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In a slow but steady stream of personal injury lawsuits, breast cancer survivors from across the country say a common chemotherapy drug can cause permanent hair loss. In fact, recent plaintiffs have alleged that French pharmaceutical giant Sanofi-Aventis was at the bottom of a concerted “cover up” to conceal Taxotere’s link to permanent hair loss from the public.
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Within three days of one another, two new lawsuits were filed in the US District Court for the Southern District of Mississippi.
In the first of these claims, a Mississippi woman who received Taxotere after being diagnosed with left breast cancer in 2006 says neither she, nor her healthcare providers, “were aware of or informed by [Sanofi] that disfiguring permanent alopecia can occur following the treatment with Taxotere.” To date, her permanent alopecia, which she describes as “disfiguring,” has lasted ten years, according to court documents. Her lawsuit was filed under the case number 3:16-cv-00404-WHB-JCG on May 31, 2016.
Three days later, on June 2, 2016, another breast cancer survivor from Mississippi would follow suit. In her own complaint, the woman describes how, after being diagnosed with right breast cancer in May of 2014, she sat down with an oncologist to discuss treatment options. While the team eventually decided on using Taxotere, no one suspected that two years after treatment she would still be bald. This second lawsuit was logged under the case number 3:16-cv-00412-HTW-LRA.
Both women make clear that some patients, after being diagnosed with breast cancer, may “accept the possibility of permanent baldness.” After all, cancer is a life-threatening condition, and while persistent alopecia can be traumatic, survival is likely the preferable option.
But Taxotere doesn’t exist in a vacuum, as the Plaintiffs rightly point out. Cancer patients have other options, including a different drug, Taxol, that employs the same mechanism of action as Taxotere.
In fact, post-marketing studies have found that Taxol works just as effectively as the drug these women ended up taking. Unlike Taxotere, however, Taxol has never been linked to permanent hair loss. These are scientifically-substantiated facts, and Plaintiffs argue that if patients were made aware of these facts, many women would likely choose to be administered Taxol rather than Taxotere. That’s a choice Sanofi actively withheld from patients, Plaintiffs allege.
Today, there’s ample scientific evidence to suggest that Taxotere can, in fact, cause permanent hair loss. In Europe, where the drug’s manufacturer is based, government regulators have known for years of the risk, even including warnings about persistent alopecia in Taxotere’s prescribing information. The story in America is different.
In the 1990s, Sanofi began sponsoring a long-term clinical trial on Taxotere, a study called GEICAM 9805. By 2005, the study’s preliminary results were available. But there was one finding from GEICAM 9805 that Sanofi neglected to tell the US Food & Drug Administration, Plaintiffs claim.
The study “demonstrated that 9.2% of patients who took docetaxel (Taxotere) had persistent alopecia, or hair loss, for up to 10 years and 5 months, and in some cases longer,” the women write. Instead of making those findings clear for doctors and patients, Plaintiffs say Sanofi chose to use “the generic, vague, and insufficient warning that ‘hair generally grows back’ ” on Taxotere’s US warning label. Clarity on the issue of permanent hair loss only came to the drug’s US labeling in December of 2015, ten years after Plaintiffs say the GEICAM 9805 study turned up evidence of the risk.
What had been happening in the meantime? According to Plaintiffs’ narrative, Sanofi was misrepresenting the effectiveness of Taxotere. Post-marketing studies conducted after the drug was approved had shown that Taxotere was no better at controlling breast cancer than Taxol. But patients say Sanofi had begun circulating “false and misleading statements” in an apparent effort to boost Taxotere’s sales.
In 2009, the company even received a “warning letter” from the FDA for “present[ing] unsubstantiated superiority claims and overstat[ing] the efficacy of Taxotere” at an oncology conference in 2008.
Plaintiffs go so far as to suggest that Taxotere itself is a sham. In their own words:
“Docetaxel (Taxotere) was defective in its design. Docetaxel […] was designed as an increased potency Taxane [a class of cancer drugs that also includes Taxol]. This increased potency resulted in increased toxicity, which can be directly related to increased adverse events. The most likely reason Defendants designed the increased potency Taxane was to enable them to obtain a patent (and the concurrent market advantage) on a product that in fact was not novel but instead only more dangerous.”
