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Smith v. Terumo Cardiovascular Systems Corp.

United States District Court, D. Utah, Central Division

July 12, 2017

BUZZIE SMITH, individually and on behalf of the Heirs and Estate of Charles A. Smith, Deceased, Plaintiff,
v.
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; IHC HEALTH SERVICES, INC.; INTERMOUNTAIN MEDICAL CENTER; INTERMOUNTAIN HEALTH CARE, INC., Defendants.

          MEMORANDUM DECISION AND ORDER GRANTING [149] MOTION TO EXCLUDE [PORTIONS OF] STEVE MALOSKY'S EXPERT TESTIMONY

          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 complications 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 (collectively “Defendants”).[1] To establish certain elements of her claims, Mrs. Smith offers Dr. Steven Malosky's expert opinion and testimony. Defendants move (Motion) to exclude various portions of Dr. Malosky's opinion and testimony.[2] Mrs. Smith opposes the Motion (Opposition).[3] Defendants reply in support of the Motion.[4]

         As discussed below, Dr. Malosky's opinions and testimony are not helpful or reliable and he is not qualified to render some of the opinions offered. Therefore, the Motion is GRANTED.

         Table of Contents

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

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

         1. Dr. Malosky's opinions related to Mr. Smith's death are not helpful or reliable. .. 6

         i. Dr. Malosky's opinion is not helpful to establish medical causation. . ....... 7

         ii. Even if Dr. Malosky's testimony about Mr. Smith's death were helpful, it is not reliable. . ........................................................................................... 10

         2. Dr. Malosky's opinion that Mr. Smith suffered a perioperative myocardial infarction is not reliable. . ...................................................................................... 14

         3. Dr. Malosky's opinion about Mr. Smith's alleged neurological injury is excluded because he is not qualified to offer it and because it is not reliable ...................... 15

         4. Dr. Malosky may state the factual bases for his opinions ..................................... 18

         Order ........................................................................................................................................... 18

         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 was used.[7] The bypass machine 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 bypass machine stopped working for 10-11 minutes.[9] After the surgery, Mr. Smith remained hospitalized.[10] And eleven months later, on August 6, 2011, Mr. Smith passed away from a myocardial infarction, (i.e., heart attack).[11]

         Dr. Malosky is a cardiologist hired by Mrs. Smith to offer opinions on the September 2010 surgery, the related complications, and Mr. Smith's death. In his opinion, Dr. Malosky lists various injuries he attributes to the September 2010 surgery and attendant complications:

As a consequence of tissues within his body being deprived of proper flow of oxygenated blood for that period of time [during the September 2010 surgery], Mr. Smith sustained injuries. The heart muscle itself was injured during the procedure, with a deterioration of heart muscle strength noted following the surgery and substantial worsening of Mr. Smith's congestive heart failure syndrome. In addition, Mr. Smith suffered an injury to the brain due to prolonged lack of oxygenated blood flow to the brain. Mr. Smith was in medical facilities for approximately 2 ½ months continuously following the surgery, and he never recovered his pre-surgery level of functioning. He died August 6, 2011, 11 months following the surgery.[12]

         Dr. Malosky then opines that “[i]t is more likely than not that proper and uninterrupted forward arterial flow during his heart valve replacement surgery would have prevented the above-described injuries and prolonged course of treatment with the resulting physical and mental deterioration that Mr. Smith endured prior to his death.”[13] Dr. Malosky concludes that the injuries Mr. Smith suffered during “the time of the heart valve replacement surgery made him less able to tolerate and/or survive additional adverse events and medical stressors.” Dr. Malosky later clarifies that by “additional adverse events and medical stressors” he is referring to the “myocardial infarction” that caused Mr. Smith's death.[14]

         DISCUSSION

         Defendants argue that portions of Dr. Malosky's testimony should be excluded for several reasons. First, Defendants argue that Dr. Malosky's “opinions related to Mr. Smith's death are unhelpful and unreliable.”[15] Second, Defendants argue that “Dr. Malosky's opinions about injuries to Mr. Smith's heart are unhelpful and unreliable.”[16] Third, Defendants argue that “Dr. Malosky is not qualified to opine on neurological injury, and his opinions are not helpful and not reliable.”[17] And fourth, Defendants argue that Dr. Malosky should not be allowed “to provide a narrative of events that can and should be provided by other witnesses and records.”[18]

         Federal Rule of Evidence 702 addresses 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 non-exhaustive 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, [26] and often times the appropriate means of attacking shaky but admissible evidence is through vigorous cross-examination, and the presentation of contrary evidence.[27] “[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.”[28]

         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.[29]

         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.”[30]

         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.[31] 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.”[32] “Expert testimony which does not relate to any issue in the case is not relevant and, ergo, non-helpful.”[33]

         1. Dr. Malosky's opinions related to Mr. Smith's death are not helpful or reliable.

         Defendants argue that Dr. Malosky's opinions regarding the alleged cause and effect relationship between the complications of Mr. Smith's surgery and his ultimate death should be excluded. First, Defendants argue that Dr. Malosky's testimony is not helpful because it fails “to show a valid scientific connection between his opinion and the issues of medical causation . . . . Dr. Malosky is unable to state, and does not opine, to a reasonable degree of medical probability that but for the complications during his September 2010 surgery, Mr. Smith would have died on August 6, 2011.”[34] And second, Defendants argue that Dr. Malosky's methodology is flawed because he speaks in vague terms, [35] fails to account for Mr. Smith's preexisting conditions, [36] and because he fails to cite, consider, or rely on any literature or studies.[37]

         i. Dr. Malosky's opinion is not helpful to establish medical causation.

         “Rule 702's ‘helpfulness' standard requires a valid scientific connection to the pertinent inquiry as a precondition to admissibility.”[38]

         Mrs. Smith alleges negligence by the defendants.[39] “A prima facie case in negligence is made out in Utah upon demonstration that (1) defendant had a duty to the plaintiff; (2) defendant breached that duty; (3) defendants conduct was the cause-in-fact of the injury as well as the proximate cause [also known as legal cause]; and (4) as a result, plaintiff sustained injury.”[40]“Cause in fact, or ‘but for' causation, means that if the harmful result would not have come about but for the negligent conduct, then there is a direct causal connection between the negligence and the injury.”[41] “For a particular negligent act to be the legal cause [i.e. proximate cause] of a plaintiff's injuries, there must be some greater level of connection between the act and the injury than mere ‘but for' causation.”[42] To establish proximate cause, a plaintiff “must prove that [defendant's] conduct was a substantial causative factor leading to his injury. However . . ., there can be more than one proximate cause or, more specifically, substantial causative factor, of an injury.”[43] “Proximate cause is that cause which, in natural and continuous sequence (unbroken by an efficient intervening cause), produces the injury and without which the result would not have occurred. It is the efficient cause-the one that necessarily sets in operation the factors that accomplish the injury.”[44] “[N]egligent conduct is not a proximate cause in bringing about harm to another if the harm would have been sustained even if the actor had not been negligent.”[45]Medical causation (both but-for and proximate) must come from expert testimony.[46]

         Therefore, to be helpful, Dr. Malosky's opinion and testimony that the September 2010 surgery and related complications had any causal-both but-for and proximate-relationship to Mr. Smith's injuries and ultimate death must be based on a “valid scientific connection.”[47]

         Dr. Malosky's deposition testimony demonstrates that his testimony is not helpful. He admits that he cannot testify with certainty that there is a causal connection between the surgery, the ten-minute lack of flow, and the heart attack that caused Mr. Smith's death:

Q: Okay. Do you think there's a causal relationship between the events of the surgery and that myocardial infarction?
A: I think that the fact -- you know, the fact that he went into the myocardial infarction in such a weakened state with worse LV function and a substantially worse congestive heart failure syndrome made it less likely that he would survive a myocardial infarction. I think that the -- the stress that he was under, the psychological stress after the incident, played some role in increasing the odds that he would have a heart attack or myocardial infarction. However, I would say that, as a person with underlying plaque, people who have coronary artery disease can have a myocardial infarction. I couldn't say with certainty that the event that happened during surgery caused his myocardial infarction. He was a person who was, by virtue of his coronary artery disease, was at risk of having a myocardial infarction. I think that the events that happened at the time of surgery simply made it more likely that he would die as a result of a myocardial infarction. But they also -- I think, you know, the issue of stress and atherosclerosis and myocardial infarction is not an issue where there's a clear consensus in the cardiology community. We were talking earlier about what causes a heart attack, and there's two things, and this is a simplification and there would be, in some rare syndromes, would be exceptions to these general rules, but there's two basic things. There's --there's the development of plaque in the artery and then there's the inciting event, what happens that day that allows an artery that was, let's say, 70 percent narrowed to become a hundred percent narrowed. The classic atherosclerotic risk factors, hypertension, diabetes, smoking, family history, those are considered to be the main contributors to the development of plaque. On the topic of psychological stress, there's a general agreement and there's some data that being under psychological stress can play a role in accelerating atherosclerosis. I don't think that's the major role in terms of why he has atherosclerosis. There's also some evidence that people who are under psychological stress, it's a contributing factor. It can increase the risk of a cardiac event. So I think that what happened is -- played a role in his having a heart attack and made it less likely that he would survive the heart attack, but I cannot say that it caused his heart attack.[48]

         This is not helpful. As Dr. Malosky admits, his testimony could just as easily be that Mr. Smith's heart attack was caused by his preexisting heart condition: Mr. Smith “was a person who was, by virtue of his coronary artery disease, . . . at risk of having a myocardial infarction.”[49] Dr. Malosky's opinion would not help a jury decide whether Mr. Smith's death “would not have come but for” the surgery and the ten-minute lack of flow.[50] His opinion would not be helpful for deciding whether “there is a direct causal connection between the negligence and the injury.”[51] Mrs. Smith seems to agree. Nowhere in the Opposition does she address this major shortcoming in Dr. Malosky's testimony.[52] This uncertainty is not something for the parties to work out in cross-examination. Evidence of this low quality and probative value should not be presented to a jury. Dr. Malosky, perhaps to his credit, has not and cannot state under oath that the September 2010 surgery and attendant complications caused Mr. Smith's death.

         Given that Dr. Malosky's opinion is not helpful for establishing but-for cause, it is not helpful for establishing proximate cause. Dr. Malosky's opinion would not help the jury decide if Mr. Smith's injury “would have [occurred] even if [Defendants] had not been negligent.”[53] As the Utah Court of Appeals stated, “no case has been found where the defendant's act could be called a proximate cause when the event would have occurred without it.”[54] Dr. Malosky's opinion would not help the jury decide whether Mr. Smith's injuries would have occurred without the September 2010 surgery and its complications. Therefore, Dr. Malosky's opinion regarding causation is not helpful.

         ii. Even if Dr. Malosky's testimony about Mr. Smith's death were helpful, it is not reliable.

         To determine reliability, courts must make a “preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.”[55] Courts consider various factors in making that assessment, including those listed in the Advisory Committee Notes to the 2000 Amendments to Federal Rule of Evidence 702. Those, in part, include:

(1) Whether experts are proposing to testify about matters growing naturally and directly out of research they have conducted independent of the litigation, or whether they have developed their opinions expressly for purposes of testifying.
(2) Whether the expert has unjustifiably extrapolated from an accepted premise to an unfounded conclusion.
(3) Whether the expert has adequately accounted for obvious alternative explanations.
(4) Whether the expert is being as careful as he would be in his regular professional work outside his paid litigation consulting.[56]

         First, the substance of Dr. Malosky's testimony regarding the cause of Mr. Smith's death aligns with his research and practice outside this litigation. His curriculum vitae confirms his extensive professional credentials as a cardiologist. Dr. Malosky has been a practicing cardiologist since July 1997.[57] Between July 1993 and June 1997, Dr. Malosky completed two fellowships, first a cardiovascular diseases fellowship and then an interventional cardiology fellowship, both at the Hospital of the University of Pennsylvania.[58] Although Dr. Malosky's list of research and presentations is a little thin, it does show that he has been involved in relevant research independent of this litigation.[59]

         Second, Dr. Malosky's causal analysis has a significant analytical gap that leads him to form an unfounded conclusion. Dr. Malosky observes that Mr. Smith had certain problems with his heart and that he had surgery that was intended to fix those problems. But the problems were not resolved, and Mr. Smith continued to decline until he ultimately died. Therefore, according to Dr. Malosky, the surgery necessarily contributed to Mr. Smith's decline and eventual death.[60]He does not provide a basis to conclude that the relationship is causal and not merely corollary. The gap between Dr. Malosky's premises and conclusion is too large.

         Third, Dr. Malosky fails to fully account for obvious alternative explanations of the cause of Mr. Smith's death. The parties each provide scholarly support for the survival rate of individuals who suffer cardiac arrest outside of a hospital setting.[61] Defendants' article states that the survival rate for those who suffer cardiac arrest outside of a hospital ranges from 1% to 3.2%.[62] Mrs. Smith's article says 10.6% survive.[63] Both numbers suggest that there is a strong likelihood Mr. Smith would not have survived the cardiac arrest because he was not in a hospital when it happened. In other words, even if the September 2010 surgery went smoothly, but Mr. Smith still suffered cardiac arrest eleven months later, he would at best have a 10.6% chance of surviving. This seriously undermines Dr. Malosky's opinion for causation.

         Mr. Smith's own medical history is full of other, potentially sufficient causes. Another expert gives a succinct summary of Mr. Smith's conditions that existed before the September 2010 surgery:

Mr. Smith, a ranch hand and a former coal miner, had a medical history that included high cholesterol, asthma, pneumoconiosis (black lung disease), chronic bronchitis, laryngeal cancer with radiation (2004), rectal cancer with resection, radiation and chemotherapy (2003), and lung cancer with wedge resection and chemotherapy (2005). He was a 1.5 to 3 pack a day smoker and had severe chronic obstructive pulmonary disease (COPD) (including chronic bronchitis and emphysematous changes). His family history was significant in that his father died of heart disease.[64]

         Despite this background, Dr. Malosky states that “it is more likely than not that proper and uninterrupted forward arterial flow during his heart valve replacement surgery would have prevented” a “deterioration of heart muscle strength, ” the “substantial worsening of Mr. Smith's congestive heart failure syndrome, ” “injury to the brain due to prolonged lack of oxygenated blood flow to the brain, ” and ultimately Mr. Smith's death.[65]

         Dr. Malosky's report goes further than his deposition. As quoted at length above, Dr. Malosky “couldn't say with certainty that the event that happened during surgery caused his myocardial infarction.”[66] But in his report, Dr. Malosky lists the various postoperative injuries, including Mr. Smith's death, and then states that a surgery without incident more likely than not would have prevented “the above-described injuries.”[67] Dr. Malosky arrives at this conclusion without any reference to methodology. Mrs. Smith's arguments that Dr. Malosky took into account the preexisting health issues are not convincing. Her memorandum again refers to Mr. Smith's condition before and after ...


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