In 2009, 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. Bayer, the company that makes Mirena, has a long history of questionable conduct.
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.
Since it was introduced in 2000, the FDA has received approximately 70,000 injury reports concerning Mirena. As a result, thousands of women have filed Mirena IUD lawsuits against Bayer. Although there is some variation between cases, all involve similar allegations that Bayer failed to provide adequate warnings about Mirena side effects and complications that can occur months or even years after implantation. Specific allegations claim that Bayer:
· Designed, produced, and knowingly sold a defective product
· Failed to research and warn the public about dangerous side effects
· Concealed the dangerous side effects
· Engaged in false and misleading marketing
· Misrepresented the benefits of the device
· Breached implied and express warranty
· Failed to issue a recall once information came to light about the complications
As of June 2017, nearly two-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.
Mirena Multidistrict and Multicounty Litigation
As the individual Mirena lawsuits started to grow, they have been consolidated into multidistrict litigation (MDL) in the federal courts and multicounty litigation (MCL) in state courts. There are currently three primary sets of mass torts covering Mirena IUDs: MDL 2434, NJ MCL 297, and MDL 2767.
MDL 2434: Mirena Migration, Perforation and Embedment
In June 2013, the Judicial Panel on Multidistrict Litigation (JPML) consolidated many Mirena IUD lawsuits into an MDL in the Southern District of New York. These cases claim complications due to device migration, organ perforation, and embedment. Growing to include 1,800 cases, the MDL argues that Mirena’s initial label (which was used from 2008 through 2014) did not contain warnings about secondary perforation. This label did state that perforation may occur during insertion and escape detection until sometime later, but claimants allege that the device could cause perforation at any time even without insertion injuries.
With over 1,200 cases pending in the MDL in 2016, the judge granted Bayer’s motion for summary judgment due to a lack of expert testimony proving secondary perforation, and the cases were dismissed. In an unusual move, the JPML later reopened MDL 2434 at the behest of Bayer who expected new cases to be filed. As of today, the decision is on appeal to the Second U.S. Circuit Court of Appeals.
MDL 2767: Mirena Pseudotumor Cerebri
While most of the Mirena IUD lawsuits revolve around device migration and perforation, many women have experienced complications due to a severe buildup of pressure in the brain. This is known as pseudotumor cerebri (PTC), also called idiopathic intracranial hypertension, and has symptoms similar to a brain tumor. Research studies have linked the levonorgestrel contained in the Mirena IUD with this dangerous condition, which can cause vision problems, severe headaches, and tinnitus (ringing in the ears). In light of this, a new group of claimants filed a motion in February of 2017 to centralize more than 100 cases claiming Mirena caused PTC. In April of 2017, the JPML consolidated all Mirena PTC lawsuits into MDL 2767 in the Southern District of New York, including 113 pending Mirena cases in 17 districts and 37 potential actions.
New Jersey MCL 297
After a growing number of plaintiffs in New Jersey made similar allegations to those in the New York MDL, the Supreme Court consolidated their cases in multicounty litigation (MCL) in 2013. According to court records, more than 2,000 cases have been added to NJ MCL 297, since their initial consolidation. These cases are currently in the discovery phase, the deadline for which was extended by the judge to June 30, 2017. Although litigation for Mirena is still in the early stages of review and analysis, potential cases are still being considered for women throughout the United States. If a settlement is not reached as part of the MDLs or MCL, each claim will be returned to the U.S. District Court where it was originally filed for an individual trial date.