Maker of IUD sued after device migrates into woman’s abdominal cavity

Michelle Keahey, East Texas Bureau Jul. 29, 2013, 11:41am

A Hardin County woman has filed a lawsuit against the intrauterine system Mirena claiming that the device migrated into her abdominal cavity and she needed surgery to remove it.

Rachael Coe filed suit against Bayer Healthcare Pharmaceuticals Inc. on July 24 in the Eastern District of Texas, Beaumont Division. 

Mirena is an intrauterine system that is inserted by a healthcare provider and releases a prescription medication used as a contraceptive.

Coe had the Mirena IUS inserted in June 2006 by Dr. Teresa Hill.  According to the lawsuit, the contraceptive insertion was uncomplicated and was properly placed.

Coe states that she began to experience fatigue, abdominal pain, pelvic pain, abnormal bleeding, back pain, ovarian cysts, urinary incontinence and other issues. In 2008, Dr. Hill could not locate the IUD by digital examination and two subsequent ultrasounds, according to the lawsuit.

In August 2010, Coe sought treatment at a local hospital emergency room and a CT scan discovered the IUD had perforated Coe’s uterus and migrated into her abdominal cavity, the suit states.

“Mirena’s label does not warn about spontaneous migration of the IUS, but only states that migration may occur if the uterus is perforated during insertion,” the lawsuit states.

The defendant is accused of defective manufacturing, design defect, negligence, failure to warn, strict liability, breach of implied warranty, breach of express warranty, fraudulent misrepresentation and fraud by concealment.

The plaintiff is seeking an award of compensatory, statutory and punitive damages, interest, court costs and attorney’s fees.

Coe is represented by B. Adam Terrell of Weller, Green, Toups & Terrell LP in Beaumont. A jury trial is requested.

U.S. District Judge Marcia A. Crone is assigned to the case.

Case No. 1:13-cv-00472

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