San Diego, CA (PRWEB) May 30, 2013
Resource4thePeople announced today an update for consumers about consolidated federal lawsuits filed by women who are alleging that they suffered serious side effects as a result of their use of the Mirena Intrauterine Device.
The United States Judicial Panel on Multidistrict Litigation has designated the lawsuits as a multidistrict litigation and assigned the cases to U.S. District Court Judge Cathy Seibel in the Southern District of New York.* The current number of lawsuits in the litigation is 46, according to the court file.**
"This is a significant development for consumers who may have been affected by their use of the Mirena IUD because a larger number of federal lawsuits containing common allegations that women suffered serious health problems as a result are now before a single judge," said Resource4thePeople.
"The role of a multidistrict litigation judge is to oversee pre-trial evidence gathering and coordinate the actions of both plaintiff and defense attorneys. The history of multidistrict litigations is for additional lawsuits to be filed as this litigation moves forward and we fully expect that to happen."
Resource4thePeople is offering free consultations to advise women of the legal options that may be available to them over allegations of complications from the Mirena IUD, which received approval from the Food and Drug Administration in 2000 as a contraceptive and was approved to treat heavy menstrual bleeding in 2009.
“We have been receiving an increasing number of inquiries from women about serious complications that they are attributing to the use of the Mirena IUD and whether they might be eligible to also seek compensation for pain and suffering, medical costs, loss of wages and other expenses they may have incurred," said Resouce4thePeople.
The Mirena IUD is designed as a t-shaped IUD, which , after being placed in the uterus, is supposed to serve as a method of preventing pregnancy for as many as five years. The method of contraception is the release into the uterus of the progestin levonorgestrel to prevent the release of eggs in a woman's ovaries.
In the years since 2000, FDA records*** now show that there have been about 50,000 Adverse Event Reports filed with the agency by women and health care professionals in which a number of side effects suffered allegedly from the use of the Mirena IUD have been submitted. Among the alleged side effects reported:
- Ectopic Pregnancy
- Ovarian Cysts
"It has become quite clear from the huge problem of Adverse Event Reports received by the FDA that both women and health care professionals have raised concerns about the safety of the Mirena IUD both in its use as a contraceptive and to treat menstrual bleeding," said Resource4thePeople.
"We recognize that the Mirena IUD has been the method of contraception for millions of American women who have also generated millions of dollars in profits for its manufacturer, Bayer AG, the huge German-based pharmaceutical company, which also is now defending itself against lawsuits filed by women alleging these side effects."
What is contained in these Mirena IUD lawsuits against Bayer in which allegations of dangerous side effects are being made? In two of the most recent**** lawsuits filed against Bayer over these allegations, lawyers for women are claiming that Bayer knew, or should have known, that the use of the Mirena IUD posed serious health risks for women and Bayer failed to adequately warn consumers or government regulators.
"Our national team of lawyers is now reviewing claims that the use of the Mirena IUD allegedly led to medical conditions including ectopic pregnancy, infertility, perforation of the uterine wall, cervix and pelvic organs, embedment of the device in the uterine wall or other organs, migration of the IUD, infertility, pelvic inflammatory disease and serious infections that may have required surgical removal of the device."
Resource4the People notes that although Bayer has marketed the device as a safe, convenient alternative to birth control pills and other contraceptives the FDA raised objections to that marketing plan and reacted against the campaign.
The FDA issued a warning letter***** to Bayer officials in 2010 in which FDA regulators objected to the marketing campaign, admonished Bayer and told the company that it was downplaying the health risks of the Mirena IUD while overstating its benefits.
Here is some of the language used by the FDA in its warning letter:
"The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act."
In addition to the FDA's warning letter over marketing concerns, the agency also, in response to the increased number of Adverse Event Reports that it said it was receiving, directed Bayer to change the side effects warning on the Mirena IUD information labels warning patients of additional side effects.******
Among the side effects affected by this new warning label language are serious health problems such as congenital anomalies, embedment, perforation, expulsion, ovarian cysts and breast cancer.
Included in this new FDA-ordered language is: “If perforation occurs, pregnancy may result (see WARNINGS, Ectopic Pregnancy and Intrauterine Pregnancy). Mirena must be located and removed; surgery may be required. Delayed detection of perforation may result in migration outside the uterine cavity, adhesions."
*In Re: Mirena IUD Products Liability Litigation, MDL 2434 U.S. District Court, Southern District of New York
****MRSL-2723-12 and MRSL-2724-12, New Jersey Superior Court, Law Division, Morris County