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TaxotereLinked to Permanent Hair Loss in Women

Taxotere Lawsuit

Taxotere is a popular chemotherapy drug that is commonly prescribed to breast cancer. Taxotere has been linked to Alopecia, a disease which causes permanent hair loss. Taxotere manufacturer, Sanofi, failed to warn consumers of all the risks associated with the chemotherapy drug, in some cases even hiding research and evidence from the public. There is currently a number of lawsuits filed on behalf of women who allege they developed Alopecia or experienced similar adverse effects as a result of Taxotere.

Litigation Updates

Lawsuit Continues to Move Forward

August 2018 - As a result of a new bellwether trial, the first Taxotere trial will begin in May 2019, under a new judge, Jane Triche Milazzo in the Eastern District of Louisiana. We have been filing cases since April 2018. If you have any questions regarding a Taxotere lawsuit, please contact us.

New Bellwether Trial Schedule Published

June 2018 – As a result of the re-assignment of the Taxotere MDL, a new bellwether trial schedule is published.  The first trial is set for May 2019.  Four additional trials are set through 2019 and 2020.

MDL is Reassigned to Different Judge

May 2018 – Judge Engelhardt, who had been presiding of the Taxotere MDL from its inception, was elevated to the United States Court of Appeals for the Fifth Circuit Judge.  The Taxotere MDL was assigned to the Honorable Jane Triche Milazzo, another United States District Judge for the Eastern District of Louisiana.

Taxotere Cases Are Being Filed

April 2018 - We are filing cases regarding branded and generic Taxotere. Bellwether trials are scheduled to start in 2019.

30 Lawsuits Consolidated into MDL

October 2016 - More than 30 lawsuits were consolidated in the Eastern District of Louisiana as the initial Taxotere multidistrict litigation (MDL).  This consolidation will allow the individual cases to proceed in an efficient and organized manner, ensuring consistent rulings and preserving the resources of the parties and the court.

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What is Taxotere?

Taxotere (active ingredient: docetaxel) is manufactured by Sanofi-Aventi and was first approved by the U.S. Food and Drug Administration in May 1996. Taxotere is used to treat an array of cancers but is most commonly prescribed to treat patients with locally advanced or metastatic breast cancer, which had progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapy. The drug is also used as an adjuvant treatment in combination with doxorubicin and cyclophosphamide for individuals with operable node-positive breast cancer. Taxotere works in stopping the spread of cancerous cells by cutting off the dividing and multiplying of cells in and around a cancerous clump. Taxotere falls under a specific class of chemotherapy treatments called taxane drugs – made from plant alkaloids.

Taxotere has also been approved to treat non-small cell lung cancer (NSCLC), prostate cancer, head and neck cancers, and stomach cancer (gastric adenocarcinoma).

Of the drugs used to treat breast cancer, Taxotere is the most prescribed drug in its class (taxane) – some sources estimate that 75% of breast cancer patients will receive Taxotere as a form of treatment.

Unlike similar chemotherapy drugs with weekly treatment plans, Taxotere’s treatment plan runs at three-week intervals. Fewer trips to the doctor for treatment makes Taxotere more attractive to both patients and doctors.

Taxotere has also been approved for administration outside of the hospital (in 60-100 mg/m2 doses). Similar chemotherapy treatments require hospitalization to cope with extended infusion times.

As is warned on the Taxotere label, toxic death occurs in around 2% of metastatic breast cancer patients and about 11.5% of patients with other tumor types with abnormal liver function who are using Taxotere.

 

Taxotere Dangers, Side Effects, and Injuries

Along with the more common side effects, there are also more life-threatening adverse effects associated with Taxotere.

Taxotere carries a black box warning for several known adverse health effects associated with the drug.

These black box adverse health effects include:

  • Toxic Death– increased risks for patients with abnormal liver function, patients prescribed higher doses, patients suffering from NSCLC and prior platinum-based therapy recipients.
  • Hepatotoxicity– liver damage caused by chemical exposure due to Taxotere treatment. Common in patients with abnormal liver function or elevated LFT, hepatotoxicity can because severe complications and even be life-threatening.
  • Fluid Retention– Taxotere’s label warns that the condition may reach severe levels for some patients.
  • Neutropenia– A low neutrophils (specific white blood cell) count makes patients more likely to contract bacterial infections. If gone untreated, these bacterial infections can cause severe health conditions and even death. Patients with neutrophil counts under 1500 cells per 3 cubic millimeters of blood volume are more susceptible to develop neutropenia and are advised against using Taxotere unless necessary. Doctors are advised to frequently check blood counts for these patients who do use Taxotere.
  • Hypersensitivity Reactions– Reactions like a rash, low blood pressure, and fatal anaphylaxis. Patients who received dexamethasone premedication are most susceptible to developing these conditions.

 

Taxotere Linked to Alopecia Hair Loss

Temporary hair loss is a common side effect of most chemotherapy treatments. However, most do not cause a complete loss of hair or the hair loss does not become permanent. Studies find that among all of the side effects associated with chemotherapy, temporary hair loss has the greatest impact on a patient’s quality of life. Taxotere has been linked to Alopecia, permanent hair loss, in those who take the drug for chemotherapeutic treatment.

Alopecia is a permanent and irreversible hair loss disease which affects all body hair, including eyebrows, eyelashes, facial hair, and pubic hair. Multiple studies have found that Taxotere use can result in Alopecia.

Evidence of Alopecia occurring in Taxotere patients includes:

  • Documents from the Sanofi-funded GEICAM 9805 study – which was presented as evidence in an ongoing litigation against Sanofi, that reveal that around 9.2% of patients suffered hair loss that lasted more than a decade.
  • A 2006 study conducted by the Rock Mountain Cancer Centers, which found that Taxotere caused 6% of women to suffer permanent alopecia.
  • A 2012 study published in the Annals of Oncology. Of the 20 female participants who received Taxotere, 19 developed permanent hair loss. One participant who was being treated for reoccurring breast cancer had previously undergone chemotherapy with a different drug and had complete hair regrowth, but after using Taxotere, she suffered from permanent hair loss.

Alopecia can severely affect a person’s quality of life, affect body image, and cause depression and distress. For women who already have to struggle with the burden of breast cancer and chemotherapy, developing Alopecia can be devastating.

For breast cancer survivors, Alopecia is more than a cosmetic effect. The disease is a constant reminder of the struggle to fight breast cancer. The 2012 study published in the Annals of Oncology found that women who suffered from Alopecia due to Taxotere suffered “significant impairment” to their quality of life.

 

Injuries We’re Pursuing in a Taxotere Lawsuit

Due to the negative effects Taxotere can have on an individual, TorHoerman Law is accepting Taoases for women who have experienced permanent thinning or loss of hair following the use of Taxotere.

 

Taxotere Lawsuit

A growing number of women and their families have filed lawsuits against Taxotere manufacturer Sanofi and against certain generic manufacturers, claiming that the manufacturers were aware of the increased risks of Alopecia, but failed to warn consumers. The plaintiffs also claim that Sanofi hid data and research that linked Taxotere to these adverse side effects.

In fact, Sanofi did warn consumers outside of the U.S. that Taxotere could be linked to “permanent hair loss” and even Alopecia but failed to warn U.S. consumers

Evidence presented in litigation against Sanofi indicates that the manufacturer tried to downplay the known risks in order to get the drug approved in 1996. Plaintiffs have made accusations that employee training incorporated teaching misrepresentation of safety and effectiveness, and alleged illegal payments in the form of “kickbacks” to doctors who prescribed Taxotere.

Lawsuits claim that Sanofi actually misled the U.S. public through advertising and marketing that assured Taxotere users that hair loss was only temporary and that there was no threat of permanent hair loss.

Plaintiffs allege that Sanofi also failed to recognize in-house data collected from the GEICAM 9805 study, which indicated that around 9.2% of patients suffered hair loss that lasted more than 10 years, and that Sanofi did not recognize the findings of Dr. Scott Sedlack of the Rocky Mountain Cancer Centers, whose findings indicated that 6% of women using Taxotere developed permanent Alopecia.

While studies indicate that Taxotere is an effective chemotherapy treatment, lawsuits allege that other treatments, which are at least as effective as Taxotere, do not subject consumers to the same risks of permanent hair loss.

 

Do You Qualify to Participate in Taxotere Lawsuit?

Currently, there is a multidistrict litigation consolidated in the Eastern District of Louisiana. The Taxotere lawsuit is comprised of women who developed Alopecia after using Taxotere.

If you currently suffer from a permanent hair loss disease and were previously prescribed Taxotere, contact the office of TorHoerman Law for a free, no-obligation evaluation and Taxotere lawsuit consultation today.

Our dedicated team of bad drug lawyers will be here to help you every step of the way, answer any questions you may have, and walk you through the steps of your Taxotere lawsuit.

Timeline

Alopecia Added as Potential Side Effect to Label

December 2015 – The potential side effect of alopecia was included on the Taxotere label for the first time.

FDA Issued Safety Communication

June 2014 – The FDA issued a safety communication about the potential for patients to experience intoxication during or after the use of Taxotere due to the presence of ethanol in docetaxel.

Study Revealed Permanent Hair Loss

May 2012 – A study published in the Annals of Oncology revealed that, of the 20 female participants who received Taxotere, 19 developed permanent hair loss. One participant who was being treated for reoccurring breast cancer had previously undergone chemotherapy with a different drug and had complete hair regrowth, but after using Taxotere, she suffered from permanent hair loss.

Study Revealed Percentage of Patients Suffered Long-Term Hair Loss

December 2010 – A release of documents from the Sanofi-funded GEICAM 9805 study revealed that around 9.2% of patients suffered hair loss that lasted more than a decade.

Study Found Taxotere Caused Permanent Alopecia in 6% of Women

December 2006 – A study conducted by the Rock Mountain Cancer Centers found that Taxotere caused 6% of women to suffer permanent alopecia.

Taxotere Approved For Yet Another Cancer Treatment

October 2006 - Taxotere was approved for use in combination with cisplatin and fluorouracil for patients being treated for inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN).

Taxotere Approved for Treatment of Advanced Gastric Adenocarcinoma

March 2006 - Taxotere was approved for use in combination with cisplatin and fluorouracil for patients being treated for advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy.

Drug Approved to Treat Another Form of Breast Cancer

August 2004 - Taxotere was approved for use in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of women with operable node-positive breast cancer.

Taxotere Approved for Use to Treat Type of Prostate Cancer

May 2004 – Taxotere was approved for use in combination with prednisone for the treatment of metastatic, androgen-independent prostate cancer.

Drug Approved for Use as Injection

December 1999 – The drug was approved for use as an injection to treat patients suffering from locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.

Taxotere Approved for Treatment of Metastatic Breast Cancer

June 1998 – Taxotere was approved for first-line treatment of metastatic breast cancer in subjects whose disease had recurred despite adjuvant therapy.

Taxotere Approved by FDA

May 1996 – Taxotere was initially approved for use by the U.S. Food & Drug Administration.

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