Donna Cisson v. C. R. Bard, Incorporated

Filing

PUBLISHED AUTHORED OPINION filed. Originating case number: 2:11-cv-00195. [999735668]. [15-1102, 15-1137]

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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.

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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:

Before GREGORY, AGEE, and DIAZ, Circuit Judges.
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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.

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GREGORY, Circuit Judge:
On August 15, 2013, a jury awarded Donna Cisson $250,000 in
compensatory
claim

damages

against

on

C.R.

a

Bard,

design

defect

Inc.

and

(“Bard”),

additional $1,750,000 in punitive damages.

failure
and

to

warn

awarded

an

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.
multi-district
against

the

This was the first jury verdict arising from

litigation

proprietors

involving

of

more

transvaginal

than
mesh

70,000

medical

cases
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.
was

hearsay

district

Bard argues that the MSDS relied on by Cisson

outside

court’s

any

jury

exception.

instruction

Third,
on

Bard

causation,

appeals
arguing

the
that

under controlling Georgia law the court should have told jurors
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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

incontinence.

pelvic

organ

prolapse

and

stress

urinary

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
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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

transferring

for

these

Virginia in 2010.

Multidistrict

cases

to

the

Litigation

Southern

had

District

begun

of

West

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
claims

June
for

4,

2013,

negligent

selling,

manufacturing

district

court

allowed

Bard

won

summary

inspection,

judgment

marketing,

Cisson’s

packaging

defect,

and

breach

of

claims

for

design

defect,

6

on

warranty.
failure

and
The
to

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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.
regarding

a

Polypropylene

MSDS
Company

Bard

There was substantial argument

received

(“Phillips”),
7

from
the

Phillips
corporation

Sumika
that

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the

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polypropylene

Avaulta Plus mesh.

pellets

used

to

extrude

the

The MSDS contained an explicit warning that

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

Internal

knew

MSDS,

about

the

monofilament
addition

to

countered
clinical

and

suppliers
raising

that

e-mails
that

from

its

and

they

hearsay

that

of

been

Bard
to

the

objection

had
the

that

sought

learning

polypropylene

settings

showed

to

executives

prevent

their

warning.

In

the

MSDS,

Bard

used

warning

for

decades

in

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.

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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

evidence to show that its conduct was reasonable.

to

admit

the

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

of

relevance,

under
and

Federal
under

Rule

Rule

prejudicial than probative.

403

Evidence

for

being

402

for

lack

substantially

of
more

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)
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A.
Although
United

States

Rule

403

v.

Wells,

district

courts

“whether

the

are

will

“generally

favor

F.3d

896

163

granted

probative

889,

“broad

value

of

admissibility,”

(4th

Cir.

discretion”

evidence

is

1998),

to

decide

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’s Rule 403 decision.

Court

will

not

overturn

a

trial

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).

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design defectiveness under a test balancing the risks inherent
in

a

product

designed.”
(Ga. 1994).

design

against

the

utility

of

the

product

so

Banks v. ICI Americas, Inc., 450 S.E.2d 671, 674
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.
510(k)

process

was

Bard argues that compliance with the

important

to

its

design

defect

defense

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

is

without
relevant,

deciding
under

that

the

Georgia’s

510(k)

risk-utility

compliance
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 pre1976 device already in use at that time.
Lohr, 518 U.S. 470, 493 (1996).

See Medtronic, Inc. v.

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
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‘special controls . . . that are necessary to provide adequate
assurance of safety and effectiveness.’”
Inc.,

179

F.3d

154,

§ 360c(a)(1)(B)).

160

In

(4th

this

Cir.

Talley v. Danek Med.,

1999)

respect,

(quoting

although

the

21

U.S.C.

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
clearance

value.

The

accomplished

qualification

for

an

Supreme
through

Court
the

exemption

has

regarded

510(k)

process

rather

than

a

product
as

“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

premarket approval] process.”

the

gauntlet

of

Lohr, 518 U.S. at 493-94.
12

the

[MDA

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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

safety

preempted

regulation

because

the

requiring

510(k)

device

established design standards.

Id.

does

not

producers

amount
to

to

meet

a

any

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
13

is

the

heart

of

the

510(k)

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review process.

2014 Guidance for Industry and Staff:

510(k) Program:
Notifications

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The

Evaluating Substantial Equivalence in Premarket

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”

“requirement,” Riegel, 552 U.S. at 322.

and

not

a

safety

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

information

underlying

product,

substantially

and

outweighed

is
by

the
the

value

of

possibility

this
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.

evidence would have initiated a battle of experts:

Bard’s
Bard was

prepared to characterize the review process as “thorough” and
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“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.
tangentially,

say

While 510(k) clearance might, at least

something

about

the

safety

of

the

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

of

courts

have

said

so,

and

having

been

cleared
The vast

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

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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

damages.
where

particularly
Under

there

misconduct,
entire

is

Georgia
“clear

malice,

want

relevant

of

law,
and

fraud,

care

which

on

the

punitive

damages

convincing
wantonness,
would

And

Georgia

courts

the

punitive
available

of

oppression,

raise

have

of

are

evidence”

conscious indifference to consequences.”
5.1(b).

question

“willful
or

that

presumption

of

Ga. Code Ann. § 51-12noted

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)

inquiry.

is

often

relevant

to

the

willfulness

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
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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.
16

F. Supp. 3d.

defendant
reviews,

chose

See Anastasi v. Wright Med. Tech., Inc.,

1032,
the

including

1036-37

FDA

(E.D.

510(k)

clinical

Mo.

process

trials,

approval under FDA regulations”).

2014)
to

(finding

“avoid

required

for

the

that

safety

pre-market

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
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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

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its

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truth

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under

the

hearsay

Pg: 19 of 41

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

the

district
However,

exceptions.

court’s
we

rulings

affirm

the

as

to

decision

to

hearsay

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,”
hearsay

for

creates

“market

an

exception

quotations,

2

to

lists,

the

prohibition

directories,

or

on

other

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.

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compilations that are generally relied on by the public or by
persons in particular occupations.”
district

court

ruled

that

the

Fed. R. Evid. 803(17).

MSDS

compilation” within this exception.

qualified

as

an

The

“other

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

objects

to

specific

where
which

ones

a
it

will

be

statute

contains

applies,

a

limited

specific terms that preceded it.
Adams,

532

reliance

on

U.S.

105,

the

114-15

general

an

general

in

its

exemplary
term

list

that

meaning

by

of

follows
the

more

Circuit City Stores, Inc. v.

(2001).

term—“other

The

district

court’s

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

that

the

warning

MSDS
and

was

disclaimer

issuing party.

not
of

factual

but

liability

rather

for

the

operated

as

a

self-interested

The warning from Phillips that polypropylene

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

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within

therefore

the

bears

MSDS

no

for

Pg: 21 of 41

self-interested

resemblance

to

the

reasons,

factual,

and

it

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.”
(1972).

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

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.
proof

or

argument

presumption

of

that

reliability

the

Cisson has offered no

disclaimer

afforded

to

warrants

market

the

quotations

same
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),

Periodicals,

or

titled

“Statements

Pamphlets,”

creates

in

Learned

Treatises,

an

exception

to

the

prohibition on hearsay when a statement in such publications is
(1) “called to the attention of an expert witness on crossexamination 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,
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or

by

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notice”;

and

(3)

Pg: 22 of 41

the

statement

is

read

evidence rather than being received as an exhibit.
Evid. 803(18).

into

Fed. R.

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.
Evid. 803(18).

Fed. R.

Therefore, without addressing whether the MSDS

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

3

Nor 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.

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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
hearsay

807,

titled

exception

for

the

“Residual

certain

Exception,”

statements

not

creates

covered

exceptions in Rule 803 or 804.

Fed. R. Evid. 807.

statement

exception

to

come

under

this

it

must

by

a
any

For a
contain

“circumstantial guarantees of trustworthiness,” be used to prove
“a material fact,” and be “more probative on the point for which
it

is

offered

“reasonable

than

any

efforts.”

other

Id.

evidence”

We

review

the

available

through

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

dangerous

for

available
human

that

polypropylene

implantation.

The

was

relative

potentially
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

pathology.

slides

evidencing

Ms.

Cisson’s

particular

The warning in the MSDS, on the other hand, was
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nothing

more

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than

an

assertion

Pg: 24 of 41

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

original
offered

hearsay

rationale
as

exceptions,

for

hearsay.

offering
Cisson

we

the

argued,

now

MSDS:
and

turn

to

that
the

Cisson’s

it

was

district

not

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.
but

argues

instead

Bard does not dispute this on appeal,

that

Cisson

used

the

MSDS

for

its

truth

during the trial and that it was therefore offered as hearsay
without an exception.
have

found

no

Having thoroughly reviewed the record we

reversible

error,

and

district court’s admission of the MSDS.

24

we

therefore

affirm

the

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“Out-of-court

Pg: 25 of 41

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).
an

out-of-court

trial.

assertion

is

hearsay

depends

on

“[W]hether

its

use”

at

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 safetyrelated

“red

flags”

she

argued

demonstrated

that its product might be unsafe.
Cisson’s

argument

investigated

the

that
safety

the
of

marketing the product immediately.
the

trial

she

did

not

rely

on

knowledge

This was used to support

company
the

Bard’s

should

Avaulta

have

Plus

further

rather

than

Cisson insists that during
the

MSDS

polypropylene was unsafe or to prove causation.

to

show

that

Bard argues,

however, that “[h]aving secured . . . a ruling that the MSDS was
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admissible for its truth, Plaintiffs took full advantage of the
rulings” by using the document to show that polypropylene was
unsuitable
injuries.

for

implantation

and

Appellant’s R. Br. 30.

contributed

Cisson

consistently

Cisson’s

Cisson’s position ultimately

proves more convincing for two reasons.
trial

to

limited

First, throughout the

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
Advanced

Darois,

Bard’s

Technology,

was

Vice
the

President
key

of

witness

Research

Cisson

used

and
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.
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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).
Cisson

used

the

testimony

(which

involving

the

unreasonable

MSDS,
again

MSDS),
but

at

to

“would

least

was

with

the

show
raise

most

Bard’s

It seems clear that
regard

to

the

significant
conduct

was

exchange
not

only

the

presumption

Id.

indifference to consequences.”

of

Darois

conscious

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[.]
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. . . .
[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

trial

arguments,

Cisson’s

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.
hunt.”

But Phillips Sumika, they don’t have a dog in the
JA 6537.

On its face, the statement appears to instruct

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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

single

stray

require

a

on

the

comment

new

question

was

trial.

not

of

causation,

enough

Federal

to

courts

because

prejudice

of

appeal

that

Bard

and

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

to

harmless,

“we

need

only

be

able

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.’”
63

F.3d

311,

325

(4th

Cir.

1995)

United States v. Heater,
(quoting

United

States

v.

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

alleged

reasons.

error

First,

Bard

in

this

has

case

was

pointed

to

harmless
only

for

one

three

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

statement.

all

convincing

is

the

“dismiss

all

the

experts”

For example, Bard argues that the MSDS was used as

substantive evidence of causation in Cisson’s opening argument,
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citing JA 2358-60.

Pg: 30 of 41

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

attempting
being

used

on

to

those

keep

in

the

pages

Phillips
Avaulta

demonstrate
in

the

Plus

dark

after

implantation warning to the MSDS in 2007.
tended

to

show

that

Bard’s

only

reaction

that

about

Bard

was

polypropylene

Phillips

added

the

Again, this evidence
to

the

warning

was

unreasonable, not that polypropylene caused Cisson’s injuries.
The MSDS simply was not being used for its truth.
30

The same is

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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.
on

its

face

interpreted

and

to

without

tell

the

context,

jurors

the

that

After all, taken
statement

they

can

can

ignore

be
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.
separate

experts

Brennan,

a

who

biomedical

testified
engineer;

on

Cisson presented three

this

Dr.

point:

Bernd

Dr.

Anthony

Klosterhalfen,

a

pathologist; and Dr. Brian Raybon, the physician who implanted
the Avaulta Plus into Cisson’s body.
31

Dr. Brennan provided the

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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.
Bard

In order for us to reverse the district court,

must

show

Greenwood,

464

that

its

U.S.

at

“substantial
553-54,

rights”

or

that

were
the

affected,
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,
design

Cisson’s

defects

to

her

polypropylene defect.
without

some

alternative

showing
theories

polypropylene

causation

theory

injuries

evidence
in

linked

addition

to

three
the

an

alleged

Bard therefore cannot meet its burden
that
of
was

the

jury

was

causation,

or

sufficiently

unpersuaded
at

central

least
to

evidentiary

ruling

was

erroneous

by
that

its

award that Bard’s substantial rights were affected.
(assuming

other

these
the

damages
See id.

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
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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

than these theories, which were central to her case.

rather

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
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causation

finding

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pursuant

to

its

denial

renewed motion for judgment as a matter of law.

of

Bard’s

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

prove they caused her injuries.

under

the

standard

to

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.

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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.
I:

See Ga. Suggested Pattern Jury Instructions, Vol.

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.
product

First, Zwiren was a medical malpractice case, not a

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.
184 F.3d at 1320.

Allison,

Thus, even in malpractice cases, “Georgia

case law requires only that an expert state an opinion regarding
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proximate

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causation

possibility.”

in

terms

Pg: 36 of 41

stronger

than

Zwiren, 578 S.E.2d at 867.

that

of

medical

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

Brennan,

scarification
a

professor

inside

and

the

expert

in

body;

and

material

Dr.

Anthony

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

enough

than

for

the

jury

to

defects caused Cisson’s injuries.

conclude

that

the

alleged

Although Bard argues that

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

Campbell, 538 U.S. 408, 416 (2003).

4

Mut.

Auto.

Ins.

Co.

v.

As such, Bard argues that

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.

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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
“(1)

the

the

constitutionality

degree

or

of

a

punitive

reprehensibility

of

damages

the

award:

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

comparable

the

civil

cases.”

penalties

Cooper

authorized

Indus.,

Inc.

v.

or

imposed

Leatherman

in

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.
U.S. at 575).

Campbell, 538 U.S. at 419 (quoting Gore, 517

Bard, however rests its challenge entirely on the

second guidepost, asserting only that the punitive award “is
constitutionally

impermissible,

as

$250,000 compensatory damages award.”
Bard’s

argument

is

based

it

is

seven

times

the

Appellant’s Br. 58.

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.

apparently

that

failed

to

realize

38

the

Court

However, Bard
went

on

to

say

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

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.

compensatory

damages

arose

its

from

The district court found that “here, the
and

punitive

misconduct

that

damages
resulted

against
in

Bard

Ms.

both

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.
therefore

find

that

the

seven-to-one

ratio

was

We
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,

split-recovery
punitive

the

statute

damages

district

court’s

garnishing

award

arising

ruling

seventy-five
from

a

that

a

percent

product

Georgia
of

any

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.
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Cisson asserts that Georgia created a property interest in such
punitive damages awards when it codified them in O.C.G.A. § 5112-5.1, and that enforcement of the state’s subsequently enacted
split-recovery
district

statute

court

decision de novo.
constitutionally

violates

rejected

that

the

Takings

argument,

and

Clause.
we

review

The
its

To succeed, Cisson must first show she has “a
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
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in

a

Filed: 01/14/2016

statutorily

Pg: 41 of 41

created

property

right).

“[I]f

a

statute creates a property right . . . , the property interest
so created is defined by the statute . . . .”
F.3d

at

184.

As

such,

under

Cisson’s

Washlefske, 234
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.

41