Motion Filed to Dismiss Taxotere Lawsuits Over Excessive Tearing Problems

Sanofi claims the Taxotere lawsuits over excessive tearing should be dismissed because of a warning added to the label in 2002.

Sanofi is asking a federal judge to dismiss Taxotere lawsuits filed by former users of the breast cancer drug left with a medical condition known as epiphora, which allege the drug maker failed to warn about tear duct obstructions and chronic tearing which users may be left with after treatment.

Taxotere (docetaxel) is a chemotherapy injection approved for treatment of individuals with locally advanced or metastatic breast cancer, which competes with several treatment alternatives that are equally effective. However, lawsuits allege Sanofi has known for years that the drug carries a significant eye damage, which may develop quickly and leave women with debilitating tearing problems. However, the drug maker did not provide any warnings for patients and oncologists.

Sanofi already faces more than 12,000 product liability lawsuits brought by women who allege they were left with permanent hair loss after the Taxotere treatment, indicating that false and misleading information was provided that suggested hair would regrow after chemotherapy. However, there are now a growing number of Taxotere tearing lawsuits being pursued by women left with eye problems, known as lacrimal damage, indicating that the issues could have been avoided if proper warnings and information had been provided.

On June 28, Sanofi filed a motion to dismiss Taxotere lawsuits (PDF) over epiphora, saying the chemotherapy drug has carried a warning approved by the FDA regarding excessive tearing and tear duct obstruction since 2002.

“Sanofi submitted a proposed safety warning to FDA, and FDA later approved the following label addition: ‘Excessive tearing which may be attributable to lacrimal duct obstruction has been reported’,” the motion states. “This warning remains in the label today.”

Plaintiffs say those warnings underplayed the risks and did not go far enough, but Sanofi argues the warning should lead to the dismissal of claims.

In response to the growing number of Taxotere eye injury lawsuits filed against Sanofi in recent months throughout the federal court system, the litigation has been centralized and consolidated before U.S. District Judge Jane Triche Milazzo in the Eastern District of Louisiana, as part of an MDL, or multidistrict litigation.

As part of the Taxotere MDL process, Judge Milazzo is presiding over coordinated discover and pretrial proceedings in the cases. If the litigation is not dismissed or otherwise resolved during pretrial proceedings, it is expected that a series of bellwether trials will be scheduled to see how juries respond to evidence and testimony about the link between Taxotere and tear duct obstructions, which would likely be repeated in most cases.