Gomez Trial Attorneys of San Diego filed one of the first Taxotere chemotherapy drug lawsuits in a Southern California federal court yesterday on behalf of a woman who is suffering from its permanent effects (US District Court – Southern District of California Case No. 16CV1861).
The lawsuit alleges that the drug’s manufacturer, Sanofi-Aventis, failed to disclose and warn women and their doctors of Taxotere®’s increased risk of permanent baldness (alopecia) following chemotherapy.
The case is the latest in a string of over 30 cases filed across the country against the French drug manufacturer. Gomez says his firm plans to file more cases to hold the manufacturer accountable for its actions. Defendants include Sanofi S.A., Aventis Pharma S.A. and Sanofi-aventis U.S. LLC.
“While our clients battled and survived breast cancer, they now must live out their lives with a disfiguring reminder of what they went through. When they were in crisis and most vulnerable, they were robbed of the opportunity to make an informed decision about their healthcare,” says John Gomez, founder and CEO of Gomez Trial Attorneys.
While it is generally accepted and understood that temporary baldness may be a side effect of chemotherapy, women were not warned of the risk of permanent baldness despite an alternative and equally effective drug being available.
In 1996 the US Food and Drug Administration (FDA) approved Taxotere as an intravenous chemotherapy treatment for metastatic and adjuvant breast cancer. Its uses would eventually be expanded to include a range of cancers, including prostate, stomach, and head and nec, according to Salient News. Taxotere is administered every three weeks over the course of an hour, in the manner of traditional chemo treatments, and most patients undergo four cycles of Taxotere. Since being approved, more than 1.5 million patients have used Taxotere as a cancer treatment.
The lawsuit cited to a 2009 warning letter issued to the drug’s manufacturer by the FDA as a result of false or misleading statements about unsubstantiated claims of Taxotere®’s superior efficacy. According to the lawsuit, and as early as 2005, Sanofi-Aventis had knowledge based on their own study of Taxotere®’s increased risk of permanent baldness. The lawsuit alleges that despite this knowledge warnings of permanent alopecia in Canada and Europe, the drug’s U.S. label contained no mention of permanent hair loss until the label was changed in January 2016.
Taxotere® is widely prescribed for the treatment of early-stage breast cancer and other cancers. It is estimated that a majority of breast cancer patients receive Taxotere® as part of their chemotherapy regimen. According to the Susan G. Komen Foundation, nearly 250,000 cases of invasive breast cancer will be diagnosed in the U.S. in 2016.