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Holding the Makers of Taxotere Responsible

Washington Canalicular Stenosis (Taxotere) Attorneys

Washington Product Liability Attorneys Ready to Fight for You

Getting cancer is one of the most serious health crises anyone can face. Questions swirl about stages, treatments, prognoses, and even death. Most people will ready accept any treatment available If there’s a glimmer of hope for eradicating the disease or prolonging their lives.

Surgery, radiation, and chemotherapy are the most common treatments for cancer. Surgery is done if it doesn’t pose further risks to the cancer patient (brain cancers, many times, can’t be treated surgically with risk of damaging other parts of the brain). Radiation may be given if it’s safer than surgery.

Chemotherapy is usually given to patients with aggressive or advanced stages of cancer because the cancer-fighting drugs fill the bloodstream to attack cancer cells wherever they are. Chemotherapy’s downside is the temporary and disagreeable side effects that patients experience during treatment.

Recently, however, previously unknown permanent and irreversible side effects of some chemotherapy drugs have come to light. These side effects are so severe that cancer survivors have persistent debilitating health issues that negatively impact their overall quality of life.

Taxotere (docetaxel) is a commonly used chemotherapy drug. Taxotere, which is manufactured by the French pharmaceutical company Sanofi-Aventis, was approved in 1998, to primarily treat advanced (metastatic or Stage IV) breast cancer. Taxotere is also used in chemotherapy for lung cancer, neck cancer, and prostate cancer.

Taxotere, in combination with other chemotherapy drugs, is explicitly marketed to target these types of breast cancer:

  • Advanced breast cancer that is resistant to other kinds of treatment
  • Advanced breast cancer that spreads beyond the original site after standard chemotherapy treatment
  • Early breast cancer that spreads to the lymph node system after breast cancer surgery

Sanofi-Aventis garnered the breast cancer treatment market in the United States with an aggressive marketing campaign that highlighted Taxotere’s superiority to other available breast cancer treatments. Not only were these claims overstated, but Sanofi-Aventis failed to disclose some of Taxotere’s severe side effects, even though they knew about them. One of these side effects was epiphora.

If you received Taxotere chemotherapy for breast cancer or any other kind of cancer and developed serious vision damage from untreated epiphora, you may be entitled to significant compensation. Take our FREE quiz here to find out if you might qualify.

Epiphora

Epiphora’s main characteristic is tear overproduction. Other symptoms may include shooting eye pain, blurry vision, redness, light sensitivity, and eyelid swelling.

Lacrimal ducts, which are located on the upper and lower parts of the inner eye, produce basal tears to protect the cornea and keep the eye lubricated and irrigated. Basal tears form a protective film that shields the eye when the lacrimal duct system works correctly.

However, if the lacrimal ducts (canaliculi) become obstructed or start to close, basal tears pool in the eyes and spill out non-stop onto the face.

Treatment of Epiphora During Chemotherapy

As soon as epiphora is diagnosed during chemotherapy, treatment can begin. If epiphora is caught very early, it may be successfully treated by a lacrimal duct specialist (ophthalmologist). Treatment includes topical steroid application and regular (every four weeks or so) canaliculi probing and irrigation.

If epiphora doesn’t respond to this treatment or it is more advanced, an ophthalmologist can perform bicanalicular silicone intubation. In this surgical procedure, semi-rigid, flexible silicone stents are temporarily placed in the canaliculi to keep them open.

Chemotherapy with Taxotere can continue after bicanalicular silicone intubation. When Taxotere completely exits the bloodstream (about six weeks after chemotherapy stops), the stents can be removed with the symptoms of epiphora gone.

If Sanofi-Aventis had disclosed epiphora as a side effect of Taxotere, oncologists and their patients could have chosen an equally effective alternative to Taxotere without the severe side effects.

Or, if they decided Taxotere was the best treatment, oncologists could have done immediate patient referrals to ophthalmologists to look for and treat epiphora.

Epiphora and Canalicular Stenosis

Canalicular stenosis occurs when epiphora is untreated and the canaliculi almost or completely close. Once the canaliculi completely close, they can’t be reopened. Canalicular stenosis is a permanent condition.

The high incidence of canalicular stenosis in cancer patients who received Taxotere chemotherapy suggests that Taxotere secretes into the eye’s tear film. Because basal tears continually flow through the lacrimal ducts, chronic inflammation – which causes the duct openings to close – occurs.

The only way to treat canalicular stenosis is dacryocystorhinostomy (DCR). This very painful and very costly surgery is also risky, and can leave patients with lifelong debilitating effects.

DCR Risks and Lasting Impacts

DCR creates an alternate lacrimal duct system to control basal tear flow to the eyes, which involves placing rigid Pyrex glass tubes into the surgically-created ducts.

DCR’s risks and lifelong impacts can include:

  • Abnormal nasal tissue fusion
  • Prominent facial scarring
  • Excessive bleeding
  • Infection
  • Stent misplacement (requires additional surgery), leading to ocular deficiencies
  • Optic nerve or infraorbital vessel damage, leading to partial or total blindness

Ophthalmologists First Discover Connection Between Taxotere and Canalicular Stenosis

Sanofi-Aventis first disclosed epiphora as a Taxotere side effect in 2014. However, as early as 2000, ophthalmologists saw a clear connection between Taxotere chemotherapy, epiphora, and canalicular stenosis.

The first ophthalmologist to report the connection was Dr. Bita Esmaeli, a prominent ophthalmologist who specialized in the lacrimal duct system. In the November 8, 2000 edition of the American Academy of Ophthalmology, Dr. Esmaeli published “Canalicular Stenosis Secondary to Docetaxel (Taxotere).”

Dr. Esmaeli demonstrated that, although Sanofi-Aventis didn’t list epiphora as a side effect of Taxotere, there was clear research evidence from cancer patients to show that epiphora was a side effect of the chemotherapy drug.

Dr. Esmaeli (and many other respected medical researchers throughout the next 13 years) advised oncologists to refer cancer patients who experienced epiphora to an ophthalmologist immediately so treatment, which reverses the condition, could begin.

Dr. Esmaeli’s research found that 80% of cancer patients who received Taxotere chemotherapy every three weeks and developed epiphora had the condition resolve with topical steroid application and regular (every four to six weeks) canaliculi probing and irrigation. The rate was 50% for cancer patients receiving Taxotere chemotherapy weekly.

Dr. Esmaeli concluded that all patients receiving Taxotere chemotherapy should simultaneously be under the care of an experienced ophthalmologist so ensure prevention of canalicular stenosis.

Breast Cancer, Taxotere, and Canalicular Stenosis

Since breast cancer patients are more likely to receive Taxotere chemotherapy, they are most susceptible to developing epiphora. The risk is higher among advanced breast cancer patients who receive weekly Taxotere chemotherapy because higher doses of Taxotere make developing epiphora more likely.

Cancer patients undergoing Taxotere chemotherapy rated epiphora as one of the worst side effects. Not only was excessive tearing embarrassing and concerning, but it significantly limited reading and driving ability.

Breast cancer patients who developed epiphora during Taxotere chemotherapy that was untreated had a higher rate of canalicular stenosis development during or after chemotherapy. While canalicular stenosis occurred in both breast cancer patients receiving weekly Taxotere chemotherapy and breast cancer patients receiving Taxotere chemotherapy every three weeks, the incidence was much higher in those receiving weekly Taxotere chemotherapy.

Why a Lawsuit Against Sanofi-Aventis?

Sanofi-Aventis knew that epiphora was a side effect of Taxotere from its clinical trials of the drug. However, those clinical trial results were deliberately hidden from the Federal Drug Administration (FDA), the authorizing agency for medications in the United States.

Epiphora, therefore, was not listed by Sanofi-Aventis as a side effect of Taxotere when it was released for public use in 1998. In fact, it would be 16 years – 2014 – before the pharmaceutical company listed epiphora as a side effect.

By hiding epiphora as a side effect of Taxotere, Sanofi-Aventis was dishonest with cancer patients and their doctors, who could have decided to go with similar chemotherapy drugs that didn’t have this severe side effect and were equally effective.

Sanofi-Aventis’ actions were motivated by greed. Having the exclusive patent on a breast cancer treatment drug meant huge profits for the company. Rather than being concerned with the long-term health of the patients Taxotere was supposed to successfully treat, Sanofi-Aventis was concerned with its bottom line.

Now cancer survivors – especially those with breast cancer – are living with serious adverse physical conditions because of Sanofi-Adventis’ willful deceit and negligence.

Think You Might Qualify for Compensation? Take Our Quiz Today

When a drug that is supposed to help you ends up doing lifelong harm and reducing the quality of your life, then the company that developed and manufactured that drug should be held accountable for that harm.

Hotze Runkle is representing Washington cancer patients who developed canalicular stenosis during or after receiving Taxotere chemotherapy. If you had cancer that was treated with chemotherapy and you developed watery eyes or excessive tearing during treatment, please take our quiz to see if you may have a case against Sanofi-Aventis.