Sanofi Taxotere Trial: Former FDA Head To Testify

Sanofi Taxotere Trial: Former FDA Head To Testify

Introduction

Dr. David A. Kessler, a former Food and Drug Administration Commissioner, may testify at an upcoming multidistrict litigation bellwether trial against Sanofi-Aventis US LLC over allegations that the drugmaker should have warned patients that the chemotherapy drug Taxotere can cause permanent hair loss. Sanofi markets and manufactures the anti-cancer drug, Taxotere which is used for treating cancers. This drug was first approved by the U.S. Food and Drug Administration (FDA) in 1996.

A trial for a plaintiff’s lawsuit is set to begin on Sept. 16, which is considered to be the first trial of all the pending federal Taxotere cases. Sanofi’s attempt to block Kessler from testifying in an upcoming trial was denied by the Eastern District of Louisiana.

In the 11-page order filed this past Tuesday, federal Judge Jane Triche Milazzo of Louisiana did not consider Sanofi’s argument over Kessler confusing the jury by testifying. As per Sanofi, Kessler will make it definite with his testify report that Taxotere led to baldness of 11,000 plus patients which gives plaintiffs right to sue the drugmakers involved in the MDL. 

Dr.Kessler in his testify report is expected to provide genuine evidence that proves causal association between Taxototere and permanent hair loss. The former FDA commissioner can also show records which states that as early as 2009, Sanofi was aware about "irreversible alopecia” caused by Taxotere, however, they failed to warn patients and their doctors about it. This led to prescription of this anti-cancer drug to thousands of patients who have been left bald even years after their cancer has been cured. 

Plaintiffs have filed permanent hair-loss lawsuit against reputed pharmaceutical companies like Pfizer, Hospira, Actavis and McKesson apart from Sanofi. These manufacturers have been accused of not warning doctors and patients about the risk of permanent baldness which can be caused after taking Taxotere for treatment of cancer. 

More than 12,000 product liability claims are filed against Taxotere manufacturer, Sanofi-Aventis, each raising similar allegations that the chemotherapy drug causes permanent hair loss in several women. The lawsuits are centralized in the Eastern District of Louisiana as part of a federal Multidistrict Litigation (MDL No. 2740; In Re: Taxotere (Docetaxel) Products Liability Litigation), presided by Chief Judge Kurt D. Engelhardt.