Taxotere lawsuits claim the chemotherapy’s maker failed to warn patients of the drug’s high risk of permanent hair loss. While temporary hair loss is a known side effect of many chemo drugs, permanent hair loss was unexpected. More than 13,500 Taxotere lawsuits have been filed against Sanofi-Aventis, but none have yet been settled.
Why are People Filing Taxotere Lawsuits?
Taxotere, also referred to as docetaxel, is a common chemotherapy drug that has been approved by the U.S. Federal Drug Administration (FDA) to treat a number of cancers, including breast cancer, non-small cell lung cancer, head and neck cancer and prostate cancer. Though it has been on the market for several decades now, it wasn’t until more recently that the drug’s manufacturer, Sanofi, began to face a mounting number of lawsuits from breast cancer patients and survivors because of false marketing and the severe side effects of the treatment. As of the most recent report, the company is facing 11,300 pending lawsuits.
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
Though patients were warned of these potential side effects, many breast cancer survivors have since taken action against Sanofi, sometimes referred to as Sanofi-Aventis, for downplaying how severe some of these side effects may be, especially after marketing the drug as being more effective than other types of chemotherapy.
Taxotere Hair Loss
Hair loss is an unfortunate, common side effect of chemotherapy since many chemotherapeutic drugs kill fast-growing cells. 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.
While breast cancer patients prescribed Taxotere were warned of the potential for hair loss, these lawsuits state that 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, and thus experienced other negative setbacks in their personal lives.
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, and 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 who had been 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. As a result, 40% of the patients stated they had an extremely poor quality of life, and 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, 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 but 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. Though the clinical trial could be considered a success in proving the effectiveness of Taxotere in reducing tumor size and achieving remission, 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 and claim that it was safer and more effective than other types of chemotherapy, especially in the United States. Though warnings began to pop up 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 U.S., with some physicians even prescribing it for ovarian cancer and cervical cancer patients.
Taxotere lawsuits claim the manufacturer downplayed the side effects, with some even alleging that the drug maker offered bribes and training to employees to continue misrepresenting the drug’s safety and effectiveness. Many of the claimants further allege that 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 transferral was ordered in October 2016, with an initial 33 lawsuits from 25 districts consolidated under the MDL in U.S. District Court for the Eastern District of Louisiana. Just about a year later, the number of lawsuits had grown to over 2,000, and since then it has soared above 13,500 lawsuits.
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, but 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, like whether the brand name drug or generic drug was used, if other chemotherapy drugs were also prescribed, and the dosage administered.
Taxotere Settlements and Verdicts
So far, there have been no Taxotere settlements or verdicts from any of these cases. The bellwether trials for MDL 2740 are slated for 2019, with the first of the five scheduled for May. The trials will be overseen by Judge Jane T. Milazzo and help set a precedent for the other cases under the MDL consolidation.