Bayer Opposes Request to Consolidate Federal Lawsuits Over Mirena IUD

In response to a motion to consolidate all federal Mirena IUD lawsuits, Bayer Healthcare has filed a response opposing the centralization of the cases as part of a multi-district litigation (MDL), arguing that it would prejudice their ability to defend the safety of the implantable birth control device.

Last month, a group of plaintiffs filed a motion to establish a Mirena MDL, which would transfer all product liability lawsuits filed against Bayer over their intra-uterine contraceptive device (IUD) to one U.S. District Judge for coordinated handling during pretrial proceedings.

At that time, eight different Mirena cases filed in the federal court system were identified, with each lawsuit pending before a different judge in eight different U.S. District Courts. In addition, product liability lawyers investigating Mirena lawsuits have suggested that hundreds, if not thousands, of complaints are likely to be filed in the near future.

In a response (PDF) filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on February 7, Bayer argued that centralization of the cases was not appropriate, and actually suggested that it would prejudice their defense by delaying the start of the first trial dates and encouraging the filing of “marginal” Mirena cases, which may require the drug maker to start negotiating Mirena settlements for business reasons, instead of legal reasons.

One of the cases identified for transfer was filed more than two years ago, and was set for trial to begin in May 2013. However, the case was stayed earlier this week pending a decision from the U.S. JPML about whether the Mirena litigation will be centralized.

Bayer argues that they would be faced with “starting over” with the MDL, which would duplicate discovery that has already been completed. The drug maker indicates that it has produced over 1.7 million pages of documents in the case and presented witnesses for depositions, suggesting that “it wants to vindicate its highly effective and currently marketed product as soon as possible.

Mirena IUD Lawsuits Involve Similar Allegations

Mirena is a T-shaped prescription intrauterine device (IUD), which is inserted into the uterus by a doctor to provide long-term birth control.

In recent weeks, a growing number of women throughout the United States have filed product liability lawsuits against Bayer alleging that they suffered severe injuries when their Mirena IUD perforated the uterus and “spontaneously” migrated following insertion.

The complaints involve common allegations that Bayer failed to adequately research the potential side effects of Mirena or warn about the risk of the IUD migrating long after it is implanted, increasing the risk of infection or serious damage to surrounding organs, often resulting in surgical removal of Mirena.

Bayer has argued that there are not sufficiently common issues of fact and law to require centralized management of the litigation, suggesting that the cases will be dominated by individual facts. The drug maker indicates that the Mirena warning label has provided information about the risk of perforation since it was introduced in 2001, so there is no need for extensive discovery about their knowledge about the risk of this complication from Mirena.

While the Mirena warning label does include information on the risk of perforation, plaintiffs argue that the language suggests that these problems only occur during insertion and that the drug maker failed to adequately warn about the risk of spontaneous migration, which may occur long after Mirena insertion. Many of the lawsuits allege that severe problems from Mirena could have been avoided if more detailed and accurate warnings had been provided.

Mirena MDL Hearing Likely in March

Consolidation of the Mirena litigation as part of an MDL, or multidistrict litigation, would result in all cases filed in U.S. District Courts throughout the country being assigned to one judge for coordinated handling in a manner similar to how a Mirena class action is managed during pretrial proceedings.

The process is designed to reduce duplicative discovery, eliminate conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts. However, while the cases are centralized, each lawsuit remains and individual claim and if a settlement or other resolution is not reached following the MDL proceedings, each case would be remanded back to the U.S. District Court where it was originally filed for a separate trial date.

Although Bayer opposes the formation of a federal MDL for the Mirena lawsuits, the drug maker did file a request to consolidate the state court Mirena litigation pending in New Jersey. However, Bayer pointed out in their recent response that the circumstances in New Jersey were unique, as all of the cases were at an early stage, with no dispositive motions pending or trial dates scheduled.

Ultimately, the New Jersey Supreme Court declined to centralize the Mirena cases as part of an MCL, or Multi-County Litigation. Although no details were provided by the New Jersey courts, centralized management may have been turned down because most of the New Jersey lawsuits over Mirena were already pending in one county.

It is expected that the U.S. JPML will schedule oral arguments over whether to establish a federal Mirena MDL at a hearing session scheduled to occur in San Diego, California on March 21, 2013.