New York, New York (PRWEB) January 14, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, has filed a lawsuit alleging that the Mirena® IUD caused physical injuries, emotional distress and economic loss for a Maryland woman implanted with the contraceptive. The suit was filed on January 2nd in the Superior Court of New Jersey Law Division, Morris County (Case No. MRS L-0037-13). Bayer Healthcare Pharmaceuticals, Inc. has been named as the Defendant.
Bayer’s Mirena® is an intrauterine device, or IUD; it is a contraceptive that is placed inside the uterus by a healthcare professional. The Mirena® IUD can remain in the body for up to five years. Mirena® is a hormonal IUD, and slowly releases the hormone levonorgestrel while implanted.
According to the Complaint, the Plaintiff received the Mirena® IUD in 2008. Initially, she appeared to tolerate the procedure well and neither she nor her doctor had any reason to believe that the device had perforated her uterus. In January 2011, however, an ultrasound indicated that the Mirena® IUD was no longer present in the uterus. Thereafter, the Plaintiff underwent laparoscopic surgery to remove the device. The lawsuit alleges that the Plaintiff suffered from severe and permanent physical injuries, substantial pain and suffering and economic loss as a result of using Mirena®. The suit also alleges that Bayer’s current warning for Mirena® is inadequate; the safety information only warns about the risk of uterine perforation when the Mirena® IUD is first inserted and does not mention the risk of spontaneous migration, which is what allegedly occurred in this Plaintiff's case.
Mirena® was approved in 2000. According to the U.S. Food and Drug Administration (FDA), the most serious adverse events associated with the device since its time on the market include:
- Perforation of the uterine wall
- Embedment of the device in the uterine wall
- Ectopic pregnancy
- Intrauterine pregnancy
- Group A streptococcal sepsis
- Pelvic inflammatory disease (PID)
The lawsuit points out that Bayer has had issues regarding Mirena® in the past. In 2009, the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) contacted Bayer over unsubstantiated claims made in the company’s “Simple Style” program. Overall, the DDMAC stated that the program overstated the benefits of Mirena® without any scientific evidence to back up those claims while also understating the risks associated with the device.
According to the American Association for Justice (AAJ) - Mirena® IUD Litigation Group, surgery required to remove the device when it perforates and migrates outside the uterus can lead to a number of injuries, including organ damage, adhesions and infections. Matthew J. McCauley, Senior Litigation Counsel at Parker Waichman LLP, co-chairs the Group.
Parker Waichman LLP continues to offer free lawsuit consultations to victims of Mirena® IUD birth control. If you or as a loved one experienced complications following the use of this device, please visit the firm's Mirena® IUD Side Effects page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
Parker Waichman LLP
Gary P. Falkowitz, Managing Attorney