Taxotere lawsuits filed by 2,400 breast cancer survivors and their families say Sanofi-Aventis U.S. LLC hid the permanent hair loss risk of the chemotherapy drug Taxotere. Litigation is ongoing. No settlements have been announced. The first four cases are set to go to trial in 2019.
Women sought legal compensation against the manufacturer of Taxotere, claiming the chemotherapy drug caused the following:
Number of Lawsuits More than 2,400
Plaintiff Injuries Permanent hair loss (alopecia)
Defendants Sanofi-Aventis U.S. LLC
Bellwether trial dates Jan. 28, 2019; April 8, 2019; July 15, 2019; Nov. 4, 2019
MDL Location U.S. District Court Eastern District of Louisiana
Class-Action Status None
Litigation Status Active
Top Settlement No global settlement announced as of yet
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 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. To date, Sanofi has faced more than 2,400 Taxotere lawsuits.
In September 2017, the court denied Sanofi’s motion to dismiss all counts. The company was still fighting 2,304 lawsuits over Taxotere permanent hair loss claims as of November 2017.
Taxotere MDL by the Numbers:
The total number of Taxotere lawsuits filed by breast cancer survivors and their families
The number of Taxotere lawsuits still pending in federal court in Louisiana
The number of Taxotere lawsuits pending when the MDL was created
The number of districts from which lawsuits were transferred to the MDL
No global settlement has been announced to resolve the more than 2,300 Taxotere lawsuits still pending in Louisiana.
In December 2016, the judge overseeing the litigation 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 Kurt D. Engelhardt set dates for four bellwether trials in the Taxotere MDL. The judge and both parties involved in the litigation will select representative cases to be the first cases to go to trial. The outcome of these trials could influence how the other cases in the MDL proceed.
Upcoming Taxotere Bellwether Trial Dates:
Breast cancer survivors who were prescribed Taxotere before December 2015 and experienced permanent baldness (permanent alopecia) as a result of Taxotere use may be eligible for compensation through a lawsuit.
Did you take Taxotere to treat breast cancer and suffer permanent hair loss?Get a Free Case Review
Although hair loss is a common side effect related to chemotherapy drugs, permanent alopecia 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.
You may be eligible for compensation through a lawsuit if you:
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.
Lawsuits accuse Sanofi of:
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.
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.
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, lawsuits say.
Lawsuits claim 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,” one woman wrote in her complaint.
Sanofi S.A., Aventis Pharma S.A. and Sanofi-Aventis U.S. LLC are the drug companies named in Taxotere lawsuits.
These companies were involved in the designing, developing, manufacturing, distributing, labeling, advertising, marketing, promoting and selling of Taxotere.
In 2009, Taxotere made over $3 billion for Sanofi before the company lost patent protection.
Doctors prescribe Taxotere 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.
Companies Named in Taxotere Lawsuits:
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.
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.
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.
Out of these women, about 40 percent showed scores that indicated “severe impairment” of quality of life. 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.
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.
Emily Miller is an award-winning writer who has held editorial positions with reputable print and online publications around the U.S. As the editor of Drugwatch.com, Emily draws on her background as both a patient and a journalist to ensure her team of writers provides consumers with the latest and most accurate information on drugs, medical devices, procedures and related lawsuits. Emily holds five Health Literacy certificates from the Centers for Disease Control and Prevention as well as a Bachelor of Science in Journalism from the University of Florida. She is a member of The Alliance of Professional Health Advocates, the American Association for the Advancement of Science, the Society of Professional Journalists and the Society for Technical Communication.
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