Taxotere (docetaxel) received U.S. Food and Drug Administration (FDA) approval in 1996. Sanofi, Aventis Pharma SA in France and Sanofi-Aventis US LLC in the United States promoted Taxotere as an effective chemotherapy medication for cancer patients. Taxotere was touted for minimizing the number of chemotherapy treatments and overall amount of time for treatment over other chemotherapy drugs.
Many women were pleased to be able to minimize the number of treatments offered with Taxotere, which also provided them with increased potency and fewer side effects than other chemotherapy drugs. Taxotere, like many other chemotherapy options does come with the loss-of-hair side effect; however, with other options, hair loss is not permanent. With Taxotere, according to plaintiffs’ allegations, Taxotere alopecia (hair loss) has been permanent.
Taxotere was originally approved to treat breast cancer. Now, the chemotherapy drug is indicated for other cancers, including head and neck, gastric, prostate, and non-small cell lung cancers. Mention of permanent alopecia as a potential side effect was not added to Taxotere’s label until December 2015.
One of the first Taxotere side effect lawsuits was filed in the US District Court for the Northern District of California by a woman who alleged that the drug makers engaged in a long-term scheme to increase usage of Taxotere as far back as when it was approved in 1996. She alleged that Sanofi employees were coached to misrepresent Taxotere’s the safety and efficacy, withholding data from the United States market concerning Taxotere hair loss that had allegedly been distributed in other countries. The lawsuit also referenced a qui tam lawsuit that had been filed by a former employee whose allegations included illegal and inappropriate marketing. A qui tam lawsuit is a type of civil lawsuit that whistleblowers bring under the False Claims Act.
According to the lawsuit, the plaintiff alleged that, “Defendants [preyed] on one of the most vulnerable groups of individual’s at the most difficult time in their lives,” adding that, “Defendants obtained billions of dollars in increased revenues at the expense of unwary cancer victims simply hoping to survive their condition and return to a normal life.” The plaintiff also referenced an FDA warning letter sent to Sanofi in 2009 concerning the drug maker’s marketing practices, alleging that Sanofi was aware in the late 1990s of a study that revealed that 9.2 percent of Taxotere patients lost their hair for more than a decade, yet Sanofi withheld this information from the public providing vague references that “hair generally grows back.”
This October, the U.S. Judicial Panel on Multidistrict Litigation issued an order for consolidation of all Taxotere lawsuits that alleged permanent hair loss in the U.S. District Court, Eastern District of Louisiana. More than 180 Taxotere lawsuits are now pending there. On November 30th, a Pretrial Order was issued concerning the filing of requests for, and return of, summons. The Court established new guidelines so that summons requests are to be filed in the docket for the member case, not the master docket. Summons returns and waivers returned executed are not to be filed into any docket, master, or member, unless necessary. In such cases, the summons return is to be filed as an exhibit to the motion, etc., to which it pertains.
The lawsuits also cite research that was published in 2006 by a Denver-based oncologist. He allegedly reported that a higher percentage of his Taxotere patients suffered from permanent hair loss years after discontinuing the drug.
Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in drug injury claims. The firm continues to offer free, no-obligation legal consultations.
Women Seek Coverage, Tax Breaks for Taxotere Hair Loss-Related Prosthesis
In December 2015, the FDA requested an update to the Taxotere product label to include alopecia as a potential side effect, this, 19 years after Taxotere was approved for release to the U.S. market.
Two women who underwent six rounds of Taxotere chemotherapy treatment both have been wearing expensive hair pieces and have had their eyebrows tattooed. They each finished chemotherapy years ago and their hair never grew back. One woman said that, “My hair is so thin in the front of my head that you can see my scalp and I have bald patches throughout,” adding that “I no longer have any bangs and my hair in the front is so thin and brittle that I can barely clip my hairpiece to it.” She also says she has “very sparse eyelashes” noting that eyelash extensions are expensive and eyebrow tattoos and eyelash extensions typically require ongoing maintenance.
“Since undergoing chemo with Taxotere back in 2003 I have visited many medical and cosmetic facilities to determine why and what could be done to halt my hair shedding,” wrote one of the women. “I no longer have any hair on my body except for a few eyelashes. I’d like to get eyelash extensions, but after paying $700 for eyebrow tattoos-and they require maintenance, I can’t afford much more. Unfortunately I don’t have extended medical insurance.” She believes that she will no hair left shortly. “No one to this day, not even my oncologist, ever told me about Taxotere side effects,” she said. “I just saw something on TV about such litigation. At the very least I would appreciate some compensation for these necessary cosmetic costs. I find this harder to take than the actual surgeries.” In addition to financial hardships, the woman has been living on disability since her cancer diagnosis.
Another breast cancer patient told Vancouver Metro that, when she had to come to terms with hair loss, she “went home, drank a bottle and a-half of wine, ate cupcakes for dinner, and had a pity party. She visited a Vancouver wig shop to discuss options and learned that a human hair wig costs at least $2,000. Typically, women suffering from alopecia must buy a new wig every two years. The owner of Vancouver’s West Coast Wigs noted that, “About 85 percent of my clients are chemo patients … and every one of them are devastated. Their loss of hair is the worst part of the treatment, and to suffer permanent hair loss is too sad.”
“Up to 75 percent of cancer survivors have had eyebrow tattoos, simulated eyebrows (tattoos) or augmented the eyebrows they have,” Kyla Gutsche, of the Medical Centre in Peterborough, Ontario, said. “The cost is over $1,000 plus another $130 in taxes.”
Many wonder why wigs and tattoos for cancer patients are not classified as prostheses and why cancer survivors are not eligible for tax breaks for these items. “If these ‘cosmetic’ costs were covered I would feel relieved,” said one of the women who underwent eyebrow tattooing. “And I would feel better if the government realizes cancer isn’t over after chemo. Even if they covered a portion of the costs, that would help. I got a tax benefit from my prosthesis and I believe wigs and tattoos should be considered prosthesis. And it should be an instant reduction, not just a tax rebate.” The woman purchased a $1,700 wig-her employer gave her $500-as well as two wiglets for another $2,300. “When I went back to work I wanted to look normal and not look like a cancer patient wearing a scarf and hat,” she said. “The wig helped my self-esteem. I wore it every day. A year after chemo I paid $700 for eyebrow tattoos but they don’t last forever.”