1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

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 MOTION IN LIMINE #10 

AND MEMORANDUM IN SUPPORT 

TO EXCLUDE EVIDENCE THAT 

DEFENDANTS NEEDED FDA 

CONSENT BEFORE ADDING A 

WARNING TO ITS LABELING OR 

ISSUING A RECALL 

(The Honorable David G. Campbell) 

(Oral Argument Requested) 

MEMORANDUM IN SUPPORT OF PLAINTIFF’S MOTION IN LIMINE TO 

EXCLUDE EVIDENCE THAT DEFENDANTS NEEDED FDA CONSENT 

BEFORE ADDING A WARNING TO ITS LABELING OR ISSUING A RECALL

Plaintiffs seek a pretrial ruling to preclude Defendants from commenting on, 

referring to, or introducing argument or evidence at trial that suggests Defendants needed 

consent from the FDA to add a warning to its label, send warning letters to physicians or 

consumers, or recall the G2 IVC Filter from the market. 

MEMORANDUM OF LAW 

The Supreme Court has clearly expressed that “the manufacturer bears 

responsibility for the content of its label at all times. It is charged both with crafting an 

Case 2:15-md-02641-DGC Document 9875 Filed 01/26/18 Page 1 of 3
2 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

adequate label and with ensuring that its warnings remain adequate as long as the drug is 

on the market.” Wyeth v. Levine, 555 U.S. 555, 571 (U.S. 2009). FDA regulations also 

specifically allow a manufacturer to recall its medical device at any time. 21 C.F.R. § 

7.46, titled “Firm-initiated recall,” states, “A firm may decide of its own volition and 

under any circumstances to remove or correct a distributed product.” 

Furthermore, Bard’s own Senior Marketing Manager, Janet Hudnall, specializing 

in the G2 line of IVC filters, admitted that Bard removed the previous version of the G2 

filter, the Recovery filter, from the market once the newer G2 line was available. See

Deposition Testimony of Janet Hudnall, Nov. 1, 2013, Exhibit A, at 136:3-12. Bard also 

testified through its corporate representative in a Rule 30(b)(6) deposition that 

manufacturers can voluntarily remove products from the market. Deposition Testimony 

of Chad Modra, Mar. 28, 2013, Exhibit B, at 169:2-169:17. 

Bard also could have sent letters voluntarily to physicians in order to warn them of 

the increased risks of migration, perforation, tilt, and fracture associated with its products. 

Bard itself admits that in safety-related events—such as a misbranding—Bard could have 

sent letters to customers informing them of the event. Chad Modra testified on behalf of 

Bard that, after a misbranding, Bard could take “various forms of action, and that would 

include sending a letter to customers . . . .” (Exhibit B, at 167:24-169:8.) Nothing, 

including FDA agreement, consent, or command precluded Bard from providing many 

levels of warning of the increased risk of migration, perforation, tilt, and fracture it 

became aware of associated with its G2 line of filters. 

Therefore, Bard should be precluded from arguing and putting into evidence 

anything that insinuates it could not have taken appropriate steps to voluntarily change its 

labeling1

 to add a warning, send letters to its customers, or effectuate a voluntary 

removal/recall from the market. Such evidence is not relevant and its probative value is 

 

1

 Labeling is not limited to the IFU, it relates to all printed or graphic material regarding a 

medical device. 21 U.S.C. 321(m). 

Case 2:15-md-02641-DGC Document 9875 Filed 01/26/18 Page 2 of 3
3 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

substantially outweighed by confusion of the issues, misleading the jury, and being 

unnecessarily time-consuming. Fed. R. Evid. 401, 402, 403. 

Based upon the foregoing, Plaintiffs respectfully move the Court in limine to enter 

an Order granting this motion and precluding Defendants from commenting on, referring 

to, or introducing evidence that suggests that Defendants needed consent from the FDA 

to add a warning to its label, send warning letters to physicians/consumers, or recall its 

filters. 

RESPECTFULLY SUBMITTED this 26th day of January, 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 26th day of January, 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 

Case 2:15-md-02641-DGC Document 9875 Filed 01/26/18 Page 3 of 3