Defense counsel in the Zoloft multidistrict litigation argued in federal court Wednesday that scientific and medical issues should take primacy in pretrial proceedings because as one lawyer said, “there’s just no science there.”
But plaintiffs counsel argued that discovery can proceed on multi-tracks for both Pfizer’s alleged liability and for the science behind the allegations that women’s use of the popular antidepressant during their pregnancies caused birth defects in their children.
U.S. District Judge Cynthia M. Rufe of the Eastern District of Pennsylvania is presiding over an MDL first created this spring.
One of the defense arguments regarding the science is that Rufe should appoint an expert.
Pfizer defense counsel Robert C. Heim, of Dechert in Philadelphia, said Rufe should “use the court’s inherent authority” to appoint an expert under Federal Rule of Evidence 706 “to advise your honor with regard to these complex scientific issues,” Heim said.
“There’s just no science there,” Heim said.
Joseph J. Zonies, one of the members of the executive committee of the plaintiffs steering committee and of Reilly Pozner in Denver, said that considering how well Rufe ran the Avandia MDL “the court doesn’t need … an expert to understand complex science.”
There is no reason why the lawyers who will address liability can’t move ahead while the scientific committee also goes ahead, Zonies said.
Scientific and medical issues need to be addressed sooner rather than later because the plaintiffs’ claim of the injuries that can be caused by use of Zoloft during pregnancy involves “literally almost every body system,” said defense counsel Mark S. Cheffo, of Skadden, Arps, Slate, Meagher & Flom in New York. “We start with the premise that, if plaintiffs are right, that this is not just the most teratogenic pharmaceutical product, but the most teratogenic substance known to man.” Teratology involves birth defects and abnormalities in development.
There are statistically significant risks for many injuries being alleged by the plaintiffs, Zonies said.
A “developing fetus is bathing in Zoloft so it’s going to affect different body systems with relative … risks,” Zonies said.
To make the argument that pregnant women should just not use Zoloft without first having the science to back up that claim is not good when weighed against the harm of telling families that a medicine a mother took during her pregnancy caused injury to their children, Cheffo said.
Cheffo also argued that not having the science established is poor public policy because untreated depression during pregnancy may lead to poor outcomes for babies such as on birth weight and on Apgar scores first given right after infants are born, Cheffo argued.
“Frankly, we don’t believe there’s a lot of controversy among legitimate scientists about the teratology of selective serotonin reuptake inhibitors like Zoloft,” Cheffo said. “We think the controversy is among litigation experts.”
Mark P. Robinson Jr., co-lead counsel of the plaintiffs steering committee’s executive committee and of Robinson Calcagnie Robinson Shapiro Davis in Newport Beach, Calif., said the case is just as much about liability regarding alleged concealment, conscious disregard of safety, and intentional misrepresentation as it is about the science.
“That’s what the whole science pitch is about, they want to scare you there is hundreds of all these claims,” Robinson said.
Dianne M. Nast of RodaNast in Lancaster, Pa., is the other co-lead counsel.
“It’s what they knew when they knew it and what they told doctors” and what they accordingly concealed from women, Robinson said.
Plaintiffs need discovery of sales representative statements, omissions of warnings, and of “opinion leaders” paid by Pfizer, among other things, Robinson said.
If core discovery is not taken in the MDL, then that discovery will be taken in state courts, Robinson said.
The selection of the plaintiffs steering committee centered on their experience with science, Cheffo said, and families should not be put through litigation if the science won’t support their claims and they won’t secure successful results.
The federal Food and Drug Administration continues to advise clinicians that they should treat depression during pregnancy, Cheffo said.
“Both sides need to be incredibly sensitive, professional and responsible in how we prosecute and defend these cases,” Cheffo said.
Even if the judge agreed to move up the timetable on the scientific issues, Rufe said the scientific issues can’t be reached without underlying discovery.
“As I understand litigation, if you can’t support your claim it disappears,” Rufe said.
Before she rules on the issue, Rufe said that she wants to see discovery plans for both sides.
Rufe said she happens “to understand the argument that science comes first but believe it or not science is related directly to the marketing so I can’t do one without the other because that’s what was allegedly told by a manufacturer to a doctor and what doctors tell their patients is something else entirely or we’re looking at the label.”
There are at least 245 cases pending in the MDL, said plaintiffs attorney Stephen A. Corr, of Doylestown, Bucks County, and plaintiffs liaison counsel.
Bryan F. Aylstock, of Aylstock Witkin Kreis & Overholtz in Pensacola, Fla., and multidistrict coordinator for the plaintiffs steering committee, said he has the impression that there are 1,000 other cases for which plaintiffs attorneys are waiting to decide to file.
While defense lawyers questioned advertising by plaintiffs lawyers about Zoloft causes of action, Rufe said that such advertising can be a public service to inform the public.
“The advertising does seem to promote a wide range of injures that are potentially reparable by damages,” Rufe said. “If that’s the case, everybody wants to know early on.”
Defense counsel for Pfizer and plaintiffs counsel also argued over what format Pfizer should produce discovery.
Zonies said that, instead of documents being turned into pictures with text and metadata extracted out of those files, that Pfizer should produce documents in their native, or original, format.
But Cheffo said that documents are in TIFF searchable formats along with some metadata, which is how defense lawyers are reviewing the documents.
The defendant is not trying to provide discovery in “some old-school, hide-the-ball kind of way,” Cheffo said.
Both sides need to justify why their preferred form of discovery production is preferable, Rufe said.