Massachusetts Product Liability Attorneys Ready to Fight for You
When you’ve been diagnosed with cancer, you and your oncologist immediately look for ways to either prolong your life or eliminate the disease altogether. Radiation and chemotherapy are standard treatments that cancer patients receive.
Both radiation and chemotherapy can have temporary and unpleasant side effects that go away after treatment end, but they are worth it for patients with cancer. However, cancer patients who survive these treatments don’t expect to beat cancer and then live with permanent and debilitating side effects from cancer treatment.
Drug manufacturers do exhaustive clinical trials on new pharmaceuticals before they are ever approved for use in the general population. Many new drugs never get beyond the testing phase because the side effects outweigh any benefits they provide.
However, some drug manufacturers are so eager to get their patented medications approved that they alter or eliminate clinical trial data that would prevent approval or they deliberately don’t disclose serious side effects to the Federal Drug Administration (FDA), doctors, and patients.
Taxotere (docetaxel), which is manufactured by Sanofi-Aventis, is one such drug. Taxotere is a chemotherapy drug commonly used to treat metastatic breast cancer. However, it can also be used to treat prostate cancer, lung cancer, stomach cancer, and neck cancer.
In 1998, Taxotere got approval as a first-line treatment for metastatic breast cancer in women with resistant-treatment cancer and Stage I breast cancer in women whose cancer spread to their lymph nodes after cancer surgery.
However, Taxotere has some potential side effects that were not fully disclosed by Sanofi-Aventis until 2014:
- Epiphora (watery eyes) caused by lacrimal duct obstruction
- Keratoconjunctivitis (dry eye syndrome)
- Alopecia (permanent hair loss)
An abnormally high number of women treated with Taxotere for breast cancer experienced epiphora during or after chemotherapy. Epiphora can be successfully treated if it is diagnosed as soon as it develops. However, an ophthalmology surgeon who specializes in the lacrimal duct system must be involved with cancer patients as soon as chemotherapy begins.
If epiphora is not treated early enough, canalicular stenosis, an irreversible and life-altering ocular condition will occur.
If you had Taxotere chemotherapy for breast cancer – or any other kind of cancer – and have been diagnosed with canalicular stenosis, you may be entitled to compensation for the permanent damage and diminished quality of life you are living with because of Taxotere’s undisclosed side effects.
[firm-name] has successfully represented cancer patients who have sustained permanent damage from chemotherapy drugs. We have recovered more than $100 million in damages for our clients. We believe that Sanofi-Aventis must be held responsible for their negligence in withholding information about the severe and permanent side effects of Taxotere and for deceptive marketing.
If you believe that you may qualify for compensation from Sanofi-Aventis, take our free, no-obligation quiz to find out if you’re eligible.
What is Canalicular Stenosis?
Every day, the eye’s lacrimal gland continually produces basal tears. Basal tears are the eye’s 24/7 defense shield. They lubricate, nourish, and protect the cornea by washing dirt and debris away.
Basal tears enter the eye through the canaliculi. The canaliculi are upper and lower tunnels that go from the lacrimal gland (near the septum of the nose) to the tear duct. When something obstructs the canaliculi to close completely, canalicular stenosis occurs, and tears continuously roll out of the eye onto the face.
Canalicular stenosis can be moderate or severe.
The Impact of Epiphora and Canalicular Stenosis on Chemotherapy Patients
The case for Taxotere’s role in cancer patients developing canalicular stenosis is evident in medical research – especially among ophthalmologists – going back to 2000. Whether cancer patients had Taxotere chemotherapy once a week, every two weeks, or every three weeks, there is a strong correlation between Taxotere and the development of canalicular stenosis as a long-term side effect, especially in breast cancer patients.
Additionally, the research shows that metastatic breast cancer patients receiving weekly chemotherapy with Taxotere were significantly more likely to develop epiphora during chemotherapy than metastatic breast cancer patients being treated every two weeks or every three weeks. The evidence points to the conclusion that the more Taxotere a metastatic breast cancer patient received, the more likely they were to develop epiphora during chemotherapy.
Cancer patients receiving weekly chemotherapy with Taxotere also rated epiphora as one of the worst side effects because it drastically affected their ability to wear makeup, to read, and to drive, but epiphora was also a frequent side effect among cancer patients who received chemotherapy less often.
Early-Diagnosed Epiphora Treatment During Chemotherapy
If epiphora is caught very early in chemotherapy, it may resolve with topical steroid application combined with regular (every four to six weeks) probing and irrigation by an ophthalmologist who specializes in the lacrimal duct system.
If this treatment doesn’t resolve epiphora, then it can be successfully reversed with a surgical procedure called bicanalicular silicone intubation. This procedure involves placing semi-rigid, flexible stents in the canaliculi to keep them open. Taxotere chemotherapy can continue with bicanalicular silicone intubation.
This procedure is usually temporary, lasting only until Taxotere is completely out of the bloodstream, which occurs about six weeks after chemotherapy ends. Vision is not impaired and all the symptoms of epiphora are gone.
How Canalicular Stenosis is Treated
Once the canaliculi are completely closed (stenosis), they can’t be reopened. The only available treatment is an expensive surgical treatment to create an alternate lacrimal duct system for basal tear flow into the eyes.
The surgery, dacryocystorhinostomy (DCR), is an extremely painful and invasive surgery with many serious risks, including
- Excessive bleeding
- Obvious facial scarring
- Infection
- Stent displacement (requires further surgeries and can cause other eye problems)
- Aberrant nose tissue fusion
- Damage to the optic nerve or infraorbital vessels, leading to partial or total blindness
For some people with canalicular stenosis, DCR isn’t effective, so they are forced to live with the condition untreated.
Ophthalmologists Warn About Link Between Taxotere and Canalicular Stenosis
In 2000, Dr. Bita Esmaeli, an ophthalmologist, wrote an article for the American Academy of Ophthalmology entitled “Canalicular Stenosis Secondary to Docetaxel (Taxotere).” In the article, Dr. Esmaeli discussed the high occurrence of epiphora and canalicular stenosis among cancer patients being treated with Taxotere.
The reason for this is that Taxotere, which floods the bloodstream with cell-shrinking agents, also entered the lacrimal ducts and mixed with the basal tears, which had a direct effect on both the canaliculi and the eye.
Dr. Esmaeli (backed by subsequent research from pharmacologists and ophthalmologists) noted that epiphora and canalicular stenosis were unknown side effects of Taxotere (Sanofi-Aventis did not have it listed as a side effect). The body of research showed that metastatic breast cancer patients who were receiving weekly chemotherapy had a much high risk of experiencing epiphora early in treatment.
Dr. Esmaeli said that oncologists who were administering Taxotere chemotherapy should immediately refer their patients to ophthalmology surgeons to monitor for epiphora. He noted that cancer patients could continue Taxotere chemotherapy after the successful treatment of epiphora without any further risk canaliculi damage.
Sanofi-Aventis’ Role
The report by Dr. Esmaeli in November 2000 (and subsequent reports by medical professionals in 2001, 2003, 2005, 2006, and 2013) shows a clear link between epiphora, canalicular stenosis, and Taxotere. These reports also show that cancer patients being treated with Taxotere need to be regularly seen by an ophthalmologist who specializes in treating the lacrimal duct system.
However, despite the medical community’s continued red flags about Taxotere and long-term eye health and function, Sanofi-Aventis did not fully disclose all the side effects of Taxotere, including very severe side effects, like epiphora, dry eye syndrome, and alopecia, until 2014.
Therefore, cancer patients – especially women with metastatic breast cancer who were receiving weekly chemotherapy – being treated with Taxotere and their doctors, including eye care professionals, weren’t aware that eye health needed to be evaluated regularly once chemotherapy began.
When Sanofi-Aventis didn’t disclose all the side effects of Taxotere, they jeopardized the long-term health of cancer patients being treated with their drug. Not only was the pharmaceutical company practicing deceit, but they were also engaged in negligence.
Like many pharmaceutical companies, Sanofi-Aventis put their bottom line before the safety of cancer patients. When cancer patients receive chemotherapy, they believe they are being given a drug that is safe and will either cure their cancer or prolong their lives. Cancer patients don’t expect that the life-saving or life-prolonging chemotherapy drug will harm them for the rest of their lives.
If cancer patients and oncologists were fully informed about all Taxotere’s side effects, they could have chosen alternative cancer treatments that were just as effective without the associated risks. However, they were denied the information they needed to make that choice.
Contact Hotze Runkle PLLC Today
If you had cancer and received chemotherapy that used Taxotere, you may be experiencing side effects even today. If you experienced epiphora during chemotherapy, and then were diagnosed with canalicular stenosis, your condition was likely caused by Taxotere.
Drug defects are covered by product liability claims and lawsuits. When consumers don’t know about drug defects, they can’t make informed decisions about whether to take the drug. When damage occurs because of the defects, then consumers are entitled to compensation from the drug manufacturer.
Sanofi-Aventis lied to cancer patients by not disclosing all of Taxotere’s side effects. Their action led to the side effects you are experiencing from canalicular stenosis.
Hotze Runkle PLLC represents Massachusetts cancer patients with canalicular stenosis from Taxotere chemotherapy. While we can’t restore the quality of life you had before you developed canalicular stenosis, we can fight for justice and compensation for your physical, emotional, and mental suffering.
Take our FREE, no-obligation quiz to find out if you qualify for compensation.