Court Opinion

ID: 2969102
Source: CourtListenerOpinion
Date Created: 2015-09-22 09:14:01.957122+00
Date Added: 2024-06-11T15:29:20.503747
License: Public Domain

UNPUBLISHED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.
Affirmed by unpublished per curiam opinion.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Unpublished opinions are not binding precedent in this circuit.

                                2
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

                                            3
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.

                                                  4
                                                 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

                                                     5
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).

                                       6
      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

                                           7
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).

                                          8
      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

                                           9
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

                                            10
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,

                                                11
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)).

                                          12
       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

                                           13
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

                                         14
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.

                                          15
      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.

                                            16