Gates v. C R Bard Incorporated et al

Filing 5

CERTIFIED TRANSFER ORDER transferring case to Western District of North Carolina. (Attachments: #1 MDL Certified Docket, #2 Case Management Order, #3 Motions in Limine Orders, #4 Deposition Designation Orders, #5 Discovery and Privilege Orders, #6 Master and Short-Form Pleadings, #7 Daubert Orders, #8 Miscellaneous Orders, #9 Case Management Orders, #10 Discovery Orders)(rth)

Case 2:15-md-02641-DGC Document 249 Filed 10/30/15 Page 1 of 8

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IN THE UNITED STATES DISTRICT COURT

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FOR THE DISTRICT OF ARIZONA

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IN RE: BARD IVC FILTERS
PRODUCTS LIABILITY LITIGATION

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This Order Relates to: All Actions

MDL No. 2641
CASE MANAGEMENT
ORDER NO. 2

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The Court held a lengthy case management conference with the parties on

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October 29, 2015. Before the conference, the parties submitted a proposed agenda and a

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memorandum setting forth positions of Plaintiffs and Defendants on various issues.

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Doc. 174. The Court entered an order with a more detailed agenda on October 19, 2015.

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Doc. 203. This order will generally follow the topics set forth in the Court’s agenda.

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I.

Identification and Selection of Parties’ Leadership.

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The Court has entered Case Management No. 1, which establishes Plaintiffs’

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Leadership Counsel. By November 6, 2015, Plaintiffs’ Lead/Liaison Counsel shall

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submit to the Court a proposed Case Management Order concerning: (a) the duties and

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authority of Plaintiffs’ Leadership Counsel in coordinating pretrial practice in this MDL;

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(b) the establishment and operation of a common fund for eventual payment and

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reimbursement of attorneys and their firms for common benefit work; (c) a procedure for

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auditing the common benefit work of Plaintiffs’ attorneys and their firms; (d) a procedure

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for making quarterly reports to the Court regarding the audits and the common benefit

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work performed by attorneys and their firms; (e) guidelines for eventual fee applications

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and

cost

reimbursement,

including

record-keeping

requirements,

time-keeping

Case 2:15-md-02641-DGC Document 249 Filed 10/30/15 Page 2 of 8

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requirements (see, e.g., Local Rule of Civil Procedure 54.2(e)), staffing limitations for

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various tasks, acceptable hourly rates, when travel time can be billed, reimbursable

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expenses (what is and is not reimbursable), and acceptable levels of expense

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reimbursement; (f) procedures or agreements designed to avoid the duplication of

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common benefit discovery already completed in some of the MDL cases; and (g) periodic

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status reports on coordination with state cases and other relevant matters.

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II.

Protective and Rule 502 Orders.

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By November 6, 2015, the parties shall jointly submit to the Court a proposed

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protective order, including Rule 502 provisions, for all cases in this MDL. If the order

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addresses the filing of confidential documents in court, it shall not say that such

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documents may be filed under seal. Instead, it should say that any party seeking to file a

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confidential document under seal shall comply with Local Rule of Civil Procedure 5.6.

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III.

ESI Protocol.

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By November 30, 2015, the parties shall jointly present to the Court an ESI

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Protocol addressing format of production, preservation, and other relevant ESI-discovery

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matters. If the parties are unable to reach agreement on all aspects of the ESI Protocol,

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they shall file a joint report setting forth the areas of agreement and disagreement and

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recommending a procedure for resolving disagreements.

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IV.

Discovery.

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A.

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By November 6, 2015, the parties shall propose to the Court profile forms to be

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completed by Plaintiffs and Defendants with respect to each new case added to this

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MDL. The intent will be to provide the parties with basic and relevant information about

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each new case. With the exception of bellwether cases, the Court generally will not

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oversee discovery relevant only to individual cases. It is anticipated that such discovery

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will be conducted in transferor districts after this MDL is completed.

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Discovery Relevant Only to Individual Cases.

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Case 2:15-md-02641-DGC Document 249 Filed 10/30/15 Page 3 of 8

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B.

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The parties will discuss whether agreement can be reached on the binding effect

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already-completed discovery will have in cases filed after the date of the discovery. If

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the parties are able to reach agreement, they shall jointly submit a stipulation to the Court

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by December 18, 2015. If the parties are unable to reach agreement, each side shall file a

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10-page memorandum setting forth its position with respect to the effect of the already-

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completed discovery by December 18, 2015. Each side may file a 5-page response

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memorandum by January 8, 2016.

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C.

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Binding Effect of Completed Discovery.

First-Phase Discovery.

By January 15, 2016, the parties shall complete a first phase of MDL discovery

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which includes the following:

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1.

Defendants shall provide an updated production of complaint

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(adverse event) files relating to the Recovery, G2, G2X, and G2 Express filters, and shall

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produce complaint (adverse event) files relating to the Eclipse, Meridian, and Denali

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filters.

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2.

Defendants shall produce updated versions of Bard’s Adverse Event

Tracking System for the various filters set forth immediately above.

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3.

By November 10, 2015, Defendants shall produce the documents

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described by defense counsel during the case management conference related to the FDA

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investigation and warning letter.

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4.

Plaintiffs may take a Rule 30(b)(6) deposition with respect to the

FDA investigation and warning letter.

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5.

Kay Fuller shall be deposed.

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D.

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The parties shall meet and confer with respect to the following discovery issues,

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and, by January 20, 2016, provide the Court with a joint report regarding their

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discussions. Areas of agreement and disagreement will be clearly identified, and each

Conferences Regarding Second Phase of Discovery.

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Case 2:15-md-02641-DGC Document 249 Filed 10/30/15 Page 4 of 8

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party’s position shall be set forth.

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procedures for resolving their disagreements.

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The parties shall propose, jointly if possible,

Updated collections and productions of previously searched

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“custodians” and ESI sources.

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duplicative discovery, but relevant information not previously searched for should be

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considered as a possible subject of discovery.

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2.

In discussing this topic, the parties should avoid

Production of ESI from custodians involved with later-generation

filter devices or employed at later time frames.

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3.

Further discovery related to the FDA inspection and warning letter.

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4.

ESI and documents that have been previously withheld, if any, as to

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Defendant’s later-generation devices, such as the Eclipse, Meridian, and Denali filters.

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5.

Discovery related to the Simon Nitinol filter.

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6.

Discovery regarding the Recovery Cone Removal System design,

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design changes, corrective actions, reasons why design changes were made, regulatory

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communications, and adverse event reports.

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7.

Custodial files and other discovery with respect to sales and

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marketing personnel.

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discovery focusing on higher-level sales and marketing personnel should be undertaken

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before discovery of lower-level personnel. The parties should also consider whether

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sales and marketing discovery should be postponed until case-specific discovery is

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undertaken with respect to bellwether cases.

In addressing this issue, the parties should consider whether

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8.

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this MDL or state-court cases.

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9.

Additional depositions of corporate and third party witnesses.

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10.

Rule 26 expert disclosures and expert depositions.

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11.

Discovery related to ESI preservation issues.

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///

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Pending Rule 30(b)(6) deposition notices in cases consolidated in

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Case 2:15-md-02641-DGC Document 249 Filed 10/30/15 Page 5 of 8

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V.

Issues to be Briefed.

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A.

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Defendants shall file a motion for protective order with respect to the Lehmann

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Report, including evidentiary material, by November 30, 2015. Plaintiffs shall file a

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response, including evidentiary material, by December 18, 2015. Defendants shall file a

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reply by January 8, 2016. The parties’ briefs should address whether the Lehmann

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Report constitutes work product, whether an evidentiary hearing is needed, and what

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effect the Court’s ruling should have in cases where this issue has already been decided.

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B.

Lehmann Report.

Privilege Logs.

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By November 13, 2015, Defendants shall provide to Plaintiffs the current version

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of all privilege logs. By the same date, Defendants shall identify for Plaintiffs all

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documents that previously were listed on privilege logs but subsequently were produced

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to Plaintiffs. A chart showing privilege log control numbers and bates numbers of

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produced documents likely would be most helpful.

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Between November 13, 2015 and early January, 2016, the parties should engage in

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the informal privilege log exchange proposed by Defendants during the case management

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conference.

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agreement on privilege log issues. For purposes of the informal exchange, the parties

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should apply the work product law set forth in the magistrate judge’s decision in the

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Nevada case, unless they agree upon different legal standards. This paragraph will not

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preclude parties from arguing for a different legal standard if privilege log issues must be

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resolved by the Court.

The purpose of this exchange will be to see if the parties can reach

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By January 20, 2016, the parties shall provide the Court with a joint report on

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their privilege log efforts, identifying areas of agreement and disagreement, setting forth

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the parties’ positions on the disagreements, and proposing procedures for resolution of

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any remaining outstanding issues.

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///

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Case 2:15-md-02641-DGC Document 249 Filed 10/30/15 Page 6 of 8

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VI.

Pleading and Filing Procedures.

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By November 30, 2015 the parties shall provide to the Court a master complaint

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drafted by Plaintiffs, a master answer drafted by Defendants, and templates of short-form

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complaints and answers agreed upon by the parties. The parties shall also submit to the

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Court a proposed case management order which provides that the master complaint and

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master answer will be filed in the master docket in this MDL proceeding; that new cases

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may be filed in the District of Arizona using the short-form complaint; that filing of a

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short-form complaint in the District of Arizona will not mean that the trial in that case

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will be held in Arizona, but instead will mean that the case will be transferred to the

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appropriate home district at the conclusion of this MDL; that Defendants may file a short-

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form answer in response to a short-form complaint; and that service of process in cases

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filed in the District of Arizona using the short-form complaint may be made by email on

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defense counsel.1

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The parties shall include in the jointly-submitted case management order a

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provision identifying cases in which the master complaint and master answer will not

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become the operative pleadings – where the existing complaints and answers will remain

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the operative pleadings. The master complaint and answer will become the operative

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pleadings in all other cases in this MDL.

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VII.

Handling of Advanced Cases.

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This MDL includes some cases in which discovery and motion practice has been

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completed. The Court does not intend to reopen already-decided Daubert motions or

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motions for summary judgment in these cases. The parties agree, however, that these

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cases should not be remanded to transferor courts at the present time. Rather, they will

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remain a part of the MDL and will be considered as possible bellwether cases in the

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future.

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The parties should address an additional issue in their November 30 filing. If
cases are filed in Arizona under such a case management order, what is the legal basis
upon which they later would be transferred to their home district? Because they would
not originally have been filed in another district, transfer under 28 U.S.C. § 1407(a)
presumably would not be available.
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Case 2:15-md-02641-DGC Document 249 Filed 10/30/15 Page 7 of 8

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VIII. Coordination with State Court Litigation.

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Plaintiffs’ Lead/Liaison Counsel shall, through the Plaintiffs’ Steering Committee,

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coordinate discovery and motion practice in this MDL proceeding with state court cases.

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As an immediate matter, Plaintiffs’ counsel shall coordinate discovery of Hill &

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Knowlton with state cases.

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IX.

Next Case Management Conference.

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The Court will hold a second case management conference on January 29, 2016

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at 9:00 a.m. The parties should file a joint report and proposed agenda by January 20,

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2016, identifying issues to be addressed at the conference.2

The purpose of the

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conference will be to address matters raised in the joint report and the various filings

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identified above. The Court will establish a second phase of fact discovery on the basis

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of the parties’ submissions and discussions at the case management conference. The

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Court will also confer with the parties about a schedule for expert disclosures,

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depositions, and Daubert motions. Because many of the cases in this MDL proceeding

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have involved no expert discovery, the Court concludes that full Rule 26 disclosures,

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followed by depositions and Daubert motions, should be conducted in this MDL. The

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effect of that discovery and motion practice in cases where experts have already been

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disclosed will be addressed later.

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X.

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Other Matters.
A.

Settlement Talks. After conferring with the parties, the Court concluded

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that it should not require global settlement talks at this stage of the litigation. The

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number and nature of cases to be added to this MDL is yet to be determined, and the

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scale of this litigation will be an important factor in settlement efforts. The Court will

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raise this issue with the parties in the future.

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B.

Discovery Disputes. The parties shall not file written discovery motions

without leave of Court. If a discovery dispute arises, the parties promptly shall contact

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Among other topics, the joint report should identify pending motions in all MDL
cases and set forth the parties’ recommendation as to what the Court should do with those
motions.
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Case 2:15-md-02641-DGC Document 249 Filed 10/30/15 Page 8 of 8

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the Court to request a telephone conference concerning the dispute. The Court will seek

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to resolve the dispute during the telephone conference, and may enter appropriate orders

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on the basis of the telephone conference. The Court may order written briefing if it does

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not resolve the dispute during the telephone conference.3 Parties shall not contact the

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Court concerning a discovery dispute without first seeking to resolve the matter through

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personal consultation and sincere effort as required by Local Rule of Civil Procedure

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7.2(j).

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C.

Briefing Requirements. All memoranda filed with the Court shall comply

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with Local Rule of Civil Procedure 7.1(b) requiring 13 point font in text and footnotes.

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Citations in support of any assertion in the text shall be included in the text, not in

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footnotes.

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D.

Rule 34 Responses. Rule 34 responses shall comply with the amended

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Rule 34 to become effective on December 1, 2015.

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Dated this 30th day of October, 2015.

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The prohibition on “written discovery motions” includes any written materials
delivered or faxed to the Court, including hand-delivered correspondence with
attachments.
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Case 2:15-md-02641-DGC Document 303-2 Filed 11/30/15 Page 2 of 6

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IN THE UNITED STATES DISTRICT COURT

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FOR THE DISTRICT OF ARIZONA

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IN RE BARD IVC FILTERS
PRODUCTS LIABILITY LITIGATION

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No. MD-15-02641-PHX-DGC
MASTER SHORT FORM COMPLAINT
FOR DAMAGES FOR INDIVIDUAL
CLAIMS

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2575 East Camelback Road
Phoenix, Arizona 85016-9225
[phone]

Gallagher & Kennedy, P.A.

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Plaintiff(s) named below, for their Complaint against Defendants named below,

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incorporate the Master Complaint for Damages in MDL 2641 by reference (Doc.___).

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Plaintiff(s) further show the Court as follows:
1.

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Plaintiff/Deceased Party:
________________________________________________________________

2.

Spousal Plaintiff/Deceased Party’s spouse or other party making loss of

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consortium claim:

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________________________________________________________________

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3.

Other Plaintiff and capacity (i.e., administrator, executor, guardian,

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conservator):

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________________________________________________________________

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4.

Plaintiff’s/Deceased Party’s state(s) [if more than one Plaintiff] of residence at

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the time of implant:

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________________________________________________________________

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Case 2:15-md-02641-DGC Document 303-2 Filed 11/30/15 Page 3 of 6

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5.

Plaintiff’s/Deceased Party’s state(s) [if more than one Plaintiff] of residence at

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the time of injury:

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________________________________________________________________

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6.

________________________________________________________________

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District Court and Division in which venue would be proper absent direct filing:
________________________________________________________________

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Plaintiff’s current state(s) [if more than one Plaintiff] of residence:

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Defendants (check Defendants against whom Complaint is made):

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□

C.R. Bard Inc.

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□

Bard Peripheral Vascular, Inc.

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9.

Basis of Jurisdiction:

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□

Diversity of Citizenship

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□

Other: ________________________________________________

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a.

Other allegations of jurisdiction and venue not expressed in Master
Complaint:

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________________________________________________________________

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________________________________________________________________

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________________________________________________________________

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10.

Defendants’ Inferior Vena Cava Filter(s) about which Plaintiff(s) is making a

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claim (Check applicable Inferior Vena Cava Filter(s)):

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□

Recovery® Vena Cava Filter

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G2® Vena Cava Filter
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Case 2:15-md-02641-DGC Document 303-2 Filed 11/30/15 Page 4 of 6

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€

G2® Express (G2®X) Vena Cava Filter

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€

Eclipse® Vena Cava Filter

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€

Meridian® Vena Cava Filter

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€

Denali® Vena Cava Filter

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€

Other: ____________________________________________________

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11.

Date of Implantation as to each product:

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________________________________________________________________

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________________________________________________________________

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12.

Counts in the Master Complaint brought by Plaintiff(s):

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□

Count I:

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Count II:

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Strict Products Liability – Manufacturing Defect
Strict Products Liability – Information Defect (Failure to

Warn)

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Count III:

Strict Products Liability – Design Defect

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Count IV:

Negligence - Design

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Count V:

Negligence - Manufacture

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Count VI:

Negligence – Failure to Recall/Retrofit

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Count VII:

Negligence – Failure to Warn

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Count VIII: Negligent Misrepresentation

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Count IX:

Negligence Per Se

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Count X:

Breach of Express Warranty

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Count XI:

Breach of Implied Warranty

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Count XII:

Fraudulent Misrepresentation
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Case 2:15-md-02641-DGC Document 303-2 Filed 11/30/15 Page 5 of 6

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Count XIII: Fraudulent Concealment

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Count XIV: Violations of Applicable ________________ (insert state)

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Law Prohibiting Consumer Fraud and Unfair and Deceptive Trade

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Practices

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Count XV:

Loss of Consortium

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Count XVI: Wrongful Death

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Count XVII: Survival

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Punitive Damages

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Other(s):

___________________ (please state the facts supporting

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this Count in the space immediately below)

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__________________________________________________________

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__________________________________________________________

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__________________________________________________________

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__________________________________________________________

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__________________________________________________________

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Case 2:15-md-02641-DGC Document 303-2 Filed 11/30/15 Page 6 of 6

RESPECTFULLY SUBMITTED this ____ day of November, 2015.

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GALLAGHER & KENNEDY, P.A.

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By:

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/s/
Robert W. Boatman
Mark S. O’Connor
Paul L. Stoller
Shannon L. Clark
C. Lincoln Combs
2575 East Camelback Road
Phoenix, Arizona 85016-9225

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LOPEZ McHUGH LLP
Ramon Rossi Lopez (CA Bar No. 86361)
(admitted pro hac vice)
100 Bayview Circle, Suite 5600
Newport Beach, California 92660

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Attorneys for Plaintiffs

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I hereby certify that on this ____ day of November, 2015, I electronically transmitted

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

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transmittal of a Notice of Electronic Filing.

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/s/
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5131774

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Case 2:15-md-02641-DGC Document 363 Filed 12/17/15 Page 1 of 10

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IN THE UNITED STATES DISTRICT COURT

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FOR THE DISTRICT OF ARIZONA

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IN RE: Bard IVC Filters Products Liability
Litigation,

No. MDL 15-02641-PHX DGC
CASE MANAGEMENT ORDER
NO. 4

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(Master Complaint, Master
Responsive Pleading, Use of Short
Form Complaint, and Waiver of
Service for Bard Defendants)

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The parties have submitted a Master Long Form Complaint and Jury Demand

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(previously docketed as Doc. 303-1) and a Master Responsive Pleading (previously

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docketed as Doc. 303-3). The Court has reviewed these proposed pleadings, finds them

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sufficient, and directs the Clerk to file them as separate documents in the Court’s docket.1

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The parties have also submitted a proposed Short Form Complaint, a copy of which is

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attached to this order. The Court also finds this proposed pleading to be sufficient.

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IT IS ORDERED:

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All allegations pled in the Master Complaint and all responses pled in the Master

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Responsive Pleading are deemed pled in any previously filed Complaint and Responsive

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Pleading in this MDL proceeding, except as expressly noted below. They are also deemed

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pled in any Short Form Complaint and Entry of Appearance filed after the entry of this

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The reference to “Federal Rule of Evidence 8” on the first page of the Master Complaint
shall be deemed to be a reference to Federal Rule of Civil Procedure 8.

Case 2:15-md-02641-DGC Document 363 Filed 12/17/15 Page 2 of 10

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order, except that the Master Complaint applies only against the Defendant or Defendants
identified in such future-filed Short Form Complaints.
The following cases will not be governed by the Master Complaint and Master

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Responsive Pleading, but will continue to be governed by the complaints (including any

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amended complaints) and answers filed in the various transferor courts prior to transfer:

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Plaintiff

Original Jurisdiction

1. Cason, Pamela

GA – N.D. Ga.

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1:12-cv-1288
2. Coker, Jennifer

GA – N.D. Ga.

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1:13-cv-515
3. Conn, Charles

TX – S.D. Tex.

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4:14-cv-298
4. Ebert, Melissa

PA – E.D. Pa.

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5:12-cv-1253
5. Fox, Susan

TX – N.D. Tex.

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3:14-cv-133
6. Henley, Angela

WI – E.D. Wis.

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2:14-cv-59
7. Keen, Harry

PA – E.D. Pa.

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5:13-cv-5361
8. Milton, Gary

GA – M.D. Ga.

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5:14-cv-351
9. Mintz, Jessica

NY – E.D.N.Y.

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2:14-v-4942
10. Ocasio, Denise

FL – M.D. Fla.

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8:13-cv-1962

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Case 2:15-md-02641-DGC Document 363 Filed 12/17/15 Page 3 of 10

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Plaintiff

Original Jurisdiction

11. Rivera (McClarty), Vicki

MI – E.D. Mich.

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4:14-cv-13627
12. Smith, Erin

TX – E.D. Tex.

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1:13-cv-633
13. Tillman, Lessie

FL – M.D. Fla.

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3:13-cv-222

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On or after December 28, 2015, any plaintiff whose case would be subject to

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transfer to MDL 2641 may file his or her case directly in this Court by using the Short

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Form Complaint. If such a case is filed in this Court without the use of the Short Form

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Complaint, Plaintiffs’ Co-Lead Counsel shall promptly advise the filing party to file an

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amended complaint using the Short Form Complaint. If the filing party fails to do so,

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Plaintiffs’ Co-Lead Counsel shall promptly notify the Court.

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Defendants are not required to file answers to Short Form or Amended Short Form

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Complaints. An Entry of Appearance shall constitute a denial of all allegations in the

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Short Form or Amended Short Form Complaints except as herein provided, and an

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assertion of all defenses included in the Master Responsive Pleading. By filing an Entry
of Appearance in response to a Short Form Complaint, in lieu of an answer, Defendants
do not waive any defenses, including jurisdictional and service defenses.
Defendants shall have 60 days from the entry of this order to file any motion for
failure of the Master Complaint to state a claim upon which relief may be granted
pursuant to Rule 12(b)(6) and 12(h)(2), and Plaintiff’s shall have 30 days to respond.
Civil actions in this MDL were transferred to this Court by the Judicial Panel on
Multidistrict Litigation for coordinated or consolidated pretrial proceedings pursuant to
28 U.S.C. § 1407. Upon completion of the pretrial proceedings related to a civil action as
determined by this Court, the case shall be transferred pursuant to 28 U.S.C. § 1404(a) or
§ 1406(a) to the District Court identified in the Short Form Complaint, provided the

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Case 2:15-md-02641-DGC Document 363 Filed 12/17/15 Page 4 of 10

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parties choose not to waive Lexecon, Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523
U.S. 26 (1998).

The fact that a case was filed directly in this District and MDL

proceeding shall not constitute a determination by this Court that jurisdiction or venue are

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proper in this District, and shall not result in this Court being deemed the “transferor

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court” for purposes of this MDL. In addition, filing a Short Form Complaint in this

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District shall have no impact on the conflict of law rules to be applied to the case. Instead,

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the law of the jurisdiction where the case is ultimately transferred will govern any conflict

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of law. Prior to transfer, Defendants may object to the district specified in the Short Form

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Complaint, based on venue or jurisdiction (including a lack of personal jurisdiction based

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on Daimler AG v. Bauman, 134 S. Ct. 746 (2014)), and propose an alternative jurisdiction

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for the Court’s consideration.

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Subject to the conditions set forth in this order, Defendant C.R. Bard, Inc. and Bard

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Peripheral Vascular, Inc. (collectively “Bard”) waive service of process in cases filed in

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this Court using the Short Form Complaint and in which they are named as defendants

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and one or more IVC filter products either manufactured or distributed by Bard is alleged

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to be at issue. For such cases, Plaintiffs shall send a Short Form Complaint and a request

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for waiver of service pursuant to the provisions of Fed. R. Civ. P. 4 to Richard B. North,
Jr. by email to [e-mail]; [e-mail]; and
[e-mail]. Counsel for Bard shall return the signed waiver
requests to the Court within the time permitted by Fed. R. Civ. P. 4. Plaintiffs submitting
a request for waiver shall not seek to hold Bard in default for failure to timely answer or
otherwise respond to a complaint in which service has been accomplished pursuant to the

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terms of this order without first giving Bard written notice of the alleged default and ten
business days in which to cure any alleged default.
Prior to a Plaintiff’s attorney filing a Short Form Complaint in this Court, that
attorney must register for or already have a District of Arizona CM/ECF log-in name and
password. If the Plaintiff’s attorney does not already have a District of Arizona CM/ECF
log-in name and password, that attorney must file the Short Form Complaint in paper

28
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1
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form with the Clerk of Court and simultaneously file an Application of Attorney for
Admission to Practice Pro Hac Vice pursuant to LRCiv 83.1(b)(2) (including all necessary
attachments and filing fee).
Dated this 17th day of December, 2015.

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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 1 of 64

1
2
3

Ramon Rossi Lopez - [e-mail]
(California Bar Number 86361; admitted pro hac vice)
Lopez McHugh LLP
100 Bayview Circle, Suite 5600
Newport Beach, California 92660
949-812-5771

4
5
6

Robert W. Boatman (009619) - [e-mail]
Gallagher & Kennedy, P.A.
2575 East Camelback Road
Phoenix, Arizona 85016-9225
602-530-8000

7
Attorneys for Plaintiffs

2575 East Camelback Road
Phoenix, Arizona 85016-9225
[phone]

Gallagher & Kennedy, P.A.

8
9

IN THE UNITED STATES DISTRICT COURT

10

FOR THE DISTRICT OF ARIZONA

11

IN RE BARD IVC FILTERS
PRODUCTS LIABILITY LITIGATION

12

No. MD-15-02641-PHX-DGC
MASTER COMPLAINT FOR DAMAGES
FOR INDIVIDUAL CLAIMS

13
14

Plaintiffs in this consolidated action, collectively and through the Plaintiffs’ Steering

15

Committee (“PSC”) as duly authorized representatives of all Plaintiffs in MDL 2641, hereby

16

file this Master Complaint for Damages for Individual Claims (“Master Complaint”) against

17

Defendants C.R. BARD, INC. and BARD PERIPHERAL VASCULAR, INC. (collectively,

18

“Bard” or “Defendants”) in MDL 2641.

19

This Master Complaint is created for the convenience of the Court and all parties as a

20

“long form” complaint giving notice, pursuant to Federal Rule of Evidence 8 and Case

21

Management Order 2, of allegations that some or all Plaintiffs in cases consolidated in this

22

MDL allege against Bard, whether those Plaintiffs’ claims are for personal injury or wrongful

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 2 of 64

1

death, and whether brought by an individual person alleging injury or statutory or common

2

law beneficiaries of claims for wrongful death of a Plaintiff or Plaintiffs’ decedent.1
This Master Complaint does not necessarily include all claims asserted in all of the

3
4

actions transferred to this Court, and it is not intended to consolidate for any purpose the

5

separate claims of Plaintiffs herein. This Master Complaint also does not constitute a waiver

6

or dismissal of any actions or claims asserted in those individual actions, and no Plaintiff

7

relinquishes the right to amend their individual complaints to seek any additional claims as

8

discovery proceeds.

9

Accordingly, Plaintiffs in MDL No. 2641 allege as follows:

10

INTRODUCTORY ALLEGATIONS
1.

11

Plaintiffs bring this action for personal injuries and/or wrongful death damages

12 suffered by an injured or deceased party or parties as a direct and proximate result of an
13 injured or deceased party being implanted with a defective and unreasonably dangerous
14 Inferior Vena Cava (“IVC”) filter medical device manufactured by Bard.
2.

15

The subject IVC filters are part of Bard’s IVC “retrievable” filter product line

®
®
®
®
®
16 and include the following devices: Recovery , G2 , G2 X (G2 Express ), Eclipse ,
®
®
17 Meridian and Denali (for convenience, these devices will be referred to in this complaint

18 under the generic term “Bard IVC Filters”). The term “Bard IVC Filters” also includes Bard’s
®
®
19 Recovery Cone Removal System .

20
21
22

1

Which causes of actions and counts are asserted in individual actions and certain claimantor claim-specific allegations will be conveyed to Defendants via individual “short form”
complaints or profile forms as agreed upon by the parties.
-2-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 3 of 64

1

3.

Plaintiffs’ claims for damages all relate to Bard’s design, manufacture, sale,

2 testing, marketing, labeling, advertising, promotion, and/or distribution of Bard IVC Filters.
3

4.

The Bard IVC Filters that are the subject of this action all reached Plaintiffs and

4 their physicians without substantial change in condition from the time they left Bard’s
5 possession.
6

5.

Plaintiffs and their physicians used the Bard IVC Filters in the manner in which

7 they were intended.
8

6.

Bard is solely responsible for any alleged design, manufacture or informational

9 defect Bard IVC Filters contain.
10

7.

Bard does not allege that any other person or entity is comparatively at fault for

11 any alleged design, manufacture, or informational defect Bard IVC Filters contain.
PARTIES

12
13

8.

Plaintiffs are those persons and estates that have brought or will bring actions

14 seeking wrongful death and/or personal injury damages caused by Bard IVC Filters. The
15 identities of individual action plaintiffs will be identified in their “Short Form Complaint.”
16

9.

Plaintiffs are persons injured, killed, or otherwise harmed by Bard IVC Filters.

17 Depending on the law applicable to a particular plaintiff or plaintiffs’ claims, Plaintiffs may
18 include deceased individuals and/or their spouses, children, parents, or personal
19 representatives, as well as injured individuals and/or their spouses, children, parents, next
20 friends, legal guardians, conservators, or other authorized representatives.
21

10.

As a direct and proximate result of having Bard IVC Filters implanted in them,

22 Plaintiffs named in their respective Short Form Complaints have suffered permanent and
-3-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 4 of 64

1 continuous injuries and damages. The injuries suffered and damages sought by Plaintiffs
2 (hereafter, “Injuries and Damages”) may include, without limitation: wrongful death of a
3 spouse, child, parent, or other legally-cognizable relationship; pain and suffering; bodily
4 injuries of any type (including, without limitation, perforation of organs and venous structures,
5 thromboembolic events, and cardiovascular injuries); disability; impairment; scarring;
6 disfigurement; dismemberment; physical; emotional and psychological trauma; anxiety;
7 diminished capacity; loss of consortium; hedonic damages; past medical expenses; future
8 medical expenses; caregiving costs; lost wages; loss of earning capacity; and any other form of
9 damages under the law of any forum which governs any individual case.
10

11.

Defendant C.R. Bard, Inc. (“C.R. Bard”) is a corporation duly organized and

11 existing under the laws of the state of Delaware and has its principal place of business in New
12 Jersey. Bard, at all times relevant to this action, designed, set specifications for,
13 manufactured, prepared, compounded, assembled, processed, marketed, distributed, and sold
®
®
®
®
®
®
®
14 the Recovery , G2 , G2 X (G2 Express ), Eclipse , Meridian , and Denali Filter Systems to

15 be implanted in patients throughout the United States including the State of Arizona and
16 Plaintiffs’ states of residence and/or injury.
17

12.

Defendant Bard Peripheral Vascular, Inc. (“BPV”) is a wholly-owned subsidiary

18 corporation of Defendant C.R. Bard, with its principal place of business at 1625 West Third
19 Street, Tempe, Arizona. BPV, at all times relevant to this action, designed, set specifications
20 for, manufactured, prepared, compounded, assembled, processed, marketed, distributed, and
®
®
®
®
®
®
®
21 sold the Recovery , G2 , G2 X(G2 Express ), Eclipse , Meridian , and Denali Filter

22
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 5 of 64

1 Systems to be implanted in patients throughout the United States, including the State of
2 Arizona and Plaintiffs’ states of residence and/or injury.
3

13.

There exists, and at all relevant times existed, a unity of interest in ownership

4 between certain defendants and other defendants such that any individuality and separateness
5 between the certain defendants has ceased and those defendants are the alter ego of the other
6 certain defendants, and exerted control over those defendants.
7

14.

Adherence to the fiction of the separate existence of these certain defendants as

8 any entity distinct from other certain defendants would permit an abuse of the corporate
9 privilege, sanction fraud, and promote injustice.
10

15.

Plaintiffs are informed and believe, and thereon allege, that at all times herein

11 mentioned each of the Defendants were the agent, servant, employee, and/or joint venturer of
12 the other co-defendants, and at all said times each Defendant was acting in the full course,
13 scope, and authority of said agency, service, employment, and/or joint venture.
14

16.

“Bard” or “Defendants” includes any and all parent companies, subsidiaries,

15 affiliates, divisions, franchises, partners, joint venturers, and organizational units of any kind;
16 their predecessors, successors, and assigns; their officers, directors, employees, agents,
17 representatives; and any and all other persons acting on their behalf.
18

17.

At all times relevant, Bard was engaged in the business of researching,

19 designing, testing, developing, manufacturing, packaging, labeling, marketing, advertising,
20 distributing, promoting, warranting, and selling in interstate commerce Bard IVC Filters,
21 either directly or indirectly through third parties or related entities.
22
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1

18.

Bard develops, manufactures, sells, and distributes medical devices and surgical

2 products throughout the United States and around the world, including Bard IVC Filters for
3 use in various medical applications including endovascular cardiology.
4

19.

Upon information and belief, at all relevant times, Defendants expected or

5 should have expected that their acts would have consequences within the United States,
6 including in the State of Arizona and in the states and territories identified in each Short Form
7 Complaint, and said Defendants derived and continue to derive substantial revenue therefrom.
JURISDICTION AND VENUE

8
9

20.

This Court has subject matter jurisdiction under 28 U.S.C. § 1332 because

10 Plaintiffs and Defendants are citizens of different states, the amount in controversy for each
11 action exceeds seventy-five thousand dollars ($75,000.00) excluding interest and costs, and
12 there is complete diversity of citizenship between each Plaintiff and Defendant.
13

21.

This Court has personal jurisdiction under 28 U.S.C. § 1391, as BPV is

14 domiciled in this District and all Defendants regularly conduct business in this State. Further,
15 Defendants are present and doing business within this State and have continuous and
16 systematic contacts in every state in the United States of America, including each Plaintiffs’
17 states of residence.
18
19
20
21
22

22.

Pursuant to the Transfer Order filed on August 17, 2015, it was determined:

[T]he actions in this litigation involve common questions of fact, and that
centralization in the District of Arizona will serve the convenience of the parties
and witnesses and promote the just and efficient conduct of the litigation. All
actions involve common factual questions arising from allegations that defects
in the design of Bard’s retrievable inferior vena cava filters (“IVC filters”)
make them more likely to fracture, migrate, tilt, or perforate the inferior vena
cava, causing injury. Centralization will eliminate duplicative discovery, avoid
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1
2
3

inconsistent pretrial rulings (including with respect to discovery, privilege, and
Daubert motion practice), and conserve the resources of the parties, their
counsel and the judiciary.
23.

Pursuant to the Transfer Order filed on August 17, 2015, cases are being

4 transferred to The Honorable David G. Campbell in the United States District Court for the
5 District of Arizona, Phoenix Division, as part of the IN RE: BARD IVC FILTERS
6 PRODUCTS LIABILITY LITIGATION MDL 2641.
7

24.

Pursuant to Case Management Order No. 2, federal cases against Bard relating

8 to Bard IVC Filters may be directly filed in this District.
9

BACKGROUND

10

INFERIOR VENA CAVA FILTERS GENERALLY

11

25.

IVC filters were first made commercially available to the medical community in

12 the 1960s. Over the years, medical device manufacturers have introduced several different
13 designs of IVC filters.
14

26.

An IVC filter is a device that is designed to filter or “catch” blood clots that

15 travel from the lower portions of the body to the heart and lungs. IVC filters were originally
16 designed to be permanently implanted in the IVC.
17

27.

The IVC is a vein that returns blood to the heart from the lower portions of the

18 body. In certain people, for various reasons, blood clots travel from the vessels in the legs and
19 pelvis, through the vena cava and into the lungs. Oftentimes, these blood clots develop in the
20 deep leg veins, a condition called “deep vein thrombosis” or “DVT.” Once blood clots reach
21 the lungs, they are considered “pulmonary emboli” or “PE.” Pulmonary emboli present risks
22 to human health.
-7-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 8 of 64

1

28.

People at risk for DVT/PE can undergo medical treatment to manage the risk.

2 For example, a doctor may prescribe anticoagulant therapies such as medications like Heparin,
3 Warfarin, or Lovenox to regulate the clotting factor of the blood. In some people who are at
4 high risk for DVT/PE and who cannot manage their conditions with medications, physicians
5 may recommend surgically implanting an IVC filter to prevent thromboembolitic events.
6

29.

As stated above, IVC filters have been on the market for decades and were

7 permanent implants. However, use of these filters was limited primarily to patients who were
8 contraindicated for anticoagulation therapy.
9

30.

In order to increase sales of these devices, Bard sought to expand the market for

10 prophylactic use among nontraditional patient populations that were temporarily at risk of
11 developing blood clots.
12

31.

Specifically, Bard targeted the bariatric, trauma, orthopedic and cancer patient

13 population. Expansion to these new patient groups would triple sales and the first
14 manufacturer to market would capture market share.
15

32.

At the same time, Bard was aware that physicians developed interest in filter

16 devices that could be easily removed after the risk of clotting in these new patient populations
17 subsided. This too was an opportunity to gain market share in the lucrative IVC filter market.
18

33.

Other manufacturers also saw this opportunity, triggering a race to market a

19 device that provided physicians the option to retrieve the filter after the clot risk subsided.
20

34.

Bard was the first medical device manufacturer to obtain FDA clearance for

21 marketing a “retrievable” IVC filter (the Bard Recovery® filter) in July 2003.
22
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 9 of 64

1

35.

This “clearance” was obtained despite lack of adequate testimony on the safety

2 and efficacy of the new line of devices.
3

36.

As shown below, Bard’s retrievable IVC filters have been plagued with

4 problems – all created by Bard itself – most notably, the absence of any evidence that the
5 products were effective in preventing pulmonary embolism (the very condition the product
6 was indicated to prevent).
7

37.

Years after the implantation of retrievable filters into the bodies of patients,

8 scientists began to study the effectiveness of the retrievable filters – studies that Bard itself
9 had never done before placing the product on the market. As recently as October 2015, an
10 expansive article published in the Annals of Surgery concerning trauma patients inserted with
11 IVC filters concluded that IVC filters were not effective in preventing pulmonary emboli, and
12 instead actually caused thrombi to occur.
13

38.

Comparing the results of over 30,000 trauma patients who had not received IVC

14 filters with those who had received them, the Annals of Surgery study published its alarming
15 results:
16



17
18

compared to those that had not received them.


19
20
21

Almost twice the percentage of patients with IVC filters in the study died

Over five times the relative number of patients with IVC filters developed
DVTs.



Over four times the relative percentage of patients with filters developed
thromboemboli.

22
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 10 of 64

1



Over twice the percentage of patients developed a pulmonary embolus – the

2

very condition Bard told the FDA, physicians, and the public that its IVC

3

Filters were designed to prevent.

4

39.

This Annals of Surgery study – and many others referenced by it – now shows

5 without any question that IVC filters are not only utterly ineffective but that they are
6 themselves a health hazard.
THE RECOVERY® FILTER

7
8

A.

9

40.

Development and Regulatory Clearance of the Recovery® Filter
Bard has distributed and marketed the Simon Nitinol Filter (“SNF”) device since

10 1992. The SNF is a permanent filter with no option to retrieve it after implantation.
11

41.

The SNF was initially manufactured by a company known as Nitinol Medical

12 Technologies. In late 1999, Bard worked with Nitinol on the redesign of the SNF in order to
13 make it retrievable. On October 19, 2001, Bard purchased the rights to manufacture, market,
14 and sell this new, redesigned product in development at the time. This product ultimately
15 became the Recovery® filter.
16

42.

Bard’s purpose for making a retrievable IVC filter was to increase profits by

17 expanding the overall IVC filter market and, in turn, Bard’s percentage share of that market.
18

43.

Bard engaged in an aggressive marketing campaign for the filter, despite

19 negative clinical data.
20

44.

On November 27, 2002, Bard bypassed the more onerous Food and Drug

21

Administration’s (“FDA’s”) approval process for new devices and obtained “clearance”

22

under Section 510(k) of the Medical Device Amendments to the Food, Drug, and Cosmetic
-10-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 11 of 64

1

Act to market the Recovery® filter as a permanent filter by claiming it was substantially

2

similar in respect to safety, efficacy, design, and materials as the SNF.

3

45.

Section 510(k) permits the marketing of medical devices if the device is

4 substantially equivalent to other legally marketed predicate devices without formal review for
5 the safety or efficacy of the said device. The FDA explained the difference between the
6 510(k) process and the more rigorous “premarket approval” (PMA) process in its amicus brief
7 filed with the Third Circuit in Horn v. Thoratec Corp., which the court quoted from:
8
9
10
11
12
13
14
15
16
17
18
19

A manufacturer can obtain an FDA finding of ‘substantial equivalence’ by
submitting a premarket notification to the agency in accordance with section
510(k) of the [Food Drug and Cosmetic Act]. 21 U.S.C. § 360(k). A device
found to be ‘substantially equivalent’ to a predicate device is said to be
‘cleared’ by FDA (as opposed to ‘approved’ by the agency under a PMA. A
pre-market notification submitted under 510(k) is thus entirely different from a
PMA which must include data sufficient to demonstrate that the IVC Filters is
safe and effective.
376 F.3d 163, 167 (3d Cir. 2004) (emphasis in original).
46.

In Medtronic, Inc. v. Lohr, the U.S. Supreme Court similarly described the

510(k) process, observing:
If the FDA concludes on the basis of the [manufacturer’s] § 510(k) notification
that the device is “substantially equivalent” to a pre-existing device, it can be
marketed without further regulatory analysis. . . . The § 510(k) notification
process is by no means comparable to the PMA process; in contrast to the 1,200
hours necessary to complete a PMA review, the § 510(k) review is completed in
average of 20 hours. . . . As one commentator noted: “The attraction of
substantial equivalence to manufacturers is clear. Section 510(k) notification
requires little information, rarely elicits a negative response from the FDA, and
gets processed quickly.”

20
21
22
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1

518 U.S. 470, 478-79 (1996) (quoting Adler, The 1976 Medical Device Amendments:

2

A Step in the Right Direction Needs Another Step in the Right Direction, 43 Food

3

Drug Cosm. L.J. 511, 516 (1988)).

4

47.

Pursuant to Wyeth v. Levine, 555 U.S. 555 (2009), once a product is cleared “the

5 manufacturer remains under an obligation to investigate and report any adverse events
6 associated with the drug . . . and must periodically submit any new information that may affect
7 the FDA’s previous conclusions about the safety, effectiveness, or labeling . . . .” This
8 obligation extends to post-market monitoring of adverse events/complaints.
9

48.

In July 2003, through this 510(k) process, Bard obtained clearance from the

®
10 FDA to market the Recovery filter for optional retrieval.

11

49.

Although Bard began aggressively marketing the Recovery® filter in 2003, full

12 market release did not occur until January 2004.
13

50.

Bard was aware that the Recovery® filter was also used extensively off-label,

14 including for purely prophylactic reasons for trauma patients or patients with upcoming
15 surgeries such as bariatric (weight loss) and orthopedic procedures.
16

51.

The Recovery® filter consists of two (2) levels of six (6) radially distributed

17 NITINOL (a nickel titanium alloy whose full name is Nickel Titanium Naval Ordinance
18 Laboratory) struts that are designed to anchor the filter into the inferior vena cava and to catch
19 any embolizing clots.
20

52.

This filter has six short struts, which are commonly referred to as the “arms,”

21 and six long struts, which are commonly referred to as the “legs.”
22
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 13 of 64

1

53.

Each strut is held together by a single connection to a cap located at the top of

2 the filter. According to the patent application filed for this device, the short struts are
3 primarily for “centering” or “positioning” within the vena cava, and the long struts with
4 attached hooks are designed primarily to prevent the device from migrating in response to
5 “normal respiratory movement” or “pulmonary embolism.”
6

54.

The alloy NITINOL possesses “shape memory,” meaning NITINOL will change

7 shape according to changes in temperature, then retake its prior shape after returning to its
8 initial temperature.
9

55.

When placed in saline, the Recovery® filter’s NITINOL struts become soft and

10 can be straightened to allow delivery through a small-diameter catheter. The NITINOL struts
11 then resume their original shape when warmed to body temperature in the vena cava.
12

56.

The Recovery® filter is inserted via catheter guided by a physician (normally an

13 interventional radiologist) through a blood vessel into the inferior vena cava. The Recovery®
14 Filter is designed to be retrieved in a similar fashion.
15

57.

According to the Instructions for Use of this medical device, only the Recovery®

®
16 Cone System could be used to retrieve the Recovery filter (as well as subsequent generations

17 of Bard’s IVC filters).
18

58.

The Recovery® Cone System is an independent medical device requiring

19 approval by the FDA under the pre-market approval process or, if a substantially equivalent
20 medical device was already on the market, clearance by the FDA pursuant to the 510(k)
21 application process.
22
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 14 of 64

1

59.

Although Bard marketed and sold the Recovery® Cone System separately, it

2 never sought or obtained approval or clearance from the FDA for this device.
3

60.

Bard’s sale of the Recovery® Cone System was, therefore, illegal.

4

61.

Bard illegally sold the Recovery® Cone System in order to promote the

®
5 Recovery filter as having a retrieval option.

6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21

B.
62.

Post-Market Performance Revealed The IVC Filters Failed to Perform as
Expected
Once placed on the market, Bard immediately became aware of numerous

confirmed events where its Recovery® filter fractured, migrated, or perforated the vena cava,
caused thrombus and clotting, and caused serious injury, including death.
63.

Premarket and post-market clinical trials revealed that the Recovery® failed and

caused serious risk of harm. In addition, peer-reviewed literature reflected that such filters
actually increased the risk of patients developing thromboembolitic events.
64.

Approximately a month after the full-scale launch of the Recovery® filter, on

February 9, 2004, Bard received notice of the first death associated with this filter. The next
day, a MAUDE analysis was performed which revealed that there had been at least two other
migration-related adverse events reported to Bard in 2003.
65.

MAUDE is a database maintained by the FDA to house medical device reports

submitted by mandatory reporters (such as manufacturers and device user facilities) and
voluntary reporters (such as health care providers and patients).
66.

Instead of pulling the Recovery® filter off the market, Bard focused on public

relations and protecting its brand and image. By February 12, 2004, Bard had formed a crisis

22
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 15 of 64

1 communication team and drafted at least four communiques to pass onto its sales force
2 containing false information designed to be relayed to concerned doctors.
3

67.

By April of 2004, at least three deaths had been reported to Bard. Yet again,

4 instead of recalling its deadly device, Bard concealed this information from doctors and
5 patients and hired the public relations firm Hill & Knowlton to address anticipated publicity
6 that could affect stock prices and sales.
7

68.

Bard made the decision to continue to market and sell the Recovery® filter until

®
8 its next generation product, the G2 IVC filter, was cleared by the FDA.

9

69.

The G2® filter, however, was not cleared for market until August 29, 2005.

10

70.

Meanwhile, the death count escalated.

11

71.

On July 12, 2004, C.R. Bard CEO Timothy Ring received an executive summary

12 reporting that there were at least 12 filter migrations resulting in four deaths and at least 17
13 reports of filter fracture, six cases of which involved strut embolization to the heart.
14

72.

This same report advised that fracture rates for the Recovery® filter exceed

15 reported rates of other filters.
16

73.

These events revealed, or should have revealed, to Bard that the Recovery® filter

17 is prone to an unreasonably high risk of failure and patient injury following placement in the
18 human body.
19

74.

Bard also learned that the Recovery® filter failed to meet migration resistence

20 testing specifications.
21

75.

In addition, multiple early studies reported that the Recovery® filter has a

22 fracture and migration rate ranging from 21% to 31.7%, rates that are substantially higher
-15-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 16 of 64

1 compared to other IVC filters. More recently, fractures were reported to be as high as 40%
2 after five and a half years from the date of implant.
3

76.

Bard had clear evidence that the Recovery® filter was not substantially

®
4 equivalent to the predecessor SNF, making the Recovery filter adulterated and misbranded,

5 requiring its immediate withdrawal from the market.
6

77.

At least one Bard executive concluded the Recovery® filter posed an

7 unreasonable risk of harm and required corrective action, including a recall.
8

78.

Likewise, Bard’s G2® filter was predicted to have fracture rates as high as 37.5%

9 after five years from date of implant.
10

79.

Subsequent Bard IVC Filter models, including the electropolished version of the

®
11 G2 filter known as the Eclipse, only marginally increased fracture resistance.

12

80.

When IVC filter fractures occur, shards of the filter or even the entire filter can

13 travel to the heart, where they can cause cardiac tamponade, perforation of the atrial wall,
14 myocardial infarction, and/or death.
15

81.

Bard IVC Filters similarly pose a high risk of tilting and perforating the vena

16 cava walls. When such tilting occurs, the filters can also perforate the adjacent aorta,
17 duodenum, small bowel, spine, or ureter, which may lead to and, upon information and belief,
18 already have led to retroperitoneal hematomas, small-bowel obstructions, extended periods of
19 severe pain, and/or death.
20

82.

The Adverse Event Reports (“AERs”) associated with all IVC filters

21 demonstrate that Bard IVC Filters are far more prone to failure then are other similar IVC
22
-16-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 17 of 64

1 filters. A review of the FDA MAUDE database from the years 2004 through 2008 shows that
2 Bard IVC Filters are responsible for the following percentages of all IVC filter AERs:
3

a.

50% of all adverse events;

4

b.

64% of all occurrences of migration of the IVC Filters;

5

c.

69% of all occurrences of vena cava wall perforation; and

6

d.

70% of all occurrences of filter fracture.

7

83.

These failures were often associated with severe patient injuries such as:

8

a.

Death;

9

b.

Hemorrhage;

10

c.

Cardiac/pericardial tamponade (pressure caused by a collection of blood
in the area around the heart);

11
12

d.

Cardiac arrhythmia and other symptoms similar to myocardial infarction;

13

e.

Severe and persistent pain; and

14

f.

Perforations of tissue, vessels and organs.

15

84.

These failures and resulting injuries are attributable, in part, to the fact that the

16 Bard IVC Filter design was unable to withstand the normal anatomical and physiological
17 loading cycles exerted in vivo.
18

85.

In addition to design defects, Bard IVC Filters suffer from manufacturing

19 defects. These manufacturing defects include, but are not limited to, the existence of “draw
20 markings” and circumferential grinding markings on the exterior of the surface of the filters.
21

86.

The presence of these draw markings and/or circumferential grinding markings

22 further compromises the structural integrity of the Bard IVC Filters while in the body. In
-17-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 18 of 64

®
1 particular, the Recovery filter is prone to fail at or near the location of draw

2 markings/circumferential grinding markings on the struts of the filters. These exterior
3 manufacturing defects render Bard IVC Filters too weak to withstand normal placement within
4 the human body.
5

87.

Bard was aware that Bard IVC Filters had substantially higher reported failure

6 rates than all other IVC filters for fracture, perforation, migration, and death. For example:
7

a.

On April 23, 2004, Bard’s Corporate VP of Quality Assurance sent an

8

email noting that the Recovery® filter’s reported failure rates “did not

9

look good compared to permanent filters” and promised to remove the

10

filter from the market if its reported death rate became “significantly

11

greater than the rest of the pack.”

12

b.

On July 9, 2004, a BPV safety analysis of reported failure rates

13

determined that the Recovery® filter had a reported failure rate that was

14

28 times higher than all other IVC filters.

15

c.

On December 17, 2004, analysis determined that the “[r]eports of death,

16

filter migration (movement), IVC perforation, and filter fracture

17

associated with the Recovery® filter were seen in the MAUDE database

18

at reporting rates that were 4.6, 4.4, 4.1, and 5.3 times higher,

19

respectively, than reporting rates for all other filters. . . . These

20

deficiencies were all statistically significant . . . [and were] significantly

21

higher than those for other removable filters.”

22
-18-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 19 of 64

d.

1

By December 2004, according to BPV’s own findings pursuant to its

2

safety procedure, the Recovery® filter had so many reported failures that

3

it was deemed not reasonably safe for human use and required

4

“correction.”
e.

5

A BPV safety analysis from June 28, 2011, revealed that the Recovery®
filter had a reported fracture rate 55 times higher than the SNF.

6
f.

7

Whereas the Recovery® filter was reported to have caused over a dozen

8

deaths by early 2005, the SNF has never — to Plaintiffs’ knowledge —

9

been reported as associated with a patient death.

10
11
12
13
14
15
16
17
18
19

C.
88.

Defendants Knew Why the Recovery® Filter Was Failing and Were Aware
of Available Design Changes that Could Substantially Reduce Failures
Bard knew why the design changes made to the Recovery® filter were causing

failures.
89.

Bard was aware that the diameter of the leg hooks was a substantial factor in a

filter’s ability to resist migration and fatigue.
90.

By reducing the diameter of the hooks on the Recovery® filter, Bard had reduced

the device’s ability to remain stable and not fracture.
91.

Bard also reduced the leg span of the Recovery® filter from that of the SNF filter

by 25%. As a result, Bard knew its retrievable IVC filters lacked a sufficient margin of safety
to accommodate expansion of the vena cava (distension) after placement.

20
21
22
-19-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 20 of 64

1

92.

Bard was also aware that its failure to electropolish the wire material prior to

2 distribution meant that Bard IVC Filters had surface damage that reduced their fatigue
3 resistance.
4

93.

Bard was also aware that the Recovery® filter had a high propensity to tilt and

5 perforate the vena cava, which substantially increased the risk of fracture.
6

94.

Bard was also aware that fatigue resistance could be increased by decreasing the

7 sharpness of the angle of the wire struts where they exited the cap at the top of the IVC filters,
8 and by chamfering (rounding or reducing the sharpness) of the cap edge against which the
9 struts rubbed.
10

95.

A few examples of Bard’s awareness of the unreasonably dangerous problems

11 with Bard IVC Filters include:
12

a.

chamfering the edge of the cap would reduce the likelihood of fracture.

13
14

On June 18, 2003, BPV engineer Robert Carr sent an email noting that

b.

On March 16, 2004, a BPV engineer sent an email admitting that the

15

surface damage seen on the Recovery® filter from the manufacturing

16

process decreases fatigue resistance and that electropolishing increases

17

fatigue resistance.

18

c.

In an April 2004 meeting, BPV was warned by its physician consultants,

19

Drs. Venbrux and Kaufman, that the migration resistance of the

20

Recovery® filter needed to be raised from 50 mmHg to 140 mmHg.

21

They further warned BPV that Bard’s Recovery® filter was a “wimpy”

22

filter and its radial force was inadequate to assure stability.
-20-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 21 of 64

d.

1

On May 5, 2004, a BPV engineer sent an email stating that adding a
“chamfer” to the filter would “address the arm fracture issue.”

2
e.

3

On May 26, 2004, a BPV engineer sent an email stating that a proposed

4

modified Recovery® filter design with a large chamfer lasted 50 bending

5

cycles before breaking, whereas another proposed modified Recovery®

6

filter with a small chamfer broke after ten bending cycles.

7

96.

Prior to Plaintiffs being implanted with a Bard IVC Filter, Bard was aware of

®
8 other design changes that could make the Recovery filter substantially safer. In a report
®
9 dated February 16, 2005, BPV describes the design changes to the Recovery filter, which
®
®
10 became known as the G2 Filter. The report states that the Recovery filter has been modified

11 to “to increase migration and fracture resistance, and to minimize the likelihood of leg
12 twisting, appendage snagging, filter tilting, and caval perforation.” The document goes on to
13 describe the design modifications, which include:
14

a.

Increased ground wire diameter of the hook from .0085” to .0105” in

15

order to improve the fracture resistance of the hook and to improve the

16

migration resistance of the filter.

17

b.

The leg span has been increased from 32mm to 40mm in order to

18

improve the ability of the filter to expand with a distending vena cava

19

reducing risk of migration.

20
21

c.

The total filter arm length has increased from 20mm to 25mm, enlarging
the arm span from 30mm to 33mm to aid in filter centering.

22
-21-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 22 of 64

d.

1

An additional inward bend has been applied to the end of the filter arm

2

in order to improve arm interaction with the vessel wall and to address

3

caval perforations and appendage snagging.
e.

4

The arc of filter arm, as it attaches to the sleeve, has been modified to

5

have a smooth radial transition instead of sharp angle. This change was

6

made in order to reduce the stress concentration generated by the sharp

7

angle and thus improve fracture resistance in the area of the filter.
f.

8

reduced the risk of fracture.

9
10

The report concludes that the design modifications have substantially

97.

Subsequent design changes only marginally improved product safety, but did not

11 fully or adequately address the Bard IVC Filters’ deadly defects.
12

98.

Electropolishing was added to the Bard IVC Filters in 2010 to reduce the risk of

13 fracture. Electropolishing implanted Nitinol IVC filters was the industry standard, and
14 increased fatigue resistance by at least 25%, according to Bard’s internal testing.
15

99.

Additional anchors were added to the anchoring system on the filter in 2011, in

16 what became known as the Meridian filter. The purpose of this improvement was to decrease
17 the risk of tilting, which increases the risk of fracture and perforation, and reduce caudal
18 migration.
19

100.

Bard added penetration limiters with the introduction of Denali Filter in May

101.

Penetration limiters are designed to reduce perforation and penetration of the

20 2013.
21

22 vena cava.
-22-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 23 of 64

1

D.

2

102.

Bard Misrepresented and Concealed the IVC Filters’ Risks and Benefits
Despite knowing that the Recovery® filter was substantially more likely to

3 fracture, migrate, tilt, and cause death than any other filter, Bard marketed its IVC filters as
4 being safer and more effective than all other filters throughout the lifecycle of the product.
5

103.

Bard further provided mandatory scripts to its Bard IVC filter sales force, which

6 required the sales force to falsely tell physicians that the Recovery® filter was safe because it
7 had the same reported failure rates as all other filters.
8

104.

Even Bard’s updated labeling in December 2004 downplayed and concealed the

®
9 Recovery filter’s dangerous effects because it suggested fractures almost always cause no

10 harm and that all filters had the same risk of failure.
11

105.

Bard’s updated labeling also downplayed the risk of harm by stating that serious

12 injuries had only been “reported” when Bard knew such injuries had in fact occurred.
13
14
15
16
17
18
19
20
21

E.
106.

Bard Chose to Keep Selling an Unsafe IVC Filter and Lied to Its Own
Sales Force to Ensure Market Share and Stock Prices
Instead of warning the public or withdrawing the IVC Filters from the market to

fix the problems with its IVC filters, Defendants retained a public relations firm, opened a task
force to prevent information from getting out to the public, and devised a plan to address the
public if it did.
107.

In 2004, Bard created a Crisis Communication Team that included members of

Bard’s upper level management, Bard’s legal department, and independent consultants.
108.

The Crisis Communication Team created a Crisis Communication Plan, which

summarized Bard’s motivation for withholding risk information from the public as follows:

22
-23-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 24 of 64

1
2
3
4

The proliferation of unfavorable press in top-tier media outlets can cause an
onslaught of negative activity: a company’s employee morale may suffer, stock
prices may plummet, analysts may downgrade the affected company’s rating,
reputations may be ruined temporarily or even permanently. Extensive
preparation is critical to help prevent the spread of damaging coverage.
109.

In an April 2004 email, BPV consultant Dr. John Lehmann, a member of the

5 Crisis Communication Team, advised Bard to conceal from the public Bard’s information
6 about the material risk of its IVC filters. Bard adopted his advice. His email states, among
7 other things:
8
9
10
11
12
13
14
15
16

Comparison with other filters is problematic in many ways, and we should
avoid/downplay this as much as possible. When pressed, we simply paraphrase
what was said in the Health Hazard. That “Estimates based on available data
suggest that there is no significant difference in the rates of these complications
between any of the IVC Filters currently marketed in the U.S., including the
Recovery IVC Filters.
***
I wouldn’t raise this subject if at possible. It would be a most unusual reporter
that will get this far. The testing data I saw in Arizona showed that although
RF was certainly within the boundaries of IVC Filters tested, in larger veins it
was near the bottom. I would avoid as much as possible getting into this
subject, because I’m not sure others would agree with the conclusion that
“Recovery Vena Cava Filter was just as or more resistant to migration than all
retrievable and non-retrievable competitors.
110.

Bard also made false representations and/omissions to the BPV sales force to

17 keep them selling the IVC filters. Bard reassured the sales force that despite the failures with
18 the Recovery® filter, the Bard IVC Filters were safe because they had the same failure rates as
19 all other IVC filters.
20

111.

By December 2004, BPV’s own safety procedure deemed the Recovery® filter

21 not reasonably safe for human use. Yet Bard continued to market and sell the Recovery® filter
22
-24-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 25 of 64

1 into September 2005 and continued to allow its defective product to sit on shelves available to
2 be implanted for an unknown period of time after September 2005.
3

112.

Even after the G2® filter was launched in September 2005, Bard still failed to

®
4 warn consumers of the increased risk posed by the Recovery filter. Instead, Bard again chose

5 to conceal information about the serious risks of substantial harm from the use of its defective
6 product.
THE G2®, RECOVERY® G2 AND G2® EXPRESS FILTERS

7
8

113.

On or about March 2, 2005, Bard submitted a Section 510(k) premarket

®
9 notification of intent to market the G2 filter for the prevention of recurrent pulmonary
®
10 embolism via placement in the inferior vena cava. In doing so, Bard cited the Recovery filter

11 as the substantially equivalent predicate IVC filter, which was an inappropriate and illegal
12 predicate device since it was being marketed while adulterated and misbranded for failing,
13 among other things, to be as safe and effective as its predicate device, SNF. Bard stated that
®
®
14 the only differences between the Recovery filter and the G2 filter were primarily

15 dimensional, and no material changes or additional components were added. It was
®
16 considered by Bard the next generation of the Recovery filter

17

114.

On March 30, 2005, however, the FDA rejected this application unless Bard and

18 BPV included “black box” warnings that read:
19
20
21
22

Warning: The safety and effectiveness of the Recovery® Filter System in
morbidly obese patients has not been established. There have been fatal devicerelated adverse events reported in this population.
[and]
[C]entral venous lines may cause the filters to move or fracture.
-25-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 26 of 64

115.

1

On April 19, 2005, prior to formally responding to the FDA’s request to add a

2 black box warning, BPV CEO Timothy Ring and C.R. Bard CEO John Weiland received an
3 executive summary reporting that there were at least 34 migrations and 51 fractures associated
4 with Bard IVC Filters.
116.

5

This same report advised Bard executives that there were then nine deaths, six of

6 which related to morbidly obese patients. Further, 18 of the 51 fractures resulted in fragments
7 migrating to the heart.
117.

8

On April 20, 2005, without alerting the FDA to the alarming information Bard

9 executives had the day before, Bard submitted a letter in response to the FDA’s request to add
10 this black box warning stating that, “There is currently a statement in the IFU linking all of our
11 complications to death.”
118.

12

On August 29, 2005, the FDA cleared the G2® filter for the same intended uses

2
13 as the Recovery® filter, except that it was not cleared for retrievable use. Contrary to the

14 FDA’s suggestion, no black box warning was added to warn the bariatric patient population of
15 fatalities associated with the use of the filter.3
16

119.

In September of 2005, Bard quietly and belatedly replaced the Recovery® filter

17 on hospital shelves with the G2® filter. Bard either told doctors or led them to believe that the
18 G2® was a new and improved version of the Recovery® filter with the same option to retrieve
19 the filter after implant.
20
21

2

The FDA did not clear the G2® filter to be used as a retrievable filter until January 15, 2008.

22

3

A warning was eventually added to the IFU in October of 2009.
-26-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 27 of 64

1

120.

At the same time Bard was selling the G2® (then a permanent use filter without

2 any retrievability option), Bard was also selling the SNF, which had the same indication for
3 use with nearly zero adverse events.
4

121.

Bard marketed the G2® filter as having “enhanced fracture resistance,”

5 “improved centering,” and “increased migration resistance” without any data to back up these
6 representations. Even if such data existed, Bard witnesses have testified that Bard would not
7 share any such information with doctors if requested.
8

122.

Moreover, as with its predecessor Recovery® filter, Bard failed to conduct

®
9 adequate clinical and bench testing to ensure that the G2 filter would perform safely and

10 effectively once implanted in the human body.
11

123.

The G2® filter’s design causes it to be of insufficient integrity and strength to

12 withstand normal stresses within the human body so as to resist fracturing, migrating, and/or
13 tilting, and/or perforating the inferior vena cava.
14

124.

In addition to the same design defects as its predecessor device, the G2® filter

15 suffers from the same manufacturing defects. These manufacturing defects include, but are
16 not limited to, the existence of “draw markings” and circumferential grinding markings on the
17 exterior of the surface of Bard IVC Filters. The presence of these draw markings and/or
®
18 circumferential grinding markings further compromises the structural integrity of the G2

19 filter while in vivo.
20

125.

In particular, the G2® filter is prone to fail at or near the location of draw

21 markings/circumferential grinding markings on the struts of the IVC Filters.
22
-27-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 28 of 64

1

126.

Put simply, the G2® filter is not of sufficient strength to withstand normal

2 placement within the human body. The presence of the aforementioned exterior
3 manufacturing defects makes Bard IVC Filters more susceptible to fatigue, failure, and
4 migration.
5

127.

Similarly, although Bard rounded the chamfer at the edge of the cap of the G2®

6 filter, it continued to fracture at that same location.
7

128.

Thus, the G2® filter shares similar defects and health risks as the Recovery®

129.

Almost immediately upon the release of the G2® filter, Bard received notice of

8 filter.
9

10 the same series of adverse events of migration, fracture, tilt, and perforation causing the same
®
11 type of harm as the Recovery filter. This time, however, a new and different adverse event
®
12 emerged: the G2 filter would caudally (moving against blood flow) migrate in the direction

13 toward the groin.
14

130.

The G2® filter failures were again associated with reports of severe patient

15 injuries such as:
16

a.

Death;

17

b.

Hemorrhage;

18

c.

Cardiac/pericardial tamponade (pressure caused by a collection of blood
in the area around the heart);

19
20

d.

Cardiac arrhythmia and other symptoms similar to myocardial infarction;

21

e.

Severe and persistent pain; and

22

f.

Perforations of tissue, vessels and organs.
-28-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 29 of 64

1

131.

Bard represents the fracture rate of the G2® filter to be 1.2%. Based upon a

2 review of the data available in the public domain (including the FDA MAUDE database
3 statistics and the published medical literature), this representation does not accurately reflect
®
4 the true frequency of fractures for the G2 filter.

5

132.

As with the Recovery® filter, Bard was aware of clinical data showing that the

6 G2® filter was not the substantial equivalent of its predecessor SNF device, requiring
7 immediate recall of the adulterated and misbranded product.
8

133.

A review of the MAUDE database from the years 2004 through 2008

®
9 demonstrates that the Bard IVC Filters (including the G2 Filter) are responsible for the

10 majority of all reported adverse events related to IVC filters.
11

134.

On December 27, 2005, Bard’s Medical Affairs Director sent an email

12 questioning why Bard was even selling the modified version of the Recovery® filter, when
13 Bard’s SNF had virtually no complaints associated with it.
14

135.

This further confirms the misbranded and adulterated nature of the device,

15 requiring corrective action, including recall.
16

136.

On January 15, 2008, the FDA allowed a retrievable option for the G2® filter, the

®
®
®
17 G2 Express filter. The G2 Express filter (also known as the “G2 X”) is identical in design
®
18 to the G2 filter except that it has a hook at the top of the filters that allows it to be retrieved

19 by snares, as well as Bard’s Recovery Cone.
20

137.

The G2®X filter contained no design modifications or improvements to alleviate

21 the instability, structural integrity, and perforation problems that Bard knew to exist with the
®
22 G2 X Filter via the 510(k) process.

-29-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 30 of 64

THE ECLIPSE® FILTER

1
2

138.

In a failed effort to resolve the complications associated with its previous filters,

®
3 Bard designed the Eclipse Vena Cava Filter as the next generation in its retrievable IVC filter

4 family.
5

139.

The Eclipse® filter was cleared by the FDA on January 14, 2010. The only

®
®
®
6 design changes from the G2 family of filters to the Eclipse filter was that the Eclipse filter

7 was electropolished.
8

140.

According to Bard’s internal testing, electropolishing supposedly increased

9 fracture resistance by 25%. However, longitudinal studies published in peer-reviewed medical
®
10 literature found that among 363 patients implanted with the Recovery filter and 658 patients
®
11 implanted with the G2 filter, the devices experienced fracture rates of 40% and 37.5%,
®
12 respectively, after five and a half years. Thus, approximately 28.125% to 30% of Eclipse

13 filters would still be projected to fracture within five and a half years.
14

141.

Without meaningful design changes, the Eclipse® filter continued to share

®
15 several of the same design defects and complications associated with the Recovery filter and
®
16 G2 family of filters.

17

142.

Soon after Bard launched the Eclipse® filter, it began receiving complaints and

®
18 reports of injuries associated with the Eclipse filter similar to those received with its

19 predecessor filters.
20

143.

Bard, however, knew and/or soon learned that the Eclipse® filter was not the

21 substantial equivalent of the SNF, making this device also misbranded and adulterated, and
22 subject to recall.
-30-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 31 of 64

THE MERIDIAN® FILTER

1
2

144.

The Meridian® filter was cleared by the FDA in August of 2011.

3

145.

Bard represented to the FDA that the Meridian was substantially similar to the

®
4 Eclipse filter and could therefore be cleared via the less onerous 510(k) process.

5

146.

Bard, however, knew and/or soon learned that the Meridian® filter was not the

6 substantial equivalent of the SNF, making this device also misbranded and adulterated, and
7 subject to recall.
8

147.

The Meridian® filter system was the next-generation of Bard’s retrievable or

®
9 optional filters. The Meridian filter is made of the same nickel-titanium alloy, NITINOL, as
®
®
®
10 the Bard Recovery , G2 , and Eclipse filters.

11

148.

The design of the Meridian is based on the Eclipse® filter, which, in turn, is

®
®
12 based entirely on the G2 filter, which, in turn is based on the Recovery Filter. Like the
®
®
13 Eclipse , the wires used in the Meridian filter are electropolished prior to the forming of the
®
14 filter. The only added feature to the Meridian filter was a caudal anchoring system added in

15 an attempt to reduce the prevalence of the filter caudal migrating toward the groin.
16

149.

However, as seen with the Recovery®, G2®, and Eclipse® filters, soon after its

®
17 introduction to the market reports surfaced that the Meridian filters were fracturing,

18 perforating, migrating, and/or tilting in the patients in which they were implanted.
19

150.

The Meridian® filter was also plagued with the same manufacturing and design

20 defects that were causing damage to the general public as Bard’s predecessor retrievable
21 filters.
22
-31-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 32 of 64

THE DENALI® FILTER

1
2

151.

The Denali® filter was cleared by the FDA on May 15, 2013. It is Bard’s latest

3 generation device in the IVC filter product line.
4

152.

Bard represented to the FDA that the Denali® was substantially similar to the

®
5 Eclipse filter, again bypassing formal pre-market FDA approval and instead utilizing the

6 510(k) process.
7

153.

The Denali® Filter is also made of NITINOL. Its design is based on the Eclipse®

®
8 filter, which in turn, was based on Bard’s predecessor filter line. Like the Eclipse , the
®
9 NITINOL wires used in the Denali filter are electropolished prior to the forming of the filter.
®
10 The added features to the Denali Filter were cranial and caudal anchoring systems (to reduce

11 the prevalence of the filter migration) and penetration limiters.
12

154.

However, as seen with the Recovery®, G2®, G2X® (G2 Express®), and Eclipse®

®
13 Filters, soon after its introduction to the market, reports were made that the Denali filters

14 were fracturing, perforating, migrating, and/or tilting in the patients in which they were
15 implanted.
16

155.

The Denali® filter was likewise plagued with the same manufacturing and design

17 defects that were causing damage to the general public in Bard’s predecessor retrievable filter
18 family.
19

156.

At all times material hereto from the design phase, testing, and manufacture of

®
®
20 the Recovery filter through the Denali filter, Bard lacked a thorough understanding

21 dynamics of caval anatomy that impacted testing methods.
22
-32-

Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 33 of 64

1

157.

At this time, all Bard IVC Filters contain the same or substantially similar

2 defects resulting in the same or substantially similar mechanism of injury to Plaintiffs and
3 their decedents.
4

158.

At this time, all Bard IVC Filters are misbranded and adulterated by virtue of

5 them failing to be the substantial equivalent of their predecessor devices, all of which were
6 required to be as safe and effective as the original predicate device, the Simon Nitinol Filter,
7 and none were/are, making them subject to corrective action, including recall, in the interest of
8 patient safety. The use of each of these subject devices was inappropriate and illegal since
9 each was being marketed while adulterated and misbranded for failing, among other things, to
10 be as safe and effective as the originating predicate device, SNF.
11

159.

At all relevant times, safer and more efficacious designs existed for this product,

12 as well as reasonable treatment alternatives.
13

ESTOPPEL FROM PLEADING STATUTES OF LIMITATIONS OR REPOSE

14

160.

Plaintiffs incorporate by reference all prior allegations.

15

161.

Plaintiffs are within the applicable statute of limitations for their claims because

16 Plaintiffs (and their healthcare professionals) did not discover, and could not reasonably
17 discover, the defects and unreasonably dangerous condition of their Bard IVC Filters.
18

162.

Plaintiffs’ ignorance of the defective and unreasonably dangerous nature of the

19 Bard IVC Filters, and the causal connection between these defects and Plaintiffs’ injuries and
20 damages, is due in large part to Bard’s acts and omissions in fraudulently concealing
21 information from the public and misrepresenting and/or downplaying the serious threat to
22 public safety its products present.
-33-

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1

163.

In addition, Bard is estopped from relying on any statutes of limitation or repose

2 by virtue of its unclean hands, acts of fraudulent concealment, affirmative misrepresentations
3 and omissions.
4

164.

Such conduct includes intentional concealment from Plaintiffs, Plaintiffs’

5 prescribing health care professionals, and the general consuming public of material
6 information that Bard IVC Filters had not been demonstrated to be safe or effective, and
7 carried with them the risks and dangerous defects described above.
8

165.

Bard had a duty to disclose the fact that Bard IVC Filters are not safe or

9 effective, not as safe as other filters on the market, defective, and unreasonably dangerous, and
10 that their implantation and use carried with it the serious risk of developing perforation,
11 migration, tilting, and/or fracture.
12

COUNT I: STRICT PRODUCTS LIABILITY – MANUFACTURING DEFECT

13

166.

Plaintiffs incorporate by reference all prior allegations.

14

167.

Prior to, on, and after the date the Bard IVC Filters were implanted in Plaintiffs,

15 Bard designed, distributed, manufactured, sold, and marketed Bard IVC Filters for use in the
16 United States.
17

168.

At all relevant times, Bard designed, distributed, manufactured, marketed, and

18 sold Bard IVC Filters that were unreasonably dangerous, unsafe, and defective in manufacture
19 when they left Bard’s possession.
20

169.

Upon information and belief, Bard IVC Filters contain a manufacturing defect,

21 in that they differed from the manufacturer’s design or specifications, or from other typical
22 units of the same product line.
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1

170.

As a direct and proximate cause of Bard’s design, manufacture, marketing, and

2 sale of Bard IVC Filters prior to, on, and after the date Plaintiffs used the Bard IVC Filters,
3 Plaintiffs suffered Injuries and Damages.
4

COUNT II: STRICT PRODUCTS LIABILITY – INFORMATION DEFECT

5

171.

Plaintiffs incorporate by reference all prior allegations.

6

172.

At all relevant times, Bard engaged in the business of testing, developing,

7 designing, manufacturing, packaging, labeling, marketing and/or promoting, selling and/or
8 distributing Bard IVC Filters and through that conduct has knowingly and intentionally placed
9 Bard IVC Filters into the stream of commerce with full knowledge that they reach consumers
10 such as Plaintiffs who would become implanted with them.
11

173.

Bard did in fact test, develop, design, manufacture, package, label, market and/or

12 promote, sell and/or distribute Bard IVC Filters to Plaintiffs, Plaintiffs’ prescribing health care
13 professionals, and the consuming public. Additionally, Bard expected that the Bard IVC
14 Filters they were selling, distributing, supplying, manufacturing, and/or promoting to reach,
15 and did in fact reach, prescribing health care professionals and consumers, including Plaintiffs
16 and Plaintiffs’ prescribing health care professionals, without any substantial change in the
17 condition of the product from when it was initially distributed by Bard.
18

174.

The Bard IVC Filters had potential risks and side effects that were known or

19 knowable to Bard by the use of scientific inquiry and information available before, at, and
20 after the manufacture, distribution, and sale of the Bard IVC Filters.
21

175.

Bard knew or should have known of the defective condition, characteristics, and

22 risks associated with Bard IVC Filters. These defective conditions included, but were not
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 36 of 64

1 limited to: (1) Bard IVC Filters posed a significant and higher risk of failure than other similar
2 IVC filters (fracture, migration, tilting, and perforation of the vena cava wall); (2) Bard IVC
3 Filter failures result in serious injuries and death; and (3) certain conditions or post-implant
4 procedures, such as morbid obesity or open abdominal procedures, could affect the safety and
5 integrity of Bard IVC Filters.
6

176.

Bard IVC Filters were in a defective and unsafe condition that was unreasonably

7 and substantially dangerous to any user or consumer implanted with Bard IVC Filters, such as
8 Plaintiffs, when used in an intended or reasonably foreseeable way.
9

177.

The warnings and directions Bard provided with Bard IVC Filters failed to

10 adequately warn of the potential risks and side effects of Bard IVC Filters.
11

178.

These risks were known or were reasonably scientifically knowable to Bard, but

12 not known or recognizable to ordinary consumers, such as Plaintiffs, or to Plaintiffs’ treating
13 doctors.
14

179.

Bard IVC Filters were expected to and did reach Plaintiff without substantial

15 change in their condition, labeling, or warnings as manufactured, distributed, and sold by
16 Bard.
17

180.

Additionally, Plaintiffs and Plaintiffs’ physicians used Bard IVC Filters in the

18 manner in which they were intended to be used, making such use reasonably foreseeable to
19 Bard.
20

181.

As a direct and proximate result of Bard’s information defects, lack of sufficient

21 instructions or warnings prior to, on, and after the date Plaintiffs used Bard IVC Filters,
22 Plaintiffs suffered Injuries and Damages.
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1

COUNT III: STRICT PRODUCTS LIABILITY – DESIGN DEFECT

2

182.

Plaintiffs incorporate by reference all prior allegations.

3

183.

At all relevant times, Bard designed, tested, distributed, manufactured,

4 advertised, sold, marketed and otherwise placed into the stream of commerce Bard IVC Filters
5 for use by consumers, such as Plaintiffs, in the United States.
6

184.

Bard IVC Filters were expected to, and did, reach Bard’s intended consumers,

7 handlers, and persons coming into contact with the product without substantial change in the
8 condition in which they was researched, tested, developed, designed, licensed, manufactured,
9 packaged, labeled, distributed, sold, and marketed by Bard.
10

185.

At all times relevant, Bard IVC Filters were manufactured, designed and labeled

11 in an unsafe, defective, and inherently dangerous condition which was dangerous for use by
12 the public in general and Plaintiffs in particular.
13

186.

Bard IVC Filters, as researched, tested, developed, designed, licensed,

14 manufactured, packaged, labeled, distributed, sold, and marketed by Bard were defective in
15 design and formulation and unreasonably dangerous in that when they left the hands of Bard’s
16 manufacturers and/or suppliers, the foreseeable risks exceeded the alleged benefits associated
17 with the use of Bard IVC Filters, and the devices were more dangerous than the ordinary
18 customer would expect.
19

187.

Physicians implanted Bard IVC Filters as instructed via the Instructions for Use

20 and in a foreseeable manner as normally intended, recommend, promoted, and marketed by
21 Bard.
22
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1

188.

Plaintiffs received and utilized Defendants’ IVC Filters in a foreseeable manner

2 as normally intended, recommended, promoted, and marketed by Bard.
3

189.

At the time Bard placed its defective and unreasonably dangerous Bard IVC

4 Filters into the stream of commerce commercially, technologically, and scientifically feasible
5 alternative designs were attainable and available.
6

190.

These alternative designs would have prevented the harm resulting in Plaintiffs’

7 Injuries and Damages without substantially impairing the reasonably anticipated or intended
8 function of Bard IVC Filters.
9

191.

As a direct and proximate result of the defective and unreasonably dangerous

10 condition of Bard IVC Filters, Plaintiffs suffered Injuries and Damages.
COUNT IV: NEGLIGENCE – DESIGN

11
12

192.

Plaintiffs incorporate by reference all prior allegations.

13

193.

At the time of the design, distribution, manufacture, advertising, sale, and

14 marketing of Bard IVC Filters, and their implantation in Plaintiffs, Bard was aware that Bard
15 IVC Filters were designed and manufactured in a manner presenting:
16

a.

An unreasonable risk of fracture of portions of the filters;

17

b.

An unreasonable risk of migration of the filters and/or portions of the
filters;

18
19

c.

wall; and

20
21
22

An unreasonable risk of filters tilting and/or perforating the vena cava

d.

Insufficient strength or structural integrity to withstand normal
placement within the human body.
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1

194.

At the time of the design, distribution, manufacture, advertising, sale, and

2 marketing of Bard IVC Filters, and their implantation in Plaintiffs, Bard also was aware that
3 Bard IVC Filters:
4

a.

Would be used without inspection for defects;

5

b.

Would be used by patients with special medical conditions such as those
of the Plaintiffs;

6
c.

7

Had previously caused serious bodily injury to its users with special
medical conditions such as those of the Plaintiffs;

8
9

d.

Had no established efficacy;

10

e.

Were less efficient than the predicate SNF;

11

f.

Would be implanted in patients where the risk outweighed any benefit or
utility of the filters;

12
13

g.

Contained instructions for use and warnings that were inadequate; and

14

h.

Required retrieval (as to the Recovery® and G2® filters) by a device
that was not approved or cleared by the FDA.

15
16

195.

Bard had a duty to exercise due care and avoid unreasonable risk of harm to

17 others in the design of Bard IVC Filters.
18
19

196.

Bard breached these duties by, among other things:
a.

Designing and distributing a product in which it knew or should have

20

known that the likelihood and severity of potential harm from the

21

product exceeded the burden of taking safety measures to reduce or

22

avoid harm;
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 40 of 64

b.

1

Designing and distributing a product which it knew or should have

2

known that the likelihood and severity of potential harm from the

3

product exceeded the likelihood of potential harm from other IVC filters

4

available for the same purpose;
c.

5

Failing to perform reasonable pre- and post-market testing of Bard IVC

6

Filters to determine whether or not the products were safe for their

7

intended use;
d.

8

Failing to use reasonable and prudent care in the design, research,
manufacture, and development of Bard IVC Filters so as to avoid the

9

risk of serious harm associated with the use of Bard IVC Filters;

10
e.

11

Advertising, marketing, promoting, and selling Bard IVC Filters for uses
other than as approved and indicated in the products’ labels;

12
f.

13

Failing to establish an adequate quality assurance program used in the
manufacturing of Bard IVC Filters; and

14
g.

15

Failing to perform adequate evaluation and testing of Bard IVC Filters

16

when such evaluation and testing would have revealed the propensity of

17

Bard IVC Filters to cause injuries similar to those that Plaintiffs suffered.

18

197.

As a direct and proximate result of the above-described negligence in design of

19 Bard IVC Filters, Plaintiffs suffered Injuries and Damages.
COUNT V: NEGLIGENCE – MANUFACTURE

20
21

198.

Plaintiffs incorporate by reference all prior allegations.

22
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1

199.

At all relevant times, Bard had a duty to exercise due care in the manufacturing

2 of Bard IVC Filters.
3

200.

Bard breached this duty by, among other things:
a.

4

Failing to adopt manufacturing processes that would reduce the
foreseeable risk of product failure;

5
b.

6

Failing to use reasonable care in manufacturing the product and by

7

producing a product that differed from their design or specifications or

8

from other typical units from the same production line;
c.

9

Failing to use reasonable and prudent care in the design, research,

10

manufacture, and development of Bard IVC Filters and their

11

manufacturing process so as to avoid the risk of serious harm associated

12

with the use of Bard IVC Filters; and
d.

13

manufacturing of the IVC Filters.

14
15

Failing to establish an adequate quality assurance program used in the

201.

As a direct and proximate result of the above-described negligence in

16 manufacture of Bard IVC Filters, Plaintiffs suffered Injuries and Damages.
17

COUNT VI: NEGLIGENCE – FAILURE TO RECALL/RETROFIT

18

202.

Plaintiffs incorporate by reference all prior allegations.

19

203.

At this time, all Bard IVC Filters are misbranded and adulterated by virtue of

20 them failing to be the substantial equivalent of their predecessor device, making them subject
21 to corrective action, including recall, in the interest of patient safety.
22
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1

204.

Prior to, on, and after the date of Plaintiffs’ implantation with Bard IVC Filters,

2 and at all relevant times, Bard knew or reasonably should have known that Bard IVC Filters
3 and their warnings were defective and dangerous or were likely to be dangerous when used in
4 a reasonably foreseeable manner.
5

205.

Prior to, on, and after the date of Plaintiffs’ implantation with Bard IVC Filters

6 and at all relevant times thereafter, Bard became aware that the defects of Bard IVC Filters
7 resulted in Bard IVC Filters causing injuries similar to those Plaintiffs suffered.
8

206.

Reasonable manufacturers and distributors under the same or similar

9 circumstances would have recalled or retrofitted Bard IVC Filters, and would thereby have
10 avoided and prevented harm to many patients, including Plaintiffs.
11

207.

In light of this information and Bard’s knowledge described above, Bard had a

12 duty to recall and/or retrofit Bard IVC Filters.
13

208.

Bard breached its duty to recall and/or retrofit Bard IVC Filters.

14

209.

As a direct and proximate result of Bard’s negligent failure to recall or retrofit,

15 Plaintiffs suffered Injuries and Damages.
COUNT VII: NEGLIGENCE – FAILURE TO WARN

16
17

210.

Plaintiffs incorporate by reference all prior allegations.

18

211.

At all relevant times, Bard knew or should have known that Bard IVC Filters

19 were defective and dangerous or were likely to be dangerous when used in a reasonably
20 foreseeable manner.
21

212.

Such danger included the propensity of Bard IVC Filters to cause injuries and

22 death similar to those suffered by Plaintiffs.
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1

213.

At all relevant times, Bard also knew or reasonably should have known that the

2 users of Bard IVC Filters, including Plaintiffs, would not realize or discover on their own the
3 dangers presented by Bard IVC Filters.
4

214.

Reasonable manufacturers and reasonable distributors, under the same or similar

5 circumstances as those of Bard prior to, on, and after the date of Plaintiffs’ use of Bard IVC
6 Filters, would have warned of the dangers presented by Bard IVC Filters, or instructed on the
7 safe use of Bard IVC Filters.
8

215.

Prior to, on, and after the date of Plaintiffs’ use of the IVC Filters, Bard had a

9 duty to adequately warn of the dangers presented by Bard IVC Filters and/or instruct on the
10 safe use of Bard IVC Filters.
11

216.

Bard breached these duties by failing to provide adequate warnings to Plaintiffs

12 communicating the information and dangers described above and/or providing instruction for
13 safe use of Bard IVC Filters.
14

217.

As a direct and proximate result of Bard’s negligent failure to warn, Plaintiffs

15 suffered Injuries and Damages.
COUNT VIII: NEGLIGENT MISREPRESENTATION

16
17

218.

Plaintiffs incorporate by reference all prior allegations.

18

219.

Prior to, on, and after the dates during which Plaintiff was implanted with the

19 IVC Filters, Bard negligently and carelessly represented to Plaintiffs, Plaintiffs’ treating
20 physicians, and the general public that Bard IVC Filters were safe, fit, and effective for use.
21

220.

These representations were untrue.

22
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 44 of 64

1

221.

Bard owed a duty in all of its undertakings, including the dissemination of

2 information concerning its IVC filters, to exercise reasonable care to ensure that it did not in
3 those undertakings create unreasonable risks of personal injury to others.
4

222.

Bard disseminated to health care professionals and consumers through published

5 labels, labeling, marketing materials, and otherwise information concerning the properties and
6 effects of Bard IVC Filters with the intention that health care professionals and consumers
7 would rely upon that information in their decisions concerning whether to prescribe and use
8 Bard IVC Filters.
9

223.

Bard, as medical device designers, manufacturers, sellers, promoters and/or

10 distributors, knew or should reasonably have known that health care professionals and
11 consumers, in weighing the potential benefits and potential risks of prescribing or using Bard
12 IVC Filters, would rely upon information disseminated and marketed by Bard to them
13 regarding the Bard IVC Filters.
14

224.

Bard failed to exercise reasonable care to ensure that the information they

15 disseminated to health care professionals and consumers concerning the properties and effects
16 of Bard IVC Filters was accurate, complete, and not misleading and, as a result, disseminated
17 information to health care professionals and consumers that was negligently and materially
18 inaccurate, misleading, false, and unreasonably dangerous to consumers such as Plaintiffs.
19

225.

Bard, as designers, manufacturers, sellers, promoters, and/or distributors, also

20 knew or reasonably should have known that patients receiving Bard IVC Filters as
21 recommended by health care professionals in reliance upon information disseminated by Bard
22 as the manufacturer/distributor of Bard IVC Filters would be placed in peril of developing the
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 45 of 64

1 serious, life-threatening, and life-long injuries including, but not limited to, tilting, migration,
2 perforation, fracture, lack of efficacy, and increased risk of the development of blood clots, if
3 the information disseminated and relied upon was materially inaccurate, misleading, or
4 otherwise false.
5

226.

Bard had a duty to promptly correct material misstatements it knew others were

6 relying upon in making healthcare decisions.
7

227.

Bard failed in each of these duties by misrepresenting to Plaintiffs and the

8 medical community the safety and efficacy of Bard IVC Filters and failing to correct known
9 misstatements and misrepresentations.
10

228.

As a direct and proximate result of Bard’s negligent misrepresentations,

11 Plaintiffs suffered Injuries and Damages.
12

COUNT IX: NEGLIGENCE PER SE

13

(Violations of 21 U.S.C. §§321, 331, 352 and 21 C.F.R. §§1.21, 801, 803, 807, 820)

14

229.

Plaintiffs incorporate by reference all prior allegations.

15

230.

At all times herein mentioned, Bard was subject to a variety of federal, state, and

16 local laws, rules, regulations and ordinances, including the Federal Food, Drug and Cosmetic
17 Act (“FFDCA”) and its applicable regulations, concerning the manufacture, design, testing,
18 production, processing, assembling, inspection, research, promotion, advertising, distribution,
19 marketing, promotion, labeling, packaging, preparation for use, consulting, sale, warning, and
20 post-sale warning and other communications of the risks and dangers of Bard IVC Filters.
21

231.

By reason of its conduct as alleged herein, Bard violated provisions of statutes

22 and regulations, including but not limited to:
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 46 of 64

1

a.

FFDCA, 21 U.S.C. §§331 and 352, by misbranding Bard IVC Filters;

2

b.

FFDCA, 21 U.S.C. § 321, by making statements and/or representations

3

via word, design, device, or any combination thereof failing to reveal

4

material facts with respect to the consequences that may result from the

5

use of Bard IVC Filters to which the labeling and advertising relates;

6

c.

21 C.F.R. § 1.21, by misleading its consumers and patients by

7

concealing material facts in light of representations made regarding

8

safety and efficacy of its Bard IVC Filters;

9

d.

21 C.F.R. § 801, by mislabeling Bard IVC Filters as to safety and

10

effectiveness of its products and by failing to update its label to reflect

11

post-marketing evidence that Bard IVC Filters were associated with an

12

increased risk of injuries due to tilting, fracture, migration and

13

perforation;

14

e.

adulterated and misbranded and failing to correct and recall the devices.

15
16

21 C.F.R. §§801.109 and 801.4 by learning that Bard IVC Filters were

f.

21 C.F.R. § 803, by not maintaining accurate medical device reports

17

regarding adverse events of tilting, fracture, migration and perforation

18

and/or misreporting these adverse events maintained via the medical

19

device reporting system;

20
21

g.

21 C.F.R. § 807, by failing to notify the FDA and/or the consuming
public when its Bard IVC Filters were no longer substantially equivalent

22
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 47 of 64

1

with regard to safety and efficacy with regard to post-marketing adverse

2

events and safety signals;
h.

3

21 C.F.R. § 820, by failing to maintain adequate quality systems

4

regulation including, but not limited to, instituting effective corrective

5

and preventative actions;
i.

6

21 CFR 201.128, by promoting each of their subject devices off-label

7

and for conditions, purposes and uses beyond their labeled and intended

8

uses; and
j.

9

210 CFR 801.4, by their knowledge of off-label uses of their devices for

10

unintended and unlabeled conditions, purposes and uses, and failing as

11

required to provide adequate labeling which accords with such unlabeled

12

and unintended uses.

13

232.

These statutes, rules and regulations, along with those listed in Count XIV, are

14 designed to protect the health, safety, and well-being of consumers like Plaintiffs.
15

233.

Bard’s violation of these statutes, rules and regulations, as well as those detailed

16 in Count XIV, constitutes negligence per se.
17

234.

As a direct and proximate result of Bard’s negligence per se, Plaintiffs suffered

18 Injuries and Damages.
COUNT X: BREACH OF EXPRESS WARRANTY

19
20

235.

Plaintiffs incorporate by reference all prior allegations.

21

236.

Plaintiffs, though their medical providers, purchased Bard IVC Filters from

22 Bard.
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 48 of 64

1

237.

At all relevant times, Bard was a merchant of goods of the kind including

2 medical devices and vena cava filters (i.e, Bard IVC Filters).
3

238.

At the time and place of sale, distribution, and supply of Bard IVC Filters to

4 Plaintiffs (and to other consumer and the medical community), Bard expressly represented and
5 warranted that Bard IVC Filters were safe; that they were well-tolerated, efficacious, fit for
6 their intended purpose, and of marketable quality; that they did not produce any unwarned-of
7 dangerous side effects; and that they was adequately tested.
8

239.

At the time of Plaintiffs’ purchase from Defendants, Bard IVC Filters were not

9 in a merchantable condition, and Bard breached its expressed warranties, in that Bard IVC
10 Filters:
11

a.

Were designed in such a manner so as to be prone to an unreasonably

12

high incidence of fracture, perforation of vessels and organs, and/or

13

migration;

14

b.

incidence of injury to the vessels and organs of its purchaser;

15
16

Were designed in such a manner so as to result in a unreasonably high

c.

Were manufactured in such a manner that the exterior surface of the

17

filter was inadequately, improperly, and inappropriately constituted,

18

causing the device to weaken and fail;

19

d.

Were unable to be removed at any time during a person’s life;

20

e.

Were not efficacious in the prevention of pulmonary emboli;

21

f.

Carried a risk of use outweighed any benefit; and

22

g.

Were not self-centering.
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 49 of 64

1

240.

As a direct and proximate result of Bard’s breach of express warranty, Plaintiffs

2 suffered Injuries and Damages.
COUNT XI: BREACH OF IMPLIED WARRANTY

3
4

241.

Plaintiffs incorporate by reference all prior allegations.

5

242.

Bard impliedly warranted that Bard IVC Filters were of merchantable quality

6 and safe and fit for the use for which Bard intended them, and Plaintiffs in fact used them.
7
8

243.

Bard breached its implied warranties by:
a.

reasonable care would have provided concerning the likelihood that Bard

9

IVC Filters would cause harm;

10
11

b.

Manufacturing and/or selling Bard IVC Filters when those filters did not
conform to representations made by Bard when they left Bard’s control;

12
13

Failing to provide adequate instruction that a manufacturer exercising

c.

Manufacturing and/or selling Bard IVC Filters that were more dangerous

14

than an ordinary consumer would expect when used in an intended or

15

reasonably foreseeable manner;

16

d.

Manufacturing and/or selling Bard IVC Filters that carried foreseeable

17

risks associated with the Bard IVC Filter design or formulation which

18

exceeded the benefits associated with that design;

19

e.

Manufacturing and/or selling Bard IVC Filters when they deviated in a

20

material way from the design specifications, formulas, or performance

21

standards or from otherwise identical units manufactured to the same

22

design specifications, formulas, or performance standards; and
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 50 of 64

f.

1

of pulmonary emboli.

2
3

Impliedly representing that its filters would be effective in the prevention

244.

As a direct and proximate result of Bard’s breach of its implied warranty,

4 Plaintiffs have suffered Injuries and Damages.
COUNT XII: FRAUDULENT MISREPRESENTATION

5
6

245.

Plaintiffs incorporate by reference all prior allegations.

7

246.

At all times relevant to this cause, and as detailed above, Bard intentionally

8 provided Plaintiffs, Plaintiffs’ physicians, the medical community, and the public at large with
9 false or inaccurate information. Bard also omitted material information concerning Bard IVC
10 Filters, including, but not limited to, misrepresentations regarding the following topics:
11

a.

The safety of the Bard IVC Filters;

12

b.

The efficacy of the Bard IVC Filters;

13

c.

The rate of failure of the Bard IVC Filters;

14

d.

The pre-market testing of the Bard IVC Filters;

15

e.

The approved uses of the Bard IVC Filters; and

16

f.

The ability to retrieve the device at any time over a person’s life.

17

247.

The information Bard distributed to the public, the medical community, and

18 Plaintiffs was in the form of reports, press releases, advertising campaigns, labeling materials,
19 print advertisements, commercial media containing material representations, and instructions
20 for use, as well as through their officers, directors, agents, and representatives.
21

248.

These materials contained false and misleading material representations, which

22 included: that Bard IVC Filters were safe and fit when used for their intended purpose or in a
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 51 of 64

1 reasonably foreseeable manner; that they did not pose dangerous health risks in excess of
2 those associated with the use of other similar IVC filters; that any and all side effects were
3 accurately reflected in the warnings; and that they were adequately tested to withstand normal
4 placement within the human body.
5

249.

Bard made the foregoing misrepresentations knowing that they were false or

6 without reasonable basis. These materials included instructions for use and a warning
7 document that was included in the package of Bard IVC Filters that were implanted in
8 Plaintiffs.
9

250.

Bard’s intent and purpose in making these misrepresentations was to deceive and

10 defraud the public and the medical community, including Plaintiffs’ health care providers; to
11 gain the confidence of the public and the medical community, including Plaintiffs’ health care
12 providers; to falsely assure the public and the medical community of the quality of Bard IVC
13 Filters and their fitness for use; and to induce the public and the medical community, including
14 Plaintiffs’ healthcare providers to request, recommend, prescribe, implant, purchase, and
15 continue to use Bard IVC Filters, all in reliance on Bard’s misrepresentations.
16

251.

The foregoing representations and omissions by Bard were false.

17

252.

Bard IVC Filters are not safe, fit, and effective for human use in their intended

18 and reasonably foreseeable manner.
19

253.

Further, the use of Bard IVC Filters is hazardous to the users’ health, and Bard

20 IVC Filters have a serious propensity to cause users to suffer serious injuries, including
21 without limitation the injuries Plaintiffs suffered.
22
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Case 2:15-md-02641-DGC Document 364 Filed 12/17/15 Page 52 of 64

1

254.

Finally, Bard IVC Filters have a statistically significant higher rate of failure and

2 injury than do other comparable IVC filters.
3

255.

In reliance upon the false and negligent misrepresentations and omissions made

4 by Bard, Plaintiffs and Plaintiffs’ health care providers were induced to, and did use Bard IVC
5 Filters, thereby causing Plaintiffs to sustain severe and permanent personal injuries and death.
6

256.

Bard knew and had reason to know that Plaintiffs, Plaintiffs’ health care

7 providers, and the general medical community did not have the ability to determine the true
8 facts intentionally and/or negligently concealed and misrepresented by Bard, and would not
9 have prescribed and implanted Bard IVC Filters if the true facts regarding Bard IVC Filters
10 had not been concealed and misrepresented by Bard.
11

257.

Bard had sole access to material facts concerning the defective nature of the

12 products and their propensities to cause serious and dangerous side effects in the form of
13 dangerous injuries and damages to persons who were implanted with Bard IVC Filters.
14

258.

At the time Bard failed to disclose and intentionally misrepresented the

15 foregoing facts, and at the time Plaintiffs used Bard IVC Filters, Plaintiff and Plaintiffs’ health
16 care providers were unaware of Bard’s misrepresentations and omissions.
17

259.

As a direct and proximate result of Bard’s fraudulent misrepresentations,

18 Plaintiffs suffered Injuries and Damages.
COUNT XIII: FRAUDULENT CONCEALMENT

19
20

260.

Plaintiffs incorporate by reference all prior allegations.

21

261.

In marketing and selling Bard IVC Filters, Bard concealed material facts from

22 Plaintiffs and Plaintiffs’ healthcare providers.
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1

262.

These concealed material facts include, but are not limited to:
a.

2

Bard IVC Filters were unsafe and not fit when used for their intended
purpose or in a reasonably foreseeable manner;

3
b.

4

Bard IVC Filters posed dangerous health risks in excess of those
associated with the use of other similar IVC filters;

5
c.

6

That there were additional side effects related to implantation and use of

7

Bard IVC Filters that were not accurately and completely reflected in the

8

warnings associated with Bard IVC Filters; and
d.

9

placement within the human body.

10
11

That Bard IVC Filters were not adequately tested to withstand normal

263.

Plaintiff and Plaintiffs’ healthcare providers were not aware of these and other

12 facts concealed by Bard.
13

264.

In concealing these and other facts, Bard intended to deceive Plaintiffs and

14 Plaintiffs’ healthcare providers.
15

265.

Plaintiffs and Plaintiffs’ healthcare providers were ignorant of and could not

16 reasonably discover the facts Bard fraudulently concealed and reasonably and justifiably relied
17 on Bard’s representations concerning the supposed safety and efficacy of Bard IVC Filters.
18

266.

As a direct and proximate result of Defendants’ fraudulent concealment of

19 material facts, Plaintiffs suffered Injuries and Damages.
20
21

COUNT XIV: VIOLATIONS OF APPLICABLE STATE LAW PROHIBITING
CONSUMER FRAUD AND UNFAIR DECEPTIVE TRADE PRACTICES
267.

Plaintiffs incorporate by reference all prior allegations.

22
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1

268.

Bard had a statutory duty to refrain from unfair or deceptive acts or practices in

2 the sale and promotion of Bard IVC Filters.
3

269.

Bard knowingly, deliberately, willfully and/or wantonly engaged in unfair,

4 unconscionable, deceptive, fraudulent, and misleading acts or practices in violation of all
5 states’ consumer protection laws identified below.
6

270.

Through its false, untrue, and misleading promotion of Bard IVC Filters, Bard

7 induced Plaintiffs to purchase and/or pay for the purchase of Bard IVC Filters.
8

271.

Bard misrepresented the alleged benefits and characteristics of Bard IVC Filters;

9 suppressed, omitted, concealed, and failed to disclose material information concerning known
10 adverse effects of Bard IVC Filters; misrepresented the quality and efficacy of Bard IVC
11 Filters as compared to much lower-cost alternatives; misrepresented and advertised that
12 Bard IVC Filters were of a particular standard, quality, or grade that they were not;
13 misrepresented Bard IVC Filters in such a manner that later, on disclosure of the true facts,
14 there was a likelihood that Plaintiffs would have opted for an alternative IVC filter or method
15 of preventing pulmonary emboli.
16

272.

Bard’s conduct created a likelihood of, and in fact caused, confusion and

17 misunderstanding.
18

273.

Bard’s conduct misled, deceived, and damaged Plaintiffs, and Bard’s fraudulent,

19 misleading, and deceptive conduct was perpetrated with an intent that Plaintiffs rely on said
20 conduct by purchasing and/or paying for purchases of Bard IVC Filters.
21

274.

Moreover, Bard knowingly took advantage of Plaintiffs, who were unable to

22 protect their own interests due to ignorance of the harmful adverse effects of Bard IVC Filters.
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1

275.

Bard’s conduct was willful, outrageous, immoral, unethical, oppressive,

2 unscrupulous, unconscionable, and substantially injurious to Plaintiffs and offends the public
3 conscience.
4

276.

Plaintiffs purchased Bard’s IVC Filters primarily for personal, family, or

5 household purposes.
6

277.

As a result of Bard’s violative conduct in each of the Plaintiffs’ respective states,

7 Plaintiffs purchased and/or paid for purchases of Bard IVC Filters that were not made for
8 resale.
9

278.

Bard engaged in unfair competition or deceptive acts or practices in violation of

10 Alaska Stat. § 45.50.471, et seq.
11

279.

Bard engaged in unfair competition or deceptive acts or practices in violation of

12 Ariz. Rev. Stat. § 44-1522, et seq.
13

280.

Bard engaged in unfair competition or deceptive acts or practices in violation of

14 Ark. Code § 4-88-101, et seq.
15

281.

Bard engaged in unfair competition or deceptive acts or practices in violation of

16 Cal. Civ. Code § 1770, et seq. (the “Consumer Legal Remedies Act”), and Cal. Bus. & Prof.
17 Code § 17200, et seq. and § 17500, et seq.
18

282.

Bard engaged in unfair competition or deceptive acts or practices in violation of

19 Colo. Rev. Stat. § 6-1-105, et seq.
20

283.

Bard engaged in unfair competition or deceptive acts or practices in violation of

21 Conn. Gen. Stat. § 42-110b, et seq.
22
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1

284.

Bard engaged in unfair competition or deceptive acts or practices in violation of

2 D.C. Code Ann. § 28-3901, et seq.
3

285.

Bard engaged in unfair competition or deceptive acts or practices in violation of

4 6 Del. Code Ann. § 2513, et seq.
5

286.

Bard engaged in unfair competition or deceptive acts or practices in violation of

6 Fla. Stat. § 501.201, et seq.
7

287.

Bard engaged in unfair competition or deceptive acts or practices in violation of

8 Haw. Rev. Stat. § 480, et seq.
9

288.

Bard engaged in unfair competition or deceptive acts or practices in violation of

10 Idaho Code § 48-601, et seq.
11

289.

Bard engaged in unfair competition or deceptive acts or practices in violation of

12 815 Illinois L.C.S. §§ 505/2, 510/2, et seq.
13

290.

Bard engaged in unfair competition or deceptive acts or practices in violation of

14 Ind. Code § 24-5-0.5, et seq.
15

291.

Bard engaged in unfair competition or deceptive acts or practices in violation of

16 Kan. Stat. Ann. § 50-623, et seq.
17

292.

Bard engaged in unfair competition or deceptive acts or practices in violation of

18 KRS § 367.170, et seq.
19

293.

Bard engaged in unfair competition or deceptive acts or practices in violation of

20 5 Me. Rev. Stat. Ann. § 207, et seq.
21

294.

Bard engaged in unfair competition or deceptive acts or practices in violation of

22 Md. Code, Commercial Law, § 13-301, et seq.
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1

295.

Bard engaged in unfair competition or deceptive acts or practices in violation of

2 Mass. Gen. Laws Ch. 93A § 1, et seq.
3

296.

Bard engaged in unfair competition or deceptive acts or practices in violation of

4 M.C.L.A. § 445.901, et seq.
5

297.

Bard engaged in unfair competition or deceptive acts or practices in violation of

6 M.S.A. § 325F.69, et seq. and M.S.A. § 325D.44, et seq.
7

298.

Bard engaged in unfair competition or deceptive acts or practices in violation of

8 Miss. Code Ann. § 75-24-5.
9

299.

Bard engaged in unfair competition or deceptive acts or practices in violation of

10 Missouri V.A.M.S. § 407.020, et seq.
11

300.

Bard engaged in unfair competition or deceptive acts or practices in violation of

12 Neb. Rev. St. § 59-1602, et seq.
13

301.

Bard engaged in unfair competition or deceptive acts or practices in violation of

14 Nev. Rev. Stat. §§ 41.600, 598.0903, et seq.
15

302.

Bard engaged in unfair competition or deceptive acts or practices in violation of

16 N.H. Rev. Stat. § 358-A:1, et seq.
17

303.

Bard engaged in unfair competition or deceptive acts or practices in violation of

18 N.J. Stat. Ann. § 56:8-1, et seq.
19

304.

Bard engaged in unfair competition or deceptive acts or practices in violation of

20 N.M. Stat. § 57-12-1, et seq.
21

305.

Bard engaged in unfair competition or deceptive acts or practices in violation of

22 N.Y. Gen. Bus. Law § 349, et seq.
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1

306.

Bard engaged in unfair competition or deceptive acts or practices in violation of

2 N.C. Gen. Stat. Ann. § 75-1.1, et seq.
3

307.

Bard engaged in unfair competition or deceptive acts or practices in violation of

4 N.D.C.C. § 51-15-02, et seq.
5

308.

Bard has engaged in unfair competition or deceptive acts or practices in

6 violation of Ohio Rev. Code. Ann. § 1345.01, et seq.
7

309.

Bard engaged in unfair competition or deceptive acts or practices in violation of

8 15 Okla. St. Ann. §§ 751-753, et seq.
9

310.

Bard engaged in unfair competition or deceptive acts or practices in violation of

10 Oregon Revised Statutes § 646.605, et seq.
11

311.

Bard engaged in unfair competition or deceptive acts or practices in violation of

12 73 Pa. Stat. § 201-1, et seq.
13

312.

Bard engaged in unfair competition or deceptive acts or practices in violation of

14 R.I. Gen. Laws § 6-13.1-1, et seq.
15

313.

Bard engaged in unfair competition or deceptive acts or practices in violation of

16 S.D. Code Laws § 37-24-1, et seq.
17

314.

Bard engaged in unfair competition or deceptive acts or practices in violation of

18 Tenn. Code Ann. § 47-18-104, et seq.
19

315.

Bard engaged in unfair competition or deceptive acts or practices in violation of

20 Tex. Bus. & Com. Code § 17.41, et seq.
21

316.

Bard engaged in unfair competition or deceptive acts or practices in violation of

22 Utah Code § 13-11-1, et seq.
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1

317.

Bard engaged in unfair competition or deceptive acts or practices in violation of

2 9 Vt. Stat. § 2451, et seq.
3

318.

Bard engaged in unfair competition or deceptive acts or practices in violation of

4 Va. Code § 59.1-200, et seq.
5

319.

Bard engaged in unfair competition or deceptive acts or practices in violation of

6 Wash. Rev. Code § 19.86.010, et seq.
7

320.

Bard engaged in unfair competition or deceptive acts or practices in violation of

8 W.Va. Code § 46A-6-101, et seq.
9

321.

Bard engaged in unfair competition or deceptive acts or practices in violation of

10 Wis. Stat. § 100.18, et seq.
11

322.

Bard engaged in unfair competition or deceptive acts or practices in violation of

12 Wy. Stat. § 40-12-101, et seq.
13

323.

As a direct and proximate result of Bard’s violations of these statutes, Plaintiffs

14 suffered Injuries and Damages and seek all available damages under each state’s law.
COUNT XV: LOSS OF CONSORTIUM

15
16

324.

Plaintiffs incorporate by reference all prior allegations.

17

325.

At all times relevant hereto, Plaintiffs’ spouses (“Spouse Plaintiffs”) and/or

18 family members (“Family Member Plaintiffs”) and/or domestic partners (“Domestic Partner
19 Plaintiffs”) have suffered injuries and losses as a result of Plaintiffs’ injuries.
20

326.

For the reasons set forth herein, Spouse Plaintiffs and/or Family Member

21 Plaintiffs and/or Domestic Partner Plaintiffs have necessarily paid and have become liable to
22
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1 pay for medical aid, treatment, and medications, and will necessarily incur further expenses of
2 a similar nature in the future as a proximate result of Defendants’ misconduct.
3

327.

For the reasons set forth herein, Spouse Plaintiffs and/or Family Member

4 Plaintiffs and/or Domestic Partner Plaintiffs have suffered and will continue to suffer the loss
5 of their loved ones’ support, companionship, services, society, love, and affection due to Bard
6 IVC Filter injury.
7

328.

For all Spouse Plaintiffs, Plaintiffs allege their marital relationship has been

8 impaired and depreciated, and the marital association between husband and wife has been
9 altered.
10

329.

Spouse Plaintiffs and/or Family Member Plaintiffs and/or Domestic Partner

11 Plaintiffs have suffered great emotional pain and mental anguish.
12

330.

As a direct and proximate result of Bard’s misconduct, Spouse Plaintiffs and/or

13 Family Member Plaintiffs and/or Domestic Partner Plaintiffs have sustained Injuries and
14 Damages.
COUNT XVI: WRONGFUL DEATH

15
16

331.

Plaintiffs incorporate by reference all prior allegations.

17

332.

Plaintiffs’ decedents died as a direct and proximate result of Bard’s misconduct

18 as alleged herein, resulting in Plaintiffs’ decedent’s use of Bard IVC Filters.
19

333.

Plaintiffs’ decedents are survived by various family members, named and

20 unnamed.
21

334.

As a direct and proximate result of the acts and/or omissions of Bard, Plaintiffs’

22 decedents’ heirs and family have been deprived of his/her future aid, income, assistance,
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1 services, companionship, society, affection and financial support, and Plaintiffs have suffered
2 Injuries and Damages.
3

335.

The representatives or administrators of Plaintiffs’ decedents’ estates bring these

4 claims on behalf of the decedents’ lawful heirs for the decedents’ wrongful death where
5 appropriate and authorized under relevant state law.
COUNT XVII: SURVIVAL

6
7

336.

Plaintiffs incorporate by reference all prior allegations.

8

337.

As a direct and proximate result of Bard’s misconduct, Plaintiffs’ decedents

9 suffered bodily injury and resulting pain and suffering, disability, disfigurement, mental
10 anguish, loss of enjoyment of life, medical expenses, loss of earnings and loss of earning
11 capacity prior to Plaintiffs’ decedents’ deaths.
12

338.

Where authorized under relevant state law, Plaintiffs and/or the appropriate

13 authorized entity seek all damages the decedents suffered as a result of Bard IVC Filter
14 injuries prior to death.
PUNITIVE DAMAGES ALLEGATIONS

15
16

339.

Plaintiffs incorporate by reference all prior allegations.

17

340.

At all times material hereto, Bard knew or should have known that Bard IVC

18 Filters were unreasonably dangerous with respect to the risk of tilt, fracture, migration and/or
19 perforation.
20

341.

At all times material hereto, Bard attempted to misrepresent and did knowingly

21 misrepresent facts concerning the safety of Bard IVC Filters.
22
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1

342.

Bard’s misrepresentations included knowingly withholding material information

2 from the medical community and the public, including Plaintiffs’ physicians, concerning the
3 safety of its Bard IVC Filters.
4

343.

Bard’s conduct, alleged throughout this Master Complaint, was willful, wanton,

5 and undertaken with a conscious indifference and disregard to the consequences that
6 consumers of their products faced, including Plaintiffs and their decedents.
7

344.

At all times material hereto, Bard knew and recklessly disregarded the fact that

8 Bard IVC Filters have an unreasonably high rate of tilt, fracture, migration, and/or perforation.
9

345.

Notwithstanding the foregoing, Bard continued to market Bard IVC Filters

10 aggressively to consumers, including Plaintiffs, without disclosing the aforesaid side effects.
11

346.

Bard knew of its Bard IVC Filters’ lack of warnings regarding the risk of

12 fracture, migration, and/or perforation, but intentionally concealed and/or recklessly failed to
13 disclose that risk and continued to market, distribute, and sell its filters without said warnings
14 so as to maximize sales and profits at the expense of the health and safety of the public,
15 including Plaintiffs, in conscious disregard of the foreseeable harm caused by Bard IVC
16 Filters.
17

347.

Bard’s intentional and/or reckless failure to disclose information deprived

18 Plaintiffs’ physicians of necessary information to enable them to weigh the true risks of using
19 Bard IVC Filters against its benefits.
20

348.

Bard’s conduct is reprehensible, evidencing an evil hand guided by an evil mind

21 and was undertaken for pecuniary gain in reckless and conscious disregard for the substantial
22 risk of death and physical injury to consumers, including Plaintiffs and their decedents.
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1

349.

Such conduct justifies an award of punitive or exemplary damages in an amount

2 sufficient to punish Bard’s conduct and deter like conduct by Bard and other similarly situated
3 persons and entities in the future.
PRAYER FOR RELIEF

4
5

WHEREFORE, Plaintiffs demand judgment against Defendants for:

6

A.

Compensatory damages, including without limitation past and future medical

7

expenses; past and future pain and suffering; past and future emotional distress; past and

8

future loss of enjoyment of life; past and future loss of consortium; past and future lost wages

9

and loss of earning capacity; funeral and burial expenses; and other consequential damages as

10

allowed by law;

11

B.

12

Punitive damages in an amount sufficient to punish Defendants and deter

similar conduct in the future;

13

C.

Disgorgement of profits;

14

D.

Restitution;

15

E.

Statutory damages, where authorized;

16

F.

Costs of suit;

17

G.

Reasonable attorneys’ fees, where authorized;

18

H.

Prejudgment interest as allowed by law;

19

I.

Post-judgment interest at the highest applicable statutory or common law rate

20
21
22

from the date of judgment until satisfaction of judgment;
J.

Any other interest recoverable under the law of any action pending in this

MDL; and
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1

K.

2

in equity.

3

Such other additional and further relief as Plaintiffs may be entitled to in law or

RESPECTFULLY SUBMITTED this ____ day of February, 2016.

4

GALLAGHER & KENNEDY, P.A.

5

By:

6

/s/
Robert W. Boatman
2575 East Camelback Road
Phoenix, Arizona 85016-9225

7
LOPEZ McHUGH LLP
Ramon Rossi Lopez (CA Bar No. 86361)
(admitted pro hac vice)
100 Bayview Circle, Suite 5600
Newport Beach, California 92660

8
9
10

Attorneys for Plaintiffs

11
12
13
14

I hereby certify that on this ____ day of February, 2016, 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.

15
16

/s/
5121823/26997-1

17
18
19
20
21
22
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1
2
3
4
5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8
9
10

IN RE: BARD IVC FILTERS
No. MDL-15-02641-PHX-DGC
PRODUCTS LIABILITY LITIGATION
CASE MANAGEMENT ORDER
NO. 5
(Plaintiff and Defendant Profile Forms)

11
12
13

The parties have agreed upon the use of an abbreviated Plaintiff Profile Form (“PPF”)

14

(Exhibit 1) attached to this Order. Except as expressly noted herein, the PPF shall be

15

completed in each currently pending case, and in all cases that become part of this MDL by

16

virtue of being filed in, removed to, or transferred to this Court on or after the date of this

17

Order.

18

Each plaintiff in currently filed cases (except as noted herein) shall submit a completed

19

PPF to defendants within 60 days of the date of this Order. In cases that have been filed in,

20

removed to, or transferred to this MDL on or after the date of this Order, each plaintiff shall

21

submit a completed PPF to defendants within 60 days of filing the complaint. Each plaintiff

22

is required to provide defendants with a PPF that is substantially complete in all respects,

23

answering every question in the PPF, even if a plaintiff can answer the question in good faith

24

only by indicating “not applicable” or “unknown.” The PPF shall be signed by the plaintiff

25

under penalty of perjury. If a plaintiff is suing in a representative or derivative capacity, the

26

PPF shall be completed by the person with the legal authority to represent the estate or the

27

person under legal disability. Plaintiff spouses with a claim for loss of consortium shall also

28

sign the PPF, attesting that the responses made to the loss of consortium questions in the PPF

Case 2:15-md-02641-DGC Document 365 Filed 12/17/15 Page 2 of 13

1

are true and correct to the best of his or her knowledge, information and belief, formed after

2

due diligence and reasonable inquiry.

3

A completed PPF shall be considered interrogatory answers under Fed. R. Civ. P. 33

4

and responses to requests for production under Fed. R. Civ. P. 34, and will be governed by

5

the standards applicable to written discovery under Federal Rules 26 through 37. The

6

interrogatories and requests for production in the PPF shall be answered without objection as

7

to the question posed in the agreed upon PPF. This section does not prohibit a plaintiff from

8

withholding or redacting information from medical or other records provided with the PPF

9

based upon a recognized privilege. If information is withheld or redacted on the basis of

10

privilege, plaintiff shall provide defendants with a privilege log that complies with Fed. R.

11

Civ. P. 26(b)(5) simultaneously with the submission of the PPF.

12

If a plaintiff does not submit a PPF within the time specified in this Order, defendants

13

shall mail an overdue letter by e-mail and U.S. mail to Plaintiffs’ Co-Lead Counsel and the

14

plaintiffs’ individual representative counsel, stating that defendants may move to dismiss that

15

plaintiff’s case within 20 days of receipt of the letter. If no PPF is received within those 20

16

additional days, defendants may move immediately to dismiss that plaintiff’s case.

17

defendants receive a PPF that is not substantially complete, defendants’ counsel shall send a

18

deficiency letter within 14 days of receipt of a PPF, as applicable by e-mail and U.S. mail to

19

Plaintiffs’ Co-Lead Counsel and the plaintiffs’ individual representative counsel, identifying

20

the purported deficiencies. Plaintiff shall have 20 days from receipt of that letter to serve a

21

PPF that is substantially complete in all respects. This letter shall include sufficient detail for

22

the parties to meet and confer regarding the alleged deficiencies.

If

23

Within 45 days of receipt of a substantially complete PPF for an individual plaintiff,

24

the defendants shall provide the plaintiff with a completed Defendants’ Profile Form

25

(Exhibit 2) attached to this order.

26

The procedures outlined in this Order shall not apply to the following cases:

27

///

28

///
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Case 2:15-md-02641-DGC Document 365 Filed 12/17/15 Page 3 of 13

1
2
3
4

Plaintiff
1. Cason, Pamela

Original Jurisdiction
GA – N.D. Ga.
1:12-cv-1288
GA – N.D. Ga.
1:13-cv-515
TX – S.D. Tex.
4:14-cv-298
PA – E.D. Pa.
5:12-cv-1253
TX – N.D. Tex.
3:14-cv-133
WI – E.D. Wis.
2:14-cv-59
PA – E.D. Pa.
5:13-cv-5361
GA – M.D. Ga.
5:14-cv-351
NY – E.D.N.Y.
2:14-v-4942
FL – M.D. Fla.
8:13-cv-1962
MI – E.D. Mich.
4:14-cv-13627
TX – E.D. Tex.
1:13-cv-633
FL – M.D. Fla.
3:13-cv-222

2. Coker, Jennifer
3. Conn, Charles

5

4. Ebert, Melissa

6

5. Fox, Susan

7

6. Henley, Angela

8

7. Keen, Harry

9

8. Milton, Gary

10

9. Mintz, Jessica

11

10. Ocasio, Denise

12

11. Rivera (McClarty), Vicki

13

12. Smith, Erin

14

13. Tillman, Lessie

15
16
17
18
19
20
21
22
23

The parties are relieved from preparing or exchanging profile forms in those particular cases.
On or before January 15, 2016, the parties shall submit proposed Plaintiffs’ and
Defendants’ Fact Sheets for the Court’s consideration. These forms will provide the parties
with more detailed information about each plaintiff and his or her case. Those forms will be
completed and exchanged only in cases designated for further discovery or for consideration
as a bellwether case. The court will issue a subsequent Order outlining the procedures
applicable to those more detailed forms.
Dated this 17th day of December, 2015.

24
25
26
27
28
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Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 1 of 14

1
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6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8
9

IN RE: Bard IVC Filters Products
Liability Litigation,

No. MD-15-02641-PHX-DGC
AMENDED CASE MANAGEMENT
ORDER NO. 5

10
(Plaintiff and Defendant Profile
Forms)

11
12
13

The parties have agreed upon the use of an abbreviated Plaintiff Profile Form

14

(“PPF”) (Exhibit 1) attached to this Order. Except as expressly noted herein, the PPF

15

shall be completed in each currently pending case, and in all cases that become part of this

16

MDL by virtue of being filed in, removed to, or transferred to this Court on or after the

17

date of this Order.

18

Each plaintiff in currently filed cases (except as noted herein) shall submit a

19

completed PPF to defendants within 60 days of the date of this Order. In cases that have

20

been filed in, removed to, or transferred to this MDL on or after the date of this Order,

21

each plaintiff shall submit a completed PPF to defendants within 60 days of filing the

22

complaint.

23

The completed PPF shall be delivered via email to: filterppf-

24

[e-mail] and to co-lead counsel via email at [e-mail]

25

and [e-mail] .

26

Each plaintiff is required to provide defendants with a PPF that is substantially

27

complete in all respects, answering every question in the PPF, even if a plaintiff can

28

answer the question in good faith only by indicating “not applicable” or “unknown.” The

Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 2 of 14

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PPF shall be signed by the plaintiff under penalty of perjury. If a plaintiff is suing in a
representative or derivative capacity, the PPF shall be completed by the person with the
legal authority to represent the estate or the person under legal disability. Plaintiff
spouses with a claim for loss of consortium shall also sign the PPF, attesting that the
responses made to the loss of consortium questions in the PPF are true and correct to the
best of his or her knowledge, information and belief, formed after due diligence and
reasonable inquiry.
A completed PPF shall be considered interrogatory answers under Fed. R. Civ. P.
33 and responses to requests for production under Fed. R. Civ. P. 34, and will be governed
by the standards applicable to written discovery under Federal Rules 26 through 37. The
interrogatories and requests for production in the PPF shall be answered without objection
as to the question posed in the agreed upon PPF. This section does not prohibit a plaintiff
from withholding or redacting information from medical or other records provided with
the PPF based upon a recognized privilege. If information is withheld or redacted on the
basis of privilege, plaintiff shall provide defendants with a privilege log that complies
with Fed. R. Civ. P. 26(b)(5) simultaneously with the submission of the PPF.
If a plaintiff does not submit a PPF within the time specified in this Order,
defendants shall mail an overdue letter by e-mail and U.S. mail to Plaintiffs’ Co-Lead
Counsel and the plaintiffs’ individual representative counsel, stating that defendants may
move to dismiss that plaintiff’s case within 20 days of receipt of the letter. If no PPF is
received within those 20 additional days, defendants may move immediately to dismiss
that plaintiff’s case. If defendants receive a PPF that is not substantially complete,
defendants’ counsel shall send a deficiency letter within 14 days of receipt of a PPF, as
applicable by e-mail and U.S. mail to Plaintiffs’ Co-Lead Counsel and the plaintiffs’
individual representative counsel, identifying the purported deficiencies. Plaintiff shall
have 20 days from receipt of that letter to serve a PPF that is substantially complete in all

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respects. This letter shall include sufficient detail for the parties to meet and confer
regarding the alleged deficiencies.
Within 45 days of receipt of a substantially complete PPF for an individual
plaintiff, the defendants shall provide the plaintiff with a completed Defendants’ Profile
Form (DPF) (Exhibit 2) attached to this order. A completed DPF shall be considered
interrogatory answers under Fed. R. Civ. P. 33 and responses to requests for production
under Fed. R. Civ. P. 34, and will be governed by the standards applicable to written
discovery under Federal Rules 26 through 37. The interrogatories and requests for
production in the DPF shall be answered without objection as to the question posed in the
agreed upon DPF. This section does not prohibit a defendant from withholding or
redacting information from medical or other records provided with the DPF based upon a
recognized privilege. If information is withheld or redacted on the basis of privilege,
defendants shall provide plaintiff with a privilege log that complies with Fed. R. Civ. P.
26(b)(5) simultaneously with the submission of the DPF.
If the plaintiff receives a DPF that is not substantially complete, plaintiff’s counsel
shall send a deficiency letter within 14 days of receipt of a DPF, as applicable by e-mail
and U.S. mail to Defendants’ Lead Counsel identifying the purported deficiencies.
Defendants shall have 20 days from receipt of that letter to serve a DPF that is
substantially complete in all respects. This letter shall include sufficient detail for the
parties to meet and confer regarding the alleged deficiencies.
The procedures outlined in this Order shall not apply to the following cases:

22
Plaintiff

Original Jurisdiction

1.

Cason, Pamela

2.

Coker, Jennifer

3.

Conn, Charles

GA – N.D. Ga.
1:12-cv-1288
GA – N.D. Ga.
1:13-cv-515
TX – S.D. Tex.
4:14-cv-298

23
24
25
26
27
28

3

Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 4 of 14

1

Plaintiff

Original Jurisdiction

4.

Ebert, Melissa

5.

Fox, Susan

6.

Henley, Angela

7.

Keen, Harry

8.

Milton, Gary

9.

2

Mintz, Jessica

PA – E.D. Pa.
5:12-cv-1253
TX – N.D. Tex.
3:14-cv-133
WI – E.D. Wis.
2:14-cv-59
PA – E.D. Pa.
5:13-cv-5361
GA – M.D. Ga.
5:14-cv-351
NY – E.D.N.Y.
2:14-v-4942
FL – M.D. Fla.
8:13-cv-1962
MI – E.D. Mich.
4:14-cv-13627
TX – E.D. Tex.
1:13-cv-633
FL – M.D. Fla.
3:13-cv-222

3
4
5
6
7
8
9
10
11

10. Ocasio, Denise

12
11. Rivera (McClarty), Vicki

13
14

12. Smith, Erin

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16

13. Tillman, Lessie

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The parties are relieved from preparing or exchanging profile forms in those particular
cases.
Dated this 2nd day of March, 2016.

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Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 5 of 14

EXHIBIT 1

Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 6 of 14

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA
MDL No. 2641
In Re Bard IVC Filter Products Liability Litigation

In completing this Plaintiff Profile Form, you are under oath and must provide information that
is true and correct to the best of your knowledge. The Plaintiff Profile Form shall be completed
in accordance with the requirements set forth in the applicable Case Management Order.

1. CASE INFORMATION
Caption:

-----------------

Date:

-----------

Docket N o . : - - - - - - - - - - - - - - - - - - - - - - - - - - - - Plaintiff's attorney and Contact information:

2. PLAINTIFF INFORMATION
Name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
Maiden Name: - - - - - - - - - - - - - - - - - - - - - - - - - - - Address: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
Date of b i r t h : - - - - - - - - - - - - - - - - - - - - - - - - - - - Social Security N o . : - - - - - - - - - - - - - - - - - - - - - - - - - Occupation:---------------------------Spouse: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
Is Spouse Making Claim for Loss of Consortium? DYes D No
3. DEVICE INFORMATION
A. Filter Model (e.g., Recovery®, G2®, e t c . ) : - - - - - - - - - - - - - - - B. LotNumber: - - - - - - - - - - - - - - - - - - - - - - - - C. Date of Bard IVC Filter implant: - - - - - - - - - - - - - - - - - D. Attach medical evidence of product identification and operative report for filter
placement.

Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 7 of 14

E. Please check all the reasons why you believe your Bard Filter was placed:
0 Filter Placed After Being Diagnosed with Deep Vein Thrombosis/Pulmonary
Embolism
0 Filter Placed in Conjunction with or before Orthopedic Procedure
D Filter Placed in Conjunction with Trauma Situation/Motor vehicle accident

0 Filter Placed in Conjunction with or before Bariatric Procedure

0 Other Reason(s) for implant (explain): - - - - - - - - - - - - - - - -

0 Unknown
0 See medical records attached

F. Provide the name and address of both the doctor who implanted the Bard Filter and
the hospital or medical facility at which the filter was placed:
Doctor: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

Hospital/MedicalFacility: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

~

"

4. FAILURE MODE ALLEGED
Please check all failure mode(s) that you allege apply to your Bard Filter:
D Fracture

0 Perforation of filter strut(s) into organs
O Migration of entire filter to heart

0 Tilt with filter embedded in wall of the IVC
0 Device unable to be retrieved
0 Bleeding
0 Other failure mode(s)

If other, please d e s c r i b e - - - - - - - - - - - - - - - - - - - - -

5. REMOVAL INFORMATION
A. Has your Bard Filter been removed?
DYes

DNo

2

Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 8 of 14

D Unknown
B. If your Bard Filter has been removed or a doctor has attempted to remove your

Filter, please check all that apply regarding the removal or attempted removal
procedure(s):
DRemoved percutaneously
D Removed via an open abdominal procedure
D Removed via an open chest procedure
D Attempted but unsuccessful percutaneous removal procedure
D Attempted but unsuccessful open abdominal procedure
D Attempted but unsuccessful open chest procedure
D Unknown
D See medical records attached

C. Provide the name(s) and address(es) of both the doctor(s) who removed your Bard
Filter (or attempted to remove it) and the hospital or medical facility where
removal/attempted removal occurred:
Filter Removal/Attempted Removal #1
Doctor: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
Hospital/MedicalFacility: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

Filter Removal/Attempted Removal #2
Doctor: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
Hospital/MedicalFacility: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

6. FRACTUREDSTRUTS
A. Do you claim that your Bard Filter fractured?
D Yes
DNo
If you answered YES, answer the below questions in this section.
If you answered NO, skip the rest of Section 6 and go below to section 7 - "Outcome
Attributed to Device."

3

Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 9 of 14

B. Are any fractured filter struts retained in your body?
D Yes
DNo
D Unknown

If yes, identify the location(s) within your body of each retained filter strut.

C. Have any fractured filter struts been removed from your body?
D Yes

DNo
D Unknown

D. If any fractured filter strut has been removed (or a doctor has attempted to remove
any strut), please check all that apply regarding the removal I attempted removal
procedure(s):
D Removed percutaneously
D Removed via an open abdominal procedure

D Removed via an open chest procedure
D Attempted but unsuccessful percutaneous removal procedure
D Attempted but unsuccessful open abdominal procedure
D Attempted but unsuccessful open chest procedure

D Unknown

E. Provide the name and address of both the doctor who removed (or attempted to
remove) the filter strut(s) and the hospital or medical facility at which it was
removed (or attempted to be removed)
Filter Strut Removal/Attempted Removal #1
Doctor: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

4

Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 10 of 14

Hospital/MedicalFacility:

-----------------------

Filter Strut Removal/Attempted Removal #2
Doctor:

----------------------------~

Hospital/MedicalFacility: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

7. OUTCOME ATTRIBUTED TO DEVICE
A. Do you claim to be suffering from any bodily injuries, including psychological
injuries that are above and beyond usual pain and suffering and mental anguish,
related to the Filter?
D Yes
DNo
If your answer is "Yes," please list all symptoms and injuries you claim to have suffered:

Of the injuries/symptoms you listed above, which do you claim to be suffering from at
the current time:

***

Plaintiff reserves the right to supplement any and all responses upon the receipt of additional
information.

Date

Signature of Plaintiff

Date

Signature of Plaintiff - Spouse (signature only
necessary if Loss of Consortium is alleged)

5

Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 11 of 14

EXHIBIT 2

Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 12 of 14

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA

IN RE: BARD IVC FILTERS
PRODUCTS LIABILITY LITIGATION

MDL No. 2641

DEFENDANT BARD CASE PROFILE FORM

For each case, the Bard Defendants must complete this Defendant Profile Form ("DPF")
in accordance with the schedule established by the Court's Pretrial Order. In completing this
Profile Form, you must answer every question.
I.

CASE INFORMATION

This defendant profile form pertains to the following case:
Case c a p t i o n : - - - - - - - - - - - - - - - - - - - - - - - - - - - Civil Action No.: - - - - - - - - - - - - - - - - - - - - - - - - - - Court in which action was originally filed: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

II.

CONTACTS WITH IMPLANTING AND REMOVING PHYSICIANS

Plaintiff has identified each healthcare provider who implanted, removed and/or
attempted to remove Bard's Filter. With respect to each of those healthcare providers, provide
the following information:
A.

CONSULTATION AGREEMENT
1. As to the identified healthcare providers, state whether Bard has consulting
agreement with the healthcare provider relating to IVC filters that Bard has been able
to locate after a reasonable and diligent search.

B.

SALES REPRESENTATIVE AND OTHER RELATED CONTACTS
As to each sales representative, territory manager and district manager who had any
contact with an identified physician or healthcare provider, set forth the following:
1.

Identity and last known address and telephone number of Representative(s):

Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 13 of 14

As to the individual who Bard believes was the territory manager and district manger for
the territory where the filter was implanted at the time of implant, set forth the following:
2.

Identify the name of the territory manager and district manger, the dates of
employment for each, and, if no longer employed by Bard, provide the last known
address:
Territory Manager:

Employment D a t e s : - - - - - - - - - - - - - - - - - If former, last known address: - - - - - - - - - - - - - - -

District Manager:
Name: - - - - - - - - - - - - - - - - - - - - - - Employment D a t e s : - - - - - - - - - - - - - - - - - If former, last known address: - - - - - - - - - - - - - - -

III.

MANUFACTURING INFORMATION

A.

Identify

B.

Identify the lot number for the Bard device used to remove or used to attempt to remove
the Bard Filter implanted into Plaintiff:

C.

Identify the location and date of manufacture for each lot set forth in response to A and B
above: - - - - - - - - - - - - - - - - - - - - - - - - - - - - IV.

A.

the

lot

number(s)

for

the

Bard

filter

implanted

in

Plaintiff:

DOCUMENTS

Please produce the following:
1. The Device History Record (DHR) for the Bard filter at issue, or, if already produced,
provide the bates number for the DHR.

2

Case 2:15-md-02641-DGC Document 927 Filed 03/03/16 Page 14 of 14

2. The Bard complaint file relating to plaintiffs claims, or, in the alternative if already
produced, provide the bates number for the complaint.
3. The bates numbers for any documents previously produced that reference the
implanting physician and/or the hospital or facility where the device as placed, that
Bard is able to identify after a reasonable and diligent search.
4. Any consulting agreement relating to IVC filters that Bard has entered with the
physician that implanted the filter.
5. With regard to the plaintiff, any Med Watch Adverse Event Reports in Bard's
possession.

Attorney for C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.

[Signature]

3

Case 2:15-md-02641-DGC Document 1108 Filed 03/17/16 Page 1 of 10

1

WO

2
3
4
5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8

IN RE: Bard IVC Filters Products
Liability Litigation,

9

No. MD-15-02641-PHX-DGC
AMENDED CASE MANAGEMENT
ORDER NO. 4

10
(Master Complaint, Master
Responsive Pleading, Use of Short
Form Complaint, Waiver of Service
for Bard Defendants, and Answer
and General Denial in Cases
Subsequently Transferred to MDL
2641)

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15
16

The parties have submitted a Master Long Form Complaint and Jury Demand

17

(previously docketed as Doc. 303-1) and a Master Responsive Pleading (previously

18

docketed as Doc. 303-3). The Court has reviewed these proposed pleadings, finds them

19

sufficient, and directs the Clerk to file them as separate documents in the Court’s docket.1

20

The parties have also submitted a proposed Amended Short Form Complaint, a copy of

21

which is attached to this order. The Court also finds these proposed pleadings to be

22

sufficient.

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IT IS ORDERED:

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All allegations pled in the Master Complaint and all responses pled in the Master

25

Responsive Pleading are deemed pled in any previously filed Complaint and Responsive

26

Pleading in this MDL proceeding, except as expressly noted below. They are also deemed

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1

The reference to “Federal Rule of Evidence 8” on the first page of the Master
Complaint shall be deemed to be a reference to Federal Rule of Civil Procedure 8.

Case 2:15-md-02641-DGC Document 1108 Filed 03/17/16 Page 2 of 10

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pled in any Short Form Complaint (attached to CMO No. 4, Doc. 363) or Amended Short

2

Form Complaint (attached to this Order) and Entry of Appearance filed after the entry of

3

Doc. 363, except that the Master Complaint applies only against the Defendant or

4

Defendants identified in such Short Form Complaints or Amended Short Form

5

Complaints.

6

The following cases will not be governed by the Master Complaint and Master

7

Responsive Pleading, but will continue to be governed by the complaints (including any

8

amended complaints) and answers filed in the various transferor courts prior to transfer:

9
Plaintiff

10
11

1.

Original Jurisdiction

Cason, Pamela

GA – N.D. Ga.
1:12-cv-1288

12
13

2.

Coker, Jennifer

GA – N.D. Ga.
1:13-cv-515

14
15

3.

Conn, Charles

TX – S.D. Tex.
4:14-cv-298

16
17

4.

Ebert, Melissa

PA – E.D. Pa.
5:12-cv-1253

18
19

5.

Fox, Susan

TX – N.D. Tex.
3:14-cv-133

20
21

6.

Henley, Angela

WI – E.D. Wis.
2:14-cv-59

22
23

7.

Keen, Harry

PA – E.D. Pa.
5:13-cv-5361

24
25

8.

Milton, Gary

GA – M.D. Ga.
5:14-cv-351

26
27

9.

Mintz, Jessica

NY – E.D.N.Y.
2:14-v-4942

28
2

Case 2:15-md-02641-DGC Document 1108 Filed 03/17/16 Page 3 of 10

1
2

Plaintiff

Original Jurisdiction

10. Ocasio, Denise

FL – M.D. Fla.
8:13-cv-1962

3
4

11. Rivera (McClarty), Vicki

MI – E.D. Mich.
4:14-cv-13627

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6

12. Smith, Erin

TX – E.D. Tex.

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8

1:13-cv-633
13. Tillman, Lessie

FL – M.D. Fla.

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3:13-cv-222

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11

On or after December 28, 2015, any plaintiff whose case would be subject to

12

transfer to MDL 2641 may file his or her case directly in this Court by using the Short

13

Form Complaint (Doc. 363). After February 23, 2016, Plaintiffs may use the Amended

14

Short Form Complaint attached to this Order. If such a case is filed in this Court without

15

the use of the Short Form Complaint or Amended Short Form Complaint, Plaintiffs’ Co-

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Lead Counsel shall promptly advise the filing party to file an amended complaint using
the Short Form Complaint or Amended Short Form Complaint. If the filing party fails to
do so, Plaintiffs’ Co-Lead Counsel shall promptly notify the Court.
Defendants are not required to file answers to Short Form Complaints or Amended
Short Form Complaints.

An Entry of Appearance shall constitute a denial of all

allegations in the Short Form Complaints or Amended Short Form Complaints except as
herein provided, and an assertion of all defenses included in the Master Responsive
Pleading. By filing an Entry of Appearance in response to a Short Form Complaint or
Amended Short Form Complaint, in lieu of an answer, Defendants do not waive any
defenses, including jurisdictional and service defenses.
Civil actions in this MDL were transferred to this Court by the Judicial Panel on
Multidistrict Litigation for coordinated or consolidated pretrial proceedings pursuant to 28
U.S.C. § 1407. Upon completion of the pretrial proceedings related to a civil action as
3

Case 2:15-md-02641-DGC Document 1108 Filed 03/17/16 Page 4 of 10

1

determined by this Court, the case shall be transferred pursuant to 28 U.S.C. § 1404(a) or

2

§ 1406(a) to the District Court identified in the Short Form Complaint or Amended Short

3

Form Complaint, provided the parties choose not to waive Lexecon, Inc. v. Milberg Weiss

4

Bershad Hynes & Lerach, 523 U.S. 26 (1998). The fact that a case was filed directly in

5

this District and MDL proceeding shall not constitute a determination by this Court that

6

jurisdiction or venue are proper in this District, and shall not result in this Court being

7

deemed the “transferor court” for purposes of this MDL. In addition, filing a Short Form

8

Complaint or Amended Short Form Complaint in this District shall have no impact on the

9

conflict of law rules to be applied to the case. Instead, the law of the jurisdiction where

10

the case is ultimately transferred will govern any conflict of law. Prior to transfer,

11

Defendants may object to the district specified in the Short Form Complaint or Amended

12

Short Form Complaint, based on venue or jurisdiction (including a lack of personal

13

jurisdiction based on Daimler AG v. Bauman, 134 S. Ct. 746 (2014)), and propose an

14

alternative jurisdiction for the Court’s consideration.

15

Subject to the conditions set forth in this order, Defendant C.R. Bard, Inc. and Bard

16

Peripheral Vascular, Inc. (collectively “Bard”) waive service of process in cases filed in

17

this Court using the Short Form Complaint or Amended Short Form Complaint and in

18

which they are named as defendants and one or more IVC filter products either

19

manufactured or distributed by Bard is alleged to be at issue. For such cases, Plaintiffs

20

shall send a Short Form Complaint or Amended Short Form Complaint and a request for

21

waiver of service pursuant to the provisions of Fed. R. Civ. P. 4 to Richard B. North, Jr.

22

by email to [e-mail]; [e-mail]; and

23

[e-mail]. Counsel for Bard shall return the signed waiver

24

requests to the Court within the time permitted by Fed. R. Civ. P. 4. Plaintiffs submitting

25

a request for waiver shall not seek to hold Bard in default for failure to timely answer or

26

otherwise respond to a complaint in which service has been accomplished pursuant to the

27
28
4

Case 2:15-md-02641-DGC Document 1108 Filed 03/17/16 Page 5 of 10

1

terms of this order without first giving Bard written notice of the alleged default and ten

2

business days in which to cure any alleged default.

3

Prior to a Plaintiff’s attorney filing a Short Form Complaint or Amended Short

4

Form Complaint in this Court, that attorney must register for or already have a District of

5

Arizona CM/ECF log-in name and password. If the Plaintiff’s attorney does not already

6

have a District of Arizona CM/ECF log-in name and password, that attorney must file the

7

Short Form Complaint or Amended Short Form Complaint in paper form with the Clerk

8

of Court and simultaneously file an Application of Attorney for Admission to Practice Pro

9

Hac Vice pursuant to LRCiv 83.1(b)(2) (including all necessary attachments and filing

10

fee).

11

Additionally, with respect to cases which are originally filed in courts other than

12

this Court which are then subsequently transferred to MDL 2641 pursuant to 28 U.S.C.

13

§ 1407, Defendants may file an Answer and General Denial with Respect to Cases

14

Subsequently Transferred to MDL 2641, incorporating the defenses and denials set forth

15

in the Master Responsive Pleading and generally denying the plantiffs’ allegations. This

16

short-form answer shall serve as the responsive pleading. Defendants shall have 60 days

17

from the date any such case is opened in this Court to file any motion for failure to state a

18

claim upon which relief may be granted pursuant to Rule 12(b)(6) and 12(h)(2), and the

19

plaintiff(s) shall have 30 days to respond.

20

Dated this 16th day of March, 2016.

21
22
23
24
25
26
27
28
5

Case 2:15-md-02641-DGC Document 1108 Filed 03/17/16 Page 6 of 10

1
2
3
4
5
6

IN THE UNITED STATES DISTRICT COURT

7

FOR THE DISTRICT OF ARIZONA

8

IN RE BARD IVC FILTERS
PRODUCTS LIABILITY LITIGATION

9

No. MD-15-02641-PHX-DGC
AMENDED MASTER SHORT FORM
COMPLAINT FOR DAMAGES FOR
INDIVIDUAL CLAIMS AND DEMAND
FOR JURY TRIAL

10
11
12

Plaintiff(s) named below, for their Complaint against Defendants named below,

13

incorporate the Master Complaint for Damages in MDL 2641 by reference (Doc. 364).

14

Plaintiff(s) further show the Court as follows:

15

1.

16
17

Plaintiff/Deceased Party:
________________________________________________________________

2.

Spousal Plaintiff/Deceased Party’s spouse or other party making loss of

18

consortium claim:

19

________________________________________________________________

20

3.

Other Plaintiff and capacity (i.e., administrator, executor, guardian,

21

conservator):

22

________________________________________________________________

Case 2:15-md-02641-DGC Document 1108 Filed 03/17/16 Page 7 of 10

1

4.

Plaintiff’s/Deceased Party’s state(s) [if more than one Plaintiff] of residence at

2

the time of implant:

3

________________________________________________________________

4

5.

Plaintiff’s/Deceased Party’s state(s) [if more than one Plaintiff] of residence at

5

the time of injury:

6

________________________________________________________________

7

6.

________________________________________________________________

8
9

7.

District Court and Division in which venue would be proper absent direct filing:
________________________________________________________________

10
11

Plaintiff’s current state(s) [if more than one Plaintiff] of residence:

8.

Defendants (check Defendants against whom Complaint is made):

12

□

C.R. Bard Inc.

13

□

Bard Peripheral Vascular, Inc.

14

9.

Basis of Jurisdiction:

15

□

Diversity of Citizenship

16

□

Other: ________________________________________________

17

a.

Other allegations of jurisdiction and venue not expressed in Master

18

Complaint:

19

________________________________________________________________

20

________________________________________________________________

21

________________________________________________________________

22
-2-

Case 2:15-md-02641-DGC Document 1108 Filed 03/17/16 Page 8 of 10

1

10.

Defendants’ Inferior Vena Cava Filter(s) about which Plaintiff(s) is making a

2

claim (Check applicable Inferior Vena Cava Filter(s)):

3

□

Recovery® Vena Cava Filter

4

□

G2® Vena Cava Filter

5

G2® Express (G2®X) Vena Cava Filter

6

Eclipse® Vena Cava Filter

7

Meridian® Vena Cava Filter

8

Denali® Vena Cava Filter

9

Other: ____________________________________________________

10

11.

Date of Implantation as to each product:

11

________________________________________________________________

12

________________________________________________________________

13

12.

Counts in the Master Complaint brought by Plaintiff(s):

14

□

Count I:

15

□

Count II:

16

Strict Products Liability – Manufacturing Defect
Strict Products Liability – Information Defect (Failure to

Warn)

17

□

Count III:

Strict Products Liability – Design Defect

18

□

Count IV:

Negligence - Design

19

□

Count V:

Negligence - Manufacture

20

□

Count VI:

Negligence – Failure to Recall/Retrofit

21

□

Count VII:

Negligence – Failure to Warn

22

□

Count VIII: Negligent Misrepresentation
-3-

Case 2:15-md-02641-DGC Document 1108 Filed 03/17/16 Page 9 of 10

1

□

Count IX:

Negligence Per Se

2

□

Count X:

Breach of Express Warranty

3

□

Count XI:

Breach of Implied Warranty

4

□

Count XII:

Fraudulent Misrepresentation

5

□

Count XIII: Fraudulent Concealment

6

□

Count XIV: Violations of Applicable ________________ (insert state)

7

Law Prohibiting Consumer Fraud and Unfair and Deceptive Trade

8

Practices

9

□

Count XV:

Loss of Consortium

10

□

Count XVI: Wrongful Death

11

□

Count XVII: Survival

12

□

Punitive Damages

13

□

Other(s):

___________________ (please state the facts supporting

14

this Count in the space immediately below)

15

__________________________________________________________

16

__________________________________________________________

17

__________________________________________________________

18

__________________________________________________________

19

__________________________________________________________

20

13.

Jury Trial demanded for all issues so triable?

21

□

Yes

22

□

No
-4-

Case 2:15-md-02641-DGC Document 1108 Filed 03/17/16 Page 10 of 10

1

RESPECTFULLY SUBMITTED this ____ day of March, 2016.

2

[SIGNATURE BLOCK]

3

By:

/s/
[Attorney name/address]

4
5
6

I hereby certify that on this ____ day of March, 2016, I electronically transmitted the

7

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

8

of a Notice of Electronic Filing.

9

/s/

10
11

5220248v1/26997-0001

12
13
14
15
16
17
18
19
20
21
22
-5-

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 2 of 30

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA
MDL No. 2641
In Re Bard IVC Filter Products Liability Litigation
______________________________________________________________________________
PLAINTIFF FACT SHEET
Each plaintiff who allegedly suffered injury as a result of a Bard Inferior Vena Cava
Filter must complete the following Plaintiff Fact Sheet (“Plaintiff Fact Sheet”). In completing
this Fact Sheet, you are under oath and must answer every question. You must provide
information that is true and correct to the best of your knowledge. If you cannot recall all of the
details as requested, please provide as much information as you can and then state that your
answer is incomplete and explain why, as appropriate. If you select an “I Don’t Know” answer,
please state all that you do know about that subject. If any information you need to complete any
part of the Fact Sheet is in the possession of your attorney, please consult with your attorney so
that you can fully and accurately respond to the questions set out below. If you are completing
the Fact Sheet for someone who cannot complete the Fact Sheet for himself/herself, please
answer as completely as you can.
The Fact Sheet shall be completed in accordance with the requirements and guidelines set
forth in the applicable Case Management Order. A completed Fact Sheet shall be considered
interrogatory answers pursuant to Fed. R. Civ. P. 33 and responses to requests for production
pursuant to Fed. R. Civ. P. 34 and will be governed by the standards applicable to written
discovery under Fed. R. Civ. P. 26 through 37. Therefore, you must supplement your responses
if you learn that they are incomplete or incorrect in any material respect. The questions and
requests for production of documents contained in this Fact Sheet are non-objectionable and
shall be answered without objection. This Fact Sheet shall not preclude Bard Defendants from
seeking additional documents and information on a reasonable, case-by-case basis, pursuant to
the Federal Rules of Civil Procedure and as permitted by the applicable Case Management
Order.
In filling out this form, “healthcare provider” shall mean any medical provider, doctor,
physician, surgeon, pharmacist, hospital, clinic, medical center, physician's office, infirmary,
medical/diagnostic laboratory, or any other facility that provides medical care or advice, along
with any pharmacy, x-ray department, radiology department, laboratory, physical
therapist/physical therapy department, rehabilitation specialist, chiropractor, or other persons or
entities involved in your diagnosis, care and/or treatment.
In filling out this form, the terms “You” or “Your” refer to the person who received a
Bard Inferior Vena Cava Filter manufactured and/or distributed by C. R. Bard, Inc. or Bard
Peripheral Vascular, Inc. (“Bard Defendants”) and who is identified in Question 1(a) below.
To the extent that the form does not provide enough space to complete your responses or
answers, please attach additional sheets as necessary, Information provided by Plaintiff will only

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 3 of 30

be used for the purposes related to this litigation and may be disclosed only as permitted under
the protective order in this litigation.
I. BACKGROUND INFORMATION
1.

Please state:
(a)

Full name of the person who received the Bard inferior vena cava filter, including
maiden name:______________________________________________________

(b)

List all names by which you have ever been known, if different from that listed in
1(a):______________________________________________________________
__________________________________________________________________

(c)

Full name of the person completing this form, if different from the person listed in
1(a) above, and the relationship of the person completing this form to the person
listed in 1(a) above: _________________________________________________

(d)

The name and address of your primary attorney:
_______________________________________
_______________________________________
_______________________________________
_______________________________________

(e)

When did you first retain an attorney to represent you in your lawsuit against
Bard? ____________________________________________________________

2.

Your Social Security Number: _______________________________________________

3.

Your Date of Birth: _______________________________________________________

4.

Your current residential address:
____________________________________________
____________________________________________
____________________________________________
____________________________________________

5.

If you have lived at this address for less than 10 years, provide each of your prior
residential addresses from 2000 to the present:
Prior Residential Address

Dates You Lived At This Address

2

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 4 of 30

6.

Have you ever been married? Yes_____

No_______

If yes, provide the names and addresses of each spouse and the inclusive dates of your
marriage to each person:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
7.

Do you have children? Yes_____

No_____

If Yes, please provide the following information with respect to each child:
Full Name of Child

8.

Date of Birth

Home Address

Whether
Biological/Adopted

Identify the name and age of any person who currently resides with you and their
relationship to you:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

9.

Identify the name and age of any person who has resided with you at any point over the
past ten (10) years:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

10.

Identify all secondary and post-secondary schools you attended, starting with high
school, and please provide the following information with respect to each:

3

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 5 of 30

Name of School

11.

Address

Dates of
Attendance

Degree
Awarded

Major or Primary
Field of Study

Please provide the following information for your employment history over the past 10
years up until the present:
Employer
Name

12.

Address

Job
Title/Description
of Duties

Dates of
Employment

Have you ever served in any branch of the military? Yes_____

Salary/Rate of Pay

No_____

If Yes, please provide the following information:
(a)

Branch and dates of service, rank upon discharge, and type of discharge received:
__________________________________________________________________

(b)

Were you discharged from the military at any time for any reason relating to your
medical, physical, or psychiatric condition? Yes_____

No_____

If Yes, state what that condition was:____________________________________
__________________________________________________________________
13.

Within the last ten years, have you been convicted of, or plead guilty to, a felony and/or
crime of fraud or dishonesty? Yes_____

No_____

If Yes, please set forth where and when and identify the felony and/or crime:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

4

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 6 of 30

14.

Before contacting any attorney regarding this lawsuit or claim, had you ever seen any
television or print advertisements regarding possible claims against inferior Vena Cava
Filter manufacturers?
Yes_____

No_____

If Yes, set forth the approximate date and nature of any such advertisement, whether the
advertisement included the name of a law firm, whether the advertisement specifically
mentioned C. R. Bard, Inc., Bard Peripheral Vascular, Inc., or “Bard”, and other details
that you recall. ___________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
II. CLAIM INFORMATION
1.

Have you ever received a Bard Inferior Vena Cava Filter? Yes_____

No_____

If Yes, please check the box(es) for each type of Bard Inferior Vena Cava Filter you have
received:

□
□

G2®

□

G2®X

□

G2®Express

□

Eclipse®

□

Meridian®

□

Denali®

□
2.

Recovery®

Other (please identify):_______________________________________________

For each Bard Inferior Vena Cava Filter identified above, please provide the following
information:
(a)

The date each Bard Inferior Vena Cava Filter was implanted in you:
__________________________________________________________________

5

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 7 of 30

(b)

The product code and lot number of each Bard Inferior Vena Cava Filter
implanted in you:
__________________________________________________________________

(c)

Current location of the Bard Inferior Vena Cava Filter, including any portion
thereof, if known:
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________

3.

Describe your understanding of the medical condition for which you received the Bard
Inferior Vena Cava Filter(s):
________________________________________________________________________
________________________________________________________________________

4.

Give the name and address of the doctor who implanted the Bard Inferior Vena Cava
Filter(s):_________________________________________________________________
________________________________________________________________________

5.

Give the name and address of the hospital or other healthcare facility where the Bard
Inferior Vena Cava Filter was implanted:_______________________________________
________________________________________________________________________

6.

Have you ever been implanted with any other vena cava filters or related product(s)
besides the Bard Inferior Vena Cava Filter(s) for the treatment of the same or similar
condition(s) identified in your response to question 3 above? Yes_____

No_____

If Yes:
(a)

Please identify any such device(s) or product(s).___________________________
__________________________________________________________________

(b)

When was this device or product implanted in you?________________________
__________________________________________________________________

(c)

Did the implantation take place before, at the same time, or after the procedure
during which you were implanted with a Bard Inferior Vena Cava Filter?
__________________________________________________________________
__________________________________________________________________

6

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 8 of 30

(d)

Who was the physician who implanted this other device or product?
__________________________________________________________________
__________________________________________________________________

(e)

At what hospital or facility was this other device or product implanted in you?
__________________________________________________________________
__________________________________________________________________

(f)

Why was this other device or product implanted in you?
__________________________________________________________________
__________________________________________________________________

7.

Prior to implantation with a Bard Inferior Vena Cava Filter, did you receive any written
and/or verbal information or instructions regarding the Bard Inferior Vena Cava Filter,
including any risks or complications that might be associated with the use of the same?
Yes_____

No_____

Don’t Know_____

If Yes:
(a)

Provide the date you received the written and/or verbal information or
instructions:
__________________________________________________________________
__________________________________________________________________

(b)

Identify by name and address the person(s) who provided the information and
instructions:
__________________________________________________________________
__________________________________________________________________

(c)

What information or instructions did you receive?
__________________________________________________________________
__________________________________________________________________

(d)

If you have copies of the written information or instructions you received, please
attach copies to your response.
__________________________________________________________________
__________________________________________________________________

(e)

Were you told of any potential complications from the implantation of the Bard
Inferior Vena Cava Filter(s)? Yes _____

7

No _____

Don’t Know _____

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 9 of 30

(f)

If yes to (e), by whom?
__________________________________________________________________
__________________________________________________________________

(g)

If yes to (e), what potential complications were described to you?
__________________________________________________________________
__________________________________________________________________

8.

Do you believe that the Bard Inferior Vena Cava Filter(s) remains implanted in you?
Yes _____

No _____

Don’t Know _____

If Yes:
(a)

Has any doctor recommended removal of the Bard Inferior Vena Cava Filter(s)?
Yes _____

No _____

If Yes:
(i)

Identify by name and address every doctor who recommended removal of
the Bard Inferior Vena Cava Filter(s):_____________________________
___________________________________________________________
___________________________________________________________

(ii)

For each doctor identified in response to question 8(a)(i) above, state your
understanding of why the doctor recommended removal.______________
____________________________________________________________
____________________________________________________________

(iii)

For each doctor identified in response to question 8(a)(i) above, state when
the doctor recommended removal.________________________________
____________________________________________________________
____________________________________________________________

9.

Has the Bard Inferior Vena Cava Filter(s) implanted in you been removed, in whole or in
part?
Yes_____

No_____

Don’t Know_____

If Yes:
(a)

Where, when, and by whom was the Bard Inferior Vena Cava Filter(s), or any
portion of it, removed?_______________________________________________
__________________________________________________________________

8

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 10 of 30

__________________________________________________________________
(b)

What portion of the Bard Inferior Vena Cava Filter(s) was removed on the date
indicated in response to question 9(a) above?_____________________________
__________________________________________________________________
__________________________________________________________________

(c)

Please check all that apply regarding the removal procedure(s):

□
□

Removed via an open abdominal procedure

□

Removed via an open chest procedure

□

Other, Describe: __________________________________

□
(d)

Removed percutaneously

Unknown

Does any portion of the Bard Inferior Vena Cava Filter(s) remain implanted in
you?

Yes _____

No _____

Don’t Know _____

If Yes, explain what portion of the Bard Inferior Vena Cava Filter(s) you believe
is still implanted in you:______________________________________________
__________________________________________________________________
__________________________________________________________________
(e)

Explain why you consented to have the Bard Inferior Vena Cava Filter(s), or any
portion thereof, removed?
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________

(f)

Does any medical provider, physician, entity, or anyone else acting on your behalf
have possession of any portion of the Bard Inferior Vena Cava Filter that was
previously implanted in you and subsequently removed?
Yes_____

No_____

Don’t Know_____

If Yes, please state the name and address of the person or entity having possession
of same.___________________________________________________________
__________________________________________________________________

9

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 11 of 30

10.

Has any doctor or healthcare provider unsuccessfully attempted to remove the Bard
Inferior Vena Cava Filter(s) implanted in you?
Yes_____

No_____

Don’t Know_____

If Yes:
(a)

How many attempts have been made to remove the Bard Inferior Vena Cava
Filter(s) implanted in you?____________________________________________

(b)

Provide the name and address of the doctor who removed (or attempted to
remove) the filter strut(s) and the hospital or medical facility at which it was
removed (or attempted to be removed).
Filter Removal/Attempted Removal #1
Doctor:_______________________________________________
Hospital/Medical Facility:________________________________
Date:_________________________________________________
Filter Removal/Attempted Removal #2
Doctor:_______________________________________________
Hospital/Medical Facility:________________________________
Date:_________________________________________________
Filter Removal/Attempted Removal #3
Doctor:_______________________________________________
Hospital/Medical Facility:________________________________
Date:_________________________________________________

(c)

Please check all that apply regarding attempted removal procedure #1:

□

Attempted but unsuccessful percutaneous removal procedure

□

Attempted but unsuccessful open abdominal procedure

□

Attempted but unsuccessful open chest procedure

□

Other, Describe: ______________________________________________
____________________________________________________________

□

Unknown

10

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 12 of 30

(d)

Please check all that apply regarding attempted removal procedure #2:

□

Attempted but unsuccessful percutaneous removal procedure

□

Attempted but unsuccessful open abdominal procedure

□

Attempted but unsuccessful open chest procedure

□

Other, Describe: ______________________________________________
____________________________________________________________

□
(e)

Unknown

Please check all that apply regarding attempted removal procedure #3:

□

Attempted but unsuccessful percutaneous removal procedure

□

Attempted but unsuccessful open abdominal procedure

□

Attempted but unsuccessful open chest procedure

□

Other, Describe: ______________________________________________
____________________________________________________________

□
11.

Unknown

Do you claim that your Bard Inferior Vena Cava Filter(s) fractured?
Yes_____

No_____

If Yes:
(i)

Please state the number of fractured struts retained in your body?
____________________________________________________________

(ii)

Please identify the location(s) within your body of each retained filter
strut.
____________________________________________________________
____________________________________________________________

(iii)

Please provide the date or approximate date when you were first informed
of each fractured strut.
____________________________________________________________
____________________________________________________________

11

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 13 of 30

(iv)

Has any health care provider recommended to you that a retained filter
strut(s) should be removed?
Yes _____

No_____

If Yes, provide the name and address of any such healthcare provider, as
well as the approximate date on which the communication occurred.
____________________________________________________________
____________________________________________________________
____________________________________________________________
(v)

Has any health care provider recommended to you that a retained filter
strut should not be removed?
Yes_____

No_____

If Yes, provide the name and address of any such healthcare provider, as
well as the approximate date on which the communication occurred.
____________________________________________________________
____________________________________________________________
____________________________________________________________
(vi)

Have any fractured struts been removed, or attempted to have been
removed, from your body?
Yes _____

No_____

If Yes:
(1)

If any fractured filter strut has been removed (or a doctor has
attempted to remove any strut), please check all that apply
regarding the removal/attempted removal procedure(s):

□

Removed percutaneously

□

Removed via an open abdominal procedure

□

Removed via an open chest procedure

□

Attempted but unsuccessful percutaneous removal
procedure

□

Attempted but unsuccessful open abdominal procedure

12

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 14 of 30

□
□

Other, Describe: __________________________________

□
(2)

Attempted but unsuccessful open chest procedure

Unknown

Provide the name and address of the doctor who removed (or
attempted to remove) the filter strut(s) and the hospital or medical
facility at which it was removed (or attempted to be removed).
Filter Strut Removal/Attempted Removal #1
Doctor:_______________________________________________
Hospital/Medical Facility:________________________________
Date:_________________________________________________
Filter Strut Removal/Attempted Removal #2
Doctor:_______________________________________________
Hospital/Medical Facility:________________________________
Date:_________________________________________________

12.

Do you claim that you suffered bodily injuries as a result of the implantation of the Bard
Inferior Vena Cava Filter(s)? Yes_____

No_____

If Yes:
(a)

Describe the bodily injuries, including any emotional or psychological injuries
that you claim resulted from the implantation, attempted removal and/or removal
of the Bard Inferior Vena Cava Filter(s)?_________________________________
__________________________________________________________________
__________________________________________________________________

(b)

When was the first time you experienced symptoms of any of the bodily injuries
you claim in your lawsuit to have resulted from the Bard Inferior Vena Cava
Filter(s)?
__________________________________________________________________
__________________________________________________________________

(c)

When did you first attribute these bodily injuries to the Bard Inferior Vena Cava
Filter(s)?__________________________________________________________
__________________________________________________________________

13

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 15 of 30

(d)

To the best of your knowledge and recollection, please state the approximate date
when you first saw a health care provider for any of the bodily injuries, or
symptoms related thereto, you claim to have experienced related to the Bard
Inferior Vena Cava Filter(s)?
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________

(e)

To the best of your knowledge and recollection, has any health care provider ever
told you orally or in writing that any symptoms related to bodily injury are related
to the Bard Inferior Vena Cava Filter(s)?
Yes_____

No_____

If Yes, please state the name and address of any such health care provider, as well
as providing the approximate date the statement was made, and provide the details
of the communication:_______________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
(f)

Are you currently experiencing symptoms related to your claimed bodily injuries?
Yes_____

No_____

If Yes, please describe your symptoms in detail:
__________________________________________________________________
__________________________________________________________________
(g)

Are you currently seeing, or have you ever seen, a doctor or healthcare provider
for any of the bodily injuries or symptoms listed above?
Yes_____

No _____

14

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 16 of 30

If Yes, please list all doctors you have seen for treatment of any of the bodily
injuries you have listed above.

Provider Name and
Address

h)

Condition Treated

Approximate Dates of
Treatment

Were you hospitalized at any time for the bodily injuries you listed above?
Yes _____

No_____

If Yes, please provide the following:
Hospital Name and
Address

13.

Condition Treated

Approximate Dates of
Treatment

Are you making a claim for lost wages or lost earning capacity?
Yes_____
(a)

No_____

If yes, state the annual gross income derived from your employment for each
year, beginning five (5) years prior to the implantation of the Bard Inferior Vena
Cava Filter(s) until the present: ________________________________________
__________________________________________________________________
__________________________________________________________________

(b)

If yes, for what period of time are you claiming lost wages?_________________
__________________________________________________________________
__________________________________________________________________

(c)

If you are claiming lost earning capacity, do you claim that you have a claim for
future lost wages?
Yes_____

No_____

If yes, for what period of time do you claim you have lost future wages?

15

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 17 of 30

__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
14.

Are you making a claim for lost out-of-pocket expenses? Yes_____

No_____

If yes, please identify and itemize all out-of-pocket expenses you have incurred.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
15.

Has anyone filed a loss of consortium claim in connection with your lawsuit regarding
the Bard Inferior Vena Cava Filter(s)?
Yes_____

No_____

If yes, identify by name and address the person who filed the loss of consortium claim
(“Consortium Plaintiff”) and state the relationship of that person to you and state the
specific nature of the Consortium Plaintiff’s claim._______________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
16.

Please indicate whether the Consortium Plaintiff alleges any of the damages set forth
below:
Claims

Yes/No

Loss of services of spouse
Impaired sexual relations
Lost wages/lost earning capacity
Lost out-of-pocket expenses
Physical injuries
Psychological injuries/emotional injuries
Other

16

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 18 of 30

17.

Please list the name and address of any healthcare providers the Consortium Plaintiff has
sought treatment for any physical, emotional, or psychological injuries or symptoms
alleged to be related to his/her claim.__________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

18.

Have you or anyone acting on your behalf had any communication, oral or written, with
any of the Bard Defendants and/or their representatives?
Yes _____

No_____

Don’t Know _____

If yes, set forth: (a) the date of any communication, (b) the method of communication, (c)
the name of the person with whom you communicated, and (d) the substance of the
communications.__________________________________________________________
________________________________________________________________________
________________________________________________________________________
III. MEDICAL BACKGROUND
1.

Provide your current: Age_____

2.

Provide your: Age_____

Height_____ Weight_____

Weight_____ (approximate, if unknown) at the time the

Bard Inferior Vena Cava Filter was implanted in you.
3.

In chronological order, list any and all surgeries, procedures and/or hospitalizations you
had in the ten (10) year period BEFORE implantation of the Bard Inferior Vena Cava
Filter(s). Identify by name and address the doctor(s), hospital(s) or other healthcare
provider(s) involved with each surgery or procedure; and provide the approximate date(s)
for each:
Approximate Date

Description of Surgery or
Hospitalization

17

Doctor or Healthcare
Provider Involved
(including address)

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 19 of 30

[Attach additional sheets as necessary to provide the same information for any and all
surgeries and hospitalizations leading up to the implantation of the Bard Inferior Vena
Cava Filter.]
4.

In chronological order, list any and all surgeries, procedures and/or hospitalizations you
had AFTER implantation of the Bard Inferior Vena Cava Filter(s). Identify by name and
address the doctor(s), hospital(s) or other healthcare provider(s) involved with each
surgery or procedure; and provide the approximate date(s) for each:
Approximate Date

Description of Surgery or
Hospitalization

Doctor or Healthcare
Provider Involved
(including address)

[Attach additional sheets as necessary to provide the same information for any and all
surgeries and hospitalizations after the implantation of the Bard Inferior Vena Cava
Filter.]
5.

To the extent not already provided in the charts above, provide the name, address, and
telephone number of every doctor, hospital or other health care provider from which you
have received medical advice and/or treatment from ten (10) years before the date the
filter was implanted to the present:
Name and Specialty

Address

18

Approximate Date/Years of
Visits

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 20 of 30

6.

Before the implantation of the Bard Inferior Vena Cava Filter(s), did you regularly
exercise or participate in activities that required lifting or strenuous physical activity?
(Please include all physical activities associated with daily living, physical fitness,
household tasks, and employment-related activities.)
Yes _____

No _____

If yes, please describe each activity in detail. ___________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
7.

Since the implantation of the Bard Inferior Vena Cava Filter(s), have you regularly
exercised or participated in activities that required lifting or strenuous physical activity?
(Please describe all range of physical activities associated with daily living, physical
fitness, household tasks, and employment-related activities.)
Yes _____

No _____

If yes, please describe each activity in detail. ___________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
8.

During the past ten (10) years, what have been your primary hobbies or recreational
activities? _______________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
(a)

Do you claim that you are unable to participate in any of the hobbies or
recreational activities listed in response to question 8 above as a result of you
having been implanted with a Bard Inferior Vena Cava Filter(s)?
Yes_____

(b)

No_____

If yes, what hobbies or recreational activities do you claim that you are unable to
participate in as a result of having been implanted with a Bard Inferior Vena Cava
Filter(s)?__________________________________________________________

19

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 21 of 30

__________________________________________________________________
__________________________________________________________________
(c)

For what period of time do you claim that you were or have been unable to
participate in any hobbies or recreational activities as a result of having been
implanted with a Bard Inferior Vena Cava Filter(s)?
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________

9.

To the best of your knowledge, have you ever been told by a doctor or another health care
provider that you have suffered, may have suffered, or presently do suffer from any of the
following:
_____ Lupus
_____ Crohn’s Disease
_____ Factor V Leiden
_____ Protein Deficiency
_____ Spinal Fusion or Other Back Procedures
_____ Anti-thrombin Deficiency
_____ Prothrombin Mutation
_____ Deep Vein Thrombosis
_____ Pulmonary Embolism
_____ Auto Immune Disorder
_____ Varicose Veins
_____ Heart Procedures
_____ Blood Disorder
Please Describe:____________________________________________________
_____ Bariatric Surgery
_____ Anticoagulation Medication (e.g., Coumadin, Warfarin, etc.)
_____ Ulcerative Colitis/Inflammatory Bowel Disease (IBD)
_____ Cancer
Please Describe:____________________________________________________

20

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 22 of 30

**********
THE FOLLOWING QUESTIONS ARE CONFIDENTIAL AND SUBJECT TO THE
PROTECTIVE ORDER APPLICABLE TO THIS CASE.
(A)

Have you been diagnosed with and/or treated for any drug, alcohol, chemical
and/or other addiction or dependency during the five (5) years prior to the filing
of this lawsuit through the present? Yes_____

No_____

If yes, specify type and time period of dependency, type of treatment received,
name of treatment provider, and current status of condition:
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
(B)

Have you experienced, been diagnosed with or received psychiatric or
psychological treatment of any type, including therapy, for any mental health
conditions including depression, anxiety, or other emotional or psychiatric
disorders during the five (5) years prior to the filing of this lawsuit through the
present? Yes_____

No_____

If yes, specify condition, date of onset, medication/treatment, treating physician
and current status of condition:
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________

**********

21

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 23 of 30

10.

Do you now or have you ever smoked tobacco products? Yes_____

No_____

If yes:
How long have/did you smoke?______________________________________________
11.

Other than the implantation of the Bard Inferior Vena Cava Filter device that is the
subject of your lawsuit, are you aware of any other Vena Cava Filter(s) implanted inside
your body at any time?

Yes_____

No_____

If yes, please provide the following information:
(a)

Product name:______________________________________________________

(b)

Date of procedure placing it and name and address of doctor who placed it:
__________________________________________________________________

(c)

Condition sought to be treated through placement of the device:
__________________________________________________________________

(d)

Any complications you encountered with the medical product or procedure:
__________________________________________________________________

(e)
12.

Does that product remain implanted inside of you today?

Yes_____

No_____

List each prescription medication you have taken for more than three (3) months at a time
during the timeframe beginning five (5) years prior to implantation of the Bard Inferior
Vena Cava Filter and continuing to the present, giving the name and address of the
pharmacy where you received/filled the medication, the reason you took the medication,
and the approximate dates of use.

Medication and
Dosage

Prescribing
Physician

Pharmacy Name
and Address

22

Reason for Taking
Medication

Approximate
Date(s) of Use

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 24 of 30

IV. INSURANCE INFORMATION
1.

Provide the following information for any past or present medical insurance coverage
from the timeframe beginning five (5) years prior to implantation of the Bard Inferior
Vena Cava Filter and continuing to the present:

Insurance Company
Name and Address

2.

Policy Number

Name of Policy
Holder/Insured (if
different than
yourself)

Approximate Dates of
Coverage

To the best of your knowledge, have you ever been approved to receive or are you
currently receiving Medicare/Medicaid benefits due to age, disability, condition, or any
other reason or basis?
Yes_____

No_____

If yes, please specify the date on which you first became eligible:___________________
[Please note: if you are not currently a Medicare-eligible beneficiary, but become eligible for
Medicare during the pendency of this lawsuit, you must supplement your response at that time.
This information is necessary for all parties to comply with Medicare regulations. See 42 U.S.C.
1395y(b)(8), also known as Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of
2007 and 42 U.S.C. 1395y(b)(2) also known as the Medicare Secondary Payer Act.]
V. PRIOR CLAIM INFORMATION
1.

Have you filed a lawsuit or made a claim in the last ten (10) years, other than in the
present suit relating to any bodily injury?
Yes_____

No_____

If yes, please specify the following:
(a)

Court in which the lawsuit/claim was filed or initiated:______________________
__________________________________________________________________

(b)

Case/Claim Number:_________________________________________________

(c)

Nature of Claim/Injury:_______________________________________________
__________________________________________________________________
23

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 25 of 30

2.

Have you ever applied for Workers’ Compensation (WC), Social Security disability (SSI
or SSD) benefits, or other State or Federal disability benefits?
Yes_____

No_____

If yes, please specify the following:
(a)

Date (or year) of application:__________________________________________

(b)

Type of benefits sought:______________________________________________

(c)

Agency/Insurer from which you sought the benefits:________________________
__________________________________________________________________

(d)

Nature of the claimed injury/disability:__________________________________
__________________________________________________________________

(e)

Whether the claim was accepted or denied:_______________________________
VI. FACT WITNESSES

1.

Identify by name, address, and relationship to you, all persons (other than your healthcare
providers) who possess information concerning your injuries and/or current medical
condition:
Name

Address

Relationship to You

Information You
Believe Person
Possesses

VII. IDENTIFICATION OF DOCUMENTS AND OTHER ELECTRONICALLY
STORED INFORMATION
For the period beginning three (3) years prior to the implantation of the Bard Inferior Vena Cava
Filter until the present, please identify all research, including on-line research, that you
conducted regarding the medical complaints or condition for which you received the Bard
Inferior Vena Cava Filter (pulmonary thromboembolism, anticoagulant therapy, etc.) Identify
the date, time, and source, including any websites visited. (Research conducted subsequent to
and for the purpose of understanding the legal and strategic advice of your counsel is not
considered responsive to this request.)
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
24

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 26 of 30

______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
VIII. DOCUMENT REQUESTS
1.

RELEASES.
NOTE:

Please sign and attach to this Fact Sheet the authorizations for the

release of records appended hereto.
2.

DOCUMENTS. State whether you have any of the following documents in your
possession, custody, and/or control. If you do, please provide a true and correct copy of
any such documents with this completed Fact Sheet.
(a)

If you were appointed by a Court to represent the plaintiff in this lawsuit, produce
any documents demonstrating such appointment.
(i)
(ii)

(b)

Not applicable _________________
The documents are attached_____

[OR] I have no documents_____

If you represent the Estate of a deceased person in this lawsuit, produce a copy of
the decedent’s death certificate and autopsy report (if applicable).
(i)
(ii)

(c)

Not applicable_________________
The documents are attached_____

[OR] I have no documents_____

Produce each and every medical record of each and every medical facility,
pharmacy, or practitioner of the healing arts identified by you in response to the
questions in Sections II and III above regarding your medical care and history for
the time period beginning ten (10) years prior to the implantation of the Bard
Inferior Vena Cava Filter and continuing to the present.
(i)
(ii)

(d)

Not applicable_________________
The documents are attached_____

[OR] I have no documents_____

Produce any communication (sent or received) in your possession, which shall
include materials accessible to you from any computer on which you have sent or
received such communications, concerning the Bard Inferior Vena Cava Filter(s)
or subject of this litigation, including, but not limited to all letters, emails, blogs,
Facebook posts, Tweets, newsletters, etc. sent or received by you. (Research

25

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 27 of 30

conducted subsequent to and to understand the legal and strategic advice of your
counsel is not considered responsive to this request.)
(i)
(ii)
(e)

Not applicable_________________
The documents are attached_____

[OR] I have no documents_____

Produce all documents, including journal entries, lists, memoranda, notes, diaries,
photographs, video, DVDs or other media, discussing or referencing the Bard
Inferior Vena Cava Filter(s), the injuries and/or damages you claim resulted from
the Bard Inferior Vena Cava Filter(s), and/or evidencing your physical condition
from three (3) years prior to the implantation of the Bard Inferior Vena Cava
Filter(s) to present. (Research conducted subsequent to and to understand the legal
and strategic advice of your counsel is not considered responsive to this request.)
(i)
(ii)

(f)

Not applicable_________________
The documents are attached_____

[OR] I have no documents_____

Produce any Bard Inferior Vena Cava Filer product packaging, labeling,
advertising, or any other product-related items in your possession, custody or
control.
(i)
(ii)

(g)

Not applicable_________________
The documents are attached_____

[OR] I have no documents_____

Produce all documents concerning any communication between you, your
attorney(s), your agent(s), your expert(s), or your representative(s) and the Food
and Drug Administration (FDA), or between you and any employee or agent of
the Bard Defendants, regarding Bard Inferior Vena Cava Filters.
(i)
(ii)

(h)

Not applicable_________________
The documents are attached_____

[OR] I have no documents_____

Produce all documents that you, your attorney(s), your agent(s), your expert(s), or
your representative(s) provided to the Food and Drug Administration (FDA)
and/or the Department of Health and Human Services regarding Bard Inferior
Vena Cava Filters.
(i)

Not applicable_________________

(ii)

The documents are attached_____

26

[OR] I have no documents_____

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 28 of 30

(i)

Produce all documents concerning any communication between you, your
attorney(s), your agent(s), your expert(s), or your representative(s) with anyone at
any television station, radio station, newspaper, periodical, magazine, weblog,
internet website, or any other media outlet regarding Bard Inferior Vena Cava
Filters.
(i)
(ii)

(j)

Not applicable_________________
The documents are attached_____

[OR] I have no documents_____

Produce all documents that you, your attorney(s), your agent(s), your expert(s), or
your representative(s) provided to anyone at any television station, radio station,
newspaper, periodical, magazine, weblog, internet website, or any other media
outlet regarding Bard Inferior Vena Cava Filters.
(i)
(ii)

(k)

Not applicable_________________
The documents are attached_____

[OR] I have no documents_____

Produce all documents in your possession, custody, or control evidencing or
relating to any correspondence or communication between C. R. Bard, Inc. or
Bard Peripheral Vascular, Inc. (or any related companies or divisions) and any of
your doctors, healthcare providers, and/or you relating to Bard Inferior Vena Cava
Filters, except as to those communications which are protected by the attorneyclient privilege or attorney work product doctrine.
(i)
(ii)

(l)

Not applicable_________________
The documents are attached_____

[OR] I have no documents_____

Produce all documents in your possession, custody, or control reflecting,
describing, or in any way relating to any instructions or warnings you received
prior to implantation of any Inferior Vena Cava Filter(s) concerning the risks
and/or benefits associated with Inferior Vena Cava Filter(s), including but not
limited to the Bard Inferior Vena Cava Filter implanted in you.
(i)
(ii)

(m)

Not applicable_________________
The documents are attached_____

[OR] I have no documents_____

Produce any and all documents reflecting the model number and lot number of the
Bard Inferior Vena Cava Filter(s) you received.
(i)

Not applicable_________________

27

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 29 of 30

(ii)
(n)

The documents are attached_____

[OR] I have no documents_____

If you underwent surgery or any other procedure to remove, in whole or in part,
the Bard Inferior Vena Cava Filter(s), produce any and all documents, other than
documents that may have been generated by expert witnesses retained by your
counsel for litigation purposes, that relate to any evaluation of the Bard Inferior
Vena Cava Filter(s) removed from you.
(i)
(ii)

(o)

Not applicable_________________
The documents are attached_____

[OR] I have no documents_____

Produce all documents in your possession, custody, or control concerning
payment by Medicare on behalf of the injured party and relating to the injuries
claimed in this lawsuit. This includes, but is not limited to Interim Conditional
Payment summaries and/or estimates prepared by Medicare or its representatives
regarding payments made on your behalf for medical expenses relating to the
subject of this litigation.
(i)

Not applicable_________________

(ii)

The documents are attached_____

[OR] I have no documents_____

[Please note: if you are not currently a Medicare-eligible beneficiary, but become eligible for
Medicare during the pendency of this lawsuit, you must supplement your response at that time.
This information is necessary for all parties to comply with Medicare regulations. See 42 U.S.C.
1395y(b)(8), also known as Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of
2007 and 42 U.S.C. 1395y(b)(2) also known as the Medicare Secondary Payer Act.]
(q)

Produce all screenshots of all webpages of each type of social media used by you
(including, but not limited to, Facebook, Twitter, Instagram, Vine, Snapchat,
YouTube, LinkedIn) showing any and all “posts” and/or “messages” from the
date of implantation to the present.
(i)
(ii)

(r)

Not applicable_________________
The documents are attached_____

[OR] I have no documents_____

Produce the Bard Inferior Vena Cava Filter(s) or any and all components thereof
previously implanted in you.

28

Case 2:15-md-02641-DGC Document 1153-1 Filed 03/18/16 Page 30 of 30

VERIFICATION
I, __________________________, declare under penalty of perjury, subject to all applicable
laws and in the presence of the below named witness, that I have carefully reviewed the final
copy of this Plaintiff Fact Sheet dated ______________ and verified that all of the information
provided is true and correct to the best of my knowledge, information and belief.

_____________________________
Signature of Witness
_____________________________
Name of Witness
_____________________________
Address of Witness

_____________________________
Signature of Plaintiff

29

Case 2:15-md-02641-DGC Document 1153-2 Filed 03/18/16 Page 2 of 9

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF ARIZONA
IN RE: BARD IVC FILTERS
PRODUCT LIABILITY LITIGATION
MDL No. 2641

This Document Relates:
Case No:______________________________

DEFENDANT FACT SHEET
For each case, the Bard Defendants must complete this Defendant Fact Sheet (“DFS”)
in accordance with the schedule established by the Court’s Pretrial Order.
The DFS shall be completed in accordance with the requirements and guidelines set
forth in the applicable Case Management Order. A completed Fact Sheet shall be considered
interrogatory answers pursuant to Fed. R. Civ. P. 33 and 34 and will be governed by the
standards applicable to written discovery under Fed. R. Civ. P. 26 through 37. Therefore, you
must supplement your responses if you learn that they are incomplete or incorrect in any
material respect. The questions and requests for production of documents contained in this
Fact Sheet are non-objectionable and shall be answered without objection, except that
Defendants may assert, where appropriate, objections based on privilege or work product
grounds; in which case they will produce a privilege log. This Fact Sheet shall not preclude
Plaintiffs from seeking additional documents and information on a reasonable, case-by-case
basis, pursuant to the Federal Rules of Civil Procedure and as permitted by the applicable
Case Management Order.
This DFS must be completed and served on all counsel representing a plaintiff in the
action identified in Section I below, as well as Co-Lead Counsel for PLC, Ramon Rossi Lopez
and Robert W. Boatman. Complete fact sheets must be answered and served in accordance
with the Case Management Plan to be entered by this Court.
Each document request and interrogatory not only calls for knowledge but also for all
knowledge that is available to you by reasonable inquiry, including inquiry of your officers,
directors, employees, contractors and agents.
To the extent that the form does not provide enough space to complete your responses
or answers, please attach additional sheets as necessary. Please identify any documents that
you are producing responsive to a question with Bates-Stamp identifiers.
1

Case 2:15-md-02641-DGC Document 1153-2 Filed 03/18/16 Page 3 of 9

In filling out this form, “document” and “documents” mean and refer to a writing
and/or recording as defined by Federal Rule 34, including, without limitation, the following
terms in their broadest sense, whether printed or recorded or reproduced by any other
mechanical process, or written or produced by hand: agreements, “communications”, State
and Federal governmental hearings and reports, correspondence, telegrams, memoranda,
summaries or records of telephone conversations, summaries or records of personal
conversations or interviews, diaries, graphs, reports, notebooks, note charts, plans, drawings,
sketches, maps, summaries or records of meetings or conferences, summaries or reports of
investigations or negotiations, opinions or reports of consultants, radiographs, photographs,
motion picture films, brochures, pamphlets, advertisements, circulars, press releases, drafts,
letters, any marginal comments appearing on any document, and all other writings.
In filling out this form, the word “communication and/or “correspondence” shall
mean and refer to any oral, written, spoken, or electronic transmission of information,
including, but not limited to, meetings, discussions, conversations, telephone calls,
memoranda, letters, emails, text messages, postings, instructions, conferences, seminars, or
any other exchange of information between Defendants and any other person or entity.
In filling out this form, “healthcare provider” shall mean any doctor, physician, or
surgeon who treated the plaintiff for deep vein thrombosis, pulmonary embolism, or
associated conditions, or who prescribed or implanted a Bard IVC Filter, who removed or
attempted to remove a Bard IVC Filter. In filling out this form, the terms “You”, “Your”, or
“Yours” refer to the person who sold, marketed, researched, designed, manufactured,
consulted, or represented a Bard Inferior Vena Cava Filter manufactured and/or distributed on
behalf of C.R. Bard Inc. “Bard Defendants” and who is identified in Question I below.
In filling out this form, “key opinion leader” or “thought leader” shall mean and refer
to physicians, who are believed by Defendants to be effective at transmitting messages to their
peers and others in the medical community. This term shall mean and refer to any doctors or
medical professionals hired by, consulted with, or retained by Defendants to, amongst other
things, consult, give lectures, respond to media inquiries, conduct clinical trials, write articles
or abstracts, sign their names as authors to articles or abstracts written by others, and
occasionally make presentations on their behalf at regulatory meetings or hearings, association
meetings, hospital department meetings, or other professional meetings including local,
regional and national meetings, and any other meeting organized and planned by or on behalf
of Defendants.

2

Case 2:15-md-02641-DGC Document 1153-2 Filed 03/18/16 Page 4 of 9

I.

CASE INFORMATION

This DFS pertains to the case captioned above:
Case Number and Court in which action was originally filed, if other than direct file into
MDL No. 2641: _________________________________________________________
Date this DFS was completed: ______________________________________________
A. Please provide the following information on the person or persons who provided

the information responsive to the questions posed in this DFS:
1. Name;
2. Current position (if no longer employed, last position with Defendant(s));
3. City of employment (if no longer employed, city of residence).

II.

CONTACTS WITH TREATING AND EVALUATING PHYSICIANS

Plaintiff has identified each healthcare provider who treated and/or evaluated Plaintiff for
deep vein thrombosis, pulmonary embolism, and/or associated conditions that led to the use of
Defendants’ Bard Inferior Vena Cava Filter, and who prescribed or implanted a Bard IVC
Filter, who removed or attempted to remove a Bard IVC Filter. As to each such healthcare
provider, provide the following information:
A. CONSULTATION AND OTHER NON-SALES REPRESENTATIVE CONTACTS

As to each identified healthcare provider with whom the Defendants were affiliated,
consulted or otherwise had contact outside the context of sales representative contacts,
set forth the following:
1.

Identify all contacts between the healthcare provider and Bard's Medical
Services and Support.

2.

Identify all past and present consulting arrangements with the healthcare
provider.

3.

Identify any document previously produced that references the
healthcare provider.

4.

Identify and produce all Form 1099's reflecting payments or
reimbursements of any nature to the healthcare provider.
3

Case 2:15-md-02641-DGC Document 1153-2 Filed 03/18/16 Page 5 of 9

5.

Identify any Dear Doctor letter or similar communication regarding
Bard's IVC filters that concern any safety-related issue and that could
have been sent to the healthcare provider (or the hospital or facility
where the filter was implanted), and identify any record reflecting
actual delivery of the communication to the provider or the facility.

6.

Identify (to the extent known) any Bard-sponsored clinical study in
which the healthcare provider participated.

7.

Identify any training provided to or by the healthcare provider
including, but not limited to, date, location, healthcare provider’s role,
cost for attending such training, and subject matter.

8.

Set forth any and all contractual relationships between the healthcare
provider(s) and any named Defendant, including, but not limited to:
a. whether the provider participated in any study or clinical trials as a

principal investigator or supervising physician at any study site which
was sponsored by Defendant(s) on Defendants’ behalf;
b. whether the provider has spoken on behalf of Defendant(s) or any of

its products;
c. whether the provider has served in any capacity on any advisory

board, etc.;
d. whether the provider has ever served as a Key Opinion Leader or

Thought Leader for, or on behalf of, any of the named defendants;
e. whether the provider has functioned in any capacity promoting

Defendants’ products;
f. whether the provider has ever been employed by or under contract to

Defendant(s).
9.

For each facility where a Bard IVC filter was implanted in the plaintiff,
set forth the number and type of Bard Inferior Vena Cava Filter(s)
purchased from you, or otherwise provided by you, for a four-year
period (spanning from 2 years before the implant until 2 years
afterward). If there are no records of filter sales to that facility during
the time period in question, identify any distributors known to the
Defendants that may have supplied filters to the facility, or the names of
all purchasers of filters from the lot number in question

4

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10.

Set forth any contact between the Defendants and the healthcare
provider with regard to the Plaintiff, this includes, but is not limited to,
any information or knowledge Defendants have with respect to research
studies conducted on or that include information related to Plaintiffs
implant or associated lot number.

B. SALES REPRESENTATIVE AND OTHER RELATED CONTACTS

As to the sales representative assigned to the territory where the implanting facility is
located, during the time period when the implant occurred, set forth the following:
1.
Identity and last known address and telephone number of the
Representative(s).
2.

The work history with you and current relationship, if any, between the
specified Defendant(s) and the Representative(s).

3.

Identity of the Representative(s)’ supervisor(s) during his/her
Employment.

4.

For each Sales Representative, Sales Manager, Marketing Organization
Representative, medical liaison, and/or Representative, please produce
the most current Curriculum Vitae or Resume. If the Company is not in
possession of a Curriculum Vitae or Resume, produce the portion of
that person’s personnel file that reflects their educational background
and experience over the past 10 years.

5.

Defendants or their Representatives, Sales Representatives,
Representative(s) or Managers have ever provided any of Plaintiffs
healthcare provider(s) with Bard Inferior Vena Cava Filter(s) samples,
please provide the identity of the person or entity who received the
samples, the date(s) the samples were shipped, the date on which the
samples were provided, the number and lot numbers of such samples,
and the name of the person who provided the samples.

11.

Set forth all information provided by the healthcare provider to the
Representatives, Sales Representatives, Representative(s) or Managers
with regard to the Plaintiff.

12.

Set forth all information provided by the Representatives, Sales
Representatives, Representative(s) or Managers with regard to the
Plaintiffs.

13.

State whether the sales representative, Sales Manager, Marketing

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Organization Representative, medical liaison, and/or Representative
while employed by you, or acting as an agent or independent contractor
on your behalf, was ever reprimanded and/or otherwise penalized by
any person, entity, or government agency for his/her sales or marketing
practices during the period of employment with you, and if so set forth
the details thereof.

III.

INFORMATION REGARDING THE PLAINTIFF: COMMUNICATIONS AND
RELATIONSHIPS WITH PLAINTIFF’S HEALTHCARE PROVIDERS
A.

Identify all data, information, objects, and reports in Defendants' possession or
control or which have been reviewed or analyzed by Defendants, with regard
to the Plaintiffs medical condition; this also includes, but is not limited to, any
study or research that includes Plaintiffs specific implant or associated lot
number. Attorney-work product is specifically excluded from this request.

B.

Identify any direct or indirect contact, either written or oral, between the
Plaintiff and any employee or representative of the Defendants, including, but
not limited to, pre-operative inquiries, post-operative complaints, “Dear
Healthcare Provider” letters, “Dear Doctor” letters, “Dear Colleague” letters or
other similar type of document or letter concerning Bard Inferior Vena Cava
Filters, recall letters, telephone or email contacts or meetings. This request
specifically includes, but is not limited to, calls to the Bard hotline and calls to
the Field Assurance Department.

C.

Identify and produce any Physician’s Information Request Letters (“PIR”) or
other similar information request that has ever been initiated between the
Plaintiff and any employee or representative of the Defendants relating to Bard
Inferior Vena Cava Filters, and identify the date of the request and the
recipient, the name and address of the sender or requestor, the corresponding
bates number of the request, and whether or not a response to the PIR or other
similar information request was sent or provided.

D.

Produce communications between the Defendants, the sales representative
company and/or sales representative(s), Sales Manager, Marketing
Organization Representative, medical liaison, and/or Representative identified
in section B above and Plaintiff, to the extent not contained in the complaint
file, if any, and identify the Bates numbers of such communications.

E.

Identify all Adverse Event Reports, Medical Devise Reports, and all versions
of any MedWatch forms and/or any other documents submitted to the FDA or
any other government agency with regard to the Plaintiff.

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F.

If you have any evidence or records indicating or demonstrating the possibility
that any person, entity, condition, or product, other than the Defendants and
their product(s), is a cause of the Plaintiffs injuries, (“Alternate Cause”) set
forth:
1.
2.

G.

IV.

Identify the Alternate Cause with specificity.
Set forth the date and mechanism of alternate causation,

In Plaintiffs Fact Sheet, Plaintiff identified his/her Implanting Healthcare
Provider(s). For each listed provider, please state and produce the following:
Do you have or have you had access to any database or information which
purports to track any of Plaintiffs Implanting Healthcare Provider's implanting
practices with respect to Bard Inferior Vena Cava Filter(s). If yes, please
produce or identify the database or document which captures that information.

MANUFACTURING INFORMATION
A.
B.

Identify the location and date of manufacture for each lot set forth in response
to A and B above.

C.

Identify the date of shipping and sale, and the person or entity purchasing, each
of Plaintiffs device(s).

E.

Identify all manufacturing facilities and associated lot number(s) of Plaintiffs
implanted device(s).

F.

V.

Identify the lot number(s) for the device(s) implanted into the Plaintiff.

Other than Bard related entities, and those entities listed in Sections IV(A-F)
herein, the chain of custody of the device from Bard to the healthcare provider.

PLAINTIFF’S MEDICAL CONDITION:
A.

Have you been contacted by Plaintiff, any of his/her physicians, or anyone on
behalf of Plaintiff concerning Plaintiff? If yes, please provide, to extent
permitted by CMO 7 the following:: a) the name of the person(s) who
contacted you; b) the person(s) who were contacted including their name,
address and telephone number; and c) produce or identify any and all
documents which reflect any communication between any person and you
concerning Plaintiff.

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VI.

DOCUMENTS

Please ensure that the production of documentation includes specific reference to the question
to which the documentation is provided in response. Documentation is defined to include all
forms of documents, including, but not limited to, paper, email, video, audio, spreadsheets, or
otherwise.
A.

Identify and attach complete documentation of all information set forth in I
through IV above; except, you may identify but not serve copies of medical
records that were provided to Defendants by Plaintiffs’ counsel.

B.

Aside from any privileged materials, identify and attach all records, documents,
and information that refer or relate to the Plaintiff in Defendants’ possession or
control, to the extent not identified and attached in response to a prior question.

C.

Produce a true and complete copy of the Device History Record for the
Plaintiffs lot number(s).

D.

Produce a true and complete copy of the complaint file relating to the Plaintiff.

____________________________________
[Bard Defendant Name]
____________________________________
[Title]

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IN THE UNITED STATES DISTRICT COURT

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FOR THE DISTRICT OF ARIZONA

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IN RE: Bard IVC Filters Products Liability
Litigation,

No. MDL 15-02641-DGC
SECOND AMENDED CASE
MANAGEMENT ORDER NO. 4

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(Master Complaint, Master
Responsive Pleading, Use of Short
Form Complaint, Waiver of Service
for Bard Defendants, and Answer and
General Denial in Cases Subsequently
Transferred to MDL 2641)

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The parties previously submitted a Master Long Form Complaint and Jury Demand

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(previously docketed as Doc. 303-1) and a Master Responsive Pleading (previously

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docketed as Doc. 303-3). The Court has reviewed these proposed pleadings, finds them

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sufficient, and directs the Clerk to file them as separate documents in the Court's docket.1

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The parties have also submitted a proposed Second Amended Short Form Complaint, a

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copy of which is attached to this order. The Court also finds this proposed pleading to be

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sufficient.

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IT IS ORDERED:

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All allegations pled in the Master Complaint and all responses pled in the Master

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Responsive Pleading are deemed pled in any previously filed Complaint and Responsive

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Pleading in this MDL proceeding, except as expressly noted below. They are also deemed

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pled in any Short Form Complaint (attached to CMO No. 4, Doc. 363) or Second

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1

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The reference to “Federal Rule of Evidence 8” on the first page of the Master
Complaint shall be deemed to be a reference to Federal Rule of Civil Procedure 8.

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Amended Short Form Complaint (attached to this Order) and Entry of Appearance filed
after the entry of this order, except that the Master Complaint applies only against the
Defendant or Defendants identified in such future-filed Short Form or Second Amended
Short Form Complaints.
The following cases will not be governed by the Master Complaint and Master
Responsive Pleading, but will continue to be governed by the complaints (including any
amended complaints) and answers filed in the various transferor courts prior to transfer:

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Plaintiff

Original Jurisdiction

1.

Cason, Pamela

GA – N.D. Ga.
1:12-cv-1288

2.

Coker, Jennifer

GA – N.D. Ga.
1:13-cv-515

3.

Ebert, Melissa

PA – E.D. Pa.
5:12-cv-1253

4.

Fox, Susan

TX – N.D. Tex.
3:14-cv-133

5.

Henley, Angela

WI – E.D. Wis.
2:14-cv-59

6.

Keen, Harry

PA – E.D. Pa.
5:13-cv-5361

7.

Ocasio, Denise

FL – M.D. Fla.
8:13-cv-1962

8.

Rivera (McClarty), Vicki

MI – E.D. Mich.
4:14-cv-13627

9.

Smith, Erin

TX – E.D. Tex.
1:13-cv-633

10. Tillman, Lessie

FL – M.D. Fla.
3:13-cv-222

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On or after December 28, 2015, any plaintiff whose case would be subject to
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transfer to MDL 2641 may file his or her case directly in this Court by using the Short
Form Complaint (Doc. 363). After April 20, 2016, Plaintiffs may use the use the Second
Amended Short Form Complaint attached to this Order. If such a case is filed in this
Court without the use of the Second Amended Short Form Complaint, Plaintiffs’ Co-Lead
Counsel shall promptly advise the filing party to file an amended complaint using the
Second Amended Short Form Complaint. If the filing party fails to do so, Plaintiffs’ CoLead Counsel shall promptly notify the Court.
Defendants are not required to file answers to Short Form, Amended Short Form,
or Second Amended Short Form Complaints. An Entry of Appearance shall constitute a
denial of all allegations in the Short Form, Amended Short Form, or Second Amended
Short Form Complaints except as herein provided, and an assertion of all defenses
included in the Master Responsive Pleading.

By filing an Entry of Appearance in

response to a Short Form, Amended Short Form, or Second Amended Short Form
Complaints, in lieu of an answer, Defendants do not waive any defenses, including
jurisdictional and service defenses.
Civil actions in this MDL were transferred to this Court by the Judicial Panel on
Multidistrict Litigation for coordinated or consolidated pretrial proceedings pursuant to 28
U.S.C. § 1407. Upon completion of the pretrial proceedings related to a civil action as
determined by this Court, the case shall be transferred pursuant to 28 U.S.C. § 1404(a) or
§ 1406(a) to the District Court identified in the Short Form, Amended Short Form, or
Second Amended Short Form Complaints, provided the parties choose not to waive
Lexecon, Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998). The fact
that a case was filed directly in this District and MDL proceeding shall not constitute a
determination by this Court that jurisdiction or venue are proper in this District, and shall
not result in this Court being deemed the “transferor court” for purposes of this MDL. In
addition, filing a Short Form, Amended Short Form, or Second Amended Short Form
Complaint in this District shall have no impact on the conflict of law rules to be applied to

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the case. Instead, the law of the jurisdiction where the case is ultimately transferred will
govern any conflict of law. Prior to transfer, Defendants may object to the district
specified in the Short Form, Amended Short Form, or Second Amended Short Form
Complaint, based on venue or jurisdiction (including a lack of personal jurisdiction based
on Daimler AG v. Bauman, 134 S. Ct. 746 (2014)), and propose an alternative jurisdiction
for the Court’s consideration.
Subject to the conditions set forth in this order, Defendant C.R. Bard, Inc. and Bard
Peripheral Vascular, Inc. (collectively “Bard”) waive service of process in cases filed in
this Court using the Short Form, Amended Short Form, or Second Amended Short Form
Complaint and in which they are named as defendants and one or more IVC filter
products either manufactured or distributed by Bard is alleged to be at issue. For such
cases, Plaintiffs shall send a Short Form, Amended Short Form, or Second Amended
Short Form Complaint and a request for waiver of service pursuant to the provisions of
Fed. R. Civ. P. 4 to Richard B. North, Jr. by email to [e-mail];
[e-mail]; and [e-mail]. Counsel for
Bard shall return the signed waiver requests to the Court within the time permitted by Fed.
R. Civ. P. 4. Plaintiffs submitting a request for waiver shall not seek to hold Bard in
default for failure to timely answer or otherwise respond to a complaint in which service
has been accomplished pursuant to the terms of this order without first giving Bard written
notice of the alleged default and ten business days in which to cure any alleged default.
Prior to a Plaintiff’s attorney filing a Short Form, Amended Short Form, or Second
Amended Short Form Complaint in this Court, that attorney must register for or already
have a District of Arizona CM/ECF log-in name and password. If the Plaintiff’s attorney
does not already have a District of Arizona CM/ECF log-in name and password, that
attorney must file the Short Form, Amended Short Form, or Second Amended Short Form
Complaint in paper form with the Clerk of Court and simultaneously file an Application
of Attorney for Admission to Practice Pro Hac Vice pursuant to LRCiv 83.1(b)(2)

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(including all necessary attachments and filing fee).
Additionally, with respect to cases which are originally filed in courts other than
this Court which are then subsequently transferred to MDL 2641 pursuant to 28 U.S.C. §
1407, Defendants’ may file an Answer and General Denial with Respect to Cases
Subsequently Transferred to MDL 2641, incorporating the defenses and denials set forth
in the Master Answer and generally denying the plaintiffs’ allegations. This short-form
answer shall serve as the responsive pleading. Defendants shall have 60 days from the
date any such case is opened in this Court to file any motion for failure to state a claim
upon which relief may be granted pursuant to Rule 12(b)(6) and 12(h)(2), and the
plaintiff(s) shall have 30 days to respond.
Dated this 20th day of April, 2016.

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