CLINTON v. MENTOR WORLDWIDE LLC

Filing 147

MEMORANDUM AND ORDER: IT IS HEREBY ORDERED that the plaintiffs motion to exclude the opinions and testimony of defendants expert Gonzalo R. Ballon- Landa, M.D., [Doc. # 104 ] is denied. IT IS FURTHER ORDERED that the plaintiffs motion to exclude th e opinions and testimony of defendants expert Marjorie Jeffcoat, D.M.D., [Doc. # 106 ] is granted in part and denied in part. IT IS HEREBY ORDERED that the plaintiffs motion to exclude the opinions and testimony of defendants expert Dr. Ruby Skin ner, M.D., [Doc. # 113 ] is granted in part and denied in part. IT IS HEREBY ORDERED that the plaintiffs motion to enforce Daubert orders [Doc. #112] is granted in part and denied in part. IT IS FURTHER ORDERED that the defendants motion to exclude certain testimony from plaintiffs expert witnesses [Doc. # 108 ] is granted in part and denied in part. Signed by District Judge Carol E. Jackson on 12/30/16. (JAB)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
EASTERN DIVISION
ANDREA RACHELLE CLINTON,
Plaintiff,
vs.
MENTOR WORLDWIDE LLC,
Defendant.

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Case No. 4:16-CV-00319 (CEJ)

MEMORANDUM AND ORDER
This matter is before the Court on plaintiff’s and defendant’s motions to
exclude expert evidence, filed pursuant to Daubert v. Merrell Dow Pharmaceuticals,
Inc., 509 U.S. 579 (1993). Additionally, plaintiff has filed a motion to enforce prior
Daubert orders [Doc. #112] entered by the MDL court.

The parties have

responded to the motions, and the issues are fully briefed.
I.

Background

This case arises out of the injuries allegedly sustained by the plaintiff, Andrea
Rachelle Clinton, from the implantation of a suburethral sling product called ObTape
Transobturator Tape (ObTape). On December 2, 2004, plaintiff underwent surgical
implantation of

ObTape for treatment of stress urinary incontinence.

Defendant

Mentor Worldwide LLC is the developer of ObTape. In December 2007, plaintiff was
diagnosed with an infection of the ObTape mesh and was advised that she needed
to undergo revision surgery to treat the infection.

The revision surgery was

performed on December 24, 2007, during which the doctor removed as much of the
ObTape as possible. A second revision surgery was performed on February 5, 2008

in order to identify and remove additional ObTape.

A third revision surgery was

performed on February 27, 2008; however the doctor was unable to find any
additional tape. A fourth and final revision surgery was performed on March 21,
2008, and additional infected portions of the ObTape were removed.
In the complaint, plaintiff asserts the following claims: (1) negligence (2)
strict liability–design defect; (3) strict liability-manufacturing defect; (4) strict
liability-failure to warn; (5) breach of implied warranty; (6) breach of express
warranty; (7) fraudulent misrepresentation; (8) fraudulent concealment; and (9)
negligent misrepresentation. [Doc. #1]. Plaintiff’s breach of express warranty and
continuing duty to warn claims were dismissed at the summary judgment stage.
[Doc. #67].
II.

Legal Standard

The admission of expert testimony in federal courts is governed by Federal
Rule of Evidence 702, which provides that a court may permit opinion testimony
from a witness qualified as an expert 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 upon 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.”
Fed. R. Evid. 702. The Eighth Circuit has summarized the inquiry under Rule 702
as follows:
First, evidence based on scientific, technical, or other specialized
knowledge must be useful to the finder of fact in deciding the ultimate
issue of fact. This is the basic rule of relevancy. Second, the
proposed witness must be qualified to assist the finder of fact. Third,
the proposed evidence must be reliable or trustworthy in an

2

evidentiary sense, so that, if the finder of fact accepts it as true, it
provides the assistance the finder of fact requires.
Johnson v. Mead Johnson & Co., LLC, 754 F.3d 557, 561 (8th Cir.2014) (quoting
Polski v. Quigley Corp., 538 F.3d 836, 839 (8th Cir.2008)). The focus of the inquiry
under Rule 702 is “solely on principles and methodology, not on the conclusions
that they generate.” Daubert, 509 U.S. at 594–95. “The proponent of the expert
testimony must prove its admissibility by a preponderance of the evidence.”
Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686 (8th Cir.2001) (citing Daubert,
509 U.S. at 592).
Under Rule 702, district courts act as gatekeepers, ensuring that expert
testimony is “not only relevant, but reliable.” Daubert, 509 U.S. at 589; see also
Kumho Tire Co. v. Carmichael, 526 U.S. 137, 141 (1999) (quoting Daubert, 509
U.S. at 597). In Daubert, the Supreme Court outlined four non-exclusive factors
that the district court may look to in evaluating the reliability of expert testimony:
(1) whether the scientific technique can be or has been tested; (2) whether the
theory or technique has been subjected to peer review or publication; (3) the
known rate of error for the technique or theory and the applicable standards for
operation; and (4) whether the technique is generally accepted. Johnson, 754 F.3d
at 562 (citing Daubert, 509 U.S. at 593–94). Daubert's progeny provide additional
factors such as:

“whether the expertise was developed for litigation or naturally

flowed from the expert's research; whether the proposed expert ruled out other
alternative explanations; and whether the proposed expert sufficiently connected
the proposed testimony with the facts of the case.” Lauzon, 270 F.3d at 687. As
the Supreme Court explained in Kumho Tire Company, “the test of reliability is
‘flexible,’ and Daubert’s list of specific factors neither necessarily nor exclusively

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applies to all experts or in every case. Rather, the law grants a district court the
same broad latitude when it decides how to determine reliability as it enjoys in
respect to its ultimate reliability determination.” 526 U.S. at 141–42. The Eighth
Circuit has described the standard in Daubert as calling for the “liberal admission”
of expert testimony. Johnson, 754 F.3d at 562.
“Regardless of what factors are evaluated, the main inquiry is whether the
proffered expert's testimony is sufficiently reliable.”
Benham, 423 F.3d 855, 861 (8th Cir.2005).

First Union Nat. Bank v.

The Eighth Circuit has admonished

district courts “not to weigh or assess the correctness of competing expert
opinions.”

Johnson, 754 F.3d at 562.

As long as the expert’s testimony “rests

upon ‘good grounds, based on what is known’ it should be tested by the adversary
process with competing expert testimony and cross-examination, rather than
excluded by the court at the outset.” Id. (quoting Daubert, 509 U.S. at 590, 596;
Nebraska Plastics, Inc. v. Holland Colors Americas, Inc., 408 F.3d 410, 416 (8th
Cir.2005) (“As a general rule, the factual basis of an expert opinion goes to the
credibility of the testimony, not the admissibility, and it is up to the opposing party
to examine the factual basis for the opinion in cross-examination.” (quoting Hartley
v. Dillard's, Inc., 310 F.3d 1054, 1061 (8th Cir.2002)). “Only if the expert's opinion
is so fundamentally unsupported that it can offer no assistance to the jury must
such testimony be excluded.”

Benham, 523 F.3d at 862.

“Doubts regarding

‘whether an expert’s testimony will be useful should generally be resolved in favor
of admissibility.’”

Clark v. Hendrick, 150 F.3d 912, 915 (8th Cir.1998) (quoting

Larabee v. MM & L Int’l Corp., 896 F.2d 1112, 1116 n.6 (8th Cir.1990)).
III.

Discussion

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A. Plaintiff’s Motions to Exclude
The plaintiff moves to exclude or limit the opinions and testimony of Gonzalo
R. Ballon-Landa, M .D. [Doc. #104], Marjorie Jeffcoat, D.M.D., [Doc. #106], and
Ruby Skinner, M.D. [Doc. #113].
Gonzalo R. Ballon-Landa, M.D.
Defendant designated Dr. Ballon-Landa to rebut conclusions that ObTape
caused plaintiff’s infections, abscess formation, necrotizing fasciitis and need to
undergo extensive, successive operative procedures and that her infection did not
originate from the ObTape sling. Dr. Ballon-Landa opines that several significant
events of physical trauma led to the development of the necrotizing fasciitis in
plaintiff’s left leg which led to the development of subclinical hematomas in the
region of the left thigh obturator muscles. Plaintiff presents four areas in which she
believes Dr. Ballon-Landa’s testimony should be excluded or, in the alternative,
limited based on unreliability.
Evidence is relevant in a case if “it has any tendency to make a fact more or
less probable than it would be without the evidence” and “the fact is of
consequence in determining the action.”

Fed. R. Evid. 401.

Dr. Ballon-Landa’s

report and testimony offers the opinion that plaintiff’s initial left thigh infection did
not originate with her ObTape but was instead caused by bacteria from her mouth.
[Doc. #105-1 and #105-2]. The opinion testimony would be helpful to a jury in
deciding whether the plaintiff’s injuries were caused by ObTape or whether there
was an alternative cause. As such Dr. Ballon-Landa’s opinions are relevant to this
claim.
1. Thigh Trauma

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Plaintiff first challenges Dr. Ballon-Landa’s expert testimony regarding thigh
trauma, arguing that his opinion is unreliable because it is based on insufficient
facts and speculation.

Testimony is unreliable under Rule 702 and should be

excluded when expert testimony is speculation upon which there is no reasonable
factual basis for the expert opinion. Weisgram v. Marley Co., 169 F.3d 514, 520
(8th Cir.1999), aff'd, 528 U.S. 440 (2000). As a general rule, the factual basis of
an expert opinion goes to the credibility of the testimony, not the admissibility, and
it is up to the opposing party to examine the factual basis for the opinion in crossexamination. Bonner v. ISP Techs., Inc., 259 F.3d 924, 929–30 (8th Cir.2001)
(quoting Hose v. Chicago Northwestern Transp. Co., 70 F.3d 968, 974 (8th
Cir.1996)). Only if the expert's opinion is so fundamentally unsupported that it can
offer no assistance to the jury must such testimony be excluded. Id.
Plaintiff argues that expert evidence based on assumptions not supported by
the record should be excluded. A certain amount of speculation is necessary, an
even greater amount is permissible (and goes to the weight of the testimony), but
too much is fatal to admission. Grp. Health Plan, Inc. v. Philip Morris USA, Inc.,
344 F.3d 753, 760 (8th Cir.2003). What is required is that when experts “testify in
court they adhere to the same standards of intellectual rigor that are demanded in
their professional work.” Id. (quoting Rosen v. Ciba–Geigy Corp., 78 F.3d 316, 319
(7th Cir.1996) (Posner, J.), cert. denied, 519 U.S. 819, (1996)). Dr. Ballon-Landa’s
opinion regarding the origin of plaintiff’s left thigh trauma relies on more than mere
speculation.

His report notes that the microbiology of the abscess included five

bacteria which are commonly found in the mouth. He also notes that there were
several episodes of trauma documented in plaintiff’s medical records in the time

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surrounding the development of her abscess, including an accident on an ATV and
an injury suffered at a water park as potential causes. While the medical record
contains no reference to any trauma to plaintiff’s left thigh after the ATV incident,
Dr. Ballon-Landa bases his opinion upon her difficulty walking after the accident
despite there being no outward trauma to the left thigh. Plaintiff also reported to
her doctor that her left leg was caught in a ride at a water park; however, there is
no reference to any trauma to her left thigh following that incident either. [Doc.
#117-7-8].
Dr. Ballon-Landa states in his deposition that an infection can be caused by a
non-visible, non-obvious trauma.

Based upon his experience, an imperceptible

trauma is sufficient to cause an infection. The point of Dr. Ballon-Landa’s opinion is
that necrotizing fasciitis can develop where there is trauma – even in an area where
trauma was not immediately apparent – and there are instances in the medical
records that would indicate potential trauma to plaintiff’s left thigh. Here, plaintiff
is challenging the factual basis of Dr. Ballon-Landa’s opinion.

The record shows

that plaintiff was involved in an ATV accident and did suffer injuries from the water
park incident. Dr. Ballon-Landa indicates in his report that he examined medical
records including reports of the pathology, microbiology and radiology departments
plus the physicians and nurse’s progress notes, and scholarly literature in
developing his expert opinion. “Although it is common that medical experts often
disagree on diagnosis and causation, questions of conflicting evidence must be left
for the jury's determination.” Bonner v. ISP Techs., Inc., 259 F.3d 924, 931 (8th
Cir.2001) (quoting Hose v. Chicago Northwestern Transp. Co., 70 F.3d 968, 976
(8th Cir.1996)). Cross-examination is the defendant’s opportunity to scrutinize and

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question the facts on which Dr. Ballon-Landa based his opinion. See Hose, 70 F.3d
at 974.

Dr. Ballon-Landa’s expert report lays out a sufficient factual basis upon

which to rest his testimony. Accordingly, plaintiff’s motion to exclude Dr. BallonLanda’s testimony about left thigh trauma will be denied.
2. Source of Initial Infection
Plaintiff further argues that Dr. Ballon-Landa’s opinion that ObTape was not
the source of the initial infection is unreliable. Dr. Ballon-Landa bases that opinion
upon his belief that if ObTape was the source of the infection, plaintiff would have
suffered a bi-lateral infection on her right thigh immediately and that the spread
would involve both thighs.

Plaintiff notes that, according to the literature Dr.

Ballon-Landa uses as references, single thigh involvement is universally found.
Further, this literature describes instances of significant post-implant delay before
presentation of necrotizing fasciitis.

The Court agrees with defendant that Dr.

Ballon-Landa’s opinion is not rendered unreliable by the instances of necrotizing
fasciitis with suburethral slings involving a single thigh. Indeed, Dr. Ballon-Landa
in his expert report notes that the same bacteria that found in plaintiff’s left leg
wound after a surgical procedure performed in 2006 was found in her right groin in
December 2007 when the vaginal erosion was diagnosed.
Plaintiff also argues that Dr. Ballon-Landa relies too much on his own
experience, rather than that of the literature. In formulating his opinion, Dr. BallonLanda relied upon multiple microbiological reports, plaintiff’s medical chronology
and medical records. There is no dispute that Dr. Ballon-Landa is qualified as an
infectious disease specialist.

Further, it is undisputed that an expert may draw

conclusions from a set of observations based on extensive and specialized

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experience. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 156 (1999). A medical
doctor does not need to have treated the specific disease at issue to opine on
medical matters relating to that condition. Kruszka v. Novartis Pharm. Corp., 28 F.
Supp. 3d 920, 927 (D. Minn. 2014) (citing Dittrich–Bigley v. Gen–Probe, Inc., Civil
No. 11–1762, 2013 WL 3974107, at *7 (D.Minn. July 31, 2013). Dr. Ballon-Landa
has extensive experience in the field of infectious diseases and he draws his
conclusions from a number of medical sources. Dr. Ballon-Landa does not need to
have experience specifically treating infections arising from ObTape to be able to
opine on infectious diseases that have impacted individuals who have implanted
ObTape devices.

Accordingly, plaintiff’s motion to exclude Dr. Ballon-Landa’s

opinion regarding plaintiff’s bilateral thigh infection will be denied.
3. Timing of Initial Infection
Lastly, plaintiff argues that Dr. Ballon-Landa’s opinion about the onset of the
ObTape infection is unsupported by the facts of this case, fails to account for
contrary radiological evidence, and should be excluded as unreliable.

In

formulating his opinion that plaintiff’s ObTape became infected with bacteria from
the left groin wound source, Dr. Ballon-Landa relied upon medical records in
determining that the transfer of bacteria from the left groin to the right groin
following one of the surgical procedures was evidence that the ObTape was not
initially infected during the first of plaintiff’s surgical procedures. Dr. Ballon-Landa
also noted the lack of symptoms of infection from the initial implantation of the
ObTape. Dr. Ballon-Landa’s opinions are based upon sufficient facts and data so as
to be reliable.

Plaintiff’s complaint that Dr. Ballon-Landa only reviewed the

deposition transcript of plaintiff’s expert radiologist and not the radiology report

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itself, may be asserted to discredit Dr. Ballon-Landa’s expert testimony; however it
is not pertinent to the issue of reliability which is the crux of Fed. R. Evid. 702 and
the Daubert analysis. When there is a sufficient factual basis for an expert opinion
to be both relevant and reliable questions of conflicting evidence must be left for
the jury's determination.
Cir.2001).

Bonner v. ISP Techs., Inc., 259 F.3d 924, 930 (8th

Accordingly, plaintiff’s motion to exclude Dr. Ballon-Landa’s opinion

regarding when plaintiff’s ObTape became infected will be denied.
Marjorie Jeffcoat, D.M.D.
Plaintiff seeks to exclude the opinions of Marjorie Jeffcoat, D.M.D., regarding:
(1) the source of plaintiff’s infection, (2) how the source bacteria traveled to the
infected area, and (3) whether methamphetamine abuse and the consequences of
“meth mouth” played a role in causing plaintiff’s infection.
#107-3].

[Doc. #107-1 and

Plaintiff argues that Dr. Jeffcoat’s opinions are not supported by

sufficient facts or data as required by the Federal Rules of Evidence and are thus
unreliable.
In her report, Dr. Jeffcoat opines that the bacteria cultured in plaintiff’s thigh
originated from her mouth based upon the dental records made available.

Dr.

Jeffcoat’s conclusions are summarized as follows: (1) plaintiff had poor dentition,
including rampant caries and severe periodontal disease, (2) her dental caries and
periodontal disease were insufficiently treated, (3) she was resistant to antibiotics,
(4) her poor dentition, trauma to the mouth, and susceptibility for infection caused
bacteremia in the blood, and (5) that bacteremia infected her thigh.

Further

supporting this opinion, the plaintiff’s thigh infection was polymicrobial and the
thigh cultures consisted of bacteria commonly found in the mouth. Dr. Jeffcoat also

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opined that plaintiff’s ObTape was not the source of the bacteria infecting plaintiff’s
thigh, specifically noting that: (1) plaintiff’s physicians did not find any connection
between her thigh infection and the vagina or sling, (2) plaintiff exhibited no signs
and symptoms of a vaginal or suburethral sling infection, including no discharge,
bleeding, odor, or pain, and (3) if the bacteria had previous colonized plaintiff’s
sling, such as when it was implanted, the infection would manifest itself soon
thereafter. This expert testimony would be useful to a jury in deciding whether the
origin of the bacterial infection occurred in the mouth of the plaintiff or as a result
of the suburethral sling as posited by the plaintiff. As such, Dr. Jeffcoat’s opinions
are relevant to the claims in this case.
1. Oral Bacteria
Plaintiff argues that Dr. Jeffcoat’s opinion that the bacteria cultured in
plaintiff’s thigh originated from her mouth is speculation that is unsupported by
facts or data.

Dr. Jeffcoat reviewed plaintiff’s dental records and dental history.

She also considered plaintiff’s history of resistance to antibiotics and the
microbiology taken from the deep tissue of plaintiff’s left upper thigh. Dr. Jeffcoat’s
opinion is based on evidence that the wound culture from plaintiff’s thigh is
comprised of bacteria commonly found in the mouth.

Further, the medical

literature presented by Dr. Jeffcoat confirms that the hematogenous spread of oral
bacteria is possible.

The standard in Daubert calls for the liberal admission of

expert testimony. Johnson v. Mead Johnson & Co., LLC, 754 F.3d 557, 562 (8th
Cir.2014). Accordingly, the Court finds that Dr. Jeffcoat’s opinions with regard to
the origination of the bacteria are supported by sufficient facts.

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The plaintiff also argues that Dr. Jeffcoat’s opinion that bacteria in the mouth
can lead to a large abscess in the thigh is unsupported by facts or data but instead
relies upon mere speculation. In making this conclusion, Dr. Jeffcoat relied upon
her personal experience witnessing the spread of oral bacteria to distant body sites
in her dental patients. Dr. Jeffcoat has extensive experience observing the spread
of oral bacteria to distant body sites and has specifically studied the spread of oral
bacteria.

Dr. Jeffcoat has specifically treated the hematogenous spread of oral

infections in her patients and has studied and treated thousands of young women.
Dr. Jeffcoat’s research specifically studies the relationship between oral and
systemic disease. Dr. Jeffcoat also reviewed and provided medical literature stating
that microorganisms, such as bacteria, could be spread through the body through
the bloodstream. The records Dr. Jeffcoat relied upon along with her background
researching these issues provide a sufficient factual background under Daubert and
Federal Rule of Evidence 702.

See Ayers Oil Co. v. American Business Brokers,

Inc., 2010 WL 2990113, at *4 (E.D.Mo. July 27, 2010) (holding opinions were
admissible based on the expert's “extensive experience” despite the absence of
objective testing or peer review; stating, “the four Daubert factors cannot be
applied to every expert in every case, and in certain fields, experience in the
industry is the predominant, if not sole, basis for reliable expert testimony”).
Alternatively, plaintiff asks that Dr. Jeffcoat’s testimony be limited to the
opinion that a mouth infection is a “possible cause” of plaintiff’s thigh infection. The
Court does not believe such a limitation is either appropriate or necessary. Plaintiff
will have ample opportunity at trial to challenge Dr. Jeffcoat’s opinions and the
factual bases upon which they rest through cross-examination and the presentation

12

of contrary evidence at trial.

After review of Dr. Jeffcoat’s expert report and

deposition testimony, the Court finds that there are sufficient facts and data to
support her opinion that the bacteria from plaintiff’s thigh originated from her
mouth and was transferred to her thigh. Accordingly, plaintiff’s motion to exclude
or limit Dr. Jeffcoat’ opinion that oral bacteria is the cause of plaintiff’s infection will
be denied.
2. Methamphetamine Use
Plaintiff next moves to exclude any testimony by Dr. Jeffcoat regarding
methamphetamine

usage.

In

her

deposition,

Dr.

Jeffcoat

testified

methamphetamine use was potentially the cause of plaintiff’s dental issues.

that
No

methamphetamine-related opinions were included in either her Rule 26 report or
her subsequent declaration.

[Doc. #107-2, 107-3].

Dr. Jeffcoat noted that she

was unable to diagnose plaintiff with “meth mouth” because she had not seen or
observed plaintiff personally and that she was merely speculating.
In its response to the motion, defendant states that Dr. Jeffcoat’s opinions
concerning the cause of plaintiff’s thigh infection does not depend on whether
plaintiff abused methamphetamines. Defendant further states that Dr. Jeffcoat will
not offer testimony at trial that plaintiff suffered from meth mouth. Based on these
representations, the plaintiff’s motion to exclude testimony by Dr. Jeffcoat about
methamphetamine usage is moot.
Ruby Skinner, M.D.
The defendant offers Dr. Skinner as an expert witness to testify that
plaintiff’s infections did not originate from her ObTape implant.

[Doc. #114-1,

#114-3]. Dr. Skinner opines that plaintiff’s infection resulted from trauma to her

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left thigh and groin area. Plaintiff asserts that Dr. Skinner’s opinions exceed the
bounds of her qualifications and are founded on insufficient facts and unreliable
methodology.
Dr. Skinner is certified by the American Board of Surgery in general surgery
and critical care and serves as Chief of the Division of Trauma and Medical Director
of the Surgical Intensive Care Unit at Kern Medical Center in Bakersfield California.
Dr. Skinner has practiced for thirteen years and has treated over one-hundred
patients with severe necrotizing soft tissue infections. Dr. Skinner was educated at
Spelman College and received her medical degree from the Boston University
School of Medicine; she then did her post-doctoral training at the University of
California-Davis and the University of Pennsylvania. Dr. Skinner has also published
extensively in the area of acute care surgery and surgical critical care, including a
paper published regarding her surgical experience with necrotizing fasciitis.
In her expert report and deposition, Dr. Skinner identified the reasons for her
opinion that the ObTape was not the cause of plaintiff’s infection: (1) plaintiff had
no local vaginal symptoms when she was treated for her initial thigh infection, (2)
the CT scan during her initial admission in 2005 showed no involvement of the
obturator or pelvic area, (3) plaintiff’s left thigh wound initially healed and plaintiff
was recovering well; and (4) plaintiff had no vaginal symptoms when the left thigh
infection recurred until after the infection spread to the right side.

Dr. Skinner

also identified several indicators that plaintiff’s infection originated in her upper
body and spread to her thigh, including recurrent dental infections, upper
respiratory infections and trauma to plaintiff’s left thigh before her initial admission.

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Dr. Skinner’s opinions and testimony would be relevant to a fact finder as
they go to the determination of the source and the cause of the necrotizing fasciitis
in plaintiff’s thigh.

Also, Dr. Skinner considered the medical records related to

plaintiff’s vaginal sling procedure, the medical records related to her initial left thigh
necrotizing fasciitis, and the medical records related to subsequent hospitalizations
and operations following the initial infection, thus grounding her testimony in both
facts and data.
1. Prior trauma
In

her

deposition,

Dr.

Skinner

testified

that

necrotizing

fasciitis

is

sometimes, but not always, preceded by a history of trauma. Contrary to plaintiff’s
assertions, Dr. Skinner did not speculate that plaintiff had suffered trauma to her
left thigh during an accident at a water park.
Plaintiff also points out that Dr. Skinner could not rule out necrotizing fasciitis
as the cause of plaintiff’s pain prior to her diagnosis. However, “[p]roponents of
expert testimony need not demonstrate that the assessments of their experts are
correct, and trial courts are not empowered to determine which of several
competing scientific theories has the best provenance.” Kuhn v. Wyeth, Inc., 686
F.3d 618, 625 (8th Cir.2012) (quoting Milward v. Acuity Specialty Prods. Grp., 639
F.3d 11, 15 (1st Cir.2011)). Dr. Skinner’s inability to rule out necrotizing fasciitis
as the source of plaintiff’s pain presents a factual dispute rather than an issue going
to Dr. Skinner’s reliability. As a general rule, the factual basis of an expert opinion
goes to the credibility of the testimony, not the admissibility, and it is up to the
opposing party to examine the factual basis for the opinion in cross-examination.
Bonner v. ISP Techs., Inc., 259 F.3d 924, 929–30 (8th Cir.2001) (citing Hose v.

15

Chicago Northwestern Transp. Co., 70 F.3d 968, 974 (8th Cir.1996)). Dr. Skinner
testified that in her experience as a critical care surgeon, necrotizing fasciitis does
not always involve a history of trauma, but that the thigh trauma is an explanation
for why the infection was located in plaintiff’s thigh. Only if the expert's opinion is
so fundamentally unsupported that it can offer no assistance to the jury must such
testimony be excluded. Id.
Here, Dr. Skinner is qualified by her experience with regard to necrotizing
fasciitis to opine about the potential causes of the infection.

Dr. Skinner has

articulated her opinions on the basis of a review of plaintiff’s medical records and
history and ultimately grounded her opinion in a review of the facts and data
available. Accordingly, the motion to exclude her testimony on this issue will be
denied.
2. Blood-Borne Spread
In her expert report, Dr. Skinner states that plaintiff had a “history of chronic
dental infections, and a recent history of an upper respiratory infection that are
potential sources” for the bacteria found in her thigh.

[Doc. # 114-1].

Plaintiff

argues that Dr. Skinner’s claim that she had a “recent history” of respiratory
infection is a mischaracterization, because the infection occurred almost six months
prior to the necrotizing fasciitis. Plaintiff also argues that the medical records which
show that her blood cultures were negative for blood borne infection are
inconsistent with Dr. Skinner’s opinion that plaintiff’s thigh infection resulted from
“hematogenous [blood-borne] spread.”

Plaintiff’s arguments present factual

challenges to the expert’s opinion—they do not present a justification for excluding

16

the testimony as unreliable. Dr. Skinner’s opinion regarding hematogenous spread
as possible cause of plaintiff’s necrotizing fasciitis will be denied.
3. Mesh Complications
The plaintiff also argues that Dr. Skinner is not qualified to opine about mesh
complications. Dr. Skinner offered the opinion that ObTape was not the cause of
plaintiff’s necrotizing fasciitis.

Dr. Skinner specifically opined that the “infection

originating from the synthetic mesh was highly unlikely given the absence of
symptoms in the vaginal region and perineum, prior to the development of the left
thigh infection.” [Doc. #114-1]. Plaintiff argues that Dr. Skinner has no experience
in urology, gynecology, urogynecology, vaginal mesh, or complications related to
slings.

Rule 702 of the Federal Rules of Evidence requires that witnesses are

qualified by “knowledge, skill, experience, training or education.”

Fed. R. Evid.

702.
In her deposition, Dr. Skinner acknowledged that she had no experience with
vaginal mesh or with complications or infections relating to suburethral slings.
However, Dr. Skinner is an expert on necrotizing fasciitis and she has extensive
experience treating patients with the same condition as plaintiff.

While deriving

conclusions regarding the complications of transvaginal mesh is outside of her area
of expertise, diagnosing necrotizing fasciitis is not.

Because the cause of the

necrotizing fasciitis is at issue, her experience and background with necrotizing
fasciitis qualifies to opine as to the cause. Furthermore, the standard in Daubert
calls for the “liberal admission” of expert testimony.

Johnson, 754 F.3d at 562.

Accordingly, the plaintiff’s request to exclude Dr. Skinner’s opinion that the mesh
was not the source of plaintiff’s infection will be denied.

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B. Plaintiff’s Motion to Enforce the MDL Daubert Orders
Plaintiff moves to enforce prior Daubert orders [Doc. #112] entered by the
MDL court regarding expert witnesses Drs. Arnold Lentnek, William Hyman, and
Ahmed El-Ghannam, whose opinions and testimony defendant seeks to exclude.
To prevent inconsistent pretrial rulings on the admissibility of expert
testimony, it is only in “exceptional cases, [that] the federal or state court to which
an MDL case is transferred or remanded may revisit a transferee court's decision.”
Deutsch v. Novartis Pharm. Corp., 768 F. Supp. 2d 420, 429 (E.D.N.Y. 2011) (citing
Manual for Complex Litigation (4th) § 20.133 (“Although the transferor judge has
the power to vacate or modify rulings made by the transferee judge, subject to
comity and ‘law of the case’ considerations, doing so in the absence of a significant
change of circumstances would frustrate the purposes of centralized pretrial
proceedings.”)). Reversing or otherwise undermining the decisions by the MDL
court could lead to the type of inconsistent pretrial rulings that Congress sought to
avoid, and therefore frustrate the very purpose of consolidation.

Id. The objective

of MDL transfer is to eliminate duplication in discovery, avoid conflicting rulings and
schedules, reduce litigation cost, and save the time and effort of the parties, the
attorneys, the witnesses, and the courts.
20.131.

Manual for Complex Litigation (4th) §

In circumstances, where causation issues predominate, it may be

appropriate for the transferee court in an MDL proceeding to conduct a Daubert
hearing on general causation issues, leaving specific causation issues for the
transferor courts on remand.

Manual for Complex Litigation (4th) § 22.87.

Centralization for pretrial proceedings as occurs with MDL is specifically necessary
to prevent inconsistent pretrial rulings on Daubert issues.

18

See In re Viagra

(Sildenafil Citrate) Prod. Liab. Litig., No. MDL 2691, 2016 WL 1403304, at *1 (U.S.
Jud. Pan. Mult. Lit. Apr. 7, 2016); In re: 100% Grated Parmesan Cheese Mktg. &
Sales Practices Litig., No. 2705, 2016 WL 3190426, at *2 (U.S. Jud. Pan. Mult. Lit.
June 2, 2016).

Furthermore, any reversal of the MDL court rulings would

undermine the purpose of the Multi-District Litigation Act, which authorizes the
coordinated and consolidated pretrial proceedings of civil actions involving one or
more common issues of fact “for the convenience of parties and witnesses and [to]
promote the just and efficient conduct of such actions.” 28 U.S.C. § 1407(a).
In the instant case, the MDL court conducted a Daubert hearing, after which
it found that the methodology employed by Dr. Lentnek in researching the medical
literature on which his opinions rested was “scientifically and medically appropriate
and reliable.” [Doc. # 120-3, p. 4]. The methodology examined by the MDL court
is the same methodology that defendant challenges here. Nevertheless, defendant
argues that because Dr. Lentnek submitted an “Additional Supplemental Rule 26
Expert Report” this Court should revisit the MDL court’s Daubert ruling. While the
receiving court has the power to vacate or modify rulings made by the MDL court,
doing so in the absence of a significant change of circumstances would frustrate the
purposes of centralized pretrial proceedings. Manual for Complex Litigation (4th) §
20.133.

Courts must ensure that “any and all scientific testimony or evidence

admitted is not only relevant, but reliable.” Daubert v. Merrill Dow Pharms., 509
U.S. 579, 589 (1993).

There appears to be no basis for finding that the

supplemental report undercuts or invalidates the reliability of Dr. Lentnek’s expert
testimony. Further, Dr. Lentnek testified at his May 26, 2015 deposition that his
updated literature review did not change his original conclusions. [Doc. #109-5].

19

The addition of the supplemental report does not rise to the level of a significant
change of circumstances which would necessitate this Court frustrating the
purposes of centralized pretrial proceedings. Accordingly, the Court will uphold the
MDL court’s Daubert ruling with respect to Dr. Lentnek.
Plaintiff also seeks enforcement of the Daubert order entered by the MDL
court permitting the testimony of Dr. El-Ghannam.

The defendant separately

moves to exclude and/or limit the testimony of Dr. El-Ghannam on the grounds that
his testimony would be both unreliable and unhelpful. [Doc. #108]. The MDL court
previously denied defendant’s motion to exclude Dr. El-Ghannam’s testimony,
finding it sufficiently reliable.

[Doc. #70].

Defendant has not presented any

information to persuade the Court to deviate from the the MDL court’s ruling with
respect to Dr. El-Ghannam’s general causation testimony regarding degradation.
Although the Court will enforce the MDL court’s ruling on Dr. El-Ghannam’s general
causation testimony, it will conduct an independent Daubert inquiry with respect to
his testimony on issues of causation that are specific to this case.
Finally, the MDL court made no ruling with respect to Dr. Hyman’s opinions.
Therefore, the plaintiff’s motion will be denied as to Dr. Hyman
C. Defendant’s Motions to Exclude
Defendant seeks to exclude or limit the testimony of the following expert
witnesses:

Dr. Arnold Lentnek, Dr. William Hyman, Dr. Ahmed El-Ghannam, Dr.

Vladimir Iakovlev, Dr. Farrin A. Manian, Dr. Doug Watanabe, Dr. Paul L’Ecuyer, and
Kristin Kucsma [Doc. #108].
Arnold Lentnek, M.D.

20

Defendant moves to exclude the opinions and testimony of Dr. Arnold
Lentnek on the grounds that they are unreliable. Dr. Lentnek’s testimony is general
causation testimony regarding ObTape and was previously allowed by the MDL
court. As discussed above, this Court will enforce the MDL court’s Daubert ruling.
The defendant’s motion is will be denied as to Dr. Lentnek.
William Hyman, Sc.D., P.E.
Plaintiff intends to present Dr. Hyman to offer opinions regarding the
adequacy of the warnings accompanying ObTape and defendant’s knowledge and
state of mind.

Dr. Hyman is a biomaterials specialist with over 45 years’

experience in biomedical engineering. He holds a bachelor's degree in mechanical
engineering from The Cooper Union, as well as a masters and doctorate of science
degrees in engineering mechanics from Columbia University.

He is Professor

Emeritus of Biomedical Engineering at Texas A & M University and an Adjunct
Professor of Biomedical Engineering at The Cooper Union.

Dr. Hyman has

educational and professional experience in biomedical engineering, biomaterials
(specifically artificial implanted materials), mechanics, medical device design and
system safety and, Food Drug Administration (FDA) regulations and has taught
classes on those subjects for many years.
The defendant first challenges Dr. Hyman’s qualifications to opine on the
adequacy of the warnings accompanying ObTape.
warnings were inadequate and

According to Dr. Hyman, the

the Instructions for Use (IFU) should have been

changed multiple times. [Doc. #109-7].

Specifically, he concludes that

defendant’s warnings were:
“Inadequate in multiple ways including: (1) Failing to warn about the
significant risk of serious and life threatening infections and abscesses;

21

(2) Failing to warn about the significant risk of erosion; (3) Failing to
warn about the potential of additional surgeries; and (4) Failing to
warn about the potential of chronic pain and dyspareunia.”
Hyman Expert Report at 10 [Doc. #109-7].
The defendant notes that Dr. Hyman has been precluded from offering these
very opinions in the past, notably in Cason v. C.R. Bard, Inc., where the court
determined that he was not qualified to testify on the issue of warnings. 1:12-cv1288, 2015 WL 9913809 (N.D. Ga. Feb. 9, 2015). The court in Cason noted that
Dr. Hyman had never drafted an IFU and never reviewed the labeling of
competitors. The device at issue in Cason was not ObTape or a similar transvaginal
mesh device; however it was a device that is surgically implanted in the body. Id.
Dr. Hyman has been permitted to testify in other Mentor vaginal mesh litigation;
however his testimony concerned the alleged defective design of the device, not
the adequacy of warnings.

See In re Mentor Corp. ObTape Transobturator Sling

Products Liability Litigation, No. 4:08-MD-2004 (CDL), 2016 WL 6138253, at *5
(M.D. Ga. Oct. 20, 2016).
Whether or not a given warning is adequate depends upon the language used
and the impression that it is calculated to make upon the mind of an average user
of the product. Robertson v. Norton Co., 148 F.3d 905, 907 (8th Cir.1998) (citing
Walton v. Sherwin–Williams Co., 191 F.2d 277, 285–86 (8th Cir.1951)). Questions
of display, syntax, and emphasis are involved in evaluating a warning, or set of
directions, and upon those matters plant pathologists and entomologists are not
necessarily qualified to speak. Id. Expert knowledge of the product at issue does
not necessarily provide the expertise on questions of display, syntax, and emphasis
that the jury would expect from a bona fide warnings expert. Id. Plaintiff argues

22

that there is no requirement for experience designing medical device warnings
before an expert can testify on the adequacy of warnings. However, Federal Rule
of Evidence 702 provides a threshold requiring specialized knowledge specific to the
expert’s opinion.

Fed. R. Evid. 702.

Further, the party offering the expert

testimony “must prove its admissibility by a preponderance of the evidence.”
Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686 (8th Cir.2001) (citing Daubert,
509 U.S. at 592).
That is a threshold plaintiff is unable to meet. Dr. Hyman has no experience
drafting an IFU for a medical device or the “complications” section of a device’s
product insert.

He also has no experience in improving existing warnings or

preparing alternative for medical devices or in reviewing the warning labels of
competitor products.

Plaintiff has not provided any relevant experience of Dr.

Hyman with respect to warnings of any kind. Plaintiff argues that Dr. Hyman does
not opine on the language, display, syntax, or emphasis of the warnings, but
instead opines on deficiencies in the severity of the risks communicated in the IFU.
Opining on the deficiencies of the severity of the risks communicated correlates
directly with opining on the language, syntax and emphasis of the warning.
Plaintiff has failed to meet her burden to demonstrate by a preponderance of
the evidence that Dr. Hyman is qualified to offer expert testimony on the adequacy
of defendant’s warnings. Accordingly, defendant’s motion to exclude Dr. Hyman’s
opinions and testimony on the adequacy of defendant’s warnings will be granted.
Defendant next challenges Dr. Hyman’s opinions regarding defendant’s
knowledge, intent, and state of mind as improper expert testimony.

Expert

testimony on intent, motives, or state of mind of corporations has no basis in any

23

relevant body of knowledge or expertise. Kruszka v. Novartis Pharm. Corp., 28 F.
Supp. 3d 920, 937 (D. Minn. 2014) (quoting Deutsch v. Novartis Pharm. Corp., 768
F. Supp. 2d 420, 442 (E.D.N.Y. 2011)). The question of corporate motive, intent,
knowledge or state of mind is one for the jury, not for an expert. In re Baycol Prod.
Litig., 532 F. Supp. 2d 1029, 1069 (D. Minn. 2007). Here, plaintiff acknowledges
that Dr. Hyman’s statements regarding defendant’s knowledge of the defects
associated with ObTape are based on the corporate documents that Dr. Hyman
reviewed. Recitation of defendant’s own corporate documents does not fall within
the purview of expert testimony under Federal Rule of Evidence 702.

Plaintiff

argues that Dr. Hyman filters the corporate documents through his experience in
medical device design and system safety and FDA regulations, and that that
combination of facts and scientific expertise will help the trier of fact. While that
may be true, it misses the point.

What Dr. Hyman proffers is his opinions on

specific information available to defendant, defendant’s actions in response to that
information, and the ways in which that response fell below the standard of care
for a medical device company. The points plaintiff argues do not go to defendant’s
corporate knowledge, intent, or state of mind. “The jury should hear and/or see
first-hand any relevant evidence pertaining to the defendant's intent.” Cason v.
C.R. Bard, Inc., No. 1:12-CV-1288-MHS, 2015 WL 9913809, at *13 (N.D. Ga. Feb.
9, 2015). “Then the jury, not the witnesses, should consider the facts and make its
own determination regarding [d]efendant's intent.” Id. Dr. Hyman is qualified to
give his opinion as to the ways in which defendant’s response fell below the
standard of care for a medical company. However, he cannot opine specifically on
the defendant’s knowledge, intent or state of mind as that is not the role of an

24

expert witness. Accordingly, defendant’s motion to exclude Dr. Hyman’s opinions
and testimony on defendant’s knowledge, intent, and state of mind will be granted.
Ahmed El-Ghannam, Ph.D.
Dr. El-Ghannam opines that the thermal bonding process by which ObTape
fibers are melted together causes ObTape to degrade after implantation. [Doc.
#109-17].

In reaching his conclusions, Dr. El-Ghannam examined segments of

degraded ObTape that had been explanted from several plaintiffs in the MDL
proceeding and conducted tests on ObTape exemplars provided by defendant. In
addition, he reviewed defendant’s internal documents regarding ObTape, as well as
a variety of peer-reviewed articles regarding polypropylene mesh products. Dr. ElGhannam observed degradation of ObTape when he viewed the explanted samples
with a scanning microscope. Based on these tests, Dr. El-Ghannam concluded that
ObTape had an unacceptable level of degradation, and opined that ObTape’s unique
thermal bonding process caused the degradation of the tape in vivo.

Dr. El-

Ghannam also noted that a different process, heat extrusion, is widely used and is
not known to cause degradation.

Dr. El-Ghannam further opined that any

polypropylene that degraded to the same extent as ObTape would be unsuitable for
implantation.

Dr. El-Ghannam’s opinion is that any product with a propensity to

degrade as ObTape did is too dangerous to be used as a permanent implantable
device because of that propensity to degrade.

Dr. El-Ghannam stated that

implantable material such as ObTape should not degrade inside the body, which, he
noted, defendant’s own internal documents confirm.

The Court finds Dr. El-

Ghannam’s general causation opinions to be sufficiently reliable.

25

The defendant argues that Dr. El-Ghannam’s opinions and testimony will not
be helpful to the trier of fact because they are untethered to any specific causation
opinions offered in this case.

Dr. El-Ghannam’s degradation theory is based upon

the premise that in vivo degradation creates toxic byproducts that kills cells and
tissue, causing adverse clinical effects.

In his expert report, Dr. El-Ghannam cites

to a number of scientific articles supporting his theory that in vivo degradation of
ObTape could cause harm to women who have been implanted with the product.
Defendant has presented no scientific basis for disputing Dr. El-Ghannam’s
conclusions or the scientific literature upon which they are based.

Although the

district court's gatekeeping function includes an analysis of the reliability of
scientific evidence, neither Rule 702 nor Daubert requires that an expert opinion
resolve an ultimate issue of fact to a scientific absolute in order to be admissible.
Bonner v. ISP Techs., Inc., 259 F.3d 924, 929 (8th Cir.2001). The only question
relevant to the admissibility of the scientific evidence is whether it is sufficiently
reliable and relevant to assist the jury's determination of a disputed issue. Bonner
v. ISP Techs., Inc., 259 F.3d 924, 929 (8th Cir.2001) (citing Daubert, 509 U.S. at
594–95). Here, Dr. El-Ghannam’s opinion on toxic byproducts is sufficiently reliable
and relevant based upon the scientific literature on which he rests his conclusions.
Accordingly, defendant’s motion to exclude Dr. El-Ghannam’s toxicity hypothesis is
will be denied.
Defendant also argues that because none of plaintiff’s specific causation
expert cites Dr. El-Ghannam’s general causation opinion as support for their specific
causation opinion with regard to plaintiff, his opinion would not be helpful in
assisting the jury in determining whether ObTape caused plaintiff’s injuries. Dr. El-

26

Ghannam’s opinion concerns the degradation of ObTape and the adverse medical
consequences of degradation.

His conclusions were reached after testing and

analysis of explanted and unimplanted ObTape devices and have support in the
literature.

“As long as the expert’s testimony is supported by relevant scientific

literature, it should be tested by the adversary process with competing expert
testimony and cross-examination, rather than excluded by the court at the outset.”
Johnson v. Mead Johnson & Co., LLC, 754 F.3d 557, 561 (8th Cir.2014) (citing
Daubert, 509 U.S. at 590, 596); see also In re St. Jude Med., Inc. Silzone Heart
Valves Prod. Liab. Litig., 493 F. Supp. 2d 1082, 1088 (D. Minn. 2007) (permitting
an expert witness to testify generally about a product when the expert had
knowledge and experience of the product and bases his opinion on relevant
scientific literature). The court cannot at this time conclude that Dr. El-Ghannam’s
opinion on this matter would be completely unhelpful to the jury. See Clark v.
Heidrick, 150 F.3d 912, 915 (8th Cir.1998) (explaining that “doubts regarding
whether an expert's testimony will be useful should generally be resolved in favor
of admissibility”).

Accordingly with respect to Dr. El-Ghannam specific causation

opinions, the defendant’s motion will be denied.
Vladimir Iakovlev, M.D.
Dr. Iakovlev is a board-certified anatomical pathologist who has been
designated as an expert witness by the plaintiff to offer general- and case-specific
causation opinions in his field as a pathologist. He opines that ObTape can degrade
– and, in plaintiff’s case, did degrade – to cause adverse clinical effects.

Dr.

Iakovlev is an anatomical pathologist and director of cytopathology at the
Department of Laboratory Medicine at St. Michael’s Hospital in Toronto, Canada.

27

Dr. Iakovlev annually examines approximately 4,000-5,000 cases of explanted
pathology specimens, reviews the available clinical information related to the
patient, and reaches conclusions about the cause of a patient’s symptoms.

Dr.

Iakovlev has examined over 230 different polypropylene mesh explants; 150 of
which were transvaginal mesh explants samples.

Of the 150 transvaginal mesh

explant samples, Dr. Iakovlev estimates that sixty percent were transvaginal mesh
slings. The explanted mesh types included a number of different designs developed
by a number of different manufacturers. Dr. Iakovlev’s data pool of mesh explant
samples contains specimens of patients from St. Michael’s Hospital, cases sent from
outside hospitals, as well as potential and active litigation cases. While reviewing
the clinical records of the plaintiff, Dr. Iakovlev looked for events and symptoms
with temporal relationship to mesh placement, alteration, or excision as well as
symptoms or procedures anatomically related to urogenital area and the mesh.
The defendant has moved to exclude both of Dr. Iakovlev’s degradation
opinions which separately detail his general and case specific causation opinions.
First, defendant argues that Dr. Iakovlev’s general causation opinions regarding
degradation are unreliable because his opinions are not based on a reliable
methodology. Defendant also notes that Dr. Iakovlev’s degradation opinions have
been excluded 28 times in mesh litigation. Dr. Iakovlev purports to offer general
causation opinions on morphological findings associated with ObTape based on his
evaluation of “over 230 different polypropylene mesh explants,” including a mixture
of hernia meshes, pelvic organ prolapse devices, and mesh slings. [Doc. #109-16].
However, his review is not specific to ObTape and was formulated for expert
testimony in other litigation.

[Doc. #109-23].

28

Also, Dr. Iakovlev acknowledges

that only some of the general opinions in his expert report are actually applicable to
ObTape.
Further, of the 230 different polypropylene mesh explants Dr. Iakovlev
reviewed, only four were samples of explanted ObTape.

The samples were

provided by plaintiff’s counsel for purposes of litigation. Under the Eighth Circuit’s
Daubert analysis, the district court is guided to look skeptically when expert opinion
is developed for the sole or primary purpose of litigation. Lauzon v. Senco Prods.,
Inc., 270 F.3d 681, 687 (8th Cir.2001).

Dr. Iakovlev does not know how the

samples were selected for his review, and there are no assurances that plaintiff’s
counsel did not opportunistically choose samples while ignoring others that might
have weakened or disproved their theory of the case.

Also, while eight ObTape

samples were provided, Dr. Iakovlov reported a review of only four of them. There
is no explanation of how the samples were selected for review or why all eight were
not reviewed. Plaintiff has made no showing that reviewing only four explants is
reliable using scientific methods. The Court finds Dr. Iakovlev’s general causation
opinions unreliable, and the motion to exclude them will be granted.
Defendant also challenges Dr. Iakovlev’s specific causation opinions as
unreliable.

Dr. Iakovlev opines that the defective nature of plaintiff’s ObTape in

2005 caused it to “harbor bacteria,” leading to a serious infection of her left thigh
through a sinus tract that allowed the infection to travel from the sling to her left
thigh.

[Doc. #109-31].

In formulating his opinion with respect to plaintiff, Dr.

Iakovlev fully incorporated the opinions in his general causation report and
separately reviewed the clinical records of plaintiff. Because the Court finds that
the expert’s opinion is unreliable with respect to general causation, it is

29

unnecessary to address defendant's arguments with respect to specific causation.
Glastetter v. Novartis Pharm. Corp., 107 F. Supp. 2d 1015, 1045 n. 29 (E.D. Mo.
2000), aff'd, 252 F.3d 986 (8th Cir.2001).

Accordingly, defendant’s motion to

exclude the specific causation opinions of Dr. Iakovlev will be granted.
Farrin A. Manian, M.D.
Plaintiff identified Dr. Farrin A. Manian as an expert expected to testify at
trial to provide differential diagnoses for the specific causation of plaintiff’s injuries
as a result of the implantation and subsequent infection of the ObTape suburethral
sling.

Dr. Manian is a medical doctor, board certified in Internal Medicine and

Infectious Diseases. He has been practicing for over 30 years, including 27 years
as Chief of Infectious Diseases and Hospital Epidemiologist at Mercy Hospital in St.
Louis.
After conducting a differential diagnosis in this case, Dr. Manian gives his
expert opinion that plaintiff’s necrotizing fasciitis was caused by a group of bacteria
seeding the ObTape at implementation.

Dr. Manian opines that plaintiff’s soft

tissue infections, including her initial bout of severe necrotizing fasciitis, was a
result of bacterial invasion of the ObTape with its subsequent spread to surrounding
tissues with episodic flare-up of infections within her left and right thighs until the
entire ObTape was removed. [Doc. #109-9]. In forming this opinion, Dr. Manian
relied upon medical records from: (1) Platinum Surgical Care, (2) Barnes-Jewish
Hospital, (3) Barnes-Jewish-West County, (4) Barnes-Jewish Center Home Care, (5)
Body Aesthetic Plastic Surgery, (6) Barnes-Jewish Urology Clinic, (7) Jefferson
Memorial Hospital, (8) Medical Arts Clinic, (9) Pain Management Center, (10)
Parkland Health Center, (11) Dr. Paul L’Ecuyer’s Consult Report. Dr. Manian also

30

reviewed dental records and considered whether plaintiff’s history of tooth
extractions and poor dental hygiene could have been the source of her infection.
[Doc. #109-10].

After doing so, Dr. Manian maintained his opinion that vaginal

flora was the primary source of plaintiff’s infection, and that the bacteria gained
access to her implanted prosthetic ObTape material by contiguous spread, not from
a distant dental site.
A “differential diagnosis [is] a technique that identifies the cause of a medical
condition by eliminating the likely causes until the most probable cause is isolated.”
Id. (citing Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262 (4th Cir.1999)).
“[A] medical opinion about causation, based upon a proper differential diagnosis is
sufficiently reliable to satisfy Daubert.”

Bland v. Verizon Wireless, (VAW) L.L.C.,

538 F.3d 893, 897 (8th Cir.2008).
Defendant argues that Dr. Manian did not perform a proper differential
diagnosis because he failed to investigate and rule out all possible causes of
plaintiff’s infection.

The Court disagrees.

As discussed above, Dr. Manian

considered the possibility that plaintiff’s infection stemmed from her poor dental
hygiene, given the fact that the bacteria cultured from plaintiff’s thigh can also be
found in the mouth. He also considered whether a soft tissue injury that plaintiff
had sustained could have been the source of her infection. In his deposition, Dr.
Manian explained in detail why, based on his experience and knowledge, he ruled
out these other potential causes. [Doc. # 120-4]. Dr. Manian also relied upon CDC
guidelines applicable to classifying surgical site infections, noting that with
implantable devices, such as ObTape, “the recommendation is to go up to a year
after surgery for diagnoses of surgical site infections.” Id. at p. 274.

31

Dr. Manian’s

ultimate conclusion was supported by: (1) the fact that the infection was diagnosed
within the timeline established by the CDC guidelines; (2) the type of bacteria
found in the infected area were the same as that commonly found in the vaginal
canal; and (3) the medical literature supporting similar type of infections occurring
after “clean-contaminated” surgical procedures like the ObTape implantation.

Dr.

Manian conducted a proper differential diagnosis that is supported by his medical
knowledge and experience, a review of the pertinent medical records, and an
evaluation of the potential sources of the infection.
Defendant next argues that Dr. Manian’s opinion is unreliable because it rests
on an unsupported assumption that the bacteria that allegedly infected the ObTape
had lain dormant for several months after the implantation and until plaintiff
presented with necrotizing fasciitis.

Dr. Manian testified that “[i[t’s been well

proven that if you have a prosthetic material, germs acquired at the time of surgery
can lay dormant.” [Doc. # 109-6, pp. 80-81]. He further testified that infections
“manifest themselves months or even a year longer after surgery” because the
bacteria lay dormant. Id. at p. 81. Although Dr. Manian was unable to “point to a
specific article” discussing how bacteria lay dormant for nine months, he was aware
of case reports of infections caused by bacteria in the same class as that found in
plaintiff that did not present until months after surgery. Id. Dr. Manian’s testimony
and reports demonstrate that his opinion is not based solely on assumptions.
The Court finds that Dr. Manian’s expert opinion regarding the source of the
plaintiff’s infection is reliable and, therefore, it will not be excluded.
Doug Watanabe, D.D.S.

32

The defendant seeks to exclude any testimony by Dr. Watanabe that
plaintiff’s infection was caused by ObTape.

Although this is an opinion Dr.

Watanabe expressed in his report, plaintiff states that he will not give this
testimony at trial. Rather, Dr. Watanabe’s expert testimony will be limited to his
opinion that plaintiff’s thigh and pelvic infections, abscesses, cellulitis, and
necrotizing fasciitis were not caused by oral bacteria.

Accordingly, the defendant’s

motion is moot.
Paul L’Ecuyer, M.D.
Defendant moves to exclude Dr. L’Ecuyer’s opinion that an undiagnosed
erosion of the ObTape sling caused plaintiff’s infection.

Defendant asserts that Dr.

L’Ecuyer is not qualified to give this opinion, because he is not a urology specialist
and he admitted that he did not know the symptoms of suburethral sling erosion.
In his deposition, Dr. L’Ecuyer testified that he had no experience with suburethral
erosions. [Doc. # 120-12, p. 158].
An expert witness must be qualified to assist the finder of fact. Johnson v.
Mead Johnson & Co., LLC, 754 F.3d 557, 561 (8th Cir.2014).
admission, Dr. L’Ecuyer is not qualified to diagnose an erosion.

By his own
The Court finds

that his opinion that an erosion caused plaintiff’s infection is based wholly on
speculation. Therefore, defendant’s motion to exclude it will be granted.
Kristin Kucsma
Plaintiff proposes to offer testimony from an economics expert, Kristin
Kucsma, on the past, present, and future economic impact of plaintiff’s injuries,
including loss of earnings. [Doc. #109-32]

Defendant argues that Ms. Kucsma’s

opinion is unhelpful and unreliable because it is based on the premise that plaintiff

33

is unable to work— a premise that plaintiff cannot establish.

The Court agrees

that the plaintiff must provide evidentiary support for the expert witness’s opinion.
However, the Court is not prepared to say that plaintiff will not be able to do so
through the medical and employment evidence that she intends to offer and
through her own testimony.

Further, defendant offers no legal support for its

contention that plaintiff cannot establish her inability to return to work without the
testimony of a vocational or employment expert.
The defendant next seeks to exclude Ms. Kucsma’s opinion on the value of
the household services plaintiff provided before the ObTape surgery.

Defendant

first argues that the opinion is unhelpful because it addresses a category of
damages that plaintiff is not entitled to recover. Under Missouri law, a plaintiff may
recover damages for the loss of the ability to perform her own household services.
LaRose v. Washington Univ., 154 S.W.3d 365, 372 (Mo. Ct. App. 2004) (finding
that the loss of ability to perform household services, or loss of ability to work, was
properly included as an economic damage, recoverable by the plaintiff), see also
Collier v. Simms, 366 S.W.2d 499, 500 (Mo. Ct. App. 1963) (holding that any
physical inability of a housewife to perform domestic duties must necessarily mean
a physical inability to work and labor and is a compensable item of damage to the
wife, and not to her husband). Because the loss of household services is a category
of damages which plaintiff is entitled to recover, Ms. Kucsma’s opinion is relevant.
Defendant also argues that Ms. Kucsma’s opinion is unreliable because it
attaches a greater value to the loss of plaintiff’s household services based on the
assumption that plaintiff would be performing services for her dependent children
until 2015, when plaintiff’s youngest child turned 18.

34

Defendant notes in

furtherance of its argument that plaintiff’s ex-husband was given sole custody of
their youngest son in November 2012 and there is no evidence that plaintiff
continued to provide services to her son after that time.

In her deposition, Ms.

Kucsma testified that her opinion rests on evidence of the services plaintiff provided
to her children that did not depend on them living with her. Additionally, plaintiff
expects to offer evidence of her extensive involvement in her children’s lives before
her injury and her inability to continue that involvement after her injury
The Court concludes that the opinions of Ms. Kucsma on the issues of loss of
earnings and loss of household services are both helpful and reliable. Therefore,
the defendant’s motion to exclude the opinions will be denied.
*

*

*

*

*

For the reasons set forth above,
IT IS HEREBY ORDERED that the plaintiff’s motion to exclude the opinions
and testimony of defendant’s expert Gonzalo R. Ballon-Landa, M.D., [Doc. #104] is
denied.
IT IS FURTHER ORDERED that the plaintiff’s motion to exclude the
opinions and testimony of defendant’s expert Marjorie Jeffcoat, D.M.D., [Doc.
#106] is granted in part and denied in part.
IT IS HEREBY ORDERED that the plaintiff’s motion to exclude the opinions
and testimony of defendant’s expert Dr. Ruby Skinner, M.D., [Doc. #113] is
granted in part and denied in part.
IT IS HEREBY ORDERED that the plaintiff’s motion to enforce Daubert
orders [Doc. #112] is granted in part and denied in part.

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IT IS FURTHER ORDERED that the defendant’s motion to exclude certain
testimony from plaintiff’s expert witnesses [Doc. #108] is granted in part and
denied in part.

CAROL E. JACKSON
UNITED STATES DISTRICT JUDGE
Dated this 30th day of December, 2016.

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