Studies link the hormonal IUD Mirena to a rare brain disorder known as pseudotumor cerebri. The condition, also called intracranial hypertension, can lead to permanent vision loss if left untreated. More than 100 lawsuits have now been filed against device manufacturer Bayer, claiming the company failed to warn of this life-altering side effect. Call today to speak with an experienced Mirena IUD lawsuit attorney.
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The hormonal intrauterine device (IUD) Mirena has been linked to major complications, including ectopic pregnancy and a severe condition known as pelvic inflammatory disease. More than 3,000 women have already filed lawsuits over these side effects. Now, a growing body of critics have called the device’s safety into question over a different risk.
Studies have linked the hormone released by Mirena to a rare, and potentially disabling, brain disorder known as idiopathic intracranial hypertension or Pseudotumor Cerebri.
To date, nearly 3,000 women have filed lawsuits against Bayer HealthCare, the manufacturer of Mirena. Most say they were never warned of the IUD’s risks prior to undergoing implantation. But their allegations go much further than that. In lawsuit after lawsuit, women accuse Bayer of manufacturing and marketing a device that is defective in design, one that presents unreasonable dangers.
This is a major litigation, but unlike other medical device lawsuits, the legal claims against Bayer aren’t centered on a single adverse side effect. In fact, it’s astonishing how many complications have been associated with Mirena.
The vast majority of lawsuits, which number in the thousands, involve perforations, ectopic pregnancies and organ damage. Perhaps more troubling, some patients have undergone what they thought were routine examinations – only to learn that the IUD had “migrated,” moving out of its correct position, puncturing the uterine wall and leaving the abdomen. Invasive surgeries are often necessary to remove the device.
Where perforations and ectopic pregnancies are concerned, many of the lawsuits were centralized in the US District Court for the Southern District of New York. Under the guidance of Judge Cathy Seibel, these lawsuits continued through “pre-trial proceedings,” which include crucial steps like evidence-gathering, as a group. Unfortunately for plaintiffs, Judge Seibel dismissed the majority of these consolidated cases, after ruling that the women would not be able to introduce their expert witness testimony at trial. The litigation itself, however, has not ended. There are still numerous other Mirena lawsuits, filed over uterine perforation and device migration, currently filed in New Jersey state courts.
Beyond these more than 3,000 lawsuits, Bayer was hit by several cases in 2014, claiming the hormone released by Mirena can cause a rare brain disorder known as idiopathic intracranial hypertension. Over 100 Mirena lawsuits involving this severe condition have emerged more recently, but they all share a common theme. Mirena’s prescribing information, the documents that doctors and patients rely on to make informed decisions, don’t say anything about this neurological disorder.
In her own lawsuit, filed in the US District Court for the Western District of Tennessee, Nicole Hamill says that she received the intrauterine device in 2004. The implantation procedure proceeded “without complication,” but within a month, Hamill began suffering from migraine headaches, confusion and memory loss, cognitive difficulties and blurred vision, according to court documents.
After seeking treatment early in 2005, she was diagnosed with Pseudotumor Cerebri, administered medication and underwent a series of “lumbar punctures,” spinal tap procedures intended to reduce the amount of cerebrospinal fluid reaching her brain. At the time, neither Hamill nor her physicians had linked the brain condition to Mirena. Even so, she eventually asked for the IUD to be removed.
Around seven years later, Hamill had another Mirena IUD inserted, but soon after, her visual symptoms and migraines returned. She sought treatment again, and her second Mirena was removed in October 2014. In a lawsuit filed on September 29, 2015, Hamill claims Bayer failed to warn patients about the link between the synthetic hormone used in Mirena IUDs and intracranial hypertension, despite more than a decade of medical research describing a possible association.
Hamill’s Mirena lawsuit, registered under the case number 2:15-cv-02645, is currently pending in a Tennessee federal district court.
The symptoms of idiopathic intracranial hypertension closely mimic those of a cancerous brain tumor, which is why the condition is sometimes referred to as Pseudotumor Cerebri. Intracranial hypertension occurs when the fluid pressure inside a patient’s skull increases to a dangerous degree. Over time, this pressure can put a real strain on the nerves that carry electrical signals from the eyes to the brain.
The condition’s symptoms can be severe and strange, especially since researchers aren’t sure what causes the disease, and that makes coming to an accurate diagnosis difficult. Mystery is actually part of the definition, according to the Mayo Clinic; you only have Pseudotumor Cerebri if the pressure inside your skull increases “for no obvious reason.” Abnormally-elevated intracranial pressure can result in:
Left untreated, a case of Pseudotumor Cerebri can force the optic nerves to swell to a point of permanent damage, leading to life-long vision loss.
Mirena, a small, T-shaped insert made of flexible plastic, is placed inside the uterus during a quick doctor’s appointment. After placement, the device begins to release levonorgestrel, a synthetic hormone based on progestin, which is often used in combined birth control pills.
Mirena is recommended for women who have already had at least one child. The device is over 99% effective in preventing pregnancy for a period of up to five years. On October 1, 2009, Mirena became the first IUD to be approved for the treatment of heavy menstrual bleeding. Mirena is often contrasted to Paragard, a non-hormonal intrauterine device that relies simply on the copper of which it is made to prevent pregnancy.
In oral contraceptives, levonorgestrel is usually accompanied by estrogen, but Mirena doesn’t contain estrogen. Instead, levonorgestrel does all the work.
While researchers still aren’t certain how the IUD acts to prevent pregnancy, it’s likely that the manufactured hormone released by Mirena thickens the mucus inside a patient’s cervix, preventing sperm from reaching the uterus. Levonorgestrel may also affect sperm themselves, by reducing their ability to move spontaneously.
But levonorgestrel has also been implicated in cases of Pseudotumor Cerebri. In fact, more than ten years ago researchers from the World Health Organization suggested that a different birth control implant, Norplant – which used the same synthetic hormone – was causing the brain disorder.
After noticing with surprise that two patients in Portland, Oregon had developed strange cases of intracranial hypertension after receiving Norplant, a subdermal levonorgestrel implant, Doctors John Alder, F.T. Fraunfelder and Ralph Edwards decided to look into the association further. In an editorial published by the New England Journal of Medicine, the doctors described the results of their search through health records from the FDA and World Health Organization. In total, they identified 56 cases of intracranial hypertension among patients who had been exposed to the hormone between 1991, when Norplant became available in the US, and 1995.
While their findings were far from conclusive, the researchers ended their report with some telling advice. Be wary, the doctors said, of using the implant in patients who already have vision problems. If a patient begins to show symptoms of increased intracranial pressure, the doctors wrote, remove the implant. In most cases reviewed by the authors, removing the levonorgestrel implant seemed to alleviate a patient’s vision symptoms.
It’s crucial to note that all of these recommendations, which certainly appear to indicate knowledge of a potential link between the hormone and intracranial pressure, had already been suggested by Norplant’s manufacturer, Wyeth Pharmaceuticals. In 1993, Wyeth even requested, and subsequently received, FDA approval to add idiopathic intracranial hypertension to the “Precautions” section of Norplant’s prescribing information packet.
By 2001, extensive references to “idiopathic intracranial hypertension” and “pseudotumor cerebri” could be found under the “Warnings” sections of Norplant’s labeling, both documents intended for physicians and those for patients. But Wyeth was already in trouble, facing tens of thousands of lawsuits filed by women who had suffered severe side effects after receiving the Norplant implants. In June 2002, only one year after officially warning patients to the hormone’s risk of intracranial hypertension, Wyeth pulled Norplant off the market entirely.
Mirena’s labeling, former patients claim, is a different story. Inserts that accompany the IUD warn physicians to use Mirena “with caution” in patients who have a history of “migraine, focal migraine with assymetrical visual loss or other symptoms indicating transient cerebral ischemia.” That’s a “mini-stroke,” a disturbance in blood flow to the brain often caused by blood clots. But the device’s labeling makes no mention of idiopathic intracranial hypertension or Pseudotumor Cerebri, despite what Plaintiffs call “a decade of literature indicating further testing regarding levonorgestrel and [intracranial hypertension] is needed.”
Since Mirena was approved in 2000, the FDA has received more than 47,000 adverse event reports involving the device. That’s over 2,900 adverse events every year. While some of these reports likely describe common, and relatively mild, side effects, many don’t. Nearly half of the reports involve expulsions, when a patient’s body literally pushes the device out of position.
Of course, none of this information was readily released to consumers. It only came to public attention after Detroit ABC affiliate WXYZ News filed a Freedom of Information Act request with the FDA in 2013.
Most of the current lawsuits, however, involve perforations of the uterine wall, punctures that often lead to “device migration,” in which the Mirena IUD travels from its site of implantation to another location. Some women have learned that their IUD migrated within the uterus, coming to scar the uterine lining, while others have discovered that the device traveled outside the uterus, threatening internal organs in the abdomen. Perforations of the intestine are not uncommon.
Ectopic pregnancy, when a fertilized egg implants somewhere other than the uterus, is another concern. In a search of the FDA’s adverse event data on Mirena, which only covers the years between 2008 and 2013, our experienced product liability attorneys identified 536 individual reports of ectopic pregnancy among patients using Mirena as a birth control method.
As of February 16, 2017, more than 100 Mirena lawsuits have been filed over the IUD’s potential link to pseudotumor cerebri. While these legal claims share many similarities, plaintiffs are currently scattered across at least 17 separate jurisdictions, having filed their lawsuits in multiple federal courts.
In order to create a more efficient litigation, several plaintiffs have asked a panel of federal judges to transfer all federal pseudotumor lawsuits to a single court in Mississippi. The Judicial Panel on Multi-District Litigation has yet to consider the request, but will hear oral argument on the issue in March 2017. If granted, the motion would see around 116 pending Mirena lawsuits sent to the US District Court for the Southern District of Mississippi.
The cases would be “consolidated” as a Multi-District Litigation, not a class action. Forthcoming pseudotumor lawsuits would also make their way to Mississippi – or be filed directly in the Gulfport federal court. Consolidation is not certain, but would provide significant advantages for the plaintiffs involved in this litigation. We will update this page when the Judicial Panel on Multi-District Litigation’s decision has been made public.