Taxotere Watery Eyes Lawsuits Cleared To Move Forward Over Inadequate Side Effect Warnings

Ruling rejects Sanofi motion to dismiss, indicating claims over the failure to warn about watery eyes from Taxotere side effects should be resolved by a jury.

The U.S. District Judge presiding over nearly 150 Taxotere watery eyes lawsuits has allowed the litigation to move closer to trial, rejecting Sanofi’s bid to have the claims dismissed.

Taxotere (docetaxel) is a Sanofi-Aventis medication approved for the treatment of locally advanced or metastatic breast cancer. In recent years, however, the manufacturer has been hit with dozens of product liability lawsuits alleging that side effects of the cancer drug can cause tear ducts to become blocked, causing debilitating and chronic watery eyes.

Taxotere Watery Eyes

The litigation emerged after a study was published in 2022, warning that Taxotere side effects can increase the risk of epiphora by a factor of seven, and can increase the risk of optic nerve damage.

Epiphora is a condition that causes excessive tears and watery eyes, often the result of a lacrimal obstruction. It can cause one to look like they are constantly crying or on the verge of tears. The condition is usually treated through medications or prescription eye drops. Other side effects can include eye pain, itchiness, red eyes, cloudy vision and sinus headaches.

That same year, Sanofi began to be hit by Taxotere lawsuits filed by users nationwide who say the manufacturer knew, or should have known, about the epiphora risks, but failed to warn patients or the medical community.

In March 2023, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal Taxotere watery eyes lawsuits into an MDL, or multidistrict litigation, in the Eastern District of Louisiana before U.S. District Judge Triche Milazzo for coordinated discovery and pretrial proceedings.

The judge is also expected to preside over a series of “bellwether” early test trials, which will put representative claims before juries to see how they process evidence and testimony that would be repeated throughout the litigation.

However, Sanofi has tried more than once to have the cases dismissed. The manufacturer has argued that there were adequate label warnings on Taxotere, but Judge Milazzo has not found their arguments compelling.

Judge Milazzo rejected a motion to dismiss Taxotere epiphora lawsuits in 2022, which claimed the cases were preempted by federal law. In response to a more recent February 2025 motion to dismiss the claims, the judge issued an order (PDF) on June 25, again rejecting the manufacturer’s efforts to have the cases thrown out.

Sanofi’s motion for summary judgment claimed plaintiffs lack admissible expert evidence on the adequacy of the Taxotere label warnings. They also claim the labels should be considered adequate as a matter of law.

The judge rejected those arguments and denied the motion to dismiss, indicating these issues should be hashed out in front of a jury.

“Significant disputes remain regarding whether the Taxotere label adequately conveyed the nature and severity of the condition, as well as whether aspects of the warning were misleading. Those disputes are for the jury to resolve.”

– U.S. District Judge Triche Milazzo

The decision means that the cases can continue to move forward toward bellwether trials. While the outcomes of these trials will not be binding on other claims, they will be closely watched, as the results could have a significant impact on any Taxotere watery eyes lawsuit settlement negotiations.

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