Submitted: January 19, 2018
Eason Primos Judge.
the Court are motions in limine filed by Plaintiffs
Matthew Kent (hereinafter "Mr. Kent") and Renee
Kent (hereinafter "Ms. Kent" and
"Plaintiffs" collectively) and by Defendants Dover
Ophthalmology ASC, LLC d/b/a Blue Hen Surgery Center
(hereinafter "BHSC"), Rebecca A. Weber Sweet, R.N.
(hereinafter "Nurse Sweet"), and Jacqueline A.
Tiller, R.N. (hereinafter "Nurse Tiller" and
"Defendants, " collectively). This opinion sets
forth the Court's decision on the motions.
are suing Defendants in medical negligence for injuries
allegedly suffered by Mr. Kent as a result of an upper
endoscopy procedure at BHSC on June 26, 2014. In their
complaint, Plaintiffs allege that prior to the procedure,
Nurse Sweet made several unsuccessful attempts to insert an
I.V. into Mr. Kent's right hand. Mr. Kent complained of
pain. Nurse Tiller then took the I.V. needle from Nurse Sweet
and inserted the same needle into Mr. Kent's right
forearm. Mr. Kent again complained of a cold and burning
pain, but the catheter was not removed, and his complaints
were not addressed. He received anesthesia, and approximately
90 minutes later, the procedure was finished and the catheter
removed. Defendants deny that the same needle was inserted
into Mr. Kent's forearm, and they deny that Mr. Kent
complained of pain. Mr. Kent argues that, as a result of the
Defendants' negligent actions regarding the insertion of
the I.V. catheter, he contracted Chronic Regional Pain
Syndrome (hereinafter "CRPS"), which caused him to
suffer various damages, including the loss of his employment
with the Delaware Capitol Police. Over three years later,
after the filing of the instant suit, an employee of BHSC,
Nurse Seaman, made certain additions to Mr. Kent's
medical chart prior to her deposition regarding Mr.
before the Court are the following motions in
limine: (1) Defendants' motion to preclude the
causation opinions of Enrique Aradillas-Lopez, M.D.; (2)
Plaintiffs' motion to exclude certain opinions of Daniel
M. Feinberg, M.D.; (3) Defendants' motion to preclude
standard of care opinions of Elizabeth Nottingham, R.N.; (4)
Defendants' motion to strike expert disclosure and
preclude the expert testimony of Michelle Smeltzer, MSN; and
(5) Defendants' motion to exclude vouching evidence.
There are two additional matters that Defendants raised in
the pretrial stipulation which, although submitted past the
deadline for motions in limine, the Court agreed to
consider and determine. These are (6) Defendants' motion
to preclude evidence of Nurse Seaman's additions to Mr.
Kent's medical chart; and (7) Defendants' motion to
preclude cumulative lifestyle testimony concerning
Defendants' Motion to Preclude Causation Opinions of
argue that two of Dr. Aradillas's opinions should be
excluded pursuant to Daubert v. Merrell Dow
Pharmaceuticals, Inc.,  because the opinions are
unreliable and not based in science or on sufficient facts
and data. Defendants object first to Dr. Aradillas's
"prolonged contact theory, " which asserts that Mr.
Kent's CRPS was caused by the needle's striking his
radial nerve and the I.V. cannula's remaining in contact
with the nerve for an extended time, continuously
traumatizing the nerve. Defendants next object to Dr.
Aradillas's "dulled needle theory, " which
asserts that multiple attempts to insert the needle into Mr.
Kent's skin caused the needle to be dulled and
contributed to the injury. Defendants argue that there is no
specific scientific basis for either opinion, and that the
opinions should not be offered into evidence.
as the proponents of Dr. Aradillas's testimony, bear the
"burden of establishing the relevance [and] reliability
[of the testimony] ... by a preponderance of the
evidence." In their response to the Daubert
motion, Plaintiffs identify the sources for the opinions. In
support of his prolonged contact causation theory, Plaintiffs
refer to three studies previously referenced by Dr.
Aradillas: (1) Effects of Graded Mechanical Compression of
Rabbit Sciatic Nerve on Nerve Blood Flow and
Electrophysiological Properties; (2) Transient Conduction
Block Following Acute Peripheral Nerve Ischemia; and (3)
Evaluation and Management of Peripheral Nerve
Injury. In the first study, nerve injury resulted
after clamping the nerves of rabbits for 10 to 20 minutes. In
the second, restricting blood flow to the nerves of rats
produced nerve injury in a 10- to 20-minute time span. The
third study generally addresses the kinds and causes of nerve
injury- noting penetrating injury and crush as potential
causes. In addition, Plaintiffs cite to Dr. Aradillas's
extensive history of treating CRPS patients as a source for
his opinion. In Dr. Aradillas's deposition, he affirmed
that he has encountered more than two dozen cases of CRPS
caused by IV placement, but that among those, there were no
"cases of CRPS caused by an IV stick where the IV was
removed immediately, " nor has he heard of any such
case's being reported in scientific
support of the needle dulling theory, Plaintiffs point to a
document produced by Becton Dickinson, the manufacturer of
the needle and IV catheter device used in this case, which
warns that the needle can be dulled and damaged "after
just one injection-and it may become worse each time you
reuse .... A reused needle doesn't inject as easily or
cleanly as a new one ...." Dr. Aradillas personally
examined Mr. Kent, and reviewed his medical records as well
as certain medical literature, prior to offering his opinion
in this case.
with Daubert, Delaware Courts use the following
factors to determine the admissibility of scientific or
technical expert testimony: "(1) the witness is
qualified as an expert by knowledge, skill, experience,
training or education; (2) the evidence is relevant; (3) the
expert's opinion is based upon information reasonably
relied upon by experts in the particular field; (4) the
expert testimony will assist the trier of fact to understand
the evidence or to determine a fact in issue; and (5) the
expert testimony will not create unfair prejudice or confuse
or mislead the jury."
given the unique context of clinical medicine, rigid
application of the above factors is inappropriate, and this
Court has previously held that a '"soundly
performed' differential diagnosis alone
satisfies the Daubert requirements for reliability
in the context of clinical medicine." The Fourth
Circuit provides a useful definition of a differential
diagnosis: "[differential diagnosis, or differential
etiology, is a standard scientific technique of identifying
the cause of a medical problem by eliminating the likely
causes until the most probable one is
isolated." A proper differential diagnosis typically
involves "conducting] a physical examination, tak[ing] a
medical history, review[ing] clinical tests, including
laboratory tests, and exclud[ing] obvious (but not
all) alternative causes."
initial matter, there is no dispute as to Dr. Aradillas's
qualifications, the relevance of the intended testimony, and
whether it would assist the trier of fact or would result in
unfair prejudice. The instant dispute concerns whether the
two opinions are based upon information reasonably relied
upon by experts in the field.
chief argument is that Dr. Aradillas has failed to rule out
the possibility that Mr. Kent's CRPS was caused by the IV
needle's initial piercing of the nerve rather than by
prolonged contact with the IV cannula. Plaintiffs respond
that Dr. Aradillas's personal experience treating CRPS
patients is a reliable basis to rule out the possibility that
the initial piercing of the nerve caused Mr. Kent's CRPS.
indicated above, this Court's inquiry is limited, as Dr.
Aradillas's opinion is given in the clinical medicine
context of his diagnosis of Mr. Kent. This Court need only
determine whether the differential diagnosis was soundly
conducted. The record indicates that Dr. Aradillas performed
a physical examination of Mr. Kent,  took his medical history,
reviewed clinical tests, including an ultrasound performed by
Dr. Johannes Roedl,  and excluded obvious alternative causes,
such as the initial needle strike.
Court finds Plaintiffs' argument convincing that Dr.
Aradillas may rely on his experience treating CRPS patients
to rule out such an alternative cause. While it appears that
there is no Delaware case law directly on this point, the
Supreme Court of Wyoming has held, for reasons this Court
finds persuasive, that a physician's experience treating
"numerous patients with" CRPS is a reliable basis
on which to base a differential diagnosis determining the
type of trauma that produced a particular patient's
Court next turns to Dr. Aradillas's dulled needle theory.
During his deposition, Dr. Aradillas stated that when a
needle is used a second time "you're going to have
to use a lot more strength to push it in and that of itself
is going to be more painful and you'll have less control
of how you stick it into the patient." When questioned
on the basis for that opinion, Dr. Aradillas answered,
"It was something that I was taught during my pain
fellowship." Plaintiffs' counsel also produced, as a
basis for the opinion, warnings issued by the manufacturer of
the needles, Becton Dickinson, which advises that "[a]
reused needle doesn't inject as easily or cleanly as a
new one and can cause pain, bleeding, and
bruising." In essence, Dr. Aradillas's
inference is that because CRPS is caused by "trauma that
must be perceived as painful for that particular patient,
" the painful injection of a reused needle
into Mr. Kent's forearm contributed to Mr. Kent's
development of CRPS. As indicated above, because this opinion
is part of Dr. Aradillas's soundly conducted differential
diagnosis, it is reliable. Further, the Court considers Dr.
Aradillas's training and the warning issued by Becton
Dickinson to be reliable bases upon which to form his
the above, Defendants have repeatedly argued that Dr.
Aradillas's opinion constitutes an ipse dixit,
in which Dr. Aradillas invokes his status as an expert as the
sole basis for his opinion, without explaining his
methodology. Defendants argue that Dr. Aradillas's
opinion is analogous to an expert opinion analyzed in this
Court's Jones v. Astrazeneca
decision. In that case, the expert "declined
to walk through her methods, and instead repeatedly intoned
that she had reviewed all of the information she was
supplied, applied her training and experience, and 'put
it all together.' She specifically denied employing a
'differential diagnosis' methodology and declined to
characterize her approach beyond her abstruse 'put it all
together' explanation." The Astrazeneca
Court found that the expert had failed to articulate a
reliable methodology for her causation opinion.
contrast, Dr. Aradillas has pointed to a variety of
supportive literature, has explained his reasoning in detail
through depositions, reports, and disclosures, and has
employed a differential diagnosis. The Court concludes that
Dr. Aradillas has sufficiently explained his methodology.
the Court finds that Dr. Aradillas's opinions are
reliable and comply with the standards set forth in the
Daubert line of cases. Defendants' motion to
preclude Dr. Aradillas's opinions is accordingly denied.
Plaintiffs' Motion to Exclude Testimony of Daniel M.
contend that Daniel M. Feinberg, M.D. (hereinafter "Dr.
Feinberg"), must be precluded from offering certain
opinions, as they are not reliable and are unduly
prejudicial. In particular, Plaintiffs object to Dr.
Feinberg's potential opinion testimony that (1) CRPS is a
known risk of the initial insertion, rather than prolonged
placement, of an IV catheter placed in accordance with the
standard of care, and (2) Mr. Kent's CRPS was in fact
caused by a non-negligent initial insertion of an IV
catheter. Plaintiffs argue that Dr. Feinberg has offered no
support for the truth or reliability of these propositions.
have stated in their written response to Plaintiffs'
motion that "[i]t is Dr. Feinberg's opinion that Mr.
Kent's CRPS was caused by the initial insertion the [sic]
of the IV needle (which no one is claiming was inserted in a
negligent matter) and was unrelated to the amount of time
that the IV catheter remained in Mr. Kent's
arm."Defendants also contend that "Dr.
Feinberg's opinions are well
supported." In Dr. Feinberg's evaluation report
of his examination of Mr. Kent, he states that "[t]he
literature cites cases in which patients develop
RSD after minor trauma, including needle
sticks and IV placement."
at oral argument, Defendants were asked what specific
literature Dr. Feinberg intended to rely on, and defense
counsel later responded in writing that Dr. Feinberg will not
be "relying on specific literature, " but instead
"will rely on his general knowledge of the medical
literature on venipuncture-caused CRPS." Additionally,
Defendants appear to retreat from their earlier
representation that Dr. Feinberg will opine that Mr.
Kent's CRPS was caused by the initial insertion of the IV
catheter. Rather, Defendants intend to elicit testimony from
Dr. Feinberg that will "make the point at [sic] the
published medical literature includes no evidence linking
prolonged compression of a nerve in the context of
venipuncture with CRPS."
Court here applies the Daubert standard explained
above, with the distinction that Dr. Feinberg did not perform
a differential diagnosis in reaching his causation
opinion. As indicated previously,
"[c]ausation of injury must be supported by more than
the word of [the expert]." The Court will not take
experts at their word that the literature says what they
claim it says, but requires opinions to be supported by
the Court finds that because Dr. Feinberg did not perform a
differential diagnosis and does not rely on any specific
literature to support his opinions, they are not reliable.
Therefore, any attempt by Dr. Feinberg to offer a medical
expert opinion that Mr. Kent's CRPS was caused by the
initial needle stick, or that CRPS is a known risk of the
proper insertion of an IV catheter, will not be permitted.
Defendants have not produced any reliable bases for these
opinions-proposing to rely merely on Dr. Feinberg's
"general knowledge of the medical literature"
without citation to any specific studies. The Court will not
permit Dr. Feinberg to offer an ipse dixit as to
what the literature does or does not say. However, insofar as
Dr. Feinberg intends merely to point out how certain studies
cited by Dr. Aradillas do not support Dr. Aradillas's
theories, and identify logical inconsistencies in his
reasoning, he is free to do so.
Defendants' Motion to Preclude Standard of Care Opinions
of Elizabeth Nottingham, R.N.
contend that the opinions of Elizabeth Nottingham, R.N.
(hereinafter "Nurse Nottingham") are inadmissible
because they are irrelevant and unduly prejudicial.
expected opinion testimony to which Defendants object is as
follows: "it was a breach of the standard of care for
medical documentation for Nurse Seaman to make late entries
to Mr. Kent's Blue Hen Surgery patient record more than
three years after his June 26, 2014 endoscopy
procedure." Defendants argue that this testimony is
irrelevant because it cannot support a claim for medical
negligence, specifically contending that there is no causal
link between the deviation from the applicable standard of
care and the alleged injury.
reply that testimony demonstrating that any chart alterations
constituted a breach of the standard of care is directly
relevant because "the accuracy of the chart is in
question, the credibility of the defense experts for relying
upon the written chart is in question, and the credibility of
the other defense witnesses is in
Court disagrees. Whether Plaintiffs should be able to impeach
defense witnesses with evidence of the chart's alteration
is not at issue. The question is whether testimony on the
standard of care for medical documentation is relevant to
Plaintiffs' casein-chief. The Court finds that this
testimony does nothing to establish Plaintiffs'
entitlement to damages. Assuming arguendo that the
chart alteration ...