Breast cancer affects hundreds of thousands of women each year. In the U.S., about 260,000 new cases are diagnosed annually. Taxotere is a popular chemotherapy drug used in a large majority of breast cancer cases. The potent drug only needs to be administered every 3 weeks, a convenience that attracts many patients to the treatment option. But Taxotere has been linked to a significant side effect not seen in similar chemotherapy drugs: permanent hair loss. Now Taxotere’s manufacturer, Sanofi, is under fire for misleading the public about the risks associated with its drug and lawsuits are being filed in courts across the country.
The breast cancer drug Taxotere has been linked to cases of permanent hair loss and its manufacturer — French pharmaceutical company Sanofi — is facing a barrage of new lawsuits accusing it of concealing the risk.
Women who underwent chemotherapy with Taxotere to treat breast cancer and are now experiencing permanent hair loss may be entitled to financial compensation. There may be significant payouts or cash settlements for those affected by the drug.
Taxotere lawyers and attorneys are actively accepting cases nationwide from women harmed by the medication. Taxotere lawsuits accuse Sanofi of several legal claims, including:
Oct. 4, 2016 — The Judicial Panel on Multidistrict Litigation ruled to consolidate federal Taxotere lawsuits in the Eastern District of Louisiana, U.S District Judge Lance M. Africk presiding. About 89 actions were pending in federal courts nationwide at the time of consolidation.
Jan. 4, 2017 — The Judicial Panel clarified in a letter that cases involving the generic form of Taxotere, docetaxel, can be included in the ongoing litigation. This effectively widened the scope of Taxotere litigation to include cases against generic manufacturers.
January 2017 — The number of Taxotere lawsuits nearly tripled between December and January, jumping from under 300 cases before the holidays to over 700 by January 2017.
February 2017 — French regulators announced an investigation into Taxotere after 5 women died from complications of the drug. Lawsuits continue to be filed against Sanofi in the U.S.
Taxotere lawsuits filed in federal court were consolidated into a multidistrict litigation (MDL) in October 2016. The MDL was coordinated in the Eastern District of Louisiana in a decision handed down by the Judicial Panel on Multidistrict Litigation.
At the time, there were less than 100 cases pending in different federal courts across the country. By March 15, 2017, roughly 6 months after the MDL’s creation, 799 lawsuits were on the list of pending cases.
MDLs help speed up the litigation process by bringing similar lawsuits together in one court. Attorneys on both sides are able to collaborate during the discovery process, which saves time and resources. A few cases are usually picked to be tried first. These are called bellwether trials. Bellwether trials give attorneys the chance to test out legal theories before a jury and can help inform settlement negotiations.
Verdicts or settlements awarded in an MDL are handed down individually in each case. This means global settlements are not split equally among all plaintiffs, like in a class action lawsuit. Instead, they are distributed among plaintiffs on a case by case basis and are often determined by the extent of the plaintiffs’ injuries.
Taxotere is a popular chemotherapy drug used to treat breast cancer. Each year, about 260,000 new cases of breast cancer are diagnosed and Taxotere is used in a majority of the treatments. The drug has brought in billions of dollars for its manufacturer, Sanofi, since it hit the market more than 2 decades ago.
Taxotere was approved in 1996 after receiving priority review by the U.S. Food and Drug Administration. Though the drug is used in a majority of breast cancer treatments, it can also treat some lung cancers, advanced stomach cancer, head and neck cancers and prostate cancer.
Sanofi has marketed its potent chemotherapy drug as a more effective treatment over other FDA-approved drugs — marketing tactics that have not passed FDA muster. The agency has warned Sanofi about misleading consumers and making false claims in their advertisements in the past.
Studies have also linked Taxotere to increased risks of permanent hair loss, a side effect Sanofi claimed was rare.
Now, women who are living with the consequences of their chemotherapy drug are filing lawsuits against Sanofi. They accuse Sanofi of designing a defective product and failing to warn about its potential risks. Some lawsuits accuse Sanofi of covering up trial results that linked the drug to the risk of permanent hair loss and claim Sanofi engaged in a long-running scheme to drive up prices at the expense of cancer patients.
Taxotere is a potent chemotherapy drug and, like all chemotherapy drugs, carries the risk of a number of side effects.
According to its instructions for use, the most common side effects of Taxotere include:
Taxotere can cause patients to lose their hair during treatment, a condition known as alopecia. This is a common side effect of most chemotherapy drugs and is not unique to Taxotere. However, Sanofi’s potent drug has been linked to cases of permanent alopecia. In these cases, hair doesn’t grow back for several years or decades — if ever. Taxotere doesn’t just affect the hair on one’s head either. Women have reported losing their eyebrows, eyelashes and even nostril hairs after using Taxotere.
Permanent hair loss can be devastating for breast cancer survivors, who feel their quality of life has forever been impacted by this one drug.
Sanofi lists permanent hair loss as a possible risk on the Taxotere label, but says hair “generally grows back.” The company estimates that about 3% of Taxotere users could lose their hair, but studies show that number could be much higher.
A study conducted by the Rocky Mountain Cancer Center in Colorado, for example, found 6.3% of patients experienced permanent alopecia after using Taxotere with other chemotherapy drugs — 2x the number of patients estimated by Sanofi.
A UK survey of Taxotere patients found 15.8% had experienced permanent alopecia after using docetaxel, the generic version of Taxotere.
The FDA also warned about the risks of permanent hair loss when using Taxotere and updated the drug’s label in 2015 after receiving reports of postmarket adverse events.
Taxotere belongs to a class of chemotherapy drugs called taxanes. These drugs work by blocking cell growth and interfering with cell division to fight cancer.
Cancer grows and spreads through the process of cell division. Cells divide to replace old cells with new ones. If a cell becomes cancerous, it starts dividing at a much faster rate than healthy cells and each new cell that is made is also cancerous.
Taxotere binds to cells and stops them from dividing. This process leads to the cells’ death and stops cancer cells from spreading further.
The active chemical ingredient in Taxotere is docetaxel.
Lawsuits involving Taxotere accuse Sanofi of hiding evidence of the drug’s hair loss risk. One of the first lawsuits filed against Sanofi alleged the company knew Taxotere was more dangerous than its competitors and frequently caused permanent hair loss. The lawsuit was filed by California resident Ami Dodson in March 2016.
The suit accused Sanofi of withholding evidence of studies from the FDA, patients and physicians that showed Taxotere was no more effective than its competitors — a claim Sanofi had promoted in its advertising in the past.
The lawsuit also claims Sanofi participated in a years-long scheme to drive up Taxotere sales and paid kickbacks to doctors to persuade them to prescribe the drug for off-label purposes.
“Defendants [preyed] on one of the most vulnerable groups of individuals at the most difficult time in their lives,” Dodson said. “Defendants obtained billions of dollars in increased revenues at the expense of unwary cancer victims simply hoping to survive their condition and return to normal life.”
Dodson said women may have accepted the possibility of permanent baldness if no other product were available to treat their cancer, but that was not the case with Taxotere. Other similar drugs were already on the market and they were at least as effective as Taxotere. These drugs also didn’t expose women to the same risks of permanent hair loss, said Dodson.
The FDA has issued several warnings about Taxotere since the drug was approved in 1996. These include black box warnings and various safety communications and label additions highlighting the drug’s potential risks.
Black box warnings are the strongest warnings issued for pharmaceutical drugs. The warnings are placed prominently on a drug’s label and highlight severe risks associated with the product.
Taxotere’s label includes a large black box warning that lists several risks associated with the chemotherapy drug. Some of these risks include:
In 2015, the FDA added new information about permanent alopecia to the Taxotere label.
The agency said cases of permanent alopecia had been reported in postmarketing experience and the information was added to the adverse reactions section on the Taxotere label.
The agency did not include any additional information about the risk of permanent hair loss, such as the percentage of patients thought to be affected by the side effect.
The FDA sent out a warning about Taxotere in 2014 saying the drug could make patients feel drunk during or after treatment. Taxotere contains ethanol, a type of alcohol, and can cause patients to feel intoxicated.
The FDA told patients to avoid driving after their treatments and said medications like pain relievers and sleep aids could worsen the intoxicating effects.
Sanofi updated Taxotere’s label to warn of the risk and physicians were advised to consider the alcohol content when prescribing Taxotere.
The FDA has required numerous changes to the Taxotere label over the years. Many of these changes included additional safety information regarding potential Taxotere side effects, including:
Taxotere is administered intravenously (IV) as a slow drip over the course of an hour.
The amount of Taxotere used during treatment depends on several factors, including the type of cancer being treated. For breast cancer, the recommended dose is 60 mg/m2 to 100 mg/m2 administered intravenously over 1 hour every 3 weeks.
Patients taking Taxotere for any indication only need to get treatment once every 3 weeks. Taxotere’s competitor paclitaxel, on the other hand, is administered once every week.
The convenient treatment schedule makes Taxotere an attractive option for many patients, but it also exposes more people to Taxotere’s risks.
There are many other chemotherapy drugs approved to treat breast cancer in the U.S.
The most common chemotherapy drugs include:
These drugs are often used in combination with one another and are administered either before or after surgery to remove a cancerous tumor. Taxotere and paclitaxel are also used to treat advanced stage breast cancers.
Paclitaxel, also known by its brand name Taxol, belongs to the same class of chemotherapy drugs as Taxotere. Both are taxanes and both treat cancer by blocking cell division. Paclitaxel, however, is a less potent taxane compared to Taxotere and has not been associated with cases of permanent hair loss.
Studies show paclitaxel is as effective as Taxotere in treating breast cancer, despite Sanofi’s claims that Taxotere is superior.
Women who filed lawsuits against Sanofi say they would not have used Taxotere in their chemotherapy treatments had they known about the risk for permanent hair loss since another treatment option — namely, paclitaxel — was available to them.
Clinical studies of Taxotere showed about 3% of users could develop alopecia as a result of treatment and Sanofi assured patients that hair “generally grows back.”
Other studies have shown the rate of alopecia may be much higher than Sanofi claims and that for some patients, hair loss is not temporary.
A study done at the Rocky Mountain Cancer Center in Colorado found up to 6.3% of breast cancer patients treated with Taxotere experienced permanent hair loss. This is nearly 2x the rate seen in Taxotere’s clinical trials.
The study looked at patients treated for breast cancer at the center between 1994 and 2004. It found 6.3% of patients (7 out of 112) treated with Taxotere experienced permanent hair loss, while 0% of patients treated with other chemotherapy drugs, including paclitaxel, experienced permanent hair loss.
The study author said the small but significant risk of such an “emotionally devastating” side effect should be taken into account when deciding on Taxotere.
A survey conducted by the Clatterbridge Cancer Centre in the UK found a high percentage of respondents said they experienced permanent hair loss after treatment with Taxotere.
The survey was conducted in October 2013 and involved patients who received treatment with Taxotere for breast cancer. About 134 out of 189 questionnaires were returned and about 15.8% of respondents said they experienced persistent hair loss following their treatment.
A number of these patients said they not only experienced hair loss on their heads, they also lost eyebrows, eyelashes and nostril hairs.
The study authors concluded that about 10% to 15% of Taxotere patients could experience persistent or permanent hair loss.
Judicial Panel on Multidistrict Litigation. Pending MDLs by District. (March 15, 2017). Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-March-15-2017.pdf
Judicial Panel on Multidistrict Litigation. Transfer Order. IN RE: TAXOTERE (DOCETAXEL)
PRODUCTS LIABILITY LITIGATION. (Oct. 4, 2016). Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2740-Initial_Transfer-09-16.pdf
Dodson v. Sanofi, et al. in the U.S. District Court for the Northern District of California (Case no. 3:16-cv-01251). (March 2016).
Law360. “Sanofi Underplayed Dangers Of Chemo Drug, Suit Says.” John Kennedy. (March 15, 2016). Retrieved from https://www.law360.com/articles/771584/sanofi-underplayed-dangers-of-chemo-drug-suit-says
Taxotere label. (December 2015). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020449s075lbl.pdf
FDA. Safety Information. “Taxotere (docetaxel) injection concentrate.” (January 2016). Retrieved from https://www.fda.gov/safety/medwatch/safetyinformation/ucm212079.htm
FDA. “FDA Drug Safety Communication: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment.” (June 2014). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm401752.htm
American Cancer Society. “Chemotherapy for Breast Cancer.” (August 2016). Retrieved from https://www.cancer.org/cancer/breast-cancer/treatment/chemotherapy-for-breast-cancer.html
Centers for Disease Control and Prevention. “Breast Cancer Statistics.” (March 2016). Retrieved from https://www.cdc.gov/cancer/breast/statistics/index.htm
FDA. Warning Letter to Sanofi. (2003). Retrieved from https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM168879.pdf
Rocky Mountain Cancer Center. “Persistent significant alopecia (PSA) from adjuvant docetaxel after doxorubicin/cyclophosphamide (AC) chemotherapy in women with breast cancer.” Sedlacek SM. Retrieved from http://aheadofourtime.org/medical-studies/
2014 National Cancer Research Institute Cancer Conference. “Long Term Hair Loss in Patients with Early Breast Cancer Receiving Docetaxel Chemotherapy.” Nicola Thorp, et al. (2014). Retrieved from http://conference.ncri.org.uk/abstracts/2014/abstracts/A218.html