Mirena MDL Over Idiopathic Intracranial Hypertension Tossed

Mirena MDL Over Idiopathic Intracranial Hypertension Tossed

Introduction

On Tuesday, the 2nd Circuit U.S. Court of Appeals dismissed the Mirena multidistrict litigation after finding that the plaintiffs lacked evidence over the allegations that the birth control device was the cause of idiopathic intracranial hypertension (IIH) in them.

Mirena is a type of long-acting, reversible hormonal intrauterine device (IUD) manufactured by Bayer Pharmaceuticals. It is a small T-shaped flexible device that is placed into the uterus by a trained healthcare provider during a routine office visit. Once implanted, Mirena releases small amounts of a progestin hormone called Levonorgestrel, locally into the uterus. It provides continuous, highly effective birth control.

It was approved in 2000 by the U.S Food and Drug Administration (FDA) and is one of two hormonal IUDs for use in the United States. In 2009, the FDA expanded Mirena's approval to treat heavy menstrual bleeding in women already using an IUD. It was also claimed to be more than 99 percent effective in controlling pregnancy for up to 5 years, after that the implant needed replacement.

The MDL consisted of more than 900 lawsuits, in which the plaintiffs linked the intrauterine device (IUD) to a disorder with similar symptoms to a brain tumor.

In October 2018, the district judge issued a 156-page opinion allowing Bayer's Daubert motion to exclude expert testimony. In June 2019, the manufacturer was granted summary judgment, and all the cases in the MDL were closed, ruling that the women failed to prove their allegations.

The plaintiffs appealed, stating that the district court focused too much on the conclusions instead of the methodologies and also argued the district court should have only excluded parts of the expert testimony.

In a recent opinion, the appellate panel upheld an award of summary judgment to Bayer, rejecting the plaintiffs' argument that the district court abused its discretion by stopping them from pursuing additional documents.

The panel noted that the rigorous analysis in the 156-page opinion undermined the women's assertion and said that the women did not identify which parts should have been included or how those parts would have shown the causation necessary for the suit to survive summary judgment.