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Mirena IUD's Harmful Side Effects Lead to Multidistrict Litigation

This article was edited for clarity and updated on September 10, 2015.

The Mirena IUD, manufactured by Bayer Pharmaceuticals, has injured thousands of women, causing idiopathic intracranial hypertension (IIH), perforation and bleeding of the uterus, hormonal issues, and even miscarriages.

A Mirena IUD Products Liability Litigation docket, MDL 2434, has been established in the Southern District of New York before Judge Cathy Seibal. To date 1,163 cases have been filed against Bayer Healthcare Pharmaceutical Inc. The actions allege that the warning label was inadequate, and involve issues arising from the alleged risk of uterine perforation and migration

Different allegations

Unfortunately, some affected women in California are unable to join the MDL against Bayer because these cases allege that birth defects were caused by the hormonal component of the product. See Order Denying Transfer issued in August by the Judicial Panel on Multidistrict Litigation (JPML).

These 31 cases were dismissed by the US District Court for the Southern District of New York in January 2015. The 31 New York dismissals, coupled with the JPML's ruling last year conerning Mirena cases alleging IIH, means they will be tried individually.

After a review of the 31 cases, Judge Seibal was shocked to find that all the attorneys handling the various cases contained claims that were time barred under the applicable statutes of limitations.

Originally, the JPML's 2014 decision did not affect the 31 cases consolidated for MDL in 2013. The New York federal court, however, dismissed the 31 cases with prejudice earlier this year, ruling in favor of defendant Bayer’s motion to dismiss. Judge Seibal discussed the negligent mistakes of the plaintiffs' attorneys in her opinion, instructing the attorneys to provide copies of the opinion to their respective clients.

Well-Pleaded Facts

Bayer’s motion to dismiss was filed in response to a case management order (CMO 22A), which the New York district court issued. Under the CMO, Bayer manufacturers were allowed to submit a letter explaining why each case should be dismissed consistent with the court’s previous opinion, Truitt v. Bayer, No. 13-CV-7811 (S.D.N.Y. July 2, 2014). Once Bayer filed its argument for dismissal, the CMO gave the plaintiffs two options:

  • Each of the plaintiffs must either voluntarily dismiss her case with prejudice, or
  • Each of the plaintiffs must set forth the specific facts and/or law that distinguished her case from Truitt.

Of the 31 cases, the court found that the manufacturers’ motions implicated four sets of issues that are cause for dismissal, and each case fit into one of the four groups.

[sws_pullquote_right] See Also:Death and Injury Suits Pending against Essure Birth Control Device [/sws_pullquote_right]

Medical-Based Fact

The Mirena IUD is a semi-permanent intrauterine device (IUD) that is surgically implanted into a woman’s uterus to prevent pregnancy. It operates by releasing the hormone levonorgestrel into a woman’s uterus over a period of about five years, thereby preventing the ovaries from releasing eggs. estimates that more than 220 lawsuits have been filed against Bayer in response to the various types of harm caused by the Mirena IUD. According to AboutLawsuits, more than 70,000 adverse events have been filed with the FDA involving Mirena IUD problems in the past decade, including at least 1,322 reports where the Mirena IUD punctured the uterus and 5,000 cases involving women who indicated the IUD migrated out of place. The migration problem alone can cause a variety of dangerous side effects, including:

  • Perforation of the uterus
  • Bleeding of the uterus
  • Perforation of the cervix
  • Severe abdominal pain
  • Dizziness and fainting
  • Infections
  • Complete expulsion of the device from the body

In the most severe cases, a woman’s decision to avoid having children becomes involuntarily permanent when the Mirena IUD causes irreversible sterility. Cases also allege the IUD can also cause IIH, a neurological disorder that is characterized by increased pressure around the brain.

Though some of the Mirena IUD litigation has been precluded from transfer to the MDL, women suffering from the painful IUD displacement and uterine perforation side effect are still able to bring lawsuits. As Judge Seibel pointed out in her district court opinion, some of the 31 dismissed cases would still proceed if several plaintiffs’ lawyers had not egregiously erred by missing case filing deadlines. Additionally, the JPML's ruling and orders will continue to prevent certain allegations from joining the New York MDL.

It will be crucial for attorneys and individual plaintiffs seeking to take on the deep pockets of big pharmaceutical companies like Bayer to carefully study jurisdictional procedural requirements, as well as allegations currently consolidated into MDL.

The New York case is Abrams v. Bayer (In Re Mirena IUD Prods. Liab. Litig.), case number 13-MD-2434 (CS).

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