That decision, a hearing for which is scheduled for June 1, has the potential to put the state court and the multidistrict court at odds with one another. Nonetheless, the testimony of expert witness Dr. Nicholas Jewell will be duly in the books regardless of which way the MDL decision goes.
The case is Robinson v. Wolters Kluwer Health, Inc., Case no. 11-5702, originally filed December 2, 2011 in US District Court, Eastern District of Pennsylvania. According to various sources, the defense took exception with the methodology used to arrive at Jewell’s conclusions related to causation that Zoloft, when used by pregnant women, can trigger Zoloft birth defects such as heart defects like transposition of the great arteries, or TGA. Pfizer, the manufacturer of Zoloft, argued that birth defect data - and especially TGA - should not have been lumped together with other data.
Judge Bernstein countered that the plaintiff’s Zoloft defects were so rare - TGA - that lumping them in with other data is not inappropriate given the rarity of the condition. “Dr. Jewell conceded that there is insufficient information to isolate TGA birth defects,” Bernstein said. “Likewise, the defense agrees that the TGA birth defects isolated in the studies are too few for statistically significant associations to be found. The failure to find statistically significant results is because of the size of the populations in the studies and the infrequency with which TGA birth defects occur. Specific birth defects can be so finely isolated that insufficient numbers exist to ever demonstrate statistically significant results.”
In his opinion, Judge Bernstein referenced Trach v. Fellin, a previous case tried in Superior Court. The case centered on circumstances where a plaintiff was provided the incorrect medication at the dispensing pharmacy, unwittingly ingesting six times the maximum allowable dosage of an antidepressant.
“Of course there never could be any studies to determine the long-term effects of taking six times the maximum permissible dosage of an antidepressant medication,” Bernstein said. “Plaintiff’s expert testified by extrapolating from the known side effects of the medication taken to opine as to the long-term effects.”
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“Since this court has found that the opinion that Zoloft can cause heart birth defects is permissible, it is logically and necessarily permissible that the specific causation experts be permitted to testify and plaintiff permitted to argue that the ingestion of Zoloft during pregnancy increased the risk of birth defects of the heart,” Bernstein said.
All eyes will now be on the Zoloft MDL in the Eastern District of Pennsylvania for the outcome of the June 1st ruling as to the allegation of Zoloft defects.