikely" category. (Ex. A, p. 12.)
Further, Dr. Wiznitzer noted that HH's medical records do not support a diagnosis of mitochondrial "dysfunction," either. (Id.) The medical records do not indicate that HH was ever even sent to a mitochondrial specialist
I find that HH did not have a mitochondrial "disorder" or "dysfunction" that predisposed her to injury by the vaccinations she received on August 26, 2005.
As noted above, Petitioners' entire presentation concerning "causation-in-fact" has been generally vague, unclear, often self-contradictory, and far from persuasive. As set forth above in Section IX (A) of this Decision, Dr. Cave has relied completely upon a misassumption of fact. As set forth in Section IX (B), she misanalyzed the evidence that shows that HH had a serious neurodevelopmental problem prior to the vaccinations in question. As set forth in Section IX (C), while Dr. Cave based her causation theory on the proposition that HH suffered from a "mitochondrial dysfunction" or "mitochondrial disorder," she in fact seriously misanalyzed the evidence in that regard too, so that there is no good reason to believe that HH even had any type of mitochondrial dysfunction or disorder.
Finally, I note again that even if one were to assume for the sake of argument, that HH did suffer from some kind of mitochondrial dysfunction or disorder, Dr. Cave made no serious attempt to explain why such a circumstance would therefore tend to show that vaccinations either initially caused or aggravated HH's neurodevelopmental disorder. Dr. Cave did not present any explanation of her theory that the presence of "mitochondrial dysfunction" would make an infant more susceptible to the unspecified "toxins" in unspecified vaccines. She simply did not explain her theory in this regard in any detail. Dr. Cave merely seemed to assume that the presence of "mitochondrial dysfunction" would render an infant more susceptible to purported vaccine-related damage. But she presented no persuasive reason why I should adopt such an assumption.
To be sure, I do not have any reason to doubt that Dr. Cave is a competent clinical practitioner in her field. My conclusion is simply that, in general, the presentation of Dr. Wiznitzer in this case was far more persuasive than that of Dr. Cave, as to all points. I thus conclude, for all the reasons set forth above, that Petitioners have failed to demonstrate that it is "more likely than not" that the vaccinations of August 26, 2005, either initially caused, or aggravated, HH's tragic neurodevelopmental disorder.
In this part of my Decision, I will explain how this case fits specifically within the interpretive standards set forth in the Althen and Loving decisions. The short answer is that I find that Petitioners' case clearly does not satisfy the standards presented in either Althen or Loving.
In this regard, as previously noted, Petitioners' presentation in this case has been so jumbled and poorly explained that it is not even clear whether they are ultimately contending (1) that the vaccinations of August 2005 initially caused HH's neurodevelopmental disorder, or (2) that those vaccinations significantly aggravated a preexisting neurodevelopmental disorder. That does not matter to the outcome of this case, since it is clear that Petitioners have clearly failed to show either. But, in this Section of my Decision, I will, therefore, analyze Petitioners' case first under Althen, assuming that they are raising an "initial causation" argument. Then I will analyze Petitioners' case under the six-part Loving/Althen test, assuming that they are advancing a "significant aggravation" claim.
First, I will analyze the Petitioners' "initial causation" claim, utilizing the Althen standard.
The U.S. Court of Appeals for the Federal Circuit declared in Althen that it is a petitioner's burden:
Althen, 418 F.3d at 1278 (citations omitted). There can be no doubt whatsoever that the Althen test ultimately requires that, as an overall matter, a petitioner must demonstrate that it is "more probable than not" that the particular vaccine was a substantial contributing factor in causing or aggravating the particular injury in question. That is clear from the statute itself, which states that the elements of a petitioner's case must be established by a "preponderance of the evidence." (§ 300aa-13(a)(1)(A).) In the pages above, of course, I have already set forth in detail my analysis in rejecting Petitioners' "actual causation" theory, including their "initial causation" portion of that theory, in this case. In this part of my Decision, then, I will briefly explain how that analysis fits specifically within the three parts of the Althen test, enumerated in the first sentence of the Althen excerpt set forth above. The short answer is that I find that Petitioners "initial causation" claim in this case clearly does not satisfy the Althen test.
One interpretive issue with the Althen test concerns the relationship between the first two elements of that test. The first two prongs of the Althen test, as noted above, are that the petitioners must provide "(1) a medical theory causally connecting the vaccination and the injury; [and] (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury." Initially, it is not absolutely clear how the two prongs differ from each other. That is, on their faces, each of the two prongs seems to require a demonstration of a "causal" connection between "the vaccination" and "the injury." However, a number of Program opinions have concluded that these first two elements reflect the analytical distinction that has been described as the "can cause" vs. "did cause" distinction. That is, in many Program opinions issued prior to Althen involving "causation-in-fact" issues, special masters or judges stated that a petitioner must demonstrate (1) that the type of vaccination in question can cause the type of injury in question, and also (2) that the particular vaccination received by the specific vaccinee did cause the vaccinee's own injury. See, e.g., Kuperus v. HHS, 2003 WL 22912885, at *8 (Fed. Cl. Spec. Mstr. Oct. 23, 2003); Helms v. HHS, 2002 WL 31441212, at *18 n. 42 (Fed. Cl. Spec. Mstr. Aug. 8, 2002). Thus, a number of judges and special masters of this court have concluded that Prong 1 of Althen is the "can cause" requirement, and Prong 2 of Althen is the "did cause" requirement. See, e.g., Doe 11 v. HHS, 83 Fed. Cl. 157, 172-73 (2008); Nussman v. HHS, 83 Fed. Cl. 111, 117 (2008); Banks v. HHS, 2007 WL 2296047, at *24 (Fed. Cl. Spec. Mstr. July 20, 2007); Zeller v. HHS, 2008 WL 3845155, at *25 (Fed. Cl. Spec. Mstr. July 30, 2008). And, most importantly, the Federal Circuit confirmed that interpretation in Pafford, ruling explicitly that the "can it?/did it?" test, used by the special master in that case, was equivalent to the first two prongs of the Althen test. Pafford v. HHS, 451 F.3d at 1352, 1355-56 (Fed. Cir. 2006). Thus, interpreting the first two prongs of Althen as specified in Pafford, under Prong 1 of Althen a petitioner must demonstrate that the type of vaccination in question can cause the type of condition in question; and under Prong 2 of Althen that petitioner must then demonstrate that the particular vaccination did cause the particular condition of the vaccinee in question.
Moreover, there can be no doubt whatsoever that the Althen test ultimately requires that, as an overall matter, a petitioner must demonstrate that it is "more probable than not" that the particular vaccine was a substantial contributing factor in causing the particular injury in question. That is clear from the statute itself, which states that the elements of a petitioner's case must be established by a "preponderance of the evidence." § 300aa-13(a)(1)(A). And, whatever is the precise meaning of Prongs 1 and 2 of Althen, in this case the overall evidence falls far short of demonstrating that it is "more probable than not" that any of the vaccines that HH received on August 26, 2005, contributed to the causation of her tragic neurodevelopmental disorder.
As explained above, under Prong 1 of Althen a petitioner must provide a medical theory demonstrating that the type of vaccine in question can cause the type of condition in question. Petitioners' primary theory in this case seems to be that HH's vaccinations of August 26, 2005, in the context of an alleged "mitochondrial dysfunction" in HH, initially caused HH's neurodevelopmental disorder. However, as described above in Section IX, Dr. Cave has not demonstrated that any type of vaccination can cause a neurodevelopmental disorder. Thus Petitioners' claim clearly fails under Althen Prong 1.
Under Prong 2, the Petitioners need to show that it is "more probable than not" that one or more of HH's vaccination of August 26, 2005, did initially cause HH's own condition. But this they have also failed to do, for all of the reasons detailed above in Sections IX of this Decision.
Since I have explained why Petitioners have failed to satisfy the first and second prongs of Althen, I need not discuss why Petitioners' case also fails to satisfy the third prong. However, as discussed above (Section IX(B)), the evidence clearly shows that HH was suffering from a neurodevelopmental disorder prior to the vaccinations in question, so that clearly those vaccinations did not initially cause her developmental disorder.
If Petitioners' arguments in fact raise an alternative "significant aggravation" claim, that claim, too, must be rejected.
The Vaccine Act states that "[t]the term `significant aggravation' means any change for the worse in a preexisting condition which results in markedly greater disability, pain or illness accompanied by substantial deterioration of health." §300aa-33(4).
The elements of an off-Table significant aggravation case were set forth in Loving v. HHS, 86 Fed. Cl. 135, 144 (2009). The United States Court of Appeals for the Federal Circuit acknowledged that "the Loving case provides the correct framework for evaluating off-table significant aggravation claims," in W.C. v. HHS, 704 F.3d 1352, 1357 (Fed. Cir. 2013). Thus, the Federal Circuit Court of Appeals, which sets binding precedent for decisions by the Office of Special Masters, endorsed the use of a six-part test for significant aggravation, which was first elaborated in Loving. A petitioner must prove by preponderant evidence that a vaccination caused significant aggravation by showing:
W.C. v. HHS, 704 F.3d at 1357 (Fed. Cir. 2013).
The standard elaborated in Loving, and endorsed in W.C. v. HHS, combines elements from previous Federal Circuit decisions. W.C. v. HHS, 704 F.3d at 1537 ("The Loving test combines the first three Whitecotton factors, which establish significant aggravation, with the Althen factors, which establish causation.") Since the last three elements of the Loving test include the entirety of the Althen test, with insignificant wording modifications, the analysis of those three elements would be the same using either standard.
In this Section, I will discuss whether Petitioners have satisfied the six-part Loving test to establish the existence of vaccine-related significant aggravation of a preexisting condition.
On August 26, 2005, during HH's well baby exam at six months of age, her pediatrician recorded that she had no significant illnesses or ongoing diagnoses. (Ex. 2, p. 6.) However, with the benefit of hindsight the evidence indicates that HH already had an abnormally small head circumference, indicating that a serious brain problem existed prior to that date. (See discussion at Section IX(B), above.)
Petitioners and Dr. Cave based their causation theories in this case on the factual assertion that HH suffered a "severe adverse event," including seizures and a dramatic alteration in her development, within a day after her vaccinations of August 26, 2005. However, for the reasons detailed above, I have rejected that factual assertion as mistaken. (See Section VII(C), above.) Therefore, I find that HH's condition soon after the vaccinations was, contrary to Petitioners' factual allegation, substantially unchanged from her pre-vaccination condition.
However, on December 21, 2005, four months after the vaccinations, HH's pediatrician expressed concern that she was not yet scooting or crawling, and indicated that her development should be monitored carefully. (Ex. 2, p. 13.) Tragically, since then HH has proved to have a very significant neurodevelopmental disorder, which has been classified as an Autism Spectrum Disorder—that is her "current condition."
As explained in the prior paragraph, I must reject Petitioners' allegation that HH suffered an aggravation of her condition soon after the vaccinations in question. However, in the Loving/Althen formulation set forth in W.C. and quoted above, one question posed is whether the vaccinee's current condition constitutes a "significant aggravation" of the vaccinee's condition prior to vaccination. W.C., 704 F.3d at 1357. As to that question, my conclusion is that HH's "current condition" is "significantly worse" than her condition appeared immediately prior to the vaccinations in question. Therefore, following the standard set forth in Loving and W.C., HH's "current condition" does amount to a "significant aggravation" of her neurodevelopmental disorder (though the worsening has definitely not been shown to have been related to her vaccinations).
As discussed above, Prongs 4, 5 and 6 of the Loving test are, in effect, the same as Prongs 1, 2, and 3 of the Althen standard. Under Prong 4 of Loving and Prong 1 of Althen, a petitioner must provide a medical theory demonstrating that the type of vaccinee in question can cause a significant worsening of the type of preexisting condition of the vaccinee. In this case, however, for the reasons stated above, the Petitioners have failed to show that the vaccinations in question can aggravate the type of neurodevelopmental disorder from which HH suffers. Further, the Petitioners have failed to show that HH was afflicted with a preexisting mitochondrial disorder, or that the vaccinations in question can aggravate a preexisting mitochondrial disorder, or any type of neurological disorder.
Specifically, in this case the Petitioners' theory seems to be that toxic substances contained in some of HH's vaccinations, especially aluminum adjuvants in the context of a mitochondrial dysfunction/disorder, significantly aggravated HH's neurodevelopmental disorder. However, in this case I have already explained in detail the numerous deficiencies in Dr. Cave's theory in that regard. Petitioners, thus, have wholly failed to show that, whether in the context of a mitochondrial dysfunction/disorder or in other circumstances, the types of vaccinations that HH received can cause an aggravation of a neurodevelopmental disorder.
Accordingly, it is quite evident that Petitioners have wholly failed to establish Prong 4 of Loving/Prong 1 of Althen in this case.
Under Prong 5 of Loving/Prong 2 of Althen, the Petitioners need to show that it is "more probable than not" that HH's vaccinations of August 26, 2005, did aggravate the specific neurodevelopmental disorder of HH herself. But they have failed to do so. As discussed at Section VII(C), above, Dr. Cave based her aggravation theory regarding HH on a misassumption of fact. Further, as shown in Section IX(C), Dr. Cave's theory about the cause of HH's neurodevelopmental delays was based upon the premise that HH suffered from a mitochondrial dysfunction/disorder, but there is no good evidence that she did suffer from any mitochondrial abnormality. Moreover, as discussed in Section IX(D) above, Dr. Cave's theory as to how components of HH's vaccinations might have allegedly worsened the effects of a pre-existing mitochondrial dysfunction/disorder lacks any evidentiary support.
Accordingly, Petitioners have failed to establish Prong 5 of Loving/Prong 2 of Althen in this case.
Since I have explained why Petitioners have failed to satisfy the first and second prongs of Althen (4th and 5th prongs of Loving), I need not discuss why Petitioners' case also fails to satisfy the Prong 3 of Althen/ Prong 6 of Loving. However, in the interest of completeness, I will analyze whether there was "a showing of a proximate temporal relationship" between the vaccinations and the alleged significant aggravation of HH's neurodevelopmental disorder.
As to an alleged significant aggravation of HH's neurodevelopmental disorder soon after the vaccinations, I note that the report of symptoms of HH's developmental delay was not made until December 21, 2005, four months after the vaccinations in question, when her pediatrician recorded his concern that she was not scooting or crawling. (Ex. 2, p. 13.) During those four months, there are no entries in the medical records linking HH's vaccinations temporally to any adverse reactions or the loss of any previously acquired skills. Thus, Petitioners have not shown a proximate temporal relationship between the vaccination and the alleged significant aggravation. They have failed establish Prong 6 of Loving/Prong 3 of Althen in this case.
As noted above, in Althen, the Federal Circuit indicated that the Vaccine Act involves "system created by Congress, in which close calls regarding causation are resolved in favor of injured claimants." Althen, 418 F.3d at 1280. Accordingly, I note here that this case is ultimately not a close call. For all the reasons set forth above, I find that Dr. Cave's causation theory, either as to "initial causation" or "significant aggravation," was not at all persuasive, while Respondent's expert was far more persuasive.
As I have stressed above, I found that Dr. Cave, despite her apparent sincerity, to be a very unpersuasive witness in this case. As explained, Dr. Cave, in general, presented a muddled, often illogical, and sometimes self-contradictory theory of causation. Dr. Cave based her theory of vaccine-causation in this case on an assertion that a child with a mitochondrial "dysfunction" would be more susceptible to vaccine-causation of a neurodevelopmental disorder, than a child without mitochondrial disease, without any coherent explanation of why that might be the case. (See Section IX(D), above.) Further, she insisted that HH suffered from a mitochondrial "dysfunction," even though she seemed to be poorly informed about the diagnosis of mitochondrial disease, and grossly misapplied the accepted set of medical criteria for diagnosing mitochondrial disorders. (See Section IX(C) above.)
Further, Dr. Cave insisted upon relying upon a factual assumption concerning HH's symptom history that was flatly contradicted by HH's medical records, even after being warned on a number of occasions by Special Master Campbell-Smith that Dr. Cave's factual assumption was untenable in light of the medical records. (See Section VII(C) above.)
Moreover, Dr. Cave's totally unpersuasive presentation in this case appears to be the norm for her. For example, as detailed above at p. 22, Dr. Cave was warned in the Berge and Blake cases, in 2010 and 2011, that her causal opinions would be rejected when contradicted by the medical records in the case. In addition, special masters have often commented negatively upon the quality of Dr. Cave's presentations as an expert witness. In Blake v. HHS, No. 03-31V, 2014 WL 2769979 (Fed. Cl. Spec. Mstr. May 21, 2014), Special Master Vowell observed that "I do not attribute great weight to Dr. Cave's opinion as she lacks expertise in the specialties relevant to the issues in this case," particularly in the fields of developmental pediatrics, pediatric neurology and pediatric immunology. Id. at *15. In Nilson v. HHS, No. 98-797V, 2005 WL 6122524 (Fed. Cl. Spec. Mstr. Aug. 31, 2005), Special Master Sweeney (now Judge Sweeney) compared the expert reports and testimony of both Dr. Cave and Dr. Wiznitzer regarding several disputed issues, and found that Dr. Wiznitzer's opinion on each was more credible. Id. at *17-*20. The special master concluded that "[i]n this case, Dr. Cave's theories of causation were effectively rebutted by a highly-credentialed pediatric neurologist, Dr. Wiznitzer, whose testimony was far more credible and compelling." Id. at *20. In Mooney v. HHS, No. 05-266V, 2014 WL 7715158 (Fed. Cl. Spec. Mstr. Dec. 29, 2014), Special Master Vowell declined to award costs for the production of Dr. Cave's expert opinion, awarding only a small amount for consultation services, adding that "I am unlikely to authorize Dr. Cave's consultant fees for hearing preparation in any similar cases filed by Mr. Cave." Id. at *14.
Finally, in Miller v. HHS, No. 02-235V, 2015 WL 5456093 (Fed. Cl. Spec. Mstr. August 18, 2015), Special Master Vowell, like Special Master Sweeney in Nilson, specifically compared the qualifications and testimony of Dr. Cave and Dr. Wiznitzer, and found Dr. Cave's testimony to be far inferior in quality and credibility. 2015 WL 5456093 at *11-12, *26-29, *34-35, *41-43. Special Master Vowell specifically found that Dr. Cave's attempts to use the Morava criteria, the same criteria at issue in this case, showed a "lack of understanding" of those criteria. Id. at *29.
Therefore, even in this case, whether it was reasonable for Mr. Cave to proceed to hearing with Dr. Cave as his sole expert is quite questionable. But certainly, I hereby put Vaccine Act attorneys (and pro se litigants) on notice that if Dr. Cave's opinion, relying on the same discredited theories and approaches, is offered in other Vaccine Act cases, I will not be likely to compensate such a petitioner for any work by Dr. Cave performed after the publication date of this Decision.
In addition, in a number of cases recently, each involving a child with an ASD, expert witnesses for petitioners have based their causation theories on an allegation that the child suffers from a mitochondrial dysfunction or disorder. But in many of those cases, as in this case, there has been a lack of any persuasive evidence that the child even has any type of mitochondrial disorder. See, e.g., Coombs v. HHS, supra; Brook v. HHS, supra; Miller v. HHS, supra; Allen v. HHS, supra; Krakow v. HHS, supra.
In all those cases, there also has been a lack of persuasive evidence that even genuine mitochondrial disorders are of any relevance—i.e., as in this case, a lack of any persuasive evidence that the existence of a true mitochondrial disorder can make a child more susceptible to the causation or aggravation of an ASD by vaccination.
In this regard, I am aware that in Paluck v. HHS, 786 F.3d 1373 (Fed. Cir. 2015), the Court of Appeals affirmed a ruling that a particular child's mitochondrial disorder was significantly aggravated by receipt of MMR, varicella, and pneumococcal vaccines, thereby affecting the course of the child's neurodevelopmental disorder. I have also reviewed the medical article by Poling et al., Developmental Regression and Mitochondrial Dysfunction in a Child with Autism, 21(2) J. Child Neurology 170 (2006). However, the facts in Paluck were quite different from the circumstances in any of the cases cited above. Moreover, in no case presented to me, nor in any of the cases cited above, has there been presented any persuasive evidence that even in a child with an actual mitochondrial disorder, vaccines can cause or aggravate that child's ASD.
Therefore, I strongly advise counsel in Vaccine Act cases to carefully scrutinize, for credibility, any cases in which an expert witness asserts that the existence of a mitochondrial disorder caused the child to be susceptible to causation or aggravation of an ASD by vaccines. If, as in this case, and in the cases cited at Section 11(A) above, there is no credible evidence that the child even suffers from a mitochondrial disorder, I will be unlikely to find that the use of such expert was reasonable, and thus compensable. Further, even in the context of an actual mitochondrial disorder, the expert must be able to supply credible evidence that a mitochondrial disorder can make a child susceptible to causation or aggravation of an ASD by vaccines, or else I may, again, be disinclined to compensate the attorney for presenting such expert.
The record of this case demonstrates plainly that HH and her family have been through a tragic ordeal. The great dedication of HH's family to her welfare is readily apparent to me.
Nor do I doubt that HH's parents are sincere in their belief that HH's vaccinations played a role in initially causing or aggravating HH's neurodevelopmental disorder. HH's parents have heard the opinion of Dr. Cave, who professes to believe in a causal connection between vaccines and neurodevelopmental disorders. After studying the extensive evidence in this case, I am convinced that the opinion provided by Petitioners' expert in this case, advising the Hardy family that there is a connection between the vaccinations in question, and the causation or aggravation of HH's neurodevelopmental disorder, was quite wrong. Nevertheless, I can understand why HH's parents found such opinion to be believable under the circumstances. I conclude that the Petitioners filed this petition in good faith.
Thus, I feel deep sympathy for the Hardy family. Further, I find it unfortunate that my ruling in this case means the Program will not be able to provide funds to assist this family, in caring for their child who suffers from a serious disorder. It is my view that our society does not provide enough assistance to families of all children with ASDs or similar disorders, regardless of the cause of their disorders. And it is certainly my hope that our society will find ways to ensure that in the future much more generous assistance is available to all such children. Such families must cope every day with tremendous challenges in caring for their children, and all are deserving of sympathy and admiration. However, I must decide this case not on sentiment, but by analyzing the evidence. Congress designed the Program to compensate only the families of individuals whose injuries or deaths can be linked causally, either by Table Injury or presumption or by preponderance of "causation-in-fact" evidence, to a listed vaccine. In this case, the evidence advanced by Petitioners has fallen far short of demonstrating such a link. Accordingly, I conclude that the Petitioners in this case are not entitled to a Program award on HH's behalf.
In Poling v. HHS, the presiding special master clarified that the family was compensated because the Respondent conceded that the Poling child had suffered a Table Injury—not because the Respondent or the special master had concluded that any vaccination had contributed to causing or aggravating the child's ASD. See Poling v. HHS, No. 02-1466V, 2011 WL 678559, at *1 (Fed. Cir Spec. Mstr. Jan. 28, 2011) (a fees decision, but noting specifically that the case was compensated as a Table Injury).
Second, in Wright v. HHS, No. 12-423 (Fed. Cl. Spec. Mstr. Sept. 21, 2015), Special Master Vowell concluded that a child, later diagnosed with ASD, suffered a "Table Injury" after a vaccination. However, she stressed that she was not finding that the vaccinee's ASD in that case was "caused-in-fact" by the vaccination—to the contrary, she specifically found that the evidence in that case did not support a "causation-in-fact" claim, going so far as to remark that the petitioners' "causation-in-fact" theory in that case was "absurd." (Decision at 2-3).
The compensation of these two cases, thus does not afford any support to the notion that vaccinations can contribute to the causation of autism. In setting up the Vaccine Act compensation system, Congress forthrightly acknowledged that the Table Injury presumptions would result in compensation for some injuries that were not, in fact, truly vaccine-caused. H.R. Rept. No. 99-908, 18, 1986 U.S.C.C.A.N. 6344, 6359. ("The Committee recognizes that there is public debate over the incidence of illnesses that coincidentally occur within a short time of vaccination. The Committee further recognizes that the deeming of a vaccine-relatedness adopted here may provide compensation to some children whose illness is not, in fact, vaccine-related.")
Dr. Cave also briefly mentioned an article by Poling, et al., suggesting that the article "discusses the possible links between the developmentally disabled and mitochondrial dysfunction." (Ex. 10-b, p. 6; Ex. 27, pp. 3-4; Tr. 33.) However, Dr. Cave did not discuss the article in detail, in any of her reports at the hearing. In their Post-Hearing Memorandum, at p. 16, Petitioners did cite the article—Poling et al., Developmental Regression and Mitochondrial Dysfunction in a Child With Autism, 21(2) J. Child Neurology 170 (2006). But the article offers no support for Dr. Cave's theory in this case, because, as explained above (Section IX(C)), the evidence in this case does not show that HH suffered from any mitochondrial dysfunction or disorder.
