Mirena Lawsuit Filed Over Pseudotumor Cerebri, Idiopathic Intracranial Hypertension

Bayer faces a new product liability lawsuit that alleges a Florida woman experienced a buildup of fluid in the brain known as pseudotumor cerebri (PTC) or idiopathic intracranial hypertension (IIH), which was allegedly caused by side effects of Mirena birth control.

The complaint (PDF) was filed by Nicole Hamill in the U.S. District Court for the Western District of Tennessee on September 29, indicating that the popular intrauterine device (IUD) caused her to suffer severe migraines, cognitive problems, vision problems, memory loss and other problems.

Hamill first received her Mirena IUD in October 2004, and just one month later she began to experience symptoms of pseudotumor cerebri. Following diagnosis of the condition in February 2005, Hamill underwent lumbar punctures to relieve intracranial pressure and had the Mirena IUD removed.

The lawsuit notes that such lumbar punctures can temporarily relieve symptoms of pseudotumor cerebri or idiopathic intracranial hypertension, but do not actually cure the condition. In addition, the punctures can cause side effects of their own, including headaches, bleeding and back pain.

Hamill was implanted with another Mirena IUD in April 2012, and began to suffer worsening symptoms of migraines and vision problems, before having the birth control implant removed again in October 2014.

Mirena is a long-acting form of birth control, known as an IUD or intrauterine device, which is implanted into the uterus to prevent pregnancy for up to five years. However, many women have experienced Mirena complications, mostly involving claims that the IUD perforated the uterus or moved out of position, causing severe internal injuries.

The case joins a growing number of other Mirena lawsuits pending in courts throughout the U.S., which allege that Bayer failed to adequately warn about certain risks associated with their popular birth control. While most of the complaints involve migration problems with Mirena, several other women have claimed they developed IIH/PTC from levonorgestrel used in Mirena.

Plaintiffs allege that Bayer knew or should have known about the link between Mirena and pseudotumor cerebri (PTC)/idiopathic intracranial hypertension (IIH), and should have provided stronger warnings about the risk of problems caused by pressure on the brain from the build-up of cerebrospinal fluid while on Mirena birth control.

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.

The intracranial hypertension from Mirena often presents as a swelling of the optic nerves, known as papilledema.

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

Hamill’s lawsuit blames the problems on levonorgestrel, a progestin that is constantly released into the body by the Mirena IUD.

“It has been estimated that approximately 1-2 people per 100,000 in the United States have PTC or IIH, although reports suggest the prevalence of the disorder is increasing. In 1994, a study found that in females between the ages of 15 to 44, IIH occurred at a rate of approximately 3.3 per 100,000 per year,” the lawsuit states. “Despite the rarity of PTC/IIH, women who use levonorgestrel-containing products, like the Mirena IUS, more commonly develop the disorder.”

The lawsuit notes that while other contraceptive devices have had proper warnings about levonorgestrel levels in the body, Bayer has failed to add the appropriate warnings to the label of the Mirena IUD in the United States.

According to the Mirena lawsuit allegations, the birth control implant’s warning label should indicate that use of levonorgestrel alone, like with the Mirena, suppresses the levels of sex hormone binding globulin (SHBG) in the body. When SHBG levels are lowered, it can cause stronger hormonal effects from LNG and similar hormones. This, according to the lawsuit, increases the risk of IIH/PTC. However, because Bayer advertises that the Mirena emits low levels of levonorgestrel, without mentioning that the hormonal effects may be increased, the lawsuit claims the label warnings are misleading and inaccurate.

Hamill’s lawsuit accuses Bayer of negligence, designing a defective product, failure to warn, strict liability, breach of warranty, negligent and fraudulent misrepresentation, and fraud by suppression or concealment. The lawsuit seeks both punitive and compensatory damages.

Mirena Migration Lawsuits

The Mirena pseudotumor cerebri lawsuits come as Bayer continues to face about 4,000 product liability claims over Mirena migration and perforation injuries, where the T-shaped implant spontaneously punctured the uterus or moved out of position.

Since April 2013, those cases pending throughout the federal court system have been centralized for pretrial proceedings before U.S. District Judge Cathy Seibel in the Southern District of New York as part of an MDL, or multidistrict litigation.

Bayer has continued to indicate that it intends to defend the migration injury cases, arguing that information about the risk of perforation was included on the warnings provided with the IUD. However, plaintiffs in that litigation maintain that the previous warnings were vague and misleading, suggesting that the risk of injury only exists at the time of insertion. Most of the complaints involve women who found that the Mirena migrated spontaneously, often long after the IUD was successfully placed in the uterus.

Plaintiffs filed a request last year with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to establish a separate MDL for Mirena IIH/PTC lawsuits. However, that request was rejected, so each case is proceeding with informal coordination of discovery among the parties.