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Mass tort builds over Mirena IUD injuries

Mass tort builds over Mirena IUD injuries

A mass tort is taking shape over the Mirena IUD, a device that many women claim migrates after insertion and becomes embedded in the uterus or punctures organs, requiring surgical removal and sometimes causing infection and other injuries.

Lawyers have filed dozens of cases against Bayer Healthcare, the maker of the contraceptive device.

There are about 75 cases in New Jersey state court and 50 cases filed in federal courts around the country, including in California, Georgia, Kentucky, Ohio, South Carolina and Texas.

Plaintiffs’ attorneys say that number is likely to multiply as they continue to screen cases.

“We’ve had several hundred intakes, and a large number of complaints overall,” said Matthew J. McCauley of Parker Waichman in Port Washington, N.Y., whose firm has filed over 50 cases in New Jersey state court and has more in the works.

Cases are also likely to snowball in federal court, where a multidistrict litigation panel has consolidated cases in U.S. District Court for the Southern District of New York.

“It was under the radar until we filed for consolidation. We realized it was necessary with so many cases coming in,” said Dawn Chmielewski, an associate at Climaco, Wilcox, Peca, Tarantino & Garofoli in Cleveland, one of the lawyers arguing for MDL consolidation in the Northern District of Ohio.

An estimated 2 million women in the U.S. are using the Mirena IUD.

“It’s going to be a very large tort. Thousands and thousands of women have been affected in this way and will likely come forward,” said Carmen Scott, an attorney at Motley Rice in Mt. Pleasant, S.C.

T-shaped device

The Mirena is a t-shaped plastic intrauterine contraceptive inserted by a physician. The device releases a daily dose of progestin levonorgestrel into the uterus, thus thinning the uterine lining.

It was approved by the Food and Drug Administration in 2000 as a drug, rather than as a device, for use for a period of five years. A similar device, SKYLA, was approved in January for use for a period of three years.

According to plaintiffs’ attorneys, the Mirena IUD is moving around and ending up where it should not be, as far away as the rib cage, and sometimes perforating or wrapping around other organs, requiring surgical removal.

The product has two strings hanging from it that are checked for proper placement after insertion. Some women are discovering that the IUD has moved when they go to their doctors for follow-up; others discover the device has moved months to years after insertion.

In a complaint filed in federal court, 29-year-old Arkansas resident Susan Harp alleges that only days after the Mirena was inserted, she felt severe abdominal pain and was vomiting. A CT scan showed that the IUD was no longer within her uterus but was moving freely within her pelvis. Removal of the device was then complicated by a kidney infection.

The complaints allege defective design and that Bayer failed to warn about the risks of migration and perforation after insertion. Some plaintiffs, including Harp, allege fraud and seek punitive damages.

“The way the label is written for Mirena, it states that after insertion of the device, the patient is to go back and have placement confirmed by her physician, then that’s it. With respect to the warnings, the current label says perforation is a risk during insertion” but not after insertion, said McCauley.

There were more than 25,000 adverse event reports as of 2010, although they include complaints such as pregnancy and bleeding, according to Scott.

As an indication of Bayer overstating the benefits of Mirena and downplaying the risks, plaintiffs’ attorneys point to a marketing program the company hosted for busy moms called the “Simple Style” program. (Mirena is only recommended for women who have already given birth). The sales program combined a social networking website with a personal visit to women’s homes by a nurse practitioner to introduce the product, similar to an Avon lady.

In 2009, the Department of Health and Human Services’ division of marketing found that the program made unsubstantiated claims that the Mirena IUD increased intimacy, romance and libido and helped make patients “look and feel great.”

Lawyers representing Bayer did not immediately respond to calls seeking comment.

Bayer spokesperson Rosemarie Yancosek emailed a statement about the litigation saying only, “Bayer will vigorously defend itself against these claims regarding Mirena.”

First trial date set

The first trial date has been set for May 6 in federal court in South Carolina.

In that case, Kelli Baugh, a 27-year-old mother, alleges that the Mirena device spontaneously perforated the lining of her uterus and moved into her uterine cavity.

“We’re alleging the design of Mirena allows for migration of the device through the uterine lining in the absence of anyone pushing it through because the way it works is by thinning the uterine lining,” said Scott, who represents Baugh.

As a result, she alleges, Baugh had to have a total hysterectomy, is in surgically induced menopause and has to take estrogen daily.

“We think the damages are horrendous. Anytime a product renders a 20-something woman unable to bear children, that’s substantial,” said Scott.


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