Pfizer Wins Massive Zoloft Birth-Defect Case

(CN) - A federal judge ruled in Pfizer's favor on claims that its depression medication, Zoloft, causes birth defects in unborn children whose mothers ingest the drug while pregnant.

Despite finding that the specific defects allegedly caused by Zoloft (sertraline hydrochloride) varied somewhat among the plaintiffs, the U.S. Judicial Panel on Multidistrict Litigation consolidated and transferred the case to Philadelphia Federal Court on April 17, 2012.

Discovery covered general medical causes of the alleged birth defects, as well as Pfizer's research, testing and warnings about Zoloft.

The court ultimately found in June 2014 that the plaintiffs' expert, Dr. Anick Bérard, an epidemiologist, didn't rely on scientifically valid methodology and reasoning.

After the court partially excluded the plaintiffs' three other general causation witnesses' opinions months later, the plaintiffs moved for partial reconsideration, excluding Bérard only.

The plaintiffs meanwhile requested to introduce Nicholas Jewell, a biostatistics professor, as an additional expert witness on general causation with regard to cardiac defects.

Though the court agreed in January 2015 to let Jewell testify, it denied the plaintiffs' motion for reconsideration regarding the other witnesses weeks later.

But after Pfizer challenged Jewell's credibility, the court excluded his report and testimony last December, finding that he didn't adequately address more recent studies that did not replicate the results in earlier ones, and improperly relied on internal Pfizer documents.

Pfizer, in turn, immediately moved for summary judgment. U.S. District Judge Cynthia Rufe granted the motion Tuesday.

"Without admissible expert testimony based on the epidemiological evidence, plaintiffs instead have cobbled together evidence of biological plausibility, specific causation opinions based on an assumption that general causation has been established, and anecdotal evidence," Rufe wrote. "Taken together, plaintiffs' potentially admissible evidence supports no more than an association between Zoloft and certain birth defects, and can only establish that much by ignoring the full universe of epidemiological evidence and disregarding the court's substantive and procedural rulings on general causation. Causation must be based upon more than a possibility."

The court refused to dismiss the case without prejudice to protect the plaintiffs from unfair treatment, instead awarding Pfizer summary judgment.

"This [multidistrict litigation, or MDL] has been extensively litigated for more than three years through substantial discovery from Pfizer and two rounds of Daubert hearings on five experts, at what must have been considerable expense," Rufe wrote.

The judge tossed aside the plaintiffs' request to bring the cases at a later time should their claims become viable, in the interests of the minor plaintiffs.

"Dismissal without prejudice under the circumstances of this MDL and in the face of this essential defect of proof would work against the fair administration of justice," Rufe wrote. "The court recognizes that the final scientific verdict as to whether Zoloft can cause birth defects may not be delivered for many years. Nevertheless, plaintiffs chose when to file their cases, and the court concludes that for the plaintiffs who have continued to pursue their claims, the litigation gates must be closed."

Pfizer's attorney, Mark Cheffo with Quinn Emanuel Urquhart & Sullivan in New York, and the plaintiffs' attorneys did not return requests for comment emailed Wednesday.

The plaintiffs' attorneys include Bryan Aylstock with Aylstock Witkin Kreis & Overholtz in Pensacola, Fla.; Kimberly Barone Baden with Motley Rice in Mt. Pleasant, S.C.; Andy Birchfield Jr. with Beasley Allen in Montgomery, Ala.; Edward Blizzard with Blizzard Mccarthy and Nabers in Houston; Thomas Cartmell with Wagstaff & Cartmell in Kansas City, Mo.; Christopher Coffin with Pendley Baudin Coffin in Plaquemine, La.; Jayne Conroy with Hanly Conroy Bierstein & Sheridan in New York; Stephen Corr with Begley Carlin & Mandio in Langhorne, Pa.; Arnold Levin with Levin Fishbein Sedran & Berman in Philadelphia; David Miceli with Simmons Browder Glanaria Angelldes & Banerd in Alton, Ill.; Dianne Nast with Nastlaw in Philadelphia; Stephanie O'Connor with Douglas & London in New York; Mark Robinson Jr. with Robinson Calcagnie Robinson Shapiro Davis Inc. in Newport Beach, Calif.; Christopher Seeger with Seeger Weiss in Newark, N.J.; Sean Patrick Tracey with Tracey Law Firm in Houston; and Joseph Zonies with Reilly Pozner in Denver.

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