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More than 2.8 million women in the U.S. have a history of breast cancer, including those receiving treatment and those who have completed their treatments. For each of them, whether they are tomboys, glamour girls, or somewhere in the middle, their hair is part of who they are. It’s their mane and their crown.
Most women have to make peace with the fact that they may lose their hair during treatment, and part of that peace is knowing that it will grow back. In fact, one of the things that symbolizes “getting back to normal” after treatment is regrowing the hair lost during chemotherapy.
Yet thousands of women have never regrown their hair, eyebrows, eyelashes and pubic hair after treatment. These women were left feeling devastated and cheated by a pharmaceutical company that promised their chemo drug was better and safer than the alternative.
If you received Taxotere chemotherapy and are suffering from permanent hair loss or alopecia, we urge you to read this guide, which will give you the most recent relevant information, as well as help you understand the legal options that may be available to you.
Important Warning Video
What is Taxotere?
Taxotere (Docetaxel) is a plant-based synthetic drug and antimicrotubule agent classified as a taxane. The chemotherapy medication is manufactured by Sanofi-Aventis and was approved by the Food and Drug Administration in 1996 for sale on the U.S. market. It the most prescribed chemotherapy medication in its class, according to the manufacturer. In fact, it’s estimated that more than three-quarters of breast cancer patients are treated with Taxotere.
What Cancers is Taxotere Used to Treat?
Currently, Taxotere is used to treat several forms of cancer including:
- Breast cancer
- Non-small cell Lung cancer
- Metastatic Prostate cancer
- Advanced Stomach cancer
- Head and neck cancer
The drug is also being investigated by researchers and doctors as a potential treatment for small cell bladder, lung, ovarian, and pancreatic cancer, as well as soft tissue sarcoma and melanoma.
How Does Taxotere Work?
Taxotere does not come in pill form and is given intravenously through IV. The amount given depends on individual factors such as height and weight, general condition of health, and the specific type of cancer or condition being treated. Your oncologist will determine the dose and duration of treatment. Taxotere is derived from the plant alkaloids of the bark of the Pacific Yew tree. It works by preventing cancer cells from dividing and spreading. It does this by inhibiting certain structures within the cell that that are required for cell division and replication. When these structures are inhibited, the cell dies, and the cancer can’t spread.
As with most drugs, patients receiving Taxotere may experience a variety of side effects, most of which will go away once treatment is completed. Because the dose and schedule are different for individual patients, those on higher doses may experience more or more severe side effects.
Side effects that occur in more than 30 percent of patients:
- Low white blood cell count
- Low red blood cell count
- Nadir – 5 to 9 days (time between cycles when low blood counts are experienced)
- Weight gain with fluid retention in ankles or abdomen
- Numbness in toes and fingers (peripheral neuropathy)
- Nausea and diarrhea
- Hair loss
- Mouth sores
- Color changes in finger and toe nails. Nails may fall off
Side effects occurring in 10 to 29 percent of patients:
- Bone, joint and muscle pain
- Low platelet counts that increase bleeding risks
- Liver problems
The FDA requires a black box warning for Taxotere for the following side-effects :
- Toxic death
- Kidney damage (hepatoxicity)
- Allergic reactions including low blood pressure, rash, and anaphylaxis
- Fluid retention
FDA Warning and Safety Labeling Changes
In 2015, the U.S. Food and Drug Administration issued a requirement for Sanofi-Aventis to change the safety label of the drug including a warning about the alopecia and permanent hair loss adverse reactions to the medication. This warning comes after several FDA warnings including-
Respiratory adverse reactions such as:
- Acute pulmonary edema
- Acute respiratory distress
- Interstitial lung disease/interstitial pneumonia
- Respiratory failure
- Pulmonary fibrosis
Eye disorders including:
- Cystoid macular edema
- Decreased vision
In 2014, the FDA required a drug safety label change notifying that the alcohol content in Taxotere could make patients feel intoxicated, and warned them not to drive or operate machinery after an infusion.
Permanent Hair Loss Linked to Taxotere
Losing your hair during chemotherapy is distressing to most people, particularly women. And while it is common for a cancer patient’s hair to fall out during treatment, it usually starts to regrow within a relatively short time after treatment stops. However, for some, the hair loss is permanent.
Unfortunately, medical studies are proving what some patients have come to realize: Taxotere can cause permanent and irreversible hair loss, a condition known as alopecia. For some, all the hair falls out, while for others, the hair loss is splotchy, or only thin, wispy strands of hair grow back. Even worse, some patients may grow hair back, only to have it fall out again for no reason.
Several studies have shown that use of Taxotere carries an increased risk of permanent hair loss including:
- Researchers at Clatterbridge Cancer Centre, Wirral, UK find that 15.8 percent of 189 early breast cancer patients experience permanent alopecia. 16 of the patients were wearing wigs and hair extensions, 5 never regrew their eyebrows, 2 did not regrow their eyelashes, 6 didn’t regrow nostril hair, and 14 experienced no regrowth to other normal hair areas, like their legs.
- Researchers published in the Annals of Oncology write that chemotherapy-induced alopecia is “one of the most distressing/troublesome side-effects of chemotherapy” and may “significantly impact an individual’s self-image with poorer body image,” causing a significantly decreased quality of life.
- Dr. SM Sedlacek at the Rocky Mountain Cancer Centers finds that up to six percent of breast cancer patients could suffer permanent hair loss and alopecia when given Taxotere in combination with other drugs. Regarding chemo-induced alopecia, Sedlacek writes, that the “emotionally devastating” long-term effects of the drug, must be taken into account when deciding on a treatment program.
- A Sanofi-sponsored study found that nearly 10 percent of patients suffered long-term/permanent hair loss.
Hair Loss Lawsuits
Currently, more than 9,100 lawsuits have been centralized in multidistrict litigation to U.S. District Court for the Eastern District of Louisiana for trial under Judge Kurt D. Engelhardt, and additional lawsuits are pending in state courts across the country, including in Delaware, New Jersey, California, and Illinois. Each trial will work to determine the liability of the drug maker according to the law.
Five bellwether trials have been scheduled starting in May 2019. These trials are often considered tests cases that can give insight into how judge and juries will respond to evidence and arguments in these and future Taxol related cases.
Currently, the bellwether trials are scheduled for:
- May 13, 2019
- September 16, 2019
- January 27, 2020
- May 11, 2020
- September 14, 2020
The plaintiffs lawsuits allege claims of injury including:
- Sanofi SA knew that its product Taxotere was more dangerous than similar alternatives
- Sanofi SA knew its medication frequently causes permanent hair loss and baldness
- Sanofi, Aventis Pharma SA and Sanofi-Aventis US LLC “went to great lengths to hide the problem” and marketed the drug as superior to its competition to drive up sales
- The actions of the pharmaceutical company caused women to be exposed to Taxotere increased toxicity as compared to similar drugs, and permanent hair loss.
These schemes started in 1996 after the drug was approved by the U.S. Food and Drug Administration for the U.S. market.
A whistleblower lawsuit filed in 2015 by a lawyer on behalf of a former employee alleges that the drug maker:
- Trained its employees to misrepresent the safety and efficacy of off-label uses to expand its market
- Paid kickbacks to medical providers to incentivize them to prescribe the drug for off-label uses.
- As a direct result of these schemes, Taxotere sales jumped from $424 million to $1.4 billion four years later
What to Do If You’ve Been Affected
If you or someone you love has suffered permanent hair loss after receiving Taxotere chemotherapy treatments, contact one of our lawyers today to discuss your cause of action. Many cancer patients have sought legal representation from an experienced attorney over claims of hair loss. Most of these patients say they would not have used the chemotherapy medication if they were given the opportunity to make an informed decision regarding the side effects of Taxotere and permanent hair loss. These patients are not blaming their physicians, or seeking malpractice claims, they are using our service to hold the manufacturer liable for their injuries.
We also believe that patients who suffer permanent hair loss because of Taxotere should be compensated for:
- Mental anguish
- Lost wages
- Diminished quality of life
- Permanent disfigurement
- Psychological damage
The attorneys at our firm have a proven record of fighting deceptive marketing practices of dangerous drug makers. We will do the same for you. If you have suffered alopecia or permanent hair loss after being treated with Taxotere, contact us today. We are aggressive advocates for the victims of Taxotere side effects, and we fight to get you the damages you need and deserve.