Zoloft Lawsuit – Birth Defects, Warnings, Lawsuits
Zoloft is an antidepressant that has been linked to serious and sometimes deadly side effects, including birth defects in children whose mother took Zoloft as prescribed during pregnancy. These side effects have been the subject of multiple warnings from the FDA, and have prompted many people across the country to file a Zoloft lawsuit seeking compensatory damages for their injuries, as well as punitive damages for the manufacturers’ failure to adequately warn the public about the risks consumers face.
Over 250 Zoloft lawsuits filed by the parents of children who suffer from birth defects have been consolidated on the on the federal level in multidistrict litigation (MDL) currently pending in the U.S. District Court in the Eastern District of Pennsylvania. More cases are expected to join the federall consolidated claims which allows for the sharing of resources among various plaintiffs in effort to reduce any inconsistent pretrial rulings and expedite the discovery phase of the legal process. The first Zoloft lawsuit is expected to go to trial in 2014.
What is Zoloft?
Zoloft, or sertraline, is an antidepressant manufactured and sold by Pfizer, Inc. Zoloft belongs to the selective serotonin reuptake inhibitor (SSRI) drug class, and is prescribed to treat not only depression, but also anxiety disorders, obsessive-compulsive disorder, and panic disorders. The medication first received FDA approval in 1991; by 2007, it was the most popular antidepressant in the United States, with more than 29 million prescriptions sold that year. It is currently sold in 10mg, 25mg, and 100 mg dosages.
SSRI drugs work by preventing the brain from absorbing serotonin that has already been released. Since serotonin causes feelings of well being and happiness, preventing re-absorption helps eliminate feelings of depression. Unlike other antidepressants, SSRI drugs have little effect on dopamine and noradrenaline, which both help regulate stress. SSRI medications, including Zoloft, take several weeks to enter the bloodstream and take effect, and may cause several side effects in the process: nausea, sleepiness, and sexual side effects. Zoloft is also linked to long-term side effects, especially birth defects and persistent, sometimes permanent sexual side effects.
Zoloft birth defects overview
Zoloft has been linked to several types of birth defects, including persistent pulmonary hypertension of the newborn (PPHN), and heart defects, including atrial septal defects (ASD) and ventricular septal defects (VSD). Other reported birth defects that have been cited in Zoloft lawsuit complaints include omphalocele, craniosynotostosis, Zoloft withdrawal, clubfoot, Tetralogy of fallot (TOF) with pulmonary atresia, transposition of the great arteries, spina bifida, premature birth, and autism.
Zoloft lawsuit plaintiffs allege the drug is responsible for birth defects such as:
- PPHN: A baby born with persistent pulmonary hypertension of the newborn (PPHN) will experience restricted blood flow to the lungs, which in turn elevates blood pressure and can cause bluish lips and skin, irregular heartbeat, chest pain, shortness of breath, dizziness and fainting.
- Heart defects: Both atrial septal defects (ASD) and ventricular septal defects (VSD) are characterized by holes in the infant’s heart, either in the upper chambers (ASD) or lower chambers (VSD).
- Omphalocele: This birth defect can be detected in utero, since it occurs when an infant’s abdominal organs form outside the belly button. According to the National Institutes of Health (NIH), 25 to 40 percent of infants with omphalocele have other birth defects.
- Craniosynotostosis: This birth defect is a physical deformation of the skull bones that results in an abnormally shaped head.
- Zoloft withdrawal: An infant suffering from Zoloft withdrawal may exhibit abnormal crying, breathing difficulties (including turning blue), convulsions, feeding problems, floppiness, fluctuating body temperatures, irritability, jaundice, jitteriness, low blood sugar, stiffness, tremors and vomiting.
History of FDA warnings about Zoloft: suicide, PPHN
Early complaints regarding Zoloft side effects focused primarily on suicide claims, one of the most serious side effects of Zoloft. Suicidal thoughts (suicide ideation) and attempts to inflict self-harm posed a real threat to users of Zoloft, especially among children and adolescents.
In 2004, the FDA issued its first warning, which limited the warning risk to teens and children. However in 2005, the FDA released a second warning to include adults in the scope of risk for this Zoloft side effect.
In 2006, the FDA issued a warning for Zoloft birth defects, specifically PPHN, for women taking the drug after the 20th week of pregnancy. And in 2007, the FDA required Pfizer to add a black box warning – the most serious side effects warning – with regard to suicide.
Zoloft lawsuit settlements
Though any settlements, if any have been reached, have so far remained confidential- courtwatchers look to the outcome of other SSRI lawsuits to gain a better understanding of the potential value of some of these cases.Legal action against the makers of other well-known SSRI medications has resulted in billions in damages. For example, the manufacturer of Paxil, GlaxoSmithKline, has also faced substantial legal battles and has already paid out over $1 billion to similar claims of suicide and birth defects. What affect these numbers will have on any jury verdicts and settlements remain to be seen.
Contact a Zoloft lawyer
If you have been injured with regard to this medication and would like to receive more information, an experienced Zoloft lawyer can evaluate your case and help determine if you are eligible to pursue compensation by filing litigation.
- U.S. News and World Report: Health, (June 27, 2007), Some Antidepressants Pose Birth Defect Risk, http://health.usnews.com/usnews/health/articles/070627
- Food and Drug Administration (FDA), (December 21, 2011), Setraline (marketed as Zoloft) information, http://www.fda.gov/Drugs/DrugSafety
- Johns Hopkins Medicine, Health Alerts, (February 7, 2006), Combating Sexual Dysfunction Caused by Antidepressants, http://www.johnshopkinshealthalerts.com/reports