Mirena Lawsuit Alleges IUD Perforated Pelvis

Massachusetts resident Carolyn Ferrara is suing Bayer Healthcare Pharmaceuticals over personal injuries and economic damages she alleges are a direct a result of the Mirena IUD.

The product liability complaint was brought in the US District Court for the Western District of Massachusetts and lists the following causes of action:

• Failure to warn
• Negligence
• Fraud by concealment
• Fraudulent misrepresentation
• Breach of Implied warranty
• Breach of Express warranty
• Design defect
• Strict product liability
• Defective manufacturing

According to her Mirena lawsuit, the IUD, after an uncomplicated implantation, had migrated and perforated the anterior region of her pelvis, requiring surgical removal.

In addition to general and compensatory damages, the plaintiff is demanding punitive reparations from Bayer, based on accusations that the defendants knew of the product’s dangers but concealed this information from the public, medical community and FDA. Ferrara joins the ranks of hundreds of other women who claim that the healthcare giant “intentionally, willfully, and maliciously concealed and suppressed” facts regarding potential Mirena complications and health risks, putting unsuspecting consumers in harm’s way.

Bayer allegedly failed to warn about Mirena migration risks

The lawsuit contends that the Mirena packaging label does not adequately caution about spontaneous migration of the device, and only says that movement may occur at the time of insertion if the uterus is perforated. Ferrara had the IUD inserted on August 18, 2011. In December of 2013, after experiencing severe pain, she had laparoscopy to remove the device, which had migrated out of its original position before puncturing organs within her pelvis.

The complaint states that surgical removal of the IUD carries with it risks of infection, adverse anesthesia reactions, perforation of adjacent organs and adhesion formations.

Ferrara argues that the Mirena intrauterine device was defectively manufactured and designed and can cause permanent injury when used as directed. Bayer conducted inadequate pre-market testing for risk of perforation and migration and associated infections, claims the plaintiff, who further contends that Bayer downplayed adverse events in their direct-to-consumer promotional activities.

In 2009, the Department of Health and Human Services Division of Drug Marketing, Advertising, and Communications (DDMAC) sent Bayer a warning letter regarding their “Simple Style Program” campaign, which overstated the advantages of Mirena while downplaying possible risks.

Mirena lawsuits mount

It is estimated that more than two million American women are currently using the Mirena IUD, which is designed to prevent unwanted pregnancy for up to five years. Other plaintiffs who are now seeking legal restitution from Bayer claim that the IUD is unreasonably dangerous, causing them to suffer other side effects and complications including:

• Pelvic inflammatory disease
• Perforation of the uterus and other internal structures
• Adhesions and abscesses
• Infertility
• Brain injury – Idiopathic Intracranial Hypertension ( IIH)

Lawsuits alleging Mirena injuries have been centralized on both the state and federal level to more efficiently process claims and reduce burdens on the judicial system. The Mirena product liability multidistrict litigation was established in New York district court on April 8, 2013. And in May of the same year, multi-county (MCL) litigation was formed in New Jersey state court, before Judge Brian Martinotti.

While the cases are consolidated to share in pretrial processes, each plaintiff’s lawsuit remains individual, ensuring claimants are entitled to their own jury verdict or settlement.

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