With 600 Mirena IUD lawsuits already having been centralized in the federal MDL before Judge Cathy Seibel in the Southern District of New York, and over 1,000 more pending in state court, progress has been made to move toward a trial in late 2015 (update: this has been revised to early 2016 – see below).
Discovery in these cases has been to find out:
- What Bayer HealthCare Pharmaceuticals knew about the risks associated with IUDs in general and, specifically, with Mirena?
- Why didn’t the company do a better job of communicating the risks of uterine perforation and migration?
- What Bayer tried to do to make its IUD as safe as possible?
- Were profits the motive to avoid making the warning clearer?
This digging has been taking some time, and there is more to do. But I believe this effort will really increase the ultimate settlement value of these cases. So it is worth the work.
In April 2013, all Mirena cases filed in the federal court system were transferred for coordinated proceedings before Judge Cathy Seibel. In other words, for discovery, this is a class action lawsuit. This month, Judge Seibel outlined the discovery process for the litigation that included a timetable for the selection of a small group of cases that will go through case-specific discovery in preparation for early trial dates, known as bellwether trials. A bellwether case is a test case, allowing the parties to see what a jury will do with a garden-variety claim so they can decide where they stand. Bellwether cases are often precursors for settlement talks.
In August 2014, Judge Seibel picked these 12 bellwether cases and tentatively set the first trial date for March 2016.
With the purpose of eliminating redundancies in the discovery process, preventing conflicting pretrial rulings, and facilitating judicial economy, nearly 4000, with close to 2,000 in total currently making their way through courts across the country.
The Problem 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 in an outpatient office visit. The problem with Mirena is that there are a lot of problems.
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 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 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.
Why a Warning Was Particularly Important in This Case
It is of course 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:
- Implanon: This device is a plastic implant rod containing progestogen etonogestrel which is surgically inserted under the skin of the upper arm
- Depo-Provera: injectable progestogen that lasts up to three months.
- 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 a doubled 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 with Implanon may be even higher for smokers.
So none of these choices are perfect. But women do have choices, and they deserve information to make the right choice for them.
What the Lawsuits Allege Bayer Did
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 clinic trials that would have uncovered the safety concerns with the device
- Failing to provide adequate safety instruction 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:
- Ectopic pregnancies
- Fetal injuries and death
- Premature menopause
- Uterus injury
- Intrauterine pregnancy
Bayer Faces More Mirena IUD Lawsuits
Some Mirena IUD lawsuits have also been filed in the New Jersey state court and have also been centralized before one judge for coordinated proceedings. There are currently almost 4000 total cases, again with more expected.
If you or a loved one has been injured by a Mirena IUD, contact us at 1.800.553.8082 or online here. We can tell you about the current state of Mirena settlements and lawsuits, and we can help you to determine if a lawsuit is right for you.
- Mirena IUD Pseudotumor Cerebri (PTC) Lawsuits
- Mirena IUD Lawsuit Update
- An Overview of These Claims: What You Can Do For Yourself