Taxotere Lawsuit- Chemotherapy Drug | Permanent Hair Loss
Taxotere is a drug that is administered intravenously and it is intended to treat many different types of cancer. The drug works as a form of chemotherapy that is supposed to slow the cell growth of the cancerous tumor. Over 15,000 victims have filed lawsuits against Sanofi asserting that the manufacturer neglected to properly warn physicians and patients concerning the potential of permanent hair loss, otherwise known as alopecia, which is widely known to be caused by Taxotere. As of August 12th, 2021 there are over 12,000 Taxotere hair loss lawsuits pending. Many victims are wondering about hair growth after taxotere. Taxotere lawsuits filed in United States Federal Court have been consolidated in the Eastern District of Louisiana as multidistrict litigation (MDL). The Eastern District of Louisiana is located in New Orleans. The consolidated lawsuits have sustained some setbacks with a number of individual lawsuits dismissed. Nonetheless, the Taxotere litigation is still one of the largest MDL’s in the United States. This drug has several side effects that can result from its usage. One of these side effects is that the hair loss that accompanies the use of this drug is permanent instead of the usual temporary hair loss that is associated with chemotherapy. This is notwithstanding the assurances from the company that the hair loss was limited in time. If you have taken this drug in conjunction with your cancer treatment and experienced permanent hair loss, you should immediately contact a Taxotere lawsuit attorney seeking a taxotere settlement amount.
The presiding justice explained the MDL as follows: “Plaintiffs in this multidistrict litigation (“MDL”) are suing several pharmaceutical companies that manufactured and/or distributed a chemotherapy drug, Taxotere or docetaxel, that Plaintiffs were administered for the treatment of breast cancer or other forms of cancer. Plaintiffs allege that the drug caused permanent alopecia—in other words, permanent hair loss. Plaintiffs bring claims of failure to warn, negligent misrepresentation, fraudulent misrepresentation, and more.” Order
Generally accepted criteria to file a Taxotere Lawsuit
- Female victim has a breast Cancer diagnosis in 2006 or after.
- The Taxotere victim has endured Chemotherapy treatments utilizing Taxotere (Docefrez/ Docetaxel)
- Permanent hair loss (Alocecia)*
*The above criteria are the best Taxotere lawsuits. Other victims without those criteria may still qualify to file a Taxotere lawsuit so you should contact a Taxotere lawsuit law firm. No one knows the eventual Taxotere lawsuit settlement amounts but if you don’t file a lawsuit you will not be eligible for a Taxotere settlement.
- Will there be a taxotere settlement in 2021?
- When will there be taxotere settlements?
- Is there a taxotere class action lawsuit?
Even though hair loss is an expected complication of chemotherapy, the taxotere lawsuits assert that the manufacturer, Sanofi-Aventis, gave incorrect and deceptive warnings concerning the complications of Taxotere. The victims allege that there are other similar medications that are equally as effective. The Plaintiff’s allege that if they had known of the Taxotere side effects and there had been proper warnings, they would have used other drugs and not taken Taxotere.
The Federal Court Consolidated Lawsuits- 411
Multidistrict Litigation name: MDL – 2740 Taxotere (Docetaxel) Products Liability Litigation
Presiding Justice: The Honorable Jane Triche Milazzo
Location of Court: 500 Poydras Street, Room C-206 New Orleans, LA 70130
Name of MDL Court: UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA
Pending lawsuits in MDL: 12,594 (as of 1/19/2021)
Taxotere lawsuit update:
Update- July 16,2021 – “Sanofi has lost a bid for summary judgment in the second bellwether case in multidistrict litigation over its chemotherapy drug Taxotere, after a federal judge ruled that a recent appeals court decision did not change the legal standard for whether Sanofi’s conduct caused plaintiff Elizabeth Kahn’s permanent hair loss. U.S. District Judge Jane Triche Milazzo of the Eastern District of Louisiana on Wednesday rejected the drugmaker’s motion for reconsideration of her earlier ruling denying summary judgment in the case, clearing the way for it to go to trial next month.” Reuters
6-2-21- “Sanofi U.S. Services Inc. defeated appeals challenges to its wins in three Taxotere suits, as the Fifth Circuit declined to revisit a ruling that the plainitffs waited too long to sue over hair loss allegedly caused by the breast cancer drug.” Bloomberg
4-30-21 –The Fifth circuit affirmed two lower court rulings in favor of the Manufacturer dismissing two victim’s lawsuit. In the first case, the Court ruled that summary judgment in favor of the Defendant was appropriate based on the Louisiana Statute of limitations. In the 2nd case the Court affirmed the dismissal of the Taxotere lawsuit determining that there was insufficient evidence to support the victim’s position “as to whether a “permanent hair loss” warning would have changed the doctor’s prescribing decision.” Lexology
11/13/2020- “French drugmaker Sanofi (Euronext: SAN) will face trial in a US court over claims that it misleadingly promoted off-label uses for a cancer drug, Law360 reports. Some allegations in a whistleblower’s 18-year-old False Claims Act (FCA) lawsuit were dismissed by a Pennsylvania judge, but others were allowed to proceed to trial, the date for which has not yet been set. The claims relate to Sanofi’s predecessor Aventis Pharmaceuticals allegedly engaging in false advertising and issuing kickbacks to physicians who promoted its cancer drug, Taxotere (docetaxel).” Pharma letter
11-2-2020- ” NEW ORLEANS — The Louisiana federal judge overseeing the Taxotere MDL has denied a bellwether plaintiff’s motion to exclude the testimony of Sanofi-Aventis’ 39(b)(6) witness, ruling that he is qualified to offer his analysis and opinions on the “Tax 316” clinical trial. In an Oct. 21 order, Judge Jane Triche Milazzo of the U.S. District Court for the Eastern District of Louisiana concluded that as a fact expert, Dr. Michael Kopreski may give lay opinion testimony about Sanofi’s clinical trial because he participated in the company’s day-to-day affairs as the former head of its oncology pharmacovigilance department.” Harris Martin
5/28/2020- “A federal judge has dismissed nearly 200 lawsuits by patients claiming Sanofi SA’s cancer treatment Taxotere caused them to suffer permanent hair loss, saying a change in the drug’s warning label in 2015 clearly explained its risks.” U.S. District Judge Jane Triche Milazzo in New Orleans on Wednesday ruled the updated Taxotere label was legally adequate as it warned patients about the precise risk of the permanent hair loss they suffered.” Reuters
3/11/2020- “The U.S. District Judge presiding over all federal Taxotere lawsuits has scheduled four additional bellwether cases for trial over the next two years, which are designed to help gauge how juries may respond to certain evidence and testimony that will be raised in thousands of similar claims brought by women who have been left with permanent hair loss from the breast cancer drug.” About lawsuits
10/10/19– “After a two-week trial in New Orleans, the jury in the first Taxotere bellwether trial delivered a defense verdict. There are approximately 11,000 claims in the multi-district litigation against manufacturer Sanofi Aventis and other defendants alleging the chemotherapy drug Taxotere (docetaxel) caused permanent alopecia.” Source
5/1/19- “Taxotere Bellwether Trials (May 2019) The first of five scheduled bellwether trials for Taxotere – a chemotherapy drug used to treat breast cancer, prostate cancer and non-small-cell lung cancer – is scheduled to start up in May 2019. Originally scheduled for January, the bellwether trials were pushed back to May to give plaintiffs and defendants more time for discovery and potential settlement discussions.” Consumer safety
August 2018- The New Jersey Supreme Court , a state Court, definitively established a Taxotere multicounty litigation (MCL). This is a State of New Jersey Consolidated lawsuit. The New Jersey MCL is in Middlesex County, New Jersey.
September 2017- The Justice of the Court denied defendant (manufacturer) motion to dismiss all allegations in the Taxotere Lawsuit.
October 2016- U.S. Judicial Panel on Multidistrict Litigation established MDL
Taxotere lawsuit news
- “Taxotere lawsuits first came to the forefront in January 2017 when the Judicial Panel on Multidistrict Litigation consolidated a handful of cases under multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana.” Id.
- Since then, more than 10,000 federal lawsuits have been filed in MDL 2740, all of them claiming that patients who received Taxotere treatment suffered permanent hair loss (alopecia).” Id.
- “The bellwether trials starting in May will be the first Taxotere cases to reach the trial phase, and they will help set precedents and inform arguments for both sides in the thousands of cases to follow.”
- “Historically, defendants who fare poorly in bellwether trials are more likely to settle the remaining cases rather than risk potentially high verdict awards.” Id.
What is Taxotere?
While Taxotere can work with many different types of tumors, its most prevalent use is for women who suffer from breast cancer. Taxotere is manufactured and sold by the French company Sanofi-Aventis. The drug was approved pursuant to FDA’s Section 505(b)(2) authority. This means that FDA approval may be granted based on information that is not developed by or for the applicant. FDA approval was granted in 1996. The drug was initially approved for use in treating breast cancer, but was soon approved for other usages as well.
- Taxotere is considered to be a cytotoxic drug.
- It is made from yew trees. Specifically, the bark or the needles of the tree can be fashioned into a chemotherapy drug.
- Now, the manufacturer is able to synthetically make the ingredients necessary for the drug in the laboratory given the number of trees that are necessary to treat one cancer patient.
- Where cancer is an obvious risk is that the cells divide as the tumor grows. Cytotoxic drugs act to stabilize the cell structure for cancerous tumors. When the structure is stabilized, the cells have a harder time breaking down and reorganizing. If the cells are overly stable and not able to break down, the tumor is less likely to spread. Taxotere’s usage increased as it was approved by the FDA for additional usages.
- At its peak, Taxotere was generating approximately $3 billion in sales for Sanofi.
- While it is still on the market, Taxotere’s sales have declined as Sanofi has newer products in the oncology space. In addition, Sanofi’s patent on this drug expired in 2010 and competition has eaten into the sales of this product.
- “Taxotere is a part of the chemotherapy family of drugs known as “Taxanes.” Taxanes are a type of chemicals called “diterpenoids,” which specifically contain a taxadienecore within the molecule, which is produced by yew trees.” Strother complain
- “Taxanes are widely used as chemotherapy agents, and several taxanes are available for cancer treatment, including but not limited to Taxol, generically known as paclitaxel, Jevtana, generically known as cabazitaxel, and of course Taxotere, generically known as docetaxel.” id.
Side Effects of Taxotere
The manufacturer has always noted that hair loss is a side effect of Taxotere. In general, chemotherapy will cause hair loss until a new hair cycle can begin and the hair is regrown. Hair is usually regrown within six months after chemotherapy ends. However, Sanofi had long stated that the hair loss experienced by patients is temporary in nature. For practically 20 years, Sanofi never acknowledged the possibility that the hair loss could be permanent.
Hair growth after taxotere
Many victims are asking, “will there be hair growth after Taxote?” Patients suffering through chemotherapy with Taxol (paclitaxel) will regrow hair subsequent their completed chemoptherapy. Taxotere is a different story because with Taxotere, hair loss may end up being permanent.
However, it is alleged that Sanofi has long had the knowledge that Taxotere can cause permanent hair loss. It is alleged that there was internal testing that began shortly after the drug was approved by the FDA that looked at the possibility that the drug could cause permanent alopecia. By 2006, Sanofi is alleged to have known that nearly one in every ten patients that received this drug had experienced permanent hair loss. One specific study found that patients could experience difficulty re-growing their hair for up to seven years after taking the drug.
Pharmaceutical companies have the obligation to update the warning labels for their products to reflect the known side effects of their products. Sanofi said nothing to the FDA regarding permanent hair loss until it alerted the FDA of this possibility in December 2015. However, this condition was not reflected on the warning label for its product. Further, by this time, sales of Taxotere had already begun to decline as the drug was replaced by a newer version of chemotherapy drug. In the meantime, there have been numerous scientific studies that have addressed the fact that Taxotere may be connected with permanent hair loss in patients as well as extensive media coverage of the issue. Warning labels in both the U.K. and Canada have been changed to reflect this side effect.
In addition to being required to update the warning label, drug manufacturers must also report each adverse drug experience for this product. It must also investigate all adverse drug experiences for a product.
There have been numerous Taxotere hair loss lawsuits filed on behalf of women who experienced permanent hair loss after taking Taxotere. These lawsuits generally allege that Sanofi knew that the drug caused permanent hair loss, but hid that fact while it continued to market and sell the drug. At the same time, the women received this drug without the knowledge that they may lose hair and not grow it back.
The lawsuits have been consolidated into a multi-district lawsuit that is currently in the Eastern District of Louisiana. As of September 15, 2020, there were over 12,597 cases that have been filed against Sanofi and other defendants that are pending in this district. Each case will proceed on its own, but there is a centralized process for discovery issues and there will be a bellweather case that is tried first. There are bellweather cases that are scheduled to be tried in 2019 and 2020. In addition, there are hundreds of cases that are pending in New Jersey state courts which have been consolidated into multi-county lawsuits in the state courts.
Is there a Taxotere class action lawsuit?
No there is no Taxotere class action. However there is Taxotere lawsuit in the form of an MDL pending in federal Court. This does not constitute a Taxotere class action lawsuit.
Taxotere settlement amounts
It is vital that you contact a Taxotere lawsuit lawyer immediately if you have taken Taxotere and have experienced permanent hair loss. The attorney can give you the potential range of a taxotere settlement amount. Since Taxotere is rarely in use anymore, it is likely that you have taken Taxotere some time ago. Accordingly, there is a statute of limitations that will apply to your case, and you will need to file the claim before the statute of limitations tolls. A taxotere attorney can give you a free consultation where they can inform you whether they believe your claim is viable and the process that must be followed to file that claim.
A checkered history
According to the DENA STROTHER AND CHRISTOPHER STROTHER taxotere lawsuit complaint filed IN THE SUPERIOR COURT OF THE STATE OF DELAWARE:
- “Upon information and belief, Aventis Pharma S.A., sought FDA approval for Taxotere in or about December of 1994 and the FDA’s Oncologic Drugs Advisory Committee Panel had unanimously recommended the rejection of the approval for Taxotere because the Taxotere was more toxic than Taxol, and recommended more testing and studies for Taxotere’s side effects.”
- On or about May 14, 1996, Sanofi Defendants obtained FDA approval for the “treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.”
- Sanofi Defendants continued to seek additional indications for Taxotere and based on self-sponsored clinical trials, Sanofi Defendants alleged superiority over other chemotherapy products approved for the treatment of breast cancer. Sanofi Defendants’ marketing claims included superior efficacy over the lower potency Taxanes, including Taxol.
- Despite Sanofi Defendants’ claims of superior efficacy, post market surveillance demonstrated that the more potent and more toxic Taxotere, in fact, did not have higher efficacy or benefits compared to the other Taxanes and Defendants concealed the existence of studies from the FDA, physicians, patients, and the public that refuted Sanofi Defendants’ claims and advertisements of superior efficacy.
- In or about August of 2007, the journal, Cancer Treatment Review, published a comparison of the relative efficacy of Taxanes in the treatment of breast cancer. This study concluded that there were no significant differences between the efficacy and outcomes obtained from Taxotere treatment and Taxol treatment.
- In or about April of 2008, the New England Journal of Medicine published a study titled, Weekly Paclitaxel in the Adjuvant Treatment of Breast Cancer, which concluded That Taxol was more effective than Taxotere for patients undergoing the standard adjuvant chemotherapy with doxorubicin and cyclophosphamide.
- Sanofi Defendants continued to make false and misleading statements, promoting the “superior efficacy” of Taxotere over the competing product Taxol, despite the studies that concluded otherwise. Specifically, in or about June 2008, Sanofi-Aventis used a “reprint carrier” citing a clinical study published in August of 2005 from the Journal of Clinical Oncology that concluded Taxotere had superior efficacy compared to Taxol “providing significant clinical benefit in terms of survival and time to disease progression, with a numerically higher response rate and manageable toxicities” in the marketing and promotional materials for Taxotere.”
- Sanofi Defendants’ statements in the “reprint carrier” materials highlighting the conclusions of the 2005 study were false and/or misleading due to the 2007 and 2008 studies finding Taxotere was not more effective than Taxol in the treatment of breast cancer.
- Consequently, on or about April 16, 2009, Keith Olin, from the FDA Division of Drug Marketing, Advertising, and Communications (DDMAC), issued a warning letter to MaryRose Salvacion, the Director of US Regulatory Affairs Marketed Products for SanofiAventis, regarding the NDA #20-449, Taxotere (docetaxel). In this letter, the DDMAC stated: The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed a professional reprint carrier [US.DOC.07.04.078] for Taxotere (docetaxel) Injection
Concentrate, Intravenous Infusion (Taxotere) submitted under cover of Form FDA 2253 by sanofi- aventis (SA) and obtained at the American Society of Clinical Oncology annual meeting in June 2008. The reprint carrier includes a reprint from the Journal of Clinical Oncology, which describes the TAX 311 study. This reprint carrier is false or misleading because it presents unsubstantiated superiority claims and overstates the efficacy of Taxotere. Therefore, this material misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the
Act), 21 U.S.C. 352(a) and 321(n). Cf. 21 CFR 202.1(e)(6)(i), (ii) & (e)(7)(ii)
- In addition, a Qui Tam lawsuit was filed against Sanofi-Aventis and its affiliates in the U.S. District Court for the Eastern District of Pennsylvania, by a former employee stating Sanofi-Aventis and its affiliates engaged in fraudulent marketing schemes, paid kickbacks, and provided other unlawful incentives to entice physicians to use docetaxel. See U.S. dx rel. Ghoil v. Sanofi-Aventis U.S. Inc., CA No. 02-2964 (E.D. Pa. 2015).
- Beginning in or around 1996, Sanofi S.A., Aventis Pharma S.A., Sanofi-Aventis U.S., LLC, Sanofi U.S. Services, Inc., and their predecessors and affiliates, designed, directed, and/or engaged in a marketing plot that promoted Taxotere for indications not approved by the FDA, also known as off label promotion. The plot had two prongs. The first prong was training and directing employees to misrepresent the safety and effectiveness of the off-label use of Taxotere, to get a foothold in other types of cancer treatment markets. The other prong was paying healthcare providers illegal kickbacks in the form of grants, speaker fees, travel, entertainment, sports and concert tickets, preceptorship fees, and free reimbursement assistance to incentivize healthcare providers to prescribe Taxotere for off label treatment.
- The Sanofi Defendants fraudulent marketing and illegal kickback scheme increased the Taxotere the revenue of sales by approximately one billion dollars from 2000’s $424 million to 2004’s $1.4 billion. U.S. ex rel. Gohil v. Sanofi-Aventis U.S. Inc., 96 F. Supp. 3d 504, 508 (E.D. Pa. 2015).
- Sanofi Defendants’ fraudulent and illegal conduct drastically increased the number of victims to be exposed to a more toxic chemotherapy treatment with no better efficacy than less toxic chemotherapy treatments already available.
- Sanofi Defendants’ fraudulent and illegal conduct caused thousands of individuals to be exposed to more frequent and/or more severe side effects, including but not limited to disfiguring and permanent alopecia (hair loss).”
Sources for Taxotere settlements:
*Consumer- Awareness -Group, -pamphlet