By Robert J. Boumis  |  January 14, 2014

Category: Legal News

Woman having a stomachachePlaintiff Rebecca Fife has filed a lawsuit against iconic medical supply company Bayer. Her lawsuit alleges that the Mirena IUD, an intrauterine device manufactured by Bayer, caused her serious health complications.

According to the Mirena IUD lawsuit, Fife’s physicians implanted the intrauterine device in November 2009. In early December 2010, an ultrasound reportedly revealed that the device had “migrated” or punctured through the wall of the uterus and gotten stuck in the abdominal quadrant. Several days later, Fife required surgical intervention in the form of laparoscopic surgery to remove the device. Per the Mirena IUD lawsuit, the IUD caused severe pain, permanent medical issues, and required hospitalization.

The Mirena IUD lawsuit asserts that Bayer had reason to believe the device was dangerous. The lawsuit states that the U.S. Food & Drug Administration (FDA) has received thousands of reports of serious problems with the IUD, including perforations. The lawsuit also states that safer and more effective contraceptives are on the market, and heavy promotion of Mirena is thus irresponsible.

Not only does the lawsuit assert that Bayer was aware of the risk of injuries like Fife’s, but the Mirena IUD lawsuit goes on to state that Bayer actively concealed these risks. To support this assertion, the lawsuit brings up a communication between Bayer and the Department of Health and Human Services Division of Drug Marketing, Advertising, and Communications (DDMAC). In 2009, Bayer received a letter from DDMAC, warning them that their advertising program of the Mirena IUD was making unsupported statements. In particular, the letter stated that the “Simple Style” program overstated the IUD’s benefits while downplaying the risks.

To further support the assertion that Bayer downplayed the Mirena IUD risks, the lawsuit points out that it was not until 2013 that Bayer included any sort of warnings pertaining to perforation—the very injury that Fife suffered. Even today, the instructions only indicate that perforation and migration can occur during insertion, not afterwards, as happened with Fife.

The Mirena IUD lawsuit asserts that Fife and her physicians complied with all written instructions included with the IUD. It also states that Fife relied on Bayer’s marketing and accompanying material for information and safety and efficacy of the IUD. The lawsuit further asserts that had Fife been fully informed of the risks associated with the Mirena IUD, she would not have used the intrauterine device.

The Mirena IUD lawsuit is formally titled Rebecca Fife v. Bayer Healthcare Pharmaceuticals Inc., Case No. 2:13-cv-2170-TSZ, in the U.S. District Court for the Western District of Washington.

Help for Victims of Mirena IUD Complications

If you or a loved one had a Mirena IUD inserted after January 1, 2000 or later and had to have surgery – or will be required to have surgery – to have it remove because it migrated, you may be eligible to take legal action against the manufacturer. Filing a Mirena IUD lawsuit may help you recover compensation for medical bills, pain and suffering and other damages. See if you qualify by filling out the short form at the Mirena IUD Injury Class Action Lawsuit Settlement Investigation.

 

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