Martinez v. Johnson & Johnson et al

Filing 236

OPINION AND ORDER: Motion 181 is GRANTED in part. Dr. Coles testimony will not be permitted as to the design and development of Restorelle Y, but will be permitted to testify as to her personal experience with polypropylene mesh, including Restorelle Y. Signed by Magistrate Judge Andrew P Rodovich on 2/14/2022. (nhc)

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UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF INDIANA
HAMMOND DIVISION
REBECCA MARTINEZ,
Plaintiff,
v.
COLOPLAST CORP. & COLOPLAST
MANUFACTURING US, LLC,
Defendants.

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Case No. 2:18-cv-220

OPINION AND ORDER
This matter is before the court on the Motion and Memorandum in Support of Motion to
Exclude Opinions and Testimony of Emily Cole, M.D. [DE 181] filed by the plaintiff, Rebecca
Martinez, on September 30, 2021. For the following reasons, the Motion [DE 181] is
GRANTED in part.
Background
Prior to 2016, the plaintiff, Rebecca Martinez, experienced a series of medical problems
including multiple forms of pelvic organ prolapse (POP). After consulting with two
gynecologists, Timothy Weiss and Andrew Waran, Martinez underwent surgery on March 17,
2016. Dr. Weiss performed a hysterectomy, and Dr. Waran implanted a surgical mesh
manufactured by the defendants.
The surgical mesh was made of polypropylene and had the product name of Restorelle Y.
Because of multiple pregnancies and age, some of Martinez’s internal organs were sagging and
in need of additional support. The Restorelle mesh was designated “Y” because of its shape.

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The three ends of the Y shaped mesh were sutured to different parts of the pelvic cavity and were
intended to provide a sling-like support for various organs.
Several months after the implantation, Martinez sought treatment for abdominal, vaginal,
pelvic, back, and leg pain. Dr. Waran found that it was unlikely that the mesh device was
causing the pain, but referred her to urogynecologist, Dr. Roger Goldberg, who agreed to
perform a partial removal surgery. On September 19, 2017, Dr. Goldberg performed an
exploratory laparotomy and partial excision of the mesh.
Martinez now complains that the surgical mesh was defective and has caused her
additional problems. In particular, she contends that the polypropylene tends to shrink and
harden in the woman’s body and that this leads to inflammation, pressure on nerves, and other
complications. The lawsuit raises both product liability and negligence claims.
The defendants have retained Emily Cole, M.D., a urologist and surgeon who specializes
in female pelvic health, as a general causation expert. Martinez is challenging Dr. Cole’s
proposed testimony regarding the design of the defendants’ mesh for several reasons including
that Dr. Cole did not review any Coloplast documents related to product design and safety of the
mesh, that she has no knowledge of the design process, that she is unaware of key literature on
the safety of the mesh, and that she relies on personal complication rates that cannot be
objectively verified. Therefore, Martinez is requesting that the court limit Dr. Cole’s testimony
to her own personal clinical experience working with and implanting mesh devices, whether she
is comfortable recommending mesh implantation to her patients, risks that she perceives from
using the mesh, and what she has found in literature regarding mesh outcomes and whether those
findings are consistent with her own clinical experience.1

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Martinez cites to Bayless v. Bos. Sci., 2020 WL 10058191, at *6 (M.D. Fla. Dec. 7, 2020), where the court excluded
Dr. Cole’s testimony as to the design of the mesh device but allowed her to testify regarding her personal clinical

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Discussion
In Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme
Court interpreted Federal Rule of Evidence 702 and imposed a gatekeeping responsibility on
district court judges when expert testimony is offered. Daubert involved scientific testimony,
and the lower federal courts were divided on whether the Daubert interpretation of Rule 702
applied to all expert testimony. In Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999), the
Supreme Court held that the gatekeeping requirement applied to all proposed expert testimony.
The final case in the so-called Daubert trilogy is General Electric Co. v. Joiner, 522 U.S. 136
(1997). In that case, the Supreme Court held that the abuse of discretion standard should be
applied on appellate review.
Rule 702 provides:
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.
In its current version, Rule 702 attempts to codify the holdings of the Daubert trilogy.
Daubert emphasized the need for expert testimony to meet the twin requirements of
reliability and relevancy. In evaluating the proposed testimony, courts have referred to a “fit”
and “intellectual rigor” requirement. Kumho Tire Co., 526 U.S. 137, 152; Harman v. EBSCO

experience working with and implanting mesh devices. Martinez asks that the court “so limit her opinions” here too.
[DE 206 at pg. 2].

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Industries, Inc., 758 F.3d 810, 819 (7th Cir. 2014). Even when there is no dispute that the
proposed witness is an expert, more is required before the opinion is admissible.
The “fit” requirement is met if there is a valid connection between the expertise of the
witness, the proposed opinion, and the issues at trial. The “intellectual rigor” inquiry is satisfied
if the expert has applied the same standard to both the proposed court opinion and an opinion
reached in her other professional endeavors.
Finally, Federal Rule of Evidence 104(a) is the mechanism for resolving a Daubert
challenge. Under Rule 104(a), the court may consider any evidence which is not privileged and
resolve any factual disputes. The court must determine whether the proponent of expert
testimony has demonstrated by a preponderance of the evidence that the Daubert requirement
have been met.
In the instant motion, Martinez primarily challenges the admissibility of Dr. Cole’s
testimony regarding the design of Restorelle Y, as detailed above. In support of her argument,
Martinez points to Dr. Cole’s deposition testimony in which she admitted that she has not
reviewed any of the defendants’ internal company documents, that she is not an expert in the
design of medical devices, and that she was unaware of the key mesh characteristics of
Restorelle Y.
The defendants state in their response that Martinez “has confounded a question and
created a straw man by attacking Dr. Cole’s qualifications for issues that she has not offered to
opine on, namely the Restorelle [Y]’s design or development process.” [DE 186 at pg. 6]. They
claim that Martinez’s “repeated attacks” on Dr. Cole’s lack of design experience “is simply
misplaced because her opinion is not being offered for that ‘specific question,’” and they do not

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“contend that [her] opinions have any foundation in the process to design or develop Restorelle
[Y] … because her opinion is wholly unrelated to that topic.” [DE 186 at pg. 7].
Dr. Cole is clearly an experienced female pelvic health surgeon. She has performed over
1,500 pelvic floor surgeries in the last ten years, with five involving Restorelle Y. She currently
serves as the Chief Urologist and Director of the Female Pelvic Health Center at Sharp RessStealy Medical Group where she maintains an active surgical practice that specializes in using
mesh implants to treat female POP and urinary incontinence conditions.
Based on her decades of clinical experience, Dr. Cole is competent to testify as to what
she has personally experienced and observed. Certainly, a surgeon who has performed over a
thousand pelvic floor surgeries, some involving mesh implants, would be qualified to testify
regarding the benefits and risks that she has observed in her patients. Therefore, in her proposed
testimony, she has applied the same standards to her court opinions and opinions reached in her
other professional endeavors.
Since Martinez is only challenging Dr. Cole’s proffered testimony regarding the design
of the mesh, and the defendants have stated that they are not offering her as an expert witness
regarding Restorelle Y’s design, the court finds there is no dispute to resolve. Dr. Cole will not
testify as to the design and development process of Restorelle Y.
Based on the findings above, Martinez’s Motion [DE 181] is GRANTED in part. Dr.
Cole’s testimony will not be permitted as to the design and development of Restorelle Y, but will
be permitted to testify as to her personal experience with polypropylene mesh, including
Restorelle Y.
ENTERED this 14th day of February, 2022.
/s/ Andrew P. Rodovich
United States Magistrate Judge
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