Taxotere Attorneys

The Comprehensive Taxotere Lawsuit Guide

If you have taken Taxotere as part of chemotherapy treatment, it is important that you understand that there is active litigation against its manufacturer, Sanofi-Aventis, Inc., a global pharmaceutical company based in France. The lawsuit alleges that Sanofi-Aventis failed to warn doctors and patients about the increased risks of permanent hair loss. The information on this page, and throughout this section is meant to give you a good understanding about the science, side effects and legal actions surrounding Taxotere. If you have used Taxotere, we encourage you to read the pages in this guide and to contact us for a free case evaluation.

Taxotere is used in the treatment of many forms of cancer. Taxotere is actually the brand name of the chemical compound “docetaxel.” In medical materials, clinical research, and published studies, one is more likely to come across the scientific name, “docetaxel.” In common usage, however, Taxotere is more widely acknowledged and understood. The company which currently manufactures and markets Taxotere is Sanofi-Aventis, Inc., a globally successful pharmaceutical company based in France.

Taxotere was developed in the mid-'90s as an alternative to the naturally derived chemical “paclitaxel,” which is currently still developed and sold under both the brand names Taxol and Abraxane. Taxotere has been FDA approved for use in the treatment of lung, prostate, breast, gastric, and head and neck cancers for almost two decades, and it is commonly prescribed. While it is usually only given in late stages of most of these cancers, in the case of breast cancer, Taxotere may be prescribed early in the treatment. Hundreds of thousands of women are diagnosed with breast cancer every year, and up to 75% of them may be treated with Taxotere.

Unlike most chemotherapy drugs, which cause temporary hair loss, Taxotere is associated with alopecia or permanent hair loss, a condition in which a patient's hair on the scalp, armpits, eyelashes, eyebrows, arms, legs and pubic area fails to regrow or only regrows partially. Although this side effect was well-documented by multiple researchers and anecdotal evidence from thousands of breast cancer survivors for over a decade and was included on safety labels in Europe and Canada for years, in the United States, permanent hair loss was not listed as a side effect of Taxotere until 2015.

Taxotere Lawsuits In The United States

Today, over 700 women have filed lawsuits across the United States against Sanofi-Aventis, the maker of Taxotere, for false marketing, false claims of superiority over their competitor, Taxol, and an intentional cover-up of the long-term toxic effects of the drug, such as permanent hair loss. These lawsuits have been bundled together in multi-district litigation, which allows the plaintiffs to share resources while maintaining autonomous claims. Uncovering the somewhat shady story behind Taxotere's development, marketing, and modern day prevalence may help breast cancer patients who have been given Taxotere understand their role in this national story and give them the confidence to take action.

Development of Taxane Chemotherapies

Taxotere (docetaxel) is part of a group of chemical compounds called “taxanes.” The taxane group is relatively small, with only two members, docetaxel, and paclitaxel. They are called taxanes because they are originally developed from plants from the Taxus genus, which includes small trees and shrubs in the yew family.

The history of this drug begins in 1962 when the National Cancer Institute sponsored a nationwide program to encourage the discovery of new drugs from natural sources. Researchers in Washington state obtained a sample of the Pacific yew tree and sent it to North Carolina, where the active ingredient, taxol, was extracted and isolated. In 1978, the compound was studied by a research group in New York, who realized the drug's cancer-fighting potential and began early testing, which was promising. The original drug, however, relied on the natural resource of the Pacific yew, which was slow growing and only existed in small populations.

Many independent research groups began to experiment with ways of synthetically producing the drug in a way which did not depend on the tree. It proved extremely difficult to synthesize, yet, in 1994, researchers succeeded. They also found a way to create a variation of the original drug taxol or paclitaxel and named it docetaxel. The new drug was almost identical to the original and worked very similarly in the body as a cancer-fighting agent. Sanofi-Aventis, the company that sponsored much of the research and development of docetaxel, filed an FDA new drug application immediately and eventually gained approval to sell the compound under the name Taxotere.

How Taxotere Works

As any cancer patient is well aware, cancer is a complicated disease that can manifest in hundreds of different ways throughout the body with vastly different symptoms, causes, and mechanisms of action. Cancer's one common defining characteristic, however, is the way in which normal cells in the body mutate and begin to grow, divide, and proliferate at uncontrollable rates. These masses of uncontrolled cell growth often form tumors or areas of malfunctioning cells that must be combatted through a combination of surgery, radiation therapy, and chemotherapy.

Taxotere, like Taxol, works by targeting a particular structure in the cell called the cytoskeleton. The cytoskeleton can be thought of as both the skeleton and the muscular system of a cell. It is made up of microtubules, which provide structural support, can be lengthened or shortened by the cell for movement, and transfer chemicals between different parts of the cell. Microtubules are essential for growth, change, and development of a cell, including its division. Taxotere works by freezing the ends of microtubules, preventing them from growing or shrinking and thereby paralyzing the cell. The cell cannot grow or divide, and will eventually die.

Since Taxotere is administered through an IV into the entire body, not just applied to the cells of the tumor, it attacks and damages all cells in the body. This is how almost all chemotherapy drugs work, which is why most chemotherapy drugs are highly toxic and have serious side effects. Chemotherapy drugs are designed to kill all cells which grow and divide particularly quickly, which means that the side effects stem from the death of other, non-cancerous cells which also grow and divide more rapidly than others. Fast growing cells in the body include hair follicles, mucous membranes, and bone marrow, which produces blood cells.

Side Effects of Taxotere

Like many highly toxic drugs, the side effects of Taxotere range from slight discomfort and pain to life-threatening conditions. During the administration of Taxotere via an intravenous drip, life-threatening allergic reactions can occur in up to 2% of patients. For this reason, the corticosteroid dexamethasone is given to a patient before Taxotere infusion. The steroid lowers the rate of allergic reaction and can lessen some of the other side effects.

The most serious common side effects of Taxotere are blood disorders, mucous membrane depletion, fluid retention, nervous system disorders, and toxic death. These side effects exhibit themselves in a multitude of unpleasant symptoms such as weakness, loss of appetite, weight loss, susceptibility to infection, rapid heart rate, hair loss, unexplained bruising, headaches, fevers, lesions in the mouth and throat, pain, pressure, or numbness in the hands, feet, or lower legs, and many others. This list is just a small sampling of the possible effects that Taxotere might have on the body.

Breast Cancer and Taxotere Treatments

Taxotere is used to treat many stages and forms of metastatic or invasive breast cancer. If the cancer is contained in a single tumor and has not spread, it will usually be treated with a combination of surgery and/or radiation. Chemotherapy is not normally advised in these cases unless there is a suspicion that the cancer may have spread. Taxotere is more often used in cases of breast cancer in which the cancer has spread from the point of origin, invading the breast tissue or surrounding lymph nodes. There are many chemotherapy drugs that might be advised depending on the particular status of the patient's cancer, such as its hormone receptivity and level of irregularity on the cellular level.

One of the main limiting factors for what kind of chemotherapy is prescribed for the treatment of breast cancer is called “cardiac toxicity.” Some drugs are particularly hard on the heart, and if a patient has a pre-existing heart condition, they will not be prescribed these drugs. Taxotere itself is not associated with cardiac toxicity, but it is often used in conjunction with other drugs that are.

Common drug regimens used to treat breast cancer which includes Taxotere are TAC (Taxotere, Adriamycin, and Cytoxan), TCH (Taxotere, carboplatin, and Herceptin) and FEC-T (Fluorouracil, Epirubicin, and Cyclophosphamide, followed by Taxotere). In each of these combinations, doctors may advise an altered order or leave out certain drugs due to particular side effects that might result in a specific case of breast cancer. The drugs are usually administered in immediate succession either weekly or every two to three weeks. With many of these combinations, Taxotere (docetaxel) can be replaced with the closely related compound paclitaxel, sold as Taxol.

Taxol Alternative to Taxotere

Taxol and Taxotere are both chemotherapy drugs from the taxane family of compounds that can be used interchangeably for the treatment of breast cancer in many instances. Taxotere is the brand name for the compound docetaxel and Taxol is the brand name for the compound paclitaxel. Paclitaxel, or Taxol, was first isolated from natural sources, and docetaxel, or Taxotere, was created as an alternative to the original that could be produced more easily from synthetic sources.

Both these compounds work in the same way, by attacking the microtubules which make up the cytoskeleton or structure of a cell and causing death in cells that are trying to grow or divide. Although their mechanisms of action are almost identical, there are a few differences in the common side effects associated with the drugs. Both Taxol and Taxotere can cause severe blood count deficiencies, deadly allergic reactions, depletion of essential mucous membranes in the body, skin, hair, and nail toxicity, and numbness in the hands and feet. With Taxol, numbness or “peripheral neuropathy” can sometimes be worse, as can “neutropenia,” or depletion of white blood cells. However, these side effects can be reduced by changing Taxol's administration schedule. Taxotere has two unique side effects: fluid retention, or “edema,” and permanent hair loss in 3-15% of patients.

While these two chemicals have minor differences in side effects, research has shown over and over again that neither is superior for long-term rates of survival in breast cancer patients. In fact, one of the most extensive studies of 5000 women with metastatic breast cancer over the period of 10 years saw no significant difference in survival in patients when treated with docetaxel (Taxotere) or paclitaxel (Taxol). After this study, the FDA sent a letter to Sanofi-Aventis, the company which manufactures and markets Taxotere, informing them that they could not make claims of superiority over Taxol (paclitaxel) because they were unsubstantiated. These claims of superiority may have influenced doctors and patients to choose Taxotere-based on faulty information, causing thousands of women to suffer unnecessarily from a degree of permanent hair loss.

Permanent Hair Loss from Taxotere

Most chemotherapy drugs can cause some level of hair loss, but the hair generally regrows after about 3 to six months post-chemotherapy. With Taxotere, however, for unknown reasons, the hair follicles which produce hair can become permanently damaged and hair may never regrow. This side effect occurs in 3-15% of patients, according to different studies done over the past decade and a half.

Emotional Trauma of Hair Loss

Any woman who has gone through the trauma of hair loss, even if it is temporary, knows how difficult it can be to readjust to a new appearance. In our culture, hair is often associated with femininity, cultural standards of beauty, and even personal identity. It is no wonder, then, that studies on hair loss from chemotherapy show that, even when hair begins to regrow, women feel less self-confident and have lower self-esteem. In addition, one study showed that almost half of women found hair loss to be the most traumatic side effect of their treatment. Some women who have taken Taxotere and experienced permanent hair loss fear that they will be seen as “sick” or as a cancer patient permanently, while others say that they seem “alien” to themselves.

Evidence for Link between Taxotere and Alopecia

In the early 2000s, Sanofi-Aventis, which sponsored research on Taxotere so that it could begin to produce it, completed a ten-year clinical trial phase including 1,060 women who had been treated for breast cancer with Taxotere. At this point, 9.2% of the women in the trial were struggling with long-term hair loss of some degree. A similar study of 744 women found that 3.9% were experiencing some level of permanent hair loss 8 years after their treatment was completed.

The first major independent study was performed by a doctor at the Rocky Mountain Cancer Centers in Denver, Colorado. In 2006, Dr. Scot Sedlacek found that 6.3% of almost 500 patients that he had personally treated with Taxotere had less than 50% of hair growth years after their treatment was completed. A group of scientists in the UK presented a study at the National Cancer Research Institute's 2014 Cancer Conference in which 15.8% of 134 women reported persistent hair loss on their scalps, with some reporting permanent hair loss of the eyelashes, legs, and nostrils.

Alopecia

Alopecia, or permanent hair loss, is a little understood condition in which the body's immune system attacks hair follicles or an environmental factor such as pollution or medication kills the hair follicles, causing them to stop producing hair. There are four different variations of alopecia: male or female pattern baldness, scarring alopecia, sudden hair follicle death, and Alopecia Areata (AA) in which the body's own immune system turns on the cells of the hair follicle. Permanent hair loss caused by chemotherapy generally falls under sudden hair follicle death or “anagen effluvium.” This means that all the hair that is currently in the growth or “anagen” phase (which usually lasts between 3 to 5 years) suddenly stops growing and begins to shed.

Usually, this kind of alopecia comes in phases, meaning that after the cause of the “effluvium” or shedding, such as pollution or toxic drug, is removed, the hair follicles repair themselves and begin to produce hair again. In the case of Taxotere, however, for somewhat mysterious reasons, patients can develop symptoms more similar to Alopecia Areata (AA) in which the hair can remain patchy, inconsistent, or completely absent throughout a cancer survivor's entire life.

Cold Caps

While there is no known successful cure for alopecia, some cancer treatment centers provide the option to purchase a service known as cold caps or cooling systems, which may lessen the rate of both temporary and permanent hair loss in those who receive chemotherapy. The most recent version of these systems use a cap or helmet device which is attached to the patient during the IV administration of their chemotherapy. The cold fluids in the cap slow blood flow to the scalp during treatment, ideally reducing the amount of toxin to which the hair follicles are exposed.

There is evidence that these devices could reduce the rate of hair loss in women. In one recent study, 36% of 122 women with breast cancer who used scalp cooling devices during their chemotherapy treatment saw only a 25% reduction or less in their hair volume. Unfortunately, these devices are rarely covered by insurance companies and can cost thousands of dollars to use. Also, only 50 medical centers in the United States currently own these systems, although non-FDA approved versions may be rented online without approval from a medical professional.

Sanofi-Aventis

The company responsible for sponsoring the clinical trials of Taxotere, developing it in mass quantities, and marketing it to doctors and hospitals around the world, is Sanofi-Aventis, Inc. This multinational drug company employs around 100,000 people worldwide and is valued at around $134 billion. Like many pharmaceutical companies, Sanofi-Aventis has a history of prioritizing profits over fair competition, patients, and transparency. In just the past couple of years, the pharmaceutical company has paid $61.5 million in settlements to a class action group for allegedly inflating the price of meningococcal vaccines for children and $19.8 million to the United States for overcharging the government for drugs for veterans. There are, additionally, three major pending lawsuits against the corporation for colluding with other pharmaceuticals to raise the price of insulin, purposefully stalling the development of a multiple sclerosis drug to avoid paying its shareholders and hiding evidence of permanent hair loss caused by the chemotherapy drug Taxotere.

Taxotere Litigation

Taxotere has been a standard part of treatment for women with breast cancer for almost 20 years; however, more and more breast cancer survivors who have experienced the long-term toxic side effects of the drug, most notably permanent hair loss, have begun to file lawsuits against Sanofi-Aventis, Inc. in the past few years. Over 700 women claim that the corporation intentionally concealed information about the potential hair loss side effects of Taxotere in order to sell their dangerous drug and make more of a profit. In addition, the lawsuits allege that Sanofi-Aventis made false claims of superiority over its competitors which had not been substantiated by medical evidence or clinical trials.

The first major lawsuit was filed in March of 2015 by breast cancer survivor Amy Dodson, who argued that she was not informed of Taxotere's dangerous potential and was now suffering from permanent hair loss. She added that Sanofi-Aventis was preying on people during one of the most vulnerable times in their lives by offering them false promises in order to make money off of them. The company, therefore, prevented women from making informed decisions about their health at a critical personal moment. In December of 2015, the FDA finally added a warning to Taxotere's label stating that permanent hair loss was possible, but even then they did not list it as a common side effect.

After this initial lawsuit, dozens more women were emboldened to file their own claims. Eventually, in October of 2016, so many people had filed lawsuits, the courts decided to combine the claims into something known as multidistrict litigation. This means that all the claims had a common defining argument, that Sanofi-Aventis “marketed Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the associated permanent hair loss.” Now, all claims against the company for this matter are filed through the Eastern District of Louisiana for pretrial screening and discovery. This system allows plaintiffs to pool resources to fight the multi-billion dollar company, but, unlike a class action, keeps each claim autonomous.

If you or someone you love has been affected by some degree of permanent hair loss after being treated with Taxotere for breast cancer, it may be time to consider taking action. The case is currently moving forward in the courts and important dates are coming up quickly. For more information on this case, call trial attorneys Charles Gilman and Briggs Bedigian today at (410) 560-4999 or contact them online.

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