The breast cancer chemotherapy drug Taxotere is the subject of a new wave of product liability lawsuits by women alleging that the drug caused permanent vision damage. The lawsuits claim that the manufacturer of Taxotere, Sanofi, knew about the risk of vision damage and deliberately failed to warn doctors or patients.
There are already 30,000 Taxotere lawsuits in a class action MDL alleging that the drug caused users to suffer permanent hair loss and that Sanofi failed to warn that this was a potential side effect. The new Taxotere vision damage cases are different from the Taxotere hair loss lawsuits and will be consolidated into a separate MDL.
January 12, 2022 Update: The Judicial Panel on Multidistrict Litigation will hold a hearing at the end of this month to decide whether to consolidate all Taxotere eye damage lawsuits into a new MDL. The proposed MDL would be separate from the existing Taxotere MDL involving 12,000 claims that the chemo drug caused permanent hair loss. Sanofi is opposing the request for a new MDL on the grounds that there are not enough Taxotere eye damage lawsuits to justify consolidation. As a fallback, however, Sanofi is asking the JPML to combine the any new MDL for eye damage cases with the existing Taxotere hair loss MDL in the Eastern District of Louisiana. The JMPL hearing is set for January 27th in Miami.
Taxotere is a chemotherapy drug that is widely used for the treatment of breast cancer. Taxotere was developed by Sanofi. Taxotere is a part of a family of cytotoxic drugs referred to as taxanes.
Taxanes are derived from yew trees, and unlike other cytotoxic drugs, taxanes inhibit the multiplication of cancer cells by over-stabilizing the structure of a cancer cell, which prevents the cell from breaking down and reorganizing for cell reproduction. They are widely used as chemotherapy agents.
The FDA approved Taxotere in 1996 for limited use—namely, for the treatment of patients with locally advanced or metastatic breast cancer that had not responded well to alternative treatments. In 2004, Sanofi obtained FDA approval for expanded use of Taxotere on all patients with “operable node-positive breast cancer.” This resulted in a greater number of patients being treated with Taxotere.Taxotere and Vision Damage
As the universe of patients taking Taxotere expanded it became apparent that a certain percentage of patients who took the drug suffered permanent damage to their vision because of the way Taxotere impacts the lacrimal system. The lacrimal system is responsible for tear production and drainage which is vital for healthy eyes and vision.
When taken for chemotherapy, Taxotere is secreted into the tear film. This can cause fibrosis in areas of the lacrimal system, including the puncta and nasolacrimal duct. This scarring can cause permanent occlusion, causing an inability for tears to drain naturally through the lacrimal system. Because the eyes are constantly producing tears, this results in persistent tearing of the eyes (epiphora).Taxotere’s Labeling Does Not Adequately Warn About the Risk of Vision Damage
There is no real dispute that Sanfoi was fully aware of the impact that Taxotere could have on the lacrimal system resulting in potential vision damage. However, Sanofi has never provided a clear and adequate warning notifying doctors and patients about this risk. The information on the Taxotere label is wholly inadequate to put users on meaningful notice of the potential risk.
The labeling information for Taxotere contains a section entitled “Post-Marketing Experiences.” This section states that “[e]xcessive tearing which may be attributable to lacrimal duct obstruction has been reported.” Additionally, in the Patient Information section of the label, Sanofi includes “redness of the eye, excess tearing” among “the most common side effects of Taxotere.”
Sanofi’s labeling information does not identify the risk of stenosis as a cause of excessive tearing, the rapid onset at which stenosis can occur, the potentially permanent nature of the injury, and the need to refer patients to a lacrimal specialist. It also fails to explain that the condition is preventable with timely intervention during chemotherapy.Medical Studies Regarding Taxotere and Permanent Stenosis
Medical literature has continued to accumulate and raise concerns that oncologists are not being properly warned of the severity of lacrimal scarring and excessive tearing caused by Taxotere.
In 2003, an article published by the American Society of Ophthalmic Plastic and Reconstructive Surgery noted that Taxotere was frequently causing “advanced cases of canalicular blockage.” Also in 2003, an article from the American Cancer Society commented:
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. All patients receiving weekly docetaxel should be monitored closely by an ophthalmologist so that the timely management of canalicular stenosis can be offered.
Bita Esmaeli, et al., Blockage of the Lacrimal Drainage Apparatus as a Side Effect of Docetaxel Therapy, 98 CANCER 504-7 (2003).Taxotere Vision Loss Lawsuits
Over the last year, a growing number of product liability lawsuits have been filed against Sanofi by women who took Taxotere for chemotherapy and suffered permanent vision damage from excessive tearing. These lawsuits allege that Sanofi failed to provide a full and adequate warning on its product labeling for Taxotere. The plaintiffs in these lawsuits allege that their eye damage could have easily been prevented if Sanofi had simply provided an adequate warning.
The rapidly growing number of Taxotere vision damage lawsuits filed recently has prompted a motion with the Judicial Panel on Multidistrict Litigation asking for all pending Taxotere vision loss cases to be consolidated into a new MDL.
- Another drug-induced eye injury claim that is big in 2022 is the Elmiron vision loss 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 our office today for a free consultation.