Pseudotumor Cerebri Side Effects of Mirena IUD Withheld by Bayer, Lawsuit Alleges

Bayer Healthcare faces yet another product liability lawsuit that alleges inadequate warnings were provided about the risk that the

Mirena IUD may cause pseudotumor cerebri (PTC), which is a condition involving a dangerous buildup of fluid pressure on the brain that has resulted in severe headaches, vision loss and other problems among women who receive the birth control implant.

In a complaint (PDF) filed late last month in the U.S. District Court for the District of New Jersey, Jessica Watson indicates that she has been left with permanent blurred vision and other side effects of pseudotumor cerebri after the intrauterine device (IUD) was implanted to provide long-term birth control.

The Mirena IUD is a small, T-shaped implant that is placed into the uterus for up to five years, releasing the progestin the progestin levonorgestrel, which has been linked to a risk of pseudotumor cerebri in other birth control products. However, the lawsuit indicates that Mirena warnings failed to adequately warn women that the IUD birth control implant may cause a dangerous buildup of pressure on the brain.

While the pressure from pseudotumor cerebri can be resolved when the product is no longer used, it can cause permanent damage to the optic nerve and other side effects.

Watson, only 30, had the Mirena implanted in January 2012 as a form of birth control. However, in July 2014 she got her vision checked after experiencing blurred vision and tinnitus. She was referred to a neurologist and underwent MRI and a diagnostic lumbar after being diagnosed with PTC, which is also commonly referred to as idiopathic intracranial hypertension (IIH).

Neither Watson nor her doctor suspected that there was a link between the pseudo brain tumor and Mirena at the time. It was not until January of this year that her doctor removed the Mirena IUD after She had to undergo another lumbar puncture to reduce fluid build-up.

“Defendants knew or should have known that Mirena, and specifically, the synthetic progestin levonorgestrel cause and/or contributes to the development of IIH/PTC, a severe and possibly irreversible brain condition that can also lead to permanent blindness,” the lawsuit states. “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 risk of developing IIH/PTC with Mirena.”

Watson presents claims of negligence, design defect, failure to warn, strict liability, breach of warranty, negligent misrepresentation, fraudulent misrepresentation, and fraud by suppression and concealment. She is seeking both compensatory and punitive damages.

Growing Mirena Pseudotumor Cerebri Lawsuits

The case is one of a growing number of similar Mirena IUD lawsuits over pseudotumor cerebri side effects filed in recent months, which each allege that Bayer withheld information from women and the medical community about the risk that levonorgestrel released by the implant may cause the sudden buildup of pressure on the brain.

Lawsuits allege that this prevented users and doctors from promptly recognizing the symptoms of PTC, which may have allowed women to avoid long-term optic nerve damage.

In several other countries, including South Africa and Hong Kong, warning information provided with the Mirena IUD indicate that papilledema is a possible side effect. However, Bayer has not given women in America or the U.S. medical community the same information.

Amid a growing number of Mirena pseudotumor cerebri cases brought throughout the federal court system against Bayer, 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 Watson’s claim and others filed by other women are proceeding without coordinated pretrial proceedings.

In addition to problems with pseudotumor cererbri, Mirena IUDs have also been linked to reports of the IUD perforating the uterus or moving out of position, causing severe internal injuries for many women. 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.