Process for Selecting Zoloft Bellwether Trials Outlined by MDL Judge

As a small group of Zoloft birth defect cases are being prepared for early trial dates in the federal court system, the U.S. District Judge presiding over the consolidated litigation has outlined the process of narrowing that pool of lawsuits down to the cases that will be eligible to go before the first juries.

There are currently more than 420 product liability lawsuits pending against Pfizer that have been centralized before U.S. District Judge Cynthia M. Rufe in the Eastern District of Pennsylvania for pretrial proceedings, as part of an MDL, or Multidistrict Litigation.

All of the cases involve similar allegations that side effects of Zoloft use during pregnancy caused children to be born with severe birth defects and malformations.

Pfizer faces claims from the families over their failure to adequately warm women or the medical community about the risks of using the popular antidepressant while pregnant, alleging that the drug maker knew or should have known about the potential for the medication to impact the development of children, yet withheld information about the importance of avoiding the medication during pregnancy.

Zoloft Bellwether Trial Process

As part of the coordinated proceedings in the federal court system, a group of 25 cases were previously selected as part of an “Initial Discovery Pool,” including 13 cases selected by Pfizer and 12 cases selected by a group of plaintiffs’ lawyers. These cases are currently going through pretrial discovery, including depositions and the exchange of documents and medical records relevant to each complaint.

These cases are being prepared for a series of “bellwether” trials, which are designed to help gauge how juries may respond to certain evidence and testimony that may be repeated throughout a number of cases. The preparation for these trials and the outcomes are designed to ultimately promote a Zoloft settlement agreement that may resolve claims without the need for hundreds of individual trials.

In an order (PDF) issued December 4, Judge Rufe outlined the process for choosing the first claims that will go to trial, indicating that five to six cases will be ready for the first trial dates.

Judge Rufe has indicated that each side will be permitted to strike up to two cases from the Initial Discovery pool, so long as the selections are made by May 5, 2014 and the strikes used by Pfizer are not directed at more than one case in which the plaintiffs are represented by the same primary counsel.

If any claims that are part of the pool of 25 cases are voluntarily dismissed, Judge Rufe has determined that it will be considered one of the plaintiffs’ strikes. Following use of both strikes, if any additional cases are dismissed by plaintiffs, Pfizer will be provided with an equal number of additional strikes to use, regardless of the plaintiffs’ lawyer involved in the case. Any strikes not exercised by May 5 will be forfeited.

By May 14, the parties have been directed to each designate three of the remaining cases for a “Trial Pool,” which will be eligible for the first trial dates. If overlapping selections result in less than five claims being added to this Trial Pool, Judge Rufe indicates that the parties will simultaneously make additional selections until there are a minimum of five and maximum of six cases.

Once the final list of Trial Pool cases is established, each side will provide a short summary of the claim to the court and it is from this list that Judge Rufe will select cases for specific trial dates.

The first Zoloft bellwether trial is currently scheduled to begin on November 3, 2014.

Zoloft Birth Defect Lawsuits

Zoloft (sertraline) is one of the most widely prescribed medications in the United States, and has been used by tens of millions of individuals. However, use of Zoloft by pregnant women has been linked to a potential increased risk of serious and potentially life-threatening birth defects and malformation for children.

In November 2006, the FDA added warnings about a potential risk of persistent pulmonary hypertension in newborns (PPHN) from Zoloft and other newer antidepressants when taken after the 20th week of pregnancy. The side effects of Zoloft and other similar medications were linked to a six times greater risk of PPHN.

In June 2007, studies found an association between the use of antidepressants like Zoloft early in the pregnancy and a risk of abnormal skull development, gastrointestinal abnormality and brain defects.

In September 2009, a study published in the British Medical Journal found that SSRI antidepressants like Zoloft increase the risk of heart defects when taken during the first trimester, a time when many women do not even know they are pregnant.

While the first cases are being prepared for early trial dates next year, the number of lawsuits filed nationwide continues to mount. Zoloft lawyers are continuing to review cases for families as they learn that their child’s birth defects or malformations may have been caused by use of the antidepressant during pregnancy, and it is expected that there may ultimately be several thousand cases brought against Pfizer.