Conference Set for Bayer Request on Mirena Statute of Limitations Motion

The U.S. District Judge presiding over all Mirena IUD birth control lawsuits filed throughout the federal court system has scheduled a pre-motion conference for January 22, in response to a request filed by Bayer over an anticipated motion to dismiss cases based on the statute of limitations.

Bayer currently faces more than 340 product liability lawsuits brought in U.S. District Courts nationwide, which all involve similar allegations that the drug maker failed to adequately warn about potential Mirena IUD complications, including a risk that the implant may perforated the uterus and migrate to other areas of the body.

In a letter (PDF) filed earlier this month, Bayer indicated that approximately 70 cases currently filed in the federal court system may fall out of their respective states’ statute of limitations periods. Such limitations periods vary from state-to-state, but generally require that any legal action be filed within a certain amount of time after a plaintiff knew or reasonably could have discovered the existence of their cause of action.

Bayer argues that since the injuries allegedly caused by IUD birth control implants are immediately obvious, the Mirena statute of limitations period should start running upon diagnosis of the injury. The drug maker has proposed that the Court rule on a Motion to Dismiss in one case, which may serve as an “exemplar” for statute of limitations issues found in dozens of other Mirena lawsuits.

“Mirena is unlike other cases claiming a pharmaceutical product caused a latent injury or a generic injury (e.g. a heart attack) with no immediately apparent connection to the product at issue,” wrote attorneys for the drug maker in a request filed January 2. “Because of the unique nature of the alleged perforation, embedment, and migration injuries – injuries where the involvement of Mirena is clear from the very diagnosis of the injury – no further discovery is needed before ruling on the proposed Motion to Dismiss.”

In a response letter (PDF) filed on behalf of the MDL Plaintiffs’ leadership on January 8, lawyers representing women who brought these lawsuits argue that Bayer is making the issue sound more cut and dry than it is, pointing out that allowing Bayer to file a motion to dismiss in one case would not be dispositive of other cases, or act as a bellwether. Plaintiffs indicate that the court will have to navigate the laws of both the plaintiff’s home state and the state of New Jersey, where Bayer is based, determining on a case-by-case basis when the plaintiffs should have discovered the cause of action.

According to a docket entry on January 14, a status conference has been set for January 22, 2014 at 3:30 p.m., where it is expected that the issue will be discussed further with the Court.

In a second letter (PDF) filed by Bayer on January 14, the drug maker also requested a pre-motion conference to discuss the filing of a Motion to Dismiss in cases where plaintiffs have failed to submit a Plaintiff Fact Sheet (PFS) as required by a prior case management order. Bayer indicates that at least 24 plaintiffs have failed to submit a PFS, and that it has been at least 30 days since each case was served with a Notice of Overdue Discovery.

Mirena IUD Injury Litigation

Mirena birth control is a levonorgestrel-releasing intrauterine system, which is also often referred to as an IUD, or intrauterine device. The small T-shaped birth control is inserted into a woman’s uterus to prevent pregnancy for up to five years.

Bayer introduced Mirena in 2000, aggressively promoting the IUD as a hassle-free form of birth control. However, a growing number of women and their doctors have reported problems where the Mirena IUD migrated from its initial implant location, perforating the uterus and other organs, causing infections and abscesses, and leaving women unknowingly unprotected against the chance of pregnancy.

Since 2000, more than 70,000 adverse events have been filed with the FDA involving Mirena IUD problems, including at least 5,000 cases involving women who indicated that Mirena migrated 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 the federal litigation, more than 488 other Mirena cases are pending against Bayer in New Jersey state court, where the lawsuits have been centralized as part of a multicounty litigation.

In both the federal MDL and state court litigation, discovery is on-going regarding generic issues that impact all cases. It is expected that a series of early trial dates, known as “bellwether” cases, will be scheduled to help the parties gauge how juries are likely to respond to certain evidence or testimony that is likely to be presented throughout the litigation.

The preparation of specific issues in these bellwether cases and the outcome of any early trial dates are designed to facilitate further negotiations to reach Mirena settlement agreements or other resolutions for the litigation without setting hundreds of individual trial dates.