Approximately 40 lawsuits filed over problems associated with the Mirena intrauterine contraceptive device have been coordinated in multidistrict litigation before a federal judge in New York.
The suits allege that the device, which a doctor implants into a woman during an office visit, can migrate from its original position, tearing the uterine wall and requiring surgery to remove it. Plaintiffs’ lawyers have said in court documents that they expect hundreds, possibly thousands of cases against Bayer Healthcare Pharmaceuticals Inc.
More than 2 million women in the United States have used the device during the past decade.
On April 8, the U.S. Judicial Panel on Multidistrict Litigation ordered the cases coordinated before U.S. District Judge Cathy Seibel in White Plains, N.Y. Seibel has scheduled the first status conference in the litigation for May 17.
John Climaco, founding partner of Climaco, Wilcox, Peca, Tarantino & Garofoli in Cleveland, Ohio, had moved to coordinate the litigation on January 16. He said his firm has "way over a couple hundred cases" ready to be filed.
"Most of the attorneys we’re working with have a couple hundred cases they’re evaluating and preparing for filing," said Dawn Chmielewski, an attorney at Climaco’s firm. "We do believe there will be several hundred cases or thousands."
Bayer HealthCare spokeswoman Rosemarie Yancosek issued a statement via email: "Bayer is aware of the decision by the U.S. Judicial Panel on Multidistrict Litigation to consolidate the federal personal injury lawsuits involving Mirena in the Southern District of New York," she wrote. "Bayer will vigorously defend itself against these claims regarding Mirena."
Mirena is a T-shaped flexible plastic device that the U.S. Food and Drug Administration approved for sale in 2000. It releases hormones into a woman’s uterus to prevent pregnancy. The device can remain in a woman’s body for up to five years, after which it must be removed by a doctor during an office visit.
In 2009, the U.S. Health and Human Services’ Division of Drug Marketing, Advertising and Communications declared that Bayer had made unsubstantiated claims in its promotional materials to "busy moms" that Mirena enhanced a woman’s sexual drive and made her "look and feel great." In fact, the agency concluded, the device carries risks of decreased libido, weight gain and acne.
Bayer noted in court documents that the product has not been recalled. The company insists that its packaging labels regarding "spontaneous migration" of the device are adequate.
But plaintiffs’ lawyers say the warnings pertain only to risks of perforation of the uterus when the device is inserted — not years down the road.
"Our position is the only warning on Mirena, on the…physician’s package insert, is that Mirena can perforate the uterus during insertion," Chmielewski said. "There’s not a warning on the device that says at any time in five years since inserted it can slowly erode the uterine wall and end up perforating the uterus."
In some cases, she said, the devices have attached to the bowels or diaphragm, requiring surgery to locate and remove them. Some women filing suits have gotten pregnant because the device was not in its proper position, Chmielewski said. Others have become infertile due to extreme uterine perforation.
Plaintiffs’ lawyers had moved for the cases to be coordinated in federal courts in California, Louisiana, Minnesota, Ohio, Pennsylvania and South Carolina. Bayer had opposed coordination altogether.
"Not only will Bayer be prejudiced by the creation of an MDL, but these cases do not even meet the basic requirements necessary to justify an MDL," wrote Bayer attorney Marie Woodbury, a partner at Shook, Hardy & Bacon in Kansas City, Mo. "For example, Bayer warned of the risk of perforation, and thus there is no need for extensive discovery about Bayer’s knowledge of the risk. Consolidation will not make this discovery any more convenient or efficient."
Woodbury declined to comment.
In the end, the MDL panel voted for coordination, but in a separate court.
"While we agree that these actions present a number of individualized factual issues, the existence of such issues does not negate the common ones, including, in particular, those concerning the alleged risk of perforation and migration posed by the product and the adequacy of the product’s warning label with respect to those risks," MDL panel acting chairwoman Kathryn Vratil wrote.
"Weighing all factors, we have selected the Southern District of New York. Bayer Healthcare LLC is located in New York and other Bayer corporate affiliates are located nearby in New Jersey, Connecticut, and Pennsylvania."
Another 85 lawsuits over Mirena are pending in state courts in New Jersey, where Bayer HealthCare’s U.S. headquarters is located. On January 2, the New Jersey Supreme Court refused to coordinate the litigation, but lawyers on both sides have asked that court to reconsider that order.
Meanwhile, Bayer is fending off tens of thousands of personal injury lawsuits over its Yaz and Yasmin birth control pills.
"The injuries are completely different with Yaz and Yasmin," Chmielewski said. "What’s going on there is the allegation that those birth control methods cause blood clotting at a higher rate than other oral contraceptives on the market."
But in both cases, she said, Bayer failed to warn of the risks.
"It goes to a pattern or practice that Bayer fails to warn or downplays the warnings," she said.
Contact Amanda Bronstad at email@example.com.