Herndon calls off Yaz, Yasmin bellwether trials; Calls in Saltzburg as mediator

Steve Korris Jan. 6, 2012, 1:03am



EAST ST. LOUIS – Nine days before starting a series of trials that would have shaped settlement of 10,678 suits against drug maker Bayer, U.S. District Judge David Herndon called off the series and kicked the ball of litigation to a mediator.

On Dec. 31, Herndon continued a bellwether trial that would have started on Jan. 9, and he held in abeyance eight more bellwether trials.

Bellwether trials streamline mass litigation by suggesting ranges of mass settlements.

Herndon appointed professor Stephen Saltzburg of George Washington School of Law to mediate claims that Bayer contraceptives Yasmin and Yaz injured women.

His action hit like a bolt from the blue.

He had ruled on qualification of experts two weeks earlier, and he had asked lawyers for pretrial orders, exhibit lists and jury instructions two days earlier.

He offered no reason for a last minute switch from mass litigation to mass mediation, beyond writing that a trial wouldn't meet the principles of a bellwether plan.

"The court finds that the interests of this litigation, plaintiffs and defendants, will be better served by an alternative plan," he wrote.

Circumstances suggest Herndon needed to wriggle out of a conflict involving the U.S. Food and Drug Administration.

In October, plaintiff lawyers asked him to strip confidentiality from 1,241 pages of documents they wanted to present to FDA advisory committees on Dec. 8.

They asserted a constitutional right to petition the government.

They urged Herndon to override German law that would subject Bayer employees to criminal prosecution for privacy violations.

Bayer lawyers answered that restrictions on materials acquired in litigation do not constitute a First Amendment violation.

They wrote that violations of German privacy law are punishable by fines, injunctive relief, restitution, and imprisonment up to two years.

They wrote that German data protection enforcement agencies can shut down operations of companies found in violation.

Herndon denied the motion in November, finding litigants do not have an unfettered First Amendment right to disseminate documents obtained through discovery.

He wrote that dissemination of 28 documents would violate German privacy laws.

Other documents "constitute trade secrets such that their dissemination would prove economically advantageous to defendant's competitors," he wrote.

He wrote that other documents would reveal intellectual property.

After the FDA committee held its hearing, former FDA commissioner David Kessler submitted a report as an expert for plaintiffs in Herndon's court.

His report does not appear on the court docket, but Bayer lawyers quoted it in a motion to exclude his opinions on Dec. 30.

They sealed the motion, but Herndon would unseal it on Jan. 3.

"Dr. Kessler opines that 'certain members of the advisory committee did have conflicts of interest such that a reasonable person with knowledge of the relevant facts could question the member's impartiality,'" they wrote.

They quoted his opinion that "the FDA advisory committee was not independent of Bayer, and its recommendations and votes need to be viewed as such."

"Dr. Kessler's status as a former FDA commissioner does not authorize him to ignore the procedures and standards that FDA applies to address conflicts of interest questions for members of advisory committees," they wrote.

"To the extent that Dr. Kessler seeks to opine that the FDA has been defrauded in some manner by the advisory committee members whose impartiality he questions, that is nothing more than rank speculation and innuendo that has no proper place in this trial.

"Dr. Kessler's status as a former FDA commissioner does not authorize him to testify as a shadow FDA, second guessing determinations by the agency."

On the same date, they moved to exclude opinions that expert Burt Gerstman offered about the FDA hearing.

"Dr. Gerstman is not a mind reader," they wrote.

Rather than hear the motions, Herndon called off the trial the next day.

"Professor Saltzburg shall consider and utilize every reasonable mediation option available to effectuate settlements in this litigation," he wrote.

"Each party is ordered to negotiate in good faith," he wrote.

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