Martinez v. Johnson & Johnson et al
Filing
232
OPINION AND ORDER granting 175 Motion to Exclude the Testimony and Opinions of Jimmy Mays, PH.D by Defendants Coloplast Corp, Coloplast Manufacturing US, LLC. Signed by Magistrate Judge Andrew P Rodovich on 02/10/2022. (jdb)
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UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF INDIANA
HAMMOND DIVISION
REBECCA MARTINEZ,
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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
Plaintiff’s Expert Jimmy Mays, PH.D. [DE 175], filed by the defendants, Coloplast Corp. and
Coloplast Manufacturing US, LLC, on September 30, 2021. For the following reasons, the
Motion [DE 175] is GRANTED.
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
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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.
Dr. Jimmy Mays is a chemistry professor at the University of Tennessee with over 40
years of experience working with polymer materials. He has published research as a polymer
scientist in over 400 peer-reviewed publications, most involved the use of polymer
characterization techniques. Dr. Mays has served as an editor and editorial advisory board
member for several peer-reviewed journals about polymer science.
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Martinez has named Dr. Mays as one of her general causation experts for trial. Dr. Mays’
proposed testimony primarily involves his opinions about polypropylene and oxidative
degradation as it relates to the mesh manufactured by the defendants. The defendants are
requesting that the court exclude the testimony of Dr. Mays for several reasons. First, they
allege that he is unqualified and his opinions lack a reliable basis. Second, they contend that he
admitted he never tested his degradation hypotheses, did not examine the mesh at issue in this
case, and could not adequately account for obvious alternative explanations. Finally, the
defendants claim that Dr. Mays relied on a publication that directly contradicted his degradation
hypothesis as well as on testing that he conducted on a mesh manufactured by a different
company, Boston Scientific.
In her response, Martinez argues that since Dr. Mays’ testimony has been permitted in
other cases and that because he has conducted tests on the Boston Scientific mesh, his opinions
as to the defendants’ mesh are reliable.
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.
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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.
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).
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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.
Dr. Mays undeniably is an experienced polymer scientist. But even decades of
experience in the field of polymer science does not automatically render his opinions on related
topics, such as polypropylene degradation, reliable. “When evaluating the reliability of expert
testimony, the district court must make a preliminary assessment of whether the reasoning or
methodology underlying the testimony is scientifically valid.” Kirk, 991 F.3d at 873. In doing
so, the court looks to various factors including whether the scientific theory can be (and has
been) tested and whether the theory has been subjected to peer review and publication. 991 F.3d
at 873.
Dr. Mays proposes to offer the opinion that the defendants’ mesh implants undergo
oxidative degradation once implanted in a woman’s body. He claims that this degradation
occurs when the implanted mesh, containing polypropylene, interacts with the chemicals
generated as a result of the human foreign body response (FBR). Therefore, the degradation
leads to a breakdown of the mesh’s mechanical properties and causes the type of injury and pain
that Martinez complains of.
Dr. Mays has come to this opinion without testing his hypotheses on the defendants’
mesh and without examining the defendants’ mesh or the mesh explanted from Martinez. [DE
177-3]; see also Kirk, 991 F.3d at 874-76 (affirming the district court’s exclusion of an expert
who failed to “test his design defect theory” on the product at issue and “did not view, inspect, or
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operate the [product] in person,” therefore the “identifiable source for [the expert’s] opinion was
his own speculation”).
Martinez argues that Dr. Mays’ testing of the Boston Scientific mesh, makes up for the
fact that he has failed to test his hypotheses on the defendants’ mesh. But, Dr. Mays testified that
there are differences between the Boston Scientific mesh and the defendants’. Specifically, he
admitted that there are different antioxidants and that different concentrations of antioxidants can
affect how long it takes for the oxidative degradation process to begin. Additionally, he stated
that he does not know all of the antioxidants in the defendants’ mesh because he has never tested
the mesh and does not know of anyone who has. [DE 177-3].
In forming reliable opinions that are admissible at trial, experts are required to “rule out
any serious alternative causes.” Kirk, 991 F.3d at 876-77. Here, the defendants point to recent
peer-reviewed literature, Thames ST, et al., The Myth: in vivio degradation of polypropylene
meshes, INT’L UROGYNECOLOGY J 2017; 28:285-297 (Thames), that they claim “debunks” Dr.
Mays’ degradation hypothesis. The Thames literature states that the “cracked” surfaces on
explanted polypropylene mesh, which were previously assumed to be degradation, actually are
layers of biological material that were deposited on the implant. Additionally, the findings in
Thames show that a properly cleaned mesh revealed no signs of chemical degradation. In
response, Dr. Mays criticized that the cleaning process used by Thames, claiming it was vigorous
enough to remove both biological material and the lawyer of oxidized degraded polypropylene.
However, Dr. Mays did not perform any tests on an explanted mesh to verify his opinions.
New research from Thames published in 2020, directly addressed Dr. Mays’ critique of
Thames’ cleaning process and found that no oxidized polypropylene had been removed by the
cleaning process. Thames S.F., et al., Implantation Time Has No Effect on the Morphology and
Extend of Previously Reported “Degradation” of Prolene Pelvic Mesh, FEMALE PELVIC MED
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RECONSTR SURG 2020. The new study compared the surface of a cleaned, explanted mesh to a
new mesh and found no differences. Thames’ research has offered a plausible rebuttal to Dr.
Mays’ criticism, and once again, Dr. Mays did not perform any tests of his own.
Dr. Mays has had a distinguished career and obviously is an expert in his field. The
hallmark of the scientific method is to test a hypothesis to verify its accuracy. Dr. Mays failed to
conduct any tests either before advancing his theory on the Thames cleaning method or after the
Thames article rejected his theory. It is clear that Dr. Mays did not apply the same “intellectual
rigor” to his litigation opinions as he did to his 400 published articles.
The defendants also have challenged Dr. Mays’ opinions on the basis that the authorities
upon which he relied are actually contrary to his conclusions. Dr. Mays relied on RAUTNER, B.,
ET AL.,
Biomaterials Science, Chapter II 2.2 by J.M. Anderson, Academic Press, San Diego, 3d
ed. 2013, in coming to his opinion that FBR continues to release oxidizing agents for the entire
time that an implant remains in the body. But the Rautner text states, “while these foreign-body
giant cells may persist for the limetime of the implant, it is not known if they remain activated
releasing their lysosomal constituents or become quiescent,” which Dr. Mays acknowledged in
his deposition. [DE 177-6]. This misquote of an article relied upon as a basis for his opinions
adds another reason to exclude them.
Lastly, Martinez has alleged that certain documents produced by the defendants during
discovery show that they were on notice of the problems caused by the polypropylene mesh in a
woman’s body. At issue is whether an expert may testify to the knowledge of the defendants.
Arguably, this is relevant to the claim for punitive damages.
As a general rule, a document “speaks for itself.” A witness cannot testify about what a
document means – that is the function of the jury. The only exception to this rule is if the
document contains specific or technical information. In that case, an expert can be used to
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explain those terms to the jury. In final arguments, the attorneys can argue the significance of
the documents and what inferences the jury should draw from them. Therefore, neither party
will be permitted to call a witness to state an opinion concerning the knowledge or state of mind
of the defendants.
For the foregoing reasons, the defendants’ the Motion [DE 175] is GRANTED.
ENTERED this 10th day of February, 2022.
/s/ Andrew P. Rodovich
United States Magistrate Judge
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