Approved as a “high-risk” medical device in 2002, Essure is a permanent birth control implant manufactured by Bayer Healthcare. Bayer claims that over 750,000 women have opted to receive the implants, rather than more traditional sterilization options like tubal ligation.
But thousands of those women have experienced alarming – and often devastating – side effects. Hundreds have chosen to file personal injury lawsuits, accusing Bayer of hiding damning safety evidence from the US Food & Drug Administration. As the litigation develops, many Essure patients have begun to ask pressing questions, including about the possibility of Essure lawsuit settlements.
Have There Been Any Essure Settlements?
No. To date, there have been no Essure lawsuit settlements.
While hundreds of women have now filed lawsuits over Essure – mainly in a Pennsylvania federal court and California state court – none of these cases has gone to trial. Bayer, the manufacturer of Essure, has not made any settlement offers yet. By all appearances, the company intends to defend against the Essure lawsuits vigorously.
In most cases, settlements only become a possibility after several initial cases have gone to trial. After the evidence and arguments on both sides have been heard by a jury, some Defendants opt to offer a settlement, and preemptively resolve the claims, rather than defend against individual lawsuits in court. Whether or not Bayer will make a similar calculation and begin settling Essure lawsuits is unknown.
Is There An Essure Class Action?
No, this is not a class action.
Attorneys are filing individual personal injury lawsuits against Bayer. It’s unlikely that an Essure class action will ever be filed – since severe personal injuries and extensive surgical procedures are involved. Class action usually isn’t the right answer for people who have suffered serious, and often very unique, injuries due to a potentially-dangerous medical device.
Class actions are more appropriate when a large group of people have sustained fairly minor injuries, or lost relatively small amounts of money due to corporate fraud. Obviously, that’s not the case when it comes to Essure.
In their lawsuits, women from around the country say that the Essure implants caused debilitating pain, abnormal bleeding, migraine headaches and a host of other severe side effects. Many of these women were forced to undergo hysterectomy to have the devices removed. As a result, the Plaintiffs are pursuing substantial amounts of compensation. We believe their interests are better served in individual personal injury lawsuits.
It’s far too difficult to predict the course of a litigation in its early stages, but one possibility – common for lawsuits involving medical devices and pharmaceuticals – is called Multi-District Litigation (MDL).
When hundreds – or thousands – of people file suit against the same Defendant, making similar allegations, a group of federal judges can choose to have the lawsuits transferred to a single federal court, under the guidance of a single federal judge. In this central court, the cases will continue together through pre-trial proceedings, like discovery, in which crucial evidence is gathered.
Consolidation Can Impact Settlement Negotiations
In many MDL proceedings, the presiding judge will select several lawsuits for trial, tapping a few cases for an initial slate of court dates. These “bellwether” trials serve as something of an experiment.
While the jury decisions will be binding, these preliminary judgments only apply to the individual plaintiffs involved. The court results, on the other hand, could make waves for the rest of the consolidated litigation, allowing plaintiffs and defendant to evaluate their arguments and evidence in a real-world setting. Defendants who lose a string of bellwether trials are often more amenable to settling other cases, since a pretrial settlement avoids the risks inherent in proceeding to court.
Has A Federal MDL Been Created For Essure Claims?
According to LexisLegalNews, a group of Essure plaintiffs asked the Judicial Panel on Multi-District Litigation to create an MDL in July 2016. But they quickly withdrew their request – after noting that a federal judge in Pennsylvania, the Honorable Petrese B. Tucker, had already begun consolidating cases in her own court. Whether or not a new request for federal consolidation will be filed is an open question.
As for the claims brought together in Pennsylvania, court records from the US District Court of Eastern Pennsylvania show that five Essure lawsuits were consolidated in March of 2015 and remain pending before the Honorable John R. Padova. This decision does not constitute a Multi-District Litigation, since each of the five lawsuits were initially filed in the Pennsylvania court.
Significant developments in a similar vein, however, have occurred on the state level. As we’ve already mentioned, hundreds of women have filed their Essure lawsuits in a California state court – the Superior Court of California for the County of Alameda. These lawsuits have now been coordinated for pre-trial proceedings.
November 18, 2016 – Essure Lawsuits Coordinated In California
More than 55 Essure lawsuits have been coordinated in a California State Court, a move that legal advocates have called a major victory for women suing over the birth control implant’s side effects. Dozens of lawsuits, which represent the claims of over 900 women, are now being transferred to a State Court in Oakland. There, the claims will progress through pre-trial proceedings as a group, allowing plaintiffs’ attorneys to share resources. The decision for coordination was handed down on September 30, 2016.
Elizabeth Graham, Esq.
After the announcement, Elizabeth Graham, an attorney at BirthControlProblems.com, told reporters: “this is a very favorable development for these injured women. I’m hoping that it’ll be a quicker, more efficient, cohesive resolution to all women’s cases in California.”
Ms. Graham has been selected to serve on the Plaintiffs’ Executive Committee, a group of attorneys responsible for coordinating the representation of women who say Essure caused their side effects. She has also been appointed as co-liaison councel for the cases coordinated in California, a role in which she will handle administrative matters for the plaintiffs.
What Is Civil Case Coordination?
Coordination is similar to the type of consolidation that occurs in a Multi-District Litigation, a legal mechanism reserved for federally-filed cases that we discussed earlier. According to the Judicial Branch of California, civil case coordination “allows two or more civil actions (cases) that share common questions of fact or law and that are pending in different counties to be joined in one court.”
The benefits for Essure plaintiffs could be huge. Coordination often speeds the progress of a large litigation, since plaintiffs’ attorneys will be able to work together, rather than being scattered across different state courts. That pooling of resources could also increase the amount of leverage plaintiffs have in settlement conferences. Beyond strategic benefits, this centralization of similar cases can save money. Consistency is another advantage. Instead of having multiple state court judges rule on the same issue, a single presiding judge can make decisions that apply to each coordinated case uniformly.
The virtues of coordination aren’t just reserved for plaintiffs. With numerous claim brought together under a single state court judge, defendants may find it easier to get a full picture of the litigation, along with a deeper understanding of the allegations involved. In fact, coordination allows for the possibility of a global settlement, in which defendants can resolve every consolidated case all at once.
How Will The Essure Litigation Develop?
As we said earlier, it’s just too hard to predict how the Essure litigation will develop over the coming months. But this process will take time. It may be a matter of years before anyone receives compensation, whether that money comes in the form of a settlement or a favorable jury verdict.
Some attorneys, however, are taking a cautious approach to the litigation, choosing to wait for further developments before filing any lawsuits. That’s certainly understandable. As a “high-risk” medical device, Essure was approved using the FDA’s “premarket approval” mechanism – a step that confers significant legal immunity to medical device manufacturers. In a 2008 ruling, the US Supreme Court held that negligence isn’t enough where “premarket approved” devices are concerned.
Victims have to prove that the medical device manufacturer violated federal law – hiding clinical trial information from the FDA, for example – to secure compensation. Proving violations of state law – like failing to warn the public about a device’s risks – just aren’t sufficient. In effect, the law currently protects Bayer from personal injury lawsuits, because Essure was put through a (supposedly) rigorous approval process. This legal doctrine, known as “preemption,” has made many attorneys hesitant about jumping into the Essure litigation.
Rather than file lawsuits right away, some lawyers have chosen to wait and see whether currently-filed lawsuits are considered “preempted.” The attorneys at BirthControlProblems.com haven’t. We believe these cases have merit, and we want to put women on a path to recovery as soon as possible.
Recent Court Victories
Recent developments, however, have highlighted some large cracks in Bayer’s preemption arguments.
First, a federal judge in Pennsylvania allowed five Essure lawsuits to proceed in March of 2016. While Judge John R. Padova of the US District Court of Pennsylvania invalidated several of the Plaintiffs’ allegations, he said the cases could move forward on two counts:
- allegations that Bayer withheld reports of adverse side effects from the FDA, and thus the public
- allegations that Bayer negligently misrepresented the Essure implants in promotional materials that were not approved by the FDA
That was a huge victory, not only for five individual Plaintiffs, but potentially for every woman who believes she was injured by Essure. A second victory came on August 2, 2016, when Judge Winifred Y. Smith of the Superior Court of California, made a similar ruling. Judge Smith allowed 11 Essure lawsuits to proceed on multiple counts. As we’ve seen, dozens of other lawsuits – representing hundreds of women – have been gathered together under Judge Smith’s guidance since her decision to strike down Bayer’s dismissal attempts.
With these two favorable rulings in the books, attorneys expect many new Essure lawsuits to be filed in the coming months. The fight is by no means over, but current and future Plaintiffs should take heart in these recent successes.
Has Essure Been Recalled?
Not in the United States. Brazil’s National Health Surveillance Agency (ANVISA), on the other hand, has ordered a full suspension on the import, distribution, marketing and use of Essure. The nation’s chief health watchdog issued a recall of all currently-distributed devices on February 17, 2016, ModernHealthcare reports. It remains unclear whether the recall will include the surgical removal of already-implanted Essure devices.
The move, which constitutes the world’s first recall of Essure, came after Brazil’s health agency reviewed “technical-scientific reports,” a press release says. “The contraceptive system is rated at maximum risk,” ANVISA continued, and “can cause changes in menstrual bleeding, unwanted pregnancy, chronic pain, perforation and migration of the device, allergy and sensitivity or immune-type reactions.”
FDA Strengthens Essure Warnings
US regulators have strengthened the warnings that accompany Essure, but not yet issued a formal recall for the device. After reviewing thousands of patient and doctor side effect reports, along with the results of recent medical studies, the US Food & Drug Administration decided to add a boxed warning – the federal agency’s most severe form of safety alert – to Essure’s labeling.
The “black box” warning cautions patients that “some patients […] have experienced and / or reported adverse events, including perforation of the uterus and / or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity.”
Alongside these warnings, the new label makes clear that resolving these side effects requires a surgical procedure. In addition to this new black box warning, the FDA has told Bayer to include a patient decision checklist in each Essure package. The checklist covers a host of relevant Essure safety and effectiveness issues, topics of discussion that both physicians and patients are meant to sign-off on (literally) prior to the device’s implantation.