Mirena IUD Lawsuit 2024 Update

There is a lot of confusion out there about Mirena lawsuits.  Women are bewildered because there have been so many lawyers in recent years who are looking to bring a Mirena lawsuit.  There are still Mirena lawsuit advertisements still up in 2024.  Yet they cannot find a lawyer for their case.  We are not handling these claims. But we can tell you about them.

If you are frustrated, I completely understand.  Let me try to explain because there are not a lot of good explanations out there online.

When these lawsuits began, plaintiffs’ lawyers filed thousands of Mirena lawsuits.  The focus of the litigation was:

1. What did Bayer HealthCare Pharmaceuticals know about the risks associated with IUDs in general and, specifically, with Mirena?
2. Why didn’t the company do a better job of communicating the risks of uterine perforation and migration?
3. What Bayer tried to do to make its IUD as safe as possible?
4. Were profits the motive to avoid making the warning clearer?

So what happened?  These cases bombed.  Why?  Was it because women were not suffering?  No.  The Mirena perforation cases failed because plaintiffs’ attorneys could not find experts that the federal court judge hearing the cases would accept.  We had four experts, and the court rejected all of them and then granted judgment without a trial in favor of Bayer.  This led to the dismissal of over 1,000 cases.

Does their dismissal mean the Mirena perforation cases were not valid claims?  No.  Sometimes, in these mass tort cases, science has not yet caught up to the facts.  It certainly has not been proven that Bayer’s mistakes did not harm these women.  But it also has not yet been proven that Bayer’s mistakes caused harm.

So if you have a Mirena migration case, you will likely have an extremely hard time finding a lawyer who will take the case.  Few, if any, lawyers are taking uterine perforation and migration cases. As for the breast cancer cases, as we discuss below, a new October 2024 study could breath new life in these cases

• In 2024, the Paragard IUD lawsuits are the latest IUD that is getting hit with new class action suits that will hopefully be more viable for victims than Mirena. There are also lawsuits involving Depo-Provera users getting brain tumors.

Mirena Breast Cancer Lawsuits

Mirena breast cancer lawsuits in federal court were hanging by a thread after this ruling.

But in October 2024, a strong new study has come out. This is a nationwide study in Denmark looked at whether using levonorgestrel-releasing intrauterine systems (LNG-IUSs), a type of hormonal IUD, could increase the risk of breast cancer in women aged 15 to 49. The study followed 78,595 women—so it was a huge study—who used LNG-IUS and compared them to a similar group of women who did not use hormonal contraceptives for an average of 6.8 years.

The results showed that women using LNG-IUS had a 1.4 times higher risk of getting breast cancer compared to those who did not use hormonal contraceptives. The longer the women used the LNG-IUS, the slightly higher their risk became, with a risk increase from 1.3 times higher for 0-5 years of use to 1.8 times higher for 10-15 years of use.

The study estimated that 14 to 71 additional women out of every 10,000 who use LNG-IUSs might develop breast cancer, depending on how long they used it. Even though the overall risk of breast cancer in younger women remains low, these findings should be part of the conversation when discussing the benefits and risks of using LNG-IUSs.

The study seems strong because it used a large number of participants and data from nationwide health records in Denmark, giving it a solid foundation. The analysis also accounted for various factors that could affect breast cancer risk—like age, previous contraceptive use, and number of children. The long follow-up period (up to 15 years) and analysis by how long women used the LNG-IUS also add to the reliability of the findings. So we will see where it goes.

Consumer Fraud Lawsuit

In October 2023, a consumer fraud claim against Bayer alleges that the company failed to disclose the contraceptive’s increased risk of breast cancer. The U.S. District Court for the Northern District of California ruled that federal labeling law does not preempt this lawsuit. The lead plaintiff alleges that despite Bayer’s awareness of studies indicating a 20% to 30% increase in breast cancer risk with Mirena use, the company did not inform doctors or consumers or amend the labeling. The lead plaintiff claims she would not have spent $50 on the Mirena IUD had she been aware of the health risks. The court stated that Bayer could have independently changed the label without awaiting FDA approval and that Bayer did not show “clear evidence” that the FDA would have declined a label change. The court confirmed that the lead plaintiff has validly alleged claims under California’s consumer protection laws but restricted the lawsuit’s scope by ruling that Bayer’s warning obligation is to physicians, not directly to consumers.

New Lawsuit Involving Mirena Also Bombed

So why are lawyers still advertising like crazy for Mirena cases?  In 2018, there is a whole new MDL In Manhattan with over around 175 lawsuits pending. Plaintiffs allege that Bayer’s Mirena Intrauterine System causes a severe, permanent, and debilitating condition called pseudotumor cerebri or intracranial hypertension (“PTC/IH”).   These lawsuits allege that Mirena’s warning does not adequately warn about non-stroke neurological conditions such as PTC/IH, despite a known link between LNG and PTC/IH.

Pseudotumor cerebri is a condition that develops when a person’s cerebrospinal fluid becomes elevated, causing increased pressure in the patient’s head. Women on Mirena who develop this condition often develop symptoms of severe migraines or migraine-like headaches with blurred vision.

They might also experience diplopia (double vision), temporary blindness, blind spots, or other visual deficiencies, papilledema, or optic disc swelling due.  Without intervention, this condition can cause blindness.

How are these cases going?  Not well.  In October 2018, the MDL judge overseeing this litigation dismissed all the plaintiffs’ experts on causation, finding a lack of scientific evidence on the causal relationship between these injuries.

What does this mean?  It means that unless the judge is overturned on appeal (2023 update: they were not), these federal court cases are likely to be dismissed.  If you came here looking for good news on this litigation, I’m sorry, but I do not have it.  Bayer won.

What Are the Problems with Mirena?

Mirena, a small, flexible T-shaped IUD, releases a hormone called Levonorgestrel, a hormone that effectively prevents pregnancy. Mirena is placed in a woman’s uterus and is inserted by a doctor during an outpatient office visit. The problem with Mirena is… that there are a lot of problems that were identified when clinical trials for Mirena began in 1985 (when Mirena was called Levonova). Now, as we talk about above, there is a breast cancer concern as well.

This intrauterine device is to be placed within seven days of the first day of menstruation and approved to remain in the uterus for as many as five years.  The warning label says that this device should be used in women who have had at least one child.

Why?  Is it because carrying a child to term is difficult after using the Mirena device?  I’ve never seen an explanation of the distinction which we should be talking about more as we flush out these cases.

Bayer admits that it doesn’t exactly know how it works, which should be the first sign of concern, right?  The theory is that the device releases Levonorgestrel to be distributed in tiny proportions directly to the lining of the uterus.

It may thicken cervical mucus to prevent the movement of sperm, and it may thin the lining of the uterus. The big problem with Mirena, as countless women have discovered, is that the small “flexible” device can puncture the uterus, which could lead to bleeding, inflammation, and infection.  It can also shift and migrate to a part of the woman’s body outside of the uterus.

After this device had been put on the market, there was a growing number of MedWatch Adverse Event reports talking about the embedment of and perforation through the uterine lining, and migration of the IUD through the uterine lining after it was implanted.  Bayer got these reports and did nothing to change its warning label so women could know these problems were a real downside of using this device. Why wouldn’t Bayer warn women?  That is pretty obvious, right?  Profits.

The IUD may need to be surgically removed and, in serious cases, the uterus could be at risk and a hysterectomy may be required. Some women experience Pelvic Inflammatory Disease (PID).  Long-term consequences include infertility, ectopic pregnancy, permanent pelvic pain, and abscesses. The Mirena lawsuit sought damages for these injuries.

Why Was Warning Was Particularly Important in the Mirena Lawsuit?

It is important for the maker of a drug or medical device to warn doctors and consumers about the risk associated with that product. When it comes to birth control, a warning matters even more because women have so many choices. Women have basically four choices when it comes to this class of birth control:

1. Mirena
2. Implanon: This device is a plastic implant rod containing progestogen etonogestrel which is surgically inserted under the skin of the upper arm
3. Depo-Provera:  injectable progestogen that lasts up to three months.
4. ParaGard Intrauterine Copper IUD: similar to Mirena but does not release steroidal hormones.

The Mirena IUD, unlike ParaGard, contains Levonorgestrel which is a steroidal hormone.  With Mirena, you have the risk of uterine perforation and also potentially the risk of ovarian cysts, irregular bleeding, pelvic inflammatory disease (PID), and cramps.

There is another troubling risk with Mirena worth considering too.  Give Bayer credit for this: women rarely get pregnant while using this form of birth control.  But it does happen.  If a woman does conceive, there is the risk of a lost fetus and permanent infertility. These are real risks.

The others come with risk too. Depo-Provera use has been shown to result in an increased risk of acquiring and transmitting HIV and a loss of bone mineral density.  Implanon has a higher risk for ectopic pregnancy and pulmonary emboli and strokes that can be fatal.  The risks of Implanon may be even higher for smokers.

So none of these choices are perfect.  But women have choices, and they deserve information to help make the right choice for them.

What Did the Mirena Lawsuits Allege?

• Negligently or fraudulently represented that Mirena has been properly tested and found to be safe and effective
• Concealed their knowledge of the IUD’s defects because their focus was on profits and not people’s health and safety
• Negligently failed to perform clinical trials that would have uncovered the safety concerns with the device
• Failing to provide adequate safety instructions for using the product
• Negligently advertising the benefits without explaining the risks
• Underreporting, underestimating, and downplaying the danger of the device to maintain and increase its market share

You can summarize the whole thing by saying Bayer said it was safe when it was not safe.

Are There More Risks Associated With Mirena?

Plaintiffs’ lawsuits allege that Mirena may cause:

• Pseudotumor cerebri
• Intracranial hypertension
• Perforation
• Migration
• Cancer
• Ectopic pregnancies
• Cysts
• Fetal injuries and death
• Premature menopause
• Bleeding
• Inflammation
• Uterus injury
• Infection
• Intrauterine pregnancy
• Embedment

Can You Still Get a Lawyer?

Our law firm is no longer handling Mirena cases for the reasons we have explained above. You can contact other lawyers but we do not have a referral for any Mirena cases.

Are Mirena Lawsuits Still Going Forward in New Jersey State Court?

In April 2021, the Multicounty Litigation designation for Mirena IUD lawsuits in New Jersey officially ended given that all “active litigation has resolved.”  This was the formal ending to litigation that has long been over. So the only remaining cases are Mirena breast cancer lawsuits.

Mirena Breast Cancer Lawsuits

Breast cancer lawsuits involving Mirena or really any product (like hair relaxers) are difficult.  In 2010, the seminal study on the connection looked a women users of LNG-IUS with a control group.   The study showed a greater risk for breast cancer in the LNG-IUS group.  The odds ratio of 1.53, which is pretty strong.  This study was replicated with similar findings.

But the cases are not going particularly well, and few lawyers are handling them.