Court Opinion

ID: 9896104
Source: CourtListenerOpinion
Date Created: 2023-11-09 16:04:39.466208+00
Date Added: 2024-06-11T09:14:00.448649
License: Public Domain

IN THE SUPERIOR COURT OF THE STATE OF DELAWARE

BREE N. ELICK, Individually and on  )
behalf of the Estate of JON S. GRALA,
                                    )
BRENDA GRALA, TRASA BARRETO,        )
And CAPREE GRALA,                   )
      Plaintiffs,                   )
                                    )
   v.                               )
                                    )             C.A. NO. N21C-03-046 DJB
CHRISTIANA CARE HEALTH              )
SERVICES, INC., THOMAS K. EVANS, )
M.D., and VASCULAR SPECIALISTS,     )
P.A., d/b/a VASCULAR SPECIALISTS OF )
DELAWARE, PA,                       )
       Defendants.                  )

                        Submitted: September 22, 2023
                          Decided: November 7, 2023

                                    ORDER

    Upon Plaintiff’s Motion in Limine Regarding Statistical Risk of Pulmonary
                             Embolism - GRANTED.

      1.    In this medical malpractice action Plaintiffs allege negligence of Dr.

Thomas K. Evans (“Dr. Evans”) and his co-defendants stemming from the failure to

treat a deep vein thrombosis (“DVT”), which is alleged to have resulted in a fatal

pulmonary embolism for Jon S. Grala (“Grala”).

      2.    The Complaint alleges that Grala was a patient of Dr. Evans, a vascular

surgeon with Defendant Vascular Specialists of Delaware, P.A., while performing

                                       -1-
services for Defendant Christiana Care Health Services at Christiana Hospital. 1 On

August 11, 2019, while under Defendants’ care, Grala was diagnosed with both a

pseudoaneurysm in his right common femoral artery and a large deep vein

thrombosis, which was adjacent to the pseudoaneurysm. Dr. Evans decided to treat

the pseudoaneurysm prior to treating the DVT and on August 12, 2019, performed a

thrombin injection as Grala’s initial treatment. Dr. Evan’s plan was to treat the DVT

with anticoagulation treatment the next day, however, Grala collapsed and died at

1:31 a.m. on the morning of August 13 prior to treatment.2

      3.     Numerous pre-trial motions have been heard and decided.3 Before the

Court now is Plaintiffs’ motion in limine to exclude defense expert, Dr. Caitlin W.

Hicks, from testifying that the statistical probability of developing a fatal pulmonary

embolism within the first 48 hours of treatment was less than 1%. Defendants jointly

opposed.4 A Daubert hearing was held at which testimony was taken by Dr. Hicks.5

Following the hearing, each party was given the opportunity to provide supplemental

submissions.

      3.     Dr. Hicks is the Director of Clinical Research at Johns Hopkins

1
  Elick, et. al. v. Christiana Care Health Services, Inc., et. al., N21C-03-046 DJB,
D.I. 1.
2
  Id.
3
  D.I. 200.
4
  D.I. 208, 221, 229.
5
  D.I. 222.
                                          -2-
Department of Surgery.        She additionally is an associate professor in the

epidemiology division at Johns Hopkins Bloomberg School of Public Health and is

co-faculty at the Welch Center, a research center. She holds a Masters of Science in

clinical research from the Cleveland Clinic Lerner College of Medicine and has

received training on analyzing and applying scientific data in a clinical setting and

has her own personal experience doing the same. She has been published and been

subjected to peer-review.6    It is without question that Dr. Hicks has the sufficient

knowledge base and qualifications to testify. Plaintiffs are not challenging her

qualifications. In their motion, Plaintiffs seek only to exclude the portion of Dr.

Hicks’ testimony that gives the statistical risk of an untreated DVT in causing a

pulmonary embolism is less than 1%.7

      4.     Plaintiffs challenge this aspect of Dr. Hicks’ testimony under both

Delaware Rules of Evidence 402, 403, 702, Daubert v. Merrell Down

Pharmaceuticals, Inc.8 Specifically, Plaintiffs argue that the two articles in support

of Dr. Hick’s statistical conclusion are not reliable, as Grala was never treated for his

DVT, unlike the patients studied in both articles upon which Dr. Hicks relies.

      5.     One study upon which Dr. Hicks relies is by Silvy Laporte, Phd., entitled

6
  D.I. 222, Trans. At 7-8.
7
  D.I. 203, Pl. Mtn. at ¶4.
8
  509 U.S. 579 (1993); Pl. Mtn. at ¶5.
                                           -3-
Clinical Predictors for Fatal Pulmonary Embolism in 15, 520 Patients with Venous

Thromboembolism, which was published in April, 2008.9 The second study upon

which Dr. Hicks relies is entitled, Thirty-day Outcomes in Patients with Proximal

Deep Vein Thrombosis Who Discontinued Anticoagulant Therapy Prematurely, by

J.A. Nieto,10 and was published in May, 2020. In addition to these articles, Dr. Hicks

relies upon a calculation given to her from the RIETC registry web page. The RIETC

registry is a database registry of over a hundred thousand patients in which their data

is inputted and used by clinicians to understand the risk factors for DVT and

pulmonary embolisms in a clinical setting. At the hearing, it was explained by Dr.

Hicks that patient information can be input and the web-based site completes a risk

calculation based upon the information of other patients in the registry.11

      6.     Plaintiff argues that because the Nieto study was concluded in 2020, it

is irrelevant as to the standard of care placed upon Dr. Evans in 2019 when treating

Grala. Plaintiffs argue this testimony is violative of Delaware Rules of Evidence 402

and 403, as irrelevant and any probative value is far outweighed by its prejudicial

effect upon the jury. In support of their D.R.E. 403 argument, Plaintiffs cite to the

9
  Silvy Laporte, Phd., Clinical Predictors for Fatal Pulmonary Embolism in 15, 520
Patrients with Venous Thromboembolism, Circulation, Apr. 1, 2008; Pl. Mtn. Ex. D.
10
   J.A. Nieto, Thirty-day Outcomes in Patients with Proximal Deep Vein
Thrombosis Who Discontinued Anticoagulant Therapy Prematurely, Thromb. Res.,
May 2020; Plt. Mtn. Ex. E.
11
   D.I. 222. Tr. Hring. at pp. 9, 11, 19-21.
                                          -4-
Delaware Supreme Court decision in Timblin v. Kent General Hospital.12

      7.     Defendants’ opposition argues that Dr. Hicks’ calculation of risk is

sound and is properly based upon the two cited peer-reviewed studies as well as the

RIETC registry. 13    Defendants argue that it is permissible for Dr. Hicks to use her

independent judgment and interpretation of others research in reaching her statistical

conclusion. Further, Defendants argue this testimony would aid the jury in its

understanding of the issues presented and the decision that was to be made by Dr.

Evans.14

      6.     Plaintiffs’ argument that neither study cited by Dr. Hicks involves

patients who been wholly untreated for DVT is relevant, but not dispositive. There

will certainly never be a study for every potential medical situation presented. It is

certainly plausible and proper, as Defendants argue, for an expert to use their own

knowledge base to rely on similar studies in applying them to various situations

presented. This is factor is considered by the Court, but again, is not dispositive.

      7.     The Nieto study is the most relevant to Grala’s case, however, since it

studies patients who have discontinued DVT treatment, which is akin to not patients

12
   640 A.2d 1021 (Del. 1994).
13
   D.I. 208, 221, 229.
14
   Def. Opp. To Pl. Suppl. Subm. At ¶4, D.I. 229. Defendants argue that Plaintiffs’
reliance on the Scottoline v. Women First, LLC, 2023 WL 2325701 (Del. Super. Ct.
2023) is misplaced. The Court agrees that Scottoline dealt with a different challenge
to expert testimony that is not presented here and is not determinative of this decision.
                                           -5-
who have not been treated, per Dr. Hicks. However, it is dispositive that this study

was published after Grala’s death and is therefore not applicable to the standard of

governing Dr. Evans. In fact, not only was this study published in 2020, but Dr.

Hicks – a research clinician – was not even aware of this study until 2021.15

       7.    Given this, the Nieto study is not relevant to the applicable standard of

care. Therefore, the basis for any statistical conclusion stemming from this study is

irrelevant under a D.R.E. 402 analysis. Even assuming this study and basis of the

statistical evidence holds relevance, it cannot survive a D.R.E. 403 analysis, as its

probative value is outweighed by its prejudicial effect. Consistent with Timblin, the

prejudicial impact of the statistical probability evidence sought to be presented is

great.16

       8.    Like in Timblin, the introduction of this purported statistical evidence

poses a danger of unfair prejudice and jury confusion.      This statistical evidence

purported by Defendants is not being offered to rebut the causation nexus, which can

potentially be relevant, but is being offered to show conformity with the standard of

care. This is improper.17 The proffered statistic invites the inference that because

there is less than 1% risk of a fatal pulmonary embolism developing from an untreated

15
   Hrg. Tr. P. 73.
16
   Timbin, 640 A.2d at 1025.
17
   Id. at 1024.
                                         -6-
DVT, the standard of care was followed.

      9.    Therefore, Dr. Hicks may testify that, even untreated, the risk of Grala

developing a pulmonary embolism was low during the relevant time frame, however,

her testimony may not include the statistical probability that there was less than 1%

chance of a pulmonary embolism resulting from an untreated DVT.

      IT SO ORDERED this 7th day of October, 2023.

                                                _____________________________
                                                   Danielle J. Brennan, Judge

Cc:   All parties via Lexis File&Serve

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