Taxotere Hair and Vision Loss Lawsuit

This is the latest update on the Taxotere class action (MDL) lawsuits.

Where are we now in the Taxotere hair loss lawsuits?  There have been two bellwether trials.  One before the pandemic in 2019 and one last year.  Both have ended in a defeat for plaintiffs.

So things are not good with the Taxotere lawsuits at this stage.  Do some mass tort lawsuits often begin with losses and then the tide turns and plaintiffs start winning and the defendant offers fair settlement amounts?  Yes.  100%.  But let’s not pretend there are many silver linings when you lose two lawsuits in a row.

Some Good Taxotere News – Appellate Win

The first texture lawsuit to go to trial ended in a tough loss for the plaintiff.  But in a huge development, the 5th Circuit Court of Appeals ruled the plaintiff should receive a new trial because Sanofi offered inadmissible expert testimony at trial.  This is a big win that breathes new life into the Taxotere lawsuits.

July 2024 Case Count and Update

The litigation involving Taxotere—the hair loss, not the vision—had 9,474 active lawsuits in the MDL in July, reflecting a slight decrease from the previous month.

In terms of settlements, there have been no payouts for hair loss or vision loss cases as of the latest updates.

Remember, there are two separate MDLs in the Eastern District of Louisiana: one for hair loss (MDL 2740) and another for eye injuries (MDL 3023). The litigation is ongoing, and plaintiffs continue to claim that the manufacturer, Sanofi-Aventis, failed to adequately warn about the risks associated with the drug, including permanent alopecia and eye damage like canalicular stenosis, which can cause excessive tearing and other vision problems.

Judge Kurt D. Engelhardt has directed pretrial orders to streamline the process and prepare for potential settlement discussions. Attorneys have been instructed to provide detailed information about all pending and anticipated claims to facilitate any eventual resolution process. While Sanofi has won some bellwether trials, the litigation continues with no definitive settlements reached yet.

June 2024 Taxotere Hair Loss Update

The MDL judge partially granted the plaintiffs’ request to reconsider a previous order in the hair loss litigation.

The court had issued a Lone Pine order, which requires plaintiffs to provide specific proof of their injuries early in the litigation to streamline the process and eliminate weak claims. The judge extended the deadlines for submitting the required “Expert Medical Declaration” and “Certificate of Willingness to Proceed” but did not vacate the order entirely. This ensures the litigation moves forward efficiently while giving plaintiffs more time to gather evidence.

Another Appellate Opinion in May 2024

On May 24, 2024, the Fifth Circuit Court of Appeals vacated a summary judgment ruling that favored four plaintiffs who alleged that Hospira Inc. and Accord Healthcare Inc. failed to warn consumers that their chemotherapy drug, docetaxel, could cause permanent hair loss. The court determined that it was impossible for the drug manufacturers to comply with both federal and state failure-to-warn laws simultaneously.

The key issue revolved around whether the drugmakers had “newly acquired information” that would have allowed them to update their labels under the FDA’s Changes Being Effected (CBE) regulation. The court found that the plaintiffs did not provide new information showing that docetaxel caused permanent hair loss at a higher rate than the original drug, Taxotere, approved by the FDA. However, the court noted that the district court did not consider all relevant data, specifically the minimal cases mentioned in the Bertrand Abstract, which could potentially indicate a higher incidence rate of permanent hair loss. Consequently, the court remanded the case to the lower court for further consideration of this issue.

Impact on Taxotere Hair Loss MDL

This decision could significantly impact the Taxotere hair loss multidistrict litigation (MDL). The Fifth Circuit’s ruling highlights the importance of demonstrating newly acquired information that meets the FDA’s criteria for label changes.

Plaintiffs in the Taxotere MDL must show that their claims are supported by new data revealing risks of greater severity or frequency than previously known. The court’s emphasis on the specifics of the Bertrand Abstract suggests that detailed examination of scientific studies and adverse event reports will be crucial in these cases.

Moreover, the ruling underscores the complexity of federal preemption in failure-to-warn claims. If the lower court, upon remand, finds that the Bertrand Abstract or other new information does not sufficiently indicate higher risks, it could lead to more dismissals of state law claims in the Taxotere MDL.

But..if the new information is deemed sufficient, it might pave the way for plaintiffs to successfully argue that the drugmakers failed to warn about the risk of permanent hair loss.

What Is Taxotere?

Taxotere is a chemotherapy drug used to treat a number of cancers, especially breast cancer. Taxotere is a taxanes.  Taxanes are diterpenes produced by the plants of the genus Taxus that have a taxadiene core.

Taxanes are widely used as chemotherapy agents. Taxotere has been one of the most widely used chemotherapy drugs since it was developed in the mid-1990s. Chemotherapy drugs like Taxotere work by attacking cancer cells within the body. Taxotere was originally developed and introduced by the New Jersey pharmaceutical company Adventis which is now Sanofi-Adventis.

What Cancer Does Taxotere Treat?

Following its approval by the FDA in 1996, a strong marketing push soon made Taxotere the chemo drug of choice for breast cancer treatment. Breast cancer is one of the most common types of all cancers with 300,000 women diagnosed annually.

By 2009, the majority of breast cancer patients were being treated at some point with Taxotere, making it the most prescribed chemo agent in the U.S. In 2009, the year before the original patent on Taxotere expired, Sanofi-Adventis reported $3 billion in revenues from its popular chemo drug.

What Does the Taxotere Lawsuit Allege?

Plaintiffs allege that the drug caused permanent alopecia which is permanent hair loss. Plaintiffs allege negligent misrepresentation, fraudulent misrepresentation, and more. But the most important claim is failure to warn. The gist of this argument is that there was a duty to warn victims of the risk of permanent hair loss to give them the choice to consider other alternatives.

Hair Loss

Taxotere has experienced a notable fall from grace since its glory days in the early 2000s. As it turns out, Taxotere has one very unfortunate flaw. In a certain percentage of women (between 10-20%, depending on what study you read), Taxotere causes permanent hair loss. Everyone generally expects their hair to fall out during chemotherapy. It’s the price you pay for getting rid of cancer.

But chemo hair loss is supposed to be a temporary side effect. When people undergo chemotherapy, they reasonably expect their hair to grow back when the chemo is over. Hair loss is a big deal, particularly for women. Unfortunately, thousands of women who were treated with Taxotere for breast cancer learned afterward that their hair was never coming back.

We now know that in a certain subset of patients, Taxotere triggers permanent hair loss. We also know that Sanofi-Adventis was well aware of this permanent side-effect for years. There are many indications are that Sanofi-Adventis knew about the permanent hair loss problem since as early as 1998. The company allegedly actively concealed this fact because it realized there was a risk that permanent hair loss would damage Taxotere’s marketability, particularly with female breast cancer patients. For over 10 years Sanfoi-Adventis knowingly failed to warn that Taxotere may cause permanent alopecia in certain patients.

The warnings in the prescribing label were not changed until 2015. To make matters even worse, Sanofi-Adventis may have made false claims about the effectiveness of Taxotere over alternative chemo drugs.

One of the main reasons Taxotere became so widely used is that Sanofi-Adventis told doctors that it was more effective at fighting cancer than other, less toxic chemo drugs like Taxol. However, in 2009 the FDA determined that these claims were completely false. Not only does Taxotere cause permanent hair loss, but it is less effective than alternative chemo drugs like Taxol.

Watery Eyes

Watery eyes are caused by an overproduction of tears, which can result in an overflow of tears onto the face. This can cause a range of symptoms, including blurry vision, irritation, and redness around the eyes. The condition can be quite uncomfortable, and it can affect a person’s ability to carry out daily activities.

The exact cause of watery eyes from docetaxel is not fully understood. However, it is believed that the Taxotere may cause irritation or inflammation of the tear ducts, leading to increased tear production. In some cases, watery eyes may be a sign of more serious side effects, such as infection or inflammation of the eye.

Taxotere Lawsuits

In the wake of Taxotere’s striking downfall, thousands of women with permanent hair loss are now bringing product liability lawsuits against Sanofi-Adventis. These former breast cancer patients claim that Sanofi-Adventis lied about the effectiveness of Taxotere and deliberately concealed the fact that the drug may cause permanent hair loss.

The evidence supporting these claims is very strong. There is no real dispute about the link between Taxotere and permanent hair loss. At least 10% of people who are treated with Taxotere will suffer permanent hair loss. It is also pretty obvious that Sanofi-Adventis knew about this side effect and deliberately concealed it for over 10 years. In some individual cases, causation may be an issue.

However, the primary battleground in the Taxotere lawsuits will likely be on the issue of damages. In most pharmaceutical lawsuits, the plaintiffs suffer serious physical injuries like heart attacks or strokes. By contrast, the Taxotere plaintiffs only lost their hair.

At first glance, losing your hair may seem somewhat trivial in comparison to suffering a stroke or losing an organ. But permanent hair loss can be just mentally and emotionally devastating, especially for a woman recovering from breast cancer.

Taxotere MDL

MDL is an acronym for Multi-District Litigation. MDL is a special process in the federal court system which is frequently used in large-scale product liability and pharmaceutical cases. In an MDL, hundreds or thousands of related cases in Federal Courts across the country get consolidated together into a single court and assigned to one judge.

The cases remain consolidated in the MDL for efficient pretrial discovery management. If there is no global settlement at the end of the pretrial / discovery phase a few individual cases will be selected and sent back for trial in their original courts. The outcome of the trials in these initial “bellwether” cases is then used as a reference in negotiating the settlement of the remaining cases. Whenever a drugmaker like Sanofi-Adventis suddenly gets hit with a wave of related lawsuits across the country, they are almost always consolidated into an MDL.

An MDL for the Taxotere hair loss lawsuits was established in October 2016 (MDL – 2740 Taxotere (Docetaxel) Products Liability Litigation). All the Taxotere cases in federal courts are now consolidated into this MDL and assigned to Judge Jane Triche Milazzo in the Eastern District of Louisiana. The size of the Taxotere MDL continues to grow very rapidly. When the MDL was first formed in 2016, there were about 5,500 cases.

At the beginning of 2024, there are now 9,603 Taxotere lawsuits in the MDL, ranking the Taxotere litigation as the 6th largest active mass tort litigation in the country. (Although the MDL judge dismissed some of these cases for failure to cooperate.)

The plaintiffs’ lawyers lost the first Taxotere lawsuit in 2019.  The second trial also bombed.  (Defendant’s attempt to dismiss this case before trial was denied by the MDL judge.) If you have a claim and this lawsuit is successful, you can expect that to have a positive impact on any future settlement compensation payouts in Taxotere lawsuits.

What Is the Settlement Value of the Taxotere Lawsuits?

After two, losses, it hard to speculate on settlement amounts.  A jury payout in the next trial will renew talk of expected individual settlement amounts in the Taxotere class action lawsuit. But now is not the time. 

It is also important to point out that our law firm is not at all involved in the Taxotere litigation (we are in the canalicular stenosis lawsuit)  so it would be hard for us to speculate on settlement compensation payouts.)

When Will the Taxotere Lawsuits be Settled?

These bellwether trials are designed to determine the settlement value of the cases.  More trials will lead to a better understanding of the appropriate settlement awards for these lawsuits. Losing two trials is tough but hopefully, it is just the beginning and hopefully there is a settlement in 2024.

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