MDL Judge Dismisses All Pseudotumor Cerebri Lawsuits Over Mirena IUD Birth Control

After excluding plaintiffs’ expert witnesses on the link between Mirena IUD and pseudotumor cerebri last year, the U.S. District Judge presiding over the litigation has dismissed hundreds of claims brought by women who suffered complications associated with the buildup of fluid pressure around the brain after receiving the birth control implant.

In an Opinion and Order (PDF) issued on June 11, a motion for summary judgment filed by Bayer Healthcare was granted, finding that plaintiffs lack sufficient evidence to establish that their injuries were caused by the Mirena IUD implant.

Bayer previously faced nearly 1,800 Mirena IUD lawsuits filed throughout the federal court system involving women who developed pseudotumor cerebri (PTC) or idiopathic intracranial hypertension (IIH), each raising similar allegations that the manufacturer failed to adequately warn women and the medical community about the risk that they may be left with severe headaches, vision problems and other complications caused by the dangerous buildup of pressure in the skull.

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Mirena is a small, T-shaped device that is placed into the uterus to provide protection against pregnancy for up to five years. Known as an intrauterine device (IUD) or intrauterine system (IUS), the polyethylene frame for Mirena contains a steroid reservoir that release levonorgestrel, which is a second generation progestin used in many forms of birth control.

While other forms of birth control that involve levonorgestrel contain warnings about a risk of pseudotumor cerebri (PTC), plaintiffs alleged that the Mirena warnings have failed to adequately alert women and physicians about risk that the birth control implant may cause a buildup of fluid pressure around the brain. Prompt diagnosis and treatment of the intracranial hypertension from Mirena is critical to avoid permanent damage to the optic nerve.

Given common questions of fact and law raised in complaints filed in U.S. District Courts nationwide, the litigation has been centralized before U.S. District Judge Paul A. Engelmayer for coordinated discovery and pretrial proceedings, as part of a federal MDL, or multidistrict litigation.

As the first cases were being prepared for trial, Judge Engelmayer issued an order late last year, which excluded the testimony of seven expert witnesses put forward by the plaintiffs, finding that the opinions were not based on sufficiently reliable science.

According to a 55 page order issued this week, the plaintiffs were left without sufficient evidence to establish general causation, and Judge Engelmayer indicated that all remaining cases pending in the MDL will be terminated. Plaintiffs are expected to appeal the decision.


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