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Mirena Lawsuits

Mirena IUD is a medical contraceptive device for woman that claims a 99.9% chance of stopping pregnancy.

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Mirena IUD is t-shaped intrauterine device, which when implanted in the patient’s uterus by a clinician claims to prevent pregnancy for up to 5 years. Mirena IUD contains a very small dosage of Levonorgestrel hormone when compared to a common birth control pill, which is released gradually over time, thus ostensibly preventing pregnancy should the device remain in place. Around 2 million Mirena IUD devices have been implanted in the United States alone.

Claims Made in Mirena Lawsuits

Bayer, the maker of the Mirena intrauterine device, has faced numerous claims from consumers regarding then failure of the device, as well as relating to fraudulent marketing practices to both consumers and medical professionals. A handful of pre-existing claims found in Mirena lawsuits include;

  • Perforation of the patient’s uterus, generally as the result of unintended movement of the IUD device
  • Migration of the IUD into the patient’s intestinal or ovarian cavity, while also failing to protect against pregnancy, also has lead to intestinal abscesses and perforation or obstruction of the patient’s bowel
  • IUD devices that have dislodged are an immediate medical concern, and as such, patient’s have made claims in light of undergoing sometimes multiple surgeries to find and remove the dislodged Mirena IUD
  • An increased risk of breast cancer in the Mirena and other similar contraceptive devices, which were not sufficiently reported to consumers and physicians
  • Painful and expensive pre-emptive removal of the Mirena IUD in light of a growing body of evidence substantiating the risks posed by the product
  • Unplanned pregnancy in light of device failure, which has also lead to dangerous cases of ectopic pregnancy
  • Pelvic inflammatory disease in light of defective Mirena devices
  • Failure to warn both medical professionals and women of these known dangers posed by the spontaneous migration of the device
  • Claims that Bayer knowingly marketed and sold a defective IUD product to consumers, with the additional caveat that marketing practices by the company were intentionally deceptive
  • Failed to notify patients and professionals of these complications, while also downplaying their frequency and misrepresenting the benefits of the device in light of these and other problems

In the case of Mirena lawsuits, the company has been under scrutiny by the FDA since at least 2009 for marketing and advertising claims, which violated the Food, Drug, and Cosmetic Act. In the incident from 2009, the company was found in breach of the Act by way of making false claims that its IUD device:

  • Increased the emotional intimacy of patient’s romantic life
  • Increased the self-confidence of the user
  • Failed to provide appropriate usage instructions for Mirena IUD users

Ultimately, the FDA held that the company acted irresponsibly in its advertising and marketing towards a consumer population of generally young women, while attempting to avoid known and otherwise documented side effects of the drug such as increased weight, appearance of acne, and breast pain in the patients. Specifically, the company employed an innovative marketing strategy using third party marketers to reach out to young women, who otherwise would have been inclined to take the more common oral contraceptive birth control pills. Part of this marketing process entailed downplaying the known risks of IUD implantation, as well as grossly overstating the potential benefits of the IUD.

To date, over 60,000 instances of violations of FDA rules and regulations, as well as adverse medical complications due to the spontaneous migration of the IUD device into the patient’s body cavities, have been substantiated by the FDA since the drug went to market in 2000. To date, the company has still yet to recall the device.

Mirena Lawsuits Currently

Following growing numbers of lawsuits filed against Bayer across the United States, multi-district consolidation have been initiated, with federal-level multi-district litigation cases consolidating as recently as October of 2015 with numerous class-action suits pending in state jurisdictions. In response, the company has settled some claims individually, however, all class-action litigation cases are pending or accepting new plaintiffs at this time.

 

Sources:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197229.pdf

http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm119274.htm

http://www.newsweek.com/2014/05/02/courtroom-controversy-behind-popular-contraceptive-mirena-248443.html

 

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