Free Opening Brief in Support - District Court of Delaware - Delaware

Case 1 :04-cv-01306-GIVIS Document 63-2 Filed 11/21 /2005 Page 1 of 4
Coturvre IA UNIVERSITY
p COLLEGE OF PHYSICIANS Sr SURGEONS
( DEPARTMENT OF PEDIATRICS
October 4, 2005
` Robert N. Hunn
Kolsby, Gordon, Robin, Shore, and Bezar
‘ One Liberty Place
1650 Market Street, 2"d Floor
Philadelphia, PA 19103
Re: Catherine Lagg, a minor, vs. A.I. DuPont Hospital for Children and
others
Dr. Mr. Hunn I
I am a physician specializing in the subspecialty of Pediatric Critical Care
Medicine, licensed to practice in the State of New York. I am certified in both
( Pediatrics and Pediatric Critical Care Medicine by the American Board of
Pediatrics and have practiced for 13 years in my subspecialty. I am an Assistant
Professor of Clinical Pediatrics at Columbia University, Collegeof Physicians and .
Surgeons and the Director ofthe Pediatric Critical Care Medicine Fellowship, a
highly-competitive training program in the subspecialty. Previous to my tenure at
Columbia, I held an academic faculty position at Yale University, School of
Medicine. I have numerous medical publications and have been invited to speak
on various topics in the Held.
This letter concerns my findings in the above named case. My review of material
includes: the office records of Catherine Laag’s pediatricians from 1993 to 2003,
the hospital records of the same patient for the period of 8/27/03 to 9/13/03, with
speciiic review of the physicians’ notes, nursing notes and bedside documentation
sheets, the respiratory therapy notes, and the resuscitation event sheet; the
depositions of Cheryl Martinenza, RN and Edward Cullen, D.O.; and the letter of
Bradley Fuhrman, MD. I
Catherine Laag was, at the time of her admission to A.I. DuPont Hospital, a 10
year old girl with Down Syndrome. Per her pediatricians’ notes, she was a highly
functioning child and was in general good health with only occasional childhood
upper respiratory illness. She contracted pneumonia and was admitted to DuPont
y Hospital on August 27, 2003. Catherine was initially treated with antibiotics and
DIVISION OF PEDIATRIC CRITICAL CARE MEDICINE
l 630 West 168th Street BHN—l0-24 New York, NY 10032 212-305-8458 Fax 212-342-2293

‘ Case 1 :04-cv-01306-GIVIS Document 63-2 Filed 11/21 /2005 Page 2 of 4
supplemental oxygen, however, her condition worsened. She was tried on Bilevel
Positive Airway Pressure (BiPAP) support, a non-invasive mode of respiratory
support, which she did not tolerate. She was intubated and placed on a
conventional mechanical ventilator (CMV). Her condition rapidly deteriorated and
she required ventilation with the High Frequency Oscillator (HF OV) to maintain
adequate oxygenation of her blood and tissues. For several days, it was also
necessary to administer Catherine a neuromuscular blocking agent to "paralyze"
her muscles to allow for optimal support on the HFOV and to minimize her tissue
_ demands for oxygen. She had a prolonged course of ventilation with gradual V
improvement so that it was possible to return Catherine to CMV 2 % days before
she was extubated, i.e. before her endotracheal tube was removed. On September
9, 2003, Catherine was removed from ventilatory support and extubated. She
suffered a cardiorespiratory arrest alter this procedure. She required full CPR
efforts and advanced life support measures, with chest compressions for greater
than 20 minutes, before her circulation was restored. As a result of this arrest, she
suffered severe, global, hypoxic-ischemic brain injury and is left with extremely
poor neurologic functioning.
The cause of Catherine’s arrest was a combination of glottic (structures of the
vocal cords and adjacent tissue) and tracheal airway obstruction and continued
( hypoxemic respiratory failure.
I will treat these two issues, and the management of them, in separate discussions.
Catherine had two risk factors for her airway obstruction, namely prolonged
endotracheal intubation and excessive physical movement. The tracheal wall may
become damaged with prolonged intubation by approximation of the semi-rigid
endotracheal tube with the tracheal wall. There is repeated trauma to the tracheal
wall, which reacts with inflammation and swelling. There was likely additional
swelling caused by Catherine’s excessive movements. The medical record makes
note of Catherine’s agitation and increased movement before extubation. Children
of her age, and especially children with mental retardation, may thrash around,
whipping their head from side-to-side in agitation a general response to the
presence of the endotracheal tube, other invasive lines and devices, and relative
immobility. Excessive movement of the head can cause the endotracheal tube to
rub against the tracheal wall causing swelling and narrowing of the airway.
It may be difficult to determine in advance of extubation the extent to which
prolonged intubation and movement-induced tracheal trauma has caused airway
swelling, prudent practice dictates that an effort at such determination be made. A
"leak test" of the airway can be of assistance in this determination. A leak test is
performed by insufflating the airway and lungs with air at relatively high pressures
and listening over the glottic airway for escape of air around the outside of the
( tube, suggesting open space between the wall of the trachea and the outer wall of

* Case 1 :04-cv-01306-GIVIS Document 63-2 Filed 11/21 /2005 Page 3 of 4
(
the endotracheal tube. Review ofthe respiratory therapy records reveals that the
cuff on Catherine’s endotracheal tube was in a deflated state before her extubation.
Deflation ofthe tube cuff is the iirst step performed in the leak test when using the
type of tube that Catherine had. However, there is no documentation that a leak
test was performed nor is there any evidence that there was a leak around the
patient’s endotracheal tube with insufflation of the airway and lungs with the usual
breaths delivered by the ventilator.
While the leak test is by no means "fool proof ’ in its determination of airway
patency, the presence of a leak generally suggests lesser likelihood of airway
obstruction, especially lesser likelihood of obstruction sufficient to cause
respiratory arrest in the immediate post-extubation period. Treatment for
suspected airway obstruction is usually to resedate the patient and wait until the
situation is improved, minimization of head movements, and removal of excess
body fluids if present and if thought to be contributing to the airway issue.
Additionally, many practitioners administer steroids before extubation to reduce
swelling. As Catherine had two risk factors for airway swelling, it is a breech of
prudent practice to not at least attempt to determine if the airway is likely to be
patent and to consider aborting the extubation attempt if significant airway
narrowing is suspected.
( The second condition that predisposed Catherine to cardiorespiratory arrest was
her hypoxemic respiratory failure. The term refers to a diminished ability of the
lung tissue to deliver oxygen to and remove carbon dioxide from the blood stream
and the need for respiratory assistance. In Catherine’s case, her hypoxemic
respiratory failure had been severe and was the result of her pneumonia, but was
improving at the time of her extubation. On the day of Catherine’s extubation she
required 50 to 60% oxygen while being supported on the ventilator. Her blood
was mildly to moderately desaturated with, according to the medical record,
saturations of the low to mid 90s, demonstrating that she absolutely required a
moderately high level of oxygen support.
The practice ordinarily employed inthe field of critical care for determining if a
patient is ready for extubation, is to consider performing the procedure when they
require 40% or less of oxygen. This standard is used for patients in whom the
hypoxemia is the result of respiratory disease, as was the case with Catherine.
Clinical practice has evolved to accept this cutoff of 40% as this amount of oxygen
that can be reliably administered using usual devices, whereas greater
concentrations cannot. Accordingly, patients, especially patients with severe
respiratory failure, are weaned until they no longer require greater than 40%
oxygen and then are extubated. Concentrations of oxygen greater than 40% can
be delivered by CPAP or BiPAP, although it is frequently difficult to sustain an
oxygen delivery of 60%, or even 50%.

‘ Case 1 :04-cv-01306-GIVIS Document 63-2 Filed 11/21 /2005 Page 4 of 4
(
To be assured that Catherine would receive a higher level of oxygen, she would
have had to remain with virtually uninterrupted BiPAP. Tolerance of BiPAP can
be difficult for a child as the BiPAP mask presses on the face. Such tolerance can
be more difficult in a I0 year child with Down Syndrome as she may not
understand the need for the device as readily as a child without this condition. In
fact, a trial of BiPAP had been performed earlier in her hospitalization and she had
become very agitated with the device. Her cooperation with the procedure could
be by no means assured and without the device insufficient oxygen would have
been delivered. Additionally on the morning of her extubation, Catherine had
copious tracheal secretions requiring frequent suctioning of her airway. After
extubation, she would have been required to cough such secretions out. Removal
of her BiPAP device and interruption of her oxygen supply would have been
required to clear secretions from her face or mouth. As her cooperation with
BiPAP could not be assured and as intemrption of BiPAP support should have
been anticipated, extubation of Catherine while still requiring greater than 40%
oxygen was a breech of good medical practice and constitutes negligence.
In the end, Catherine’s cardiorespiratory arrest was the combination of a narrowed
airway and continued need for moderate oxygen support. Her degree of airway
narrowing would have required reintubation, but had she had less lung disease and
( less of an oxygen requirement, the maneuvers used before her extubation (hand
i ventilation with 100% oxygen) would have resulted in better delivery of oxygen to
her bloodstream and tissues. It is likely that she could have sustained a longer
period of time with the airway obstruction without cardiac arrest.
These events are regrettable, as is Catherine’s outcome. Unfortunately, the results
stem from a breech in care.
Sincerely, M
Katherine Biagas, M.D.
Director, Pediatric Critical Care Medicine Fellowship
Assistant Professor of Clinical Pediatrics
Columbia University, College of Physicians and Surgeons
New York Presbyterian Hospital