Mirena Lawsuit – Pseudotumor & Intracranial Hypertension
If you are considering a Mirena lawsuit, contact our lawyers today for a free, confidential consultation. Our law firm is currently filing Mirena lawsuits alleging that the IUD, which uses a synthetic form of progestin, causes serious side effects, including idiopathic intracranial hypertension and pseudotumor cerebri, a condition in which increased blood pressure in the brain causes symptoms similar to a brain tumor. These brain injuries can lead to vision loss, damage to the optic nerve (papilledema), migraines, tinnitus, and can require surgical treatment.
This page answers several frequently asked questions about filing a Mirena lawsuit. You can read more about our Mirena lawyers at the bottom of this page. You can reach me by calling my office toll-free at (844) 459-8719, emailing me at firstname.lastname@example.org, or by using the contact form at the bottom of the page.
What Do The Mirena Lawsuits Allege?
Bayer, the company that makes Mirena (as well as Essure), has a long history of questionable conduct. In 2009, for example, the Food and Drug Administration sent Bayer two warnings about Mirena, including a warning that their television commercials were misleading and a warning that their internet advertisements were misleading.
The prescribing information for Mirena says that Mirena should be used with caution in patients who have “migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia.” This language reveals the possibility of an ischemic stroke, which involves a blood clot in the brain, but Mirena does not anywhere warn about the possibility of idiopathic intracranial hypertension or pseudotumor cerebri. Each Mirena lawsuit relating to these conditions alleges that Bayer was negligent in failing to warn about these conditions and is responsible for the injuries women suffer as a result.
As of April 2017, nearly one-hundred lawsuits have been filed alleging Mirena caused their intracranial hypertension. These cases are different from the perforation and migration cases that have been filed over the past few years. Given how new this litigation is, none of these cases have proceeded to a jury trial and there have been no reported settlements of cases. We believe the cases are strong, that they would prevail before a jury in a court of law, and that they should settle and provide adequate compensation for the harm women have suffered. The settlement amounts themselves would be confidential and determined by a number of factors, including the court’s rulings and the strength of the evidence, such as expert witness testimony. In other types of medical device cases, like transvaginal mesh cases, thousands of our clients have accepted the settlement amounts that we have secured for them, and we will take the same approach in this litigation: the settlement must provide adequate, fair, and reasonable compensation or we go to trial.
On April 6, 2017, the federal Judicial Panel on Multidistrict Litigation granted a petition to “centralize” all of the intracranial hypertension lawsuits in a single federal court, ordering that all of the cases be consolidated for pre-trial proceedings before the Honorable Paul A. Engelmayer in the Southern District of New York. This centralization process is typical for nationwide drug lawsuits. Judge Engelmayer will not be required to follow the rulings of the Western District of Missouri, where a court has already considered scientific arguments for the Mirena lawsuits, evidence for Bayer’s culpability, and has ruled on the medical experts’ qualifications to testify, but those prior court decisions will obviously help inform future decisions.
Does The Birth Control Implant Mirena Cause Idiopathic Intracranial Hypertension / Pseudotumor Cerebri?
We believe so. Mirena is an intrauterine device (IUD) that releases levonorgestrel, an artificial form of the hormone progestin. Levonorgestrel is the same synthetic hormone used in Norplant. Medicine has known of the connection between hormones and headaches for decades. These hormonal changes are why, for example, over 12 million women in the United States suffer migraines before or during their menstrual periods.
Over twenty years ago, in 1995, an article in the New England Journal of Medicine linked levonorgestrel with intracranial hypertension. The scientific evidence has only grown since then. In fact, levonorgestrel, a “second generation progestin,” reacts with more types of hormonal receptors than any of the other progestins used as a contraceptive. In 2006, neurologists discussed a case in which a 23-year-old woman developed idiopathic intracranial hypertension (diagnosed by way of her “headaches associated with horizontal diplopia, photopsias, tinnitus, and nausea”) as a result of taking Depo-Provera, which also uses the hormone progestin. In 2014, the prominent scientific journal Nature published an analysis of how pediatric pseudotumor cerebri syndrome was linked to hormonal regulation of cerebrospinal fluid dynamics. In 2015, researchers reviewed the FDA’s database of Mirena side effects and found an unusually high number of reports for intracranial hypertension and papilledema in women who used intrauterine levonorgestrel devices.
In April 2017, the journal Neuro-Ophthalmology published “An Estimation of the Risk of Pseudotumor Cerebri among Users of the Levonorgestrel Intrauterine Device.” That study reviewed extensive medical records from databases and found that Mirena users were over seven times more likely to develop pseudotumor cerebri. This study is by far the largest and most thorough analysis of the risk of intracranial hypertension among Mirena users, and is compelling evidence of an association between the IUD and brain injuries.
What Is Idiopathic Intracranial Hypertension / Pseudotumor Cerebri?
When a person has symptoms of a brain tumor, but no actual tumor, doctors refer to it as idiopathic intracranial hypertension (IIH). Idiopathic means “a disease that arises spontaneously or with no known cause,” intracranial means “within the skull,” and hypertension means “high blood pressure.” Doctors sometimes call it pseudotumor cerebri (PTC). Pseudotumor means “false growth” and cerebri means “of the skull.”
The most common symptoms include visual loss, brief instances of blindness, a ringing of the ears with the beating of the heart, and a headache that begins behind the eyes. Many times, these eye problems are caused by papilledema, a swelling in the optic disc caused by increased blood pressure in the skull. Unfortunately, many of these symptoms can become permanent, even after the drug or hormone that caused the condition is removed.
How Is Idiopathic Intracranial Hypertension / Pseudotumor Cerebri Diagnosed?
Pseudotumor cerebri used to be a “diagnosis of exclusion.” That is to say, doctors didn’t have a clear way to diagnose IIH / PTC but, instead, reached the diagnosis when they had ruled out any other causes of high blood pressure in the brain, like a brain tumor. Recent advances in neuroradiology, like more specific MRI findings, have enabled doctors to truly diagnose IIH / PTC, usually by way of changes in the optic nerve. Some medical studies have shown that patients with IIH have a narrowing of the sinuses in their brain, and so that “stenosis” is sometimes used as a diagnostic marker.
What Is The Treatment For Idiopathic Intracranial Hypertension / Pseudotumor Cerebri?
Patients with idiopathic intracranial hypertension / pseudotumor cerebri will typically follow up with at least two specialists, a neurologist, who considers the nervous system and the spinal cord, and an ophthalmologist, who watches for eye problems. Doctors first treat IIH with a diuretic to help get rid of water and salt in the body. Lasix is perhaps the most common diuretic used. Sometimes, women are given a lumbar puncture to lower their cerebrospinal fluid pressure.
There are several types of surgical treatments available for IIH, and the choice of treatment usually depends on the symptoms the patient is suffering.
- In patients with visual loss and papilledema, a common surgical treatment is optic nerve sheath fenestration, in which the meninges around the optic nerve are sliced open to reduce pressure.
- In patients with higher cranial pressure, “shunts” are often used to divert the pressure, such as lumboperitoneal shunts and ventriculo-peritoneal shunts. Unfortunately, both types of shunts have significant failure and revision rates.
- The latest surgical procedure is cerebral venous sinus stenting. Although this form of surgery for pseudotumor cerebri has not been well-studied, it appears very promising, and clinical trials are underway.
Other clinical trials have attempted to administer hormones to reverse the androgen disorders that are believed to contribute to pseudotumor cerebri, like polycystic ovary syndrome.
Who are the Mirena lawyers behind this website?
I wrote everything you see on this website myself. I’m not a an actor on a television commercial or someone in a call center, and this isn’t one of those misleading websites that doesn’t even tell you who is behind it. I’m a real lawyer who has successfully tried serious injury and wrongful death cases in front of juries, and a five-time winner of the American Bar Association Journal’s award for legal writing online. For years, I’ve represented women in gynecologic and obstetrical malpractice cases and women injured by transvaginal mesh implants, recovering millions of dollars for them in settlements. You can read more about me here.
If you use the contact form below, the email goes to me. If you call (844) 459-8719, it will be answered by me or by my receptionist. But it’s not just about me. I am of counsel with TorHoerman Law, the nationwide product liability firm that negotiated the $2.4 billion Actos settlement and the $650 million Pradaxa settlement. We will bring to your Mirena case the same resources, perseverance, and exceptional legal representation.