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Smith v. Terumo Cardiovascular Systems Corp.

United States District Court, D. Utah, Central Division

August 7, 2017

BUZZIE SMITH, individually and on behalf of the Heirs and Estate of Charles A. Smith, Deceased, Plaintiff,


          David Nuffer, District Judge

         The decedent Charles A. Smith (“Mr. Smith”), represented in this litigation by Buzzie Smith (“Mrs. Smith”), underwent surgery on his heart in September 2010. There were problems during the surgery. Eleven months later, Mr. Smith passed away. Mrs. Smith brings this action against the hospital and a manufacturer of a device used during the surgery.[1] To establish certain elements of her product liability claims against the device manufacturer, Mrs. Smith offers Alfred Stammers's (“Mr. Stammers”) expert opinion and testimony. Defendant Terumo (“Terumo”) moves (“Motion”) to exclude Mr. Stammers's opinion and testimony.[2] Mrs. Smith opposes the Motion (“Opposition”).[3] Terumo replies in support of the Motion.[4] As set forth below, Mr. Stammers is not qualified to offer an opinion on an alleged defect in the device used during the surgery and the methodology he uses to formulate that opinion is not reliable. The Motion is GRANTED.


         Background ..................................................................................................................................... 2

         Discussion ....................................................................................................................................... 4

         1. Mr. Stammers lacks the necessary qualifications to opine on an alleged defect in the System 1........ 6

         2. Even if Mr. Stammers is qualified to opine on a defect in the System 1, his opinion is not reliable...... 9

         Order ........................................................................................................................................... 11

         BACKGROUND [5]

         On September 13, 2010, Mr. Smith underwent heart valve replacement surgery (“September 2010 surgery”).[6] As part of the surgery, a Terumo Advanced Perfusion System 1 heart/lung bypass machine (“System 1”) was used.[7] The System 1 was to provide for the circulation of blood and oxygen through Mr. Smith's body while surgery was being performed on his heart valve.[8] At some point, the System 1 stopped working for 10-11 minutes.[9] Eleven months later, on August 6, 2011, Mr. Smith passed away from a myocardial infarction, (i.e., heart attack).[10]

         Mrs. Smith hired Alfred Stammers, a licensed perfusionist, to offer opinions regarding the perfusion care provided to Mr. Smith during the September 2010 surgery. Included in Mr. Stammers's opinions is the following:

The cardiopulmonary bypass machine manufacturer (Terumo Cardiovascular Systems Corporation, from Japan with its main United States office in Ann Arbor, MI) provided its users with Air Bubble Detection Systems [ABD][11] which created safety issues for patients, and which could have caused problems with allowing the operators of this Advanced Perfusion System 1 to establish forward arterial flow after the ABD detected an event. Safety alerts were issued by Terumo Cardiovascular for the Advanced Perfusion System 1 machine noting that inadvertent shut down of the cardiopulmonary bypass machine could occur related to issues concerning the Air Bubble Detection System, which resulted in an Urgent Medical Device Recall that occurred on June 18, 2012 (after the Smith surgery). [See also the Urgent Field Safety Notice FSN109 2011-03.] Absent evidence that Terumo had modified its ABD, then these problems existed at the time of the Smith surgery [and the recall states that “prior corrective actions on the sensor (from 2007 and 2010) did not fully eliminate the possibility for malfunction”][12]. Upon review of the Advanced Perfusion System 1 Report Log from the Smith surgery, it is evident that the centrifugal pump went into the ‘Coast' mode as a response to an over-pressurization alarm that occurred.[13]

         “As evidenced by the safety alerts and recall notices, ” according to Mr. Stammers, this issue with the Air Bubble Detection system is a defective condition and “could render this cardiopulmonary bypass machine unreasonably dangerous in its operation . . . and dangerous to the safety of patients, and could cause the injuries to a patient, including Charles Smith, due by an inadequate forward flow during perfusion.”[14] Because “no evidence has been presented that this Terumo Advanced Perfusion System 1 machine used in the [September 2010 surgery], which was sold by Terumo and installed by Terumo at Intermountain Medical Center in 2007, was altered by Intermountain Medical Center, ” Mr. Stammers ultimately concludes that “this defective condition was present when this cardiopulmonary bypass machine was sold by Terumo to [Intermountain Medical Center].”[15]


         Terumo does not dispute that Mr. Stammers is qualified to opine on the standard of care applicable to perfusionists and facilities where perfusion services are offered.[16] However, Terumo argues that Mr. Stammers's opinions and testimony regarding the presence of an alleged defect in the System 1 should be excluded for two reasons. First, Terumo argues that that Mr. Stammers is not qualified to “testify about a potential defect in the System 1 that may (or may not) have exhibited itself during the [September 2010 surgery]” because he “has no experience in product design, development, or manufacture.”[17] And second, Terumo argues that because “Mr. Stammers has engaged in nothing more than a review of Terumo safety notices and deposition testimony to conclude it is possible the System 1 malfunctioned[, ]” Mr. Stammers has not “engage[d] in any analysis, let alone a reliable analysis to conclude that it was possible that the System 1 malfunctioned.”[18]

         Federal Rule of Evidence 702 establishes the standard for the admissibility of expert testimony.

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to 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.[19]

         “Under the Rules the trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable.”[20] The inquiry of scientific reliability is flexible and focuses on principles and methodology.[21] The Supreme Court has offered several nonexhaustive factors that a court may rely on for determining reliability such as, whether the testimony can be tested, has been peer reviewed, has a known or potential rate of error, and has attracted acceptance in the relevant scientific community.[22]

         District courts serve as the gatekeepers of expert evidence, and must therefore decide which experts may testify and present evidence before the jury.[23] Courts are given “broad latitude” in deciding “how to determine reliability” and in making the “ultimate reliability determination.”[24] The Federal Rules of Evidence, however, generally favor the admissibility of expert testimony.[25] Excluding expert testimony is the exception rather than the rule, and often times the appropriate means of attacking shaky but admissible evidence is through vigorous cross-examination, and the presentation of contrary evidence.[26] “[T]he Federal Rules of Evidence favor the admissibility of expert testimony, and [courts'] role as gatekeeper is not intended to serve as a replacement for the adversary system.”[27]

         The inquiry into whether an expert's testimony is reliable is not whether the expert has a general expertise in the relevant field, but whether the expert has sufficient specialized knowledge to assist jurors in deciding the particular issues before the court.[28]

         Expert testimony is subject to Federal Rule of Evidence 403. “The court may exclude relevant evidence if its probative value is substantially outweighed by a danger of one or more of the following: unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.”[29]

         In determining whether expert testimony is admissible the first step is to determine whether the expert is qualified, and then if the expert is qualified determine whether the expert's opinion is reliable by assessing the underlying reasoning and methodology.[30] If the expert is qualified and the opinion reliable, the subject of the opinion must be relevant; i.e. the opinion must “help the trier of fact to understand the evidence or to determine a fact in issue.”[31] “Expert testimony which does not relate to any issue in the case is not relevant and, ergo, non-helpful.”[32]

         1. Mr. Stammers lacks the necessary qualifications to opine on an alleged defect in the System 1

         In Mr. Stammers's opinion, the air bubble detection system on the System 1 generated a false alarm during the September 2010 surgery.[33] This false alarm, according to Mr. Stammers, is a defective condition that renders the System 1 unreasonably dangerous.[34] Despite acknowledging that Mr. Stammers is an expert in perfusion and possesses the requisite knowledge to operate the System I, Terumo argues that “expertise in proper perfusion techniques is not sufficient to analyze the design and technical functionality of a heart bypass machine.”[35]Absent the appropriate qualifications based on necessary engineering or mechanical knowledge, Terumo maintains that Mr. Stammers cannot “say, with any degree of expertise and reliability, that the System 1 malfunctioned or was defective.”[36]

         To qualify as an expert under Federal Rule of Evidence 702, the expert must have “such skill, experience or knowledge in that particular field as to make it appear that his opinion would rest on substantial foundation and would tend to aid the trier of fact in his search for truth.”[37]“[A]s long as an expert stays within the reasonable confines of his subject area . . . a lack of specialization does not affect the admissibility of [the expert] opinion, but only its weight.”[38]“The dispositive question” is whether the opinion that the expert offers can be considered “within the reasonable confines of [the expert's] subject area.”[39]

         Mr. Stammers's own admissions show that his ultimate opinion that the System 1 contained a defect is outside the reasonable confines of his expertise as a perfusionist. Immediately following Mr. Stammers's explanation in his deposition of his current status as a Certified Clinical Perfusionist, Mr. Stammers admits that he is not an engineer and does not intend to offer any sort of engineering or manufacturing opinion, specifically as to the design of medical devices:

Q: My understanding, Mr. Stammers, that you don't consider yourself an engineer?
A: That is correct.
Q: And you don't intend to express any opinions that would be on engineering?
A: No, sir.
Q: And would that include opinions relating to design engineering as it relates ...

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