Jon Campisi Jan. 29, 2013, 9:03am

A Pennsylvania woman is suing the makers of the Mirena birth control system over

allegations that the product’s manufacturers understated the potential harmful side effects that could occur in some women who have the contraceptive device inserted into their bodies.

Tricia Prendergast alleges in her civil action that Bayer Pharmaceuticals Corp. and various company subsidiaries did not fully divulge the problems associated with Mirena, instead misrepresenting its efficacy and pushing the product as being generally safe for public use.

The lawsuit, which was filed at the U.S. District Court in Philadelphia on Jan. 25 by Philadelphia attorneys Dianne M. Nast, Daniel N. Gallucci and Joanne E. Matusko, of the firm NastLaw, says that Mirena, which is a birth control device made of flexible plastic that is inserted into a woman by her doctor, and to date has been used by more than 15 million women worldwide, can spontaneously migrate throughout the body.

Mirena’s label does not warn about spontaneous migration, but only states that migration can occur if the uterus is perforated during insertion, the lawsuit states.

The warning label does not disclose what the complaint calls the “true risks” associated with Mirena, including the fact that the device can become dangerously embedded within the body.

“Defendants have a history of overstating the efficacy of Mirena while understating the potential safety concerns,” the complaint reads.

The defendants failed to properly inform the consuming public about the serious conditions associated with Mirena use, including susceptibility to infection and the possibility of a miscarriage if a woman becomes pregnant while using the product, the suit states.

The lawsuit does not appear to specify exactly what types of alleged injuries the plaintiff sustained as a result of her use of the product, only that she required surgical removal of the device.

The lawsuit contains counts of defective manufacturing, design defect, negligence, failure to warn, strict liability, breach of implied and express warranties, negligent misrepresentation, fraudulent misrepresentation, and fraud by concealment.

The complaint accuses the defendants of failing to properly and thoroughly analyze and test Mirena before releasing it to the market, failing to conduct sufficient post-market testing and surveillance of Mirena and failing to exercise due care when advertising and promoting Mirena.

The plaintiff seeks compensatory and punitive damages, along with interest, costs and attorney’s fees.


The federal case number is 2:13-cv-00450-JP.

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