A Pennsylvania woman is suing Bayer Healthcare Pharmaceuticals over
claims that she became pregnant while on the Mirena birth control system because the implanted device had migrated from its original spot in her body.
Rebecca Syx filed suit in U.S. District Court in Philadelphia on Feb. 10 accusing the pharmaceutical giant of negligence, defective manufacturing, defective design, strict liability and other violations in connection with her ordeal.
The complaint says Syx, 33, had her doctor insert the Mirena intrauterine device during a visit to the physician’s office in the spring of 2011.
When she went for a follow-up in mid-June of that year, the device was confirmed to be in its proper location, but during a subsequent visit a month later, the doctor discovered that Syx was pregnant.
Days later, Syx underwent an ultrasound, which failed to locate the Mirena.
Another ultrasound in early August, however, showed that the device was located in the vescio-uterine wall just posterior to the bladder and anterior to the uterus, the lawsuit states.
The plaintiff was then told doctors would remove the migrated Mirena when she came back to the hospital to deliver her baby.
She gave birth via caesarian section to a healthy newborn in early 2013, at which time the birth control device was surgically removed from her body.
The lawsuit contains additional counts of failure to warn, failure to adequately test, breach of implied and express warranties, negligent misrepresentation, fraudulent misrepresentation, fraud by concealment, and violations of Pennsylvania Unfair Trade Practices and Consumer Protection Law.
The plaintiff seeks unspecified compensatory and punitive damages, along with interest, litigation costs, attorneys’ fees and other court relief.
In support of her claim for punitive damages, Syx says that Bayer knew Mirena was dangerous and ineffective, and that the company concealed the dangers and health risks from members of the public and physicians, made misrepresentations as to the safety and efficacy of Mirena, and sold and distributed the device with full knowledge of the health risks associated with the product.
The lawsuit was filed by attorneys James R. Ronca, Gregory S. Spizer and Joseph J. Fantini, of the Philadelphia firm Anapol Schwartz.
The federal case number is 2:14-cv-00844-AB.