Mirena IUD Bayer

An attorney for more than 1,200 women who say they were injured by the Mirena intrauterine device argued before a federal appeals court on Monday that their lawsuit should be revived based on Bayer’s own admissions that its device can perforate the uterus.

But the attorney for Bayer, which successfully argued for summary judgment last year after U.S. District Judge Cathy Seibel of the Southern District of New York disqualified all three of the plaintiffs’ causation experts, said the admissions, contained in internal emails, do not meet the burden of proof for causation.

Mirena delivers a hormone called levonorgestrel that prevents pregnancy for up to five years; labels on Mirena warn that perforation of the uterus can occur when the device is inserted.

But the plaintiffs in the multidistrict litigation argue that Bayer failed to warn Mirena users after 2008 and prior to 2014 that the product could potentially perforate the uterus after the IUD is properly inserted—”secondary perforation” or “spontaneous migration”—and enter a user’s abdominal cavity.

Bayer argues that there is scientific consensus that secondary perforation cannot occur.

The causation experts that the plaintiffs presented for the district court, Bayer argues in its appellate brief, tried to float “cooked up for-this-litigation-only theories that eschewed the scientific method.”

For example, one of the experts, Roger Young, an OB/GYN, whose analysis included a study of pig hearts that he said could shed light on the human uterus because uteruses that he had removed for hysterectomies resembled “pig hearts that my grandmother used to buy,” according to Bayer’s brief.

After Seibel disqualified the plaintiffs’ experts, finding that they did not meet the standard established under Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), Bayer moved for summary judgment.

The plaintiffs argued that, in the absence of its experts, internal statements by Bayer employees establish causation, such as a 2004 email to a Bayer drug safety officer stating that “of course” there are cases in which the IUD migrated through the uterine wall either by itself or with the “help of uterine contractions.”

Seibel waved off the plaintiffs’ argument that it didn’t need causation experts to explain to “simple soft-tissue cases” to a jury of laypersons and said using the “out of context” statements of Bayer employees would leave jurors “at sea” as well as “stifle free discussion of adverse event reports and potential label changes, and discourage pharmaceutical companies and other manufacturers from open discourse.”

At oral arguments before a panel of the U.S. Court of Appeals for the Second Circuit, Jay Breakstone of Parker Waichman, argued that Bayer’s admissions as succinct and as direct as a statement of “I love you,” or a defendant in a criminal case saying “I did it,” and thus would be easy enough for jurors to understand without an expert.

“The jury doesn’t need an expert to understand that,” Breakstone said.

But, arguing for Bayer, Lisa Blatt of Arnold & Porter Kaye Scholer argued that the admissions amounted to employees commenting on case reports, which she said would not be admissible by an expert.

“It would be the height of all irony … to say, ‘Well, my experts just got excluded, but could I rely on something else that’s unreliable?’” Blatt said.

During arguments by Breakstone, the judges on the panel, Judges Reena Raggi and John Walker Jr., appeared skeptical about the strength of the employee communiques to meet the Daubert standard.

“It doesn’t admit anything itself,” Raggi said of the admissions. “It acknowledges that there are reports.”