San Diego, CA (PRWEB) June 22, 2013
Resource4thePeople announced today its latest update for consumers who are following the progress of federal lawsuits filed by women alleging that they suffered serious side effects as a result of their use of the Mirena Intrauterine Device.
The first news involves the scheduling of an important status hearing in the multidistrict litigation in which cases from across the country have been consolidated before a single federal judge, according to the court docket in the litigation.*
The hearing was scheduled by U.S. District Court Judge Cathy Seibel in the Southern District of New York, who was assigned to oversee the consolidated lawsuits by the United States Judicial Panel on Multidistrict Litigation.
"We are pleased that the judge has scheduled this important hearing at which an update of the status of this litigation that involves women who are alleging they have suffered serious side effects from the use of Mirena IUDs will be discussed in open court," said Resource4thePeople.
"Attorneys for the women who have filed these Mirena IUD lawsuits and lawyers for Mirena will be asked to present to the judge and update about the status of these cases and we will provide further updates after the hearing."
Resource4thePeople also reports that the current number of lawsuits in the litigation is 46, according to the court file, which provides the latest statistics compiled in May.**
"As this litigation continues other women who are alleging that they have suffered serious health problems as a result of their use of the Mirena IUD will continue to be eligible to file their own legal actions," said Resource4thePeople.
"In the meantime, in response to the inquiries we have been receiving from consumers over this litigation our national network of lawyers will continue to offer free consultations to women who wish to inquire about their own eligibility to join in this litigation."
Resource4thePeople notes that as the multidistrict litigation judge in this case, Judge Seibel will oversee pre-trial evidence gathering and coordinate the actions of both plaintiff and defense attorneys.
The lawsuits, according to the court file, involve common 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.
“The allegations we have been reviewing from women about serious complications they are attributing to the use of the Mirena IUD involve whether they might be eligible to 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 the number of Adverse Event Reports filed with the agency has climbed to over 50,000 from women and health care professionals reporting side effects allegedly suffered from the use of the Mirena IUD. Among the alleged side effects reported:
"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.
"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 the device's manufacturer, Bayer Pharmaceuticals, 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.
"The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena," the FDA said. "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