Multidistrict litigation (MDL) is a method that courts use to merge lawsuits. Unlike a class action lawsuit, individual cases remain separate in an MDL. However, certain phases of litigation are combined for all the lawsuits. This speeds up the process of trying hundreds of similar cases.
Sanofi-Aventis faces more than 15,000 lawsuits for its chemotherapy drug, Taxotere. Plaintiffs claim the drug caused permanent hair loss. Sanofi is accused of negligence for not warning patients of this permanent side effect. No Taxotere lawsuits have been settled yet.
Why Are People Filing Taxotere Lawsuits?
Taxotere (docetaxel) is a common chemotherapy drug. The U.S. Food and Drug Administration (FDA) approved Taxotere to treat a number of cancers, including:
- breast cancer
- non-small cell lung cancer
- head and neck cancer
- prostate cancer
Taxotere has been on the market for several decades now. However, it wasn't until recently that the drug's manufacturer, Sanofi began to face a mounting number of lawsuits. Breast cancer patients and survivors sued the company for false marketing. The lawsuits also blame the company for not disclosing severe side effects of the drug.
Like other types of chemotherapy and cancer treatments, Taxotere can cause a number of side effects. Upon its approval, the FDA noted the potential side effects, which are all rather typical of any chemotherapy drug.
Common Side Effects of Taxotere
- Low blood cell count
- Nausea or vomiting
- Hair loss
- Allergic reaction
- Fluid retention
- Muscle pain
Patients were warned of these potential side effects. However, many breast cancer survivors blame Sanofi for downplaying side effect severity. This was especially problematic because the drug was marketed as a more effective alternative to other types of chemotherapy.
Taxotere Hair Loss
Hair loss is an unfortunate, common side effect of chemotherapy. Though hair loss is often expected for cancer patients undergoing chemotherapy, permanent hair loss or alopecia is not. For most patients, hair usually begins to grow back within 3 to 6 months after treatment is complete.
Breast cancer patients prescribed Taxotere were warned of the potential for hair loss. However, these lawsuits state Sanofi did not adequately prepare patients for the high risk of permanent hair loss.
Researchers have seen that even when cancer patients are prepared for the potential hair loss, it is still an overall traumatic experience. On average, studies have found that 6 - 9% of Taxotere-treated breast cancer patients experienced permanent alopecia.
How Hair Loss Affects Quality of Life
Numerous studies have investigated the impact of chemotherapy-induced alopecia on cancer survivors' quality of life. Research has shown that survivors face anxiety, poor body image and low self-esteem. Some patients can have difficulty transitioning back into work or everyday life.
One study notes that a person's hair is seen as an integral part of one's identity.
A smaller study observed the quality of life of 20 breast cancer patients. These patients were treated with Taxotere and experienced permanent hair loss. Despite undergoing treatments to stimulate hair growth, oncologists saw only a very slight improvement in a handful of patients. 40% of the patients stated they had an extremely poor quality of life. 70% chose to wear a wig or scarf to hide their alopecia.
Sanofi's Marketing Neglected Study Evidence
Warnings about the potential for alopecia weren't mentioned by the drug manufacturers until 2013. This was more than 15 years after the chemotherapy drug was first introduced on the market. But, knowledge of the risk of alopecia had been discovered years earlier.
In 1998, just a few years after Taxotere was introduced, Sanofi funded a research study called GEICAM 9805. The study was not published until 2010. The results of the study showed a high risk of hair loss for patients treated with Taxotere.
GEICAM 9805 studied the efficacy of Taxotere against another chemotherapy drug, fluorouracil (Adrucil). Both drugs were applied in combination with two other chemo drugs, doxorubicin and cyclophosphamide. The clinical trial could be considered a success in proving the effectiveness of Taxotere in reducing tumor size and achieving remission. However, researchers noted it was much more toxic than the other treatment regime. By its completion, the study also revealed about 96% of women in the study faced hair loss because of the cancer treatment.
Despite the study, the drug maker continued to heavily market the drug in the United States. Sanofi claimed Taxotere was safer and more effective than other types of chemotherapy.
Following this and other studies in Europe and other countries, Sanofi neglected to make American oncologists or patients aware of some potential side effects.
Based upon the manufacturer's marketing claims, Taxotere use expanded in the United States. Some physicians even began prescribing it for ovarian cancer and cervical cancer patients.
Taxotere lawsuits claim the manufacturer downplayed the side effects. Some even allege the drug maker offered bribes and training to employees to continue misrepresenting the drug's safety and effectiveness. Many of the claimants further allege the company didn't properly test the drug in the first place, entitling plaintiffs to various legal damages.
Taxotere hair loss lawsuits were consolidated under MDL No. 2740 IN RE: Taxotere (Docetaxel) Products Liability Litigation. The multidistrict litigation was created in October 2016. Initially 33 lawsuits from 25 districts were consolidated under the MDL in U.S. District Court for the Eastern District of Louisiana. About a year later, the number of lawsuits had grown to over 2,000. It has since soared above 15,000 lawsuits.
In May 2020, Judge Jane Triche Milazzo dismissed roughly 200 Taxotere lawsuits. Milazzo explained the drug's current label clearly explained the risks. According to Reuters, Sanofi's label has explained the risk of permanent hair loss since 2015. Plaintiffs who experienced severe side effects after this time no longer have valid claims because the warning label was sufficient.
Taxotere Class Action Lawsuits
Currently, there are no active class action lawsuits pending against Sanofi-Aventis. In 2016, three women filed a Taxotere class action lawsuit. A judge ultimately denied the certification for the claim in 2017. The claim was denied because the judge noted a lot of elements in the women's cases that were specific to the individual including:
- Whether the brand name drug or generic drug was used.
- If other chemotherapy drugs were also prescribed.
- The dosage administered.
Taxotere Settlements and Verdicts
In September 2019, Judge Jane T. Milazzo presided over the first Taxotere bellwether trial. The Louisiana jury found favored Sanofi in its verdict. The jury decided Taxotere was not the cause of permanent hair loss for the female plaintiff. This was the first of five bellwether trials slated for MDL 2740.