Court Opinion

ID: 3169759
Source: CourtListenerOpinion
Date Created: 2016-01-14 20:00:42.533301+00
Date Added: 2024-06-11T12:01:21.025793
License: Public Domain

PUBLISHED

                 UNITED STATES COURT OF APPEALS
                     FOR THE FOURTH CIRCUIT

                             No. 15-1102

In Re: C.R. BARD, INCORPORATED, MDL. No. 2187,
  Pelvic Repair System Products Liability Litigation

------------------------------

DONNA CISSON; DAN CISSON,

               Plaintiffs - Appellees,

          v.

C.R. BARD, INCORPORATED,

               Defendant – Appellant,

SAMUEL S. OLENS, Attorney General of the State of Georgia,

               Intervenor.

------------------------------

FEDERATION OF DEFENSE & CORPORATE COUNSEL; PRODUCT LIABILITY
ADVISORY COUNCIL, INCORPORATED; COOK BIOTECH INCORPORATED;
CHAMBER OF COMMERCE OF THE UNITED STATES OF AMERICA; COOK
INCORPORATED; COOK MEDICAL LLC,

               Amici Supporting Appellant,

PUBLIC JUSTICE; NATIONAL CENTER FOR HEALTH,

               Amici Supporting Appellees.
                               No. 15-1137

In Re: C.R. BARD, INCORPORATED, MDL. No. 2187,
  Pelvic Repair System Products Liability Litigation

------------------------------

DONNA CISSON; DAN CISSON,

                Plaintiffs - Appellants,

           v.

C.R. BARD, INCORPORATED,

                Defendant – Appellee,

SAMUEL S. OLENS, Attorney General of the State of Georgia,

                Intervenor.

------------------------------

FEDERATION OF DEFENSE & CORPORATE COUNSEL; CHAMBER OF
COMMERCE OF THE UNITED STATES OF AMERICA; PRODUCT LIABILITY
ADVISORY COUNCIL, INCORPORATED,

                Amici Supporting Appellee,

PUBLIC JUSTICE; NATIONAL CENTER FOR HEALTH,

                Amici Supporting Appellants.

Appeals from the United States District Court for the Southern
District of West Virginia, at Charleston.   Joseph R. Goodwin,
District Judge. (2:11-cv-00195)

Argued:   September 16, 2015                 Decided:   January 14, 2016

Before GREGORY, AGEE, and DIAZ, Circuit Judges.

                                    2
Affirmed by published opinion. Judge Gregory wrote the opinion,
in which Judge Agee and Judge Diaz joined.

ARGUED:   Elliot H. Scherker, GREENBERG TRAURIG, P.A., Miami,
Florida, for Appellant/Cross-Appellee.     Anthony J. Majestro,
POWELL & MAJESTRO, PLLC, Charleston, West Virginia, for
Appellees/Cross-Appellants.   Julie Adams Jacobs, OFFICE OF THE
ATTORNEY GENERAL OF GEORGIA, Atlanta, Georgia, for Intervenor.
ON BRIEF: Lori G. Cohen, R. Clifton Merrell, II, Sean P. Jessee,
Atlanta, Georgia, Daniel I.A. Smulian, GREENBERG TRAURIG, LLP,
New York, New York; Brigid F. Cech Samole, Jay A. Yagoda,
GREENBERG TRAURIG, P.A., Miami, Florida; Melissa Foster Bird,
NELSON MULLINS RILEY & SCARBOROUGH, Huntington, West Virginia,
for Appellant/Cross-Appellee.    Allison Van Laningham, TURNING
POINT LITIGATION, Greensboro, North Carolina; Henry G. Garrard,
III, Josh B. Wages, BLASINGAME, BURCH, GARRARD, ASHLEY PC,
Athens, Georgia, for Appellees/Cross-Appellants.      Samuel S.
Olens, Attorney General, W. Wright Banks, Jr., Deputy Attorney
General, OFFICE OF THE ATTORNEY GENERAL OF GEORGIA, Atlanta,
Georgia, for Intervenor.       Debra Tedeschi Varner, MCNEER,
HIGHLAND, MCMUNN & VARNER LC, Clarksburg, West Virginia; Stacy
A. Broman, MEAGHER & GEER PLLP, Minneapolis, Minnesota, for
Amicus Federation of Defense & Corporate Counsel. Chilton Davis
Varner, Stephen B. Devereaux, Madison H. Kitchens, Atlanta,
Georgia, Jeffrey S. Bucholtz, Paul Alessio Mezzina, KING &
SPALDING LLP, Washington, D.C., for Amici Product Liability
Advisory Council, Inc. and Chamber of Commerce of the United
States; Hugh F. Young, Jr., PRODUCT LIABILITY ADVISORY COUNCIL,
INC., Reston, Virginia, for Amicus Product Liability Advisory
Council, Inc.; Kathryn Comerford Todd, Sheldon Gilbert, NATIONAL
CHAMBER LITIGATION CENTER, INC., Washington, D.C., for Amicus
Chamber of Commerce of the United States.      Douglas B. King,
WOODEN & MCLAUGHLIN LLP, Indianapolis, Indiana, for Amici Cook
Incorporated, Cook Medical LLC, and Cook Biotech Incorporated.
Michael J. Quirk, Esther E. Berezofsky, Joseph Alan Venti,
WILLIAMS CUKER BEREZOFSKY, LLC, Philadelphia, Pennsylvania, for
Amici Public Justice, P.C., and National Center for Health
Research.

                               3
GREGORY, Circuit Judge:

      On August 15, 2013, a jury awarded Donna Cisson $250,000 in

compensatory       damages    on    a    design      defect      and    failure     to    warn

claim      against     C.R.    Bard,       Inc.      (“Bard”),          and     awarded     an

additional $1,750,000 in punitive damages.                        The punitive damages

award was split pursuant to a Georgia statute, with seventy-five

percent going to the State of Georgia and twenty-five percent

going to Cisson.         This was the first jury verdict arising from

multi-district        litigation         involving        more     than        70,000    cases

against     the    proprietors      of    transvaginal           mesh    medical        devices

used to treat pelvic organ prolapse and other pelvic issues, of

whom Bard is one.

      We    address    several      issues      on    appeal.           The     first    issue

raised by Bard is the district court’s refusal to admit evidence

relating      to     Bard’s    compliance            with     the        Food     and     Drug

Administration’s (“FDA”) Section 510(k) product safety process

(“510(k) process”).           Second, Bard challenges the denial of its

motion in limine asking the district court to exclude evidence

and argument pertaining to a material data safety sheet (“MSDS”)

produced for polypropylene, a key material in the Avaulta Plus

surgical mesh.         Bard argues that the MSDS relied on by Cisson

was   hearsay      outside    any   exception.            Third,        Bard    appeals    the

district     court’s    jury    instruction          on     causation,         arguing    that

under controlling Georgia law the court should have told jurors

                                            4
that causation must be demonstrated by expert testimony stated

to a reasonable degree of medical probability.            Bard also argues

that, as a matter of law, the evidence Cisson presented to prove

causation was insufficient to meet this more rigorous standard.

Bard’s final challenge on appeal is to the constitutionality of

the punitive damages award, which it argues is excessive and in

violation of the Due Process Clause.         In a cross-appeal, Cisson

argues that the district court committed constitutional error by

failing to find that the Georgia split-recovery statute violates

the Takings Clause.      For the reasons that follow, we affirm the

district court on all issues.

                                    I.

     Cisson was implanted with the Avaulta Plus, a transvaginal

mesh medical device developed and marketed by Bard, on May 6,

2009,   to    address   pelvic   organ   prolapse   and    stress   urinary

incontinence.     The surgery was performed by Dr. Brian Raybon, a

physician who had provided input to Bard during the development

of the Avaulta Plus and who trained other physicians to use the

device.      Prior to her procedure, Cisson received warnings about

a number of risks that could result from the surgical implant

and signed a consent form acknowledging these warnings.               Three

months after the surgery, Cisson’s doctor diagnosed “an adhesion

band” of scar tissue running across her vagina that was taut

                                     5
like a “banjo string” and was causing Cisson pain.                           Dr. Raybon

resected the mesh, which involved cutting out a thick band of

scar tissue and mesh encased in the tissue.                         Three weeks after

the resection surgery, Cisson returned to Dr. Raybon who said

she was healing well and should return in a year.                            Instead, a

few months later, Cisson went to a different doctor who referred

her to Dr. John Miklos.               Dr. Miklos explanted the Avaulta Plus

from Cisson’s body, although complete removal of the mesh was

not possible.

     Complaining that the surgical mesh marketed by Bard caused

ongoing     “loss      of     sexual     feeling”        and      “severe    pain     with

intercourse and otherwise,” Cisson filed a lawsuit against Bard

in March 2011 in the Northern District of Georgia.                          Bard already

faced suits from other claimants dating back to 2009, and the

Judicial     Panel          for   Multidistrict            Litigation        had      begun

transferring      these       cases    to    the       Southern    District      of   West

Virginia in 2010.             In re Avaulta Pelvic Support Sys. Prods.

Liab. Litig., 746 F. Supp. 2d. 1362 (J.P.M.L 2010).                                Cisson’s

suit was added to these and would later become the first to

reach a jury verdict.

     On    June   4,    2013,     Bard      won    summary     judgment     on   Cisson’s

claims     for    negligent       inspection,           marketing,      packaging      and

selling,    manufacturing         defect,        and    breach    of   warranty.        The

district    court      allowed    claims      for      design     defect,    failure    to

                                             6
warn, and loss of consortium to proceed to trial.                             During the

trial, Cisson focused both her design defect and failure to warn

claims on several alleged dangers presented by the Avaulta Plus.

Expert witnesses were brought to testify that the design of the

device’s      arms,     used    to     anchor      the   Avaulta       Plus    inside     a

patient’s body, resulted in ongoing pain to a patient as long as

the device was implanted.              Experts also testified that the pores

in the mesh component of the Avaulta Plus were too small and

that the mesh was subject to shrinking after implantation, with

the result being a rigid scar plate and increasing tension on

internal      tissue.          Cisson’s      experts     further       testified     that

polypropylene, from which the monofilament used in the Avaulta

Plus   mesh    was    made,     may    be    attacked    by     the    patient’s    body,

causing inflammation of the tissue and degradation of the mesh.

Slides   were       presented    to    the    jury     that   Cisson’s     expert,      Dr.

Bernd Klosterhalfen, testified showed the polypropylene of the

Avaulta Plus in Cisson’s body was being attacked, causing a scar

plate to form.

       Beyond presenting evidence that the Avaulta Plus had caused

her injuries, Cisson also painted a picture of Bard as ignoring,

and at times hiding from others, the warning signs that its

product could cause injuries.                     There was substantial argument

regarding       a     MSDS      Bard        received      from        Phillips     Sumika

Polypropylene         Company        (“Phillips”),        the     corporation        that

                                              7
manufactured        the    polypropylene         pellets     used       to        extrude    the

Avaulta Plus mesh.           The MSDS contained an explicit warning that

polypropylene should not be used in short- or long-term human

implantations.            Internal      e-mails    showed       that    Bard        executives

knew   about      the     MSDS,   and    that     they   sought        to    prevent       their

monofilament        suppliers       from    learning       of     the        warning.         In

addition     to   raising     its    hearsay       objection       to       the    MSDS,    Bard

countered      that     polypropylene        had    been     used       for       decades     in

clinical      settings      and   that     the    warning       was     with       respect    to

polypropylene pellets, not to the extruded monofilament used in

the Avaulta Plus.

       Bard argued to the jury that its product was similar to the

Avaulta      Classic—a      predecessor      surgical       mesh       device       that    Bard

contended had been safely used for years—and that it had taken

appropriate steps to ensure biocompatibility and product safety.

Bard argued to the judge (on evidentiary motions) that it was

unfair to allow Cisson to attack its product’s safety while Bard

was prevented from presenting evidence that it complied with the

FDA’s 510(k) process.

       The   jury     ultimately        credited    Cisson’s       evidence,         awarding

damages for the design defect and failure to warn claims.                                    The

jury returned a verdict for Bard on the consortium claim.                                   Bard

timely noted this appeal.

                                             8
                                                  II.

         Bard’s first claim on appeal is that the district court

abused        its    discretion       by    granting          Cisson’s    motion     in   limine

asking the court to exclude all evidence that Bard had complied

with         the    FDA’s   510(k)     process.               Bard   sought    to    admit    the

evidence to show that its conduct was reasonable.                                   Bard argued

that this was relevant to its defense to the design defect claim

under Georgia’s product liability case law, as well as to the

question of punitive damages.                       The district court excluded the

evidence           under    Federal        Rule    of     Evidence       402   for     lack    of

relevance,           and    under   Rule      403       for    being     substantially        more

prejudicial than probative.                   We affirm the court’s ruling based

on Rule 403 and therefore need not address its reliance on Rule

402. 1

         1
       We also need not address Bard’s contention that state law,
rather than federal, controls the question—at least not at any
great length.   Because this is a diversity case, the “general
rule” is that federal courts apply state substantive law and
federal procedural law. Hottle v. Beech Aircraft Corp., 47 F.3d
106, 109 (4th Cir. 1995).      As procedural rules, the Federal
Rules of Evidence control over conflicting state evidentiary
rules in diversity cases.    Id.  Only where a state evidentiary
rule is “bound-up” with substantive state policy will it control
over the federal rule. Id. at 110. This is not such a case.
     First, Bard fails to point to a state evidentiary rule
contradicting Rule 403.    Instead, Bard argues that regulatory
compliance has been ruled relevant in numerous Georgia product
liability cases. But the rulings Bard points to are just that—
rulings, not rules. Bard does not demonstrate that Georgia law
requires evidence of regulatory compliance to be admitted in all
(Continued)
                                                   9
                                           A.

       Although   Rule    403     will    “generally         favor      admissibility,”

United   States   v.     Wells,    163 F.3d 889,    896   (4th    Cir.      1998),

district    courts     are      granted     “broad          discretion”     to       decide

“whether    the   probative        value        of   evidence      is     substantially

outweighed by the danger of unfair prejudice, misleading the

jury, or confusion of the issues,” Minter v. Wells Fargo Bank,

N.A., 762 F.3d 339, 349 (4th Cir. 2014).                       “[E]xcept under the

most ‘extraordinary’ of circumstances, where that discretion has

been   plainly    abused,”      this     Court       will    not   overturn      a    trial

court’s Rule 403 decision.               United States v. Simpson, 910 F.2d
154, 157 (4th Cir. 1990) (quoting United States v. Heyward, 729
F.2d 297, 301 n.2 (4th Cir. 1984)) (internal quotation marks

omitted).

       Cisson’s claim for design defect is controlled by Georgia

product liability law.            Georgia uses a “risk-utility” test for

product liability claims, requiring the trial court to “evaluate

cases regardless of probative value or prejudicial effect, so
there is no competing rule.
     Second, Bard fails to demonstrate that the alleged rule is
sufficiently    “bound-up”    with  substantive    state   policy.
Regulatory compliance is one of at least thirteen non-exclusive
factors Georgia courts consider under the risk-utility test—
hardly   a   cornerstone   of   the  state’s   product   liability
jurisprudence.   Ga. Suggested Pattern Jury Instruction, Vol. I:
Civil Cases § 62.650 (5th ed. 2015).

                                           10
design defectiveness under a test balancing the risks inherent

in   a    product     design    against    the   utility       of     the   product    so

designed.”          Banks v. ICI Americas, Inc., 450 S.E.2d 671, 674

(Ga. 1994).          This test includes some reliance on “negligence

principles,” and “incorporates the concept of ‘reasonableness,’

i.e., whether the manufacturer acted reasonably in choosing a

particular product design, given the probability and seriousness

of   the    risk . . . ,        the   usefulness       of    the     product    in    that

condition, and the burden on the manufacturer to . . . eliminate

the risk.” Id. at 673-74.             Bard argues that compliance with the

510(k)      process    was     important    to    its       design    defect    defense

because it shows that the company’s conduct was reasonable.

         Assuming     without    deciding       that    the        510(k)   compliance

evidence     is     relevant,    under     Georgia’s        risk-utility       test   the

probative value of that evidence must depend on the extent to

which the regulatory framework safeguards consumer safety.                             The

510(k) process allows some medical devices to avoid the strict

safety      testing    requirements        imposed      by    the     Medical    Device

Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act,

so long as the device is “substantially equivalent” to a pre-

1976 device already in use at that time.                     See Medtronic, Inc. v.

Lohr, 518 U.S. 470, 493 (1996).                  Thus, devices approved under

the 510(k) process “may be marketed without premarket approval”

as would be required by the MDA, although they “are subject to

                                           11
‘special controls . . . that are necessary to provide adequate

assurance of safety and effectiveness.’”                     Talley v. Danek Med.,

Inc.,   179 F.3d 154,    160    (4th     Cir.      1999)   (quoting      21    U.S.C.

§ 360c(a)(1)(B)).         In    this     respect,         although    the     process      is

certainly not a rubber stamp program for device approval, it

does    operate   to    exempt       devices       from    rigorous      safety     review

procedures.

       While some courts have found evidence of compliance with

the 510(k) equivalence procedure admissible in product liability

cases, the clear weight of persuasive and controlling authority

favors a finding that the 510(k) procedure is of little or no

evidentiary    value.          The    Supreme       Court    has     regarded       product

clearance     accomplished           through       the    510(k)      process       as     “a

qualification     for    an     exemption         rather     than    a   requirement.”

Riegel v. Medtronic, Inc., 552 U.S. 312, 322 (2008).                          This is in

part because the “process impose[s] no requirements with respect

to the design of the device.”                     Duvall v. Bristol-Myers-Squibb

Co., 103 F.3d 324, 329 (4th Cir. 1996).                     “Thus, even though the

FDA may well examine 510(k) applications . . . with a concern

for the safety and effectiveness of the device,” the agency’s

clearance rests only on whether the device is “substantially

equivalent to one that existed before 1976” before allowing it

“to    be   marketed    without        running      the     gauntlet     of    the       [MDA

premarket approval] process.”             Lohr, 518 U.S. at 493-94.

                                             12
       Bard points out that much of this precedent stems from the

Supreme Court’s decision in Lohr, and argues that the case and

its progeny should not be controlling here.                        Bard argues that

because Lohr held only that state common law claims were not

preempted by the MDA and the 510(k) process, id., and not that

compliance with the 510(k) process was inadmissible as evidence

to refute such claims, it is an inapposite precedent.                           However,

the Supreme Court held that state law product liability claims

were   not   preempted    because      the    510(k)       does   not     amount     to   a

safety    regulation     requiring        device         producers      to    meet      any

established design standards.             Id.       The entire analysis turned

on the Court’s finding that “the § 510(k) exemption process was

intended to . . . maintain the status quo with respect to the

marketing    of    existing     medical      devices       and    their      substantial

equivalents,” not impose new regulatory requirements on devices.

Id. at 494.       Numerous courts, including this one, have relied on

that reasoning in cases over the past two decades, and at a

minimum the Supreme Court’s statements about the 510(k) process

(repeated    most    recently    in    2008)       are    very    persuasive       as     to

whether and how compliance speaks to the relative safety of a

device.

       Nor is Bard helped by FDA statements claiming that “the

principles of safety and effectiveness underlie the substantial

equivalence       determination”      that    is    the     heart    of      the   510(k)

                                        13
review process.               2014 Guidance for Industry and Staff:                           The

510(k) Program:              Evaluating Substantial Equivalence in Premarket

Notifications           6.     Such   statements      merely       show    that        the    FDA

believes an equivalence determination is sufficient to “provide

a reasonable assurance of safety and effectiveness,” id. at 7,

but this was also the case when the Supreme Court found the

510(k)   process         insufficiently        tied-up      with    safety       to    preempt

state tort actions, Lohr, 518 U.S. at 493-94, and again when the

Court    called         the    process    an    “exemption”        and     not     a    safety

“requirement,” Riegel, 552 U.S. at 322.                      Bald assertions by the

FDA do little to alter the analysis of the basic question:                                    How

much information does 510(k) clearance provide a jury about the

safety   of    the       underlying      product,     and    is    the    value        of    this

information        substantially          outweighed     by       the     possibility         of

prejudice in a particular case?

     Turning, then, to the district court’s ruling, it is clear

that the court did not abuse its discretion by excluding Bard’s

evidence      of    510(k)       clearance.         In   one       of    several       related

rulings, the court stated that bringing in such evidence would

result in a “mini-trial” about (1) the strengths and weaknesses

of the process and (2) whether Bard had in fact made all of the

disclosures        it    should    have    made     during    the       process.        Bard’s

evidence would have initiated a battle of experts:                                    Bard was

prepared to characterize the review process as “thorough” and

                                               14
“robust” and the FDA’s clearance of the Avaulta Plus as “an

affirmative safety . . . decision” based on “specific safety and

efficacy findings.”         JA 613-15.         Cisson was prepared to argue,

as she has done before this Court, that these characterizations

wildly inflate the significance of the process, and that in any

event Bard failed to make necessary disclosures to the FDA.

      All of this, the district court reasoned, presented “the

very substantial dangers of misleading the jury and confusing

the   issues.”       JA    1251.      The      court   expressed     concern     that

subjecting the jury to many hours, and possibly days, of complex

testimony    about      regulatory    compliance       could    lead    jurors     to

erroneously conclude that regulatory compliance proved product

safety.     In   other     words,    having     a   “mini-trial”     could     easily

inflate the perceived importance of compliance and distract the

jury from the central question before it—whether Bard’s design

was unreasonable based on any dangers it posed versus the costs

required to avoid them.            While 510(k) clearance might, at least

tangentially,     say     something    about     the   safety   of     the    cleared

product, it does not say very much that is specific.                         The vast

majority    of   courts    have    said   so,    and   having   been    thoroughly

briefed not only by the parties but by several amici, we say so

again today.       As such, the district court did not abuse its

discretion when it determined that allowing the 510(k) evidence

                                          15
in on the question of design defect would be substantially more

prejudicial than probative.

                                           B.

       Bard also argues that evidence of 510(k) compliance would

have    been   particularly        relevant     on   the     question      of   punitive

damages.       Under    Georgia     law,     punitive      damages    are       available

where    there   is    “clear      and   convincing        evidence”       of   “willful

misconduct,      malice,      fraud,     wantonness,         oppression,        or    that

entire    want   of    care     which    would       raise    the    presumption        of

conscious indifference to consequences.”                   Ga. Code Ann. § 51-12-

5.1(b).        And     Georgia      courts      have    noted       that    regulatory

“compliance does tend to show” this high willfulness standard

has not been met.          Barger v. Garden Way, Inc., 499 S.E.2d 737,

743 (Ga. App. 1998).

       Although the question remains one of federal, not state,

evidentiary law, federal courts are not likely to disagree with

the Georgia courts that evidence regarding regulatory compliance

(or     non-compliance)       is    often       relevant     to     the    willfulness

inquiry.       See Restatement (Third) of Torts, Prod. Liab. § 4.

Nevertheless, Bard’s argument is ultimately unpersuasive.                            While

such evidence may be relevant, the compliance at issue in this

case was, at most, minimally so.                 Again, the 510(k) process has

been repeatedly characterized as something less than a safety

requirement, gaining the applicant an exemption from regulation

                                           16
rather than subjecting the applicant to regulation.                      Riegel, 552
U.S. at 322; see also Almy v. Sebelius, 679 F.3d 297, 308 (4th

Cir. 2012); Rodriguez v. Stryker Corp., 680 F.3d 568, 574 (6th

Cir. 2012) (“The 510(k) process does not comment on safety.”).

Thus, the decision to pursue 510(k) clearance was a choice to

minimize the burden of compliance, potentially cutting in favor

of punitive damages.        See Anastasi v. Wright Med. Tech., Inc.,

16 F. Supp. 3d.   1032,    1036-37       (E.D.   Mo.     2014)    (finding    that

defendant   chose   the    FDA    510(k)    process      to    “avoid    the   safety

reviews,    including     clinical    trials,      required        for    pre-market

approval under FDA regulations”).             As such, the district court

is entitled to put 510(k) evidence before the jury, but it is

not obligated to do so.          The court was within its discretion to

determine that the value of putting the controversy over the

510(k)   process,   and    Bard’s    compliance       or      non-compliance     with

that process, before the jury was substantially outweighed by

the likelihood of confusing the issues and misleading the jury.

                                       C.

      This Court does not reach the district court’s ruling that

the 510(k) evidence could be excluded as irrelevant under Rule

402 because the evidence was properly excluded under Rule 403.

The district court’s Rule 403 ruling implicitly indicates that

even if the evidence is relevant, it is insufficiently relevant

to warrant admission.            We agree that the district court was

                                       17
within its discretion in denying admission of the evidence using

the lower standard in Rule 403, and therefore decline to address

the more difficult question presented by the Rule 402 ruling.

                                  III.

     The second issue on appeal is whether the district court

erred   when   it   overruled   Bard’s   hearsay   objections   to   the

admission of a MSDS pertaining to polypropylene, a material used

in the construction of the Avaulta Plus implanted in Cisson’s

body.   There is, of course, a presumption that hearsay will not

be admitted into evidence in federal courts.       Fed. R. Evid. 802.

The MSDS in question in this case read in pertinent part as

follows:

     MEDICAL APPLICATION CAUTION:     Do not use this . . .
     material in medical applications involving permanent
     implantation in the human body . . . .       Do not use
     this . . . material in medical applications involving
     brief or temporary implantation in the human body or
     contact with internal body fluids or tissues, unless
     the   material   has   been   provided   directly   from
     [Phillips]   under   an    agreement   which   expressly
     acknowledges the contemplated use.

JA 4826.

     The district court accepted Cisson’s argument that the MSDS

could come in as non-hearsay for the limited purpose of showing

that the statement was made and that Bard was aware of it.           The

court also ruled, sua sponte, that the MSDS was admissible for

                                   18
its   truth   under   the    hearsay   exceptions        contained        in    Federal

Rules of Evidence 803(17), 803(18), and 807.

      We review the district court’s applications of the hearsay

rules, like applications of all Federal Rules of Evidence, for

abuse of discretion, and its interpretations of such rules de

novo.     Precision Piping & Instruments, Inc. v. E.I. du Pont de

Nemours & Co., 951 F.2d 613, 619 (4th Cir. 1991).                     Doing so, we

reverse    the    district     court’s      rulings      as     to    the       hearsay

exceptions.       However,    we    affirm    the     decision       to   admit      the

evidence as non-hearsay, finding that any use of the evidence by

the plaintiff that went beyond the limited purpose for which it

was admitted as non-hearsay resulted in harmless error and was

not prejudicial to Bard’s defense. 2

                                       A.

      Rule 803(17), titled “Market Reports and Similar Commercial

Publications,”     creates     an   exception       to    the    prohibition           on

hearsay    for   “market    quotations,      lists,    directories,            or   other

      2 Cisson argues that Bard waived its right to attack the
MSDS rulings on appeal by failing to continually object. Bard,
however, was relieved of this obligation by Rule 103(b) once the
court had “definitively” ruled on the matter.      Fed. R. Evid.
103(b).     Cisson also argues that Bard waived this attack by
introducing earlier versions of the MSDS for discussion by its
witnesses, but this, of course, was in response to the district
court overruling Bard’s several objections to admission of the
MSDS.    Once a court has definitively decided evidence can come
in, the opposing party must be allowed to defend against that
evidence without losing its otherwise well-preserved objection.

                                       19
compilations that are generally relied on by the public or by

persons in particular occupations.”                    Fed. R. Evid. 803(17).                The

district     court       ruled    that    the     MSDS    qualified        as    an    “other

compilation” within this exception.                    We disagree.

      The district court’s ruling relied on its interpretation of

the term “other compilation” in Rule 803(17).                              A question of

interpretation going to the scope of the rule is reviewed de

novo.      See Precision Piping, 951 F.2d at 619.                        Our analysis is

guided by ejusdem generis, a statutory canon of interpretation

holding     that    where    a     statute      contains      an    exemplary         list    of

objects     to     which    it     applies,       a    general     term    that       follows

specific     ones    will     be    limited       in    its     meaning     by    the    more

specific terms that preceded it.                      Circuit City Stores, Inc. v.

Adams,     532 U.S. 105,    114-15     (2001).         The    district         court’s

reliance     on     the    general       term—“other       compilations”—concluding

Rule 803(17)’s exemplary list makes the canon applicable.

      The narrower terms listed by the rule—“market quotations,

lists,     directories”—are         items     that     recite      established        factual

information.        In general, a MSDS might contain similarly factual

information.        But in this case, Cisson sought to use a portion

of   the   MSDS     that    was    not    factual       but   rather      operated       as    a

warning     and    disclaimer       of    liability       for      the    self-interested

issuing party.            The warning from Phillips that polypropylene

should not be used in human implants was an opinion the company

                                             20
issued    within       the     MSDS    for    self-interested       reasons,    and   it

therefore       bears     no     resemblance       to    the      factual,    list-type

documents enumerated in Rule 803(17).

        An advisory note to Rule 803(17) states that “[t]he basis

of trustworthiness” for evidence admitted under the exception

should be “the motivation of the compiler to foster reliance by

being accurate.”             Fed. R. Evid. 803(17), advisory comm. note

(1972).        Disclaimers of the sort in the MSDS are not typically

so motivated, being intended instead to prevent any use of a

product that might create a liability.                        Cisson has offered no

proof     or    argument        that    the    disclaimer         warrants    the   same

presumption       of    reliability      afforded       to   market   quotations      and

directories, and a disclaimer clearly lacks the hallmarks of

reliability that make market reports an exception.                       The district

court therefore erred in holding the MSDS admissible for its

truth under Rule 803(17).

                                              B.

     Rule       803(18),       titled    “Statements         in   Learned    Treatises,

Periodicals,       or        Pamphlets,”      creates        an   exception    to     the

prohibition on hearsay when a statement in such publications is

(1) “called to the attention of an expert witness on cross-

examination or relied on by the expert on direct examination”;

(2) the reliability of that statement is established “by the

expert’s admission or testimony, by another expert’s testimony,

                                              21
or   by   judicial    notice”;   and   (3)    the   statement   is   read   into

evidence rather than being received as an exhibit.                     Fed. R.

Evid. 803(18).       The district court ruled, again sua sponte, that

the MSDS could come in for the truth of the matter asserted as a

“pamphlet” within the exception.             Again, we disagree.     We review

this application of Rule 803(18) for abuse of discretion.

      The MSDS, as used in this case, does not meet any of the

rule’s three facial requirements.             First, it was not “relied on

by [an] expert on direct examination,” nor was it “called to the

attention of an expert witness on cross-examination”:                 Cisson’s

expert witnesses did not address the MSDS, and Bard’s witnesses

attacked     the     MSDS   on   direct      examination.       Second,      the

publication was not “established as a reliable authority” for

the same reasons—because Cisson’s witnesses did not address the

MSDS and Bard’s witnesses attacked it, no witness testifying at

trial ever sought to demonstrate the reliability of the MSDS.3

Finally, Cisson introduced the MSDS as an exhibit rather than

having it read into evidence as required by the rule.                  Fed. R.

Evid. 803(18).        Therefore, without addressing whether the MSDS

presented in this case could have qualified as a “pamphlet,” we

      3Nor did the district court invoke judicial notice to
establish the reliability of the MSDS. The reliability of the
MSDS warning was clearly in dispute at trial, and judicial
notice would have been improper.

                                       22
find that the district court abused its discretion by admitting

it under Rule 803(18) because the reliability of the evidence

was not established according to the rule’s requirements.

                                               C.

       Rule     807,     titled     the    “Residual           Exception,”      creates     a

hearsay       exception    for    certain       statements        not      covered   by   any

exceptions in Rule 803 or 804.                        Fed. R. Evid. 807.              For a

statement        to     come    under     this        exception       it     must    contain

“circumstantial guarantees of trustworthiness,” be used to prove

“a material fact,” and be “more probative on the point for which

it     is     offered    than     any     other       evidence”       available      through

“reasonable       efforts.”         Id.        We     review    the     district     court’s

application of the rule here for an abuse of discretion, noting

however that the residual hearsay exception “was meant to be

invoked sparingly.”             Heyward, 729 F.2d at 299 (quotation marks

omitted).

       As discussed in more detail below, the MSDS was hardly the

best        evidence    available       that        polypropylene       was    potentially

dangerous       for     human    implantation.           The     relative      dangers     of

polypropylene in pellet and monofilament form was an issue that

received substantial attention from both parties’ experts who

themselves relied on studies, reports, empirical evidence, and

tissue        sample     slides     evidencing           Ms.     Cisson’s       particular

pathology.        The warning in the MSDS, on the other hand, was

                                               23
nothing    more      than   an    assertion      made        by    the     self-interested

manufacturer of polypropylene that the product should not be

implanted in humans.              The MSDS made no attempt to explain why

polypropylene might be dangerous or how Phillips had come to

this    conclusion.         Because        there    was          ample    other       evidence

available to address polypropylene’s viability as a material for

surgical implants, we find that the district court abused its

discretion in finding, again sua sponte, that the MSDS could

come in for its truth under Rule 807.

                                            D.

       Having reviewed and reversed the district court’s several

sua sponte rulings that the MSDS could come in for its truth

under    various      hearsay      exceptions,         we    now     turn       to    Cisson’s

original    rationale       for    offering      the    MSDS:            that    it    was   not

offered    as   hearsay.          Cisson    argued,         and    the     district        court

agreed, that the warning in the MSDS would not be hearsay if it

was offered to show only that Phillips made, and Bard received,

the warning statement.              Bard does not dispute this on appeal,

but    argues   instead     that     Cisson      used       the    MSDS    for       its   truth

during the trial and that it was therefore offered as hearsay

without an exception.             Having thoroughly reviewed the record we

have    found   no    reversible     error,      and        we    therefore      affirm      the

district court’s admission of the MSDS.

                                            24
       “Out-of-court        statements        constitute         hearsay        only    when

offered in evidence to prove the truth of the matter asserted.”

Anderson     v.    United      States,      417 U.S. 211,    219     (1974).        A

statement that would otherwise be hearsay may nevertheless be

admissible if it is offered to prove something other than its

truth, and this includes statements used to charge a party with

knowledge of certain information.                   Gardner v. Q.H.S., Inc., 448
F.2d 238, 244 (4th Cir. 1971) (finding out-of-court statements

admissible      “to     show    defendants’        knowledge     of     the    harm    their

product could inflict, provided only that [the statements] were

brought to the attention of the defendants”); see United States

v. Macias-Farias, 706 F.3d 775, 781 (6th Cir. 2013).                            “[W]hether

an    out-of-court       assertion     is   hearsay       depends      on     its    use”   at

trial.    David F. Binder, Hearsay Handbook § 1:9 (4th ed. 2015).

       Cisson originally sought to introduce the MSDS to show that

Bard had received the warning from Phillips, one of many safety-

related    “red    flags”       she   argued      demonstrated         Bard’s       knowledge

that its product might be unsafe.                       This was used to support

Cisson’s       argument        that   the      company        should        have     further

investigated       the     safety     of     the       Avaulta       Plus     rather    than

marketing the product immediately.                     Cisson insists that during

the    trial      she    did    not    rely       on    the     MSDS     to     show    that

polypropylene was unsafe or to prove causation.                               Bard argues,

however, that “[h]aving secured . . . a ruling that the MSDS was

                                            25
admissible for its truth, Plaintiffs took full advantage of the

rulings” by using the document to show that polypropylene was

unsuitable       for     implantation             and     contributed       to     Cisson’s

injuries.       Appellant’s R. Br. 30.                  Cisson’s position ultimately

proves more convincing for two reasons.                          First, throughout the

trial    Cisson        consistently           limited       use     of     the    MSDS     to

establishing that Bard received the warning and then responded

either   by     ignoring    it    or    withholding         it    from    other    parties.

Second, even if Cisson did at any time use the MSDS for its

truth, she did so in a way that did not prejudice the defendant.

       Roger     Darois,     Bard’s          Vice       President    of     Research      and

Advanced       Technology,       was     the        key    witness       Cisson    used    to

establish that Bard had received, and then ignored and withheld,

the MSDS warning regarding human implantation.                            Throughout that

testimony, Cisson’s attorney pressed Darois on Bard’s response

to the warning, pointing out that (1) the company did not reach

out to Phillips to clarify why the warning had been added to the

MSDS    in   2007   after    decades         of     polypropylene        production,      (2)

Bard’s supplier of monofilament refused to continue supplying

processed       polypropylene          for     medical       applications         after    it

learned of the MSDS warning, and (3) Darois told Bard staff

members to take steps that would prevent Phillips from learning

that Bard was implanting medical devices made with polypropylene

into human patients.

                                              26
     As Bard pointed out in its appeal on the 510(k) issue,

Georgia     product    liability          law     incorporates           reasonableness

principles, ICI Americas, 450 S.E.2d at 673-74, and the punitive

damages     standard   in   Georgia         requires         a    jury    to    find     the

defendant was willful and wanton in its disregard for the safety

of others, Ga. Code Ann. § 51-12-5.1(b).                          It seems clear that

Cisson    used   the   MSDS,    at    least       with       regard      to    the    Darois

testimony     (which   again        was     the       most       significant     exchange

involving    the   MSDS),      to    show       Bard’s       conduct     was    not    only

unreasonable     but   “would       raise       the    presumption        of    conscious

indifference to consequences.”                 Id.     None of the questions to

Darois went to proving the actual truth of the MSDS warning,

that is, the testimony did not address whether polypropylene was

actually dangerous or could have caused Cisson’s injuries.

     Bard argues that Cisson relied on the MSDS as substantive

evidence of causation not only during the Darois testimony, but

throughout the trial, claiming that “Plaintiffs’ counsel went so

far as to tell the jury that it could . . . find for Plaintiffs

based solely on the MSDS.”            Appellant’s R. Br. 30.                  It is first

worth noting that this assertion stands in stark contrast to

Bard’s characterization of the MSDS testimony in its closing

argument at trial:

     The MSDS sheet.   Think about it.  Go back to your
     notes. Think about it. Not a single witness for the
     plaintiff talked about the MSDS sheet.    Nobody[.]

                                          27
    . . . .       [T]heir  experts,  Dr.   Brennan   and
    Dr. Klosterhalfen and Dr. Hoyte, they didn’t talk
    about it.   Nobody linked it up.  Nobody linked this
    issue up.

JA 6578.      At that time, Bard apparently felt that the MSDS

simply had not been used in a way that could support causation,

but on appeal it argues Cisson ubiquitously abused the district

court’s mistaken ruling that the MSDS could be used for its

truth, causing an incurable prejudice to Bard.               At oral argument

Bard’s counsel called the MSDS the “centerpiece” of Cisson’s

case to the jury.       Oral Argument 15:05.       Having reviewed a great

deal of the more than 7000 pages of record before us (not only

the portions cited by Bard to support its contentions, but many

more pages of testimony, transcripts, exhibits, and rulings), we

find Bard’s characterization generally overwrought.                  We tend to

agree instead with their earlier statements to the jury that

Cisson    never   sought    to   link    the    MSDS   to   the     question   of

causation.

     There is, however, one statement made by Cisson’s counsel

that has given us some pause.           After bringing up the MSDS during

closing    arguments,      Cisson’s     trial   counsel     said,    “Now,     the

interesting thing about that is you can dismiss all the experts.

You can say, well, this expert is biased and that expert is

biased.      But Phillips Sumika, they don’t have a dog in the

hunt.”    JA 6537.   On its face, the statement appears to instruct

                                        28
the jury that the MSDS is more reliable than the experts and can

therefore establish causation.                         But we need not decide whether

the statement was an attempt to use the MSDS to overcome adverse

expert       testimony         on    the     question        of    causation,         because      that

single       stray       comment       was      not    enough       to    prejudice         Bard     and

require       a    new     trial.          Federal        courts     of    appeal       review       the

fairness of district court proceedings “without regard to errors

or defects which do not affect the substantial rights of the

parties.”          28 U.S.C. § 2111; McDonough Power Equip., Inc. v.

Greenwood, 464 U.S. 548, 553-54 (1984).                                  To find the alleged

error    harmless,          “we       need      only      be      able    to    say     ‘with      fair

assurance, after pondering all that happened without stripping

the erroneous action from the whole, that the judgment was not

substantially swayed by the error.’”                               United States v. Heater,

63 F.3d 311,       325    (4th       Cir.    1995)       (quoting        United       States    v.

Nyman, 649 F.2d 208, 211 (4th Cir. 1980)).

       The     alleged         error       in   this      case     was    harmless         for   three

reasons.           First,           Bard     has      pointed       to    only       one     actually

problematic statement from Cisson’s counsel over the course of a

ten day trial.             Although Bard cites several parts of the record

it claims show the MSDS being used for its truth, the only one

that    is    at     all    convincing          is     the     “dismiss        all    the    experts”

statement.         For example, Bard argues that the MSDS was used as

substantive evidence of causation in Cisson’s opening argument,

                                                     29
citing JA 2358-60.                That portion of the transcript, however,

shows Cisson’s attorney explaining to jurors that the MSDS was

produced by the polypropylene manufacturer, that it contained a

warning that material should not be used in implants, that the

MSDS (and its warning) was in Bard’s possession, and that Bard

should have taken the warning seriously by verifying that the

material was safe for its medical device.                       None of that goes to

causation, and all of it supports Cisson’s contention that the

MSDS was being used to show Bard was warned about potential

dangers and acted irresponsibly in response to that warning.

Bard cites other parts of the opening argument, but these show

Cisson’s attorney referring to the MSDS, not as scientific proof

that polypropylene is unsafe, but rather as a “red flag” and a

“safety     alert”         that    should     have       put    Bard     on    notice    to

investigate further.

        Bard also points to a portion of the Darois testimony at JA

4424-27 (and a related exhibit at JA 4652-54), but the questions

and   answers         on   those    pages    demonstrate        only   that      Bard   was

attempting       to    keep      Phillips    in    the   dark    about    polypropylene

being     used    in       the    Avaulta    Plus     after     Phillips        added   the

implantation warning to the MSDS in 2007.                       Again, this evidence

tended     to    show       that    Bard’s        reaction     to   the       warning   was

unreasonable, not that polypropylene caused Cisson’s injuries.

The MSDS simply was not being used for its truth.                             The same is

                                             30
true of all Bard’s citations to the record on this point, with

the exception of the one statement we have noted.                         The fact that

there was only one such instance during ten days of evidence

cuts strongly in favor of finding the alleged error harmless.

     Second, Cisson presented substantive evidence showing that

the polypropylene implanted in her body was degraded, providing

the jury with a much more compelling reason to conclude that

polypropylene contributed to her injuries than simple reliance

on a warning in a MSDS.               Had Cisson’s “dismiss all the experts”

statement been repeated, particularly on separate occasions and

thereby developed into a theme, we might be more persuaded that

there was error and that it was not harmless.                        After all, taken

on   its   face     and     without       context,      the        statement     can     be

interpreted    to    tell       the    jurors    that       they    can    ignore      both

Cisson’s experts, who testified that polypropylene can degrade

in   the   body     and    cause       injuries,     and     Bard’s       experts,      who

testified this was undemonstrated and unlikely.

     However, the jury in this case heard substantial evidence

to support the conclusion that the polypropylene in Cisson’s

Avaulta Plus degraded and harmed her.                       Cisson presented three

separate   experts        who   testified       on   this    point:        Dr.   Anthony

Brennan,   a   biomedical         engineer;      Dr.    Bernd       Klosterhalfen,       a

pathologist; and Dr. Brian Raybon, the physician who implanted

the Avaulta Plus into Cisson’s body.                    Dr. Brennan provided the

                                           31
jury with an opinion that fluids in the human body can degrade

polypropylene, Dr. Raybon testified that the polypropylene in

Cisson’s implant had degraded, and Dr. Klosterhalfen reviewed

Cisson’s pathology and told the jury she had an inflammatory

reaction and scar plate, symptoms consistent with polypropylene

degradation.        In order for us to reverse the district court,

Bard   must   show    that    its    “substantial        rights”    were   affected,

Greenwood, 464 U.S.      at     553-54,     or     that     the     jury      was

“substantially swayed by the error,” Heater, 63 F.3d at 325, but

the fact that the jury had substantial expert testimony on one

side and a single stray comment by Cisson’s attorney on the

other again cuts strongly in favor of finding the alleged error

harmless.

       Finally,    Cisson’s     causation     evidence      linked       three      other

design    defects    to   her      injuries   in    addition       to    the    alleged

polypropylene defect.           Bard therefore cannot meet its burden

without   some     showing    that    the   jury   was     unpersuaded         by   these

alternative       theories    of     causation,     or     at     least    that      the

polypropylene      theory    was     sufficiently       central    to    its    damages

award that Bard’s substantial rights were affected.                             See id.

(assuming     an     evidentiary       ruling      was     erroneous       and       then

considering all of the evidence adduced at trial to determine

the likelihood of prejudice).               Specifically, Cisson’s evidence

included expert testimony to the effect that the mesh in the

                                         32
Avaulta Plus was subject to shrinking post-implantation, that

the pores in the mesh were too small and therefore likely to

result in the formation of rigid scar tissue, and that the arms

used   to   hold    the   Avaulta   Plus     in   place   in    the    body    were

defectively designed and contributed to Cisson’s pain.                         Bard

fails to demonstrate, or even argue, that the jury based its

conclusions    on   the   polypropylene       degradation      evidence    rather

than these theories, which were central to her case.                   Cisson, on

the other hand, presented multiple experts in support of each

causation theory and linked them to her injuries.

       Bard has failed to demonstrate that the one problematic

statement regarding the MSDS it has managed to identify in the

record had a significant effect on the jury’s decision.                       Given

the very significant evidence Cisson presented on causation, and

given that the problematic statement was, at most, addressed to

one of Cisson’s four theories of causation, we cannot find that

Bard’s substantial rights were affected.             We therefore find the

alleged error harmless and affirm the district court’s admission

of the MSDS.

                                      IV.

       The third issue raised by Bard on appeal is whether the

district    court    erred    in    its     instruction    to    the    jury    on

causation, as well as in its subsequent ruling upholding the

                                      33
jury’s    causation     finding       pursuant     to    its        denial      of   Bard’s

renewed motion for judgment as a matter of law.                            Bard charges

that it was prejudiced because the court’s causation instruction

did not reflect Georgia law.

      Rulings    on    jury     instructions      are    reviewed       for      abuse    of

discretion, but where there is an error of law we review de

novo.     Emergency One, Inc. v. Am. Fireeagle, Ltd., 228 F.3d 531,

538 (4th Cir. 2000).          We review to ensure that the “charge [was]

accurate on the law and [did] not confuse or mislead the jury.”

Hardin    v.   Ski    Ventures,      Inc.,   50 F.3d 1291,       1294      (4th    Cir.

1995).     Because the court’s instruction met this standard, and

because    the   jury     had    ample    evidence       on    which       to    base    its

causation finding, we affirm the district court.

      Bard’s     position       is    that     Georgia        law    requires        injury

causation be proved by “expert testimony stated to a reasonable

degree of medical probability or certainty,” that the court was

wrong to deny its request for an instruction reflecting that

standard, and that Cisson failed to offer expert testimony on

two   alleged    design    defects       sufficient      under       the     standard     to

prove they caused her injuries.                But Bard’s characterization of

Georgia law incorrectly states the standard of proof applicable

here, inserting the standard for medical malpractice cases into

this product liability case.

                                          34
       The district court charged the jury using Georgia’s pattern

jury instructions for strict liability tort cases, which defines

the burden of proof for proximate cause as a preponderance of

the evidence.    See Ga. Suggested Pattern Jury Instructions, Vol.

I:     Civil Cases §§ 60.200 & 62.610 (5th ed. 2015).             It is also

established under Georgia law that plaintiffs in medical implant

cases “may present medical as well as non-medical evidence to

show causation.”       Allison v. McGhan Med. Corp., 184 F.3d 1300,

1320 (11th Cir. 1999).

       Bard cannot point to a single Georgia case (or any case

applying Georgia law) stating that the standard in the pattern

jury    instruction    is   incorrect.     Instead,   Bard   points   to    an

inapposite Georgia Supreme Court case, Zwiren v. Thompson, 578
S.E.2d 862 (Ga. 2003), a comparison that suffers from multiple

problems.    First, Zwiren was a medical malpractice case, not a

product    liability   case.     Second,   while   the   Zwiren   court    did

indeed adopt the “reasonable medical probability or certainty”

standard Bard advocates, the thrust of the opinion was to reduce

the standard from “reasonable medical certainty” to “reasonable

medical probability.”        Id. at 867.    This lower standard “is the

functional equivalent of preponderance of the evidence”—the same

standard expressed by the pattern jury instruction.                 Allison,
184 F.3d at 1320.           Thus, even in malpractice cases, “Georgia

case law requires only that an expert state an opinion regarding

                                     35
proximate       causation      in    terms     stronger       than       that     of    medical

possibility.”           Zwiren, 578 S.E.2d at 867.                      In medical implant

cases the need for exclusively medical evidence is abrogated.

Allison, 184 F.3d at 1320.

       Cisson presented ample expert and non-expert testimony for

a jury to find that the design defects caused her injuries.                                    In

addition to the evidence already described in Part III of this

opinion, Cisson presented the following testimony to the jury:

Dr. Lennox Hoyte, a urogynecologist, and Dr. John Miklos, one of

Cisson’s    treating         physicians,      respectively           testified         that   the

arms on the Avaulta Plus constituted a design defect and caused

Cisson’s       pain;     Dr.   Bernd       Klosterhalfen,           a    pathologist,         and

Dr. Jim Ross testified that inadequate pore size can cause the

implanted mesh to shrink and can lead to inflammatory reactions

and     rigid       scarification         inside    the      body;       and    Dr.     Anthony

Brennan,        a    professor      and     expert      in    material          sciences      and

biomedical engineering, Dr. Klosterhalfen, and Dr. Brian Raybon,

another     of        Cisson’s       treating        physicians,           testified          that

polypropylene can degrade in the human body, degradation can

cause    internal        inflammation,       and     that     Ms.       Cisson’s       mesh    was

degraded.           This and the other evidence presented at trial was

more    than        enough   for    the    jury    to   conclude         that    the    alleged

defects caused Cisson’s injuries.                       Although Bard argues that

Cisson’s burden was to show precisely how each alleged defect

                                              36
caused particular injuries, under Georgia product liability case

law “it is not necessary for the plaintiff to specify precisely

the nature of the defect”; a plaintiff need only show that “the

device did not operate as intended and this was the proximate

cause    of   [the   plaintiff’s]   injuries.”       Trickett    v.    Advanced

Neuromodulation Sys., Inc., 542 F. Supp. 2d 1338, 1345 (S.D. Ga.

2008) (emphasis removed) (quoting Williams v. Am. Med. Sys., 548
S.E.2d 371, 373 (2001)) (quotation marks omitted).

     We therefore find that the district court did not err in

giving the Georgia pattern jury instruction, in denying Bard’s

request for a modified instruction, or in upholding the jury’s

causation finding.

                                      V.

     The jury awarded Cisson $250,000 in compensatory damages

and $1.75 million in punitive damages. 4         “The Due Process Clause

of the Fourteenth Amendment prohibits the imposition of grossly

excessive or arbitrary punishments on a tortfeasor” in the form

of   punitive    damages.     State    Farm   Mut.    Auto.     Ins.   Co.   v.

Campbell, 538 U.S. 408, 416 (2003).           As such, Bard argues that

     4 The punitive damages were subject to a split-recovery
statute, dividing the award between the plaintiff and the State
of Georgia.    As a result, Cisson only received twenty-five
percent of the award, while Georgia received the remaining
seventy-five percent. See Part VI. infra.

                                      37
the punitive award in this case was constitutionally excessive.

We review this constitutional question de novo, id. at 418, and

affirm the award.

       The Supreme Court has articulated three “guideposts” for

reviewing     the   constitutionality           of   a     punitive         damages     award:

“(1)    the     degree     or     reprehensibility              of      the      defendant’s

misconduct, (2) the disparity between the harm (or potential

harm) suffered by the plaintiff and the punitive damages award,

and (3) the difference between the punitive damages awarded by

the    jury   and   the    civil     penalties       authorized             or   imposed     in

comparable      cases.”        Cooper     Indus.,        Inc.     v.    Leatherman          Tool

Group, Inc., 532 U.S. 424, 440 (2001)) (citing BMW of N. Am.,

Inc. v. Gore, 517 U.S. 559, 574-75 (1996)).                                 The Court also

noted that the first of these factors, reprehensibility, is the

most important.          Campbell, 538 U.S. at 419 (quoting Gore, 517
U.S. at 575).       Bard, however rests its challenge entirely on the

second guidepost, asserting only that the punitive award “is

constitutionally         impermissible,         as    it     is        seven     times      the

$250,000 compensatory damages award.”                    Appellant’s Br. 58.

       Bard’s    argument       is   based      principally            on     the     Campbell

Court’s observation that “an award of more than four times the

amount of compensatory damages might be close to the line of

constitutional impropriety.” 538 U.S. at 425.                    However, Bard

apparently      failed    to    realize    that      the    Court       went     on    to   say

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“these ratios are not binding” and to conclude that “[s]ingle-

digit    multipliers       are     more     likely      to   comport       with       due

process . . . than awards with ratios in range of 500 to 1.”

Id.

       Bard effectively urges this court to adopt a bright line

rule against punitive damages exceeding a ratio of four-to-one,

despite the Supreme Court itself “declin[ing] again to impose a

bright-line ratio which a punitive damages award cannot exceed”

in Campbell.       Id.       The district court found that “here, the

compensatory     damages     and    punitive      damages    against       Bard      both

arose    from    its     misconduct       that    resulted    in     Ms.       Cisson’s

injuries,” JA 7139-40 n.8, and grounded its refusal to overturn

the award in reprehensibility of Bard’s conduct, JA 7138-43.                           We

therefore       find     that      the     seven-to-one       ratio        was        not

constitutionally excessive in this case and affirm the district

court.

                                          VI.

       The final issue before us comes from Cisson who challenges,

by    cross-appeal,    the    district      court’s     ruling     that    a    Georgia

split-recovery     statute       garnishing      seventy-five      percent      of    any

punitive    damages       award    arising       from    a   product       liability

judgment, O.C.G.A. § 51-12-5.1(e), does not violate the Takings

Clause of the Fifth Amendment of the United States Constitution.

                                          39
Cisson asserts that Georgia created a property interest in such

punitive damages awards when it codified them in O.C.G.A. § 51-

12-5.1, and that enforcement of the state’s subsequently enacted

split-recovery     statute     violates     the   Takings    Clause.         The

district   court    rejected    that    argument,    and     we    review    its

decision de novo.     To succeed, Cisson must first show she has “a

constitutionally    protected    property     interest”     in    the   punitive

damages award at issue.         See Washlefske v. Winston, 234 F.3d
179, 184 (4th Cir. 2000).       Cisson contends that she has a vested

property interest in the entire punitive damages award, but, in

the scant briefing she has provided to this Court on the issue,

she has failed to articulate a viable theory in support of that

contention.

     Cisson makes no claim that her right to punitive damages

arises from the common law or is otherwise fundamental, so we

need not address the opinions of some courts which have found

that no such right is cognizable under the Takings Clause.                  E.g.

Enquist v. Oregon Dep’t of Agric., 478 F.3d 985, 1002-04 (9th

Cir. 2007).   Instead she argues that her property interest was

created by Georgia statute.       Appellee’s Br. 92.         But Cisson does

not explain how Georgia exceeds its authority by defining the

contours of the right it has allegedly created.              Washlefske, 234
F.3d at 184; see Cheatham v. Pohle, 789 N.E.2d 467, 473 (Ind.

2003) (holding that the legislature could define a plaintiff’s

                                       40
interest     in   a   statutorily    created    property   right).    “[I]f   a

statute creates a property right . . . , the property interest

so created is defined by the statute . . . .”                Washlefske, 234
F.3d    at   184.       As   such,    under     Cisson’s   own   theory   “the

legislature may lawfully regulate the amount of punitive damages

which can be awarded,” Mack Trucks, Inc. v. Conkle, 436 S.E.2d
635, 639 (Ga. 1993), and she has therefore provided no basis for

us to find the state’s actions unconstitutional.

       As such, we affirm the judgment of the district court.

                                         VII.

       For the foregoing reasons, the judgment of the district

court on all issues raised in this appeal is

                                                                     AFFIRMED.

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