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WO

IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF ARIZONA 

IN RE: Bard IVC Filters Products Liability 

Litigation, 

___________________________________ 

Sherr-Una Booker, an individual, 

Plaintiff, 

v. 

C. R. Bard, Inc., et al. 

Defendants. 

No. MDL 15-02641-PHX DGC 

No. CV-16-00474-PHX-DGC 

ORDER 

This multidistrict litigation proceeding (“MDL”) involves thousands of personal 

injury cases related to inferior vena cava (“IVC”) filters manufactured and marketed by 

Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, “Bard”). 

Plaintiff Sherr-Una Booker, who had a Bard filter implanted ten years ago, brought one 

of the MDL cases. Plaintiff Booker’s case has been selected as one of several bellwether 

cases and is set for trial in March 2018. 

Plaintiffs have filed a motion in limine based on Federal Rules of Evidence 402 

and 403 to preclude evidence of (1) the premarket clearance of Bard IVC filters by the 

Food and Drug Administration (“FDA”), and (2) the lack of FDA enforcement action 

against Bard. Doc. 9529. The motion is fully briefed, and the parties agree that oral 

argument is not necessary. The Court will deny the motion. 
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I. Background.

 The IVC is a large vein that returns blood to the heart from the lower body. IVC 

filters are small metal devices implanted in the IVC to catch blood clots before they reach 

the heart and lungs. Seven different versions of Bard IVC filters are at issue in this MDL 

– the Recovery, G2, G2 Express, G2X, Eclipse, Meridian, and Denali. 

 IVC filters and other medical devices must be approved or cleared for market by 

the FDA. The FDA may approve a medical device that is shown to be safe and effective 

through a process known as “premarket approval[.]” 21 U.S.C. § 360e(a). Such approval 

is not required, however, for most medical devices. Through a less rigorous process 

known as section “510(k)” review, a manufacturer can obtain “clearance” to market a 

device by showing that it is substantially equivalent to a device already on the market. 

21 U.S.C. § 360c(f)(1)(A). Each Bard IVC filter at issue in this MDL received FDA 

clearance through 510(k) review.1

 Plaintiffs allege that Bard filters are more dangerous than other IVC filters because 

they have a higher risk of tilting, perforating the IVC, or fracturing and migrating to 

neighboring organs. Plaintiffs further allege that Bard failed to warn physicians and 

patients about these higher risks. Doc. 303-1. Bard disputes Plaintiffs’ allegations, 

contending that overall complication rates for Bard filters are comparable to those of 

other IVC filters and that the medical community is aware of IVC filter risks. 

 Plaintiff Booker was implanted with a G2 filter in June 2007 and suffered injuries 

from the filter’s failure. She asserts various claims against Defendants under Georgia 

law. Doc. 1, CV-16-00474-PHX-DGC. The following claims remain for trial: design 

defect, failure to warn, and punitive damages. See Doc. 8874 at 22. 

II. Federal Rules of Evidence 401, 402, and 403.

The relevance and admissibility of evidence at trial is governed in part by 

Rules 401, 402, and 403. Evidence is relevant under Rule 401 if it has any tendency to 

 

1

 For further discussion of IVC filters and the FDA regulatory process, see the Court’s order regarding preemption. Doc. 8872 at 2-5. 
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make a material fact more or less probable. Fed. R. Evid. 401(a)-(b). Rule 402 provides 

that relevant evidence is admissible unless otherwise excluded by the rules, a federal 

statute, or the Constitution; irrelevant evidence is not admissible. Fed. R. Evid. 402. 

Under Rule 403, relevant evidence may be excluded if its probative value is substantially 

outweighed by the danger of “unfair prejudice, confusing the issues, misleading the jury, 

undue delay, wasting time, or needlessly presenting cumulative evidence.” Fed. R. Evid. 

403. Trial courts have discretion to limit or exclude evidence under Rules 402 and 403. 

United States v. Scholl, 166 F.3d 964, 971 (9th Cir. 1999). 

III. Discussion. 

A. The FDA’s Clearance of the G2 Filter Under 501(k) Review. 

 Plaintiffs argue that Defendants intend to assert an “FDA defense” at trial by 

implying that the 510(k) clearance process demonstrates filter “safety and effectiveness” 

and the reasonableness of Bard’s conduct. Plaintiffs contend that such evidence is not 

relevant to any issue in the case and should be excluded under Rule 402. Doc. 9529 

at 1-2. The Court does not agree. 

 Georgia courts have adopted a risk-utility analysis for design defect claims like 

those asserted by Plaintiff Booker. This analysis incorporates negligence principles and 

the “concept of ‘reasonableness,’ i.e., whether the manufacturer acted reasonably in 

choosing a particular product design[.]” Banks v. ICI Ams., Inc., 450 S.E.2d 671, 673 

(Ga. 1994). One of the many factors a jury may consider in its reasonableness 

determination is the manufacturer’s compliance with federal regulations. Id. at 675 

& n.6. Compliance with the regulations may not render a manufacturer’s design choice 

immune from liability, but it can be a “piece of the evidentiary puzzle.” Doyle v. 

Volkswagenwerk Aktiengesellschaft, 481 S.E.2d 518, 521 (Ga. 1997); see Duran v. 

Paccar, Inc., 549 S.E.2d 755, 762 (Ga. Ct. App. 2001) (“[C]ompliance with federal 

standards or regulations is probative of Paccar’s reasonableness under the risk-utility 

analysis.”). Given these principles of Georgia law, the Court finds that evidence of 

Bard’s compliance with the 510(k) process, while certainly not dispositive, is nonetheless 
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relevant to the reasonableness of Bard’s conduct and whether the company defectively 

designed the G2 filter. 

The evidence is also relevant to Plaintiff’s punitive damages claim. Under 

Georgia law, punitive damages may be awarded only where 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). Compliance with federal regulations is not sufficient to 

preclude an award of punitive damages, see Doc. 8874 at 18, but it is probative of 

whether the manufacturer acted with conscious indifference to the dangers posed by its 

device. See Stone Man, Inc. v. Green, 435 S.E.2d 205, 206 (Ga. 1993) (noting that 

generally “compliance with county, state, and federal regulations is not the type of 

behavior which supports an award of punitive damages”); Barger v. Garden Way, Inc., 

499 S.E.2d 737, 743 (Ga. Ct. App. 1998) (same). 

Plaintiffs note, correctly, that the 510(k) process focuses on device equivalence, 

not device safety. Doc. 9529 at 2 (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 

(1996)). But this does not render evidence of the 510(k) process irrelevant to the 

reasonableness of Bard’s conduct. The FDA grants 510(k) clearance only where the 

device “is as safe and effective as a [predicate device] and does not raise different 

questions of safety and efficacy than the predicate device.” Safe Medical Devices Act of 

1990, Pub. L. No. 101-629, § 12(a)(1)(A)(ii). The 510(k) process may not speak directly 

to the applicable standard of care under Georgia law, but it does have probative value in 

the determination of this action. See Winebarger v. Boston Sci. Corp., No. 3:15CV211-

RLV, 2015 WL 5567578, at *7 (W.D.N.C. Sept. 22, 2015) (“The fact that BSC followed 

the requisite 510(k) protocol – limited as it is – prior to marketing its [medical] device 

has minimal probative value regarding BSC’s efforts to adhere to FDA processes and 

procedure generally.”). 

The Court, according to Plaintiffs, already “found that 510(k) clearance is 

irrelevant to Plaintiffs’ state law claims.” Doc. 9529 at 2. The Court made no such 
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finding, and has not previously addressed the question now before it – whether evidence 

of the 510(k) process is relevant to the claims and defenses in the Booker case.2

In their reply brief, Plaintiffs cite a suggested Georgia jury instruction for the 

proposition that juries are limited to considering only those regulations related to 

“safety.” Doc. 9824 at 2. Plaintiffs note that the cases cited in support of the instruction 

are the very cases Defendants cite in arguing that a jury may consider federal standards. 

Id.; see Doc. 9842-1 at 3 (citing Banks and Doyle). But in Banks, the Georgia Supreme 

Court made clear that in determining the reasonableness of a manufacturer’s conduct, 

“no finite set of factors can be considered comprehensive or applicable under every 

factual circumstance, since such matters must necessarily vary according to the unique 

facts of each case.” Banks, 450 S.E.2d at 675. And nothing in Doyle suggests that only 

safety regulations may be relevant in design defect cases. See Doyle, 481 S.E.2d at 521. 

Plaintiffs contend that 510(k) evidence should be excluded under Rule 403 

because any probative value it may have is substantially outweighed by the risk of 

confusion as to whether Bard filters were found by the FDA to be safe and effective. 

Doc. 9526 at 3-6. Plaintiffs further contend that admission of such evidence would 

cause the case to devolve into a series of mini-trials regarding the 510(k) process and 

Bard’s compliance with it. Id. Plaintiffs note that other courts, including the district 

court in Cisson, have excluded 510(k) evidence under Rule 403. Id. at 3-5 & n.2. 

In Cisson, the court was concerned that allowing 510(k) evidence would create a 

“substantial risk of misleading the jury to believe that FDA 510(k) clearance might be 

 

2

 In its ruling on Defendants’ preemption motion, the Court noted that “[m]any cases interpret Riegel and Lohr to mean that PMA approval preempts different or additional requirements imposed by state tort law, while 510(k) clearance does not.” 

Doc. 8872 at 11. The Court then provided a string cite of these cases that included Cisson v. C. R. Bard, Inc., No. 2:11-cv-00195, 2013 WL 5700513, at *12 (S.D. W. Va. 

Oct. 18, 2013), with this parenthetical quote from Cisson: “[T]he 510(k) process does not address product safety and efficacy and therefore is not relevant to Bard’s obligations under Georgia state tort law.” Id. Plaintiffs cite this citation as support for their claim that the Court has resolved the issue in this motion in limine, but that is a real stretch. 

Not only was the Court not addressing any evidentiary issue in the preemption discussion, it was not even approving the cases included in the string cite. To the contrary, two pages later the Court held that the 510(k) process can in some circumstances preempt state law claims. Id. at 13-14. 
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dispositive of the plaintiffs’ state law claims” and would result in a “mini-trial on the 

510(k) process and enforcement[.]” In re C.R. Bard, Inc., Pelvic Repair Sys. Prod. Liab. 

Litig. (Cisson), No. 2:10-CV-01224, 2013 WL 3282926, at *2 (S.D.W. Va. June 27, 

2013). The Court understands these concerns, but believes they can be adequately 

addressed without excluding relevant evidence to the detriment of Defendants. 

Both sides, through appropriate expert testimony or other admissible evidence, 

will be permitted to tell the jury about the role of the FDA in its oversight of medical 

device manufacturers, the regulatory clearance process for devices such as IVC filters, 

and Bard’s participation in the 510(k) process and its compliance (or lack thereof) with 

that process. See Doc. 9433 at 8-9, 16; Block v. Woo Young Med. Co., 937 F. Supp. 2d 

1028, 1047 (D. Minn. 2013) (allowing expert witness to testify to “the general nature of 

the FDA’s approval and regulatory process, the FDA’s general expectations with respect 

to testing and marketing of new products, and [the defendant’s] actions in that respect”); 

Musgrave v. Breg, Inc., No. 2:09-CV-01029, 2011 WL 4620767, at *3 (S.D. Ohio Oct. 3, 

2011) (denying Rule 403 challenge to 510(k) evidence and noting that the plaintiffs “may 

argue about what it means, but they cannot keep the jury from hearing the fact that the 

FDA cleared . . . the [device]”). Defendants will not, however, be permitted to present 

evidence or argument that the FDA “approved” the G2 filter for market, or that clearance 

of the device under 510(k) review constitutes a finding by the FDA that the filter is “safe 

and effective.” As relevant FDA regulations explain: “Any representation that creates an 

impression of official approval of a device because of complying with the [510(k)] 

premarket notification regulations is misleading[.]” 21 C.F.R. § 807.97. Plaintiffs 

certainly will be free to present evidence and argument that the 510(k) process is a 

comparative one that requires only substantial equivalence to a predicate device, that 

510(k) regulations are not safety regulations, and – as Plaintiffs claim – that Bard 

withheld information from the FDA and otherwise failed to fully comply with the 510(k) 

regulations. 
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Moreover, any potential confusion can be cured, if necessary, by a limiting 

instruction regarding the nature of the 510(k) process. See Winebarger, 2015 WL 

5567578, at *7 (finding 510(k) evidence admissible with “a limiting instruction that 

510(k) clearance is not to be considered as evidence that the FDA authorized the [device] 

as safe and approved its intended use as such,” or that the defendant “satisfied any 

standard of care in designing the . . . device”). 

It is worth noting that the absence of any evidence regarding the 510(k) process 

would run the risk of confusing the jury as well. Many of the relevant events in this case 

occurred in the context of FDA 510(k) review, and much of the evidence is best 

understood in that context. Attempting to remove any references to the FDA from the 

trial would risk creating a misleading, incomplete, and confusing picture for the jury. 

Additionally, the Court is not convinced that all FDA-references could be removed, given 

that much of the evidence – such as the MAUDE database – comes from the FDA. And 

if the evidence was half-baked, containing some references to the FDA but not explaining 

what role the FDA played with respect to the Bard filters, the jury would be left to 

speculate about the FDA’s involvement and conclusions.

The Court is also convinced that efficient management of the evidence and 

adherence to the Court’s time limits will avoid any risk of unnecessary or timeconsuming mini-trials. Plaintiffs argue that the parties’ regulatory experts likely will take 

a day each for direct and cross-examination, and that the time limitations set by the Court 

will prove prohibitive. Doc. 9529 at 6 & n.4. The Court does not agree. The Court is 

confident that counsel for each side will be able to adequately and efficiently try this case 

in the time allotted by the Court. See Doc. 9415 at 2. 

B. The Lack of FDA Enforcement.

Plaintiffs argue that evidence of the lack of FDA enforcement action against Bard 

is irrelevant, and that it would be misleading and prejudicial for Bard to suggest to the 

jury that the lack of enforcement signifies product safety. Doc. 9529 at 6-8. Whether 

evidence that the FDA took no enforcement action against Bard is relevant and otherwise 
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admissible will depend heavily on the context in which the evidence is offered, including 

evidence presented by Plaintiffs (such as the FDA warning letter). The Court will make 

this ruling during trial. 

IT IS ORDERED that Plaintiffs’ Motion in Limine #1 to exclude evidence of 

FDA 510(k) clearance and lack of FDA enforcement (Doc. 9529) is denied. 

Dated this 29th day of January, 2018.