FDA Releases New Patient Info for Taxotere (Docetaxel) Cancer Drug

taxotere2The FDA Center for Drug Evaluation and Research approved new safety labeling changes for the Taxotere (Docetaxel) breast cancer drug in July 2016, adding the following to the list of adverse reactions:

  • Acute Myeloid Leukemia
  • Cutaneous Reactions
  • Neurologic Reactions
  • Eye Disorders
  • Asthenia
  • Alcohol Intoxication

The agency noted that additional of cases of permanent alopecia have been reported, and lawsuits are proliferating that the Taxotere cancer drug causes permanent hair loss.

Mass Tort Nexus has prepared a briefcase of files about Taxotere litigation.

The emerging litigation is ripe for a motion to consolidate them into a federal multi-district litigation docket, because complaints involving Taxotere (Docetaxel) have been filed in multiple jurisdictions, including US District Courts in Illinois, North Carolina, Florida, Mississippi, Kansas, Louisiana and Colorado.

  • Defendant Sanofi S.A. is a corporation or Société Anonyme organized and existing under the laws of France, having its principal place of business in Paris, France.
  • Defendant Aventis Pharma S.A. is a corporation or Société Anonyme organized and existing under the laws of France, having its principal place of business in Antony, France.
  • Defendant Sanofi-Aventis U.S. LLC is a Delaware limited liability company, which has its principal place of business at 55 Corporate Drive, Bridgewater, New Jersey.

Taxotere is a drug used to treat various forms of cancer, including but not limited to breast cancer. It is a part of a family of drugs commonly referred to as Taxanes.

Disfiguring permanent alopecia

A leading The California case is Ami Dodson v. Sanofi S.A, Case 4:16-cv-01251-PJH. US District Judge Phyllis J. Hamilton ordered that lead counsel shall confer and file a joint case management statement addressing jurisdiction and service, facts, legal issues, motions, amendment of pleadings and evidence preservation.

Following a March 3rd, 2010 left breast biopsy, Dodson met with her oncologist to discuss further treatment. Neither she nor her treating healthcare providers were aware of or informed by defendants that disfiguring permanent alopecia can occur following treatment with Taxotere. Accordingly, she  underwent chemotherapy that included Taxotere. Following the chemotherapy, she lost all of her hair as a result of receiving chemotherapy with Taxotere.

A study published in 2008 in the New England Journal of Medicine concluded that Taxol (paclitaxel) was more effective than Taxotere (docetaxel) for patients undergoing standard adjuvant chemotherapy with doxorubicin and cyclophosphamide. Despite the publication of these studies, the defendants continued to make false and misleading statements promoting the “superior efficacy” of Taxotere over the competing product paclitaxel Taxol, according to the complaint.

Defendants’ statements in a “reprint carrier” marketing the conclusions of the 2005 JCO study were false and misleading in light of the 2007 and 2008 studies finding that Taxotere was not more effective than paclitaxel in treating breast cancer. As a result of these false and misleading statements, in 2009, the FDA issued a warning letter to Sanofi-Aventis.

Defendants knew or should have known that the rate of permanent alopecia related to Taxotere was far greater than with other products available to treat the same condition as Defendants’ product. Permanent baldness (permanent alopecia) is a disfiguring condition, especially for women. Women who experienced disfiguring permanent alopecia as a result of the use of Taxotere suffer great mental anguish as well as economic damages, including but not limited to loss of work or inability to work due to significant psychological damage.


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