Zoloft Birth Defect Lawsuit - Consumer Justice Foundation

Zoloft Birth Defect Lawsuit

Written by Faith Anderson on June 11, 2015
Zoloft Lawsuit

Internal Memos Suggest Pfizer Knew About Birth Defect Risk from Zoloft

According to new documents presented at trial this week, Zoloft maker, Pfizer, may have known for years about the potential for the popular antidepressant drug to cause birth defects in babies exposed to the medication in utero. A Philadelphia jury is currently hearing evidence in a Zoloft birth defect case brought by the family of eight-year-old Mia Robinson, who was born with a “hole in the heart” malformation and other cardiac birth defects allegedly caused by her mother’s use of Zoloft during pregnancy. The lawsuit involves allegations that the drug company failed to provide consumers and the medical community with adequate warnings about the alleged link between Zoloft and devastating birth defects in exposed babies.

Potential Risk of Birth Defects from Zoloft

Zoloft (sertraline) is one of the best-selling medications in the United States, used by tens of millions of people struggling with major depression, social anxiety disorder, panic disorder, post-traumatic stress disorder and obsessive-compulsive disorder. Zoloft was approved by the U.S. Food and Drug Administration (FDA) in 1991, and belongs to a class of antidepressants known as SSRIs (selective serotonin reuptake inhibitors), which function by restoring the balance of serotonin in the brain. However, a growing number of studies have identified a risk of severe birth defects allegedly associated with Zoloft use in pregnancy, and former Zoloft users across the country are now pursuing birth defect claims against Pfizer as a result.

This latest Zoloft birth defect lawsuit comes on the heels of a week-long trial in Missouri state court, which resulted in a defense verdict in favor of Pfizer. However, that case, which was the first product liability lawsuit to go to trial over Zoloft birth defect claims, was missing several key documents that were brought to light in the recent case filed by the Robinson family. According to evidence presented to the jury in the Robinson’s lawsuit, internal Pfizer memos suggest that the company’s own scientists have believed for years that Zoloft may pose a serious risk of birth defects for unborn babies exposed to the medication during pregnancy.

Zoloft Birth Defect Warnings

In an April 2014 review by Francesca Kolitsopoulous, associate director of Pfizer’s Worldwide Safety Strategy department’s epidemiology group, executives at the drug company were warned that studies revealed a link between Zoloft use in pregnancy and heart birth defects, like atrial septal defects and ventricular septal defects. The review suggested that the Pfizer drug label should be modified to include information about the potential Zoloft birth defect risk. Prior to Kolitsopoulous’ report, Pfizer reviewers warned the drug maker in an October 1998 report, about the potential for Zoloft use during pregnancy to cause birth defects in unborn babies.

Despite these early indications that Zoloft may pose serious risks to an unborn baby, it wasn’t until November 2006, that the FDA warned consumers about the potential risk of persistent pulmonary hypertension of the newborn (PPHN) from Zoloft and other SSRI antidepressants drugs, when taken after the 20th week of pregnancy. In studies published in the years since, researchers have identified a potential link between Zoloft use in pregnancy and congenital malformations like brain defects, abnormal skull development, gastrointestinal abnormalities and heart defects. In light of these risks, the FDA has classified Zoloft as a pregnancy Category C medication, which means the drug may cause harm to a human fetus when taken by pregnant women.

Lawsuits Filed Over Alleged Zoloft Birth Defects

Pfizer currently faces several hundred Zoloft lawsuits filed on behalf of families whose children were born with congenital malformations after being exposed to the SSRI antidepressant drug during pregnancy. According to allegations raised in the Zoloft birth defect lawsuits, Pfizer knew or should have known about the potential pregnancy risks associated with Zoloft, and failed to notify the public about these risks. Pfizer also faces dozens of Zoloft lawsuits filed in the federal court system, which have been consolidated for coordinated pretrial proceedings before U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania, as part of a multidistrict litigation (MDL).

In this latest Zoloft lawsuit, Mia Robinson’s family is seeking $2.4 million in damages against the drug manufacturing company, over the eight-year-old child’s septal heart defect and other cardiac malformations, allegedly caused by her exposure to Zoloft in utero. While verdicts reached in early Zoloft trials are not binding on other birth defect lawsuits, they may have an impact on any eventual settlement negotiations between Pfizer and plaintiffs in future cases. Following a series of bellwether trials in the Zoloft MDL, if Pfizer fails to reach settlement agreements or otherwise resolve the birth defect litigation, the drug company could face hundreds of individual Zoloft lawsuits in U.S. District Courts across the country.

Contact an Experienced Zoloft Attorney Today

As Zoloft birth defect studies continue to examine the pregnancy risks allegedly associated with the popular antidepressant drug, families across the country are pursuing birth defect claims on behalf of their children exposed to Zoloft in utero. If you took Zoloft while pregnant, and your child was born with a heart birth defect, PPHN, or another potentially life-threatening congenital malformation, contact an experienced Zoloft attorney today to discuss your options for legal recourse. With a qualified Zoloft lawyer on your side, you can ensure that your legal rights are protected, and pursue the financial compensation you deserve for your child’s injuries, medical expenses, and pain and suffering.

Sources:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124348.htm

http://bmjopen.bmj.com/content/2/3/e001148.full

Posted Under: Birth Defects, Dangerous Drugs, Drugs During Pregnancy, Legal, News, Zoloft
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