Update: Dozens of Victims of Taxotere Side Effects File Suit in Cook County Circuit Court
January 22, 2018 – A number of women who claim their hair fell out and never grew back due to a side effect of Taxotere have filed a products liability lawsuit against the manufacturer in Cook County Circuit Court. The complaint names several dozen plaintiffs who bring counts of alleged breach of implied warranty, design defect, and product liability against Sanofi and at least 6 other defendants.
Taxotere is an FDA-approved chemotherapy medication used to treat breast cancer, non-small cell lung cancer, advanced stomach cancer, head / neck cancer and metastatic prostate cancer. The drug is classified as a plant alkaloid, and works by attacking cancer cells during various stages of division. Additionally, Taxotere inhibits the microtubule structures within cancer cells, which ultimately results in cell death.
What’s the Problem?
Sanofi, the company that makes Taxotere, is being investigated for failing to adequately warn that the product may cause alopecia or permanent baldness in some users. Hair loss may occur in the scalp, eyebrows, eyelashes or elsewhere on the body, and typically begins 3-4 weeks after the first dose.
While alopecia associated with typical chemotherapy treatments is temporary, 15% of women who took Taxotere suffered permanent hair loss, according to a study by the National Cancer Research Institute (NCRI). Nearly 3 million U.S. women currently have a history of breast cancer, and about 75% of them are treated with Taxotere.
Taxotere Alopecia Studies
- A manufacturer-sponsored study known as “GEICAM 9805” found that 9.2% of cancer patients treated with Taxotere experienced permanent hair loss.
- In 2006, a study conducted at the Rocky Mountain Cancer Centers in Colorado found that 6.3% of breast cancer patients grew back less than 50% of their hair after being treated with Taxotere, particularly when taken with Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide).
FDA Warning & Taxotere Label Change
In December 2015, FDA warned that it had received reports of permanent alopecia and baldness in chemotherapy patients treated with Taxotere. The agency subsequently required an update to be added to the drug’s boxed warning to reflect this risk.
Can Alopecia be Reversed?
Unfortunately, there is no cure for Taxotere-induced hair loss. However, cold caps — tightly fitting, strap-on hats filled with cold gel — may help lessen alopecia associated with chemotherapy. Because the caps are cold, they constrict blood vessels beneath the skin of the scalp, reducing the amount of chemotherapy drug that reaches the hair follicles. With fewer medications in the follicles, the hair may be less likely to fall out.
Are There Other Side Effects?
In addition to increasing the risk of permanent hair loss, Taxotere may cause the following side effects in some users:
- Pain / swelling at the injection site
- Excessive tearing
- Loss of appetite
Attorneys Ordered to Identify All Claimants for Possible Taxotere Settlement
September 18, 2017 – The Louisiana court in charge of overseeing the federal Taxotere litigation has ordered plaintiffs’ attorneys to identify all claimants in anticipation of a potential settlement in the hair loss lawsuits. The court further ordered all parties to immediately report on any new individuals with potential Taxotere lawsuits, even if the complaints have not yet been filed. Identifying and reporting all potential claims is required for participating in any settlements resulting from the litigation.
Taxotere MDL Grows to Nearly 1,300 Hair Loss Lawsuits
July 19, 2017 – At least 156 new Taxotere alopecia lawsuits have been added to MDL No. 2740, according to an update issued Monday by the JPML. The federal litigation now includes at least 1,272 complaints, which are currently pending in the Eastern District of Louisiana before Judge Kurt D. Englehardt.
Louisiana Court Orders Taxotere Bellwether Trials
June 1, 2017 – A Pretrial Order issued by the U.S. District Court for the Eastern District of Louisiana has directed the litigation parties to submit an order pertaining to discovery and dates for bellwether trials. Bellwethers are common in complex pharmaceutical litigation in which multiple lawsuits are filed against a defendant or defendants alleging similar damages.
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.
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.
California Woman Alleges Permanent Hair Loss from Taxotere
December 1, 2016 – A breast cancer survivor in California has filed a products liability lawsuit against Sanofi-Aventis alleging that Taxotere caused her to suffer permanent alopecia. Plaintiff Mary Gardner of Los Angeles was diagnosed with stage II breast cancer in 2009 and battled the disease for over 3 years, including undergoing chemo with Taxotere. Although Gardner eventually overcame her illness, she developed permanent hair loss as a result of treatment with the drug, according to the lawsuit.
Taxotere Alopecia Lawsuit Filed in Louisiana
November 21, 2016 – A Louisiana woman who claims she lost hair that never came back after undergoing chemotherapy with Taxotere has filed a lawsuit against Sanofi-Aventis. Plaintiff Irene Guidry alleges that she lost hair after chemo for breast cancer with Taxotere in 2011, and it never grew back. She claims that Sanofi marketed the drug as superior to other chemotherapy treatments, without warning that the risk of hair loss may be permanent, while this is only a temporary side effects in similar products.
Taxotere Lawsuits Consolidated in Louisiana
October 6, 2016 – The JPML has ordered all federal Taxotere lawsuits involving claims of permanent hair loss to be centralized in a multidistrict litigation (MDL No. 2740) in the Eastern District of Louisiana before Judge Lance M. Africk. At least 33 complaints pending in 16 federal jurisdictions will immediately be transferred into the MDL, with another 56 actions in 26 districts eligible for transfer in the near future.
Breast Cancer Survivor Files Taxotere Lawsuit
August 18, 2016 – “Julie,” a breast cancer survivor who lives in Maine, decided to file a products liability lawsuit against Sanofi-Aventis after spending large sums of money on hair treatments that were unsuccessful as a result of undergoing chemotherapy with Taxotere. Julie underwent 6 rounds of chemo, and her hair fell out after the second round. The problem is that almost none of it grew back after her chemo was complete.
Motion Filed to Consolidate Taxotere Lawsuits
July 27, 2016 – Plaintiffs’ lawyers have requested a multidistrict litigation (MDL) for lawsuits alleging that Taxotere can cause permanent hair loss, particularly in breast cancer patients, according to Reuters. In a motion filed July 22, lawyers for 2 plaintiffs asked a panel of federal judges to send the Taxotere litigation – which now consists of 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 alleges she suffered permanent alopecia after undergoing a cycle of 6 chemotherapy rounds with Taxotere has filed a products liability lawsuit (PDF) against Sanofi. Plaintiff Alina S. Gorniak claims that Taxotere is more dangerous than other widely-available chemotherapy drugs, and that Sanofi was aware of the Alopecia risk with Taxotere years before lawsuits started being filed. The lawsuit is: Gorniak v. Sanofi S.A. et al (1:16-cv-00637), Texas Westerns District Court.
Breast Cancer Survivor Claims Sanofi Failed to Warn of Alopecia Risk with Taxotere
May 17, 2016 – A lawsuit (PDF) was filed today in Louisiana by a woman who allegedly suffered permanent hair loss after undergoing chemotherapy with Taxotere for invasive ductal carcinoma (IDC), the most common type of breast cancer, in 2010. Plaintiff Yvonne Bemiss, whose cancer is now in remission claims that neither she nor her cancer care team was aware of the potential for permanent alopecia with Taxotere. Bemiss is demanding in excess of $75,000 in damages from Sanofi for her injuries.
New Taxotere Lawsuit Filed in Mississippi
April 20, 2016 – A woman who allegedly developed permanent alopecia after undergoing chemo treatment with Taxotere following a recurrence of invasive ductal carcinoma in her left breast has filed a products liability lawsuit (PDF) against Sanofi. The complaint, which was filed in the U.S. District Court, Southern District of Mississippi, alleges that plaintiff thought her hair loss would be temporary; however, 2 years later and her hair still hasn’t grown back.
“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 suit says. “Defendants concealed the existence of studies from the FDA, physicians and patients that refuted Defendants’ claims.”
Sanofi Underplayed Dangers of Taxotere, Lawsuit Says
March 17, 2016 – A federal lawsuit filed last week in a California federal court accuses Sanofi SA and associates of hiding information regarding Taxotere’s ability to cause permanent hair loss and other serious side effects, and of aggressively marketing the drug to promote its alleged superiority, according to Law360. Plaintiff Ami Dodson, who filed the suit, alleges the companies trained employees to misrepresent the safety and effectiveness of Taxotere’s off-label uses to increase marketability, and paid kickbacks to healthcare providers in order to persuade them to prescribe the drug for unapproved purposes. As a result, sales of Taxotere skyrocketed from $424 million in 2000 to $1.4 billion in 2004.
“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,” Dodson said. “Defendants concealed the existence of studies from the FDA, physicians and patients that refuted defendants’ claims.”
Taxotere vs. Taxol
Taxotere and Taxol (generic: paclitaxel) are both classified as taxanes. These medications show a high level of activity when used as single agents in metastatic breast cancer. In reviews of studies, when compared with standard therapies Taxotere appears to be the most active single agent for treating metastatic breast cancer.
How You May be Affected
The physical and emotional trauma women with breast cancer endure through the treatment process is immeasurable. Combining permanent hair loss or baldness from Taxotere can be unbearable. At Schmidt & Clark, LLP, we believe women who have suffered from such an experience should be justly compensated for their damages.
Has a Class Action Been Filed?
No class action has yet been filed in the Taxotere litigation. However, patients who suffered permanent hair loss or balding after being treated with the drug may be able to pursue a settlement through the filing of an individual lawsuit. If our lawyers determine that you have a valid claim, you may be entitled to compensation to assist with medical expenses, lost wages, pain and suffering, and more.