Mirena contraceptive device. Photo Credit: Bayer

None of the expert witnesses offered by the plaintiffs in a massive multidistrict litigation over alleged side effects to contraceptive implants manufactured by the pharmaceutical company Bayer will be allowed to testify, U.S. District Judge Paul Engelmayer of the Southern District of New York ruled Wednesday.

The 150-plus page order dealt a significant blow to the 113 cases that stretched across 17 districts now proceeding in Manhattan federal court. The plaintiffs contend that the company's female contraception implant Mirena caused a disease that caused increased fluid in the skull that can lead, in the most extreme cases, to blindness.

Engelmayer's order came as each side in the dispute filed motions to exclude the expert testimony of their counterparts based on the tests established by the U.S. Supreme Court in 1993's Daubert v. Merrell Dow Pharmaceuticals.

The plaintiffs submitted testimony from seven potential experts—two OB/GYNs, an ophthalmologist, a neuroscientist, a pediatric neurologist, an epidemiologist and a pharmacologist-toxicologist. In ruling to exclude the testimony of all seven, Engelmayer found that their collective testimony was at various points “unreliable,” “flawed,” and suffering from “serious methodological deficiencies” and a “lack of rigor.”

In a statement sent by a spokesman, Bayer said it was pleased with the decision Wednesday to deny the plaintiffs' expert witnesses.

“Without such testimony, we do not believe that the plaintiffs can prove their cases,” the company said.

Earlier on in the lengthy opinion, Engelmayer appeared to set the stage for the dismissals. In detailing the record of medical research into whether or not a link could be found between the hormone injections and the specific medical condition described by the plaintiffs, the judge found there simply was no credible record to show the causal link existed.

“In the face of this assembled historical record, with no medical organization or regulator or peer-reviewed scientific literature having found that Mirena or any contraceptive product using LNG is a cause of IIH, an expert witness who so opine as to Mirena necessarily would break new ground in this litigation,” he wrote.

Going through each of the experts and applying the Daubert test, he pointed to the fact that each expert for the plaintiffs managed to reach a medical conclusion not supported by outside evidence.

“None has done so through an experiment, laboratory work, or a new epidemiological study of his or her own,” Engelmayer noted. As such, each of the experts fell short of the Daubert test and required being precluded from testifying, he found.

While dismissing the plaintiffs' potential expert witnesses, Engelmayer said he saw no reason to resolve their motion to have the defendants' own testimony excluded, as it largely amounted to rebutting of the plaintiff experts. With the likely next step being a motion for summary judgment on the issue of general causation coming from the defense, resulting in the issue being potentially moot, Engelmayer denied the motion. He did, however, do so without prejudice should the case survive such a motion.

The Bayer defendants are led by co-lead counsel, Goldman Ismail Tomaselli Brennan & Baum partner Shayna Cook and Covington & Burling partner Paul Schmidt. They referred to Bayer's statement when asked for comment.

The plaintiffs are represented by co-lead counsel, Jones Ward name attorney Lawrence Jones II and Davis Crump name attorney Martin Crump. Neither responded to a request for comment.

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