U.S. District Judge Cynthia Rufe or the Eastern District of Pennsylvania made the only call she could on Tuesday: the postponement of Daubert hearing in Zoloft birth defects case until September. The multidistrict litigation (MDL) against Pfizer, claiming its popular antidepressant, Zoloft causes birth defects, came to a halt as the plaintiffs’ expert was disqualified due to errors in the article upon which he was basing his argument in the plaintiffs’ favor.
The postponement came during the Daubert hearing – one that allows parties to challenge each other’s expert testimony pre-trial to save time later – when defendant Pfizer revealed a report from its own medical expert, Dr. Stephen E. Kimmel. After reviewing Dr. Nicholas Jewell’s article in the New England Journal of Medicine, Dr. Kimmel noted some data errors. Dr. Jewell’s article provided plaintiffs’ needed support in their argument that Zoloft causes congenital heart defects when used by pregnant women.
Dr. Kimmel’s report states that he contacted Dr. Jewell and told him of the errors, at which point Dr. Jewell confirmed the mistakes. Dr. Jewell then contacted the Journal to request corrections. Based on this finding, Dr. Kimmel gave the opinion that Dr. Jewell’s article could no longer be used.
Judge Rufe had no other course of action but to agree with Dr. Kimmel and decided that the rest of the Daubert hearing would have to wait until the fall so the plaintiffs could conduct further discovery and depositions. Jared: Do we want to link to the CDC piece here as a suggestion?
According to Judge Rufe, plaintiffs’ legal team has “a lot of people to talk to, we have to give them some time. I do see an advocate’s responsibility to try to determine how this change occurred.”
This isn’t the first blow plaintiffs have received in terms of experts. Anick Bérard, the first expert, was removed following a weeklong Daubert hearing in 2014. Contrary to common practice, the judge allowed a second expert. It’s unclear if the plaintiffs will get a third. That isn’t the extent of the expert epic, though.
Judge Rufe ruled in favor of Pfizer in a motion to produce a report by plaintiffs’ expert Dr. Jewell from similar litigation involving Prozac. She ordered plaintiffs to turn over both the report and the testimony from Dr. Jewell.
According to Pfizer, “Dr. Jewell and plaintiffs’ counsel, who are also counsel in the Prozac litigation, insist that the entirety of Dr. Jewell’s expert report and deposition are confidential and thus subject to a protective order. That blanket assertion is highly suspect and implausible. Dr. Jewell is a general causation expert who presents a statistical analysis of data. He typically does not review or discuss plaintiff-specific information or medical records and has not done so in this matter. His opinions in the Prozac litigation, as they are in this litigation, are presumably based primarily upon publicly available, peer-reviewed literature.”
As stated, the plaintiffs were ordered to release the report. Despite Pfizer’s assertions, there were parts that Eli Lilly had identified as confidential redacted. There were also parts that contained personal health information normally protected by HIPAA.
Pfizer’s motion further stated, “In making a blanket assertion of confidentiality over the entire deposition and report, plaintiffs’ and Dr. Jewell’s motives are transparent: They do not want the defendants or the court to ascertain and explore whether there are any inconsistencies in his methodologies in the different SSRI litigations.”
To date, Pfizer has won two of the Zoloft birth defects cases out of the approximately 550 total cases.