Pritchett v. I-Flow Corporation et al

Filing 128

ORDER denying 106 Defendant I-Flow Corporations Motion to Exclude Expert Opinions of Dr. Jon Hyman Under Fed. R. Evid. 702, by Magistrate Judge Kristen L. Mix on 4/17/2012.(ervsl, )

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLORADO
Civil Action No. 09-cv-02433-WJM-KLM
JOEL M. PRITCHETT,
Plaintiff,
v.
I-FLOW CORPORATION,
Defendant.
_____________________________________________________________________
ORDER
_____________________________________________________________________
ENTERED BY MAGISTRATE JUDGE KRISTEN L. MIX
This matter is before the Court on Defendant I-Flow Corporation’s Motion to
Exclude Expert Opinions of Dr. Jon Hyman Under Fed. R. Evid. 702 and Request for
Hearing [Docket No. 106; Filed October 4, 2011] (the “Motion”).

Plaintiff filed an

Opposition to Defendant I-Flow’s Motion to Exclude Expert Opinions of Jon Hyman,
M.D. [Docket No. 114; Filed October 28, 2011], and Defendant filed I-Flow, LLC’s Reply
in Support of its Motion to Exclude Expert Opinions of Dr. Jon Hyman Under Fed. R.
Evid. 702 [Docket No. 115; Filed November 14, 2011]. The Court held a hearing on the
Motion on January 10, 2012. [#122]. The Court has reviewed the pleadings, the exhibits,
the entire case file and the applicable law, and is fully advised in the premises. For the
reasons set forth below, the Motion is DENIED.
I. Summary of the Case
Plaintiff had shoulder surgery in August of 2005. The surgeon used a pain pump
manufactured by Defendant I-Flow to inject anesthetic into Plaintiff’s shoulder joint for more
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than 48 hours. Plaintiff subsequently developed a condition called “chondrolysis,” which
involves partial or complete loss of cartilage in the shoulder joint. Plaintiff alleges that his
chondrolysis was caused by continuous injection of anesthetics into his shoulder joint, and
that I-Flow manufactured and marketed the pain pump “without doing a single study to
determine whether pain pump anesthetics could harm cartilage. Once on notice about the
risk of shoulder chondrolysis, [I-Flow] waited years to inform physicians about the risks
[and] the warnings . . . were all wholly inadequate to advise physicians about the risk of
cartilage destruction.” Sched. Ord., [#62] at 3. Plaintiff brings claims against I-Flow for
“negligence, negligent misrepresentation, fraud, strict product liability (design defect and
failure to warn), breach of implied warranty and breach of express warranty.” Id.
Defendant denies liability and causation and asserts that its “pain pumps were
cleared by the FDA and were accompanied with adequate warnings and instructions.” Id.
Plaintiff offers the expert opinion of Dr. Jon Hyman to testify that Plaintiff’s “left
shoulder function has been irretrievably lost [and that] this condition was caused by the
infusion pain pump and anesthetics delivered to his shoulder joint in 2005.” Expert Report
Jon Hyman, M.D. (hereinafter “Hyman Report”), [#106-5] at 15.
Defendant asserts multiple grounds for excluding Dr. Hyman’s testimony under Fed.
R. Evid. 702. First, I-Flow argues that Dr. Hyman’s opinions are based on insufficient facts
or data and his methods are unsound. More specifically, I-Flow contends that the case
series on which Dr. Hyman relies are insufficient to establish general causation, that Dr.
Hyman improperly extrapolates from in vitro studies, that Dr. Hyman improperly relies on
in vitro animal studies, and that Dr. Hyman’s opinion is the only connection between the
data and his conclusion. Motion, [#106] at 3-13. Second, I-Flow argues that Dr. Hyman’s
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differential diagnosis of specific causation is invalid in light of the lack of evidence of
general causation and because Dr. Hyman failed to rule out other potential causes of
Plaintiff’s shoulder injury. Id. at 13-15.
Plaintiff counters I-Flow’s arguments by asserting, in a nutshell, that they are not a
basis for excluding his testimony, as they merely “go to the weight and credibility of his
testimony.” Resp., [#114] at 2-15.
II. Analysis
A.

General Principles of Federal Rule of Evidence 702
“Admission at trial of expert testimony is governed by Fed. R. Evid. 702, which

imposes on the district court a gatekeeper function to ‘ensure that any and all scientific
testimony or evidence admitted is not only relevant, but reliable.’” United States v.
Gabaldon, 389 F.3d 1090, 1098 (10th Cir. 2004) (quoting Daubert v. Merrell Dow
Pharmaceuticals, Inc., 509 U.S. 579, 589 (1993)). The gatekeeper function “requires the
judge to assess the reasoning and methodology underlying the expert’s opinion, and
determine whether it is both scientifically valid and applicable to a particular set of facts.”
Dodge v. Cotter Corp., 328 F.3d 1212, 1221 (10th Cir. 2003). The district court’s discretion
in admitting or excluding expert testimony under Daubert is broad, “both in deciding how
to assess an expert’s reliability, including what procedures to utilize in making that
assessment, as well as in making the ultimate determination of reliability.” Id. at 1223.
Rule 702 provides the foundational requirements for admission of expert opinions:
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
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(b)
(c)
(d)

determine a fact in issue;
the testimony is based on sufficient facts or data;
the testimony is the product of reliable principles and methods;
and
the expert has reliably applied the principles and methods to
the facts of the case.

Adopted in response to Daubert, Rule 702 was revised effective December 1, 2000 and
December 1, 2011.
Under the current version of Rule 702, a witness’ qualifications are no longer
sufficient foundation, standing alone, to admit expert testimony. In addition to showing that
the witness has appropriate qualifications, the proponent of the witness’ opinions must
demonstrate that the process by which the witness derived his or her opinions is reliable.
See Dodge, 328 F.3d at 1222. To be reliable, an expert’s scientific testimony must be
based on scientific knowledge, which “implies a grounding in the methods and procedures
of science” based on actual knowledge, not “subjective belief or unsupported speculation.”
Daubert, 509 U.S. at 590. Rule 702 anticipates that, if challenged, the factual foundation
supporting the specific testimony will be provided by the proponent of the witness. Dodge,
328 F.3d at 1222. However, the proponent need not prove that “the expert is undisputably
correct or that the expert’s theory is ‘generally accepted’ in the scientific community.”
Mitchell v. Gencorp Inc., 165 F.3d 778, 781 (10th Cir. 1999). Instead, the proponent must
show that the method used by the expert in reaching the conclusion is scientifically sound
and that the opinion is based on facts which satisfy Rule 702's reliability requirements. Id.
In the Tenth Circuit, determination of the sufficiency of the foundation for admission of
expert testimony requires factual findings, preferably after an evidentiary hearing. Dodge,
328 F.3d at 1222.

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A Rule 702 hearing is meant to address only the foundational requirement for
challenged opinions, and the Court rules on only the specific challenges raised by the party
opposing the opinions. United States v. Crabbe, 556 F. Supp. 2d 1217, 1220 (D. Colo.
2008). “The Court does not determine the weight or persuasiveness of the opinion, nor
consider other evidentiary objections[, such as relevance, etc.,] which are more
appropriately addressed at trial.” Id. Instead, “[t]he focus . . . must be solely on principles
and methodology, not on the conclusions they generate.” Daubert, 509 U.S. at 595.
1.

Burden of Proof

The proponent of expert testimony bears the burden of proving the foundational
requirements of Rule 702 by a preponderance of the evidence. See Cook ex rel. Estate
of Tessier v. Sheriff of Monroe Cnty., 402 F.3d 1092, 1107 (11th Cir. 2005) (citing Daubert,
509 U.S. at 592 n.10). The proponent is not required to prove that the opinion is objectively
correct. Mitchell, 165 F.3d at 781. Instead, the proponent must show that the witness has
sufficient expertise to choose and apply a methodology, that the methodology was reliable,
that sufficient facts and data as required by the methodology were used and that the
methodology was otherwise reliably applied. Id.; Daubert, 509 U.S. at 595; see also
Dodge, 328 F.3d at 1222. The burden on the proponent of the expert is heavy, as any
inadequacy in the proof on any of Rule 702's elements may render the entire opinion
inadmissible. Mitchell, 165 F.3d at 782.
2.

Rule 702 Analysis

In the Tenth Circuit, the Rule 702 analysis has two steps: (1) the Court must
determine whether the expert is qualified to give the proffered opinion, and (2) the Court
must examine whether the opinion itself is reliable. 103 Investors I, L.P. v. Square D Co.,
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470 F.3d 985, 990 (10th Cir. 2006). The second step of the analysis focuses on the
process or means by which the witness developed the opinion, i.e., the methodology or
application of principles. Id. “This analytical framework makes the Rule 702 determination
more opinion-centric than expert-centric.” Crabbe, 556 F. Supp. 2d at 1221 (emphasis in
original).
a.

Qualifications

Rule 702 requires that a witness have “expert[ise resulting from] knowledge, skill,
experience, training, or education,” and such qualifications are considered in relation to the
particular opinion or testimony proffered. United States v. Dysart, 705 F.2d 1247, 1252
(10th Cir. 1983). Any one of these qualifications can be sufficient to support a finding that
an expert is qualified.

See Fed. R. Evid. 702 Advisory Committee Notes, 2000

Amendments.1 However, in some fields, experience alone is the “predominant, if not sole,
basis for a great deal of reliable expert testimony.” Id.
Some of the factors provided in Daubert are applicable to the question of whether
the witness is sufficiently qualified. For example, the Court should consider whether the
witness proposes to testify about the matters growing naturally and directly out of research
he or she conducted independent of the litigation, whether the witness developed opinions
expressly for purposes of testifying, and whether the field of expertise claimed by the
witness is known to reach reliable results for the type of opinion the witness tends to
express. Daubert, 509 U.S. at 595.

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Because the witness’ qualifications must relate to the opinions offered in the present case,
the fact that the witness has given expert testimony in other cases is not relevant unless the
testimony was of the same nature using the same methodology.

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b.

Derivation of the Opinion

Rule 702 also requires that the means or method by which the testimony or opinion
is derived be reliable. As such, the Rule sets out three specific requirements: (1) a showing
that the “testimony is based upon sufficient facts or data,” (2) a showing that “the testimony
is the product of reliable principles and methods,” and (3) a showing that “the expert has
reliably applied the principles and methods to the facts of the case.” Fed. R. Evid. 702(b)(d).
i.

Sufficient Facts and Data

The proponent of the opinion must first show that the witness gathered “sufficient
facts and data” to formulate the opinion. In the Tenth Circuit, assessment of the sufficiency
of the facts and data used by the witness is a quantitative, rather than a qualitative,
analysis. Fed. R. Evid. 702, Advisory Committee Notes to 2000 Amendments; see also
United States v. Lauder, 409 F.3d 1254, 1264 n.5 (10th Cir. 2005). That is to say, the
Court does not examine whether the facts obtained by the witness are themselves reliable;
whether the facts used are qualitatively reliable is a question of the weight that should be
given to the opinion by the fact-finder, not the admissibility of the opinion. Lauder, 409 F.3d
at 1264. Instead, “this inquiry examines only whether the witness obtained the amount of
data that the methodology itself demands.” Crabbe, 556 F. Supp. 2d at 1223.
ii.

Methodology

Methodology, or the requirement that an opinion be derived from reliable principles
or methods, involves two related inquiries: (1) identification of the methodology the witness
used to reach the opinion; and (2) determination of whether the methodology is generally
considered “reliable” in the field in which the expert works. Crabbe, 556 F. Supp. 2d at
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1222. These inquiries are solely factual, and “the proponent of the opinion must establish
both inquiries by sufficient, competent evidence.” Id.
The first inquiry simply requires that the witness explain how he or she reached the
opinion at issue – a simple explanation of the process normally is sufficient. Id. The
second inquiry, whether the methodology is reliable, requires that the court assess whether
that method is “scientifically valid.” Hollander v. Sandoz Pharmaceuticals Corp., 289 F.3d
1193, 1204 (10th Cir. 2002); Truck Ins. Exchange v. MagneTek, Inc., 360 F.3d 1206, 1210
(10th Cir. 2004). A determination that a method is “scientifically valid” requires an inquiry
into whether it is a scientific or logical method that can be replicated and validated. Kumho
Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152 (1999). Depending on the methodology at
issue, courts have the wide discretion to consider a variety of appropriate factors in
assessing reliability. These factors, include, but are not limited to: (1) whether the
methodology is one that can be tested or falsified – that is, whether the witness’ approach
can be challenged in some objective sense, or whether it is instead simply a subjective,
conclusory approach that cannot reasonably be assessed for reliability; (2) whether the
method or technique has been subject to peer review and publication; (3) whether there are
known or potential rates of error with regard to the use of the method; (4) whether there are
standards controlling the operation of the technique; and (5) whether the method or
approach has “general acceptance” in the “relevant scientific community.” See Daubert,
509 U.S. at 593-94, Kumho Tire, 526 U.S. at 149-50.
However, the above factors are not exclusive nor dispositive. Crabbe, 556 F. Supp.
2d at 1223. For instance, a methodology that is not peer reviewed or tested may still be
considered reliable if only because it is considered a generally-accepted practice in the
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discipline. See Bitler v. A.O. Smith Corp., 400 F.3d 1227, 1235 (10th Cir. 2004). However,
a methodology may have almost universal acceptance in a particular discipline, but the
Court may find that the entire discipline itself (e.g., astrology) is not reliable. Kumho Tire,
526 U.S. at 151. A court must consider and balance the factors in light of each other, and
also considering the particular circumstances of the case. For example, where the
methodology is unique or lacks general acceptance in the relevant field, the need for the
witness to validate the theory through more extensive testing increases. See, e.g.,
MagneTek, 360 F.3d at 1212. On the other hand, an otherwise reliable methodology does
not instantly become unreliable merely because the witness did not test it thoroughly in all
applicable situations. See Bitler, 400 F.3d at 1236. Instead, once a court is satisfied that
the methodology is generally reliable, suggestions that the witness should have engaged
in additional testing to achieve certainty in his or her conclusions simply go to the weight
of the opinion, not its admissibility. Id.
iii.

Application

The final step requires that the witness reliably apply the methodology to the facts
and data he or she has obtained. Once again, “the requirement that the witness ‘reliably’
do so is not an invitation to a court to assess the worth of the opinion itself.” Crabbe, 556
F. Supp. 2d at 1223. Instead, the Court’s inquiry focuses on “whether the witness followed
the dictates of the methodology in considering the facts and data.” Id. In assessing this
reliability, the Court may consider a variety of factors, including, but not limited to: (1)
whether the expert employed the same degree of intellectual rigor in formulating the opinion
as he or she would be expected to employ in his or her own professional life; (2) whether
the expert has unjustifiably extrapolated from an accepted premise to an unfounded
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conclusion (or, whether the gap between the analytical data and the opinion proffered is
too large); and (3) whether the expert adequately accounted for obvious alternative
explanations. See generally Kumho Tire, 526 U.S. at 152; General Elec. Co. v. Joiner, 522
U.S. 136, 146 (1997); Bitler, 400 F.3d at 1233.
Finally, even if an expert is deemed qualified and his or her opinions are considered
reliable, admissibility still requires a determination that the opinions are relevant. That is,
the Court must consider “whether expert testimony . . . is sufficiently tied to the facts of the
case that it will aid the jury in resolving a factual dispute.” Daubert, 509 U.S. at 591
(citation omitted). Courts have routinely excluded expert testimony that was based on
nothing more than speculation. See, e.g., Jetcraft Corp. v. Flight Safety Int’l, 16 F.3d 362,
366 (10th Cir. 1993) (expert testimony excluded as professional speculation); Eastridge
Dev. Co. v. Halpert Assoc., Inc., 853 F.2d 772, 783 (10th Cir. 1988) (expert testimony
excluded as “tentative and speculative”). However, “[d]oubts about whether an expert’s
testimony will be useful should generally be resolved in favor of admissibility unless there
are strong facts such as time or surprise favoring exclusions.” Cook v. Rockwell Int’l Corp.,
580 F. Supp. 2d 1071, 1083 (D. Colo. 2006) (quoting Robinson v. Mo. Pac. R.R. Co., 16
F.3d 1083, 1090 (10th Cir. 1994)).
B.

Admissibility of Dr. Hyman’s Expert Opinions
Following an extensive review of Dr. Hyman’s expert report, the Court concludes

that his opinions are admissible, and that the jury should decide whether he is correct. As
indicated by another court in a similar case, “taking [I-Flow’s] argument to its logical
conclusion, [I-Flow] would have [Plaintiff] prove causation to a medical certainty before
expert testimony could be admitted. I find [I-Flow’s] argument wholly inconsistent with
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Daubert and the fundamental premise of Rule 702.” McClellan v. I-Flow Corp., 710 F.
Supp. 2d 1092, 1101 (D. Or. 2010).
As noted by the McClellan court, Daubert did not “impose an exacting standard of
causality beyond the preponderance of the evidence simply because scientific issues are
involved.” Id. (internal quotations omitted). The issue is not whether the proponent of
expert testimony can prove that the expert is correct; it is whether the testimony is “reliably
derived from scientific methodology and is relevant to the facts of the case.” Id.
Dr. Hyman’s opinions are indeed derived from scientific methodology, including a
comprehensive review of Plaintiff’s relevant medical records, an independent medical
examination of Plaintiff, a review of applicable medical literature, a review of radiographs
of Plaintiff’s shoulder from the date of the surgery, and use of “the technique of differential
diagnosis.” Hyman Report [#106-5] at 7-15. I agree with the McClellan court that Dr.
Hyman’s use of differential diagnosis does not doom his opinions under Daubert. As that
court held, “numerous courts have approved opinions based on differential diagnosis to
show general causation, despite the absence of conclusive causal evidence.” McClellan,
710 F. Supp. 2d at 1104. Generally “the basis for establishing the scientific validity of a
differential diagnosis will vary depending on the type of injury and whether it involves a
complicated biological explanation, a long latency period or the lack of a single sharp
exposure event.” Id. at 1103 (citing Marcum v. Adventist Health System/West, 193 P.3d
1 (Or. 2008)). Case-specific factors, such as the temporal relationship between the
continuous infusion and Plaintiff’s development of chondrolysis, Plaintiff’s lack of other toxic
exposures, and Plaintiff’s lack of other systemic disease or injury unrelated to the area or
purpose of exposure, increase the reliability of the differential diagnosis methodology used
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here. In these circumstances, Dr. Hyman’s testimony on general causation should be
admitted because it is based on “a reliable differential diagnosis and reliably flows from the
underlying facts of the case.” Yarchak v. Trek Bicycle Corp., 208 F. Supp. 2d 470, 499 (D.
N.J. 2002).
III. Conclusion
For the reasons set forth above, Defendant I-Flow Corporation’s Motion to
Exclude Expert Opinions of Dr. Jon Hyman Under Fed. R. Evid. 702 [#106] is DENIED.
Dated: April 17, 2012

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