A Kansas couple is challenging the Sanofi group of companies, alleging they failed to issue proper warnings about Taxotere risks.

Plaintiff Debra G. says she suffered permanent alopecia (hair loss) and other severe and permanent injuries after undergoing chemotherapy that included treatment with the drug Taxotere.

She is now suing defendant Sanofi U.S. Services Inc. and its related companies, arguing her injuries are traceable to Sanofi’s failure to properly address the risks associated with Taxotere.

Debra says she began chemotherapy treatment with Taxotere in March 2011. She experienced hair loss, which commonly happens after beginning chemotherapy. However, according to Debra, her hair did not grow back.

She says she was diagnosed with permanent and severe alopecia, or hair loss, in October 2016.

Plaintiff Claims Inadequate Warning of Taxotere Risks

Taxotere is a chemotherapy drug, one of the class of plant-derived drugs known as taxanes. It was developed by a corporate predecessor to Debra’s Sanofi defendants. After some false starts, it was finally granted approval by the FDA in 1996.

Debra says she wasn’t properly apprised of the relevant Taxotere risks before she elected to undergo treatment with that drug. She says that if she had known that Taxotere was associated with a risk of permanent hair loss, she would not have used Taxotere.

Other chemotherapy drugs are available that do not present the same risk of permanent hair loss, she says, and she would have chosen to use one of those other treatments if she had known what could happen with Taxotere.

Debra says her experience with Taxotere was inconsistent with what she was reasonably led to expect from the warnings and product information distributed by Sanofi.

The company’s promotional materials led her to believe that, as with other drugs, Taxotere would likely cause hair loss but that such hair loss would not be permanent.

Yet Sanofi knew that Taxotere had been linked to permanent hair loss, she claims. Results of the GEICAM 9805 study showed that more than nine percent of the patients treated with Taxotere ended up with persistent alopecia for as long as 10 years and 5 months, and sometimes even longer than that.

Debra claims that as long as Sanofi has made and sold Taxotere, it has been purposely withholding information about Taxotere risks from patients and their physicians.

Sanofi allegedly promoted Taxotere as being more effective than other drugs. However, Debra argues, post-market reports show otherwise.

She says these reports show Taxotere is no more effective than other taxane drugs, and she accuses Sanofi of concealing the existence of studies that showed the same conclusion.

Debra’s Taxotere lawsuit raises claims for strict liability, defective design and manufacture, negligence, and breaches of express and implied warranties. She seeks an award of compensatory and punitive damages and reimbursement of her court costs and attorneys’ fees.

Debra’s husband Victor, also a named plaintiff, is bringing his own claim for loss of consortium, a type of claim that seeks compensation for the effect of Debra’s harm on their marital relationship.

Debra and Victor’s Taxotere Lawsuit is Case No. 1:16-cv-01067 in the U.S. District Court for the District of Delaware.