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Kent v. The Dover Ophthalmology Asc, LLC

Superior Court of Delaware, Kent

March 2, 2018


          Submitted: January 19, 2018


          Noel Eason Primos Judge.

         I. Introduction

         Before 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.

         Plaintiffs 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. Kent's treatment.

         Currently 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 Plaintiffs' damages.

          II. Discussion

         A. Defendants' Motion to Preclude Causation Opinions of Enrique Aradillas-Lopez

         Defendants argue that two of Dr. Aradillas's opinions should be excluded pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., [1] 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.

         Plaintiffs, 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."[2] 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.[3] 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 literature.[4]

         In 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.

         Consistent 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."[5]

         However, 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."[6] 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."[7] 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."[8]

         As an 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.

         Defendants' 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.

         As 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, [9] took his medical history, [10] reviewed clinical tests, including an ultrasound performed by Dr. Johannes Roedl, [11] and excluded obvious alternative causes, such as the initial needle strike.[12]

         The 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 CRPS.[13]

         The 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."[14] In essence, Dr. Aradillas's inference is that because CRPS is caused by "trauma that must be perceived as painful for that particular patient, "[15] 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 opinion.

         Despite 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.[16] 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."[17] The Astrazeneca Court found that the expert had failed to articulate a reliable methodology for her causation opinion.[18]

         In 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.

         Therefore, 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.

         B. Plaintiffs' Motion to Exclude Testimony of Daniel M. Feinberg, M.D.

         Plaintiffs 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.

         Defendants 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."[19]Defendants also contend that "Dr. Feinberg's opinions are well supported."[20] 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[21] after minor trauma, including needle sticks and IV placement."

         However, 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."[22] 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."[23]

         The 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.[24] As indicated previously, "[c]ausation of injury must be supported by more than the word of [the expert]."[25] 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 scientific bases.

         Here, 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.

         C. Defendants' Motion to Preclude Standard of Care Opinions of Elizabeth Nottingham, R.N.

         Defendants contend that the opinions of Elizabeth Nottingham, R.N. (hereinafter "Nurse Nottingham") are inadmissible because they are irrelevant and unduly prejudicial.

         The 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."[26] 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.[27]

         Plaintiffs 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 question."[28]

         The Court disagrees. Whether Plaintiffs should be able to impeach defense witnesses with evidence of the chart's alteration is not at issue.[29] 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 ...

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