Scottoline v. Women First, LLC

IN THE SUPERIOR COURT OF THE STATE OF DELAWARE
LAUREN SCOTTOLINE, individually )
and as Parent and Guardian of J.S.S., a )
Minor, and STEVEN SCOTTOLINE, )
Parent of J.S.S., a Minor, )
) C.A. No: N19C-08-135 AML
Plaintiffs, )
)
v. )
)
WOMEN FIRST, LLC, and )
CHRISTIANA CARE HEALTH )
SYSTEM, INC. )
)
Defendants. )
Submitted: December 15, 2022
Decided: March 1, 2023
MEMORANDUM OPINION
Upon Defendants’ Motion to Exclude Unreliable
Causation Opinion of Plaintiffs’ Expert: GRANTED.
Bruce L. Hudson, Esquire, and Joshua J. Inkell, Esquire of HUDSON & CASTLE
LAW, LLC, Wilmington, Delaware, Attorneys for Plaintiffs.
Bradley J. Goewert, Esquire, and Thomas J. Marcoz, Jr., Esquire of MARSHALL
DENNEHEY WARNER COLEMAN & GOGGIN, Wilmington, Delaware, and
David Batten, Esquire of BATTEN LEE, Raleigh, North Carolina, Attorneys for
Defendant Women First, LLC.
John D. Balaguer, Esquire, and Roopa Sabesan, Esquire, of WHITE AND
WILLIAMS LLP, Wilmington, Delaware, Attorneys for Defendant Christiana Care
Health System, Inc.
LEGROW, J.
This is a medical negligence case stemming from the birth of a child. The
plaintiffs allege the child was deprived of oxygen during labor and delivery and
sustained several injuries as a result of the defendants’ negligent medical care. It is
undisputed that the child, now age seven, has an ongoing and permanent behavioral
syndrome that falls within the autism spectrum. The plaintiffs’ expert opines that
the brain injury the minor child sustained during delivery proximately caused the
behavioral condition that has been diagnosed as consistent with an autism spectrum
disorder. Accordingly, some of the damages the plaintiffs seek are associated with
that disorder.
The defendants have moved to exclude the expert’s opinion that the brain
injury caused the minor child’s autism spectrum disorder. The defendants argue the
expert’s opinion is inadmissible under the rules of evidence because it is not
supported by appropriate scientific evidence. The defendants also argue the opinion
is inadmissible because it is not the product of a reliable methodology that
considered and excluded the other, diverse possible causes of an autism spectrum
diagnosis. Because the proffered expert’s opinion is not borne out by the evidence
he cites in support of his causation conclusion, and because he did not use a reliable
methodology to rule out the other potential causes for this condition, the expert
opinion is not admissible. The defendants’ motion therefore is granted.
1
FACTUAL AND PROCEDURAL BACKGROUND
The minor child, J.S.S., was born at Christiana Hospital on July 28, 2015.
Four years later, J.S.S.’s parents filed this action against Christiana Care Health
Services, Inc. (“CCHS”) and Women First, LLC (“Women First” and collectively
with CCHS, “Defendants”), the practice that delivered J.S.S. Plaintiffs allege
Defendants’ negligence caused J.S.S. to be deprived of oxygen during the birth,
resulting in tissue and organ damage, including a permanent Hypoxic Ischemic
Encephalopathy (“HIE”) injury to his brain. The complaint alleges J.S.S. also
suffered injuries to other organs, including his kidneys, liver, and muscle systems as
a result of oxygen deprivation.
J.S.S. was born with “no respiratory effort” and falling blood oxygenation
levels. He was intubated within five minutes of his birth and experienced seizures
approximately 20 minutes after his birth. The treating neurologist’s and
neonatologist’s records indicate he was “extremely sick” and initial testing was
“consistent with severe encephalopathy.” J.S.S. was diagnosed with HIE six days
after he was born.
J.S.S. spoke before his first birthday and walked at approximately 16 months.1
At 18 months, he stopped speaking. He slowly developed three-word sentences, but
1
Defs.’ Mot. to Exclude Causation Opinion of Daniel Adler, M.D., Ex, 1, Report of Daniel Adler,
M.D. dated June 4, 2019 (hereinafter, the “First Adler Report”) at 2.
2
those sentences rarely were purposeful.2 He began reading at age three but has
significant attention issues at school.3 J.S.S. receives Special Education services
along with occupational and speech therapy.4
In 2017 and 2018, J.S.S.’s treating clinicians noted developmental delays and
behaviors “consistent with” an Autism Spectrum Disorder (“ASD”) diagnosis.5 In
May 2018, J.S.S. was diagnosed with ASD by his school district.6 He was
reevaluated in February 2021, and that evaluation confirmed the previous ASD
diagnosis. Further testing showed significant developmental delays, including in
speech and language, social responsiveness, auditory comprehension, and
expressive language.7
Plaintiffs filed this action on August 15, 2019 on behalf of J.S.S. and Lauren
Scottoline, J.S.S.’s mother. The Amended Complaint, filed March 2, 2021, alleges
Defendants provided negligent medical care while Lauren Scottoline was
hospitalized and during her labor and delivery with J.S.S., and Defendants’ alleged
negligence proximately caused J.S.S.’s injuries, including “physical injuries,
emotional pain and suffering past and future, increased risk of harm, loss of chance,
2
Id. at 2.
3
Id.
4
Id. at 1-2.
5
Pls.’ Response to Defs.’ Mot., Ex. A, at CCHS00480, 483-84, 485-86, 489.
6
Id., Ex. B.
7
Id., Ex. D at 2-3, 10-13, 56, 69.
3
loss of enjoyment of life past and future, extensive medical bills past and future,
extensive lifetime care bills, [and] loss of earnings.”8
One of Plaintiffs’ experts, Dr. Daniel Adler, is a pediatric neurologist whose
opinion Plaintiffs offer to prove causation and damages. Dr. Adler examined J.S.S.,
reviewed his medical history, and issued two reports in this matter: one report dated
June 4, 2019 (the “First Adler Report”) and the other dated July 14, 2021 (the
“Second Adler Report”).9 In the First Adler Report, after summarizing J.S.S.’s
relevant medical and social history, Dr. Adler opined that “all of J.S.S.’s
neurological and neurodevelopmental disabilities are the result of the hypoxic
ischemic brain injury [he] suffered during the labor and delivery process.” 10 More
specifically, Dr. Adler opined that his examination of J.S.S. “confirms that [his]
behavior falls within the autism spectrum,” and “while the causes of autism are
diverse, in this case, the cause of J.S.S.’s qualitative disturbance in social interaction
and play is [HIE].”11 Dr. Adler further opined that J.S.S.’s neurological injuries and
disabilities are permanent in nature, he will not be able to live independently or be
employed in the competitive job market, and he will “continue to require
extraordinary medical care.”12 The Second Adler Report confirmed that Dr. Adler’s
8
Am. Compl. at 8.
9
Defs.’ Mot. to Exclude Causation Opinion of Daniel Adler, M.D., Ex, 2, Report of Daniel Adler,
M.D. dated July 14, 2021 (hereinafter, the “Second Adler Report”).
10
First Adler Report at 2-3.
11
Id. at 3.
12
Id. at 3.
4
previous findings and opinions remained unchanged after his July 2021 examination
of J.S.S.13
CCHS moved to exclude Plaintiffs from introducing at trial evidence that HIE
caused J.S.S.’s ASD, including any testimony to that effect by Dr. Adler.14 In
support of its motion, CCHS offers two independent bases to exclude Dr. Adler’s
opinion. First, CCHS argues Dr. Adler’s opinion should be excluded under
Delaware Rule of Evidence 702 because Dr. Adler has not identified any scientific
data or study showing a causal link between HIE and ASD. CCHS contends the
articles Dr. Adler cited at most identify an association between ASD and HIE, which
is not enough to establish causation. Second, CCHS separately argues Dr. Adler’s
opinion should be excluded because he has not established specific causation with
respect to J.S.S. That is, Dr. Adler acknowledges there are numerous possible causes
of ASD, including genetics, but he did not rule out those other causes or utilize a
reliable methodology to conclude that J.S.S.’s ASD was caused by HIE.
Plaintiffs respond that CCHS mischaracterizes Dr. Adler’s opinion as stating
that “HIE causes ‘Autism’” when his opinion “is that [J.S.S.] suffered an HIE injury
at birth which caused physical injuries and also neurological and neurobehavioral
symptoms consistent with [ASD].”15 Plaintiffs argue Dr. Adler’s opinion, once
13
Second Adler Report at 2.
14
Women First, LLC joined CCHS’s motion. See D.I. 163, 169.
15
Pls.’ Response to Defs.’ Mot. at 4-5.
5
properly characterized, is the product of his training and experience as a pediatric
neurologist, and he relied on four articles that “support his contention that an HIE
injury can produce certain behaviors that would fall within the autism spectrum.”16
Finally, Plaintiffs argue Dr. Adler made a differential diagnosis on the basis of his
examination of J.S.S. and review of his medical history.
ANALYSIS
Delaware Rule of Evidence 702 controls the admissibility of expert testimony.
Rule 702 allows a qualified expert to testify if (a) the expert’s specialized knowledge
will help the trier of fact understand the evidence or determine a fact in issue; (b) the
testimony is based on sufficient facts or data; (c) the testimony is the product of
reliable principles and methods; and (d) the expert has reliably applied the principles
and methods to the facts of the case. The Delaware rule is substantially similar to
Federal Rule of Evidence 702, which the United States Supreme Court construed in
Daubert v. Merrell Dow Pharmaceuticals, Inc.17 The Delaware Supreme Court has
expressly adopted Daubert and its progeny as the correct interpretation of Delaware
Rule of Evidence 702.18
16
Id. at 13.
17
509 U.S. 579 (1993).
18
M.G. Bancorporation v. Le Beau, 737 A.2d at 513, 521 (Del. 1999).
6
Consistent with Daubert, Delaware courts apply a five-step test to determine
the admissibility of scientific or technical expert testimony.19 That test examines
whether:
(a) the witness is qualified as an expert by knowledge, skill, experience,
training, or education;
(b) the evidence is relevant;
(c) the expert’s opinion is based upon information reasonably relied upon by
experts in the particular field;
(d) The expert testimony will assist the trier of fact to understand the evidence
or to determine a fact in issue; and
(e) the expert testimony will not create unfair prejudice or mislead the jury.20
A trial judge acts as a “gatekeeper” in deciding whether an expert’s opinion
has “a reliable basis in the knowledge and experience of the relevant discipline.”21
Ultimately, the Court will examine an expert’s opinion based on the expert’s
principles and methodology rather than on the conclusions generated.22 The party
seeking to introduce expert testimony bears the burden of establishing its
19
Bowen v. E.I. DuPont de Nemours & Co., Inc., 906 A.2d 787, 795 (Del. 2006).
20
Id.21
Id. at 794 (quoting M.G. Bancorporation v. Le Beau, 737 A.2d at 523).
22
Tumlinson v. Advanced Micro Devices, Inc., 81 A.3d 1264, 1269 (Del. 2013) (quoting Daubert,
509 U.S. at 595).
7
admissibility by a preponderance of the evidence.23 There is a “strong preference”
for admitting expert opinions “when they will assist the trier of fact in understanding
the relevant facts or the evidence.”24
I. Dr. Adler’s causation opinion as to J.S.S.’s Autism Spectrum
Disorder is not admissible because it does not have a reliable
scientific basis.
Once expert testimony is challenged, the reviewing court must ensure that the
proffered testimony is both relevant and reliable.25 Evidence is relevant if it would
assist the fact finder in “understand[ing] the evidence or determin[ing] a fact in
issue.”26 Expert testimony is reliable if it is premised on technical or specialized
knowledge, which requires the testimony to be grounded in reliable methods and
procedures and “supported by appropriate validation – i.e., ‘good grounds,’ based
on what is known.”27
In his reports, Dr. Adler opines that all J.S.S.’s neurological and
neurodevelopmental disabilities are a result of the HIE injury he suffered during
labor and delivery.28 Dr. Adler confirmed that J.S.S.’s behavior “falls within the
autism spectrum.”29 While acknowledging that “causes of autism are diverse,” Dr.
23
Bowen, 906 A.2d at 795.
24
Norman v. All About Women, P.A., 193 A.3d 726, 730 (Del. 2018).
25
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993).
26
Id. at 591 (quoting Fed. R. Evid. 702).
27
Id. at 590.
28
First Adler Report at 3; Second Adler Report at 2.
29
First Adler Report at 3; see also Second Adler Report at 2 (“J.S.S. remains a boy with . . . a
behavioral syndrome that is within the autism spectrum.”)
8
Adler states that “in this case, the cause of J.S.S.[’s] qualitative disturbance of social
interaction and play is [HIE].”30 Dr. Adler’s reports do not further explain how he
reached this conclusion.
Dr. Adler’s reports do not cite any article, study, or other authority in support
of his conclusion that HIE can cause ASD. When asked before and during his
deposition for the sources he relied on in forming his opinion, Dr. Adler identified
four medical articles as well as the diagnostic criteria for ASD listed in the DSM-
5.31 None of those sources, however, identify HIE as a cause of autism.
The first article, titled “Long-Term Outcome After Neonatal Hypoxic-
Ischaemic Encephalopathy,” discusses outcomes for full-term infants with neonatal
encephalopathy with hypoxic-ischemic origin, and identifies cognitive and memory
difficulties that may continue into childhood even if the infant does not experience
motor deficits.32 The authors conclude that “childhood survivors of [neonatal
encephalopathy] . . . are at an increased risk of cognitive, behavioral and memory
problems.”33 The article identifies another study that “reported an elevated rate of
[ASD] in children with moderate and severe [neonatal encephalopathy],” but the
30
First Adler Report at 3.
31
Deposition of Daniel Adler, M.D., Nov. 2, 2021 (hereinafter cited as “Adler Dep.”) at 5-8.
32
Linda S de Vries & Marian J Jongmans, Long-term Outcome after Neonatal Hypoxic-Ischaemic
Encephalopathy, ARCHIVES OF DISEASE IN CHILDHOOD -FETAL AND NEONATAL ED., May 5, 2010,
at F220, Defs.’ Opening Br. Ex. 4.
33
Id. at F223.
9
article does not conclude that neonatal encephalopathy or HIE causes ASD.34 The
second article, a “Point of View” article titled “Neonatal Encephalopathy: An
Inadequate Term for Hypoxic-Ischemic Encephalopathy,” addresses the
terminology used to describe neonatal encephalopathy presumably caused by HIE
and discusses the imaging studies and human and animal studies conducted
regarding that disorder.35 The article describes the use and limitations of MRI to
diagnose HIE, but does not reference ASD.
A third article, “Perinatal Features of Children with Autism Spectrum
Disorder,” offers a retrospective review of births of 75 children with ASD.36 The
article identifies findings showing “a higher prevalence of prematurity, low birth
weight, and perinatal asphyxia among children with ASD,” but notes that the
retrospective study design and small sample size were limitations to the study and
that “Large prospective studies are needed to clarify the possible association
between perinatal complications and ASD.”37 The fourth article, “Long-Term
Medical and Social Consequences of Preterm Birth,” discusses various medical and
social disabilities associated with preterm birth.38 That article, which was based on
34
Id.35
Joseph J. Volpe, M.D., Neonatal Encephalopathy: An Inadequate Term for Hypoxic-Ischemic
Encephalopathy, ANNALS OF NEUROLOGY, 2012, Defs.’ Opening Br. Ex. 5.
36
Gabriela F. Fezer et al., Perinatal Features of Children with Autism Spectrum Disorder, THE
REVISTA PAULISTA DE PEDIATRIA, (2017), Defs.’ Opening Br. Ex. 6.
37
Id. at 130 (emphasis added).
38
Dag Moster, M.D., Ph.D., et al., Long-Term Medical and Social Consequences of Preterm Birth,
THE New ENG. J. of MED. (2008), Defs.’ Opening Br. Ex.7.
10
a cohort of people born in Norway between 1967 and 1983, states that a recent study
“showed an association of preterm birth with features of the autism spectrum,” but
cautioned that the findings were based on a very small number of cases in the lowest
gestational age groups.39 Finally, the DSM-5 identifies the characteristics of ASD
but does not identify HIE as a potential cause for ASD.40
Defendants do not contest that Dr. Adler is a well-qualified expert. They
instead argue that Dr. Adler’s opinion is not reliable because he has not identified a
scientific basis, including the sources discussed above, to support his opinion that
HIE causes ASD. Plaintiffs respond that Defendants are mischaracterizing Dr.
Adler’s opinion, that his actual opinion is “that the qualitative disturbance of social
interaction suffered by J.S.S. is caused by his HIE brain injury,”41 and that the
articles Dr. Adler cites support his contention that “an HIE injury can produce certain
behaviors that would fall within the autism spectrum.”42
Plaintiffs’ arguments are unconvincing. First, Defendants do not
mischaracterize Dr. Adler’s opinion. If anything, it is Plaintiffs who do so. Dr.
Adler opined that J.S.S.’s behavior falls within the autism spectrum and that the
cause of his disturbances in social interaction and play is HIE.43 In their opposition
39
Id. at 265-66.
40
See CTR. FOR DISEASE CONTROL AND PREVENTION, DIAGNOSTIC CRITERIA, AUTISM SPECTRUM
DISORDER (ASD) (2019), Defs.’ Opening Br. Ex. 8.
41
Pls.’ Response to Defs.’ Mot. at 10.
42
Id. at 13.
43
First Adler Report at 3.
11
to the motion in limine, Plaintiffs suggest that although J.S.S. was diagnosed with
ASD for purposes of receiving educational supports and other therapies, that
diagnosis was not appropriate under the DSM-5 because his behavioral disturbances
were better explained by a global developmental delay.44 But Dr. Adler never
offered this opinion in his reports. Rather, during his deposition, Dr. Adler agreed
with J.S.S.’s ASD diagnosis and confirmed that it is his opinion that HIE is one of
the causes of ASD.45
Second, Dr. Adler’s opinion—that HIE is one cause of ASD—lacks a reliable
scientific basis. At most, the articles he cited identify an association between HIE
and ASD. Dr. Adler could not point to any published medical studies or literature
stating that HIE causes ASD.46 He acknowledged that a statistical association does
not imply causation and explained that a statistical association means two conditions
are “related to each other but not necessarily linked in terms of cause. You see them
together, but they’re not necessarily causal, meaning you could see hypoxia with
autism but hypoxia doesn’t necessarily cause autism.”47 Studies showing an
association between two conditions are not, standing alone, sufficient evidence to
support an opinion as to causation.48 For example, a recent decision of this Court
44
See Defs.’ Opening Br. at 5-8.
45
Adler Dep. at 84, 86-88.
46
Id. at 96-97.
47
Id. at 93.
48
See Wilant v. BNSF Railway Co., 2020 WL 2467076, at *4-5 (Del. Super. May 13, 2020)
(partially vacated on other grounds, 2020 WL 3887881 (Del. Super. July 9, 2020)).
12
excluded expert testimony as to causation of the plaintiff’s bladder cancer because
the medical evidence cited in support of that opinion identified, at most, a positive
association between bladder cancer and the diesel fume exposure at issue in that
case.49 The Court concluded the expert’s opinions were not borne out by the
evidence he cited in support of his opinion.50 The same is true here.
Plaintiffs also invoke Dr. Adler’s training and experience as sufficient support
for his opinion.51 But Plaintiffs cannot cite Dr. Adler’s training and experience as a
pediatric neurologist without explaining how that experience leads to Dr. Adler’s
conclusions, why the experience is a sufficient basis to support the conclusion, or
how the experience was applied to the facts in this case.52 Plaintiffs have not done
so in this case, and for all the foregoing reasons Dr. Adler’s opinion that J.S.S.’s HIE
injury caused his ASD or behaviors diagnosed as ASD is not reliable under Rule
702.
49
Id. at 5.
50
Id.; See also Melnick v. Consolidated Edison, Inc., 959 N.Y.S.2d 609, 623 (N.Y. Supreme Feb.
15, 2013) (conducting an analysis under Frye v. U.S., 293 F. 1013 (D.C. Cir. 1923) and barring
plaintiffs’ expert from offering an opinion that the minor child’s diagnoses of autism or pervasive
developmental disorder were caused by her preterm delivery with a low birth weight because the
opinion “was not based on generally accepted science,” would be “pure speculation,” and required
too great an analytical gap between the statistical associations in the expert’s cited studies and the
actual facts of the case).
51
Pls.’ Response to Defs.’ Mot. at 11.
52
FED. R. EVID. 702, Advisory Committee Notes for 2000 Amendments (“If the witness is
relying solely or primarily on experience, then the witness must explain how that experience
leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and
how that experience is reliably applied to the facts. The trial court’s gatekeeping function
requires more than simply ‘taking the expert’s word for it.’”) (citing Daubert, 43 F.3d 1311,
1319 (9th Cir. 1995)).
13
II. Dr. Adler’s opinion as to J.S.S.’s Autism Spectrum Disorder also is
not admissible because it is not the product of a reliable
methodology and amounts to little more than the expert’s ipse dixit
conclusions.
Even if the Court concluded that Dr. Adler’s opinion as to the causal link
between HIE and ASD was reliable as a general matter, the opinion nevertheless
fails to satisfy Rule 702’s admissibility standard because Dr. Adler did not employ
a reliable methodology to conclude that J.S.S.’s ASD was caused by HIE as opposed
to another possible cause. When a disease or disorder has several possible
independent causes, an expert must “employ a definitive scientific process to rule in
and rule out” the many potential causes of the disorder before reaching a
conclusion.53
For example, in Minner v. American Mortgage & Guaranty Co., this Court
excluded an expert’s opinion that the plaintiffs’ illnesses were caused by exposure
to toxic agents found within the building where the plaintiffs worked because the
expert failed to account for and eliminate other possible causes for those syndromes.
The Court explained that “[t]he fatal flaw [in the expert’s opinion was] that she
refused to adequately consider, and eliminate, other possible causes of the Plaintiffs’
illnesses through a definitive scientific process.”54 In Minner, there was no known
53
Scaife v. AstraZeneca LP, 2009 WL 1610575, at *16 (Del. Super. Jun. 9, 2009) (citing Minner
v. American Mortg. & Guar. Co., 791 A.2d 826, 854 (Del. Super. 2000)).
54
Minner, 791 A.2d at 854.
14
cause of the particular illness at issue, and the expert did not provide a consistent
diagnostic or scientific methodology to exclude other possible causes of the illness.55
The same is true of Dr. Adler’s opinion. Dr. Adler concedes there is no
scientific study showing a causal link between HIE and ASD, and that there are
numerous potential causes of ASD, including genetic disorders associated with
autism.56 Moreover, Dr. Adler testified that ASD is a common diagnosis and is four
times more common among boys than it is among girls.57 Although the disease is
common, has no established cause, and has many potential causes, Dr. Adler’s
reports do not make any attempt to distinguish J.S.S.’s diagnosis and rule out those
other potential causes. Instead, Dr. Adler opines in a conclusory manner that HIE
caused J.S.S.’s behavioral conditions that fall within the autism spectrum. That ipse
dixit opinion is not based on a reliable methodology and therefore is not admissible
under Rule 702.
CONCLUSION
For the foregoing reasons, Plaintiffs are precluded from introducing at trial
Dr. Adler’s opinion or testimony that Hypoxic Ischemic Encephalopathy caused
J.S.S.’s behavioral syndrome that falls within the autism spectrum. IT IS SO
ORDERED.
55
Id. at 854.
56
Adler Dep. at 99-100.
57
Id. at 116-17.
15