Smith v. Terumo Cardiovascular Systems et al

Filing 217

MEMORANDUM DECISION AND ORDER granting 149 Motion to Exclude Portions of Dr. Maloskys Opinion and Testimony. Signed by Judge David Nuffer on 7/12/17 (Attachments: # 1 Exhibit 1) (alt)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF UTAH, CENTRAL DIVISION
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.,

MEMORANDUM DECISION
AND ORDER GRANTING
[149] MOTION TO EXCLUDE
[PORTIONS OF] STEVE MALOSKY’S
EXPERT TESTIMONY
Case No. 2:12-cv-00998-DN
District Judge David Nuffer

Defendants.

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

1

Amended Complaint, docket no. 17, filed October 7, 2013.

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

2

Terumo Cardiovascular Systems Corporation’s Motion to Exclude Steve Malosky (Motion), docket no. 149, filed
May 12, 2017; Notice of Joinder in Terumo’s Motion to Exclude Steve Malosky, docket no. 161, filed May 16,
2017.
3

Plaintiff’s Opposition to Terumo Cardiovascular System Corporation’s Motion to Exclude Steve Malosky
(Opposition), docket no 176, filed June 3, 2017.
4
Reply Memorandum in Support of Terumo Cardiovascular Systems Corporation’s Motion to Exclude Dr. Steve
Malosky, docket no. 191, filed June 20, 2017.
5

The undisputed material facts will be determined in the rulings on the motions for summary judgment. The facts
described below are provided only for context and are taken as alleged in the Complaint.

6

Complaint ¶ 11.

7

Id. ¶ 12.

2

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

8

Id. ¶ 13.

9

Id. ¶¶ 15–17; though the Complaint fails to specify how many minutes the bypass machine was not working, the
parties seem to agree on between 10 and 11 minutes. See Motion at 4.
10

Id. ¶ 17.

11

Id.

12

Exhibit 2 Report of Expert Opinions Rendered by; Dr. Steve Malosky (Dr. Malosky Report) at 1, docket no. 149,
filed May 12, 2017. The exhibits were included in the file for the motion proper. They do not have a separate docket
entry.
13

Id.

3

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

14

Deposition of Steven Anthony Malosky at 55:13–18, docket no. 185-5, filed June 14, 2017.

15

Motion at 6.

16

Id. at 9.

17

Id. at 12.

18

Id. at 19.

19

Fed. R. Evid. 702

20

Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 589 (1993).

4

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

21

See Id. at 595

22

See Id.

23

See Id. at 579.

24

Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 142 (1999), (citing General Electric Co. v. Joiner, 522 U.S.
135 (1997)).

25

See Daubert, 509 U.S. at 588.

26

See Fed. R. Evid. 702 Advisory Notes.

27

See Daubert, 509 U.S. at 596.

28

THOIP v. Walt Disney Co., 690 F. Supp. 2d 218, 230 (S.D.N.Y. 2010).

29

Kumho, 526 U.S. at 156.

5

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

30

Fed. R. Evid. 403.

31

U.S. v. Nacchio, 555 F.3d 1234, 1241(10th Cir. 2009).

32

Fed. R. Evid. 702 (emphasis added).

33

Daubert, 509 U.S. at 591.

34

Motion at 6.

6

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

35

Id. at 8.

36

Id.

37

Id.

38

Daubert, 509 U.S. at 591–92.

39

Complaint at 3 and 8.

40

Andersen v. Brigham Young University, 879 F. Supp. 1124, 1129 (D. Utah 1995) (citing Harris v. Utah Transit
Auth., 671 P.2d 217 (Utah 1983)).
41

Raab v. Utah Ry. Co., 221 P.3d 219, 226 n.17 (Utah 2009).

42

Id. at 226.

7

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.” 45Medical 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
43

McCorvey v. Utah State Dept. of Transp., 868 P.2d 41, 45 (Utah 1993).

44

Crestwood Cove Apartments Business Trust v. Turner, 164 P.3d 1247, 1256 (Utah 2007).

45

Proctor v. Costco Wholesale Corp., 311 P.3d 564, 569 (Utah Ct. App. 2013).

46

Fredrickson v. Maw, 119 Utah 385, 387 (Utah 1951) (overruled on different grounds in Swan v. Lamb, 584 P.2d
814 (Utah 1978)) (“in those cases which depend upon knowledge of the scientific effect of medicine, the results of
surgery, or whether the attending physician exercised the ordinary care, skill and knowledge required of doctors . . . ,
must ordinarily be established by the testimony of physicians and surgeons.”); see also Fitz v. Synthes (USA), 990
P.2d 391 (Utah 1999) (“This court has held that medical expert testimony is required to prove proximate cause in a
medical injury case” citing Fredrickson); see also Reeves v. Geigy Pharmaceutical Inc. a Div. of Cib-Geigy Corp.,
764 P.2d 636, 640 (Utah Ct. App 1988) (for negligence claim, “expert medical testimony was required to establish
causation, the standard of care, and its breach.”); see also Hoopiiania v. Intermountain Health Care, 740 P.2d 270,
271 (Utah Ct. App. 1987) (“In medical malpractice actions the plaintiff must provide expert testimony to establish:
1) the standard of care . . . ; 2) defendant’s failure to comply with that standard . . . ; and 3) that defendant caused
plaintiff’s injuries.”).
47

Daubert, 509 U.S. at 591.

8

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

48

Deposition of Steven Anthony Malosky at 51:9–53:9 (emphasis added).

49

Id. at 51:25–52:2.

50

Raab, 221 P.3d at 226 n.17.

9

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

51

Id.

52

Though she does respond that there can be “more than one cause of the same harm,” Opposition at 15, but this
relates to proximate cause. She does not address but-for cause.

53

Proctor, 311 P.3d at 569 (alterations omitted).

54

Id. (alterations omitted).

55

Daubert, 509 U.S. 592–93.

10

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

56

Advisory Committee Notes to the 2000 Amendments to Fed. R. of Evid. 702 (internal citations and quotation
marks omitted).

57

Exhibit Steve Malosky, MD Curriculum Vitae at 2, docket no. 149, filed May 12, 2017.

58

Id. at 1.

59

Id. at 2–3.

11

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
60

Opposition at 12–13 (citing and summarizing Dr. Malosky’s report and deposition).

61

Motion at 8; Opposition at 16.

62

Motion at 8; see Marc Eckstein et al., Cardiac Arrest Resuscitation Evaluation in Los Angeles: CARE-LA, 45(5)
Annals of Emergency Medicine 504 (May 2005), available online at
https://www.researchgate.net/publication/7881986_Cardiac_arrest_resuscitation_evaluation_in_Los_Angeles_CAR
E-LA.
63

Opposition at 16; see Dariush Mozaffarian, et al., HEART DISEASE AND STROKE STATISTICS—2016 UPDATE: A
REPORT FROM THE AMERICAN HEART ASSOCIATION 5 (2016), available online at
http://circ.ahajournals.org/content/circulationaha/early/2015/12/16/CIR.0000000000000350.full.pdf.

12

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 the surgery. 68 But she does not show that Dr. Malosky took
into account the many health issues Mr. Smith was facing and their possible role in Mr. Smith’s
ultimate decline and death.
Therefore, Dr. Malosky’s testimony about the causal connection between the surgery, the
ten or eleven minutes without forward flow, and Mr. Smith’s death is excluded. It is not allowed
at trial, and it will not be considered in the outstanding motions for summary judgment.

64

Report of C. Alan Brown, M.D. at 3, docket no. 149, filed May 12, 2017.

65

Dr. Malosky Report at 1 (emphasis added).

66

Deposition of Steven Anthony Malosky at 51:23–25.

67

Dr. Malosky Report at 1.

68

Opposition at 12–14.

13

2. Dr. Malosky’s opinion that Mr. Smith suffered a perioperative myocardial
infarction is not reliable.
The autopsy report states that Mr. Smith’s heart had no “fibrotic areas consistent with an
old infarct present.” 69 In other words, there was no postmortem evidence that Mr. Smith had
suffered a heart attack at an earlier date. 70 Dr. Malosky, however, determined that Mr. Smith had
suffered a heart attack during the 2010 surgery (i.e., perioperative myocardial infarction) based
on Mr. Smith’s post-surgery troponin levels and a post-surgery electrocardiogram. 71
Defendants argue that Dr. Malosky’s opinion that Mr. Smith’s heart was damaged due to
the lack of circulation during his surgery is not helpful or reliable because it “contradicts and
ignores the results of an autopsy that revealed no significant scarring to Mr. Smith’s heart
muscle.” 72
There appears to be near consensus that an autopsy is the diagnostic gold standard, 73
especially for diagnosing myocardial infarctions. 74 Mrs. Smith apparently agrees. She does not
contradict the Defendants’ and the articles’ characterizations of autopsy. Instead, she argues that
Dr. Malsoky’s contrary findings create a factual issue for the jury to decide. 75

69

Surgical Pathology Report, docket no. 149, filed May 12, 2017.

70
Plaintiff appears to be conflating the two alleged myocardial infarctions. There is the alleged myocardial
infarction that is the immediate cause of his death. The parties do not seem to dispute that this happened. And there
is the alleged perioperative myocardial infarction—the one that allegedly occurred during the September 2010
surgery. This second myocardial infarction is the one in dispute. The Autopsy Report distinguishes between these
two alleged myocardial infarctions in a way that makes it unnecessary to address Plaintiff’s argument.
71

Deposition of Steven Anthony Malosky at 143:14–144:7.

72

Motion at 10.

73

RW Giard, et al., [Truth after death], N. Tijdschr Geneeskd, English abstract available at
https://www.ncbi.nlm.nih.gov/pubmed/10590770; I. Pakis, et al., Comparison of the clinical diagnosis and
subsequent autopsy findings in medical malpractice, 31(3) Am. J. Forensic Med. Pathol., 218 (2010) available at
https://www.ncbi.nlm.nih.gov/pubmed/20473143; M. Costache, Clinical or Postmortem? The Importance of the
Autopsy; a Retrospective Study, 9(3) Maedica – a Journal of Clinical Medicine, 261 (2014).
74

See I. Pakis, et al. supra note 70.

75

Opposition at 7.

14

Trial courts are the gatekeepers of expert testimony. 76 They should exclude expert
testimony that uses methods not generally accepted 77 or where an expert is not “being as careful
as he would be in his regular professional work outside his paid litigation consulting.” 78 Expert
testimony cannot be used as a springboard for jury consideration of an unsubstantiated theory.
Dr. Malosky’s methods are not generally accepted. There is no indication (e.g., peer
reviewed research) that clinical diagnostic indicators are in some instances more reliable than
autopsy results. Indeed, it seems unlikely that in any setting other than this litigation Dr. Malosky
would rely on the clinical diagnostic indicators over an autopsy. To allow the jury to hear Dr.
Malosky’s opinion on this point would be to allow the jury to hear conclusions based on inferior
diagnostic metrics. This will not be permitted.
Therefore, Dr. Malosky’s testimony about the alleged perioperative myocardial infarction
is excluded. This does not mean, as Mrs. Smith properly points out, 79 that Dr. Malosky is
generally precluded from testifying that Mr. Smith’s heart was injured during the September
2010 surgery. A copy of Dr. Malosky’s report is attached to this order. The excluded portions
have red strikethrough and other indicators. Dr. Malosky may testify regarding the remaining
portions of the report.
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.
Dr. Malosky opines that “Mr. Smith suffered an injury to the brain due to prolonged lack
of oxygenated blood flow to the brain.” 80 Defendants argue that Dr. Malosky’s opinion regarding

76

Daubert, 509 U.S. at 597.

77

Id. at 594.

78

Advisory Committee Notes 2000 Amendments.

79

Opposition at 8.

80

Dr. Malosky Report at 1.

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any alleged neurological injury to Mr. Smith should be excluded because he is not qualified to
opine on neurological injuries 81 and that even if he were, his opinion is not based on reliable
methodology. 82
To qualify as an expert, 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.” 83 It is not enough for the expert to have
some marginal familiarity with the subject area: 84 “merely possessing a medical degree is not
sufficient to permit a physician to testify concerning any medical-related issue.” 85
Dr. Malosky is not qualified to opine on Mr. Smith’s alleged neurological injuries. Dr.
Malosky candidly admits that he is “not an expert on the neuropathology literature.” 86 Even
though Dr. Malosky bases his opinion on his “own experience with . . . patients who had cardiac
arrest,” 87 he does not indicate any “knowledge, skill, experience, training, or education” that
would qualify him to diagnose neurologic injuries.
But even if Dr. Malosky were qualified to opine on Mr. Smith’s alleged neurological
injuries, his methodology is flawed. Dr. Malosky reviews notes and comments of various
individuals who met with Mr. Smith after the September 2010 surgery and formed his decision
based on their descriptions and assessments. Specifically, Dr. Malosky opines that Mr. Smith

81

Motion at 13–15.

82

Id. at 15–18.

83

LifeWise Master Funding v. Telebank, 374 F.3d 917 (10th Cir. 2004) (internal quotation marks omitted).

84

Ralston v. Smith & Nephew Richards, Inc., 275 F.3d 965, 970 (10th Cir. 2001).

85

Id.

86

Deposition of Steven Anthony Malosky at 40:22–23.

87

Id. at 39:17–20.

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suffered from hypoxic encephalopathy. 88 But in the autopsy of Mr. Smith’s brain, there is no
sign of any hypoxic encephalopathy. 89 Dr. Malosky’s explanation for the disparity between his
diagnosis and the autopsy does not bespeak any methodology:
if a person has a typical event that would commonly cause hypoxic
encephalopathy and he’s seen multiple times by multiple different providers, all
of whom feel, including a neurologist, that he has an encephalopathy, if the
neuropathologist [i.e. the doctor performing the brain autopsy] says I don’t see
any sign here of injury, . . . I interpreted that to mean he had a mild
encephalopathy.” 90
There is no basis for this opinion. It is not clear what led him to believe that when a
neuropathologist sees no sign of injury in an autopsy but others—in a clinical setting—believe
there may have been injury, that the injury necessarily must have been a mild version that would
not show up in an autopsy. Dr. Malosky offers no methodological bridge, only speculation. He
continues:
I’m not an expert on the neuropathology literature. I wondered -- or I should say I
thought that you could have a mild encephalopathy from a hypoxic injury and
would not necessarily see scarring findings on pathology either because of
sampling error or because a lot of the neuropathology findings that are described
were described in cases where people had grievous injuries and died within a few
days or a month or so of their injury from coma and vegetative state. His injury
was not as severe as that. So I did see the neuropathologist’s report, but I didn’t
think that that report in and of itself obviated what happened and then the clinical
course over the ensuing 11 months. 91

88

Id. at 39:20.

89

Exhibit 10 Dr. Heidingsfelder Autopsy Report at 1, docket no. 149, filed May 12, 2017 (“There is no evidence of
ischemia, infection, or neoplacia.”).
90

Deposition of Steven Anthony Malosky at 40:14–40:21.

91

Id. at 40:22–41:10 (emphasis added).

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Dr. Malosky is not “being as careful as he would be in his regular professional work
outside his paid litigation consulting.” 92 A jury has no use for “I wondered – or I should say I
thought,” 93 especially from someone whose expertise lies elsewhere.
Therefore, Dr. Malosky’s testimony regarding the alleged neurological effect of the
September 2010 surgery on Mr. Smith is excluded.
4. Dr. Malosky may state the factual bases for his opinions.
An expert may of course “base an opinion on facts or data in the case that the expert has
been made aware of or personally observed.” 94 And the expert can inform the jury of those
bases. The expert, however, cannot take the place of a fact witness.
Therefore, Dr. Malosky may indicate what he relied on to form his opinions. He may not
give a general narration of Mr. Smith’s health before, during, and after the surgery.
ORDER
IT IS HEREBY ORDERED that Terumo Cardiovascular Systems Corporation’s Motion
to Exclude Steve Malosky 95 is GRANTED. A copy of Dr. Malosky’s report is attached to this
order. The portions now excluded have red strikethrough and other indicators. Dr. Malosky may
testify regarding the remaining portions of the report.
Dated July 12, 2017.
BY THE COURT:
____________________________
David Nuffer
United States District Judge

92

Rule 702 Advisory Committee Notes 2000 Amendments.

93

Deposition of Steven Anthony Malosky at 40:23.

94

Fed. R. Evid. 703.

95

Docket no. 149, filed May 12, 2017.

18