CHRISTIAN J. MORAN, Special Master.
On July 29, 2013, Ryan and Mary Swick filed a petition on behalf of their deceased son, J.R.S., under the National Vaccine Injury Compensation Program (the "Vaccine Program"), 42 U.S.C. § 300aa-10 through 34 (2012). This ruling is focused on resolving inconsistent factual details surrounding J.R.S.'s death on August 11, 2011. When special masters are confronted with discrepancies among medical records and affidavits, they are encouraged to hold a hearing to evaluate the testimony of the affiants.
On July 25, 2011, J.R.S. received the hepatitis B, rotavirus, diphtheria-tetanus-acellular pertussis ("DTaP"), haemophilus influenzae type b, inactivated poliovirus (IPV), and pneumococcal conjugate vaccines. Pet. ¶ 5. Mr. and Mrs. Swick ("the Swicks" or "petitioners") allege a vaccination, or combination of vaccinations, caused J.R.S.'s death a month later.
In addition to submitting the medical records and affidavits, petitioners were ordered to file an expert report outlining the basis of their theory. Neurologist Dr. Walter Kozachuck's first report opined that J.R.S. died as a result of posterior reversible encephalopathy syndrome, which can begin soon after vaccination. Exhibit 11 at 12. The Secretary filed her Rule 4 report shortly after Dr. Kozachuck's report, and concluded there was insufficient evidence to prove petitioners are entitled to compensation. Resp't's Rep. at 10. With her report, the respondent submitted blog posts by Mrs. Swick dated April 26, 2012 (updated April 27, 2012) and February 20, 2012. Exhibit A; exhibit B.
The case was then transferred to the undersigned. Order, filed June 5, 2014. Following the transfer, Dr. Kozachuck authored a supplemental expert report in response to the Secretary's Rule 4 report. This report was filed on August 19, 2014. The supplemental report concluded that additional autopsy studies are required to rule out sudden infant death syndrome (SIDS) as a cause of death and establish a more certain cause of death.
After reviewing the filings in the case, the undersigned determined that there were factual discrepancies concerning the time period from J.R.S.'s vaccination through his death. Specifically, differences exist between medical records, affidavits, blog posts, and manuscripts regarding J.R.S.'s temperament, cough, vomiting, and C-Phen intake, as well as what transpired the morning of J.R.S.'s death, and whether anyone else was ill in the Swicks' home around the time J.R.S died.
On October 30, 2014, a fact hearing was held to address factual discrepancies in the record by evaluating the testimony of the affiants. Five people testified. The undersigned has considered their testimony as well as the documentary evidence.
Following the hearing, petitioners filed proposed findings of fact on December 22, 2014, which outline the chronology of events leading to J.R.S.'s death. On January 20, 2015, respondent submitted her response to petitioners' proposed findings of fact. The Secretary agreed with, or did not dispute, many of petitioners' proposed facts. She did, however, object to certain proposed facts, in particular challenging the proposed timeline for J.R.S.'s symptom onset, and whether he was found with a blanket over his head, which affects whether asphyxia could be ruled out as a cause of death.
Petitioners are required to establish their case by a preponderance of the evidence. 42 U.S.C. § 300aa-13(1)(a). The preponderance of the evidence standard requires a "trier of fact to believe that the existence of a fact is more probable than its nonexistence before [he] may find in favor of the party who has the burden to persuade the judge of the fact's existence."
The process for finding facts in the Vaccine Program begins with analyzing the medical records, which are required to be filed with the petition. 42 U.S.C. § 300aa-11(c)(2). Medical records created contemporaneously with the events they describe are presumed to be accurate.
Not only are medical records presumed to be accurate, they are also presumed to be complete, in the sense that the medical records present all the problems of the patient. Completeness is presumed due to a series of propositions. First, when people are ill, they see a medical professional. Second, when ill people see a doctor, they report all of their problems to the doctor. Third, having heard about the symptoms, the doctor records what he or she was told.
Appellate authorities have accepted the reasoning supporting a presumption that medical records created contemporaneously with the events being described are accurate and complete. A notable example is
Decisions by judges of the Court of Federal Claims have followed
The presumption that contemporaneously-created medical records are accurate and complete is rebuttable, however. For cases alleging a condition found in the Vaccine Injury Table, special masters may find when a symptom first appeared despite the lack of a notation in a contemporaneous medical record. 42 U.S.C. § 300aa-13(b)(2). By extension, special masters may engage in similar fact-finding for cases alleging an off-Table injury. In such cases, special masters are expected to consider whether medical records are accurate and complete. To overcome the presumption that contemporaneous written records are accurate, testimony is required to be "consistent, clear, cogent, and compelling."
Special masters will consider various explanations for inconsistencies between contemporaneously created medical records and later given testimony. The Court of Federal Claims listed four such explanations. Inconsistencies can be explained by: (1) a person's failure to recount to the medical professional everything that happened during the relevant time period; (2) the medical professional's failure to document everything reported to her or him; (3) a person's faulty recollection of the events when presenting testimony; or (4) a person's purposeful recounting of symptoms that did not exist.
In weighing divergent pieces of evidence, special masters usually find contemporaneously-written medical records to be more probative than oral testimony.
The relative strength or weakness of the testimony of a fact witness affects whether this testimony is more probative than medical records. An assessment of a fact witness's credibility may involve consideration of the person's demeanor while testifying.
These criteria are considered in the analysis below.
The respondent does not dispute many of the underlying facts proposed by petitioners. The parties do not dispute the dates of J.R.S.'s birth (May 14, 2011), vaccinations (July 25, 2011), or date of death (August 11, 2011). They also do not dispute the location of the Swicks' home, the Swicks' education, the history of the Swicks' other children, and the account of J.R.S.'s birth and medical history up to his leaving the hospital. Resp't's Resp. to Pet'r's Proposed Findings of Fact at ¶¶ 1-9, 11-12. Respondent also did not dispute J.R.S.'s healthy appearance on May 28-30, 2011, or the history of J.R.S.'s vaccinations.
Two other proposed facts were not disputed by the respondent, although clarified. First is J.R.S.'s gestation at birth. Petitioners and respondent agree to 36 weeks and 3 days despite slight variations in the medical records.
The parties dispute the facts in six general areas. Those areas are: (1) the degree, if any, to which J.R.S.'s temperament became more "fussy" after vaccination; (2) when J.R.S. began coughing after his vaccination; (3) the magnitude and characterization of J.R.S.'s oral expelling which occurred roughly four to five days before J.R.S.'s death; (4) whether J.R.S. ingested C-Phen; (5) the events that occurred from the time J.R.S. was taken to his bed the morning of August 11, 2011, until the arrival of the EMTs later that morning; and (6) whether anyone was ill in the Swicks' home immediately prior to J.R.S.'s death.
The submitted evidence is summarized below in six sections.
The Swicks have testified and stated in their affidavits that prior to J.R.S.'s July 25, 2011 vaccinations, he was a content and happy child, rarely fussy or colicky.
At a June 21, 2011 medical appointment, the doctor noted that J.R.S. was receiving more formula, but was fussier with formula than with breast milk. Exhibit 2 at 10. On June 23, 2011, Mrs. Swick called the doctor and reported J.R.S. was constipated and fussy.
At the July 12, 2011 doctor's visit, Mrs. Swick reported that J.R.S. had a fever and was vomiting prior to his last bowel movement, and reported that those issues resolved with the bowel movement. Exhibit 2 at 22. As a result, J.R.S. was given a daily glycerin suppository to help with constipation.
On July 25, 2011, J.R.S. was seen for a well child examination.
Mrs. Swick testified that J.R.S.'s constipation returned during the two week period between July 25, 2011, and August 11, 2011. She stated: "[Constipation] was pretty constant. We were still using the suppositories, they just didn't seem to be working as well as they had before. He wasn't going regularly now. Now it could be every three or four days." Tr. 39.
Mrs. Swick further testified that J.R.S.'s outbursts and crying were random after he received his July 25, 2011 vaccinations. Tr. 24. She testified that J.R.S. previously cried only "when he was hungry or when his tummy hurt when he was constipated."
Mrs. Swick's testimony states J.R.S. was constipated for multiple days at a time between July 25, 2011, and August 11, 2011. It would not be surprising for a constipated four-month-old baby to be fussy. Thus, Mrs. Swick's observation and testimony that J.R.S. was fussy is credited. However, Mrs. Swick was not persuasive in attempting to distinguish J.R.S.'s random outbursts and crying from those previously triggered by constipation.
The parties remain free, within the confines of these factual findings, to argue causation regarding J.R.S.'s temperament shifts.
The Swicks testified that J.R.S. developed a cough roughly five days after he received his July 25, 2011vaccinations, and that the cough progressively got more frequent, though still intermittent. Tr. 22, 46 to 47, 65. They also testified that the cough progressed to the point that it would wake him up. Tr. 22, 65. In contrast to this testimony, respondent highlights the Iowa medical examiner's records, and multiple blog posts by Mrs. Swick, as fixing the onset of the cough much closer to the date of J.R.S.'s death.
Specifically, respondent relies on a notation in the medical examiner's August 11, 2011 report, which is contemporaneous with J.R.S.'s death. The medical examiner's report states: "coughing started 8-10-11 — coughed up/gagging clear phlegm — 0200 8/11/11." Exhibit 6 at 11. August 10, 2011, was 17 days after J.R.S.'s vaccination, and one day before his death.
Additionally, Mrs. Swick's February 2012 blog post, the closest in time to J.R.S.'s August 2011 death, does not mention J.R.S. having a cough, and the April 2012 blog post states: "I was a few weeks late on getting [J.R.S.] his shots, but the night we came home [July 25, 2011], [J.R.S.] had a slight fever, (normal), and then later developed a cough. The night he developed the cough he passed away." Exhibit A; exhibit B.
Respondent argues that if J.R.S. had a cough, it would have been mentioned in the February 2012 blog post, which is closest in time to J.R.S.'s death. Further, Mrs. Swick's April 2012 blog post, which is closer in time to J.R.S.'s death than either her affidavit or testimony, puts J.R.S.'s cough onset as August 10, 2011, not days before.
The August 11, 2011 statement regarding the timing of the onset of J.R.S.'s cough states "coughing started 8-10-11." Exhibit 6 at 11. The specific onset date is clear. Although the Swicks provided this history in an extremely stressful situation, the preponderance of the evidence suggests the Swicks, as the diligent parents they are, would have noted all of J.R.S.'s coughing, even slight coughing, that began in proximity to the date of his death. There is no such notation of an earlier cough, and no explanation for the absence of the notation.
Due to the specificity and timeliness of the August 11, 2011 statement, its evidentiary value outweighs other contrary evidence about J.R.S.'s coughing. The February 2012 blog post contains no information about J.R.S.'s cough, but the lack of mention of a cough is not important because the Swicks agree he had a cough.
Petitioners allege that J.R.S. had a significant vomiting incident four to five days before his death. Pet'rs' Proposed Findings of Fact at ¶ 33. Various testimony characterized J.R.S.'s vomit as "more than a baby would be expected [to vomit.]"
The testimony presented by petitioners through Mr. Swick and Mrs. Meyer leaves no doubt that J.R.S. threw up, as opposed to spit up, and that the volume produced relative to J.R.S.'s age and size was significant. Tr. 73 to 74, 85 to 88. It is unclear whether the Secretary is disputing these facts by citing Mrs. Meyer's testimony that she was "puked on a lot of times." Resp't's Resp. to Pet'r's Proposed Findings of Fact at ¶ 33; Tr. 86. Regardless, Mrs. Meyer's testimony as to her experience with children's vomiting supports her ability to recognize an anomalous quantity of vomit.
Petitioners ask for a finding that the incident Mrs. Meyer witnessed in early August was more severe than J.R.S.'s previous vomiting.
Nonetheless, the parties remain free, within the confines of these factual findings, to argue the significance of J.R.S.'s early August vomiting.
It is undisputed that the Swicks attempted to give J.R.S. roughly one-quarter milliliter of C-Phen for his cough on the morning of August 11, 2011. Tr. 41. However, while petitioners state that J.R.S. spit the entire amount out, respondent says such a statement is conclusory. Resp't's Resp. to Pet'r's Proposed Findings of Fact at ¶ 35. The active ingredients in C-Phen, chlorpheniramine and dextromethorphan, were part of the comprehensive toxicology panel performed on J.R.S.'s heart blood and were reported as negative. Exhibit 6 at 20. While the toxicology panel suggests that J.R.S. did not consume any C-Phen, the evidence is not definitive, as questions remain regarding the rate of metabolism of C-Phen. Therefore, the parties remain free, within the confines of these factual findings, to argue the significance of J.R.S.'s receiving C-Phen.
Testimony surrounding the morning of August 11, 2011, concentrated on three main issues: (1) whether a blanket was covering J.R.S.'s face when he was found by Mrs. Swick; (2) how J.R.S. was laid to sleep; and (3) J.R.S.'s physiological condition when found. Issue one is analyzed and resolved below, while issues two and three remain unresolved. While unresolved, the clarifications provided below on issues two and three should assist the parties in directing their respective experts.
The parties dispute whether J.R.S. was found with a blanket covering his head.
Though respondent has identified significant contemporaneous records and temporally closer statements that argue against Mrs. Swick's oral testimony, that evidence still must be balanced against the persuasiveness of Mrs. Swick's testimony.
As discussed previously, to overcome the presumption that contemporaneous written records are accurate, testimony is required to be "consistent, clear, cogent, and compelling."
Furthermore, more than three years transpired between August 2011 and October 2014, when Mrs. Swick testified. The lapse of time with associated decline in memory is an additional factor reducing the overall persuasiveness of Mrs. Swick's testimony. Regardless of the myriad explanations for the various inconsistencies, the undersigned finds the contemporaneous documentation regarding how J.R.S. was found relative to his blanket more persuasive than Mrs. Swick's later October 2014 testimony. The undersigned finds that J.R.S. was discovered on August 11, 2011, with a blanket covering his head.
The remaining issues are how J.R.S. was laid to sleep, and J.R.S.'s physiological condition when found. While no definitive finding can be made, it is possible to narrow the parties' disputes.
Regarding how J.R.S. was laid to sleep, it is unclear whether Mr. Swick placed J.R.S. on his back (supine) or stomach (prone) the morning of August 11, 2011. Contemporaneous records suggest prone.
In addition to the evidence being unclear, the significance of how J.R.S. was placed to sleep is also unclear. Therefore, an expert's opinion about causation may draw support from either scenario, that is, J.R.S. was laid to sleep on his back, or on his stomach. If using either scenario, the expert must thoroughly explain why J.R.S.'s original position upon being placed to sleep matters in his (or her) opinion.
The final issue to address is J.R.S.'s physiological condition, that is, temperature and overall appearance, when Mrs. Swick found him, until the time the EMTs arrived. Mr. Swick testified that J.R.S. was warm when found the morning of August 11, 2011. Tr. 69 to 70. Mrs. Swick testified that J.R.S. was warm to the touch, sweaty, pale, limp, and still. Exhibit 6 at 10; Tr. 34 to 37. She also testified that just before she stopped CPR, the area below J.R.S.'s lips started to turn blue, but his lips were not blue, nor his face. Tr. 37. This testimony by the petitioners is credible. Further, respondent does not dispute the Swicks' subjective impressions. Resp't's Resp. to Pet'r's Proposed Findings of Fact at ¶¶ 38-40.
While the physiological conditions above are findings of fact, the undersigned declines at this time to draw any further inference from them. For example, whether J.R.S. was still alive when found depends on all evidence, including expert reports, and cannot be determined based on the evidence currently of record.
The Swicks testified that J.R.S. was the only sick family member during the time surrounding his death. Tr. 24, 53, 78. Respondent highlights a contemporaneous notation in the medical examiner's report which asks, "Anyone Else in Household or Other Contacts (e.g. daycare) Recently Ill?" Exhibit 6 at 11. In response, "Yes" is selected, with a handwritten note stating, "colds both parents and 2 older sibs [siblings] all in past 2 wks."
The contemporaneous medical examiner's report is persuasive. The report is more persuasive not only because it is contemporaneous, unlike the Swicks' more recent testimony, but also because it includes a specific notation which identifies the family (both parents and two older siblings) and a timeframe in which the illnesses occurred. Exhibit 6 at 11. While a scrivener's error in selecting "yes" or "no" could be imagined, it strains reasonableness to argue that not only did the person completing the form err in selecting yes or no, but went so far as to provide details to support the erroneous marking. Given the greater persuasiveness of the medical examiner's contemporaneous report, the undersigned finds the preponderance of the evidence supports that both J.R.S.'s parents and two older siblings were sick at some point during the two weeks prior to J.R.S.'s death.
The undisputed and clarified facts, as listed above, and found in Petitioners' Proposed Findings of Fact and the Response to Petitioners' Proposed Findings of Fact, are adopted by the undersigned as findings of fact.
The undersigned has considered the respondent's additional proposed findings of fact, but finds them to either be a restating of the undisputed existing record, or the domain of expert opining, and therefore does not address them.
Finally, the following findings of fact reflect the determinations concerning the six general areas of dispute above:
1. J.R.S.'s normal temperament was to cry only when hungry, constipated, or his tummy hurt. Tr. 24.
2. J.R.S.'s temperament was fussier than normal between June 21 and July 11, 2011. Exhibit 2 at 10-22.
3. J.R.S. was constipated for portions of time between June 21 and July 11, 2011. Exhibit 2 at 10-22.
4. J.R.S.'s temperament was not fussier than normal, and he was not constipated, between July 12 and July 24, 2011.
5. J.R.S.'s temperament after his July 25, 2011 vaccinations was fussier than normal, and comparable to his fussier than normal temperament between June 21 and July 11, 2011. Tr. 15, 61 to 62; exhibit 7 at ¶ 6; exhibit 15 at ¶ 4.
6. J.R.S. was constipated for portions of time between July 25 and August 11, 2011. Tr. 39.
7. J.R.S.'s cough began the evening of August 10, 2011. Exhibit 6 at 11. The cough was significant enough that it woke J.R.S. from his sleep and compelled the Swicks to give J.R.S. C-Phen. Tr. 33, 40 to 41.
8. Around July 12, 2011, J.R.S. vomited prior to a bowel movement. The bowel movement resolved the vomiting issue. Exhibit 2 at 22.
9. Four to five days before his death, J.R.S. had a single vomiting incident in which he vomited a significant amount relative to his size and age. Tr. 73 to 74, 85 to 88.
10. The Swicks gave J.R.S. one-quarter milliliter of C-Phen on the morning of August 11, 2011. Tr. 41.
11. J.R.S., in response to receiving the C-Phen, spit up. Tr. 41.
12. The active ingredients in C-Phen were not found in the toxicology panel performed on J.R.S.'s blood following his death. Exhibit 6 at 20.
13. Mrs. Swick found J.R.S. with a blanket covering his head. Exhibit 6 at 8, 10; exhibit 4 at 2; exhibit 7 at ¶ 15(f); exhibit B at 3; exhibit 19 at 5-6.
14. When Mrs. Swick found J.R.S. he was warm to the touch, sweaty, pale, limp, and still. Exhibit 6 at 10; Tr. 34 to 37, 69 to 70. His face and lips were not blue, but the area below J.R.S.'s lips started to turn blue just before Mrs. Swick stopped performing CPR. Tr. 37.
15. The Swicks and J.R.S.'s two older siblings were sick at some point during the two weeks prior to J.R.S.'s death. Exhibit 6 at 11.
The parties are ordered to provide these Findings of Fact to any expert whom they may retain to offer an opinion in this case. An expert's assumption of any fact that is inconsistent with these findings of fact will not be credited.
A status conference is set for