Mirena IUD Side Effects Label Warning Misrepresents Levonorgestrel Risks: Lawsuit

Bayer healthcare has misled women and doctors about the potential side effects of the Mirena IUD, withholding information about serious health risks associated with leveonorgestrel released by the birth control implant, according to allegations raised in a lawsuit filed by a 42 year old woman who developed a dangerous buildup of fluid pressure around the brain.

The complaint (PDF) was filed by Stacy Camino on July 12, in the U.S. District Court for the Southern District of New York

Camino indicates that she had a Mirena intrauterine device (IUD) implanted in April 2014, and began to suffer severe headaches, vision loss and other complications. In September 2015, she was diagnosed with idiopathic intracranial hypertension (IIH), which is also known as pseudotumor cerebri (PTC) and has been linked to other birth control products that involve the hormone levonorgestrel.

The Mirena IUD is a T-shaped plastic device implanted in the uterus to prevent pregnancy for up to five years. The device also releases the hormone levonorgestrel (LNG), but no Mirena warnings indicated that women should be on the lookout for signs or symptoms of IIH or PTC.

The buildup of fluid pressure around the brain caused by levonorgestrel released by the Mirena IUD can cause migraine headaches and permanent damage to the optic nerve, potentially leaving women with long-term vision problems even after the pressure is relieved.

According to allegations raised in the complaint, Bayer failed to adequately warn women or the medical community about these potential side effects, instead pointing to low serum levels of levonorgestrel delivered by the implant as signs that it is safe.

“In claiming that plasma LNG is lower with Mirena than with oral contraceptives, the label omits the material information that in reality, free LNG causes progestogenic effects, and free LNG may be higher with Mirena than with combined oral contraceptives,” the lawsuit states. “In claiming that plasma LNG is lower with Mirena than with oral contraceptives, the label omits the material information that oral contraceptives may use different progestins, which may have fewer progestogenic or other hormonal effects compared to LNG, despite a higher total or free serum level.”

Camino’s claim joins a growing number of Mirena IUD lawsuits filed in federal courts nationwide, each raising similar allegations that women may have avoided serious injuries if adequate information had been disclosed to consumers and the medical community.

In late April 2017, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all cases brought by women diagnosed with PTC/IIH from the Mirena birth control implant, centralizing the claims before U.S. District Judge Paul A. Englemayer in the Southern District of New York.

As Mirena lawyers continue to review and file claims for women nationwide, it is expected that the size and scope of the litigation will continue to grow over the coming weeks and months.

As part of the coordinated pretrial proceedings, it is expected that Judge Englemayer will establish a bellwether program, where a small group of cases will be prepared for early trial dates to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.