Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_16-md-02691/USCOURTS-cand-3_16-md-02691-33/pdf.json

Nature of Suit Code: 367
Nature of Suit: TORTS - Personal Injury - Health Care/Pharmaceutical Personal Injury/Product Liability
Cause of Action: 28:1332 Diversity-Personal Injury

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Case No. 16-md-02691-RS – Order Concerning Service of Defendant Fact Sheets 

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UNITED STATES DISTRICT COURT 

NORTHERN DISTRICT OF CALIFORNIA 

(SAN FRANCISCO DIVISION) 

IN RE: VIAGRA (SILDENAFIL 

CITRATE) AND CIALIS (TADALAFIL) 

PRODUCTS LIABILITY LITIGATION 

This Document Relates to: 

ALL ACTIONS 

Case No. 16-md-02691-RS 

MDL No. 2691

PRETRIAL ORDER NO. 17: 

DEFENDANT FACT SHEETS 

IT IS HEREBY ORDERED that: 

1. Scope of Order. This Order governs the completion and execution of Defendant

Fact Sheets (“DFS”) and the production of related documents by Defendants. This Order shall 

govern the cases: (1) transferred to this Court by the Judicial Panel on Multidistrict Litigation 

(“JPML”), pursuant to its Order(s) of April 7, 2016 and December 7, 2016; (2) transferred to 

this Court by the JPML pursuant to Rule 7.4 of the Rules of Procedure of that Panel; or (3) 

directly filed in this Court, transferred, or properly removed to this Court. This Order is binding 

on all parties and their counsel in all cases currently pending or subsequently made a part of 

these MDL Proceedings and shall govern each case in the proceedings. 

Nothing in the DFS shall be deemed to limit the scope of inquiry at depositions or the 

admissibility of evidence at trial. The scope of inquiry at depositions shall remain governed by 

Case 3:16-md-02691-RS Document 966 Filed 08/12/19 Page 1 of 14
Case No. 16-md-02691-RS – Order Concerning Service of Defendant Fact Sheets 

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the Federal Rules of Civil Procedure. The admissibility of information provided in responding 

to the DFS shall be governed by the Federal Rules and no objections are waived by virtue of 

any DFS response. 

2. Service of DFSs and Responsive Documents. With respect to each

Plaintiff in each case in which Pfizer Inc and/or Eli Lilly and Company have been named as a 

Defendant and served with the operative complaint, each such defendant named and served 

shall complete and serve upon Plaintiff a DFS, in the form attached as Exhibit 1 with 

Responsive Documents through MDL Centrality and in accordance with Pretrial Order No. 16 

(Document 820 filed on December 12, 2018). 

SO ORDERED. 

Dated: 8/12/19 ____________________________________ 

THE HONORABLE RICHARD SEEBORG 

UNITED STATES DISTRICT JUDGE 

Case 3:16-md-02691-RS Document 966 Filed 08/12/19 Page 2 of 14
EXHIBIT 1 

Case 3:16-md-02691-RS Document 966 Filed 08/12/19 Page 3 of 14
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IN THE UNITED STATES DISTRICT COURT 

FOR THE NORTHERN DISTRICT OF CALIFORNIA 

MDL No. 2691 

 In Re: Viagra (Sildenafil Citrate) and Cialis (Tadalafil) Products Liability Litigation 

______________________________________________________________________________ 

Defendant Fact Sheet 

For each filed case in which the specific Defendant(s), Pfizer Inc and/or Eli Lilly Company, 

is named, the Defendant(s) must complete this Defendant Fact Sheet (“DFS”) and identify (by 

document number) or provide documents and/or data responsive to the questions set forth below 

to the best of their knowledge and in good faith. Please identify any documents that you are 

producing as responsive to a question or request by document number. Within 120 days of the 

latest of (1) entry of this order, (2) receiving a Verified Plaintiff Fact Sheet (“PFS”); or (3) the 

deadline set forth in Amended Pretrial Order 15 (Document 918 filed on April 9, 2019), 

Defendants must complete and serve this DFS as set forth within this Pretrial Order and in Pretrial 

Order No. 16 (Document 820 filed on December 12, 2018). Any Defendant may request one 

extension of thirty (30) days to serve a completed DFS, which the Plaintiff(s) shall not 

unreasonably withhold. Such requests must be made in writing via email to Plaintiff’s counsel 

with a simultaneous copy to Plaintiff’s Fact Sheet designated Counsel before the expiration of the 

deadline. 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. 

Each Defendant’s DFS responses are made subject to the Protective Order entered in this 

litigation. Unless otherwise marked as Highly Confidential, all information disclosed in a DFS, 

the DFS itself, and all related documents or information produced pursuant to the DFS shall be 

deemed confidential and treated as “Confidential Information” as defined in the Protective Order. 

Additionally, some of the information produced may be redacted to protect the privacy rights of 

third parties. 

Case 3:16-md-02691-RS Document 966 Filed 08/12/19 Page 4 of 14
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Definitions 

YOU, YOUR or YOURS: As used herein, these terms mean the responding Defendant(s). 

DEFENDANT(S): As used herein, this term means Pfizer Inc and/or Eli Lilly and Company. 

VIAGRA®/REVATIO®: The two drugs are part of a class of drugs known as PDE5 inhibitors. 

The active ingredient in both is sildenafil and the manufacturer is Pfizer Inc 

CIALIS®/ADCIRCA®: These two drugs are part of a class of drugs known as PDE5 inhibitors. 

The active ingredient in both is tadalafil and the manufacturer is Eli Lilly and Company. 

CALL NOTES: Entries in Defendant’s call notes database(s) reflecting contacts with 

Prescribing Healthcare Providers related to Viagra®/Revatio® (as to Pfizer Inc’s DFS response) 

or Cialis®/Adcirca® (as to Eli Lilly and Company’s DFS response). 

KEY OPINION LEADER or THOUGHT LEADER: Physicians, often academic researchers, 

who are believed by Defendant(s) 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 Defendant(s) to, amongst other things, consult, give 

lectures, respond to media inquiries, conduct clinical trials, author or contribute to articles or 

abstracts, sit on advisory boards and make presentations on their behalf at regulatory meetings or 

hearings. 

RELEVANT TIME PERIOD: From five (5) years prior to the date on which Plaintiff was first 

prescribed Viagra®/Revatio® (as to Pfizer Inc’s DFS response) or Cialis®/Adcirca® (as to Eli 

Lilly and Company’s DFS response) as set forth in PFS Section III.A.7 through the later of (1) 

date of the last prescription of Viagra®/Revatio® (as to Pfizer Inc’s DFS response) or 

Cialis®/Adcirca® (as to Eli Lilly and Company’s DFS response) to Plaintiff, as set forth in PFS 

Section III.A.7, or (2) the date of Plaintiff’s Alleged Injury as set forth in PFS Section IV.A. 

REMUNERATION: Anything of monetary value greater than $50 in cash or in kind, but 

specifically excludes samples, discounts and rebates, in-kind items for charity care, educational 

materials intended for patients, medical devices loaned for clinical trials, and warranty services. 

SALES REPRESENTATIVE: Any person presently or formerly engaged or employed by 

Defendant(s) whose job duties include calling on physicians or other healthcare professionals, 

healthcare facilities, hospitals, and/or physician practice groups for the purpose of promoting 

Viagra®/Revatio® (as to Pfizer Inc’s DFS response) or Cialis®/Adcirca® (as to Eli Lilly and 

Company’s DFS response) to physicians or other healthcare providers. 

Case 3:16-md-02691-RS Document 966 Filed 08/12/19 Page 5 of 14
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PRESCRIBING HEALTHCARE PROVIDER: Any provider of healthcare, including but not 

necessarily limited to physicians, general practitioners, medical specialists, medical doctors, 

surgeons, plastic surgeons, nurses, nurse practitioners, physician assistants, rehabilitation 

specialists, physical therapists, occupational therapists, counselors and pharmacists, identified in 

the PFS Section III.A.7 as a Prescribing Healthcare Provider who prescribed Viagra®/Revatio® 

and/or Cialis®/Adcirca® to the Plaintiff. 

TREATING HEALTHCARE PROVIDER: Any provider of healthcare, including but not 

necessarily limited to physicians, general practitioners, medical specialists, medical doctors, 

surgeons, plastic surgeons, nurses, nurse practitioners, physician assistants, rehabilitation 

specialists, physical therapists, occupational therapists, counselors and pharmacists, identified in 

the PFS Section IV and/or PFS Section V.A. 

VERIFIED PLAINTIFF FACT SHEET: A Plaintiff Fact Sheet is deemed verified if it (1) is 

served in the manner set forth by Pretrial Orders 15 (Document 804 filed on November 30, 2018 

as amended by Document 918 filed on April 9, 2019) and 16 (Document 820 filed on December 

12, 2018); (2) is substantially complete, (that is, a reasonable effort has been made to answer each 

question in good faith, even if Plaintiff can only answer the question with responses such as 

“cannot recall,” “not applicable,” “I don’t know,” or “unknown”); and (3) includes the required 

completed verification, authorizations, and documents identified in Section VIII of the Plaintiff 

Fact Sheet. 

Case 3:16-md-02691-RS Document 966 Filed 08/12/19 Page 6 of 14
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I. CASE INFORMATION 

This DFS pertains to the following case: 

Case Caption: ________________________________________________________ 

MDL Case Number: ___________________________________________________ 

DFS Completion Date: ________________________________________ 

DFS Supplement Date: ________________________________________ 

II. CONTACTS WITH HEALTHCARE PROVIDERS 

A. Healthcare Provider Information Request Letters. For each Prescribing 

Healthcare Provider and Treating Healthcare Provider identified in the PFS, please 

provide the following information.

If any of Plaintiff’s Prescribing Healthcare Provider(s) and/or Treating Healthcare 

Provider(s) has (have) initiated a request for information regarding 

Viagra®/Revatio® and/or Cialis®/Adcirca® that is captured in a database, please 

identify or provide as an attachment to this DFS the (a) name and address of the 

requestor (i.e., the physician who contacted Defendant(s)); (b) the date of the 

inquiry, (c) the format of the inquiry, if available (d) the date of the response, if 

any, the person who responded including their title and department, if available in 

the relevant database(s), and (e) the address to which the response was sent (i.e., 

fax number, mailing address); and produce the document(s) reflecting that written 

inquiry and any document sent in response, if available: 

Original 

PIR or 

Request 

Document 

Date 

Date 

Response 

Sent 

Identity of 

Individual who 

Made Request/ 

Response Recipient 

(Name & Address) 

Identity of Sender 

(Name & Address, 

Title and 

Department, if 

available) 

Bates Number of 

Supporting 

Documentation 

 

Case 3:16-md-02691-RS Document 966 Filed 08/12/19 Page 7 of 14
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B. Other Contacts.

1. Call Notes.

(a) Identify by name any of the Defendants’ Sales Representatives who called on

the Prescribing Healthcare Provider(s) in any way related to Viagra®/Revatio®

and/or Cialis®/Adcirca® during the Relevant Time Period and please provide

dates of each contact (or produce report listing the same).

To the extent that the Relevant Time Period includes dates prior to January 1,

2005: (1) If Plaintiff’s claims are covered by Sections A and B of Amended

Pretrial Order 15 (Document 918), Defendant Lilly shall respond in supplement

to this query with respect to those dates on or before December 28, 2019. (2)

If Plaintiff’s claims are covered by Section C of Amended Pretrial Order 15

(Document 918), Defendant Lilly shall respond in supplement to this query as

follows:

 Verified Plaintiff Fact Sheets received between January 1 through April

30 of each calendar year shall be responded to by Defendant Lilly by

the last day of August of that calendar year.

 Verified Plaintiff Fact Sheets received between May 1 through August

31 of each calendar year shall be responded to by Defendant Lilly by

the last day of December of that calendar year.

 Verified Plaintiff Fact Sheets received between August 1 through

December 31 of each calendar year shall be responded to by Defendant

Lilly by the last day of April of that calendar year.

Name of Prescribing 

Healthcare Provider 

Contacted 

Name of Sales 

Representative 

Date(s) of each Contact with 

Prescribing Healthcare 

Provider 

(b) For each Sales Representative identified in this DFS, please produce for the

Relevant Time Period Call Notes, if any, for each contact between the

Prescribing Healthcare Provider and the Sales Representative related to and/or

regarding Viagra®/Revatio® and/or Cialis®/Adcirca® in a format that

Plaintiffs’ Counsel can search and review electronically.

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To the extent that the Relevant Time Period includes dates prior to January 1, 

2005: (1) If Plaintiff’s claims are covered by Sections A and B of Amended 

Pretrial Order 15 (Document 918), Defendant Lilly shall respond in supplement 

to this query with respect to those dates on or before December 28, 2019. (2) 

If Plaintiff’s claims are covered by Section C of Amended Pretrial Order 15, 

Defendant Lilly shall respond in supplement to this query as follows: 

 Verified Plaintiff Fact Sheets received between January 1 through April

30 of each calendar year shall be responded to by Defendant Lilly by

the last day of August of that calendar year.

 Verified Plaintiff Fact Sheets received between May 1 through August

31 of each calendar year shall be responded to by Defendant Lilly by

the last day of December of that calendar year.

 Verified Plaintiff Fact Sheets received between August 1 through

December 31 of each calendar year shall be responded to by Defendant

Lilly by the last day of April of that calendar year.

2. Dear Healthcare Provider Letters. Please produce through MDL Centrality any Dear

Doctor, Dear Healthcare Provider, Dear Colleague or similar type of letter or document

sent by Defendants regarding Viagra®/Revatio® and/or Cialis®/Adcirca®.

3. Samples. If Plaintiff indicated in the PFS receipt of samples of Viagra®/Revatio® and/or

Cialis®/Adcirca®, have Defendants or their Sales Representatives provided any

Viagra®/Revatio® (if receipt of Viagra®/Revatio® samples was indicated in the PFS)

and/or Cialis®/Adcirca® samples (if receipt of Cialis®/Adcirca® samples was indicated

in the PFS) to Plaintiff’s Prescribing Healthcare Provider(s) identified in the PFS during

the Relevant Time Period?

Yes No Not Applicable

If the above answer is “Yes,” please identify below or produce as an attachment a report 

containing, for the Relevant Time Period: 

a. The Prescribing Healthcare Provider(s) identified in the PFS that received the

samples.

b. The date(s) on which such samples were provided.

c. The product name, amount and dosage of each sample.

d. The name of the Sales Representative(s) or Department who provided the

samples.

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To the extent that the Relevant Time Period includes dates prior to January 1, 2005: (1) If 

Plaintiff’s claims are covered by Sections A and B of Amended Pretrial Order 15 

(Document 918), Defendant Lilly shall respond in supplement to this query with respect to 

those dates on or before December 28, 2019. (2) If Plaintiff’s claims are covered by Section 

C of Amended Pretrial Order 15 (Document 918), Defendant Lilly shall respond in 

supplement to this query as follows: 

 Verified Plaintiff Fact Sheets received between January 1 through April 30 of each 

calendar year shall be responded to by Defendant Lilly by the last day of August of 

that calendar year. 

 Verified Plaintiff Fact Sheets received between May 1 through August 31 of each 

calendar year shall be responded to by Defendant Lilly by the last day of December 

of that calendar year. 

 Verified Plaintiff Fact Sheets received between August 1 through December 31 of 

each calendar year shall be responded to by Defendant Lilly by the last day of April 

of that calendar year. 

Prescribing Healthcare 

Provider 

Name of Sales 

Representative or 

Department 

Date Shipped 

and/or 

Provided 

Product Name, 

Amount and Dosage 

 

III. OTHER CONTACT AND CONSULTING WITH PLAINTIFF’S PRESCRIBING 

HEALTHCARE PROVIDER(S) 

Consulting and Professional Relationships: If any of Plaintiff’s Prescribing Healthcare 

Providers identified in the PFS have been provided with Remuneration by Defendant(s) as 

a Key Opinion Leader, Thought Leader, member of a speaker’s bureau, clinical investigator 

or consultant, or speaker at a conference or Continuing Medical Education event, please 

identify, for the Relevant Time Period, the date(s) that each Prescribing Healthcare Provider 

was retained and/or remunerated; the nature of the affiliation; and the amount of any 

Remuneration and/or reimbursement for expenses. 

Prescribing 

Health Care 

Provider 

Date(s) 

Retained 

and/or 

Remunerated 

Nature of 

Affiliation 

Amount of 

Remuneration 

and/or 

Reimbursement 

Reason for 

Remuneration 

 

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IV. PLAINTIFF’S PRESCRIBING HEALTHCARE PROVIDERS

For each Prescribing Healthcare Provider identified in the PFS, please state and produce

the following:

A. Do you have documents or other information reflecting prescriber-level data (e.g. IMS

data) in a database searchable by prescriber name that tracks or purports to track the

prescribing practices of Plaintiff’s Prescribing Healthcare Provider(s) identified in the

PFS with respect to Viagra®/Revatio® and/or Cialis®/Adcirca®?

Yes No 

B. If the answer is “Yes,” please provide a report containing, or identify below and produce,

all such data for each of Plaintiff’s Prescribing Healthcare Provider(s) identified in the

PFS regarding Viagra®/Revatio® or Cialis®/Adcirca® for the Relevant Time Period,

subject to the agreement with the data vendor to release the data, which approval and/or

agreement Defendants will request, and subject to the execution of IQVIA’s (or

applicable vendor’s) consent approval letter by Pfizer Inc and Lilly.

Prescribing 

Healthcare 

Provider 

Tracking Information 

- Database, Document

or Information 

Description 

If Database 

Utilized, please 

identify name of 

tracking 

database 

Document 

Number(s) 

V. PLAINTIFF’S MEDICAL CONDITION

A. Is there a record or records in Defendants’ Medical Information (as to Pfizer Inc) or

The Lilly Answer Center (as to Lilly) databases documenting contact between

Defendant and Plaintiff or anyone acting on Plaintiff’s behalf (other than Plaintiff’s

counsel) concerning Plaintiff and Viagra®/Revatio® or Cialis®/Adcirca, prior to the

date Plaintiff filed his or her lawsuit?

Yes  No 

If the answer is “Yes,” please identify below, or attach a report containing, the 

person(s) or entity who contacted Defendant, the person who communicated a 

response, if any, and the dates of the contact(s) and response(s), and identify and 

produce all documents from such databases created before the filing of this lawsuit 

which reflect such communications between any person and Defendant concerning 

Plaintiff. 

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Name and 

Address of 

Person Who 

Initiated 

Contact 

Date of 

Contact 

Name and 

Address of 

Person 

Communicating 

Response 

Date of 

Response 

Document Numbers of Supporting 

Documentation Related to 

Communications 

B. Is there a record or records in Defendant’s adverse event database, dated prior to the

filing of this lawsuit, regarding an adverse event report pertaining to Plaintiff and the

use of Viagra®/Revatio® and/or Cialis®/Adcirca®?

Yes  No 

If the answer is “Yes,” please produce a copy of such MedWatch form. 

MedWatch forms shall be redacted as necessary per federal law. 

VI. FUTURE DOCUMENT PRODUCTION 

To the extent that Plaintiff’s case is selected for case-specific discovery involving additional, casespecific document production by Defendant, Defendant will produce without further need for 

document request by Plaintiff: 

i. Any non-privileged documents that (1) are in collected case-specific

custodial material, that is, they are in the custody of an agreed-upon casespecific document custodian and contain search terms to be agreed upon;

(2) were created prior to the filing of Plaintiff’s lawsuit; and (3) relate to or

refer to Plaintiff; and

ii. Any non-privileged documents that (1) are in collected case-specific

custodial material, that is, they are in the custody of an agreed-upon casespecific document custodian and contain search terms to be agreed upon;

(2) were created prior to the filing of Plaintiff’s lawsuit; and (3) track or

purport to track the prescribing practices of Plaintiff’s Prescribing

Healthcare Provider(s) identified in the PFS with respect to

Viagra®/Revatio® and/or Cialis®/Adcirca®.

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CERTIFICATION 

I, _____________, am authorized to provide verification of discovery responses on behalf 

of Defendant _________________. Some of the information and facts within this Defendant Fact 

Sheet is not within my personal knowledge. Such information has been assembled by authorized 

employees and/or counsel of ________________, upon whose advice and information I relied and 

who have informed me that the information and facts are true and accurate. Therefore, I declare 

under penalty of perjury that the information as to the foregoing Defendant provided in this 

Defendant Fact Sheet is true and correct to the best of my knowledge upon information and belief. 

Further, I acknowledge that I have an obligation to supplement the above responses, in 

accordance with the Federal Rules of Civil Procedure, if I learn that they are in some respect 

incomplete or incorrect. 

___________________________________________ ____________________

Signature Date

____________________________________________ 

Print Name 

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CERTIFICATE OF SERVICE

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CERTIFICATE OF SERVICE

I hereby certify that a copy of the foregoing was electronically filed through the Court’s 

CM/ECF system on June 24, 2019, which shall send notification of such filing to all CM/ECF 

participants. 

/s/Rachel Abrams 

Rachel Abrams

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