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Knox v. United States

United States District Court, D. South Carolina, Rock Hill Division

July 3, 2018

Zekiya Knox, Plaintiff,
The United States of America; Amisub of SC, Inc., d/b/a Piedmont Medical Center; South Carolina Emergency Physicians, LLC; Jeffrey Warden, MD; Brian Fleet, PA; Piedmont General Surgery Associates, LLC; Alex Espinal, MD; Bret Garretson, MD; and Digestive Disease Associates, Defendants.



         Through this action, Zekiya Knox ("Plaintiff) seeks recovery for alleged medical malpractice by a variety of medical providers involved in her care from September 2013 through May 2014.[1] Plaintiff alleges these providers failed to properly and timely diagnose and treat her underlying condition, Crohn's disease, and that this failure led to the development of sepsis. Plaintiff further alleges various Defendants failed to properly treat her sepsis and that the collective errors led to Plaintiffs loss of three limbs. Plaintiff asserts a single claim for medical negligence against all Defendants, though the specifically alleged errors vary between Defendants. See ECF No. 88 (Second Amended Complaint).

         The matter is before the court on motions of Defendant Piedmont for exclusion of expert testimony (ECF No. 124) and summary judgment (ECF No. 125). The first motion seeks to exclude a portion of the anticipated opinion testimony of Plaintiff s expert Paul Marik, MD ("Dr. Marik").[2] Specifically, Piedmont seeks to exclude Dr. Marik's opinion administration of a 75 mcg/min dose of the vasopressor Levophed caused Plaintiffs loss of three limbs. ECF No. 124.[3]

         Piedmont's second motion seeks summary judgment based on: (1) the absence of causation evidence; (2) application of S.C. Code Ann. § 15-32-230, which establishes a gross negligence standard for recovery for certain emergent, in-hospital errors, and (3) arguments Piedmont is not liable for the actions of non-employee physicians. ECF No. 125. For reasons set forth below, the motion to exclude aspects of Dr. Marik's causation testimony is denied. The motion for summary judgment is granted to the extent Piedmont seeks a ruling S.C. Code Ann. § 15-32-230 applies to the anesthesiologist's actions during Plaintiffs May 5, 2014 surgery and Plaintiff has failed to proffer evidence to satisfy the gross negligence standard imposed by that statute. The motion is denied in all other respects.


         Plaintiffs claim against Piedmont arises from her brief hospitalization there, which began on May 4, 2014, and ended with Plaintiff s transfer to Carolinas Medical Center ("CMC") on May 6, 2014. The Second Amended Complaint includes the following relevant allegations:

3. Defendant Amisub of SC, Inc. d/b/a Piedmont Medical Center ("Piedmont") is a South Carolina corporation with its principal place of business in York County, SC. Piedmont runs a hospital, and in connection with that, employs a number medical professionals, including nurses, technicians, and others. Piedmont also enters into contracts with certain physicians for the exclusive provision of medical services in its hospital such as ER physicians, radiologists, hospitalists, and others. Each of the underlying medical professionals, be they doctors, nurses, or others were at all times relevant hereto acting within the course and scope of their actual or apparent agency or employment with Piedmont.
37. Instead [of receiving proper treatment for her Crohn's disease], Ms. Knox was left to continue to suffer from her condition, only to be returned to [Piedmont] on May 4, 2014. This time, she was ultimately worked up and got a CT. She had, and has had for months, untreated and, unknown to her, Crohn's disease. This condition was fully treatable if caught frankly anytime within a day or two of her presentation back to [Piedmont] on May 4. The condition in her lower right abdominal cavity had caused significant damage to her intestines and caused a life threatening infection. This infection is called sepsis, a body wide inflammatory reaction to the raging infection.
38. Sepsis causes a number of life threatening problems within the human body and the condition is caused by infection. In the case of Ms. Knox, the sepsis caused among other things a decrease in her blood pressure. This necessitated the use of pressors, powerful drugs that constrict the vessels, in the hope to raise blood pressure to feed the brain and other vital organs. What is gained for the brain and other organs comes at the expense of the extremities. The pressors tend to cut off flow to the extremities, thus starving them of vital oxygen and nutrition to survive.
38.1 If used properly, pressors do not result in limb loss. There is a critical balance between maintaining the blood pressure at adequate levels while not causing too much "squeeze" which can cause a damaging lack of blood flow. Here, the nurse at the Piedmont ICU used the pressors in a grossly negligent and reckless manner. This was a substantial contributing cause of the limb loss. Particularly, the nurse on the night shift from May 5 to May 6 overdosed the pressors by giving 75 mics/min (in excess of the order and the hospital policy), improperly relied on a knowingly inaccurate arterial line, and failed to report the signs and symptoms of ischemia that arose during this time.
39. Ms. Knox suffered these consequences of the sepsis and mismanagement of the pressors-she has lost three limbs. She went from a college athletic scholarship recipient to a triple amputee- Two above the knee amputations and a loss of her right arm below the elbow. She also lost the tips of her fingers on her remaining hand. All of this was avoidable.

ECF No. 88 ¶¶ 3, 38-39 (emphasis added); see also Id. at 15, 16 (summarizing allegations of errors by "Nurses at Piedmont").


         Piedmont's motions to exclude Dr. Marik's causation testimony and for summary judgment are addressed, in order, below.

         I. Exclusion of Dr. Marik's Causation Testimony

         A. Arguments of the Parties

         Piedmont's Arguments.

         Piedmont seeks to exclude Dr. Marik's opinion testimony "that the vasopressor drug [Levophed] administered at a dosage of 75 micrograms per minute ["mcgs/min"] caused [Plaintiff] to suffer irreversible injuries to her limbs leading to amputations." ECF No. 124 at 1. Piedmont argues Dr. Marik's "method for assessing causation is scientifically unreliable" because he "does not rely on a single peer-reviewed study" and admits no scientific experiments have been done. Id. at 1, 2. In making this argument, Piedmont focuses on eight case studies, reports, and presentations on which Dr. Marik relied, in whole or in part, in forming his opinion. Id. at 8 (explaining the case reports "are papers reporting observations made in particular clinical cases," that "do not test his hypothesis[, ]" "were not designed to test whether a particular dose of [Levophed] is associated with permanent tissue injury[, ]" and all lacked "placebo control[s]"); id. at 9-14 (addressing each case study, report or presentation).

         Plaintiffs Response.

         In response, Plaintiff argues her claim against Piedmont

focus[es] on her providers' choice and management of vasopressors, a powerful group of blood pressure-boosting medications. [She] alleges [Piedmont] doctors misjudged her illness by attributing her low blood pressure to a blood vessel issue when the clinical evidence showed her real problem was inefficient heart function. ... [Piedmont] medical providers compounded this error by the way they prescribed and managed the vasopressor [Levophed]. [Plaintiff] received [Levophed] doses far in excess of what her doctor ordered and far above [Piedmont's] standing order for the drug. . . . The highest [Levophed] doses Piedmont providers administered, up to 75 mcg/min, were not documented anywhere in [Plaintiffs] chart, a violation of both industry standard and South Carolina law. . . . [Plaintiff] also faults [Piedmont] for the way [Levophed] was adjusted from one dose to another. [Levophed] must be adjusted to attain and maintain a safe blood pressure, but [Plaintiffs] blood pressure readings were not properly documented during her May 4, 2014 [sic], surgery and her nurses failed to realize a blood pressure-measuring device was reporting misleading data.

ECF No. 140 at 1, 2. Plaintiff further asserts she began showing signs of ischemia after the Levophed dosage was increased, but her nurses failed to properly report and her physicians failed to properly address these signs. Id. at 3.

         Plaintiff argues the "strong connection between high-dose [Levophed] and ischemia" is supported both by Dr. Marik's testimony and by two of Plaintiff s treating physicians at Piedmont. Id. at 3 (citing Dr. Start dep. at 76-77; Dr. Coplin dep. at 53).[4] She characterizes Dr. Marik's opinion that 75 mcg/min is an excessive dose of Levophed as based on maximums recognized by "the world's leading physicians in this specialty" and routine limits imposed by hospitals. Id. (citing Dr. Marik dep. at 15, 16, 97.

         In subsequent discussion, Plaintiff points to Dr. Marik's testimony medical providers at Piedmont made multiple errors in treating Plaintiff during her May 2014 hospitalization including: (1) incorrectly diagnosing "vasodilatory shock" rather than "cardiogenic shock," which led to the treatment with vasopressors (id. at 6 (citing Dr. Marik dep. at 17-18, 53))[5]; (2) using the "wrong blood pressure measurement" to adjust the Levophed (id. at 7 (citing Dr. Marik dep. at 51, 52, for proposition providers improperly relied on systolic blood pressure rather than mean arterial pressure ("MAP")); and (3) failure by nurses to identify problems with the electronic monitoring system leading to improper alteration of dose (id. at 7 (citing Dr. Marik dep. at 42-48, 53, 54)). Plaintiff argues these errors "contributed to the decision to administer dangerously high [Levophed] doses." Id. at 7. While acknowledging Levophed's manufacturer does not state a maximum dose, she cites Dr. Marik's testimony that there is a '"general consensus' among international leaders in critical care medicine" that doses should be limited to "20 mcg/min with 40-60 mcg/min doses ... in extreme cases." Id. (citing Dr. Marik dep. at 14-16, 97 and referring to "research presented at ¶ 2017 international medical conference").

         Plaintiff argues Dr. Marik's causation opinion is properly based on the "whole clinical picture, the known pharmacology of [Levophed], a general consensus on its acceptable use, and the published cases of negative consequences from high doses. Id. at 8. She notes Dr. Marik relied on "differential diagnosis principles" in ruling out the alternative cause suggested by Piedmont's expert witness (disseminated intravascular coagulation ("DIC")). Id. at 9; see also Id. at 17-20 (addressing differential diagnosis analysis). Plaintiff also refers to multiple notations in medical records relating to her care at CMC, immediately after her stay at Piedmont, attributing her limb ischemia to the use of vasopressors.[6]

         Piedmont's Reply.

         In reply, Piedmont notes Plaintiffs failure to cite any peer-reviewed study or to defend the adequacy of the case studies addressed in Piedmont's opening memorandum. ECF No. 154 at 2. Piedmont also argues Plaintiff is seeking to "change the argument" by devoting significant discussion to "unrelated questions such as whether vasopressors generally increase the risk of ischemia, or differential diagnosis, or issues with damping the blood pressure measurement system." Id. at 3. Piedmont notes its motion "deals with Dr. Marik's causation opinion . . . that the administered dose of 75 mcg/min caused the Plaintiff s limb ischemia and resulted in Plaintiff s amputations." Id. at 3.

         B. Standard

         As recently summarized in Plaintiffs Appealing CMO 100 v. Pfizer, Inc., __F.3d__, No. 17-1140 (4th Cir. June 12, 2018):

In assessing the admissibility of expert testimony, a district court assumes a "gatekeeping role" to ensure that the "testimony both rests on a reliable foundation and is relevant to the task at hand." [Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 597 (1993)]. The district court's inquiry is a "flexible one," whose focus "must be solely on principles and methodology, not on the conclusions that they generate." Id. at 594-95. Dauberfs design is to "make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field." Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152(1999).

Slip. Op. at 10.

         C. Discussion

         Piedmont is correct in noting Plaintiffs response focuses on issues not raised in its motion for exclusion. That motion is limited to challenging the admissibility of Dr. Marik's causation testimony linking the 75 mcg/min dose of Levophed to Plaintiffs ultimate injuries. To the extent Plaintiff addresses other alleged errors, her arguments are not germane to the sole issue raised in Piedmont's motion for exclusion. Nonetheless, focusing on the sole issue raised, the court finds Piedmont's motion should be denied.

         Piedmont's challenge focuses on the sufficiency of eight case reports, articles, and presentations to support Dr. Marik's causation opinion. The court agrees (and Plaintiff does not contest) these reports do not, alone, support Dr. Marik's causation opinion.[7] Dr. Marik's causation opinion does not, however, rest on so narrow a foundation. He, instead, relies first on what appears to be an undisputed premise that vasopressors in large doses may cause limb ischemia.[8] Dr. Marik then applies differential diagnosis techniques to rule out other causes, most critically the alternative cause Piedmont's expert, Dr. Hotchkiss, opined was the sole cause of Plaintiffs limb loss, disseminated intravascular coagulation or "DIC." See Westberry v. Gislaved Gummi AB', 178 F.3d 257, 262-63 (4th Cir. 1999) (defining differential diagnosis as "a standard scientific technique of identifying the cause of a medical problem by eliminating the likely causes until the most probable one is isolated" and holding "a reliable differential diagnosis provides a valid foundation for an expert opinion").

         Dr. Marik noted the absence of any statement in Plaintiffs chart that she had DIC. Dr. Marik dep. at 66 (also stating he was "not sure she met the full-blown criteria for DIC" and opining she, instead, had "coagulopathy of sepsis"). He explained that a DIC diagnosis requires coagulopathy as well as "bleeding at multiple sites," and Plaintiffs records support ...

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