The Mirena IUD was approved by the FDA in 2000 as a form of birth control. Since then, thousands of lawsuits against Bayer HealthCare Pharmaceuticals, the device’s manufacturer, have called the IUD’s effectiveness into question. Although promoted as a safe and reversible way to prevent pregnancy, many women have suffered severe and debilitating complications from using Mirena IUDs, including severe pain, bleeding, and perforation of the uterus. Bayer is accused of concealing the risk of these complications.
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FDA Warnings About the Marketing of Mirena IUDs
In April 2009, the FDA warned Bayer and the public about the company’s misleading representation of the Mirena IUD’s efficacy. Bayer’s initial marketing failed to indicate that Mirena should only be used for up to five years before replacement, implying the IUD can be used indefinitely. Bayer also failed to state that Mirena was primarily recommended for women who had had at least one child.
Since it was introduced in 2000, the FDA has received approximately 70,000 injury reports concerning Mirena. As a result, thousands of women have filed Mirena IUD lawsuits against Bayer. Although there is some variation between cases, all involve similar allegations that Bayer failed to provide adequate warnings about Mirena side effects and complications that can occur months or even years after implantation. Specific allegations claim that Bayer:
- Designed, produced, and knowingly sold a defective product
- Failed to research and warn the public about dangerous side effects
- Concealed the dangerous side effects
- Engaged in false and misleading marketing
- Misrepresented the benefits of the device
- Breached implied and express warranty
- Failed to issue a recall once information came to light about the complications
Individual Mirena IUD Lawsuits
While the seriousness of complications varies from patient to patient, the first Mirena IUD lawsuits generally concerned device migration. Below is a summary of complications experienced by some of the earliest claimants, and their allegations against Bayer:
Desaree Nicole Lee Johnson
Desaree’s Mirena IUD perforated her uterus and moved to her abdomen. After undergoing surgery to remove it, she became pregnant, experienced vaginal bleeding, and had a miscarriage. Sadly, she may be infertile. Her complaint alleges that Bayer knowingly released an unsafe and defective product, leading to her injuries.
After experiencing severe pain and abdominal cramping less than a year after having the Mirena IUD implanted, Melody Williams required surgical removal of the device. When the first removal failed, surgeons attempted a second procedure and found that the IUD had migrated through the opening of her fallopian tube. Due to the pain, distress, and numerous medical procedures she went through as a result of the IUD, Williams and her husband filed a suit accusing Bayer of negligence and reckless disregard for public safety.
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Mirena Multidistrict and Multicounty Litigation
As the individual Mirena lawsuits started to grow, they have been consolidated into multidistrict litigation (MDL) in the federal courts and multicounty litigation (MCL) in state courts. There are currently three primary sets of mass torts covering Mirena IUDs: MDL 2434, NJ MCL 297, and MDL 2767.
MDL 2434: Mirena Migration, Perforation and Embedment
In June 2013, the Judicial Panel on Multidistrict Litigation (JPML) consolidated many Mirena IUD lawsuits into an MDL in the Southern District of New York. These cases claim complications due to device migration, organ perforation, and embedment. Growing to include 1,800 cases, the MDL argues that Mirena’s initial label (which was used from 2008 through 2014) did not contain warnings about secondary perforation. This label did state that perforation may occur during insertion and escape detection until sometime later, but claimants allege that the device could cause perforation at any time even without insertion injuries.
With over 1,200 cases pending in the MDL in 2016, the judge granted Bayer’s motion for summary judgment due to a lack of expert testimony proving secondary perforation, and the cases were dismissed. In an unusual move, the JPML later reopened MDL 2434 at the behest of Bayer who expected new cases to be filed. As of today, the decision is on appeal to the Second U.S. Circuit Court of Appeals.
MDL 2767: Mirena Pseudotumor Cerebri
While most of the Mirena IUD lawsuits revolve around device migration and perforation, many women have experienced complications due to a severe buildup of pressure in the brain. This is known as pseudotumor cerebri (PTC), also called idiopathic intracranial hypertension, and has symptoms similar to a brain tumor. Research studies have linked the levonorgestrel contained in the Mirena IUD with this dangerous condition, which can cause vision problems, severe headaches, and tinnitus (ringing in the ears). In light of this, a new group of claimants filed a motion in February of 2017 to centralize more than 100 cases claiming Mirena caused PTC. In April of 2017, the JPML consolidated all Mirena PTC lawsuits into MDL 2767 in the Southern District of New York, including 113 pending Mirena cases in 17 districts and 37 potential actions.
New Jersey MCL 297
After a growing number of plaintiffs in New Jersey made similar allegations to those in the New York MDL, the Supreme Court consolidated their cases in multicounty litigation (MCL) in 2013. According to court records, more than 2,000 cases have been added to NJ MCL 297, since their initial consolidation. These cases are currently in the discovery phase, the deadline for which was extended by the judge to June 30, 2017. Although litigation for Mirena is still in the early stages of review and analysis, potential cases are still being considered for women throughout the United States. If a settlement is not reached as part of the MDLs or MCL, each claim will be returned to the U.S. District Court where it was originally filed for an individual trial date.
Filing a Mirena IUD Lawsuit
If you or someone you care about has experienced complications as a result of the Mirena IUD, you may be entitled to file a claim. The statute of limitations for filing a Mirena lawsuit varies from state to state. For this reason, it’s important to consult a lawyer specializing in Mirena cases to understand your rights, have your case evaluated, and determine your best course of action.
Report Problems to the FDA
If you are experiencing problems or complications with your IUD, we encourage you to report the device to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. You can submit reports in any one of the following ways:
- Download the MedWatcher Mobile App: iTunes Download | Google Play Download
- Complete the Online MedWatch Form.
- Download and print the printable MedWatch form.
- Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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