Woman Files Mirena Lawsuit after “Unethical” Clinical Trial of Mirena

A new Mirena lawsuit has been filed against the Washington University School of Medicine in St. Louis, Missouri, on behalf of a woman who allegedly sustained permanent injuries during a clinical trial involving the off-label use of the Mirena IUD.

According to the lawsuit, which is pending in St. Louis Circuit Court, the researchers conducting the study ignored the safety information contained in the Mirena prescribing information, and implanted the IUD in the woman immediately following childbirth. Within days of the insertion, the plaintiff developed endocarditis, and subsequently had to undergo two heart surgeries. Endocarditis is an inflammation of the heart valves that can sometimes be caused by a bacterial infection.

According to the lawsuit, Washington University researchers failed to explain to the plaintiff that one of the purposes of the clinical trial was to assess the safety of post-placental insertion of Mirena, despite warnings from the manufacturer that the IUD should not be inserted earlier than four to six weeks after a woman gives birth. According to Bayer Healthcare Pharmaceuticals, the manufacturer of the Mirena IUD, the uterus may be prone to infection in the weeks immediately following delivery.

The Mirena IUD was brought to market in 2000 and is now approved and used as both a birth control method and as treatment for heavy menstrual bleeding in women who choose to use IUD for contraception. The U.S. Food and Drug Administration (FDA) received more than 70,000 adverse event reports from Mirena users, including many involving device dislocation and uterine perforation. In 2009, the FDA issued Bayer a warning letter, after finding that one of its Mirena promotions overstated the benefits associated with the IUD and understated its risks.

Bayer Healthcare Pharmaceuticals has been named in more than 1,000 lawsuits that have been filed in state and federal courts on behalf of women who allegedly suffered serious Mirena complications, according to court documents. These include at least 660 Mirena IUD lawsuits pending in New Jersey’s Bergen County Superior Court. Another 428 claims have been filed in a federal multidistrict litigation underway in U.S. District Court, Southern District of New York.

All of these lawsuits allege that Bayer has a history of downplaying the risks associated with Mirena, exaggerating its benefits. While women in Mirena lawsuits allegedly experienced the device migrating after proper insertion of the IUD, the complaints note that the labeling for the device warns that migration might occur if the uterus if perforated during its insertion.

If you or a loved one suffered adverse effects after insertion of the Mirena IUD, you may be entitled to compensation for your damages. Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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