Cymbalta Withdrawal Litigation Unsealed Documents 2018-02-20T10:44:05+00:00

Cymbalta Withdrawal Litigation Unsealed Documents

Cymbalta Litigation Unsealed Documents

Declassified court documents obtained by Baum Hedlund during the course of the Cymbalta Withdrawal Litigation show that Eli Lilly and Company (the manufacturer of Cymbalta) was well aware of Cymbalta’s withdrawal risks, that they occur frequently and can be quite severe.  Instead of being upfront about the risk, Lilly hid behind a misleading label, making it appear the risk was rare and symptoms mild.

Cymbalta Withdrawal Expert Trial Testimony and Exhibits

Expert Witness, Dr. Joseph Glenmullen, explains how Lilly obscured the risk of Cymbalta withdrawal.

Exhibit 001: Dr. Glenmullen Expert Witness Testimony

Exhibit 011: Clinical Report Form – Fluoxetine v. Sertraline and Paroxetine in Major Depression

Exhibit 022: Highlights of Prescribing Information for Cymbalta

Exhibit 069: Duloxetine v. Venlafaxine Extended Release in Treatment of Major Depressive Disorder

Exhibit 070: Cymbalta: Supportive Optional Document to Duloxetine Core Data Sheet Pre-Read Based on Clinical Trial Data in Adult Population

Exhibit 078: Journal of Clinical Psychiatry Supplement – Antidepressant Discontinuation Syndrome: Update on SSRIs 1997

Exhibit 093: Journal Affective Disorders – Symptoms Following Abrupt Discontinuation of Duloxetine Treatment in Patients with Major Depressive Disorder 2005

Exhibit 110: Table 4.138: Treatment-Emergent Adverse Events MedDRA

Exhibit 111: Table 4.35: Treatment-Emergent Adverse Events AMDP-5

Exhibit 112: Table 4.20: Treatment-Emergent-Adverse-Events-AMDP-5

Exhibit 119: Biological Psychiatry – SSRI Discontinuation Syndrome: A Randomized Clinical Trial 1998

Exhibit 151: Illustration Brain Cell Sending and Receiving SSRI Messages (1 of 2)

Exhibit 152: Illustration Brain Cell Sending and Receiving SSRI Messages (2 of 2)

Exhibit 661: Journal of Clinical Psychiatry – Prospective Studies of Adverse Events Related to Antidepressant Discontinuation 2006

Cymbalta Withdrawal Factual Summary and Exhibits

These court documents show Lilly’s knowledge of Cymbalta withdrawal.

Appendix A: Plaintiffs’ Proposed Facts – Hagan-Brown, Ali v. Eli Lilly

Exhibit 01: Deposition of Michael J. Detke

Exhibit 02: Walter Deberdt Email Re: Comments on SUI Clinical Expert Report

Exhibit 03: Journal Clinical Psychiatry – Antidepressant Discontinuation Syndrome: Update on SSRIs (1997)

Exhibit 04: SSRI Discontinuation Syndrome: A Randomized Clinical Trial (1998)

Exhibit 05: Ali v. Eli Lilly Defendant’s Responses to Plaintiff’s Amended First Set of Requests for Admission

Exhibit 06: Brintnall & Nicolini – Prozac Pyramid Positioning / Message Development Research

Exhibit 07: Eli Lilly U.S. Strategic Pricing Study – Cymbalta (2002)

Exhibit 08: Lilly Internal Email – Perahia, Detke, Wohlreich RE: Discontinuation Data

Exhibit 09: Deposition of Madelaine Wohlreich (4/29/2015)

Exhibit 10: Cymbalta Patient Segmentation Study (2004)

Exhibit 11: Saavedra v. Eli Lilly – Declaration of Sarah Helgeson (2013)

Exhibit 12: Study: Symptoms Following Abrupt Discontinuation of Duloxetine Treatment in Patients with Major Depressive Disorder (2005)

Exhibit 13: Ali v. Eli Lilly – Defendants’ Responses to Plaintiff’s First Set of Requests for Production of Documents

Exhibit 14: Hagan-Brown v. Eli Lilly – Defendants’ Responses to Plaintiff’s First Set of Requests for Production of Documents

Exhibit 15: Letter – Covington to Baum Hedlund RE: Hagan-Brown, Ali v Eli Lilly (March 2015)

Exhibit 16: Cymbalta Annex I – Summary of Product Characteristics

Exhibit 17: Side by Side Comparison of U.S. and European Labels for Cymbalta

Exhibit 18: Deposition of Sharon Hoog

Exhibit 20: Deposition of Dr. Navera Ahmed

Exhibit 21: Deposition of Matt Kuntz

Exhibit 22: Lilly Internal Email – Williams, Detke RE: Withdrawal Scale for Duloxetine

Exhibit 23: Duloxetine vs. Venflaxine Extended Release in the Treatment of Major Depressive Disorder (2002-2003)

Exhibit 24: Deposition of Madelaine Wohlreich (4/30/2015)

Exhibit 25: Boehringer Ingelheim Clinical Trial Protocol Revision A (June 2004)

Exhibit 26: Lilly Clinical Report Form – Fluoxetine v. Sertraline and Paroxetine in Major Depression: Comparison of Discontinuation-Emergent Symptoms

Exhibit 27: Table 4.35 Treatment-Emergent Adverse Events Collected by AMDP-5

Exhibit 28: Table 4.20 Treatment-Emergent Adverse Events Collected by AMDP-5

Exhibit 29: Lilly Internal Email – Perahia, Spencer, Brannan RE: HMBU Taper Period (Oct. 2002)

Exhibit 30: Clinical Study Report: Duloxetine Hydrochloride 60mg or 120mg Once Daily Compared with Placebo in Patients with Generalized Anxiety Disorder

Exhibit 31: Lilly Internal Email – Wang, Bump, Sakai, Detke, Stephens RE: Follow-up on PLR Meeting

Exhibit 32: Deposition of Christine Phillips PhD

Exhibit 33: Memo From Division of Medication Errors and Technical Support (2007)

Exhibit 34: Letter from Dr. Glenmullen to Matthew Leckman (Sept. 2014)

Exhibit 35: Dr. Glenmullen Addendum to Cymbalta Withdrawal General Causation Report May 2015

Exhibit 36: Louis Morris PhD Expert Report Cymbalta Discontinuation Litigation

Exhibit 37: Louis Morris PhD Supplemental Expert Report Cymbalta Discontinuation Litigation

Exhibit 38: Deposition of Dr. Michael Clark

Exhibit 39: Guidance for Industry Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products – Content and Format

Exhibit 40: Lilly Internal Email – Lee, Perahia RE: Question on DEAE’s (Dec. 2010)

Exhibit 41: Lilly Internal Email – Ziering, Perahia RE: Duloxetine/Cymbalta Withdrawal Question (Oct. 2006)

Exhibit 44: Lilly Internal Email – Miles, Detke, Kajdasz, Desaiah RE: Resubmitted. Your Review Required Again for Disclosure Approval Request

Exhibit 45: Study: A Randomized, Double-Blind Comparison of Duloxetine and Venlafaxine in the Treatment of Patients with Major Depressive Disorder (2008)

Exhibit 46: Declaration of Dr. Joseph Glenmullen (Aug. 2013)