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I am a Missouri licensed pediatrician practicing in St. Louis County, Missouri. I am a native of Nashville,
Tennessee and graduated from Vanderbilt University Medical School. I have been certified by the
American Board of Pediatrics in both pediatrics and neonatology. I am a fellow of the American
Academy of Pediatrics. I have had a private practice in pediatrics for thirty years and served as Chief of
Pediatrics at Missouri Baptist Medical Center from 1990 to 2018. I hold the title of Professor of Clinical
Pediatrics at Washington University School of Medicine and teach residents in my clinic. My curriculum
vitae and list of recent cases in which I have provided testimony are submitted hereafter.
I have been retained by Branstetter, Stranch & Jennings, PLLC, to render opinions about the diagnosis
and prognosis of Baby Doe, a minor.1 I have been provided the usual and customary documents
including but not limited to the child’s medical records. For the basis of my opinions I rely on my
education and training, my experience as a neonatologist and pediatrician, and my tenure as Chief of
Pediatrics and Missouri Baptist Medical Center, during which I oversaw the implementation of a
Neonatal Abstinence Syndrome (NAS) protocol and policies. All of the opinions which I render are more
likely than not within a reasonable degree of medical certainty.
Baby Doe was delivered by Cesarean section at Holston Valley Medical Center in Kingsport, Tennessee
on . His mother had been prescribed Subutex, an opioid, so Baby Doe was managed
according to the hospital’s NAS protocol. Further screening per protocol revealed that he had also been
exposed in utero to clonazepam and nicotine but did not suffer from any co-morbid infection or other
condition that might complicate or masquerade as NAS. Baby Doe was evaluated every three hours
during his hospitalization using the Finnegan Neonatal Abstinence Scoring System. Not only did his score
reach the severe level, at one point he manifested sixteen of the twenty-one monitored symptoms.
Baby Doe required placement in the Neonatal Intensive Care Unit, not only for the increased nursing
attention, but also for administration of intravenous fluids and nasogastric tube feedings. He required
treatment with both morphine, clonidine, pantoprazole, and special formula. The length of his hospital
stay was twenty-four days, roughly three weeks longer than is typical for a baby delivered by Cesarean
section.
On Baby Doe was seen by his pediatrician, , for his three year check-
up. At that visit his grandparents expressed concern about abnormal behaviors: he exhibited outbursts
of anger and would throw tantrums and hit people; he was easily frustrated.
Baby Doe’s abnormal behavior, including impulsivity and emotional dysregulation, is a consequence of
his in utero opioid exposure and subsequent NAS. His injury is likely permanent but will have different
manifestations as he ages. He will benefit from evaluation and treatment by a pediatric behavioral
specialist (child psychiatrist, child neurologist, or developmental pediatrician). He will likely benefit from
1
My fee is $500 per hour ($600 for deposition testimony). My compensation is not dependent on the result of this
litigation.
This opinion is to a reasonable degree of medical certainty. I reserve the right to add to or alter my
opinions.
Introduction
Neonatal Abstinence Syndrome (NAS) is a withdrawal syndrome that occurs in newborns exposed to
opioids in utero. Management of newborns so affected requires prolonged hospitalization for nursing
care, social services evaluation, and medical evaluation and intervention. Children exposed to opioids in
utero (with or without NAS) are at risk for developmental abnormalities that require ongoing monitoring
and therapies throughout childhood (1,2).
The incidence of NAS in the United States increased almost five-fold between 2000 and 2014 (from 1.20
to 5.8 per 1000 live births). The incidence rate in Tennessee is among the highest in the country and is
three times the national average. Northeast Tennessee has been particularly affected with some counties
reporting NAS rates exceeding 60 per 1000 live births, more than ten times the national average (3,4).
The alarming rate of NAS in northeastern Tennessee is a public health crisis that is increasing health care
and educational costs while also straining foster care and other social services (4,5).
Screening
Beginning with the first prenatal visit, it is incumbent that obstetricians, family care physicians, and nurse
midwives screen every pregnant patient for use of alcohol and drugs, including prescribed opioids as well
as drugs of abuse. Mothers should be made aware that this screening is routine and should be done in a
non-judgmental caring fashion. There are several validated screening questionnaires including 4 Ps, NIDA
quick screen, and, CRAFFT – Substance Abuse Screen for Adolescents and Young Adults. Urine drug
screening may be appropriate as well. When a pregnant woman has been identified, she should be
counseled regarding her risky behavior, providing feedback and advice. Referral to drug abuse treatment
specialists or other services may be indicated (1).
Considering the extremely high incidence of maternal opioid use in northeastern Tennessee, all newborns
there should be screened for in utero exposure to opioids and other harmful drugs since universal
screening of pregnant women is imperfect and in utero exposure to opioids even without NAS may cause
permanent injury. The preferred method of screening is umbilical cord tissue analysis since the cord is
always available at birth and the results of the assay should be available before the baby is discharged
from the hospital. Umbilical cord testing provides a longer history of prenatal drug exposure but may also
detect drugs delivered during labor and delivery (2,6).
Neonatal Abstinence Syndrome
Symptoms typically become manifest two or three days after birth but may occur on the first day of life
or be delayed for a week and may continue for several weeks. NAS affects the central nervous system, the
autonomic nervous system, and the gastrointestinal tract. Symptoms may include excessive crying and
irritability, sleep disturbances, increased muscle tone and hyperactive reflexes, tremors, seizures, fever,
rapid breathing, nasal congestion, excessive sucking and other feeding problems, vomiting and diarrhea,
and gastroesophageal reflux (1,2). These babies are more likely to have low birth weight (7).
The appearance of NAS symptoms may mimic other disorders so in addition to screening for in utero
exposure to opioids and other drugs, evaluation for hypoglycemia, hypocalcemia, sepsis, or intracranial
hemorrhage may be indicated. When an infant is determined to have suffered in utero opioid exposure
further evaluation for co-morbid conditions such as Hepatitis C Virus exposure (7).
NAS victims often require prolonged hospitalization, accruing hospital and physician charges. Infants
exposed to opioids in utero require frequent monitoring for signs and symptoms of NAS performed by a
knowledgeable nurse. All of the babies require additional laboratory testing and many of them must be
treated with medications such as morphine. The babies often suffer from poor feeding which requires
longer interactions with the nursing staff and may require evaluation by an occupational therapist. Social
services evaluation during the hospital stay is mandatory and may also result in delayed discharge. In
addition to all of these extra costs incurred by the NAS patient, the increased work load may put a strain
on the resources available such as hospital rooms and nursing staff.
All mothers at risk for giving birth to infants with NAS and all infants diagnosed with NAS should be
enrolled in an intensive home visiting program. Because of the medically complex challenges posed by
NAS, home visits should be conducted by nurses trained to provide evidence-based assistance. Each
nurse should have a caseload of no more than ten families, with typical visits conducted at least weekly
from the time a mother or infant is determined to be at risk until the infant is school age. At risk
mothers who give birth to infants not suffering from NAS would cease to need the services of NAS
trained home visit nurses, but might benefit from other visiting programs which are beyond the scope of
this report (9).
Special evaluations should include audiologic, ophthalmologic, and psychosocial evaluations for each
child prior to school age, timing to be determined by the child’s primary care provider. Any
developmental delays that are determined during routine pediatric visits should prompt referral to the
Tennessee Early Intervention System and to a specialist such as a child neurologist or developmental
2
pediatrician as available. Such children are likely to require ongoing physical, occupational, and speech
therapy. Children with speech delays should be referred to a speech therapist and children with sensory
disorder should be referred to an occupational therapist. If at any time strabismus becomes apparent
the child should be referred to an ophthalmologist. Strabismus may not be clinically obvious but may be
diagnosed with a photo-screening device. Screening should be done annually starting at twelve months
of age (by an ophthalmologist if such a device is not available). If torticollis with or without
plagiocephaly develops the child should be referred to physical therapy promptly and to a plastic
surgeon for an orthotic remolding helmet if the plagiocephaly persists beyond four months. Screening
for Hepatitis C exposure should be done at eighteen months of age (8). Psychometric testing for
Attention Deficit-Hyperactivity Disorder and learning disabilities should be performed about age six or
earlier if deficits are suspected.
It will be important that appropriate care is coordinated so that children who suffer with NAS receive
continuity of care, and that their medical monitoring is evaluated. At a minimum, this will require that
for every fifty children suffering from NAS in the relevant nine-county area, that health departments be
augmented, at minimum, with 1 counselor, 2 social workers and 2 vocational or academic specialists and
one administrative staff member. In addition, the regional effort will require management by an MD
medical director, a licensed psychiatrist, a physical therapist, a speech pathologist, an optometrist, and
appropriate support and research staff.
The lives of these children are often affected by having a mother who suffers from an opioid use
disorder as well as other behavioral or psychiatric diagnoses. It is important that social services, mental
health services, and medical services be available to these mothers so as to minimize the impact of their
condition on their developing children. It is imperative that infants who experienced opioid exposure in
utero be allowed to live with a family member if at all possible (1,5). The costs of monitoring and
treating children who experienced exposure to opioids in utero and their mothers are staggering. The
volume of care required places a burden on the hospitals, the health care providers, social workers, and
the foster care system. All impediments to accessing care should be identified and rectified. Ultimately
emphasis must be placed on preventing maternal opioid use.
References
1) ACOD COMMITTEE OPINION, Opioid Use and Opioid Use Disorder in Pregnancy, Number 711, August
2017.
2) Neonatal Abstinence Syndrome (NAS), North Carolina Pregnancy & Opioid Exposure Project, School of
Social Work, University of North Carolina at Chapel Hill, 2018.
3) Miller, AM and McDonald, M. Neonatal Abstinence Syndrome Surveillance Annual Report 2018,
Tennessee Department of Health, Division of Family Health and Wellness.
4) Patrick SW, Davis MM, Lehman CU, and Cooper WO. Increasing Incidence and Geographic Distribution
of Neonatal Abstinence Syndrome: United States 2009-2012, J Perinatol. August 2015; 35(8) 650-655.
3
5) Wadhwani, A. Driven by Opioid Crisis, More Children in Tennessee Living in Foster Care; DCS Seeks
Additional Funding, Nashville Tennessean, January 28, 2019.
6) Substance-Exposed Infants: State Responses to the Problem, United States Department of Health and
Human Services, Substance Abuse and Mental Health Services Administration, Administration for Children
and Families, 2009.
7) Erwin, PC, Lindley, L, Meschke, LL, and Ehrlich, SF. Neonatal Abstinence Syndrome in East Tennessee:
Characteristics and Risk Factors among Mothers and Infants in one area of Appalachia, J Health Care Poor
Underserved. 2017;28(4): 1393-1408.
8) Hall, ES, McAllister, JM, and Waxelblatt, SC. Developmental Disorders and Medical Complications
Among Infants with Subclinical Intrauterine Opioid Exposures, Population Health Management, Volume
22, Number 1, 2019.
9) Tennessee Home Visiting Annual Report, July 1, 2017 – June 30, 2018, Tennessee Department of Health,
Division of Family Health and Wellness, Nashville, 2018.
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CURRICULUM VITAE
Name:
Joel S. Koenig, M.D.
Committees (continued):
1999-2000
Washington University Physician Network,
Pediatric Subcommittee on Integration of Care
1999
Health Management Partners,
Clinical Quality Improvements Committee
2000-2001
Washington University Physician Network,
Board of Director’s Nomination Committee
2001
Missouri Baptist Medical Center,
Strategic Planning Steering Committee
Publications:
•
Koenig JS, Thack BT, Upper airway (UAW) mass loading alters
UAW caliber, resistance and closing pressure.
J Appl Physiol 64:2294-2299, 1988
•
Thach BT, Davies AM, Koenig JS. Pathophysiology of sudden upper airway
obstruction in sleeping infants and its relevance for Sudden Infant Death Syndrome.
Annals of the NY Acad of Sciences 533:314-328, 1988
•
Davies AM, Koenig JS, Thach BT. Characteristics of upper airway chemoreflex
prolonged apnea in human infants. AM Rev Dis 139:668-673, 1989
•
Koenig JS, Davies AM, Thach BT. Coordination of breathing, sucking, and swallowing
during bottle feedings in human infants.
J Appl Physiol 69:1623-1629, 1990
Selected Abstracts:
•
Davies AM, Koenig JS, Thach BT. Potency of saline water in eliciting prolonged apnea,
a laryngeal chemoreflex response in human infants.
Ped Res 21:447A
•
Koenig JS, Davies AM, Thach BT. Mechanism of decreased ventilation during bottle
feedings
in infants. Ped Res 23:513A, 1988
•
Koenig JS, Davies AM, Thach BT. Dual mechanisms by which swallowing interferes
with breathing chemoreceptors in man, AM Rev Dis 139:A176, 1989
•
Davies AM, Koenig JS, Thach BT. Dual mechanisms by which swallowing interferes
with breathing during bottle feedings in infants. AM Rev Dis 139:A176, 1989
•
Thach BT, Davies AM, Koenig JS. Importance of upper airway mechanoreceptors in the
regulation of upper airway patency. Proceedings of the International Union of Physiological Science
XVII, 1989.
•
Koenig JS, Davies AM, Thach BT. Relation of physiologic hypoapnea to prolonged
apnea during bottle feedings in human infants. Presented at FASEB meeting.
Washington, D.C. April 1990.
•
Khalil S, Benecke J, Koenig JS. Infant hearing screening Missouri Baptist Medical
Center, St. Louis, MO. American Academy of Pediatrics Section of Perinatal Pediatrics, 1995.
Editorships:
Book authored:
VIDA ZOE FLORES, in her capacity as Special Conservator for BRISSA LOPEZ, a
minor vs. NORTHSIDE MEDICAL CLINIC/WALK IN L.L.C., et al
SUPERIOR COURT OF THE STATE OF ARIZONA IN AND FOR THE COUNTY OF
YUMA
No. S1400-CV2012-00550
Deposition given May 10, 2016
Retained by Mr. Jeffrey L. Victor