Steve Leshner wins $250,000 Award in Vaccine Court Claim Stephen I. Leshner PC Attorneys Phoenix Arizona

Steve Leshner wins $250,000 Award in Vaccine Court Claim

Posted by: Stephen Leshner
October 26, 2010
Topic: NATIONAL VACCINE INJURY COMPENSATION PROGRAM

In a published decision by the U.S. Court of Federal Claims, Special Masters Division, Phoenix, Arizona attorney Stephen I. Leshner won a $250,000.00 verdict on behalf of a Phoenix couple whose infant son died after receiving a DTaP vaccination. At the time of the vaccination, the infant was 4 months old. He was born prematurely, was blind, hydrocephalic, on a feeding tube, and living in a skilled nursing facility when he was administered a series of well-baby vaccinations, including DTaP. Steve Leshner was able to prove that the DTaP vaccination caused the infant’s death. The Special Master awarded the parents $250,000.00, which is the maximum general damage award available in that Court. The full decision is attached below:

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 09-284V

September 30, 2010

To be Published

* * * * * * * * * * * * * * * * * * * * * * * * * * * * *

MARQIANO JAMES, deceased, by and through *

his natural mother, COLLEEN CHEE, and his *

natural father, MARCO JAMES, *

Petitioners, * DTaP; incomplete brain

* more vulnerable to apnea;

v. * cardiac arrest; death

SECRETARY OF THE DEPARTMENT OF *

HEALTH AND HUMAN SERVICES, *

Respondent. *

* * * * * * * * * * * * * * * * * * * * * * * * * * * * *

Stephen I. Leshner, Phoenix, AZ, for petitioners.

Heather L. Pearlman, Washington, DC, for respondent.

MILLMAN, Special Master

DECISION1

Petitioners filed a petition on May 5, 2009 under the National Childhood Vaccine Injury

Act, 42 U.S.C. § 300aa-10 et seq., alleging that their son Marqiano James (hereinafter,

1 Vaccine Rule 18(b) states that all decisions of the special masters will be made

available to the public unless they contain trade secrets or commercial or financial information

that is privileged and confidential, or medical or similar information whose disclosure would

constitute a clearly unwarranted invasion of privacy. When such (a decision or designated

substantive order) is filed, petitioner has 14 days to identify and move to delete such information

prior to the document’s disclosure. If the special master, upon review, agrees that the identified

material fits within the banned categories listed above, the special master shall delete such

material from public access.

Marqiano) died on December 12, 2007 as a result of the vaccinations administered to him on

December 11, 2007, in particular the pertussis component of DTaP.

The disagreement between the parties concerns whether Marqiano, born prematurely and

without a neocortex, died from apnea and cardiac arrest because he had a vaccine reaction or

because he was medically fragile from birth. There was no autopsy in this case.

A hearing was held on July 21, 2010. Testifying for petitioners were Marqiano’s mother

and petitioners’ expert Dr. Steven Pike. Testifying for respondent was Dr. Mary Ann

Guggenheim.

FACTS

On August 12, 2007, Marqiano was born at 34 weeks gestation by caesarean section at

Maricopa Medical Center (MMC). CHEE/MMC 101.2 Dr. Kim H. Manwaring recommended

early delivery because Marqiano had severe fetal hydrocephalus3 and hydronephrosis.4 Id. at

101, 339-40. At birth, Marqiano had major brain malformation with massive head enlargement

due to the severe hydrocephalus, dysmorphic facial features, hypogonadism, and cystic

enlargement of a kidney. Id. at 909, 918, 920.

2 Petitioners’ method of pagination includes initials of providers. For example,

Maricopa Medical Center records are paginated as MMC and the number of the page. Phoenix

Indian Medical Center records are paginated as PIMC and the number of the page. Hacienda

Healthcare records are paginated as HH and the number of the page. Sometimes these

abbreviations are preceded by CHEE, the last name of Marqiano’s mother.

3 Hydrocephalus is “a condition marked by dilatation of the cerebral ventricles, most

often occurring secondarily to obstruction of the cerebrospinal fluid pathways...and accompanied

by an accumulation of cerebrospinal fluid within the skull.” Dorland’s Illustrated Medical

Dictionary, 30th ed. (2003) at 870.

4 Hydronephrosis is distention of the pelvis and calices of the kidney with urine, as a

result of obstruction of the ureter.” Dorland’s, supra note 3, at 872.

Dr. Manwaring operated on Marqiano to place an external ventricular drain for the

temporary remediation of his hydrocephalus. MMC 1181. Marqiano was diagnosed with

aqueduct stenosis. Id. at 573. On August 19, 2007, Dr. Manwaring removed the external

ventricular drain and implanted a left frontal lobe pressure ventriculoperitoneal shunt. MMC

1183. The diagnosis was severe near end-stage hydrocephalus, congenital, secondary to

aqueductal stenosis. Id.

On August 21, 2007, a brain MRI showed Marqiano had marked hydrocephalus

involving the lateral ventricles and the third ventricle. MMC 707. The study suggested stable,

marked hydrocephalus, lobar holoprosencephaly5 with septo-optic dysplasia,6 and a kinking of

the cervicomedullary junction, likely related to Marqiano’s abnormal brain anatomy. Id. at 708.

Marqiano had difficulty feeding and also reflux. Therefore, on September 7, 2007, a

gastrostomy tube was placed in him to provide nutrition. MMC 813, 827, 830, 833, 901, 1185.

On September 26, 2007, Marqiano was evaluated at the Phoenix Indian Medical Center

(PIMC) where he received his first series of vaccinations: DTaP, inactivated polio, HiB

(haemophilus B influenza), hepatitis B, and pneumococcal vaccines. PIMC 006.

On October 4, 2007, certified nurse practitioner Kathleen Klas discuss with Marqiano’s

family his very grim prognosis because of severe damage to his brain tissue due to

hydrocephalus. MMC 526. Marqiano’s family stated they wanted Marqiano to receive

5 Holoprosencephaly is a “failure of cleavage of the prosencephalon with a deficit in

midline facial development.” Dorland’s, supra note 3, at 859. The prosencephalon is “the part

of the brain developed from the anterior of the three primary vesicles of the embryonic neural

tube; it comprises the diencephalon and telencephalon..... Called also forebrain.” Id. at 1520.

6 Dysplasia is “abnormality of development.” Dorland’s, supra note 3, at 577.

everything that could be done for him. Id. Marqiano’s gastrostomy button was leaking. Id. at

527.

Marqiano was frequently evaluated at PIMC for failure to thrive and his leaking

gastrostomy tube. PIMC 11-17. On October 27, 2007, he was taken to the MMC emergency

room after he turned blue from coughing and vomiting while receiving a tube feeding. MMC

306. He had not gained weight for a month. Id. at 314. Admitted to the hospital, Marqiano had

multiple episodes of vomiting, apnea, hypoxia, and bradycardia. Id. at 323-45. He was

discharged from the hospital on November 5, 2007 with a diagnosis of aspiration pneumonia,

multiple congenital anomalies, holoprosencepahly, gastric tube dependence, hydrocephalus, and

blindness. MMC 308.

The next day, November 6, 2007, Marqiano was admitted to MMC because of his

continuing gastrostomy tube leakage. MMC 171. The tube was replaced twice while he was

hospitalized. Id. at 168. He was discharged on November 13, 2007. Id. at 169.

On November 17, 2007, Marqiano returned to the MMC emergency room because of the

leaking gastrostomy tube and an intermittent fever. MMC 37. A replacement tube was on order

and not yet available. Id. Therefore, Marqiano was discharged to the Hacienda Medical

Facility, which is a skilled nursing facility, to await the new gastrostomy tube delivery. MMC

37. Hacienda evaluated him as having a good discharge potential but a bad rehabilitation

potential and prognosis. Id. at 52-53.

On December 11, 2007, Dr. Tom Herr evaluated Mariqano during a general pediatric

visit. HH 245. Marqiano received his second series of vaccinations: DTaP, hepatitis B, and

inactivated polio combined as Pediarix, HiB, Prevnar, RotaTeq, and Synagis (respiratory

syncytial virus) vaccines. Id. (Synagis is not on the Vaccine Injury Table.)

On December 12, 2007, Marqiano died in his sleep in the Hacienda Medical Facility.

The nurse’s entry at midnight reflects that a report from the night nurse at 10:00 p.m. was that

Marqiano was stable, asleep in his crib, without signs of distress. HH 78. At the 3:10 a.m.

nurse’s check-up, he was gray. Id. At 3:15 a.m., the nurse got a respiratory therapist who

detected that Marqiano had no pulse and was not breathing. Id. at 77. Paramedics arrived at

3:25 a.m. Marqiano was pronounced dead at Maricopa Medical Center at 4:21 a.m. Id. The

death certificate listed the cause of death as cardiopulmonary arrest due to or as a consequence of

aspiration due to or as a consequence of congenital brain malformation. Ex. 1, p. 1.

TESTIMONY

Marqiano’s Mother

Marqiano’s mother testified first for petitioners. Tr. at 4. Marqiano was born

prematurely and had hydrocephalus. Tr. at 5-6. Marqiano was placed at Hacienda Skilled

Nursing because his gastrotube was leaking. Tr. at 6. Marqiano responded to her when she

spoke to him by opening his eyes and smiling. Tr. at 7. She took Marqiano to see Dr. Sipperly,

a retinal consultant, on the day of his vaccinations because Marqiano could not see. Tr. at 7-8.

She also took him to Dr. Herr at the Phoenix Indian Medical Center for Marqiano’s four-month

well baby check-up. Tr. at 8-9. Marqiano had no sign of illness. Tr. at 9. Marqiano received

his immunizations. Id. She took Marqiano back to Hacienda at 4:30 p.m. Id.

At 3:30 a.m. the next morning, one of the nurses from Hacienda called her and told her

they had found Marqiano unresponsive and CPR was being done. Tr. at 10. She went to

Maricopa Medical Center where she was informed that Marqiano died, but no one gave her a

cause of death. Tr. at 11.

Petitioners’ Expert Dr. Pike

Dr. Steven Pike testified next for petitioners. Tr. at 12. He is board-certified in

toxicology, emergency medicine, occupational and environmental medicine, and industrial

hygiene. Tr. at 13. He practices emergency medicine and medical toxicology primarily. Id. Dr.

Pike’s opinion is that Pediarix (which Marqiano received) contains acellular pertussis

components that can cause acute and chronic persistent and severe neurological dysfunction.

This view is consistent with the medical literature and with the Institute of Medicine (IOM)

opinions on DPT vaccine. Tr. at 14.

Dr. Pike continued that Pediarix can also cause post-immunization apnea,

cardiopulmonary arrest, and death (mentioned in the manufacturer’s product insert). Tr. at 15.

Dr. Pike opined that Marqiano’s post-immunization apnea, cardiorespiratory arrest, and death

were the kind of consequences that Pediarix or DTaP can cause in premature infants. Id. His

opinion is that Pediarix was more likely than not the proximate cause of Marqiano’s apnea,

cardiorespiratory arrest, and death. Id.

In explaining the mechanism of pertussis vaccine injury, Dr. Pike testified that the most

serious component is pertussis toxin itself even though, in the acellular formulation, there is an

attempt to neutralize its toxicity. Tr. at 16. The mechanisms to neutralize pertussis toxin’s

toxicity are imperfect and some residual toxicity can exist. There are also idiosyncratic reactions

that can occur in individuals. Id.

Pertussis toxin can increase the permeability of the blood-brain barrier, allowing fluid

and material to enter the brain, stimulating T-cells which can release certain types of proteins

called cytokines that can attract other forms of inflammatory cells. Id. The activated T-cells and

inflammatory cells can produce swelling and edema around the nerve cells and glial cells,

producing numerous clinical effects: encephalopathy, seizure activity, anaphylaxis, or sudden

apnea. Tr. at 17. Apnea in premature infants such as Marqiano can lead to death and Dr. Pike

believes this is what happened to Marqiano. Tr. at 17-18.

Dr. Pike believes Marqiano’s death certificate is incorrect in listing aspiration as a cause

of his death. The death certificate is correct in listing cardiopulmonary arrest. Tr. at 20. The

reason he believes there was no aspiration is that the Hacienda nurses were monitoring Marqiano

and did not report him to have any evidence of vomiting when they discovered him to be apneic.

Id. There was no vomit reported in his mouth, on the crib, or in his vicinity. Id.

When the paramedics arrived, they did not report any evidence of vomiting or aspiration.

This would be routine and very important information for paramedics to give emergency

physicians. Tr. at 20-21. Dr. Pike has experience as an emergency physician. The paramedics

will almost always inform him if there is any evidence of vomiting or aspiration because they

know the importance of starting certain types of antibiotics early and the possible need for

bronchoscopy to remove foreign material from the bronchus to the main stem or branching

bronchi. Tr. at 21. When the paramedics intubated Marqiano, they did not report that they had

to suction his oral pharynx, providing further proof that Marqiano had not aspirated. Id. They

had no problem inserting the endotracheal tube other than Marqiano’s congenital facial

deformities. Id. Furthermore, after intubation, the paramedics did not report that any vomit

came out of the endotracheal tube. Typically, after an endotracheal intubation, if a person has

aspirated, vomit would come through the tube and have to be suctioned out. But this was not

observed with Marqiano. Tr. at 21-22.

Moreover, the paramedics reported hearing good breath sounds with their ventilatory

efforts through the endotracheal tube. In the emergency department, there was no report of any

gurgling or rhonchi (loud sounds occurring when there is a lot of phlegm). Tr. at 22. The

emergency physician at Maricopa Medical did report cardiorespiratory failure. His second

diagnosis was holoprosencephaly. Tr. at 22. Holoprosencephaly is a combination of Marqiano’s

lack of formation of the cortex of his brain, his aqueductal stenosis, and his hydrocephalus. Tr.

at 24. Nowhere did the emergency physician write down aspiration. Tr. at 23. Dr. Pike has no

idea why the death certificate has aspiration as one of the reasons for Marqiano’s death, although

it is not unusual for death certificates to be erroneous. Id.

Dr. Pike said he agreed with Dr. Guggenheim, respondent’s expert, that Marqiano’s death

was caused by perturbation of brain function, but he believes that the cause of that perturbation

was Pediarix vaccine which contains pertussis toxin and other pertussis components. Tr. at 25.

The undersigned asked Dr. Pike how Marqiano could seemingly be fine at night and then

a few hours later be in trouble. Tr. at 26. Dr. Pike responded that inflammation in brain tissues

and breaches of the blood-brain barrier can occur over hours. The rate at which a change occurs

depends on the toxin’s potency in the case of pertussis and the rate at which leakage of the

blood-brain barrier occurs. Id. The exact mechanism for sudden apnea in premature infants who

receive this vaccine has not been completely worked out, but there is an increased rate of apnea

in these patients. Tr. at 27.

The purpose of the blood-brain barrier is not only to prevent unwanted proteins and other

materials from entering the brain but also to limit the amount of fluid entering the calvarium to

prevent compression of the brain or brain swelling. Tr. at 27-28. Marqiano already had swelling

of the brain from his aqueductal stenosis and hydrocephalus, which required shunts to be

implanted. Tr. at 28. The shunts would have protected him from increased intracranial pressure,

but would not have protected him from the direct effects that pertussis toxin has on neurons. Id.

The mechanisms are not well understood to explain how pertussis toxin causes apnea in

premature infants. Id.

Marqiano was born at 34 weeks gestation, whereas the normal gestational age is 40

weeks. Tr. at 28-29. He was born with a congenital anomaly of his brain, hydrocephalus, and

blindness, showing his premature status regarding the central nervous system was more

significant. Tr. at 29. Although Marqiano was born six weeks premature, his brain maturity was

much less than his gestational age. Tr. at 30. He had no developed cortex and very limited

capability of brain function as evidenced by his blindness and hydrocephalus. Id. Brain

immaturity made Marqiano more vulnerable to the effects of pertussis toxin even in a purified

state. Id. One could argue that Marqiano’s brain development arrested perhaps as early as 20

weeks gestation or even less because he did not form the significant major brain structures. Tr.

at 32.

The stenosis of his aqueduct, a certain portion of the brainstem where cerebral spinal

fluid flows through the ventricles that usually would be in the cortex, caused his hydrocephalus.

The hydrocephalus can compress cortical neurons to create a very thin cortex. Marqiano had an

absence of development of cortical tissue in addition to having hydrocephalus. Id.

Dr. Pike did not believe that Marqiano would have died in any event at four months.

Marqiano actually seemed to be doing fairly well given his limitations. Tr. at 33. He had

trouble with feeding but he was improving and getting therapy. Id. He had an expectation of a

much less degree of functioning than most infants, but there was no reason to believe that he was

not going to sustain life. Id. His brainstem was functioning. He could breathe on his own. His

heart was strong. The centers of his brain that controlled vital functions such as ventilation,

cardiac activity, and blood pressure seemed intact. Id.

The problem with Marqiano was that he had no cortex. The neocortex was missing,

meaning he was blind because he had no occipital cortex. Tr. at 33-34. He probably could not

think or have any rational thoughts because he had no other form of cortical functioning. Tr. at

34. Dr. Pike thinks Marqiano could have lived for an indefinite period of time. Id. If the

doctors had not expected him to survive, they would have had no reason to vaccinate him. Id.

There was a reasonable expectation for Marqiano to achieve his maximum abilities, even though

those may have been very severely compromised. Id. Had it not been for the pertussis element

of his vaccinations on December 11, 2007, Marqiano would not have died on December 12,

2007. Tr. at 35-36. He had sudden apnea after his vaccination which the vaccination caused and

which compromised his vital centers. Tr. at 36-37. The toxins in the vaccine affected the

respiratory center to cause apnea. Apnea means total cessation of breathing. Tr. at 37.

Dr. Pike testified that there is medical literature supporting his opinion. The vaccine

table itself recognizes anaphylaxis and encephalopathy as Table injuries due to pertussis. The

IOM relied on a large United Kingdom study showing a relationship between pertussis toxin and

severe neurological dysfunction in concluding there was a relationship between them. Tr. at 39.

That is the National Childhood Encephalopathy Study or NCES. Tr. at 40. The problem with

epidemiology, however, is that we are dealing with extremely rare events. Tr. at 41. These

extremely rare events require an extremely large number of individuals to be studied in order to

have sufficient epidemiologic power to detect a difference. Id.

Dr. Pike stated there are a number of studies reporting infants with post-immunization

apnea. Tr. at 43. The product insert for Pediarix cautions physicians not to administer Pediarix

in premature infants. Id. Because of severe disability from his congenital malformations,

Marqiano was highly susceptible to developing infectious disease of any type, including

Bordetella pertussis, which could cause whooping cough and death from Bordetella pertussis

pneumonia. Tr. at 46. Vaccination was an important component of Marqiano’s well-baby care.

Tr. at 47. It was reasonable to vaccinate him. Id.

Dr. Pike testified that Marqiano died 14 hours after vaccination, too long for

anaphylaxis, but long enough for direct toxic effects from permeability, immunological response,

release of cytokines, disinhibition of neuromembrane stability with gamma aminobutyric acid

(GABA), and sodium channel activation. Tr. at 51. Absent the DTaP vaccination, Marqiano

would not have died. Tr. at 53. The vaccination caused apnea which caused asystole, complete

absence of electrical activity in Marqiano’s heart. Tr. at 56-57. A perturbation of the brain is

encephalopathy. Tr. at 59. The neurons that were affected were primarily in the brainstem. Tr.

at 60. What was observable was that Marqiano stopped breathing (the apnea) and his heart was

no longer beating (the cardiac arrest). Tr. at 61. The only evidence Dr. Pike has for the toxic

effects of pertussis on Marqiano’s nerve cells is circumstantial. Tr. at 62. There is obviously no

way for the biomolecular events he described as the mechanisms of the toxic actions of pertussis

toxin to be directly observable, but the signs of the toxin’s effect are directly observable, i.e., the

apnea and cardiac arrest. Tr. at 68.

If someone had been sitting in the dark with a flashlight on Marqiano during his last

night, they would have seen increasing difficulty with breathing, probably agonal ventilations,

and then no breathing for a long time. Tr. at 68-69. Had the observer taken a pulse, he or she

might have noted the pulse was low and also that Marqiano’s color had changed. He would be

starting to get blue around the lips and around his fingers and ears. Then all of his skin would

turn somewhat blue. When the nurse found him eventually, Marqiano’s skin color was ashen,

meaning there was no circulation basically. Tr. at 69.

There was no sign in the midnight note recounting the 10:00 p.m. nurse’s visit to

Marqiano to indicate he had an adverse event from pertussis toxin. Tr. at 74. Because of the

nature of the event Marqiano had, Dr. Pike does not think the other vaccinations Marqiano

received on December 11, 2007 had anything to do with his death. Id. Marqiano had a

catastrophic event, apnea and cardiac arrest, with which pertussis vaccine is mostly implicated.

Tr. at 75.

Anatomic brainstem abnormalities can be associated with apnea. Tr. at 75. Other than

aqueductal stenosis, which caused hydrocephalus that was resolved with the placement of shunts

into his ventricles to drain cerebral spinal fluid and relieve pressure, Marqiano did not have any

brainstem abnormalities. Tr. at 76. Marqiano did not have any functional abnormality of his

brainstem because he did not have any problem maintaining ventilation, heart rate, or blood

pressure on his own. Id.

The MRI of August 21, 2007 showed Marqiano had kinking of the cervical medullary

junction, which is part of the brainstem, but the vital centers for respiration are above it. Tr. at

77-78. If there had been a substantial functional problem, Dr. Pike would have expected some

type of paralysis such as quadriparesis (paralysis of his arms and legs), but Marqiano did not

have that. Tr. at 78.

Marqiano’s brain abnormalities made him more vulnerable to pertussis toxin. Id. Those

abnormalities made his brain seem more premature than his gestational age. Tr. at 78-79. A

study examining apnea divided children into three groups: (1) the very premature; (2) those less

than 31 weeks gestation but normal; and (3) those born after 31 weeks gestation and normal.

Marqiano was more likely to fit in Group 1 because the very premature children were somewhat

unstable. Tr. at 79. He did not have the central nervous system development of a normal child,

but more like premature infants in terms of his neurological function. Id. He did not have the

brain of an infant born at 34 or more weeks of gestation whose brain was normal. Tr. at 80. His

brain functioned at a premature level that was perhaps much less than 31 weeks gestation. Id.

Marqiano’s holoprosencephaly put him in the category of premature children born under

31 weeks gestation because of his compromised functional abilities. Id. Prematurity is an

important part of Dr. Pike’s opinion. Tr. at 81. Marqiano did not develop the neocortex in his

brain. Tr. at 82. He was born at 34 weeks gestation but with a brain that was much more

premature in its development than the age at which he was actually born. Id. Because pertussis

toxin targets the central nervous system, Marqiano had a greater susceptibility more like those

children born at 31 weeks or less of gestational age due to the prematurity of his brain. Tr. at 82-

83.

Dr. Pike is neither a neurologist nor a pediatrician. Tr. at 83. He has treated over 80,000

patients, one-quarter of them children. Id. He has treated children with severe hydrocephalus

who have also been blind. Tr. at 84. Dr. Pike’s concentration is in emergency medicine. Id.

At the time Marqiano died, he had been improving from therapy. Tr. at 85. On

November 26, 2007, the occupational therapist said Marqiano was progressing. Tr. at 88. On

December 3, 2007, the therapist notes that progress was slow but significant. Id. These were

little improvements but showed progression. Tr. at 89.

Respondent’s Expert Dr. Guggenheim

Dr. Mary Anne Guggenheim, a board-certified pediatric neurologist, testified for

respondent. Tr. at 92, 93. She is also board-certified in pediatrics. Tr. at 93. The last time she

had a private clinical practice was in 1995. Tr. at 94. Five years ago, she stopped all clinical

child neurology. Id. Her opinion is that there is no evidence of Marqiano having an adverse

reaction to his vaccination. She thinks his death was due to his underlying condition. Tr. at 98.

Children with very complex brain malformations seem stable until they die and doctors usually

do not know a precise cause of death, as we do not know in this case. Id.

Marqiano was delivered at 34 or 36 weeks gestational age, depending on the record, by

caesarean section due to concern that his hydrocephalus might further compromise his brain

function if it were not shunted. Tr. at 99. He had an enlarged head circumference and was very

infantile. Id. He had only reflex behaviors. Id. Marqiano had holoprosencephaly which is a

complex malformation of the forebrain. Id. “Prosencephalon” means the frontal part of the

brain or forebrain. Tr. at 99-100. The anterior portion of the brain failed to develop and,

consequently, the lateral and third ventricles fused. Tr. at 100. His holoprosencephaly was of

moderate severity but not the most severe. Id. Virtually all those born with holoprosencephaly

die by the time there are in their twenties or so. Id. They do not progress beyond an infantile

state of essentially reflex behaviors. Id. They may have difficulty feeding and sucking as

Marqiano did. Id. A cerebral cortex is necessary to develop beyond an infantile state, but people

with holoprosencephaly are born without that part of their brain and are severely

developmentally impaired as a consequence. Tr. at 100-01. Not all people with

holoprosencephaly die in infancy. Tr. at 101. An English study of decades of people with

holoprosencephaly states that 29 percent of infants with holoprosencephaly in the southern part

of England survived past their first year. Id. Marqiano was enrolled in a hospice program which

is aimed at providing comfort to those in a severe state of impairment. Id.

Marqiano had two other brain abnormalities: (1) aqueductal stenosis which caused his

hydrocephalus, and (2) a kink in the cervical medullary junction of an anatomic type. Tr. at 101-

02. In aqueductal stenosis, the conduit between the third and fourth ventricles did not develop

normally and the spinal fluid could not flow through it. Tr. at 102. The kink in the cervical

medullary junction indicates there was a bend in the lower part of the brainstem where it merges

with the other part of the spinal cord. Id.

In addition, Marqiano had microphthalmia which is small eyes. Tr. at 103. This is a part

of holoprosencephaly. He never had any useful vision. Id. He also had an abnormality in the

collection system of his kidneys on one side which blocked the ureter that conveys urine to the

bladder, causing hydronephrosis, a swelling of the kidney. Id. Marqiano also had micropenis

and either absent or very small testes, reflecting in utero abnormalities of hormonal control over

secondary sexual characteristics. Id. It also indicates underlying abnormalities of his

hypothalamus and his pituitary gland function, also a common part of holoprosencephaly

because the hypothalamus is in the forebrain. Tr. at 104.

Marqiano developed spasticity, described as increased tone, and he had cortical thumbs,

i.e., having his thumbs fisted. This just reflects that the signals coming from his brain affecting

muscle tone were abnormal. Id. Because of lack of cerebral hemisphere development, he had no

head control and a poor suck. Tr. at 105. He had very limited, if any, responsiveness other than

tactile and sometimes auditory. Id. He was essentially a newborn infant and remained that way.

Newborns run on automatic pilot. The difference from a newborn is that Marqiano did not have

a good suck. Id. He was never able to roll over. Id. Dr. Guggenheim did not see any evidence

that Marqiano made any progress. Id.

Marqiano had a poor suck and inability to swallow and could not adequately take in

nutrition. Tr. at 106. He had a feeding tube at two or three weeks of age, but the gastrostomy

tube was not working well. Id. After six weeks of age, Marqiano did not grow any more and

had failure to thrive. Tr. at 107. Two weeks prior to his death, Marqiano was stable although

there was trouble with the feeding tube. Tr. at 107-08. Basically, he lay in his crib with his eyes

closed although he could open his lids sometimes. Tr. at 108. He had a weak cry and could suck

weakly on a pacifier. Id. He was rolled from side to side so he would not develop pressure

sores. Id. He did react to either touch or noise but not to visual stimuli. Id. He had difficulty

maintaining his temperature, probably due to hypothalamic dysfunction, and was wrapped up

and sometimes had a cap on. Id.

Dr. Guggenheim does not agree that Marqiano was improving at the time of his second

vaccinations and his death. Id. The reason he was vaccinated is that the American Academy of

Pediatrics recommends it to all infants, even the very premature, to keep the child healthy and to

reduce the likelihood of epidemics. Tr. at 109-10.

Dr. Guggenheim does not see any evidence that Marqiano had an acute encephalopathy

which would be seizures, obtundation, and marked changes in tone. Tr. at 110-11. She thinks

the reason no autopsy was done on Marqiano was that people thought his underlying

holoprosencephaly and brain malformation were the underlying causes of his death and, because

he was in an institution, no one was concerned about abuse or injury. Tr. at 111. There is

nothing in the record to indicate that the treating doctors thought that Marqiano died because of

his vaccinations. Tr. at 111-12.

Marqiano received acellular DTP, not whole-cell DPT. Tr. at 112. In acellular DTP, the

pertussis toxin is nullified although there are still small fragments that can induce

immunogenicity. Id. Children who receive acellular pertussis have much less incidence of fever

and other inflammatory responses. Tr. at 113. Marqiano had no change clinically from the time

he was immunized in the early afternoon until about 12 hours later when he was found dead. Tr.

at 114. No one found a local reaction or swelling or inflammation. Id. Marqiano went from

being a stable child with a very infantile state due to his underlying brain malformation, to being

dead. Dr. Guggenheim calls this an “abrupt jump, not an evolutionary sequence.” Tr. at 115.

There are no stepwise changes. He went from stable to dead. Id.

Dr. Guggenheim knows of no mechanism by which vaccinations can cause apnea in

premature infants. Tr. at 116. Holoprosencephaly is a malformation due to genetic instructions.

Tr. at 118. Dr. Guggenheim disagrees with Dr. Pike that Marqiano’s brain was immature. It was

malformed. Tr. at 119. Those parts not affected by the malformation are otherwise normal. Tr.

at 120. The magic line for neonatologists looking at premature babies is usually 31 to 32 weeks.

Tr. at 121. These babies are vulnerable to a whole variety of both somatic and neurologic

problems. Id.

Marqiano had a weak suck and weak ability to swallow because his brain did not work

right. Id. The outflow for sucking comes from the medulla of the brainstem through the lower

cranial nerves, but the cerebral hemispheres can clearly affect it. Id. She does not think it

possible to know whether his weak suck and weak ability to swallow were primarily due to a

brainstem abnormality or to the lack of cortical feedback and information to brainstem centers.

Tr. at 122.

The studies to which Dr. Pike referred were retrospective except for one paper. Id.

Marqiano was not as premature as the children in those studies. Although giving pertussis

vaccine to premature infants might result in some apnea and some cardiac abnormalities, a

randomized, prospective study showed no difference in the rate of apnea among premature

infants who received DTaP and those not immunized. Tr. at 123-24. Dr. Guggenheim does not

believe that the vaccinations contributed to or hastened Marqiano’s death. Tr. at 128.

In Dr. Guggenheim’s expert report, she wrote that a perturbation of brain function caused

Marqiano’s death. Tr. at 129. She meant that Marqiano appeared to have central apnea, as

opposed to an obstructive type of apnea. Id. She agrees with Dr. Pike that there is no evidence

that Marqiano had aspiration of a lung or airway problem. Id. She stated that something went

wrong with Marqiano’s brain control of his breathing. Tr. at 130. She does not know whether

Marqiano had a primary cardiac malfunction or primary apnea. Id. The primary centers for

control of breathing and heart rate are in the brainstem, but that connects to the cortex. Id.

There is no way to know whether the initial event was that Marqiano had trouble breathing,

stopped breathing, had apnea, and then, as a consequence, his heart failed because it was no

longer being oxygenated or the converse, i.e., his heart stopped beating, resulting in the lack of

oxygenation which caused him secondarily to stop breathing. Tr. at 130-31. He had a

cardiorespiratory event. Tr. at 131.

When the undersigned asked Dr. Guggenheim what caused Marqiano’s cardiac asystole

and apnea, she answered, “Well, it went wrong.” Tr. at 132. She stated something went wrong

in his brain and added it is not uncommon to see children with complex brain malformations and

severe developmental problems requiring total care to be stable and then die. Tr. at 133. No one

knows the internal mechanism for that. All we know is that their brains are abnormal and, at an

unpredictable time, their brains do not function normally in a crucial respect of cardiorespiratory

function. “So these kids are stable until they die.” Id.

There were times when Marqiano had alterations in his vital signs for no apparent

external reason, which is consistent with the abnormal internal stability of his brain function. Tr.

at 137. Dr. Guggenheim cannot give a mechanism of why, one minute, Marqiano was breathing

and, the next minute, he was not. Tr. at 138. Dr. Guggenheim is not a board-certified

toxicologist. Id.

Dr. Pike on Rebuttal

Dr. Pike testified on rebuttal that, in his opinion, the apnea occurred first. Tr. at 143.

The respiratory center is primarily responsible in the brainstem for stimulating the spinal nerves

that allow the periodic expansion of the lungs. Id. The heart is controlled primarily from the

brainstem through the vagus nerve. Id. Dr. Pike thinks the respiratory apnea had to have

occurred first because the cardiac myocytes, i.e., the heart muscle cells themselves, have inherent

automaticity. The heart will beat even when completely denervated from the brain. Tr. at 144.

Even if the cardiac center of the brainstem had been damaged, the automaticity of the heart cells

themselves would have continued to beat. Tr. at 145-46. That is why the apnea had to be the

inciting event leading to Marqiano’s death. Tr. at 146.

As for pertussis toxin being present in acellular DTP, Dr. Pike stated that the idea is that

pertussis toxin is inactivated either through the use of glutaraldehyde or formaldehyde or other

chemicals to produce a toxoid. Id. Even though there is pertussis toxoid in the vaccine, there are

also pertussis proteins there. Id. We assume that the chemicals are 100 percent effective in

destroying pertussis toxin, but assays used to determine whether the toxin is completely

inactivated are very crude and rely on whether a mouse injected intraperitoneally with the

vaccine died. Tr. at 147. We do not have a very good means of knowing in any particular lot or

sample how much of the pertussis toxoid is totally inactive. We also do not know that the toxoid

is completely void of any effects that are toxic to neurons. Id.

Dr. Pike agrees with Dr. Guggenheim that the acellular form of the vaccine is much less

toxic than the whole-cell form. Tr. at 149. However, the acellular pertussis concentrates the

most active component of the pertussis toxin, presumably inactivated, to deliver the

immunogenicity intended against Bordetella pertussis bacterium. Tr. at 149-50. In the FDA’s

clinical trials, adverse effects were seen with both DTaP and DPT. Tr. at 150. The toxicity is

less, but not absent, in the acellular form. Id. We know this because there are still adverse

effects reported from acellular vaccine, e.g., fevers, sores, pain, malaise, seizures, anorexia,

fussiness, diarrhea, restlessness, insomnia, unusual crying, encephalopathy, but they occur less

often than with whole-cell. Id.; tr. at 151. He explained the failure to find apnea among

premature recipients of pertussis vaccine as due to it being a rare event. Tr. at 152. Prospective

studies are not sufficiently powerful to be able to detect an extremely rare event. Tr. at 154.

Retrospective studies, however, have looked at infants who had apnea after vaccination, and

noted that the premature infants were more likely to have apnea than those that were not

premature. Id.

Dr. Pike reiterated Dr. Guggenheim’s description of holoprosencephaly in which the full

brain does not develop, although the part of the brain that controls ventilation, i.e., the midbrain,

is not the forebrain and was not affected except for some type of anatomical kinking reported on

MRI. Tr. at 155. Marqiano’s brain development was arrested at a critical point in time in

gestation, probably six months forward. Tr. at 156. His brain was more like a premature brain

because it had not developed compared to a normal brain. Id. The studies Dr. Pike cited dealt

with premature infants with normal brains and normal brain maturation after birth, but that was

not Marqiano’s brain. Id.

Dr. Pike said that Marqiano’s brain was arrested at a very premature stage in utero during

fetal development and never progressed past what he had. Tr. at 157. His premature infant brain

made Marqiano more susceptible to the pertussis toxin in the DTaP. Tr. at 158. Even children

with congenital malformations often have inciting events, for example urinary tract infection or

pneumonia, that cause a perturbation leading to death. Tr. at 159. Death just does not happen to

them. There has to be a reason. Marqiano’s physicians were not expecting him to die that night.

Id. “This was a death that was totally unexpected, shocked everybody, needed an explanation

and should have been a medical examiner’s case, but for some reason that didn’t happen,” said

Dr. Pike. Tr. at 160. Marqiano’s brainstem was functioning perfectly well and something, as

Dr. Guggenheim wrote, perturbed that function. Dr. Pike believes it was the pertussis vaccine

that perturbed that function and led to his apnea and death. Id.

Dr. Pike testified that it is the actual absorption of the pertussis toxoid/toxin into the

bloodstream crossing the blood-brain barrier and interacting with neurons or glial cells at a

biomolecular cellular level that causes the damage. Tr. at 161. It does not take a lot of toxin to

cause substantial damage in the nervous system when we talk about Bordetella pertussis because

the toxin is extremely potent in very small quantities. Tr. at 162.

Other Submitted Material

Dr. David Hirsch, medical director of Hacienda HealthCare (where Marqiano died) and a

board-certified pediatrician specializing in developmental disabilities, wrote a report dated May

21, 2008 in which he said that the vaccines Marqiano received together with his underlying

medical condition caused his death. This opinion differs from his statement in the record that the

vaccines were unlikely to have caused his death. He stated he did additional research and

consideration of the timing and circumstances which explains his change of opinion. Ex. 8, pp.

1, 2.

Dr. Hirsch provided a supplemental report, dated August 8, 2009 and filed August 21,

2009, after reviewing material he did not previously have, stating that Marqiano had an unstable,

likely progressive neurological condition related to an underlying congenital brain malformation.

Page 1. After his second series of vaccinations, there was “no reason to believe that he was

going to get worse that evening or the next day, let alone dying. The only variable was the

vaccinations he received at his four month check-up.” Page 2. The physical examination

performed by Dr. Herr prior to administering the four-month vaccinations did not indicate any

signs of clinical distress. Page 3.

Respondent’s expert Dr. Guggenheim stated in her report, filed January 29, 2010 as

Exhibit A, that “it is reasonable to conclude that a perturbation of brain function caused his

[Marqiano’s] death.” Ex. A, p. 3.

Respondent filed as Exhibit D an article entitled “Absence of an Increase in

Cardiorespiratory Events After Diphtheria-Tetanus-Acellular Pertussis Immunization in Preterm

Infants: A Randomized, Multicenter Study” by T. Carbone, et al., 121 Pediatrics 5:e1085-90

(2008). The authors inoculated 93 preterm children with DTaP and used a control group of 98

preterm children whom they did not inoculate, and found almost the same rate of bradycardia

(2.6 in the immunized group and 2.7 in the control group). The degree of apnea was the same in

both groups: 0.5 episodes. Id. at e1085. The authors conclude that preterm infants who received

DTaP at two months were no more likely to experience prolonged apnea and bradycardia than

preterm infants who were not vaccinated. Id. The study was done because of case reports

describing severe apnea requiring resuscitation after immunization of preterm infants, and

numerous studies subsequently reporting an increased incidence in apnea and bradycardia in

preterm infants even when acellular pertussis vaccine was used instead of whole-cell pertussis.

Id. at e1086. The mean postconceptional age for the DTaP group in Carbone’s study was 34.9

weeks and for the control subjects, 35.1 weeks. Id. at e1087. The authors state that these

extremely preterm infants “were at increased risk for significant cardiorespiratory events.” Id. at

e1088. They continue:

The study population clearly represented an extremely vulnerable

group of infants, as indicated by their gestational age, birth weight,

and the high incidence of the common complications of marked

prematurity.... The vulnerability of the study population is also

demonstrated by the high incidence of both prolonged apnea and

prolonged bradycardia, as well as the high incidence of severe

cardiorespiratory events.

Id. They describe these infants as “medically fragile.” Id. The authors were concerned that

pediatricians were not vaccinating the extremely preterm infants even though the American

Academy of Pediatrics (AAP) recommended that they do so. Id. The results of the study were

supportive of the AAP recommendations. Id. at e1089. The authors acknowledge that the high

dropout rate of infants from the study due to technical difficulties with monitoring equipment is a

limitation on the study. Id.

DISCUSSION

Petitioners have not alleged a Table case, but a causation in fact case. To satisfy their

burden of proving causation in fact, petitioners must prove by preponderant evidence "(1) a

medical theory causally connecting the vaccination and the injury; (2) a logical sequence of

cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of

a proximate temporal relationship between vaccination and injury.” Althen v. Sec’y of HHS,

418 F.3d 1274, 1278 (Fed. Cir. 2005). In Althen, the Federal Circuit quoted its opinion in Grant

v. Sec’y of HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992):

A persuasive medical theory is demonstrated by “proof of a logical

sequence of cause and effect showing that the vaccination was the

reason for the injury[,]” the logical sequence being supported by

“reputable medical or scientific explanation[,]” i.e., “evidence in

the form of scientific studies or expert medical testimony[.]”

In Capizzano v. Sec’y of HHS, 440 F.3d 1317, 1325 (Fed. Cir. 2006), the Federal Circuit

said “we conclude that requiring either epidemiologic studies, rechallenge, the presence of

pathological markers or genetic disposition, or general acceptance in the scientific or medical

communities to establish a logical sequence of cause and effect is contrary to what we said in

Althen ....” Such an approach is inconsistent with the use of circumstantial evidence. Id. The

Federal Circuit stated in Althen, 418 F.3d at 1280, that “the purpose of the Vaccine Act’s

preponderance standard is to allow the finding of causation in a field bereft of complete and

direct proof of how vaccines affect the human body.”

Close calls are to be resolved in favor of petitioners. Capizzano, 1440 F.3d at 1327;

Althen, 418 F.3d at 1280.

Without more, "evidence showing an absence of other causes does not meet petitioners'

affirmative duty to show actual or legal causation." Grant, 956 F.2d at 1149. Mere temporal

association is not sufficient to prove causation in fact. Id. at 1148.

Petitioners must show not only that but for the vaccine, Marqiano would not have had the

apnea, cardiac arrest, and death, but also that the vaccine was a substantial factor in bringing

about his apnea, cardiac arrest, and death. Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed.

Cir. 1999).

In essence, the special master is looking for a medical explanation of a logical sequence

of cause and effect (Althen, 418 F.3d at 1278; Grant, 956 F.2d at 1148), and medical probability

rather than certainty (Knudsen v. Sec’y of HHS, 35 F.3d 543, 548-49 (Fed. Cir. 1994)). To the

undersigned, medical probability means biologic credibility rather than specification of an exact

biologic mechanism. As the Federal Circuit stated in Knudsen:

Furthermore, to require identification and proof of specific biological mechanisms

would be inconsistent with the purpose and nature of the vaccine compensation

program. The Vaccine Act does not contemplate full blown tort litigation in the

Court of Federal Claims. The Vaccine Act established a federal “compensation

program” under which awards are to be “made to vaccine-injured persons quickly,

easily, and with certainty and generosity.” House Report 99-908, supra, at 3, 1986

U.S.C.C.A.N. at 6344.

The Court of Federal Claims is therefore not to be seen as a vehicle for ascertaining

precisely how and why DTP and other vaccines sometimes destroy the health and

lives of certain children while safely immunizing most others.

35 F.3d at 549.

As the Federal Circuit stated in Knudsen, 35 F.3d at 548, “Causation in fact under the

Vaccine Act is thus based on the circumstances of the particular case, having no hard and fast

per se scientific or medical rules.” The undersigned’s task is to determine medical probability

based on the evidence before the undersigned in this particular case. Althen, 418 F.3d at1281

(“judging the merits of individual claims on a case-by-case basis”).

Basically, the dispute in the instant action is whether because of Marqiano’s brain

abnormalities, Marqiano was more vulnerable to the effects of acellular pertussis vaccine and

suffered a reaction and died or he was going to die at any moment regardless of vaccination.

Both sides agree Marqiano was vulnerable. Dr. Guggenheim wrote in her initial report

that Marqiano died from a brain perturbation. But she does not think the perturbation was due to

acellular pertussis vaccine. She did think he had cardiac arrest first and then apnea. Dr. Pike

noted that acellular pertussis vaccine, although toxoided to remove its toxicity, is incompletely

toxoided and can cause adverse reactions. For someone as medically fragile as Marqiano, this

toxicity tipped the scales for him. Dr. Pike testified that Marqiano developed apnea first and

then cardiac arrest. He stated that someone’s heart can keep beating even if the brainstem is not

functioning properly due to automaticity of the heart cells, but someone whose brainstem is not

functioning properly will get apnea and stop breathing. Dr. Pike’s explanation of the course of

events (first apnea; then cardiac arrest) in Marqiano’s death is persuasive and takes into

consideration the lack of proper functioning of Marqiano’s brain.

Dr. Guggenheim emphasized the Carbone study in which preterm infants were divided

into two groups: one receiving DTaP and the other group not being immunized. As Dr. Pike

testified, these children were premature, but were not identified as having a missing cortex or

other brain difficulties such as hydrocephalus. Nevertheless, both groups in the Carbone study

had the same incidence of apnea and bradycardia regardless of vaccination status. Those events

were very infrequent among both groups. Of the 93 immunized preterm children, only 2.6 had

bradycardia (slowed heart beat). Only 0.5 of the 93 had apnea. Of the 98 unimmunized preterm

children, only 2.7 had bradycardia. Only 0.5 of the 98 had apnea. Beyond the question of how a

fraction of a child has either bradycardia or apnea, the undersigned can agree that these are very

small numbers. Dr. Pike pointed out that the Carbone study describes only a small number of

infants, too small to detect a very rare event as occurred in the instant action. Dr. Pike’s concern

about the failure of epidemiology to detect very rare events echoes the Federal Circuit’s concern

in Knudsen.

The Federal Circuit in Knudsen ruled for petitioners even when epidemiological evidence

directly opposed causation from DPT vaccine. The case concerned the cause of a baby’s

encephalopathy after vaccination. Respondent filed epidemiologic evidence showing that more

encephalopathies are caused by viruses than by vaccines, resulting in dismissal of the petition

based on those epidemiologic studies. But the Federal Circuit held that epidemiologic evidence

should not bar petitioners from prevailing, stating:

The bare statistical fact that there are more reported cases

of viral encephalopathies than there are reported cases of DTP

encephalopathies is not evidence that in a particular case an

encephalopathy following a DTP vaccination was in fact caused by

a viral infection present in the child and not caused by the DTP

vaccine.

35 F.3d at 550.

Dr. Hirsch, the medical director of Hacienda where Marqiano died, submitted two reports

stating that the vaccines caused Marqiano’s death. He stated that no one at the facility expected

Marqiano to die. The Federal Circuit in Capizzano emphasized that the special masters are to

evaluate seriously the opinions of petitioner’s treating doctors since “treating physicians are

likely to be in the best position to determine whether a logical sequence of cause and effect

show[s] that the vaccination was the reason for the injury.” 440 F.3d at 1326. See also Andreu

v. Sec’y of HHS, 569 F.3d 1367, 1375 (Fed. Cir. 2009). Although Dr. Hirsch was the head of

the facility where Marqiano died and not necessarily a treater, he was associated with those who

did treat Marqiano and has familiarity with the expectations of those treaters. Dr. Hirsch

explained that his initial opinion in the medical records that the vaccines did not cause

Marqiano’s death was a consequence of his being uninformed of the particulars of the case and

his focus on the Synagis vaccine that Marqiano received with DTaP and other vaccines. In his

two reports, Dr. Hirsch states that the only variable leading to Marqiano’s death was the

vaccinations.

In concert with Dr. Hirsch’s opinion that no one at Hacienda expected Marqiano to die,

Dr. Pike testified that if Marqiano’s pediatrician Dr. Herr expected Marqiano to die, why would

he give him his second series of vaccinations. The natural conclusion is that Marqiano’s treaters

expected him to benefit from the vaccinations which were to protect him from illness. Being

protected from illness would be important for an individual as medically fragile as Marqiano.

Moreover, respondent’s expert Dr. Guggenheim stated that children born with

holoprosencephaly can live until their twenties or beyond and that almost one-third can live

beyond one year. There is nothing persuasive then in the record to show that Marqiano was

going to die exactly when he did die irrespective of vaccination.

Dr. Pike’s thesis is that because Marqiano was grievously brain-damaged, he was more

vulnerable to the effect of the numerous vaccines he received, particularly pertussis. His opinion

makes sense. The Carbone study authors call children born at 35 weeks medically fragile. This

is about the age of gestation when Marqiano was born, but he was born not just prematurely; he

was missing his neocortex.

The fact that someone has a known factor unrelated to the vaccine that is a substantial

factor in causing illness and death does not prevent petitioners prevailing under the Vaccine

Program. In Shyface, Cheyenne Shyface received whole-cell pertussis vaccine at the same time

he harbored the beginning of an E-coli infection. Both the vaccine and the infection can produce

fever. After the vaccination, Cheyenne had a fever of 109 degrees and, when it reached 110

degrees, he died. 165 F.3d at 1345. Testimony from his treating doctor was that both the wholecell

DPT and the E-coli infection caused Cheyenne’s fever and death. Id. at 1347. The Federal

Circuit held that both the DPT and the infection were equal substantial factors in causing

Cheyenne’s vaccine reaction and death, and that without his receiving the vaccination, he would

not have gotten such a high fever and died. The Federal Circuit awarded compensation to

petitioners. Id. at 1353.

In Zatuchni v. Sec’y of HHS, 69 Fed. Cl. 612 (2006), Barbara Snyder’s estate’s

representative appealed a denial of compensation for Ms. Snyder’s prior allegation that the

rubella component of MMR vaccine caused her fibromyalgia. The appeal was successful and

her fibromyalgia was deemed a vaccine injury. 69 Fed. Cl. at 624. The case was remanded to

determine if her death were caused by her vaccine injury. Her treating doctor testified that Ms.

Snyder died from smoking-induced chronic obstructive pulmonary disease (COPD). 2006 WL

1499982 (Fed. Cl. Spec. Mstr. 2006), adopted in part, vacated in part on other grounds, 73 Fed.

Cl. 451 (2006), aff’d on other grounds, 516 F.3d 1312 (Fed. Cir. 2008). Ms. Snyder would have

died in any event from her primary illness COPD. But her fibromyalgia made it impossible for

her to exercise for 13 years. Had she been able to exercise, she would have not died at the time

she did from COPD, but later on. 2006 WL 1499982, at *4. Ms. Snyder’s representative

prevailed even though the known factor unrelated to the vaccine, i.e., the COPD, was the

predominant substantial factor in causing her death because the vaccine injury fibromyalgia was

also a substantial factor. Similarly, Marqiano’s grievous birth condition would have led to an

early death which could have happened after the age of one or even in his twenties. But he died

sooner than that because of his vaccine reaction.

The Federal Circuit in Shyface stated that the vaccine does not have to be a predominant

substantial factor in causing the injury and death, merely a substantial factor. 165 F.3d at 1353.

In Shyface, the vaccination and the infection were equal substantial factors.

In Zatuchni, the COPD was the predominant substantial factor and the fibromyalgia from

the rubella vaccine was merely a substantial factor in causing Ms. Snyder’s death. 2006 WL

1499982, at *5.

In the instant action, the combination of the absent neocortex and medical fragility of

Marqiano’s brain and the effects of the pertussis toxin were both substantial factors in causing

his apnea and cardiac arrest, leading to his death. Without his having received acellular pertussis

vaccine, he would not have died at that time, although he would have died at some time in the

future, just as Ms. Snyder in Zatuchni would have died from COPD eventually if not for her

fibromyalgia. Whether the severe prematurity of Marqiano’s brain was a predominant

substantial factor or merely substantial is irrelevant since, as long as the vaccine is a substantial

factor, without which the injury and death would not have occurred, petitioners prevail.

The undersigned accepts that, in light of the reports of vaccine adverse reactions

following DTaP, there are still rare difficulties with the toxoidal processing of pertussis toxin.

The undersigned accepts that a medically fragile premature infant is more susceptible to the

challenge of receiving pertussis vaccine even in its acellular form. The undersigned further

accepts that had Marqiano not received his second DTaP, his life would probably have been

shortened because of his grievous physical condition, but there is no indication medically, from

the opinion of Dr. Hirsch, or the testimony of Dr. Pike, that he would have died on the night he

did die. Dr. Guggenheim admitted in her initial report that Marqiano died from a perturbation in

his brain. The undersigned holds that that perturbation came from the acellular pertussis vaccine

which can, in rare cases, cause apnea and cardiac arrest in a medically fragile vaccinee (Althen

prong one), and did cause apnea and cardiac arrest in this case (Althen prong two) within a

medically appropriate time interval (14 hours) to signify causation (Althen prong three), and that

without having received acellular pertussis vaccine, Marqiano would not have died when he did.

Petitioners have proven causation in fact.

CONCLUSION

Petitioners are entitled to $250,000.00, the award for a vaccine-related death under §

300aa-15(a)(2) of the Vaccine Act. A check shall be made payable to petitioners in the amount

of $250,000.00. In the absence of a motion for review filed pursuant to RCFC, Appendix B, the

clerk of the court is directed to enter judgment herewith.7

IT IS SO ORDERED.

September 30, 2010 s/ Laura D. Millman

DATE Laura D. Millman

Special Master

7 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party’s

filing a notice renouncing the right to seek review.

Seriously Outstanding

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