ANAPOL,
SCHWARTZ, WEISS, COHAN LEVIN
FISHBEIN SEDRAN
FELDMAN
& SMALLEY, P.C. AND
BERMAN
BY:
SOL H. WEISS, ESQUIRE BY:
ARNOLD LEVIN, ESQUIRE
I.D.
NO. 15925 I.D.
NO. 02280
1900
DELANCEY PLACE 510
WALNUT STREET SUITE 500
PHILADELPHIA,
PA 19103-6690 PHILADELPHIA, PA 19106
(215)
735-1130; FAX (215) 735-2024 (215)
592-1500
GREITZER
& LOCKS
BY:
LEE BALEFSKY, ESQUIRE
I.D.
NO. 25321
1500
WALNUT STREET, 20TH FLOOR
PHILADELPHIA,
PA 19103
(215)
893-0100
PLAINTIFFS’ LIAISON COUNSEL
_____________________________________________________
IN THE COURT OF COMMON PLEAS
PHILADELPHIA COUNTY, CIVIL TRIAL DIVISION
IN RE: BAYCOL LITIGATION : NOVEMBER TERM, 2001
IN THE PHILADELPHIA COURT :
OF COMMON PLEAS : MASTER DOCKET NO. 0001
_____________________________________________________
PLAINTIFFS’
REQUEST FOR PRODUCTION OF DOCUMENTS
AND OTHER
THINGS (MASTER SET) TO DEFENDANTS PFIZER, WARNER-LAMBERT & PARKE DAVIS
Pursuant to Rule 4009.1 et seq. of the Pennsylvania Rules of Civil Procedure, plaintiffs request that the defendants produce each of the documents and other things, including writings, drawings, graphs, charts, photographs, electronically created data, and other compilations of data from which information can be obtained, set forth in the attached Schedule of Documents and Other Things. The documents and other things shall be produced for inspection and copying at the office of Levin Fishbein Sedran & Berman, in Philadelphia, PA within thirty (30) days after service of these requests, or at such other time as ordered by the Court.
INSTRUCTIONS
1. Each Request refers to documents in the custody, control, and possession of Defendant, or known to Defendant, as well as in the custody, control, and possession of or known to Defendant’s counsel, representatives, agents, servants, investigators, and consultants, and unless otherwise privileged, their counsel, employees, representatives, agents, servants, investigators and consultants.
2. If any requested document is unavailable, because it was lost or destroyed by Defendant or its agents, or for any other reason, the defendant shall, after fully identifying the document, state:
(a) When and where it was destroyed, or why it is otherwise unavailable;
(b) The name and address of each person who destroyed it;
(c) The name and address of each person who directed, approved, or knew of its destruction; and,
(d) The name and address of each person who has knowledge of such document.
3. If there is a claim of privilege with respect to any document requested, the defendant shall:
(a) Identify in its Answer each document for which a privilege is claimed;
(b) A description of the document;
(c) The date of the document;
(d) The names of the addressees and addressors;
(e) The identity and address of every person to whom a copy was given or communicated;
(f) The general subject matter of the document;
(g) A statement of the facts constituting the basis for any claim of privilege; and,
(h) The specific basis on which the privilege is claimed.
4. If you cannot produce documents for any other reason, respond to the extent possible, stating your reasons for your inability to respond in full.
5. These Requests shall be deemed continuing, to the full extent required or permitted under the Pennsylvania Rules of Civil Procedure, so as to require supplementary production when Defendant obtains access, custody, possession or control of any document not previously produced, which is responsive to any of these Requests.
6. The headings used herein are for guidance and clarity only, and should not be deemed to restrict the scope of any request.
7. Unless otherwise set forth the relevant time is from the beginning of time until the present.
DEFINITIONS
1. “Defendant”, “You” and “Your” refers to every corporation, person, or entity upon which plaintiffs serve these discovery requests, (including, but not limited to, every manufacturer, marketer, distributor or developer of Gemfibrozil and/or Lopid, as defined below). “Defendant”, “You” and “Your” includes every predecessor in interest of each such company, each of its successors in interest, and every company affiliated with each such company by common ownership or control.
2. The term, “Lopid,” refers to Gemfibrozil and/or Lopid.
3. AFDA@ means the United States Food & Drug Administration, any committee, subcommittee or advisory committee thereto, and any person, employee or agent acting as a representative thereof.
4. AForeign Government Regulatory Authority@ means any agency, committee, subcommittee or advisory committee of any government other than the United States of America, which bears responsibility or exercises authority over the manufacture, distribution, labeling, sale and/or marketing of pharmaceutical products or human health in any jurisdiction, and any employee or agent acting as a representative thereof.
5. As used throughout this Request for Production of Documents, the term Adocument@ or any similar term is used in its broadest possible sense. The term “document” shall include, but not be limited to, any original, reproduction or copy, and non-identical copy (i.e., copy with marginal notes, deletions, etc.) of any kind, and shall include written, printed, typed, electronically created or stored, or other graphic matter of any type, documentary material, or drafts thereof, including, but not limited to, any correspondence, memoranda, interoffice or intra-office communications, notes, diaries, journals, calendars, contract documents, publications, calculations, estimates, vouchers, minutes of meetings, invoices, reports, studies, computer tapes, computer disks, computer cards, computer files, e-mails, photographs, negatives, slides, dictation belts, voice tapes, telegrams, notes of telephone conversations and notes of any oral communications.
6. The headings that precede the document requests are informational and are not to be deemed exclusive or limiting. Rather, Defendant shall reply in full to the specific substance of each and every Request.
SCHEDULE OF DOCUMENTS & OTHER THINGS
TO BE PRODUCED
A. CORPORATE DATA
1. Every general liability, comprehensive general liability, advertising liability or product liability insurance policy (and any other insurance policy which may provide coverage for any personal injury) that you purchased or on which you are a named insured (including policies purchased by related corporate entities), including all excess layers, for the years 1992 to the present, inclusive.
2. Every chart or schedule of layers of insurance or self-insured retention for each of the respective years of coverage.
3. Every document relating or referring to any disputes or reservations of rights as to coverage for any and all claims arising out of the use or concerning Lopid.
4. Every document relating to, referring to or containing any indemnity agreements, agreements to assume liability, agreements to assume the defense, and joint defense agreements, made by Defendant, insurers for Defendant, or any other entities that may be financially affected by any of the claims asserted in this litigation.
5 Every document relating to, referring to or containing all licenses, contracts, royalty arrangements or other agreements made by Defendant and any other entity related to the transfer, in whole or in part, of responsibility for the sale, marketing, manufacturing, testing or compliance with FDA regulations for Lopid.
6. Every document reflecting your year-end financial statements for the years 1992 to the present.
7. All Quarterly reports for the current fiscal year, including, but not limited to, 10-Ks and 10-Qs for publicly traded companies.
8 Every filing with the National Association of Securities Dealers for the years 1992 through 2001.
9. Every Annual Report for the years 1992 through 2001.
10. Every document that relates to, refers to or contains any and all patents and patent applications for Lopid.
11. All patent litigation or dispute documents relating to Lopid,
as well as any patent applications filed by the Defendant in the United States
or any other country for components/metabolites of Lopid.
12. Every document that relates to, refers to or contains any and all licensing agreements concerning any product or technology contained in the patents referred to in the preceding Request.
13. Every document that relates to, refers to or contains any and all proposed or contemplated licensing agreements concerning Lopid, and all documents provided to proposed or contemplated licensees.
14. Every document that relates to, or refers to infringement or alleged infringement of any of the aforesaid patents.
15. Each and every one of the defendant=s document retention or document destruction policies in effect for the years 1992 through 2001, and all documents that discuss or refer thereto.
16. Each of the defendant’s Articles of Incorporation, By-Laws, and any amendments thereto, that were in effect, approved, or amended, for the years 1992 through 2001.
17. For each year the defendant designed, tested, manufactured, sold, marketed, licensed, or distributed Lopid, please provide every document relating to, referring to, or containing:
a. General corporate organizational charts.
b. Sales department organizational charts.
c. Marketing department organizational charts.
d. Research and development department organizational charts.
e. The names of all corporate officers for the last five years.
f. The names of all members of the Board of Directors for the last five years.
g. The names of all persons or entities which owned 5% or more of Defendant’s common stock for the last five years; and
h. Annual organization charts for any entity that owned more than 5% of Defendant’s common stock during the last ten years.
i. Regulatory affairs organizational charts for the last ten years.
18. For any entity with which you are affiliated through common ownership and control, and which is involved in the manufacture, testing, marketing, licensing, sale or distribution of Lopid, every document that describes in any way the responsibilities that each such entity has concerning Lopid.
19. Every document relating to, referring to or containing any financial relationship and/or contract between Defendant and any physician, clinic, hospital or other healthcare provider involving medical care or treatment for the reduction of cholesterol, including, but not limited to, summaries of the annual gross sales of Lopid to any such persons or entities.
20. All indices, including, but not limited to, computer printouts, listing the name and case caption, plaintiff’s attorney’s name, address and fax and telephone numbers, and/or status of every lawsuit filed against the Defendant regarding Lopid, including cases that have been dismissed, settled, withdrawn or tried to verdict.
21. Every document relating to, referring to or containing the minutes of all Board of Directors meetings at which Lopid was referred to in any way.
22. Every document relating to, referring to, or containing notice of claims, claims projections, loss estimates or risk management related to Lopid.
23. Every document relating to, referring to or containing any correspondence, communications, contracts or other discussions of any kind between Defendant, its agents or any party acting on Defendant’s behalf, and any other Defendant concerning Lopid.
24. Every document relating to, referring to or containing any correspondence, communications, contracts or other discussions of any kind between Defendant, or any subsidiary or affiliate thereto, its agents or any party acting on Defendant’s behalf concerning Lopid.
25. Every document relating to, referring to or containing any codes of conduct or ethical standards promulgated, adopted or followed by Defendant between 1992 and 2001 with respect to the marketing or labeling of drug products.
26. Every document relating to, referring to or containing any codes of conduct or ethical standards with respect to the marketing or labeling of drug products that were promulgated or adopted by any trade organization of which defendant was a member between 1992 and 2001.
B. FDA AND GOVERNMENT REGULATORY DOCUMENTS
27. Every document relating to, referring to, or containing the complete and current New Drug Application(s) [ANDA@], and amendments or supplements thereto, submitted by or on behalf of Defendant concerning Lopid.
28. Every document relating to, referring to or containing any Investigational New Drug Application(s) [AIND@], and amendments or supplements thereto, submitted by or on behalf of Defendant concerning Lopid.
29. Every document relating to, referring to or containing all Abbreviated New Drug Application(s) [AANDA@], and amendments or supplements thereto, and Supplemental New Drug Application(s) [“SNDA”], and ammendments or supplements thereto, submitted by or on behalf of Defendant concerning Lopid.
30. Every document relating to, referring to or containing communications between Defendant, or any agent or consultant of Defendant, and the FDA regarding Lopid, including, but not limited to, all documents that relate or refer to the safety, efficacy, approval, recall or warnings regarding Lopid.
31. Every document concerning any FDA Advisory Panel meetings regarding Lopid, including, but not limited to:
a. All documents relating to, referring to, or containing any communications between Defendant (or any agent or consultant of Defendant), and the FDA or any Advisory Panel Member.
b. All documents relating or referring to any financial contributions or other items of value provided to Panel Members or their institutions/organizations.
c. All documents relating to, referring to or containing minutes of meetings, agendas, dossiers, submissions, test summaries, and/or internal memoranda regarding strategies and issues, Questions and Answers, scheduling, or any other documents concerning the Advisory Panel, submissions thereto, or the topic(s) discussed.
d. All documents, whether submitted or not, concerning the Defendant’s preparation for Advisory Panel meetings relating to Lopid.
32. Every document relating to, referring to or containing inspection reports that pertain in any way to Lopid.
33. Your complete files relating to all adverse reaction reports associated with the use of Lopid, alone and/or in combination with another statin.
34. All summaries (including, but not limited to, computerized data), analyses or interpretations of adverse reaction reports, associated with the use of Lopid alone and/or in combination with another statin.
35. All documents associated with the use of Lopid that discuss, relate to, or refer to adverse reaction reports, or any summaries, analyses or interpretations of adverse reaction reports.
36. All documents associated with the use of Lopid relating to, referring to adverse drug reactions, or alleged adverse drug reactions that occurred in any country other than the United States.
37. All documents associated with the use of Lopid relating to, referring to, or containing summaries, computerized data, analysis, or interpretation of adverse drug reaction or alleged adverse drug reaction reports.
38. All documents associated with the use of Lopid relating to, referring to or containing the submission of adverse drug reaction or alleged adverse drug reaction reports to any government regulatory authority, whether FDA or foreign.
39. All documents associated with the use of Lopid relating or referring to the failure to submit adverse drug reaction or alleged adverse drug reaction reports to any government regulatory authority, whether FDA or foreign.
40. Every document that relates to, refers to or contains any such incidents or reports of adverse drug reactions or alleged adverse drug reactions associated with the use of Lopid.
41. Any and all reports prepared by or for the Defendant, which
summarize adverse reactions caused by statins when used in combination with
Lopid, and/or adverse reactions caused by Lopid when used in combination with
statins.
42. Any and all internal reports prepared by or for the Defendant
which summarize adverse reactions caused by statins when used in combination
with Lopid, and/or adverse reactions caused by Lopid when used in combination
with statins.
43. Every document relating to, referring to or containing any communication with or submissions to the FDA or any foreign government regulatory authorities regarding regulation, approval, safety or testing of Lopid.
44. Every document relating to, referring to or containing any communication with or submissions to the FDA or any foreign government regulatory authority regarding adverse reactions caused by Lopid.
45. All documents, whether final copies or drafts, relating to, referring to or containing any communications between Defendant, including its agents and consultants, and any physician, pharmacist or other healthcare provider regarding Lopid, including, but not limited to, any Dear Doctor or Dear Pharmacist letters concerning Lopid.
46. All documents relating to, referring to, or containing any communications with the FDA or any foreign government regulatory authority regarding the content and/or approval of Lopid labeling and advertising.
47. Every document relating to, referring to or containing any information received by Defendant from any physician regarding, relating to or referring to Lopid.
48. Every document relating to, referring to or containing any discussions, negotiations or contracts to engage any third party to represent Defendant’s interests before the FDA or any foreign government regulatory authority, or any Committee or subcommittee thereof, concerning Lopid, including, but not limited to, retainer agreements or consultant agreements.
49. Every document relating to, referring to or containing any discussion or submission between Defendant and any state government regulatory agency or any state medical society concerning Lopid.
C. PRODUCT TESTING
50. Every document relating to, referring to or containing any pre-clinical studies or testing of Lopid, including, but not limited to, test protocols, data compilations, laboratory notebooks, summaries of results, drafts of reports, interim reports, final reports, published articles, financial remuneration, engagement of consultants/investigators, internal memoranda and submissions of data to the FDA or any Foreign Government Regulatory Authorities, including, but not limited to, tests for the following:
a. toxicity testing;
b. pharmacology testing;
c. drug metabolism testing;
d. absorption studies;
e. reproduction studies;
f. teratogenicity studies;
g. bioavailability studies; and,
h. all other animal and chemical studies;
51. Every document relating to, referring to or containing any clinical studies or testing regarding Lopid, including, but not limited to, names and addresses of each person or entity performing the studies or testing, test protocols, data compilations, laboratory notebooks, summaries of results, drafts of reports, interim reports, final reports, published articles, financial remuneration, engagement of investigators, internal memoranda and submissions of data to the FDA or any Foreign Government Regulatory Authorities.
52. All clinical trial investigator protocols provided by the Defendant or any contractor firm to physicians, clinical investigators, etc. for clinical trials for Lopid and all contracts/agreements, including the names and addresses of each person or entity performing the studies or testing, with clinical trial investigators for these clinical trials.
53. Every document relating to, referring to or containing any epidemiology studies regarding Lopid, including, but not limited to, names and addresses of each person or entity performing the studies or testing, test protocols, data compilations, summaries of results, drafts of reports, final reports, published articles, financial remuneration, engagement of investigators, internal memoranda and submissions of data to the FDA or any Foreign Government Regulatory Authorities.
54. Every
document relating to, referring to or containing any epidemiology studies
regarding Lopid, including, but not limited to, names and addresses of each
person or entity performing the studies or testing, test protocols, data
compilations, summaries of results, and drafts of unpublished studies (conducted by the companies and by
clinical investigators of independent consulting services).
55. Every document relating to, referring to or containing any
epidemiology studies regarding Lopid, including, but not limited to, names and
addresses of each person or entity performing the studies or testing, test
protocols, data compilations, summaries of results, and drafts of ongoing studies (conducted by the
companies and by clinical investigators of independent consulting services),
whether published or unpublished.
56. Every document relating to, referring to or containing follow-up or long term studies of participants in Phase IV or other clinical studies regarding Lopid, including, but not limited to, names and addresses of each person or entity performing the studies or testing, safety and efficacy results obtained after approval of the NDA or ANDA, or after conclusion of the initial study period.
57. Every document concerning any receipt, discussion, studies, analysis or review of clinical experience reports for Lopid, including, but not limited to, formally submitted adverse reaction reports, communications (whether written or oral) concerning case reports, published clinical experience reports, or any other such report made known to Defendant concerning any experience with Lopid.
58 Every document relating to, referring to or containing studies on the safety or efficacy of Lopid conducted by any third parties, including, but not limited to, those conducted or funded by trade groups or associations.
59. Every document relating to, referring to or containing Defendant’s review, analysis, investigation or interpretation of results of studies on the safety or efficacy of Lopid conducted by any third parties, including, but not limited to, those conducted or funded by trade groups or associations.
60. Every document relating to, referring to or containing any attempts by Defendant to submit data from Defendant’s review, analysis, investigation or interpretation of results of studies on the safety or efficacy of Lopid conducted by any third parties, including, but not limited to, those conducted or funded by trade groups or associations to the FDA or any Foreign Government Regulatory Authority.
61. Every document relating to, referring or containing any testing of Lopid that Defendant did not complete, did not publish, or did not submit to the FDA or any Foreign Government Regulatory Authority.
62. For each clinical, animal or other study currently sponsored by, financed by, undertaken by, or suggested by Defendant regarding Lopid, provide all documents concerning each study, including, but not limited to, engagement letters, contracts, protocols, status reports, raw data, summary of findings, internal memorandum, drafts of reports, final reports, manuscripts, submissions to publishers, submissions to FDA or any Foreign Government Regulatory Authority, or discussions, communications or analysis of the current or final results.
63. All documents relating to, referring to or containing a bibliography of articles or reports concerning Lopid, including, but not limited to, monographs, presentations, letters to the editor, abstracts, and any other published reports.
64. All documents containing copies of each article or report in Defendant=s possession concerning Lopid, including, but not limited to, monographs, presentations, letters to the editor, abstracts, and any other published reports.
65. Every document relating to, referring to or containing any unpublished reports, speeches, data compilations, clinical observations or other communications concerning Lopid.
66. All documents relating to, referring to or containing any laboratory testing and/or studies regarding the pharmacology, pharmacokinetics and/or biochemical properties of Lopid.
67. All documents relating to, referring to or containing any laboratory testing and/or studies regarding the pharmacology, pharmacokinetics and/or biochemical properties of any cholesterol-reducing drug other than Lopid.
68. Every document relating to, referring to or containing any communications by Defendant with any publisher, editor, author, reporter or employee of or for any lay, scientific, medical or news publication or any free lance writer concerning Lopid.
69. All documents that refer to, discuss or examine Lopid and its likely effects based upon comparison and/or experience with any other cholesterol reducing medication.
70. All documents that refer to, discuss or examine Lopid and its likely effects based upon comparison and/or experience with any cholesterol-reducing drug, and/or its chemical and pharmacologic properties, other than Lopid.
71. All documents that refer to, discuss or examine the chemical or pharmacological properties, risks, adverse effects or side effects, clinical experience, pre-clinical testing and clinical testing of Lopid manufactured, marketed, distributed, licensed and/or tested by Defendant.
72. All documents that refer to, discuss or examine the chemical and/or pharmacological properties, risks, adverse effects or side effects, clinical experience, pre-clinical testing and clinical testing of Lopid when used alone and/or in combination with another statin.
73. All documents that refer to, discuss or examine the chemical or pharmacological properties, risks, adverse effects or side effects, clinical experience, pre-clinical testing, and post-marketing of any cholesterol lowering drug, excluding Lopid, which was manufactured, marketed, distributed, licensed and/or tested by Defendant.
74. All documents that refer to, discuss or examine the chemical or pharmacological properties, risks, adverse effects or side effects, clinical experience, pre-clinical testing and post-marketing clinical testing of any cholesterol lowering drug, excluding Lopid, other than those cholesterol lowering drugs which were manufactured, marketed, distributed, licensed and/or tested by Defendant.
75. All documents relating to, referring to or containing any efforts by Defendant to study, monitor or test for the risk of side effects, adverse responses or development of any physical harm associated with the use Lopid, either alone or in combination with another drug.
76. All documents relating to, referring to, or containing any efforts by Defendant to study, monitor, or test for the risk of side effects, adverse responses or development of any physical harm associated with the use any cholesterol-lowering drug, other than Lopid, either alone or in combination with another drug.
77. Every document that relates to, refers to or contains any communication, report or inquiry between Defendant and the Centers For Disease Control concerning Lopid.
78. Every document that relates to, refers to or contains any communication, report or inquiry between Defendant and the National Institutes of Health concerning Lopid.
79. Every document that relates to, refers to or contains any communication, report or inquiry between Defendant and the World Health Organization concerning Lopid.
80. Every document that relates to, refers to or contains any communication, report or inquiry between Defendant and the Drug Enforcement Agency (DEA) concerning Lopid.
81. All documents, (including, but not limited to, drafts) concerning recall notices, Dear Doctor letters, letters to insurers, physicians, pharmacists or other health care providers, newspaper or other print advertisements, press releases, questions and answers or other public statements regarding Lopid
82. Every document relating to, referring to or containing the retention of persons in any medical discipline, by or on behalf of Defendant, whether retained directly by Defendant or otherwise, to study, assess or analyze the safety of Lopid.
83. Full color copies of any and all draft and final copies of advertisements placed for Lopid, identifying the date and the journal/magazine or other media (e.g., television and radio), and the cost of each advertisement .
E. LABELING
84. Every document relating to, referring to, or containing any labeling for Lopid, including drafts and revisions thereto.
85. For each change in Lopid labeling, every document relating to, referring to or containing each label change.
86. Every document relating to, referring to or containing communications by Defendant, and any other materials distributed by Defendant to physicians, pharmacists or consumers regarding any change in the labeling or recommendations for use of Lopid, including, but not limited to, Dear Doctor letters.
87. Every document relating to, referring to or containing any communications with the FDA or any Foreign Government Regulatory Authority regarding changes in the label or recommendations for use of Lopid.
88. Any and all documents, including, but not limited to, internal memoranda, minutes of meetings, and draft proposals, regarding any consideration, discussion, decision or attempt to revise any label or recommendations for use of Lopid.
89. Every document relating to, referring to or containing information published in any Physicians’ Desk Reference (“PDR”) concerning Lopid, and every document relating to, referring to or containing revisions, alterations or discussions of PDR data.
90. Every document relating to, referring to or containing materials provided to consumers upon purchase of Lopid, such as package inserts, instructions or warnings included within the packaging and every document relating to, referring to or containing drafts of each document, discussions of each document or revision or alteration thereto.
F. MARKETING
91. All documents relating to, referring to, or containing any direct consumer advertisements, in both final form and draft, for Lopid, including, but not limited to, an exemplar color copy of each advertisement.
92. All documents relating to, referring to or containing any drafts, discussions, FDA approvals or revisions of any direct consumer advertisements for Lopid, including, but not limited to, an exemplar color copy of each advertisement.
93. All documents relating to, referring to, or containing any press releases or public relations material for Lopid.
94. All documents relating to, referring to, or containing any drafts, discussions, FDA approvals, or revisions of any press releases or public relations material for Lopid.
95. Any and all documents and other things ever provided by Defendant to physicians, diet clinics, pharmacies, and/or consumers, to promote the use of Lopid, including, but not limited to, notepads, calendars, office supplies, meals, promotional materials, financial contributions, product descriptions, product literature, books regarding Lopid, free samples, and other such promotional materials.
96. All documents relating to, referring to, or containing any sponsorship, financial support, contribution of product, consultation agreements, or other items of value given by Defendant to any person, scientific group or organization devoted to the study of reducing cholesterol.
97. All documents relating to, referring to or containing any efforts by Defendant to establish or contribute to charitable or non-profit educational entities that are engaged in activities related to medical treatment, research or consumer education regarding the lowering of cholesterol.
98. All documents relating to, referring to or containing every purchase by Defendant of published literature, including books, supporting the use of Lopid, either alone or in combination with a statin, to effectuate reducing cholesterol.
99. All documents relating to, referring to or containing any efforts by Defendant to distribute, publicize or promote published literature, including books, supporting the use of Lopid, either alone or in combination with a statin, to effectuate reducing cholesterol, to the medical community.
100. Every document relating to, referring to or containing training, instructions, memorandum, films, questions and answers or other materials supplied to detail persons or other sales persons employed by Defendant to promote Lopid.
101. Any and all videotapes, instruction manuals or other visual aids created by Defendant to advertise or promote the use of Lopid, whether or not such material was ever distributed or actually used by the defendant.
102. All documents that discuss, refer or relate to videotapes, instruction manuals or other visual aids created by Defendant to advertise or promote the use of Lopid.
103. All promotional materials developed, supplied, or publicized by Defendant in order to encourage and/or discourage use of Lopid in order to reduce cholesterol and any documents, which relate or refer thereto.
104. Every document relating to, referring to or containing sponsorship, financial support, contribution of product, consultation agreements, or other items of value provided to or for any person, organization, institution, or healthcare facility studying the safety and/or efficacy of the use of Lopid.
105. Every document relating to, referring to or containing any minutes, agendas, brochures, memoranda or correspondence relating to meetings of any trade group or of any other group or association which was attended, supported or sponsored by Defendant involving the topic of reducing cholesterol or the use of Lopid.
106. Every document relating to, referring to or containing analysis of market share, projection of future sales, marketing strategies, or promotional plans of Lopid.
107. Every document relating or referring to revenue, sales, profits, and costs for Lopid.
108. Every document that relates to, refers to, concerns, analyzes, or discusses in any manner the use of Lopid in combination with any other product for the purpose of changing the plasma concentration levels of cholesterol or triglycerides.
109. Every document relating or referring to meetings, training and discussions with marketing personnel regarding Lopid, including, but not limited to, any documents regarding questions, comments and/or inquires received by or requested from sales force personnel and/or training materials or handouts provided to any detailmen or sales representatives.
110. Every document relating to, referring to or containing stock purchase agreements, stock option agreements, agreements to serve as members of a Medical Advisory Board or Panel, employment or consulting agreements and/or any other documents concerning financial benefits provided to any physician, clinic, hospital, or health care provider engaged in providing treatment for reducing cholesterol.
111. All documents relating or referring to medical seminars, conferences or lectures conducted, sponsored in whole or in part, or in which defendant or its agents participated, in which the topic of safety, efficacy or adverse effects associated with the use of Lopid were discussed.
112. All documents relating or referring to the name, address and specialty of every physician in attendance at medical seminars, conferences or lectures conducted, sponsored in whole or in part, or in which defendant or its agents participated, in which the topics of safety, efficacy or adverse effects associated with the use of Lopid were discussed.
113. All documents relating to, referring to or containing any presentations made by or on behalf of Defendant and any materials displayed, relied upon or distributed by Defendant at medical seminars, conferences or lectures conducted, sponsored in whole or in part, or in which defendant or its agents participated, in which the topics of safety, efficacy or adverse effects associated with the use of Lopid were discussed.
114. Any and all contracts and/or agreements between Defendant and
any contractor for: marketing, detailing; professional meetings; scientific
writing/publications.
115. Every document detailing Defendant’s marketing budget for Lopid from 1992 to the present, including all outlays, as well as the names, addresses and telephone numbers of all contractors/service providers.
G. PHYSICIANS AND SCIENTISTS
116. Every document relating to, referring to or containing any opinion by a physician, a scientist, or a medical or scientific expert, regarding the safety or efficacy of Lopid, including, but not limited to, reports prepared in legal proceedings, opinions expressed in depositions or trial, reports submitted to scientific journals, opinions expressed at medical conferences, and opinions provided as testimony, reports or statements to the FDA or any foreign government regulatory authority, or any advisory committee thereof.
117. Every document relating to, referring to, or containing any financial payments, contributions, or support provided by Defendant to any physician, scientist, medical or scientific expert that is the subject of the preceding Request, or any institution, agency or entity with which said individual is affiliated.
118. Every document relating to, referring to or containing any attempt by Defendant to retain, engage or otherwise provide financial support or item of value to any person engaged in scientific or medical study of Lopid.
119. Every document relating to, referring to or containing any attempt by Defendant to retain, engage or otherwise provide financial support or item of value to any medical professional or scientific professional, or other professional of a discipline involved in the care, treatment or study of disease, injury and health, which is in any way related to the claims of injuries alleged in this litigation from use of Lopid.
H. HEALTHCARE INSURERS AND PHARMACIES
120. Every document relating to, referring to or containing any financial relationship and/or contract, or containing any discussions or negotiations relating to each and every contract or other financial relationship between Defendant and any pharmacy, healthcare insurer, health maintenance organization (AHMO@), or self insured employer, with regard to Lopid, including, but not limited to, summaries of annual gross sales of Lopid for each of these customers.
121. Every document relating to, referring to or containing any communications between Defendant, or any agent or consultant of Defendant, and any pharmacy, healthcare insurer, health maintenance organization (AHMO@), or self insured employer regarding Lopid.
122. Every document relating to, referring to or containing communications between Defendant, or any agent or consultant of Defendant, and any pharmacy, healthcare insurer, health maintenance organization (AHMO@), or self insured employer regarding Lopid which relate, regard or refer to the safety, efficacy, approval, or warnings regarding Lopid.
123. Every document relating to, referring to or containing any communication between Defendant, or any agent or consultant of Defendant, and any pharmacy, healthcare insurer, health maintenance organization (AHMO@), or self insured employer regarding the regulation, approval, safety or testing of Lopid.
124. Every document relating to, referring to or containing any communication between Defendant, or any agent or consultant of Defendant, and any pharmacy, healthcare insurer, health maintenance organization (AHMO@), or self insured employer regarding the safety of Lopid, alone and when used in combination with a statin.
125. All documents relating to, referring to or containing any communication between Defendant, or any agent or consultant of Defendant, and any pharmacy, healthcare insurer, health maintenance organization (AHMO@), or self insured employer that refer to, discuss or examine Lopid and its safety or likely effects based upon comparison and/or experience with any other cholesterol reducing medication.
126. All documents relating to, referring to or containing any communication between Defendant, or any agent or consultant of Defendant, and any pharmacy, healthcare insurer, health maintenance organization (AHMO@), or self insured employer that refer to, discuss or examine Lopid and its safety or likely effects based upon comparison and/or experience with any cholesterol reducing drugs other than Lopid.
127. Every document relating to, referring to or containing communications and any other materials distributed by Defendant, or any agent or consultant of Defendant, and any pharmacy, healthcare insurer, health maintenance organization (AHMO@), or self insured employer regarding any change in the labeling or recommendations for use of Lopid, including, but not limited to, Dear Doctor letters.
128. Every document relating to, referring to or containing any advertisements, brochures, press releases, informational materials, promotional materials, product descriptions, product literature, books regarding Lopid, and other such promotional materials for Lopid, that were provided by Defendant, or an agent or consultant of Defendant, to any pharmacy, healthcare insurer, health maintenance organization (AHMO@), or self insured employer.
I. OTHER DOCUMENTS CONCERNING THIS LITIGATION
129. Every document that you were required to identify in response to Plaintiffs’ Interrogatories (Master Set) as well as each document upon which Defendant relied in answering those Interrogatories.
130. Every document upon which Defendant relies to support each and every item of New Matter asserted in its Answer to the Plaintiffs’ First Amended General Master Long Form Complaint and Jury Demand, when filed.
131. Every document that Defendant intends to utilize as an Exhibit at trial in this matter, whether as direct evidence, rebuttal evidence, or any other purpose, including impeachment of witnesses.
Respectfully submitted,
Respectfully submitted,
ANAPOL,
SCHWARTZ, WEISS, COHAN
FELDMAN
& SMALLEY, P.C.
______________________________________
SOL H. WEISS, ESQUIRE
Liaison Counsel for Plaintiffs
GREITZER
& LOCKS
______________________________________
LEE BALEFSKY, ESQUIRE
Plaintiffs’ Liaison Counsel
LEVIN FISHBEIN SEDRAN & BERMAN
________________________________________
ARNOLD LEVIN, ESQUIRE
Dated: ____________________