Bloomberg (1/28/13) notes that a lawsuit has been filed by Tricia Prendergast, who says she was not warned that Mirena can either move from its implant site or cause an ectopic pregnancy. Prendergast reportedly suffered complications from the IUD and required surgery to remove the device. In the complaint, filed January 25, 2013, the plaintiff’s attorney alleges that the risks associated with Mirena outweigh any benefits.
Mirena is inserted in the uterus and prevents pregnancy by releasing a synthetic progestogen. But plaintiffs allege Mirena can migrate from implant site, causing serious internal injuries, including uterine perforations, sepsis and abscesses.
The United States Judicial Panel on Multidistrict Litigation met in March to decide whether or not to consolidate pretrial proceedings on Mirena lawsuits into a multidistrict litigation. Plaintiffs requested a transfer of the lawsuits to the United States District Court for the Northern District of Ohio. Included in the motion were lawsuits from a variety of states, including California, Arkansas and Kentucky. Following the hearing, the panel reportedly agreed to consolidate federal lawsuits in the Southern District of New York. A date for the initial conference concerning the litigation is now set for May 17, 2013.
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Along with allegations about serious complications associated with Mirena are concerns that some advertising regarding the IUD was misleading. In 2009, the US Food and Drug Administration (FDA) sent a letter to Bayer Healthcare Pharmaceuticals (maker of Mirena) warning the company that its marketing of the IUD overstated its effectiveness.
The lawsuit is Prendergast v. Bayer Pharmaceuticals Corp., 13-00450, U.S. District Court Eastern District of Pennsylvania (Philadelphia). The multidistrict litigation is In re: Mirena IUD Products Liability Litigation, MDL No. 2434 (JPML).