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Zoloft MDL cases dismissed by the hundreds

A package of branded Zoloft 100 mg (sertraline HCl).  Via Wikimedia Commons.
A package of branded Zoloft 100 mg (sertraline HCl). Via Wikimedia Commons.

By P.J. D’Annunzio, From The Legal Intelligencer

The Zoloft birth-defect multidistrict litigation based in Philadelphia, which once had as many as 600 cases, has been reduced to roughly half its original size. The drop is the result of hundreds of cases involving non-cardiac injuries being dismissed.

In June, the docket listed 550 total active cases, and over the course of the summer, hundreds of cases were dismissed, bringing the current number to 278, according to the MDL clerk’s office. The cases dismissed all related to non-cardiac birth injuries, as opposed to the cardiac-only injury cases moving forward in the MDL.

“Plaintiffs who filed Zoloft lawsuits in the Zoloft MDL or state courts alleging any non-cardiac injuries have advised the court that they will dismiss their claims. As a result, pending Zoloft cases alleging non-cardiac injuries will be dismissed,” said a spokesperson of Zoloft’s manufacturer, Pfizer. “If any are refiled they must meet several conditions established by the court. These cases were not settled.”

Local counsel to the plaintiffs, Dianne Nast of NastLaw, said the plaintiffs moved to dismiss the cases and proceed in cardiac-only matters for greater efficiency. Nast said cases can be refiled with the understanding that the statute of limitations will not be running.

Nast pointed to U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania’s decision to exclude the testimony of the plaintiffs’ non-cardiac birth injury expert, Dr. Anick Bérard, as a factor in the decision to dismiss the cases.

“I’m not saying we would have made a different decision if she had passed muster with the court,” Nast said, because efficiency was the primary concern.

As for whether the dismissed cases will be refiled individually, Nast said, “I think they would remain part of the MDL, because they have the commonality that all the people took Zoloft,” despite the differing injuries.

The Pfizer spokesperson also said, “While Pfizer has sympathy for the families, the company has maintained from the outset of this litigation that Zoloft is an important medicine and does not cause birth defects and, accordingly, is pleased that plaintiffs will dismiss pending non-cardiac Zoloft claims.”

Most recently in the case, at a long-postponed 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—the plaintiffs’ cardiac causation expert was under scrutiny.

In addition to claiming expert Nicholas Jewell’s conclusions were not peer-reviewed and based on bad science, one of Pfizer’s lawyers, Mark Cheffo, told the court last month that new studies have surfaced, including some from the American Heart Association and the New England Journal of Medicine, indicating that “a causal relationship between Zoloft and birth defects does not exist.”

Cheffo said in drawing his conclusions that Zoloft presented an increased risk of causing cardiac birth defects when taken by pregnant women, Jewell, a professor of biostatistics at the University of California, Berkeley, was trying to “fit a square peg in a round hole.”

Cheffo also claimed Jewell was unqualified in his capacity as a causation expert because he is a statistician, not a medical doctor. He further attacked Jewell’s opinions for being overly broad. Cheffo said Jewell also relied on a study that actually reported there was no significant relationship between selective serotonin reuptake inhibitors (SSRIs)—the class of drug Zoloft belongs to—and causing birth defects. He also presented statements in which Jewell seemingly questioned the relationship between Zoloft and birth defects.

Finally, Cheffo said that on Aug. 14, the U.S. Food and Drug Administration said the recommended label on Zoloft should include the phrase, “There is no increased risk of cardiac malformation.”

However, an attorney for the plaintiffs, Joseph J. Zonies, said in his rebuttal at the hearing that Pfizer was cherry-picking parts of Jewell’s conclusions and presented his statements out of context.

Zonies claimed Jewell operated using sound methodology and drew from peer-reviewed studies in developing his report.

Zonies also took issue with the American Heart Association’s study, claiming it relied on only two prior studies out of many to come to its conclusions. In that vein, Zonies questioned how Pfizer could “come up here and excoriate Dr. Jewell.”

Finally, Zonies summed up his argument by telling the court that Pfizer didn’t take into account all the factors within the studies it cited, providing an incomplete picture.

Photo: Wikimedia Commons

For more on this story go to: http://www.thelegalintelligencer.com/id=1202738961249/Zoloft-MDL-Cases-Dismissed-by-the-Hundreds#ixzz3nu3VfuDH

 

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