A western Pennsylvania woman is suing the makers of the Mirena birth control system over allegations that she sustained injuries as a result of having the product implanted inside of her body.
Sherry Broadwater, who lives in Uniontown, Pa., which is about 50 miles southeast of Pittsburgh, filed suit last week in the Western District of Pennsylvania against Bayer Healthcare Pharmaceuticals over injuries she claims to have suffered in the spring of 2011.
The plaintiff was inserted with the Mirena intrauterine system in early 2010, the complaint states.
Having tolerated the procedure well, the 29-year-old woman had no reason to suspect that the device would perforate her uterus and/or migrate throughout her body, the lawsuit says.
But that’s exactly what ended up occurring, according to the complaint.
After the medical procedure, Broadwater began experiencing recurrent episodes of severe abdominal discomfort, headaches, diarrhea, nausea, severe mood swings and generalized feelings of fever and sickness, according to the products liability complaint.
The plaintiff didn’t learn that the device had moved from its spot until she went to her doctor to request that the Mirena be taken out because she had received a positive pregnancy test.
At the time, doctors believed that the device had been “expulsed,” since it was unable to be located during the time of the plaintiff’s examination, the lawsuit states.
In late 2011, an abdominal X-ray revealed that the birth control system had perforated the woman’s uterus, migrated to another part of the body, and had to be surgically removed.
“Although Plaintiff followed all instructions accompanying Mirena and used the product as directed, after implant of Mirena Plaintiff suffered serious and life-threatening side effects and injuries, including but not limited to extreme lower torso pain, medical therapy, surgical removal of Mirena and hospitalization, continuing treatment, and medical monitoring,” the complaint states.
The plaintiff also claims she has suffered from permanent bodily impairment, mental anguish and a diminished enjoyment of life as a result of her ordeal.
Broadwater seeks an unspecified amount of compensatory and punitive damages, costs, attorney’s fees, and other relief.
In her complaint, Broadwater’s lawyer, Monte J. Rabner, wrote that while he was filing the case in Pittsburgh, he believes the matter is appropriate for inclusion in the multidistrict Mirena products liability litigation that has been consolidated in the Southern District of New York.
Mirena, an intrauterine birth control system, was first approved by the FDA for use in the United States in December 2000, according to the complaint.
Today, more than two million women use the birth control method in the U.S. and more than 15 million women have used the product worldwide.
The Mirena label doesn’t warn about spontaneous migration of the birth control system, but only states that migration may occur if the uterus is perforated during the procedure to insert the device, the lawsuit states.
The product’s warning label also describes perforation as an “uncommon” event, despite the fact that there have been numerous women who have suffered migration and perforation after the insertion procedure, “clearly demonstrating this assertion to be false,” the complaint reads.
The lawsuit contains counts of defective manufacturing, design defect, negligence, failure to warn, strict liability, breach of warranty, negligent misrepresentation, fraudulent misrepresentation, fraudulent concealment, and unjust enrichment.
The federal case number is 2:13-cv-01583-MRH.