Bayer Healthcare Pharmaceutical Sued For Mirena Birth Control Problems
“If you want to have a true, care-free birth control that is effective for up to five years, the Mirena IUD may be the best option,” writes Michael Bomberger for Hive Media on April 5th, 2013. However, this is not the rosy picture that plaintiffs intend to tell in court over the coming months. The Mirena IUD lawsuits are starting to pile up.
What is Mirena?
The federal Food and Drug Administration (FDA) approved Mirena as a birth control method in December 2000. Since then, it has been used by more than 15 million women worldwide. The system works by delivering synthetic progestogen directly into the uterus via a plastic ring that is inserted in the uterus, where it may remain for up to five years.
Manufacturer Bayer Pharmaceuticals is on record as saying, “It is not known exactly how Mirena works,” but it’s believed to thicken cervical mucus, inhibit sperm movement and thin the uterine lining to prevent pregnancy. The packaging materials warn that “carrying a child to term may be complicated” after Mirena use and that “migration may occur if the uterus is perforated during insertion.”
The Mirena IUD lawsuits begin
Plaintiff, 24-year-old Brandy N. Scott of Bullitt County, Kentucky had her Mirena IUD inserted on March 14th, 2012, without incident. She went for a follow-up visit with her doctor the following month. Dr. Michael Buck determined by ultrasound that the device was not in its proper place – but had, in fact, perforated the uterus and migrated to the far right of her pelvis.
The plaintiff underwent laparoscopic surgery on April 23rd, 2012 to remove the IUD. “The plaintiff has suffered and will continue to suffer economic loss, and has been physically, emotionally and economically injured as a result of the defendant’s negligence,” according to the suit drawn up by Brandy Scott’s lawyer. His client is seeking $1 million, plus compensatory and punitive damages, interest, and fees.
The lawsuit further contends that women using Mirena birth control were not adequately warned about possible side effects, such as: perforation, migration, embedment, increased risk of ectopic and intrauterine pregnancy, cyst and cancer risks, possible fetal injury or death, or premature menopause.
Bayer has a documented history of misleading public
Bayer Pharmaceuticals was contacted by the Department of Health and Human Services in March 2009 warning that their advertising materials “misbranded the IUD” in violation of the law. Not only did they fail to communicate the risks associated with the product, but they also “overstated the efficiency.”
The company was contacted a second time in December 2009 for violating the law again with their “Simple Style Statements Program” for “busy moms,” which contended that Mirena could increase intimacy and emotional satisfaction between sexual partners, despite the lack of evidence and the fact that 5 percent of clinical trial patients actually reported “decreased libido” after use. Other side effects found in the trial included weight gain, acne and breast pain.
Mirena lawyers poised to file more lawsuits
Mirena lawyers suggest that hundreds, if not thousands, of similar cases will likely soon be filed. On April 8, 2013 federal Mirena IUD lawsuits were consolidated into multidistrict litigation. The first management conference will be held on May17 in the Southern District of New York. Women who have had Mirena birth control problems are encouraged to contact a Mirena attorney about this developing litigation.