Mirena Lawsuits: Settlements, Symptoms & Hiring a Lawyer
Mirena Lawsuits: Settlements, Symptoms & Hiring a Lawyer
When side effects from Mirena warrant pursuing a lawsuit
Two million women have been implanted with the Mirena intrauterine device since it was marketed in 2001. The Food and Drug Administration has received more than 70,000 complaints from patients experiencing complications and side effects from pain to pseudotumors to organ perforation. Learn more about Mirena lawsuits and whether you should pursue a claim.
Overview of Mirena lawsuits
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.
FDA actions regarding Mirena
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.)
Mirena was marketed as birth control for “busy moms” - FDA blasted misleading ads. Tweet this
The first update to the Mirena warning label came in 2008. The FDA ordered Bayer to update the label to reflect:
Ectopic pregnancies (up to 50% of pregnancies that occur while using Mirena are ectopic)
Increased susceptibility to pelvic infections
Sepsis (pain can occur within hours of insertion and resulting sepsis within days)
Uterine and cervix perforation
More changes were required later that same year, including warnings of :
Birth defects (masculinization of external female genitalia)
Embedment of device in uterine wall
Expulsion of device
Types of Mirena lawsuits
Multidistrict litigation for Mirena
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.
Enjuris tip: Experiencing pain and alarming symptoms or side effects after having an IUD inserted? Speak with your OB/GYN first and eliminate other possibilities before pursuing a lawsuit.
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:
Failure to provide adequate warnings
Concealment of side effects
Production and sale of defective products
Misrepresentation of medical benefits
Bayer called the side effects “uncommon,” which, patients noted in their lawsuits, was a gross understatement.
Class-actions for Mirena patients
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.
Mirena lawsuits by individuals
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.
What to do if you think you may have a Mirena lawsuit
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.
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.
Possible side effects and complications caused by Mirena