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Mirena IUD Lawsuit

Mirena is an intrauterine birth control device manufactured by Bayer Pharmaceuticals that promised to provide effective contraception to women but which has instead prompted a wave of products liability litigation.  Women filing a Mirena lawsuit argue that Bayer should be held responsible for serious and unexpected complications that were not sufficiently warned about, and that the IUD suffers design and manufacturing defects.

Mirena promises protection but linked to serious side effects

Mirena has been sold in the United States since 2000, and is T-shaped device that is inserted into theuterus in order to prevent pregnancy. The device must be inserted by a health care provider and it works by releasing hormones into the body. The hormones, which are the same hormones as those found in oral contraceptive pills, cause the uterine lining to thicken, which reduces the chances of pregnancy.  Bayer Pharmaceuticals indicated that the contraceptive device could provide easy protection from pregnancy for as long as five years.

To market Mirena, Bayer ran a “busy moms” campaign, suggesting that the use of Mirena could help women to “look and feel great,” and inspire “increased levels of intimacy, romance and by implication emotional satisfaction.”  Unfortunately, these claims were not substantiated and the Food and Drug Administration advised Bayer in 2009 that its marketing efforts were in violation of the Federal Food, Drug and Cosmetic Act.

The advertising issues and deceptive marketing were not Bayer’s only problems. Not only was Mirena not the wonder-device that Bayer promised, but was linked to serious side effects of the Mirena IUD and adverse health problems for women. Within a few years after the device launched, it became clear that Mirena could cause serious complications.

In fact, the FDA received more than 45,000 adverse event reports from patients who alleged they were harmed by Mirena.

Some of the different problems and side effects that patients claimed to be suffering because of the Mirena birth control include:

Migration of the Mirena IUD is one of the most common complaints and it is a very serious problem since the device can cause infections, internal organ damage, abscesses and peritonitis when it moves.

Concerns about IUD migration stem not just from reports of adverse Mirena side effects to the FDA, but also from medical studies showing that migration can occur, that migration can sometimes go undetected, and that the IUD can move into the abdomen and become difficult to find.  Migration can also be misdiagnosed if the device moves and doctors don’t see it and assume that it has simply been expelled from the body. A misdiagnosis increases the risk of infection and potentially life-threatening health issues.

A Mirena lawsuit can hold Bayer accountable

Patients who are injured due to the use of Mirena have certain legal rights. A Mirena IUD lawsuit may be justified when a woman experiences severe complications from the device, when used as directed. If a lawsuit is filed by an injured plaintiff, it is a personal injury case.  Lawsuits can also be filed by surviving family members of those who died from complications associated with Mirena.

Though the FDA has not implemented a Mirena recall, any women have already come forward to try to hold Bayer accountable for damages they have endured by filing a civil lawsuit against the company. In fact, 300 Mirena lawsuits have been consolidated into a multi-county litigation (MCL) in New Jersey, while other cases are pending throughout the United States including a multidistrict litigation with around 160 lawsuits in the United States District Court for the Southern District of New York.

The purpose of coordinated litigation such as MCL or MDL is to have similar lawsuits against a common defendant brought before one judge. Each plaintiff retains control over his or her own case; the claims aren’t joined together like a class action. However, a single judge assigned to hear the many different Mirena cases can make decisions on questions that are common to all complaints, such as whether a certain expert witness should be allowed to testify, or whether specific evidence should be admitted when a Mirena lawsuit goes to court.   This makes the process of hearing claims more expedient so those who are taking legal action can achieve resolution more quickly.

Allegations raised by plaintiffs

Plaintiffs have a number of different legal arguments to hold the IUD manufacturer liable.

For example, plaintiffs allege that Bayer:

  • Misrepresented the advantages of using Mirena
  • Failed to provide accurate information about Mirena risks
  • Understated the dangers associated with Mirena use
  • Failed to do adequate pre-market testing before releasing Mirena
  • Engaged in deceptive marketing
  • Failed to provide warning to consumers about Mirena side effects
  • Knowingly produced, distributed and sold a product that was defective

If plaintiffs can prove that Bayer fell short of fulfilling its legal obligations to the public, then those who were harmed by Mirena and who have taken action should be able to recover compensation for losses and damages caused by the IUD.

Legal advice for women harmed by the Mirena IUD

A product liability lawyer can provide assistance to patients who want to take action against Bayer. If a Mirena lawsuit is warranted, an attorney can help gather evidence to prove the health care giant failed to warn of potential side effects, and  if the case should become part of a multidistrict or multi-county litigation. Contacting a Mirena attorney in a timely manner is important as there is a statute of limitations in which a case must be filed in order for the injured victim to obtain the compensation she deserves.

  1. Food and Drug Administration, Mirena (levonorgestrel-releasing intrauterine system),
  2. The Harvard Medical School Family Health Guide, New IUD,
  3. Bayer Health Care, Patient Information: Mirena,
  4. United States Judicial Panel on Multidistrict Litigation, In Re: Mirena IUD Products Liability Litigation, Transfer Order,