A woman from North Carolina claims several pharmaceutical companies withheld information about breast cancer hair loss from chemotherapy patients.

The new Taxotere lawsuit, brought by plaintiff Gail S., names a long list of corporate defendants, all of whom she says are involved in the development, manufacture, marketing, distribution or sale of Taxotere or its generic non-bioequivalents.

Gail says after she was diagnosed with breast cancer, she consulted two different oncologists about her chemotherapy options. She says that neither of these consulting oncologists was aware of any link between Taxotere and permanent hair loss.

She underwent six cycles of chemotherapy using Taxotere or a generic non-bioequivalent. Following that treatment, she developed disfiguring permanent alopecia, or hair loss.

Gail now blames her breast cancer hair loss on the defendants’ failure to warn her and her physicians about the side effects associated with Taxotere.

Even though the defendants disclosed the associated risks to patients and regulatory authorities in other countries, they failed to disclose them to the scientific community or to the general public in the U.S., she claims.

She also accuses the defendants of failing to adequately investigate the safety of Taxotere, failing to update the warnings for Taxotere regarding disfiguring permanent alopecia, and failing to disclose the risks shown by new studies as that information became available.

Taxotere is one of a class of plant-derived chemotherapy drugs known as taxanes. Other taxane drugs include cabazitaxel and paclitaxel, marketed under the brand name Taxol. Generic non-bioequivalents of Taxotere are available marketed under the names docetaxel, docetaxel anhydrous and Docefrez.

Permanent Breast Cancer Hair Loss Risk Concealed?

At the core of Gail’s Taxotere lawsuit is the claim that defendants failed to adequately warn the public that the hair loss associated with Taxotere can be permanent.

While hair loss is a common side effect of chemotherapy, Gail says it’s not typical for that hair loss to be permanent. She says the defendants misled her, the medical community and the general public to believe that breast cancer hair loss associated with Taxotere would resolve on its own.

She says the rate of permanent alopecia is much higher in Taxotere patients than in those who took other chemotherapy drugs. She believes the defendants purposely kept this fact under wraps.

Meanwhile, Gail alleges, thousands of women who underwent chemotherapy with Taxotere were exposed to a risk of permanent breast cancer hair loss, when they could have avoided that risk by using an alternative chemotherapy drug.

Gail says that in seeking FDA approval for additional indications for Taxotere, the defendants claimed it was more effective than Taxol, a lower potency drug and Taxotere’s primary competitor.

But contrary to those claims, Gail says, postmarket studies have shown that Taxotere offers no particular benefit over comparable taxane medications.

In 2009, the FDA sent a letter to defendant Sanofi-Aventis warning the company that these statements were false or misleading because they presented unsubstantiated claims of superiority and because they overstate the efficacy of Taxotere.

Gail’s Taxotere lawsuit includes claims for negligence, design and manufacturing defects, failure to warn, breach of express and implied warranties, fraudulent and negligent misrepresentation, fraudulent concealment, fraud and deceit, infliction of emotional distress, and violation of the North Carolina Consumer Unfair and Deceptive Trade Practices Act.

The Breast Cancer Hair Loss Lawsuit is Case No. 4:16-cv-215 in the U.S. District Court for the District of North Carolina, Eastern Division.