Many of us have heard of an IUD and have heard of Mirena, but don’t actually know what they are. Mirena is a type of intrauterine system, more commonly known as an IUD. But what is that, exactly? According to the Mirena website, an IUD, or intrauterine device, is a small, T-shaped device that is placed into the uterus by a trained healthcare provider during a routine office visit. It provides continuous, highly effective birth control. Mirena is a hormone-releasing IUD that releases small amounts of a progrestin hormone called levonorgestrel locally into the uterus. Mirena lasts for as long as you want, for up to 5 years.
Mirena’s website has a long list of potential side effects which begs the question – should it even be approved by the FDA? Many have started to file lawsuits due to the serious complications they have endured as a result of having the Mirena intrauterine device. Recently, a class action of approximately 1,200 lawsuits which contend that Bayer Healthcare (the company who owns Mirena) failed to warn of the risk that the T-shaped flexible piece of plastic could puncture the uterine wall even if it is inserted correctly by a doctor, an injury referred to as secondary perforation. Bayer’s defense? Bayer says that the women haven’t shown they were injured or that the device was to blame. And in a recent filing, Bayer asked for summary judgment, arguing that because nearly all of the plaintiffs’ experts have been excluded, none of them can prove that the IUD, even if properly inserted, could puncture the uterine wall. Bayer cited a 2010 case from the Southern District of West Virginia, Meade v. Parsley, over the heartburn medicine metoclopramide and its connection with tardive dyskinesia, an uncontrollable shaking. As Bayer describes it, the plaintiffs had no general-causation expert, instead relying on the bottle’s label: “WARNING: TARDIVE DYSKINESIA — Chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible.” In that case, the court said that simply wasn’t good enough, that “causation evidence in toxic tort cases must be in the form of expert scientific testimony,” as Bayer quotes it, and that the plaintiffs had provided no support for their view that drug labels could serve as general-causation proof. Bayer says the Mirena case is analogous.
The women have told a judge they can prove their case without experts, contending Bayer’s own admissions about Mirena’s danger are adequate to back up their claims.
“For years, Bayer has admitted — everywhere but in the courtroom — that Mirena can perforate the uterus after being properly inserted,” the women said. “A party’s admissions are admissible evidence, and when such evidence shows that a defendant has admitted general n causation — that is, admitted that the complained-of injury can occur — no expert testimony on that subject is required.”
Bayer argued back that the plaintiffs cannot actually point to any true admission that any secondary perforation actually exists and any random admission they cite to reconfirms the need for causation testimony. But the problem goes further, according to the drugmaker, which says that the company statements cited by the plaintiffs as admissions of secondary perforation actually weren’t admissions. In January 2013, the FDA approved Bayer’s Skyla, a slightly smaller version of Mirena, whose label warns perforation may occur, “most often during insertion,” but may not be detected until later. That’s the same language the FDA approved for Mirena’s label in May 2014, the plaintiffs said. And in 2010, the company told the Canadian public that Mirena can perforate the uterus at the time of insertion or after. But it didn’t offer that warning to doctors or patients in the U.S., the women said.
One excluded expert, Roger C. Young, said the Mirena IUD can exert a force of 390 pounds per square inch, which he said is enough to penetrate the uterus, compared to the amount of force necessary to penetrate heart muscle, which is about 290 pounds per square inch.
As of now, the parties are waiting to hear what the court will decide.
http://www.law360.com/articles/810071/with-experts-barred-bayer-says-iud-patients-have-no-case & http://www.mirena-us.com/safety-considerations/ & http://www.law360.com/articles/814605/bayer-admissions-can-carry-iud-claims-consumers-say?article_related_content=1
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