A panel of plaintiffs’ attorneys, the Plaintiffs’ Steering Committee, has been appointed to handle high-level issues of discovery (gathering evidence) and legal strategy. This group will spearhead the effort to probe the allegations that each lawsuit shares. Meanwhile, individual plaintiffs’ attorneys are working through the details unique to their own clients’ cases.
Efficiency & Settlement: The Two Goals Of MDL
The idea behind this sort of consolidation, which is known as MDL (or Multi-District Litigation, since the lawsuits were originally filed in multiple federal district courts), is to promote efficiency.
Instead of stretching its defense team across numerous jurisdictions, Sanofi-Aventis can focus on a single court, addressing all of the similar Taxotere lawsuits in one place. And rather than filing myriad identical requests for evidence, the consolidated group of plaintiffs can all benefit from the submission of a single application.
At bottom, the point is to work through these pre-trial proceedings as quickly and cheaply as possible.
Bellwether Trials: Starting January 2019
So what happens after pre-trial proceedings are over? In theory, the Honorable Kurt D. Engelhardt, who has been selected to preside over the litigation, can send each lawsuit back to its original court for further proceedings, including a trial. That’s unlikely to happen.
Most litigations that are consolidated end in some form of settlement in the federal court to which they have been transferred. But that doesn’t mean a number of cases won’t go to trial first. In fact, Judge Engelhardt has already scheduled four of these initial trials, which are set to kick off in January 2019. The early trials selected from an MDL are known as “bellwether” trials.
At some point in the near future, both sides in the dispute, plaintiffs and Sanofi-Aventis, will sit down to pick out four cases that adequately represent the essential aspects of the Taxotere litigation. These four lawsuits will then go to trial, in front of actual federal juries. Those juries will render actual decisions, assigning liability or choosing to absolve Sanofi of responsibility.
What Impact Will Trials Have On Settlement Negotiations?
If one or more plaintiffs secure compensation, the jury will calculate how much their damages are worth and order Sanofi to pay up. All of these results are data, concrete information from real-world trials. In light of this new data, plaintiffs and Sanofi will have gained an invaluable understanding of where their opposing cases fail or succeed. This newfound understanding will, in turn, come to structure the course of ongoing settlement proceedings.
Think about it. If you lost four initial trials, how excited would you be to fight through nearly 1,600 more? Less excited, probably. And, if you won a number of preliminary cases, you would likely become more confident in the legal strategy you’d been employing. Plaintiffs who secure bellwether victories gain leverage in settlement talks, and can demand more money in compensation. In a complementary fashion, defendants who win a few bellwether trials become less likely to settle the cases at all, or at least can justify offering a lower sum in damages.
A Golden Road To Resolution?
As we can now see, the entire process of Multi-District Litigation is geared toward shaping the conversations that take place in the conference room. Needless to say, the Taxotere MDL is still at an early point. The first bellwether trial won’t be held until January 2019.
But would it be smart to wait before filing a new case? We don’t think so. In important respects, MDL proceedings, despite being held in a centralized federal court, are still governed by a battery of state-based product liability laws. One of these laws is the statute of limitations.
Pay Attention To The Statute Of Limitations
Every state has a statute of limitations, a law that restricts the amount of time breast cancer patients will have to file suit. Miss this all-important deadline and Sanofi is almost certain to request an immediate dismissal, with little resistance from the court. So it would behoove any prospective plaintiff to contact an experienced attorney as soon as possible.
To find information on your state’s statute of limitations for product liability claims, check out this guide at FindLaw.
What’s At Issue In Taxotere Lawsuits?
While around half of all systemic chemotherapy drugs cause a degree of hair loss, the side effect is almost always temporary. Oncologists frequently reassure their patients, for whom hair loss can be a distressing complication, that any alopecia experienced will begin to resolve within one month of a treatment regimen’s end.
Chemotherapy & Permanent Hair Loss
The same cannot be said for many Taxotere patients, according to a wealth of medical studies. In fact, two of Sanofi’s own clinical trials, conducted prior to the drug’s approval in 2004, revealed evidence that between 3% and 9% of women who underwent breast cancer treatment with Taxotere could experience “persistent” hair loss. Many of the women in these trials were followed for up to 8 years. But in America, Taxotere’s warning label contained no mention of this risk.
A section on common side effects listed “hair loss,” but gave no clue as to how long this alopecia could last, let alone that it could last forever. More to the point, Taxotere’s US labeling appeared to take an encouraging tone, saying only that “hair generally grows back” after treatment.
It’s highly likely that, in light of these statements, medical providers in America had little reason to think Taxotere was any different from competitor drugs, none of which are known to cause permanent alopecia.
Why Did US Patients Only Get A Warning In 2015?
Things were different, however, overseas. Separate documentation, prepared for Taxotere’s release in the European Union, noted that “cases of permanent alopecia have been reported.” That reference appeared in Europe as early as 2009. A similar warning was quietly issued in Canada in 2012. But it was only in 2015, more than a decade after those two fateful clinical trials, that Sanofi-Aventis would finally provide a warning for consumers in the US market. Today, the drug’s FDA-approved label contains two references to permanent hair loss.
The current range of estimates suggests that between 3% and 15% of Taxotere patients will never regrow their hair. Is that a high enough proportion to warrant a public warning? The European Medicines Agency certainly thinks so. Any side effect that occurs in between 1% and 10% of patients is considered “common” by the European regulatory body. The FDA takes a similar line.
So why did Sanofi-Aventis choose to omit permanent hair loss from Taxotere’s US warning label? That question, perhaps the most important question we will address, is the subject of some 1,500 lawsuits, most of which have been consolidated in the US District Court for the Eastern District of Louisiana.