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Mirena IUD Lawsuit Cites Uterine Perforation Injuries

Anne O’Neill, a 51-year-old Pennsylvania resident, filed a Mirena IUD lawsuit in the Eastern District of Pennsylvania in September of 2013. The plaintiff is pursuing a claim against Bayer Healthcare Pharmaceuticals, alleging the company produced a dangerous medical device, failed to warn her of the risks, and breached express and implied warranties.

O’Neill is seeking compensation because the IUD produced by Bayer reportedly perforated her uterine wall and migrated to the peritoneal cavity. Because of the Mirena uterine perforation, removal from the abdominal cavity through a laparoscopy procedure was necessary and the plaintiff incurred medical costs and suffered physical harm.  She is demanding more than $75,000 in compensation for non-economic damages, as well as punitive damages and payment of related medical bills.

Mirena IUD lawsuit allegations 

The Mirena IUD is a T-shaped device made of soft plastic and inserted into the uterus by a healthcare professional. The device releases hormones into the body and claims to be more than 99 percent effective at preventing pregnancy for up to five years after implantation.

Bayer Pharmaceuticals promotes Mirena by promising the device is effective, convenient, reversible, free of estrogen and approved for heavy periods.  O’Neill’s lawsuit, however, alleges Bayer Pharmaceuticals has a “history of overstating the efficacy of Mirena while understating the potential safety concerns.”

One of the most significant health concerns related to the IUD is the potential for Mirena uterine perforation and migration of the device. While the FDA warns about these dangerous possibilities, the label on the IUD describes perforation as uncommon and fails to alert patients to the potential the device will migrate throughout the body.

Attorneys for Anne O’Neill allege that she was diagnosed with perforation and migration of the Mirena in 2010, approximately two years after her IUD was inserted in June of 2008. O’Neill required surgical intervention to remove the device and is now reportedly at risk of future medical complications.

Bayer Pharmaceuticals accused of misleading marketing 

O’Neill asserts she had a Mirena IUD implanted after being targeted by a consumer-directed program entitled “Mirena Simple Style Statements Program.” The advertising material and information provided allegedly omitted details about the dangerous side effects of Mirena, giving rise to O’Neill’s complaints that Bayer failed to warn her of the risks of the drug as well as to allegations of fraudulent misrepresentation and fraud by concealment.

O’Neill’s lawsuit also contends that Bayer was negligent during both design and testing of the product and that both express and implied warranties were breached.   The lawsuit seeks to hold the drug company responsible as a result of these reported warranty breaches; as a result of the breached duty of care to the public; as a result of the defective design and/or manufacturing of the Mirena IUD devices, and as a result of the failure to warn patients of the risks of the Mirena IUD.

Lawsuits against drug companies also arise under strict liability rules. The law mandates pharmaceutical manufacturers can be held liable whenever they release a product that causes unexpected harm when used as intended. In this case, Mirena attorneys for the plaintiff argue the intrauterine birth control device was unreasonably dangerous when it left the hands of the manufacturer.  If its benefits exceeded its risks and if the device caused harm to users, Bayer may be held responsible for compensating victims for loss.

Compensation for victims of Mirena complications 

O’Neill is one of more than two million women in the United States who chose Mirena as a birth control solution.  The contraceptive device remains on the market despite more than 50,371 reports of adverse events from Mirena users between 1997 and 2012.  Many of these women have reportedly experienced complications including uterine perforation, intrauterine pregnancy, ectopic pregnancy and other serious side effects.

Many women have taken legal action through filing a Mirena IUD lawsuit. Other claims against the drug company allege similar failures that seek to hold Bayer Pharmaceuticals liable for paying damages to cover medical bills; lost income; pain and suffering; and punitive damages.