- A U.S. district judge in Philadelphia this week dismissed over 300 lawsuits against Pfizer, ruling there was not enough evidence to link the company's depression med Zoloft to birth defects in children born to mothers who took the drug during pregnancy.
- For the last year, Pfizer has been facing lawsuits alleging that Pfizer failed to disclose the risk of birth defects, specifically congenital heart defects, associated with taking Zoloft (sertraline) during pregnancy.
- Pfizer won two similar lawsuits in Philadelphia and St. Louis courts last year on similar grounds.
- Although Judge Cynthia Rufe rule in favor of Pfizer, the trial did reveal documentation that Pfizer scientists had warned of possible links between the drug and birth defects, according to FiercePharma.
In 2005, Zoloft was the best-selling antidepressant, generating roughly $3.3 billion in revenues that year. It is widely used by physicians to treat a broad cross-section of depressed patients, including pregnant women. Zoloft went off patent in 2006, however, and now earns substantially less in annual revenue.
Pfizer has prevailed in all of the suits which made it to trial so far.
The most recent Philadelphia trial also led to the presentation of an internal report from 1998 which showed company researchers had found over a dozen side effect reports on birth defects associated with Zoloft, as Fierce reports.
The report was written by Francesca Olitsopolous, who was then associate director of Pfizer's Worldwide Safety Strategy unit's Epidemiology group. Her extensive review led her to conclude the scientists had found links between Zoloft and septal heart defects, as well as omphalocele, a birth defect of the abdominal wall in which the intestines and organs form outside the belly. However, she determined the risks were very small.
The evidence presented has not convinced jurors. But the FDA last year requested Pfizer update its label with information from the researchers who had documented an increased risk of congenital heart defects associated with Zoloft.