In 2000, the pharmaceutical giant, Bayer Healthcare Pharmaceuticals Inc., released its long-lasting method of birth control, the Mirena IUD (intrauterine device). In 2009, the U.S. Food and Drug Administration (FDA) additionally approved Mirena to treat heavy menstrual bleeding.
The Mirena IUD is a popular birth control device manufactured by Bayer Healthcare Pharmaceutical. However, ever since its market release, the device has been linked to several complications. Many physicians discourage use of the hormonal IUD, despite its popularity. In their opinion, the device will only do more harm than good.
According to court documents, manufacturer Bayer originally marketed the Mirena IUD as a more convenient option for busy women who didn’t want to worry about taking a daily birth control pill. The device is a small, t-shaped, plastic device, which is inserted directly into a woman’s uterus by a healthcare provider. Mirena releases a hormone at a set daily rate for five years. After five years, the device must be removed because it will have expired.
Mirena has been implanted in an estimated 2 million women in the United States and 15 million women worldwide. Since its release, over 47,000 adverse events (any unwanted side effects associated with a prescription drug or medical device) have been reported to the FDA involving Mirena.
Mirena’s label does warn of serious injuries, including pelvic inflammatory disease, ectopic pregnancy (pregnancy outside of the uterus) and perforation upon insertion.
However, Mirena’s warning label does not warn of several severe injuries that women worldwide have experienced. This includes “spontaneous migration” of the device to areas outside of the uterus. When this occurs, Mirena may perforate the uterus, cervix or other internal organs and reposition itself in areas within the abdominal cavity.
When spontaneous migration and perforation occurs, it can cause a variety of complications. Not only will this injury likely cause Mirena to fail as contraception, it often requires surgery to remove the device. Device migration and perforation can lead to serious, even life-threatening injuries. These injuries include possible infertility, infection, hemorrhage and sepsis.
In December 2009, the FDA issued a warning letter to Bayer accusing the company about overstating the benefits of the Mirena, while minimizing the risks. According to the agency, Bayer’s marketing claims of helping women improve their sex lives had no merit.
Kristie B. Donovan of New York filed a product liability lawsuit against Bayer, in the U.S. District Court for the Western District of N.Y., indicating that she became pregnant while her Mirena IUD was in place because the device perforated her uterus and migrated into her upper abdomen, causing multiple complications.
According to the Mirena lawsuit, Donovan’s doctor inserted the IUD in October 2006. However, Donovan discovered that she was pregnant in April 2011 and testing confirmed that the Mirena IUD was no longer in her uterine cavity.
Following the delivery of her child in December 2011, x-rays revealed that the Mirena IUD had moved out of the uterus and was located in her upper abdomen. This required multiple surgeries to remove the IUD, leaving her with severe and permanent injuries.
Bayer faces a growing number of similar product liability lawsuits over the Mirena IUD, which alleges that the manufacturer failed to adequately warn about the risk of complications that may develop long after the birth control device is inserted.
According to the lawsuit, Donovan’s physician checked the implant approximately 45 days after it was inserted and confirmed that the IUD was in the proper place.
The lawsuit accuses Bayer of defective manufacturing and design, negligence, failure to warn, strict liability, breach of warranty, negligent misrepresentation and fraud. The lawsuit calls for compensatory and punitive damages.
A motion is currently pending with the U.S. Judicial Panel on Multidistrict Litigation (JPMDL) asking to consolidate and centralize the federal Mirena litigation as part of an MDL, or multidistrict litigation. A group of plaintiffs are asking that all the cases filed in the U.S. District Courts throughout the United States be centralized before one judge for coordinated pretrial proceedings, reducing duplicative discovery, eliminating conflicting rulings from different judges and promoting judicial efficiency.
If the Mirena MDL is established, Donovan’s case will be transferred into the consolidated proceedings. The U.S. JPMDL is expected to hear oral arguments on the motion next month, at an upcoming hearing date scheduled in San Diego, California on March 21, 2013.
Mirena IUD manufacturer, Bayer Healthcare Pharmaceutical has filed a motion opposing the consolidation of federal Mirena lawsuits for purposes of pretrial proceedings.
Bayer argued in the February 7th filing that multidistrict litigation would prejudice the company for several reasons, among them that because Bayer has been preparing documents for discovery in an individual case for the past two years, it would now have to spend further time and money to go through the process again for a federal MDL case. The company also argued that the creation of an MDL would attract “marginal” claims against the company over its Mirena hormonal IUD.
Mirena has demonstrated the potential to cause women serious side effects, according to the FDA drug label. These include device perforation (puncture of the uterine wall), migration (the shifting of the device outside of the woman’s uterus), and embedment (the device becomes stuck in the uterine wall).
The manufacturer of Mirena, Bayer Healthcare Pharmaceuticals, did not release any form of public warning regarding device migration after proper insertion. Therefore, several injured women have filed lawsuits against Bayer for withholding vital information. These pharmaceutical companies must be held accountable for their negligence. Many of these women were left permanently injured; some lost the ability to have children.
Recently, there were several lawsuits filed against the makers of Yaz and Yasmin for their risk of blood clots. The manufacturers of these pills paid billions of dollars to settle lawsuits. These big pharmas care more about profits than the safety of the consumers. Maybe if they are hit in their pocketbooks, they will clearly list warnings on their labels.
Feel free to comment on this blog post. You can contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).