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Drugs & Medical Devices

End of the Mirena MDL as Bayer Wins Summary Judgment

— August 1, 2016

Back in March, I wrote about how Blocked Expert Testimony Isn’t Necessarily the End of Mirena MDL. Then, at the end of June, I wrote about how Mirena Plaintiffs Prepare Response to Bayer’s Summary Judgment Motion. Sadly today, I get to write about the end of the Mirena MDL as Bayer wins summary judgment.

Back in March, I wrote about how Blocked Expert Testimony Isn’t Necessarily the End of Mirena MDL. Then, at the end of June, I wrote about how Mirena Plaintiffs Prepare Response to Bayer’s Summary Judgment Motion. Sadly today, I get to write about the end of the Mirena MDL as Bayer wins summary judgment.

Image courtesy of
Image courtesy of

Apparently, all our hopes were pinned on logic and the fact that the IUD (or any implantable medical device) just doesn’t travel throughout the human body without causing some damage. The opinion and order issued by U.S. District Judge Cathy Seibel is 40-pages long and can be read in its depressing entirety via the link in the first paragraph. My original snark about the devices having transporter technology or being manufactured by Hogwarts’ graduates to explain their spontaneous migrations is still, in my opinion, more logical than the judge’s reasoning.

In a nutshell, the over 1,300 women injured by Mirena will not get justice because they lack expert testimony on causation, i.e., just how the device migrated. The legal standard in medical device product liability cases is that expert medical testimony is required for causation in instances where the mechanism of injury is beyond the ability of the ordinary layperson to comprehend. Plaintiffs, unfortunately, did not choose the best experts and their testimony was excluded.

The judge wrote in her opinion that, “It might be obvious that the Mirena had traveled from where it belonged to where it ended up, but it is not obvious how that could happen in an undamaged uterus.”

Well, duh. At one point in the opinion, the judge wrote that:

“…the [Mirena] label does not distinguish between injury caused upon insertion (whether by the sound, the inserter or the Mirena itself) and injury caused by the Mirena later going into or through the opening created by that injury. It thus conflates in one sentence several different phenomena, and cannot fairly be read as a concession that what occurs ‘most often during insertion,’ and therefore occasionally after insertion, is a spontaneous journey of the Mirena out of the uterine cavity in the absence of any damage upon insertion.” [Emphasis added.]

This begs the question: is it possible for a medical device to find its way back to the original perforation potentially caused by insertion and then migrate elsewhere? I have better odds of becoming the next Hollywood heartthrob than the odds of such a Mirena implant actually finding that original perforation, if one existed.

Summary judgment is granted when “the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a).”

A material fact is one that “might affect the outcome of the suit under the governing law.”

It would seem to me that secondary perforation is a question of material fact.

According to the judge’s opinion, the “Federal Rule of Evidence (“FRE”) 801(d)(2) provides that a statement is not hearsay if:

[t]he statement is offered against an opposing party and:

(A) was made by the party in an individual or representative capacity; [or]

(B) is one the party manifested that it adopted or believed to be true; [or]

(C) was made by a person whom the party authorized to make a statement on the subject; [or] (D) was made by the party’s agent or employee on a matter within the scope of that relationship and while it existed . . .

[B]ecause admissions against a party’s interests are received into evidence without many of the technical prerequisites of other evidentiary rules – such as, for example, trustworthiness and personal knowledge – admissibility under the rule should be granted freely.”

The plaintiffs tried, unsuccessfully, to substitute defendant admissions for expert testimony and to focus on the issue of secondary perforation (Mirena perforating the uterus at a time other than at insertion) as a case of simple soft tissue injury not requiring expert medical testimony. Some of the evidence plaintiffs submitted included statements from Bayer employees that secondary perforation was, in fact, possible. However, Judge Seibel said, “No!” to that idea because such admissions could have been taken out of context. She further said that allowing such admissions would have a chilling or stifling effect on Big Pharma’s ability or willingness to discuss potential problems and create adequate labels.

As though Big Pharma actually wants to be transparent! Judge Seibel puts great faith in the industry if she thinks that it really wants to tell the public, and even the FDA, everything it knows about its products. It is a faith that is not only illogical, but one that I do not share.

Even if, under the FRE, the admissions were not admissible (and they should be), there is still the issue of a question of material fact. Common sense dictates that the Mirena device doesn’t just magically move from inside the uterus to outside the uterus, minus a uterine perforation. As the judge is fond of citing common sense in her opinion, it strikes me as odd that she couldn’t see it here.

Yes, all jurisdictions require expert testimony in “complex” medical device product liability cases. No, the plaintiffs didn’t provide good experts and no, they weren’t allowed (for procedural reasons) to find new ones. However, I still side with the plaintiffs in that this case is so utterly “commonsensical” that expert testimony should not be required.

Logic dictates that an object placed in a cavity (here, the uterus) that is eventually found outside this cavity has either:

  1. found a natural opening through which to exit; or
  2. made an opening (a perforation) of its own.

If the average layperson cannot understand that without expert testimony, we, as a species, are doomed.

And, sadly, so is the Mirena MDL. The injured plaintiffs must simply live with their injuries because neither Bayer, nor justice, is going to help them. That, my friends, is just wrong.


Blocked Expert Testimony Isn’t Necessarily the End of Mirena MDL

Mirena Plaintiffs Prepare Response to Bayer’s Summary Judgment Motion

Bayer wins summary judgment

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