Jon Campisi Aug. 1, 2013, 6:53am


A New England woman has filed suit against pharmaceutical giant Bayer Healthcare over

claims that she sustained personal injuries after the defendant’s Mirena intrauterine device became defective.

Jessica Dinicola, who resides in Connecticut, says in her civil action that the birth control system, which was implanted inside her body by a physician in the spring of 2009, migrated by 2011.

The device migrated, the lawsuit claims, because it was negligently and defectively designed.

Bayer Healthcare knew that the Mirena had a higher migration rate than other IUDs on the market, but never adequately disclosed these facts to the plaintiff or her doctor, states the complaint, which was filed in U.S. District Court on July 31 by Philadelphia lawyers Dianne Nast, Daniel Galluci and Joanne Matusko, of the firm NastLaw.

Dinicola ended up having to have the Mirena surgically removed in late August 2011 because it had migrated from its proper position, a procedure that caused the plaintiff to experience physical pain and suffering, financial loss and permanent risk of placenta accrete, according to the civil action.

Like other Mirena products liability claims filed against Bayer in recent times, the Dinicola lawsuit maintains that the drug manufacturer knew or should have known that the risk of uterine embedment and perforation is increased until as long as six months post-partum, but that the defendant failed to adequately warn consumers of this risk.

The Mirena label, which describes perforation as an “uncommon” event, warns that the device has the potential to perforate the uterus during insertion, but does not warn about the rates of embedment or spontaneous perforation, migration, organ damage, infertility, or the risk of the need for surgical intervention, including after successful insertion, the lawsuit states.

The complaint also faults the defendant for allegedly not doing enough to warn lactating women of their increased risk for Mirena embedment and perforation.

Bayer, the suit claims, has a history of overstating the efficacy of Mirena but understating its risks and safety concerns.

“Although Defendant received reports of embedment, perforation, organ damage, infertility, and the need for surgical removal, including after successful insertion, it failed to study the rate at which these injuries were occurring, and failed to disclose these risks and rates,” the complaint reads. “Defendant failed to issue warnings of the risks associated with the Mirena IUD that were commensurate with the risks of which they were aware, and Defendant concealed the knowledge it had of the risks from Plaintiff, her prescriber, the medical profession generally and from governmental regulatory bodies including the FDA.”

The complaint says that prior to inserting the device, Dinicola’s doctor discussed the risks and benefits of Mirena IUD, but because Bayer never disclosed the true risks of perforation, migration and embedment, it was impossible for the physician to adequately discuss the true risks and benefits of the device with his patient.

“Plaintiff would not have elected to have the Mirena IUD implanted in her if she knew of the true risks associated with the use of Mirena,” the suit states.

The complaint contains counts of strict products liability, breach of express and implied warranties, negligence, fraud and misrepresentation, consumer fraud, negligent misrepresentation, fraudulent misrepresentation, negligent infliction of emotional distress, and unjust enrichment.

Dinicola seeks unspecified compensatory damages for pain and suffering and severe and permanent personal injuries, healthcare costs, medical monitoring, and interest, as well as punitive damages, treble damages, attorney’s fees and costs.

The plaintiff is demanding a jury trial.

 

The federal case number is 2:13-cv-04419-JP.

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