2018 Mirena Lawsuit News: As of September 2018, there were 660 Mirena lawsuits in federal courts over the severe side effect known as pseudotumor cerebri. If you or a loved one experienced PTC or intracranial hypertension after receiving a Mirena implant, talk to a medical device lawyer today for a free case review.
The Mirena intrauterine device was approved by the U.S. Food and Drug Administration (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 intrauterine device’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 pseudotumor cerebri, pain, bleeding, and perforation of the uterus.
Why Women Are Filing Mirena Lawsuits
The legal complaints filed by women against Bayer for its IUDs are all related to the severe side effects of Mirena. Many of the lawsuits currently being filed have to do with a serious condition known as pseudotumor cerebri (“false tumor”), which can cause tumor-like symptoms in the brain. In early 2018, Bayer announced a settlement that resolved thousands of other lawsuits related to perforations and migrations caused by Mirena birth control devices.
Pseudotumor Cerebri / Idiopathic Intracranial Hypertension
Pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (ITC), is a buildup of cerebrospinal fluid in the brain. As fluid accumulates, it can cause pressure on the brain, leading to a number of symptoms similar to a brain tumor (“pseudotumor” means “false tumor”), from vision and balance issues to mental or memory problems.
While pseudotumor cerebri can happen to anyone, certain medications are known to increase the risk of developing this dangerous medical condition. Among those drugs is levonorgestrel, the progestin-based hormone used in Mirena. A 2015 study by Canadian researchers showed that women who used Mirena were more likely to develop PTC than women who did not use Mirena, as well as women who used another form of birth control.
Women who have experienced pseudotumor cerebri or intracranial hypertension while using a Mirena IUD could be eligible for compensation. Talk with a product liability lawyer for a free case review to see if your situation applies.
Symptoms of Pseudotumor Cerebri
- Vision changes (e.g., double vision, loss of vision, etc.)
- Neck stiffness
- Difficulty walking
- Tinnitus (ringing in the ears)
- Memory problems
FDA Warnings About Mirena IUD Marketing
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
Mirena Multidistrict and Multicounty Litigation
While Bayer has settled thousands of Mirena lawsuits, there are still some cases that are currently going through trial courts and appeals. Many individual Mirena lawsuits have been consolidated into multidistrict litigation (MDL) in the federal courts and multicounty litigation (MCL) in state courts. There are currently three sets of mass torts covering Mirena IUDs: MDL 2434 and MDL 2767 in United States District Courts, and NJ MCL 297 in New Jersey State Courts.
MDL 2767: Mirena Pseudotumor Cerebri
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 2017, the U.S. Judicial Panel on Multidistrict Litigation (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. According to the JPML’s September 2018 update, there were 660 cases in MDL 2767.
MDL 2434: Mirena Migration, Perforation and Embedment
In June 2013, the 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 nearly 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 Mirena IUD perforation may occur during insertion and escape detection until sometime later, but claimants allege that the contraceptive device could cause perforation at any time even without insertion injuries.
The majority of these cases were settled in April 2018, and as of September 2018, there were no member cases in this MDL. However, the MDL is still listed as active according to the JPML.
New Jersey MCL 297
After a growing number of plaintiffs in New Jersey made similar allegations to those in the New York MDL, the NJ Supreme Court consolidated cases in multicounty litigation (MCL) in 2013. As of August 2018, there were 2,046 active cases in the MCL.
In April 2018, Judge Rachelle Harz appointed a Special Master to oversee settlement negotiations between Bayer and plaintiffs in MCL 297, and Garretson Resolution Group was appointed in June 2018 as the lien resolution administrator. This settlement was part of the 4,100-case settlement announced by Bayer in April 2018.
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 suffered when her Mirena IUD perforated her uterus and moved into 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.
Melody Williams began experiencing severe pain and abdominal cramping less than a year after her Mirena IUD was implanted. As a result, 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.
Mirena Lawsuit Settlement Amounts
In April 2018, Bayer signed an agreement to settle approximately 4,000 Mirena lawsuits related to claims that the IUD caused perforations in the women who used it. The settlement includes cases in federal MDL 2434 and NJ MCL 297, as well as cases filed in St. Louis City Circuit Court (Missouri) and all pending cases in California.
The total settlement amount is $12.2 million, but individual settlement amounts for Mirena lawsuits will vary depending on the details of each individual case.
Note that this settlement only resolves cases related to perforation by the Mirena device. Other claims related to ectopic pregnancy and idiopathic intracranial hypertension (ITC) are still outstanding. Having settled the perforation lawsuits, however, the pharmaceutical company may be more inclined to settle these other claims in the future as well.
Mirena Lawsuit FAQs
Responses to some of the most common questions about Mirena lawsuits are provided below.
Can I File a Mirena Lawsuit?
Women who received a Mirena IUD implant and experienced one of the following severe side effects may be eligible for compensation:
- Perforation of the uterus or another organ
- Migration of the device
- Intense cranial pressure or headaches – idiopathic intracranial hypertension (ITC) or pseudotumor cerebri (PTC)
- Unintended pregnancies
- Ectopic pregnancies or other pregnancy complications
If you or a loved one suffered from any of these conditions due to your Mirena IUD, you should talk with a lawyer to understand the merits of your case.
How Much Is the Mirena Lawsuit Individual Settlement Amount?
The Mirena settlement announced in April 2018 covered about 4,000 perforation cases in federal courts, as well as the state courts of New Jersey, Missouri, and California. The total settlement amount announced in Bayer’s financial filings was $12.2 million, which amounts to about $3,050 per person. However, though the exact amount will differ based on the final number of plaintiffs who agree to the settlement, and adjustments may be made based on the severity of each individual’s experience with Mirena IUDs.
Additional settlements could be reached for other outstanding cases, and plaintiffs who choose not to sign onto the April 2018 settlement could still receive favorable verdicts at jury trial. If your Mirena IUD caused a serious side effect, you should talk with a medical device law firm to find out how much your case could be worth. Don’t wait, because each state has its own deadline (statute of limitations) that could prevent you from receiving anything if file too late.
What Does a Mirena Lawyer Cost?
Mirena lawsuits are filed on what is known as a contingency basis. Basically, this means that you will not have to pay anything up front. Instead, your lawyer will receive payment from the compensation as part of a settlement or jury verdict – meaning that they will not receive any money unless you do.
It’s important to discuss costs up front with your lawyer during your case evaluation. Schedule your free review today to get the process started.