Taxotere Class Action Lawsuit
Taxotere Class Action Lawsuit
Taxotere (docetaxel) is a chemotherapy drug that has been linked to permanent hair loss.
Hair loss (alopecia) is particularly common during chemotherapy, except the loss is usually temporary. After the chemotherapy treatment is complete, hair tends to grow back. There is always a slight risk of permanent hair loss, but with Taxotere, the risk appears to be greater.
The manufacturer, Sanofi warned doctors and patients in Canada and Europe for years about the potential risk of permanent hair loss. But in the United States, no such warning was provided until 2015.
Patients are now filing lawsuits against Sanofi saying they were never properly warned about the risks of alopecia. Many are saying they would have chosen different treatment options if they had known about the risks of permanent hair loss.
What is Taxotere?
Taxotere is from a family of chemotherapy drugs known as taxanes. Taxanes are one of the most powerful classes of cancer-fighting drugs and work by inhibiting cell growth and work by inhibiting cell growth.
Taxotere is manufactured by the French pharmaceutical company Sanofi as a competitor to another chemotherapy drug called Taxol. Taxol (paclitaxel) is manufactured by Bristol-Myers Squibb.
Taxotere was created to be a more powerful taxane. However, increasing the potency can also lead to greater toxicity as well.
When Sanofi originally sought approval from the Food and Drug Administration (FDA) in 1994, the FDA rejected the request. In the rejection of the initial approval, the FDA noted that Taxotere was more toxic than competing drugs.
Approval was granted in 1996, for advanced cancers that had not responded to prior chemotherapy. Taxotere warned of the greater toxicity, as did many similar drugs, however the warnings did not detail the significant additional risks of long-term alopecia.
How does Taxotere Cause Permanent Hair Loss?
The medical term for balding, or hair loss, is Alopecia. Hair loss can occur not only on the head, but also across the entire body, including legs, arms, face, underarms, and pubic region.
Alopecia is commonly a side effect of chemotherapy and radiation treatment for cancer. These treatments attack fast-growing cells in cancer, but can also harm other fast-growing cells the ones found in hair follicles.
Different chemo drugs can be more or less likely to cause alopecia. But usually, this hair loss is not permanent and will begin to regrow after treatment is completed.
Taxotere appears to cause a greater risk of permanent alopecia than similar drugs. Permanent hair loss is a disfiguring condition, particularly to women. Lawsuits against the manufacturer Sanofi have alleged that the company knew about the risks but failed to fully disclose that information to doctors and patients in the United States.
Taxotere Manufacturer Sued Under False Claims Act
In 2009, the FDA sent a letter to Sanofi reprimanding the drug maker for circulating promotional materials that were “false or misleading because it presents unsubstantiated superiority claims and overstates the efficacy of Taxotere.”
This is in line with a previous study published in the New England Journal of Medicine in 2008, that concluded that the competitor Taxol was more effective than Taxotere.
In 2015, Sanofi was sued by a former employee alleging that the manufacturer had directed representatives to promote Taxotere for off-label and unapproved uses.
The scheme allegedly involved misrepresenting the safety and effectiveness of the drug between 1996 and 2004, when revenue from Taxotere more than tripled to $1.4 billion. The scheme was said to involve sham grants, speaking fees, entertainment, travel, and kickbacks to encourage healthcare providers to prescribe the drug.
Who Can File a Taxotere Lawsuit?
Any patient who took Taxotere as directed by a doctor and suffered hair loss or serious adverse events could be eligible for a lawsuit.