Carolyn Lewis v. Johnson & Johnson; Ethicon, Inc.

UNPUBLISHED
UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT
No. 14-1244
CAROLYN LEWIS,
Plaintiff - Appellant,
and
KENNETH LEWIS; AUGUSTINA BROWN-SINGLETARY; ANDRE SINGLETARY-
SMITH; KARIN HARRISON; ROBERT HARRISON; PATRICIA HEADRICK;
DARRELL HEADRICK; KATIE USZLER; NICK USZLER; KELLY YOUNG;
KENNETH YOUNG,
Plaintiffs,
v.
JOHNSON & JOHNSON; ETHICON, INC.,
Defendants - Appellees,
and
ETHICON WOMEN’S HEALTH AND UROLOGY; GYNECARE; AMERICAN
MEDICAL SYSTEMS, INC.,
Defendants.
Appeal from the United States District Court for the Southern
District of West Virginia, at Charleston. Joseph R. Goodwin,
District Judge. (2:12-cv-04301; 2:12-md-02327)
Argued: January 27, 2015 Decided: March 2, 2015
Before MOTZ and DIAZ, Circuit Judges, and DAVIS, Senior Circuit
Judge.

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Affirmed by unpublished per curiam opinion.
ARGUED: Adam Steffen Davis, WAGSTAFF & CARTMELL LLP, Kansas
City, Missouri, for Appellant. David B. Thomas, THOMAS COMBS &
SPANN, PLLC, Charleston, West Virginia, for Appellee. ON BRIEF:
Julie L. Rhoades, MATTHEWS & ASSOCIATES, Houston, Texas, for
Appellant. Charles C. Lifland, Los Angeles, California, Stephen
D. Brody, David K. Roberts, O'MELVENY & MYERS LLP, Washington,
D.C.; Philip J. Combs, THOMAS COMBS & SPANN, PLLC, Charleston,
West Virginia; Christy D. Jones, BUTLER SNOW LLP, Ridgeland,
Mississippi, for Appellees.
Unpublished opinions are not binding precedent in this circuit.

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PER CURIAM:
Texas resident Carolyn Lewis brought this diversity
products liability suit against Ethicon, Inc., a subsidiary of
Johnson & Johnson. She seeks damages for injuries allegedly
resulting from tension-free vaginal tape (TVT) manufactured by
Ethicon. Lewis appeals the grant of summary judgment on her
failure-to-warn claim, and the judgment as a matter of law on
her design defect claim. We affirm.
I.
In 2009, urogynecologist Muriel Boreham diagnosed Lewis
with stress urinary incontinence (SUI), a condition causing
urine leakage during physical exertion. After a series of
tests, Dr. Boreham recommended the insertion of a TVT mesh
device to correct the SUI.
In October of that year, Dr. Boreham implanted a TVT in
Lewis. At a follow-up visit, Dr. Boreham told Lewis that she
“was healing” and implied that Lewis could resume sexual
activity with her husband. Lewis attempted to do so, but found
that she suffered from pain during sexual activity. She also
developed intermittent pelvic pain during daily activities.
Lewis never returned to or further consulted with Dr. Boreham.
Almost three years later, on July 25, 2012, Lewis filed
this action in the Northern District of Texas, seeking

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compensatory and punitive damages. Pursuant to the
Multidistrict Litigation Statute, 28 U.S.C. § 1407, the case was
later transferred to the Southern District of West Virginia.
Prior to trial, in May 2013, Lewis visited urologist Dr.
Philippe Zimmern to discuss her symptoms. Dr. Zimmern told
Lewis about the option of “explant” surgery to remove parts of
the TVT. Lewis elected to have the procedure. After Dr.
Zimmern performed the surgery in September 2013, Lewis’s pain
decreased noticeably, but she was still not “a hundred percent
better.”
In December 2013, Ethicon moved for summary judgment, which
the district court granted as to Lewis’s failure-to-warn claim.
At trial on her remaining claims, Lewis presented testimony from
current and former Ethicon employees and from five experts. At
the conclusion of Lewis’s case, the court requested briefing on
the possibility of a directed verdict. After the parties
briefed the issue and the district court heard argument, it
directed a verdict for Ethicon on Lewis’s design defect claim.
Lewis noted a timely appeal.
II.
We first address the district court’s grant of summary
judgment to Ethicon on Lewis’s failure-to-warn claim.

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A.
We review a district court’s grant of summary judgment de
novo. Glynn v. EDO Corp., 710 F.3d 209, 213 (4th Cir. 2013).
In so doing, we apply the same legal standards as the district
court. We view the evidence in the light most favorable to the
non-moving party, and affirm the grant of the motion only where
there is no genuine dispute as to a material fact and the moving
party is entitled to judgment as a matter of law. See Nader v.
Blair, 549 F.3d 953, 958 (4th Cir. 2008).
To prevail on a failure-to-warn claim under Texas law,
which the parties agree applies in this case, a plaintiff must
show both that the warning was inadequate, and that the
inadequate warning “was a producing cause of the plaintiff’s
condition or injury.” Porterfield v. Ethicon, Inc., 183 F.3d
464, 468 (5th Cir. 1999) (per curiam) (applying Texas law). To
establish a “producing cause,” a plaintiff must show that a
warning’s alleged inadequacies “would have changed [the]
prescribing physician[’s] decision to prescribe” the device.
Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 172 (Tex. 2012).
Under Texas law, a device manufacturer’s duty to warn of risks
extends only to the physician prescribing the device, “the
learned intermediary,” and not to the “end user” of the device.
Id. at 157. When a plaintiff offers no evidence that a
different warning would have changed her physician’s decision to

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prescribe a device, the inadequate warning cannot have caused
the plaintiff’s injury. Id. at 170-71.1
B.
Lewis presented no evidence that Dr. Boreham relied on the
warning in Ethicon’s patient brochure in deciding to prescribe
the TVT. Dr. Boreham herself testified that she did not recall
whether she had a TVT patient brochure at the time of Lewis’s
surgery, and that if she had one, she might have given it to
Lewis or used the picture of the procedure in the brochure to
explain how the device works. Dr. Boreham further stated that
she would not have verified the accuracy of the information in
the brochure. None of this testimony establishes that Dr.
Boreham considered the patient brochure warning, let alone
relied on it, in deciding to prescribe the TVT to Lewis.
1 Citing McNeil v. Wyeth, 462 F.3d 364, 373 (5th Cir. 2006),
Lewis argues that a plaintiff may prevail on a failure-to-warn
claim by showing that a stronger warning would have led the
plaintiff to withhold consent to the procedure. But McNeil
explicitly acknowledges that the relevant test is whether the
“alleged inadequacy caused [the plaintiff’s] doctor to prescribe
the drug.” 462 F.3d at 372 (quotations and citation omitted).
And McNeil certainly does not alter the rule that courts must
look to the prescribing doctor’s behavior in deciding whether
the inadequate warning is the “producing cause” of a plaintiff’s
injury. Moreover, the Supreme Court of Texas recently
reaffirmed that the inquiry under Texas law remains whether the
warning would have changed the decision of the prescribing
physician. Centocor, 372 S.W.3d at 170; see also Ackermann v.
Wyeth Pharm., 526 F.3d 203, 208 (5th Cir. 2008).

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Nor did Lewis offer evidence that Dr. Boreham relied on the
TVT’s instructions for use in deciding to prescribe the device.
Although Dr. Boreham testified that she had read the document
during her surgical fellowship in 2002, she stated that she did
not read it again before prescribing the TVT to Lewis in 2009.
Moreover, when asked whether she relied on the instructions for
use in prescribing the TVT, Dr. Boreham answered: “I did not.”
Dr. Boreham testified that she instead relied on Lewis’s
symptoms, bladder diary, urodynamics, physical exam, and
discussions regarding her desired outcomes in deciding to
prescribe the TVT.
This evidence does not establish that “but for the
inadequate warning,” Dr. Boreham “would not have used or
prescribed” the TVT. Ackermann, 526 F.3d at 208 (quotation
omitted) (emphasis added). When a physician relies on her own
experience and examination of a patient in deciding to prescribe
a device, and not on the device’s warning, the warning is not
the cause of the patient’s injury.
The Fifth Circuit, applying Texas law, has so held. In
Pustejovsky v. PLIVA, Inc., the court upheld a grant of summary
judgment to the defendants on a failure-to-warn claim where the
prescribing physician testified that she had not read or relied
on the medical device’s package insert. 623 F.3d 271, 277 (5th
Cir. 2010). Similarly, in Porterfield, the court upheld a grant

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of summary judgment to a surgeon who testified that he had not
read the device’s instructions for use or any other literature
from the manufacturer. 183 F.3d at 468. Lewis attempts to
distinguish these cases on the basis that Dr. Boreham did, at
one time, read the instructions for use, but she offers no
evidence to rebut Dr. Boreham’s own testimony that she did not
rely on the document in deciding to prescribe the TVT.
Accordingly, we agree with the district court that Lewis
did not offer sufficient evidence to create a dispute as to
material fact regarding whether a different warning would have
changed Dr. Boreham’s decision to prescribe the TVT.
III.
We next address Lewis’s challenge to the district court’s
exclusion of parts of Dr. Uwe Klinge’s expert opinion testimony.
Lewis argues that the court erroneously prevented Dr. Klinge
from connecting his observations about the condition of Lewis’s
mesh with her pain. We review evidentiary rulings, including
rulings on the admissibility of expert testimony, for abuse of
discretion. United States v. Davis, 690 F.3d 226, 257 (4th Cir.
2012). When reviewing a district court’s rulings on expert
opinion testimony, the Supreme Court has instructed that
“deference . . . is the hallmark of abuse-of-discretion review.”
Gen. Elec. Co. v. Joiner, 522 U.S. 136, 143 (1997).

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Before trial, Ethicon moved to exclude portions of Dr.
Klinge’s expert report related to the TVT mesh. It did so on
the grounds that Dr. Klinge, a former hernia specialist and not
a pathologist, was unqualified to offer expert testimony on that
issue, and that his testimony was unreliable. The district
court granted the motion. It found that Dr. Klinge’s testimony
was unreliable, noting that his report did not explain how he
had selected the TVT samples on which his opinions were based
and did not indicate that his analysis “controlled for error or
bias.”
At trial, Ethicon again raised these issues at sidebars and
in objections, including a continuing objection, throughout Dr.
Klinge’s direct examination. Although the court allowed Dr.
Klinge to testify regarding the general characteristics of mesh
samples explanted from Ms. Lewis, it concluded that Dr. Klinge
was not qualified to offer testimony regarding specific
causation. On this basis, it sustained several of Ethicon’s
objections. Lewis challenges three of these rulings: first,
the ruling preventing Dr. Klinge from opining on whether
“entrapped nerves in this slide . . . would indicate chronic
pain for Ms. Lewis”; second, the striking of Dr. Klinge’s answer
to the question whether plaintiff’s slides “would relate to any
complications of pain in Ms. Lewis”; and third, the striking of

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Dr. Klinge’s opinion that loose particles from the TVT “can very
good explain the manifestation of pain” in Ms. Lewis.
The district court did not abuse its discretion in making
these rulings. Dr. Klinge was a specialist in hernia surgery,
not pathology or stress urinary incontinence. He did not
receive training or board-certification in pathology. Dr.
Klinge had never treated Lewis, performed surgery to treat SUI,
or collected and studied mesh explants from SUI patients. The
district court was clearly within its discretion in concluding
that Dr. Klinge’s opinions regarding Lewis’s pain and mesh
explant were beyond his area of expertise, and so did not abuse
its discretion in excluding those portions of Dr. Klinge’s
testimony.
IV.
Finally, we consider Lewis’s contention that the district
court erred in directing a verdict for Ethicon on her design
defect claim.
A.
We review the grant of a motion for a directed verdict de
novo. Teague v. Bakker, 35 F.3d 978, 985 (4th Cir. 1994).
“[T]he test is essentially whether, without weighing the
evidence or considering the credibility of the witnesses, there
can be but one conclusion as to the verdict that reasonable

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jurors could have reached.” Gairola v. Va. Dept. of Gen.
Servs., 753 F.2d 1281, 1285 (4th Cir. 1985) (quotation and
citation omitted). We affirm “when any verdict in favor of the
nonmoving party necessarily will be premised upon speculation
and conjecture” because “a mere scintilla of evidence is not
enough to defeat a motion for a directed verdict.” Id.
(quotation and citation omitted).
To avoid a directed verdict, “the plaintiff must present
sufficient evidence to establish a prima facie case.” Id.
Under Texas law, “[t]o recover for a products liability claim
alleging a design defect, a plaintiff must prove that (1) the
product was defectively designed so as to render it unreasonably
dangerous; (2) a safer alternative design existed; and (3) the
defect was a producing cause of the injury for which the
plaintiff seeks recovery.” Timpte Indus., Inc. v. Gish, 286
S.W.3d 306, 311 (Tex. 2009). The district court directed a
verdict for Ethicon based on the third element.
With respect to this element, “[a] plaintiff must establish
a causal connection between the defective condition and the
plaintiff’s injuries or damages.” Am. Tobacco Co., Inc. v.
Grinnell, 951 S.W.2d 420, 434 (Tex. 1997) (internal citation,

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alteration, and quotations omitted).2 That is, the defect in the
product “must be a substantial factor in bringing about the
injury, and a cause without which the injury would not have
happened.” BIC Pen Corp. v. Carter, 346 S.W.3d 533, 541 (Tex.
2011).
Whether expert opinion testimony is necessary to prove a
plaintiff’s theory of causation is a question of law. Mack
Trucks, Inc. v. Tamez, 206 S.W.3d 572, 583 (Tex. 2006). Texas
law does not always require that an expert conclusively opine
that the defect in a product caused the plaintiff’s injury.
Kindred v. Con/Chem, Inc., 650 S.W.2d 61, 63 (Tex. 1983).
Rather, in many cases, a jury may infer causation, “like any
other ultimate fact,” from circumstantial evidence. Gladewater
v. Pike, 727 S.W.2d 514, 518 (Tex. 1987).
2 Lewis’s assertion that a plaintiff need merely establish
that the TVT –- and not some defect in it -– caused her injuries
fails. Although, as Lewis notes, a Texas statute codifying the
specific causation requirement in design defect cases does not,
by its own terms, “apply to” medical device cases, the section
also “is not declarative . . . of the common law . . . and shall
not be construed to restrict the courts of this state in
developing the common law with respect to any product which is
not subject to this section.” Tex. Civ. Prac. & Rem. Code
§ 82.005(d)(2), (e) (2011). The Supreme Court of Texas has been
clear that Texas common law requires a plaintiff in a strict
liability design defect case to show both the defective
condition of a product and a causal connection between that
defect and a plaintiff’s injuries. Lucas v. Tex. Indus., Inc.,
696 S.W.2d 372, 377 (Tex. 1984); Armstrong Rubber Co. v.
Urquidez, 570 S.W.2d 374, 376 (Tex. 1978)).

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However, the Supreme Court of Texas has repeatedly made
clear that “[e]xpert testimony [on causation] is required when
an issue involves matters beyond jurors’ common understanding.”
Mack Trucks, 206 S.W.3d at 583. In a products liability case,
proof other than expert testimony provides sufficient evidence
of causation “only when a layperson’s general experience and
common understanding would enable the layperson to determine
from the evidence, with reasonable probability, the causal
relationship” between the defect and the injury. Id. at 583.
For example, in Mack Trucks, the Supreme Court of Texas
required expert testimony to establish causation because a “lay
juror’s general experience and common knowledge do not extend to
whether design defects such as those alleged in this case caused
the releases of diesel fuel during a rollover accident.” 206
S.W.3d at 583. Similarly, in BIC Pen, that court required
expert testimony to establish causation because “the impact of
[defects in a lighter] on how [the lighter] would have
functioned in the hands of a child . . . is not an issue within
a lay juror’s general experience and common understanding.” 346
S.W.3d at 542.
Texas courts have regarded expert testimony on causation as
particularly vital in cases involving complex medical devices
and medical diagnoses. “The general rule has long been that
expert testimony is necessary to establish causation as to

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medical conditions outside the common knowledge and experience
of jurors.” Guevara v. Ferrer, 247 S.W.3d 662, 665 (Tex. 2007);
see also Anderson v. Siemens Corp., 335 F.3d 466, 475 (5th Cir.
2003) (applying Texas law) (“[o]rdinarily, expert testimony is
needed to satisfy the reasonable medical probability standard
for establishing a causal link.”).
B.
Here, Lewis alleges that the TVT’s heavyweight, small-pore
mesh caused degradation, scar tissue, and nerve entrapment,
which in turn caused her pelvic pain and dyspareunia. She also
alleges that the mechanical cutting of the TVT’s mesh caused
loose particles, which in turn caused her injuries. Whether any
of these defects caused Lewis’s pain involves complex and
technical medical issues beyond common knowledge and experience.
We therefore agree with the district court that Texas law
required Lewis to present expert testimony establishing a causal
link between these alleged defects in the TVT and her injuries.
We also agree with the district court that Lewis’s failure
to present such expert testimony doomed her design defect claim.
Not one of Lewis’s expert witnesses opined, let alone opined to
a reasonable degree of medical certainty, that a defect in the
TVT caused Lewis’s injuries. Dr. Zimmern testified that the
“presence” of the TVT caused Lewis’s pain, but did not testify
that a defect in the TVT caused her pain. Moreover, he could

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not identify what characteristic of the TVT, defective or not,
caused her pain. When asked what property of the TVT caused
Lewis’s pain, Dr. Zimmern answered: “It’s anybody’s
guess. . . . We really don’t know the answer to that question.”
Dr. Bruce Alan Rosenzweig’s testimony was similarly
insufficient. He testified that “small particles” from a TVT
“can fall off into the vagina,” and that these particles “can
migrate and cause pain during intercourse.” However, Dr.
Rosenzweig did not testify that this happened in Lewis’s case.
In fact, he acknoweledged that he had never examined or treated
Lewis, and that his opinions were not specifically about her.
As the district court explained, evidence “that a product can
cause injuries is insufficient to show that it did cause those
injuries in a particular case.” See also BIC Pen, 346 S.W.3d at
545 (“specific causation involves whether the substance at issue
in fact caused the particular injury at issue.”).
The same shortcoming characterizes Dr. Bernd
Klosterhalfen’s testimony. He opined that he “found in most
meshes of patients suffering chronic pain . . . destructive or
damaged nerve structures [or] nerve fibers in the interface of
the mesh, just by contact of the mesh to the nerve fiber.” But
his testimony failed to establish a causal link between a defect
in Lewis’s TVT and Lewis’s injuries.

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Nor did Dr. Howard Jordi’s testimony establish a link
between a defect in Lewis’s TVT and her pain. Dr. Jordi
testified to a reasonable degree of scientific certainty that
the TVT degraded in Lewis’s body and that what remained would
continue to degrade. But Dr. Jordi did not testify that this
degradation, or any effect of it, caused Lewis’s pain.
Finally, the testimony of Lewis’s fifth expert, Dr. Klinge,
did not satisfy the reasonable medical probability standard that
a design defect in the TVT caused Lewis’s pain. Although Dr.
Klinge opined that loose particles from the TVT “can very good
explain the manifestation of pain” in Lewis, the district court
did not abuse its discretion, as explained above, in finding him
unqualified to share this opinion with the jury.
Lewis does not argue that the remaining testimony -- by,
for instance, employees of the defendant -- establishes
causation. Thus, because Lewis failed to proffer any expert
testimony that a defect in the TVT caused her pelvic pain, the
district court did not err in directing a verdict for Ethicon.
V.
For the foregoing reasons, the judgment of the district
court is
AFFIRMED.

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