Hair loss is perhaps the first side effect that comes to mind when thinking about cancer chemotherapy. In popular culture, cancer patients are often depicted as bald individuals, mostly because the vast majority of chemotherapy agents rapidly disrupt the activity of hair follicles, causing the hair to become thin, dull and eventually fall out. However, as soon as the treatment is over, hair will slowly grow back over the course of the next three to six months. This is a critical aspect of the terrible journey that cancer patients must endure, a signal that they finally left the worst part of that torment behind their backs. However, according to the recent wave of litigations filed in court, the baldness caused by the effect of Taxotere may be irreversible, leaving a permanent scar on the heads and souls of all those patients unfortunate enough to use this chemotherapy agent.
Taxotere (docetaxel) is an anti-mitotic agent originally manufactured by Sanofi-Aventis that received approval by the U.S. Food and Drug Administration (FDA) in 1996. A few years later, in 2005, the European Medicine Agency found that some patients who used this medication as a second-line therapy for breast, lung and prostate cancer suffered from an irreversible form of baldness called Persistent Chemotherapy-Induced Alopecia. Patients who suffered from this condition were never able to grow their hair back even when treated with other medications that may help regrowth such as minoxidil and Ultraviolet A therapy. Clinical studies later found convincing evidence that confirmed this risk, yet the American regulator kept waiting until 2015 before a label change was issued to warn patients about this danger.
Several patients who used this drug found too late that their hair may never grow back, causing them severe distress, loss of self-esteem and, in some instances, even anxiety and depression. Irreversible alopecia may, in fact, disrupt a person’s body image, especially in women, leading to detrimental effects on their sexual and social lives and hampering their quality of life. The drug was rapidly called “Taxo Tears,” and many victims decided to file a lawsuit to seek compensation in the U.S. courts.
According to court documents, Sanofi-Aventis was already aware of this risk back in 2005 since the GEICAM 9805 pivotal clinical trial revealed that nine percent of patients who used docetaxel suffered from permanent baldness. Plaintiffs claim they would have chosen a different therapy protocol if only they knew about the risk beforehand. Last October, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to consolidate all the cases in the MDL no. 2740. A total of 200 victims joined the products liability litigation which is scheduled to be held in the Eastern District of Louisiana under the guidance of Chief Judge Kurt D. Engelhardt.