A federal
judge has ruled in favor of Bayer against all the 1300 lawsuits filed by women who
claimed to have suffered from internal injuries after Mirena was inserted.
It all
started in 2011 when a woman filed the first complaint. Since then other have
joined in claiming to have uterine perforation, inflammation, organ damage, and
a host of other medical complications. Bayer has long marketed the IUD as
a “hassle free” birth control for busy, on the go moms.
Bayer was
warned by FDA in 2009 to scale down the positive effects of Mirena and also put
forth the negative effects. The letter also stated that Mirena’s advertisements
are misleading consumers by exaggeration of its abilities and do not display
the side effects and risks of the IUD. Mirena was approved by the FDA in 2000, and
since than Bayer has spent tens of millions of dollars advertising the IUD directly
to the consumers.[1]
By the year
2009, it was so popular among women that nearly 7.5% American women had it implanted
by then and have generated billions of dollars in revenue for the manufactures.
The lawsuits
against Mirena comes in many forms, and in multiple states across the US. Women
have claimed to have uterine perforation, increased risk of neurological damage
and painful surgical removal, ovarian cysts, headache, migraines, acne,
depression, and mood swings. The most common complaint is device migration ,
damaging and perforating the internal organs. A website TheTruth About Mirena contains many other side effects and makes a grim reading.
In the year 2015, Bayer had settled 8,250 cases for $1.7 billion but
there are still lawsuits pending in national and state courts across the
country. All are individually filed complaints but still a class action
lawsuit is not filed yet.
In March
2016, US District Judge Cathy Seibel granted Bayer’s motion to bar the
plaintiff’s expert witnesses from testifying in the court about perforation
caused by the device. She found that the testimony was not backed by scientific
literature and was made up just for the purpose of litigation.
Bayer’s
lawyer claimed that perforations might have occurred during insertion, but were
only detected later and there is no evidence that Mirena causes uterine
perforations.[2]
Without
expert witness testimony, no jury could rule in favor or against the IUD. So, on
August 1, 2016 she ordered that the verdict should go in favor of Bayer in all
13000 cases.[3]
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