Articles Posted in Taxotere Hair Loss

Baseluos Law Firm is currently engaged in the representation of multiple women throughout the United States who have suffered from alopecia caused from cancer treatment. The primary defendant is Sanofi Aventis, who is suspected to have known for the last two (2) decades that its chemotherapy product taxotere caused permanent hair loss in breast cancer victims. In fact, a former employee of Sanofi Aventis filed a qui tam lawsuit against the company in 2015. A qui tam lawsuit is a type of civil suit in which company whistleblowers bring cases under the False Claims Act. The whistleblower in the Sanofi Aventis case assists the government in stopping fraud by Sanofi Aventis, by exposing the company’s illegal marketing tactics and illegal bribes to physicians to push taxotere.

Specifically, beginning in 1996, Sanofi and its affiliated companies / subsidiaries promoted a marketing scheme designed to push off-label uses for taxotere that were never formally approved by the FDA. An off label use refers to medication that is being utilized outside the approved uses on the FDA approved label. Specifically, Sanofi is alleged to have instructed their employees to lie about the safety and efficacy of Taxotere, so that the market for taxotere would expand into the off label market. Secondly, Sanofi is alleged to have engaged in a kickback scheme with doctors such that physicians would be encouraged to prescribe taxotere. The qui tam lawsuit has highlighted a very sophisticated scheme of bribery to push sales of taxotere to almost $1.5 billion dollars in 2004 alone. As  a result of their sophisticated marketing and bribery tactics, thousands of women have become victims of toxic chemotherapy with taxotere. The most prominent and debilitating side effect from such toxic chemotherapy was alopecia caused from cancer treatment.

While temporary hair loss is expected to be a side effect of chemotherapy, permanent hair loss is most certainly an unacceptable side effect. Using false marketing materials and incomplete studies, Sanofi Aventis is alleged to have duped the public into believe taxotere was safer and more effective than its rival taxol and the defendants conveniently omitted warnings of permanent hair loss. Thousands of women mistakenly believed their hair would grow back only to learn the agonizing news of taxotere permanent hair loss. Sanofi Aventis is alleged to have been extremely aware that the rate of permanent hair loss associated with taxotere greatly exceeded any permanent hair loss associated with taxol.

Baseluos Law Firm is currently assisting plaintiffs throughout the country to recover injuries sustained by women with breast cancer who underwent chemotherapy and suffered permanent alopecia (hair loss) from taxotere. Lawsuits are currently being filed against the makers of taxotere, Sanofi Aventis, in connection with the design, development, and marketing of this cancer prescription.  Taxotere, part of the drug family known as taxanes, is used in the chemotherapy treatment of various cancers, with a primary emphasis on breast cancer. The taxanes are part of a family of chemical components known as diterpenes produced naturally from plants.

Bristol Myer Squibbs manufactures paclitaxel (taxol) , the major competitor to taxotere.  However, Sanofi designed taxotere as a highly potent taxane alternative to its rival taxol. Since 1989, Sanofi through its subsidiary Aventis controlled and developed all patents related to taxotere. Sanofi enrolled patients in clinical testing trials beginning in 1990. This fact is critical because Sanofi is alleged to have withheld information and data from those tests from doctors (especially oncologists), patients, and the FDA. It should be noted that in 1994, the FDA’s Oncologic Drugs Advisory Committee panel unanimously recommended the rejection of taxotere, because the drug was deemed to be much more toxic than Bristol’s taxol, which had previously received FDA approval. The FDA recommended more testing on the side effects of docetaxel , the chemical name for taxotere. In May 1996, FDA finally approved taxotere, limiting use of taxotere to treat advanced or metastatic breast cancer after failure of prior chemotherapy.

After the initial FDA approval, Sanofi sought approval for expanded applications of taxotere. Specifically, Sanofi and its subsidiaries now claimed their drug was a more effective chemotherapy drug against breast cancer. Specifically, they now claimed taxotere was more effective than its rival taxol, and they reiterated such misleading comparisons in their marketing. Today, post market surveillance has shown Sanofi’s claims of superior efficacy to be fraudulent. A 2008 study in the New England Journal of Medicine measured the efficacy of taxol and taxotere and concluded that taxol was a more effective chemotherapy drug than taxotere. Despite overwhelming statements in a reputable medical journal, Sanofi continued to proclaim taxotere’s superiority. Their actions led to a stern warning letter from the FDA in 2009 in which the FDA cited Sanofi’s unsubstantiated superiority claims and overstatement of the efficacy of Taxotere. The FDA  found Sanofi Aventis in violation of the Federal Food, Drug, and Cosmetic Act.

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