Categories: Medical Drug Safety

On July 22, a motion was filed requesting a new multidistrict litigation (MDL) for lawsuits alleging that Sanofi SA’s chemotherapy drug, Taxotere, can cause permanent hair loss, particularly in those being treated for breast cancer. Multidistrict litigation is a special procedure in which federal civil (noncriminal) cases from around the country are transferred to one court. The motion specifically asks that the litigation be transferred to the U.S. District Court for the Eastern District of Louisiana.

So far the federal litigation currently includes about 33 lawsuits in approximately 16 federal courts. The lawsuits allege that Sanofi knew or should have known that the rate of permanent hair loss (alopecia) related to Taxotere was far greater than with other products available to treat the same condition. Yet, through its publications and marketing material, Sanofi allegedly misled the patients, the public, and the medical community to believe that, as with other chemotherapy drugs that cause alopecia, patients’ hair would grow back. For example, one breast cancer survivor from Ohio, Hattie Carson, decided to take on Sanofi in Ohio Federal Court. According to her lawsuit, Ms. Carson underwent a core biopsy in April 2004 of her right breast after receiving abnormal results from a routine mammogram. The biopsy demonstrated an infiltrating ductal carcinoma, nuclear grade 3, and a ducal carcinoma, solid type with microcalcification in her right breast. After a lumpectomy and sentinel node biopsy were performed on her right breast, Ms. Carson met with her oncologist to discuss further treatment. Ms. Carson alleged that neither she nor her treating healthcare providers were aware of or informed by manufacturer, Sanofi, that disfiguring permanent alopecia could occur following treatment with Taxotere.  She underwent chemotherapy with Taxotere and suffered and continues to suffer from disfiguring permanent hair loss.

The Taxotere lawsuits also allege that contrary to the manufacturer’s claims of superior efficacy, post market surveillance has shown that the more potent and more toxic Taxotere does not in fact offer increased efficacy or benefits over other similar drugs, as the manufacturer has claimed and advertised.

The Food and Drug Administration approved the drug in 1996 “for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.” The FDA later approved additional indications for Taxotere.

For more information about the Taxotere lawsuits or to discuss a potential claim, contact Pharmaceutical/ Medical Device Litigation Attorney Pamela A. Borgess of Borgess Law, LLC at (567) 455-5955 or toll-free at (844) LAW-9144. You can also contact Borgess Law, LLC by submitting a free online inquiry.