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Ramon Rossi Lopez – rlopez@lopezmchugh.com

(California Bar Number 86361; admitted pro hac vice) 

Lopez McHugh LLP 

100 Bayview Circle, Suite 5600 

Newport Beach, California 92660 

949-812-5771 

Mark S. O’Connor (011029) – mark.oconnor@gknet.com

Gallagher & Kennedy, P.A. 

2575 East Camelback Road 

Phoenix, Arizona 85016-9225 

602-530-8000 

Co-Lead/Liaison Counsel for Plaintiffs 

UNITED STATES DISTRICT COURT 

DISTRICT OF ARIZONA 

In Re Bard IVC Filters Products 

Liability Litigation 

No. MD-15-02641-PHX-DGC

SHERR-UNA BOOKER, an 

individual, 

Plaintiff, 

v. 

C.R. BARD, INC., a New Jersey 

corporation and BARD 

PERIPHERAL VASCULAR, an 

Arizona corporation, 

Defendants. 

PLAINTIFF’S RESPONSE TO 

DEFENDANTS’ MOTION IN LIMINE

#3 TO EXCLUDE EVIDENCE OF FDA 

WARNING LETTER 

(The Honorable David G. Campbell) 

(Oral Argument Requested) 

Bard’s Motion in Limine No. 3 [Doc. 9864] (“Motion”) seeking to exclude 

evidence of the FDA’s July 13, 2015, warning letter to Bard (“Warning Letter”) on the 

bases of relevance, undue prejudice and hearsay should be denied. 

A. The Warning Letter is relevant. 

Bard’s claim that the Warning Letter is a “red herring” is wrong. First, and most 

importantly, Bard vigorously opposed Plaintiffs’ efforts to exclude (see Plaintiffs’ Motion 

in Limine No. 1 [Doc. 9529]) evidence of FDA clearance or activity related to Bard’s IVC 

filters. See Defendants’ Response to Plaintiffs’ Motion in Limine No. 1 [Doc. 9690]. 

Case 2:15-md-02641-DGC Document 9927 Filed 02/02/18 Page 1 of 4
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Bard argued that “compliance with federal regulatory standards . . . is certainly probative 

under Georgia law on the issues of reasonableness of the design, manufacture, and 

warnings of the G2 Filter.” Id. at 2. Based on Georgia law, the Court agreed with Bard. 

See Order Denying Motion in Limine No. 1 [Doc. 9881]. 

Given this posture, the Warning Letter is now an essential piece of evidence to 

rebut Bard’s suggestion that the FDA took no action and expressed no concerns related to 

its IVC filters. If Bard can use FDA’s clearance of its filter as a shield in support of its 

defenses, fair play requires that Plaintiffs be allowed to use the Warning Letter to rebut 

any suggestion that, once the FDA cleared the filters, it had no concerns about their 

performance. The FDA’s finding that Bard failed in its reporting and handling of cases 

involving filter failure in patients is of particular relevance given the nature of Plaintiffs’ 

claims concerning failure rates and comparative product performance.1

 

Bard’s argument that the Warning Letter is irrelevant since it is not a “final agency 

determination” is equally flawed. The FDA’s position is that: 

Warning Letters are issued only for violations of regulatory 

significance. Significant violations are those violations that 

may lead to enforcement action if not promptly and adequately 

corrected. A Warning Letter is the agency's principal means of 

achieving prompt voluntary compliance with the Federal Food, 

Drug, and Cosmetic Act (the Act). 

FDA Regulatory Procedures Manual, Exhibit 1, at § 4-1-1. Warning letters are direct 

communications with device manufacturers designed to ensure compliance. The fact that 

Bard may have avoided further action does not render the FDA’s findings of violations 

irrelevant or inadmissible, particularly when Bard is expected to open the door relating to 

FDA clearance and regulation of its devices. See Sadler v. Advanced Bionics, Inc., 2013 

WL 1311148 at *1-2 (W.D. Ky. 2013) (FDA warning letter relevant and admissible). 

 

1

 This is true regardless of whether Dr. D’Ayala relied on MAUDE database information 

in electing to use the G2 filter for Ms. Booker. 

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B. The Warning Letter is not unduly prejudicial. 

 Given Bard’s arguments relating to Plaintiffs’ Cisson motion, Bard can hardly be 

heard now to complain of undue prejudice from Plaintiffs introducing evidence of the 

Warning Letter in response to Bard’s evidence concerning FDA clearance and regulation 

of its filters. Any prejudice due to evidentiary heft the jury places on a regulatory 

agency’s determinations is invited by Bard. The same goes for Bard’s contention that it 

would be required to spend an inordinate amount of time to place the Warning Letter in 

context. Motion at 3. Any time spent placing the Warning Letter “in proper context” 

pales in comparison to the amount of time Plaintiffs will spend placing other FDA actions, 

including clearance of the devices for market, “in proper context.” Moreover, Bard’s 

acknowledgment that it can put such evidence into context for the jury ameliorates any 

risk of undue prejudice. See Sadler, 2013 WL 1311148 at *1-2 (“[Defendant] will have 

ample opportunity to show that the statements in the documents are mere observations.”). 

C. The Warning Letter is a Public Record and Admissible. 

 Under Rule 803(8), a public record such as the Warning Letter may be admitted as 

a hearsay exception as long as it “contains factual findings and satisfies [the] 

trustworthiness requirement.” Sabel, 737 F.Supp. at 142.2

 Before it can issue a warning 

letter, the FDA considers whether (1) evidence shows that a product is in violation of law 

or regulations and failure to correct the violation may result in enforcement action; and (2) 

the violations are of regulatory significance. Exhibit 1 at § 4-1-3. These factors 

demonstrate that, while the FDA is not making a final determination when it issues a 

warning letter, it is providing (1) factual findings taken from an examination performed 

 

2

 While district courts are divided on the issue, many have held that FDA warnings, like 

the Warning Letter, are admissible under the public records hearsay exception in Rule 

803(8). See Guthrie v. Ball, 2014 WL 5314576 at *4 (E.D. Tenn. 2014); Musgrave v. 

Breg, Inc., 2011 WL 4502032 at *6 (S.D. Ohio 2011)(“These portions of 

the FDA bulletins fall within the hearsay exception defined by Rule 803(8) because they 

are statements directly from the FDA ‘setting forth matters observed pursuant to duty 

imposed by law as to which matters there was a duty to report’”) (quoting Rule 

803(8)); Sabel, 737 F.Supp. at 135. 

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(2) in the course of its administrative role—both of which place the warning letters within 

the public records hearsay exception articulated in Rule 803(8). See Sadler, 2013 WL 

1311148 at *1-2 (finding that FDA warning letter was within the Rule 803(8) hearsay 

exception; “FDA officials conducted the investigation themselves as a neutral party with 

motivations to protect public health and safety. Therefore, the Court finds these 

documents sufficiently reliable to be excepted from the hearsay rule”).3

 For these reasons, evidence concerning the Warning Letter is admissible. 

RESPECTFULLY SUBMITTED this 2nd day of February, 2018. 

GALLAGHER & KENNEDY, P.A. 

By: /s/ Mark S. O’Connor 

Mark S. O’Connor 

2575 East Camelback Road 

Phoenix, Arizona 85016-9225 

LOPEZ McHUGH LLP 

Ramon Rossi Lopez (CA Bar No. 86361) 

(admitted pro hac vice) 

100 Bayview Circle, Suite 5600 

Newport Beach, California 92660 

Co-Lead/Liaison Counsel for Plaintiffs 

CERTIFICATE OF SERVICE 

I hereby certify that on this 2nd day of February, 2018, I electronically transmitted 

the attached document to the Clerk’s Office using the CM/ECF System for filing and 

transmittal of a Notice of Electronic Filing. 

/s/ Gay Mennuti 

 

3

 Some of the cases Bard cites in support of its claims of inadmissibility are 

distinguishable. For instance, in Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. State, the 

decision in that case turned on divergent language in Arkansas’ version of Rule 803 to 

exclude a DDMAC warning letter. 432 S.W.3d 563, 579-80 (Ark. 2014). Moreover, three 

justices joined in a dissenting opinion that noted it was “apparent” the warning letter fell 

“clearly within the public-records exception.” Id. at 581. 

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