Taxotere Lawsuit

Taxotere (generic name: docetaxel) is a chemotherapy drug used to inhibit cell division and promote cell death. It belongs to a group of chemotherapy drugs called taxanes, which come from plant alkaloids, specifically the bark of the Pacific Yew tree. It is used to treat various kinds of cancers including breast cancer, metastatic non-small cell lung cancer, as well as prostate, stomach, head, and neck cancers.

Although usually mixed with other chemotherapy agents, Taxotere can also be prescribed by itself. It is administered via an intravenous infusion. The dose and treatment schedule depends on several factors like height and weight, other health issues, and the specific type of cancer being treated.

Taxotere is manufactured by Sanofi (formerly Sanofi-Aventis), a global pharmaceutical company with 2017 annual revenues of over 40 billion dollars.

There is no accurate way for the drug to target cancer cells only. It works by inhibiting mitosis for all rapidly reproducing cells, regardless of whether the cells are cancerous.

This means that otherwise healthy, rapidly growing cells—including cells in the hair, nails, skin, gastric lining, and bone marrow—are affected by Taxotere.

This process explains why the common side effects of Taxotere include a disturbance to these tissues, like hair loss (alopecia), vomiting and diarrhea, and increased risk of bruising, bleeding, and infections.

In 2006, Sanofi released an internal study stating that only 3% of patients who received Taxotere experienced long-term hair loss (known as alopecia). However, in the same year, a study conducted by Dr. Scot Sedlacek from Rocky Mountain Cancer Centers showed that the risk of permanent hair loss increases when Taxotere is combined with doxorubicin and cyclophosphamide. Out of 112 breast cancer patients that received the drug cocktail, 6.3% grew back less than 50% of their hair.

When Taxotere causes Alopecia, all body hair is affected, including eyebrows, eyelashes and pubic hair.

Sanofi revised Taxotere’s warning label in 2005 for some European countries to include a warning that some permanent hair loss had been observed in patients taking Taxotere.

Despite the fact that this warning was published in many European countries in 2005, this warning was not published in the US until 10 years later, in December 2015, when FDA added the same warning under adverse reactions in the label. While alopecia was indicated as a side effect prior to this addition, there was no indication that Taxotere could cause permanent hair loss.

To date, over 9,500 lawsuits have been filed against Sanofi, mostly from breast cancer patients and their families. The main grounds for the lawsuit include failure to warn healthcare providers and patients about the risk of permanent hair loss, as well as downplaying the side effects caused by the drug.

On October 2016, Taxotere hair loss lawsuits were consolidated to multi-district litigation (MDL) in the US District Court for the Eastern District of Louisiana. (An MDL consolidates multiple similar lawsuits together into one venue for ease of judicial administration.)

Meanwhile, in August 2018, Taxotere cases were granted multicounty litigation (MCL) status in New Jersey, where Sanofi’s U.S. headquarters are located. Currently, there are over 350 complaints pending in state court.