A South Carolina plaintiff who filed one of the first Mirena lawsuits in the nation has challenged Bayer Healthcare Pharmaceutical’s bid to have her claim dismissed, alleging she was never adequately warned that spontaneous migration following insertion of the device was a possible Mirena complication. For its part, Bayer claims the plaintiff’s doctor was aware of this risk, and is trying to have the Mirena lawsuit dismissed under South Carolina’s “learned intermediary doctrine,” which requires the plaintiff show Bayer’s warning to her physician was inadequate and that a different warning would have deterred the doctor from prescribing the IUD.

Mirena Lawsuit Allegations

The South Carolina lawsuit was filed in 2011 in the U.S. District Court, District of South Carolina. The plaintiff alleges the Mirena IUD spontaneously migrated after insertion, and she suffered uterine perforations after doctors were unable to locate it in her body. As a result, she underwent several surgeries, including hysterectomy, causing her to go into surgically-induced menopause when she was 26-years-old.

Bayer filed a motion to have the Mirena lawsuit dismissed in December. Among other things, Bayer’s motion points out that the plaintiff’s doctor testified that the risk of IUD migration and perforation was known to her for 20 years.  As such, the company asserts that the plaintiff is unable to prove that Bayer’s failure to warn was a proximate cause of the alleged injuries.

In a brief filed January 2nd opposing Bayer’s motion, the plaintiff claims that Bayer’s assertions make no sense. Among other things, the brief points out that the warnings that accompany the Mirena IUD include a caution against perforation at the time the device is inserted. However, the plaintiff is claiming her injuries resulted from spontaneous migration and perforation that occurred after insertion – a scenario Bayer officials have claimed is impossible.

“Plaintiffs note that it is quite impossible for Bayer to argue on the one hand that spontaneous migration not associated with insertion of Mirena is ‘biologically implausible,’ and on the other hand argue that Bayer’s duty to warn of said event was satisfied; that [plaintiff’s doctor] knew spontaneous migration of Mirena could occur; and that information related to spontaneous migration was communicated by her to Plaintiff,” the brief sates.

Among other things, the brief notes that the plaintiff’s doctor was not independently aware of the risk that Mirena could spontaneously migrate, as her previous experience had only been with copper IUDs.

Mirena Complications

The Mirena IUD is small, plastic, hormone-releasing t-shaped device that is inserted into a woman’s uterus, where it can remain in place for up to five years. In 2009, Bayer was cited via a U.S. Food & Drug Administration (FDA) warning letter for overstating the benefits of Mirena and downplaying its potential side effects in one of its marketing programs for the IUD.

A growing number of lawsuits allege that spontaneous migration of the device caused women to suffer serious Mirena complications, including:

  • Abscesses
  • Erosion of nearby tissue
  • Infertility
  • Peritonitis
  • Intestinal perforations or obstruction
  • Pelvic Inflammatory Disease
  • Uterine perforation
  • Embedment in the uterine wall
  • Ectopic pregnancy

Earlier this month, the New Jersey Supreme Court rejected a request made by Bayer to centralize all Mirena lawsuits filed in the state in one proceeding in Middlesex County Superior Court.  However, just this week, plaintiffs with Mirena claims pending in federal court petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to transfer all federally-filed lawsuits to federal court in Ohio for pre-trial proceedings.

Have You Suffered a Mirena Complication?  Speak with an Attorney Today

If you or someone you love suffered a serious injury associated with spontaneous migration of a Mirena IUD, you may be entitled to compensation for your pain and suffering. The attorneys of Bernstein Liebhard LLP offer free legal evaluations to victims of Mirena complications. To learn more about Mirena lawsuits, please call us today at 1-877-779-1414.

Published January 16, 2013 by