The Case Against Essure: Is the Tide Turning? [UPDATE]

It’s been nearly a year since we last blogged about Essure, a permanent birth control device that has reportedly caused serious injuries for thousands of women across the country. In the post, we detailed how a legal doctrine known as “federal preemption” has left women who say they were injured by the device without any legal recourse for their pain and suffering, medical bills and mental anguish.

Well, now it seems that the tide may be turning. Or at least, lawyers are stepping up to the challenge that this case presents.

The Current State of the Litigation

Right now, there is only one known lawsuit on file involving the Essure implant. In the suit, plaintiff Heather Walsh claims that federal preemption should not apply to her case because the FDA’s conditional premarket approval (CPMA) of the device – the very thing that’s stopped women from seeking compensation for their injuries – is invalid.

She says that Bayer failed to comply with the conditions of the CPMA order by neglecting to meet the FDA’s reporting requirements and manufacturing Essure at an unlicensed facility, among other things. According to her suit, Essure is “adulterated” and “misbranded” and should never have been sold pursuant to federal law.

So Many Injuries – Why Only One Lawsuit?

The reason is simple: getting around the federal preemption is an uphill battle and a challenge that many lawyers are unwilling to accept, at least at this stage. There are some lawyers waiting on the sidelines for a ruling in this case – specifically whether or not it could survive a motion to dismiss. If it does, the floodgates may open. If it doesn’t, well that could very well be another setback for women injured by the device. But where most lawyers appear to be playing it safe, others are starting to step forward.

The Future of Essure Lawsuits

No one can say how the suit in Pennsylvania will resolve or whether women injured by Essure will ever have their day in court. Courts are notorious for moving very slowly – but there are some attorneys out there who aren’t satisfied with this pace. They’re looking to be proactive, to develop a strategy that will hopefully bring recourse to the thousands of women injured by Essure and, most importantly, to start talking to women about their legal options and the challenges their cases present.

“There are a few firms mulling this over, but we’re ready to move now. We are ready to start working with our clients,” said Ed Wallace, a partner with Chicago law firm Wexler Wallace LLP.

In Wallace’s ideal world, he would be able to file a lawsuit in a state other than Pennsylvania – and, hopefully, a jurisdiction that’s friendlier to plaintiffs – in an effort to strengthen the current state of the litigation.

“You always want to file the best case first and that requires a lot of vetting on the front end,” Wallace said. “We have to get the right client, prepare the right complaint and look for the right jurisdiction to file in. This will put us in a better position for all the other women who have been injured by the device.”

Wallace warns that it won’t be easy and admits that it might take some time to get his first lawsuit on file – but it’s all part of a strategy that could hopefully open the courthouse doors for the thousands of women injured by Essure.

“We’re not going to run out and file lawsuits just to file. We need to do this strategically,” said Wallace, who has experience serving on the plaintiffs’ steering committee for the transvaginal mesh litigation – another device that has reportedly caused harm for thousands of women. “If we can survive a motion to dismiss with our first case, we can start filing other lawsuits and hopefully create some momentum for these women.”

Still, he cautions that these lawsuits are “risky” and that potential plaintiffs face significant legal challenges.

“Bayer is trying to use premarket approval as an escape hatch,” Wallace said. “These cases aren’t going to be easy to win, but we’re willing to try.”

The E-Free Act: A Fight to Get Essure Off the Market

As attorneys begin to map out their legal strategies for what will most likely be a lengthy legal battle, hundreds of women are seeking their own resolution – and that includes taking their fight to Congress. This week, Pennsylvania Congressman Mike Fitzpatrick, whose office reportedly received countless phone calls from women complaining about Essure, will introduce the E-Free Act. The purpose of the Act? To remove the FDA’s premarket approval for Essure and get the device off the market once and for all.

Like the litigation, the Act is not a sure thing – but the challenges presented by both the litigation and the introduction of the bill haven’t dampened the spirits of thousands of women who have taken to social media to make their voices heard.

“For the thousands of women injured by Essure, and for the world, I want them to know one thing,” said Janie Garcia, one of 14 administrators for Essure Problems, a grassroots movement against Essure. “Regardless of what happens in Congress and with this litigation, we’re not going to give up.”