The popular hormonal intrauterine device Mirena may increase the risk for intracranial hypertension, a rare disorder that can lead to permanent vision loss. More than 100 women have now filed lawsuits against Bayer Pharmaceuticals, the manufacturer of Mirena, accusing the company of failing to warn patients about this potential risk.
Decades of research suggest that levonorgestrel, a synthetic hormone released by Mirena, is associated with dangerous increases in cerebrospinal fluid. Yet the device’s warning label, intended to inform patient and physician decision-making, makes no mention of intracranial hypertension or pseudotumor cerebri, another name for the disorder.
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No, this is not a class action.
Mirena patients are filing individual personal injury lawsuits, seeking individual compensation for individual injuries. Our experienced attorneys believe that class action is not the appropriate legal avenue for lawsuits that involve allegedly harmful medical devices.
Class action is a beneficial option for large numbers of people who are harmed in the same – relatively minor – way. Without banding together, most of these potential plaintiffs would have no way of winning a lawsuit. The cost of litigation would simply be too great to justify the years of legal work required to prepare and prosecute a successful case. By joining forces in a class action, however, hundreds or thousands of plaintiffs can share the costs of litigation, expenses that would likely become prohibitive otherwise.
The problem with class action is that a select number of plaintiffs must represent the best interests of thousands of other people. This isn’t an issue when we’re talking about cell phone contracts that lie about hidden fees or business practices that unfairly deprive workers of their earned wages. Cases like these don’t involve personal injuries, physical or psychological, and can’t even come close to the deeply troubling injuries alleged in Mirena lawsuits.
Plaintiffs accuse Bayer of hiding the connection between levonorgestrel, a synthetic hormone in Mirena, and pseudotumor cerebri, a strange and debilitating condition that closely mimics the effects of a cancerous brain tumor. In fact, the term pseudotumor cerebri literally means “false brain tumor,” indicating the disorder’s horrible symptoms, which include severe headaches and progressive vision loss. Left untreated, pseudotumor can result in permanent blindness.
Class action is appropriate for lawsuits that come down to financial forms of loss. Individual plaintiffs become largely interchangeable – at least in relation to how they were harmed.
Let’s take a real cell phone class action as an example. In 2016, several T-Mobile customers filed a class action, claiming that the company’s “no contract” cell phone plan actually charged them an illegal termination fee when they canceled their service. In this context, one plaintiff can serve as an adequate representative for another. Each person was hit with the same termination fee for the same exact reason. Thus, Betsy can stand in for John, representing his best interests in a court of law.
The Mirena lawsuits filed over pseudotumor cerebri don’t work like that. Many plaintiffs claim to have suffered devastating losses; some women are now permanently blind after having been implanted with the IUD. Other women, however, have suffered progressive vision loss, but not yet gone blind. Their treatments have also varied widely. Some women have been forced to undergo therapeutic shunting procedures, while others have received brain stents.
Each of these procedures has a different cost and those costs will vary depending on where the procedure is performed. In short, the damages suffered by each Mirena patient will be different, to say nothing of the ongoing medical care that some plaintiffs will require. Filing individual injury lawsuits will allow each plaintiff to pursue the damages unique to her situation, rather than relying on another patient who may have been harmed in different ways. There’s simply no way for a class action to handle all of these unique differences. Attorneys will have to focus on investigating these issues individually to best represent their clients.
Each case will also depend on a number of unique facts. What information, for instance, did a doctor share with the patient prior to the device’s implantation? Did Bayer send some doctors additional information about Mirena side effects, but fail to notify other professionals? These may or may not be crucial questions, but their answers will necessarily vary from case to case.
While only 116 Mirena lawsuits involving intracranial hypertension have been filed so far, most legal observers believe that thousands of other women may be eligible to join the growing litigation. Class action isn’t the right way to bring these cases together, but there may be another option.
When numerous plaintiffs file similar lawsuits in different federal courts, a special panel of federal judges can elect to transfer the numerous lawsuits to a single jurisdiction. In this central location, a Multi-District Litigation can be formed, allowing the lawsuits to go through several important pre-trial steps as a group. Plaintiffs’ attorneys can work together, developing their legal arguments in tandem and collecting evidence and information more efficiently.
This process, often referred to as “consolidation,” also eliminates the possibility of contradictory court decisions, since a single federal judge will be appointed to preside over the entire litigation.
The Mirena lawsuits filed over pseudotumor cerebri haven’t been consolidated as an MDL yet, but it’s a distinct possibility. A group of plaintiffs has already petitioned the Judicial Panel on Multi-District Litigation, asking for the pseudotumor lawsuits to be transferred to a federal court in Mississippi. The panel, comprised of six distinguished federal judges, is scheduled to hear oral arguments on the proposal on March 30, 2017.
While the panel denied a 2014 petition for consolidation, we should note that only nine Mirena lawsuits mentioned intracranial hypertension at the time. With more than 100 pseudotumor lawsuits now filed, the arguments for consolidation have certainly grown more convincing.
In the Southern District of New York, a separate Multi-District Litigation has been formed to consolidate Mirena cases alleging uterine perforations and device migrations. That MDL, In Re: Mirena IUD Products Liability Litigation, does not include any cases related to pseudotumor cerebri. In their current petition before the Judicial Panel on Multi-District Litigation, plaintiffs have asked for a distinct MDL to be created in a different jurisdiction.
That remains to be seen. This litigation is still in its earliest stages and no settlement agreements have yet been announced. In most cases, defendants will only choose to settle remaining lawsuits after one or more existing claims have proceeded to trial.
Trial, of course, is where both sides in a lawsuit find out where they stand, arguing the case in front of a real jury. After a few courtroom losses, many large corporate defendants decide that settling claims is a far more cost-effective strategy than taking each remaining case to trial.
Most MDL proceedings attempt to accelerate this process. Once crucial pre-trial stages are complete, the majority of MDL judges will select a slate of representative lawsuits for trial. These “bellwether” trials go before a real jury first. While the jury’s decision is entirely binding, it will only apply to the specific case at issue. In conducting bellwether trials, both sides of the dispute gain a better understanding of the legal terrain. How did a real jury respond to our side of the story? Did our expert witnesses provide convincing testimony? The answers to these questions can help inform settlement negotiations in the lawsuits that remain pending.