PENNSYLVANIA RECORD

Another products liability complaint has been filed against pharmaceutical giant Bayer

and various corporate subsidiaries over claims that the defendants’ birth control system Mirena can cause serious injuries in patients who have the device implanted into their bodies.

The latest claim was filed at the U.S. District Court for the Eastern District of Pennsylvania by Rochester, N.Y. resident Sara Ann De Wolf, who had the Mirena device implanted by a physician at the Women’s Health Center at Rochester General Hospital back in March 2010.

The lawsuit claims that the plaintiff’s doctor would never have placed the device in De Wolf’s body had the medical professional known of the “true rate of migration, embedment and perforation of the Mirena.”

Litigation against Bayer over alleged Mirena injuries alleges that the product, which is an intrauterine contraceptive system made of flexible plastic that is inserted by a healthcare provider during a doctor’s office visit, does not warn physicians and patients about the possibility for the device to migrate throughout the body.

Specifically, Mirena lawsuits like this latest one allege that migration can occur if a woman’s uterus is perforated during the process to insert the device.

The complaint says that the Mirena label doesn’t disclose the risk of the device becoming embedded within the body, or the true risk of ectopic pregnancy, a complication in which the embryo implants outside of the uterine cavity.

“Defendants have a history of overstating the efficacy of Mirena, while understating the potential safety concerns,” the suit reads.

In her complaint, De Wolf claims that two months after having the Mirena implanted in her body, the device migrated, with subsequent testing revealing that the device was improperly located somewhere in the pelvis.

“The Mirena IUD migrated because it was negligently and defectively designed,” the suit states. “Defendants knew that the Mirena IUD was negligently and defectively designed when it left Defendants’ control, and Defendants knew that it migrated at a higher rate than other IUDs on the market.”

The plaintiff had the Mirena surgically removed from her body on May 3, 2010, according to the complaint.

The suit alleges that the surgery caused De Wolf to experience pain and suffering, as well as financial loss, and caused permanent injury to the plaintiff, including a scar and permanent risk of placenta accreta, which is a complication involving a deep attachment of the placenta to the muscular layer of the uterine wall without penetrating it.

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

The individual defendants named in the lawsuit are Bayer Corp., Bayer Healthcare LLC, Bayer Pharmaceuticals Corp., Bayer Healthcare Pharmaceuticals Inc., Berlex Laboratories Inc. and Berlex Inc.

The plaintiff seeks unspecified compensatory, statutory and punitive damages, along with interest, costs, attorneys’ fees and other relief.

De Wolf is being represented by attorneys Dianne M. Nast, Daniel N. Gallucci and Joanne E. Matusko, of the Philadelphia firm NastLaw LLC.

 

The federal case number is 2:13-cv-02422-JP.