Can Mirena Plaintiffs Win without Expert Witnesses?


. By Jane Mundy

Expert witness testimonies for plaintiffs in the Mirena IUD Multidistrict Litigation (MDL) have been blocked but Bayer’s clinical and causation experts stay, said Judge Cathy Seibel.

But can the plaintiffs prove causation without their experts testifying? “It depends. We have a tough judge and she has leaned toward the defendants every time so that is an issue,” says attorney and physician Shezad Malik. “But the plaintiffs have a strong argument. Bayer has admitted - in its warning label, to the FDA and to plaintiffs - that the Mirena can perforate after insertion and if you make an admission, it can be used against you.”

Expert witnesses in some cases may be called upon to testify at the trial to explain, for instance, how the plaintiff’s accident happened, how the defendant violated his or her legal duty, and to what extent the victim suffered. The main issue in this Mirena MDL is whether uterine perforation can occur after the IUD is inserted. Plaintiffs assert this indeed happened to them. They also accuse Bayer of failure to warn (but they agree with Bayer that it warned of perforation upon insertion), negligence and design defect. Bayer argues it has adequately warned of perforation.

Plaintiffs’ witnesses included two ob-gyn witnesses and a uterine physiologist. But the court found most of their testimony “hypothesis” rather than scientific evidence. According to Legal Reader (March 2016), Judge Seibel barred four of the plaintiffs’ experts completely, saying they were either unqualified to offer testimony, unreliable, or both. This left two plaintiffs’ experts who were limited as to the scope of their testimony. The judge also limited two of Bayer’s experts.

In a turn of events last week, plaintiffs said they don’t need expert testimony to win their case against Bayer. They told Judge Seibel that Bayer’s admission to secondary perforation, meaning the IUD can perforate the uterus after insertion, is enough evidence.

Again, Legal Reader (Jun 13, 2016) reported the following claim from plaintiffs: “To this day, the risk of spontaneous perforation unrelated to insertion - well understood by Bayer - has never been clearly communicated to the millions of women using Mirena, or the physicians who prescribe it. This ongoing failure to warn underlies every lawsuit in the Mirena MDL.”

“It is unclear how Judge Seibel will rule, but if it is negative, the plaintiffs will appeal,” says Malik. Because most courts and people are on summer break, anticipate a ruling by September. Stay tuned…


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