Former Food and Drug Administration director David Kessler can’t testify as an expert about regulation of seizure drug Depakote at a trial over birth defects, U.S. District Judge Nancy Rosenstengel ruled on March 17.

She denied a motion to substitute Kessler for regulatory expert Cheryl Blume at a trial against Abbott Laboratories, starting May 23.

“There is no indication in the record that Dr. Blume is unavailable to serve as an expert witness in this or any other case,” Rosenstengel wrote.

She expressed doubt about the motive behind the motion.

“Given the way this request unfolded and the significance of the regulatory expert’s testimony, the prejudice and surprise to Abbott is apparent,” she wrote.

She has chosen Beatrice Sifuentes as primary plaintiff for the trial, but has ordered lawyers to prepare three other cases so the slot won’t go to waste.

Christopher Cueto of Belleville represents about 700 Depakote plaintiffs in Rosenstengel’s court, in association with lawyers in Houston.

Former district judge Patrick Murphy presided over Depakote cases as a mass action, rather than a class action, until his retirement in 2013.

District Judge David Herndon presided for six months and reassigned the mass to Rosenstengel, a new judge, in 2014.

She held a bellwether trial in 2015, to set a range of possible settlements.

After 15 days, jurors ruled in favor of Abbott.

Rosenstengel decided last year to abandon the bellwether approach and hold joint trials resolving as many common issues as possible with each trial.

She set the second trial to start this March 27, for Sifuentes.

On Feb. 15, Cueto moved to substitute Kessler for Blume.

“Dr. Kessler is already known to Abbott as he is the designated regulatory expert in three other Depakote cases pending in this court,” Cueto wrote.

He wrote that Abbott cross examined Blume at several depositions and four trials.

“Abbott has routinely made Dr. Blume’s fees in other cases a focal point of its cross examination at trial,” he wrote.

He wrote that Abbott would oppose Kessler’s substitution because they intended to engage in that type of cross examination.

Abbott counsel Dan Ball, of Bryan Cave in St. Louis, answered on Feb. 23 that plaintiffs were aware of Blume’s vulnerability on the topic for years.

He wrote that if Kessler expressed the same opinions as Blume in the same way, his credentials presented a materially different challenge.

“Abbott selected its counter expert in response to plaintiff’s designation of Dr. Blume,” Ball wrote.  

The trial schedule broke down on Feb. 27, when Abbott notified Rosenstengel that illness would prevent an expert from testifying.

Rosenstengel, reluctant to postpone, entered an order to obtain the expert’s telephone number on March 2.

On March 3, she vacated the trial date and set it back about two months.        

Two weeks later she denied Kessler’s substitution, finding Sifuentes failed to demonstrate meaningful diligence in moving for substitution.

She added that, “the reason alleged in support of the substitution, that is, prejudice created through cross examination on the fees Dr. Blume was paid in this and other cases, is not a substantial justification or basis to establish good cause.”

“While the court has very little information concerning the fee arrangement or employment parameters of Dr. Blume, this issue was at a minimum influenced by plaintiff’s own choices,” she wrote.

“Whether Dr. Blume was exceedingly inefficient in preparing her report or was engaged to prepare reports for all or some of the other plaintiffs, the information presented to Abbott included a very vague billable summary with only two values, year and dollar amount.”

“If this is the most detailed breakdown Dr. Blume provided concerning her payment, then there can be no surprise when Abbott exploits a $900,000 listed fee payment.”

Rosenstengel wrote that in the bellwether trial, Blume testified on direct examination that the Depakote project required roughly 6,000 person hours.

She wrote that the impression provided to the jury was that she and her team spent 6,000 hours on that case.

“It is axiomatic then that Abbott would ask how much she and her team were paid for those 6,000 hours of work,” she wrote.

She wrote that even if Blume itemized her work for each plaintiff, Kessler’s substitution would not alter the unfair prejudice Sifuentes alleged.

“Dr. Kessler charges double the fee for his litigation consultation service as Dr. Blume,” she wrote.

Blume testified that she charged $400 to $500 an hour, she wrote, and Kessler testified that he charged $1,000.

Rosenstengel wrote that Kessler could eclipse the $1 million mark in quick order if he has not already done so.

“On the facts before this court, there is no discernible distinction between Dr. Kessler’s and Dr. Blume’s fees,” she wrote.

“Whether there is a perceived tactical advantage in using a former head of the FDA as the regulatory expert or simply a case of buyer’s remorse, there can be little doubt that Abbott’s cross examination strategy was not the true motivation for plaintiff’s motion.

“Plaintiff’s assertion that because Abbott was aware of and deposed Dr. Kessler in other cases he can easily slide into Sifuentes is simply inaccurate.”

She wrote that Blume never worked for FDA.

“This distinction alone dramatically alters the testimony these two doctors provide, a distinction that likely lies at the heart of the motivation behind the instant request,” she wrote.

“The bottom line is that Dr. Kessler cannot be easily interchanged into the case without a partial or complete retooling of Abbott’s defense.”

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