Analysis of Causes That Led to Baby Robert Benjamin Quirello’s Respiratory Arrest and Death in August of 2000

 

 
Mohammed Ali Al-Bayati

Ph.D., DABT, DABVT

Toxicologist & Pathologist

 

Toxi-Health International

150 Bloom Dr.

Dixon, CA 95620

 

Phone: (707) 678-4484

Fax: (707) 678-8505

 

maalbayati@toxi-health.com

http://www.toxi-health.com

 

 

 

 

Date of preparation

 

 

3/23/2004

 


 

Table of Contents

 

Title Page…………………………………………………………………………………1

Table of Contents………………………………………………………………………...2

List of Tables………………………………………………………………………….….4

Summary………..……………………………………………..….………………………5

 

Section I. Review of Crystal Dawn Quirello’s Medical Records

During Her Pregnancy With Robert and After Delivery……………………………12

 

I-A. Crystal’s health condition during her pregnancy……………………………….12

I-B. Crystal’s premature labor and her treatment with corticosteroid……………….13

      I-C. Crystal’s post delivery diabetes and her treatment with micronase…………….13

     

Section II. Review of Robert Quirello’s Medical Records From

                His Birth on March 22nd to August 2nd, 2000………………………………14

 

II-A. Robert’s treatment with corticosteroid and his exposure

         to micronase in milk……………………………………………………………14

II-B. Robert’s symptoms induced by his treatment with             

           corticosteroid…………………………………………………………………14

 

II-B1. Polyurea…………………………………………………………………..15

            II-B2. Gastrointestinal and feeding problems……………………………………15

II-B3. Excessive weight gain…………………………………………………….15

II-B4. Muscle weakness…………………………………………………………16

II-B5. Vision problems…………………………………………………………..17

 

     II-C. Vaccines given to Baby Robert and his thymic atrophy………………………..17

 

     II-D. Adverse reactions to vaccines given to Baby Robert…………………………..19

 

Section III. Review of Robert Quirello’s Medical Records During His

                 Hospitalization on August 2nd Through 10th, 2000………………………22

 

III-A. Case history and treatments given by the emergency

                       teams on August 2nd……………………………………………………22

 

III-A1. History given by Brian Herlihy………………………………..22

III-A2. Treatment given by the emergency teams……………………..23

 

III-B. Robert’s symptoms and treatments given at Shands

           Hospital on 8/2-10/2000……………………….………………………24

 

III-B1. Treatment at the emergency room……………………………….24

III-B2. Head and neck region CT scan results

            taken on August 2nd through August 4th …………………….…...24

III-B3. Robert’s symptoms and treatment given

            at the PICU on the morning of August 2nd……………………….25

III-B4. Robert’s heart problem…………………………………………..26

III-B5. Baby Robert’s metabolic and hematology

            values during his hospitalization…………………………………27

III-B6. Retinal bleed and other lesions observed in Robert’s eyes………30

III-B7. Treatments given to Baby Robert on

            August 2nd through the 10th………………………………………30

 

Section IV. Review of the Medical Examiner’s Autopsy Findings and Pathology

                    Reports…………………………………………………………….………33

 

IV-A. External examination of Robert’s body did not reveal bruises…………..33 

IV-B. The subdural hemorrhage indicates that the baby had

           pre-existing condition…………………………………………………….33

IV-C. The brain lesions indicate that the baby suffered from

           anoxia and ischemia………………………………………………………33

IV-D. Bleeding in the eyes………………………………………………………36

IV-E. Thymus atrophy…………………………………………………………...36

IV-F. Robert’s spleen weight appeared less than normal………………………..37

IV-G.  Inadequate examination of the heart……………………………………..37

 

Section V. Analysis of Clinical Events and Causes That Led to Baby Robert’s               

                 Respiratory Arrest and Death……………………………………………...38 

 

V-A. Events that led to Robert’s respiratory arrest on August 2nd, 2000………..39

V-B. The biomechanisms of Robert’s injuries…………………………………..40

V-C. Corticosteroids cause neurological problems in children………………….41

 

V-C1. Treatment with corticosteroid and neurological problems……….41

V-C2. The release of high levels of endogenous corticosteroid
           also causes neurological problems………………………………..43
                        V-C3. Abnormal changes in the nervous system caused by 
           corticosteroid can also be reproduced in experimental animals….44
 

            V-D. Corticosteroid causes cardiomyopathy in infants………………………….45

V-E. Corticosteroid causes hypertension, diabetes,

         and other systemic problems………………………………………..……..46

      V-F. Corticosteroid increases the risk for infections in infants………………….48

V-G. Corticosteroid causes retinopathy and other vision problems in  

         patients……………………………………………………………………..49

 

Section VI.  Brian Herlihy’s Jury Trial and Analysis of the Evidence Presented….50

 

  VI-A. Analysis of the testimonies given by the State’s expert witnesses………51

 

Section VII. Conclusions and Recommendations…………………………………….54

References……………………………………………………………………………….57

 

 

 

List of Tables

 

Table 1. Crystal’s body weights during her pregnancy with Robert………………….…12

 

Table 2. Robert’s growth measurements from birth through August 2nd, 2000…………16

 

Table 3. Robert’s vaccination history……………………………………………………18

 

Table 4.  Compositions of vaccines administered to Baby Robert

              two weeks prior to his respiratory arrest and seizure…………………………...18

 

Table 5. Baby Robert’s vital signs between 0938 and 0958 on August 2nd, 2000……….24

 

Table 6.  Indicators of myocardial infarction in Baby Robert’s blood…..………………27 

 

Table 7. Baby Robert’s serum chemistry values on August 2nd and August 3rd…..…….28

 

Table 8. Baby Robert’s metabolic parameters measured following his

              respiratory arrest……………………………………………………………….28

 

Table 9. Baby Robert’s hematology parameters measured following his

  respiratory arrest……………………………………………………………….29

 

Table 10. Partial list of medications given to

               Baby Robert in Shands Hospital………………………………………………32
SUMMARY

Brian Herlihy is a 32-year-old, white man.  He was accused of, and arrested for killing Baby Robert Benjamin Quirello by vigorous shaking in August of 2000. Robert was a four and a half month-old infant, who suffered from respiratory arrest while at Brian’s apartment on the morning of August 2nd, 2000. That day, Robert’s mother arrived at Brian’s apartment shortly after 0900. She asked him to watch the baby for a short time. He had cared for the baby on five occasions in the past, for a few hours per day. On August 3rd, 2000 Brian was arrested based on verbal communications between the treating physicians and the police, while the baby was still alive in the hospital. The treating physicians told the police that the baby was suffering from injuries caused by shaking. On August 10th, 2000 Baby Robert died.

Brian Herlihy’s jury trial was held in the Eighth Judicial Circuit in Alachua County, Florida on September 10th, 2002. His trial lasted sixteen days (Case No. 01-2000-CF-2753-A). The State claimed that Baby Robert Quirello was perfectly fine and that absolutely nothing was wrong with him when his mother brought him to Brian’s shortly after 0900 on August 2nd, 2000. The State asserted that while Baby Robert was alone with  Brian, he suffered from violent shaking which ultimately resulted in fatal neurological damage and his death. The State furthermore claimed that Brian punished Baby Robert because the baby was crying and that had annoyed, maddened, and frustrated him. 

In addition, the State alleged that Baby Robert was never lethargic or anxious from the time of his birth until the morning of August 2nd, 2000. Brian entered a plea of not guilty.  He stated that he took very good care of the baby and that he never harmed him in any way. However, in September of 2002, Brian was convicted of involuntary manslaughter in the death of Baby Robert and sentenced to 15 years in prison.

 

Brian Herlihy and his family requested that I evaluate the medical evidence in Baby Robert’s case in order to find the factual cause(s) that led to Robert’s respiratory arrest and death in August of 2000.  I evaluated Robert’s case by reviewing: The medical records of the mother during her pregnancy with him, Robert’s medical records, autopsy report, adverse reactions to medications and vaccines given to Robert, trial documents and testimonies of expert witnesses, and the medical literature pertinent to this case.  I used differential diagnosis to evaluate the contribution of agents relevant to this case and the possible synergistic actions among agents in causing Robert’s respiratory arrest, bleeding in the subdural space and retina, pathologic changes in the brain and other tissues, and his death.

 

I present my review of the mother’s medical records during her pregnancy with Robert in Section I. Section II contains a review and analysis of Baby Robert’s medical records from birth on March 22nd, 2000 up until the time of his respiratory arrest on August 2nd, 2000. I also elaborate upon and explain the adverse reactions to vaccines given to Robert in this section. In Section III, I illustrate the clinical events that occurred during Robert’s eight-day stay in the hospitals following his respiratory arrest, and my analysis of these events.

 

Furthermore, my review and analysis of the medical examiner’s autopsy report are presented in Section IV. In Section V, I define the pathogenesis of Robert’s illnesses and their contributions to his respiratory arrest. I also describe adverse reactions to corticosteroids in infants. My review and analysis of the testimonies given by the State’s expert witnesses are presented in Section VI. Section VII contains my conclusions and recommendations.

 

Robert’s mother, Crystal Dawn Quirello was involved in a serious car accident on January 10th, 2000 when she was at 26th weeks of gestation. Her abdominal region was struck by the steering wheel and she experienced pain in her back, legs, and arms along with severe cramping. She was hospitalized at Alachua General Hospital (AGH) for about one week and released. Then she had premature labor at the 34th week of gestation. She spent eight days in labor and Robert was born four weeks premature on March 22nd, 2000 with a broken collarbone.

 

Robert’s mother was treated with betamethasone (corticosteroid) during the last week of her pregnancy and due to this treatment Robert was exposed to corticosteroid in utero. It seems that Crystal developed diabetes as a result of her treatment with corticosteroid because she was treated with the anti-diabetic drug, micronase. Micronase is not recommended as a treatment in nursing mothers due to its risk of causing hypoglycemia in infants. However, she breast-fed Robert during her treatment with micronase.

 

Baby Robert suffered from serious health problems that resulted from his exposure to corticosteroid in utero and after birth. These include: gastrointestinal disturbance and reduction in food intake, polyurea, excessive weight gain, myopathy, neurological problems, brain atrophy, chronic subdural and retinal hemorrhage, vision problems, atrophy of the thymus, diabetes, and sinus and ear infections. These symptoms and lesions have been reported in infants treated with corticosteroids as I describe in Section V. However, none of the physicians who evaluated this case ever addressed this issue.

 

Furthermore, Baby Robert was given six vaccines on May 9th, 2000 and his vaccination with these six vaccines was repeated on July 19th. Premature babies are usually more susceptible to adverse reaction to vaccines than full term infants. Robert was born four weeks premature. Furthermore, vaccines should not be given to children treated with corticosteroid and other immunosuppressant agents. Robert suffered from severe thymic atrophy as a result of his treatment with corticosteroid and his thymus weight was less than 20% of normal for an infant of his age. Thymus weight is a very sensitive biomarker for exposure to corticosteroid. 

 

The vaccines given to Robert increased his susceptibility to infections. The baby suffered from sinus and ear infections as shown by his cerebral CT scans taken on August 2nd.  Also, DTP vaccines have been known to increase children’s risk of developing neurological disorders, such as encephalopathy or complicated convulsion(s).

 

Baby Robert suffered from respiratory arrest on August 2nd, 2000 between 0920 and 0935 and the events that led to his respiratory arrest can be explained as follows: 1) Baby Robert suffered from a seizure prior to 0935 and his seizure resulted from a neurological problem and brain atrophy caused by his prenatal and postnatal treatment with corticosteroids. In addition, the vaccines received on July 19th, 2000 might have also played a role in triggering the seizure. 2) The severe seizure caused the baby to vomit and thereby blocked his airway with fluids, which subsequently led to his respiratory arrest. The baby vomited a significant amount of formula like fluid. In addition, the paramedic used a vacuum to remove about 10 mL of formula fluid from his mouth and nose.  The baby had been fed approximately 8 ounces of formula milk within 30 minutes prior to his seizure.

 

Baby Robert suffered from respiratory arrest for at least 60 minutes and that led to severe anoxia, which caused brain and cardiac damage. In addition, the baby suffered from a chronic subdural bleed and retinal bleed as a result of his treatment with corticosteroid. Corticosteroid given at high doses induces diabetes, hypertension, brain atrophy, and increases capillary fragility and abnormal vascular growth in the retina. Glucocorticoid causes hypertension and cardiovascular disease due to its capacity to promote sodium retention and increase blood pressure.

 

The cerebral CT scan taken on August 2nd, 2000 at 1028 showed that Robert had a multi-generation subdural bleed. The fresh bleed was estimated to be 20-25% of the total bleed. The occurrence of the fresh bleed in the subdural space on August 2nd can be explained by the synergistic actions of several factors. These include: 1) the presence of previous vascular injury in the subdura which led to re-bleeding. 2) Robert suffered from a severe seizure that led to an increase in the intracranial pressure. 3) Robert had an elevated heart rate and that led to increased blood pressure. Robert’s pulse rate was 172 at 0938 on August 2nd.  4) Robert was given relatively large volumes of fluid by intravenous route   and that can lead to an increase in the blood pressure.

 

The retinal bleed and other retinal vascular changes observed by Dr. Lawrence Levine on August 2nd can be explained by Robert’s treatment with corticosteroid and diabetes. These conditions have been known to cause retinopathy and retinal hemorrhage as described in Section V.

 

The medical examiner and the State’s expert witnesses alleged that Baby Robert’s respiratory arrest, neurological damage, and death were caused by violent shaking while he was at Brian Herlihy’s apartment prior to 0937 on August 2nd, 2000. However, none of these physicians reviewed the baby’s prenatal and postnatal medical records to learn about his pre-existing health problems, his treatment with corticosteroid, or his adverse reactions to corticosteroid and vaccines. 

 

Review of the medical evidence in this case revealed that some of these physicians were aware that Baby Robert was suffering from chronic health conditions such as a chronic subdural bleed, brain atrophy, and sinus and ear infections. However, they did not make any attempt to investigate the links between the baby’s chronic illnesses and his respiratory arrest on the morning of August 2nd, 2000. The following is a list of medical evidence that verifies that the State’s expert witnesses conducted an incomplete medical investigation in this case and that they rushed to judgment in accusing Brian. Their conclusions that the baby died as a result of shaking were based solely upon a theory and not on medical facts.

 

1) The emergency teams, several physicians, and the medical examiner examined the baby on August 2nd through August 10th and they did not find any sign of injuries on the baby’s head or body that was caused by trauma or abuse.

 

2) The four cerebral CT scans taken from August 2nd through August 4th indicated that Baby Robert was suffering from a chronic subdural bleed. However, none of the physicians who testified for the State ever investigated the causes of the bleed. Furthermore, the medical examiner did not take a sample from the dura to be examined under the microscope in order to date the bleed.  The data described in Section V of this report shows that prenatal and postnatal treatments of infants with corticosteroid have caused hypertension, hyperatrophic cardiomyopathy, encephalopathy, and an increase in capillary fragility; these conditions can lead to subdural bleeding. Robert had been treated with corticosteroid.

 

3) The treating physician, Dr. Dickison and the neuropathologist, Dr. Nelson were aware that Baby Robert suffered from brain atrophy but they did not investigate the cause(s) of the atrophy or the link between the atrophy and the baby’s seizure and respiratory arrest that occurred on August 2nd. Dr. Dickison stated that “the baby had a smaller brain than the size of the skull, meaning that there was probably some atrophy or wasting of the surface of the brain or that the brain was not growing as rapidly as it should have been”. Dr. Nelson also commented that “Robert’s brain was an immature brain and it is inconsistent with a brain of a child of four and a half months of age”.

 

It has been reported that premature infants treated with dexamethasone exhibited a 30% reduction in total cerebral tissue volume when compared to both control term infants and premature infants not treated with dexamethasone. Furthermore, dexamethasone administered postnatally to infants has demonstrated increased risk of neurologic impairment, neurodevelopmental disability, and the rate of cerebral palsy in preterm infants and later in survivors. Baby Robert was treated with high therapeutic doses of corticosteroid as indicated by the severity of his thymic atrophy.

 

4) At autopsy, the lesions observed in Robert’s brain consisted of edema and cell necrosis, which were caused by severe global anoxia and ischemia and not by trauma. The baby was not breathing well for at least 60 minutes. Brian found the baby was not breathing at 0937 on August 2nd.  Additionally, Dr. Dickison found the baby was not breathing well at approximately 1100 because the baby was suffering from a severe seizure and his tongue was very stiff blocking the airways. 

 

5) Dr. John Hellrung, Baby Robert’s pediatrician stated during Brian’s trial that the baby was normal. However, his examinations showed that the baby suffered from excessive weight gain, polyurea, muscle weakness in the neck region, neurological and possible vision problems. The baby had poor head and neck control, decreased muscle tone in the shoulders and neck, and tight hip flexors. In addition, the baby’s tracking with his eyes was not consistent following an object more than a hundred degrees. These symptoms have been reported in infants treated with corticosteroid.

 

6) Dr. Hamilton, the medical examiner found that the weight of Robert’s thymus was 4 grams, which is about 20% of normal.  However, he stated that Robert’s thymus was normal. The average thymus weight (g) in a white infant male at Robert’s age (4-1/2-month old) is expected to be about 22.5g. The treatment with corticosteroid causes immune depression as measured by the reduction in the size and the functions of the lymphoid tissues. It is clear that the medical examiner overlooked an extremely important biological indicator that showed Baby Robert was suffering from severe adverse reactions to corticosteroid.

 

7) Dr. Lawrence Levine examined the baby’s eyes and found retinal hemorrhage, white spots in the back of the eye, (which he called “Purtscher’s retinopathy”), and a crack in the back of the eye, (which he referred to as a choroidal rupture). He claimed that the above lesions were caused by trauma, but his examination of the eyes and eyelids did not reveal any sign of external injuries caused by trauma.

 

The findings of several studies in Section V show that the treatment of children and adults with corticosteroid caused retinopathy, hypertension, diabetes, and increased capillary fragility. Hypertension and diabetes are also known to cause retinopathy. The baby was treated with high doses of corticosteroid and suffered from diabetes. It is very clear that Dr. Levine overlooked crucial medical evidence that demonstrated the link between the baby’s treatment with corticosteroids and the lesions found within the retina.  

 

The extensive medical evidence presented in this report clearly shows that Baby Robert died as a result of adverse reactions to corticosteroid and vaccines. Brian Herlihy is innocent. The evidence also shows that Brian was wrongly convicted and imprisoned as a consequence of sloppy and incomplete medical investigations.  I believe that the state of Florida has the responsibility to review the evidence presented in this report.  The State should furthermore take immediate action to free him from prison. In addition, Brian should be reimbursed for all incurred legal expenses and he should also be compensated for his pain and suffering. 

 

The objective of the State and physicians should be to focus on determining the factual causes that lead to the illness or death of a child so that they can prevent such problems from happening to other children. Accusing innocent people of abusing and killing children based on a faulty theory that has no medical or scientific evidence to support its claims will not prevent the death of other children by vaccines and adverse reactions to medications. However, it certainly places innocent people in prison and causes great suffering. It also costs taxpayers huge sums of money to pay for unnecessary trials and legal fees.

 

I spent approximately 280 hours evaluating the medical evidence in this case in order to find the factual causes of injuries and death and to write this detailed report. I have also evaluated three other alleged ‘Shaken Baby Syndrome’ cases from the USA within the last 12-month period involving children, who died as a result of adverse reactions to medications and vaccines. In all of these cases, either the parent or caretaker was falsely accused of killing them by shaking and consequently imprisoned.

 

 It is my hope that the state of Florida, the Federal Government, physicians, and our society will take the time to review the evidence presented in these cases.  The government and American Medical Association have an obligation to act immediately as the theory behind the Shaken Baby Syndrome diagnosis must be re-evaluated. The theory itself is unsupported by science. Differential diagnosis must be used to solve complicated medical problems, as I have used in these cases in order to determine the factual causes of the presenting symptoms, illnesses and death.

 

Section I. Review of Crystal Dawn Quirello’s Medical Records During Her Pregnancy With Robert and After Delivery

 

I-A. Cystal’s health condition during her pregnancy

 

Baby Robert’s mother, Crystal Dawn Quirello is a white female. She was 20-years old at the time of her pregnancy with Robert in July of 1999. She was born on August 26th, 1979. During her pregnancy with Robert, Crystal suffered from severe nausea for several months (September 21st, 1999 through January 13th, 2000) and she was treated with phenergan, (anti-nausea drug). Crystal was involved in a serious car accident on January 10th, 2000, at 26th weeks of gestation. She rear-ended a car that was making a turn in front of her and the front of her car was badly damaged. Her abdominal region was struck by the steering wheel and she experienced pain in her back, legs, and arms along with severe cramping. She was hospitalized at Alachua General Hospital (AGH) for about one week and was released [1,2].

 

Crystal only gained two-and-half-pounds during her entire pregnancy with Robert (Table 1). She reached her highest body weight of 120 pounds at the 34th week of gestation. She lost three pounds between the 34th and 35th week of gestation as a result of problems with her pregnancy, which was the result of her car accident a few weeks earlier (Table 1).

 

Table 1. Crystal’s body weights during her pregnancy with Robert

Date                    Weeks of gestation            Weight (lb)

                                          Pregravid                    115.0       

9/13/1999                            9                                110.5

9/30/1999                          11                                110.5

10/28/1999                        15                                107.5              

12/27/1999                        24                                116.0

1/18/2000                          27                               115.0

1/24/2000                          28                               117.5

2/7/2000                            30                               117.5        

2/21/2000                          32                               119.0       

3/6/2000                            34                               120.8       

     3/14/2000                           35                               117.5     

 

I-B. Crystal’s premature labor and her treatment with corticosteroid

 

I believe that Crystal’s car accident on January 10th induced premature labor. At 35 weeks of gestation, Crystal had a premature contraction and she was treated with btamethasone (corticosteroid) to mature the baby’s lungs [3]. Her labor was induced by medication and she was in labor for eight days. Baby Robert was born premature at the 36th week of gestation on March 22nd, 2000 with a broken collarbone. His Apgar scores were eight at one minute and nine at five minutes [4]. The baby and his mother stayed in the hospital for three days and were released.

 

I-C. Crystal’s post delivery diabetes and her treatment with micronase

 

Based on blood and urine tests performed during Crystal’s pregnancy on January 24th, 2000 and March 3rd, 2000 respectively, Crystal’s medical record indicates that she did not suffer from gestational diabetes during her pregnancy.  However, her medical record shows that she was treated with an anti-diabetic drug, micronase (glyburide) after delivery.  She was advised to stop taking micronase on June 8th, 2000 [1].  It seems that Crystal developed diabetes following her treatment with corticosteroid. The baby also developed diabetes as a result of the corticosteroid treatment. Crystal took micronase during the period when she was breast-feeding Baby Robert. 

 

Micronase (glyburide) is an oral blood-glucose-lowering drug of the sulfonylurea class.

Glyburide appears to lower the blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Single dose studies with micronase tablets in normal subjects demonstrate significant absorption of glyburide within one hour and it reached a high peak level at about four hours. The blood glucose lowering affects generally persist for 24 hours following a single morning dose of micronase in non-fasting diabetic patients [5, page 2496].

 

Some sulfonylurea drugs are excreted in human milk. In nursing infants, the potential for developing hypoglycemia exists, therefore, treatment of nursing mothers with micronase is not recommended during the breast-feeding period [6]. In addition, the safety of micronase in children has not yet been established [5].

 

Section II. Review of Robert Quirello’s Medical Records From His  Birth on March 22nd to August 2nd,  2000

 

II-A. Robert’s treatment with corticosteroid and his exposure to micronase in milk

 

Baby Robert was born four weeks premature on March 22nd, 2000 and his mother was treated with betamethasone (corticosteroid) during the last week of her pregnancy [3]. Betamethasone was given to reduce the baby’s risk of developing chronic respiratory disease. Robert’s mother was in labor for eight days and the baby was born with a broken collarbone. The baby’s birth weight was 5 pounds and 14 ounces. The mother and the baby stayed in the hospital for three days and then were released. The baby was noted to have some difficulty latching onto the mother’s breast [1].  

 

Three days following birth, Robert’s mother noticed that the baby’s lips and the inside of his cheeks were yellow. He suffered from mild jaundice. The baby was breast-fed between March 27th and June 8th, 2000 and he was also fed formula milk as a supplement during this period.  Robert’s mother was taking the anti-diabetic drug, micronase, which is not recommended as a treatment in nursing mothers because of the associated risk of causing hypoglycemia in infants. However, she breast-fed Robert during her treatment with micronase [1]. Robert’s mother was also put on the progesterone pill as birth control on May 9th, 2000.

 

II-B. Robert’s symptoms induced by his treatment with corticosteroid

 

My review of Baby Robert’s medical records revealed that he suffered from serious health problems that directly resulted from his exposure to corticosteroid in utero and after birth [1, 3]. These include:

 

 

 

II-B1. Polyurea

 

    Baby Robert had polyurea as a consequence of his treatment with corticosteroid. On April 17th, 19th, and 26th, 2000, his grandmother stated that she was changing wet diapers 8-10 times per day. Robert’s grandmother was his principle caretaker during most of his life because his parents were working [7].  It is possible that the baby had diabetes at that time. On August 2nd, 2000, his blood glucose level was 317 mg/dL and he also suffered from glycosuria [8].

 

II-B2. Gastrointestinal and feeding problems

 

On April 13th and 19th, 2000, Baby Robert’s grandmother stated that the baby was spitting formula milk frequently and he did not have a bowel movement from April 13th through the 17th. On June 6th, she also stated that the baby was feeding poorly. On July 19th, the baby was treated with mylocon to relieve his problem with intestinal gas. Treatment of infants with corticosteroid is known to cause gastrointestinal problems as described in Section V of this report.

 

II-B3. Excessive weight gain

 

     Baby Robert gained excessive weight between April 17th and August 2nd. He gained 10 pounds and 7 ounces in 136 days as shown in Table 2. His weight at four months and twelve days was about 3.5 times his birth weight. The approximate weight gain for an infant should be one ounce per day and 2 pounds per month during the first three months of life and 1 and ¼ pound per month between three to six months of age [9]. The approximate weight gain for Baby Robert should not have been more than 7 and ½ pounds during his life.

 

His abnormal weight gain was very obvious. On April 19th, his pediatrician reported that Robert gained 8 ounces in two days. On May 9th, 2000, his body weight indicated that he had gained 23 ounces in two weeks, which is twice the normal weight gain for a baby at his age. On May 9th, he was six weeks old. He was average in length, slightly below average weight, and slightly above average in head circumference (75%). However, on July 19th, 2002, his height was in the 75th percentile, his weight was in the 80th percentile, and his head size was within the 85th or 90th percentile. He was already larger than the average baby at his age who was not born premature [10, 11]. 

 

The baby experienced rapid weight gain in spite of his feeding and gastrointestinal problems described above. His rapid weight gain is one of the signs of corticosteroid toxicity that was due to water and salt retention, and disturbance in fat, protein, and carbohydrate metabolism. His weight gain was not due to building muscle mass. Robert’s serum creatinine values on August 2nd and 3rd, 2000 were less than 25% of normal values and they indicated that Baby Robert was suffering from a muscle wasting problem [8]. Muscle wasting and rapid weight gain are signs of adverse reactions of treatment with high therapeutic doses of corticosteroid.

 

Table 2. Robert’s growth measurements from birth through August 2nd, 2000

Date                     Age               Weight          Height          Head    

                           Months                                  Inches       Circumference (cm)

3/22/2000            birth          5 lb and 14 oz

3/27/2000                             5 lb & 8 oz

4/5/2000               0.5           6 lb                     20                35.5

4/17/2000                             6 lb and 9 oz 

4/19/2000             1.0            7 lb & 1 oz         21.5           

4/26/2000                              7 lb & 10 oz

5/9/2000                               9 lb & 1 oz         22                39.0     

6/6/2000                               12 lb

7/19/2000              4             15 lb & 12 oz     25.5            43.5

8/2/2000                               17 lb 8 oz           26.4           

8/10/2000                                                                          43.1

 

II-B4. Muscle weakness

 

Baby Robert exhibited muscle weakness in the neck region. His doctor’s exam on May 9th, 2000 revealed that he had poor, floppy neck control. The nurse also noted that the baby had tight hip flexors on June 6th.  The baby had decreased muscle tone in the shoulders and neck.  He still was not holding his head up in prone position on June 6th and July 19th, 2000 [11]. His very low serum creatinine values measured on August 2nd and 3rd confirmed that the baby was suffering from muscle wasting illness.

 

II-B5. Vision problems

 

On May 9th, 2000, the pediatrician’s nurse noted that his tracking with his eyes was not consistent, following an object more than a hundred degrees [11]. Treatment of infants with high therapeutic doses of corticosteroid has been known to cause retinopathy, encephalopathy, diabetes, hypertension, and increased capillary fragility; all of these problems can cause vision problems. At autopsy, Robert’s thymus weight was about 20% of the normal weight for a baby at his age. Thymus weight is a very sensitive biomarker for the effect of corticosteroid. Exposure to high levels of corticosteroid causes thymic atrophy as described below (II-C).

 

II-C. Vaccines given to Baby Robert and his thymic atrophy

 

Baby Robert was given six vaccines on May 9th, 2000 and his vaccination with these six vaccines was repeated on July 19th as shown in Table 3. The compositions of these vaccines are presented in Table 4. Premature babies are generally more susceptible to adverse vaccine reactions. Robert was born four weeks premature. Furthermore, vaccines should not be given to children treated with corticosteroid and other immunosuppressant agents.  Baby Robert exhibited severe thymic atrophy as described below.

 

At autopsy, Baby Robert showed severe thymic atrophy. His thymus weight was 4 grams, which was about 20% of normal [12]. The average thymus weight (g) in a white infant male at three months and six months of age were found to be 20 and 25, respectively [13]. Baby Robert was 4-1/2-months-old and his thymus weight should have been approximately 22.5 g. Treatment with corticosteroid causes immune depression as measured by the reduction in size and function of the lymphoid tissues.


 

Table 3. Robert’s vaccination history

 

Date            Age (months)                   Vaccines given

5-9-2000       1.5               DTaP (Diphtheria & Tetanus Toxoids and acellular Pertussis)

                                          OPV/IPV (Oral Polio vaccine) 

                                          Hib (Haemophilus Influenzae B)

                                          Hep B (Hepatitis B)

 

7/19/2000      4.0             DTaP (Diphtheria & Tetanus Toxoids and acellular Pertussis)

                                        OPV/IPV (Oral Polio vaccine) 

                                         Hib (Haemophilus Influenzae B)

                                        Hep B (Hepatitis B)

 

 

Table 4.  Compositions of vaccines administered to Baby Robert at two weeks prior to his respiratory arrest and seizure*

__________________________________________________________________

 

Vaccine                      Compositions

__________________________________________________________________

 

DTaP                         Each dose (0.5 mL) contains 0.625 mg aluminum; 25

                                  Diphtheria toxoid; 10 tetanus toxoid; 25 mg pertussis toxin;

                                  25 mg filamentous  hemagglutinin; 8 mg pertacin; 2.5 mg

                                              2-phenoxyethanol; 4.5 mg sodium chloride; and 0.1 mg

                                              formaldehyde. 

 

Hepatitis B                 Each dose (0.5 mL) contains 0.25 mg aluminum;

                                  10 mg of hepatitis B antigen; 4.5 mg sodium chloride;

                               25 mg thimerosal (organic mercury); 0.49 mg disodium   

                               phosphate dihydrate; and 0.35 mg sodium dihydrogen

                               phosphate dihydrate.

 

HIB                             Each dose (0.5 mL of 0.4% sodium chloride solution)

                                    contains 10 mg of purified Haemophilus capsular   

                                    polysaccharide.

 

OPV                            Each dose (0.5 mL of buffered solution) contains less than 

                                    25 mg of each of the antibiotics (streptomycin and                  

                                     neomycin) and attenuated poliovirus.

    *Described in the Physicians’ Desk Reference [5].

 

 

 

 

II-D. Adverse reactions to vaccines given to Baby Robert

 

Serious adverse reactions to the vaccines given to Baby Robert (Tables 3 and 4)  requiring medical intervention (such as apnea and cardiac problems) are commonly observed in preterm infants. Baby Robert was born four weeks premature and he was suffering from severe immune depression as indicated by his thymus weight measured on August 10th.  Vaccination is not recommended in children who have been treated with corticosteroids and other immunosuppressant compounds.

 

Furthermore, the authors of many well-documented studies concluded that the risk and benefit of vaccination in preterm infants should be evaluated prior to administering the vaccines. They also emphasized that preterm infants who receive vaccines should be monitored. The following are descriptions of several selected studies conducted in the USA and other countries that describe adverse vaccine reactions in preterm infants.

 

1)      Case histories of 45 preterm babies who were vaccinated with DTP/Hib (diphtheria, tetanus toxoids, and pertussis/Haemophilus influenzae type B conjugate were studied retrospectively [14]. Apparent adverse events were noted in 17 of 45 (37.8%) babies: 9 (20%) had major events, i.e., apnea, bradycardia or oxygen desaturations, and 8 (17.8%) had minor events, i.e., increased oxygen requirements, temperature instability, poor handling and feeding intolerance. Age at vaccination of 70 days or less was significantly associated with increased risk (p < 0.01). Of 27 babies vaccinated at 70 days or less, 9 (33.3%) developed major events compared with none when vaccinated over day 70.

 

The authors concluded that vaccine-related cardiorespiratory events are relatively common in preterm babies. Problems were much more common when the vaccine is administered at or before day 70. Therefore, these babies should be monitored post-vaccination. Baby Robert was given six vaccines at 46 days of age and his vaccination with these vaccines was repeated at four months of age (Table 3). At this time the baby was suffering from severe thymic atrophy. 

 

2) After the occurrence of apnea (a respiratory pause of 20 seconds) in two preterm infants following immunization with DTP and Hib, Sanchez et al. conducted a prospective surveillance of 97 preterm infants (50 girls, 47 boys) younger than 37 weeks of gestation who were immunized with DTP (94 also received Hib at the same time) to assess the frequency of adverse reactions, and, in particular, the occurrence of apnea. For each infant, data were recorded for a 3-day period before and after receipt of the immunization [15]. Their study showed that apneic episodes occurred in 34 infants (34%) after immunization. Twelve infants (12% of total) experienced a recurrence of apnea, and 11 (11%) had at least a 50% increase in the number of apneic and bradycardiac episodes (heart rate less than 80 beats/min) in the 72 hours following immunization. Some of these infants required new medical interventions for the increased episodes [15].

           

3) Botham et al. conducted a prospective study of 98 preterm infants (53 males, 45 females), of gestational age 24-31 weeks who were immunized at approximately 2 months postnatal age with diphtheria-tetanus-whole-cell pertussis vaccine (DTPw). Half the infants also received Haemophilus influenzae type b conjugate vaccine (Hib) simultaneously [16]. All infants were monitored for apnea and bradycardia during the 24-hour pre- and post-immunization periods.

 

The study showed that only one infant had apnea and/or bradycardia pre-immunization, compared with 17 post-immunization. For 12 infants these events were brief, self-limiting and not associated with desaturations (oxygen saturation < 90%). However, for five infants (30%), these events were associated with oxygen desaturation, and two of these infants required supplemental oxygen. When considering immunization for preterm infants, the benefits of early immunization must be balanced against the risk of apnea and bradycardia [16].

            

4) Slack et al. reported that four premature infants developed apnea severe enough to warrant resuscitation after immunization with diphtheria, tetanus, pertussis (DTP), and Haemophilus influenzae B (Hib). One required intubation and ventilation. They also reported that although apnea after immunization are recognized they are not well documented [17].    

 

5) Botham et al. conducted a prospective study of 97 preterm infants who were immunized with diphtheria-tetanus-pertussis to document respiratory and cardiac events [18]. The mean gestational age at birth was 28.1 weeks (range 24-34) and the mean age at immunization was 80.6 days (range 44-257). They found that nineteen (20%) infants developed apnea or bradycardia within 24 hours of immunization. Two infants who developed concurrent upper respiratory tract infections required additional oxygen, and one of them was treated with oral theophylline.            

 

Adverse reactions of vaccines that were administered to Baby Robert are not limited to preterm infants. They have also been reported in full term infants. Below are brief descriptions of selective studies that describe the incidence of illnesses associated with vaccinations in children. Some of these studies are described in the Physicians’ Desk Reference [5].

 

1)      In the USA, reports submitted to the Vaccine Adverse Event Reporting System (VAERS), concerning infant immunization against pertussis between January 1, 1995 and June 30, 1998 were analyzed. During the study period, there were 285 reports involving death, 971 nonfatal serious reports (defined as events involving initial hospitalization, prolongation of hospitalization, life-threatening illness, or permanent disability), and 4,514 less serious reports after immunization with any pertussis-containing vaccine [19].    

 

2) Systemic adverse events occurring within 3 days following vaccination of 4,696 Italian infants with DTP at 2, 4, and 6 months of age were recorded. These included fever of more than 100.4 F in 7% of total; irritability in 36.3%; drowsiness in 34.9%; loss of appetite in 16.5%; vomiting in 5.8%; and crying for 1 hour or more in 3.9% [5, p. 3063].

 

3) The whole-cell DTP vaccine has been associated with acute encephalopathy [5]. A large case-control study that included children 2 to 35 months of age that suffered from serious neurological problems was conducted in England. Acute neurological disorders, such as encephalopathy or complicated convulsion(s) occurred in children who were more likely to have received DTP vaccine the 7 days preceding onset than their age-matched controls. Among children presumed to be neurologically normal before entering the study, the relative risk (estimated by odds ratio) of a neurological illness occurring within a 7-day period following receipt of DTP dose, compared to children not receiving DTP vaccine in the 7-day period before onset of their illness, was 3.3 (p< 0.001).

 

4) Three hundred sixty-five infants were inoculated with Hib, and some of them developed systemic adverse reactions. The following adverse reactions and their percentages occurred in two-month-old infants during the 48 hours following inoculation: Fever > 100.8 F (0.6%); irritability (12.6%); drowsiness (4.9%); diarrhea (5.2%); and vomiting (2.7%) [5, p. 2318].

 

5) The database from the 1994 National Health Interview Survey (NHIS) in the USA that included 6,515 children less than six years of age who received the hepatitis B vaccine were analyzed to evaluate the vaccine related adverse reactions. Hepatitis B vaccine was found to be associated with prevalent arthritis, incident of acute ear infections, and incident of pharyngitis/nasopharangitis [19].

 

The above selected studies clearly show that serious health problems and even death can result from vaccinating infants and children, especially among premature infants and infants suffering from pre-existing conditions. The authors of these studies emphasized that premature infants should be monitored following the administration of vaccines. Furthermore, the Physicians’ Desk Reference states that vaccines should not be given to children treated with corticosteroid compounds [5].

 

Fourteen days prior to Baby Robert’s respiratory arrest on August 2nd, he was given six vaccines. At the time the infant was administered these vaccines on July 19th, he was suffering from severe immune depression as indicated by his thymus weight measured on August 10th, 2000. The CT scan taken on August 2nd of the head region showed that Robert had bilateral sinus and ear infections. The vaccines given to Robert on July 19th increased his risk of contracting sinus and ear infections and also predisposed him to have the seizure on August 2nd. Baby Robert additionally suffered from brain atrophy as a result of his treatment with corticosteroid [8].

 

 

Section III. Review of Robert Quirello’s Medical Records During His

Hospitalization on August 2nd Through 10th, 2000

 

III-A. Case history and treatments given by the emergency teams on August 2nd

 

III-A1. History given by Brian Herlihy

Robert’s mother, Crystal went to Brian Herlihy’s apartment with her 4 ½ month old, Baby Robert shortly after 0900 on August 2nd, 2000.  She fed the baby four ounces of formula milk and left the apartment at about 0920 leaving the baby with Brian. Brian is a white male and in August of 2000, he was 29 years old. He had cared for Baby Robert in the past on five occasions, for a few hours each time.

 

Brian fed the baby approximately four ounces of formula milk. The mother laid the baby on his back between two pillows on the bed, and left the room. After about five minutes, Brian returned to find the infant on his back at the end of the bed with his nose angled towards the floor. Baby Robert’s head was lower than his body and his head was wedged between the mattress and the bars of the footboard [20]. He gently tugged on the infant in order to free his head.

 

The infant vomited formula milk on the floor near the bed and on the bed covering an area of about 4-6 inches in diameter. The baby was not breathing [21]. Brian left the baby on the bed and called 911 at 0935 asking for help. Brian told the person who took the 911 call that the baby was draining white fluid like formula milk from his mouth and his nose. The baby was also coughing [22]. Brian was instructed by 911 personnel to place the baby on the floor and to begin CPR. Brian then proceeded to perform mouth-to-mouth resuscitation.  No chest compressions were administered.

 

 

 

III-A2. Treatments given by the Emergency Teams

 

The Alachua County Fire Rescue teams (EMTs) arrived on the scene at 0937 and found the baby lying on his back on the bedroom floor. Baby Robert was unconscious, unresponsive, and he was not breathing. His color was ashen gray. The baby was throwing up white milky fluid from his mouth. They bagged the baby and provided him with 100% oxygen and his blood oxygen saturation came up from 84% to 100%.

They then placed a cardiac monitor on the baby and it revealed a sinus tachycardia at the rate of 170 beats per minute. The baby had palpable pulses in all distal extremities.

 

In addition, the EMTs placed a line in the baby’s right tibia and gave him a 100 cc of fluid. The baby’s body weight was 6.8 kg.  Brian was very upset and he stated that the baby had vomited and aspirated. The EMTs did not see any signs of struggle in the bedroom or elsewhere. No bruises or abrasions were noted on the baby’s head, trunk, flank, back or extremities [21].

 

A second emergency team from the Gainesville Fire Department arrived at Brian’s apartment at 0943 and also found the baby not breathing [23]. Kenneth A. Johnson, the firefighter and paramedic responsible for the EMTs, stated that the baby was pale, white and unresponsive. He removed about 10 cc of red and clear mixed liquid from the baby’s nose and mouth using a suction unit. The baby had a pulse rate of 190 per minute and sinus tachycardia [24]. Table 5 shows the baby’s vital signs during the rescue on August 2nd.

 

Seven minutes after arrival, the EMTs managed to improve the baby’s condition. The  baby started to breathe on his own, but it was not sufficient to sustain his life.  At 0955 the baby was placed on a backboard and was transported to the hospital. He showed some improvement on the way to the hospital. His skin color became pinkish and his respiratory efforts increased. The baby made the first audible sounds when he was wheeled into Shands Hospital at 0958 [23, 24]. 

 

 

Table 5. Baby Robert’s vital signs between 0938 and 0958 on August 2nd, 2000

--------------------------------------------------------------------------------------

Time           Pulse   Blood           Respiration          Heart condition

                              Pressure       Rate/min.

------------------------------------------------------------------------------

0938           172      80                0                           Sinus Tachycardia

0944           190      70                0                           Sinus Tachycardia

0955           190      70                5                           Sinus Tachycardia

0955           180      70                12                         Sinus Tachycardia

0958           160      70                20                         Sinus Tachycardia

  

 

 III-B. Robert’s symptoms a