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A group of twelve Mirena IUD lawsuits have been selected as bellwether claims in the federal court system, which will be prepared for a bellwether trial set to begin in 2016, designed to help the parties gauge how juries may respond to certain evidence and testimony that could be repeated throughout hundreds of similar cases pending nationwide.
Mirena birth control is a plastic T-shaped intrauterine device, or IUD, which is implanted into the uterus to prevent pregnancy for up to five years.
There are currently more than 2,000 product liability lawsuits involving Mirena birth control filed against Bayer throughout the United States, with about 600 of the cases consolidated in the federal court system as part of an MDL, or multidistrict litigation. The federal litigation is centralized before U.S. District Judge Cathy Seibel in the Southern District of New York to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
All of the cases involving similar allegations that the manufacturer failed to adequately warn about the risk of painful and debilitating injuries that may occur when the Mirena birth control implant migrates out of the uterus, causing internal damage, infections and other complications.
Last month, Judge Seibel outlined the process for completing case-specific discovery in a small group of cases, which are designed to be representative of other lawsuits in the litigation. The first federal Mirena trial date is expected to begin on March 7, 2016, but the specific case that will go forward at that time has not yet been selected.
In an order (PDF) issued August 11, Judge Seibel identified 12 cases that will be part of an Initial Deposition Pool, which will go through preliminary discovery. In May 2015, it is expected that this group will be narrowed down to six cases, which will go through expert witness discovery and dispositive motions, before the Court selects the specific case that will go to trial first.
While the outcome of the bellwether trial will not be binding on other cases, it may help the parties determine the strengths and weaknesses of their arguments, potentially resulting in a Mirena birth control settlement that may avoid the need for hundreds of individual trials nationwide.
Mirena Birth Control Complications
While Mirena has been promoted by Bayer as a “hassel-free” form of birth control, plaintiffs allege that the device is prone to spontaneously puncture the uterus and move out of position, causing severe and debilitating internal injuries.
Since 2000, more than 70,000 adverse events have been filed with the FDA involving Mirena IUD complications, including at least 5,000 cases involving women who indicated that Mirena moved out of place since 2008, and 1,322 reports where the Mirena IUD punctured the uterus.
Bayer has attempted to defend the cases, arguing that information about the risk of perforation was included on the warnings provided with the IUD. However, plaintiffs maintain that the previous warnings were vague and misleading, suggesting that the risk of injury only exists at the time of insertion. Most of the complaints involve women who found that the Mirena migrated spontaneously, often long after the IUD was successfully placed in the uterus.
In addition to cases filed at the federal level, nearly 1,000 cases have been filed in New Jersey state court, where similar consolidated proceedings have been established, centralizing all Mirena IUD lawsuits before Judge Brian R. Martinotti in Bergen County.
Mirena Statute of Limitations Dismissals
The selection of the Mirena bellwether trials comes shortly after Judge Seibel issued an order dismissing one case based on a statute of limitations defense, which could impact dozens of other cases pending in the litigation.
Following a motion filed by Bayer, which argued that the Mirena statute of limitations should start running when the plaintiff first experienced complications from the birth control implant, Judge Seibel issued an order (PDF) on July 2, dismissing a lawsuit filed by Amanda Truitt, which was selected as an exemplar for this motion.
Truitt experienced complications from Mirena birth control in July 2011, but did not file her lawsuit until September 2013, which the drug maker argued exceeded the two year statute of limitations that should be applied to her case.
Bayer argued that since the injuries caused by Mirena birth control implants are immediately obvious, the statute of limitations should start running following diagnosis of the injury.
Although Truitt’s attorneys argued that she did not actually know that she had a cause of action when she suffered the complications, indicating that she thought it had been implanted incorrectly and pointing out that no doctor specifically informed Truitt that the migration was a result of the product’s design, Judge Seibel dismissed all counts presented in the complaint, except for a fraud claim.
“There simply was no mystery regarding a possible connection between Plaintiff’s injuries and the Mirena – i.e., the connection was sufficiently obvious that a diligent individual in Plaintiff’s position would have inquired into whether she had a claim regarding her Mirena,” Judge Seibel wrote in the decision. “When the plaintiff knows that the IUD is no longer in the uterus and has to be removed from wherever it has migrated, the conclusion that the statute of limitations is triggered seems unavoidable.”
On August 7, Judge Seibel issued an order (PDF) was issued advising that Bayer can file individual requests to apply the reasoning behind that decision to other pending lawsuits that it believes should be dismissed based on the statute of limitations.
After sending a letter of no more than three pages explaining why a specific case should be dismissed, the plaintiff will have 30 days to either file a voluntary dismissal of their case or provide a response explaining why the facts or law applicable in their case makes the Truitt decision inapplicable.
It is unknown how many cases may be impacted by the ruling.