The Essure birth control lawsuit settlements have resulted in Bayer, the device’s manufacturer, paying out approximately $1.6 billion to resolve claims from tens of thousands of women who alleged the permanent contraceptive device caused serious injuries. These settlements, reached primarily between 2020 and 2022, compensated women who experienced device migration, chronic pain, perforation of the uterus or fallopian tubes, autoimmune reactions, and other complications. However, Bayer settled these cases without admitting liability or wrongdoing, and individual settlement amounts varied significantly based on the severity of injuries and specific circumstances of each case.
For example, a woman who required a hysterectomy to remove a migrated Essure device and subsequently developed chronic health conditions likely received a substantially higher settlement than someone who experienced less severe complications. The settlements came after years of litigation and growing pressure from regulatory agencies and patient advocacy groups, ultimately leading Bayer to discontinue Essure sales in the United States in 2018. This article covers the history of Essure litigation, who qualified for settlements, how compensation amounts were determined, current options for those who may still have claims, and what the future holds for affected women.
Table of Contents
- What Led to the Essure Birth Control Lawsuit Settlements?
- How Essure Settlement Amounts Were Determined
- The Role of Federal Preemption in Essure Litigation
- Who Qualified for Essure Lawsuit Settlements?
- Current Options for Essure Victims
- Bayer’s Response and Market Withdrawal
- The Future of Medical Device Accountability
- Conclusion
What Led to the Essure Birth Control Lawsuit Settlements?
Essure was FDA-approved in 2002 as the first non-surgical permanent birth control option for women. The device consisted of small metal coils inserted into the fallopian tubes, where scar tissue would form around them to block sperm. Marketed as a safer, less invasive alternative to tubal ligation, Essure was implanted in approximately 750,000 women in the United States before being pulled from the market. Problems began emerging relatively quickly after widespread adoption.
Women reported a range of serious adverse events, including chronic pelvic pain, heavy or irregular bleeding, device migration into the uterus or abdominal cavity, punctured organs, nickel allergies and autoimmune responses, unintended pregnancies, and ectopic pregnancies. By 2017, the FDA had received over 26,000 adverse event reports related to Essure, prompting the agency to mandate a boxed warning””its strongest safety warning””and require Bayer to conduct additional safety studies. Lawsuits began accumulating across the country, with plaintiffs alleging that Bayer knew or should have known about the device’s dangers and failed to adequately warn patients and physicians. Unlike many mass tort situations, Essure cases faced a significant legal hurdle: the FDA’s premarket approval process, which defendants argued provided protection from state-law claims under federal preemption doctrine. This legal complexity shaped the trajectory of the litigation and ultimate settlement negotiations.
How Essure Settlement Amounts Were Determined
Bayer announced its first major settlement in August 2020, agreeing to pay approximately $1.6 billion to resolve roughly 90% of the nearly 39,000 pending claims. Individual settlement amounts were not publicly disclosed, but legal experts estimated that payments ranged from several thousand dollars to six figures depending on specific factors. The severity and permanence of injuries played the most significant role in determining compensation. Women who required surgical removal of the device, particularly those who underwent hysterectomies, generally received higher settlements. Those who developed documented autoimmune conditions, experienced organ perforation, or had other objectively verifiable medical complications also received more substantial compensation.
Cases where women could demonstrate clear causation between Essure and their injuries through medical records and expert testimony commanded higher values. However, not all claimants received significant compensation. Women with less severe or less well-documented injuries often received lower settlement offers. Additionally, the preemption defense that Bayer maintained throughout litigation created uncertainty about trial outcomes, which influenced settlement values downward for some claimants. Some women rejected initial settlement offers, believing the amounts inadequate given their suffering, but faced the difficult reality that pursuing litigation to trial involved substantial risk given the unsettled legal questions surrounding federal preemption.
The Role of Federal Preemption in Essure Litigation
Federal preemption became the central legal battleground in Essure cases and significantly impacted settlement negotiations. Under the doctrine established by the Supreme Court’s 2008 decision in Riegel v. Medtronic, manufacturers of medical devices that received FDA premarket approval are generally protected from state-law product liability claims arguing the device was defectively designed or inadequately labeled. Bayer aggressively pursued preemption defenses in Essure litigation, arguing that because the FDA had approved the device and its labeling, plaintiffs could not bring state-law claims challenging those decisions.
Several early court rulings favored Bayer on preemption grounds, creating significant obstacles for plaintiffs. For instance, courts in Pennsylvania and other jurisdictions dismissed or narrowed cases based on preemption, leaving plaintiffs with limited legal theories to pursue. Some plaintiffs found success by arguing narrow exceptions””such as claims that Bayer failed to report adverse events to the FDA or manufactured devices that deviated from FDA-approved specifications. These “parallel claim” theories survived preemption challenges in some courts. However, the legal landscape remained uncertain and varied by jurisdiction, which ultimately pushed both sides toward settlement rather than risking definitive appellate rulings that could dramatically affect case values one way or the other.
Who Qualified for Essure Lawsuit Settlements?
Generally, women who had Essure devices implanted and subsequently experienced documented adverse health effects qualified to file claims. The settlement process required claimants to demonstrate they had the device implanted, experienced complications, and could provide medical records supporting their injuries. Specific qualifying criteria included complications such as device migration, organ perforation, chronic pain requiring medical treatment, allergic or autoimmune reactions, unintended pregnancy, ectopic pregnancy, and the need for surgical intervention including hysterectomy. Women who experienced these complications needed medical documentation establishing both the injury and its temporal relationship to Essure implantation.
Expert medical opinions connecting the device to the claimed injuries strengthened cases considerably. Importantly, simply having an Essure device implanted without complications did not qualify someone for settlement compensation. Women who were dissatisfied with their birth control choice but experienced no adverse health effects generally could not pursue claims. Additionally, statutes of limitations applied, meaning women who experienced injuries many years before the litigation began may have faced time-bar defenses depending on their jurisdiction and when they discovered the connection between their symptoms and the device.
Current Options for Essure Victims
As of recent reports, the major Bayer settlement resolved the vast majority of pending Essure claims, and the window for filing new claims has largely closed. However, the legal landscape for Essure victims continues to evolve, and some options may remain for certain individuals. Women who opted out of the main settlement or whose claims were filed after the settlement deadline may still have pending cases, though these are becoming increasingly rare. Those who developed new symptoms or complications after the settlement period may potentially have claims, though proving causation years after device removal or discontinuation presents significant evidentiary challenges.
Anyone who believes they may have an active Essure claim should consult with an attorney experienced in medical device litigation promptly, as statutes of limitations continue to run. The tradeoff between accepting settlement offers and pursuing individual litigation remains relevant for any remaining claimants. Settlement provides certain compensation without the risks and delays of trial, but amounts may be lower than potential jury awards. Litigation offers the possibility of larger recoveries but carries substantial risk of receiving nothing if preemption or other defenses succeed. Given the mature state of this litigation, finding attorneys willing to take new Essure cases may prove difficult.
Bayer’s Response and Market Withdrawal
Bayer discontinued Essure sales in the United States effective December 31, 2018, citing declining sales rather than safety concerns. The company had already stopped selling the device in all other markets by that point.
Throughout the litigation, Bayer maintained that Essure was safe and effective when used as directed and that the company acted responsibly in its development, testing, and marketing. The FDA’s increasingly stringent restrictions on Essure””including the 2016 boxed warning requirement and 2018 mandatory patient consent checklist””preceded the market withdrawal. While Bayer characterized the withdrawal as a business decision unrelated to safety, critics noted the timing coincided with escalating regulatory scrutiny and mounting litigation.
The Future of Medical Device Accountability
The Essure litigation has had lasting implications for medical device regulation and accountability. In response to Essure-related concerns and similar cases involving other devices, the FDA has faced pressure to reform its premarket approval process and postmarket surveillance systems.
Advocates continue to push for legislation that would limit the preemption doctrine’s application in medical device cases, arguing that current law inappropriately shields manufacturers from accountability. While no major legislative changes have occurred as of recent reports, the Essure experience remains a touchstone in debates about balancing innovation incentives with patient safety. For women considering permanent contraception today, the Essure saga serves as a reminder to carefully research any medical device, discuss alternatives with healthcare providers, and understand both the benefits and potential risks before proceeding.
Conclusion
The Essure birth control lawsuit settlements represent one of the largest medical device litigation resolutions in recent history, with Bayer paying approximately $1.6 billion to compensate women injured by the permanent contraceptive device. The settlements brought closure to tens of thousands of women who suffered complications ranging from chronic pain to device migration to the need for surgical removal, though compensation amounts varied significantly based on injury severity and individual case factors.
For anyone who may still have questions about Essure-related claims, consulting with a qualified medical device attorney remains the most important next step. While the main settlement has resolved most cases, individual circumstances vary, and legal advice tailored to specific situations is essential. The Essure experience also underscores the importance of careful consideration before undergoing any medical device implantation and maintaining thorough medical records should complications arise.