Bayer Faces 2,500 Mirena Lawsuits in State, Federal Court

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November 19, 2014 — Bayer HealthCare is facing nearly 2,500 lawsuits involving Mirena, an intrauterine device (IUD) that woman claim can spontaneously perforate the uterus, migrate, and require surgery to remove.

About half of the lawsuits have been centralized in a federal Multi-District Litigation (MDL) in the Southern District of New York, overseen by U.S. District Judge Cathy Seibel.

According to an update (PDF), there are 1,089 lawsuits pending in the MDL. The first “bellwether” trial is scheduled to begin in March 2016.

An additional 1,250 Mirena lawsuits are pending in state court in New Jersey, where they are overseen by Judge Brian R. Martinotti.

Women accuse Bayer of failing to include adequate warnings about uterine perforation. The label only includes warnings about perforation during the insertion procedure, despite thousands of adverse event reports describing spontaneous migration and perforation — sometimes months or years after insertion.

Complications may include scarring, adhesions, infections, infertility, intestinal perforations, and more. In some cases, women suffered complications for years before doctors realized that the IUD had not fallen out and was actually lost inside the abdomen.

Bayer is also facing at least 9 lawsuits from women who were diagnosed with Intracranial Hypertension — high pressure inside the skull due to excess cerebrospinal fluid — a complication that was first linked to levonorgestrel-releasing IUDs in the 1990s.

This is not the first time Bayer has been accused of downplaying risk information. In 2009, the FDA issued a warning letter after finding that some of the promotion materials for Mirena made misleading claims about the safety and efficacy of the contraceptive implant.

 

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