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In Re: Pradaxa (Dabigatran ) Etexilate Products

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF ILLINOIS


January 23, 2013

IN RE: PRADAXA (DABIGATRAN ) ETEXILATE PRODUCTS LIABILITY LITIGATION

This Document Relates to:

ALL CASES

DEFENDANT FACT SHEET FOR BIPI

For each case, Boehringer Ingelheim Pharmaceuticals, Inc. must complete this Defendant Fact Sheet ("DFS") and identify or provide documents and/or data relating to each plaintiff, responsive to the questions set forth below, to the best of Defendant‟s knowledge. In completing this DFS, you are under oath and must provide information that is true and correct to the best of your knowledge. You must supplement your responses if you learn that they are incomplete or incorrect in any material respect. You must also supplement your responses in the event that additional information is provided from the Plaintiff. The DFS shall be completed in accordance with the requirements and guidelines set forth in the applicable Case Management Order. In the event the DFS does not provide you with enough space for you to complete your responses or answers, please attach additional sheets if necessary. Please identify any documents that you are producing as responsive to a question or request by bates-stamp identifiers.

This DFS must be completed and served on all counsel representing a plaintiff in the action identified in Section I below. This must be answered and served in accordance with CMO 20.

As used herein, the terms "you," "your" or "yours" means the responding defendant.

As used herein, the phrase "provided" means sold, distributed, shipped, delivered or otherwise placed into the stream of commerce.

As used herein the phrase "Prescribing Health Care Provider" means each of Plaintiff‟s physicians or medical providers who prescribed or dispensed Pradaxa to Plaintiff.

I.Case Information

This DFS pertains to the following case:

Case caption: _____________________________________________________

Civil Action No.__________________________________________________

Name and Address of all persons who provided information responsive to the questions posed in this DFS:

A: ________________________________

(Name)

________________________________ (Address)

________________________________ (Phone Number)

________________________________ (Title within Defendant Company and Company employed by)

B: ________________________________

(Name)

________________________________ (Address)

________________________________ (Phone Number)

________________________________ (Title within Defendant Company and Company employed by)

II.Contacts With Prescribing Health Care Provider

In Section VII(A) of Plaintiff‟s Fact Sheet, (s)he identifies persons or entities who prescribed or provided samples of Pradaxa to the Plaintiff. For each Prescribing Health Care Provider identified, please state the following:

A. Dear Doctor Letters:

1. Please identify the "Dear Doctor" or "Dear HealthCare Provider" letter that you contend was actually sent to the Plaintiff‟s Prescribing Health Care Provider concerning Pradaxa. _____________________________________________

_____________________________________________

_____________________________________________

NOTE: Please attach hereto a copy of each letter allegedly sent to Plaintiff's Prescribing Health Care Provider.

2. For each "Dear Doctor" or "Dear Healthcare Provider" letter that you contend was actually sent to Plaintiff‟s Prescribing Health Care Provider, please state the date that each "Dear Doctor" or "Dear HealthCare Provider" letter was actually sent to Plaintiff‟s Prescribing Health Care Provider and the person to whom each letter was sent.

_____________________________________________

_____________________________________________

_____________________________________________

_____________________________________________

3. For each "Dear Doctor" or "Dear HealthCare Provider" letter identified that you contend was actually sent to Plaintiff‟s Prescribing Health Care Provider, please identify any and all lists or databases which you contend demonstrate that these letters were actually sent, and please provide a relevant copy of same that identifies that the letter was sent.

_____________________________________________

_____________________________________________

_____________________________________________

B. Professional Information Request Letters:

1. Please identify any responses to any "Professional Information Request" letter that you contend was actually sent to the Plaintiff‟s Prescribing Health Care Provider concerning Pradaxa. _____________________________________________

_____________________________________________

_____________________________________________ NOTE: Please attach hereto a copy of the letter addressed to Plaintiff's Prescribing Health Care Provider that you maintain was sent.

2. For each response to any "Professional Information Request" letter that you contend was actually sent to Plaintiff‟s Prescribing Health Care Provider, please state the date that each "Professional Information Request" letter was actually sent to Plaintiff‟s Prescribing Health Care Provider and the person to whom each letter was sent.

_____________________________________________

_____________________________________________

_____________________________________________

3. For each "Professional Information Request" letter identified that you contend was actually sent to Plaintiff‟s Prescribing Health Care Provider, please identify any and all lists or databases which you contend demonstrate that these letters were actually sent.

_____________________________________________

_____________________________________________

C. Other Contacts

1. In Section VII(A) of Plaintiff‟s Fact Sheet, Plaintiff identified

Plaintiff‟s Prescribing Health Care Provider(s). Please identify all known contacts between the Prescribing Health Care Provider and Defendant‟s Sales Representatives / Sales and Marketing Organization / Employees, and please produce the following information:

Plaintiff's Prescribing Health Care Provider Identity and last known address of Defendant's Sales Representative / Employee / "detail persons" who contacted Plaintiff's Prescribing Health Care Provider about Pradaxa The current relationship (e.g., employed, agent, independent contractor, co-promotional agreement(s)), if any, between Defendant and the Sales Representative or detail person All dates of Contact*fn1

2. For each Prescribing Health Care Provider, please state whether Defendant or its representatives ever provided him/her (or anyone in their practice) Pradaxa samples. If the answer is "yes," please state:*fn2

(a). The number of sample packets provided and the dosages provided;

(b). The dates that they were shipped and/or provided; and

(c). The identity of the person or persons who provided the

Samples.

3. For each Sales Representative or detail person identified in Section II (C) above, please identify and produce any and all notes or other documents of that person or persons, including all personal notes, calendar entries, and computer entries, that reflect or refer to any communication with any of Plaintiff‟s Prescribing Health Care Providers.*fn3

___________________________________________________________

___________________________________________________________

___________________________________________________________

4. For each Sales Representative or detail person identified in Section II(C) above, please identify and produce any and all notes or other documents of that person or persons, including all personal notes, calendar entries, computer entries, backgrounder documents, marketing information, video and/or audio recordings and files, and/or tapes, email correspondence, text and/or audio messages, logs, database entry or other documents referred to in the sales call notes and other materials that is/was in their possession concerning Pradaxa or any other anticoagulant.*fn4

___________________________________________________________

___________________________________________________________

___________________________________________________________

5. For each Sales Representative or detail person identified in Section II(C) above, please identify and produce all informational or promotional information that the Sales Representative or detail person distributed to any of Plaintiff‟s Prescribing Health Care Providers. Included in this request is information related to Pradaxa (e.g., Patient information booklets, pamphlets or handouts) that is designed to be seen or possessed by the consumer that the Sales Representative left with the Health Care Provider or in the Health Care Provider‟s office.*fn5

___________________________________________________________

___________________________________________________________

___________________________________________________________

6. For each Sales Representative or detail person identified in Section II(C) above, please identify and produce copies, in native format (or a format that makes any electronic information functional in the manner it was when utilized by the sales representative), of all information related to Pradaxa that the Sales Representative showed to Plaintiff‟s Health Care Provider via use of a tablet, mobile app., laptop computer, or any other mobile electronic device.*fn6

___________________________________________________________

___________________________________________________________

___________________________________________________________

7. For each Sales Representative or detail person, including third parties, identified in Section II(C) above, please identify and produce all information relating to any form of patient discount or coupon for the purchase of Pradaxa at a reduced price (or for free), including any information relating to rebates, that the Sales Representative or detail person distributed to any of Plaintiff‟s Prescribing Health Care Providers. *fn7

___________________________________________________________

___________________________________________________________

___________________________________________________________

III. Consulting With Plaintiff's Prescribing Health Care Provider

A. In Section VII(A) of Plaintiff‟s Fact Sheet, Plaintiff identified his/her Prescribing Health Care Provider(s). If you have ever retained any of Plaintiff‟s Prescribing Health Care Providers as a "key opinion leader," a "thought leader," a member of a "speaker‟s bureau," a "clinical investigator", a "consultant", or in any other capacity on the subject of anticoagulants (including Pradaxa) and/or the treatment of Atrial Fibrillation and/or stroke prevention from January 2008 until present, please provide the following information:

From January 2008 to present, identity of Plaintiff's Prescribing Health Care Provider who was retained by Defendant Date(s) that he or she was paid All documents, if any, provided to health care provider by Defendant concerning Pradaxa

B. In Section VII(A) of Plaintiff‟s Fact Sheet, Plaintiff identified his/her Prescribing Health Care Provider(s). If you have ever retained any of Plaintiff‟s Prescribing Health Care Providers as a "key opinion leader," a "thought leader," a member of a "speaker‟s bureau," a "clinical investigator"," a "consultant", or in any other capacity on the subject of anticoagulants (including Pradaxa) and/or the treatment of Atrial Fibrillation and/or stroke prevention, from January 2002 until December 2007, please provide the following information:*fn8

From January 2002 to December 2007, identity of Plaintiff's Prescribing Health Care Provider who was retained by Defendant Amount of Payments and Date(s) that he or she was paid

C. For each of Plaintiff‟s Prescribing Health Care Providers identified in Section III(A) and III(B) above, please state whether you have paid any money, and the amount thereof, for expenses, honoraria and/or fees per calendar year, and either produce all 1099 or other IRS tax forms issued by Defendant to Plaintiff‟s Prescribing Health Care Providers evidencing such payments OR identify the reasons any money(ies) were paid and the reasons for each specific amount. ___________________________________________________________

___________________________________________________________

D. For each of Plaintiff‟s Prescribing Health Care Providers identified in Section III(A) and III(B) above, please provide all consulting agreements and contracts.

E. For each of Plaintiff‟s Prescribing Health Care Providers identified in Section III(A) and III(B) above, Defendant shall do a reasonable search and then please state whether each physician identified attended any Defendant sponsored conferences or events("Programs"). If your answer is "yes," please state:

1. The identity of the Prescribing Health Care Providers: __________________________________________

2. The title, location and date of the Program attended: ______________________________________

3. The topic of the Program: ______________________________________

4. Please provide or identify the agenda/brochure for the Program ______________________________________

F. Have any of Plaintiff‟s Prescribing Health Care Provider sever contacted you to request information concerning Pradaxa, its indications, its effects, and/or its risks? Yes____ No____.

If Yes, please identify and attach any document which relates or refers to your communication with Plaintiff‟s Prescribing Health Care Providers.

IV. Plaintiff's Prescribing Health Care Provider's Prescribing Practices

In Section VII(A) of Plaintiff‟s Fact Sheet, Plaintiff identifies his/her Prescribing Health Care Providers. For each listed provider, please state and produce the following:

A. Do you have, or have you had, access to any database or information which purports to track any of Plaintiff‟s Prescribing Health Care Providers‟ prescribing practices with respect to Pradaxa or any other anticoagulant (including, but not limited to the product(s) prescribed, the number or prescriptions, the number of refills and the time frame when these products were prescribed or refilled). If your answer is "yes," please identify the database or document which captures that information and provide such information:

V. Plaintiff's Medical Condition

A. After reasonable search, has Defendant determined if it has been contacted by Plaintiff, any of his/her physicians, or anyone on behalf of Plaintiff concerning Plaintiff(other than counsel for Plaintiff)?

___________ ___________

Yes No

B. If you have been contacted by any person or entity concerning Plaintiff, please state the name of the person(s) who contacted you and the person(s) who were contacted stating their name, address and telephone number. _____________________________________________________

____________________________________________________

C. Please produce any and all documents which reflect any communication between any person and you, concerning Plaintiff.

D. Please produce a copy of any MedWatch form and/or Adverse Event Report, including any update thereto, which refers or relates to Plaintiff and his/her use of Pradaxa, including back-up documentation concerning Plaintiff and any evaluation you did concerning Plaintiff, excluding any MedWatch form and/or Adverse Event Report created only as a result of the filing of Plaintiff‟s lawsuit.

VI. Advertising

A. Did you advertise Pradaxa in the Media Market in which Plaintiff lived at the time that (s)he used Pradaxa?

___________ ___________

Yes No

B. Did you advertise Pradaxa in the Media Market in which Plaintiff's Prescribing Health care provided office was located at the time that Plaintiff was prescribed Pradaxa?

Yes No

VII. FACT WITNESSES

A. Please identify all persons you believe possess information concerning Plaintiff and/or any case-specific claims or case-specific defenses, other than plaintiff's than health care providers expert witnesses, and please state their name, address and his/her relationship to you (attach additional pages as necessary):

Name Address, City, State, Zip Relationship to you

B. If there are any individuals who witnessed the injury as it occurred, other than healthcare providers, who are not listed in the chart directly above, please identify them here by name, address and their relationship to you.

Name: Address: City: State: Zip: Relationship to Defendant(s):

VIII. Documents

A. To the extent you have not already done so, please produce a copy of all documents and things that fall into the categories listed below. These include documents in the possession of any of your present and former employees, including information provided to your attorneys:

1. Any non-privileged document which relates to or refers to Plaintiff, other than documents received or produced in discovery in this matter.

2. Subject to the limitations set forth in this fact sheet, any document sent to or received from any of Plaintiff‟s Prescribing Health Care Providers.

3. Any and all documents reflecting any actual communication(s) between you and Plaintiff's Prescribing HealthCare Providers.

4. Any documents reflecting any contracts or actual communications between you and any of Plaintiff‟s Prescribing Health Care Providers regarding Pradaxa.

5. Any and all Adverse Event Reports for Plaintiff and all back-up data, including but not limited to any and all correspondence to/from the FDA regarding said AER and/or said Plaintiff, consistent with the information requested in Section III.F, above.

6. Any document which purports to describe the prescribing practices of any of Plaintiff‟s Prescribing Health Care Providers, with the production of any such materials being subject to the express approval of the owner of such information to release the data without charge to Defendant, to the extent needed.

CERTIFICATION

Pursuant to 28 U.S.C § 1746, I declare under oath and do hereby swear and affirm that all of the information provided in this Defendant Fact Sheet is true and correct to the best of my knowledge, information and belief formed after due diligence and reasonable inquiry.

_____________________ _____________________ __________________ Signature Print Name Date


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