Taxotere lawsuits are currently being filed by women who are experiencing permanent alopecia, which is the absence of new hair growth after six months to a year after treatment with the popular chemotherapy medication. The lawsuits against Sanofi-Aventis allege that the company knew of the risk of permanent alopecia and did not warn the public. As a result, plaintiff’s were unable to make an informed medical decision about whether the benefit of Taxotere treatments outweighed the risks.
What is Taxotere?
The hair loss drug, Taxotere (docetaxel), is a popular chemotherapy medication used in the treatment of breast cancer, non-small cell lung cancer, and prostate cancer. Taxotere works by attacking cancer cells in the body and is given via an infusion in the vein. Taxotere treatments are touted as being more effective and capable of successfully treating cancer with fewer rounds of chemotherapy in less time.Taxotere IV treatments generally take about an hour and people generally receive Taxotere every 3 weeks.The amount of Taxotere and frequency of infusions are determined by a doctor.
While Taxotere (docetaxel) is considered to be an effective cancer treatment, its use also brought about a troubling side effect: permanent Taxotere hair loss, also known as Taxotere alopecia. Although early Taxotere labels noted that hair loss on the head, underarm, pubic hair, eyebrows, and eyelashes is common, the patient leaflet instructed to be given to the patient with FDA approval on 3/2009 told patients:
“Once you have completed all your treatments, hair generally grows back”
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- Did you or a loved one undergo chemotherapy in the past?
- Does hair loss or thinning hair remain today?
On December 11, 2015, the FDA finally recognized what many patients had already discovered – Taxotere’s horrific hair loss side effect was not temporary, it was permanent.
The highly potent drug, like many chemotherapy medications, can lead to hair loss, but unlike other such drugs, hair loss associated with Taxotere use can be permanent. The absence of new growth after six months to a year points to permanent hair loss.
Hair loss can have a major effect on a woman’s mental health. According to a 2004 study on the importance of hair conducted at Arizona State University, hair “is personal, growing directly out of our bodies. It is public, on view for all to see. And it is malleable, allowing us to change it more or less at whim. As a result, it’s not surprising that we use our hair to project our identity and that others see our hair as a reflection of our identity.” Said another way, when women lose their hair, they lose a part of their identity, and every aspect of their lives may be affected.
As a result of permanent hair loss, many women have filed a Taxotere lawsuit against the manufacturer, Sanofi-Aventis, alleging that the company knew that permanent hair loss related to Taxotere use occurred at a higher rate than it claimed, and instead of informing patients and the medical community, the company attempted to downplay that side effect in the interest of profits.
Breast Cancer Treatment with Taxotere
Approximately 300,000 women are diagnosed with breast cancer in the U.S. each year. Doctors prescribe Taxotere to treat the majority these cases, making it is the most prescribed drug in its class, making over $3 billion for manufacturer Sanofi-Aventis in 2009 before the company lost patent protection.
FDA Label Updated for Taxotere Alopecia
Sanofi knew in the late 1990s that 9.2 percent of people who took Taxotere lost their hair after taking it but knowingly withheld that information from the public.
Although information regarding Taxotere and alopecia was provided to doctors and patients in Europe as early as 2005 and Canada in 2012, it was not until December 2015, that the FDA updated its safety information on Taxotere to include the following information:
“Permanent cases of alopecia have been reported.”
The Taxotere label previously indicated that approximately three percent of patients could experience permanent hair loss when using the drug, although studies have indicated that percentage could actually be as high as six to 16 percent.
In 2003, the FDA sent a warning letter to Aventis Pharmaceuticals objecting to the company’s direct-to-consumer print advertising of Taxotere, calling the advertisements “misleading.”
In 2009, the FDA sent a warning letter noting that Sanofi continued to market its medication using the term “superior efficacy” despite a 2008 New England Journal of Medicine study that concluded that a competing drug was more effective for certain patients.
The Louisiana Taxotere multidistrict litigation (MDL) that began in the Eastern District of Louisiana in 2016 with just several dozen Taxotere alopecia lawsuits now includes more than 1,100 plaintiffs.
The Taxotere claims allege that although many patients who undergo chemotherapy as a cancer treatment experience hair loss, Taxotere-related alopecia is far more likely to result in permanent hair loss than other equally effective chemotherapy medications.The Taxotere complaints further allege that:
- Defendant, Sanofi-Aventis, engaged in a pattern of deception by overstating the benefits of Taxotere as compared to other alternatives while simultaneously failing to warn of the risk of permanent alopecia.
- Plaintiffs were not presented with a chance to make an informed choice as to whether the benefits of Taxotere outweighed its associated risks.
- As a direct result of the manufacturer’s actions, the plaintiffs suffered serious injury, harm, mental anguish, damages, economic and non-economic loss and will continue to suffer such harm, damages, and losses in the future.
Plaintiffs claim that if they had known about this side effect, they would have opted for the less potent but equally effective chemotherapy drug Taxol, which has not been linked to permanent hair loss.
The plaintiffs in these lawsuits allege that Taxotere maker Sanofi-Aventis was aware of decades-old research suggesting that 9.2 percent of Taxotere patients experienced persistent hair loss for up to 10 years or longer, yet failed to warn doctors and consumers, and also claim that the company illegally promoted the use of the drug for patients with early-stage breast cancer.
In 2009, the FDA sent Sanofi a warning letter accusing the company of making false and misleading statements about the safety and efficacy of Taxotere
Ami Dodson, a California woman noted that she is suing Sanofi-Aventis because they “obtained billions of dollars in increased revenues at the expense of unwary cancer victims simply hoping to survive their condition and return to a normal life.” According to her lawsuit, Dodson alleges that Sanofi-Aventis concealed the existence of studies from the FDA, physicians and patients and as a direct result of this hidden risk, sales of Taxotere jumped from $424 million in 2000 to $1.4 billion in 2004.
Taxotere Lawsuit Updates
February 2017 – U.S. District Judge Kurt Engelhardt issued an order approving the 30-page fact sheet that plaintiffs will use going forward with their lawsuits against Sanofi, and appointed representatives of the plaintiffs and defendants to settlement committees, which will collaborate for potential resolution of the cases. The next status conference for those committees is set for March 17, 2017.
April 2017 – According to an April 27th Order filed in the U.S. District Court, Eastern District of Louisiana. According to the Order, the Court met recently with the parties’ liaison counsel to discuss several issues, including the litigation’s recent “Science Day.”
Science Days provide parties to large, complex litigations with the opportunity to inform the court regarding the medical and scientific issues that are central to their respective cases. Science Day discussing the long-term side effects of Taxotere was held on May 3. Presentations made during Science Days are typically off the record and non-adversarial in nature.
Bellwether protocol and discovery timelines are expected to be discussed shortly.
Taxotere Lawsuit Frequently Asked Questions
There have been no taxotere settlements yet. However, in a somewhat sudden and surprising move, a settlement committee was formed in December 2016 in the Taxotere multidistrict litigation (MDL) pending in U.S. District Court in the Eastern District of Louisiana. Settlement committees are typically set up later in the litigation when discussion with a mediator has begun. But, under Pretrial Order #6, the court set up a system whereby both the plaintiffs and defendants are to engage in continuous general settlement discussions on a regular basis.
A number of plaintiff and defense attorneys have been assigned to the settlement committee, which has been ordered to hold regular discussions in hopes of resolving cases or issues relevant to the Taxotere litigation. Committee members are expected to hold monthly sessions in an attempt to “establish common understandings, potential ground rules, component parts and concepts, anticipated relief, necessary approvals, and ultimately financial details, including drafting of all pertinent documents, in an attempt to resolve this matter prior to remand of some or all of the member cases,” according to the order.
TruLaw uses the Taxotere Instant Case Evaluator as a tool to help you understand your legal rights. We hope you find the Instant Case Evaluator to be helpful in your determination of whether a lawsuit is right for you.
If TruLaw determines that you have experienced alopecia and that you used Taxotere in your treatment of your cancer, you are likely to qualify for consideration for a taxotere product liability case. If you qualify for the Taxotere lawsuit, you will be sent an electronic contract. We will not be able to move forward in legally representing you until this contract is signed.
Please call us if you would prefer a hard copy of the contract.
Very basically, there are two parts to the taxotere lawsuit – Injury and Use. Taxotere lawsuits are being filed on behalf of individuals who have experienced permanent hair loss (permanent alopecia). If you underwent chemotherapy treatments and you are experiencing incomplete hair regrowth 6 months after chemotherapy, your injury may qualify for this lawsuit.
Secondly, this lawsuit is being filed against Sanofi for their product, Taxotere. Taxotere was used in the majority of chemotherapy treatments prior to 2011, after 2011, we will need to verify the use of Taxotere via medical records.
To check your qualification report for your situation, fill out our Taxotere Instant Case Evaluation form to view your report online now.
Nothing unless/until we are successful in your lawsuit.
No, the lawsuits that we are filing are against the manufacturer of the drug, Sanofi. The Taxotere lawsuits allege that Sanofi was aware of the risk of permanent hair loss and did not warn the public or medical professionals. When manufacturers of drugs such as Taxotere do not give the public full information about their drugs, there is no way to make an informed decision, and they should be held accountable when injuries occur.
Taxotere is given via IV in your physician’s office or clinic, therefore it is unlikely you are aware if you were given Taxotere. Until Taxotere went generic in November 2011, Taxotere was used in the majority of chemotherapy treatments.
Since the drug went generic, there are many other versions of the drug that could have been used. The medication used during your chemotherapy treatment will be indicated in your medical records. You may want to contact your doctor’s office or clinic to gather this information, or we will assist you in gathering this information.