Kelli Baugh’s menstrual cramps were becoming severe. Sex was extraordinarily painful, and no amount of feminine products could stanch her excessive bleeding. So in 2006, she went to her doctor, who suspected her symptoms might be related to an intrauterine contraceptive device she had had implanted the year before. It was called a Mirena.
But the diagnosis was inconclusive, and Baugh lacked insurance to pay for exploratory surgery. It took two years before she underwent laparoscopic surgery to remove the device, which by then had burst through her uterus. But her problems weren’t over. After giving birth to her third child, Baugh, now 27, was forced to undergo a hysterectomy, allegedly forced by adhesions and endometriosis the device caused.
"It’s a really tragic case, and unfortunately she’s not alone," said Baugh’s lawyer, Carmen Scott of Motley Rice in Mount Pleasant, S.C. "There are many, many cases like hers, and had she known this spontaneous perforation would have happened, she would have made different decisions."
On April 8, the U.S. Judicial Panel on Multidistrict Litigation ordered all personal injury cases involving the Mirena IUD — now numbering more than 40 — coordinated before U.S. District Judge Cathy Seibel in White Plains, N.Y. Seibel has scheduled the first status conference for May 17. John Climaco, founding partner of Climaco, Wilcox, Peca, Tarantino & Garofoli in Cleveland, who moved to coordinate the litigation on January 16, 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."
The suits allege that the Mirena, which a doctor implants into a woman during an office visit, can migrate from its original position, tearing the uterine wall and requiring surgical removal.
More than 2 million women in the United States have used the device during the past decade. The lawsuits target the manufacturer, Bayer Healthcare Pharmaceuticals Inc. Company 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 as a contraceptive in 2000. It releases levonorgestrel, a synthetic progestogen, into a woman’s uterus to prevent pregnancy. The device, which is recommended for women who have already given birth to a child, can remain in a woman’s body for up to five years, after which it must be removed or replaced 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 for Mirena during its "Simple Style" program, which claimed 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 the device’s packaging labels, which warn of risks of uterine perforation, are adequate. But plaintiffs lawyers say the warnings pertain only to risks of perforation when the device is inserted — not years down the road. Nor do they address "spontaneous migration" of the device within a woman’s body.
"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 become pregnant because the device was not in its proper position, Chmielewski said. Others have become infertile due to extreme uterine perforation.
Baugh, a resident of Florence, S.C., filed her suit in 2011. Her case, which was scheduled for trial on May 6, is now the oldest in the MDL and has resulted in numerous depositions, including that of three Bayer executives, according to court documents. It was stayed pending the MDL panel’s decision on coordination.
Bayer has moved for summary judgment, arguing that Baugh exceeded South Carolina’s statute of limitations because she had suspicions as early as 2006 that her problems were due to the Mirena. Bayer also argued it was not liable for failure to warn because Baugh’s doctor admitted she was aware of the risks of migration and perforation with the Mirena. Baugh, in response, claimed she became definitively aware that the Mirena was the cause of her problems in 2008.
Another case, also handled by Motley Rice and filed in 2011, alleges that doctors have been unable to safely remove the Mirena from Carrie Osborne’s body. Osborne, a resident of Harrison, Ga., underwent surgery to remove an ovary after she developed an abscess. In 2009, the suit says, it was discovered that her Mirena, which had been implanted three years earlier, had migrated outside her uterus.
"Her case is quite interesting because the location of the Mirena is so high it’s essentially in her rib cage," Scott said. "Her physicians, both OB/GYN and general physician, have been unable to determine a way to get the Mirena out because it is so precariously placed."
‘QUESTIONABLE ‘ LAWSUITS
Bayer, in opposing coordination, argued that because discovery was so far along in both cases, especially Baugh’s, an MDL would be counterproductive.
"A prompt trial date in Baugh is important because, as the lead trial, it would set the tone for any remaining lawsuits, sharpen the issue going forward, and provide guidance as to the viability of similar claims," wrote Bayer attorney Marie Woodbury, a partner at Shook, Hardy & Bacon in Kansas City, Mo., in a February 7 filing before the MDL panel. "Yet these benefits will be lost if an MDL is created. An MDL would deny Bayer the ability to defend its product in the near future and effectively force it to begin the entire process anew."
Woodbury declined to comment. But in the filing, she argued that the creation of an MDL would encourage the filing of "questionable" lawsuits over Mirena. She pointed to a flurry of cases soon after plaintiffs attorneys moved to coordinate the proceedings.
"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," she wrote. "This could inundate a defendant with hundreds or thousands of cases, thereby forcing settlement for business rather than legal reasons."
She noted that one case involved a woman in Houston who alleged that her Mirena, which was implanted in 2009 at a local Planned Parenthood clinic, caused her to be diagnosed with lupus, an autoimmune disorder. The panel refused to transfer that case into the MDL and, on April 10, U.S. District Judge Melinda Harmon threw it out after the plaintiff, Siria Gonzalez, failed to amend her complaint on a remaining failure-to-warn claim. On March 12, Harmon had dismissed all the other claims, finding that Gonzalez could not cite "medical literature on the subject nor allege any other facts showing how or why Bayer knew or should have known of the risks of the contraceptive causing autoimmune reactions."
In the rest of the cases, plaintiffs lawyers had moved for coordination in federal courts in California, Louisiana, Minnesota, Ohio, Pennsylvania or South Carolina. 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.
At the time of its first application, on August 9, Bayer, represented by Lorna Dotro, of counsel to Coughlin Duffy in Morristown, N.J., cited 16 cases pending in Morris County, N.J., Superior Court. In a joint application filed on March 6, lawyers on both sides said the number of cases has increased to more than 60, most of which are being handled by Parker Waichman.
Matthew McCauley, senior litigation counsel to Parker Waichman in New York, did not return a call for comment. Dotro declined to comment.
Amanda Bronstad is a reporter for The National Law Journal, a Legal affiliate based in New York.