Donna Cisson v. C. R. Bard, Incorporated , 810 F.3d 913 ( 2016 )

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