Mirena IUD Complications Lawsuit Allegations Update: Resource4thePeople Reports Number of Cases Continues to Increase
San Diego, CA (PRWEB) July 18, 2013 -- http://www.resource4thepeople.com/defectivemedicaldevices/mirena-IUD-lawsuits.html
Resource4thePeople announced today new information for consumer in connection with 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.
Since the last consumer update the number of lawsuits that have been filed in both state and federal consolidated litigation has increased under the supervision of judges who have been assigned to oversee pre-trial evidence gathering and other legal actions in the cases involving allegations of serious health problems caused by the Mirena IUD.
“We anticipate these numbers to increase as this litigation advances on both the state and federal court levels,” said Resource4thePeople. “There also have been an increasing number of consumer inquiries in connection with allegations of ectopic pregnancies, sepsis, perforations and ovarian cysts.”
“We are announcing the continuation of our national network of attorneys’ offer of free consultations to women who are seeking information about what legal rights they may have to compensation in such cases. We ask that they follow the link to our web site and take advantage of our toll-free access line.”
A check of the court files in the cases reveals that as of July 10, 2013 there are 105 Mirena lawsuits now consolidated in U.S. District Court in the Southern District of New York* alleging that the Mirena IUD caused serious health problems for which the women seek compensation.
Among the allegations in these cases, according to the court file, are claims that the device migrated from its original positioning and caused problems as severe as perforated uteruses and other serious side effects.
These cases are under the jurisdiction of U.S. District Court Judge Cathy Seibel, who was assigned consolidated federal Mirena IUD lawsuits from across the country by the United States Judicial Panel on Multidistrict Litigation.
"Judge Seibel recently scheduled a status conference with lawyers from both sides of the litigation which is one of the stepping stones in the progress of such legislation,” said Resource4thePeople. “As more details about the progress of the litigation become public we will continue to update consumers who may have been affected by similar allegations in connection with the Mirena IUD.
Meanwhile, the number of Mirena lawsuits assigned to a separate state court multicounty litigation in New Jersey has climbed to at least 170, according to the court file in that litigation.** These lawsuits contain the same allegations as the federal cases alleging serious complications from the use of the contraceptive.
The lawsuits, according to the court files in both litigations, 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 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.
"Our lawyers are 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,” said Resource4thePeople.
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."
Sources:
*In Re: Mirena IUD Products Liability Litigation, MDL 2434 U.S. District Court, Southern District of New York
**In Re: Mirena Multicounty Litigation, Bergen County Superior Court of New Jersey Case #297
*****http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm121936.htm
Bill Callahan, iLawSuit, 858 602-2749, [email protected]
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