Mirena Multidistrict Litigation Regarding Intracranial Hypertension. Women who claim that they have experienced symptoms that mimic brain tumors from using the Mirena Intrauterine Device (IUD) will have their day in court. The plaintiffs sought to consolidate lawsuits filed throughout the country will have their cases heard in the United States District Court for the Southern District of New York according to an order issued by the Judicial Panel on Multidistrict Litigation (JPML). The court consolidated the cases into one larger case referred to as MDL 2767. Merging the claims in one court is one of the many legal hurdles the plaintiffs will face as they seek compensation for the side effects they suffered from using the Mirena IUD.
Parker Waichman LLP’s dedicated, experienced, and zealous medical device defects attorneys are in the process of reviewing claims made by women who used the IUD and have suffered adverse side effects. Time is of the essence. Therefore, any woman who fell ill, especially from intracranial hypertension is advised to contact Parker Waichman LLP today to discuss their rights and options.
Who is responsible for the adverse side effects caused by Mirena?
The answer to that question which has not been resolved to this point. Bayer and its subsidiaries designed, manufactured, and marketed the product. The women have sued Bayer contending that the active ingredient in the IUD, a hormone called Levonorgestrel, causes intracranial hypertension. Bayer denies these allegations.
While the woman all say that they had not experienced any symptoms from a condition known as “Pseudotumor Cerebri,” which is another term for idiopathic intracranial hypertension until they used the Mirena IUD. Consequently, the plaintiffs allege that Bayer failed to give the appropriate warnings for the product, failed to recall the product after learning of the potential problems the device caused, misleading the plaintiffs, making false claims, manufacturing defects, and design defects.
Bayer vigorously defends its actions. Bayer cited in its opposition to the plaintiffs’ motion to consolidate the cases in the MDL that the device is intended to be implanted in overweight or obese women. Bayer cited a study which concluded that 63 percent of the women who use Mirena are overweight or obese as support for its contention. According to Bayer, that statistic is important because women who are at risk for suffering from intracranial hypertension are overweight or obese females. Bayer claims that two other risk factors, age and a recent increase in weight are also present in an overwhelming segment of the population of plaintiffs. Therefore, Bayer argues, the plaintiffs cannot prove that the hormone used in Mirena is actually causing the Pseudotumor Cerebri.
Causation remains a contentious issue for the parties. The plaintiffs cannot prevail in their cases if they cannot prove causation. The lack of causation has already let Bayer off the hook in one segment of Mirena MDL cases. In MDL 2434, the plaintiffs alleged that the Mirena IUD migrated around their bodies after implantation. The women found the IUD all over their abdomens after they suffered significant and painful side effects. The women said that Bayer never warned them about the possibility of what the plaintiffs called “secondary migration.” In other words, the IUD perforated the uterine wall and entered into other parts of the women’s bodies. Bayer defended their position by demonstrating that they warned that perforation could occur during insertion. With that difference of opinion, the JPML consolidated the cases in the Southern District of New York, and the litigation commenced.
This particular case did not end well for the plaintiffs. Over 1,300 women filed suit against Bayer and lost because they could not prove that the device was capable of perforating a woman’s uterus after insertion. The court struck the plaintiffs’ proposed experts and left them without any way of proving that secondary migration was even possible. Therefore, the judge granted summary judgment in favor of Bayer. Many plaintiffs involved in that litigation continue to fight on in their respective state courts.
How is MDL 2767 different?
The chief complaint made by the plaintiffs in this action distinguishes this case from the cases in which Bayer prevailed. Pseudotumor Cerebri is an increase in pressure inside of the afflicted’s head without any apparent cause. The symptoms overall appear to be a brain tumor, but imaging diagnostic quickly reveals that no tumor is present.
In addition to pressure in the head, pseudotumor cerebri is known to cause symptoms such as:
- Severe headaches behind the eyes,
- Pulsatile Tinnitus, or ringing in the ears, which pulses which each heartbeat,
- Dizziness, nausea, and vomiting,
- Impaired vision which is typically blurry,
- Momentary loss of vision in one or both eyes,
- Trouble with peripheral vision,
- Light flashing, and
- Pain in the upper back, through the shoulders and into the neck area.
The cause of pseudotumor cerebri is generally unknown when it occurs in the general population, which is infrequent. The condition occurs in 1 or 2 out of every 100,000 people. Although pseudotumor cerebri can surface in men and children, obese women of childbearing age are most susceptible to suffering from the malady.
Researchers believe that the problem may arise from an excess of cerebrospinal fluid in the brain. Cerebrospinal fluid forms a cushioning barrier around our spinal cords and brains. Physicians believe that the build-up of the fluid causes pressure to develop in the skull because there is little to no room to accommodate an excess of fluid. Some physicians wonder whether the build-up happens when blood does not absorb the cerebrospinal fluid.
Clinicians have connected pseudotumor cerebri to three causes that are not disease related. Pseudotumor Cerebri has been linked to taking growth hormone, tetracycline (a powerful antibiotic), and an excess of vitamin A. There are many disorders and diseases which researchers have related it to intracranial hypertension.
Bayer claims that the plaintiffs are candidates for pseudotumor cerebri because some fit a particular physical profile. They appear to be ignoring the fact that an occurrence of pseudotumor cerebri occurs is very rare. However, among the plaintiffs, they have one thing in common: the Mirena IUD.
The Mirena IUD is a T-shaped device that physicians implant in the patient’s uterus. The shape of the device prevents pregnancy. Additionally, the IUD secretes the hormone levonorgestrel which works to stop sperm from fertilizing the egg.
At least one research study, which was reported on by the National Institute of Health, observed a clinical link between levonorgestrel as used in Mirena and an increased risk of intracranial hypertension. The study’s authors suggested that more work should be done to explore the reasons behind the connection.
The plaintiffs, however, cannot hang their collective hats on this one study. They need to obtain learned medical experts who use the scientific method to reach the same conclusion at which the NIH researchers arrived.
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