Martinez v. Johnson & Johnson et al

Filing 243

OPINION AND ORDER: The defendants' First MOTION in Limine Motion to Exclude Becker filed by Rebecca Martinez 165 is GRANTED in part. Dr. Becker is permitted to testify about the industry standards and practices as it pertains to the defendants' and the medical device industry in general. Signed by Magistrate Judge Andrew P Rodovich on 02/22/2022. (jdb)

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF INDIANA
HAMMOND DIVISION
REBECCA MARTINEZ,

)
)
)
)
)
)
)
)
)
)

Plaintiff,
v.
COLOPLAST CORP. & COLOPLAST
MANUFACTURING US, LLC,
Defendants.

Case No. 2:18-cv-220

OPINION AND ORDER
This matter is before the court on the Motion to Exclude Opinions and Testimony of
Karen Becker, PHD [DE 165], filed by the plaintiff, Rebecca Martinez, on September 30, 2021.
For the following reasons, the Motion [DE 165] 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. During the same operation, Dr. Waran also implanted a sling
manufactured by Ethicon to support her bladder.
The surgical mesh was made of polypropylene and had the product name of Restorelle Y.
The Restorelle mesh was designated “Y” because of its shape. Because of multiple pregnancies
and age, some of Martinez’s internal organs were sagging and in need of additional support. 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 the sagging organs.
Throughout the pleadings, the parties have drawn a distinction between a surgical mesh
and a sling. Both are intended to correct POP problems in women. The Restorelle Y surgical
mesh is designed to be attached to the woman’s sacrum, to extend downward, and to be attached
to the vagina. It is implanted under the woman’s small bowel. The sling is implanted to provide
support for the woman’s bladder and is not attached to the surgical mesh. (See generally,
Daubert Hearing, Ex. A).
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 surgical mesh was
causing the pain, but he referred her to a 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. The parties have used the term
“explanted” to describe both the procedure and the portion of the mesh removed.
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 identified Dr. Karen Becker as an expert witness to opine on
medical device industry practices and the Food and Drug Administration’s (FDA) regulation of
medical devices. The defendants also seek to offer her testimony in response to Martinez’s
regulatory expert, Dr. Peggy Pence.1

1

The court excluded all the proffered testimony of Dr. Peggy Pence on February 11, 2022. [DE 233].
2

In this motion, Martinez is requesting that the court exclude Dr. Becker’s opinions
regarding the FDA in general as well as its regulatory process as it pertains to labeling, adverse
event reporting system, and the §510(k) clearance process. Additionally, Martinez asks that Dr.
Becker’s opinions regarding industry standards and the defendants’ compliance with them be
excluded.
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. All three cases discussed factors that the court should consider in
evaluating proposed expert testimony.
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.
3

In its current version, Rule 702 attempts to codify the holdings of the Daubert trilogy.
Even when there is no dispute that the proposed witness is an expert, more is required
before the opinion is admissible. Daubert emphasized the need for expert testimony to meet the
twin requirements of reliability and relevancy. In evaluating the proposed testimony, courts also
have referred to a “fit” and an “intellectual rigor” requirement. Kumho Tire Co., 526 U.S. 137,
152; Harman v. EBSCO Industries, Inc., 758 F.3d 810, 819 (7th Cir. 2014).
The “fit” requirement is met if there is a logical 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 diligence to both the proposed court opinion and an opinion
reached in his other professional endeavors. In Schultz v. AKZO Nobel Paints, LLC, et al., 721
F.3d 426 (7th Cir. 2013), the Seventh Circuit stated:
Although [Daubert] places the judge in the role of the gatekeeper for
expert testimony, the key to the gate is not the ultimate correctness of
the expert’s conclusions. Instead, it is the soundness and care with which
the expert arrived at h[is] opinion …”
721 F.3d at 431.
See also Kirk v. Clark Equipment Company, 991 F.3d 865, 873 (7th Cir. 2021).
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 requirements
have been met.
Martinez spends a majority of her motion arguing that Dr. Becker’s testimony regarding
the FDA, and its regulations and procedures, should be excluded for the possibility that it could
result in prejudice, confusion, or mislead the jury. The court need not address this because it has
4

already excluded all evidence concerning the FDA’s regulatory process, and specifically, its
§510(k) clearance process.2 [DE 239].
The only issue that remains is whether Dr. Becker’s opinions regarding the defendants’
compliance with industry standards and practices are admissible. Martinez argues that the
opinions should be excluded because there is no authoritative basis for them in Dr. Becker’s
report and that they “only tie back to her FDA regulatory opinions.” The defendants claim that
her opinions are the product of her work as an industry consultant for the last 27 years.
Additionally, Dr. Becker explained in her deposition that industry practices are “a bit different”
than FDA regulatory compliance. [DE 192-1]. “[A]n example of industry practice is when you
go above and beyond the regulations or you implement procedures that help you confirm with
the regulations.” [DE 192-1].
The court appreciates the possibility of overlap between the FDA regulations that a
medical device company must follow and common industry practices. However, unlike FDA
regulations, industry practices are not governed by a set of codified rules. They are established
by gathering data regarding the common operations of businesses within the relevant industry.
There is no question that Dr. Becker is qualified to opine on such practices, for she has worked in
the medical device industry as a consultant for decades. The fact that FDA regulations and
industry practices are independent of one another, coupled with Martniez’s undeveloped
argument that Dr. Becker’s testimony be wholly excluded, the court finds that Dr. Becker’s
testimony on the topic of industry practices, separate and distinct from the FDA, is admissible.

2

The Medical Device Act of 1976 (MDA) exempts from premarket review, any medical device which
has been given §510(k) clearance from the FDA. Kaiser v. Johnson & Johnson, 947 F.3d 996, 1004 (7th
Cir. 2020). The FDA will grant such clearance if the device is “substantially equivalent” to another
device already on the market. Kaiser, 947 F.3d at 1004.
5

For the foregoing reasons, the defendants’ the Motion [DE 165] is GRANTED in part.
Dr. Becker is permitted to testify about the industry standards and practices as it pertains to the
defendants’ and the medical device industry in general. However, the court is refraining from
expressing an opinion as to the specific testimony of Dr. Becker’s that will be admissible, as it
has not been provided the details of those opinions. In no event will Dr. Becker be permitted to
testify beyond the bounds of her report.
ENTERED this 22nd day of February, 2022.
/s/ Andrew P. Rodovich
United States Magistrate Judge

6