The thing about internal organs is that they shouldn’t have holes in them. This is called “perforation” and is just as bad as it sounds. It can happen for a number of reasons, though in this case it was the fault of an implantable medical device called Mirena.
You know what else a medical device isn’t supposed to do? Cause a buildup of pressure in the skull or migrate around the body.
Bayer Pharmaceuticals’ intrauterine birth control device, Mirena, did all those things. This IUD has been featured in many lawsuits for unwanted side effects, deceptive advertising and more.
Mirena was introduced in 2001 as the birth control option for “busy moms” (as this form of contraceptive is intended for woman with children). The advertising campaign was lambasted as misleading and inaccurate by the U.S. Food and Drug Administration, since an IUD isn’t necessarily responsible for rekindling intimacy with your partner. Bayer also glossed over the possible complications and side effects, of which there are many.
One of our “busy mom” editors almost had Mirena implanted. During the insertion procedure, when her doctor went to cut the attached thread, the device decided to come back out. Taking it as a sign from her uterus, she went with Essure instead. (That would be a whole different article.)
The first update to the Mirena warning label came in 2008. The FDA ordered Bayer to update the label to reflect:
More changes were required later that same year, including warnings of :
Multidistrict litigation (MDL) is a form of federal relief that consolidates similar cases from all across the country. By grouping them and not duplicating the discovery process, everything is streamlined and goes faster for everyone involved. Medical device lawsuits typically take the form of an MDL, because there are a large number of patients experiencing similar side effects and complications from the same product.
The cases in Mirena MDLs are based on a type of negligence called products liability, or defective products. The Second Court of Appeals dismissed nearly 1,300 Mirena cases that had been consolidated as an MDL; the judge found that the plaintiffs’ theory of secondary perforation did not hold up to evidentiary standards. A large number of lawsuits centered on pseudotumor cerebri, also referred to as intracranial hypertension, also referred to as pressure buildup in the skull. These cases were consolidated as an MDL and set before a judge in New York.
Approximately 2,000 cases relate to device migration, which resulted in injuries. These cases are in New Jersey’s Bergen County Court.
Women claimed that Bayer knew the IUD would harm them, but put it on the market anyway. The label did not warn of potential risks and complications; Bayer knew or should have known its product was dangerous.
Other claims include:
Bayer called the side effects “uncommon,” which, patients noted in their lawsuits, was a gross understatement.
There are currently no class actions in regard to Mirena. There are a few key differences between a class action and an MDL; the consensus is that a class action is not a good choice for medical device lawsuits.
Plaintiffs can pursue claims through state court if the defendant is located within their home state, unless they have been ordered to join an MDL by the judges in charge of all MDLs. If the defendant is in another state, the case will be filed in federal court.
If state court is a better option for your case, an attorney can help explain why.
If you believe that your Mirena implant is causing side effects, your first stop should be your doctor’s office. An examination will reveal whether the IUD is causing pain, infection, perforation or other complications. The most important thing is to keep your health under control.
If you have dealt with health side effects and your doctor says it’s because of your IUD, talk to an attorney.
Keep in mind that every state has a statute of limitations, after which you will no longer be able to file a claim. Some states only offer one year in which to file lawsuits for personal injury, so preserve your rights and file. You can always change attorneys later if necessary. Here is a worksheet with questions to ask a personal injury attorney to determine if that lawyer is the right fit.
If you have not met with an attorney yet, consider checking the Enjuris lawyer directory for someone in your state.
As previously mentioned, Mirena was approved by the FDA in 2001. Since then, more than 2 million women have had the IUD inserted.
As of 2013, more than 70,000 patient complaints were reported by News 5 in Cleveland. When these journalists pursued the story, the FDA sent them the following statement:
It's important to note that all drugs have side effects; no drug is absolutely safe. FDA-approved drugs have demonstrated that their benefits outweigh their known risks. The agency continuously monitors all approved drugs for new safety concerns, and we update the drug labeling or take regulatory action as appropriate.
Mirena's benefits and risks are outlined in the drug labeling, including the risks of embedment in the myometrium and perforation of the uterine wall or cervix. There are currently many FDA-approved birth control methods available. Women should discuss with their doctor the most appropriate birth control method for them.
Here is a comprehensive list of health complications and side effects that can arise as a result of taking Mirena:
If you feel your complications and pain after taking Mirena may warrant a lawsuit, these resources will be helpful: