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’ INTERROGATORIES
(MASTER SET)
TO DEFENDANTS WARNER LAMBERT,
PARKE DAVIS & PFIZER
Pursuant to Rule 4005 et seq. of
the Pennsylvania Rules of Civil Procedure, the plaintiffs propound the
following interrogatories to the Defendants, to be answered separately and
fully, in writing, and under oath as prescribed by the Rules, within 30 days,
or at such other time as ordered by the Court.
INSTRUCTIONS
1. Each Interrogatory refers to information in the custody,
control, and possession of the defendants, or known to the defendants, as well
as in the custody, control, and possession of or known to Defendants’ counsel,
representatives, agents, servants, investigators, consultants, and other third
parties retained by the defendants, and their counsel, employees,
representatives, agents, servants, investigators and consultants.
2. 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.
3. When asked to identify a person, or if the response involves
a person, for each person please state the full name, business title, and the
current and/or last known home and business addresses and telephone numbers.
4. When asked to identify a communication, or if an answer
involves a communication, for each communication please state the parties to
the communication, the nature of the communication (e.g., written, oral, and/
or recorded), witnesses to the communication, and the substance of the
communication.
5. When asked to identify a document, or when an answer
involves a document, please state the person who wrote, composed or created the
document, the intended recipients, the date originated, the date sent, the date
received, all persons having copies of the document, and the subject matter and
content. In lieu of identifying a document, a copy of the document can be
attached to these responses.
6. For each Interrogatory, identify any persons providing
information, and state whether the response is based on the personal knowledge
of the person providing the information. If the response is not based on the
personal knowledge of the person providing the information, identify the
sources (e.g. persons and/or documents) of that information.
7. If information contrary to that provided in an answer was
provided by any person to the person providing the answer, or to your
attorneys, identify each person, providing conflicting information, state the
conflicting information, and state the reasons the conflicting information was
not relied upon.
8. For each answer, identify all documents that you believe
support your response.
9. If in the course of this litigation you have produced, or
will produce, documents or exhibits that are not covered in the categories
listed in the Plaintiffs’ Request for Production of Documents, please, with
respect to each of those documents, identify each by Bates number and/or by any
other appropriate description.
10. These interrogatories shall be deemed continuing, to the full
extent required or permitted under the Pennsylvania Rule of Civil Procedure, so
as to require supplementary responses as soon as practical after you receive
information which renders any of your answers to these interrogatories
incomplete or inaccurate.
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.
The term
“person” is used in its broadest possible sense and includes a natural person,
corporation, firm, association, organization, business, trust, corporation,
governmental or other public entity.
6.
The term
“document” or any similar term is used in its broadest possible sense and shall
include, but is not limited to any original, reproduction or copy, and
nonidentical copy (i.e., copy with marginal notes, deletions, etc.) of any kind
of written, printed, typed, electronically created or stored, or other graphic
matter of any type, documentary material, or drafts thereof. Such “document(s)”
shall include, but are 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.
7.
The term
“communication” is used in its broadest sense and refers to any oral, written,
video, photographic, or other means utilized to express an idea, thought, or
information from one person to another, or among persons.
8.
The relevant
time period is 1992 to the present.
1. State
the corporate name of Defendant, any name under which Defendant does business,
where the Defendant is incorporated, and where the defendant’s principle place
of business is located.
ANSWER:
2. State
the full corporate name and principal address of each entity with whom you are
affiliated through common ownership and control. With respect to each such
entity, describe its past and present role in connection with the design,
testing, manufacture, marketing, sale and/or distribution of Lopid.
ANSWER:
3. If
you, or any of your divisions, subsidiaries, or other entities retained or
owned (wholly or in part) by you, manufactured, tested, licensed, sold and/or
distributed Lopid, state: (a) the generic name of the product; and (b) each of
your brand names or trade names for the product.
ANSWER:
4. Identify
each division, subsidiary, operating unit and any independent contractor or
consultant, or other third party engaged by you responsible for or involved in
the following with regard to Lopid:
i. Product
design;
ii. Pre-clinical
testing;
iii. Clinical
testing;
iv. Regulatory
approval and compliance;
v. Manufacturing;
vi. Marketing;
vii. Labeling;
viii. Promotion;
9.
Distribution;
and
x.
Post-market testing
ANSWER:
5. State
whether Defendant has given or received a license regarding the manufacture,
distribution, or sale of Lopid. If so,
state the details of such arrangements, and the identity of any licensee or
licensor.
ANSWER:
9.
State the name,
title, current or last known address and telephone number of each person who
has ever participated on any committee that approves advertising, promotions,
marketing and/or labeling for Lopid;.
ANSWER:
7. State
the name, title, current or last known address and telephone number of each
person who has ever participated on the regulatory affairs committee, any other
committee, or regulatory affairs department, however denominated, which has
supervised or directed regulatory affairs regarding Lopid .
ANSWER:
8. State
the name, title, current or last known address and telephone number of each
person who headed the following departments from 1992 to the present, stating
for each individual the inclusive dates during which they held the position and
the nature of their responsibilities pertaining to Lopid. If organizational
charts or diagrams exist containing such information, please provide each such
chart or diagram for the time set forth herein and identify the applicable time
frame.
1) Legal;
2) Manufacturing;
3) Sales,
Marketing and/or Promotion;
4) Finance;
5) Medical
Communications;
6) Research
and Development;
7) Regulatory
Affairs; and
8)
Post-marketing surveillance.
ANSWER:
9.
With regard to the previous interrogatory, also identify each person,
including name, title, current, or last known address and telephone number,
from the following departments who was assigned any supervisory duties or
responsibilities regarding Lopid:
1) Legal;
2) Manufacturing;
3) Sales,
Marketing and/or Promotion;
4) Finance;
5) Medical
Communications;
6) Research
and Development;
7)
Regulatory
Affairs;
ANSWER:
10. State
the name, title, current or last known address and telephone number of each
person who has ever been in charge or control of the following, stating for
each individual the inclusive dates during which they held the position and the
nature of their responsibilities pertaining to Lopid. If organizational charts
or diagrams exist containing such information, please provide each such chart
or diagram for the time set forth herein and identify the applicable time
frame.
8.
Pre-clinical
animal testing of Lopid or liaison with healthcare providers or organizations
or companies regarding pre-clinical animal testing of Lopid.
b. Pre-market
human or clinical testing of Lopid or liaison with healthcare providers or
organizations or companies regarding pre-market human or clinical testing of
Lopid.
c. Post-market
human or clinical testing of Lopid or liaison with healthcare providers or
organizations or companies regarding post-market human or clinical testing of
Lopid.
d. Post-market
medical surveillance of Lopid or liaison with healthcare providers or
organizations or companies regarding post-market medical surveillance of Lopid.
e. Product licensing regarding Lopid.
f. Product manager regarding Lopid.
ANSWER:
11. Identify
the following with regard to any government investigation, regulatory action,
indictment, information, charge and/or civil lawsuit that has ever been made or
brought against Defendant as it pertains to the promotion, marketing, sale or
distribution of Lopid, excluding matters filed in the Pennsylvania Court of
Common Pleas, Philadelphia County, Civil Trial Division, under the Master
Docket No. 0001:
a. The
product(s) involved;
b. The
court, agency and jurisdiction involved;
c. The
filing date;
d. The
time period at issue;
e. The
current status or disposition of the investigation, regulatory action, suit or
charge; and