Taxotere [docetaxel] Lawsuit
MANUFACTURER: Sanofi-Aventis [French multinational pharmaceutical company]
INJURIES: Permanent hair loss [alopecia], ranging from patches of hair missing to complete baldness
A drug used for breast cancer chemotherapy for lumpectomy or mastectomy patients, which causes PERMANENT [not temporary], disfiguring hair loss. Many of these breast cancer victims have excellent prognosis with early diagnosis and treatment, and are usually middle age, in their 30-50’s. None of these patients or their doctors were told that they could choose between 2 different drugs: both effective in curing the cancer, but that one drug [Taxotere] would cause permanent hair loss and the other would not. The stories these women tell about the permanent disfigurement they live with every day is heart-wrenching. Wigs are their only option for the rest of their life!
The disturbing evidence we plaintiffs attorneys have discovered, is that the manufacturer, Sanofi-Aventis, knew this fact for at least 10 years and failed to warn doctors, the FDA and the women of this country. What makes this even more egregious is that there are other alternative chemotherapy medications available which only cause temporary hair loss, not permanent. Thousands of women have been permanently disfigured by this drug. Taxotere is one of two major chemo drugs used for the treatment of breast cancer, and it is the only one that permanently damages the hair follicules & prevents it from growing back.
Taxotere was FDA approved in 1996 and was found to be more cellularly active and more potent than its counterpart, Taxol [manufactured by Bristol Myers Squibb], which does not cause permanent hair loss. Sanofi-Aventis claimed it was more effective than Taxol but that claim has not been proven by the medical literatue. In a 2008 study, the estimated 5-year survival rate for the best regimen of Taxol vs Taxotere, showed Taxotere had a 5 year survival of 81.2% vs 81.5% for Taxol [See Joseph A. Sparano, MD, et al, “Weekly Paclitaxel in the Adjuvant Treatment of Breast Cancer”, Vol. 358, No. 16, NEJM, 4.17.2008]. Other studies in the medical literature reported that both regimens have comparable efficacy but Taxotere had more toxicity and was less tolerable than Taxol.
Various medical reports documenting patient follow up post Taxotere in 2006, and 2014 noted the permanent hair loss from Taxotere ranged from 6.3% to 10-15%; whereas there was ZERO permanent hair loss in the Taxol group.
In 2009 the FDA demanded Sanofi stop marketing Taxotere based on a false promise of better results. FDA sent letters to Sanofi stating their reprint carrier presented unsubstantiated superiority claims & overstated the efficacy of Taxotere.
SANOFI TOLD THE REST OF THE WORLD ABOUT THE PERMANENT HAIR LOSS LONG BEFORE THEY TOLD U.S. DOCTORS & U.S. PATIENTS
However, Sanofi told the European Medicines Agency [AMS] in 2005 that “alopecia persisted into the follow up period [median follow-up time of 10 years and 5 months] and was observed to be ongoing”.
In 2012, Sanofi told the Canadians and British Columbians in the Cancer Drug Manual that there were cases of poor hair re-growth & persistent hair loss reported, possibly irreversible.
SANOFI SAID NOTHING FROM 1999-DEC. 2015 ABOUT PERMANENT HAIR LOSS.
There were no US warnings about permanent or even persistent hair loss from 1999-2010. In fact, their label said “Once you have completed all your treatments, hair generally grows back.” From 2010-2015 the only change was that Sanofi removed the statement that “hair generally grows back.”
1.2016 FDA REQUIRED SANOFI TO ADD “WATERED DOWN” INFORMATION ABOUT PERMANENT HAIR LOSS TO THE PATIENT COUNSELING INFORMATION SECTION
The doctor is supposed to explain to the patient that hair loss, cases of permanent hair loss have been reported associated with Taxotere. However, as a plaintiffs’ attorney, I believe this warning is still inadequate and should be at the beginning of the label in the form of a black box warning for all to read.
We are currently accepting clients who were prescribed Taxotere for breast cancer and sustained permanent hair loss [alopecia], either in patches or complete baldness, that lasted at least 6 months after their last Taxotere treatment.
Please spread the word to other women you know who may be undergoing chemotherapy for breast cancer. If you or a loved one have experienced any of these side effects, please call today for your free evaluation as you have limited amount of time to protect your rights.