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Bayer Stocks Fall After Mirena Lawsuits Filed

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According to a recent article in Bloomberg, Mirena IUD manufacturer Bayer AG’s stocks fell by 2.8 percent after a Pennsylvania woman sued the company for failing to provide adequate warnings about the risks associated with the birth control device. She filed the complaint on January 25, 2013.

The FDA’s Adverse Event Database has received 45,000 reports of problems related to the Mirena, including perforation of the uterus, migration of the device to other pelvic organs, and ectopic pregnancy. As more women come forward to file complaints, plaintiffs recently petitioned the U.S. Judicial Panel on Multidistrict Litigation to consolidate all federal cases into one court for more efficient pre-trial proceedings.

Bayer Facing Another Wave of Litigation

Bayer has already spent $750 million in settlements for plaintiffs alleging injuries from Yaz and Yasmin birth control pills. The progestin used in the pills has been linked to a higher risk of blood clots than other progestins like levonorgestrel. More than 8,000 of these lawsuits are still pending in state and federal courts.

Now, it seems as though the company will be defending another wave of litigation related to the Mirena IUD. The small, t-shaped plastic device is professionally inserted into the uterus and gradually releases small amounts of the progestin levonorgestrel, which prevents pregnancy. More than 15 million women worldwide use the product, including 2 million in the U.S.

According to the complaint submitted by the Pennsylvania woman, the Mirena label doesn’t warn that it may be come embedded in the body or cause ectopic pregnancy, and that it fails to warn of complications that could require additional corrective surgeries.

Mirena Lawsuits Increasing in Number

At least 16 lawsuits are already pending in New Jersey, with plaintiffs alleging the Mirena IUD caused serious injuries including uterus perforation and embedment into other body organs. In August 2012, Bayer requested the New Jersey Supreme Court centralize those cases into one court, but the court denied the request for unknown reasons.

More claims have been filed in California, Iowa, Ohio, and Arkansas. Plaintiffs bring counts of failure to warn, manufacturing and design defects, and negligence, and claim that Bayer should have done more to ensure the safety of the product before releasing it to the public.

Of the 45,000 reports received by the FDA, over 5,000 involved dislocation and over 1,400 involved migration of the device, both of which may require hospitalization or corrective surgery.

Bayer Continues to Promote Mirena

The FDA has already warned Bayer once about the Mirena, sending a letter to the company in December 2009. The agency accused Bayer of overstating the benefits of the device during presentations to consumers, when they claimed it would help moms “look and feel great” and enjoy more intimacy in their relationship, when none of the clinical trials completed for the approval of the device showed any evidence that it would do these things.

The agency also warned Bayer that they were downplaying the risks of the drug, including the risk of getting pregnant while using the Mirena, which can result in the loss of the baby or infertility.

Despite the lawsuits and the drop in stocks, Bayer continues to heavily promote Mirena and its other birth control products. Commercials emphasizing the benefits of the device air on television regularly, without mention of the most serious side effects named in lawsuits.