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.