Pharmaceutical

First federal Zoloft birth defects trial scheduled for January 2016

Zoloft 435x348 First federal Zoloft birth defects trial scheduled for January 2016Five cases in an ongoing federal multidistrict litigation (MDL) alleging Pfizer’s antidepressant Zoloft caused heart defects in children born to women who took the drugs during pregnancy have been selected to go to trial, with the first scheduled to begin in January 2016.

The first trial is that of plaintiff Deidra Long, who filed her lawsuit in Pennsylvania state court in May 2012. She claims that her son, Hudson Long, was born in January 2008 with congenital birth defects as a result of exposure to Zoloft while in utero.

Since his birth, the boy has suffered serious birth defects including complex congenital heart disease, pulmonary stenosis, ventricular septal defect, L-transposition dextrocardia, and right ventricular hypoplasia. The conditions have required him to undergo multiple corrective surgeries and significant, ongoing medical treatment and care. Deidra Long claims had she known the birth defects risks with Zoloft, she would have never taken the medication while pregnant.

Zoloft is in a commonly prescribed class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. This class also includes Prozac, Lexapro, Paxil and Celexa.

The other four trials to follow Diedra Long’s include lawsuits filed by Dana Goulet and Russell McGoun. Both Pfizer and plaintiffs had input into which cases would be selected from the trial pool, though U.S. District Judge Cynthia Rufe made the final decision on which cases would be heard.

Pfizer has argued that the risk of birth defects in babies born to women in the general population is about 3 to 5 percent, which the drug company says has not been affected since Zoloft hit the market in the early 1990s. Pfizer also referred to conclusions made by organizations such as the American Psychiatric Association and the American College of Obstetricians and Gynecologists, that current data has not shown “consistent information” regarding birth defects in developing fetuses exposed to SSRI antidepressants.

Several studies have linked SSRI use during pregnancy to birth defects, in particular heart defects and a serious lung defect known as persistent pulmonary hypertension in newborns, or PPHN. However, most SSRIs, including Zoloft, are listed as Category C pregnancy drugs, meaning there are no studies to prove the drugs cause birth defects if taken by pregnant women.

Only Paxil is listed as a Category D pregnancy drug, meaning studies have established a link between use during pregnancy and birth defects.

Source: Law360