OFFICE OF THE SPECIAL MASTERS  (No. 93-0438V)  (Filed January 31, 1997) 
 
 

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DANYELLE R. CARRAGGIO and MARK  *
ANDERSON, as Parents and Next *
Friends of JASON LUCAS ANDERSON, *
deceased, *
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Petitioners, *
*
vs.  *
* PUBLISH
SECRETARY OF THE DEPARTMENT *
OF HEALTH AND HUMAN SERVICES,  *
*
Respondent. *
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Ronald C. Homer, Esq., Boston, Massachusetts, for petitioners.

Elizabeth F. Kroop, Esq., U.S. Department of Justice,

Washington, D.C., for respondent. DECISION

WRIGHT, Special Master.

On July 14, 1993, the petitioners filed a claim on behalf of Jason Lucas Anderson (Jason), under the National Vaccine Injury Compensation Program (hereinafter "Vaccine Act" or the "Act").(1) Petitioners claimed that as the direct result of a DPT vaccination administered on August 30, 1991, Jason suffered a hypotonic-hyporesponsive episode (HHE) as defined by the Vaccine Injury Table, resulting in his death on the evening of August 31, 1991. I.   PROCEDURAL BACKGROUND 

On October 12, 1993, respondent filed a report in this matter recommending compensation be denied. An evidentiary hearing was held on April 18, 1996, in Seattle, Washington. Petitioners presented the testimony of Ms. Danyelle R. Robinson,(2) Jason's mother, and Mrs. Cleo Meckle, Jason's maternal grandmother. Petitioners also filed the depositions of the following: Heather Ricks,(3) the baby sitter who was watching Jason when he died; Tracee Stout,(4) a friend of Ms. Robinson's; Dr. Michael Donlan,(5) Jason's treating physician; Dr. George R. Lindholm,(6) the forensic pathologist who performed the autopsy on Jason; and, Dr. Graham McConnell,(7) the Spokane County Coroner. In addition, petitioners filed an initial and supplemental expert report of Dr. Mark Geier, an obstetrical geneticist. Respondent filed an expert report of Dr. Mary Anne Guggenheim, a board certified pediatric neurologist. II.  FACTUAL BACKGROUND 

The following evidence is contained in the record in this matter:(8) Factual Evidence

Jason was born on June 30, 1991, after an uncomplicated delivery. His APGAR scores were 9 and 10.(9) P. Ex. 4 at 1. On July 15, 1991, Jason was taken to his pediatrician, Dr. Michael A. Donlan, for his 15-day check-up and was noted to be a "super baby" after a complete physical exam. P. Ex. 5 at 2; Donlan Dep. at 22-23-24.

On August 30, 1991, Jason was taken to Dr. Donlan's office for a two-month well-baby check. Ms. Robinson, Jason's mother, testified that at that time, Jason was an active two-month-old baby who seemed content, happy and playful. Tr. at 51. She stated that Jason smiled, giggled, grabbed for things, and could grasp her fingers. Tr. at 51, 59. A normal day for Jason at that time consisted of waking at 6:00 a.m., nursing, then falling back to sleep until approximately 9:00 a.m. when he again would nurse. Tr. at 53. After this feeding, Jason would "play" until 10:00 a.m. when he would go back to sleep until noon, when he would awaken, nurse, and play again. Tr. at 53-54. Jason took his afternoon nap around 1:00 or 1:30 p.m. In the evening, Jason went to sleep around 11:00 p.m. or 12:00 midnight and would wake up at 3:00 a.m. for a feeding. Tr. at 57. Ms. Robinson testified that when Jason was breast fed, he would usually nurse for approximately ten minutes on each side, and would take approximately two-ounces when given a bottle. Tr. at 58.

At the well-baby visit on August 30, 1991, Jason was determined by the doctor to be healthy and was administered his first DPT and oral polio vaccines.(10) Donlan Dep. at 23, 24. Ms. Robinson arrived home with Jason around 4:30 p.m. Tr. at 64. According to Ms. Robinson, Jason was "extremely fussy." Tr. at 64. Ms. Robinson would carry him around until he seemed to be asleep and put him down, only to have him awaken five or ten minutes later. Tr. at 69. Ms. Robinson testified that Jason did not eat at 6:00 p.m. as he normally did but rather would only take a couple of sucks on the breast. Jason did not play that evening, but was irritable and cried continuously. Tr. at 65-66.

Ms. Robinson testified she had made plans to go out that evening with a friend, Tracee Stout. Tr. at 67. Her mother, Mrs. Cleo Meckle, was going to babysit. Ms. Robinson dropped Jason off at her mother's home between 8:30 p.m. and 9:00 p.m. that evening and told her mother that Jason had been cranky and irritable after his shot. Tr. at 13, 64, 68. Mrs. Meckle testified that before he fell asleep, Jason was fussy and moody and it took a great deal of effort to feed him his bottle. Jason was not his usual responsive self and Mrs. Meckle could not get him to coo or smile, although he did not seem to have a fever.(11) Tr. at 16-17, 21. However, Jason did take most of his two and a half ounce bottle. Tr. at 14, 17, 20. At about 9:45 p.m., Jason fell asleep and she laid him down on the bed. Tr. at 17. Ms. Robinson arrived around 2:00 or 2:30 a.m. to pick Jason up. Tr. at 45, 70.

Ms. Robinson testified that Jason did not awaken when she put on his coat or put him in the car and he slept in the car during the ride to her friend Tracee's house where they were going to spend the night. He remained asleep the rest of the night, not waking until 6:00 a.m. Tr. at 46, 70, 72, 101. When Jason awoke at 6:00 a.m. on August 31st, Ms. Robinson fed him and then he fell back to sleep with her. Tr. at 72. Jason next awoke between 9:30 and 10:00 a.m. At that time, he refused to eat, only taking a few sucks at the breast. Tr. at 72-73. Ms. Robinson testified Jason did not play as he usually did at that time, even after she attempted to stimulate him. Tr. at 73. Jason wanted to be held and would only sleep for five or ten minutes at a time and then wake up. He continued this routine for several hours. Tr. at 77. However, Ms. Robinson stated that at no time after Jason received his DPT vaccination did he exhibit any fever. P. Ex. 14 at 3.

According to Ms. Robinson, Jason did not eat again until 1:00 or 1:30 p.m. that day and then fell asleep. Tr. at 76, 78. Tr. at 78. At approximately 1:30 or 2:00 p.m., Ms. Robinson left Jason and her other children with a baby sitter, Heather Ricks, and went with her friend, Tracee Stout, to the bowling alley then to the racetrack.(12) Tr. at 80. Heather had taken care of Ms. Stout's children on numerous occasions but had never met Ms. Robinson or taken care of her children. Ricks Dep. at 8. Ms. Stout had great faith in Heather's abilities as a baby sitter. Stout Dep. at 8.

Heather testified Ms. Robinson did not give her any special instructions regarding any of the children, although she told her Jason had been a little fussy. Ricks Dep. at 12, 14, 30-31. Heather testified that Jason did seem fussy to her, although not abnormally so. Ricks Dep. at 12-13, 33. According to Heather, when she tried to feed Jason his bottle, he would drink a little then stop, although he drank about a quarter of his bottle. Ricks Dep. at 12-13, 35. After each attempt to feed him, she would lay Jason down, thinking he was tired, but he would only sleep for about 10 minutes. Ricks Dep. at 35. When Heather picked him up, she testified, Jason seemed comforted and very responsive and he stopped crying, although after awhile he would get squirmy and fussy again. Heather remembered that during the evening, Jason smiled. Ricks Dep. at 37, 39-40.

Eventually, Heather laid Jason down on a water bed and placed a pillow on either side of him.(13) Ricks Dep. at 14. Heather would then check on Jason every 15 minutes whether he was fussy or not. Ricks Dep. at 15. After about an hour, at around 8:00 p.m. Heather went in to check on Jason and found him in the same position as she had left him. He was not breathing and appeared pale and white.(14) Ricks Dep. at 16, 18-19. She picked him up, found he had no pulse and started to perform cardio-pulmonary resuscitation and then called 911. Ricks Dep. at 19-21, 47. The paramedics arrived in approximately ten minutes and transported Jason to the hospital, Ricks Dep. at. at 21-23; P. Ex. 9 at 2. where he was pronounced dead after resuscitative efforts failed.(15)

Jason's death certificate lists Sudden Infant Death Syndrome ("SIDS") as the cause of death. P. Ex. 10. A coroner's investigative report indicates that a history of "no recent illness" was reported. P. Ex. 11. It was also noted that Jason was found on a water bed. Id. An autopsy was performed on September 3, 1991 by Dr. G. R. Lindholm, a forensic pathologist. In the autopsy report, Dr. Lindholm, while considering SIDS as the cause of death because of the observed petechiae, was "compelled to designate the death as asphyxia due to airway occlusion," because of the fact that Jason was found face down on a water bed. P. Ex. 12 at 1. A VAERS adverse event report noted that Jason's mother had reported Jason did not seem to have any reaction to the childhood immunizations he received. P. Ex. 7.

Ms. Robinson testified that when an investigator questioned her about Jason's health before his death, she told the investigator that Jason had exhibited no unusual behavior and had no recent illnesses before his death. Tr. at 84. Ms. Robinson explained she thought Jason was having a normal reaction to his shot. Tr. at 84. Ms. Robinson further testified that her son, Blaine, had a similar reaction to a DPT shot, and had been irritable, sleepy, unresponsive and not feeding well. Tr. at 93, 94.

Petitioners filed the deposition of Dr. Michael A. Donlan, Jason's pediatrician.(16) Donlan Dep. at 4. It is Dr. Donlan's opinion that there is no cause and effect relationship between the DPT vaccine and brain damage in children. Id. at 18. Dr. Donlan believed that the findings surrounding Jason's death were most compatible with SIDS. Id. at 27. Dr. Donlan testified that fussiness, irritability and a low grade temperature were normal reactions to the DPT vaccination. Id. at 11.

Petitioners filed the deposition of Dr. George R. Lindholm, the pathologist who performed the autopsy on Jason.(17) By letter dated March 30, 1992, Dr. Lindholm wrote to the Spokane County Coroner, Dr. Graham McConnell, recommending that the cause of death be changed from SIDS to "undetermined" because of new information regarding events following the administration of the DPT vaccination in question, of which Dr. Lindholm previously had been unaware. P. Ex. 13 at 1. While this might suggest Dr. Lindholm considered the DPT vaccination may have played a role in Jason's death, to the contrary, Dr. Lindholm clarified in deposition that, while he believed the designation of SIDS was appropriate, he thought a change to "undetermined" as the cause of death might be more correct because of the possibility of asphyxia by placement on a water bed. Lindholm Dep. at 39-40. Further, Dr. Lindholm asserted it would be improbable or unlikely that DPT played a role in Jason's death.(18) Lindholm Dep. at 28. He testified Jason did not show any evidence of cerebral edema or cerebral hemorrhages but rather evidenced typical findings consistent with a SIDS death. Id. at 28-29.

Petitioners also filed the deposition of Dr. Graham S. McConnell.(19) McConnell Dep. at 4-5. Ms. Robinson contacted him numerous times after Jason's death because she wanted him to change the cause of death listed on Jason's death certificate from "SIDS" to "undetermined." Id. at 10-11. Dr. McConnell declined to do so. Id. at 11. Dr. McConnell testified that he was unsure how Jason died although he believes there is a strong possibility Jason's death may have been due to the vaccination. Id. at 17, 65. However, Dr. McConnell did not seem to be aware of how DPT vaccinations can cause death or of the precise circumstances surrounding Jason's death.

Expert evidence

Petitioners submitted two affidavits from Dr. Mark, R. Geier.(20) In the first affidavit, filed with the petition, Dr. Geier opined, to a reasonable degree of medical certainty, that Jason suffered an HHE after his August 30, 1991, DPT inoculation which led to his death. P. Ex. 16 at 7. Dr. Geier based his opinion on the observations that Jason "was less responsive to his environment, had prolonged sleeping, was hard to arouse and had a lessened state of consciousness." Id. He also noted that Jason experienced "loss of muscle tone and cardiac and respiratory arrest leading to his death." Id. Dr. Geier also noted that Jason's DPT vaccination was from an "exceptionally reactogentic lot of DPT and under CDC's previous designations would have been called a "hot lot." Id.

After reviewing the deposition testimony of Heather Ricks, Dr. Donlan, Dr. McConnell, Dr. Lindholm, and Tracee Stout, Dr. Geier prepared a supplemental affidavit in which he declared that the "new information" elicited from the deponents in no way changed his opinion as to the cause of Jason's death. P. Ex. 17 at 7. Dr. Geier noted that Heather Ricks described "a child who was really tired, and fussy." Id. He added he believes "these symptoms fit the description of an HHE as described by the Vaccine Compensation Act."(21) Id. He believes Jason was not yet dead during the resuscitation attempts. Id. at 9. He added, "Therefore, during this time period it is indisputable that this child had various symptoms that fit [the] Vaccine Compensation Act under the heading of HHE including loss of consciousness, turning pale or blue, lessening of awareness of the environment, etc. . . . Therefore, I think virtually all of the signs and symptoms described under the Vaccine Compensation Table, clearly were observed in this child when he was not dead." Id. at 9-10.

Respondent filed the report of Dr. Mary Anne Guggenheim.(22) Respondent's June 20, 1996, Notice of Filing, Exhibit A (hereafter "Guggenheim Report"). Dr. Guggenheim opined, based upon her review of the medical records, affidavits, and depositions in this matter, that Jason died of SIDS. Guggenheim Report at 1. III.  DISCUSSION 

Causation in Vaccine Act cases can be established in one of two ways: either through the statutorily prescribed presumption of causation, or by proving causation in fact. Petitioners must prove one or the other in order to recover under the Act.(23) The Vaccine Injury Table lists certain injuries and conditions which, if found to occur within a prescribed time period, create a rebuttable presumption that the vaccine caused the injury or condition.(24) The Table lists hypotonic-hyporesponsive collapse (HHE) as a compensable injury which creates such a presumption if the onset occurs within 72 hours of the administration of the vaccine in question.(25) The presumption may be overcome by an affirmative showing that the injury was caused by a factor unrelated to the administration of the vaccine.(26)

Hypotonic-hyporesponsive collapse ("HHE")

As noted, the Vaccine Injury Table lists HHE as a compensable injury if its onset occurs within three days of the administration of a DPT vaccination. Section 14(a)(I)(C). The Act's aids to interpretation describe HHE as follows:

A shock-collapse or a hypotonic-hyporesponsive collapse may be evidenced by indicia or symptoms such as decrease or loss of muscle tone, paralysis (partial or complete), hemiplegia or hemiparesis, loss of color or turning pale white or blue, unresponsiveness to environmental stimuli, depression of consciousness, loss of consciousness, prolonged sleeping with difficulty arousing, or cardiovascular or respiratory arrest.

Section 14(b)(1).

In his initial report, Dr. Geier based his opinion that Jason suffered an HHE and died as a result of the fact that Jason was less responsive to his environment, exhibited prolonged sleeping, was difficult to arouse, had a lessened state of consciousness, and experienced loss of muscle tone and cardiac and respiratory arrest.(27) The facts as elicited in the depositions, however, did not support Dr. Geier's scenario. There was clearly not the downward spiral that Dr. Geier first described. After reviewing the depositions, Dr. Geier held to his opinion that Jason's death was due to a vaccine-related HHE, although he changed the basis for that view. In his second report, he noted that Heather Ricks described Jason as "really tired, and fussy." P. Ex. 17 at 7. These symptoms, he noted, "fit the description of an HHE as described by the Vaccine Compensation Act." Id. In addition, he believes Jason was not yet dead during the paramedics' resuscitation efforts. Accordingly, he believes Jason indisputably turned pale or blue, lost consciousness and suffered virtually all the signs and symptoms listed in the Act's definition of HHE.

As an initial matter, it is well settled that in a death case, the signs and symptoms of a Table injury must be proved to have occurred prior to the agonal event itself. Petitioners must show that Jason's death was the sequela of an otherwise compensable Table injury the symptoms of which preceded the immediate dying process. Hellebrand v. Secretary of HHS, 999 F.2d 1565 (Fed. Cir. 1993). Hodges v. Secretary of HHS, 9 F.3d 958 (Fed. Cir. 1993). Obviously any death is accompanied by change in color, loss of consciousness and cardiovascular and respiratory arrest. The Act is intended to reimburse only those deaths in which it has been shown, by a preponderance, that a listed Table injury occurred and death was a sequela of that injury or condition. Id.

On the other hand, it has been held that there is "nothing in the Vaccine Act which precludes death from being used as evidence of a Table injury. . . ." Jay v. Secretary of HHS, 998 F.2d 979 (Fed. Cir. 1993). However, in the Jay case, the child died within 18 hours of receiving a vaccine after experiencing symptoms of over six hours of unconsolable screaming alternating with periods of crying and sleep in a limp condition. Id. at 980. There is no indication that the child was responsive and smiling within an hour or two of death, as Jason was here. Moreover, respondent did not present any expert evidence at hearing in Jay, thus leaving unrebutted petitioner's expert's testimony. Here, although no hearing was held on medical issues, respondent filed a lengthy expert report analyzing the evidence in detail.

Dr. Donlan, Jason's treating pediatrician, testified that irritability and fussiness were normal reactions to the DPT vaccine. The coroner's investigative report notes that Jason had had no recent illnesses. The VAERS report indicated Jason did not seem to have any reaction to the vaccinations he received. In fact, even Ms. Robinson and Ms. Stout testified they believed at the time Jason was having a normal reaction to the DPT. These observations are buttressed by the fact that Ms. Robinson left Jason in the care of her mother on the night of the vaccination, and in the care of a 16 year old baby sitter, whom she had never met before, on the following afternoon. Further, there is no indication Ms. Robinson was especially concerned when she left Jason with Heather Ricks on the evening of his death, nor did she give her any special instructions. She merely mentioned Jason had been fussy. Indeed, Heather also observed that Jason was fussy and seemed to want attention. Heather further reported, however, that Jason took at least some of his bottle, and was very responsive and stopped crying when she picked him up. She also reported she got him to smile.

Dr. Guggenheim stated in her report:

As best as I can reconcile the testimony of the four adults who were with Jason in the 28 hours preceding his death it appears that he was more fussy than usual, and had deviated from his usual eating/sleeping routine. The latter must be put in the context of his being moved first to his grandmother's house and then to Tracee's house during this time period. The grandmother describes "swelling" and diminished responsiveness ("couldn't get him to smile"; she "just thought he was tired"). No other observers mention any swelling and no evidence of abnormal fluid retention was found on autopsy. None of the four observers describe anything more than an irritable and fussy child who was not on his regular schedule. He was never unconscious. He continued to take feedings. None of the caretakers had concerns that caused them to seek medical help and no special concerns were voiced by the mother when she left him with the baby-sitter. Although Dr. Geier has interpreted the situation as diagnostic of HHE, the descriptions given by the four caretakers are not at all like what has been described in the medical literature about this condition.

Guggenheim Report at 3. Dr. Guggenheim described what is usually present during an HHE:

A hypotonic hyporesponsive episode (HHE) in an infant (also sometimes called shock-collapse) is a dramatic event characterized by lack of responsiveness (to the point of an unconscious state), pallor, hypotonia, and, often, fever. It usually occurs within 12 hours after an immunization. No such event is described in the mother's testimony.

Guggenheim Report at 2.

Dr. Guggenheim is a board certified pediatrician as well as a board certified pediatric neurologist. Dr. Geier is a board certified geneticist with a specialty in obstetrical genetics. Both physicians have testified before me in other cases. Although Dr. Geier is undoubtedly knowledgeable in the area of the toxins present in pertussis vaccine and in the literature written about vaccine reactions, when it comes to actually diagnosing whether a particular injury occurred, I simply credit the opinion of Dr. Guggenheim over that of Dr. Geier.

Tragically, Jason died. His death was preceded by fussiness, sleeping more than usual and eating less than usual. However, the person who was with him in the several hours before his death, Heather Ricks, described a child who responded when picked up, drank from his bottle and smiled. I find convincing Dr. Guggenheim's opinion that Jason's symptoms simply are not consistent with the symptoms of HHE. Accordingly, petitioners have not met their burden that Jason suffered a vaccine-related injury and died as a result.

Decision on written information and fact testimony.

Finally, I note here that in this case I have diverged from my usual pattern of holding an evidentiary hearing on factual issues and then, once I have determined the facts warrant it, holding a second hearing to elicit testimony from medical experts. This is an unusual case in that, while there are certain discrepancies between witnesses, the totality of the testimony, taken at face value, does not, in my view, warrant the further expenditure of court resources in holding an evidentiary hearing on medical issues. I have given the parties the opportunity to present detailed written expert reports. Indeed, because Dr. Geier did not have the benefit, when he submitted his initial report, of reading the factual affidavits of Heather Ricks, Tracee Stout, Dr. Donlan, Dr. Lindholm or Dr. McConnell, I gave petitioners an opportunity to submit a supplemental affidavit from Dr. Geier. He continued to maintain his position that Jason suffered an HHE and died as a result after reviewing the factual testimony elicited in depositions. In addition, the parties were given the opportunity to submit written closing arguments addressing the issues presented.

As Senior Judge Harkins as stated:

In the Program, a special master is not required to allow every proposed witness to testify. The statute obligates a special master to "afford all interested persons an opportunity to submit written relevant information." Section 12(d)(3)(B)(iv). The statute directs that the Vaccine Rules shall "include the opportunity for parties to submit arguments and evidence on the record without requiring routine use of oral presentations, cross-examinations, or hearings." Section 12(d)(2(D). The Vaccine Rules accord the special master wide latitude in the receipt of evidence, governed by principles of fundamental fairness to both parties. In receiving evidence, the special master will not be bound by common law or statutory rules of evidence. The special master will consider all relevant, reliable evidence. Evidence may be taken in the form of documents, affidavits, oral testimony at a hearing in person or via telephone; or even, in appropriate circumstances, video tape. Sworn written testimony may be submitted in lieu of oral testimony. Vaccine Rule 8(b). A case may be decided on the basis of written filings without an evidentiary hearing. Vaccine Rule 8(d).

Skinner v. Secretary of HHS, 30 Fed.Cl. 402, 409-10 (1994). See also, Burns v. Secretary of HHS, 3 F.3d 415 (Fed. Cir 1993); Snyder v. Secretary of HHS, 36 Fed.Cl. 461 (1996). In keeping, I have attempted to adhere strictly to the principles of fundamental fairness in conducting the proceedings as described. I simply feel that the medical issues in this case are so clear as not to warrant further elucidation on the record.

Indeed, the case of Jason Anderson is a tragic one, and due to the temporal association between Jason's immunization and his death, reasonable minds might conclude that there may have been some association between the vaccination and his death. However, in cases in which a death is claimed to be vaccine-related, the Vaccine Act only compensates those petitioners who are able to prove, by a preponderance, that an individual suffered a Table injury and that his or her death was a sequela of that injury. Without the underlying injury, the death is not compensable. In this case, petitioners were simply unable to prove that Jason suffered an HHE within the meaning of the Vaccine Act before he died. IV.  FINDINGS OF FACT 

1. Petitioners have not previously collected an award or settlement of a civil action in connection with Jason's death due to the administration of the DPT vaccine in question. Section 11(c)(1)(E); Petition at unnumbered p. 4

2. Jason was administered a vaccine listed in the Vaccine Injury Table. Section 11(c)(1)(B)(i)(I); P. Ex. 5 at 2.

3. Said vaccine was administered in the United States, in Spokane, Washington. Section 11(c)(1)(B)(i)(I); P. Ex. 5

4. There is not a preponderance of the evidence that Jason suffered an HHE as defined by the Vaccine Injury Table with onset within 72 hours of the administration of the DPT vaccination on August 30, 1991.
 
  V.  CONCLUSION 

Based on the foregoing, the undersigned finds, after considering the entire record in this case, that petitioners are not entitled to compensation in this case under the Vaccine Act. In the absence of a motion for review filed pursuant to RCFC Appendix J, the clerk of the court is directed to enter judgement in accordance herewith.
 
 

IT IS SO ORDERED.
 
 
 
 

_________________________________

Elizabeth E. Wright

Special Master
 
 
 
 

1. The National Vaccine Injury Compensation Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (codified as amended at 42 U.S.C.A. 300aa-1 through -34 (West 1991 & Supp. 1995)). References shall be to the relevant subsection of 42 U.S.C.A. 300aa.

2. Although the caption in this matter has never been changed, Danyelle R. Carraggio, one of the petitioners herein, now goes by the name of Danyelle Robinson.

3. See Petitioners' August 15, 1994, Notice of Filing (hereafter, "Ricks Dep.").

4. See Petitioners' January 26, 1995, Notice of Filing (hereafter "Stout Dep.").

5. See Petitioners' January 26, 1995, Notice of Filing (hereafter "Donlan Dep.").

6. See Petitioners' January 26, 1995, Notice of Filing (hereafter "Lindholm Dep.").

7. See Petitioners' January 26, 1995, Notice of Filing (hereafter "McConnell Dep.").

8. The evidence in the record consists primarily of exhibits submitted as part of the petition filed in this case ("P. Ex. ____"), respondent's exhibits filed in this matter ("R. Ex. ____"), plus evidence taken at the evidentiary hearing in this matter ("Tr. at ____").

9. A delivery room report indicated that the pregnancy was complicated by a previous cesarean section and an active herpes lesion. P. Ex. 4 at 1.

10. Dr. Donlan testified that he advised Ms. Robinson to give Jason some Tylenol after the vaccination because he may experience fussiness, fever and irritability from the inoculation. P. Ex. 5 at 2; Donlan Dep. at 24, 30.

11. Mrs. Meckle also thought Jason appeared to be somewhat bloated. Tr. at 15, 20, 24.

12. Ms. Stout testified that prior to leaving, she thought Jason seemed a little fussy and listless. Stout Dep. at 13, 65. According to Ms. Stout, Ms. Robinson had informed her that Jason had gotten a DPT shot, so Ms. Stout dismissed Jason's behavior as similar to how her own children had acted after receiving their shots. Stout Dep. at 13.

13. Heather testified that the water bed was firm. Ricks Dep. at 38.

14. While Heather testified she went to check on Jason the last time around 8:30 or 9:00, records indicate a call was made to LifeFleet at 8:07 p.m. P. Ex. 8 at 1.

15. Ricks Dep. at 21-23; P. Ex. 10 at 2. Ms. Robinson testified that while they were out, Ms. Stout called Heather to check on the children and Heather told her that everything was fine. Tr. at 110. According to Ms. Robinson, at about 4:30 or 5:00 p.m., Ms. Robinson telephoned Heather to again check on the children and Heather informed her that Jason had awakened and was eating. Tr. at 80. Ms. Robinson testified that Ms. Stout then called Heather again at 7:30 p.m. but the phone was busy. Tr. at 111. When Ms. Stout tried calling again at 8:00 p.m., according to Ms. Robinson, she discovered something was wrong and they immediately drove to Ms. Stout's house. Tr. at 81, 114. When they arrived, the paramedics were already there. Tr. at 115. The paramedics took Jason to the hospital and Ms. Robinson followed. Jason's father, Mark Anderson, was also at the hospital when Ms. Robinson arrived. Tr. at 90. Tr. at 117. Once at the hospital, Ms. Robinson was informed that Jason was dead. Tr. at 118.

16. Dr. Donlan is board certified in medical genetics and practices pediatric endocrinology as a subspecialty. Donlan Dep. at 9.

17. Dr. Lindholm has practiced forensic anatomic and clinical pathology since 1981 and is a board certified pathologist. Lindholm Dep. at 6-7.

18. Dr. Lindholm cited an article in the Journal of the American Medical Association indicating that studies had failed to show a causal connection between DPT immunizations and SIDS. Id. at 32-33.

19. Dr. McConnell was a general practitioner who was born in 1915 and was the elected county coroner at the time of Jason's death. McConnell Dep. at 4-5.

20. Dr. Geier is certified by the American Board of Medical Genetics and is a specialist in the field of obstetrical genetics. P. Ex. 15 at 1-2.

21. Dr. Geier also noted that Dr. McConnell expressed the view, in his deposition, that there was a strong possibility Jason's death was caused by the DPT vaccination in question. P. Ex. 17 at 9.

22. Dr. Guggenheim is a board certified pediatric neuro- logist. Respondent's June 20, 1996, Notice of filing, Exhibit B.

23. Petitioners must prove their case by a preponderance of the evidence, which requires that the trier of fact "believe that the existence of a fact is more probable than its nonexistence before [the special master] may find in favor of the party who has the burden to persuade the [special master] of the fact's existence." In re Winship, 397 U.S. 358, 372-73 (1970) (Harlan, J., concurring) quoting F. James, Civil Procedure 250-51 (1965). Mere conjecture or speculation will not establish a probability. Snowbank Enter. v. United States, 6 Cl.Ct. 476, 486 (Cl. Ct. 1984).

24. Section 14(a).

25. Section 14(a)(I)(C).

26. 26 Section 13(a)(1)(B). Other prerequisites to compensation include: (1) that the vaccine was administered in the United States. Section 11(c)(1)(B)(i)(I); (2) that the petitioners did not previously collect a judgment or settlement in a prior civil action. Section 11(c)(1)(E); and (3) that the action be brought by the injured person's legal representative. Section 11(b)(1)(A).

27. He also believes the vaccine lot from which Jason's DPT inoculation was taken was a "hot lot."

 
 
  No. 93-438V  (Filed: May 21, 1997 )  _______________ 

DANYELLE R. CARRAGGIO and ) Vaccine; petitioners'
MARK ANDERSON, as parents and ) burden of proof;
next friends of JASON LUCAS ) table injury must
ANDERSON, deceased, ) precede death;
) hypotonic-hyporesponsive
Petitioners, ) collapse (HHC) as table
) injury; death as sequela
v. ) of table injury; SIDS
) as factor unrelated.
SECRETARY OF THE )
DEPARTMENT OF HEALTH )
AND HUMAN SERVICES, )
)
Respondent. )
)

  _______________ 

Ronald C. Homer, Boston, Massachusetts, for the petitioners.

Elizabeth F. Kroop, Washington, D.C., with whom was Assistant Attorney General Frank W. Hunger, for the respondent. _______________  OPINION  

YOCK, Judge.

This case comes before the Court on the petitioners' Motion for Review of Special Master Elizabeth Wright's Decision, Carraggio v. Secretary of the Dep't of Health & Human Servs., No. 93-438V (Fed. Cl. Sp. Mstr. January 31, 1997) (the Decision), which denied the petitioners' claim for compensation under the National Childhood Vaccine Injury Act, 42 U.S.C. 300aa-1-300aa-34 (1994) (the Vaccine Act or Vaccine Program). After thorough consideration of the entire record in this matter, including the parties' respective submissions and the transcript from the hearing before the special master, the petitioners' Motion for Review is denied, and the Decision of the special master is affirmed. Factual Background

Jason Lucas Anderson was born on June 30, 1991. At Jason's fifteen-day check-up, Dr. Michael A. Donlan, Jason's pediatrician, noted that Jason was a "super baby." Petition for Vaccine Compensation (Pet. for V. Comp.), filed July 14, 1993, Ex. 5 at 2. According to Ms. Danyelle Robinson (previously Carraggio), Jason's mother, during the time period immediately prior to his vaccinations, Jason was an active two-month-old baby who could smile, giggle, grab for objects, and grasp fingers. A typical day for Jason consisted of waking at 6:00 a.m., nursing, then falling back to sleep until about 9:00 a.m, when he again would nurse. After the 9:00 a.m. feeding, Jason would "play" until about 10:00 a.m. and then go back to sleep until noon, when he would wake up, nurse, and play. Jason took his afternoon nap around 1:00 or 1:30 p.m. and usually nursed again at 3:00 p.m. and at 6:00 p.m. Jason went to sleep in the evening between 11:00 p.m. and 12:00 midnight and would wake up at around 3:00 a.m. to be fed.

On August 30, 1991, Ms. Robinson took Jason to Dr. Donlan's office for his two-month well-baby check-up. During that check-up, Jason received his first DPT, oral polio, and hemophilus influenza type b (HIB) vaccinations. Ms. Robinson and Jason arrived home from Dr. Donlan's office around 4:30 p.m. According to Ms. Robinson, Jason was "extremely fussy." Tr. at 64. Ms. Robinson carried Jason around in order to comfort him until he fell asleep, but when she would lay him down he would only sleep for about five to ten minutes. Jason did not eat at 6:00 p.m., as he normally would, and did not play that evening but was irritable and cried continuously.

Ms. Robinson planned to go out that evening with a friend, Ms. Tracee Stout, and Mrs. Cleo Meckle, Ms. Robinson's mother, was going to babysit Jason. Ms. Robinson dropped Jason off at her mother's house around 8:30 p.m. and informed her mother that Jason was irritable because of his vaccinations. During the time that Mrs. Meckle babysat, Jason was fussy and it took a great deal of effort to feed him his bottle. According to Mrs. Meckle, Jason was not his usual responsive self, did not coo or smile, and appeared to be swollen or bloated and pale in the upper part of his body. After much coaxing, Jason drank most of his two and a half-ounce bottle. At about 9:45 p.m., Jason fell asleep, and Ms. Robinson picked him up from her mother's house around 2:30 a.m. According to Ms. Robinson, Jason did not awaken when she put his coat on or put him in the car, and he slept in the car during the ride to Ms. Stout's house, where they were going to spend the night. Jason did not wake up for his 3:00 a.m. feeding.

On August 31, the day after his vaccinations, Jason woke up at 6:00 a.m. At that time, Ms. Robinson fed Jason, and he fell asleep until 9:30 or 10:00 a.m. When he woke up, Jason did not want to eat or play like he normally did at this time. For several hours, Jason wanted to be held by Ms. Robinson and would only sleep for periods of five to ten minutes. Jason did not eat again until about 1:00 p.m. and then fell asleep until about 4:30 or 5:00 p.m. During the time period after his DPT vaccination, Jason never exhibited a fever.(1) At 1:30 or 2:00 p.m., Ms. Robinson and Ms. Stout left their six children, including Jason, with the babysitter, Heather Ricks, at Ms. Stout's house. Upon leaving, Ms. Robinson told Ms. Ricks that Jason had been fussy lately, but she did not mention his recent vaccinations.

During the time period that Ms. Ricks was babysitting, Jason was fussy off and on and would only drink a little out of his bottle each time she tried to feed him. After feeding Jason, Ms. Ricks would lay him down to sleep but he would only do so for about ten minutes at a time and then would wake up crying. Jason was responsive to attention given to him and seemed comforted when Ms. Ricks picked him up. According to Ms. Ricks, Jason smiled during the evening. Ms. Ricks testified that Jason did not exhibit any swelling, fever, or trouble breathing, never lost consciousness, and did not appear limp. Around 4:30 or 5:00 p.m., Ms. Robinson telephoned Ms. Ricks to check on the children, and she was informed that Jason was awake and eating. At some time during the evening, Ms. Ricks laid Jason down on a water bed face down on his stomach and placed a pillow on either side of him. Ms. Ricks checked on Jason about every fifteen minutes. At around 8:00 p.m., during one of her routine check-ups of Jason, Ms. Ricks found him in the same position as she had left him earlier. He was not breathing and appeared to be pale and white. Ms. Ricks picked Jason up, felt no pulse, started to perform cardio-pulmonary resuscitation (CPR),(2) and called 911. During the 911 call, Ms. Stout again called to check in and was informed by Ms. Ricks that something was wrong with the baby. Ms. Stout and Ms. Robinson immediately drove to Ms. Stout's house.(3) After the 911 call, the paramedics arrived approximately ten minutes later, attempted CPR, and transported Jason to the hospital where he was pronounced dead.

Jason's death certificate lists sudden infant death syndrome (SIDS) as the cause of death. A coroner's investigative report, dated August 31, 1991, indicates that "[n]o recent illness" was reported and that Jason was found on a water bed. On September 3, 1991, Dr. George R. Lindholm performed an autopsy on Jason. While Dr. Lindholm considered SIDS as the cause of death, he felt "compelled to designate the death as asphyxia due to airway occlusion (laid to rest face down on a waterbed)." Autopsy Report at 1. In addition, Dr. Lindholm found petechiae, i.e., little ruptured blood vessels, on Jason's heart and lungs, which are a sign of asphyxiation. A Vaccine Adverse Event Reporting System (VAERS) report was filed, which reported that "[m]other state[d] baby did not seem to have had any reactions to the childhood immunizations." Pet. for V. Comp. Ex. 7. According to Ms. Robinson, she thought Jason's reactions to the vaccinations were normal because her older son had similar reactions after his DPT vaccination, i.e., he was irritable, sleepy, unresponsive, and not feeding well.

On July 14, 1993, Ms. Robinson and Mr. Mark Anderson, Jason's natural father, filed a petition for compensation in the United States Court of Federal Claims, as parents and next friends of their son, Jason, as a result of his death that the petitioners contend was caused by his DPT vaccination. In the petition, the petitioners alleged that Jason experienced a hypotensive-hyporesponsive episode (HHE), see 42 U.S.C. 300aa-14(b)(1),(4) within the table period established pursuant to the Vaccine Act, and that his death occurred as the proximate and direct result of the DPT vaccination that he received on August 30, 1991. The respondent (the Government or the Secretary of the Department of Health and Human Services) countered that the petitioners have failed to prove that Jason suffered the onset of an HHE or any other on-table injury, within the time periods required by the Vaccine Act, of which their son's death was a sequela. In the alternative, the respondent contends that the petitioners have failed to prove that the DPT was, in fact, the cause of Jason's death.

On April 18, 1996, the special master held an evidentiary hearing on factual issues, at which time Ms. Robinson and her mother, Mrs. Meckle, testified about Jason's changes in behavior prior to and after his August 30, 1991 DPT vaccination. Ms. Stout and Ms. Ricks did not testify at the hearing, but their depositions were taken and filed in this case. In addition, the special master did not receive oral testimony from any medical experts, but depositions and expert reports were obtained from several doctors regarding the circumstances of Jason's death.

On behalf of the petitioners, Mark R. Geier, M.D., Ph.D., filed an expert report in which he concluded that Jason suffered an HHE, and ultimately died, as a result of his DPT vaccination. It was Dr. Geier's opinion that

Jason was observed to have most if not all of the symptoms described in the aids to interpretation of the Vaccine Compensation Act table under hypotensive hyporesponsive episode. These included that he was less responsive to his environment, had prolonged sleeping, was hard to arouse and had a lessened state of consciousness. It also included loss of muscle tone and cardiac and respiratory arrest leading to his death.

Pet. for V. Comp. Ex. 16 at 7. In addition, Dr. Geier noted that Jason's DPT vaccination was from an "exceptionally reactogentic lot of DPT and under CDC's previous designations would have been called a 'hot lot'" because at least fifty adverse reaction reports were filed for that lot. Id. Finally, in Dr. Geier's opinion, there was no "provable alternate cause for Jason's death other than the DPT shot that he received on 8/30/91." Id. at 8. Dr. Geier filed a supplemental affidavit after reviewing the deposition testimony of Ms. Ricks, Ms. Stout, and Drs. Donlan, Lindholm, and Graham S. McConnell, and found that this new information did not change his opinion that the DPT vaccination caused Jason's death.

On behalf of the respondent, Mary Anne Guggenheim, M.D., a pediatric neurologist, filed a report concluding that "Jason Anderson died from SIDS, a tragic and unexpected event of unknown cause, unrelated to his prior immunization other than the temporal association." Report of Dr. Guggenheim at 1. More specifically, Dr. Guggenheim stated that:

As best I can reconcile the testimony of the four adults who were with Jason in the 28 hours preceding his death it appears that he was more fussy than usual, and had deviated from his usual eating/sleeping routine. The latter must be put in the context of his being moved first to his grandmother's house and then to Tracee's house during this time period. The grandmother describes "swelling" and diminished responsiveness ("couldn't get him to smile"; she "just thought he was tired"). No other observers mention any swelling and no evidence of abnormal fluid retention was found on autopsy. None of the four observers describe anything more than an irritable and fussy child who was not on his regular schedule. He was never unconscious. He continued to take feedings. None of the caretakers had concerns that caused them to seek medical help and no special concerns were voiced by the mother when she left him with the baby-sitter. Although Dr. Geier has interpreted the situation as diagnostic of HHE, the descriptions given by the four caretakers are not at all like what has been described in the medial literature about this condition.

The clinical events and autopsy are characteristic of SIDS. It is my opinion that this was indeed the cause of Jason Anderson's death. It occurred approximately 28 hours after he received routine immunizations. Afterwards, he was somewhat fussy but did not manifest behaviors of either HHE or acute encephalopathy. There is no evidence to suggest that either SIDS in general nor Jason's death in particular was caused by the immunizations he received.

Id. at 3-4.

In addition to the expert reports, Drs. Michael A. Donlan, George R. Lindholm, and Graham S. McConnell gave deposition testimony in this case. First, Dr. Donlan, Jason's pediatrician, who is board certified in medical genetics, testified. Dr. Donlan stated that there are normal reactions to a DPT shot, which include fussiness, irritability, a low-grade temperature, eating less, disruptive sleeping patterns, and possible swelling at the injection site. Next, Dr. Donlan stated that the serious reactions to the pertussis portion of the DPT vaccination that he was aware of were a "hyper-responsive state, which is unusual and excessive irritability; a hypo-responsive state where kids kind of act goo-goo eyed and kind of out of it; and children who have a seizure within 72 hours with or without a fever." Dep. of Dr. Donlan at 14. Dr. Donlan signed Jason's death certificate with the cause of death listed as SIDS and believed that the findings surrounding Jason's death were most compatible with SIDS.(5)

Next, Dr. Lindholm, the pathologist who performed the autopsy on Jason, testified. Dr. Lindholm testified that during the autopsy he found "small petechial hemorrhages present, that is, little slender hemorrhages present on the lungs and * * * on the heart," which were consistent with SIDS or other asphyxia. Dep. of Dr. Lindholm at 11. In Dr. Lindholm's opinion, Jason died from asphyxia by smothering on a water bed and "it would be improbable or unlikely that DPT plays a role in this death" because Jason

did not show any evidence of cerebral edema, that is the swollen brain. There was no evidence of hip prominent occlusion or prominent application of cerebellar tonsil to the brain, no indication, if you like, of cerebral edema. There was no cerebral hemorrhages, which one may see an encephalitis type of picture, that is, weepy vessels, which would then see that redness. As well as microscopically there was no evidence whatsoever of what I would call cerebral edema, though that is somewhat subjective the way people read slides on that, the findings that you're looking for.

But there was certainly no evidence of an inflammatory kind of reaction as one might suspect, if I can use the loose term, allergic type of abnormality. I did not see encephalitis.

Id. at 28-29. In addition, Dr. Lindholm stated that "in the absence of any cerebral edema or blood pressure abnormalities, one would be way out on a limb to say that DPT is necessarily involved here." Id. at 29. Next, Dr. Lindholm noted that SIDS is a relatively common occurrence, which usually occurs by coincidence during the same time period that infants are receiving vaccinations. Dr. Lindholm also testified that, while he did not object to leaving Jason's cause of death on his death certificate as SIDS, he later sought to change the cause of death from SIDS to "undetermined" because of Jason's placement on the water bed. Moreover, contrary to Mrs. Meckle's statements, Dr. Lindholm did not note any swelling in Jason's neck or extremities during the autopsy. Finally, Dr. Lindholm testified to a reasonable degree of medical probability that there was no association between the DPT shot and Jason's death.

Finally, the parties took the deposition of Dr. McConnell, the Spokane County Coroner at the time of Jason's death. Ms. Robinson contacted Dr. McConnell numerous times because she wanted to change the cause of death listed on Jason's death certificate from "SIDS" to "undetermined," but Dr. McConnell refused to do so.

On January 31, 1997, the special master issued a decision denying compensation to the petitioners. Specifically, the special master found Dr. Guggenheim's opinion to be more credible than Dr. Geier's opinion and, therefore, held that the facts of this case do not support the petitioners' contention that Jason suffered the onset of an on-table HHE within the seventy-two-hour time period after his DPT vaccination. In addition, the special master relied on two decisions of the United States Court of Appeals for the Federal Circuit, Hellebrand v. Secretary of the Dep't of Health & Human Servs., 999 F.2d 1565 (Fed. Cir. 1993) and Hodges v. Secretary of the Dep't of Health & Human Servs., 9 F.3d 958 (Fed. Cir. 1993), for the proposition that Jason's on-table HHE must be proven to have occurred prior to his death in order for the petitioners to recover for a table injury. The special master found that the petitioners failed to prove, by a preponderance of the evidence, that Jason's death was the sequela of an on-table HHE. On February 28, 1997, the petitioners timely moved for review by the United States Court of Federal Claims. According to the petitioners, the special master's holding that Jason's symptoms of HHE had to precede or to have occurred prior to the agonal event reduced the seventy-two-hour on-table time period afforded to the petitioners under the Vaccine Act and, therefore, was arbitrary, capricious, and an error of law.
 
  Discussion

The Vaccine Act provides that:

[T]he United States Court of Federal Claims shall have jurisdiction to undertake a review of the record of the proceedings [before the special master] and may thereafter--

(A) uphold the findings of fact and conclusions of law of the special master and sustain the special master's decision,

(B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or

(C) remand the petition to the special master for further action in accordance with the court's direction.

42 U.S.C. 300aa-12(e)(2). Thus, the Vaccine Act contemplates three distinct levels of review. "Fact findings are reviewed under the arbitrary and capricious standard. Legal questions are reviewed under the 'not in accordance with law' standard, and discretionary rulings are reviewed under the abuse of discretion standard." Perreira v. Secretary of the Dep't of Health & Human Servs., 27 Fed. Cl. 29, 32 (1992), aff'd, 33 F.3d 1375 (Fed. Cir. 1994); see also Staples v. Secretary of the Dep't of Health & Human Servs., 30 Fed. Cl. 348, 353-54 (1994). The arbitrary and capricious standard is a narrow one. This Court will not overturn a decision of the special master unless there was a clear error of judgment. Johnston v. Secretary of the Dep't of Health & Human Servs., 22 Cl. Ct. 75, 76 (1990).

The Court reviews questions of statutory interpretation de novo. Hossack v. Secretary of the Dep't of Health & Human Servs., 32 Fed. Cl. 769, 773 (1995). Despite this Court's de novo review, "[w]hen examining issues of law in vaccine cases, 'recognition is to be given to the special master's expertise in the development of these novel procedures. A decision on issues of law should be overturned only when error is unmistakenly clear.'" O'Connor v. Secretary of the Dep't of Health & Human Servs., 24 Cl. Ct. 428, 429 (1991) (quoting Munn v. Secretary of the Dep't of Health & Human Servs., 21 Cl. Ct. 345, 348 (1990)), aff'd, 975 F.2d 868 (Fed. Cir. 1992); see also Johnson v. Secretary of the Dep't of Health & Human Servs., 33 Fed. Cl. 712, 720 (1995), aff'd, 99 F.3d 1160 (Fed. Cir. 1996); Song v. Secretary of the Dep't of Health & Human Servs., 31 Fed. Cl. 61, 67, aff'd, 41 F.3d 1520 (Fed. Cir. 1994). Therefore, this Court will overturn the special master's Decision only if the petitioners can demonstrate that there was clear error in the Decision.

In their motion for review, the petitioners submit the following objection to the special master's Decision:

The Special Master ruled that Jason's symptoms of HHE had to "precede" or "have occurred prior" to the "agonal event." In so doing, the Special Master has dramatically reduced the 72 hour Table time period afforded to petitioners to exhibit symptoms ( 300aa-14). To do so was arbitrary and an abuse of discretion under 300aa-12(e)(2)(B). It was an error of law under 300aa-12(e)(2)(A).

Pets.' Mot. for Rev. at 7. According to the petitioners, the facts relevant to this case and the applicable case law establish, by a preponderance of the evidence, that Jason suffered an HHE and that his death was a sequela of that HHE. Moreover, the petitioners contend that the respondent has not rebutted the petitioners' evidence because SIDS is not a factor unrelated to the administration of the vaccine. The central issue surrounding the petitioners' objection is whether or not the special master properly applied section 300aa-14 regarding the determination of an on-table HHE.

According to the Vaccine Act:

(1) Compensation shall be awarded under the Program to a petitioner if the special master or court finds on the record as a whole--

(A) that the petitioner has demonstrated by a preponderance of the evidence the matters required in the petition by section 300aa-11(c)(1) of this title, and

(B) that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition.

The special master or court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.

42 U.S.C. 300aa-13(a)(1). Thus, a petitioner must show, by a preponderance of the evidence, either that a table injury was sustained or that the vaccine, in fact, caused the injury. 42 U.S.C. 300aa-11(c)(1).

To demonstrate a table injury, a petitioner must show that the individual who was given the vaccination suffered an injury listed on the table within the table's prescribed time periods. 42 U.S.C. 300aa-14. Thus, if a petitioner can show, by a preponderance of the evidence, that a table injury was sustained within the required time period, then there is a presumption that the petitioner is entitled to compensation, unless the respondent can show, by a preponderance of the evidence, that the injury was caused by factors unrelated to the administration of the vaccine.
 
 

A. HHE.

In order for the petitioners to recover for Jason's death based on the onset of an HHE, they are required to establish, by a preponderance of the evidence, that: (1) within seventy-two hours of receiving his DPT vaccination, Jason suffered the onset of HHE, see 42 U.S.C. 300aa-14(a)(I)(C); and (2) Jason's death was a sequela(6) of the HHE, see 42 U.S.C. 300aa-14(a)(I)(E). The Federal Circuit stated these requirements as follows:

In the case of a Table claim based upon death following a DTP vaccination, Congress has made its intent very clear. In order for a petitioner to recover for a death which follows a DTP vaccination, based on a Table claim, two things must be established by a preponderance of the evidence. First, the petitioner must show that one of the four injuries or conditions listed in the Table occurred within the time period specified in the Table for that injury or condition. Second, the petitioner must show that death occurred as a sequela of that injury or condition. That these two requirements must be met is demonstrated by the way in which the part of the Table which covers DTP vaccinations is structured. * * * [T]he Table first lists, in paragraphs A through D, four injuries or conditions and for each such injury or condition, a time period for first onset or manifestation of such injury or condition. See 42 U.S.C. 300aa-14(a)I. Then, the Table establishes in paragraph E that there also may be recovery under the Program for "[a]ny acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed." Id. The arrangement of the words in paragraph E renders the meaning of the paragraph clear. Recovery for a death following a DTP vaccination based on a Table claim is conditioned upon the death being a sequela of an illness or condition listed in paragraph A, B, C, or D "which arose within the time period prescribed" in the Table for that illness or condition.

Hellebrand, 999 F.2d at 1569-70. Therefore, for the purposes of the present action, a finding that Jason's death was the sequela of the onset of the on-table HHE must occur after a petitioner has proven, by a preponderance of the evidence, that there was an on-table injury. Frank v. Secretary of the Dep't of Health & Human Servs., 34 Fed. Cl. 29, 37-38 (1995); Abbott, 27 Fed. Cl. at 793; Allen v. Secretary of the Dep't of Health & Human Servs., 24 Cl. Ct. 295, 296 (1991).

In their Motion for Review, the petitioners contend that they proved, by a preponderance of the evidence, that Jason suffered an HHE within the statutory time period. According to the petitioners, the symptoms relied on by the special master-- fussiness, eating less, responsive to being picked up, and smiling--in denying compensation were not the bases for their petition. In other words, the petitioners did not claim that Jason experienced an on-table HHE prior to Ms. Ricks finding him unconscious on the water bed. Instead, the petitioners argue in their petition that they relied on those symptoms exhibited by Jason after he was found by Ms. Ricks on the water bed. See Pets.' Mot. for Rev. at 8. This Court agrees that the petitioners do not contend that Jason experienced an on-table HHE prior to Ms. Ricks finding him on the water bed, and, as this Court finds for the purpose of proving, by a preponderance of the evidence, an on-table injury within the table period, Jason could not and did not experience an on-table HHE before Ms. Ricks found him unconscious on the water bed. In addition, this Court finds that the petitioners did not prove, by a preponderance of the evidence, that Jason suffered an HHE after he was found unconscious on the water bed.

The Vaccine Act describes an HHE as follows:

A shock-collapse or a hypotonic-hyporesponsive collapse may be evidenced by indicia of symptoms such as decrease or loss of muscle tone, paralysis (partial or complete), hemiplegia or hemiparesis, loss of color or turning pale white or blue, unresponsiveness to environmental stimuli, depression of consciousness, loss of consciousness, prolonged sleeping with difficulty arousing, or cardiovascular or respiratory arrest.

42 U.S.C. 300aa-14(b)(1). In addition, in the respondent's expert report, Dr. Guggenheim outlined what is usually present during an HHE:

A hypotonic hyporesponsive episode (HHE) in an infant (also sometimes called shock-collapse) is a dramatic event characterized by lack of responsiveness (to the point of an unconscious state), pallor, hypotonia,(7) and, often, fever. It usually occurs within 12 hours after an immunization. No such event is described in the mother's testimony.

Report of Dr. Guggenheim at 2.(8)

Moreover, several decisions of this Court describe the symptoms present during an HHE. See Hossack, 32 Fed. Cl. at 771 (affirming special master's finding of an on-table HHE where child was lethargic, limp, and lacked interest in food or attention after DPT vaccination); Zinko v. Secretary of the Dep't of Health & Human Servs., 24 Cl. Ct. 430, 431 (1991) (affirming special master's finding of an on-table HHE where child was limp and lifeless, had a dazed appearance, failed to recognize family members or surroundings, was lethargic, slept for four to eight hours at a time, and was not easily aroused when awakened for feedings); Allen, 24 Cl. Ct. at 296 (affirming special master's finding of an on-table HHE due to child's fever, unusual sleep patterns, unresponsiveness, and lack of muscle tone after DPT vaccination); Morris v. Secretary of the Dep't of Health & Human Servs., 20 Cl. Ct. 14, 18-19 (1990) (affirming special master's finding of an on-table HHE where child who was previously administered DPT vaccination was pale, very drowsy, and could not be aroused); Bell v. Secretary of the Dep't of Health & Human Servs., 18 Cl. Ct. 751, 757 (1989) (affirming special master's finding of an on-table HHE where child had a depression of consciousness, refused to eat, was listless and limp, and unresponsive to stimuli after DPT vaccination); Rochester v. United States, 18 Cl. Ct. 379, 385 (1989) (affirming special master's finding of an on-table HHE where child had loss of muscle tone, was unresponsive to environment, lost skin color and appeared pale, and autopsy found evidence of pulmonary edema and congestion after DPT vaccination).

In this case, the evidence demonstrates that after his vaccination, Jason was fussy but appeared to calm down when he was picked up, lacked interest in food but eventually ate, only slept for five to ten minutes at a time, and smiled at least once when he was left with the babysitter, Ms. Ricks. While this Court has found, on at least two occasions, an on-table HHE based, in part, on the child's lack of interest in food or refusal to eat, see Hossack, 32 Fed. Cl. at 771; Bell, 18 Cl. Ct. at 757, the petitioner places too much weight on that individual symptom. The fact that Jason may have exhibited one or more of the symptoms of an HHE does not demonstrate that Jason experienced an on-table HHE by a preponderance of the evidence. See Raspberry v. Secretary of the Dep't of Health & Human Servs., 33 Fed. Cl. 420, 423 (1995).

There are no other symptoms described in the Vaccine Act or the case law that are the same as, or similar to, those symptoms exhibited by Jason after his vaccination. Specifically, during August 30 and 31, Jason was not unresponsive to environmental stimuli. To the contrary, he responded almost immediately when he was picked up by his mother or Ms. Ricks and stopped crying or fussing. In addition, there is no evidence that Jason lost muscle tone or appeared limp during the time period at issue. Also, Jason never exhibited a fever. Moreover, Jason was not lethargic, did not sleep for long periods of time, and was never to the point of being unconscious.(9) To the contrary, Jason only slept for periods of five to ten minutes at a time. Finally, Jason did not appear to be pale or blue.(10) Despite testimony of Mrs. Meckle that Jason had appeared to be bloated during the evening after his vaccinations, contemporaneous medical records do not indicate any such symptoms. See Grant v. Secretary of the Dep't of Health & Human Servs., 956 F.2d 1144, 1147 (Fed. Cir. 1992). Based on the evidence, or the lack thereof, of HHE symptoms, this Court finds that the special master's decision that Jason did not suffer the onset of an HHE after his DPT vaccination and before he was found unconscious on the water bed was not arbitrary, capricious, or an error of law. See id.; Raspberry, 33 Fed. Cl. at 423.

Next, in their Motion for Review, the petitioners contend that the special master erroneously ruled that Jason's onset of HHE had to precede the agonal event (i.e., his death). According to the petitioners, this was an error because it reduced the seventy-two-hour time period available to the petitioners to establish an on-table HHE under the Act. The respondent contends in response that the petitioners misunderstand the law, which, in fact, does require that the onset of a table injury, including HHE, precede death. As set forth below, this Court rejects the petitioners' argument.

A petitioner must prove, by a preponderance of the evidence, that death was the sequela of the HHE. To meet this burden,

a petitioner must show that a sequela is caused by a Table injury. This Court finds, along the lines of Song[, 31 Fed. Cl. at 65] and Allen[, 24 Cl. Ct. at 295], that a preponderance of the evidence must show that some logical, direct causal link exists between the presumed Table injury and the alleged sequela. This is not a difficult burden and requires less than medical certainty. Yet, * * * [a petitioner] must present some evidence, such as expert testimony, fact testimony, or documentation, to convince the special master that, more likely than not, * * * death was connected to the HHE/shock collapse * * *.

Hossack, 32 Fed. Cl. at 776.

This Court agrees with the respondent that, in order for the petitioners to recover, Jason's on-table HHE must have preceded his death. Recently, the Federal Circuit articulated the controlling rule for determining when death is the sequela of an on-table HHE and, thus, compensable under the Vaccine Act:

Clearly an HHC or death following HHC is compensable * * *. * * *

Thus, death alone is not compensable if a table injury has not been established, regardless of the interval between vaccination and death. Symptoms which are consistent with HHC but are also part of death do not on these facts establish an HHC that is a table injury.

Hodges, 9 F.3d at 960 (emphasis added).

In contending that Jason suffered the onset of an HHE before his death and then died, both of which the petitioners contend were caused by the DPT vaccination, the petitioners rely on Dr. Geier's opinion that during the paramedics' attempts to resuscitate Jason, Jason was not yet dead and was, at that time, experiencing on-table HHE symptoms, which were compensable because they occurred before death. According to Dr. Geier, Jason

probably did have a ventricular fibrillation electrical pattern from his heart during resuscitation attempts. This means that this child was not dead at the time during which resuscitation was being attempted. Therefore, during this time period it is indisputable that this child had various symptoms that fit Vaccine Compensation Act under the heading of HHE including loss of consciousness, turning pale or blue, lessening of awareness of the environment, etc. My understanding is that a child whose [sic] is undergoing resuscitation and has ventricular fibrillation is not legally dead until the team stops the resuscitation, and until he is pronounced dead. Therefore, I think that virtually all of the signs and symptoms described under the Vaccine Compensation Table, clearly were observed in this child when he was not dead.

Supp. Aff. of Dr. Geier at 9-10 (emphasis added).

However, the special master rejected Dr. Geier's opinion and found Dr. Guggenheim's opinion more credible. The special master has broad discretion in determining the credibility of the expert witnesses whose testimony was taken. Bradley v. Secretary of the Dep't of Health & Human Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993); Hellenbrand-Sztaba v. Secretary of the Dep't of Health & Human Servs., 35 Fed. Cl. 222, 224-25 (1996), aff'd, 106 F.3d 426 (Fed. Cir. 1997); Raspberry, 33 Fed. Cl. at 423. Because the special master considered the facts and circumstances surrounding the witnesses' testimony and opinions, this Court cannot find that the rejection of Dr. Geier's opinion, as to the cause of Jason's death, was arbitrary and capricious. See id.

Even if this Court could disregard the special master's credibility determinations, the Court finds that the petitioners' argument does not meet the standard for finding the sequela of an on-table injury as set forth in Hodges. According to Dr. Geier, during the time that the paramedics were attempting to resuscitate Jason, he had several of the symptoms associated with HHE, including "loss of consciousness, turning pale or blue, lessening of awareness of the environment, etc." Supp. Aff. of Dr. Geier at 9.(11) Based on Dr. Geier's opinion regarding Jason's symptoms, the petitioners argue that Jason's HHE is compensable simply because the symptoms occurred prior to his death. Pets.' Mot. for Rev. at 9-10. However, that is not the test. Contrary to the petitioners' contention, it is "relevant when Jason exhibited the HHE symptoms." Id. at 10. HHE symptoms that occur as part of the dying process do not constitute symptoms of an on-table HHE under the Vaccine Act. See Hodges, 9 F.3d at 960. While this Court agrees that Jason's symptoms are consistent with HHE, as it is defined in section 300aa-14(b)(1), under the facts of this case they were also a part of the dying process at the time that the paramedics were attempting, unsuccessfully, to revive him. Jason's HHE symptoms do not independently establish an on-table HHE that resulted in his death. See Hodges, 9 F.3d at 960; Hellebrand, 999 F.2d at 1570-71. As a result, the petitioners did not prove, by a preponderance of the evidence, that Jason experienced an on-table HHE (independent of death) as a result of the DPT vaccination and that his death was caused by, or connected to, the HHE. See id. Therefore, the special master's application of the Vaccine Act and Hodges to the present facts was not arbitrary, capricious, or an error of law.

B. Factors Unrelated to the Administration of the Vaccine.

Finally, in their Motion for Review, the petitioners contend that the respondent has offered no evidence that Jason's death was caused by factors unrelated to the administration of the August 30, 1991 DPT vaccine because SIDS is not a determined or determinable cause of death. In response, the respondent counters that the burden of proof to demonstrate an unrelated factor did not shift to it because the petitioners failed to meet their initial burden that Jason suffered a table injury.

After a petitioner has met its prima facie case of an on-table injury under the Act, the Government can rebut that presumption of a vaccine-related injury by demonstrating, by a preponderance of the evidence, that the illness, disability, injury, condition, or death was caused by factors unrelated to the administration of the vaccine. 42 U.S.C. 300aa-13(a)(1)(B); see also Cucuras v. Secretary of the Dep't of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993) (finding that burden shifts to the respondent to demonstrate an alternative cause only after the presumption of a vaccine-related injury is proven by the petitioner); Bradley, 991 F.2d at 1575 (finding that section 300aa-13(a)(1)(B) does not apply until a petitioner has demonstrated a table injury by a preponderance of the evidence).

Moreover:

(2) For purposes of paragraph (1), the term "factors unrelated to the administration of the vaccine"--

(A) does not include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition, and

(B) may, as documented by the petitioner's evidence or other material in the record, include infection, toxins, trauma (including birth trauma and related anoxia), or metabolic disturbances which have no known relation to the vaccine involved, but which in the particular case are shown to have been the agent or agents principally responsible for causing the petitioner's illness, disability, injury, condition, or death.

42 U.S.C. 300aa-13(a)(2).

SIDS is the "sudden and unexpected death of an apparently healthy infant, typically occurring between the ages of three and five months and not explained by careful post-mortem studies." Hellebrand, 999 F.2d at 1566 n.2 (quoting Dorland's Illustrated Medical Dictionary 1644-45 (27th ed. 1988)). This Court has found that SIDS cannot be a factor unrelated to the administration of the vaccine for the purpose of rebutting a petitioner's prima facie case of an on-table injury because SIDS, by definition, is the absence of an identifiable cause of death and, therefore, is an idiopathic or unexplained cause under section 300aa-13(a)(2)(A) of the Vaccine Act. See Hossack, 32 Fed. Cl. at 771 n.4; Morris, 20 Cl. Ct. at 22 n.7; Monteverdi v. Secretary of the Dep't of Health & Human Servs., 19 Cl. Ct. 409, 413 (1990); Greene v. Secretary of the Dep't of Health & Human Servs., 19 Cl. Ct. 57, 63 (1989); Bell, 18 Cl. Ct. at 759 n.11 (1989). Therefore, this Court is prohibited from denying compensation to the petitioners on the basis that SIDS was an alternative cause to Jason's injuries and death. See Rochester, 18 Cl. Ct. at 386.

However, sections 300aa-13(a)(1)(B) and 300aa-13(a)(2)(A) do not apply in this case because, as the special master and this Court found, the petitioners have failed to prove that Jason suffered an on-table HHE by a preponderance of the evidence. See Hellenbrand-Sztaba, 35 Fed. Cl. at 225; Frank, 34 Fed. Cl. at 38. The burden of proving that Jason's injuries and death were the result of factors unrelated to the administration of the vaccine never shifted to the respondent. Therefore, the petitioners' argument that the respondent failed to prove that Jason's death was caused by factors unrelated to the DPT vaccination is without merit. CONCLUSION

For the foregoing reasons, this Court denies the petitioners' Motion for Review and affirms the January 31, 1997 Decision of the special master. The clerk of the Court is directed to enter judgment accordingly.

Each party is to bear its own costs.

1. Ms. Stout stated that Jason was a little fussy during the day but did not seem swollen or bloated.

2. Jason did not respond to Ms. Ricks' attempts to revive him.

3. Upon arriving home, Ms. Stout saw Jason being attended to by the paramedics. According to Ms. Stout, Jason looker puffier than normal and there was a darker coloration around his chest.

4. HHE, hypotonic-hyporesponsive collapse (HHC), and shock collapse are used synonymously under the Vaccine Act.

5. In a letter to Ms. Robinson on October 30, 1991, after Jason's death, Dr. Donlan expressed his opinion that there was no relationship between the water bed and Jason's death.

6. A sequela is "'any lesion or affection following or caused by an attack of disease,' Dorland's Illustrated Medical Dictionary 1509 (27th ed. 1988), or a 'condition following as a consequence of a disease,' Stedman's Medical Dictionary 1407 (25th ed. 1990)." Hossack, 32 Fed. Cl. at 774; see also Abbott v. Secretary of the Dep't of Health & Human Servs., 27 Fed. Cl. 792, 794 (1993), aff'd in part, rev'd in part, 19 F.3d 39 (Fed. Cir. 1994). In addition, sequela has been defined as "[a]ny abnormal condition which follows a disease and is the result of it." 4 Schmidt's Attorney's Dictionary of Medicine S-86 (1995).

7. Hypotonia has been described as "[a] condition in which there is a diminution or loss of muscular tonicity, in consequence of which the muscles may be stretched beyond their normal limits." Stedman's Medical Dictionary 755 (25th ed. 1990).

8. The petitioners contend that the special master erroneously credited "Dr. Guggenheim's opinion that HHE's occur within 12 hours." Pets.' Mot. for Rev. at 12. This Court agrees with the respondent that the petitioners' contention is unsupported by the record. The special master simply credited Dr. Guggenheim's opinion over Dr. Geier's opinion regarding the finding of an on-table HHE and that Jason did not experience an on-table HHE within the seventy-two-hour time period. See Dec. at 11, 13. There is no evidence that the special master applied a time period other than that set forth in the Vaccine Act.

Moreover, the petitioners contend that Dr. Guggenheim agrees with Dr. Geier that Jason experienced HHE symptoms while he was alive. This Court rejects that contention, however, as clearly contrary to Dr. Guggenheim's opinions in her written report. See Report of Dr. Guggenheim at 3-4.

9. Of course, this Court does agree that the facts show that Jason was unconscious when Ms. Ricks found him on the water bed not breathing. However, as established, infra at 22-24, Hodges, 9 F.3d at 960, prevents the finding of an on-table HHE based on symptoms that are a part of the dying process.

10. Ms. Ricks testified that Jason appeared to be pale and white when she found him unconscious on the water bed. However, see supra, note 9.

11. In their Motion for Review, the petitioners contend that the special master ignored Jason's symptoms after he was found unconscious on the water bed and "swept aside these symptoms as irrelevant," which was an error of law. See Pets.' Mot. for Rev. at 11. This Court, however, finds that the special master specifically addressed these symptoms and Dr. Geier's opinion relating to them. The special master rejected Dr. Geier's opinion that Jason was alive when resuscitation attempts were being made and correctly found that, under Hodges, 9 F.3d at 960, Jason's HHE symptoms could not independently establish an on-table HHE prior to his death because they occurred during the dying process. See Dec. at 10.