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.

To experience permanent baldness is an extremely agonizing experience, adding injury to insult for women undergoing breast cancer therapy. There are not only mental and emotional damages associated with permanent alopecia from taxotere, but economic loss as well in the form of inability to return to work as a result of suffering severe psychological trauma. Taxol, which did not cause permanent hair loss, was always available as an alternative chemotherapy drug for breast cancer. Yet women were simply not given that choice, because the warnings on debilitating taxotere side effects were effectively masked by a greedy pharmaceutical manufacturer. No woman given the information regarding taxotere and the equally effective taxol alternative, would have chosen taxotere over taxol, and risked permanent hair loss. Sanofi is alleged to have deceived women with sophisticated kickbacks to physicians that resulted in women believing taxotere was more effective at treating their breast cancer than taxol. The breast cancer chemotherapy market contained multiple drugs that were not only more effective than taxotere but also did not carry the massive risks of permanent hair loss. Please contact Baseluos Law firm to discuss your options regarding a chemotherapy drug lawsuit.

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.

Today, Michael Baseluos is a taxotere lawyer actively pursuing cases for taxotere victims who have suffered permanent and disfiguring hair loss in women. Breast cancer patients with alopecia after undergoing chemotherapy with taxotere are eligible for compensation. Sanofi Aventis failed to issue previously undisclosed warnings until December 2015. The original taxotere warning labels misled breast cancer survivors into believing they would recover their hair loss, when in fact there is permanent alopecia from taxotere. The FDA forced Sanofi to update their label to reflect the side effect of permanent alopecia after chemotherapy treatment. Since its first clinical trials, there is deep suspicion that Sanofi has know for almost two (2) decades about taxotere causing permanent hair loss. A little known fact is that Sanofi updated its warning labels of cancer treatment hair loss in Europe in 2005 and in Canada in 2012. Those same warnings were not revealed to US customers until December 2015. Taxotere Permanent Hair Loss (Alopecia) cases are now part of Multi District Litigation (MDL) in the US District Court, Eastern District of Louisiana assigned to Judge Englehardt, Chief Judge of the Eastern District of Lousiana.