SSRI Antidepressant Lawsuits - Paxil, Zoloft, Prozac
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SSRI Antidepressant Lawsuits

Selective serotonin reuptake inhibitors (SSRIs) are third-generation antidepressant medications used to treat conditions like depression, generalized anxiety disorders, social phobia, post-traumatic stress disorder and obsessive compulsive disorders. Occasionally, doctors may also prescribe SSRIs off-label to treat irritable bowel syndrome (IBS), fibromyalgia and erectile dysfunction. The drugs function by blocking the reabsorption of serotonin – a mood enhancing chemical — in the brain, and are only available via prescription.

Nearly a dozen SSRIs are available in the U.S, including Prozac (fluoxetine), Paxil (paroxetine) and Zoloft (sertraline).

Selective serotonin reuptake inhibitors

Current statistics indicate that ten percent of Americans, including adults and adolescents, take at least one antidepressant medication; and studies have raised concerns about the rampant over prescription of SSRIs to treat patients with few or no symptoms of depression or anxiety disorder.

Common side effects of selective serotonin reuptake inhibitors include nausea, changes in appetite, drowsiness, photosensitivity, sleep disturbances, vivid dreams, apathy and headaches.

However, the FDA has issued safety drug safety communications regarding more dangerous side effects linked to antidepressant therapy, including an increased risk of suicidal tendencies and a possibility of cardiac defects in babies born to women who take them while pregnant. Several of these popular drugs have been the topic of product liability lawsuits which contend that the medications are inherently hazardous and were marketed without sufficient warning of potential risks.

The Sanders Firm has been on the forefront of pharmaceutical mass tort litigation involving Avandia, Celebrex and Fosamax, and is uniquely qualified to assist individuals who were harmed and incurred financial losses after taking an SSRI antidepressant. Our veteran staff of drug injury attorneys works diligently to pursue just compensation on behalf of clients, while holding drug manufacturers responsible for failing to warn of potential health risks.

FDA warnings concerning Prozac, Paxil and Zoloft

Prozac, launched in 1988, was the first SSRI to be approved by the FDA. It is one of the few SSRI antidepressants approved to treat depressive symptoms in children age 8 and older. In 2004, U.S. health regulators asked the manufacturers of Prozac and all antidepressant drugs to include a black-box warning to their products indicating a risk of suicidal tendencies in children and teenagers, amid reports of suicide attempts and actual suicides among teens taking the medication. This suicide warning was updated in 2007 to include all patients 24 and younger.

In 2006, the FDA published a separate safety communication regarding the dangers of taking Triptans (a migraine headache treatment) with an SSRI or SNRI. The combination can cause a life-threatening condition called serotonin syndrome, which ensues when the body has too much serotonin. The symptoms include hallucinations, loss of coordination, rapid heartbeat, blood pressure elevation, overactive reflexes, vomiting and nausea. If not caught early, serotonin syndrome can lead to shock and death.

That same year, another advisory was issued by the FDA concerning the risk of heart defects in babies who were exposed to Paxil and other SSRIs in utero. The warning was prompted by a study published in the New England Journal of Medicine, in which researchers found a six-fold increased risk of Persistent Pulmonary Hypertension (PPHN) in newborns whose mothers took an SSRI after their 20th week of pregnancy. PPHN affects a child’s ability to breathe normally outside of the womb and can lead to organ and brain damage, and even death.

In 2011, the agency issued a new safety alert concerning SSRIS during pregnancy, stating that “…there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.”

SSRI pregnancy risks to the unborn fetus

The FDA categorizes most SSRIs as pregnancy grade C drugs, indicating that laboratory tests on animals have shown the drug can cause harm to unborn fetuses. In 2005, the FDA asked Paxil manufacturer GlaxoSmithKline to amend the pregnancy category from grade C to D. Category D means that observational research in pregnant women has shown a verifiable risk to the fetus. The updated product labeling was mandated on the basis of two studies, which found that women who took Paxil during their first trimester were 1.5 to two times more likely to have a child with cardiac malformations as those who took other antidepressants.

The majority of heart defects observed in babies exposed to Paxil were atrial and ventricular septal defects (ASD and VSD) — holes in the walls of the heart.

Additional research has suggested that women who take Zoloft in the first three months of their pregnancy were nearly 3 times more likely to have a baby with defects such as omphalocele or the gastroschisis. The SSRI has also been associated with PPHN and heart defects when taken during pregnancy. Manufacturer Pfizer, like other SSRI drug makers, maintains that its antidepressant Zoloft does not cause birth defects.

Despite assertions by manufacturers that SSRIs are safe when used for their intended purpose, hundreds of families have initiated litigation, arguing the antidepressants caused fetal harm, including the following types of birth defects:

  • Cleft lip or cleft palate
  • Brain and skull defects
  • PPHN
  • Neural tube defects
  • Respiratory distress
  • Septal heart defects
  • Anencephaly

SSRI litigation and settlements

Lawsuits involving SSRI side effects and injuries have been filed against the makers of Prozac, Zoloft and Paxil, based on allegations of design defect, failure to warn, breach of implied warranty and negligence, among other causes of action. While some claims are still pending in the federal court system, others have already been settled.

In 2003, Prozac manufacturer Eli Lilly settled a case brought by the parents of a South Carolina teen who hanged himself just three weeks after he began taking the antidepressant.

GlaxoSmithKline ultimately agreed to resolve more than 800 lawsuits regarding Paxil-related birth defects in 2010 after being ordered to pay a $2.5 million verdict in 2009. Each plaintiff secured roughly $1.2 million in the staggering $1.14 billion accord.

The London-based manufacturer also settled Paxil cases involving suicide and attempted suicide to the tune of $390 million.

Hundreds of federal Zoloft lawsuits have been coordinated before Judge Cynthia M. Rufe in Pennsylvania district court under multidistrict litigation. Pfizer has been cleared of liability of failing to warn about birth defect risks in the first two trials, though these outcomes are not binding on other plaintiffs.

Legal options for families

As SSRI litigation continues to unfold on a national scale, The Sanders Firm is currently reviewing cases in all 50 states. If you or a family member has suffered adverse effects from Paxil, Zoloft or Prozac, we encourage you to explore your rights to legal compensation. Our attorneys work on a contingency-fee basis and are currently offering free case reviews. Call 1-800-FAIR-PLAY.


  1. FDA, FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies http://www.fda.gov/Drugs/DrugSafety/ucm283375.htm

  2. FDA, FDA Public Health Advisory: Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/018936orig1s093.pdf

  3. British Medical Journal, Selective Serotonin Reuptake Inhibitors in Pregnancy and Congenital Malformations: Population Based Cohort Study http://www.bmj.com/content/339/bmj.b3569

  4. Web MD, Paxil: Stronger Birth Defects Warning http://www.webmd.com/news/20051208/paxil-stronger-birth-defects-warning

  5. US District Court, Eastern District of Pennsylvania, In Re: Zoloft (Sertraline Hydrochloride) Products Liability Litigation http://www.paed.uscourts.gov/documents2/mdl/mdl2342

  6. PBM, Glaxo Said to Have Paid $1 Billion in Paxil Suits http://pbmattorneys.com/blog/2009/12/glaxo-said-paid-1-billion-paxil-suits/