Taxotere

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Taxotere containing docetaxel is a chemotherapy drug manufactured and marketed by Sanofi-Aventis, popularly used in the United States and other countries and first approved by the U.S. Food and Drug Administration (FDA) in 1996.

Taxotere acts as a microtubule inhibitor and indicated for treatment of Breast Cancer, Non-Small Cell Lung Cancer, Hormone Refractory Prostate Cancer, Gastric Adenocarcinoma and Squamous Cell Carcinoma of the Head and Neck Cancer but doctors prescribe this drug mainly to treat the breast cancer cases in the U.S making it the most prescribed drug in its class.

Taxotere has disfiguring side effects with permanent hair loss, also called as Alopecia which severely decreased their quality of life, affected body image and caused depression and distress along with other side effects including Cutaneous reactions, Neurologic reactions, Eye disorders.

The company Sanofi was aware by the year 2005 about the results of a trial of GEICAM 9805 which was sponsored by Sanofi in the late 1990s, that 9.2% of women who used the drug Taxotere suffered permanent alopecia. In spite of that Sanofi, manufacturer misled the public by falsely assuring them that hair would grow back after chemotherapy.

Serious Alleged Injuries may include:

  • Persistent or permanent hair loss following the completion of chemotherapy treatment with Taxotere

FDA SAFETY WARNINGS:

In June 2014: The FDA required a revision of drug labels for all docetaxel-containing drugs to reflect a warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, patients may be experiencing intoxication or feel drunk during and after treatment. 

There are black-box warnings for several conditions that can result in serious injury or death for patients given the chemotherapy drug.

  • Liver damage or abnormal liver function are at a greater risk of dying while being treated with Taxotere.
  • Fluid retention is another serious side effect because it can be severe.
  • Hypersensitive which can lead to a severe allergic reaction called anaphylaxis, which can quickly lead to death if not treated as a medical emergency.
  • In December 2015, the Food and Drug Administration ordered that the warning label for the chemotherapy drug Taxotere be updated to include risks for permanent hair loss or alopecia.

Lawsuit Allegations:

Breast cancer survivors and their families are filing lawsuits against Sanofi manufacturer with claim stating that, the company failed to warn women in the U.S. of the risk as the words "permanent hair loss" or "Alopecia" do not appear in any information published in the U.S. and hid research related to this drug to the toxic side effects. Plaintiffs may also claim that the company promoted the drug, knowing what the risks were and knowing that Taxotere was likely not more effective than a lower-potency, similar drug called Taxol.

On October 4, 2016, Taxotere lawsuits were centralized resulting in the formation of MDL2740 (In Re: Taxotere (Docetaxel) Products Liability Litigation) in the Eastern District of Louisiana, to be presided by  Judge Kurt D. Engelhardt. The bellwether trials will begin on: January 28, 2019; April 8, 2019; July 15, 2019; November 4, 2019. Hundreds of lawsuits are a part of the MDL and the number is expected to grow.

Evidences:

  • Diagnosis and treatment of cancer
  • Usage in in Medical and Pharmacy Records
  • Duration of Taxotere usage in Medical and Pharmacy Records
  • Complications and treatment in follow up records

Medical Record Review and claim validation of Taxotere case should take approximately 2 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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