Bayer Healthcare faces a new product liability lawsuit involving allegations that side effects of the Mirena IUD caused a Pennsylvania woman to suffer a serious and dangerous build up of cerebral fluid around her brain, known as pseudotumor cerebri (PTC).

The complaint (PDF) was filed by Brittany Greco in the U.S. District Court for the District of New Jersey on February 15, indicating that she suffered severe migraines, vision problems and other complications after receiving the long-acting birth control implant.

The case is one of a growing number of pseudotumor cerebri lawsuits filed by women who received a Mirena implant, alleging that Bayer failed to adequately warn about the risk that levonorgestrel released by the T-shaped implant may cause the sudden buildup of pressure on the brain, which is sometimes referred to as idiopathic intracranial hypertension (IIH).

Greco is a 31 year old woman from Brackenridge, Pennsylvania, who indicates that she experienced PTC/IIH problems from Mirena after she received the implant in April 2009, suffering symptoms like migrains and pressure headaches associated with visual obscurations, including loss of peripheral vision and sensitivity to light.

In May 2012, Greco indicates that she sought treatment for these vision problems and was diagnosed with papilledema, which involves swelling of the optic nerves. A subsequent MRI and MRV examination of her brain ruled out intracranial abnormalities, and she underwent a diagnostic lumbar puncture for the headaches and vision problems, which ultimately led to a diagnosis of pseudotumor cerebri.

Intracranial hypertension develops when cerebrospinal fluid levels become elevated. This causes increased pressure in the skull, acting like a tumor. Victims develop severe migraines, double vision, temporary blindness, and other vision loss symptoms. They often develop swelling of the optic disk, and ringing in the ears known as tinnitus.

As a result of Bayer’s alleged failure to adequately warn about the link between Mirena and pseudotumor cerebri, most doctors were unaware that the birth control implant may be a potential cause of migraines, vision problems or a build up of pressure around the brain. Greco indicates that her Mirena IUD was not removed until March 2014.

“Defendants knew or should have known that Mirena, and specifically, the synthetic progestin levonorgestrel causes and/or contributes to the development of IIH/PTC, a severe and possibly irreversible brain condition that can also lead to permanent blindness,” according to the complaint. “Despite an increasing number of adverse events, including reports of intracranial hypertension, blindness, papilledema and increased intracranial pressure, Defendants have made no effort to warn physicians, the healthcare community, or patients of the risks of developing IIH/PTC with Mirena.”

Mirena is an increasingly popular form of long-acting birth control, allowing women to avoid pregnancy for up to five years without needing to remember to take a daily pill. However, a number of women have reported experiencing a number of different complications from Mirena. In addition to problems with pseudotumor cererbri, Mirena has also been linked to reports of the IUD perforating the uterus or moving out of position, causing severe internal injuries for many women.

In several other places around the world, including South Africa and Hong Kong, Mirena warning labels include information about the risk that papilledema as a possible side effect of Mirena. However, Bayer has not given women in America or the U.S. medical community the same warning.

Amid a growing number of Mirena pseudotumor cerebri cases filed throughout the federal court system, a request was filed last year with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize the cases before one judge. However, that request was rejected, so Greco’s claim and others filed by other women are proceeding without coordinated pretrial proceedings.

There is a separate multidistrict litigation (MDL) established for Mirena migration injury lawsuits, which currently includes about 4,000 complaints pending before U.S. District Judge Cathy Seibel in the Southern District of New York, where a small group of “bellwether” cases are being prepared for early trial dates.

Tags: Bayer, Birth Control, IIH, IUD, Mirena, PTC