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Snell & Wilmer

 L.L.P.

LAW OFFICES 

One Arizona Center, 400 E. Van Buren, Suite 1900 

Phoenix, Arizona 85004-2202 

602.382.6000 

James R. Condo (#005867)

Amanda C. Sheridan (#027360) 

SNELL & WILMER L.L.P.

One Arizona Center 

400 E. Van Buren, Suite 1900 

Phoenix, Arizona 85004-2202 

Telephone: 602.382.6000 

Facsimile: 602.382.6070 

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 

201 17th Street, NW / Suite 1700 

Atlanta, GA 30363 

Telephone: (404) 322-6000 

Facsimile: (404) 322-6050 

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’ NOTICE OF 

SUPPLEMENTAL INFORMATION 

REGARDING FDA INSPECTION 

AND WARNING LETTER 

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

(“BPV”) (C. R. Bard and BPV are collectively referred to as “Bard”) hereby give notice 

of supplemental information (received within the past week) regarding the FDA 

inspection and Warning Letter. Specifically, the FDA has just recently issued two Form 

483 Letters, 1 one directed to Bard’s IVC filter manufacturing facility, Glens Falls 

 

1 An FDA Form 483 Letter is a notification from the FDA to a medical device 

manufacturer that documents observations by an inspector that certain conditions 

observed during an inspection may constitute violations of the Food Drug & Cosmetic Act 

or related Acts or FDA regulations. An FDA Form 483 Letter is not a final FDA 

determination that an alleged violation has occurred. See FDA’s Form 483 Frequently 

Asked Questions, available at http://www.fda.gov/ICECI/Inspections/ucm256377.htm. 

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Snell & Wilmer

 L.L.P.

LAW OFFICES 

One Arizona Center, 400 E. Van Buren, Suite 1900 

Phoenix, Arizona 85004-2202 

602.382.6000 

Operations (“GFO”), and one directed to BPV, following FDA inspections at those 

facilities in February 2016. See Form 483 Letters attached as Exhibit “A.” As with 

FDA’s inspection and Warning Letter, these Form 483 Letters have little, if any, relevance 

to the issues at stake in the Bard IVC Filter Litigation. Indeed, these Form 483 Letters do 

not impact or alter Bard’s argument that it has provided Plaintiffs with substantial 

discovery regarding the Warning Letter, and that significant additional discovery 

regarding the Warning Letter (or these Form 483 Letters) is unwarranted. See Bard’s 

Memorandum Regarding the Warning Letter [Dkt. No. 693]. 

The FDA’s Form 483 Letter to GFO concerns certain IVC filter cleanliness 

inspections performed in March 2015. The FDA alleges that Bard’s internal protocol 

required that inspections be performed three times but that Bard inspected them two times. 

Bard has reported to the FDA that it has corrected the alleged deficiency, although FDA 

has not yet verified the correction in a follow-up inspection. Nothing in the Letter 

suggests that the alleged deficiency impacts the integrity of Bard’s IVC filters or 

otherwise impacts Plaintiffs’ manufacturing defect claims. In short, the Form 483 Letter 

to GFO has no impact on this litigation. 

Likewise, the Form 483 Letter to BPV has little impact on this litigation and the 

arguments made by Bard in its Memorandum Regarding the Warning Letter [Dkt. No. 

693]. The Letter to BPV concerns Bard’s written procedure for comparing complaint 

rates month-to-month. It asserts that for products that are no longer on the market, the 

procedure does not provide for documented methods to conduct “early detection” trending 

when comparing complaint rates month-to-month, because Bard’s early detection system 

is based on monthly sales. 

While the FDA’s Form 483 Letter to BPV addresses Bard’s written procedure for 

complaint trending, it does not criticize or otherwise call into question Bard’s methods for 

computing its internal complaint rates for IVC filters. In this litigation, where Plaintiffs 

allege that Bard’s IVC filter complaint rates are comparatively higher than competitors, 

and that Bard had a duty warn about such comparative rates, whether Bard’s methods for 

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Snell & Wilmer

 L.L.P.

LAW OFFICES 

One Arizona Center, 400 E. Van Buren, Suite 1900 

Phoenix, Arizona 85004-2202 

602.382.6000 

computing its internal rates are adequate is most important, not whether Bard has a written 

procedure adequately designed to document monthly changes in complaint trends for 

products that are no longer marketed.2

 Therefore, at most, the FDA’s Form 483 Letter to 

BPV may warrant a short follow-up 30(b)(6) deposition of Mr. Chad Modra -- who was 

Bard’s witness regarding the Warning Letter and who has been involved with FDA’s 

recent inspections -- regarding the FDA’s observations. However, the Letter does not 

warrant the expansive discovery regarding the FDA inspection or Warning Letter that 

Plaintiffs have previously demanded. 

DATED this 4th day of March, 2016. 

SNELL & WILMER L.L.P.

By: s/ Amanda C. Sheridan James R. Condo 

Amanda C. Sheridan 

One Arizona Center 

400 E. Van Buren, Suite 1900 

Phoenix, Arizona 85004-2202 

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 

201 17th Street, NW, Suite 1700 

Atlanta, GA 30363 

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

Peripheral Vascular, Inc. 

 

2

 Bard further notes that it does have numerous tools and methods to conduct complaint 

trending for products that are no longer marketed, although those tools and methods are 

not explicitly described in Bard’s written procedure for complaint trending. 

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Snell & Wilmer

 L.L.P.

LAW OFFICES 

One Arizona Center, 400 E. Van Buren, Suite 1900 

Phoenix, Arizona 85004-2202 

602.382.6000 

CERTIFICATE OF SERVICE 

I hereby certify that on March 4, 2016, the foregoing was electronically filed with 

the Clerk of Court using the CM/ECF system which will automatically send e-mail 

notification of such filing to all attorneys of record. 

 s/ Amanda C. Sheridan 

23633156 

Case 2:15-md-02641-DGC Document 989 Filed 03/04/16 Page 4 of 4