Attorneys defending Bayer Corp. are seeking consolidation of New Jersey suits alleging its intrauterine contraceptive Mirena causes reproductive and other injuries.

Bayer filed an application on Aug. 9 for centralized management of the litigation in Middlesex County.

Mirena, a T-shaped plastic device that is implanted in the uterus and releases contraceptive hormones for up to five years, was introduced in the United States in 2000 and was in use by upward of 2 million women as of 2010.

According to the application for multicounty litigation (formerly mass tort) status, 16 suits were pending, all filed by out-of-state plaintiffs.

The plaintiffs claim Bayer has used deceptive tactics to market the device and as a result, they were left unaware of its potential risks and complications.

Bayer marketed Mirena — which is recommended for women who have given birth to at least one child — directly to “busy moms” through in-home events, and made exaggerated claims as to how the product would make them look and feel, the plaintiffs allege, pointing to a December 2009 letter from the Food and Drug Administration warning the company about its marketing.

The problems include migration of the product, which causes conditions such as uterine and cervical perforation, pelvic inflammatory disease or other infection, ovarian cysts, embedment of the device, irregular pregnancy, irregular spotting or bleeding, and breast tenderness.

In one suit, Mashala v. Bayer Corp., MRS-L-1910-12, a 24-year-old Indiana woman claims she was implanted with the device in March 2009 but it could not be found when doctors attempted to remove it in September 2010.

A subsequent CT scan showed the device had migrated to the left abdominal wall, requiring a laparoscopic procedure to remove it, according to Parker Waichman in Edison, a firm representing the 16 New Jersey plaintiffs.

Also representing the plaintiffs is Motley Rice of Mount Pleasant, S.C.

There are at least seven additional suits over Mirena in other jurisdictions. Federal suits were filed in South Carolina, Texas and Georgia, and four in Louisiana, Missouri and New York state courts.

Bayer contends that the New Jersey litigation meets the criteria for centralized management set out in Administrative Directive No. 08-12, issued Aug. 7 by the state judiciary.


  • There are a large number of cases — 16 suits that include claims from at least 24 plaintiffs in 10 states — and indications, such as attorneys’ advertising, are that more are on the way.
  • Though related matters are pending in other jurisdictions, the New Jersey filings are the most numerous.
  • The existing suits allege similar facts and demand similar damages.
  • Centralized management will promote fairness, and avoid divergent discovery rulings and redundant motion practice.
  • Bayer’s general counsel is located in Pittsburgh, while the plaintiffs’ firms involved are scattered geographically.

Middlesex County is the best of the three multicounty litigation venues because of New Brunswick’s proximity to Newark Airport for traveling lawyers and because its caseload decreased 64 percent in the past year, while Bergen’s and Atlantic’s increased 50 percent and 82 percent, respectively, Bayer contends, citing judiciary statistics.

After a comment period ending Oct. 15, the Supreme Court will rule on the application.

Attorneys from Shook, Hardy & Bacon’s Houston and Kansas City, Mo., offices are serving as Bayer’s national counsel in the litigation.

Lorna Dotro of Coughlin Duffy in Morristown, who filed the application on Bayer’s behalf, did not return a call Tuesday, but company spokeswoman Rosemarie Yancosek says, “Bayer will vigorously defend itself against these claims.”

Bayer already is defending multicounty litigation over another contraceptive product, Yaz and Yasmin, which are alleged to cause potentially fatal medical issues, including stroke. The cases were centralized with Bergen County Superior Court Judge Brian Martinotti in February 2010. Claims against Ocella, a generic version made by Teva Pharmaceuticals, are included in that litigation. As of Aug. 4, there were 1,164 cases filed, according to judiciary data.