Mirena Litigation Setback for Plaintiffs

New York, NYExpert testimony for Mirena plaintiffs was blocked by a New York federal judge last week. About 1,200 Mirena cases are pending in the Mirena MultiDistrict Litigation (MDL).

On March 8, Judge Cathy Seibel, who presides over the MDL, excluded plaintiffs’ medical causation experts and also denied the plaintiffs’ motion to exclude Bayer’s clinical and causation experts. She said that “all seven of Defendants’ experts have the necessary qualifications and have utilized reliable methods in their opinions and their testimony will assist the trier of fact,” according to Bloomberg BNA (March 9).

The main issue in this MDL is whether uterine perforation can occur after the Mirena is inserted, and not only during insertion, which Bayer attests and has warned of.

Plaintiffs Jennifer Danley and Christie Hayes agree that Bayer warned of this possibility, but Bayer failed to warn that uterine perforation could occur after and unrelated to insertion. Both women accuse Bayer of failure to warn, design defect and negligence.

Danley claims her Mirena IUD migrated to her abdominal cavity after she became pregnant, and Hayes alleges the Mirena migrated outside her uterus. Both instances perforated the uterine wall. Both women argue that the risk of perforation can occur even if the Mirena is properly inserted. Bayer, on the other hand, said that neither plaintiff can show that they have suffered a secondary perforation injury or that Mirena was the cause of the injury. But both plaintiffs have medical documentation, including ultrasounds, to show the Mirena had migrated, therefore a perforation must have occurred. How else could the IUD move outside the uterus?

The plaintiffs’ experts included ob-gyn Roger C. Young; engineer John Jarrell, PhD, PE; uterine physiologist Susan Wray, PhD; and ob-gyn Richard Strassberg. For the most part, the court found their testimonies “hypothesis” rather than scientific evidence. Most damning testimony came from Dr. Young, who compared a uterus to a pig’s heart, which turned out to be more anecdotal than factual.

Young said he “felt a lot of uteruses that had been taken out at the time of hysterectomy, and it feels remarkably like the pig hearts that my grandmother used to buy when I was a kid,’ according to Law360. He later said it was a chicken’s heart... No doubt Danley’s and Hayes’s, and their attorneys’, hearts sunk.

The MDL is scheduled to resume March 2 but it could be remanded until mid-April, determined due to plaintiffs’ attorneys’ request.