Hundreds of breast cancer patients say Taxotere, a common chemotherapy drug, causes permanent hair loss.

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The Taxotere litigation is now moving quickly. Bellwether trials have already been scheduled and time may be running out for patients who have yet to file suit. Contact our experienced product liability lawyers now for a free consultation.

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Nearly 1,600 women have filed product liability lawsuits against Sanofi-Aventis, accusing the French pharmaceutical company of concealing a link between the chemotherapy drug Taxotere and permanent hair loss.

Why Women Are Filing Taxotere Lawsuits

Between 3% and 10% of women who receive Taxotere, a chemical frequently prescribed for breast cancer, will develop life-long alopecia, a condition that can lead to emotional distress and other psychosocial complications. And substantial evidence suggests that Sanofi was aware of this risk for over a decade, but failed to provide adequate warnings in the drug’s prescribing documents. Now, breast cancer patients are fighting back, filing claims for financial compensation in the hundreds.

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Hair Loss Claims Consolidated In Louisiana Court

Today, over 1,500 Taxotere lawsuits are “consolidated” in the US District Court for the Eastern District of Louisiana, a federal court in New Orleans. Guided by the Honorable Kurt D. Engelhardt, the claims have been coordinated as a Multi-District Litigation for pre-trial proceedings. Instead of working on their cases in isolated pockets across the United States, plaintiffs can now collaborate to gather crucial evidence and develop legal strategies.

Trials Begin January 2019

While there is no guarantee of a successful resolution in Multi-District Litigation (MDL), District Judge Engelhardt has scheduled four bellwether trials, beginning in January of 2019. As settlement negotiations intensify, the results of these future trials will become all-important. Are plaintiffs’ attorneys or defense counsel more persuasive in front of real juries? What conclusions do actual jurors reach based on the evidence?

We’ll begin to get answers to these questions in 2019, and those answers will come to structure ongoing settlement conferences.

Group Highlights Psychological Trauma Of Alopecia

Many women have joined support groups to share their personal experiences, advocate for further medical research and provide support to one another during the Taxotere litigation. The most prominent of these groups, A Head of Our Times, is particularly devoted to educating medical professionals. While it may seem perverse at this point, numerous oncologists continue to be ignorant of Taxotere’s link to permanent hair loss.

There is, in practice, a strange silence within the medical community around persistent cases of alopecia in chemotherapy patients. Perhaps cancer physicians have simply become inured to the condition, since at least half of the most commonly-prescribed chemo agents cause a degree of hair loss. And, as we’ve seen, the vast majority of these drugs lead only to temporary hair loss, a side effect that, while distressing, is short-lived.

Why Don’t Researchers Take Chemo Hair Loss Seriously?

In light of the drastic consequences posed by a cancer diagnosis, temporary hair loss is a complication that patients are willing to accept. Doctors have likewise become dismissive of the side effect; it’s just not important, many physicians think, considering that the alternative, an untreated case of cancer, will likely prove fatal. Even today, chemotherapy-induced alopecia “is given minimal attention in clinical trials and in the literature,” according to an international group of cancer researchers writing in Supportive Care in Cancer.

But in reality, even temporary hair loss can have a “major impact” on patients, the team says. Hair loss “can visually turn a healthy person into a cancer patient”; it is a mark, a sign to the world that one has a severe disease. Thus, hair loss can serve both to stigmatize patients in social settings and become a personal source of emotional trauma. Patients are reminded, every time they look into the mirror, of their disease.

Studies Often Disregard Alopecia, Despite Patient Outcomes

Throughout the medical literature, researchers report that chemotherapy-induced hair loss is the most dreaded of all chemo side effects. Yet chemo-induced alopecia receives far less attention than other common chemotherapy side effects, like nausea and vomiting. A cursory search for studies on “chemotherapy nausea” in the National Library of Medicine database returns 33,286 articles. A similar search for “chemotherapy alopecia” finds only 7,484 articles. In short, for every research program that addresses hair loss, five studies address nausea.

That’s true even though hair loss is an objectively-verifiable symptom of chemotherapy, while tracking cases of nausea is largely a matter of gauging patient self-reports. The point is not that nausea is an unimportant side effect. It’s that both nausea and hair loss are important, but medical researchers only seem to be taking one of these conditions seriously.

All this may be true for other chemotherapy drugs, but it can’t be said for Taxotere.

Trials Revealed Evidence Of Permanent Hair Loss

It now seems clear, reviewing the results of early clinical trials on the drug, that Sanofi-Aventis knew or should have known that Taxotere can cause permanent hair loss.

Studies conducted by Sanofi prior to the drug’s approval revealed that at between 3.9% and 9.2% of breast cancer patients who received Taxotere failed to regrow hair up to 8 to 10 years after treatment had ended. More recent research has found even higher rates of long-term hair loss, with one survey of breast cancer survivors discovering that nearly 15% of women were still living with persistent alopecia.

When Should Side Effects Be Listed?

But even assuming the lowest risk found in clinical trials (3.9%), patients argue, the research warranted a mention on the product’s warning label.

Guidelines set by the World Health Organization define a “common” or “frequent” side effect that occurs in between 1% and 9.9% of patients. Seeing that drug warning labels in the United States, including the one for Taxotere, contain a prominent section for “common” side effects, we could reasonably expect it to include a reference to permanent hair loss. At least when a drug’s clinical trials show that at least 10% of patients receiving the treatment experience permanent hair loss.

Taxotere’s warning label, however, did not contain such a reference. While hair loss was mentioned, the drug’s prescribing information was oddly reassuring about the effect, noting that a patient’s hair would generally grow back, but never indicating that, in at least 4% of women, it never would.

References To “Persistent” Alopecia In Euro Label

The situation was strangely different in Europe. When Taxotere was approved for sale in the European Union in 2005, the drug’s clinical prescribing pamphlet contained 95 references to “alopecia,” many of which note the “persistent” or “non-reversible” nature of this hair loss. Under the document’s entry for “Skin and subcutaneous tissue disorders,” Taxotere’s European labeling clearly states that “cases of persisting alopecia have been reported.”

No Similar Warnings In US

Nothing of the sort appeared in Taxotere’s labeling for US patients and medical providers, even though the drug had received approval from the Food & Drug Administration six years earlier, in 1999. A warning would only come for American breast cancer patients in 2015, when Sanofi quietly added two references to permanent hair loss to the “Patient Counseling Information” section of the drug’s prescribing document:

  • “Explain to patients that side effects such as nausea, vomiting, diarrhea, constipation, fatigue, excessive tearing, infusion site reactions, and hair loss (cases of permanent hair loss have been reported) are associated with docetaxel administration.”
  • “hair loss: in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed.”

While these new warnings are certainly welcome, breast cancer patients who have experienced permanent hair loss can’t help but wonder why Sanofi did not provide notice earlier. Of course, many of these patients, especially the women who have already filed lawsuits, have a theory.

Women Strike Out At Sanofi “Fraudulent” Marketing

Taxotere doesn’t exist in a vacuum. It’s not the only chemotherapy agent used to treat breast cancer, nor is it necessarily the most attractive option. Another drug, also a taxane, called paclitaxel has been approved to treat breast cancer since 2004.

The Problem Of Paclitaxel

Many researchers have found that paclitaxel is just as effective at combatting cancer as Taxotere, if not more effective. It’s also a generic drug, so it’s far cheaper than Taxotere. But just as important, paclitaxel (sold as Taxol in America) has been judged to be less toxic than Taxotere. That means, on average, fewer side effects.

So Taxotere has a major competitor, one that many patients would probably choose over Taxotere. Sanofi’s choice, in this competitive environment, was simply to lie about Taxotere, plaintiffs claim in their lawsuits. Instead of coming clean with the medical community, the women allege, Sanofi designed a “fraudulent” marketing campaign to present Taxotere in a more favorable light.

Whistleblower Says Sanofi “Misled” Medical Providers

Many of these allegations originate in a 2001 whistleblower lawsuit filed by Yoash Gohil, who worked as a sales representative for Sanofi-Aventis between 1982 and 2002.

In his complaint, Gohil accuses company executives of employing “corrupt” business practices to increase Taxotere sales. Illegal kickbacks were promised to physicians who prescribed Taxotere for unapproved purposes, Gohil writes. And sales professionals were trained to “overstate” the chemo drug’s benefits, while downplaying its significant risks, the former employee claims.

FDA Warns Over Deceptive Taxotere Marketing

Crucially, at least for federal health regulators, Gohil said that Sanofi had been circulating “misleading” marketing materials, in which hyperbolic claims of efficacy were mixed with outright falsehoods. True to Gohil’s allegations, government watchdogs at the FDA hit Sanofi with a number of warnings about how the company was marketing Taxotere.

In one 2001 letter, FDA experts called the pharmaceutical manufacturer out for distributing a pamphlet at conferences that falsely claimed Taxotere had been approved as a “front-line treatment” for mestatic breast cancer. In reality, Taxotere was classified as a second-line treatment. A 2002 warning told Sanofi to stop using a brochure that “manipulated” data from weak studies to mislead physicians on the efficacy of Taxotere.

And seven years later, in 2002, the FDA again asked the company to destroy a binder of information, distributed to doctors, that mischaracterized the results of a study comparing Taxotere to paclitaxel. While Sanofi’s marketing book said the study had found Taxotere could “outperform” its competitor, the research actually found no statistically-significant difference in the two drugs’ performance.

All of these infractions, Taxotere patients claim, speaks to an intentional scheme of deception. How hard is it to imagine, they ask, that Sanofi misled the public on permanent hair loss, when it’s been mischaracterizing Taxotere (either intentionally or unintentionally) for over a decade?

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