A number of Zoloft lawsuits were recently dismissed by a Philadelphia judge presiding over a multi-district litigation alleging that Pfizer, the maker of the antidepressant, was negligent in the birth defects of children born to women who took it during pregnancy. That doesn’t mean that parents and the children affected are ready to give up the fight. They have to live with the ongoing cost of birth defects and may continue to use legal action to get justice from Pfizer.
Zoloft is an antidepressant that has been on the market since 1991 and which has been popular as it was promoted by Pfizer as a safe and effective medication. Not everyone agrees with this and some say that the drug maker was misleading about claims. In addition to the possibility of birth defects, Zoloft is also known to increase the risk of suicidal thoughts in young people. Both of these complications have led to devastating consequences for many people.
Zoloft for Depression and Anxiety
Pfizer developed the generic drug sertraline, which was first created in a laboratory in the 1970s, and eventually tested it for treating depression and gave it the brand name Zoloft. The U.S. Food and Drug Administration (FDA) did not grant approval to Zoloft as an antidepressant until 1991. At this point, Pfizer began heavily marketing its new drug and eventually made billions with it.
The FDA eventually approved Zoloft for treatment in children between six and 18. This indication, however, was limited to those children suffering from obsessive compulsive disorder, a specific anxiety disorder. For adults Zoloft may be used to treat major depression and a range of anxiety disorders including obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, and social anxiety disorder. Doctors may also prescribe Zoloft to treat premenstrual dysphoric disorder.
Zoloft is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). SSRIs treat anxiety and depression by increasing the amount of serotonin in the brain. Serotonin is a brain messaging chemical that is thought to be involved in various mood disorders like depression.
The Risk of Suicide and Lawsuits
One of the most serious risks associated with Zoloft and other SSRIs is that it increases the likelihood of experiencing suicidal thoughts in young people, especially those under 18. This is why the drug is not approved for use in kids and teens, with the exception of treating obsessive compulsive disorder. It doesn’t happen with every young person who takes the drug, but in those who do experience these thoughts, the risks of attempted suicide are serious.
Numerous individuals and families have filed Zoloft lawsuits and lawsuits against other antidepressants over the risk of suicide. The loved ones of those who committed suicide and died believe that Pfizer did not warn them enough of the risk. Some makers of antidepressants have even been accused of promoting their drugs for the off-label use in children, knowing that there is this life-threatening risk.
Most of the lawsuits over suicide were filed in the 1990s and early 2000s. The FDA did not require that Zoloft carry a black box warning about suicide until 2007. Before that happened, many families claim that there was no adequate warning of the risk of letting a child or teen take the drug. Once the warning went into place the number of lawsuits dropped.
Zoloft and Birth Defects
What spurred even more lawsuits against Zoloft and Pfizer is the possibility that the drug can increase the risk of birth defects in the children born to women who took it while pregnant. Many women experience depression during pregnancy and find relief in treatment. They have to weigh the risks of using an antidepressant with the benefits of treatment, but many believe that they did not have all the facts when they made the decision.
The evidence for the possibility of Zoloft triggering birth defects comes both from adverse events reports and studies. Among the many adverse events reported to the FDA are mothers who took Zoloft while pregnant and gave birth to children with heart defects, gastrointestinal defects, and a dangerous condition called persistent pulmonary hypertension of the newborn.
Some studies have also found a connection between using Zoloft while pregnant to autism spectrum disorders. The risk that a child will be diagnosed, according to this study, is increased as much as 200 percent in those whose mothers used Zoloft or other SSRI antidepressants, especially in the second and third trimesters.
Birth Defect MDL
Hundreds of lawsuits against Pfizer and Zoloft for birth defects were consolidated into a multidistrict litigation (MDL) in Pennsylvania. These were mostly filed by the mothers and fathers of children who were born with defects that include spina bifida, club foot, heart defects, skull defects, gastrointestinal defects, and many other types of birth defects.
The plaintiffs in the MDL believe that Zoloft caused the defects and that Pfizer is negligent. They claim that the drug maker did not do enough to test the safety of the drug in pregnant women and that the company failed to warn them of the potential risk. They started lawsuits to seek compensation. Treating birth defects can be both expensive and emotionally devastating. These parents and their children face years of treatments and consequences of birth defects.
Unfortunately for the plaintiffs in this particular MDL, the judge presiding over the consolidated cases ultimately decided in favor of Pfizer. The federal judge assigned to the MDL dismissed the hundreds of lawsuits without even taking most of them to trial. The judge stated that the plaintiffs did not bring adequate evidence that Zoloft contributed to their children’s birth defects, although she did recognize that in the future more evidence may come to light proving that they were correct.
If you suffered because of using Zoloft, or you were born with defects because of Zoloft, hope is not lost for getting justice or compensation. As studies continue into the safety of antidepressants during pregnancy, there is a good chance that enough evidence will be found to implicate Zoloft and Pfizer and to help people like you win compensation.
Sources
- http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108905.htm
- http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm116470.htm
- http://www.mayoclinic.org/diseases-conditions/serotonin-syndrome/basics/definition/con-20028946
- http://www.bmj.com/content/351/bmj.h3190
- http://archpedi.jamanetwork.com/article.aspx?articleid=2476187
- http://www.medscape.com/viewarticle/861734#vp_1