Appeals Court Affirms Dismissal of Mirena IUD Lawsuits Over Pseudotumor Cerebri (PTC)

A federal appeals court rejected an effort by women diagnosed with pseudotumor cerebri (PTC) to reinstate lawsuits against the makers of the Mirena IUD, affirming the dismissal of hundreds of claims alleging the birth control implant may cause a dangerous buildup of fluid pressure in the brain.

The Mirena IUD is a small, t-shaped device that is placed into the uterus to provide long-term protection against pregnancy for up to five years. The polyethylene frame contains a steroid reservoir that releases levonorgestrel, which is a second generation progestin, which has been linked to a pseudotumor cerebri risk in other forms of birth control.

According to allegations raised in Mirena IUD lawsuits filed in prior years, Bayer withheld warnings and information for women and the medical community about the importance of monitoring women for symptoms of the buildup of fluid pressure in the brain, which can cause serious and permanent damage if not promptly diagnosed and treated.

Following coordinated pretrial proceedings in a federal multidistrict litigation (MDL), U.S. District Judge Paul A. Engelmayer dismissed the Mirena PTC lawsuits in June 2019, after excluding the testimony of seven expert witnesses proposed by the plaintiffs. The trial court found that the opinions were not based on sufficiently reliable science under the federal Daubert standard, leaving plaintiffs without enough evidence to establish general causation at trial.

Plaintiffs appealed this decision to the U.S. Court of Appeals for the Second Circuit, arguing that the judge abused his discretion by taking the decision about the weight of the expert witness testimony out of the hands of a jury.

In an unsigned opinion (PDF) issued on Tuesday, the panel of three judges affirmed the decision, which resulted in the dismissal of nearly 1,800 lawsuits.

“In sum, the district court appropriately undertook a rigorous review of each of plaintiffs’ experts, and based on that review reasonably found that the experts’ methods were not sufficiently reliable and that their conclusions were not otherwise supported by the scientific community,” the appellate court wrote in its decision. “Accordingly, the district court did not abuse its discretion in precluding the experts’ conclusions.”

The appeals court affirmed the granting of summary judgment to Bayer, the manufacturer.