Drugs used in chemotherapy for cancer patients have numerous side effects, one of which is hair loss. In most cases, hair starts to grow back once the course of treatment is completed. However, for patients treated with Taxotere (docetaxel), the hair loss is often permanent.
This is the cause of action in numerous lawsuits against the manufacturer, Sanofi SA. Thirty-three of those lawsuits, filed in sixteen districts across three states, allege the manufacture engaged in an aggressive and deceptive marketing campaign, claiming that its product was superior to that of its competitors – while they were aware that it frequently resulted in permanent, irreversible hair loss. Those complaints further allege that the company took extraordinary measures to conceal that information from patients and doctors.
One of those lawsuits, filed by one Ami Dodson of California, alleges that Sanofi's marketing scheme was designed for the sole purpose of increasing sales figures – regardless of the effects on unsuspecting patients. As a result, thousands of those patients were unnecessarily exposed to the elevated toxicity of Taxotere when there were other, less toxic alternatives.
According to Dodson's complaint, Sanofi initiated its marketing scheme shortly after Taxotere won approval from the FDA in 1996.
The allegations, if true, are all-too-familiar. First of all, Sanofi trained its sales staff to underplay and misrepresent the drug's dangers and promote it for off-label uses – for which it had not yet been tested nor approved. For example, a report published in 2015 revealed that Taxotere was being used to treat metastatic prostate cancer even before Phase III trials (the stage at which the drug is administered to actual patients under clinical testing conditions) for that purpose had been completed.
Secondly, Sanofi allegedly paid kickbacks to doctors in order to encourage them to prescribe Taxotere for those off-label purposes. Any “clinical trials” involved were sponsored by the company itself, calling into question their objectivity and reliability. Sanofi's fraudulent marketing practices and the kickbacks have been coming to light in a qui tam (whistleblower) lawsuit filed in Pennsylvania by a former employee.
The scheme paid off handsomely. Between 2000 and 2004, Taxotere sales more than tripled, going from $424 million to $1.4 billion. Meanwhile, post-marketing surveillance reports indicated that although Taxotere was more potent than its competitors, it wasn't necessarily more effective in treating cancer. In fact, a study published in 2008 in the New England Journal of Medicine concluded that another drug by one of Sanofi's competitors was actually superior for many patients. That didn't stop Sanofi's marketing department from continuing its claims of “superior efficacy,” however. This deceptive campaign eventually resulted in a warning letter from the FDA.
The growing body of evidence strongly indicates that Sanofi was aware of the risk of permanent hair almost from the beginning. Ironically, the French pharmaceutical company did issue such warnings about irreversible alopecia in other countries, no such warnings were given to U.S. consumers. This too is not unheard of. An antipsychotic medication known as Abilify, made by the Japanese drug maker Otsuka, can cause compulsive gambling. As is the case with Taxotere, warnings were issued in virtually every country except the U.S.
Currently, lawsuits against Sanofi are being consolidated before a federal judge in Louisiana.