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The U.S. District Judge presiding over all federal Mirena IUD migration and perforation lawsuits granted summary judgment last week for Bayer, finding that it would be impossible for plaintiffs to prove their claims in court.
While the decision is likely to be appealed, it will result in the dismissal of at least 1,300 product liability lawsuits filed throughout the federal court system against Bayer, which each allege that women suffered severe and debilitating injuries after the birth control implant moved out of position, punctured the uterus or otherwise failed.
The Mirena IUD is a T-shaped plastic implant placed into the uterus to prevent pregnancy for up to five years. While it has been marketed as a safe and trouble free form of birth control, a large number of women have reported experiencing severe internal injuries or complications that arose spontaneously following implant, often resulting in the need for surgical removal of the IUD.
Since April 2013, all lawsuits over Mirena IUD injuries filed in U.S. District Courts nationwide have been consolidated in the federal court system for pretrial proceedings, as part of a federal MDL, or multidistrict litigation. The cases have been centralized before U.S. District Judge Cathy Seibel in the Southern District of New York to reduce duplicative discovery into common issues that may arise in the cases, avoid contradictory pretrial rulings from different courts and to serve the convenience of the witnesses, parties and the courts.
Following several years of pretrial litigation, Judge Seibel issued an order (PDF) on July 28, granting a motion for summary judgement filed by Bayer, the manufacturer of the Mirena IUD. The decision came following a ruling in March, in which Judge Seibel excluded the testimony of several expert witnesses for plaintiffs, potentially leaving them without the ability to establish causation in their cases.
Plaintiffs allege that Bayer failed to adequately warn about the risk of Mirena problems. The Mirena warning label did indicate that there was a risk of perforation or migration at the time of implant, but plaintiffs claimed that the manufacturer failed to disclose that Mirena IUD complications may occur months or years later, often following a successful implant procedure. Plaintiffs maintain that the device was unreasonably dangerous and defective.
In granting the motion for summary judgement, Judge Seibel found that the exclusion of several expert witnesses for the plaintiffs left them without the ability to prove to a jury that the Mirena injuries occurred due to spontaneous migration and perforation, as compared to a problem with the initial implanting procedure. Plaintiffs’ attorneys argued that they could still prove it to a lay jury without expert witnesses, but the judge disagreed
“It might be obvious that the Mirena had traveled from where it belonged to where it ended up, but it is not obvious how that could happen in an undamaged uterus,” she in her opinion and order. “It simply cannot be said that lay people understand that a Mirena might spontaneously penetrate an intact uterine wall, let alone why or how. Expert testimony would thus normally be required to prove that secondary perforation can occur with Mirena.”
Judge Seibel ordered the cases dismissed on those grounds, but expressed regret in doing so.
“The Court reaches this conclusion reluctantly, knowing that it will doom hundreds of cases, but in the Court’s view it is compelled by the law,” she said.
Mirena Pseudotumor Cerebri Cases To Proceed
The order may effectively end litigation regarding Mirena perforation and migration cases, unless plaintiffs are able to overturn the summary judgment on appeal. However, it does not affect a growing number of lawsuits filed by women who claim to have suffered vision loss and other injuries caused by a condition known as psuedotumor cerebri or idiopathic intracranial hypertension (PTC/IIH)
In recent months, Bayer has faced a mounting number of product liability lawsuits involving allegations that side effect of the Mirena IUD caused a dangerous buildup of fluid pressure around the brain, often resulting in severe headaches, permanent vision problems and other complications.
Plaintiffs in those cases allege that Bayer withheld information from women and the medical community about the risk that levonorgestrel released by the implant may cause a sudden buildup of pressure on the brain. The lawsuits indicate that this prevented users and doctors from promptly recognizing the symptoms of PTC, which may have allowed women to avoid long-term optic nerve damage.
In several other countries, including South Africa and Hong Kong, warning information provided with the Mirena IUD indicate that papilledema is a possible side effect. However, Bayer has not given women in America or the U.S. medical community the same information.
Amid a growing number of Mirena pseudotumor cerebri cases brought throughout the federal court system against Bayer, a request was filed last year with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize the cases before one judge. However, that request was rejected and the cases have moved forward individually, and that litigation will not be effected by Judge Seibel’s ruling last month.
The fate of hundreds of Mirena perforation and migration cases pending at the state court level in New Jersey and other states is currently unclear, however.