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Nelson Mullins Riley & Scarborough

L.L.P.

201 17t h Street NW, Suite 1700

Atlanta, GA 30363

(404) 322-6000

James R. Condo (#005867)

Amanda C. Sheridan (#027360)

SNELL & WILMER L.L.P.

One Arizona Center

400 E. Van Buren, Suite 1900

Phoenix, AZ 85004-2204

Telephone: (602) 382-6000

jcondo@swlaw.com

asheridan@swlaw.com

Richard B. North, Jr. (admitted pro hac vice)

Georgia Bar No. 545599

Matthew B. Lerner (admitted pro hac vice)

Georgia Bar No. 446986

NELSON MULLINS RILEY & SCARBOROUGH LLP

Atlantic Station

201 17th Street, NW, Suite 1700

Atlanta, GA 30363

Telephone: (404) 322-6000

richard.north@nelsonmullins.com 

matthew.lerner@nelsonmullins.com

Attorneys for Defendants

C. R. Bard, Inc. and 

Bard Peripheral Vascular, Inc.

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF ARIZONA

IN RE: Bard IVC Filters Products Liability 

Litigation,

No. 2:15-MD-02641-DGC

DEFENDANTS’ MOTION AND 

MEMORANDUM IN SUPPORT OF 

MOTION IN LIMINE NO. 3 TO 

EXCLUDE EVIDENCE OF FDA 

WARNING LETTER

(Assigned to the Honorable David G. 

Campbell)

Case 2:15-md-02641-DGC Document 9864 Filed 01/26/18 Page 1 of 6
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Nelson Mullins Riley & Scarborough

L.L.P.

201 17t h Street NW, Suite 1700

Atlanta, GA 30363

(404) 322-6000

Bard moves in limine to exclude any evidence concerning the July 13, 2015 FDA 

Warning Letter. 1 See Exhibit A. Evidence of the Warning Letter should be excluded 

because (a) it is an irrelevant, informal advisory statement by FDA that does not constitute 

a final agency action, (b) the prejudicial effect of the FDA Warning Letter substantially 

outweighs any probative value, and (c) it is inadmissible hearsay. The Warning Letter was 

issued more than eight years after Plaintiff received her G2® Filter in 2007. The 

following chart categorizes the issues raised in the Warning Letter and illustrates how it is 

not relevant2: 

Warning Letter Item Nos. Why it Is Not Relevant

Nos. 1 and 2 regarding the 

Recovery Cone 

 Plaintiff makes no allegations that the Recovery Cone 

caused or contributed to her injuries. 

Nos. 4(b), 5, and 6 regarding 

the manufacturing process of 

the Denali Filter 

 Plaintiff did not receive a Denali Filter, and any 

criticism by FDA regarding the manufacturing process 

of the Denali Filter has absolutely no impact on this 

case.

No. 4(a) regarding cleaning 

process of Bard’s filters 

 Plaintiff has made no allegation that her G2 Filter 

suffered from some alleged inadequate cleaning 

process. 

Nos. 3, 7, 8 regarding Bard’s 

complaint handling and 

MDR reporting procedures 

 Although the FDA raised questions regarding Bard’s 

complaint handling and medical device reporting 

practices, none of FDA’s concerns impact the accuracy 

or integrity of Bard’s complication rate calculations.3

 While the FDA questioned a handful of Bard’s 

categorizations of MDR reports that are published on 

FDA’s MAUDE database, there is no evidence that the 

implanting physician, Dr. D’Ayala, relied upon 

information on the MAUDE database when deciding 

to use the G2 in or before 2007.

ARGUMENT AND CITATION OF AUTHORITY

The FDA Warning Letter is a red herring that has no relevance to this case. Instead, 

 

1 Counsel for Defendants conferred with counsel for Plaintiffs and this motion is opposed.

2 Bard refers the Court to, and incorporates by reference here, the background information 

concerning the Warning Letter provided in Defendants’ Memorandum at Doc. 693. 

3

In its prior briefing, Bard explained why FDA’s questions do not impact the integrity or 

accuracy of Bard’s internal trending and rate analyses. See, e.g., Doc. 693 at 11-15. 

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Nelson Mullins Riley & Scarborough

L.L.P.

201 17t h Street NW, Suite 1700

Atlanta, GA 30363

(404) 322-6000

it has the strong potential to cause extreme prejudice to Bard and to confuse the jury. 

First ̧ the Warning Letter is an irrelevant, “informal” “advisory” statement by FDA 

that does not constitute a “final agency action” or determination. See Chapter 4 of FDA’s 

Regulatory Procedures Manual4at p. 4-2 to 4-3; see also Dietary Supp. Coalition, Inc. v. 

Sullivan, 978 F.2d 560, 562–63 (9th Cir. 1992) (“[T]he type of informal letter issued by 

the FDA . . . does not constitute . . . formal or final agency action.” (internal quotation 

marks omitted)). The Warning Letter does not tend to prove or disprove a material fact for 

the simple reason that it is not a final agency determination or opinion on the matters 

expressed therein. Additionally, as shown by the chart above, the Warning Letter does not 

tend to prove or disprove a material fact because nothing in the Letter constitutes a 

criticism of the design or labeling of the G2. When a Warning Letter does not tend to 

prove or disprove a material fact, it should be excluded as irrelevant. See, e.g., In re 

Seroquel Prod. Liab. Litig., No. 6:06MD1769-ORL-22DAB, 2009 WL 223140, at *5 

(M.D. Fla. Jan. 30, 2009); In re Viagra Prod. Liab. Litig., 658 F. Supp. 2d 950, 966–67 

(D. Minn. 2009) (finding that three FDA letters regarding Viagra advertisements were 

irrelevant and inadmissible because two of the letters were issued after Plaintiff stopped 

using Viagra and there was no evidence Plaintiff saw the advertisements in the third). 

Second, the Court should exclude evidence of the Warning Letter under Rule 403, 

because any probative value is substantially outweighed by the danger of unfair prejudice 

to Bard, misleading the jury, and wasting time. Many courts have expressed concern that 

reports issued by governmental agencies, because of their “official” nature, may cause a 

jury to give the evidence inordinate weight. Johnson v. Ford Motor Co., 988 F.2d 573 (5th 

Cir. 1993); see also, e.g., Black v. Ryder/P.I.E. Nationwide, Inc., 15 F.3d 573, 587 (6th 

Cir. 1994) (decision by the NLRB properly excluded because “the jury would be quite 

likely to assign greater value to this decision than it is worth, given that it is the product 

only of an administrative investigation, and not of an adjudicatory procedure”). Because 

 

4 Available at http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProcedures 

Manual/ (last accessed 1/19/2018). 

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Nelson Mullins Riley & Scarborough

L.L.P.

201 17t h Street NW, Suite 1700

Atlanta, GA 30363

(404) 322-6000

of the heightened risk of prejudice associated with government reports, such as Warning 

Letters, courts have excluded Warning Letters because their probative value is 

substantially outweighed by the prejudicial effect. See, e.g., Ortho-McNeil-Janssen 

Pharm., Inc. v. State, 432 S.W.3d 563, 580 (Ark. 2014) (reversing judgment of the trial 

court in favor of plaintiff based in part on trial court’s erroneous admission of an FDA 

Warning Letter, noting that the letter is “more prejudicial than probative”); Newman v. 

McNeil Consumer Healthcare, No. 10 C 1541, 2013 WL 4460011, at *18 (N.D. Ill. Mar. 

29, 2013) (excluding FDA Warning Letter on the grounds that it is “highly prejudicial”). 

Here, if Plaintiff were allowed to introduce evidence regarding the Warning Letter, 

it would unfairly suggest to the jury that wrongdoing must have occurred simply because 

the FDA got involved, even though the Warning Letter has no bearing on the issues in this 

case. Additionally, introduction of the Warning Letter would require Bard to spend an 

inordinate amount of time putting the it into proper context, explaining to the jury that it is 

not a final agency determination, that the FDA’s assertions do not impact Plaintiff’s 

allegations, and the rigorous actions Bard undertook in response to the Warning Letter. 

Third ̧ the Warning Letter is inadmissible hearsay, and it does not fall within any 

hearsay exception, including without limitation Rule 803(8)’s “Public Records” 

exception. Rule 803(8) applies only to official or formal activities of the FDA “setting 

forth the activities” of the FDA, not to “preliminary or interim evaluative opinions of 

agency staff members” such as those expressed in the Warning Letter. See Smith v. Isuzu 

Motors, Ltd., 137 F. 3d 859, 862 (5th Cir. 1998). Because the Warning Letter constitutes 

an informal and preliminary statement by FDA, it does not fall within Rule 803(8)’s 

hearsay exception. See, e.g., Toole v. McClintock, 999 F.2d 1430, 1434 (11th Cir. 1993) 

(preliminary “FDA report is not the kind of trustworthy report described in Rule 803”). 

CONCLUSION

For the foregoing reasons, Bard respectfully moves for an entry of an in limine

order to exclude any evidence regarding the July 13, 2015 FDA Warning Letter issued to 

Bard. 

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Nelson Mullins Riley & Scarborough

L.L.P.

201 17t h Street NW, Suite 1700

Atlanta, GA 30363

(404) 322-6000

RESPECTFULLY SUBMITTED this 26th day of January, 2018.

s/ Richard B. North, Jr.

Richard B. North, Jr.

Georgia Bar No. 545599

Matthew B. Lerner

Georgia Bar No. 446986

NELSON MULLINS RILEY & SCARBOROUGH, LLP

Atlantic Station

201 17th Street, NW / Suite 1700

Atlanta, GA 30363

PH: (404) 322-6000

FX: (404) 322-6050

richard.north@nelsonmullins.com

matthew.lerner@nelsonmullins.com

James R. Condo (#005867)

Amanda Sheridan (#027360)

SNELL & WILMER L.L.P.

One Arizona Center

400 E. Van Buren

Phoenix, AZ 85004-2204

PH: (602) 382-6000

jcondo@swlaw.com

asheridan@swlaw.com

Attorneys for Defendants C. R. Bard, Inc. and 

Bard Peripheral Vascular, Inc.

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Nelson Mullins Riley & Scarborough

L.L.P.

201 17t h Street NW, Suite 1700

Atlanta, GA 30363

(404) 322-6000

CERTIFICATE OF SERVICE

I hereby certify that on this 26th day of January, 2018, the foregoing was 

electronically filed with the Clerk of Court using the CM/ECF system which will 

automatically send email notification of such filing to all attorneys of record.

s/Richard B. North, Jr.

Richard B. North, Jr.

Case 2:15-md-02641-DGC Document 9864 Filed 01/26/18 Page 6 of 6