NEW ORLEANS — The first case in multi-district litigation (MDL) revolving around permanent hair loss from a breast cancer drug has been set for trial in September 2018.
The plaintiffs involved in the litigation have claimed that they were not warned prior to taking Taxotere that it could cause alopecia, a medical condition in which the immune system attacks hair follicles, resulting in hair loss.
“They wake up every morning and they look in the mirror and they feel as if they are still a victim of cancer," Dan Markoff, an attorney at Atkins & Markoff, told the Louisiana Record. "That is very difficult for many of them.”
Markoff’s firm is representing hundreds of the plaintiffs, and he said the heart of the case was there was another drug on the market that was similar to the one his clients were given called Taxol.
“So, you have two drugs that are equally effective at fighting breast cancer," Markoff said. "The difference between the two drugs is that with Taxol and Taxotere almost every time a woman is going to lose her hair. But with Taxol, it is almost always as far as my research shows that it is going to grow back in six months.”
Taxotere was approved by the FDA in 1996. It is a chemotherapy drug used to treat breast cancer, non-small lung cancer and prostate cancer.
“The oncologists that we have met and spoken to all say that they had no idea, and if they did know about the potential for permanent alopecia, then, yes, they certainly would have informed their patients,” Markoff said.
Markoff said there was an FDA warning in December 2015 that forced the company to change the label to indicate it can cause alopecia.
The drug is manufactured by Sanofi, which is a pharmaceutical company in France that has said it has reported testing results to the FDA regularly.
“As early as 2004, Sanofi submitted data about persistent alopecia to the FDA as part of a proposed Taxotere label update," the company told the Louisiana Record in an email statement. "Additional information on this condition was subsequently provided to FDA at various points in time, including in 2009 and 2011. In December 2015, following discussion between FDA and Sanofi, the label was updated to reflect that cases of permanent alopecia have been reported following use of Taxotere, although at an unknown frequency. All prescribing decisions are made by treating physicians who understand their patient's needs and weigh the risks and benefits of treatment options.”
As of May 10, there were 1,116 cases in the MDL, which have been given to U.S. District Judge Kurt Engelhardt.