Mirena is a hormone intrauterine device (IUD) that was approved within the United States in 2000 for contraception. It is shaped like a T, implanted inside the uterus which releases the hormone Levonorgestrel (a progestin) as time passes. Although it is extensively used and is generally effective in birth control, since its launch some users have complained of serious adverse results and have filed lawsuits claiming design deficiencies as well as failure to inform and misrepresentation of risk.

Basis of the Litigation

The case between Bayer (the manufacturer) and Bayer (the producer) typically arises under U.S. product liability (and associated) laws:

1. Design defect/manufacturing problem Plaintiffs assert that the product was not properly created to create unacceptable risk (for instance, for example migration, perforation, or rupture in the uterus) even when properly utilized.
2. Inability to warn or insufficient instructions – Claim that Bayer was unable to provide adequate information to patients and physicians about the serious dangers (e.g. the uterine perforation, device migratory, pseudotumor cerebri and breast cancer) that are associated with Mirena.
3. False representations / claims in marketing claims that Bayer did not accurately describe the risks from the technology (or overstated its safety) while engaging in deceitful marketing.
4. Medical negligence Some cases also include claims against doctors or clinics due to improper placement or the monitoring by the equipment.

In essence the simplest terms, these lawsuits are based on the claim that women who took Mirena suffered serious injuries (or the threat of injury) due to issues they claim were caused by the device, and that they should have been notified or avoided.

Key Injuries & Allegations

The lawsuits have centered on several broad types of harm:

• Uterine perforation/migration: The device allegedly perforates the uterine wall or migrates outside the uterus into the abdomen or other organs, requiring surgical removal and causing complications.
• Pseudotumor Cerebri/idiopathic intracranial hypertension (IIH): A condition that causes elevated intracranial pressure (mimicking the appearance of a brain tumor) that causes headaches, vision issues and possibly blindness. There have been lawsuits that claimed mirena’s hormonal (levonorgestrel) caused this.
• Risk of breast cancer Recent lawsuits have included allegations of Mirena (or its hormone that it produces) is associated with an increased risk of breast cancer, as well as claims that Bayer failed to warn users. Bayer to alert users.
• Others complications including ectopic pregnancy implanting devices and pelvic inflammatory diseases, infertility, as well as emotional/hormonal effects (sometimes called informally”the “Mirena crash”).

Litigation Developments & Outcomes

Multidistrict Litigation (MDL) and State Consolidations

• A number of Mirena cases were combined to form Multidistrict Litigation (“MDL”) to improve effectiveness before federal courts. For example, one MDL in the Southern District of New York (MDL 2434) addressed migration/perforation claims.
• In New Jersey a multicounty litigation (MCL) consolidated cases alleging device migration/perforation in state court.

Settlements and Dismissals

• In 2017/2018, Bayer offered a settlement (publicly reported at about US$12.2 million) to resolve many of the uterine perforation/migration claims.
• In the federal MDL dealing with the IIH/pseudotumor Cerebri claims, plaintiffs’ experts’ evidence was rejected in the judgment of the judge (on causality grounds) and numerous lawsuits were dismissed. In one instance in 2017, the Second Circuit affirmed dismissals in 2017.
• As of 2025, the major federal MDLs are closed, and many attorneys are no longer accepting new migration/perforation cases.
• A different line of lawsuit (breast risks for cancer) is ongoing In 2023, a U.S. federal judge cleared a class action claim to proceed, even though the parties agreed to dismiss in 2024.

Legal Challenges & Considerations

From an U.S. law perspective, these Mirena lawsuits are a good example of a variety of concerns:

• Causation Finding out it was Mirena has caused injury (general causality) and that a specific injury resulted from its usage (specific causality) is a major hurdle. Many claims were denied due to the fact that plaintiffs could not demonstrate that the device, in addition to other factors that caused the injury.
• Statute of limitations/ time-bar Many cases were dismissed because plaintiffs had filed claims in the wrong time (beyond the time limit for filing). For instance, in the 2014 decision, many claims filed in MDL 2434 were dismissed because they were time-barred.
• Warning obligation and intermediary role of a physician Courts have grappled with the question of whether the obligation of a manufacturer to inform is directed at the end-users (patients) and/or physicians who prescribe medications. One source cites an appeals court ruling that Bayer’s duty to warn was primarily to physicians and but not specifically to the consumer.
• Magnitude of the compensation Although certain settlements have been made but the sums (in most instances) have been small and a lot of cases were dismissed instead of settled in favor of plaintiffs.
• A product that is still available: Despite a lawsuit the device is been unable to been banned in the U.S. and is an FDA-approved product which can impact the perception of risk and legal strategies.

Current Status & What Injured Individuals Should Know

• If you think you’ve been victimized by Mirena If you believe that you were harmed by Mirena, consult an expert product liability lawyer immediately. Due to the time limit (statute of limitation) and the ever-changing the law regarding the causation issue, early assessment is crucial.
• Even though major MDLs for migration/perforation are closed, new claims (especially around breast cancer risk) may still be viable depending on jurisdiction and facts.
• Compensation (if given) can cover expenses like medical costs and lost wages, as well as the pain and suffering as well as punitive damages in the event of unjustifiable conduct by a manufacturer.
• Maintain all your medical and implant information as well as communications with your physician and any other device-related diagnostic or surgical information as they will be essential in assessing any claim.
• Realize that product-liability litigation against large pharmaceutical/manufacturing companies is typically complex, takes time, and requires significant proof of causation and risk.

Take-away

“The “Mirena lawsuit” phenomenon is an outstanding instance of medical device litigation throughout the United States: a widely-used contraceptive device that provides benefits to many, yet is also believed (by certain users) to be a risk that is not fully disclosed of serious injuries. While many lawsuits have been resolved or dismissed and litigation has proved extremely difficult for plaintiffs, legal landscape is constantly changing — particularly with the advent of new claims that involve breast cancer risk.

You or someone you know has used Mirena and suffered complications legal, it’s advisable to seek out an attorney who is experienced in the field of defective medical devices litigation to determine whether a legitimate claim can be made.