Judge to Review Expert Testimony on Mirena Pseudotumor Cerebri Risk This Week

The U.S. District Judge presiding over all federal Mirena IUD lawsuits over the development of pseudotumor cerebri (PTC) will hear presentations this week as part of a “science day”, which is designed to educate the Court about the link between the controversial birth control implant and the build up of fluid pressure on the brain, which has caused women to suffer headaches, vision problems and other complications.

There are currently more than 400 lawsuits pending against Bayer Healthcare over failure to warn women and the medical community about the potential risk of pseudotumor cerebri associated with Mirena IUDs, which are commonly used among women to provide protection against pregnancy for up to five years.

Given common questions of fact and law raised in cases filed by women nationwide, the litigation is centralized before U.S. District Judge Paul A. Engelmayer for coordinated discovery and the management of a series of early “bellwether” trials, which are designed to help the parties gauge how juries may respond to similar evidence and testimony that will be repeated throughout other cases.

In an order (PDF) issued on March 30, Judge Engelmayer laid out the rules that will apply to the “Science Day” hearing set to begin today. The presentations will cover the female reproductive system, contraception, the Mirena IUD and how it’s used; how PTC/IIH affects patients, and how it is diagnosed and treated, as well as its incidence rate in the population. It will also address different types of scientific evidence and how they apply to linking the Mirena to PTC/IIH injuries.

During the non-adversarial presentations, the parties will not discuss general causation, levels of levonorgestrel, links between other contraceptives and PTC/IIH and some other topics, according to the order. The proceedings will also be held off the record, including presentations made by physicians and scientists, who will not undergo cross examination.

It is common for Courts to schedule such scientific presentations in complex product liability litigation, where a large number of claims have been brought alleging that individuals suffered similar injuries or medical issues as a result of the same product. “Science Days” are designed to allow the parties to explain issues that will come up in a case.

This week, Judge Engelmayer will also hold Daubert hearings, to consider each side’s challenges to the admissibility of certain expert testimony, weighing the reliability of studies used by those experts to form the basis of their opinions. Those hearings are scheduled for Tuesday and Wednesday, but may also carry over to Thursday if additional time is needed, according to another order (PDF) issued on March 30.

Mirena IUD Pseudotumor Cerebri Litigation

Each of the complaints in the litigation raise similar questions about whether Bayer withheld important warnings from consumers and the medical community about risk that their birth control implant may cause a dangerous build up of fluid pressure around the brain, known as pseudotumor cerebri (PTC).

Plaintiffs argue that users should have been warned to seek immediate medical attention if they experience severe headaches, vision problems or other symptoms of PTC after a Mirena IUD is implanted.

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 have been associated with a risk of pseudotumor cerebri (PTC), the Mirena warnings have failed to 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.

Following the coordinated litigation in the MDL, if lawyers are unable to negotiate Mirena settlements with Bayer, or the litigation is not otherwise resolved, each of the claims may eventually be remanded back to the U.S. District Court where it was originally filed for a separate trial date in the future.