Our Taxotere Alopecia litigation attorneys are representing women nationwide in a lawsuit against the drug manufacturer and pharmaceutical giant, Sanofi-Aventis. The claim alleges they failed to warn women who elected to use Taxotere as part of their breast cancer chemotherapy regimen and their medical providers of the potential side effect of permanent hair loss (alopecia).
If you have experienced hair loss that has not grown back since completing chemotherapy treatment for two months or longer, you may be entitled to damages for medical expenses, wage loss, pain and suffering, loss of enjoyment of life, and loss of consortium. A recently filed lawsuit suggests the drug manufacturer knew of the potential side effect of alopecia through their own company-sponsored study but hid the results.
“Thank you so much for standing up for so many that were not told the truth about Taxotere. I, personally, want to know ALL the side effects of a medication before taken. I believe that is my right to know and my decision.”
– J., Taxotere Client
March 2017 – Docetaxel Possibly Linked to Five Deaths in France
The French National Drug and Health Product Safety Agency (ANSM) is investigating five deaths within a six month period due to neutropenic enterocolitis in patients who received docetaxel (Taxotere), either alone or as part of combination chemotherapy for breast cancer. The victims were between 46–73 years old.
Neutropenic enterocolitis is an inflammation of part of the large intestine located near the appendix, usually affecting immunocompromised patients. It can lead to bowel perforation, sepsis, and death.
Although official results of an ANSM pharmacovigilance investigation will be published on March 28, 2017, they did state that the quality of the docetaxel lots did not appear to be to blame.
“It is fully in accordance with the standards,” explained the ANSM general director, Dominique Martin.
The Institut Curie issued a press release on February 16, 2017, announcing it would stop using docetaxel after one patient expired after her first treatment of docetaxel and a similar death prior to that.
“As a precaution, given the occurrence within an unusually short period of time, of these two similar cases at the Institut Curie and those at other healthcare facilities in France, the Institut Curie has stopped using docetaxel to treat breast cancer. It has been replaced with paclitaxel,” reads the press release.
“A risk-benefit assessment will need to be made if it is decided to withdraw docetaxel from the market, to suspend its marketing. This is presently being looked at,” explained Dr. Martin.
The ANSM says that “no recommendation has been made to date, given the absence of additional investigative findings,” but adds, “paclitaxel may be an alternative to docetaxel.”
February 2017 – Study Finds Taxotere Has More Side Effects and Lower Survival Rate.
A new study has raised concerns that the controversial drug Taxotere may not only cause more side effects than competing drug Tecentriq but may also have lower survival rates.
In the study, researchers found a median overall survival rate of 13.8 months for patients who received Tecentriq for treatment of lung cancer, compared to 9.6 months for patients who received Taxotere. It was also found that just 15% of patients who had received Tecentriq experienced grade 3 or 4 adverse events, compared to 43% of those who had received Taxotere.
Read more about the study here.
March 2016 – Federal Lawsuit Filed Against Sanofi-Adventis
A federal lawsuit has been filed in the state of California by a woman who blames her permanent hair loss on the popular breast cancer chemotherapy drug, Taxotere. Ami Dodson claims the drug manufacturer and corporate giant, Sanofi-Aventis, engaged in a fraudulent marketing scheme to drive sales while hiding this serious side effect of the drug.
“Defendants obtained billions of dollars in increased revenues at the expense of unwary cancer victims.”
“Defendants [preyed] on one of the most vulnerable groups of individuals at the most difficult time in their lives,” Dodson said in the lawsuit. “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.” With other chemotherapy drugs widely available, she says she would not have used the drug had she been made aware of the potential side effect.
“Permanent baldness is a disfiguring condition, especially for women,” said Dodson. “Women who experienced disfiguring permanent alopecia as a result of the use of Taxotere suffer great mental anguish as well as economic damages, including but not limited to loss of work or inability to work due to significant psychological damage.”
It has been alleged that Sanofi-Aventis knew as early as the late 1990’s that Taxotere could cause permanent hair loss but went to great lengths to hide the problem. The claim also cites a warning letter issued by the FDA in 2009, as the company continued to market the drugs’ “superior efficacy” although a 2008 study published by the New England Journal of Medicine concluded that a competing drug was actually more effective for certain patients.
December 2015 – FDA Requires Safety Labeling Change Due to Adverse Reactions
A safety labeling change has been mandated by the FDA for the popular chemotherapy drug, Taxotere. The warning comes after cases of permanent alopecia having been reported post-marketing the drug.
ABOUT THE LAWSUIT
With prescriptions written for nearly 75% of all breast cancer patients, Taxotere has been noted as the most frequently used breast cancer drug in its class. Since 2004, drug sales have skyrocketed to about $1.4 billion annually for the company.
Permanent hair loss is considered uncommon in chemotherapy treatment as in most cases, hair grows back 3-6 months after treatment. Studies show, however, that with Taxotere there is an increased risk of permanent hair loss that can occur anywhere on the body.
Ami Dodson, plaintiff, claims in a lawsuit filed in March that the company has known since possibly the late 1990s that 9.2 percent of people who used the drug had experienced hair loss for a duration of more than 10 years. Dodson says these study results were deliberately hidden from the public and instead the company kept the warning vague, stating instead that “hair generally grows back.”
The lawsuit also alleges that a scheme by the company to promote sales and downplay risks of the drug began when the drug was first approved by the FDA in 1996. First, that Sanofi trained employees to expand the market by misrepresenting the effectiveness and safety of off-label use and then, that kickbacks were paid to medical professionals who would prescribe the drug. As a result, sales jumped from $424 million in the year 2000 to $1.4 billion in 2004.
“Although women might accept the possibility of permanent baldness as a result of the use of Taxotere if no other product were available to treat their cancer, this was not the case,” Dodson said. “There were already similar products on the market that were at least as effective as Taxotere and did not subject female users to the same risk of disfiguring permanent alopecia.”
In the Eastern District of Pennsylvania, an ex-Sanofi employee has filed a whistleblower lawsuit alleging engagement in fraudulent marketing by the company and kickbacks paid relating to Taxotere (U.S. ex rel. Gohil v. Sanofi-Aventis U.S. Inc., Civil Action No. 02-2964).
The most recent lawsuit against the company with regard to Taxotere is in early stages and the drug has not been recalled. The company has not yet responded to the allegations and is potentially facing thousands of lawsuits by women across the United States.
What is Taxotere?
Taxotere is the brand name for docetaxel, a member of taxane chemotherapy drugs.
How is Taxotere administered?
Taxotere is administered intravenously over one hour approximately every three weeks. If you received chemotherapy treatment for breast cancer more frequently than that, you probably did not receive Taxotere.
What types of cancer does Taxotere treat?
Taxotere has been approved to treat head and neck cancer, stomach cancer, breast cancer, prostate cancer, and non-small cell lung cancer.
Who makes Taxotere?
Sanofi-Aventis is the manufacturer of Taxotere.
What are the common side effects of Taxotere?
The Prescribing Information (PDF) lists the most common side effects of Taxotere to be: changes in your sense of taste, feeling short of breath, constipation, decreased appetite, changes in fingernails or toenails, swelling of hands, feet or face, feeling weak or tired, joint and muscle pain, nausea and vomiting, diarrhea, mouth or lips sores, hair loss, rash, redness of the eye, excess tearing, skin site reactions, and tissue damage.
Serious side effects are listed to include: acute myeloid leukemia, other blood disorders, skin reactions, and neurologic symptoms.
Signs of an allergic reaction may include rash, hives, difficulty breathing, swelling of the face, lips, tongue, or throat.
Sanofi-Aventis updated warning labels to include permanent hair loss in Europe in 2005 and in Canada in 2012. Labels were not updated in the United States until December 2015.
Why are lawsuits being filed against Sanofi-Aventis?
Lawsuits filed against the pharmaceutical company alleging that they knew about the risk of permanent hair loss as early as the late 1990s through their own company-sponsored study but went to great lengths to hide the results. Patients claim if they had known of the risk, they may have chosen alternate treatment regimens.
Has Taxotere been recalled?
No, the FDA has not recalled the drug. At this point, they have just required that the manufacturer update the labels to adequately warn of the risk of permanent hair loss.
What other chemotherapy drugs are used to treat breast cancer? Are any of them included in this lawsuit?
Some other chemotherapy drugs used to treat breast cancer are listed below. None of these drugs are included in the lawsuit.
Taxotere has been the most frequently prescribed breast cancer chemotherapy drug in the United States to date, used in about 75% of cases.
- Cytoxan (cyclophosamide)
- Adriamycin (doxorubicin)
- Ellence (epitubicin)
- Maxtrex (methotrexate)
- Taxol (paclitaxel)
- Xeloda (capecitabine)
- Paraplatin (carboplatin)
- Cytoxan (cyclophosphamide)
- Halaven (eribulin)
- Adrucil (5-fluorouracil)
- Gemzar (gemcitabine)
- Ixempra (ixabepilone)
- Doxil (liposomal doxorubicin)
- Abraxane (paclitaxel, albumin-bound)
- Navelbine (vinorelbine)
SANOFI-AVENTIS IN OTHER NEWS
Sanofi-Aventis has a history of allegations of illegal activities.
As reported by CNBC, “In 2012, Sanofi agreed to pay the federal government $109 million to resolve allegations that the company violated the False Claims Act by giving physicians free units of the knee injection Hyalgan in order to induce them to buy and prescribe the drug, in violation of the Anti-Kickback Statute.”
“In 2012, Sanofi agreed to pay the federal government $109 million…for violations of the Anti-Kickback Statute.”
CNBC also reported that “In March 2013, two ex-Sanofi employees were sentenced by a court in Germany to suspended sentences, and Sanofi was fined 28 million euros ($29.8 million) in connection with a bribery case there. A spokesman for prosecutors told the Reuters news agency that the former employees made illicit payments to a consulting company that was advising a Sanofi client in order to get the client to order more drugs from Sanofi.”
Ex-employee Diane Ponte, paralegal, in a pending whistleblower lawsuit against the company, stated by written affidavit in Newark, New Jersey “prior to my last position with Sanofi, I had been working in the Sanofi litigation department for approximately seven years. In the course of my working in the Sanofi litigation department, I became personally aware of many instances in which documents were deliberately destroyed by Sanofi attorneys to avoid turning over said documents in discovery.”
VICTORIA MANIATIS LEADS LITIGATION
Victoria Maniatis leads Sanders Phillips Grossman’s Taxotere Alopecia litigation team. She is passionate about women’s health issues and has many years of experience in mass tort litigation, concentrating specifically on pharmaceutical and medical device claims.
Both federal and state judges have appointed Ms. Maniatis as lead counsel on various Plaintiffs’ steering committees, including Fosamax Femur Fracture litigation as well as the Bard, Boston Scientific, Ethicon, and American Medical Systems cases within the Transvaginal Mesh litigation. She is lead counsel in New Jersey’s Propecia Multi-County Litigation.
She is one of the founding members of the Mass Tort Medical School’s annual medical seminar for Plaintiffs’ attorneys and committee co-chair for the Women en Masse mass tort group.
Ms. Maniatis is also an avid triathlete and has one son.
Read more about Sanders Phillips Grossman attorneys here.
DO I HAVE A CASE?
Sanders Phillips Grossman is currently accepting cases from women across the United States who underwent chemotherapy at some point between 2006 – 2016 and suffered permanent baldness or hair loss that lasted two or more months after treatment. A successful outcome of your claim could entitle you to damages for medical expenses, wage loss, pain and suffering, loss of enjoyment of life, and loss of consortium.
WHAT WILL AN ATTORNEY COST ME?
We represent our clients on a contingency fee basis. This means that you pay no attorney fees until we win your claim. If we are unable to successfully resolve your claim, you are not obligated to pay attorneys’ fees.
IS THIS A CLASS ACTION LAWSUIT?
No. The litigation against Sanofi-Aventis is proceeding as a mass tort. That means each woman we represent will have her own individual claim against the drug manufacturer for her own distinct damages because the nature and extent of injuries are separate and distinct. We will negotiate settlements considering the facts of each individual case to ensure compensation to the degree of damages suffered.
In a class action, all plaintiffs have the same or similar damages. An example would be consumers who purchased the same defective product, such as a washing machine with a defective part. A class action will bring thousands of victims together and aggregate claims where it may be impractical to efficiently pursue claims individually.
ABOUT SANDERS PHILLIPS GROSSMAN
Sanders Phillips Grossman has been holding pharmaceutical companies responsible for injuring individuals by their defective drugs and devices for over 30 years. Defective drugs are pharmaceuticals with side effects that potentially harm, injure, or kill the patient to the point that they outweigh the drug’s intended benefits. Defective devices, such as faulty prosthetics, implants, pacemakers, or surgical instruments can harm patients when the product is defective in the manufacturing process, design, or marketing strategy.
Pharmaceutical companies are some of the largest, wealthiest, and most influential corporate entities in the world. Sanders Phillips Grossman and its predecessors have recovered over one billion dollars for injured consumers. Our firm’s history in dealing with drug and medical device injury claims has allowed us to take leadership roles in many of the national defective drug and device litigations.
Nationally recognized as a leading plaintiff’s law firm, we handle cases in all 50 states and Puerto Rico.
Read more about our attorneys here.