Our lawyers are handling Taxotere eye injury lawsuits throughout the United States for women with permanently watery eyes from docetaxel.
Taxotere (docetaxel) is a widely used breast cancer chemotherapy drug. New evidence has emerged showing that Taxotere may be causing some users to suffer permanent vision loss or damage.
This has led to a wave of product liability Taxotere lawsuits by women who claim that Taxotere damaged their eyesight. The manufacturer of Taxotere, Sanofi, allegedly knew about the risk of vision damage but chose not to warn doctors or patients about this risk.
This Taxotere class action lawsuit is separate from the Taxotere hair loss lawsuit.
August 2022 Taxotere Eye Injury Lawsuit Update
Plaintiffs in the Taxotere eye damage MDL filed a response to defendant Sanofi’s motion to dismiss. In their response, the plaintiffs contend that Sanfoi’s failure to state a claim argument should be rejected because the adequacy of Taxotere’s warning label is an inherently factual question for a jury.
The plaintiffs were similarly dismissive of Sanofi’s argument that federal preemption applies because there was no “new risk information” to justify a warning label change under FDA rules.
The plaintiffs cite numerous medical studies that identify a new risk and could have been used to trigger a warning label change under the applicable rules.
Taxotere Breast Cancer Drug
Taxotere (the brand name for docetaxel) is a type of chemotherapy drug that is used by millions of women for the treatment of breast cancer. Taxotere is manufactured by the international pharmaceutical company Sanofi. Taxotere belongs to a group of cytotoxic drugs known as “taxanes,” which are derived from yew trees.
Taxanes like Taxotere are one of the most common types of chemotherapy drugs used in cancer treatment. Cancer cells reproduce and multiply when individual cells become unstable and break down. Taxanes block or slow down this method of cellular reproduction by over-stabilizing the chemical structure of the cancer cells and preventing them from breaking down.
Taxotere was first approved for use by the FDA in 1996. Initially, Taxotere’s FDA approval was limited to the treatment of patients with breast cancer who were metastatic or locally advanced and not responsive to other forms of treatment.
The FDA expanded the approval of Taxotere in 2004 for the treatment of all “node-positive” breast cancer. This dramatically expanded the market for Taxotere and it soon became a standard chemo drug for breast cancer.
Taxotere Causes Vision Damage
For the first few years that Taxotere was on the market, it was only used by patients with advanced cancer. Sadly, not many of these initial cancer patients lived long enough to suffer long-term side effects from Taxotere.
As the number of people taking Taxotere grew to include cancer patients with a much higher long-term survival rate, a growing number of these patients began to experience serious vision problems. New research has now established that Taxotere can cause epiphora (watery eyes) from scarring of the lacrimal (tear) system resulting in permanent eye damage.
The lacrimal system is vital for the proper function of the eyes and vision because it produces and drains tears. The lacrimal system includes the lacrimal gland (above the eyes), lacrimal punctum, canaliculi (tear duct), lacrimal sac, and nasolacrimal duct. When Taxotere is administered intravenously for cancer treatment, it is regularly discharged into tear film.
The secretion of Taxotere into the tears eventually causes fibrosis (scar tissue) in parts of the lacrimal system involving drainage of tears. As this scarring of the lacrimal drainage system gets worse, it can eventually lead to permanent stenosis (narrowing) of these ducts. When this occurs, it prevents the lacrimal system from being able to drain tears. The continual production of tears without drainage eventually results in persistent epiphora (watery eyes). This condition can significantly impair vision.
Sanofi Failed to Warn About the Risk of Vision Impairment
There is overwhelming evidence that Sanofi, the manufacturer of Taxotere, was fully aware of the impact that Taxotere had on the lacrimal system in the eyes and that this could result in permanent vision impairment from watery eyes Despite being aware of this issue, however, Sanofi never provided a clear and appropriate warning alerting doctors and patients about this risk.
The Taxotere drug label contains a section entitled “Post-Marketing Experiences.” This section of the label lists a number of reported incidents or adverse events following expanded use approval of the drug. One of these adverse events is described as “[e]xcessive tearing which may be attributable to lacrimal duct obstruction has been reported.” In the Patient Information section of the label, Sanofi identifies “redness of the eye, excess tearing” as one of “the most common side effects of Taxotere.”
These vague references fall way short of proper notice about the possibility of permanent vision impairment. None of these statements in the product label mention the risk of stenosis from lacrimal scarring as a cause of excessive tearing and the rapid onset at which this canalicular stenosis can occur. The label also does not convey the potentially permanent nature of the vision impairment that can result from this condition, and the need to refer patients to a lacrimal specialist. The label also fails to explain that permanent watery eyes are preventable with timely intervention during chemotherapy.
- Stories of excessive tearing from Taxotere that do not go away
- More stories for patients seeking answers for what helps watering eyes from Taxotere
Sanofi Had a Duty to Update the Taxotere Label and Warnings
As a manufacturer, Sanofi is responsible for timely communicating complete, accurate, and current safety and efficacy information related to Taxotere because it has superior, and in many cases exclusive, access to the relevant safety and efficacy information. To fulfill this responsibility, Sanofi must monitor all incoming information and timely provide updated safety and efficacy notices to the healthcare community and patients.
In fact, Sanofi was required under federal law to update its product labeling as information about adverse events becomes available. Under 21 C.F.R. § 201.57(c)(6)(i), “labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established.” Thus, for example, drug manufacturers must warn of an adverse effect where there is “some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.” 21 C.F.R. § 201.57(c)(7).
Lawsuits Allege Sanofi Knew Taxotere Caused Eye Problems
Since 2002, Sanofi’s Taxotere label has advised that “excessive tearing which may be attributable due to lacrimal obstruction has been reported.”
Despite this language, the medical literature has continued to accumulate and raise concerns that oncologists are not being properly warned of the severity of this permanent side effect – and in response, Sanofi has done nothing to notify oncologists or patients.
The following studies, published after 2002, highlight concerns about the increased frequency and severity of permanent stenosis in cancer patients taking Taxotere, the increased need for monitoring, and the lack of awareness among oncologists and their patients regarding the true nature of the damage:
Bita Esmaeli, et al., Docetaxel-Induced Histologic Changes in the Lacrimal Sac and Nasal Mucosa, 19 OPHTHALMIC PLASTIC AND RECONSTRUCTIVE SURGERY 4, pp. 305-308 (2003):
“Better education of oncologists who prescribe docetaxel is needed as we continue to encounter new cases of advanced canalicular blockage.”
Bita Esmaeli, et al., Blockage of the Lacrimal Drainage Apparatus as a Side Effect of Docetaxel Therapy, 98 CANCER 504-7 (2003):
“Despite the previous publication of several articles by our group regarding canalicular stenosis and lacrimal obstruction resulting from docetaxel therapy, we still frequently encounter advanced cases of this condition because of delayed diagnosis. Thus it appears that oncologists need to become better educated regarding this side effect.”
Polly Kintzel, et al., Docetaxel-related Epiphora, 26 PHARMACOTHERAPY 6 (2006):
Moreover, epiphora may be an underrecognized adverse effect of docetaxel because excess tearing after chemotherapy administration is not as stringently monitored as life-threatening toxicities . . . This adverse effect warrants evaluation because weekly administration is being used more commonly for the treatment of advanced solid tumors, and epiphora can interfere with the activities and quality of daily life.
Bita Esmaeli, et al., Prospective Study of Incidence and Severity of Epiphora and Canalicular Stenosis in Patients With Metastatic Breast Cancer Receiving Docetaxel, 24 JOURNAL OF CLINICAL ONCOLOGY 22 (2006):
Previous retrospective studies and our clinical experience suggested that the incidence of epiphora might be as high as 50% in patients treated with weekly docetaxel and less than 10% in patients who receive docetaxel every 3 weeks. In this prospective, observational study, epiphora was seen in 64% of patients in the weekly docetaxel group and in 39% of the docetaxel every 3 weeks group.
Taxotere Vision Loss Lawsuits
The medical evidence linking Taxotere to vision damage has prompted a growing number of product liability lawsuits against Sanofi by women who took docetaxel for chemotherapy and suffered permanent damage to their lacrimal system.
These docetaxel lawsuits claim that Sanofi failed to provide an adequate warning on its product labeling for Taxotere. Chemo eye lawsuit attorneys in these lawsuits allege that their eye damage from canalicular stenosis could have easily been prevented if Sanofi had simply provided an adequate warning.
The Taxotere vision loss lawsuits in federal courts were recently consolidated into a new mass-tort MDL in the Eastern District of Louisiana: In Re: Taxotere (Docetaxel) Eye Injury Products Liab. Lit. (MDL No. 3023). The Taxotere Eye Injury MDL has been assigned to Judge Jane Milazzo.
Taxotere Lawyers’ Defense
We know how Taxotere lawyers will defend these lawsuits. Watery eyes are awful but a small price to pay for defeating cancer.
Everyone gets that chemotherapy is an awful evil that is necessary to cure patients from something more awful. Chemotherapies have side effects that can not just cause watery eyes but side effects that can kill you. Don’t think for a second that plaintiffs’ watery eyes lawyers – and forgive the double negative – don’t get that.
But there are other forms of therapy, including other chemotherapies, that are available for patients. Should doctors and patients get all the information in a warning to access the risk of a drug? Because some women many might decide that another form of treatment that is equally designed to save their lives is the more appropriate therapy given the risks. That’s what the Taxotere eye injury lawsuit is all about.
Contact Miller & Zois About Taxotere Eye Injury Lawsuits
Our firm is currently investigating claims against Sanofi by anyone who took Taxotere for chemotherapy and suffered permanent vision damage as a result of excessive tearing and complications caused by the chemo drug. Contact a chemo eye lawsuit attorney today at 800-553-8082 or get a free online consultation.