In a case management order issued in November, the U.S. District judge presiding over all federal Effexor birth defect lawsuits has approved the cases to proceed in the first round of bellwether trials. Each party must choose seven cases to include in the bellwether trials, with the plaintiffs’ decisions due before December 25 and Pfizer’s due in January 2015.

Since August 2013, an Effexor multidistrict litigation (MDL) has been established for all product liability lawsuits filed against Pfizer in U.S. District Courts nationwide. These bellwether cases all claim that while pregnant, a woman took Effexor and eventually gave birth to a child with birth defects.

Effexor Birth Defect Litigation

There are currently at least 68 Effexor lawsuits pending in the MDL, which has been centralized before U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania. The purpose of the Effexor MDL is to avoid conflicting pretrial rulings from different judges, increase judicial efficiency in bringing new claims, avoid the delays associated with transferring cases from other districts.

In MDLs, evidence and testimony from very similar lawsuits are combined to streamline the legal system when large numbers of similar lawsuits have been filed. Birth defect lawsuits within the MDL allege that antidepressants like Effexor have been linked to several types of birth defects, including heart, skull, and lung birth defects. This includes cleft lip, cleft palate, heart birth defects, and PPHN.

What is Effexor?

Effexor is an antidepressant drug that is used to treat major depressive disorder, anxiety, and panic disorder. Effexor inhibits the re-uptake of both norepinephrine and serotonin. The U.S. Food and Drug Administration (FDA) approved Effexor for these uses in 1993. However, allegations have since emerged that Pfizer marketed Effexor as safe for pregnant women despite knowledge of increased risks for certain birth defects.

Should Pregnant Women Take Effexor?

The FDA has named Effexor a Pregnancy Category C drug, meaning that it could potentially harm a fetus, particularly when used during the third trimester. By placing Effexor into Category C, the FDA is warning that while the drug has not been tested in humans, animal studies have shown that it presents a risk to a fetus. Category C drugs, like Effexor, can still be administered during pregnancy if the doctor believes that its potential benefits outweigh its risks to the child. The label advises that that woman tell their doctors if they become pregnant or intend on becoming pregnant during treatment.

In 2004, the label for Effexor was updated to advise patients that infants who were exposed to the drug during the third trimester had developed complications which warranted tube feeding, prolonged hospitalization and respiratory support.

Allegedly as a result of inadequate warnings provided to consumers and the medical community, many women have been given the popular antidepressant while pregnant, which may have unknowingly exposed their unborn child to an increased risk of severe and dangerous birth defects, including:

• Abdominal birth defects
• Anal atresia
• Heart defects
• Craniosynostosis
• Pulmonary stenosis
• Limb defects
• Genital defects

The Effexor Birth Defects MDL is In Re: Effexor (Venlafaxine Hydrochloride) Product Liability Litigation, MDL No. 2458, in the U.S. District Court for the Eastern District of Pennsylvania.