Potentially dangerous Mirena IUDs sparking U.S. lawsuits

February 26, 2013 (Press-News.org) Potentially dangerous Mirena IUDs sparking U.S. lawsuits

Article provided by Bohrer Law Firm, L.L.C.
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Millions of women in the United States and around the world are living with implanted Mirena intrauterine devices, commonly called Mirena IUDs, and some of these women have had nightmarish experiences from dangerous side effects of the devices. Approved by the U.S. government for birth control and to lessen abnormally heavy menstrual bleeding, reports of severe injuries and ectopic pregnancies (outside the uterus) because of Mirena UIDs have become common in the media, as have reports of related lawsuit filings.

Nationwide Mirena lawsuits

For example, a February 15, 2013, Westlaw search of nationwide pleadings shows several Mirena personal injury complaints filed in February alone against the manufacturer Bayer HealthCare Pharmaceuticals, Inc., and against some health care providers. The recent suits are from all across the country in both state and federal courts.

The Mirena IUD

Although the reasons that IUDs prevent pregnancy are not fully understood, the Mirena, a plastic T-shaped device normally inserted for up to five years in the uterus, is thought to block sperm from fertilizing eggs because hormones released by the device thicken mucus, narrow uterine lining and prevent some ovulation, according to the Mayo Clinic.

Serious side effects

The primary problem sued for in complaints is that the Mirena IUD can shift out of its proper position in the uterus and either become embedded in the uterine wall, lodged partly in and partly outside the uterine wall or break through the uterine wall and migrate to other parts of the body. The complaints allege that the Mirena IUDs ended up in many places. For example, one plaintiff asserts that the device broke into three pieces that "embedded themselves in her stomach, intestines, and bowel."

These problems normally require surgical removal of the devices and cause severe pain and distress. Several of the lawsuits allege permanent injury, and past and future loss of earnings and medical expenses. Some of the plaintiffs are concerned about their future ability to have children.

Manufacturer's warnings

Bayer does include safety warnings about Mirena on its website (as of February 15, 2013), including pelvic inflammatory disease, uterine perforation, dangerous pregnancy with potential miscarriage or infertility, and more. The lengthy "full prescribing information" document (revised February 2013) is also available on the company website and contains many more side effect warnings with heightened detail.

FDA action

Nevertheless, the U.S. Food and Drug Administration, or FDA, has previously warned Bayer by official letter that at least one of the Mirena advertising programs has been "misbranded" and "misleading," especially assertions that the IUD enhances the emotional aspect of intimate relationships and makes women appear and feel "great."

Causes of action

The lawsuits each bring several causes of action against Bayer. Examples include:
-Violations of federal product safety laws
-Violations of state product liability laws
-Defective manufacturing
-Defective design
-Breach of implied and express warranties
-Fraudulent or negligent misrepresentation
-Negligence
-Failure to warn
-Strict liability
-Fraud by concealment

Safety advocates, the medical community, pharmaceutical companies, government regulators and patients will watch for news of the outcomes of these Mirena lawsuits with keen interest.

Legal counsel

In the meantime, anyone who suffers injury because of a Mirena IUD, or whose loved one was harmed, should discuss the situation with an experienced defective medical device attorney who has worked with Mirena cases. A knowledgeable personal injury lawyer can explain the potential legal claims and damages that may be available to compensate for resulting medical bills, lost wages, pain and suffering, disfigurement, permanent injury and more.