Both sides in the Zoloft MDL focused on the testimony of plaintiffs expert Dr. Anick Berard and her assertions that Zoloft causes birth defects as the Daubert hearing got started Monday.
Berard, a professor at the University of Montreal who researches the effect of medications on pregnancy, is an expert witness presented by the plaintiffs in the cases alleging that the Pfizer antidepressant Zoloft causes birth defects in the babies born to women who took the drug while pregnant.
“The real issue for this court … hotly debated by both sides [is] when we’re talking about birth defects, is there a difference between SSRI drugs” or can you lump them together and treat them as a class, said Sheila Birnbaum, a partner with Quinn Emanuel Urquhart & Sullivan in New York who is on Pfizer’s defense team. She was referring to antidepressant drugs that operate as “selective serotonin reuptake inhibitors” and showed a slide that pictured the chemical compounds for five different SSRIs, including Paxil and Zoloft, all of which looked different.
“They’re very different,” Birnbaum said, building the defense’s argument that SSRI drugs can’t be treated as a class of medicines with shared characteristics and effects.
Outside of the courtroom, though, Pfizer believes that SSRIs operate the same way, said Sean Tracey, of the Tracey Law Firm in Houston who is on the plaintiffs steering committee, in his introduction to the court.
“Why?” he asked. “Because it’s true.”
When Pfizer was trying to get Zoloft approved for use by juveniles in Europe, regulatory agencies there ordered it to perform various studies, to which it responded that pharmaceutical company Eli Lilly had already done those studies and Zoloft would perform similarly, Tracey said, adding, “And they’re right.”
From the start of the litigation, said Quinn Emanuel lead defense lawyer Mark Cheffo, the plaintiffs have said, “‘We’re lumpers, we’re going to lump everything together’… and, frankly, Dr. Berard is a lumper as well.”
Berard maintains that a host of more than a dozen birth defects—from problems with the development of the heart to club feet—are attributable to Zoloft and similar SSRIs, Cheffo said.
“What’s particularly troubling, well, troubling and instructive here, is that Dr. Berard looked at the same data that the world’s scientists and professional organizations and regulatory agencies have looked at, yet she’s come to the conclusion that Zoloft causes all of these birth defects, where all of the other scientists and professional organizations and regulatory agencies have determined that it doesn’t even cause one of these birth defects,” Cheffo said. “It’s Dr. Berard against the world.”
Tracey shot back during his introduction, saying that Berard isn’t “an island.” He pointed out that the defense hasn’t questioned her credentials, but, rather, her conclusions.
Berard has published more than 100 papers on issues in this case, Tracey said, and Pfizer Canada has given her grant money.
Berard is the only perinatal epidemiologist offered to the court in this litigation and, Tracey said, Pfizer, “with all their influence, all their money, all the experts they issue grants to each and every year” weren’t able to get a perinatal epidemiologist to be an expert for the defense.
Birnbaum relied on the U.S. Food and Drug Administration’s treatment of Zoloft, which was approved in 1991 and has been on the market since 1992.
She noted that the FDA put Paxil in category D for medications during pregnancy, a higher-risk category than C, where Zoloft and other SSRIs are situated. She read that as meaning that the FDA doesn’t see Zoloft as a risk to fetuses.
Tracey, though, pointed to the low budget and short resources of the FDA and said, “Believe it or not, the FDA gets things wrong sometimes.”
Topamax, a drug that treats epilepsy and migraines and has been the target of another major litigation brought by mothers who took the drug while pregnant and gave birth to children with defects, was marketed as a category C drug for 12 years, Tracey said.
In 2009, for litigation over GlaxoSmithKline’s antidepressant drug Paxil, Berard had said that antidepressant drugs like Zoloft, as opposed to Paxil, were suitable first-line treatments for pregnant women with depression, Birnbaum told the court.
Now, in this multidistrict litigation, Berard will testify that Zoloft, too, can cause birth defects, Birnbaum said.
“We believe these are litigation-driven opinions,” she said.
Responding to that characterization of Berard, Tracey said, “They have accused our experts, each and every one of them, of coming into court with litigation opinions, whatever that means.”
“The way I, essentially, take litigation opinions is: They’re getting paid to say something,” he said, before launching into a discussion of the methodology used by all four of the plaintiffs’ experts, including Berard.
U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania is handling the case and invited Philadelphia Court of Common Pleas Judge Lisa Rau, who is handling all of the Zoloft cases on the Philadelphia docket, to sit.