Taxotere Litigation Guide
Just like many other chemotherapy agents, Taxotere might cause hair loss. However, Sanofi-Aventis never warned patients that their alopecia could be irreversible, forcing many of them to file a lawsuit and seek compensation.
Used to treat several cancer types including breast, lung, and stomach, docetaxel is a highly toxic medicine whose side effects include anemia, diarrhea, and weight loss. Plaintiffs argue that if they knew about the risk of becoming permanently bald, they would have chosen a different drug.
What Type of Medication is Taxotere?
Taxotere (docetaxel) is a drug of the “taxane” class used to treat many cancer types including gastric, breast, lung and prostate cancer. Originally manufactured by Sanofi-Aventis, this chemotherapy agent was approved by the U.S. Food and Drug Administration (FDA) in 1996. It is an anti-mitotic agent that acts by disrupting cellular division. Since tumor cells replicate at a much higher speed than normal ones, this medicine can stop them in their tracks while they spread through the body (metastasis).
It is usually administered intravenously over the course of a hour-long infusion cycle that is then repeated every 3-4 weeks. This chemotherapy agent is generally used in combination with other drugs such as doxorubicin, cyclophosphamide, fluorouracil, capecitabine, and cisplatin to fight off cancer and improve the patient’s chances of survival. While it was a branded medication, Taxotere was one of the most sold medicines worldwide, with over $1.2 billion sales from the US market alone. Before its patent expired in 2010 and the market was flooded with generic competition, the average cost of an 18-weeks treatment in Europe was about $7,500.
Cancer types for which Docetaxel is approved
Non-small cell lung cancer (NSCLC) | Breast cancer | Prostate cancer | Gastric cancer | Head and neck cancer
Persistent Chemotherapy-Induced Alopecia
While hair loss is a common side effect associated with many other antiblastic agents, it is usually a temporary one since hair follicles can grow back after the treatment is over. Several studies, including a large one published in the Journal of the American Academy of Dermatology in 2011, found evidence that docetaxel may cause a condition called Persistent Chemotherapy-Induced Alopecia. In patients affected by this condition, hair loss is irreversible even if treated with substances that help regrowth such as vitamins, spironolactone, minoxidil or Ultraviolet-A therapy. In a paper published in the medical journal Annals of Oncology in the same year, a group of French scientists tried to figure out the reasons why the hair of the affected patients did not regrow, excluding all common causes of irreversible baldness such as zinc or iron deficiency. Both the two studies were performed by researchers from the Old Continent, though. Many product liability lawyers pointed out that the European prescribing information of docetaxel already acknowledged this risk since at least 2005, in fact.
But why similar warnings only appeared in late 2015 in the United States? For years Sanofi-Aventis kept reassuring patients that the drug was safe and effective, even though it knew a terrible truth. The pharmaceutical company knew the results of the GEICAM 9805 clinical trial back in 2005, a study that revealed that 9.2 percent of patients who used the medication suffered from irreversible alopecia. Even though many women started to wore scarves or wigs to cover their heads, baldness is a serious adverse reaction which may negatively affect the patients quality of life and body image. Its effects may hamper social functioning, self-esteem, and sexuality, leading to significant distress, anxiety, and depression. Women who were left with just a few clumps of hair decided to find the best attorney and file a Taxotere lawsuit to seek compensation. The Big Pharma purposely decided to withhold crucial information which prevented plaintiffs from choosing another chemotherapic agent for their cancer therapies.
Common Taxotere Side Effects
Taxotere side effects are experienced by up to 90 percent of the patients treated, and the drug’s toxicity must be closely monitored since it may even reach potentially lethal levels. All drugs from the taxane class target both malignant and healthy cells. Although tumor cells are more sensitive to its effects to some degree, a significant toxicity is exerted even on normal cells, especially those with a high replication speed. Most of the toxic effects are seen or felt on all the organs and systems that are continuously renewed, such as the immune system, the blood, and the hair follicles. Although these side effects are very common, plaintiffs cannot ask their lawyers to seek financial compensation for them since the medication’s label properly warns about them (unlike permanent alopecia, instead).
In 2014, the FDA also found that some formulations of this medication contained significant quantities of ethanol and caused several cases of alcohol intoxication. Patients treated with this antiblastic agent should be warned before driving vehicles or operating machinery. This taxane has been classified as “Pregnancy Category: D”, meaning that there is positive evidence of fetal risk, especially if administered during the first trimester. Pregnant women who took it to treat their breast cancer later gave birth to babies with congenital malformations such as gastric stenosis and cerebral birth defects.
The most frequent adverse reactions of docetaxel are:
Neutropenia | Alopecia (hair loss) | Anemia |Thrombocytopenia | Nausea | Infection | Fever |Stomatitis |Esophagitis | Weight loss | Severe diarrhea | Leukemia | Heart failure |Neurosensory disturbances |Fluid retention | Nail discoloration
Taxotere Multidistrict Litigation
Sanofi-Aventis widely advertised Taxotere as a safer and more effective medicine compared to its competitor Taxol (paclitaxel), an already established chemotherapy agent. Paclitaxel, however, was significantly less dangerous and could be used at lower doses, causing a reduced number of adverse reactions and a substantially lower toxicity. In April 2009, the FDA issued a warning letter to the pharmaceutical company because it presented “unsubstantiated superiority claims” over its competitor, releasing to the public false or misleading information that overstated the efficacy of docetaxel.
In October 2016, 33 hair loss lawsuits were been filed in 16 federal courts across the country. Taxotere attorneys thus asked a panel of judges to centralize all claims in a single U.S. District Court to speed up the proceedings and preserve the resources of the parties and courts by coordinating the discovery phase.
On July 22, 2016, a Motion for Transfer has already been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML). On October 4, the Panel consolidated the cases in the products liability litigation MDL no. 2740 in the Eastern District of Louisiana, overseen by Chief Judge Kurt D. Engelhardt after being reassigned from Honorable Judge Lance M. Africk. To date, on November 2017, more than 2,300 victims decided to step forward and tell their stories by filing a legal dispute, and the litigation is expected to grow even further within the next few months.
Current Taxotere lawsuits
Kimberly Free v. Sanofi-Aventis, et al.
On April 2016, plaintiff Kimberly Free filed another dispute against Sanofi in the U.S. District Court for the Northern District of Texas. The woman was treated with docetaxel from October 2012 through February 2013 to fight off her breast cancer. More than three years later her hair still didn’t grow back, leaving her self-esteem scarred and causing her immense distress. According to Free’s claim, defendants concealed the existence of studies that proved the risk from the regulators, doctors, and patients. The woman holds the company liable for negligence and failure to warn, breach of warranty, fraudulent concealment and misrepresentation, fraud and deceit.
Ami Dodson Alopecia Case
One of the first permanent hair loss lawsuit filed against the manufacturer of Taxotere was Ami Dodson’s one. According to court documents presented in the U.S. District Court for the Northern District of California, the woman was diagnosed with breast cancer on March 3, 2010. After she had undergone breast surgery (mastectomy), Dodson had to choose her chemotherapy regimen, but neither she nor her doctor knew of the risk for long-lasting alopecia. Even long after her treatment was over, the woman’s hair never grew back, leaving her with a lifelong disfigurement. The plaintiff now seeks just compensation for all the damage she had to endure, as well as the emotional challenges and struggles she faced. In her lawsuit, Dodson claims that the company only gave a vague warning about the risk of baldness, but they never said that this side effect could be irreversible.
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