Taxotere Lawsuit

Approved in 1996 by the US Food and Drug Administration (FDA), Taxotere, also called docetaxel, is a well-known anti-mitotic chemotherapy medication. It is a part of the taxane family; which work to slow down the growth of cells in the body.

Since its approval, Taxotere has been used to treat a wide range of cancers, including gastric cancer, hormone-refractory prostate cancer, head and neck cancer, non small-cell lung cancer, and advanced or metastatic breast cancer.

Although the drug is approved for use as a single agent, it can also be used with other chemotherapeutic medications. Taxotere is typically administered by injecting it into the patient’s vein in one-hour sessions every 3 weeks.

Taxotere Complications: Taxane Side Effects

Since anti-mitotic drugs and taxanes are unable to distinguish between healthy or cancerous cells, any drug that inhibits the division of cells will have serious side effects.

So while taxanes stop the division of cells in harmful tumor cells, they also kill healthy cells like bone marrow, hair follicles, and other germ cells. In most cases, the side effects that patients experience dissipate after the end of the treatment, but they may also be permanent in some cases.

Taxotere Adverse Effects and Complications

Although most taxanes come with the same side effects, there are unique side effects that only Taxotere has – its competitor drugs do not. In most cases, people do not experience all of the side effects of this medication but will experience some.
The side effects of Taxotere may vary based on the dosage. If the drug is taken in high doses, the side effects will be more severe.

The packaging of Taxotere has classified possible side effects into the following categories:

• Allergic Reactions (affects roughly 1 in 10 patients):
• Fever or chills
• Itching, flushing skin reactions
• Low blood pressure
• Back pain
• Difficulty breathing, tightness of the chest
• More severe reactions

Very Common Side Effects (affects more than 1 in 10 patients):

• Fever
• Headache
• Loss of appetite (anorexia)
• Joint pain
• Insomnia
• Sores in mouth
• Bleeding from nose
• Swelling
• Alteration in sense of taste
• Infections – reduced number of red or white blood cells (required to fight infection) and platelets
• Excessive tearing or inflammation of the eye
• Nausea, vomiting
• Indigestion – including constipation and diarrhea
• Abdominal pain
• Muscle aches and pains
• Short-term hair loss (this can be permanent with Taxotere)

Other Taxotere side effects and complications are also listed on the label under the “Very Common” classification.

These side effects are common and frequent during treatment. Health care professionals advise patients not to eat before treatment in order to relieve nausea and suggest eating small meals throughout the day to control nausea and vomiting.

Common Side Effects (affects less than 1 in 10, but more than 1 in 100 patients):

• Dehydration
• Loss of hearing
• Oral candidiasis
• Decrease in blood pressure
• Hemorrhage
• Esophagitis
• Heart failure
• Raised liver enzymes

Uncommon Side Effects (experienced in less than 1 in 10, but over 1 in 100 patients):

• Phlebitis (infection at injection site)
• Fainting
• Inflammation of the small intestine (intestinal perforation), colon

Taxotere Hair Loss Side Effect: Permanent Alopecia

While the side effects and complications of Taxotere generally subside after treatment is discontinued, there is one side effect that is known to be a permanent one.

A study in 2012 showed that in all cases where patients suffered permanent hair loss following chemotherapy, Taxotere or docetaxel was involved. According to the study, alopecia, or hair loss, induced by chemotherapy is one of the most troublesome and distressing side effects of the treatment, along with fatigue, nausea, and vomiting.

It may have a significant effect on the self-image of an individual and research has found that patients experience low self-esteem and anxiety.

Despite the phrase, “in most cases, hair growth should return”, Taxotere does not mention permanent hair loss in their list of possible side effects. However, it is too late for many patients who have used the drug for their chemotherapy. This permanent side effect is irreversible and includes eyelashes and eyebrows in addition to the hair on the head.

It is known that hair loss is a common side effect of chemotherapy since a lot of different types of the drugs are used in the treatment to kill fast-growing cancer cells.

Although hair loss is often expected in patients who undergo chemotherapy, alopecia or permanent hair loss is not. In most cases, patients’ hair usually begins growing back within 3 to 6 months after the completion of the treatment.

While breast cancer patients who were prescribed Taxotere were warned about the potential hair loss that might come with the drug, Taxotere lawsuits state that Sanofi-Aventis US LLC, the manufacturer of the drug, did not adequately warn patients about the high risk of permanent hair loss.

According to research, even when cancer patients are prepared for the hair loss they may experience, it is still a very traumatic experience. Studies have found that on average, 6% to 9% of patients of breast cancer had to deal with permanent alopecia, thereby having to cope with other negative setbacks in their personal lives.

A small study observed 20 breast cancer patients’ quality of life after being treated with Taxotere and experiencing permanent hair loss. Despite undergoing treatments to help in stimulating hair growth, patients and oncologists saw that only a handful of patients saw a very slight improvement in their condition.

As a result, 40% of the patients said that their quality of life was extremely poor, and 70% choose to wear a scarf or wig to hide their alopecia – this is only logical.

Taxotere Lawsuits

Although Taxotere has been on the market for a number of decades now, it was not until more recently that Sanofi began to face a growing number of lawsuits by patients and survivors of breast cancer as a result of false marketing and the treatment’s severe side effects.

As of the most recent report, the pharmaceutical company is facing 7,820 pending lawsuits. The latest update from the US District Court for the Eastern District of Louisiana states that the first Taxotere bellwether trial will begin in January of 2019.

Allegations Against Manufacturers of Taxotere

In lawsuits filed against Sanofi by women and families, it is alleged that the pharmaceutical giant was aware of the link between the use of Taxotere and permanent hair loss and failed to warn patients.

According to the lawsuits, Sanofi also marketed Taxotere as more effective than other drugs used in chemotherapy when they were equally effective without the associated permanent loss of hair.

Taxotere lawsuits accuse Sanofi of:

• Not testing Taxotere properly before selling it
• Failing to determine whether or not the drug was safe
• Selling the drug without disclosing the risks or dangers
• Failing to provide proper warning to health care providers and patients
• Misleading the public in marketing and advertising
• Concealing information from the public
• Manufacturing a dangerous drug
• Downplaying the dangers and risks associated with Taxotere

Lawsuits Say Sanofi Concealed Information About Hair Loss Side Effects

According to lawsuits, Sanofi misled the public by giving them false reassurance that hair would grow back after stopping chemotherapy. But the company should have had knowledge that there was a higher rate of permanent alopecia in their drug than similar drugs on the market.

Studies that Sanofi should have been aware of include the following:

1998: Sanofi sponsored a study that was named GEICAM 9805. The company knew by 2005 that this trial’s results revealed that 9.2% of women who used Taxotere suffered permanent alopecia.

2006: The Rocky Mountain Cancer Centers’ Dr. Scot Sedlacek conducted a study that showed that Taxotere could cause over 6% of women to suffer permanent hair loss.

Despite informing patients in other countries, Sanofi failed to warn women in the United States of this risk for years.

Lawsuits say that the words “alopecia” or “permanent hair loss” did not appear in any information that was published in the US.

Accusations of Promoting Sales at the Expense of Patients

Taxotere lawsuits question Sanofi’s motives since the initial FDA approval of the drug in 1996. They say that the company downplayed the drug’s risks and trained employees to misrepresent its effectiveness and safety.

According to a lawsuit filed by one of the former employees of Sanofi in 2015, the company engaged in illegal “kickback” payments to health care professionals to prescribe Taxotere. Lawsuits say that the misconduct resulted in soaring sales of the drug.

It is claimed that Taxotere’s sales went up from $424 million in 2000 to $1.4 billion in 2004 through illegal payment of kickbacks and misrepresentation.

In her complaint, one woman wrote that one of the most vulnerable groups of individuals were preyed upon by the defendants at the most difficult time of their lives and that the defendants obtained increased revenues of billions of dollars at the expense of cancer patients who were unwary and simply hoping to survive their condition and begin living a normal life once more.

Manufacturers of Taxotere Facing Lawsuits

The drug companies that are named in Taxotere lawsuits are Sanofi SA, Sanofi-Aventis US LLC and Aventis Pharma SA. These companies were involved in the design, development, manufacture, distribution, labeling, marketing, advertisement, promotion, and sales of Taxotere.

In 2009, before Sanofi lost patent protection, Taxotere made more than $3 billion for the company.

Taxotere is prescribed by doctors to treat the majority of cases of breast cancer in the United States, and approximately 300,000 women are diagnosed with the cancer each year. It is also the most prescribed drug in its class.

Taxotere Class Action

There are no class action lawsuits at present over claims that Taxotere results in permanent hair loss. Three women filed a Taxotere class action lawsuit in December 2016. In April of the following year, the women asked the court to certify the class.
This step is necessary in order for the class action to proceed. A judge denied the request for class action certification in July 2017.

According to the court order that denied class action certification, the cases had too many differences for them to be considered a class. Differences surrounding the claims that were denied class action certification include:

• Whether the patients were administered brand name Taxotere or a generic equivalent
• What combination of chemotherapy agents was used in connection with the drug or its generic equivalent
• The Taxotere or generic equivalent dosage that was administered
• The number of cycles of treatment that took place
• The description of the alleged injury
• The damages that were sought by the plaintiffs

Studies Reveal that Alopecia Leads to a Diminished Quality of Life

Hair loss ranks as one of the most distressing cancer treatment side effects consistently and has a profound effect on the patient’s well-being and quality of life.
In some studies, about 9% of patients of breast cancer suffered alopecia that lasted for 10 years or more, negatively affecting body image, severely decreasing their quality of life and causing distress and depression.

In 2008, Lemieux et al. published a review of 38 articles that analyzed the impact of hair loss on breast cancer patients. Authors of the study looked at the quality of life that related to body image, distress, anxiety, self-esteem, social functioning, sexuality, and the ability to return to work.

In 2012, Klugel et al. published a study in the Annals of Oncology following 20 patients who used Taxotere as part of their cancer therapy. All of the 20 patients suffered permanent hair loss after being treated with the drug. Despite various treatments for alopecia, the women were left with clumpy, sparse, and incomplete hair regrowth.

About 40% of these women showed scores indicating “severe impairment” of quality of life.

One of the women in the study said that she would have preferred not receiving any chemotherapy for her breast cancer rather than experiencing such a distressing and permanent side effect. About 70% of the women who participated in this study wore wigs or scarves to cover their heads – as already somewhat indicated.

Taxotere Lawsuits – Speak With a Taxotere Lawyer

If you or somebody you know took Taxotere and developed permanent hair loss, you may be entitled to compensation for your injuries, pain, and suffering.  Contact a Taxotere lawyer by using the form below.