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The judge presiding over all federal Zoloft lawsuits, involving claims brought on behalf of children who developed birth defects after their mothers were given the popular antidepressant during pregnancy, has pushed back the start of the first trials to October 2004, according to a new order issued this week.
A growing number of families throughout the United States are filing product liability lawsuits against Pfizer, alleging that the drug maker failed to adequately warn about the risk of severe birth defects from Zoloft use while pregnant.
In the federal court system, more than 250 complaints filed in U.S. District Courts throughout the country have been consolidated before U.S. District Judge Cynthia M. Rufe in the Eastern District of Pennsylvania, where a small group of cases are being prepared for early trial dates to help the parties gauge how juries are likely to respond to evidence and testimony that will be repeated throughout the Zoloft birth defect litigation.
While the first trial dates were expected to begin in September 2014, according to an amended pretrial order (PDF) issued by Judge Rufe on February 25, the tentative date established for the first Zoloft bellwether trial to begin is now October 13, 2014.
In a second pretrial order (PDF) issued the same day, Judge Rufe pushed back the deadlines previously established for the parties to select a group of 25 cases that will undergo case-specific discovery in preparation for the first trial date.
The Plaintiff’s Steering Committee, which is a group of Zoloft lawyers appointed to leadership roles in the litigation, now have until March 15 to select 12 cases for inclusion in an “Initial Discovery Group.” The Defendants will then select an additional 13 cases by March 22, and this group of 25 claims will undergo depositions and other case-specific discovery in preparation for early trial dates.
By April 15, the parties have been directed to submit joint or competing proposals regarding the process for selecting the first cases to be tried and other pre-trial scheduling deadlines.
Zoloft Linked to Birth Defect Risks
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, 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 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.
The lawsuits allege that Pfizer knew or should have known about the risks associated with using Zoloft while pregnant, but failed to provide adequate warnings for women of child-bearing potential, preventing them from taking steps to avoid using the medication while pregnant.