Free Confidential Lawsuit Evaluation: If you or a loved one suffered permanent hair loss, alopecia or balding after chemo with Taxotere, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: Nearly 1000 Hair Loss Lawsuits Centralized in Taxotere MDL
April 18, 2017 – The federal Taxotere litigation (MDL No. 2740) continues to grow at a rapid pace, with at least 949 claims filed on behalf of cancer patients who allegedly suffered permanent hair loss or “alopecia” after undergoing chemotherapy with the drug. This number represents an increase of at least 150 new Taxotere lawsuits consolidated in the MDL since last month.
Taxotere (generic: docetaxel) is primarily used to treat breast cancer; however, it may also be prescribed for the treatment of non-small cell lung cancer, prostate cancer, stomach (gastric) cancer and head/neck cancer. The drug works by interfering with the growth and spread of cancer cells in the body. Taxotere is made by Sanofi SA, and was first approved by the U.S. Food & Drug Administration (FDA) in 1996.
Taxotere Hair Loss Studies
There are currently about 2.8 million women in the U.S. with a history of breast cancer, according to breastcancer.org. Of these, about 75% were prescribed Taxotere for the treatment of their symptoms. A number of studies have been conducted suggesting a link between the use of Taxotere and the development of permanent hair loss (alopecia):
- June 2011 study published in the American Journal of Dermatopathology determines that chemotherapy drugs that contain taxanes could contribute to the development of permanent hair loss and baldness.
- In February 2012, a study published in the Annals of Oncology (PDF) finds that Taxotere is associated with an increased risk of permanent alopecia. The study involved 20 female breast cancer patients who were treated with docetaxel and subsequently developed permanent hair loss. Researchers ruled out mineral deficiencies and thyroid disorders as contributing factors, and noted that all but one of the women had no history of alopecia.
- In a presentation to the National Cancer Conference (2014), researchers find permanent hair loss as a side effect in 10-15% of patients who took Taxotere. “Long term significant scalp alopecia (here lasting for up to 3.5 years following completion of chemotherapy) may affect 10-15% of patients following docetaxel for EBC [early breast cancer],” they said. “This appears to be unrelated to other patient and treatment characteristics. ”
- A 2008 study published in the New England Journal of Medicine (NEJM) found no significant difference in survival rates between cancer patients treated with Taxotere and those taking Taxol (generic: pacitaxel), another chemotherapy drug that has not been linked to permanent alopecia.
- Sanofi’s own internal studies indicate that up to 10% of patients treated with Taxotere would suffer permanent hair loss.
In December 2015, FDA acknowledged there have been reports of permanent hair loss and baldness in chemotherapy patients treated with Taxotere. The agency’s announcement preceded a label change for the product, noting the possibility of permanent hair loss.
Chemo Drug Bringing More Suffering to Women’s Lives: Ring of Fire Video
What is Alopecia?
Alopecia, or hair loss, is a potential side effect of chemotherapy and radiation therapy. The condition may occur anywhere on the body, with hair falling out entirely, gradually, or in sections. In some cases, hair will simply become thin and may become duller or dryer. Hair loss related to cancer treatment is usually temporary, but in patients treated with Taxotere, the condition may be permanent. When this occurs, the condition may be referred to as permanent significant alopecia, or PSA.
Types of Alopecia
- Alopecia Areata – The most common form of the disease, presenting as round, smooth patches of various sizes.
- Alopecia Totalis – Total loss of hair on the scalp.
- Alopecia Universalis – The rarest form of alopecia, presenting as the loss of hair over the entire scalp and body.
Managing Hair Loss
Learning how to manage hair loss before, during, and after treatment may help cancer patients cope with alopecia. For many people, hair loss is more than just a change in physical appearance – losing your hair can be emotionally challenging, affecting your self-image and quality of life.
Discussing these feelings with a counselor, someone with a similar experience, family member, or friend may help ease the process. It may also be helpful to talk about potential hair loss before it occurs. Expecting and preparing for changes in physical appearance helps lower fear or anxiety.
Scalp Cooling as a Treatment for Alopecia
Some cases of alopecia can be minimized by scalp cooling. This involves wearing a ‘cold cap’ before, during and after chemotherapy treatment. Cold caps will not work for all patients, and effectiveness depends on specific medications and doses administered during chemotherapy.
Taxotere Side Effects
In addition to increasing the risk of permanent hair loss, Taxotere may cause the following side effects in certain patients:
- Pain / swelling at the injection site
- Excessive tearing
- Loss of appetite
Court Overseeing Taxotere MDL Convenes “Science Day”
March 31, 2017 – The court overseeing the Taxotere litigation in the Eastern District of Louisiana will hold a “Science Day” on May 3 to discuss medical and scientific issues related to the litigation. The event is intended to provide a sort of tutorial so that the court can learn more about the case and the science involved. Cross-examination is forbidden, and transcripts of the proceedings are not shared with the parties.
Generic Taxotere Lawsuits Allowed in MDL
March 15, 2017 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) has allowed claims involving generic docetaxel to be included in the Taxotere MDL currently underway in the Eastern District of Louisiana. JPML said the Taxotere litigation included docetaxel in its formal title, suggesting the MDL involved lawsuits against both name-brand and generic forms of the drug. As of mid-February, there were at least 755 Taxotere lawsuits pending in the MDL.
Number of Lawsuits in Taxotere MDL Jumps
January 13, 2017 – It’s only been 3 months since the Taxotere MDL was formed in Louisiana, but in that time the number of claims added to the litigation has increased dramatically. At the time the MDL was created, there were 33 lawsuits filed in 16 district courts. As of mid-December, that number has jumped to 267, and it is likely to continue to grow in the coming weeks and months.
Taxotere Settlement Committee Appointed in Federal Hair Loss Litigation
December 20, 2016 – Judge Kurt D. Engelhardt has assigned a Taxotere settlement committee aimed to resolve cases or issues relevant to lawsuits in the MDL. According to a Pretrial Order (PDF) issued last Tuesday, members of the committees are to engage in regular discussions rather than partake in detailed discovery or trial preparations, as those activities could distract the parties from “pursuing avenues for potential resolution of some or all of the issues” in the Taxotere hair loss litigation.
Following No Hair Growth After Chemo, Oklahoma Woman Files Taxotere Lawsuit
December 8, 2016 – An Oklahoma woman who allegedly suffered permanent hair loss after undergoing chemotherapy with Taxotere has filed a products liability lawsuit against Sanofi-Aventis. Plaintiff Connie Shatswell was diagnosed with breast cancer in 2010. After undergoing chemo, she beat her diagnosis and has lived cancer-free ever since. However, her life has not completely returned to normal, as her hair never grew back following breast cancer treatment.
Taxotere Alopecia Lawsuits Centralized in Louisiana
October 6, 2016 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered all federal lawsuits alleging permanent hair loss or ”alopecia” from Taxotere to be consolidated into a multidistrict litigation (MDL No. 2740) for pretrial handling in the Eastern District of Louisiana. At least 33 federal complaints pending in 16 states accuse Sanofi-Aventis of marketing Taxotere as superior to other chemo treatments, despite having knowledge that it could cause permanent hair loss.
MDL Sought for Taxotere Litigation
July 27, 2016 – Plaintiffs’ lawyers have requested a multidistrict litigation (MDL No. 2740) for lawsuits alleging that Taxotere can cause permanent hair loss or alopecia in women, particularly those being treated for breast cancer, according to Reuters. In a motion filed last Friday, lawyers for 2 plaintiffs asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to send the Taxotere litigation – currently comprising at least 33 lawsuits in 16 federal courts – to the U.S. District Court for the Eastern District of Louisiana.
Taxotere Hair Loss Lawsuit Filed in Texas
June 16, 2016 – A Texas woman who claims she suffered permanent hair loss after undergoing chemo with Taxotere has filed a lawsuit (PDF) against Sanofi. Plaintiff Alina S. Gorniak claims these side effects caused her “severe and debilitating emotional distress,” and “impairment of the quality and enjoyment of life.” She is seeking compensation against Sanofi for medical expenses, loss of earning capacity, as well as both physical and mental pain.
Taxotere Recall Issued Over Manufacturing Errors
June 9, 2016 – Fifteen batches of Taxotere have been recalled over a problem in the manufacturing process that could have led to the vials being too concentrated, according to the U.K.’s Regulatory Affairs Professionals Society (RAPS).
“Some of the vials released to the market may have already been used,” the European Medicines Agency (EMA) said, noting that a “small risk that patients who have received the affected vials may have received more docetaxel than was intended.”
As a consequence of the recall, Taxotere 20mg/1 ml and 80 mg/4ml concentrate solution for infusion may become unavailable in France, Ireland, Italy and Spain, though normal supply is expected to resume on August 19, 2016, according to the EMA.
Breast Cancer Survivor Claims Sanofi Failed to Warn About Permanent Hair Loss with Taxotere
May 17, 2016 – A lawsuit filed today alleges that Sanofi not only failed to warn about the potential link between Taxotere and permanent alopecia, but actively hid information about the condition from the public and medical communities in its effort to promote the drug. The complaint was entered on behalf of Yvonne Bemiss, who allegedly underwent chemotherapy with Taxotere after she was diagnosed with ductal carcinoma in her right breast in 2010.
Although she expected her hair to grow back after she was done with chemo, Bemiss claims she continues to suffer from embarrassing hair loss years later, and that she was unaware of the risks with Taxotere until this year, when other lawsuits started being filed. The complaint was filed in the U.S. District Court for the Eastern District of Louisiana under case number 2:16-cv-06425 (PDF).
Mississippi Woman Alleges Permanent Hair Loss from Taxotere
April 20, 2016 – A lawsuit (PDF) was filed today in the U.S. District Court, Southern District of Mississippi, by a woman who was allegedly treated with Taxotere following a recurrence of invasive ductal carcinoma in her left breast in 2014. The chemotherapy resulted in hair loss, which the plaintiff believed would be temporary. However, her hair has not grown back, according to the lawsuit.
“Contrary to Defendants’ claims of superior efficacy, post market surveillance has shown that the more potent and more toxic Taxotere does not in fact offer increased efficacy or benefits over other Taxanes, as Defendants have claimed and advertised,” the complaint states. “Defendants concealed the existence of studies from the FDA, physicians and patients that refuted Defendants’ claims.”
U.K. Issues Taxotere Recall for Concentration Errors
April 20, 2016 – The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a recall today for one batch of Taxotere over a potential risk that the solution may contain over-concentrated amounts of the drug’s active ingredient, docetaxel. Sanofi issued the recall after it found that a software failure may have caused the evaporation of Ethanol from some vials, leading to increased levels of docetaxel.
The recall affects Taxotere (Docetaxel) Concentrate for Solution for Infusion, 80 mg per 4 ml, batch #5f219A, expiration date Aug. 31, 2018. The incidence rate is anticipated to be about 0.09% of the batch.
California Woman Claims Sanofi Underplayed Dangers of Taxotere
March 17, 2016 – A California woman has filed a federal lawsuit against Sanofi SA alleging that it knew about an increased risk of permanent hair loss and other serious side effects with Taxotere, but went to great lengths to hide the problem and promote the drug’s alleged superiority. Plaintiff Ami Dodson claims Sanofi and its affiliates collaborated in a long-running scheme to increase sales of Taxotere – a plan that caused thousands of cancer patients to suffer permanent hair loss, baldness and alopecia.
“Defendants [preyed] on one of the most vulnerable groups of individuals at the most difficult time in their lives,” Dodson said. “Defendants 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.”
The complaint is: Dodson v. Sanofi SA, et al., case number 3:16-cv-01251, in the U.S. District Court for the Northern District of California.
Has There Been a Recall?
In March 2001, a voluntary recall was issued for Taxotere Injection Concentrate 20-mg active and diluent vials. Affected lot numbers included: 0P273 (active), which was packaged together with diluent vials with lot numbers 0T446 and 0T449. The recall was issued after it was determined that the 20mg vial containing the active ingredient was inadvertently labeled as a “diluent” vial. The manufacturer received at least 1 complaint relating to this mislabeling.
Taxotere Settlement Information
To date, there have been no large settlements involving Taxotere’s alleged link to alopecia. This is because the first lawsuits have only recently been filed. Our lawyers are actively pursuing Taxotere litigation in the discovery stage, and we are continually uncovering more information regarding the link between Taxotere and permanent hair loss.
In most cases, settlements are not reached until several lawsuits are tried before a jury, and the manufacturer is able to calculate its potential financial losses. However, this does not mean you should wait to hire a lawyer and file a lawsuit. In fact, if you wait you could permanently lose your legal rights, even if a settlement does occur at some point in the future. This is because every state has a statute of limitations (SOL) in which you can file a lawsuit for injuries suffered after undergoing treatment with Taxotere.
Is There a Class Action?
No class action lawsuit has yet been filed in the Taxotere litigation; however, complaints are being handled on an individual basis. In a class action, a group of plaintiffs are joined together who have suffered similar injuries or side effects from a common product. An individual or small group would represent the interests of the “class” and seek resolution in a single court proceeding. Any settlement monies would be split by the group, and all class members are bound to whatever verdict is handed down.
The problem with class action lawsuits is that class members are often forced into a blanket “low ball settlement” and higher attorney fees. At Schmidt & Clark, LLP we understand that our clients are suffering emotionally and economically due to loss of wages and/or high medical bills and we plan to maximize each client’s recovery by filing individual Taxotere lawsuits on their behalf.
Sanofi Aventis is being investigated for failure to warn about the risk of alopecia from Taxotere. Although hailed as a “wonder drug” for the treatment of breast cancer, patients should have been informed of all their medication options, many of which do not carry the risk of permanent hair loss.
While hair loss is a small price to pay in order to stay alive, permanent alopecia from Taxotere is avoidable. Living with the condition can feel as though you’re still battling cancer, even if you’ve conquered the disease. This is unfair and unjust, and our lawyers are here to help you through this difficult time.
Do I Have a Taxotere Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Taxotere lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if you went bald, suffered permanent hair loss or alopecia from Taxotere, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and we can help.