Drug marker Sanofi is under fire with at least 13,200 lawsuits with more expected due to plaintiff’s permanent hair loss. Temporary hair loss was a known side effect but permanent hair loss caught patients by surprise
What is Taxotere?
It is a chemotherapy medication used to treat a number of types of cancer. This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer, and non-small-cell lung cancer. It may be used by itself or along with other chemotherapy medication. It is given by a slow injection into a vein. The drug is produced by French biopharmaceutical company Sanofi.
Though it has been on the market for several decades now, it wasn’t until more recently that Sanofi began to face a mounting number of lawsuits claiming false marketing.
What is the Plaintiff’s Claim(s)
The plaintiff’s claim that Sanofi failed to warn patients of the drug’s high risk of permanent hair loss. It was known that temporary hair loss is a side effect of many chemotherapy drugs, permanent hair loss was unexpected.
How Many Lawsuits have been Filed?
More than 13,200
Does the Plaintiff’s Have Evidence Required for Civil Lawsuit Threshold?
It is not known yet as these cases are still going through the courts. The patient plaintiffs claim they were warned of side effects; however, a major claim is that Sanofi downplayed the severity levels of some key side effects. Since Sanofi marketed the drug as being more effective than other types of chemotherapy many plaintiffs possibly assumed that the side effects would be better than others.
The Main Complaint: Taxotere-driven Hair Loss
Hair loss is an unfortunate but recognized side effect of chemotherapy. Although hair loss is expected by the patient undergoing chemotherapy, permanent hair loss or alopecia is not. For most chemo patients hair will grow back within 3 to 6 months
Did Sanofi’s Marketing Neglect Study Evidence?
According to attorney’s collateral, Sanofi didn’t mention alopecia in product marketing until 2013, more than 15 years after the drug was first introduced to the market. But knowledge of the risk of alopecia had been discovered years earlier. In 1998, Sanofi the GEICAM 9805 study which showed a high risk of hair loss for patient however, the study wasn’t published till 2010. Thereafter it started to reveal serious hair loss risks.
GEICAM 9805 studied the efficacy of Taxotere against another chemotherapy drug called fluorouracil (Adrucil). Both drugs were applied in combination with other chemo drugs called doxorubicin and cyclophosphamide. The clinical could be considered a success in proving the effectiveness of Taxotere in reducing tumor size and achieving remission. However, the investigators noted the drug was far more toxic than the other treatment regime. By the study completion, the study also revealed about 96% of women in the study faced hair loss because of the cancer treatment.
Drug manufacturers have responsibility for honest and truthful marketing. If it can be demonstrated that the evidence clearly establishes that Sanofi intentionally hid or avoided the alopecia topic then this is really bad and the courts will probably move in favor of plaintiffs. On the other hand, if it can be showed that Sanofi didn’t make false or misleading claims then the outcome may go in their favor.Source: ConsumerSafety