Jon Campisi Jul. 16, 2013, 6:55am


Bayer Pharmaceuticals is facing yet another product liability claim stemming from

allegations that a woman was injured by her use of the birth control system Mirena.

Lourdes Gonzalez claims in her newly filed federal civil action that she became injured after the Mirena, which was inserted into her body by a Pittsburgh doctor in early 2009, began to migrate throughout her body by late June 2011.

The device ended up perforating the plaintiff’s cervix, the suit states.

Gonzalez had to undergo surgery in late July of that year to have the medical product removed because it had migrated and was no longer in its proper position.

The surgery to remove the device caused the woman to experience pain, suffering, financial loss and caused permanent injury to Gonzalez in the firm of scarring and a permanent risk of placenta accreta, the complaint states.

Gonzalez says that she would never have elected to have had the birth control system implanted inside of her body had she been made aware of the true risks associated with the use of Mirena.

“In other words, Ms. Gonzalez would not have elected to have the Mirena device implanted if she knew the true rate of migration, embedment and perforation of the Mirena,” the suit reads.

The complaint asserts that the plaintiff’s doctors couldn’t make their patient aware of the injury risks associated with Mirena implantation because they themselves had not been told of the problems associated with the device.

Bayer and the other defendants in the suit have a history of overstating the efficacy of Mirena and of understating the potential safety concerns relating to the use of the device, the complaint reads.

Mirena, which is an intrauterine contraceptive system made of flexible plastic, was approved by the Food and Drug Administration in 2000.

More than two million American women use the device today, and it has been used by more than 15 million women worldwide to date, according to the complaint.

Nevertheless, the suit claims, the defendants never placed a warning on the device’s label that tells of the potential for Mirena to spontaneously migrate throughout the body; the label on the product only states that migration may occur if the uterus is perforated during insertion.

“Additionally, the Mirena label does not disclose the true risk of Mirena, including, but not limited to, the risk of it becoming embedded within the body, or the true risk of ectopic pregnancy,” the suit states.

Bayer Pharmaceuticals and various company subsidiaries are listed as defendants in the suit.

The complaint contains counts of defective manufacturing, design defect, negligence, failure to warn, strict liability, breach of implied and express warranties, negligent and fraudulent misrepresentation, and fraud by concealment.

The plaintiff seeks more than $150,000 in compensatory, statutory and punitive damages, in addition to interest, litigation costs, attorneys’ fees and other legal relief.

Gonzalez is being represented by attorneys from Philadelphia-based NastLaw LLC.

 

The federal case number is 2:13-cv-04082-JP. 

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