Almer v. Peanut Corporation of America

Filing 621

Almer v. Peanut Corporation of America

Doc. 621 Att. 8

EXHIBIT 8

Dockets.Justia.com

Page 1
UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA THIRD DIVISION ___________________________________* IN RE: GUIDANT CORPORATION * MDL No. 1708 (DWF/AJB)

IMPLANTABLE DEFIBRILLATORS PRODUCTS* LIABILITY LITIGATION *

___________________________________*

VIDEOTAPED DEPOSITION OF: DALE W. DeVRIES VOLUME I August 9, 2006 9:14 a.m.

Reported by: Melanie Giamarco CSR/RMR/RPR/CRR

Page 35
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

my purview in 1992. Q. A. And that's at the same time this report That's correct. That's -- at the time is issued for the FDA? this report was assembled for this particular product that we were using for submission to the FDA, correct. Q. Did you stay in that role of head of quality assurance, regulatory and clinical studies through the present? A. No. Actually, subsequent to that point in time in early 2000 -- I think it was 2000 or 2001, my position was actually split into two pieces, and subsequent to that point in time, I had responsibility for clinical programs, regulatory affairs worldwide, compliance and audit. Q. A. Q. A. Q. A. I no longer had any of the quality assurance functions. And that was as of 2000 or 2001? I believe it was 2001. January 2001? It was early 2001. Then, today, what is your job? I am currently still responsible for all I'm

aspects of regulatory affairs worldwide.

responsible for clinical programs related to

Page 36
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

assessment of products related to safety and effectiveness. Q. A. pieces: And I'm also responsible for compliance and audit related to manufacturing. And what does compliance mean? The way that we have organized one is related to assessing regulations,

compliance, compliance is broken into two main interpreting those regulations and making sure that we understand them and making sure that we have policies and procedures in place throughout the company to ensure that we have a process in place to assure compliance in all of our activities. And I also have an audit group that reports in through the same director, and that audit group goes back and does inspection related to whether or not people are following our processes. And we do that on a reoccurring basis or as requested by management. Q. A. Q. A. president. Q. president? And when did you first become a vice Is your title vice president? My title is vice president. Has that title changed over time? It has not changed since I became a vice

Page 37
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

A. 1990. Q. A. Q. A. Q. A. Q.

I believe it was back in 19 -- back in And that's at the time Cardiac That's correct. Were you a vice president of Eli Lilly? No. You were vice president of Cardiac That's correct. And then when -- Cardiac Pacemakers, MR. PRATT: Object to the form of that

Pacemakers, Inc. was still owned by Eli Lilly?

Pacemakers, Inc.?

Inc. was acquired by Guidant Corporation in 1994. question. A. Q. 1994? A. terminology. I'm not sure of the exact legal We were either spun off or split off Actually, we were not acquired by (By MS. FLEISHMAN) What happened in Guidant Corporation.

from Eli Lilly and Company, and Guidant was formed at that point in time in 1994, and we were part of that formation of Guidant. Q. And Cardiac Pacemakers, Inc. was renamed as a business unit of Guidant, Cardiac Rhythm

Page 38
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Management; is that correct? MR. PRATT: question. A. Corporation. Q. (By MS. FLEISHMAN) MR. PRATT: A. Q. A. Today. (By MS. FLEISHMAN) Today? Today, I'm -- to the best of my And are you a vice president of Guidant Corporation today? Vice president. I'm not exactly sure what the official We were part of Guidant terminology would be. Object to the form of the

knowledge, I am considered a vice president of Boston Scientific CRM division. Q. And before the acquisition of Boston Scientific of much of the Guidant Corporation stock, were you a vice president of Guidant Corp? A. Corporation. Q. A. Q. Did you sit on the board of directors No, I did not. And today, do you sit on the board of for Guidant Corp? I was vice president of Guidant CRM. I believe it was considered a division of Guidant

directors for Boston Scientific?