Taxotere, a popular chemotherapy treatment for breast cancer, is causing permanent hair loss in thousands of women. As a wave of litigation hits the drugâs manufacturer, our team of Taxotere lawyers details how this drug evaded FDA and public scrutiny for so long.
Temporary hair loss from chemotherapy treatments is well known and accepted. Like other chemotherapies, Taxotere is given through injection, causing a range of side effects from mouth sores to nausea. Until 2010, Taxotereâs labels explicitly stated that hair generally grows back after treatments stop. Now, we know that this claim is not true, has never been true, and that the manufacturer knew all along.
Taxotere is made by Sanofi and was approved in 1996. To boost sales, Sanofi executives set into motion a marketing scheme to misrepresent the safety and effectiveness of Taxotereâs off-label uses (meaning prescribing the drug for anything other than breast cancer treatment) to increase the market and profits. Saofi also paid doctors to persuade them to prescribe Taxotere off-label.
This type of marketing scheme is extremely common in the drug industry. It is also illegal. Big Pharma knows this, but chooses to pay the federal criminal and civil fines rather than stop these deceitful, insidious, and dangerous practices. Why? Because it works. In 2004, Taxotere made $1.4 billion in sales.
A former Sanofi employee recently filed a qui tam (or whistleblower) lawsuit against the company, accusing it of engaging in fraudulent marketing schemes and paying kickbacks to doctors to prescribe Taxotere. That case is pending in Pennsylvania.
Recent data and studies show that the notoriously toxic Taxotere is not more effective or more beneficial than other similar treatments, as Sanofi so aggressively advertised. One of these studies was published in 2008, finding that one of Taxotereâs competing drugs was indeed more effective in certain patients. Despite this, Sanofi continued promoting its drug as superior.
In 2009, the FDA sent a warning letter to the company stating its promotional materials were misleading, overstating Taxotereâs efficacy and claiming it to be superior without any data to prove this. That letter concluded, âFDA is not aware of substantial evidence or clinical experience to support the claims made regarding Taxotereâs level of efficacy or superiority to paclitaxel. If you have such evidence, please submit it for FDA review.â
Permanent Hair Loss Known Since 1990s
Needless to say, Sanofi did not have any such evidence. It did, however, hide studies from the FDA, doctors and the public that showed Taxotere was causing permanent hair loss. Sanofi allegedly learnedÂ of this side effect in the late 1990s, when a study showed nearly 10% of Taxotere patients lost their hair for more than 10 years after taking it.
Another study found that as many as one in 16 Taxotere patients could suffer permanent hair loss. News stories profiling women who suffered permanent hair loss started emerging in 2010, after Sanofi removed the line on Taxotere labels stating âhair generally grows back.â it took another five years for the company to add labels stating âcases of permanent hair loss have been reported.â Keep in mind this was nearly two decades after the company originally learned of this side effect.
Devastating Women Worldwide
A breast cancer diagnosis is traumatic enough. Patients face overwhelming fear and anxiety over not only the illness itself, but also the debilitating treatments that come with it. To think that a drug company knew a chemotherapy aimed specifically at women would cause permanent hair loss and blatantly chose to hide this from patients, doctors and the government is disgusting. To think the company engaged in this cover-up for 20 years is even more repulsive.
Breast cancer is a leading cause of cancer death among American women, claiming nearly 40,500 lives in 2015. Currently, there are more than 2.8 million women with a history of breast cancer in the U.S., and you can be sure that these women were never told their treatments could cause permanent hair loss. Neither were their doctors. These women were denied the choice of making their own medical decisions, during what was likely the most difficult, vulnerable time of their life, when they needed and deserved that power of choice.
Women have begun filing lawsuits against Sanofi. If you or a loved one suffered permanent hair loss from Taxotere treatment, contact Pintas & Mullins Law Firm for more information on this litigation. We are currently reviewing these claims and have helped hundreds of women harmed by similarly dangerous drugs and products, including talcum powder. We provide free consultations and accept clients nationwide.