Plaintiffs' Experts Axed in First Mirena Test Cases

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By Julie A. Steinberg

March 9 — Women who allege harm from Bayer Healthcare's Mirena intrauterine contraceptive device suffered a significant setback as their medical causation experts were excluded in the first two federal cases set for trial.

Significant portions of the proffered testimony from the plaintiffs' regulatory experts was also barred March 8 by Judge Cathy Seibel of the U.S. District Court for the Southern District of New York.

The plaintiffs allege that the Mirena devices can move and perforate the uterus after insertion. But the court here described their causation experts' opinions as to how that can happen as based on unreliable methodologies and little more than hypothetical.

The court even said of one plaintiffs' expert that he “was given a conclusion by lawyers and worked backwards to hypothesize a mechanism by which it might occur.” The judge criticized still another expert's opinions for their lack of vetting by peers in the medical community.

Seibel, who presides over the Mirena MDL, also denied the plaintiffs' motion to exclude Bayer's clinical and causation experts. She held 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.”

Some 1,200 cases are pending in the Mirena MDL, according to a Feb. 16 statistics report.

No Scientific Opinion Left

“We are pleased that the court granted Bayer’s motions to exclude testimony of all of plaintiffs’ experts as to medical causation—both general and specific—in their entirety,” the company said in a statement e-mailed to Bloomberg BNA March 9.

“As a result of the Court’s ruling, plaintiffs are left with no scientific opinion—either from their own paid experts or in the medical community at large—to support their claims against Bayer,” the company said.

“The court found Plaintiffs' expert opinions unreliable because they were based on hypotheses that had not been tested or studied; much less peer-reviewed and published; because they were created for purposes of litigation; and because they were not supported by reliable scientific evidence,” Bayer said.

Attorneys representing the plaintiffs didn't respond to requests for comment March 9.

Plaintiffs' Alleged Harm

Plaintiffs Jennifer Danley and Christie Hayes raised failure-to-warn, design defect and negligence claims against Bayer Healthcare Pharmaceuticals Inc. and related companies, and sought punitive damages.

Danley alleges her contraceptive device didn't work and that an X-ray, taken after she became pregnant, showed the device had migrated to her abdominal cavity, the opinion said.

Hayes alleges that when she sought to have her Mirena device removed, doctors discovered it had migrated outside her uterus.

The parties agree that Bayer warned about the possibility of uterine perforation during insertion. They also agree that Bayer didn't warn that perforation could occur after and unrelated to insertion, the court said.

Whether such a possibility of post-insertion perforation actually exists is at the heart of the dispute in this MDL.

Plaintiffs' Causation Experts

The plaintiffs offered four causation experts: obstetrician/gynecologist Roger C. Young; engineer John Jarrell, Ph.D., P.E.; uterine physiologist Susan Wray, Ph.D.; and obstetrician/gynecologist Richard Strassberg.

The court said Young's testimony as to how spontaneous migration of an IUD outside the uterus could occur wasn't based on reliable methodology. The court also barred Young from testifying specifically as to how perforation occurred in Danley's case.

Additionally, Young “was given a conclusion by lawyers and worked backwards to hypothesize a mechanism by which it might occur,” the court said.

“This exercise does not seem to have involved any scientific methodology, but rather consisted of reverse-engineering a theory to fit the desired outcome. This does not rise to the level of intellectual rigor employed in the medical or scientific field, and alone would warrant exclusion,” the court said.

Jarrell was found unqualified to address one of his theories as to how uterine perforation could occur, and the court said the rest of his causation opinions weren't based on reliable methodology.

The court similarly found Wray’s general causation opinion unreliable.

“Her conclusions have not been subject to peer review; there is no evidence that she has published her work in journals or elsewhere, or that she even gave any thought to secondary perforation of IUDs before being retained in this case,” the court said.

Mere Hypothesis

Wray's theory “is merely a hypothesis; it may be a very good hypothesis begging for testing and further study, but it is only an untested hypothesis,” the court said.

The court also found unreliable the opinion of Strassberg, who said there is no reason to believe perforation occurred at the time Hayes’ Mirena was inserted; and that after being properly placed, the Mirena subsequently perforated her uterus.

Strassberg's report “does not cite any publications or medical literature in support of his opinions, and he acknowledged at his deposition that he did not review any medical literature in reaching them,” the opinion said.

Turning to the plaintiffs' regulatory experts, the court said Suzanne Parisian—who formerly worked at the Food and Drug Administration—may only address the FDA regime generally, Bayer’s conduct in complying with regulatory standards and the adequacy of the Mirena label.

The court also only allowed some testimony from the plaintiffs' epidemiology expert, Dr. April Zambelli-Weiner.

Diogenes P. Kekatos of Seeger Weiss LLP in New York and James R. Ronca of Anapol Weiss in Philadelphia are plaintiffs' liason counsel. Matthew J. McCauley of Parker Waichman LLP in New York and Fred Thompson III of Motley Rice LLC in Mt. Pleasant, S.C., are plaintiffs' co-lead counsel. Michael K. Johnson, Kenneth W. Pearson and Rolf T. Fiebiger, all of Johnson Becker PLLC in Minneapolis, are members of the Plaintiffs' Steering Committee.

Shayna S. Cook, Brian P. O'Donoghue and Christopher J. Cook, all of Goldman Ismail Tomaselli Brennan & Baum LLP in Chicago, are lead counsel for Bayer.

E. James Shepherd of Shook Hardy & Bacon LLP in Houston and William P. Harrington of Bleakley Platt & Schmidt LLP in White Plains, N.Y., also represented Bayer.

To contact the reporter on this story: Julie A. Steinberg in Washington at

To contact the editor responsible for this story: Steven Patrick at