Taxotere

  • Taxotere Medical Record Review & Outsourcing Services

Taxotere (docetaxel) is a cytotoxic intravenous chemotherapy drug used to treat various cancers like breast, lung, prostate, stomach, etc. This anti-cancer drug is manufactured and marketed by Sanofi-Aventis and was first approved by the U.S. Food and Drug Administration (FDA) in 1996.

Taxotere belongs to a class of chemotherapy drugs called plant alkaloids also known as antimicrotubule agents. Antimicrotubule agents inhibit the microtubule structures within the cell required for cell division and self-replication; inhibition of these structures ultimately results in cell death. Taxotere is approved in the treatment of breast cancer, non-small cell lung cancer, advanced stomach cancer, head and neck cancer and metastatic prostate 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 that include permanent hair loss, also known as Alopecia, which severely impacts the quality of life, which could lead to depression and distress. Other side effects include cutaneous reactions, neurologic reactions, eye disorders. The company Sanofi was aware by the year 2005 about the results of a trial 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 misled the public by falsely reassuring them that hair would grow back after chemotherapy.

Thousands of women are bringing product liability lawsuits against Sanofi-Aventis, alleging permanent hail loss. These plaintiffs are claiming that Sanfoi-Adventis knew about the effectiveness of Taxotere and the fact that the drug may cause permanent hair loss, yet did not provide any warning.

Chemotherapy drugs are known for being harsh on the body; as cancer is difficult to destroy otherwise. Unfortunately, it’s still one of the most effective methods to combat cancer. Around Six to nine percent of patients using Taxotere may have experienced permanent baldness or alopecia which may be partial or total hair loss and may contribute to psychological problems.

The common side effects of chemotherapy drugs are:

  • Fatigue

  • Anemia

  • Infections

  • Nausea and vomiting

  • Constipation

  • Hair loss

  • Diarrhea

  • Nerve tingling

  • Changes to skin and nails

  • Weight fluctuations

  • Difficulty concentrating

  • Mouth and throat pain

Serious Alleged Injuries may include:

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

FDA Safety Warnings:

  • 2009: The FDA sent a letter demanding Sanofi to stop marketing Taxotere-based on the false promise of better results. (Sanofi had been marketing Taxotere as more effective than Taxol, the competitor)

  • 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, and patients may experience intoxication or feel drunk during and after treatment.

  • December 2015: The FDA ordered that the warning label for the chemotherapy drug Taxotere be updated to include risks for permanent hair loss or alopecia.

Legal Updates:

Defendants: Sanofi S.A., Aventis Pharma S.A., and Sanofi-Aventis U.S., LLC, and Winthrop US.

Defendant Law Firm: Sanofi, Aventis Inc., and Aventisub LLC are represented by Richard L. Scheff of Montgomery McCracken Walker & Rhoads LLP, and Robert J. McCully of Shook Hardy & Bacon LLP.

Defendant Liaison Counsel: Douglas J. Moore - Irwin Fritchie Urquhart & Moore LLC; John F. Olinde - Chaffe McCall, LLP

Allegations: The defendant faces allegations that it intentionally deceived the medical community and the patients by not making them aware of the risk of permanent hair loss associated with the use of Taxotere; selling the drug without proper testing; misleading the public in its advertising and marketing. Additionally, compensations have also been demanded to state the drug has severely impacted the consumers’ quality of life further leading to anxiety, body image issues, sexual dysfunction, and even an inability to return to work.

Plaintiff Steering Committee:

  • Andrew Lemmon - Lemmon Law Firm, LLC

  • Emily Jeffcott - The Lambert Firm, PLC

  • Christopher Coffin - Pendley, Baudin & Coffin, LLP

  • J. Kyle Bachus - Bachus & Schanker, LLC

  • Anne Andrews - Andrews Thornton Higgins Razmara, LLP

  • Karen Barth Menzies - Gibbs Law Group LLP

  • Hunter J. Shkolnik - Napoli Shkolnik PLLC

  • Genevieve Zimmerman - Meshbesher & Spence LTD

  • Abby E. McClellan - Stueve Siegel Hanson LLP

  • Lawrence J. Centola, III - Martzell, Bickford, & Centola

  • Alexander G. Dwyer - Kirkendall Dwyer LLP

  • David F. Miceli - Simmons Hanly Conroy

  • Rand P. Nolen - Fleming, Nolen & Jez, LLP

  • Daniel Markoff - Atkins & Markoff Law Firm

All appointments were for a term beginning from Pre-Trial Order- 93 dated January 2019 until January 1, 2020, when the Court will address the appointment or reappointment of counsel.

Lawsuit Status:

In October 2016, around 33 lawsuits Taxotere lawsuits from 25 districts were  consolidated under MDL No. 2740 IN RE: Taxotere (Docetaxel) Products Liability Litigation in U.S. District Court for the Eastern District of Louisiana before  Judge Kurt D. Engelhardt. Within a year, the number of lawsuits grew to over 2,000. The count increased to nearly 12,000 as of January 2019.

As of February 2019, no active class action lawsuits are pending against Sanofi-Aventis.

Important Verdicts & Settlements

The bellwether trials for MDL No. 2740 are scheduled for 2019 to be overseen by Judge Jane T. Milazzo.

The initial trials are set for the following dates by the court:

  • May 13-24, 2019

  • September 16-27, 2019

  • January 27-February 7, 2020

  • May 11-22, 2020

  • September 14-25, 2020

There have been none settlements as of January 2019.

In a case management order issued on April 17, Judge Jane Triche Milazzo presiding over all Taxotere hair loss lawsuits announced that the first bellwether trial in the litigation is scheduled for September 2019.

Evidence:

  • 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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