Donna Cisson v. C. R. Bard, Incorporated

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

38
“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.

41