Birth Defect Lawsuit Over Effexor to be Prepared for Trial to Begin Sept. 2016

As dozens of Effexor birth defect lawsuits continue to move forward in the federal court system, the U.S. District Judge presiding over the litigation has outlined the process for preparing a small group of cases for early “bellwether” trials, with the first case expected to begin in September 2016.

There are currently at least 68 product liability lawsuits filed against Pfizer in U.S. District Courts nationwide, which all involve similar allegations that side effects of Effexor use during pregnancy caused children to be born with severe malformations, developmental defects and other injuries.

Since August 2013, the federal cases have been consolidated as part of an MDL, or multidistrict litigation, with all complaints centralized before U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania to reduce duplicative discovery, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

In a case management order issued November 18, Judge Rufe outlined the process for selecting a group of 14 cases that will go through case-specific discovery as part of a bellwether trial program, which is designed to help the parties gauge the relative strengths and weaknesses of their cases.

Plaintiffs have been directed to identify seven cases to be included in this “Initial Discovery Group” by December 22, with Pfizer identifying another 7 cases by January 26, 2015. These cases will then go through “threshold discovery”, including exchange of documents and written fact sheets by each side, as well as limited depositions of parents or legal guardians of minor plaintiffs, healthcare providers who prescribed Effexor, no more than two treating physicians for the mother and two physicians who treated the child. Plaintiffs will also be permitted to take depositions of no more than two Pfizer sales representatives who called on the mother’s healthcare providers.

By November 30, 2015, Judge Rufe indicates that each side may strike one of the cases selected by the opposing party from the Initial Discovery Pool, which will make the ineligible for the first trial date.

By December 2, 2015, each side will designate two cases for a “Trial Pool”. Those cases will then go through additional discovery in preparation for trial, including expert witness discovery and challenges to the admissibility of expert testimony. The final decision as to the order in which the cases will go to trial will be made by the Court.

Judge Rufe has scheduled the first Effexor bellwether trial to tentatively begin by September 6, 2016, with each side being permitted a total of 25 hours to present its case, including opening statements, closing arguments and testimony.

Effexor Birth Defect Litigation

Effexor (venlafaxine) belongs to a class of antidepressants known as serotonin-norepinephrine reuptake inhibitors (SNRIs), which are very similar to the more popular selective serotonin reuptake inhibitors (SSRIs) such as Zoloft. SNRIs are known to have many of the same side effects as SSRIs.

Plaintiffs allege that there were signs of the potential pregnancy side effects during clinical trials on animals and that there were indications that Effexor may affect children during pregnancy following post-marketing data as well.

The lawsuits allege that Pfizer’s Wyeth subsidiary aggressively marketed the drug as safe for pregnant women, when no such assertion could be justified when looking at the scientific data.

Several studies have suggested that exposure to Effexor before birth may cause children to develop a number of different serious health problems, including heart defects, malformations or abnormal developments.

The litigation raises several allegations similar to those presented against Pfizer in more than 500 Zoloft birth defect lawsuits, which are also consolidated before Judge Rufe in the federal court system.

While the outcomes of these early Effexor bellwether trials are not binding on other claims, the process is designed to help predict how the Court and juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

Following the trial of a small group of cases in the MDL, if Effexor settlement agreements are not reached to resolve other cases, Judge Rufe may begin remanding lawsuits back to the U.S. District Courts where they were originally filed for separate trial dates across the country.