US District Judge Cathy Seibel’s decision has affected more than 1,200 lawsuits in the multidistrict litigation, which consolidated the lawsuits in 2013. In the two years leading up to the MDL Mirena claims increased, leading to a consolidation because of the similar issues of “the alleged risks of uterine perforation and migration associated with Mirena and the adequacy of the product’s warning label.”Plaintiffs’ experienced a setback in March - when Seibel excluded four plaintiffs’ experts - paved the way for last month’s ruling in Bayer’s favor. Seibel decided that, without expert testimony, no jury would have a sound basis to find in favor of plaintiffs. “The court reaches this conclusion reluctantly, knowing that it will doom hundreds of cases, but in the court's view it is compelled by the law,” Seibel said (Case 7:13-mc-02434-CS-LMS D).
Why did Seibel disallow their experts’ testimonies to show that Mirena could cause uterine perforation after insertion, or “secondary perforation”? In March she said the testimony would have been biased, finding that “their opinions were not supported by scientific literature and had been developed for the purpose of the litigation”.
It Ain’t Over til it’s Over
In June, plaintiffs told Seibel that they can prove their case without experts. They had to demonstrate that the Mirena starts to move through tissue after insertion, and when the insertion procedure produced no injury. And that the Mirena labels - when they were prescribed the product (the wording had changed somewhat) - inadequately warned of that risk. Bayer stated that there is no "secondary perforation" and that perforations always start with some injury during insertion.
READ MORE MIRENA IUD LEGAL NEWS
Instead, the court reasoned that "an analysis of the anatomy and physiology of the uterus, the strength of its muscles, the types of injuries that could be caused by the Mirena insertion procedure, and whether and how such injuries can be detected with existing technology" would be "well beyond the common understanding of lay jurors," according to druganddevicelawblog.com, meaning that plaintiffs did need expert testimony.
More than 1,200 Mirena claimants in the MDL are likely hopeful that it ain’t over till the appeal is over…
READER COMMENTS
Tara Jager
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Bekah Gatchel
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Ms. Reed placed an IUD in order to help stop extreme bleeding in early 2016. The bleeding eventually stopped after a couple of months with the IUD and taking progesterone. However, a few months in I experienced SEVERE abdominal pain and cramping for about 48 hours straight. After my GI doc scanned my belly and found nothing, I went to Ms. Reed questioning the possibility the IUD out of place and causing the pain. She checked for the strings and told me it was fine and there was no way the IUD would cause such pain. The following month near my cycle, more intense pain for a few days straight this time and again called them but was assured IUD in place and no way could be the pain. But I insisted a vaginal ultrasound done to make sure the IUD in place. Well, turns out the IUD had perforated my uterus and was out of place. Still, Ms. Reed did not want to remove the IUD because she was concerned the bleeding would commence...she instead scheduled an ablation. It was also noticed on the ultrasound that I had 2 tiny cysts on my right ovary. So I continued to trust her. The very next week, on halloween, I suddenly hit the floor in SUCH extreme abdominal pain and cramping at work! I couldn't even stand up straight. I was sobbing...when I could finally hobble into an empty conference room I called the nurse and left voicemail. She called me back about an hour later, asking if I was still in so much pain; when I told her I was she told me they could do nothing for me in the office so I needed to go to the ER if it hurt that badly. I finished work scrunched in my chair crying, drove as scrunched as possible home, and had hubby take me to ER. As soon as I got in the car the pain intensified so incredibly that I curled into a sobbing ball; I could not even get myself out of the car or stand up. I proceeded to sit in a wheelchair in the ER lobby and CRH for 3 hours before they took me into a room. Two rounds of pain meds did nothing to abate the pain whatsoever. After another belly scan they said nothing wrong except the IUD, which they refused to remove. So I was sent home, endured the night full of intense pain, went to work the next day in the same pain because I could not afford to miss work, called the OBGYN office but they would not get me in or help me. So at lunch I went to the office in tear, doubled over and insisted they get me in and remove the IUD. There were no appointments until the next week supposedly, but they told me to sit and they would have someone triage me. Well, when that gal finally came out and brought me back, she reprimanded me for walking in without an appointment. When I told her the situation and that no one would help me, and that I needed them to see how much pain I was in, she told me seeing me was not going to help me get in at all and to never do that again. She insisted the IUD was in the correct place, even when I told her THEIR office was the one who told and showed me the previous week that the IUD was indeed perforating my uterus. I told her to look at the ultrasound. After debating with her for 5-10 minutes as I sobbed, she reluctantly told me that there had been a cancellation with the brand new PA for Ms. Reed in an hour, so if I wished to sit in the waiting room for an hour they would allow her to remove it to get that off my plate so I could rule out the IUD being the cause of the pain. Well, as I sat in the waiting room crying and doubled over, those advertisements play on their tv. Over and over the ad for Mirena played and over and over stated if a patient has any of these symptoms....to immediately inform their doctor as these are signs the IUD is out of place. Hhhhmmmnnn....EVERYTHING I had been telling Ms. Reed the past three months, as she insisted there was NO way the Mirena was out of place or could cause this pain. So they finally brought me back. When the PA came in, she too told me the IUD was in the proper place and there was no reason to remove it. Did I still wish her to remove it? When I said yes, she said she would appease me by removing it, but it was in the correct place. I hurt so badly that just for her to touch me sent me shooting up the table! She slightly chuckled and then removed it, asking me if I wanted to see it! As I lay there in such pain, she just told me to take my time and she hoped her removing it would take that concern from me (that the IUD had been causing the pain). Well, within a couple hours the pain began to subside and within 48 hours near nothing. So I hit the search for new OBGYN and a friend said she trusts Dr. Albers with her life and loved him so much she named her son after him. When I met him, he was so kind. He immediately did an ultrasound and saw the cysts. Oh yes, and just to get the records of that vaginal ultrasound that showed the IUD perforating my uterus, I had to contact a CRH patient advocate; they would not give me my own records! This incredibly long story shorter, Doc Albers monitored ovaries and cysts over a period of the next couple months and also did bladder testing to address those issues because on initial exam he noticed my uterus prolapsed, much leaking, and super spazzy bladder. So the testing showed many issues so started on meds for that. Each month when we did the ultrasound, the cysts not only doubled or more in size, they multiplied. At the end of the calendar year, because I again started the new insurance year we tried to wait three months to check the cysts to see if they continued to grow and such. We had partial hysterectomy and removal of right ovary and cysts on the table at that point because ablation would have done nothing to help any of my issues. Well, beginning of January I had MUCH pain and cramping again and could not deal with it so we checked in a couple months earlier than planned. Cysts on right ovary again multiplied and increased in size plus ovary much enlarged, AND now large ovary and cysts on left ovary. So...I had to have a total hysterectomy, remove both ovaries and cysts, hike up the bladder muscles to my back, and...my right cysts and ovary were attached to my colon and bowels and had to be disengaged; also endometriosis. So massive fail on Ms. Reed's part. Then to top it off, twice I have had to again contact my patient advocate with CRH because Ms. Reed's office twice billed me incorrectly for the whole ordeal and then also double billed my health insurance AFTER my health insurance had already paid them the claim! I am SO not happy with it all, and continue seeking ways to make sure that this never happens to any other woman. But I have hit dead ends most everywhere except through speaking the truth on social media and hope women spread the word to RUN from OBGYN Associates and SCREAM at the OBGYN to remove an IUD if there are ANY concerns or pain whatsoever! I truly believe that if she would have believed me and removed that IUD the first time there was pain, I could have avoided all this. And of course now I have residual issues due to that surgery I needed to complete; in SO many ways!! If I had the possibility of any of those docs from that practice touching me or my child, I would go to another hospital to deliver my precious. That's just me...
This is a very brief description of what I have thus far dealt with because of Mirena and an incompetent doctor. And I also had a TIA within two months of the Mirena placement...which my OBGYN assured me could never have been caused by the IUD.
Four months now since my surgery, and I STILL have continual discomfort, issues with my bladder, repeated bladder infections, etc.
Jane doe
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