The FDA first approved Taxotere in 1996, becoming an instant hit. By 2009, this drug alone generated over $3 billion in profit for Sanofi-Aventis every year. However, these large profits came at a price for hundreds of thousands of breast cancer survivors.
Most chemotherapy drugs trigger hair loss, but the hair grows back after a few weeks or months. The issue with Taxotere is that the hair loss patients experience is permanent.
For most breast cancer survivors, this permanent hair loss can be a heartbreaking reminder of the effects of cancer battle on the quality of life.
Taxotere lawsuits claim Sanofi-Aventis Inc. was aware of the permanent hair loss or alopecia since 1999. In fact, the drugs they supplied to Europe since 2005 and Canada since 2012 had adequate warnings.
Sanofi-Aventis did not warn the medical community and consumers in the US until it was mandatory in January 2016.
Out of over 3 million patients with breast cancer in the States, 75% use Taxotere. These patients were unaware of the possible life-altering side effects.If you or your loved one suffered permanent alopecia or severe vision issues after using Taxotere or docetaxel, Join the Many for all the resources and support you need to exercise your legal rights and benefit.
A Brief History of Taxotere
Taxotere is a product of Sanofi-Aventis, patented by the previous company, Rhone-Poulenc, in 1986. Sanofi and Aventis Pharmaceuticals merged in 2004, the same year the FDA authorized Taxotere as a chemotherapy drug.
Taxotere belongs to a class of drugs called taxanes. Taxanes are alkaloid chemotherapy drugs that come from the yew tree.
These drugs stop cancer cells from multiplying by over-stabilizing the cancer cell’s structure. They inhibit cell growth and interrupt the microtubular networks within the cancer cells. The cells can’t break down and re-organize to reproduce.
Taxotere benefits patients with metastatic or locally advanced breast cancer that fails to respond to chemotherapy. It’s also combined with cyclophosphamide and doxorubicin to treat node-positive breast cancer.
Taxotere is quite effective against breast cancer and other types of cancer. The issue arises with severe side effects, including permanent hair loss and watery eyes due to canalicular stenosis.
Multiple studies show the link between Taxotere and a high risk of permanent hair loss or alopecia. Unlike other chemotherapy drugs that trigger hair loss, Taxotere doesn’t allow the hair to grow back after a short period.
Alopecia is irreversible and permanent, affecting all hair in the body, including:
- Facial hair
- Pubic hair
- Head hair
- Eyelashes
- Eyebrows
- Body hair
Despite Sanofi-Aventis Inc. knowing these risks, they failed to add alopecia as a side effect for Taxotere in the US.
When patients asked for data showing the rate of hair loss or alopecia associated with Taxotere, Sanofi-Aventis alleged they didn’t maintain records. The American Taxotere adverts still stated that hair grows back after the patient completes treatment.
Surprisingly, Sanofi-Aventis updated Taxotere’s warning label to include alopecia as a common adverse reaction in Europe back in 2005. The company updated the label in 2015, following an FDA mandate.
Taxotere primarily treats breast cancer, so more women experience the devastating effects of alopecia. Permanent hair loss can remain a constant reminder of a challenging time. It can also affect self-esteem and body image, triggering emotional distress and depression.
Overview of Research Findings
Taxotere causes various side effects. Since it’s a cancer medication, most people overlook the side effects, which often include:
- Joint and muscle pain
- Fatigue
- Nausea
- Diarrhea
- Loss of appetite
- Swelling, discoloration, or pain at the injection site
- Constipation
- Weakness
- Vomiting
- Damage to toenails and fingernails
- Irregular menstrual periods
- Hair loss.
Taxotere also has more severe side effects listed on the warning label, including:
- Asthenia
- Leukemia
- Hypersensitivity reactions
- Fluid retention
- Death associated with Taxotere’s toxicity or toxic death
- Neurologic reactions, including pain, dysesthesia, and paresthesia
- Low white blood cell count or neutropenia
- Liver damage caused by Taxotere’s toxicity or hepatotoxicity
One essential side effect of Taxotere was notably missing from the warning label till early 2015. Instead of normal hair regrowth about three or four months after chemo, patients using Taxotere did not grow hair or grow back less than 50%.
Taxotere and Permanent Hair Loss
Evidence shows that Sanofi-Aventis was aware of the high risk of alopecia from the early 2000s. The company conducted research on Taxotere before production started.
The research involved a ten-year clinical trial phase of 1,060 breast cancer patients who took Taxotere. The team noted that 9.2% of women in the trial developed long-term hair loss.
In 2010, researchers conducted the GEICAM 9805 study involving 1060 women. All the women had surgery due to breast cancer and used Taxotere every three weeks for six chemo cycles.
The team discovered that about 9.2% of patients experienced hair loss for up to ten years.
In 2014, researchers presenting at the NCRI National Cancer Conference highlighted that 10-15% of patients who used Taxotere suffered permanent hair loss. After completing the chemo treatments, the effects lasted more than three and half years.
In 2018, the Journal of the American Academy of Dermatology highlighted similar results. About 6% of women who used Taxotere developed alopecia.
Taxotere and Watery Eyes
Taxotere also has another severe side effect: affected patients suffer from epiphora or excessively watery eyes. This condition can advance and cause vision loss or significant eye damage.
Taxotere affects the lacrimal system that produces and drains tears to ensure proper vision and healthy eyes.
Taxotere enters the tear film during chemo, triggering fibrosis in some parts of the lacrimal system. For instance, it can affect the nasolacrimal and puncta ducts, causing scarring and permanent blockage.
The blockage prevents the tears from draining naturally via the lacrimal system. Since eyes constantly secrete tears, the patient experiences persistent watery eyes or epiphora.
Sanofi-Aventis knew about the possible effects of Taxotere on the lacrimal system and permanent watery eyes. Although the company acknowledged this risk, the current lawsuits claim they needed to offer more details about it.
Taxotere’s label information includes a section called “Post-Marketing Experiences.” This part acknowledges reports of excessive tearing due to lacrimal duct obstruction.
The Patient Information segment notes the possible side effects as excessive tearing and redness of the eye. The label doesn’t mention that the excessive tearing could be due to canalicular stenosis. It fails to mention the related injuries’ risks or their permanent nature.
There’s no mention of the need for a lacrimal specialist or the fact that early intervention can prevent the condition.
Sanofi-Aventis was aware before introducing Taxotere to the US market, whether it’s the risk of alopecia or vision damage. They failed to warn the medical community or vulnerable consumers adequately.
If you or your loved one used Taxotere before December 2015 and experienced such challenges, you deserve compensation for your losses, pain, and suffering; join the many who are seeking justice.
Lawsuit History
Sanofi-Aventis now faces thousands of Taxotere lawsuits from breast cancer survivors who used it before December 2015. The first major claim against Sanofi-Aventis was by Amy Dodson, a breast cancer survivor.
According to the lawsuit submitted in March 2015, Amy was unaware of Taxotere’s dangerous side effects. The drug caused her to develop permanent hair loss.
The lawsuit further claims Sanofi-Aventis preyed on thousands of people during their most vulnerable periods in life. They offered false promises to encourage sales to profit from vulnerable people.
Sanofi-Aventis hindered women from making smart decisions regarding their health care.
The FDA finally mandated Sanofi-Aventis to update Taxotere’s warning label to include possible permanent hair loss. Even after the update, the company did not list alopecia as a common side effect.
This lawsuit encouraged more women, such as Elizabeth Kahn, to take legal action against Sanofi-Aventis for failure to warn. These women endured chemo treatments and suffered alopecia while they were unaware and unprepared for it.
The affected women claim that this undisclosed side effect caused them to struggle when returning to normalcy. They survived cancer yet lost a crucial part of their identities for good.
These brave survivors still face stigma due to baldness, the universal cancer signifier, after completing cancer treatment. The hair loss serves as a permanent reminder that they remain cancer victims.
The lawsuits further claim that Sanofi-Aventis did not report the results of their studies to the FDA. They proceeded to advertise Taxotere without mentioning these possible effects.
Besides the personal injury lawsuits, Sanofi-Aventis also faces multiple strict product liability lawsuits. Some of the common claims in these lawsuits include:
- Negligent misrepresentation
- Negligence
- Fraud and deceit
- Breach of express warranty
- Fraudulent concealment
- Fraudulent misrepresentation
The Taxotere Multidistrict Litigation
The US Judicial Panel on Multidistrict Litigation (JPML) merged all Taxotere lawsuits into multidistrict litigation (MDL) in October 2016.
An MDL is different from a class action suit because the cases remain independent. In a class action lawsuit, the participants select a few representative cases on behalf of the others.
An MDL is for convenience, as it streamlines discovery and fastens the litigation process. The MDL (No. 2740) is before Judge Kurt D. Engelhardt in the federal court in the Eastern District of Louisiana.
These lawsuits claim Sanofi-Aventis marketed Taxotere as a superior alternative, knowing it could trigger permanent hair loss. The Taxotere lawsuits also mention other companies involved with selling and distributing Taxotere or docetaxel, including:
- Sun Pharmaceuticals
- Actavis
- Pfizer
- Hospira Worldwide
- Sandoz
- Accord Healthcare
The Taxotere MDL is the fifth largest open MDL in the US, with over 30,000 cases. If you or someone you care about developed permanent hair loss after using Taxotere before December 2015, you should also file your lawsuit. Join the Many connects you with experienced attorneys who will fight for the compensation you deserve.
Taxotere Eye Damage MDL
Although most Taxotere lawsuits involve permanent hair loss, there are other lawsuits related to eye problems. These lawsuits cover injuries such as:
- Loss of vision
- Narrowing of the tear ducts or nasolacrimal duct obstruction
- Blocked tear ducts
- Eye irritation
- Swelling near and in the eyes
- Blurred vision
- Epiphora or Excessive watery eye
- Dry eyes syndrome or keratoconjunctivitis
- Eye surgery
These lawsuits claim Sanofi-Aventis did not adequately warn oncologists and consumers that the eye damage could be fast and irreversible.
In 2022, JPML formed a separate MDL for Taxotere lawsuits involving eye damage and vision loss. This MDL now has over 12,000 cases.
Taxotere Lawsuit Verdicts and Settlements
The first bellwether trial involving the Taxotere hair-loss lawsuits took place in 2019, and the second in 2021. In both trials, the judge’s ruling favored Sanofi-Aventis, but Elizabeth Kahn appealed the verdict from the first trial.
Bellwether trials are test trials that allow the courts to predict how the following cases will likely proceed. Although disappointing the outcome, it shouldn’t discourage you from filing your Taxotere lawsuit. The results of the Bellwether trials do not affect future cases.
Mississippi’s Attorney General also filed a lawsuit against Sanofi involving Taxotere’s marketing.
How Much Can I Expect from My Taxotere Lawsuit?
We have not seen any settlements for Taxotere lawsuits, so it’s hard to predict how much to expect from your claim. The eye damage and hair loss lawsuits are also different, so the settlements will likely differ.
Although alopecia is often stressful, vision loss has more severe impacts, so these lawsuits will likely receive higher amounts.
In your lawsuit, you can pursue compensation for damages such as:
- Medical expenses
- Pain and suffering
- Emotional distress
- Lost wages
- Loss of quality of life
Statute of Limitations for Taxotere Lawsuits
Naturally, most people wonder whether there’s time to file a Taxotere lawsuit. The statute of limitation in your state dictates the time you have from the time you discover your injury to when you file your claim in court.
Every state has a different statute of limitations, with some allowing one, two, or up to six years. The specifications of the statute also vary from state to state.
If you believe you have a valid Taxotere lawsuit, don’t waste any time or you may miss your opportunity to exercise your legal rights and benefit. It’s important you have the best legal care available. We’ll make this process easier than you may think it is.
You Don’t Deserve to Suffer Alone in Silence; Join the Many
At Join the Many, we understand that the legal process can feel complex and intimidating. We empower you with the best legal resources to go against negligent businesses that try to evade responsibility.
