Taxotere

  • taxotere

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 hair 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 Legal Proceedings, Verdicts & Settlements:

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

June 2018: The U.S. District Judge Milazzo proposed a bellwether schedule for five Taxotere hair loss lawsuits slated to begin on May 13, 2019.

August 2018: The New Jersey Supreme Court announced the centralization of the cases in the Garden State and assigned the group to Superior Court Judge James Hyland.

January 2019: Plaintiffs and defendants involved in the Taxotere hair loss multidistrict litigation submitted a joint report indicating the increasing size of the litigation in the past months with more than 12,340 lawsuits pending against the defendant, Sanofi-Aventis.

April 2019: U.S. District Judge Jane Triche Milazzo indicated that the start of the first bellwether trial was delayed until September 16, 2019.

September 2019: Dr. David A. Kessler, a former Food and Drug Administration Commissioner, was selected to testify at the first multidistrict litigation bellwether trial.

September 2019: The first bellwether trial, underway in Louisiana federal court, resulted in the jury clearing the defendant manufacturers of liability.

October 2019: The plaintiff in the first Taxotere lawsuit to go before a jury, asked the Louisiana federal court for a new trial, which went in favor of the defendants.

January 2020: Louisiana Federal Judge Jane Triche Milazzo rejected reconsidering lawsuits filed by two Taxotere patients after finding that their cases were filed too late under Louisiana law. 

June 2020: Judge Jane Triche Milazzo passed a defense motion to dismiss the cases filed after December 2015, when new warning labels were added about the risk of permanent hair loss associated with the chemotherapy drug.

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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