New Mirena Lawsuit Claims Woman Sustained Permanent Injuries During "Unethical" Clinical Trial Testing Off-Label Use of Mirena IUD
NEW YORK, March 26, 2014 /PRNewswire/ -- A new Mirena lawsuit (http://www.themirenalawsuitcenter.com) has been filed against the Washington University School of Medicine in St. Louis, Missouri, on behalf of a woman who allegedly sustained permanent injuries during a clinical trial involving the off-label use of the Mirena IUD. According to the lawsuit, which is pending in St. Louis Circuit Court, the researchers conducting the study ignored safety information contained in the Mirena prescribing information, and implanted the IUD in the woman immediately after she gave birth. Within days of the insertion, the plaintiff developed endocarditis, and subsequently had to undergo two heart surgeries. Endocarditis is an inflammation of the heart valves that can sometimes be caused by a bacterial infection.
According to the lawsuit, Washington University researchers failed to explain to the plaintiff that one of the purposes of the clinical trial was to assess the safety of post-placental insertion of Mirena, despite warnings from the manufacturer that the IUD should not be inserted earlier than four to six weeks after a woman gives birth. According to Bayer Healthcare Pharmaceuticals, the manufacturer of the Mirena IUD, the uterus may be prone to infection in the weeks immediately following delivery.
"While Bayer is not named as a defendant in this complaint, the company is facing hundreds of other Mirena IUD lawsuits that have been filed on behalf of women who were allegedly injured when the device was used in accordance to label directions," says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices, including numerous women who were allegedly harmed by Mirena. The Firm is currently offering free legal evaluations to women who sustained uterine perforations, infections, scarring, organ damage or other Mirena complications allegedly associated with spontaneous migration of the IUD.
The Mirena IUD was brought to market in 2000, and is now approved as both a method of birth control and as a treatment for heavy menstrual bleeding in women who wish to use an IUD for contraception. Since its initial approval, the U.S. Food & Drug Administration (FDA) has received more than 70,000 adverse event reports implicating Mirena, including many that involve device dislocation and uterine perforation. The FDA issued Bayer a warning letter in 2009, after finding that one of its Mirena promotions overstated the benefits associated with the IUD and understated its risks.
According to court documents, Bayer Healthcare Pharmaceuticals has been named in more than 1,000 lawsuits that have been filed in state and federal courts on behalf of women who allegedly suffered serious Mirena complications that followed spontaneous migration of the device. These include at least 660 Mirena IUD lawsuits that are pending in New Jersey's Bergen County Superior Court. (In Re: Mirena Litigation; Case No. 297). Another 428 claims have been filed in a federal multidistrict litigation underway in U.S. District Court, Southern District of New York. (In re: Mirena IUD Products Liability Litigation, MDL No. 2434)
All of these lawsuits claim that Bayer has a history of downplaying the risks associated with Mirena, and exaggerating its purported benefits. While women in Mirena lawsuits allegedly experienced device migration following the proper insertion of the IUD, the complaints point out that the labeling for the device only warns that migration might occur if the uterus is perforated during its insertion.
Compensation may be available for women who suffered serious Mirena complications allegedly related to spontaneous migration of the IUD. To learn more about filing a Mirena lawsuit, please visit Bernstein Liebhard LLP's website, or the Firm's Facebook page: https://www.facebook.com/mirenalawsuithelp. For a free legal consultation, please call (888) 340-4807.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the Plaintiffs' Hot List, recognizing the top plaintiffs firms in the country, for the past 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since the list was first published in 2003.
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