Sherr-Una Booker v. C. R. Bard, Inc.

FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
IN RE BARD IVC FILTERS No. 18-16349
PRODUCT LIABILITY
LITIGATION, D.C. Nos.
2:15-md-02641-DGC
2:16-cv-00474-DGC
SHERR-UNA BOOKER,
Plaintiff-Appellee,
OPINION
v.
C. R. BARD, INC., a New Jersey
corporation; BARD PERIPHERAL
VASCULAR, INC., a subsidiary
and/or Division of defendant
C.R. Bard, Inc., an Arizona
corporation,
Defendants-Appellants.
Appeal from the United States District Court
for the District of Arizona
David G. Campbell, District Judge, Presiding
Argued and Submitted February 3, 2020
Phoenix, Arizona
Filed August 13, 2020
2 IN RE BARD IVC FILTERS PRODS. LIAB. LITIG.
Before: Susan P. Graber, Andrew D. Hurwitz,
and Eric D. Miller, Circuit Judges.
Opinion by Judge Miller
SUMMARY *
Preemption / Medical Devices
The panel affirmed the district court’s judgment in favor
of a plaintiff who brought product-liability claims based on
injuries she sustained from a medical device designed and
manufactured by C.R. Bard, Inc.
Plaintiff brought this action in the District of Arizona as
part of a multidistrict litigation, asserting claims under
Georgia law. Bard filed an omnibus motion for summary
judgment for all cases in the multidistrict litigation, arguing
that the federal Medical Device Amendments of 1976
preempted all state-law claims.
The case involved Bard’s G2 Filter – an “intravascular
filter” that the Food and Drug Administration (“FDA”)
reclassified as a Class II device with three “special controls.”
The panel held that, because Bard’s preemption defense
presented a purely legal question, the panel would consider
the merits of the district court’s denial of its motion for
summary judgment. The panel held that Bard’s preemption
*
This summary constitutes no part of the opinion of the court.
It has been prepared by court staff for the convenience of the reader.
IN RE BARD IVC FILTERS PRODS. LIAB. LITIG. 3
argument failed because plaintiff’s claim rested on an
asserted state-law duty to warn of the risks posed by the
particular design of Bard’s G2 Filter, and the FDA had not
imposed any requirements related to the design of that
device or how a device of that design should be labeled.
Bard next argued that the district court erred in denying
summary judgment on plaintiff’s negligent failure-to-warn
claim because Georgia law did not recognize a duty to warn
of the comparative risks posed by different products. The
panel held that Georgia courts had not adopted a categorical
prohibition on basing a failure-to-warn claim on the absence
of a comparative warning. The panel concluded that the
district court correctly allowed a jury to decide the adequacy
of the warning here.
Bard argued that the district court erred by denying its
renewed motion for judgment as a matter of law, which
challenged the evidentiary sufficiency for the punitive
damages award. The panel held that Bard’s challenge to the
punitive damages award was largely derivative of its
argument that it had no duty to warn of comparative risks.
The panel concluded that the evidence was adequate to
support the jury’s award of punitive damages.
COUNSEL
James C. Martin (argued), Michael K. Brown, and Kasey J.
Curtis, Reed Smith LLP, Los Angeles, California; Richard
B. North Jr., Nelson Mullins Riley & Scarborough LLP,
Atlanta, Georgia; for Defendants-Appellants.
David C. Frederick (argued), Brendan J. Crimmins, and
Collin R. White, Kellogg Hansen Todd Figel & Frederick
4 IN RE BARD IVC FILTERS PRODS. LIAB. LITIG.
P.L.L.C., Washington, D.C.; Ramon Rossi Lopez and
Joshua Mankoff, Lopez McHugh LLP, Newport Beach,
California; Julia Reed Zaic, Heaviside Reed Zaic, Laguna
Beach, California; for Plaintiff-Appellee.
Chilton Davis Varner and J. Franklin Sacha Jr., King &
Spalding LLP, Atlanta, Georgia, for Amicus Curiae Product
Liability Advisory Council Inc.
Robert S. Peck, Center for Constitutional Litigation P.C.,
Washington, D.C.; Elise Sanguinetti, President, American
Association for Justice, Washington, D.C.; for Amicus
Curiae American Association for Justice.
OPINION
MILLER, Circuit Judge:
Sherr-Una Booker sued C. R. Bard, Inc. and Bard
Peripheral Vascular, Inc. (collectively, “Bard”), asserting
product-liability claims based on injuries she sustained from
a medical device designed and manufactured by Bard. The
jury found Bard liable for negligent failure to warn,
awarding $1.6 million in compensatory damages and
$2 million in punitive damages. On appeal, Bard argues that
the district court erred by denying summary judgment on its
preemption defense, that a failure-to-warn claim is
unavailable in these circumstances, and that the award of
punitive damages was not supported by the evidence. We
affirm.
I
For more than a century, the Food and Drug
Administration has been responsible for approving new
IN RE BARD IVC FILTERS PRODS. LIAB. LITIG. 5
drugs before they enter the market. See 21 U.S.C. § 301 et
seq. Until 1976, however, medical devices were not subject
to FDA regulation. In the Medical Device Amendments of
1976 (MDA), Pub. L. No. 94-295, 90 Stat. 539, Congress
provided for FDA regulation of medical devices.
The MDA directs the FDA to divide medical devices into
three classes based on the level of risk they present, and it
provides for different regulation of each class. 21 U.S.C.
§ 360c(a)(1). Class I, the lowest-risk category, comprises
products such as bandages and tongue depressors. Class I
devices are subject to “general controls” such as labeling
requirements. Id. § 360c(a)(1)(A). Class II devices are those
for which general controls “are insufficient to provide
reasonable assurance of . . . safety and effectiveness.” Id.
§ 360c(a)(1)(B). In addition to being subject to general
controls, Class II devices are subject to “special controls”
such as “performance standards, postmarket surveillance,
. . . recommendations, and other appropriate actions as the
[FDA] deems necessary” to ensure safety and effectiveness.
Id. Class III devices, the highest-risk category, are devices
that cannot be determined to provide a “reasonable assurance
of . . . safety and effectiveness” under Class I or II controls,
and that either are marketed as life-supporting devices or
pose an unreasonable risk of illness or injury. Id.
§ 360c(a)(1)(C).
Class III devices are generally subject to premarket
approval by the FDA. 21 U.S.C. § 360e. Premarket approval
is a rigorous process that requires the manufacturer to submit
a detailed application including studies of the device’s safety
and effectiveness. See id. § 360e(c)(1); Riegel v. Medtronic,
Inc., 552 U.S. 312, 317–18 (2008). The FDA may approve
the device only if has “reasonable assurance” that the device
is safe and effective. 21 U.S.C. § 360e(d)(2)(A)–(B).
6 IN RE BARD IVC FILTERS PRODS. LIAB. LITIG.
By contrast, Class I and II devices are generally subject
to a far less rigorous process referred to as section “510(k)
approval,” Riegel, 552 U.S. at 322, which requires the
manufacturer to show only that the device is “substantially
equivalent” to an existing Class I or Class II device.
21 U.S.C. § 360c(f)(1)(A)(ii); see Medtronic, Inc. v. Lohr,
518 U.S. 470, 478–79 (1996). To grant approval, the FDA
must find that the device “has the same technological
characteristics as the predicate device,” or, if the device has
different technological characteristics, that it “is as safe and
effective as a legally marketed device, and . . . does not raise
different questions of safety and effectiveness than the
predicate device.” 21 U.S.C. § 360c(i)(1)(A).
This case involves an “intravascular filter,” a device used
in patients who have, or are at risk of developing, blood clots
in the veins in their legs. Such clots can migrate to arteries
in the lungs, causing a pulmonary embolism, a potentially
life-threatening condition. Physicians can prescribe
medications to inhibit clotting and prevent the formation of
blood clots. But not all patients are able to use such
medications. For those patients, physicians may prescribe an
intravascular filter, which is implanted in the inferior vena
cava, a large vein through which blood returns to the heart
from the lower body. There, the filter can intercept clots
before they travel to the lungs. (To visualize the filter,
imagine the frame of an umbrella turned inside out by the
wind. The spokes of the umbrella have small hooks that hold
the structure in place on the walls of the vein.)
Until 2000, intravascular filters were regulated as
Class III devices. In that year, the FDA issued a final rule
reclassifying them as Class II devices and adopting three
“special controls.” 21 C.F.R. § 870.3375(b); see Medical
Devices; Reclassification of 28 Preamendments Class III
IN RE BARD IVC FILTERS PRODS. LIAB. LITIG. 7
Devices into Class II, 65 Fed. Reg. 17,138, 17,144 (Mar. 31,
2000). The first special control is the “Use of International
Standards Organization’s ISO 10993 ‘Biological Evaluation
of Medical Devices Part I: Evaluation and Testing,’”
21 C.F.R. § 870.3375(b)(1), which relates to
biocompatibility and seeks to reduce “potential adverse
tissue reactions” associated with “devices that contact the
body.” Medical Devices; Reclassification of
38 Preamendments Class III Devices into Class II, 64 Fed.
Reg. 12,774, 12,777 (Mar. 15, 1999). The second special
control is the “510(k) Sterility Review Guidance and
Revision of 2/12/90 (K90-1),” 21 C.F.R.
§ 870.3375(b)(2)(i), which relates to sterilization and sets
out “information about the use and application of national
and international sterility consensus standards for devices to
be labeled as ‘sterile’” so as to reduce “[t]he potential risk of
infection.” 64 Fed. Reg. at 12,777. The third special control
is the “Guidance for Cardiovascular Intravascular Filter
510(k) Submissions,” 21 C.F.R. § 870.3375(b)(2)(ii), which
sets forth certain “labeling, biocompatibility testing,
mechanical testing, sterilization procedures and labeling,
and clinical data controls” related to intravascular filters,
64 Fed. Reg. at 12,778.
Bard manufactures several different intravascular filters,
including the G2 Filter, which received section 510(k)
approval in 2005. Bard distributed the G2 Filter with a label
addressing various potential complications, including
“fracture” (the filter breaks into pieces), “migration” (the
filter moves from where the physician implanted it), and
“perforation” (the filter, or fragments of the filter, punctures
the wall of the vein). After it began selling the G2 Filter,
Bard received reports of complications associated with the
filter and conducted various internal analyses to review those
risks. Its analysis revealed that the G2 Filter’s rates of
8 IN RE BARD IVC FILTERS PRODS. LIAB. LITIG.
fracture, migration, and perforation were significantly
higher than those of other competing filters. Bard did not
include that information in the product’s labeling.
In 2007, Booker’s physician implanted a G2 filter in her
inferior vena cava. Several years later, after Booker began to
experience severe pain, an examination revealed that the
filter had fractured and perforated her inferior vena cava. She
underwent two surgeries to attempt to remove the filter and
its fractured pieces, but the surgeries were only partially
successful, and one piece of the filter remains embedded in
the wall of her inferior vena cava.
Booker brought this action against Bard in the District of
Arizona as part of a multidistrict litigation involving
thousands of similar cases. Booker is a resident of Georgia,
and she asserted design-defect and failure-to-warn claims
under Georgia law, which the parties agree governs this case.
Bard filed an omnibus motion for summary judgment for
all cases in the multidistrict litigation, arguing that the MDA
preempted all state-law claims. Bard relied in part on the
MDA’s express preemption clause, which preempts any
state “requirement . . . which is different from, or in addition
to, any requirement applicable under this chapter to the
device, and . . . which relates to the safety or effectiveness of
the device or to any other matter included in a requirement
applicable to the device under this chapter.” 21 U.S.C.
§ 360k(a). The district court denied the motion, reasoning
that the MDA preempts state law only when the FDA has
established “device-specific requirements,” and concluding
that the agency had not done so here.
After Booker’s case was selected for trial, Bard filed a
motion for partial summary judgment on all of Booker’s
claims, apart from the design-defect claims. As relevant
IN RE BARD IVC FILTERS PRODS. LIAB. LITIG. 9
here, Bard argued that Booker’s failure-to-warn claims were
contrary to Georgia law. According to Bard, Georgia
imposes on manufacturers a duty to warn of the risks posed
by their products but does not impose a duty to warn about
how those risks compare to the risks posed by other
competing products. The district court denied summary
judgment, concluding that the adequacy of the warning was
a question for the jury.
At trial, the jury found Bard liable for negligent failure
to warn, awarding $1.6 million in compensatory damages
and $2 million in punitive damages. The jury found for Bard
on the other claims. After trial, Bard challenged the
sufficiency of the evidence to support the punitive damages
award, but the district court held that the evidence, construed
in favor of the verdict, “supported a finding that despite
knowing that G2 filters placed patients at a greater risk of
harm, Bard chose not to warn physicians and instead
downplayed the risk.”
Bard appeals.
II
We first consider whether Bard’s preemption argument
is properly before us. Bard raised its preemption defense
only in its motion for summary judgment; it did not reassert
the defense in a motion for judgment as a matter of law after
trial. “Ordinarily, orders denying summary judgment do not
qualify as ‘final decisions’ subject to appeal.” Ortiz v.
Jordan, 562 U.S. 180, 188 (2011) (quoting 28 U.S.C.
§ 1291). Relying on that principle, the Supreme Court held
in Ortiz that an order denying summary judgment is
generally not reviewable after trial. Id. at 184–85.
10 IN RE BARD IVC FILTERS PRODS. LIAB. LITIG.
Before Ortiz was decided, however, we held that the
general rule does not apply to purely legal issues—in other
words, “to those denials of summary judgment motions
where the district court made an error of law that, if not
made, would have required the district court to grant the
motion.” Banuelos v. Constr. Laborers’ Tr. Funds for S.
Cal., 382 F.3d 897, 902 (9th Cir. 2004). Purely legal issues,
we held, are reviewable after trial even if raised only in a
motion for summary judgment. Id. 902–03. Under Miller v.
Gammie, 335 F.3d 889 (9th Cir. 2003) (en banc), we must
continue to follow our decision in Banuelos unless it is
“clearly irreconcilable” with later Supreme Court authority.
Id. at 900.
We conclude that it is not. In Ortiz, the Supreme Court
acknowledged the possibility that the general rule of non-
reviewability might include an exception for “purely legal”
issues, and the Court expressly declined to consider that
question. 562 U.S. at 190. Because Ortiz allowed for the
possibility of a Banuelos-like exception, it is not clearly
irreconcilable with Banuelos. Indeed, several circuits have
continued to recognize an exception for purely legal issues
even after Ortiz. See Frank C. Pollara Grp., LLC v. Ocean
View Inv. Holding, LLC, 784 F.3d 177, 185–86 (3d Cir.
2015) (citing cases).
Because the preemption issue here presents a purely
legal question, we proceed to consider the merits of the
district court’s denial of summary judgment. Our review is
de novo. Banuelos, 382 F.3d at 902.
The Supremacy Clause provides that the “Constitution,
and the Laws of the United States” are “the supreme Law of
the Land . . . any Thing in the Constitution or Laws of any
State to the Contrary notwithstanding.” U.S. Const. art. VI,
cl. 2. The Supreme Court “has sometimes used different
IN RE BARD IVC FILTERS PRODS. LIAB. LITIG. 11
labels to describe the different ways in which federal statutes
may displace state laws,” including “express, field, and
conflict preemption.” Virginia Uranium, Inc. v. Warren,
139 S. Ct. 1894, 1901 (2019) (plurality opinion). In this
appeal, Bard invokes only the doctrine of express
preemption, under which “Congress may withdraw specified
powers from the States by enacting a statute containing an
express preemption provision.” Arizona v. United States,
567 U.S. 387, 399 (2012).
“When a federal law contains an express preemption
clause, we ‘focus on the plain wording of the clause.’”
Chamber of Commerce of U.S. v. Whiting, 563 U.S. 582, 594
(2011) (quoting CSX Transp., Inc. v. Easterwood, 507 U.S.
658, 664 (1993)). As noted above, the MDA’s preemption
clause prohibits States from establishing any requirement
with respect to a medical device “which is different from, or
in addition to, any requirement applicable under this chapter
to the device, and . . . which relates to the safety or
effectiveness of the device or to any other matter included in
a requirement applicable to the device under this chapter.”
21 U.S.C. § 360k(a). Our interpretation of that provision is
“‘substantially informed’ by the FDA regulation set forth” at
21 C.F.R. § 808.1(d), which addresses the statute’s
preemptive scope. Riegel, 552 U.S. at 322 (quoting Lohr,
518 U.S. at 495). That regulation provides that state
requirements are preempted only when the FDA has
established “specific requirements applicable to a particular
device under the [MDA], thereby making any existing
divergent State or local requirements applicable to the device
different from, or in addition to, the specific [FDA]
requirements.” 21 C.F.R. § 808.1(d).
Two Supreme Court cases guide our interpretation of the
MDA and the regulation. First, in Lohr, the Court considered
12 IN RE BARD IVC FILTERS PRODS. LIAB. LITIG.
product-liability claims asserted against the manufacturer of
a device that had received section 510(k) approval. 518 U.S.
at 480. The Court held that federal manufacturing and
labeling requirements applicable to almost all medical
devices did not have preemptive effect because they were
not requirements specific to the device in question but
instead reflected “entirely generic concerns about device
regulation generally.” Id. at 501. And although the FDA’s
determination of substantial equivalence under section
510(k) is device-specific, the Court rejected the proposition
that section 510(k) approval itself imposed a “specific,
federally enforceable design requirement” that preempts
state law. Id. at 492. As the Court explained, when the FDA
conducts substantial-equivalence review, it does not require
a device “to take any particular form for any particular
reason.” Id. at 493.
In Riegel, by contrast, the Court held that the FDA’s
premarket approval of a medical device does establish
device-specific federal requirements that can preempt state-
law claims. 552 U.S. at 323. The Court emphasized that
“premarket approval is specific to individual devices.” Id.Unlike section 510(k) approval, the Court explained,
premarket approval may be granted only if the FDA
“determines that a device offers a reasonable assurance of
safety and effectiveness.” Id. Having made that
determination, “the FDA requires a device that has received
premarket approval to be made with almost no deviations
from the specifications in its approval application.” Id.For our purposes, the key principle established in Lohr—
and confirmed in Riegel—is that “the scope of preemption is
limited to instances where there are specific FDA
requirements applicable to a particular device.” Papike v.
Tambrands Inc., 107 F.3d 737, 742 (9th Cir. 1997) (quoting
IN RE BARD IVC FILTERS PRODS. LIAB. LITIG. 13
Anguiano v. E.I. Du Pont De Nemours & Co., 44 F.3d 806,
809 (9th Cir. 1995)); accord 21 C.F.R. § 808.1(d). Lohr
further established that section 510(k) approval does not
itself impose such device-specific requirements. 518 U.S.
at 493–94.
Bard does not dispute either of those propositions.
Instead, it argues that when the FDA reclassified
intravascular filters as Class II devices, the agency imposed
specific requirements in the form of the three special
controls applicable to such devices. The preemption issue in
this case therefore turns on whether the special controls
constitute “specific requirements applicable to a particular
device.” 21 C.F.R. § 808.1(d).
As an initial matter, Booker argues that the special
controls are not “requirements” because they are guidance
documents that lack the force of law. Bard responds that the
FDA has treated the special controls as if they were legally
binding, not merely advisory. We need not resolve that
dispute. Instead, we assume, without deciding, that the
special controls are requirements, but we nevertheless
conclude that they are not “specific” requirements
“applicable to a particular device” under 21 C.F.R.
§ 808.1(d).
The lack of specificity of the special controls is
particularly apparent in the case of the biocompatibility and
sterilization guidance documents. The biocompatibility
guidance addresses “risks to health related to adverse tissue
reaction,” which are “common to devices that contact the
body.” 64 Fed. Reg. at 12,777. The sterilization guidance
addresses “risks to health related to infection,” which are
likewise “common to the use of many devices.” Id. The
former applies to 13 different kinds of devices, the latter to
18 kinds. See 65 Fed. Reg. at 17,140. Neither contains
14 IN RE BARD IVC FILTERS PRODS. LIAB. LITIG.
anything specific to intravascular filters, let alone to the
particular intravascular filter at issue here. Like the general
requirements in Lohr, the documents “reflect important but
entirely generic concerns about device regulation generally,
not the sort of concerns regarding a specific device or field
of device regulation that the statute or regulations were
designed to protect from potentially contradictory state
requirements.” 518 U.S. at 501.
The intravascular-filter guidance is at least focused on
the kind of device at issue here—intravascular filters.
64 Fed. Reg. at 12,778. Even so, we conclude that it does not
have preemptive effect for two reasons. First, the guidance
does not impose “specific requirements applicable to a
particular device,” 21 C.F.R. § 808.1(d) (emphasis added),
such as Bard’s G2 Filter. Instead, it applies generally to
every member of the class of intravascular filters.
Second, the requirements that the intravascular-filter
guidance imposes are not relevant to Booker’s failure-to-
warn claim. State requirements cannot meaningfully be
described as “different from, or in addition to, the specific
[FDA] requirements” if the two requirements are not
relevant to each other. 21 C.F.R. § 808.1(d). Consistent with
that understanding, the Supreme Court explained in Lohr
that “in most cases a state law will be pre-empted only to the
extent that the FDA has promulgated a relevant federal
‘requirement.’” 518 U.S. at 496 (emphasis added); see id.
at 501 (explaining that preemption is appropriate when the
FDA has “weighed the competing interests relevant to the
particular requirement in question . . . and implemented that
conclusion via a specific mandate on manufacturers or
producers”). As Justice Breyer observed, it would make little
sense to conclude that “the existence of one single federal
rule, say, about a 2-inch hearing aid wire, would pre-empt
IN RE BARD IVC FILTERS PRODS. LIAB. LITIG. 15
every state law hearing aid rule, even a set of rules related
only to the packaging or shipping of hearing aids.” Id. at 505(Breyer, J., concurring in part and concurring in the
judgment). In such a regime, the FDA would be forced to
federalize all requirements for a particular device if it chose
to adopt any requirement, because adopting just one
requirement would displace all state regulation of that
device.
Booker’s claim is predicated on the theory that the G2
Filter’s labeling was inadequate because it did not warn that
the G2 Filter posed greater risks of migration and perforation
than other kinds of filters. The intravascular-filter guidance
does not prescribe the content of a filter’s label in any
manner relevant to such a warning. To be sure, the guidance
says that the label should describe the product’s indications
for use (“for the prevention of recurrent pulmonary
embolism via placement in the vena cava”) and that it should
state whether the device is safe in patients who may undergo
an MRI. It also sets out one contraindication that the label
should contain: “Vena Cava filters should not be implanted
in patients with risk of septic embolism.” But it says nothing
about whether or how to warn of the risks of filter migration
and perforation, and its only reference to the design of a
particular device does not impose any requirement at all:
“Your labeling may include other contraindications which
are specific to your particular device design.” As permitted
by the guidance, the G2 Filter’s label consists of two pages
of detailed instructions, including 3 contraindications,
10 warnings, 11 precautions, and 15 potential complications,
only one of which—the contraindication for patients at risk
of septic embolism—has anything to do with the contents of
the guidance.
16 IN RE BARD IVC FILTERS PRODS. LIAB. LITIG.
We emphasize that the problem with Bard’s preemption
argument is not simply that the FDA did not prohibit Bard
from adding additional warnings. The MDA’s express
preemption clause applies even when there is not a direct
conflict between state and federal requirements, and it
prohibits States from imposing a requirement “in addition to
. . . any requirement” imposed by the FDA. 21 U.S.C.
§ 360k(a); see McMullen v. Medtronic, Inc., 421 F.3d 482,
489 (7th Cir. 2005) (“Where a federal requirement permits a
course of conduct and the state makes it obligatory, the
state’s requirement is in addition to the federal requirement
and thus is preempted.”); accord Stengel v. Medtronic Inc.,
704 F.3d 1224, 1234 (9th Cir. 2013) (en banc) (Watford, J.,
concurring). Instead, the preemption argument fails because
Booker’s claim rests on an asserted state-law duty to warn of
the risks posed by the particular design of Bard’s G2 Filter,
and the FDA has not imposed any requirements related to
the design of that device or how a device of that design
should be labeled. Cf. Papike, 107 F.3d at 741 (failure-to-
warn claims were preempted “because the FDA ha[d]
established specific counterpart regulations with respect to
labeling” the product); see also Lohr, 518 U.S. at 496, 501.
III
Bard next argues that the district court erred in denying
summary judgment on Booker’s negligent failure-to-warn
claim because Georgia law does not recognize a duty to warn
of the comparative risks posed by different products.
Bard relies on Farmer v. Brannan Auto Parts, Inc.,
498 S.E.2d 583 (Ga. Ct. App. 1998), in which the court held
that the distributor of a product “had no duty to communicate
to users a danger already clearly listed on the product itself”
by the manufacturer. Id. at 585. But as Bard acknowledges,
Farmer did not consider comparisons of risks between
IN RE BARD IVC FILTERS PRODS. LIAB. LITIG. 17
different products, so it has little relevance to the existence
of a duty to provide such a comparison. Instead, Bard’s
theory is principally supported by non-Georgia decisions.
For example, the Sixth Circuit, applying Ohio law, has held
that a drug manufacturer must “make a reasonable disclosure
of all the risks inherent in its own drug” but need not
“provide a comparison of its drug with others.” Ackley v.
Wyeth Labs., Inc., 919 F.2d 397, 405 (6th Cir. 1990); accord
Pluto v. Searle Labs., 690 N.E.2d 619, 621 (Ill. App. Ct.
1997).
There is some logic to those decisions: manufacturers
generally do not have special access to information about
their competitors’ products, and such information might be
difficult for consumers to evaluate meaningfully. On the
other hand, a jury could find it significant that the warnings
in this context are not provided directly to the ultimate
consumer. Under the learned-intermediary doctrine, “the
manufacturer of a prescription drug or medical device does
not have a duty to warn the patient of the dangers involved
with the product, but instead has a duty to warn the patient’s
doctor, who acts as a learned intermediary between the
patient and the manufacturer.” McCombs v. Synthes
(U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003). Comparative-risk
information that might be meaningless to a layperson could
be very important to a physician, or so a jury could find.
In any event, because this case is governed by Georgia
law, our task is not to apply the rule we think would be best,
or the rule we think is reflected in the leading decisions from
state courts around the country. Rather, we must determine
what rule the Georgia courts would apply. See Erie R.R. Co.
v. Tompkins, 304 U.S. 64, 78–80 (1938); Norcia v. Samsung
Telecomms. Am., LLC, 845 F.3d 1279, 1284 (9th Cir. 2017).
18 IN RE BARD IVC FILTERS PRODS. LIAB. LITIG.
The Georgia Supreme Court has held that “the
manufacturer of a product which, to its actual or constructive
knowledge, involves danger to users, has a duty to give
warning of such danger.” Chrysler Corp. v. Batten,
450 S.E.2d 208, 211 (Ga. 1994) (quoting Ford Motor Co. v.
Stubblefield, 319 S.E.2d 470, 476 (Ga. Ct. App. 1984)).
“Normally, where a warning has been provided by a
manufacturer, ‘[t]he sufficiency of that warning is for the
jury.’” Copeland v. Ashland Oil, Inc., 373 S.E.2d 629, 630
(Ga. Ct. App. 1988) (quoting Beam v. Omark Indus.,
237 S.E.2d 607, 610 (Ga. Ct. App. 1977)). Georgia has not
adopted a categorical prohibition on basing a failure-to-warn
claim on the absence of a comparative warning. And other
federal courts applying Georgia law have allowed such
claims. See, e.g., Watkins v. Ford Motor Co., 190 F.3d 1213,
1220 (11th Cir. 1999); In re Mentor Corp. ObTape
Transobturator Sling Prods. Liab. Litig., 711 F. Supp. 2d
1348, 1377–78 (M.D. Ga. 2010). Consistent with those
decisions, we conclude that the district court correctly
allowed the jury to decide the adequacy of the warning here.
IV
Finally, Bard argues that the district court erred by
denying its renewed motion for judgment as a matter of law,
which challenged the evidentiary sufficiency for the punitive
damages award. We review the denial of such a motion de
novo, viewing the evidence in the light most favorable to the
verdict. Harper v. City of Los Angeles, 533 F.3d 1010, 1021
(9th Cir. 2008). We must uphold the punitive damages award
“if it is supported by substantial evidence, which is evidence
adequate to support the jury’s conclusion, even if it is also
possible to draw a contrary conclusion.” Id. (quoting Pavao
v. Pagay, 307 F.3d 915, 918 (9th Cir. 2002)).
IN RE BARD IVC FILTERS PRODS. LIAB. LITIG. 19
Under Georgia law, a jury may award punitive damages
when “it is proven by clear and convincing evidence that the
defendant’s actions showed 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); see
Roseberry v. Brooks, 461 S.E.2d 262, 268 (Ga. Ct. App.
1995) (explaining that an award of punitive damages
requires “circumstances of aggravation or outrage”). The
Georgia Supreme Court has articulated “a general rule” that
punitive damages are “improper where a defendant has
adhered to . . . safety regulations.” Stone Man, Inc. v. Green,
435 S.E.2d 205, 206 (Ga. 1993). But that rule does not
“preclude[] an award of punitive damages where,
notwithstanding the compliance with applicable safety
regulations, there is other evidence showing culpable
behavior.” General Motors Corp. v. Moseley, 447 S.E.2d
302, 311 (Ga. Ct. App. 1994), abrogated on other grounds
by Webster v. Boyett, 496 S.E.2d 459 (Ga. 1998). When a
failure to warn reflects “a conscious disregard for the safety
of others,” punitive damages may be appropriate. Zeigler v.
CloWhite Co., 507 S.E.2d 182, 185 (Ga. Ct. App. 1998).
Bard’s challenge to the punitive damages award is
largely derivative of its argument that it had no duty to warn
of comparative risks. In Bard’s view, punitive damages are
inappropriate because it sold a product that was “not
defective and sold with an adequate warning.” But the jury
found that the warning was not adequate. As the district
court explained, “[t]he evidence supported a finding that
despite knowing that G2 filters placed patients at a greater
risk of harm” than other available filters, “Bard chose not to
warn physicians and instead downplayed the risk.” Although
it would have been possible for the jury “to draw a contrary
conclusion,” we conclude that the evidence was adequate to
20 IN RE BARD IVC FILTERS PRODS. LIAB. LITIG.
support the jury’s award of punitive damages. Harper,
533 F.3d at 1021.
AFFIRMED.