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Mirena Lawsuit

Mirena Lawsuit

Mirena is an intrauterine device (IUD) that has been linked to a rare brain disease that can cause chronic headaches and blindness. Many women have filed lawsuits accusing Bayer of failing to warn about these risks.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Mirena induced brain injury cases in all 50 states. If you or somebody you know has been diagnosed with Pseudotumor Cerebri (PTC) or Intracranial Hypertension, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Overview

Mirena is a type of birth control known as an intrauterine device (IUD). Mirena is sold by Bayer HealthCare and it was approved by the FDA in 2000. Since then, more than 2 million woman have used Mirena. It is more than 99% effective at preventing pregnancy for up to five years.

How Does Mirena Work?

Mirena is inserted into a woman’s uterus (womb), where it slowly releases levonorgestrel (a synthetic version of the hormone progestin). It thickens cervical mucous, which helps prevent sperm from entering the uterus. It also makes the lining of the uterus thinner, which reduces the chances that a fertilized egg will implant and grow.

Brain Injuries Linked to Mirena

In early 2014, Bayer was hit with nine lawsuits accusing them of downplaying risk information about brain injuries from Mirena, including:

Mirena Brain Injury Lawsuits

Attorneys petitioned a panel of federal judges to centralize the litigation in May 2014. However, in August, the judges denied the petition because there were not enough cases. The cases will proceed individually at the state level. In October 2015,  a woman who was diagnosed with PTC after using Mirena has filed a lawsuit against Bayer HealthCare for failing to adequately warn about the risk

FDA Warning Letters for Mirena

In December 2009, the FDA sent a Warning Letter (PDF) to Bayer due to a promotional program for Mirena. The marketing program featured parties hosted by experts who claimed that Mirena could help a woman “look and feel great,” improve a woman’s sexual relationships, and quality of life. According to the FDA:

“The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”

The FDA also pointed out that many women do not “feel better.” In fact, about 5% of women who use Mirena actually reported a decrease in libido, which could potentially harm sexual relationships.

Failure to Warn About Side Effects

The FDA also sent Bayer a Warning Letter (PDF) in March 2009. This time, the FDA was concerned that Bayer’s sponsored links on internet search engines are misleading because they make representations and/or suggestions about the efficacy of Mirena, but fail to communicate any risk information.

By law, advertisements for drugs and medical devices must include risk information. By omitting important risk information, including the most frequently occurring risks and side effects, the ads misleadingly suggest that Mirena is safer than it really is. By August 2013, the FDA had received over 70,000 reports of adverse events associated with Mirena.

Do I have a Mirena Lawsuit?

The Schmidt Firm, PLLC is currently accepting Mirena induced brain injury cases in all 50 states. If you or somebody you know has been diagnosed with Pseudotumor Cerebri (PTC) or Intracranial Hypertension, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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