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In re Rezulin Prods. Liab. Litig.

United States District Court for the Southern District of New York

March 14, 2005, Decided ; March 14, 2005, Filed

MDL No. 1348, Master File 00 Civ. 2843 (LAK)

Opinion

 [*399] Table of Contents

I. The Legal Backdrop and the Positions of the Parties

II. Proceedings on the Motion

 [*400]  III. Scientific Background

A. Relevant Physiology

1. Cells

2. The Liver

3. Mechanisms of Cell Death

 [**2]  B. Drugs, Toxicity to the Liver, and Rezulin

C. Patient Population

D. Evidence of Causation in Medicine

IV. The Proposed Testimony

A. The Experts and Their Opinions

1. Dr. Smith

2. Dr. Reed

3. Dr. Julie

4. Dr. Day

5. Dr. Bonkovsky

6. Summary

B. The Science upon Which the Experts Rely

1. Early Links in the Proposed Causal Chain: The Claim that Rezulin Causes Apoptosis Through Effects on the Mitochondria or the BSEP

a. Studies Connecting Rezulin to Apoptosis

b. Studies Connecting Rezulin to Mitochondrial Damage

c. Studies Connecting Rezulin to an Effect on the BSEP

2. The Last Link in the Chain: The Claim that Apoptosis from Rezulin Causes Silent Injury

C. Arguments that Rezulin Can Cause Silent Liver Injury Through Mechanisms Other than Apoptosis

D. Patients Whose Liver Enzymes Were Not Monitored

V. Law Governing the Admission of Expert Testimony

A. Daubert and Its Progeny

B. The Daubert Standards Apply to Opinions About General and Specific Causation

VI. Daubert Analysis of the Proposed Testimony

A. Testing and Error Rate, Peer-Review, Publication, Widespread Acceptance

 [**3]  B. Independence from Litigation

C. Consideration of Contrary Evidence

D. "Fit" and the "Analytical Gap"

1. The Experts Have No Evidence for the Crucial Link in Their Causal Chain

2. The Experts Have Failed To Link the Studies on Mitochondria and the BSEP into Their Causal Chain

3. The Research on Apoptosis in Cell Cultures Does Not "Fit" the Opinion at Issue

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369 F. Supp. 2d 398 *; 2005 U.S. Dist. LEXIS 3790 **

In re: REZULIN PRODUCTS LIABILITY LITIGATION, This document relates to: All Cases.

Subsequent History: As Amended, August 11, 2005.

Summary judgment granted by, Claim dismissed by In re Rezulin Prods. Liab. Litig., 361 F. Supp. 2d 268, 2005 U.S. Dist. LEXIS 3938 (S.D.N.Y., Mar. 15, 2005)

Prior History: In re Rezulin Prods. Liab. Litig., 2004 U.S. Dist. LEXIS 25038 (S.D.N.Y., Dec. 9, 2004)

Disposition: Defendants' motion to exclude plaintiffs' expert testimony granted.

CORE TERMS

cells, liver, apoptosis, studies, troglitazone, patient, concentrations, silent, plaintiffs', cancer, mitochondrial, mitochondria, hepatocytes, elevation, enzymes, induced, rat, causation, clinical, tissue, doses, extrapolation, reliable, liver disease, membrane, differential, scientific, diagnosis, in vitro, cultures

Environmental Law, Hazardous Wastes & Toxic Substances, Toxic Torts, Evidence, Admissibility, Scientific Evidence, General Overview, Torts, Elements, Causation, Testimony, Expert Witnesses, Civil Procedure, Judicial Officers, Judges, Daubert Standard, Standards for Admissibility, Expert Witnesses, Procedural Matters, Preliminary Questions, Helpfulness, Bodily Evidence, Toxicology