By Saranac Hale Spencer, The Legal Intelligencer

Several months after tossing the key expert witness for plaintiffs who allege that Pfizer’s antidepressant drug Zoloft causes birth defects, a federal judge in Philadelphia considered allowing them to offer a new one.

Her decision could spell the end of the case if she decides not to allow it.

U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania, who is handling the multidistrict litigation case, held arguments Tuesday over whether she should allow them to offer the new expert, a move that would prompt another Daubert hearing.

The first Daubert hearing—which allows parties in a case to challenge expert testimony before the start of trial and is named for the 1993 U.S. Supreme Court case Daubert v. Merrell Dow Pharmaceuticals—lasted for about a week last April and focused mostly on Dr. Anick Bérard, who was the plaintiffs’ initial key expert.

In July, Rufe barred her testimony, finding several problems with Bérard’s research and proffered testimony.

The original schedule for the case had the first bellwether trials starting in January, Rufe noted at the start of arguments Tuesday. She asked Michael Fishbein of Levin, Fishbein, Sedran & Berman, who was arguing for the plaintiffs’ steering committee, when the first trial could be ready if she were to grant their motion to present a new expert.

“There’s no reason it can’t be quickly,” he said.

“And only moving forward with cardiac cases?” Rufe asked, since the new expert, Nicholas Jewell, has proposed testimony on his research linking the use of Zoloft in pregnant women to congenital heart defects in their babies. Bérard’s research had linked Zoloft to a plethora of various birth defects.

If the plaintiffs would be able to use Jewell as an expert witness, they would only pursue the cardiac defects, Fishbein said.

He and the plaintiffs’ steering committee argued that Rufe had erred in her opinion barring Bérard’s testimony by setting the wrong standard.

“The court’s reasoning was predicated in part upon a requirement that an expert must rely on repeated, consistent, statistically significant epidemiological findings in order to have a reliable basis for inferring a causal link between a drug and an adverse event. … However, this holding is contrary to United States Supreme Court, Third Circuit, and other federal court precedent, as well as the teachings of Sir Austin Bradford Hill, the author of the Bradford Hill criteria,” according to a brief filed by the steering committee.

It’s important to correct that matter of law, Fishbein told Rufe.

“The reason it’s important is because even if Pfizer achieves its fondest wish and gets summary judgment in all 600 cases that are pending before you … that’s not the end of this litigation,” Fishbein said, explaining that Zoloft is still on the market and the science studying it is continuing to evolve, so plaintiffs will keep filing suits over it.

Those plaintiffs will come to court with expert reports from “a Dr. Jewell, or Dr. A, or Dr. B, or Dr. C,” Fishbein said. So, it’s essential for the court to set the correct legal standard by which to assess whether the proffered experts meet it.

“The law, it seems to me, has to follow the science,” Fishbein said.

“But then what happens to finality?” Rufe asked.

A case has to be tried at a certain point in time and it has to be tried based on what is available at that time, he answered.

Mark Cheffo of Quinn Emanuel Urquhart & Sullivan, who argued on behalf of Pfizer, however, characterized the plaintiffs’ motion to introduce a new expert as highly unusual, calling it a “Daubert do-over,” using language adapted from the U.S. Court of Appeals for the Seventh Circuit.

“It’s really a question of … is this really disrupting an orderly and efficient trial in the MDL, are you prejudiced … I want to really know: How is Pfizer harmed and isn’t it just as harmful not to grant the right to have Dr. Jewell come in?” Rufe told Cheffo.

Granting the plaintiffs’ motions would lead to “piecemeal litigation with no finality and no end in sight,” Cheffo said.

Courts must decide cases based on the science before them, he said, since they must rule quickly and with finality.

Pfizer moved in August for summary judgment and, Rufe asked, if she were to grant that motion, which cases would be subject to it?

“All cases in the MDL would be subject to this,” Cheffo said.

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