FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

IN RE BARD IVC FILTERS 

PRODUCT LIABILITY 

LITIGATION,

SHERR-UNA BOOKER,

Plaintiff-Appellee,

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.

No. 18-16349

D.C. Nos.

2:15-md-02641-DGC

2:16-cv-00474-DGC

OPINION

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 nonreviewability 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 statelaw 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-towarn 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-towarn 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.