A Florida grandmother has filed a complaint against the maker of the antidepressant Zoloft over a birth injury suffered by her grandchild. The lawsuit was filed November 28, 2012 in federal court in the Northern District of Florida, which is in Pensacola.
According to the complaint against drug maker Pfizer Inc., her daughter took Zoloft during her pregnancy, causing the child to suffer serious heart defects. Zoloft is a selective serotonin reuptake inhibitor (SSRI) and the complaint says Pfizer failed to adequately warn doctors and patients about the potential side effects of taking the drug during pregnancy. The daughter took the antidepressant as prescribed by her doctor throughout her pregnancy.
The infant was born November 28, 2008 and was rushed to intensive care after it was determined she suffered from Supraventricular Tachycardia, an elevated heart rate, which requires constant monitoring. The little girl was also born with a clubfoot which required her to undergo surgeries and spend time in a number of casts to correct the malformation.
The lawsuit claims the company displayed a reckless and negligent disregard for the rights of others and concealed the adverse event potential of Zoloft. This has deprived the child of a normal childhood, says the complaint.
A 2006 clinical trial demonstrated that SSRI use by women at least 20 weeks pregnant could elevate the risk by six times of giving birth to a child with Neonatal Persistent Pulmonary Hypertension (PPHN), a potentially fatal condition. Despite early indications that taking Zoloft during pregnancy resulted in birth defects, Pfizer still failed to warn the public says the complaint.
On December 14, 2011, the FDA issued a warning about the potential risk of PPHN.
The Judicial Panel on Multi-District Litigation (MDL) established MDL No. 2342 Zoloft which coordinates cases filed against Pfizer in federal court in the Eastern District of Pennsylvania. For the most part these are cases filed by the parents and families of children like this little girl, who were born with defects that could and should have been prevented, had the mother known of the risk of injury to her unborn child.
Zoloft was approved by the FDA in 1991 for the treatment of depression, obsessive-compulsive and panic disorders as well as social anxiety disorder and pre-menstrual dysphoric disorder.
Because of a host of malformations associated with SSRI use during pregnancy hundreds of actions have been filed against the makers of this class of drugs.