April 9, 2015 — Bloomberg reports that lawyers have accused Pfizer of failing to warn women on Zoloft that they should use birth control to reduce the risk of having a baby with a heart defect.
Those accusations were presented in opening arguments in the first trial out of more than 1,000 lawsuits involving birth defects associated with Zoloft (sertraline), an antidepressant.
The lawsuit was filed by 31 year-old Kristyn Pesante, who had a child with several major heart defects after using Zoloft during pregnancy. Her 11 year-old son, Logyn, has survived three open-heart surgeries but continues to suffer from side effects.
Attorneys for the family said Pfizer included recommendations about the use of birth control in Zoloft’s “Core Data Sheet,” but failed to make those same recommendations in safety labeling in the United States.
Pfizer is accused of concealing the risks of Zoloft to justify marketing it as superior to other antidepressants. Once the top-selling antidepressant on the market, Zoloft was raking in $2.5 billion in 2005, the year before its patent protection expired.
The trial is currently underway in Missouri state court. Another state-court trial is scheduled to begin next month in Philadelphia. The outcomes will be closely watched. Pfizer is facing hundreds of similar lawsuits, including dozens in other states and about 550 in a federal Multi-District Litigation (MDL) in Pennsylvania.
Several studies have suggested that Zoloft increases the risk of having a baby with a heart defect, especially “hole in the heart” defects. In 2011, the FDA warned about a possible increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN), a life-threatening heart and lung defect.
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