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If you suffered infection, uterine perforation, an abscess, or were unable to conceive after being implanted with the Mirena IUD birth control device, you may be eligible to pursue a Mirena lawsuit.
The plastic, t-shaped device has been suggested to cause a myriad of side effects that have led more and more women to file Mirena lawsuits against the manufacturer, Bayer Healthcare Pharmaceuticals. Many Mirena side effects, which include abscesses, embedment in the uterine wall, uterine perforations, infection and ectopic pregnancies, occur when the device migrates from the uterus, where it was originally implanted by a health care provider.
Unfortunately, many Mirena complications can only be corrected by way of a revision surgery, and can permanently jeopardize a woman’s ability to conceive a child—causing more and more women to consider Mirena lawsuits.
Despite the potential for these side effects to occur, the Mirena IUD is still being hailed as a first-line form of birth control by some members of the medical community. In a recent article published in USA Today, the American College of Obstetricians and Gynecologists (ACOG) recommended that young women and teenagers consider using IUDs over condoms and birth control pills, but glossed over the side effects that could stem from the contraceptive device. The group of medical experts also contradicted information on Mirena’s website, on which Bayer says that only women who already have had one child should use an IUD.
The Mirena IUD was approved in 2000 as a contraceptive in the U.S. Before its approval in America, the device had been used by thousands of women in Europe, where it was marketed by Berlex Laboratories, Inc. Mirena’s list of uses was later expanded in 2009 to treat heavy menstrual bleeding in women who used the device as a form of birth control. It is estimated that approximately 2 million women in the U.S. currently use Mirena.
Upon approving the IUD, Kathleen Uhl, M.D., director of the FDA’s Office of Women’s Health issued the following statement: “Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening. Bleeding can be so heavy that women must miss work, school, or social activities.”
Despite the fact that the U.S. Food and Drug Administration (FDA) has reportedly received thousands of adverse event reports naming Mirena side effects, Bayer had not revised its product labeling to include the risk for device migration and perforation of the uterine lining as of April 2013.
Despite the fact that Mirena has been on the market for some time, the first claims alleging spontaneous migration of the IUD and other injuries were not filed until recently.
The first claim was filed on April 12, 2012, on behalf of an Ohio woman whose lawsuit said she was forced to undergo a hysteroscopy to remove the birth control implant. Given the fact that thousands of women use this IUD, however, the number of cases is likely to rise. On December 4, 2012, lawyers for a Florida woman filed a case over Mirena after the IUD allegedly migrated from its original point of insertion in her uterus, which it later perforated. Later, revision surgery was necessary to remove the device.
Additionally, a woman in Kentucky filed her case against Bayer on January 2, 2013 after suffering spontaneous migration of the device and uterine perforations. Her Mirena IUD lawsuit said she had to have the device surgically removed.
Mirena lawsuits allege Bayer failed to warn of the potential for the IUD to spontaneously migrate outside the uterus, where it is implanted by a health care provider. Thus, plaintiffs claim the Mirena IUD was defectively designed.
On April 8th, 2013, federally-filed Mirena lawsuits were consolidated in the U.S. District Court for the Southern District of New York. According to the Order issued on that date by the U.S. Judicial Panel on Multidistrict Litigation (JPML), this location would be most convenient since the manufacturer of the birth control device is based in New York, and has corporate affiliates in New Jersey, Connecticut and Pennsylvania. Pretrial proceedings for these cases will be overseen by Judge Cathy Seibel. (In re: Mirena IUD Products Liability Litigation, MDL No. 2434)
In its Order, the JPML said, “Thus, the primary witnesses and documentary evidence on the common factual issues likely will be located in New York and the surrounding area. This district also will be easily accessible for this nationwide litigation.”
The decision to establish a multidistrict litigation (MDL) was reached after plaintiffs petitioned to centralize federal cases in the Northern District of Ohio on Jan. 16, and also after Bayer requested that the New Jersey Supreme Court consolidate all future lawsuits be consolidated into a multicounty litigation in Superior Court, Middlesex County, NJ. Both of these requests were later denied. Lawsuits filed on behalf of women allegedly injured as a result of Mirena allege Bayer failed to provide adequate warnings about its risk for complications.
Since the creation of this federal MDL, Mirena lawsuits have continued to move forward. As of June 2013, nearly 50 claims had been filed in the Southern District of New York on behalf of women who allegedly suffered spontaneous device migration, uterine perforation and other injuries caused by the device.
Additionally, a consolidated litigation for Mirena IUD lawsuits filed in the state of New Jersey has been established in Bergen County Superior Court. In June, court records indicated that approximately 100 claims over the IUD had been filed in the proceeding, which was formed by the New Jersey Supreme Court on May 24th, 2013. (In Re: Mirena Litigation; Case No. 297)
On June 17, 2013, NewsChannel5 in Cleveland, Ohio reported that over 70,000 adverse event reports involving the Mirena IUD have been logged with the FDA since its U.S. approval in 2000, including thousands citing uterine perforations and dislocation.
Bayer Healthcare Pharmaceuticals, the pharmaceutical division of Bayer Healthcare AG, markets products to over 100 countries worldwide. In 2012, the company generated more than €10,803 million in sales, and is comprised of 37,700 employees around the world. 7,500 of Bayer’s staff members work in research and development alone, according to the company’s website. Cardiovascular and blood diseases, oncological diseases, ophthalmology, women’s healthcare and imaging techniques represent Bayer’s five major focuses.
Bayer AG is one of the largest multinational corporations focusing on medical products and drugs. The subdivision was formed in 2006 when Bayer Healthcare AG purchased the research company, Schering AG for $19.8 billion. The purchase is one of the largest takeovers in the healthcare industry.
For those who were implanted with the Mirena IUD and suffered injuries, you may be eligible to join the growing number of women in the U.S. who have gone on to file claims against the manufacturer seeking compensation for any lost wages and medical bills as well as any pain and suffering incurred by their injuries. For more information about your legal options and how to file a Mirena lawsuit, call an attorney at Bernstein Liebhard LLP at .