Essure was a permanent birth control device that is inserted without surgery. It was marketed as an alternative to tubal ligation, a method of sterilization for women that requires invasive surgery.
Since it came on the market in 2002, more than three-quarters of a million devices have been implanted. It was also advertised as 100% effective.
According to CNN’s analysis of data from the federal government, between 2013 and 2017, $2.5 million dollars were given to over ten thousand doctors in the form of “consulting fees” by Bayer. One such doctor was given over one hundred thousand dollars. After tens of thousands of adverse health events were reported to the FDA, the product was pulled from the U.S. market in 2018.
In 2020, Bayer Pharmaceuticals settled against over thirty thousand women who claimed severe damages caused by the device. Adverse events included perforation of the uterus, ectopic pregnancies, and miscarriages. As of writing, 49 deaths have been linked to the implantation of the device.
- What Should I Do if I Have Been Affected by Essure?
- How Do I Know if I Qualify to Be a Part of an Essure Lawsuit?
- How Does an Essure Lawsuit Work?
- What Is Essure?
- Essure Lawsuits
- Contact a Lawyer Today
What Should I Do if I Have Been Affected by Essure?
If you believe you or a family member has been negatively affected or harmed by Essure, it is essential to act quickly. Removal of the device is now possible, and you should speak to your doctor immediately about doing so. If you have had the device removed and are concerned that emerging health problems may be related, please seek medical advice.
You may be entitled to compensation for your suffering, and you should speak to a lawyer as soon as possible. Use our form, and you will be able to talk to a nearby lawyer about your circumstances. These meetings are free and require no commitment on your behalf.
How Do I Know if I Qualify to Be a Part of an Essure Lawsuit?
If you have an Essure device implanted before 2019 and have experienced health problems, you may qualify to be a part of a lawsuit. Health problems can be wide-ranging and include menstrual issues, pregnancy issues, severe obesity, fatigue, gastrointestinal issues, and even death.
How Does an Essure Lawsuit Work?
If your lawyer has determined that your case is strong enough, they will then consult with other lawyers, perhaps those who litigated past class actions, then review what cases already exist. The result may be a decision to go to court with other, similar cases. Depending on your jurisdiction and current litigation, you may even end up part of a country-wide suit.
Your lawyer will represent you, which means, in many cases, you will not have to attend court. You will still be needed for official legal action sometimes and in rare cases, will possibly need to take the stand as a witness. At the very least, you will be part of a detailed collaboration between you and your lawyer and need to prepare for many hours of work.
Do I Need a Lawyer to Join an Essure Lawsuit?
Essure cases can be complicated matters, mostly because of federal laws that protect companies from certain types of claims. While settlements have been made already in Essure cases, this does not guarantee that your lawsuit will have the same result. In almost every case, you should seek legal representation for a class action.
Civil law attorneys regularly work on contingency; the lawyer will take no upfront fees to represent you and only receives payment if you receive compensation yourself. Speaking with a lawyer about your case will not cost you money and will save much stress and suffering in the long term.
Fill out our form, and we can connect you to a lawyer in your area. They will be happy to discuss your case with no obligation to continue working with them.
How Long Does It Take to Settle an Essure Lawsuit?
While Bayer recently settled most of the Essure cases that were currently outstanding, some of these cases first started as far back as 2015. However, because of these settlements that come with existing precedents, future cases could take far less time. It is reasonable to expect that a case brought before Bayer today would settle in less than twelve months, although there are no guarantees.
What Is the Statute of Limitations on an Essure Lawsuit?
The statute of limitations is the time in which you have the opportunity to sue for damages. This period of time can be different in each state, so where you lived at the time and where you were implanted with Essure may both play a role.
Determining the statute of limitations with Essure cases is complicated by a range of factors; how long we have known the dangers of Essure, the amount of time since it was pulled from the market, and when you first developed symptoms can all affect the statute. To work out if your case is still within the statute of limitations, fill out our form and we can connect you to a lawyer in your area. Never assume that your case falls outside the statute of limitations without previous discussion with a lawyer.
How Much Can You Get From an Essure Lawsuit?
It is difficult to accurately determine in advance a final settlement, as all cases differ. If a claim is settled, the minimum expected amount covers a person’s medical and legal expenses. However, amounts often include extra money to cover the ongoing pain and suffering of the client. Clients who have lost loved ones or suffered permanent injury can receive settlements worth tens of millions of dollars. The total existing pool for Essure settlements is $1.6 billion.
How Long Does It Take to Get Your Money After You Settle a Lawsuit?
After a lawsuit has settled, or a judge has ordered damages to be paid, it may still take some weeks before you receive payment. This is especially true if you are a part of a class action. This is because there is a process the money goes through, first paying all outstanding medical bills, later paying lawyers, and later cash settlements.
After this point, however, things move quickly. As soon as your lawyer receives the rest of the settlement, they will take their pre-arranged fee; this will be the first time they will be paid after possibly years of work. As soon as they take this fee, they send you the money via check or electronic transfer.
The U.S. court system has strong protections to ensure that nothing stops you from getting the money you deserve from a settlement. Delays are unlikely after a settlement is reached.
What Is Essure?
Essure is a birth control device that was available in the USA between 1999 and 2018. It is a small metal coil. This coil is placed into the fallopian tubes using a catheter and requires no surgery or general anesthetic. The coil should then cause fibrosis and blockage, permanently locking off the tube much like a tubal ligation would. Essure does not use hormones in any way, which can be a benefit to many women.
Many women have had Essure devices with no side effects. It is not necessarily the case that you should remove your device when there are no medical issues. Removal requires surgery, and that comes with its own risks.
Women who use Essure are three times more likely to get pregnant than those with tubal ligations. Most-market studies have now shown that Essure causes more abdominal bleeding and pelvic pain than tubal ligation. In up to 4% of cases, the coil perforates the fallopian tube, causing great danger. According to the FDA, twenty-two women have died due to Essure and nearly two thousand miscarriages have been recorded. Minor yet highly inconvenient side effects include abdominal pain.
Since 2002, thousands of plaintiffs have come forward against Bayer Pharmaceuticals. They allege that Bayer intentionally misled customers and their doctors about the risks involved. They also allege that the company hid information regarding unsafe manufacturing practices. For a variety of reasons, no country-wide multidistrict or class action suit has gone to trial, although a settlement has been reached to pay out victims.
De La Paz v. Bayer AG et al (2016)
Tanya De La Paz experienced significant pain in the months after “successful” implantation in 2015. The coil had broken inside her fallopian tubes. It required multiple surgeries to be removed. In her complaint, De La Paz alleged that Bayer had received notice from the FDA that some of their devices were being manufactured in unlicensed facilities.
Bailey et al. v. Bayer AG et al. (2016)
Stephanie Bailey was implanted with Essure in 2010 before experiencing pelvic pain, numbness in her legs, and migraines. She had an emergency hysterectomy due to Essure and died during the procedure. Her husband led a lawsuit against Bayer, seeking damage for “loss of love, companionship, and comfort, as well as outstanding medical and funeral expenses.”
The Problem of Preemption
Several lawsuits against Bayer have been dismissed due to the concept of “preemption.” As the FDA is a federal regulatory body, its decisions overrule decisions of lower courts. It must be evidenced that the FDA did not have the appropriate information during the approval process. Otherwise, Bayer is not held liable as they had made legally necessary efforts.
De La Paz unsuccessfully argued that many of the issues with Essure came from manufacturing negligence after approval, rather than design negligence. However, that was difficult to prove.
Judges have differing opinions on preemption, and many times have refused to dismiss on this basis. Likewise, Bayer has had little success trying to move the liability onto the gynecologists performing the procedure.
Unfortunately, due to a concept called “sovereign immunity,” you cannot sue the FDA for approving defective drugs and devices. Approval was initially granted on the provision of future studies, which never eventuated. No studies at the time compared it to tubal ligation.
In August 2020, Bayer announced that it would spend $1.6 Billion to resolve many of the outstanding cases. By doing so, they do not acknowledge liability or wrongdoing. However, this will go a long way to compensating for the loss the plaintiffs have experienced. Not all cases will be settled. Plaintiffs may still bring cases against Bayer; they can also be eligible for a payment from the existing fund.
Contact a Lawyer Today
If you had an Essure implant at any time and suffered pain or injury because of it, you may be eligible for compensation. If you have had any ill health since the time you had the implant and may not be aware of how Essure played a role, it’s worth talking with a legal professional. Fill out the form and we can connect you to a lawyer in your area who will talk you through the situation and recommend healthcare professionals who are experts in this area.
Center for Devices and Radiological Health. “Problems Reported with Essure.” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/essure-permanent-birth-control/problems-reported-essure
Tobah, Yvonne Butler. “Essure Discontinued: What Does That Mean for You?” Mayo Clinic, Mayo Foundation for Medical Education and Research, 16 Oct. 2020, www.mayoclinic.org/healthy-lifestyle/birth-control/expert-answers/essure-discontinued/faq-20436674
The Washington Post, 2020. Bayer did not report thousands of Essure complaints to FDA, lawsuit filing alleges. [online] Available at: https://www.washingtonpost.com/business/economy/bayer-did-not-report-thousands-of-essure-complaints-to-fda-lawsuit-filing-alleges/2020/07/10/137455d6-c2a2-11ea-9fdd-b7ac6b051dc8_story.html [Accessed 1 February 2021]
Reuters, 2020. Bayer to pay $1.6 billion to resolve U.S. claims for Essure birth-control device. [online] Available at: https://www.reuters.com/article/us-bayer-essure/bayer-to-pay-1-6-billion-to-resolve-u-s-claims-for-essure-birth-control-device-idUSKBN25G24Y
Luhana, Roopal. Latest Bayer Report Shows Thousands More Essure Adverse Events. New York Injury Law News, Legal Examiner, 9 Jan. 2021, https://newyork.legalexaminer.com/health/latest-bayer-report-shows-thousands-more-essure-adverse-events/