Pfizer Seeks Dismissal of Zoloft Lawsuits Over Birth Defects Suffered by Children

After the U.S. District judge presiding over all federal Zoloft birth defect lawsuits excluded key expert witnesses in the cases, Pfizer has filed a motion to dismiss all claims brought on behalf of children injured by exposure to the antidepressant during pregnancy and lawyers for the families are urging the Court to allow the designation of different general causation experts.

Pfizer currently faces more than 525 product liability lawsuits that are pending in the federal court system, all involving similar allegations that side effects of Zoloft use during pregnancy caused children to be born with severe birth defects and malformations.

All of the complaints are consolidated for pretrial proceedings as part of a federal MDL, or Multidistrict Litigation, which is centralized before U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania to reduce duplicative discovery and avoid conflicting rulings from different judges on issues that are common to all claims.

In August, Judge Rufe issued an order restricting what some plaintiffs’ experts will be allowed to testify about regarding the connection between Zoloft and birth defects for unborn children. While the experts will be permitted to testify on matters other than human causation, the ruling may leave plaintiffs without sufficient evidence to support their claim.

On November 4, Pfizer filed a motion for summary judgment (PDF), which urges Judge Rufe to dismiss all cases in the MDL due to the lack of reliable testimony on general causation in humans.

The drug maker argues that the Zoloft lawsuits filed over birth defects suffered by children of women who used the antidepressant during pregnancy should fail as a matter of law, since the exclusion of expert witnesses has left plaintiffs without admissible and sufficient evidence to establish an essential element of their claims.

In a pretrial order (PDF) issued this week, Judge Rufe indicated that the plaintiffs must file any motion for partial reconsideration of the Court’s prior ruling on the exclusion of the expert witnesses by November 12. In addition, oral arguments have been scheduled for November 18 on a pending motion filed by Plaintiffs requesting leave to identify and present a new general causation expert in the cases.

An opposition to Pfizer’s motion to dismiss the Zoloft birth defect cases must be filed before December 8, with any reply memoranda by Pfizer due by December 22, 2014.

Zoloft Birth Defect Risk

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, several studies have suggested that 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.

All of the claims in the Zoloft litigation raise similar allegations, claiming that Pfizer has known for years about the risk of birth defects, yet withheld information from consumers and the medical community in an attempt to avoid damaging sales of the blockbuster antidepressant.

If the cases survive the motion for summary judgment, it is expected that a number of Zoloft trials will be scheduled in the MDL, to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. Although the outcomes of these “bellwether” trials will not be binding on other cases, they may ultimately facilitate Zoloft settlement agreements to avoid the need for hundreds of individual trials nationwide.