If you or a loved one developed permanent alopecia (substantial loss of hair or baldness) or suffered any other serious complication after taking Taxotere or its generic form, docetaxel, you may be entitled to compensation through a lawsuit filed against their manufacturers.
For more than half a century, the accomplished personal injury attorneys of Gerling Law have fought passionately to help their clients who have been harmed through no fault of their own and deserve compensation for their injuries.
Contact Gerling Law today for a free, no-obligation consultation with one of our knowledgeable Taxotere lawyers. We will thoughtfully listen to your story and evaluate the details of your case to determine whether we can help you. If so, we will zealously represent you by holding the pharmaceutical companies accountable for the damage they caused and help you receive the maximum compensation you deserve for your injuries and suffering.
What Is Taxotere?
Taxotere is a popular chemotherapy drug manufactured by Sanofi-Aventi that was first approved by the Food and Drug Administration (FDA) in May 1996. Taxotere falls under a specific class of chemotherapy treatments called taxane drugs, which are made from plant alkaloids. Taxotere is commonly prescribed to treat an array of cancers, but is popular for metastatic breast cancer treatment. Of the drugs used to treat breast cancer, Taxotere is the most prescribed drug in the taxane class – some sources estimate that 75% of breast cancer patients will receive Taxotere as a form of treatment. It has also been approved to treat non-small cell lung cancer (NSCLC), prostate cancer, head and neck cancers, and stomach cancer (gastric adenocarcinoma).
Taxotere is a synthetic version of a naturally-occurring compound known as Taxol, manufactured by Bristol-Meyer Squibb. This drug, also used to treat a number of solid tumor cancers, is derived from the bark of the Pacific yew tree. Taxol is a plant alkaloid that has been proven to inhibit the growth of malignant tumors. Unlike the natural extract from the Pacific yew tree, the active ingredient in Taxotere, docetaxel, is much stronger. Drug companies also charge substantially more for the synthetic version. As of 2015, the cost for a vial of docetaxel was over $85 USD, whereas a vial of paclitaxel was under $14, according to the International Medical Products Price Guide. Several other manufacturers started making Taxotere’s generic form, which is just called docetaxel, in 2011.
Taxotere Treatment Plan
Unlike similar chemotherapy drugs with weekly treatment plans, Taxotere’s treatment plan runs at three-week intervals. Fewer trips to the doctor for treatment makes Taxotere more attractive to both patients and doctors. It is usually administered intravenously through a vein during one hour-long infusion cycles that are then repeated every 3-4 weeks.
Taxotere has also been approved for administration outside of the hospital (in 60-100 mg/m2 doses). Similar chemotherapy treatments require hospitalization to cope with extended infusion times.
The drug works by stopping the spread of cancerous cells by cutting off the dividing and multiplying of cells in and around a cancerous clump. As a cytotoxic chemotherapeutic agent, Taxotere is designed to kill off cancer cells by preventing them from reproducing. Unfortunately, the cytotoxic effect extends to healthy cells as well, including those of hair follicles.
Why Is Taxotere Unsafe?
The Food and Drug Administration (FDA) received 46,079 reports of serious adverse events related to Taxotere between 2006 and 2020. Of those reports, 6,264 were deaths.
As is warned on the Taxotere label, toxic death occurs in around 2% of metastatic breast cancer patients and about 11.5% of patients with other tumor types with abnormal liver function who are using Taxotere. However, another well-known, common side effect of chemotherapy is alopecia or hair loss. In most cases, this hair loss is temporary and hair growth resumes within a few months after the course of treatment has been completed–but not in Taxotere’s case.
Based on conclusions from a U.K. study conducted in 2013, up to 15 percent of women who undergo treatment with Taxotere experienced permanent hair loss. The permanent and irreversible hair loss disease can affect all body hair, including eyebrows, eyelashes, facial hair, and pubic hair. The psychological and social consequences can be devastating, and even have a negative effect on long-term survival rates. Unlike the danger of toxic death, permanent alopecia was not adequately warned about by manufacturers. The drug itself was approved by the FDA in 1996, but warnings about the possibility of permanent alopecia did not appear on packaging until nearly twenty years later.
It was not until December 2015 that the FDA required that Taxotere’s label be revised to include warnings about permanent alopecia.
By now, it has become abundantly clear that Sanofi-Aventis was fully aware of the risk of their product. However, instead of a clear warning, U.S. package labels contained only vague information about possible hair loss, with the claim that it “generally regrows.”
According to an attorney, Ben Gordon, who has been handling Taxotere litigation, Sanofi-Aventis believed it could improve upon Taxol. In 2016, he explained, “They made a synthetic version. It’s poison. It’s toxic. It’s the same molecule, but they made it twice as strong, so they could try to beat Bristol Myers and they could get that market share.” This toxicity is what causes the permanent destruction of hair follicles.
Studies Link Taxotere To Alopecia Hair Loss
Multiple studies, including the aforementioned U.K study, have found that Taxotere use can result in alopecia. Temporary hair loss is a common side effect of most chemotherapy treatments. However, most do not cause complete permanent or disfiguring loss of hair.
Documents from the Sanofi-funded GEICAM 9805 study that were presented as evidence in ongoing litigation against Sanofi revealed that Sanofi failed to recognize in-house data collected from the GEICAM 9805 study revealing that around 9.2% of patients suffered hair loss that lasted more than a decade, and that Sanofi did not recognize the findings of Dr. Scott Sedlack of the 2006 Rocky Mountain Cancer Centers study, whose findings indicated that 6% of women using Taxotere suffered permanent alopecia.
A 2012 study published in the Annals of Oncology reported that, of the 20 female participants who received Taxotere, 19 developed permanent hair loss. One participant who was being treated for recurrent breast cancer had previously undergone chemotherapy with a different drug and had complete hair regrowth, but after using Taxotere, she suffered from permanent hair loss.
Studies find that among all of the side effects associated with chemotherapy, hair loss has the greatest impact on a patient’s quality of life, especially for women. The 2012 study published in the Annals of Oncology found that women who suffered from alopecia due to Taxotere suffered “significant impairment” to their quality of life. Alopecia can severely affect a person’s quality of life, affect body image, and cause depression and distress. For breast cancer survivors, alopecia is more than a cosmetic effect. The disease is a constant reminder of the struggle to fight breast cancer. And for women who already have to struggle with the burden of breast cancer and chemotherapy, developing alopecia can be devastating. Lemieux et al. published a 2008 review of 38 articles analyzing the impact of hair loss on women with breast cancer. Study authors looked at quality of life relating to anxiety, body image, distress, sexuality, social functioning, self-esteem, and the ability to return to work and found that hair loss consistently ranked among the most troublesome side effects, was described as distressing, and affected the body image.
Taxotere Dangers, Side Effects, and Injuries
In addition to permanent alopecia, other adverse side effects include:
- A Feeling Of Pins And Needles On Skin
- A Nail Disorder
- A Skin Rash
- Abnormal Peeling Of Skin
- Absence Of Menstrual Periods
- Decreased Appetite
- Erythema Or Skin Redness
- Generalized Weakness
- Low Energy
- Muscle Pain
- Stomatitis, A Condition With Painful Swelling And Sores Inside The Mouth
- Taste Impairment
- Trouble Breathing
- Water Retention
- Widening Of Blood Vessels
- A High Alanine Transaminase Level
- A High Aspartate Transaminase Level
- Abnormal Liver Function Tests
- Erythrodysesthesia Or Tingling, Pain, Redness, And Edema In The Hands And Feet
- High Amount Of Bilirubin In The Blood
- Inflammation Of The Esophagus
- Low Blood Pressure
- Significant Redness Of The Skin
- A Disorder Of The Peripheral Nerves That Enable Movement Called Peripheral Motor Neuropathy
- Difficulty Swallowing
- Excessive Watery Eyes
- Joint Pain
- Pink Eye
- Puffy Skin
- Reactions At The Site Of The Injection
- Red Eyes
- Stomach Cramps
- Weight Gain
- A Clot In The Lung
- A Condition Where Parts Of The Skin Becomes Tough And Tightened Called Pseudoscleroderma
- A Condition Where There Is Formation Of Fibrous Tissue In The Lung Called Pulmonary Fibrosis
- A Condition With Symptoms That Resemble Lupus
- A Heart Attack
- A Hole In The Intestine
- A Significant Type Of Allergic Reaction Called Anaphylaxis
- A Skin Disorder With Blistering And Peeling Skin Called Stevens-Johnson Syndrome
- A Skin Disorder With Blistering And Peeling Skin Called Toxic Epidermal Necrolysis
- A Sudden Worsening Of Heart Related Chest Pain Called Angina
- A Type Of Blood Clotting Disorder Called Disseminated Intravascular Coagulation
- A Type Of Inflammation Of The Lung Called Interstitial Pneumonitis
- A Type Of Skin Disorder Called Acute Generalized Exanthematous Pustulosis
- Abnormal Heart Electrical Signals
- Abnormal Heart Rhythm
- Acute Myeloid Leukemia, A Type Of Blood Cancer
- Acute Respiratory Distress Syndrome, A Type Of Lung Disorder
- An Increase In Uric Acid Due To Cancer Chemotherapy
- Atrial Fibrillation
- Atrial Flutter
- Blockage Of The Stomach Or Intestine
- Blocked Bowels With Decreased Peristaltic Movement
- Blood Clot In A Deep Vein Of The Extremities
- Decreased Kidney Function
- Erythema Multiforme, A Type Of Allergic Skin Reaction
- Hearing Loss
- Heart Failure
- High Blood Pressure
- Inflammation Of The Liver Called Hepatitis
- Inflammation Of The Small And Large Intestine
- Inflammation Of The Vein, Or Phlebitis After Infusion
- Insufficient Blood Supply To The Colon
- Kidney Failure
- Low Amount Of Magnesium In The Blood
- Low Amount Of Potassium In The Blood
- Low Amount Of Sodium In The Blood
- Lung Failure Causing Loss Of Breath
- Lung Tissue Problem
- Macular Swelling And Degeneration Of The Eye
- Muscle Inflammation
- Myelodysplastic Syndrome, A Bone Marrow Disorder
- Neutropenic Colitis
- Non-Hodgkin’s Lymphoma
- Radiation Recall Syndrome
- Rapid Onset Of Fluid In The Lungs
- Renal Cell Carcinoma
- Significantly Low Blood Pressure
- A Change In Vision
- Abnormal Sensations Of The Skin
- Chest Pain
- Chest Tightness
- Discoloration Of Nail
- Fast Heartbeat
- Lymphedema, Or Swelling Due To Blockage Of Lymph Nodes
- Sinus Tachycardia, A Type Of Fast Heart Rate
- Subacute Cutaneous Lupus Erythematosus
- Thrombophlebitis, An Inflamed Vein Due To A Blood Clot
Taxotere carries a black box warning for five (5) complications that can be severe or fatal. These black-box serious adverse health effects include:
- Neutropenia (abnormally low white blood cell count)
- A low neutrophils (specific white blood cell) count makes patients more likely to contract bacterial infections. If not treated, these bacterial infections can cause severe health conditions and even death. Patients with neutrophil counts under 1500 cells per 3 cubic millimeters of blood volume are more susceptible to develop neutropenia and are advised against using Taxotere unless necessary. Doctors are advised to frequently check blood counts for these patients who do use Taxotere.
- Fluid Retention
- Taxotere’s label warns that the condition may reach severe levels for some patients.
- Hypersensitivity reactions (allergic reactions)
- Reactions like a rash, low blood pressure, and fatal anaphylaxis. Patients who received dexamethasone premedication are most susceptible to developing these conditions.
- Hepatotoxicity (liver toxicity)
- Liver damage caused by chemical exposure due to Taxotere treatment. Common in patients with abnormal liver function or elevated LFT, hepatotoxicity can because of severe complications and even be life-threatening.
- Toxic death (sepsis)
- Increased risks for patients with abnormal liver function, patients prescribed higher doses, patients suffering from NSCLC, and prior platinum-based therapy recipients.
What Injuries Qualify For a Taxotere Lawsuit?
You may be eligible for compensation through a Taxotere lawsuit if you:
- Took Taxotere or docetaxel
- Developed permanent alopecia (substantial hair thinning, hair loss, or baldness)
Damages you may be able to recover are:
- Medical expenses
- Cost of hairdresser, wigs, and extensions
- Lost wages
- Decreased earning ability
- Pain and suffering
- And other losses
If you or a loved one experienced permanent disfiguring from the thinning or loss of hair following the use of Taxotere or docetaxel, contact Gerling Law for a free, confidential, no-obligation case evaluation and Taxotere lawsuit consultation today. Our Taxotere lawyers will be here to help you every step of the way, answer any questions you may have, and walk you through the steps of your Taxotere lawsuit.
Taxotere Lawsuits Filed Against Manufacturers
When women did not regrow their hair after using Taxotere, its manufacturer, Sanofi-Aventis, was accused of downplaying the risk and misleading patients and the medical community about alopecia being a potential risk. A growing number of women and their families have filed lawsuits against Taxotere manufacturer, Sanofi, and against certain generic manufacturers, claiming that the manufacturers were aware of the increased risks of alopecia, but failed to warn consumers. The plaintiffs also claim that Sanofi hid data and research that linked Taxotere to these adverse side effects.
Evidence presented in litigation against Sanofi indicated that the manufacturer tried to downplay the known risks in order to get the drug approved in 1996. Plaintiffs have made accusations that employee training incorporated teaching misrepresentation of safety and effectiveness, and alleged illegal payments in the form of “kickbacks” to doctors who prescribed Taxotere.
In fact, Sanofi did warn consumers outside of the U.S. that Taxotere could be linked to “permanent hair loss” and even alopecia but failed to warn U.S. consumers. Of particular concern, the manufacturer, Sanofi-Aventis, issued a warning about the possibility of permanent alopecia on package labels in the European Union and Canada in 2005. But, no such warnings were given to U.S. doctors and patients until a decade later in 2015. Sanofi’s own studies in 2006 had indicated that the risk of permanent alopecia was only approximately 3 percent, which the French pharmaceutical company decided did not warrant a warning for U.S. patients. However, independent studies conducted later that year had concluded that the figure was twice that high.
Lawsuits claim that Sanofi actually misled the U.S. public through advertising and marketing that assured Taxotere users that hair loss was only temporary and that there was no threat of permanent hair loss.
While studies indicate that Taxotere is effective chemotherapy treatment, lawsuits allege that other treatments, which are at least as effective as Taxotere, do not subject consumers to the same risks of permanent hair loss.
What Are The Allegations In The Taxotere Lawsuits?
- Taxotere is defective and unreasonably dangerous;
- Sanofi-Aventis was negligent in the manufacturing of Taxotere;
- Sanofi-Aventis failed to properly test Taxotere, and failed to warn doctors and patients of the potential for alopecia; and
- Sanofi-Aventis concealed evidence of the dangers of Taxotere and misrepresented the effectiveness and safety of it in its marketing material.
The Taxotere Multidistrict Litigation
There are currently over 12,000 lawsuits pending in the Multidistrict Litigation (MDL) – 2740 Taxotere (Docetaxel) Products Liability Litigation against the manufacturers of Taxotere. These were granted mass tort status in 2017 and consolidated before the U.S. District Court Judge of the Eastern District of Louisiana 16-2740. In addition to Sanofi-Aventis, named defendants include Accord Healthcare, Sandoz, Hospira Worldwide, Pfizer, Actavis, and Sun Pharmaceuticals, all of which sold or distributed the medication under a license or in a generic form. The MDL is titled In Re: Taxotere (Docetaxel) Products Liability Litigation.
The Taxotere lawsuit is composed of women who developed alopecia after using Taxotere or docetaxel. The plaintiffs allege that the drug caused alopecia, bringing claims of failure to warn, negligent misrepresentation, fraudulent misrepresentation, and more. The first bellwether trial was held in September 2019, and the second is set for February 1, 2021.
If you currently suffer from a permanent hair loss disease and were previously prescribed Taxotere, contact the office of Gerling Law for a free, no-obligation evaluation and Taxotere lawsuit consultation today. Our dedicated team of dangerous drug lawyers will be here to help you every step of the way, answer any questions you may have, and walk you through the steps of your Taxotere lawsuit.
Filing a Taxotere Lawsuit
Drug companies have the responsibility to notify the public if a drug may cause harmful side effects. Patients who have suffered severe side effects, including permanent hair loss, after taking Taxotere are encouraged to learn more about their rights and remedies by seeking the advice of a Taxotere lawsuit attorney.
If you believe that you may qualify to participate in a Taxotere lawsuit, the first step you should take is to mitigate injuries and future potential damages. In order to properly mitigate costs, seek proper medical treatment right away and follow your doctor’s orders.
You should then familiarize yourself with the civil litigation process so that you know what is to come of your Taxotere lawsuit.
Hiring a personal injury lawyer to act as your Taxotere lawyer is an important next step. Be sure to ask plenty of questions about your potential lawyer’s experience, payment structure, and anything else you deem to be important.
Hiring a Taxotere Lawyer
Your Taxotere lawyer will work to build a strong case to prove that liability for your injuries falls on the manufacturer.
Your Taxotere attorney will work to gather evidence to show liability, assess damages that you incurred from your injuries, file legal documents on your behalf, and work to gain you compensation for your injuries in the form of a settlement or verdict.
Your state’s statute of limitations limits the time you have to file a Taxotere lawsuit after your injuries first became apparent and/or were diagnosed, so be sure to reach out to a Taxotere lawyer as soon as possible to start the litigation process.
Gerling Law, Your Taxotere Lawyer
Gerling Law has a dedicated team of dangerous drug lawyers who are experienced at litigating on behalf of individuals who suffered injuries and losses through no fault of their own. Our firm offers free, no-obligation case consultations to anyone who needs legal advice and guidance related to Taxotere hair loss and other Taxotere injuries. We operate on a contingency fee basis, which means that our clients do not ever pay any legal fees until after they have been awarded compensation – no compensation, no fees. So contact Gerling Law, your Taxotere hair loss lawyer, and learn how we can serve you today.
How an Experienced Taxotere Lawyer Can Help
Cases involving dangerous drugs are complex and require in-depth expertise of the legal issues involved. This is a stressful process, so you need a lawyer who can not only successfully navigate the various U.S. court system procedures in effectively advocating for you, but also calm your anxiety and confusion. For people burdened with the pain and stress of a personal injury caused by another’s negligence, the legal process can seem overwhelming. Whether you are looking for help with a personal injury, mass tort, medical malpractice, or product liability, you can be confident about placing your trust in Gerling Law’s successful legal team.
An experienced attorney knows how to thoroughly investigate how the unsafe product caused your injury and identify all the potentially responsible parties, along with their insurance companies. Then the attorney will work with medical experts to build a compelling case establishing your right to receive maximum compensation for your injuries from the at-fault parties. If you have suffered a disabling injury, you may require ongoing medical care and therapy. The future costs of your injury should be considered as well as the costs to date. We work with a life care planner to develop an estimate of your future medical expenses and ensure they are taken into account in any settlement.
Unfortunately, in dangerous drug cases, it is common for numerous people to have been harmed before the danger of the product comes to light. Evidence in a dangerous drug case may come from an FDA action, such as a recall, from independent research begun after problems are publicized, or from manufacturers’ documents about the drug and its testing, which a court has ordered released.
If you or a loved one has suffered alopecia — or permanent hair loss –from the drug Taxotere, please contact a knowledgeable, experienced attorney at Gerling Law today for a free consultation. There is no charge unless we help you recover money for the injury you received. The Gerling Law team will always work diligently and efficiently in handling all aspects of your claim so that you can be relieved of the burden of dealing with the legal matters and focus only on your restoration of health.
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What's The First Step?
If you or a loved one has been injured by Taxotere, you may have a claim against the manufacturer. If you have experienced any of the symptoms listed above, contact your physician immediately. The first step in the legal process is to contact a Taxotere lawyer for a free consultation. Gerling Law's staff of attorneys, paralegals, and case support personnel are skilled at providing the extraordinary personal attention that your lawsuit deserves. Your lawyer will review your work history, medical history, and other facts pertinent to your case and advise you on your eligibility to participate in a Taxotere lawsuit. Contact Gerling Law today for a free, no-obligation lawsuit consultation.
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