Plaintiffs Allege Taxotere Makers Failed to Warn of Alopecia
Sanofi-Aventis continues to face lawsuits over Taxotere, a chemotherapy drug. Plaintiffs in the litigation allege that the cancer treatment drug caused permanent hair loss, also known as alopecia, and that they were never warned about this potential side effect. Taxotere permanent hair loss lawsuits continue to move forward, as cases mount in the Taxotere multidistrict litigation (MDL).
Parker Waichman LLP is a national law firm representing numerous clients in drug injury claims. The firm continues to offer free legal consultations to anyone with questions about filing a Taxotere permanent hair loss lawsuit.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated Taxotere permanent hair loss lawsuits into an MDL in the U.S. District Court, Eastern District of Louisiana. An MDL is a type of mass tort that transfers similar lawsuits to one court before one judge. This type of consolidation eliminates duplicate discovery and makes the overall litigation more efficient. According to court records, there are over 260 Taxotere lawsuits pending in the MDL.
The Taxotere litigation is continuing to move forward, as several Pretrial Orders have been issued. The Plaintiff and Defendant fact sheets were due last month. In a Jan. 11 Pretrial Order, the U.S. District Court for the Eastern District of Louisiana clarified that the MDL will include both brand-name and generic versions of the chemotherapy drug.
Hair loss is a well-recognized side effect associated with chemotherapy. Plaintiffs in the litigation typically allege that they knew about the risk of hair loss, but believed that this adverse event was temporary. Taxotere makers never warned that the drug has a higher risk of permanent hair loss compared to other drugs, lawsuits allege. Plaintiffs allege that they would have chosen a different treatment option if they were fully informed of the risks.
Additionally, plaintiffs point out that the Taxotere label was updated to include permanent hair loss in Europe, but this information was not included on the United States label until 2015.
In December 2015, the U.S. Food and Drug Administration (FDA) announced that the Taxotere label would be updated to include information about permanent alopecia. The “Postmarketing Experience” section has been revised to state that “Cases of permanent alopecia have been reported” in patients taking Taxotere.
Plaintiffs allege that the unexpected and permanent loss of hair takes a psychological toll. Lawsuits allege that drug makers knew about this risk but failed to warn patients or their physicians. Among other things, plaintiffs cite the GEICAM 9805 study, in which permanent hair loss occurred in 9.2 percent of patients taking Taxotere.
“Despite Defendants’ knowledge of the relevant findings from the GEICAM 9805 study, as well as reports of patients who had taken Taxotere and suffered from permanent alopecia, Defendants failed to provide accurate information and proper warnings to physicians, healthcare providers, and patients in the United States, including Plaintiffs,” a Taxotere complaint states.
Permanent hair loss was also documented in another study, published in the Annals of Oncology in 2012. The authors wrote that, “Considering the increasing role of taxane-based therapies in adjuvant treatment, physicians and patients should be aware of this new distressing side-effect,”
The FDA approved Taxotere in 1996. The drug, known by its generic name as docetaxel, is used to treat cancers of the head and neck, breast cancer, prostate cancer, stomach cancer and non-small-cell lung cancer.
Other brand name versions of docetaxel include Docefrez, and Docetaxel Injection.
Taxotere Side Effects: Alcohol Intoxication
In 2014, the FDA issued a Drug Safety Communication warning that Taxotere may cause patients to feel intoxicated after treatment. This is because the medication contains ethanol, the type of alcohol consumed in alcoholic beverages. When taken intravenously, Taxotere can cause patients to feel drunk, the FDA warned.
The label was updated to reflect this risk. Regulators advised doctors to consider the amount of alcohol contained in Taxotere when prescribing the drug to patients, particularly in cases where alcohol should be avoided.
Patients taking Taxotere should know that it can cause intoxication after treatment. “Patients should avoid driving, operating machinery, or performing other activities that are dangerous for one to two hours after the infusion of docetaxel,” the FDA alert said. “In addition, some medications, such as pain relievers and sleep aids, may interact with the alcohol in the docetaxel infusion and worsen the intoxicating effects.”
Filing a Taxotere Lawsuit
If you or someone you know suffered permanent hair loss after taking Taxotere, you may have valuable legal rights. Parker Waichman offers free, no-obligation case evaluations. For more information, contact our firm today by filling out our online form or calling 1-800-YOURLAWYER (1-800-968-7529).