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The Taxotere Bellwether Trials: A Summary


Sanofi-Aventis is a company that manufactures (docetaxel) Taxotere, a drug commonly prescribed during chemotherapy to treat various types of cancer. The manufacturer has been at the center of many lawsuits because of allegations that it did not warn patients of the dangerous side effects of Taxotere.

Taxotere is the brand name for the chemical compound docetaxel. Sanofi, formerly Rhone-Poulenc, patented the drug in 1986. In 2004, the company merged with Aventis Pharmaceuticals and received approval from the U.S. Food and Drug Administration (FDA) to market Taxotere as a chemotherapy drug.

Taxotere belongs to a family of drugs called taxanes. They work by preventing the growth of cancer cells. Although effective at treating multiple forms of cancer, patients have reported adverse side effects and medical conditions after receiving the drug during chemotherapy regimens. Some have accused Sanofi of not disclosing the potential risks, including eye damage and hair loss.

Multidistrict Litigation for Taxotere Lawsuits

Lawsuits against Sanofi regarding the harmful effects of Taxotere were consolidated into multidistrict litigation (MDL) in 2016. An MDL differs from a class action lawsuit.

Class action cases involve one or several plaintiffs representing an entire class of people who sustained similar injuries under the same circumstances. Instead of pursuing multiple cases, plaintiffs combine their lawsuits into a single action against the same defendant. In an MDL, a group of individual lawsuits is combined in one court.

One judge hears pre-trial and discovery motions in sample cases. These cases are called bellwether cases. After listening to the motions, the judge sends the cases back for another judge to hear them individually.

Currently, there are over 30,000 lawsuits in MDL involving hair loss complaints and 12,000 cases in MDL for eye damage complaints. One federal district judge will oversee these MDLs in a Louisiana federal district court.

Complications of Taxotere for Cancer Treatment

Initially, the most common side effects listed on Taxotere labels included:

  • Nausea
  • Injection site swelling or pain
  • Loss of appetite
  • Vomiting
  • Constipation
  • Diarrhea
  • Toenail and fingernail changes
  • Temporary hair loss

Although labels mentioned temporary hair loss as a common side effect, the drug company didn’t disclose alopecia as a potential risk of taking Taxotere. Typically, chemotherapy patients lose their hair while treating cancer, but eventually, their hair grows back. However, patients have filed lawsuits claiming they developed permanent hair loss on the scalp or body due to their use of Taxotere.

Taxotere can also lead to epiphora, a condition causing excessive eye watering. Chronic inflammation and irritation of a vital structure called the canaliculus can lead to canicular stenosis, an irreversible condition.

Sanofi added canalicular stenosis to the list of possible side effects in 2014. However, plaintiffs allege the company didn’t adequately detail the risks of vision loss or eye damage.

Taxotere Lawsuits for Hair Loss

Plaintiffs are pursuing lawsuits against Sanofi-Aventis for hair loss and eye damage caused by Taxotere. They allege the manufacturer knew about the long-term effects of the chemo drug but didn’t disclose the necessary information to doctors and patients promptly.

Despite FDA approval of Taxotere to treat various forms of cancer in 2004, studies have shown a link between permanent hair loss and Taxotere use. The results of one study published in the National Library of Medicine mentioned a higher risk of persistent alopecia in adjuvant treatment with docetaxel for breast cancer patients.

Plaintiffs argue that Sanofi knew about the risks of chemo-induced alopecia since 2006 but didn’t take the appropriate measures to warn patients and doctors. Other plaintiffs believe Sanofi was aware of the dangers before researchers published their findings.

In 2009, the FDA determined Sanofi’s claims about Taxotere being more effective than other chemotherapy drugs were false.

In 2016, the courts established an MDL for lawsuits related to hair loss from receiving Taxotere treatment. One judge heard the discovery and pre-trial motions but dismissed nearly 200 cases in 2020.

Initially, Sanofi won the first two bellwether cases in MDL for Taxotere hair loss. However, an appeals court overturned the decision in February 2022. The judge in one of the bellwether trials in Louisiana ruled in Sanofi’s favor in 2021. The plaintiff has plans to appeal the ruling.

Additional lawsuits involving hair loss are pending in other states.

Taxotere Lawsuits for Vision Damage

Most lawsuits against Sanofi are for allegations of permanent hair loss from Taxotere. Other lawsuits allege vision damage, vision loss, and other eye problems. Although Sanofi included epiphora on its warning labels, patients believe the drug company failed to warn oncologists and patients about the irreversible and quick damage Taxotere can cause.

According to a study reported in JAMA Ophthalmology, epiphora can occur in 77 percent of patients on a weekly docetaxel regimen. Researchers believe secretions from the drug interact with a person’s tears, causing inflammation and obstructions in the tear ducts. Eventually, the obstructions cause the canaliculi to close, preventing tear drainage into the nasal cavity.

The MDL for eye damage and vision problems related to Taxotere is in the pre-trial phase. Cases have been consolidated and moved to the Louisiana federal district court, the same court handling the MDL for hair loss.

Find Out if You’re Eligible for a Taxotere Lawsuit

THE TAXOTERE BELLWETHER TRIALS_ A SUMMARY 2You might be able to sue Sanofi for compensation if you received Taxotere to treat your cancer and experienced adverse effects, such as:

  • Vision loss
  • Blocked tear ducts
  • Swelling in and around the eyes
  • Narrowing of the tear ducts
  • Dry eyes
  • Excessive eye watering
  • Blurry vision
  • Permanent hair loss

You must ensure you are within the required statute of limitations to pursue a lawsuit. The statute of limitations allows a specific timeframe to file suit against another party. Once the timeframe passes, you cannot initiate a lawsuit against Sanofi for your hair loss, eye damage, or another medical issue due to Taxotere.

The Taxotere lawsuit attorneys of Hotze Runkle PLLC can review your case and determine whether you qualify for a lawsuit against the drug manufacturer. You can depend on us to protect your rights and fight for the compensation you deserve. Call us at (800) 763-6155 or take our Taxotere Case Evaluation Quiz if you have experienced side effects from treating cancer with Taxotere