San Diego, CA (PRWEB) August 11, 2013
http://www.resource4thepeople.com/defectivemedicaldevices/mirena-IUD-lawsuits.html
Resource4thePeople announced today its latest consumer update about the progress of lawsuits filed by women alleging that they suffered serious side effects as a result of their use of the Mirena Intrauterine Device.
The most important news is that an important Aug. 14, 2013 court hearing has been set by the judge in U.S. District Court for the Southern District of New York who is overseeing consolidated federal lawsuits* alleging Mirena IUD serious side effects.
A check of the court file in the federal multidistrict litigation reveals that as of July 10, 2013 there were 105 Mirena lawsuits consolidated under U.S. District Judge Cathy Seibel alleging that the Mirena IUD caused serious health problems.
"It is an encouraging sign that Judge Seibel has set this hearing and scheduled others to keep this litigation on track and move women who are alleging that the Mirena IUD is a defective product closer to having their day in court," said Resource4thePeople.
"As this litigation progresses our national team of experienced attorneys will continue to provide free consultations and review allegations from other women who may be seeking compensation over similar claims."
The court file in these cases shows that among the allegations are claims that the Mirena IUD migrated from its original positioning and subjected women to perforated uteruses and other serious side effects.
Judge Seibel, who was assigned the consolidated federal Mirena IUD lawsuits from across the country by the United States Judicial Panel on Multidistrict Litigation because they contain common allegations.
Resource4thePeople also is reporting that another key court hearing has been scheduled for Aug. 13, 2013 in a separate state court multicounty litigation in New Jersey with at least 170 cases, according to the court file in that litigation.** These lawsuits contain the same allegations as the federal cases.
"Based on the increasing number of consumer inquiries in response to this litigation we anticipate the number of claims and lawsuits involving Mirena IUD allegations to increase as this litigation advances on both the state and federal court levels,” said Resource4thePeople.
“Our team of attorneys are currently reviewing these allegations that include claims of ectopic pregnancies, sepsis, perforations and ovarian cysts.”
Resource4thePeople also reports that among the most recent Mirena IUD lawsuits alleging serious side effects is one filed by an Ohio woman in a Pennsylvania federal court.***
That woman claims that a Mirena IUD migrated, punctured her cervix and has caused her serious health problems for which she has incurred medical and other expenses, according to the court file in the case.
The woman also claims that officials at Bayer Pharmaceuticals, the contraceptive's manufacturer, knew that the product posed such risks and put it on the marketplace without adequate warnings to consumers, according to the file.
"As more Mirena IUD lawsuits alleging serious health problems are filed and more information becomes available about this product we will continue to update consumers," said Resource4thePeople.
The Mirena IUD received approval from the Food and Drug Administration in 2000 as a contraceptive and was approved to treat heavy menstrual bleeding in 2009.
The device is 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 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.
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
*** Gonzalez v. Bayer Pharmaceuticals Corp. et al., Case # 2:13-cv-04082-JP, U.S. District Court for the Eastern District of Pennsylvania
****http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm
*****http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197229.pdf
******http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm121936.htm