Lawsuits say Taxotere’s manufacturer, Sanofi-Aventis, knew Taxotere could cause permanent hair loss, or alopecia, but failed to warn doctors and their patients of the risk. Plaintiffs also accuse the company and its offshoots — Sanofi S.A., Aventis Pharma S.A. and Sanofi-Aventis U.S. LLC — of falsely marketing Taxotere (docetaxel), which is a chemotherapy drug widely used in the treatment of breast cancer.
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.
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. At the time, another 56 related lawsuits were pending in 25 districts.
In September 2017, the court denied Sanofi’s motion to dismiss all counts. As of September 2018, there were 9,182 Taxotere lawsuits pending.
In August 2018, The New Jersey Supreme Court created a Taxotere multicounty litigation (MCL). MCLs are New Jersey’s method of combining similar state cases. The New Jersey MCL consolidated 353 Taxotere lawsuits into a court in Middlesex County.
- Antoinette Durden, Case No. 2:16-cv-16635 (Primary Plaintiff)
- Tanya Francis, Case No. 2:16-cv-17410
- Barbara Earnest, Case No. 2:16-cv-17144
- Lisa Tuyes, Case No. 2:16-cv-15473
Do You Qualify for a Lawsuit?
Breast cancer survivors who were prescribed Taxotere before December 2015 and experienced permanent baldness as a result of Taxotere use may be eligible for compensation.
Although hair loss is a common side effect related to chemotherapy drugs, permanent baldness is not.
Permanent baldness is a disfiguring condition, especially for women. Women who experience disfiguring permanent alopecia as a result of Taxotere use not only suffer physical and emotional loss, but also financial loss, including loss of work or inability to work due to significant psychological damage.
“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.
Studies Showed Permanent Alopecia
Women and families suing Sanofi allege the company was aware of the link between permanent hair loss and Taxotere use 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.
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.
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.
Despite informing patients in other countries, Sanofi for years did not warn women in the U.S. of this risk. The words “permanent hair loss” or “alopecia” did not appear in any information published in the U.S., lawsuits say.
Sanofi Accused of Promoting Sales at Patients’ Expense
Taxotere lawsuits call into question Sanofi’s motives since Taxotere’s initial FDA approval in 1996.
They say Sanofi downplayed the risks of the drug and trained employees to misrepresent its safety and effectiveness.
According to a 2015 lawsuit filed by one of Sanofi’s former employees , the company engaged in illegal payment of kickbacks to health care professionals to prescribe the drug.
As a result of this misconduct, Taxotere’s sales soared.
“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,” one woman wrote in her complaint.
Class Action Was Denied
There are currently no certified class action lawsuits over claims Taxotere causes permanent hair loss.
In December 2016, three women filed a Taxotere class action lawsuit. In April 2017, the women asked the court to certify the class, a step necessary for the class action to proceed. In July 2017, a judge denied the request for class action certification.
According to the court order denying class action certification, there were too many differences in the cases for them to be considered a class.
- Whether brand name Taxotere or a generic equivalent was administered
- What combination of chemotherapy agents was used in connection with Taxotere or its generic equivalent
- The dosage of Taxotere or its generic equivalent that was administered
- The number of treatment cycles that took place
- The description of the alleged injury
- The damages sought
Studies Show Hair Loss Diminishes 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.
In some studies, 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.
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.
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.
Out of these women, about 40 percent showed scores that indicated “severe impairment” of quality of life. Quoting one woman in the study, authors 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.
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.
Please seek the advice of a medical professional before making health care decisions.