As of October 2017, 1,626 Taxotere lawsuits were pending in federal court in Louisiana. The lawsuits — filed by breast cancer survivors and their families — have been centralized under a multidistrict litigation, or MDL, which aims to increase efficiency by allowing a single judge to oversee similar cases. Chief Judge Kurt D. Engelhardt is overseeing the MDL, known as MDL -2740 IN RE: Taxotere (Docetaxel) Products Liability Litigation.
All lawsuits under the MDL allege breast cancer survivors experienced permanent hair loss as a result of using Taxotere (docetaxel), a widely used chemotherapy drug manufactured by Sanofi-Aventis. Plaintiffs claim Sanofi was aware of this possible side effect and failed to warn patients. The company also marketed Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the associated permanent hair loss, according to the lawsuits.
The U.S. Judicial Panel on Multidistrict Litigation created the MDL in October 2016, transferring 33 lawsuits from 16 districts to the Eastern District of Louisiana. Another 56 related lawsuits were pending in 25 districts.
In December 2016, the judge appointed settlement committees to engage in continuous general settlement discussions. Meanwhile, the number of Taxotere lawsuits continued to grow, and the court moved forward with preparations for bellwether trials, or test trials that help both sides gauge the strength of their arguments.
In August 2017, Judge Engelhardt set dates for four bellwether trials: Jan. 28, 2019; April 8, 209; July 15, 2019 and Nov. 4, 2019. Most recently, in September 2017, the court denied Sanofi’s motion to dismiss all counts.
Taxotere Most Prescribed Chemo Drug in U.S.
Doctors prescribe the drug Taxotere (docetaxel) to treat the majority of breast cancer cases in the U.S., and each year about 300,000 women are diagnosed with the disease. The drug is also the most prescribed drug in its class. In 2009, Taxotere made over $3 billion for Sanofi before the company lost patent protection.
The treatment plan for Taxotere is once every three weeks, unlike paclitaxel — a drug in the same class — which is weekly. So, patients make a trip to receive treatment less often, an idea that is attractive to many women. Some doctors prescribe Taxotere to their patients for reasons of convenience, though studies show paclitaxel is just as effective.
But, studies also linked the drug to a disfiguring side effect – permanent hair loss, also called alopecia. In some cases, about 9 percent of breast cancer patients suffered alopecia that lasted for a decade or more, severely decreasing their quality of life, negatively affecting body image, and causing depression and distress.
Why Women File Taxotere Lawsuits
Hair loss during chemotherapy is expected. It is a very common side effect of fighting cancer. But, women who underwent treatment with Taxotere did not prepare themselves for permanent loss of their hair. What angers many of these women and their families is that they were never properly warned of the risk so they could make an informed choice.
“The painful reality is that I will forever look like a cancer patient.”
– Breast cancer patient
Despite informing other countries, Sanofi did not warn women in the U.S. The words “permanent hair loss” or “alopecia” do not appear in any information published in the U.S., according to lawsuits.
The permanent loss of hair is more than cosmetic. For breast cancer survivors, it is a constant reminder of their struggle. For them, life will never be the same. The loss is emotional, physical and financial.
“I did not anticipate that years out of treatment I would be left with fine wisps of hair that grew in clumps around my head, but offered no coverage and no relief from the wigs and scarves that I had been wearing during the treatment,” said one breast cancer patient who told her story on “A Head of Our Time,” an online support group.
Lawsuits filed against Sanofi-Aventis claim several legal actions against the drug maker, including:
- Selling the drug without properly testing it
- Failing to determine whether the drug was safe
- Selling the drug without disclosing the dangers or risks
- Failing to properly warn patients and health care providers
- Misleading the public in advertising and marketing
- Manufacturing a dangerous drug
- Concealing information from the public
- Downplaying the dangers associated with the drug
Lawsuits Say Sanofi Hid Hair Loss Side Effects
According to lawsuits, Sanofi misled the public by falsely assuring them that hair would grow back after chemotherapy. But, the company should have known that their drug had a higher rate of permanent alopecia than similar drugs on the market.
Studies the company should have been aware of include:
Sanofi sponsored a study called GEICAM 9805. By 2005, the company knew that the results of this trial revealed 9.2 percent of women who used the chemo drug suffered permanent alopecia.
Dr. Scot Sedlacek of the Rocky Mountain Cancer Centers conducted a study that revealed Taxotere could cause more than 6 percent of women to suffer permanent alopecia.
Women Who Filed Taxotere Lawsuits
Ami Dodson is one of the first women to file a permanent alopecia lawsuit against Sanofi. According to court documents, Dodson had a left breast biopsy on March 3, 2010. Doctors found a tumor in her breast. After she had a partial mastectomy, Dodson spoke with her doctor about chemotherapy.
Neither she nor her doctor was aware of the risk for permanent alopecia. Following her treatment, her hair never grew back.
“Before Defendants’ wrongful conduct resulted in thousands of women being exposed to the side effects of Taxotere, there were already similar products on the market that were at least as effective as Taxotere and did not subject female users to the same risk of disfiguring permanent alopecia as does Taxotere,” Dodson wrote in her complaint.
Promoting Sales at Patients’ Expense
Dodson’s lawsuit calls into question the company’s motives since Taxotere’s initial FDA approval in 1996.
Dodson claimed that by downplaying the risks of the drug, training employees to misrepresent its safety and effectiveness, and allegedly engaging in illegal payment of “kickbacks” to health care professionals to prescribe the drug (according to a lawsuit filed by one of Sanofi’s former employees in 2015), Taxotere’s sales soared.
Dodson claimed that Taxotere’s sales escalated from $424 million in 2000 to $1.4 billion in 2004 through misrepresentation and illegal payment of “kickbacks.”
“Defendants preyed on one of the most vulnerable groups of individuals at the most difficult time in their lives [and] Defendants obtained billions of dollars in increased revenues at the expense of unwary cancer victims simply hoping to survive their condition and return to a normal life,” Dodson wrote in her complaint.
Loss of Quality of Life
Hair loss consistently ranks as one of the most distressing side effects of cancer treatment and has a profound impact on well-being and quality of life.
Lemieux et al. published a 2008 review of 38 articles analyzing the impact of hair loss on women with breast cancer. Study authors looked at quality of life relating to anxiety, body image, distress, sexuality, social functioning, self-esteem and the ability to return to work. Results showed that “hair loss consistently ranked amongst the most troublesome side effects, was described as distressing, and may affect the body image.”
Klugel et al. published a 2012 study in the Annals of Oncology that followed 20 patients who used Taxotere as a part of their therapy. All 20 suffered permanent hair loss after treatment. Despite various alopecia treatments, the women were left with incomplete, sparse and clumpy hair regrowth.
Compared to a healthy population, these women showed “significant impairment” of quality of life. Out of these women, about 40 percent showed scores that indicated “severe impairment.” One woman in the study said, “‘she would have preferred not to receive any chemotherapy for her breast cancer’ rather than being affected by such a distressing and permanent side-effect.”
About 70 percent of the women in this study wore wigs or scarves to cover their heads.
Kristin Compton is a medical writer with a background in legal studies. She has experience working in law firms as a paralegal and legal writer. She also has worked in journalism and marketing. She’s published numerous articles in a northwest Florida-based newspaper and lifestyle/entertainment magazine, as well as worked as a ghost writer on blog posts published online by a Central Florida law firm in the health law niche. As a patient herself, and an advocate, Kristin is passionate about “being a voice” for others.