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Have you been prescribed Taxotere, a chemotherapy drug? Common side effects of using the medication are:
Come people have come forward claiming Taxotere causing long term hair loss and are now filing lawsuits against the drug maker Sanofi.
A decade of research shows that Taxotere can cause permanent hair loss, unlike many other chemo choices for breast cancer. In hundreds of lawsuits, women from across the country are standing up to Sanofi-Aventis, the drug’s manufacturer.
Did you or a loved one experience permanent hair loss after being administered Taxotere? Our experienced attorneys can help.
Taxotere, a chemotherapy drug used primarily for breast cancer treatment, has come under fire for a distressing, unexpected side effect— permanent alopecia.
As of January 2018, tens of thousands of Taxotere lawsuits are consolidated in the US District Court for the Eastern District of Louisiana. Under the guidance of District Judge Kurt D. Engelhardt, hundreds of women have seen their hair loss cases move through pre-trial proceedings as members of a Multi-District Litigation, or MDL. A legal structure that allows multiple similar lawsuits to come together in a single court, MDL has pushed the pace of the Taxotere litigation, enabling defendant Sanofi-Aventis to focus on one jurisdiction, rather than courts across the country.
What’s next? After all of the evidence is gathered, and the legal arguments have been honed, the cases will be ready for trial. Judge Engelhardt has already scheduled four of these trials for 2019:
These four initial trials are known as “bellwether” trials. Real plaintiffs. Real juries. Real evidence and arguments and, at the end, a real verdict. But bellwether trials are far more than that. After these four cases have been decided, the plaintiffs and Sanofi-Aventis will have gained a real-world understanding of what their case is worth. In turn, the judgments will come to affect ongoing settlement negotiations.
Though it’s widely-known that chemotherapy frequently causes hair loss, this side effect is almost always temporary, and patients typically see hair growth restored only months after treatment has ended. Permanent hair loss used to be practically unheard-of among chemotherapy patients.
But some women who took Taxotere have yet to see regrowth a decade post-treatment. Worse yet, medical research suggests Taxotere permanent hair loss is far from rare, with current risk estimates ranging from 3% to 15%.
Patients in the U.S. have started filing Taxotere lawsuits against Sanofi, the drug’s manufacturer, accusing the corporation of carelessly omitting or even actively concealing permanent hair loss risks. According to these lawsuits, by failing to provide proper side effect warnings, Sanofi prevented patients from seeking out lower-risk competitor drugs that may have spared their hair and gained billions of dollars in increased revenues at the expense of patient well-being.
Taxotere is a chemotherapy drug manufactured by Sanofi, the world’s 5th-largest pharmaceutical company, which is headquartered in France. Taxotere’s active ingredient, docetaxel, is approved in the US, Canada and throughout Europe for the treatment of several types of cancer.
The FDA initially approved Taxotere on May 14, 1996, for treating locally advanced or metastatic breast cancer in cases where other types of chemotherapy have proven ineffective. The drug was later approved for a number of additional indications, including:
Taxotere is commonly used in combination with other chemotherapy drugs, but it can also be used by itself (as a “monotherapy”). One cycle of the drug typically consists of an intravenous infusion administered over a one-hour session followed by a 3-week rest period. Dosage and number of cycles are assigned according to a number of factors, including cancer type, stage of cancer, and individual sensitivity to the drug’s side effects.
Docetaxel,the active compound in Taxotere, belongs to the taxane class of chemotherapy agents. Taxanes are plant-based chemicals classified as “mitotic inhibitors,” which disrupt the process of mitosis (or cell division) and thus prevent cancer cells from reproducing, as well as killing existing cancer cells.
In particular, taxanes target microtubules, thread-like structures that play a pivotal role in mitosis and also serve other vital cell functions such as skeletal support and transport within the cell.
In order to function properly, microtubules must be able to constantly lengthen and shorten themselves to achieve “dynamic instability,” a balance between growing and shrinking phases. Docetaxel throws off this vital balance by binding to microtubules in such a way that prevents them from shortening.
Taxotere was discovered during the development of its leading competitor drug, Bristol-Myers Squibb’s Taxol, a closely-related taxane chemotherapy drug that was first approved by the FDA in 1992.
Taxol’s active ingredient, paclitaxel, was first isolated from the inner bark of the rare Pacific Yew tree (Taxus brevifolia) in 1971, and by the late 70’s, scientists discovered that it exhibited a new, unique type of anti-cancer activity. But harvesting enough of the compound to make it into an effective chemotherapy drug would be harmful to the environment, requiring about 3 trees to be cut down to treat just one patient. Though the potential environmental impact of Taxol production sparked public controversy, the medical community couldn’t simply abandon a drug that held such immense potential for cancer treatment.
So a considerable amount of research was focused on developing new production methods as well as exploring related compounds. One of these was docetaxel, Taxotere’s active ingredient, discovered by Pierre Potier, a French researcher working for RhonePoulenc, a corporation which would later become part of Sanofi. Though Docetaxel was found to be roughly twice as potent as paclitaxel, its production didn’t require chopping down trees, as the necessary extracts come from the leaves rather than the bark of the common European Yew (Taxus baccata).
Thankfully, the environmental impact of producing both docetaxel and paclitaxel has been greatly reduced after researchers developed semi-synthetic methods of manufacturing them. For taxanes, semi-synthetic production, in which scientists take a “pre-cursor” molecule from a natural extract that already significantly resembles the desired product and then finish the rest of the transformation in the lab, has proven to be a much more cost-effective alternative to both the environmentally harmful approach of relying on harvested extracts and the impractical total synthesis route (that is, starting “from scratch” in the lab, which is very inefficient and expensive for large complicated molecules like taxanes).
Now that Taxotere no longer has the advantage of being easier to produce and better for the environment than Taxol, healthcare professionals can instead focus on the drug’s effectiveness and side effect considerations when weighing options for a chemotherapy regimen. Predictably, Sanofi advertises Taxotere as a better choice than Taxol, but what does the research say?
A 2007 study published in the New England Journal of Medicine found that women with “axillary lymph node–positive or high-risk lymph node–negative breast cancer” experienced higher disease-free survival and overall survival rates on a weekly paclitaxel regimen than those on an every 3 weeks paclitaxel or docetaxel regimen. The researchers also noted that patients suffered a much higher rate of “grade 3 or 4 toxic effects” on docetaxel (71% for every 3 weeks and 45% for weekly) than on paclitaxel (30% for every 3 weeks and 28% for weekly).
A randomized, controlled 2009 study published in the Lancet found that adding Taxotere to standard anthracycline chemotherapy offers no benefit to patients with early-stage breast cancer. 4,000 patients in the UK and Belgium were randomly assigned to receive either a standard FEC or CMF regimen by itself or along with Taxotere. The disease-free survival rates at 5 years only increased by 0.6% to 2.5% with the addition of docetaxel, which the authors judged as “not clinically worthwhile.” Again, there was a “significantly greater” ratio of patients experiencing grade 3 or 4 toxicities in the docetaxel group than in the control group.
Taxotere was initially rejected by the FDA over toxicity concerns. Now, many critics believe that Taxotere’s higher potency is responsible for increased toxicity, leading to a greater number of side effects as well as higher side effect severity in comparison to the less potent Taxol.
Permanent hair loss, a particularly dreaded side effect that was once considered extremely rare in chemotherapy, is increasingly linked to Taxotere in medical research.
Taxotere was strongly indicated as a cause of permanent alopecia in a 2006 study performed by Dr. Scot Sedlacek from the Rocky Mountain Cancer Centers in Denver. Sedlacek set out to shed light on Persistent Significant Alopecia (PSA) in breast cancer patients receiving adjuvant chemotherapy. Though PSA was thought to be exceedingly rare among chemo patients, Sedlacek had seen a “small but significant” number of affected patients over his years as a practicing oncologist.
Collecting data on nearly 500 patients whom he’d treated personally over a period of 11 years (from Jan. 1994 to Dec. 2004), Sedlacek grouped patients by the adjuvant chemotherapy regimen they were assigned:
In order to ensure that cases of persistent alopecia could be accurately diagnosed, only patients with at least one year of follow-up data were included in the study. The average time elapsed since the last dose of chemotherapy received was 4 years, with a range of 19 to 85 months.
Sedlacek found that 6% of Group C participants developed PSA, which he defined as the loss of more than 50% of pre-chemo coverage lasting longer than 6 months.
On the other hand, none of the patients treated with docetaxel-free regimens suffered from PSA. The patients with PSA coped with their condition by wearing wigs and described the appearance of their hair loss as similar to male pattern baldness. Sedlacek concluded that Taxotere is a possible cause of permanent hair loss. Noting that alopecia is among the most dreaded side effects of chemotherapy for patients, he urges doctors and patients to consider the risks of the “emotionally devastating” side effect when deciding on the optimal adjuvant treatment plan.
Today, over 1,500 of these Taxotere lawsuits are now consolidated in the US District Court for the Eastern District of Louisiana. In New Orleans, the cases have been moving through pre-trial proceedings as a group, allowing plaintiffs to collaborate in developing evidence and legal arguments.
And once all the evidence has been shared, a group of initial lawsuits will head to trial. District Judge Kurt Engelhardt, who has been selected to preside over the consolidated Multi-District Litigation, has scheduled four of these “bellwether” trials to begin in January of 2019.
According to these lawsuits, Sanofi has been putting cancer patients at risk for permanent alopecia without warning. Plaintiffs say the company deprived them of the opportunity to seek out alternative choices, like the closely-related drug Taxol, which appears to harbor no risk of permanent hair loss and is just as effective as Taxotere. The plaintiffs are each requesting over $75,000 in damages for being subjected to a “disfiguring” condition that they say could have been avoided if Sanofi had issued proper warnings.
Contrary to what they’d been led to expect, these women never saw their hair grow back to its former thickness, if at all, even years after ending treatment. Despite the fact that hair loss is a leading concern for many chemotherapy patients, warnings about Taxotere’s permanent hair loss risks were only added to the drug’s U.S. label in December 2015. Strangely, European labeling had already mentioned these risks at least 6 years earlier.
Outraged victims have started filing Taxotere lawsuits, accusing the manufacturer of failing to warn American patients of hair loss risks and falsely marketing the drug as better than alternatives.
The number of women considering legal action against Sanofi is quickly growing, as more patients learn about their legal right to seek compensation for hardship and loss. Hundreds of breast cancer survivors have already filed Taxotere lawsuits in federal district courts throughout the U.S.
Ohio resident Hattie Carson first found out that she had breast cancer on April 15, 2004, after an abnormal mammogram. Three weeks later, she underwent a lumpectomy and a sentinel node biopsy on her right breast. She and an oncologist then decided on an adjuvant chemotherapy regimen, which included the widely-prescribed drug Taxotere, as the next step in her treatment plan.
Carson says that neither she nor her doctors knew that Taxotere could cause permanent hair loss, because Sanofi didn’t provide any information about these risks at the time.
After receiving Taxotere, Carson discovered that she had developed permanent alopecia, and she says the condition caused her considerable physical, mental, and emotional suffering, as well as financial loss, both from decreased earnings and from counseling, therapy, and medical expenses resulting from her ordeal.
In demanding compensation, plaintiffs must put forth specific reasons that the defendant(s) owe them relief and form arguments based on relevant legal theories. Hattie Carson’s lawsuit asserts 12 separate claims for relief, which include:
Defendants are said to be negligent if they cause injury to someone by performing their duties carelessly. In order for the legal theory of negligence to apply, the defendant(s) must have owed a responsibility to behave in a certain way toward the plaintiff(s) and have directly caused a plaintiff’s injury through their negligence. The standard for what counts as negligence is what a reasonably competent person with the same level of training or education as the defendant would do in the same situation.
Carson is accusing Sanofi of negligence because drug manufacturers have a responsibility to provide patients with reasonably safe products and to warn the public of side effects. She points out that Sanofi knew that Taxotere was more potent and likely more toxic than Taxol, and also knew about the increased incidence of certain side effects from early clinical trials.
She then asserts that any reasonable manufacturer seeking to uphold its duties to protect patients would have responded to this knowledge both by doing further research on the side effects of Taxotere and by making sure to inform doctors and patients of research findings as they become available.
This legal theory says that manufacturers are liable for product defects even if they did their very best to exercise proper care and diligence in all the tasks they perform to bring products to market, including design, production, testing, distribution, sales, and advertising. Carson claims that Taxotere is defective in its:
According to Carson, not only did Sanofi fail in its manufacturing responsibilities with Taxotere and fail to warn the public, the company intentionally skewed its public image of the drug, making it seem safer and more effective than it actually is, as demonstrated by research and postmarket surveillance.
The recent wave of patient lawsuits isn’t the first time that Sanofi has come under fire for alleged misconduct with regard to Taxotere.
In 2010, Sanofi lost two of its patents for Taxotere due to a court ruling by Judge Gregory Sleet, which said that the company was guilty of withholding information on patent applications.
In order to secure these patents, which would grant Sanofi the exclusive right to create drugs using Taxotere’s active ingredient and obtain billions of dollars in increased revenue, the company made the drug seem more “novel” by not including some previous references to its development. But after looking over the patent application and more information about the production of docetaxel, Judge Sleet decided that the patents were “unenforceable” because the creation of docetaxel was “obvious” after full consideration of previously-developed drugs.
This court ruling opened the door for the development of generic versions of docetaxel.
As the recent hair loss lawsuits explain, Sanofi had already been accused of Taxotere-related fraud in litigation initiated more than a decade ago. Back in 2001, the company faced a Qui Tam lawsuit—a complaint filed by a citizen “whistleblower” on behalf of the United States to recover funds stolen from the government –alleging that Sanofi had committed multiple types of marketing fraud to illegally obtain millions of dollars in reimbursement from government medical assistance programs.
According to the lawsuit, filed by Yoash Gohil, who worked as a sales representative in Sanofi’s Oncology Sales division for over 20 years, Sanofi ran a “fraudulent marketing scheme” from 1996 to 2002 which involved offering “illegal kickbacks” to medical professionals as incentives for promoting off-label uses and too-high doses of Taxotere. The company gave out these kickbacks to doctors, hospitals, pharmacists, and researchers in various forms, including:
In exchange for these items, Gohil said, doctors were persuaded to prescribe Taxotere for uses that had not yet been FDA-approved at the time or even those that were never approved at all. Back then, Taxotere was only approved for 2 or 3 indications, but doctors were giving the drug to patients for over 15 off-label indications.
Gohil claims that Sanofi didn’t stop at off-label prescriptions, but also influenced doctors to prescribe much higher dosages of Taxotere than was FDA-approved, just to sell more of the drug.
For example, instead of the approved 60-100mg per square meter of body area once every 3 weeks, doctors receiving kickbacks reportedly prescribed around 40 mg per sq. meter every week—effectively up to twice as much. Such high doses, Gohil speculated, may have led to increased incidence and/or severity of common Taxotere side effects, causing unnecessary discomfort or even harm to patients. This concern would later be echoed in patient lawsuits like Hattie Carson’s, which declares that Sanofi’s misconduct caused “thousands of individuals [to be] exposed to increased frequency and more severe side effects, including but not limited to disfiguring permanent alopecia.”
In addition to providing potential customers with skewed summaries of relevant medical research, the complaint points out that the FDA itself had to step in multiple times to warn Sanofi about certain misleading advertisements and statements it was distributing.
But the big issue that FDA had with Sanofi’s Taxotere marketing campaign concerned a “gloss” that summarized a particular clinical trial saying that the results support Taxotere’s effectiveness. According to the FDA, the gloss overreached the actual study results, which didn’t actually reveal anything very positive for Taxotere. Thus the summary provided by Sanofi was misleading to readers and the FDA demanded that Sanofi stop using any printed materials using the summary. However, Sanofi ignored these FDA warnings and continued to use the gloss, as evidenced by the FDA sending a second warning letter regarding these materials.
Many patients depend on the assistance of government programs like Medicare and Medicaid to help them afford expensive drugs like Taxotere, which at the time cost about $15,000 per patient. Gohil believes that illegal claims filed by healthcare providers under the “corrupt influence” of Sanofi played a large part in enabling the company to earn over $814 million from Taxotere sales in 2001, a figure that more than doubled by 2004 when Sanofi reportedly earned over $1.75 billion from Taxotere.
Gohil also says that Sanofi attempted to conceal its alleged fraud through “false and misleading statements to the public, healthcare providers, and the FDA,” and even instructed its employees to hide evidence whenever possible.
Though Gohil’s lawsuit was originally filed on May 17, 2002, in the US District court for the Eastern District of Pennsylvania, it has been dismissed and re-submitted several times since. Predictably, Sanofi filed a motion to get the case dismissed, but Judge Lawrence Strengel permitted Gohil to file again on March 30, 2015, and this latest version of the complaint is still pending in court.
If you’re planning to file a lawsuit against Sanofi over Taxotere hair loss, you shouldn’t expect to be able to make a solid case without legal counsel. Since the drug is a manufactured product, marketed to hospitals, doctors, and patients, Taxotere litigation fits under Product Liability Law. This is an area of law that tends to be particularly complicated and difficult, especially when there’s a large amount of compensation at stake.
Presenting drug cases adequately in a lawsuit and in court requires considerable experience and finesse. The laws governing product liability are often subtle and complex. Also, pharmaceutical suits frequently require extensive supporting details, such as summaries of relevant medical studies, which the judge will need to understand clearly in order to fairly weigh the case.
Furthermore, pharmaceutical corporations usually have vast resources at their command and are able to employ teams of seasoned, aggressive defense attorneys to fight for them. Sanofi is certainly no exception, as the fifth-largest pharmaceutical manufacturer in the world. To stand a chance against such opposition, it’s best to have a highly experienced lawyer on your side – someone who’s stood up to huge pharmaceutical corporations before.
Risk-benefit considerations for chemotherapy are often complex. It’s certainly possible that some women would have chosen Taxotere, even if they’d been aware of its permanent hair loss risks if the drug offered the best chance of effective treatment.
The fact remains, however, that these women had the right to know – they had the right to be given relevant information that would help them make the best decision for their long-term well-being. But the Taxotere plaintiffs feel that their freedom of choice was stolen from them, and they were unfairly subjected to risks they weren’t aware of.
Women whose Taxotere alopecia persisted long after the end of their chemotherapy treatments are now seeking compensation for suffering and financial loss caused by their ongoing hair loss. Permanent alopecia often proves to be a life-altering condition that causes considerable emotional and psychological stress, taking a heavy toll on a patient’s self-esteem and social life. Even patients’ finances can be negatively impacted if hair loss-related anxiety and discomfort interferes with their ability to work.
Recently-filed lawsuits say Sanofi purposely concealed Taxotere’s risks to boost sales, virtually robbing patients of their right to seek out equally effective alternatives that could have likely spared their hair. Taxotere plaintiffs who have filed suits and those who have yet to file are hoping to achieve justice against Sanofi through litigation.
After all, pharmaceutical companies, just like any other establishments in the medical community, are obligated to put patient safety and well-being first, and those who fail to uphold that duty should expect to face consequences for harm needlessly inflicted on consumers.
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