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Taxotere Lawsuit

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Taxotere Lawsuit

Although cancer is the second leading cause of death in this country, there are more than 15 million cancer survivors currently living here in the United States. And while numerous cancer treatment options are available, they can be painful, draining, and leave people transformed in multiple ways.

Many people can go on to live normal and healthy lives after battling cancer. However, a growing number of patients are experiencing permanent changes as a result of a chemotherapy drug named Taxotere.

Cancer survivors are claiming that Taxotere caused permanent and unexpected hair loss, and they are taking the makers of Taxotere to court for failing to warn them of unexpected side effects, misleading the public with false advertising, and marketing a dangerous drug.

Taxotere Background Information

Taxotere is a chemotherapy drug1 that interferes with a cancer cell’s most basic functions.

Sometimes known as docetaxel, Taxotere is injected into a vein using an IV once every three weeks to inhibit a cell’s mitosis function. By interfering with cell division and replication, Taxotere helps to control and stop the spread of cancerous cells.

The drug was first approved by the U.S. Food and Drug Administration in 1999 to treat non-small cell lung cancer, and for prostate cancer and breast cancer treatment in 2004. The drug also received approval for use in the treatment of stomach, head, and neck cancers in 2006. It is manufactured and marketed by Sanofi-Aventis.

Taxotere is currently one of the most popular breast cancer drugs on the market, but is also used for cancer of the lung, stomach, head, neck, and prostate.

Most Common Taxotere Side Effects

Like many chemotherapy drugs, Taxotere has a number of side effects. According to its prescribing information sheet,2 Taxotere’s most common side effects include:

  • changes in sense of taste
  • shortness of breath
  • constipation
  • decreased appetite
  • changes in fingernails or toenails
  • swelling of hands, face or feet
  • feeling weak or tired
  • joint and muscle pain
  • nausea and vomiting
  • diarrhea
  • mouth or lip sores
  • hair loss: in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed
  • rash
  • redness of the eye, excess tearing
  • skin reactions at the site of TAXOTERE administration such as increased skin pigmentation, redness, tenderness, swelling, warmth or dryness of the skin
  • tissue damage if TAXOTERE leaks out of the vein into the tissues

The prescribing information sheet also warns of potentially serious side effects associated with Taxotere, such as acute myeloid leukemia, blood disorders, skin reactions, neurologic symptoms, vision problems, intoxication, and death.

Taxotere Linked to Permanent Hair Loss

Hair loss is a common side effect of chemotherapy treatments. However, the hair usually grows back after treatment ceases.

Some patients taking Taxotere have reported that their hair loss became permanent, a condition known as alopecia, and several studies have backed up these claims.

One study in 2006 conducted by the Rocky Mountain Cancer Center found 6.3% of women taking Taxotere for breast cancer had suffered long-term hair loss described as “male pattern baldness.”

Another study3 published in March 2011 noted five out of the seven chemotherapy-induced cases of alopecia from a pool of more than 8,000 had been treated with Taxotere.

In a 2012 prospective study4 of 20 breast cancer chemotherapy patients with alopecia, researchers concluded that “Permanent and severe alopecia is a newly reported complication of the FEC 100–docetaxel breast cancer regimen.”

Thousands of Women File Taxotere Lawsuits

Undergoing treatment and surviving breast cancer is a harrowing experience for most women. But the permanent loss of hair following treatment can be equally as devastating for some.

In 2006, studies were already warning about the potential alopecia risks from Taxotere. “Such an emotionally devastating long term toxicity from this combination must be taken into account when deciding on adjuvant chemotherapy programs in women who likely will be cured of their breast cancer,” one researcher wrote.

This life-altering side effect led thousands of breast cancer survivors and their families to file lawsuits against Sanofi-Aventis, claiming that the manufacturer knew the drug could cause alopecia but failed to warn healthcare professionals or patients of the risk. Patients have also accused Sanofi-Aventis of false marketing.

Taxotere Makers Stand by Drug

It wasn’t until December 2015 when the FDA ordered the company to update the warning label to include the risk of permanent hair loss did more women become aware of its possible side effects.

Even after studies and experts exposed the risks, Sanofi-Aventis insisted there was insufficient evidence. Before being revised, Taxotere’s prescription information sheet2 stated that once chemotherapy is finished, “hair generally grows back.” While this is true for the majority of women treated with Taxotere, some women will have to deal with the side effects for the rest of their lives.

Because of Sanofi-Aventis’ failure to warn patients of the risks, users of Taxotere who suffer from permanent alopecia may be entitled to compensation for their emotional and physical damage.

Taxotere Settlement Information

So far there has been no global settlement resolving the thousands of cases still pending in U.S. courts, though legal experts say the likelihood of a settlement is increasing. But for a settlement to be reached, several lawsuits may first have to go to trial as test cases. These bellwether trials provide a clearer picture on both sides about the strength of the cases. If the verdicts go in favor of plaintiffs, Sanofi-Aventis will be more likely to settle cases out of court.

Judge Kurt D. Engelhardt of the United States District Court for the Eastern District of Louisiana, where Taxotere cases have been consolidated into multidistrict litigation, has scheduled the first of the bellwether trials for September 2018. Four additional trials are slated for 2019.

Managing Permanent Hair Loss

Although hair loss can feel like a crippling and isolating experience, it is not out of the ordinary among cancer survivors. The American Cancer Society5 has programs to help those with cancer manage their lives through treatment and recovery. Support groups are a wonderful way for women to regain self-esteem and confide in other women who have been through similar struggles.

Those who have suffered permanent hair loss after receiving Taxotere are encouraged to contact a qualified attorney for legal advice.

References

  1. Drugs.com. “Taxotere”, Drugs.com, https://www.drugs.com/taxotere.html. Accessed April 9, 2018.
  2. Sanofi. “Taxotere Prescribing Information”, Sanofi.us, http://products.sanofi.us/Taxotere/taxotere.html. Accessed April 9, 2018.
  3. Palamaras, Loulios MD; Misciali, Cosimo MD; Vincenzi, Colombina MD; Robles, Wanda S. MD, PhD; Tosti, Antonella MD. “Permanent chemotherapy-induced alopecia: A review”, Journal of the American Academy of Dematology, https://www.jaad.org/article/S0190-9622(10)00370-1/fulltext. Accessed April 9, 2018.
  4. Kluger, N.; Jacot, W.; Frouin, E.; Rigau, V.;l Poujol, S.; Dereure, O.; Guillot, B.; Romieu, G. Bessis, D. “Permanent scalp alopecia related to breast cancer chemotherapy by sequential fluorouracil/epirubicin/cyclophosphamide (FEC) and docetaxel: a prospective study of 20 patients”, Annals of Oncology, https://academic.oup.com/annonc/article/23/11/2879/234091. Accessed April 9, 2018.
  5. American Cancer Society. “Find Support Programs and Services in Your Area”, American Cancer Society, https://www.cancer.org/treatment/support-programs-and-services.html. Accessed April 9, 2018.
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