Taxotere Lawsuit

Taxotere Chemo IV

Hair loss is a common side effect of most chemo drugs, making it a universal symbol of cancer survivors. However, the hair loss after chemo is temporary, and the cancer survivors anticipate the hair will regrow. 

Sadly, cancer patients who used Taxotere may never experience hair regrowth and were unaware of this possible side effect. Studies also show that this drug can cause severe and permanent vision loss and eye damage. 

Taxotere lawsuits are against the manufacturer, Sanofi-Aventis Inc, for failing to disclose these severe side effects. They claim the manufacturer was aware that Taxotere caused permanent hair loss or alopecia since the 1990s. They did not inform the medical community and consumers in the US until January 2015.

These lawsuits seek financial compensation for damages such as:

  • Physical pain
  • Medical expenses
  • Pain and suffering
  • Mental distress
  • Lost wages
  • Loss of future earning ability

If you or your loved one used Taxotere before December 2015 and suffered permanent hair loss or eye damage, we’re ready to stand with you.  Join the Many who are fighting back and demanding justice and compensation for their suffering. 

History of Taxotere

Taxotere is a chemo drug under a class of cytotoxic drugs known as taxanes. The history of Taxotere dates back to 1962 when the National Cancer Institute financed a national program.

The program primarily focused on discovering new cancer medications derived from natural resources. A team from Washington sent a sample from the Pacific yew tree to North Carolina for isolation and extraction of taxol, the active ingredient.

In 1978, a team from New York discovered the cancer-fighting potential of the yew tree and started early tests. The results were promising, but the natural Pacific yew trees were limited.

More independent research groups started experimenting with the synthetic production of the drug to avoid relying on the natural yew resources. It was a challenging process, and the breakthrough finally came in 1994.

Scientists created the synthetic drug and a variation of taxol, the original drug called docetaxel. The new version was nearly identical to the original form and functioned similarly. 

Sanofi-Aventis financed the majority of the research and production of docetaxel. After the discovery, the company immediately applied for FDA approval for the new drug under the name Taxotere.

The FDA first approved Taxotere for limited use in 1996. The agency allowed the drug to treat metastatic or locally advanced breast cancer patients that didn’t respond to other treatments.

Sanofi-Aventis then applied for FDA approval to expand the usage of Taxotere. In 2004, the FDA approved the drug to treat anyone suffering from operable node-positive breast cancer.

After this approval, more patients started using Taxotere, and the number kept growing. The drug was so popular that about 75% of all women with breast cancer were using Taxotere.

The FDA also approved Taxotere to treat other types of cancer, including:

  • Metastatic prostate cancer
  • Neck and head cancer
  • Advanced stomach cancer or gastric adenocarcinoma
  • Non-small cell lung cancer

There’s no argument that Taxotere is an effective cancer treatment. The issue is that the patients and their doctors were unaware that alopecia and eye damage were possible side effects.

Evidence shows that Sanofi-Aventis knew about these risks and intentionally omitted detailed warnings on Taxotere’s label to optimize profits.

Thousands of breast cancer patients in the US were unaware of permanent hair loss until the FDA mandated the warning update in 2015. The agency’s move followed many reports from doctors and patients that Taxotere caused alopecia. 

However, this wasn’t the first time Sanofi-Aventis discovered the issue. According to the current lawsuits, Sanofi updated Taxotere’s warning label in Europe back in 2005. The company also published internal research in 2005, highlighting the risks of alopecia. 

Sanofi-Aventis deliberately avoided including this information on drugs in the US for an entire decade. They downplayed the risks to promote sales, marketing Taxotere as a better alternative to other less expensive chemo drugs.

Sanofi-Aventis pushed the drug, yet they knew that similar drugs from competitors were safer than Taxotere. During chemotherapy, even the slightest difference in the drug’s effectiveness could mean some fatalities were avoidable. 

All Names Taxotere Goes by

Taxotere is the primary brand name for the IV chemo drug produced by Sanofi-Aventis. A generic version of this drug is also available under the name docetaxel or Docefrez.

Taxotere and docetaxel became available in the US market in the 1990s. Other companies also manufacture and distribute docetaxel, including:

  • Polymed Therapeutics
  • Sun Pharmaceuticals
  • Hospira Worldwide
  • Actavis
  • Accord Healthcare
  • Sandoz
  • Pfizer

Besides Sanofi-Aventis, the current Taxotere lawsuits also mention some of these companies. 

Taxotere treatments often involve one-hour infusion sessions after every three or four weeks. Since it minimizes the frequency and amount of chemo doses, it was a welcome relief for most breast cancer patients.

Overview of Research Findings

Chemotherapy drugs directly attack cancer cells because they grow and multiply faster than normal cells. They inhibit cell division, preventing the cancerous masses from developing. 

Taxotere targets the cell structure or cytoskeleton, which allows the cells to function. The cells become paralyzed and finally die off.

Taxotere is an IV drug that comes into contact with the whole body, not only the areas affected by cancer. This means the drug can potentially attack all cells within the body, causing severe side effects. 

Chemotherapy drugs target fast-growing cells, which can include other non-cancerous cells that grow at the same rate, such as:

  • The bone marrow that generates blood cells
  • Mucous membranes in the mouth and intestines
  • Hair follicles

This is why one of the most common side effects of chemotherapy is hair loss. Once the patient completes treatment, the healthy cells start recovering and regenerating.

Taxotere and Hair Loss

Most patients expected that hair would regrow after using Taxotere, like with other chemo drugs. Unfortunately, the hair failed to grow back entirely or less than 50%.

Sanofi-Aventis knew that permanent hair loss was a possible side effect of Taxotere. 

In 1998, the company sponsored a five-year study involving over 1,000 breast cancer patients on Taxotere. The study’s goal was to evaluate the long-term effects of using Taxotere. 

The team noted that about 9.2% of the patients developed permanent hair loss. The effects lasted for more than ten years in some women.

In 2006, the Rocky Mountain Cancer Centers published a study involving breast cancer patients using Taxotere and other chemo drugs like Cytoxan and Adriamycin.

The researchers noted that about 6.3% of the patients experienced less than 50% hair regrowth. 

The Journal of the American Academy of Dermatology also published a study in 2010 highlighting similar results. The study cautioned a growing number of cases where Taxotere caused alopecia.

Two years later, in 2012, the Annals of Oncology published a study involving 20 women who used Taxotere from 2007 to 2011. The researchers discovered that 19 of the 20 women developed permanent hair loss, affecting even the eyelashes and eyebrows. 

Taxotere and Eye Damage

Researchers discovered that some people experienced permanent vision damage as more breast cancer patients used Taxotere. The drug affected the lacrimal system that produces and drains tears. 

Several studies highlighted the link between Taxotere and optic neuropathy or epiphora. A Canadian team from the University of British Columbia conducted such a study. 

The team noted that Taxotere triggered watery eyes and excessive tearing. These symptoms advanced to a condition called epiphora and increased the risk of damaging the optic nerves or optic neuropathy by four times.

Taxotere penetrates the tear film during treatment, causing fibrosis in the lacrimal system. These unusual growths permanently block the nasolacrimal and puncta ducts. 

The lacrimal system loses the ability to drain tears, causing persistent watery eyes or epiphora.

There’s no doubt Sanofi-Aventis knew about the possible effects of Taxotere on the lacrimal system. The company knew that the drug could potentially cause permanent watery eyes. 

Although Taxotere’s label mentions excess tearing and eye redness as possible side effects, there are no further details. Sanofi-Aventis did not provide adequate and clear warnings to consumers or the medical community. 

The label fails to highlight that the excessive tearing could be due to canalicular stenosis. This condition has a rapid onset and causes permanent or irreversible damage to the eyes.

Sanofi-Aventis doesn’t specify that timely intervention can prevent canalicular stenosis and permanent damage.

If you or someone you care about developed alopecia or eye damage after using Taxotere before December 2015, you deserve compensation for your injuries.

Schedule a free case review with experts from Join the Many to discuss your legal options. 

Recalls

Taxotere (docetaxel) is a precious drug that even the World Health Organization recognizes as an essential medicine. So far, there are no official recalls of the drug, and it’s still available on the market.

However, Sanofi-Aventis updated Taxotere’s warning label in 2015. This decision followed a warning by the FDA, requiring the brand to include permanent hair loss as a side effect.

The Safety Information page now mentions that some patients report experiencing alopecia after using Taxotere. 

General Physician Sentiment

Since Taxotere is a cytotoxic chemo drug, it can damage and kill normal, healthy cells in the body. 

As Dr. Ananya Mandal, MD highlights, Taxotere can affect the number of red blood cells in the body. The shortage of red blood cells causes anemia, fatigue, and shortness of breath. 

Other common side effects of Taxotere include:

  • Permanent hair loss on the head, eyebrows, eyelashes, and other body hair
  • Peripheral neuropathy or numbness and tingling in the feet and legs
  • Diarrhea, nausea, or constipation due to damage to the gastrointestinal lining
  • Joint, bone, and muscle pain
  • Chronic fatigue and weakness
  • Infections due to low white blood cell count
  • Changes in the nail color

Studies show that Taxotere can also affect your vision and damage your eyes. If you’re using or previously used Taxotere, ensure you watch out for symptoms of eye damage such as:

  • Loss of vision
  • Blurred vision
  • Swollen eyelids
  • Blocked tear ducts or nasolacrimal duct obstruction
  • Narrowing of the tear ducts or stenosis
  • Dry eye syndrome or keratoconjunctivitis
  • Itchiness or eye irritation
  • Watery eyes and excessive tearing or epiphora
  • Eye damage that requires surgical intervention

If you notice such symptoms after Taxotere treatment, ensure you seek medical attention as soon as possible. Early intervention can help prevent permanent damage to your vision and eyes.

The severe side effects of Taxotere on the vision make it challenging to handle routine activities such as driving and reading. They can also lower someone’s self-esteem and affect interpersonal relationships.

These challenges make it difficult for cancer survivors to resume their everyday lives after treatment. Permanent vision loss and eye damage also affect the ability to earn income. 

No one should have to shoulder such losses at their most vulnerable moments. That’s why Join the Many supports people like you and your loved ones with the necessary legal resources to pursue your Taxotere lawsuit.  

Brief Lawsuit History

Most Taxotere lawsuits allege Sanofi-Aventis did not adequately warn the medical community and consumers of the risks of alopecia and eye damage.

The lawsuits further allege that Sanofi-Aventis was aware of the side effects but concealed the information from US consumers until it wasn’t an option in 2015.

A good example of a Taxotere lawsuit is the claim filed by Hattie Carson, a breast cancer survivor from Ohio. According to the case, Sanofi-Aventis did not update Taxotere’s label in the US, despite making the changes in Canada in 2012 and Europe in 2005.

The Taxotere Hair Loss MDL

As more people submitted Taxotere lawsuits, the US Judicial Panel on Multidistrict Litigation (JPML) merged all cases into multidistrict litigation (MDL).

Since the individual cases would have similar processes, the MDL merges them to streamline the procedures. However, every lawsuit remains independent, so the verdict on one case doesn’t apply to all others in the MDL. 

The MDL (No. 2740), formed in October 2016, is under Judge Kurt D. Engelhardt in the federal court in the Eastern District of Louisiana. 

Both sides selected a few cases from the MDL that proceeded to bellwether trials in 2019 and 2021. Bellwether trials are test trials that allow the court and both sides predict how future cases will likely proceed. 

The trials provide an opportunity to determine how much a jury is likely to award and which arguments are persuasive. Although the judge ruled in favor of Sanofi-Aventis in the first two trials, attorneys are confident the subsequent trials will have different outcomes. 

The Taxotere MDL currently has over 30,000 cases and is the fifth-largest open MDL in the US.

Taxotere Eye Damage MDL

As more people filed Taxotere lawsuits alleging eye damage and vision loss, the JPML merged them into a separate MDL in 2022. The MDL now involves more than 12,000 lawsuits

It’s Time to Take Action; Join the Many.

Legal processes are often complex and challenging to handle without professional assistance. Most people shy away from taking legal action for lack of resources to go against established businesses.

At Join the Many, we level the playing field by connecting you with the best team to handle your case.

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