In 1991, Pfizer launched Zoloft, a prescription SSRI antidepressant. Backed by catchy-but-simple ads, complete with a bouncing ball representing sadness, the medication soon became one of the most popular antidepressants in the United States. However, it was not long before the drug became linked to reports of serious SSRI birth defects in children who had been exposed to the drug while in utero. The medication can also cause serious depression, suicide, and other adverse side effects.
With the emergence of more patient complaints and recent medical studies exposing Zoloft birth defects, affected families around the country have come forward and filed legal complaints against Pfizer.
Common Zoloft lawsuit allegations
Birth defects resulting from prenatal Zoloft use can be life-threatening. In addition to the pain endured by the afflicted child, family members carry their own emotional distress pursuant to their child’s injuries, as well as soaring healthcare costs, lifestyle changes, lost wages, and other financial consequences.
A typical Zoloft lawsuit contains the following allegations against Pfizer:
- Marketing and sale of a dangerous drug
- Negligently failing to warn the public, the FDA, or the medical community of the link between Zoloft and birth defects
- Failure to conduct post-marketing reviews into the ongoing safety of Zoloft, and that the company did not report any such risk information to the public
- Failure to disclose study results to the public, the FDA, or the medical community
- Willful misrepresention that Zoloft was safe for use in pregnant women
- Promotion and sale of the SSRI to pregnant women, even when the company had knowledge of Zoloft birth defects
- Failure to act in the best interest of the public, instead choosing profit over patient safety
Birth defects linked to Zoloft
Alleged Zoloft birth defects include a range of health problems including:
- Clubfoot: Clubfoot is also called congenital talipes equinovarus (CTEV), and is characterized by deformed feet. Children with clubfoot may experience malformed limbs, or feet that twist inward or face downward. This condition requires correction.
- Craniosynostosis: This is a type of skull deformation, or malformation, that can affect a fetus’s growth and development. After birth, children with craniosynostosis may develop seizures, developmental delays, and other problems. This condition requires surgical correction.
- Heart Defects: Zoloft has been linked to heart defects, including atrial septal defects (ASD) and ventrical septal defects (VSD), or holes in the heart. This condition requires correction, in rare cases with open-heart surgery, and can be fatal.
- Omphalocele: Also known as an umbilical hernia, omphalocele occurs in utero, when a child’s internal organs (liver, intestines, and other abdominal organs) form outside the body. Requires surgical correction.
- Persistent Pulmonary Hypertension of Newborn (PPHN): This is a serious lung and heart disorder that is fatal in 10% of all babies who receive the diagnosis. It can cause cyanosis, low blood-oxygen, tachycardia (rapid heart rate), tachypnea (rapid breathing), heart murmur, and respiratory distress. Over time, PPHN can cause seizures, permanent lung damage, neurological delays, hearing problems, and developmental delays.
- Other Zoloft birth defects: Zoloft has also been linked to infant side effects like spina bifida, Tetralogy of fallot (TOF) with pulmonary atresia, congenital heart defects, and transposition of the great arteries.
Current litigation & the Zoloft lawsuit MDL
After hundreds of Zoloft lawsuits had been filed in the United States, the U.S. Judicial Panel on Multidistrict Litigation (JPML) voted to consolidate federal complaints into multidistrict litigation on January 18, 2012. The Zoloft MDL is centralized under the honorable Judge Cynthia M. Rufe in the U.S. District Court for the Eastern District of Pennsylvania.
Judge Rufe soon appointed the Plaintiffs Steering Committee, which is responsible for helping manage all cases in the MDL. During pre-trial preparations, millions of documents have been generated during discovery. Currently, status conferences are scheduled through mid-2013. Pre-trial discovery along with ongoing status conferences are paving the way for the first trials, known as bellwether cases, which will help set the tone for MDL litigation. The first bellwether trial is expected to begin around September 2014.
In addition to the MDL, a joint Zoloft lawsuit was filed in the Wayne County Circuit Court of Virginia. The plaintiffs are now adults, but claim to have been the victims of birth defects as children, after their mothers took Zoloft during pregnancy.
Hundreds of plaintiffs have filed Zoloft lawsuits. To date, no Zoloft birth defects cases have reportedly been settled or reached jury verdict.
Some plaintiffs who have recently filed Zoloft lawsuits:
- A Washington mother, whose daughter was born in 1995, claims that her prescribed use of Zoloft during pregnancy caused her daughter to be born with a hypoplastic left heart that necessitated several surgeries while she was an infant. She claims Pfizer knew of the birth defects associated with use of Zoloft during gestation from earlier clinical trials, but failed to alert the public or doctors.
- An Oregon mother who took the antidepressant throughout her pregnancy claims that as a result her child was born with child was born with atrial septal defect, congenital atresia, and stenosis of the large intestine and rectum, requiring multiple operations, including a double barrel transverse colostomy. The plaintiff seeks punitive damages for Pfizer’s “conscious and deliberate disregard for the rights and safety of consumers.”
- A Zoloft lawsuit plaintiff in Florida claims that after birth her child was immediately placed in intensive care due to Supraventricular Tachycardia (SVT), which required consistent monitoring, tests and medication. The infant was also born with congenital clubfoot that called for repeated castings and operations during her early months of life.
Zoloft mediation & settlements
Hundreds of plaintiffs currently await their day in state and federal court. It is possible that Pfizer will settle some of these cases through out-of-court mediation, while others will be up to jury verdict.
Meanwhile, millions of dollars have also been paid out among other areas of Zoloft litigation and related SSRI matters.
Noteworthy cases include:
- U.S. Government: In 2009, Pfizer settled with the U.S. Government for $2.3 billion – the largest fine in U.S. history. The settlement agreement stated, “Pfizer paid illegal remuneration for speaker programs, mentorships, preceptorships, journal clubs, and gifts (including entertainment, cash, travel and meals) to health care professionals to induce them to promote and prescribe the drugs Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft, and Zyrteck… As a result of the foregoing conduct, Pfizer caused false claims to be submitted to Medicaid and TRICARE.”
- Phil and Brynn Hartman: After taking Zoloft, Brynn Hartman allegedly suffered suicidal thoughts. She shot and killed her husband, famous comedian Phil Hartman, before committing suicide. Her family reportedly settled out-of-court with Pfizer.
- Paxil litigation: GlaxoSmithKline, the manufacturer of Paxil – an antidepressant similar to Zoloft – reportedly paid $1 billion in settlements for SSRI birth defects resulting from their blockbuster drug.
- Sertraline (marketed as Zoloft) Information, http://www.fda.gov/Drugs/DrugSafety/
- U.S. News and World Report: Health, (June 27, 2007), Some Antidepressants Pose Birth Defect Risk, http://health.usnews.com/usnews/health/articles/070627
- WebMD, Antidpressants Linked to Birth Defect, http://www.webmd.com/baby/news/20090924/antidepressants-linked-to-birth-defect