Zoloft Birth Defects Experts Allowed To Testify Subject to Restrictions

The U.S. District Judge presiding over all federal Zoloft birth defect lawsuits has issued a ruling that restricts what some plaintiffs’ experts will be allowed to testify about in the litigation.

There are currently more than 500 product liability complaints pending against Pfizer in the federal court system, which all involve similar claims that children were born with birth defects and malformations after the mothers were prescribed the antidepressant Zoloft during pregnancy. Plaintiffs allege that Pfizer withheld information from consumers and the medical about the link between Zoloft and birth defects.

Given the common issues of fact and law in the cases, the federal Zoloft litigation has been centralized before U.S. District Judge Cynthia M. Rufe in the Eastern District of Pennsylvania for coordinated pretrial proceedings, to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

In response to a motion filed by Pfizer seeking to completely exclude the testimony of three plaintiffs’ experts, who were designated to explain how and why Zoloft could cause birth defects, and the likelihood of it happening when Zoloft is used at clinically appropriate doses during the first trimester, Judge Rufe issued a memorandum opinion (PDF) on August 12, which allows the experts to be used, but restricts what they may testify about.

While Pfizer did not raise issues over the qualifications of the expert witnesses, the drug maker did challenge whether they used sound science to reach their conclusions that side effects of Zoloft increase the risk of birth defects.

After considering the arguments, Judge Rufe determined that the only methodology in question was their arguments of human causation, and ruled that their opinions on human causation must be excluded, but that they could still serve as expert witnesses on a variety of other matters.

“The experts at issue here have conducted and reviewed in vitro research which they believe demonstrates the existence of one or more plausible biological mechanisms by which altered concentrations of [Zoloft] in a developing embryo may cause birth defects,” Judge Rufe determined. “The Court finds that the methodology these experts used to reach their conclusions about biological plausibility is generally reliable, and will not exclude their opinions regarding biological mechanisms.”

Zoloft Litigation

As part of the coordinated pretrial proceedings Judge Rufe, a small group of lawsuits involving Zoloft birth defects are being prepared for early trial dates, known as “bellwether” cases. Although the outcomes of these trials are not binding in other cases, they are designed to help the parties gauge how juries may respond to evidence and testimony that may be offered throughout the litigation.

On August 12, Judge Rufe issued a stay in Zoloft litigation for 30 days, cancelling a September status conference due to the court’s unavailability during that time.

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 (BMJ) 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.

As the first cases are being prepared for early trial dates, the number of lawsuits filed nationwide continues to mount as Zoloft lawyers review additional cases for families with children born with malformations or birth defects that may have been caused by use of the antidepressant during pregnancy. It is ultimately expected that there may be more than one thousand cases brought against Pfizer over the blockbuster antidepressant.

If Pfizer does not reach Zoloft settlement agreements following a number of early bellwether trials, Judge Rufe may begin remanding all of the cases in the federal MDL back to the U.S. District Courts where they were originally filed for separate trial dates.