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Arkansas Woman’s Mirena IUD Migrated Outside of Uterus, Prompting Need for Surgery, Alleges Parker Waichman LLP in Lawsuit
Date:9/19/2013

tiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197229.pdf" onclick="linkClick(this.href)" rel="nofollow">warning letter sent to the company by the U.S. Food and Drug Administration (FDA) on December 30, 2009, the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) criticized Bayer for making unsubstantiated claims about the Mirena while failing to mention its risks in the company’s “Simple Style” program. The DDMAC criticized Mirena for a number of statements, including the company’s assertion that Mirena helps women “look and feel great.”

Bayer’s Mirena IUD was approved in 2000 and is a contraceptive meant to prevent pregnancy for up to five years. The IUD is a small, plastic, “t”-shaped device attached to two strings. Once placed inside the uterus by a healthcare professional, the Mirena releases the hormone levonorgestrel, the lawsuit notes.

According to an October 1, 2009, FDA press release, the most serious side effects associated with the Mirena IUD include:

  •     Embedment of the device in the uterine wall
  •     Perforation of the uterine wall
  •     Intrauterine pregnancy
  •     Ectopic pregnancy
  •     Group A streptococcal sepsis
  •     Pelvic inflammatory disease (PID)

Court documents indicate that the Supreme Court of New Jersey recently reconsidered a prior decision and has moved to centralize Mirena IUD lawsuits in Bergen County, where Superior Court Judge Brian R. Martinotti will manage the lawsuits.

The attorneys at Parker Waichman LLP have been actively involved in the Mirena IUD litigation.
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