Essure Lawsuit

The Essure controversy has sparked widespread media attention. The problematic implant has affected women around the world, leading to severe health complications and legal actions.

Key Takeaways

  • Essure, a permanent birth control device, caused severe health complications in many women leading to lawsuits against Bayer, the manufacturer.
  • The FDA received reports of complications and mandated stricter warnings on Essure labeling, culminating in a black box warning in 2016 and restrictions on sales in 2018.
  • Lawsuits alleged Bayer failed to warn about risks. Bayer settled most claims in 2020 for $1.6 billion without admitting wrongdoing.
  • Lawsuits alleged Bayer downplayed risks and some studies showed higher rates of chronic pain and bleeding in Essure patients compared to other sterilization methods.
  • Bayer's defense relied on federal preemption, arguing FDA approval shielded them from liability. This defense was not always successful.
  • If you have health problems potentially linked to Essure, consult a lawyer specializing in medical device litigation to understand your options and deadlines for filing a lawsuit.
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Lawsuit Updates

Aug 2020

Bayer Announces $1.6 Billion Settlement

On August 20, 2020, Bayer announced a monumental $1.6 billion settlement to address approximately 90% of the nearly 39,000 claims filed in the United States concerning injuries allegedly caused by Essure. This settlement, which did not include an admission of wrongdoing or liability by Bayer, aimed to resolve a significant majority of the litigation, allowing the company to refocus on its commitments to women’s health amidst ongoing controversy over the device’s safety.

Oct 2016

Centralization of California Lawsuits

In a significant legal development during October 2016, a California judge ordered that numerous Essure lawsuits be centralized in the Alameda County Superior Court as part of a Judicial Council Coordinated Proceeding. This centralization was intended to streamline the processing of these cases, reflecting the growing complexity and volume of litigation surrounding Essure’s alleged safety issues and the harm reported by many users.

Feb 2016

FDA Imposes Black Box Warning

On February 29, 2016, the FDA mandated a Black Box Warning for Essure, its most stringent warning. This decision followed an extensive review of numerous adverse event reports that highlighted complications like persistent pain and device migration. The Black Box Warning was designed to ensure that all potential users were fully aware of the serious risks associated with Essure, emphasizing the critical need for careful patient selection and thorough pre-use counseling.

Sep 2015

FDA Demands Updated Labeling

Responding to the growing body of adverse reports from users and healthcare providers, the FDA required Essure’s labeling to be updated to include more detailed information about potential risks. This directive aimed to enhance the clarity of the device’s safety profile, covering complications such as chronic pain, bleeding, allergic reactions, and the potential need for surgical intervention. The updated labeling was intended to better inform patients and healthcare providers, facilitating more informed decision-making regarding its use.

Mar 2014

Commencement of Legal Actions

In 2014, the first lawsuits were filed against Bayer, the manufacturer of Essure, marking the start of serious legal challenges to the device. Plaintiffs in these cases brought forth claims citing severe health issues such as chronic pelvic pain and device migration, which were purportedly caused by the Essure implants. These legal actions challenged Bayer’s assertions of safety and highlighted significant personal and systemic issues associated with the device.

Jun 2009

Initial FDA Reports and Scrutiny

By 2009, the US Food and Drug Administration started to receive a significant influx of adverse reports concerning Essure. These early reports, detailing serious complaints such as persistent pain, bleeding, and unintended pregnancies, were pivotal in initiating the FDA's closer scrutiny of the device. This marked the beginning of increased regulatory oversight over Essure, laying the groundwork for subsequent actions and investigations into its safety and efficacy.

The Origin and Controversy of Essure

Essure is a permanent birth control device developed by Bayer, consisting of small coils inserted into the fallopian tubes. The device sparked controversy due to severe side effects, leading to numerous lawsuits. Plaintiffs claimed Essure caused complications like chronic pain and organ perforation, resulting in significant legal and regulatory challenges for Bayer.

History of Essure and Its Side Effects

Once touted as revolutionary, Essure is a non-surgical, permanent birth control device developed by Conceptus Inc. and later acquired by Bayer. Introduced in the early 2000s, it offered women a less invasive alternative to tubal ligation through the insertion of small coils into the fallopian tubes to prevent pregnancy.

However, the reality of Essure's impact on women's health soon diverged sharply from its promise. Over time, a significant number of users began reporting severe and debilitating side effects including chronic pelvic pain, device migration, and even perforation of internal organs.

One of the most harrowing accounts, the one of Keisha Carney, illustrates the profound personal impacts, including unexpected pregnancies and severe health complications that required major surgeries such as hysterectomies​.

As the volume of complaints grew, legal actions inevitably followed. Starting around 2014, thousands of women affected by Essure began to sue Bayer, alleging that the company had failed to adequately warn them about the risks associated with the device.

Bayer defended its product by standing behind the safety and efficacy supported by their research but faced increasing pressure as lawsuits mounted and stories of suffering gained public attention​.

The legal strategy of the plaintiffs evolved over time, culminating in the centralization of numerous lawsuits in California and the Eastern District of Pennsylvania, aimed at streamlining the complex litigation process. This coordinated approach helped build a more formidable case against Bayer, leading to significant legal proceedings.

The growing evidence and public outcry contributed to a shift in the narrative around Essure​. The culmination of these legal battles and mounting public pressure led Bayer to announce a substantial $1.6 billion settlement in 2020 to resolve about 90% of the claims filed against it in the United States, though without admitting liability or wrongdoing.

This settlement marked a significant moment in the controversy, representing an acknowledgment of the pain and suffering endured by thousands of women​.

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FDA Warnings on Essure

The FDA has diligently addressed the numerous issues related to Essure products, and has continually updated the public through various communications including evaluations, safety assessments, guidances, and the dissemination of detailed spreadsheets.

The agency has also required updates on websites to clearly communicate Essure's risks to potential users. Among these efforts, two official warnings stand out:

  • Black Box Warning (2016): This most severe FDA warning highlights significant risks such as chronic pain and device migration. It was issued in response to thousands of adverse event reports and aimed to ensure that all potential users are fully aware of these risks before deciding to use Essure.
  • Restrictions on Sale and Distribution (2018): To further mitigate risks, the FDA restricted the sale of Essure to healthcare providers who could ensure patients understood these risks comprehensively. This was enforced through mandatory discussions using a checklist during patient consultations, enhancing informed decision-making.

Although Essure is no longer sold in the US, and all unused Essure implants have been returned to Bayer, as of December 31, 2019, the FDA continues to monitor its safety and effectiveness, ensuring that the health of those who have used the device is not compromised.

The Basis of Legal Action

The Essure controversy has been a focal point in legal circles and a significant challenge for legal professionals worldwide. In the following section, we will explore the basis of the allegations raised by the plaintiffs against Bayer, as well as discuss aspects related to the defense.

Complaints and Allegations in Essure Lawsuits

The complaints in the Essure lawsuits revolve primarily around the allegations that Bayer and Conceptus have failed to disclose critical risks associated with the Essure device.

Namely, thousands of plaintiffs have reported severe complications including chronic pain, bleeding, organ damage, and migration of the device. These severe side effects have not only caused physical harm but also led to numerous additional surgeries, including some cases that necessitated hysterectomy.

Studies have corroborated the severe complications associated with the Essure device, particularly chronic pain and abnormal bleeding.

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Higher Rates of Chronic Lower Abdominal Pain and Abnormal Uterine Bleeding

Research has shown that Essure patients report significantly higher rates of chronic lower abdominal or pelvic pain and abnormal uterine bleeding compared to those who underwent tubal ligation. Specifically, about 9.1% of Essure patients experienced chronic pain, and 16.3% reported abnormal bleeding, highlighting a considerable impact on quality of life compared to other sterilization methods. [1]

Need for Additional Gynecologic Surgeries

Furthermore, there have been findings on surgical interventions following Essure implantation, where nearly 20% of women required additional gynecologic surgeries, such as device removal or treatments for heavy bleeding, significantly higher than in non-Essure patients. These studies underline the serious and often debilitating side effects linked to the Essure device, reinforcing the concerns raised by many patients over the years. [1]

The lawsuits further allege that Bayer and Conceptus engaged in systematic underreporting of these adverse events to the FDA, thus keeping the medical community and the public unaware of the true risks associated with Essure.

This alleged failure to report has been cited as contributing to the widespread use of Essure despite its potential dangers, exacerbating the health risks to thousands of women.

The Defendants in Essure Lawsuits

The defendants in the Essure lawsuits include both Bayer AG and Conceptus Inc., the original developer of Essure. Bayer acquired Conceptus in 2013, inheriting the product and the ongoing legal responsibilities associated with it.

When the allegations emerged, the defendants relied on the defense strategy of "federal preemption," which posits that FDA approval of the device precludes conflicting state claims. By using this strategy, the defendants were able to contest the legitimacy of the lawsuits and make it challenging for plaintiffs to assert their claims and for cases against them to proceed.

However, despite this defense, some claims have been allowed to proceed, particularly those that the courts found did not seek to impose standards that would conflict with federal regulations.

This is how allegations involving deceptive marketing practices and failure to warn of potential risks were allowed to advance in court. These exceptions have provided a pathway for some plaintiffs to seek redress despite the broad protections typically afforded by federal preemption.

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Essure Legal Proceedings and Settlements

The Essure legal proceedings have been extensive, involving numerous lawsuits against Bayer and Conceptus for severe health issues linked to the Essure device. These proceedings culminated in a substantial settlement in 2020, reflecting the complex and contentious nature of the litigation.

Bayer's Defense Tactic

Bayer's primary defense in the Essure lawsuits hinged on the legal doctrine of "federal preemption," which asserts that FDA approval of a medical device shields the manufacturer from liability under state laws.

This defense was based on the premise that federal law, which governs FDA approvals, supersedes conflicting state regulations. Bayer argued that because Essure had received FDA approval, the company was protected from claims regarding the device's safety and efficacy.

However, this defense was not universally accepted in courts; some judges allowed claims to proceed, especially those that did not seek to impose standards conflicting with federal regulations​.

Essure Lawsuit Settlements

In 2020, Bayer reached a significant milestone by agreeing to a $1.6 billion settlement to resolve approximately 90% of the pending US Essure claims. This settlement aimed to cover all jurisdictions with substantial case volumes, without Bayer admitting any wrongdoing or liability.

The settlement reflected Bayer's strategy to mitigate the ongoing legal uncertainties and public relations challenges associated with the Essure litigation.

The amount each plaintiff received varied depending on the extent of their injuries, demonstrating Bayer's approach to resolving these cases while continuing to assert the safety and efficacy of Essure as per their official stance.

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Legal Guidance for Potentially Affected Parties

If an Essure device has negatively affected your health, you may have several different legal avenues to pursue. The following section will provide you with guidance on taking legal action and the timelines for filing a lawsuit, and ensure you can seek appropriate legal recourse for your troubles with this problematic implant.

Taking Legal Action Against Essure

When taking legal action against Essure, it is crucial that you understand the process thoroughly and seek the appropriate legal recourse. Not everyone may be eligible to file a lawsuit, and eligibility typically depends on having documented health issues directly linked to Essure and experiencing complications that have led to significant harm or additional medical treatments.

Here is a step-by-step overview of the entire process:

Gather Documentation

Collect all medical records related to your Essure implantation, including initial procedure details, follow-up visits, and any treatments for complications.

Compile documentation of health issues experienced post-implantation, such as chronic pain, device migration, organ perforation, and any surgeries related to Essure removal or complications.

Consult an Experienced Attorney

Seek a lawyer who specializes in medical device litigation. Experienced attorneys can provide a comprehensive assessment of the case's viability and offer guidance on the best course of action.

Many law firms offer free initial consultations to evaluate potential claims. During this consultation, lawyers will review the gathered documentation and provide an initial assessment of the case.

Filing the Lawsuit

Lawsuits against Bayer typically allege severe complications caused by Essure, such as chronic pain, device migration, and organ perforation. Plaintiffs claim that Bayer failed to adequately warn users about these risks and misrepresented the device's safety.

Your lawyer will help in preparing and filing the necessary legal documents, ensuring all procedural requirements are met.

Unfortunately, there is currently no Multidistrict Litigation (MDL) for Essure. While there were attempts to create an MDL for Essure lawsuits, these motions were withdrawn, and the cases have not been consolidated under an MDL.

Instead, many cases have been coordinated through state-level processes like the Judicial Council Coordinated Proceedings (JCCP) in California​ and the Eastern District of Pennsylvania where cases have been consolidated for more efficient processing.

Take legal action before the deadline

The Time Limit to File an Essure Lawsuit

The time limit for filing an Essure lawsuit is governed by the statute of limitations, which varies by state. Generally, plaintiffs must file within two to four years from the date they discovered or should have discovered the injury caused by Essure. For this reason, it is crucial to act promptly as missing the deadline can result in losing the right to pursue compensation.

Some states may have specific rules that extend the filing period if the injury was discovered later through the discovery rule, which allows the statute of limitations to begin when the injury was or should have been discovered.

Consulting with a legal expert early can ensure that all deadlines are met and that the case is filed within the allowable time frame. Legal firms can provide guidance on the specific statutes applicable to each case and help ensure that claims are filed correctly and timely.

Moreover, specialized legal professionals can help you gather necessary documentation, navigate complex legal procedures, assess the strength of your case, and represent you in court or settlement negotiations, maximizing your chances of receiving fair compensation.

They can also provide emotional support and advocacy, ensuring that your rights are protected throughout the legal process.

Frequently Asked Questions

Yes, Bayer agreed to a $1.6 billion settlement in August 2020 to resolve approximately 90% of the nearly 39,000 Essure claims in the United States. This settlement provided financial relief to many affected women, although Bayer did not admit any wrongdoing as part of the agreement​.

As of May 2024, Essure has not been recalled. However, Bayer voluntarily discontinued sales of the device in the US in December 2018, citing declining demand. This decision came after years of adverse event reports and increased regulatory scrutiny.

Yes, Essure can cause problems years after implantation. Complications such as chronic pain, device migration, and organ perforation have been reported long after the initial procedure. These long-term issues have led to numerous additional surgeries and severe health problems for many women around the world.

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