Attorneys for those injured from using Bayer’s Mirena have asked the New Jersey Supreme Court to reconsider its earlier denial of Bayer Health Care Pharmaceutical’s request for creation of a coordinated docket for the numerous Mirena cases filed.
Mirena, the intrauterine contraceptive device (IUD), has been implanted in an estimated 2 million women in the United States and 15 million women worldwide. Since its release there have been more than 47,000 adverse events reported to the U.S. Food and Drug Administration (FDA).
Those injured from Mirena released a statement which said that these lawsuits involve “numerous claims with common, recurrent, and complex issues of fact and law” by the same defendant. In their application for reconsideration, the plaintiffs assert that the actions “allege substantially similar, and in some cases identical, violations of law by essentially the same defendant and are based upon the same or substantially similar underlying facts surrounding the safety profile of Mirena.”
Mirena’s label does not warn of serious injuries, including pelvic inflammatory disease, ectopic pregnancy (pregnancy outside the uterus) and perforation upon insertion.
Furthermore, Mirena’s warning label does not warn of the many severe injuries that women worldwide have experienced. Some of these injuries include “spontaneous migration” of the device to areas outside of the uterus, where it belongs. When this occurs, Mirena may perforate the uterus, cercix or other internal organs and reposition itself in areas within the abdominal cavity. These complications can cause permanent damage, including possible infertility, infection, hemorrhage and sepsis.
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. Mirena is a small device, which is inserted into the uterus by a health care provider. For the following five years, a hormone is released daily to prevent pregnancy, although it was originally approved to treat heavy menstrual bleeding.
In December 2009, the FDA issued a warning letter to Bayer accusing them of overstating the benefits of Mirena, while minimizing the serious risks. According to the agency, Bayer’s marketing claims of helping women improve their sex lives had no merit.
Some lawsuits filed allege that they became pregnant while their Mirena IUD was in place due to the device perforating the uterus, migrating into the abdomen. Following the birth of the child, multiple surgeries were required to remove the IUD, leaving the victims with severe, permanent injuries.
Bayer is faced with a growing number of similar product liability lawsuits over the Mirena IUD, which alleged that manufacturer failed to adequately warn about the risk of complications that may develop long after the birth control device is inserted. Bayer’s response to the application for reconsideration stated that it “does not agree with many of the factual and legal assertions made by plaintiffs, but it does agree that the request for reconsideration is appropriate.”
Essentially, the parties would like for the court to select one court to hear all of these cases at the same time. This would conserve judicial resources, as well as prevent both parties from having to spend extra money on multiple discoveries for each lawsuit.
The lawsuit accuses Bayer of defective manufacturing and design, negligence, failure to warn, strict liability, breach of warranty, negligent misrepresentation and fraud. The lawsuits call for compensatory and punitive damages.
For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).